[Federal Register Volume 59, Number 19 (Friday, January 28, 1994)]
[Unknown Section]
[Page ]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-1592]
[Federal Register: January 28, 1994]
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Part II
Department of Health and Human Services
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Food and Drug Administration
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21 CFR Parts 123 and 1240
Proposal To Establish Procedures for the Safe Processing and Importing
of Fish and Fishery Products; Proposed Rule
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 123 and 1240
[Docket Nos. 90N-0199 and 93N-0195]
Proposal To Establish Procedures for the Safe Processing and
Importing of Fish and Fishery Products
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule.
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SUMMARY: The Food and Drug Administration (FDA) is proposing to adopt
regulations to ensure the safe processing and importing of fish and
fishery products (hereinafter referred to as seafood). These procedures
include the monitoring of selected processes in accordance with Hazard
Analysis Critical Control Point (HACCP) principles. HACCP is a
preventive system of hazard control that can be used by food processors
and importers. FDA is proposing these regulations because a system of
preventive controls is the most effective and efficient way to ensure
that these products are safe.
DATES: Written comments by March 29, 1994. The agency is proposing that
any final rule that may be issued based upon this proposal become
effective 1 year following its publication.
ADDRESSES: Written comments, data, or information to the Dockets
Management Branch (HFA-305), Food and Drug Administration, rm. 1-23,
12420 Parklawn Dr., Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: Philip Spiller, Center for Food Safety
and Applied Nutrition (HFS-401), Food and Drug Administration, 200 C
St. SW., Washington, DC 20204, 202-254-3885.
For further information concerning the guidance entitled ``Fish and
Fishery Products Hazards and Controls Guide,'' contact: Donald W.
Kraemer (address above).
For further information concerning the economic impact analysis
contained in this proposal, contact: Richard A. Williams, Jr., Center
for Food Safety and Applied Nutrition (HFS-726), Food and Drug
Administration, 200 C St. SW., Washington, DC 20204, 202-205-5271.
SUPPLEMENTARY INFORMATION:
I. Overview
The purpose of these proposed regulations is to establish mandatory
preventive controls to ensure the safety of seafood products sold
commercially in the United States and exported abroad. These preventive
controls will be based on a system known as HACCP. HACCP is a system by
which food processors and importers can evaluate the kinds of hazards
that could affect their products, institute controls necessary to keep
these hazards from occurring, monitor the performance of these
controls, and maintain records of this monitoring as a matter of
routine practice.
FDA is proposing to require that domestic and foreign processors
and importers adopt HACCP controls to prevent the occurrence of hazards
that could affect the safety of these seafood products for consumers.
If these regulations are adopted, FDA will review the adequacy of HACCP
controls as part of its program of mandatory inspections and import
examinations. Such a review will occur in addition to traditional
inspection activities. FDA is also encouraging, but not proposing to
require, that processors and importers adopt the same types of controls
for nonsafety hazards relating to economic adulteration and quality.
FDA is proposing to make HACCP mandatory for the seafood industry
for the following reasons:
1. Adoption of HACCP controls by the seafood industry, coupled with
inspections by FDA based on the HACCP system, will produce a more
effective and more efficient system for ensuring the safety of seafood
products than currently exists. The current inspection system places
too great a burden on Government inspectors to uncover problems and to
take regulatory action to address those problems. HACCP places primary
responsibility upon the industry to demonstrate that hazards are
understood and are being prevented.
2. A nationally mandated HACCP system will provide a basis for
enhanced consumer confidence in the safety of seafood products.
Consumers should not be afraid to eat foods, such as seafood, that are
recommended as useful lower fat and lower saturated fat substitutes for
higher fat meats (Ref. 1, p. 13; Ref. 2, p. 21).
3. The know-how for applying HACCP to seafood is in an advanced
state of development. A considerable amount of work on applying HACCP
to seafood has already been done by some States, academia, and the
Federal Government as well as through cooperative activities between
the Federal Government and industry and through independent industry
efforts.
4. Seafood industry representatives have urged the Federal
Government to institute a mandatory, HACCP-type inspection system for
their products.
5. A nationally mandated HACCP-type system of controls appears to
be a prerequisite for continued access to world markets.
II. Safety
A. Background
Ensuring the safety of seafood presents special challenges to both
the industry that produces it and to Government agencies charged with
protecting the public health. Seafood is unique in many respects. While
often thought of as homogeneous in nature, seafood is actually a
variety of products encompassing literally hundreds of species that
have little in common other than an aquatic origin. Collectively,
seafoods have perhaps the most diverse and complex microbiology of any
food commodity (Ref. 3, p. xi).
The range of habitats for edible species is also extraordinary and
diverse ranging from cold to warm water, bottom dwelling to surface
feeding, deep sea to near shore, and fresh water to saltwater. Fish are
exposed to the bacteria and viruses that naturally occur in their
environment as well as to those that enter the water through pollution.
Chemicals, some of which are toxic to humans, can accumulate in fish as
well. Fish can also accumulate natural toxins and parasites that are
specific to marine animals. As a consequence, fish are subject to a
wide range of hazards before harvest.
B. The Safety Data
The question of how safe is the seafood in the marketplace has been
the subject of public debate in recent years. This debate has occurred
partly because precise data on the numbers and causes of foodborne
illnesses in the United States do not exist. Foodborne illnesses tend
to be significantly underreported to public health authorities. Data on
foodborne illnesses that are meaningful from an epidemiological
standpoint are difficult and expensive to develop.
The Centers for Disease Control and Prevention (CDCP) of the U.S.
Public Health Service (PHS) compiles data in its Foodborne Disease
Surveillance System that are reported from State and local health
authorities. All foodborne illnesses are underreported to this system
(Ref. 4).
Nonetheless, CDCP data are the best available and can at least be
used to identify trends and emerging concerns about various diseases
(Ref. 5, p. 219). The data suggest that most seafood-related illnesses
result from certain natural toxins in finfish and from viruses in
molluscan shellfish consumed raw or partially cooked (Ref. 4). The wide
range of other hazards that can affect seafood undoubtedly result in
illnesses, but the available data indicate that such illnesses are not
as common. Thus, according to the CDCP data, the actual occurrence of
problems tends to be limited relative to the range of hazards that
could cause problems and tends to be associated with a minority of
commercially available species.
In the CDCP system, seafood accounted for 4.8 percent of reported
cases of foodborne illness for the period 1973 to 1987 (Ref. 4).
However, as CDCP has pointed out, variations in rates of underreporting
among different foods and varying etiologies make it impossible to
compare safety among different foods based solely on CDCP data (Ref.
4). This is certainly true for seafood. Some seafood-related illnesses
tend to be overreported to CDCP's system relative to other foodborne
diseases, due largely to their distinctive characteristics, while
others are probably underreported relative to other causes because they
are less distinctive and more difficult to diagnose (Ref. 4).
FDA has attempted to determine the relative safety of seafood
through risk assessment. The results of this effort indicate that the
risk of illness associated with molluscan shellfish consumed raw or
partially cooked is greater than for any cooked flesh food. However,
seafood overall is as safe or safer than other flesh foods in terms of
frequency of illness (Refs. 5, p. 25; and 6).
The conclusions of the National Academy of Sciences' (NAS)
Institute of Medicine, in its 1991 report entitled ``Seafood Safety,''
are consistent with the CDCP data and the FDA risk assessment.
According to NAS, ``Most seafoods available to the U.S. public are
wholesome and unlikely to cause illness in the consumer'' (Ref. 7, p.
1). Moreover, in reviewing the CDCP data, the report noted that the 23
percent increase in seafood consumption in the United States in the 10-
year period ending 1989 was not accompanied by a concomitant increase
in reported seafood-borne illnesses (Ref. 7, p. 27). Nevertheless, as
NAS pointed out, ``there are areas of risk'' (Ref. 7, p. 1). The report
addressed at some length virtually every possible risk that could
affect seafood and made numerous recommendations relating to existing
and proposed control measures. NAS recommended that improvements be
made in the present system of regulatory control (Ref. 7, p. 1) and
repeatedly recommended HACCP controls wherever appropriate.
``Inspection and testing should focus on actual problems (as in HACCP
systems),'' NAS concluded (Ref. 7, p. 16).
C. The Principal Hazards
The most notable seafood-related hazards involve the following:
1. Bacteria
Because bacteria either naturally live in, or can survive in,
aquatic habitats, there are a large number of pathogenic bacteria that
can be found in seafood, particularly molluscan shellfish. Many of
these bacteria are far more harmful to specific human subpopulations,
such as the elderly, immunocompromised, or persons with specific
underlying diseases, than to the population as a whole. The size of
these subpopulations is increasing, however. Therefore, concerns about
bacterial contamination of seafood, particularly molluscan shellfish,
are increasing.
In the United States, 4.4 percent of botulism outbreaks have been
attributed to seafood. The predominant type of botulism organism in
aquatic environments is the kind most readily destroyed by heat. Thus,
many types of processing, if done properly, can negate the risk of
botulism from seafood. Nonetheless, with the trend toward greater use
of modified atmosphere and vacuum packaging (i.e., packaging that
excludes oxygen) to enhance the shelf life and the desirability of
refrigerated foods, traditional controls need to be enhanced because
Clostridium botulinum can grow in the absence of oxygen.
Other bacteria of concern include Listeria monocytogenes, a
hazardous foodborne microorganism that is ubiquitous in nature and is
commonly found in food processing environments; Salmonella, which is
not a marine organism but can contaminate seafood through improper
handling and sanitation practices; and Staphylococcus aureus, another
pathogen associated with sanitation and handling (Ref. 8, pp. 14 and
15).
2. Viruses
Several viruses that are infectious to humans enter aquatic
habitats through sewage. These viruses can concentrate in shellfish and
be present and infective even when bacterial indicators of fecal
pollution are absent. Viruses probably cause the bulk of seafood-
associated disease, particularly the Norwalk and Norwalk-like agents,
which are linked to the consumption of contaminated raw or undercooked
molluscan shellfish (Ref. 7, p. 30).
3. Natural Toxins
Problems associated with naturally occurring toxins in fish have
been recognized for centuries. Ciguatera poisoning is perhaps the most
significant problem associated with a natural toxin. The toxin is
produced by microscopic organisms and can be transmitted to humans
through the consumption of finfish that have eaten these organisms
through the food chain (Ref. 7, p. 89). The larger, more predacious
fish (groupers, snappers, barracuda, amberjack) and reef fish belonging
to the crevally or ulua (Carangidae) family are generally more likely
to contain ciguatoxin than other types of fish (Ref. 7, p. 89). Because
the toxin is heat stable, cooking does not make the fish safe to eat
(Ref. 9, p. 1).
On average, 70 cases of ciguatera poisoning are reported annually
in the United States and its possessions and territories (Ref. 7, p.
89). Deaths are rare, and the acute symptoms of the disease are usually
of short duration; however, neurological symptoms can persist for
extended periods. Ciguatera is geographically localized, with the
majority of illnesses reported from tropical or subtropical areas.
Other toxins of public health concern include domoic acid, which
was detected in seafood from the U.S. Pacific coast for the first time
in the fall and winter of 1991-1992 (Ref. 10, p. 1,113); and saxitoxin,
or paralytic shellfish poison, which has periodically made molluscan
bivalves toxic and has recently affected Pacific Northwest crab
harvests (Ref. 11).
4. Parasites
Parasites, such as anasakid nematodes (round worms), naturally
infect certain fish and ocean mammals (Ref. 12, p. 724). Human
parasitic infections almost always occur from the consumption of raw
(sushi, sashimi) or undercooked fish. Historically, probably no more
than five cases are reported on average in the United States each year
and the likelihood of occurrence is estimated to be very low (Ref. 5,
p. 25). Problems with parasites are avoidable through commercial
freezing of the raw fish before consumption.
5. Chemical Contaminants
The presence of toxic chemicals in the aquatic environment creates
the potential for contamination of seafood products. These chemicals
include pesticides; other industrial chemicals, such as polychlorinated
biphenyls; heavy metals, such as lead, cadmium, and mercury; and
petroleum hydrocarbons.
Marine species, especially deep sea varieties, comprise the
majority of seafood consumed in this country. This seafood has little
potential to contain most chemical contaminants at levels of
toxicological concern (Ref. 13, p. 6). However, there are some
contaminants that can be present at significant levels, methylmercury
in certain species being perhaps the most notable. Fresh water species,
especially nonmigratory bottom feeders, are generally the most exposed
to a variety of chemical contaminants (Ref. 13, p. 6).
6. Decomposition
Finfish are generally regarded as being much more perishable than
terrestrial flesh foods (Ref. 14, p. 3). Decomposition is a problem
with seafood products frequently encountered by FDA and is the subject
of the majority of regulatory actions taken by the agency against
violative seafood products (Ref. 15). It is largely an economic and
aesthetic problem; however, in some species it can lead to illness
because of the formation of scombrotoxin (histamine) during
decomposition. Scombroid poisoning is completely preventable by proper
handling, i.e., by proper time and temperature controls.
D. Additional Factors Affecting Safety
Unlike beef and poultry, seafood is still predominately a wild-
caught flesh food that frequently must be harvested under difficult
conditions and at varying distances from processing, transport, and
retail facilities. There are nearly 100,000 vessels in the U.S. fishing
fleet alone (Ref. 7, p. 22). These conditions, distances, and duration
of fishing trips, can tax any system of controls designed to ensure
safety and prevent spoilage.
In addition, several hundred vessels are seagoing processing
factories, many of which operate in remote waters. For regulators,
these ships that process at sea can be difficult and expensive to reach
while they are operating, and individual inspectors face hazards such
as ship-to-ship transfers on the high seas.
There may be as many as 350 commercially marketed species (Refs.
16; and 19, p. 35). Consumer preferences for one species over another
and significant price differences between species can lead to economic
fraud through the substitution of cheaper species for more expensive
ones.
Unlike beef and poultry, seafood is subject to significant
recreational harvest. Beyond the 15 pounds of seafood consumed per
capita from commercial channels, an additional 4 pounds may be consumed
from recreational sources. Some recreational catch finds its way into
commercial channels as well.
Thus, recreational fishing can have a bearing on the safety of
commercial seafood. Commercial fishermen avoid or are prohibited from
harvesting from polluted areas, but recreational fishermen, especially
recreational harvesters of molluscan shellfish, might not be as aware
of, or might ignore, local advisories or water closures. Processors
need to be aware of and control the source of their raw materials, and
importers must ensure that their shipments are obtained from acceptable
sources.
An additional complicating factor in ensuring the safety of seafood
is the fact that no other flesh food is imported in the quantity, or
from as many countries, as seafood. Imports include finished products
as well as products to be further processed domestically. Over 55
percent of seafood consumed in this country is imported. It comes from
approximately 135 countries. Several of these countries have advance
regulatory structures for seafood safety, but many others are
developing nations that lack structures for seafood regulation
comparable to those in more developed nations (Ref. 35, pp. 113 and
114).
Therefore, it is of utmost importance, that those who handle and
process seafood commercially, including importers, understand the
hazards associated with this type of food, know which hazards are
associated with the types of products with which they are involved, and
keep these hazards from occurring through a routine system of
preventive controls. The seafood industry, indeed, the food industry as
a whole, must be primarily responsible for the safety and quality of
the food that it produces. The regulator's primary role should be to
verify that the industry is meeting this responsibility and to take
remedial action when it is not. The alternative of relying solely on
Government inspectors to identify problems and provide solutions would
involve enormous costs to the public and would be extremely
inefficient, assuming it could be done at all.
For the most part, seafood processors and importers are not
required, through licensure or examination, to understand seafood
hazards as a prerequisite to being able to do business. (There are
exceptions. A few States, such as Alaska, do require processors to
conform to HACCP as a condition of doing business (Ref. 17).) While
many processors and importers have such an understanding, this
knowledge is not universal. It is not unusual for FDA to receive
inquiries about safety requirements and related matters from those who
wish to process or import seafood, or who already do, that indicate a
lack of awareness of hazards specific to their products. Most of the
industry does not have HACCP-trained personnel, and many firms lack
dedicated quality assurance personnel (Ref. 18, p. 35).
Seafood processing in the United States is done by several thousand
businesses, many of which are small, old, and family operated (Ref. 19,
p. 35). This situation is in contrast to the beef and poultry
industries, in which market share is concentrated among a small number
of large processors. Seafood firms tend to be small, fragmented
operations sized in reference to anticipated benefits, because of the
significant, uncontrollable risks involved in this business (Ref. 5, p.
225). Also, because many harvests are seasonal, many of their
operations are intermittent (Ref. 20). The seasonal nature of the
industry can affect worker skills and practices relating to safety,
while older facilities and equipment can be more difficult to maintain
in terms of adequate sanitation and proper processing and storage
temperatures (Ref. 20).
III. The Need for Regulations
A. The Current Inspection System Is Not Well-Suited to Seafood
Seafood processors are subject to periodic, unannounced, mandatory
inspection by FDA. Seafood processors and importers are also able to
purchase inspection services from the National Marine Fisheries Service
(NMFS) of the U.S. Department of Commerce. These inspection services
have been primarily trade-related, such as grading.
Until recently, FDA's overall regulatory program for seafood
received slightly over $20 million per year. Because much of the
program involves activities such as research, laboratory analyses, and
technical assistance and training to States, a substantial portion of
it has tended to be invisible to the general public. Public interest
and debate tends to focus on the more visible aspects of regulation,
primarily inspection. The congressional debate of the past several
years over the adequacy of the Federal regulatory program for seafood
has been framed, more often than not, in terms of the need for
mandatory inspection. Traditionally, FDA inspected the equivalent of a
quarter of its total domestic inventory of seafood establishments per
year.
Since 1990, however, FDA has received significant funding increases
for seafood. The current budget of slightly over $40 million has
permitted the agency to increase the frequency of its inspections. It
now inspects so-called high risk processors at least once per year and
all others at least biennially. (Because States also inspect
processors, the collective frequency is actually higher.)
Even so, because of seafood's unique characteristics (e.g., the
fact that it is predominantly wild caught and presents a wide range of
possible hazards), it is questionable whether the current regulatory
system, which was developed for the general food supply, is best suited
for the seafood industry. The current system provides the agency with a
``snapshot'' of conditions at a facility at the moment of the
inspection. However, assumptions must be made about conditions before
and after that inspection on the basis of the ``snapshot,'' as well as
about important factors beyond the facility that have a bearing on the
safety of the finished product. The reliability of these assumptions
over the intervals between inspections creates questions about the
adequacy of the system, particularly, as the congressional hearings on
the subject over the past several years have shown, for seafood.
FDA's inspections are based upon the regulations on current good
manufacturing practice in manufacturing, packing, or holding human food
at part 110 (21 CFR part 110). For the most part, these guidelines
consist of broad statements of general applicability to all food
processing on sanitation, facilities, equipment and utensils,
processes, and controls. HACCP-type controls are listed as one of
several options available to prevent food contamination
(Sec. 110.80(b)(13)(i)) but they are otherwise not integral to the
guidelines.
Current Federal inspection and surveillance strategies verify the
industry's knowledge of hazards and preventive control measures largely
by inference, i.e., whether a company's products are in fact
adulterated, or whether conditions in a plant are consistent with
current good manufacturing practice (CGMP). Consequently, the current
system places the burden on the Government to prove that a problem
exists rather than on the firm to establish for itself, for the
regulator, and for consumers, that adequate controls exist to ensure
safety. The current approach is inefficient and, unless Government
inspections are conducted with some frequency, can lead to conditions
that can elevate risk and erode public confidence. It also has the
potential to cause some inequities. While the same standards of
adulteration apply to all products in interstate commerce, processors
and importers who use a system of preventive controls coupled with
adequate monitoring must compete against those who do not.
A survey conducted by FDA in 1992-1993 of manufacturers of ready-
to-eat seafood products revealed conditions that strongly suggest the
need for a system that emphasizes preventive controls to ensure that
products are safe by design. Ready-to-eat products require special care
in processing because they do not require, and are unlikely to receive,
any further cooking by consumers that would destroy pathogenic
microorganisms. The survey focused on whether preventive controls exist
rather than on the results of expensive end-product sampling. The
agency found that, in significant measure, firms have not been
employing the types of preventive processing steps necessary to ensure
a safe and wholesome product. Some of the preliminary results are as
follows (Ref. 21).
1. Fifty-four percent of the firms that pasteurized products had
not established the adequacy of their pasteurization process to destroy
pathogenic microorganisms such as the spores of C. botulinum, type E,
which can cause significant illness and death in humans. The
pasteurization process is not simple and must be done with precision in
order to consistently deliver a thermal process that will inactivate
the spores of C. botulinum, type E and prevent recontamination of the
product after it has been heat treated. The CGMP at part 110 state that
pasteurization must be adequate. Realistically, the only way for FDA to
determine, or at least infer, the adequacy of the process now is to
analyze samples of finished product for the presence of pathogens.
2. Twenty-seven percent of the firms that pasteurized products did
not have temperature-indicating devices on their pasteurizers, and 35
percent did not have temperature-recording devices. Temperature
monitoring is essential to ensure that a thermal process is properly
controlled. Part 110 addresses temperature indicating and recording
devices only for refrigeration, while pasteurization involves cooking.
A temperature-recording device is important for purposes of preventive
control because it provides a continuous history of the cooking step.
3. Forty-two percent of firms that pasteurized products did not
perform can seam evaluations or performed them less frequently than
every 12 hours. Such evaluations are necessary to ensure that there
will not be microbiological contamination of the finished pasteurized
product. FDA's regulations for the processing of low acid canned food
(parts 108 and 113 (21 CFR parts 108 and 113)) require such evaluations
every 4 hours as an HACCP-type control, but products that need
refrigeration (e.g., pasteurized products) are outside the scope of
those regulations. Again, part 110 states only that the pasteurization
process should be adequate. FDA must conduct end-product sampling and
analysis to determine, or at least infer, whether a pasteurization
process is adequate.
4. Forty-three percent of firms that pasteurized products did not
perform cooling water sanitizer strength checks to ensure that the
pasteurized product would not be contaminated during this process. The
presence of a sanitizer in the cooling water is important to prevent
contamination of the product after pasteurization because during
cooling, some water can be drawn into hot cans. Part 110 does not
specifically mention a cooling water sanitizer. The ``adequate''
provision cited above is the closest relevant provision, and FDA must
conduct end-product sampling and analysis to determine, or at least
infer, whether a pasteurization process is adequate.
5. Eighty-four percent of the firms did not monitor the internal
temperature of products during the various stages of processing. Such
monitoring is important because time/temperature abuse can result in
the growth of pathogenic microorganisms, decomposition, and, in some
cases, the formation of histamine. Part 110 states that all reasonable
precautions should be taken to prevent contamination and recommends
temperature control as one type of precaution. Again, end-product
sampling is the only practical way for FDA to measure compliance.
6. Fourteen percent of the firms did not have temperature-
indicating devices on their finished product coolers, and 89 percent
did not have temperature-recording devices. Part 110 states that
processors should have one or the other but does not specifically
require that processors monitor either one. While 14 percent were out
of compliance, most who were in compliance opted for the control that
did not provide a continuous record.
7. Thirty-one percent of the temperature-indicating devices on
finished product coolers were more than 5 deg.F out of adjustment.
Fifty-five percent of these were giving readings that were too low. For
these, the deviation would permit the growth of pathogenic
microorganisms, decomposition, and histamine formation. Part 110
specifically states that thermometers should be accurate. Five degree
deviations are clearly out of compliance. A significant percentage of
firms surveyed were not paying attention to a significant preventive
control.
8. Twenty-three percent of temperature-indicating devices on
pasteurizers and 80 percent of such devices on finished product coolers
were never calibrated. Again, part 110 calls for accuracy. The failure
to calibrate means that these firms have no assurance that their
devices are accurate. A preventive control is not being applied, and
thus a significant percentage of processors are apparently relying on
Government investigators to determine accuracy during inspections.
Also, this deficiency may account in part for the deviations described
in section III.A.7. of this document.
9. Twenty-nine percent of temperature-recording devices on finished
product coolers were never checked for accuracy, while 34 percent of
such devices on pasteurizers and 74 percent on finished product coolers
were checked less frequently than once a month. Temperature-recording
devices are easily jarred out of calibration and must be routinely
adjusted to agree with an accurate temperature-indicating device. Thus,
they need to be checked for accuracy at least at the start and the end
of each processing day in order to determine whether they remained
accurate throughout the day's production.
10. Forty-eight percent of the firms cleaned and sanitized the
processing equipment less frequently than every 4 hours, while 13
percent cleaned and sanitized less than every 12 hours. Part 110 states
that sanitation practices should occur as frequently as necessary. In
order to control salmonella and other undesirable bacteria within a
facility, the frequency should be at least every 4 hours, and more
frequently if feasible. This frequency helps reduce the likelihood that
these microorganisms will enter a rapid phase of growth during which
their numbers increase logarithmically (Ref. 22, p. 114; Ref. 23, p.
2).
11. Twenty-two percent of the firms did not perform plant or
equipment sanitation audits (i.e., inspections), and 35 percent did not
check the strength of hand or equipment sanitizing solutions. These
results reveal that a significant number of plants are not checking up
on themselves to ensure that they were doing an adequate job of
sanitation. In such plants, the only check on sanitation is provided by
the Government investigators who visit the plant.
Other survey and inspection findings by FDA and others strongly
indicate that the seafood industry does not always operate on the basis
of preventive controls. For example, recent FDA and State surveys
showed that many processors of smoked and smoke-flavored fish are
operating outside of the parameters that have been demonstrated through
scientific research to be necessary to ensure that the hazard from
botulism is adequately controlled. These parameters are process times
and temperatures and salinity levels. A number of firms surveyed did
not even know their own operating parameters, let alone the
scientifically established ones (Refs. 24, 25, and 26). For seafood
products such as these that require no cooking by the consumer,
preventive measures by the processor to eliminate C. botulinum, type E
to the maximum extent possible are critically important.
B. Alternatives Other Than HACCP
Continuous visual inspection of seafood is not a viable
alternative. Few hazards associated with seafood are detectable through
visual inspection. Moreover, the costs of such a system would likely
exceed the nearly half-billion-dollar public outlay now required to
operate this kind of system for meat and poultry.
Another alternative would be to direct significant additional
resources toward greatly increasing the frequency of FDA's inspection
of seafood, as well as increasing the agency's sampling, laboratory
analysis, and related regulatory activities with respect to seafood.
While thousands of samples of domestic and imported seafood products
are collected each year for analysis in FDA laboratories, and these
samples are scientifically designed to represent a broad range of
products, they are generally perceived by the public to represent only
a small fraction of the total poundage of seafood consumed in this
country. Substantial new expenditures would be needed to increase
laboratory analyses to nationally statistically significant levels.
Even if the funds for increased inspection and increased sampling
and analysis were available (which they are not), this approach alone
would likely not be the best way for the agency to spend its money to
protect the public health. Reliance on end-product testing involves a
certain amount of inefficiency that can require very large sample sizes
to overcome. NAS recently observed that ``the statistical uncertainties
associated with lot sampling make this an unreliable method for
ensuring safety of food products * * *'' (Ref. 7, p. 283). FDA has
traditionally sought to minimize this type of inefficiency by targeting
its efforts based on its experiences, but some inefficiency is
unavoidable. NAS recommended the HACCP system as an alternative (Ref.
7, p. 283).
C. Current Import System Is Not Well-Suited to Seafood
Similar considerations apply to imports. FDA does not generally
inspect processing facilities in other countries to determine whether
seafood products are being prepared, packed, or held there under
appropriate conditions. Such inspections are extremely costly and
require an invitation from the foreign country. Traditionally,
therefore, FDA's primary strategy for seafood imports has involved: (1)
Reviewing all customs entries documents to determine which imported
products to examine or sample; (2) conducting wharf examinations of
selected products based on that review; and (3) sampling and laboratory
analyses as appropriate.
One concern about this process that has been voiced with some
regularity in the media, Congress, and elsewhere is that FDA physically
looks at less than 5 percent of all imports. This figure is somewhat
misleading because it refers to seafood lots that can vary
substantially in size. Also, it does not take into account such factors
as the representative nature of the examinations, FDA's automatic
detention program for imports that requires importers of products with
a history of problems to obtain a laboratory analysis and certification
prior to entry, or the fact that imports receiving further processing
in the United States become subject to domestic inspection.
Nonetheless, it is certainly true that most imported seafood is not
physically sampled or examined by a Federal health official.
The total number of customs entries for seafood each year is
approaching 200,000 (Ref. 27) from about 135 countries (compared to
about 33 countries for beef and poultry (Ref. 28)), and huge sums of
money would be needed to enable FDA to increase its physical
examination and sampling program to nationally, statistically
significant levels. Still, many developing countries export seafood
products to this country, and their regulatory protections tend to be
comparatively weak, if they exist at all. Processing conditions in such
countries do not always meet U.S. standards for sanitation.
While many importers are conscientious about the safety and quality
of the products that they import, others have little understanding of
potential hazards. The denial of entry of a violative lot may be
regarded as simply a cost of doing business, which is offset in many
cases by insurance purchased against just such an eventuality. Such
policies are identified as ```FDA rejection' insurance'' and usually
the premium is 2 to 3 percent of the value of the shipment (Ref. 29).
It is reasonable to assume that this cost is being passed on to the
consumer. The insurance also permits importers to buy seafood from
foreign processors without first ensuring that it meets FDA
requirements, i.e., that it is safe, wholesome, and properly labeled.
This system leaves much to be desired. It, too, is a ``snapshot''-
type approach that places a significant burden on the Government to
uncover problems without fostering or promoting industry
responsibility. It lacks the preventive controls that the agency has
tentatively concluded are the minimum necessary to ensure safety.
Moreover, it has not provided full public confidence in the safety of
imported seafood.
D. Public Confidence
Continuing public concerns about the safety of seafood provide
additional evidence that the current regulatory system is not well-
suited for seafood. Consumers have become increasingly concerned about
the effects of pollution on seafood. Medical wastes washing up on
beaches, ocean dumping of toxic wastes, chemical run-off, and multiple
oil spills continually dramatize the fact that bodies of water, no
matter how large, can be adversely affected by human activity.
Media and other public attention on seafood safety and quality, and
on the adequacy of the current regulatory program for seafood, has been
substantial in recent years, and there is no reason to expect that this
attention will decrease. Problems with some seafood products draw
attention to, and has tended to raise concerns about, all seafood, a
situation that is bad for consumers because seafood is a low fat
product, and bad for an industry that can ill afford it.
Several hearings on the sufficiency and direction of the Federal
seafood safety program have been held in both houses of Congress since
in 1989. In addition, numerous bills have been introduced in Congress
for the stated purpose of establishing a Federal program of mandatory
inspection of seafood. Different bills passed the House and the Senate
in 1990 but were not reconciled before the end of the 101st Congress.
This legislative activity has tended to reinforce the view that the
public is placed at some risk because no Federal mandatory program for
seafood exists. While this view is inaccurate in a number of respects,
it is fueled in part by the notable differences in the frequency with
which regulatory agencies inspect the processors of different types of
flesh foods. As stated above, beef and poultry slaughterhouses are
subject to continuous visual inspection under programs operated by the
U.S. Department of Agriculture (USDA).
Public concerns about seafood regulation persist despite the recent
increases in Federal resources and inspections for seafood. A major
U.S. newspaper recently published an article entitled ``A Sea of
Uncertainties,'' which expressed anxiety about the coverage of seafood
inspection. ``The odds are,'' it observed, ``that the bit of fish you
cook tonight got to your table without ever being poked or prodded or
even glanced at by a government inspector'' (Ref. 30).
No realistic system, however, could possibly look at every piece of
fish. Moreover, in the current budget climate, improvements in the
system for ensuring the safety of seafood will likely have to be
qualitative rather than quantitative. Estimated combined Federal,
State, and local outlays for regulatory activities relating to seafood
are about $100 million annually (Ref. 31), but pressures to cut back
funding exist at all of these levels.
IV. The HACCP Option
Thus, the Government must find new approaches to food safety that
enable it to become more efficient and minimize costs wherever
possible. A new paradigm is needed for seafood inspection, one that
provides an ongoing, scientifically established system of intensive,
preventive monitoring but that does not require undue resources.
When faced with similar pressures, Canadian health authorities
responsible for seafood safety came to the following conclusion:
One of the key challenges will be to endure the scrutiny of the
informed consumer and demanding marketplace * * *. The Canadian
Government, as well as other western governments will be under
constant pressure to limit spending as the aging population places
more and more demands on services and as the Federal deficit is
addressed. This means inspection programs cannot expect to have ever
increasing resources to meet the challenges of the 1990's. Smarter
and more cost effective ways must be developed to carry out their
mandate.
(Ref. 32, p. 502.)
The ``smarter and more cost effective way'' chosen by the Canadians
is HACCP.
A. What is HACCP?
HACCP is a preventive system of hazard control. Its application to
food production was pioneered by the Pillsbury Company (Pillsbury)
during that company's efforts in the early 1960's to create food for
the U.S. space program. Pillsbury concluded that then existing quality
control techniques could not provide adequate assurance that the food
being produced was not contaminated. The end-product testing necessary
to provide such assurance would be so extensive that little food would
be left for space flights. According to Howard E. Bauman:
We concluded after extensive evaluation that the only way we
could succeed would be to develop a preventive system. This would
require us to have control over the raw materials, process,
environment, personnel, storage, and distribution as early in the
system as we possibly could. We felt certain that if we could
establish this type of control, along with appropriate record
keeping, we should be able to produce * * * a product we could say
was safe. For all practical purposes, if this system was implemented
correctly, there would be no testing of the finished packaged
product other than for monitoring purposes.
(Ref. 33, p. 2.)
In the succeeding years, the system devised by Pillsbury has been
recognized worldwide as an effective system of controls. The system has
undergone considerable analysis, refinement, and testing. FDA believes
that HACCP concepts have matured to the point where they can be
formally implemented for seafood on an industry wide basis.
HACCP consists first of an identification of the likely hazards
that could be presented by a specific product, followed by the
identification of the critical control points in a specific production
process where a failure would likely result in a hazard being created
or allowed to persist. These critical control points are then
systematically monitored, and records are kept of that monitoring.
Corrective actions are also documented.
The National Advisory Committee on Microbiological Criteria for
Foods (NACMCF), which was established by USDA in conjunction with FDA
at the recommendation of NAS, has developed seven widely accepted HACCP
principles that explain this process in greater detail (Ref. 34). These
HACCP principles follow.
1. Hazard Analysis
The first step in the establishment of an HACCP system for a food
process is the identification of the hazards associated with the
product. NACMCF defined a hazard as a biological, chemical, or physical
property that may cause a food to be unsafe for consumption (Ref. 34,
p. 186). The hazard analysis step should include an assessment of both
the likelihood that these hazards will occur and their severity if they
do occur. It should also involve the establishment of preventive
measures to control them. To be addressed by the HACCP system, the
hazards must be such, according to NACMCF, that their prevention,
elimination, or reduction to acceptable levels is essential to the
production of a safe food. Even factors beyond the immediate control of
the processor, such as how the food will be distributed and how it will
be consumed, must be considered because these factors could influence
how it should be processed. Hazards that involve low risk and that are
not likely to occur need not be considered for purposes of HACCP.
NACMCF has developed numerous issues to be considered during hazard
analysis. These issues relate to matters such as ingredients,
processing, distribution, and the ultimate intended use of the product.
FDA urges seafood processors and importers to become familiar with
these issues. They include, for example, whether a food contains any
sensitive ingredients that may present microbiological hazards,
chemical hazards, or physical hazards; whether sanitation practices can
affect the safety of the food that is being processed; and whether the
finished food will be heated by the consumer. For seafood, this
analysis is particularly important because it is consumed raw or
partially cooked to an extent unrivaled for other flesh foods. Examples
of seafoods that are consumed in this way include raw molluscan
shellfish, sushi, steamed clams, and cold smoked salmon.
2. Identify the Critical Control Points in the Process
Points in a manufacturing process that may be critical control
points, as listed by the NACMCF, include cooking, chilling, specific
sanitation procedures, product formulation control, prevention of cross
contamination, and certain aspects of employee and environmental
hygiene. For example, a cooking step that must be operated at a
specific temperature and for a specified time in order to destroy
microbiological pathogens is a critical control point. Likewise,
refrigeration required to prevent hazardous microorganisms from
multiplying or toxins from forming is a critical control point.
3. Establish Critical Limits for Preventive Measures Associated With
Each Identified Critical Control Point
In essence, this step involves establishing a criterion that must
be met for each preventive measure associated with a critical control
point. Critical limits can be thought of as boundaries of safety for
each critical control point and may be set for preventive measures such
as temperature, time, physical dimensions, moisture level, water
activity, Ph, available chlorine, or sensory information such as
texture, aroma, or visual appearance. Critical limits may be derived
from sources such as regulatory standards and guidelines, literature
surveys, experimental studies, and experts.
4. Establish Procedures To Monitor Critical Control Points
Monitoring is a planned sequence of observations or measurements to
assess whether a critical control point is under control and to produce
an accurate record for future use in verification. NACMCF identifies
three main purposes for monitoring: (1) It tracks the system's
operation so that a trend toward a loss of control can be recognized,
and corrective action can be taken to bring the process back into
control before a deviation occurs; (2) it indicates when loss of
control and a deviation has actually occurred, and corrective action
must be taken; and (3) it provides written documentation for use in
verification of the HACCP plan.
As NACMCF points out, continuous monitoring is possible with many
types of physical and chemical methods. For example, temperature and
time for a scheduled thermal process can be recorded continuously on
temperature-recording charts. When it is not possible to monitor a
critical limit on a continuous basis, monitoring intervals must be
reliable enough to permit the manufacturer to determine whether the
hazard is under control.
5. Establish the Corrective Action To Be Taken When Monitoring Shows
That a Critical Limit Has Been Exceeded
While the HACCP system is intended to prevent deviations in a
planned process from occurring, perfection is rarely, if ever,
achievable. Thus, NACMCF states that there must be a corrective action
plan in place to: (1) Determine the disposition of any food that was
produced when a deviation was occurring; (2) fix or correct the cause
of noncompliance to ensure that the critical control point is under
control; and (3) maintain records of corrective actions.
6. Establish Effective Recordkeeping Systems That Document the HACCP
System
This principle requires the preparation and maintenance of a
written HACCP plan that sets out the hazards, critical control points,
and critical limits identified by the firm, as well as the monitoring,
recordkeeping, and other procedures that the firm intends to take to
implement the plan. Secondly, this principle requires the maintenance
of records generated during the operation of the plan.
Ultimately, it is the recordkeeping associated with HACCP
procedures that makes the system work, both from the standpoint of the
HACCP operator (industry) and the regulator. One conclusion in a study
of HACCP performed by the Department of Commerce is that correcting
problems without recordkeeping almost guarantees that problems will
reoccur (Ref. 35, p. 85). The requirement to record events at critical
control points on a regular basis ensures that preventive monitoring is
occurring in a systematic way.
7. Establish Procedures to Verify That the HACCP System Is Working
This process involves: (1) Verifying that the critical limits are
adequate to control the hazards; (2) ensuring that the HACCP plan is
working properly, e.g., that it is being followed, and that appropriate
decisions are being made about corrective actions; and (3) ensuring
that there is documented, periodic revalidation of the plan to make
sure that it is still relevant to raw materials as well as to
conditions and processes in the plant. Government regulatory activities
also help ensure that the HACCP system is working.
B. Specific Applications to Seafood
As NAS has pointed out, most health risks associated with seafood
originate in the environment (Ref. 7, p. 1). Many of these risks are
the subject of research by FDA, the National Oceanic and Atmospheric
Administration (NOAA) of the Department of Commerce, the Environmental
Protection Agency (EPA), and others. This research is designed both to
produce information that will provide a better understanding of the
toxins, bacteria, chemical contaminants, and other phenomena and to
provide a basis for developing more advanced types of controls for
them. Within the limits of existing scientific knowledge, however, the
industry can and should use HACCP to control the source and condition
of raw materials based on an understanding of the likely hazards that
need to be prevented.
The Pillsbury team that first applied HACCP to food production
began with a systematic review of raw materials to ensure that they
were not bringing hazards into the plant. As Bauman pointed out:
This required the development of a familiarity with the raw
materials that was not a normal process in food product development
* * *. The areas of concern ranged from the potential presence of
pathogens, heavy metals, toxins, physical hazards and chemicals, to
the type of treatments the ingredients might have received such as
pesticide applications or a pasteurization step. (Ref. 33, pp. 2 and
3.)
While all these areas that were of concern to Pillsbury are not
germane to all seafoods, they certainly cover the range of hazards to
which seafoods are susceptible.
Of the three most frequently reported seafood-related illnesses,
two are environmentally related: ciguatera in warm water reef fish, as
described previously, and water-borne viruses in molluscan shellfish
consumed raw and partially cooked. While a rapid test to detect
ciguatoxin in fish continues to be the target of research at FDA and
elsewhere, processors and importers can exercise control by ensuring
that they are obtaining fish from responsible sources that are not
harvesting from waters where ciguatoxin is being found.
Ciguatera has been associated with recreational fishing. Processors
and importers should address through HACCP any safety considerations
that might exist with the commercial sale of recreational catch
generally, depending upon species and locale.
For viruses from molluscan shellfish to be controlled, HACCP
measures must be in place to ensure that molluscan shellfish harvested
from polluted waters are not entering commerce. Other key safety
controls relate to proper refrigeration to keep potentially harmful
microbes from reaching dangerous levels.
The third seafood-related illness, scombroid poisoning, is caused
by a toxin created as part of the process of decomposition after a fish
has died. The formation of scombrotoxin can be triggered by time/
temperature abuse anywhere in the commercial system and beyond,
including as early as on the harvesting vessel if good handling
controls are not followed.
FDA is considering whether to develop good handling practice
requirements (not necessarily HACCP) specific to fishing vessels and
invites comment on this matter. FDA has traditionally refrained from
directly regulating fishing vessels, largely because of the huge number
of such vessels in the U.S. fleet, even though it has authority to do
so. FDA invites comment on whether those boats that harvest
scombrotoxin-forming species, or any other specific component of the
fleet, should be subject to mandatory HACCP controls.
Meanwhile, processors and importers of scombrotoxin-forming species
can exercise HACCP controls aimed at ensuring that their incoming raw
materials or imported shipments have not been time/temperature abused.
Because any HACCP plans for such processors or importers would be
clearly inadequate if scombrotoxin were not identified as a hazard and
appropriate controls were not in place and systematically monitored,
processors and importers should consider placing time/temperature
requirements on vessel owners as a prerequisite to doing business.
HACCP can also be applied to control of hazards from chemical
contaminants, even though the full range of possible chemical hazards
is still imperfectly understood. Government and academia have important
roles to play in researching the toxicities of these chemicals, in
monitoring them, and in performing various forms of risk assessment. In
some cases, these efforts may result in the establishment of national
maximum limits. In other cases, regional advisories may be more
appropriate. The seafood industry has a responsibility to know whether
chemical hazards are associated with the species they are handling,
whether the occurrence of such hazards depends on harvest site or other
factors, and whether a sampling and analysis program on their part
would be appropriate. Processors and importers should monitor the
origin of raw materials and imported shipments to ensure, for example,
that harvest did not occur in locations subject to public health
advisories.
These are but a few examples of environmentally related hazards to
which HACCP can be applied. HACCP controls can also ensure that hazards
are not being created inside a processing facility through improper
handling, cooking, or storing.
C. Regulatory Considerations
From a regulatory standpoint, inspections of processing facilities
and of importers' plans and records would become more efficient and
would be likely to have a much greater impact if HACCP controls were in
place. A key feature of an inspection system tied to implementation of
HACCP is access by Government investigators to the HACCP plan and to
monitoring records kept under that plan. In contrast to the
``snapshot'' provided by current inspections, examination of HACCP
records will enable an investigator to see how the processing facility
or the importer operates over time. It will enable an investigator to
determine whether problems have occurred, and how they were addressed.
It will also enable an investigator to spot trends that could lead to
problems, and thus to help prevent them from occurring. Additionally,
it will enable the regulator to review the adequacy of the processor's
or importer's preventive control system itself. Under such an
inspection system, inadequate preventive controls would warrant
remedial or regulatory action regardless of whether the processor's or
importer's product is actually contaminated or unsafe.
HACCP is not a zero risk system, however. Problems in food
production and processing will still occur. HACCP systems are designed
to detect and document those problems, so that they can be corrected as
quickly as possible. Thus, regulatory action would not be warranted on
the basis of the mere occurrence of processing problems. It would be
warranted, though, if the HACCP system is not functioning properly to
detect and correct the problems, or if adulterated food is allowed to
enter into commerce.
An inspection program tied to mandatory industry adoption of the
HACCP system would not be industry self-certification, nor would it be
deregulatory. An investigator under such a program would perform HACCP
reviews but not to the exclusion of other inspection activities. Thus,
it is highly doubtful whether any falsification of records would go
undetected. Investigators are taught to recognize falsification of
records, and the inspection techniques they use would likely reveal any
instances in which the records do not reflect actual conditions and
practices. Falsification of records carries strict penalties under
Federal law.
Unlike the other inspection options discussed previously that would
involve continuous or high-frequency inspection and commensurate costs,
an inspection system tied to HACCP would not necessarily require an
increase over current inspection frequencies. Recordkeeping and record
inspection will provide the inspector, however, with a broader view.
Moreover, to the extent that States adopt equivalent inspection
programs in response to these proposed regulations, the resultant
network of consistent inspections would, in effect, increase the
frequency of inspections at no additional cost. The value to the nation
of such a network would be substantial.
FDA recognizes that many States are under considerable pressure to
cut back funding in areas where a Federal presence also exists. For
seafood, however, FDA urges that the States maintain their programs,
strengthen them to the extent possible, and work with the agency to
integrate them into a HACCP-based, Federal/State network. Such an
approach would be consistent with recommendations relating to the role
of States made by NAS in its 1991 report on seafood safety (Ref. 7, p.
16). FDA especially invites comment on how the proposed FDA program
should mesh with an existing State HACCP program for seafood, such as
the program that exists in Alaska, so that inconsistent Federal and
State HACCP requirements are not imposed.
V. The Proposal
A. Decision To Propose To Make Use of HACCP Mandatory
For the foregoing reasons, FDA has tentatively concluded that a new
system of regulatory controls for seafood is necessary, and that HACCP
is the appropriate system. Therefore, FDA is proposing to add part 123
to establish procedures for the safe processing and importing of fish
and fishery products. FDA is proposing these procedures under sections
402(a)(1), 402(a)(4), and 701(a) of the Federal Food, Drug, and
Cosmetic Act (the act) (21 U.S.C. 342(a)(1), 342(a)(4), and 371(a)), in
conjunction with section 361 of the Public Health Service Act (the PHS
Act) (42 U.S.C. 264). Section 402(a)(1) of the act states that food is
adulterated if it bears or contains any poisonous or deleterious
substance that may render it injurious to health. Section 402(a)(4) of
the act was included in the act to provide additional control over
insanitary and contaminated foods. (H.R. Rept. No. 2139, 75th Cong., 3d
sess. 6 (1938).) Section 701(a) of the act authorizes the agency to
adopt regulations for the efficient enforcement of the act. Section 361
of the PHS Act authorizes the agency to adopt regulations to prevent
the spread of communicable diseases.
The proposed regulations set out those requirements that the agency
tentatively has concluded are the minimum necessary to ensure that, to
the extent possible, the processing and importation of fish and fishery
products will not result in a product that is injurious to health.
These requirements include the establishment of HACCP preventive
controls that take into account the unique characteristics of seafood
products. If a processor or an importer fails to adopt and implement an
HACCP plan that complies with the requirements that FDA is proposing,
or otherwise fails to operate in accordance with these proposed
provisions, it will be preparing, packing, or holding the food under
insanitary conditions under which the food may be rendered injurious to
health. Thus the food will be adulterated under section 402(a)(4) of
the act and subject to regulatory action by FDA. The agency has
reflected this fact in proposed Sec. 123.6(d).
FDA's tentative decision to adopt regulations that require the
implementation of HACCP principles by the seafood industry is grounded
in the statutory objective of preventing food safety and sanitation
problems. Section 402(a)(4) of the act does not require that FDA
demonstrate that food is actually hazardous or contaminated in order to
deem the food adulterated and to exclude it from commerce. Instead,
under section 402(a)(4) of the act, food producers must assure that the
food is not ``prepared, packed, or held under insanitary conditions
whereby it may have been contaminated with filth, or whereby it may
have been rendered injurious to health.'' [emphasis added.]
In enforcing section 402(a)(4) of the act, FDA has considered,
among other things, prevailing industry standards and the technical
state-of-the-art in determining on a case-by-case basis whether the
conditions under which a company is processing or handling food satisfy
section 402(a)(4) of the act. This proposed regulation would codify an
appropriate state-of-the-art means of assuring seafood safety and of
preventing sanitation problems under FDA's authority to promulgate
regulations for the ``efficient enforcement'' of the act (section
701(a) of the act (21 U.S.C. 371(a))).
The factual record that FDA has developed concerning the safety and
sanitation issues posed by seafood illustrates the need for codifying
appropriate preventive methods consistent with the emerging technical
state-of-the-art and explains why FDA's initial focus in implementing
HACCP is on seafood. Proof that any particular process or set of
manufacturing conditions in the production of seafood has in fact
caused injuries or sanitation problems is not, however, a legal
prerequisite to this rule.
The proposed adoption of this rule is supported by several
additional factors. First, as stated above, the application of HACCP to
the seafood industry has been the subject of a substantial amount of
work, by the Federal government, some States, academia, and the seafood
industry itself, to develop specific HACCP models and otherwise to
apply HACCP to seafood processing and importation. The Model Seafood
Surveillance Project (MSSP) was conducted by NOAA at the request of
Congress in 1986 to design an inspection system for seafood consistent
with HACCP principles. This project resulted in the development of 16
regulatory models for specific seafood products that describe the basis
for a mandatory seafood inspection system. Each model applies many of
the NACMCF principles described above in the context of a specific
product, such as breaded shrimp, raw fish, and molluscan shellfish
(Ref. 35, pp. 67 to 73).
The MSSP was conducted with significant industry involvement. The
importance of industry participation in the development of HACCP
systems was stressed by NAS in its 1985 study of HACCP (Ref. 36, pp.
13, 309, and 310). As part of the MSSP project, 49 workshops were
conducted involving 1,200 industry, State, and university participants.
HACCP controls were considered for economic fraud and plant sanitation/
hygiene as well as for safety because economic fraud and sanitation
have been problems in the seafood industry. The MSSP models cover
nearly all the types of seafood products consumed in the United States
except for low acid canned seafood, which is already subject to a
mandatory HACCP control and inspection system under the low acid canned
food regulations adopted by FDA.
Low acid canned seafood products represent about 25 percent of all
seafoods consumed in the United States (Ref. 7, p. 23). The regulatory
system in place for them represents the first formal application of
HACCP principles to food by a regulatory agency. As with this proposal,
the regulations for low acid canned foods were requested by industry,
and they were developed through cooperation between Government and
industry.
Although the low acid canned food regulations apply HACCP concepts
to two hazards only, i.e., botulism in canned foods and contamination
because of poor container integrity, they are regarded as a major
success and demonstrate the benefits that HACCP can provide. Botulism
in canned goods has been effectively controlled under the low acid
canned food regulations and is no longer a particular source of
consumer concern. NAS recently concluded that canned fish is among the
safest of seafood items. (Ref. 7, p. 320).
Seafood industry associations have been active in developing HACCP
systems that their members could use. For the past several years, the
New England Fisheries Development Association (NEFDA) has been
assisting firms in the northeast to implement HACCP systems through
Federal grants. NEFDA's activities include a pilot project for 15
processing firms and participation in a retail seafood HACCP pilot
(Ref. 18, p. 26).
Academia has been active as well. For example, the Oregon Sea
Grant, which services the Oregon marine community as part of the
national Sea Grant extension service, has issued a publication,
``Hazard Analysis & Critical Control Point Applications to the Seafood
Industry'' (Ref. 37). This publication explains the fundamentals of
HACCP, inventories microbial hazards of seafoods, and describes model
HACCP systems for specific types of seafood processing operations.
As a result of efforts like these by Government, industry, and
academia, a considerable amount of literature and expertise now exist
to facilitate the development of HACCP systems by seafood processors
and importers, significantly more than for most other major segments of
the food industry. Given the advanced state of knowledge about the
application of HACCP to the seafood industry, FDA is proposing to make
the use of HACCP mandatory for the seafood industry to ensure that
there is compliance with section 402(a)(1) and 402(a)(4) of the act.
Second, seafood industry representatives have been urging the
Federal Government to adopt a mandatory, HACCP-based system for years.
The National Fisheries Institute, the largest seafood industry trade
association, and others from the seafood industry testified repeatedly
at congressional hearings from 1989 through 1992 in support of
legislation that would mandate such a system.
Indeed, nearly all of the seafood bills introduced in the Congress
since the late 1980's, including the bills that passed both chambers in
1990, contained HACCP elements. While there were different views on the
merits of these legislative proposals, virtually all Government
agencies, both Federal and State, that testified on these proposals--as
well as most other witnesses--expressed support for the HACCP concept
as it applies to seafood. The Chairman of the Interstate Shellfish
Sanitation Conference (ISSC), an organization of States, Federal
agencies, and industry that considers issues relating to molluscan
shellfish safety, testified that a HACCP-type approach is now being
used for aspects of the shellfish program and endorsed HACCP for all
seafood.
Significant elements of the seafood industry continue to press for
the Federal Government to institute a HACCP-based program. An article
in a 1992 edition of a seafood trade publication on the advantages of
HACCP concluded: ``With the seafood industry under a continuing barrage
of negative press regarding the wholesomeness and safety of product,
the industry is impatient to get started with a seafood inspection
program that will reassure consumers * * *'' (Ref. 19, p. 39).
In February, 1993, the Executive Vice President of the National
Fisheries Institute wrote to the Secretary of Health and Human Services
asking that she ``initiate a state-of-the-art program for seafood which
would be of significant benefit to consumers * * *. HACCP-based
regulation is very feasible for the seafood industry * * *. There is no
reason to wait for congressional action to put this modern technology
in place'' (Ref. 38). As recently as April, 1993, the President of the
Pacific Seafood Processors wrote to FDA expressing support for a
mandatory seafood HACCP program (Ref. 39). The members of that
organization process the majority of domestically harvested seafood.
These requests provide further evidence of the appropriateness of this
proposal.
B. Preparing for HACCP
FDA recognizes that this proposal involves a significant departure
from current practices for most processors and importers and intends to
work cooperatively with the industry in the establishment of this
proposed system. The agency's experiences under both its HACCP-based
low acid canned food regulations and the HACCP-based pilot programs for
seafood that it conducted with NOAA in 1991 demonstrate the need for
cooperation and technical support between the agency and the industry
in order to establish HACCP and to make it work.
The FDA/NOAA joint pilot programs involved the development and
implementation of HACCP-based systems by seafood processors and HACCP-
based inspections by the two agencies. Even though the FDA/NOAA pilots
involved highly motivated seafood firms that volunteered to adopt
HACCP, the firms found it difficult initially to identify hazards and
critical control points associated with their own products and
processes (Ref. 40). As both the agencies and the firms discovered,
HACCP involved new ways of thinking and behaving that were not readily
understood or implemented. A considerable amount of consultation and
assistance between the firms and the Government proved to be extremely
helpful.
This experience reinforces the view that regulations that impose a
HACCP-based system are needed for the seafood industry and thus
represents a third factor supporting the appropriateness of this
proposal. The systematic kind of preventive thinking that HACCP
requires is not universal, but it can be adopted. Regulations will
ensure that processors and importers do so. Significantly, once
participants in the pilot programs made the transition to HACCP, they
were able to identify benefits from using HACCP to themselves and to
consumers in terms of product safety and quality, as well as plant
sanitation and organization (Ref. 40).
VI. International Trade
Although not a public health issue, international trade is also a
major consideration in determining the advisability and benefits of a
new system of seafood regulation and therefore will be addressed here.
It is estimated that close to 40 percent of the fish and shellfish
harvested from the world's oceans, lakes, and other bodies of water
entered international trade in 1991 (Ref. 41). This movement reflects
the need to match supplies with demand. Nations often have species in
their waters for which there is little or no demand among their
consumers, while consumers in other countries may prefer these species.
In addition, sometimes foreign markets are willing to pay higher prices
than domestic markets.
Participation in the international trade in seafood is critical to
U.S. consumers and industry. Approximately 55 percent of the U.S.
supply of edible seafood is imported. In 1991, 3,014,819,000 pounds
were imported, worth $5,617,887,000, making the United States the
world's second largest seafood importing nation (Ref. 42).
At the same time, the United States is the world's largest exporter
of fishery products. In 1991, the United States exported more than $3
billion worth of seafood, making a significant positive contribution to
this country's balance of payments as well as to the many coastal State
economies in which these products are produced (Refs. 42 and 43). Our
largest market is Japan, followed by the European Community (EC) and
Canada. Both Canada and the EC have implemented or are in the process
of implementing mandatory HACCP-based seafood inspection systems (Refs.
32 and 44).
Given the significance of both international and domestic trade,
ongoing efforts to harmonize or make equivalent country inspection
systems and requirements takes on great significance. The current
multilateral round of trade negotiations under the General Agreement on
Tariffs and Trade (GATT) has resulted in further focus on this area.
The draft text on sanitary and phytosanitary measures acknowledges the
desire of the contracting parties, including the United States, to
support ``the use of harmonized sanitary and phytosanitary measures
between contracting parties, on the basis of international standards,
guidelines, and recommendations developed by the relevant international
organizations including the Codex Alimentarious Commission * * *''
(Ref. 45, p. L.35). This move toward harmonization, coupled with the
current recommendations of the Codex Committee on Food Hygiene
encouraging the international use of the HACCP system (Ref. 46),
clearly argue for the adoption of this approach in the United States
for seafood. Failure by the United States to adopt a mandatory, HACCP-
based inspection system may ultimately undermine its export success,
with considerable economic consequences. For example, in addition to
the EC, Canada, Iceland, Australia, and many other fishing nations have
moved to a mandatory HACCP approach that could affect United States
competitiveness in the major seafood markets.
The EC is the United States' second largest export market,
purchasing $441 million worth of U.S. products in 1991. On July 22,
1991, EC Council Directive 91/493 was issued to set out the conditions
for the production and placing on the EC market fish and fishery
products (Ref. 44). This Directive requires, as of January 1, 1993,
that both member States and third countries:
* * * take all necessary measures so that, at all stages of the
production of fishery products * * * persons responsible must carry
out their own checks based on the following principles:
--Identification of critical control points in their establishments
on the basis of the manufacturing processes used;
--establishment and implementation of methods for monitoring and
checking such critical control points; * * *
--keeping a written record * * * with a view to submitting them to
the competent authority * * *.
While the directive provides some flexibility in terms of
equivalence, it is clear that the EC is looking for a mandatory HACCP
system along the lines proposed in this regulation. Maintaining and
expanding this export market is likely to be facilitated if this
proposal is adopted.
Similarly, ongoing discussions with Canada under the terms of
section 708 of the U.S./Canada Free Trade Agreement (FTA) to harmonize
or make equivalent the two nations' respective inspection systems and
standards have made it clear that this proposed HACCP regulation will
significantly facilitate the process (Ref. 47). Canada has recently
completed implementation of a mandatory, HACCP-based seafood inspection
program. Because Canada is the United States' third largest export
market and largest supplier of imported seafood, adoption of an
equivalent system would not only achieve the objectives of the FTA but
potentially would save resources currently devoted to monitoring
shipments between our two countries. Similar potential benefits could
be expected under the proposed North American FTA, particularly at this
formative stage in that process. Thus, facilitation of international
trade is a fourth factor supporting the appropriateness, and thus
providing a rational basis, for FDA's proposed course of action.
VII. The Proposed Regulations
These proposed regulations consist of a subpart of general
applicability (subpart A) and one subpart that sets forth specific
additional provisions for raw molluscan shellfish (subpart C). The
agency is also setting forth guidelines, in the form of appendices,
that will provide assistance to processors of cooked, ready-to-eat
products (Appendix A), and to processors of scombrotoxin forming
species (Appendix B), on how to meet various requirements in subpart A
relating to the development and implementation of HACCP plans. The
products addressed in the guidelines involve special considerations or
special hazards for which additional guidance would be useful.
Processors and importers that follow these guidelines will increase the
likelihood that FDA will find their preventive controls acceptable. FDA
requests comments on the need for, and the substance of, the guidelines
that it has set forth. Comments should address whether it would be more
appropriate for FDA to adopt the guidelines as regulations. If the
comments provide a convincing basis for doing so, FDA will include some
or all of the guidelines in the regulations in any final rule that
results from this rulemaking.
FDA is also including a guideline on how to ensure product
integrity relating to economic adulteration (Appendix D). FDA is
including this guideline because economic adulteration is a particular
problem in the seafood industry.
In Appendix 1 to this document, FDA is also providing samples from
a package of general guidance, to be published separately, for
processors to use in understanding and implementing HACCP principles in
their operations. One of these samples is specific guidance on the
processing of smoked and smoke-flavored fish. FDA requests comments on
whether the latter guidance should remain as such, be provided as
guidelines in an appendix to the regulations, or be made mandatory by
incorporating them into any final rule that results from this
proceeding.
A. Definitions
The agency is relying generally on the definitions contained in the
act, in the umbrella good manufacturing practice guidelines in part
110, and in other agency regulations. The agency is using these
definitions because it considers consistency in how it uses terms in
its regulations to be necessary and appropriate. Thus, Sec. 123.3(o) is
derived from Sec. 113.3(s), and Sec. 123.3(r) is derived from
Sec. 110.3(q). Additional definitions are proposed in Sec. 123.3 that
are specific to the proposed HACCP program for fish and fishery
products.
The agency is proposing to define ``certification number'' in
Sec. 123.3(a) as a unique combination of letters and numbers assigned
to a shellfish processor by a shellfish control authority, usually the
State. These numbers are used to identify the processor on tags and
labels and in recordkeeping required under proposed Sec. 123.28. States
issue certification numbers to processors who receive shellfish from
safe sources, keep requisite records of shellfish purchases and sales,
and operate in accordance with CGMP and the other certification
requirements of the State. This system of State issued numbers is used
to identify the approximately 2,000 State certified shellfish dealers
that are included on the Interstate Certified Shellfish Shippers List.
The agency is proposing in Sec. 123.3(b) to define ``cooked, ready-
to-eat fishery product'' as a fishery product that is subjected by a
commercial processor to either a cooking process before being placed in
a final container, or to pasteurization in the final container, or to
both. Cooked, ready-to-eat products undergo a heat treatment by a
processor that results in the coagulation of the protein. Because their
organoleptic qualities suggest that they are fully cooked, and thus
ready-to-eat, these products will likely be eaten without any further
heat treatment by the consumer sufficient to eliminate pathogenic
microorganisms and preformed toxins.
As defined, cooked, ready-to-eat fishery products include products
that must be stored either frozen or refrigerated. Products such as
canned seafoods that are subjected to a cooking process after being
placed in a final container, while technically considered cooked,
ready-to-eat products, are not included in the definition because they
are virtually sterile in the final container. As used in these proposed
regulations, the term applies to cooked, ready-to-eat products that do
not receive a heat treatment in the final container by the processor
sufficient to destroy all pathogens and create a shelf-stable product
that does not need refrigeration.
The agency is proposing in Sec. 123.3(c) to define ``critical
control point'' for purposes of these regulations as a point in a food
process where there is a high probability that improper control may
cause, allow, or contribute to a hazard in the final food. This is a
modification of the definition of the same term in Sec. 110.3(e). Under
that definition, a ``critical control point'' is a point where an
improper control could cause, allow, or contribute to ``filth in the
final food or decomposition in the final food'' as well as to a
``hazard'' in the final food. Clearly, that definition is intended to
apply both to human food safety and to certain quality issues that
would not normally cause illness. In this document, FDA is proposing to
require the identification of critical control points for safety only
and is encouraging, but not requiring, the identification of certain
critical control points for hazards not normally related to safety. The
modification of the part 110 definition being proposed here represents
the least revision necessary to achieve that purpose.
The agency is proposing to define ``critical limit'' in
Sec. 123.3(d) as a maximum or minimum value to which a physical,
biological, or chemical parameter must be controlled at a critical
control point to minimize the risk of occurrence of the identified
hazard. This definition is consistent with that of NACMCF, which
defined ``critical limit'' as ``a criterion that must be met for each
preventive measure associated with a critical control point'' (Ref. 34,
p. 186), but FDA's proposed definition is somewhat more explanatory.
Critical limits can be either maximum values, such as the maximum
amount of histamine that can be allowed in a fish, or minimum values,
such as the minimum temperature needed during a cooking step to kill
pathogens.
The proposed definition states that control is for the purpose of
minimizing risk. While complete prevention of a hazard is obviously the
most desirable of all possible outcomes, the proposed definition
recognizes that, in reality, complete prevention cannot always be
ensured. A processor can minimize a microbiological hazard with a
cooked, ready-to-eat product by proper cooking, but the hazard could
still occur if the product is contaminated or otherwise abused
elsewhere in the distribution system or in the home. This aspect of the
definition is consistent with the view of NACMCF, which states that:
``Each CCP [critical control point] will have one or more preventive
measures that must be properly controlled to assure prevention,
elimination or reduction of hazards to acceptable levels'' (Ref. 34, p.
196).
The agency is proposing in Sec. 123.3(e) to define ``fish'' and
broadly to encompass the range of seafood products that are processed
or marketed commercially in the United States. Thus, the term ``fish''
includes all fresh or saltwater finfish, molluscan shellfish,
crustaceans, and other forms of aquatic animal life. Birds are
specifically excluded from the definition because commercial species of
birds are either nonaquatic or, as in the case of aquatic birds such as
ducks, regulated by USDA. Mammals are also specifically excluded
because no aquatic mammals are processed or marketed commercially in
this country.
``Fishery products'' in proposed Sec. 123.3(f) are any edible human
food product derived in whole or in part from fish, including fish that
has been processed in any manner. This definition reflects the
tentative conclusion of the agency to propose mandatory HACCP
requirements at this time to control hazards associated with processing
and importing seafood products intended for human consumption. The
proposed definition includes products that contain ingredients other
than seafood in keeping with the scope of FDA's regulatory authority.
The control of hazards is as important for products that contain
ingredients other than fish as it is for products consisting of fish
alone.
The agency is proposing in Sec. 123.3(g) to define ``harvester'' as
a person who commercially takes molluscan shellfish from their growing
waters, by any means. Harvester is defined because, under this
proposal, this person has responsibility for tagging the product as to
where it was harvested and when. Harvesters are expected to have an
identification number issued by a shellfish control authority.
Harvesting is generally illegal without such a number.
The agency is proposing to define the term ``importer'' in
Sec. 123.3(h) as the owner of the imported goods or his representative
in the United States. This is the person who is responsible for
ensuring goods being entered are in compliance with all laws affecting
the importation. Importers may not always directly handle the imported
food, but they are responsible for the safety and wholesomeness of
products they offer for entry into the United States and therefore are
subject to part 123.
The agency recognizes that the term ``importer'' is often used to
describe not only the owner of the goods or his representative in the
United States (that is, the importer of record) but also includes
freight forwarders, food brokers, food jobbers, carriers, and steamship
representatives. These other agents often represent the importer for
legal and financial purposes that are not necessarily related to the
safety of the product. Therefore, the agency has tentatively concluded
that it is inappropriate to focus the HACCP requirements that bear on
imports on these persons if they do not have authority to make
decisions affecting the product's safety or wholesomeness.
FDA is proposing to define a ``lot of molluscan shellfish'' in
Sec. 123.3(i) as no more than one day's harvest from a single, defined
growing area, by one or more harvesters. This definition establishes
the quantity of shellfish that represents a single lot for tagging or
labeling purposes. Lot distinctions are needed to differentiate
shellfish harvested from different growing areas or at different times.
The time limit of one day is imposed because the safety of a harvesting
area can change daily as the result of rainfall, tides, winds, and
other events that can bring contaminants into the area. The ultimate
safety of raw molluscan shellfish is contingent on the water quality of
the harvesting area. To ensure product safety, shellfish harvesting
areas that are subject to appropriate state control are closed to
harvesting within 24 hours of a finding of adverse conditions. The lot
definition, coupled with the harvest date on the harvesting tag,
provides evidence that the shellfish were harvested when the area was
safe and open for harvesting.
The agency is proposing in Sec. 123.3(j) that ``molluscan
shellfish'' means any edible species, or edible portion of fresh or
frozen oysters, clams, mussels, and scallops, except were the scallop
product consists entirely of the shucked adductor mussel. The
distinction between molluscan shellfish and crustacean shellfish, which
include crabs, shrimp, and lobsters, is made because molluscan
shellfish are commonly eaten whole and raw, while crustacean shellfish
are not. The safety of molluscan shellfish therefore reflects the
quality of the waters from which they are harvested and requires
special public health controls. Furthermore, the agency is proposing to
amend the definition of ``shellfish'' in Sec. 1240.3(p) (21 CFR
1240.3(p)) to make it consistent with the proposed definition in
Sec. 123.3(j). The agency is proposing to amend the term ``shellfish''
in Sec. 1240.3(p) to read ``molluscan shellfish'' to make the terms
consistent between parts 123 and 1240. Because the term shellfish in
its common usage, i.e., an edible mollusk or crustacean, includes crabs
and lobsters, the agency believes that it is necessary to be more
specific and accurate in its definition and consequent application of
the requirements in its regulations. The proposed requirements for
tagging do not apply to crabs and lobsters or to scallops when the
final product is the shucked adductor muscle only. The agency is
proposing to expand the definition in Sec. 1240.3(p) to include
scallops to make it consistent with the definitions in proposed part
123 and with requirements under NSSP.
The agency is proposing to define ``potable water'' in
Sec. 123.3(k) as water that meets EPA's primary drinking water
regulations as set forth in 40 CFR part 141. Those regulations provide
limits for certain microbiological, chemical, physical, and
radiological contaminants that can render water unsafe for human
consumption.
The proposed definition is slightly different from the definition
of ``potable water'' in Secs. 1240.3(k) and 1250.3(j) (21 CFR
1250.3(j). That definition also references the regulations of EPA in 40
CFR part 141 but further includes FDA sanitation requirements in 21 CFR
parts 1240 and 1250. Those sanitation requirements apply to interstate
travel conveyances that must take on water at watering points. Such
requirements are not relevant to these proposed regulations and thus
were not included in the proposed definition.
FDA is proposing to define ``processing'' and ``processor'' in
Sec. 123.3(m) and (n) broadly to ensure the safety of seafood through
the application of HACCP principles throughout the seafood industry.
The definition of ``processor'' is intended to include all seafood
processors that handle products in interstate commerce, such as
shuckers and other processors of raw molluscan shellfish, factory
ships, packers, repackers, wholesalers, and warehouses. Those who
process low acid canned foods are also included, even though they are
subject to the HACCP controls of part 113. Those controls are targeted
toward a limited number of safety hazards. These proposed regulations
require that processors apply HACCP controls to all likely safety
hazards.
Consistent with the regulations at part 113, the proposed
definition of ``processor'' also includes persons engaged in the
production of foods that are to be used in market or consumer tests.
FDA has tentatively concluded that HACCP controls are needed for such
products because the hazards associated with them are no different from
those that can affect other commercial products.
There are, however, certain handlers of seafood that are not
included in the coverage of the proposed definition. Fishing vessels
that essentially only harvest are not covered by the proposed HACCP
regulations. As explained earlier, FDA has traditionally refrained from
directly regulating fishing vessels. The agency anticipates that the
regulations being proposed here would affect vessels indirectly through
processor and importer controls over raw materials and imported
shipments, e.g., preventive controls such as the purchasing of raw
materials only from fishing vessels that engage in proper sanitation
and time/temperature practices and that harvest only from approved
areas.
Transportation companies that carry, but do not otherwise process,
fish and fishery products are also outside the scope of the proposed
definition, although the agency expects that transporters will be
affected indirectly in the same manner as fishing vessels (see also
Sec. 110.93). FDA invites comment on this aspect of the coverage of the
proposed regulations. Proper refrigeration during transport is
important for the safety of scombroid species products and of cooked,
ready-to-eat products. Time and temperature conditions during shipment
can also affect decomposition related to other factors bearing on
seafood quality. These proposed regulations will affect transportation
companies indirectly through the preventive controls the processor or
importer will need to impose to ensure that the raw materials or
imported shipments that it receives are free of relevant hazards and
have been appropriately handled. FDA invites public discussion on
whether this approach is adequate, and, if not, whether HACCP
requirements should be applied directly to transportation companies.
This issue is complex, especially because it is not unusual for
transporters to deliver a variety of food products, including seafood,
to several consignees during a single shipment.
The agency has also tentatively decided to exclude retail
establishments from the definition of ``processor.'' As with fishing
vessels, FDA has traditionally exercised enforcement discretion with
regard to retail establishments. The number of retail establishments in
this country--literally in the hundreds of thousands--would totally
overwhelm any rational Federal inspection system. FDA has traditionally
provided training and other forms of technical assistance to States and
local governments to inspect retail food establishments through the
agency's retail Federal/State cooperative program. A major part of that
cooperative program involves the development of model codes, some of
which have been widely adopted by State and local governments. FDA is
now consolidating those model codes into a single, updated food code
for the retail sector. Appropriate HACCP-based controls are included to
address seafood hazards at retail. Consequently, FDA will continue to
operate through the Federal/State cooperative mechanism and has not
included a retail component in proposed part 123. FDA requests comments
on this tentative approach.
States are strongly encouraged, however, to consider how the
principles in these regulations could be applied to seafood at retail
and to shift to HACCP-type inspection systems as appropriate. Because
of the high perishability of fresh seafood and the sometimes lengthy
and complex distribution chain, these products can have relatively
short shelf lives by the time they reach fresh fish counters and
restaurants. In addition, seafood can be subject at retail both to
cross-contamination because of poor handling practices and to species
substitution.
Improper handling of seafood and other problems at retail have been
documented in recent years. NAS has concluded that a significant number
of reported acute health problems were likely linked to handling and
preparation practices in food service establishments (Ref. 7, p. 27).
The February, 1992 edition of Consumer Reports magazine reported on a
number of such problems with regard to seafood that were observed in
retail establishments. A number of studies have found lack of adequate
temperature controls in retail facilities (Ref. 48, p. 75).
The agency is proposing to define ``shellfish control authority''
in Sec. 123.3(p) as the government entity responsible for implementing
a comprehensive shellfish sanitation program. The shellfish control
authority, among other things, is responsible for classifying shellfish
growing waters, performing inspections of shellfish processors, and
issuing certification numbers to shellfish processors. FDA relies on
recognized governmental public health and food control agencies, both
domestic and foreign, to carry out these functions.
The agency is proposing to define ``shellstock'' in Sec. 123.3(q)
as meaning raw, in-shell molluscan shellfish. This specific product
form designation is needed because the applicability of the tagging,
labeling, and recordkeeping requirements proposed in Sec. 123.28(b) and
(c) is determined by whether the product is shellstock or shucked
product, respectively.
The agency is proposing to define ``shucked shellfish'' in
Sec. 123.3(s) as meaning molluscan shellfish that have one or both
shells removed. The labeling and recordkeeping requirements proposed in
Sec. 123.28(c) apply to shucked shellfish.
The agency is proposing to define ``tag'' in Sec. 123.3(t) as a
record of harvesting information attached to a container of shellstock
by the harvester or processor. Under proposed Sec. 1240.60(b), the tag
or bill-of-lading will identify the processor, harvester, date of
harvest, and State, including the specific location of harvest. Most
shellfish-producing States and countries currently require that
shellfish harvested in their waters bear documentation with such
information. This information is the minimum necessary to permit ready
identification of site and time of harvest of the shellfish. Because
raw molluscan shellfish directly reflect the quality of the harvesting
area, this information is necessary to provide assurance that the
shellfish were harvested from an area that was safe and open for
harvesting.
B. Purpose and Criteria
Section 123.5(a) of the proposed regulations references the
umbrella CGMP guidelines in part 110 as providing general guidance with
regard to such matters as facility design, materials, personnel
practices, and cleaning and sanitation procedures. Because part 110
provides guidance of general applicability to all foods, the agency
intends that this guidance will continue to be valid for seafood
processors when the proposed regulations at part 123 are issued in
final form. Proposed Sec. 123.5(b) makes clear that the purpose of
subpart A of part 123 is to set forth requirements specific to the
processing and importation of fish and fishery products.
C. HACCP Plans
1. Summary
FDA is proposing to require in Sec. 123.6 that commercial
processors and importers of fish and fishery products develop and
implement HACCP plans in keeping with Principle 6 of the NACMCF
discussed previously. Development and implementation of an HACCP plan
requires that processors think through the entire process flow from raw
materials to finished product shipping to ensure that safety hazards
are controlled by design, and that they operate that process as a
matter of daily routine. For importers, the thought process will begin
with a decision from whom and from where to buy fishery products and
follow through to arrangements for shipment to the United States,
storage in the United States, and end when the product leaves the
control of the importer. The plan provides the structure for the
preventive controls, including the recordkeeping associated with those
controls, that a processor or importer is to employ.
In summary, FDA has tentatively concluded that the essential
elements of this structure must include: (1) The identification of
hazards to ensure that the processor or importer knows what the hazards
are, so that it controls them by design rather than by chance (proposed
Sec. 123.6(b)(1)); (2) the identification of critical control points to
ensure that the processor or importer knows where to monitor to prevent
or minimize the occurrence of the relevant hazard (proposed
Sec. 123.6(b)(2)); (3) the identification of critical limits that must
be met at each critical control point, so that the processor or
importer has objective standards in place by which to determine whether
it is controlling the relevant hazard (proposed Sec. 123.6(b)(3)); (4)
the identification of procedures for how and when the processor or
importer will monitor the critical control points to ensure both that
monitoring is done as a matter of routine, and that it is done in an
appropriate manner and with sufficient frequency to establish
preventive control (proposed Sec. 123.6(b)(4)); and (5) a recordkeeping
system for that monitoring that will establish for the processor's or
importer's benefit that it is effectively implementing a system of
preventive controls, and record how those controls are operating over
time (proposed Sec. 123.6(b)(5)).
The recordkeeping system is the key to HACCP. As explained above,
the records will enable the processor or importer, and ultimately the
regulator, to see the operations of the processor or importer through
time, rather than only how they are functioning at a particular moment
in time. Among other things, HACCP records can reveal trends that might
otherwise go undetected until significant problems occurred.
All of these requirements reflect the HACCP principles developed by
NACMCF.
FDA is not proposing to require that the HACCP plan be signed by
any official of a company, but invites comment on the merits of such a
requirement in the final regulations as a means of both ensuring and
demonstrating formal adoption of the plan by that company. FDA also
invites comment on who in the firm would be the appropriate individual
to sign the plan.
2. Guidelines and Other Assistance
FDA recognizes that HACCP plans will vary in complexity, from those
having many critical control points, such as plans for multicomponent,
ready-to-eat products, to those having only a few critical control
points, such as a plan for a fish filleting plant. Plan development can
be facilitated by technical assistance from many sources and by the
detailed advice provided in the literature. NACMCF, for example, has
recommended that, to facilitate the development of HACCP plans,
processors should create an HACCP team, identify the intended use and
likely consumers of the food, and prepare a flow diagram of the entire
manufacturing process to help identify critical control points.
The agency favors simplicity and the rapid development of HACCP
plans without undue expense. The appendices at the end of the proposed
regulations are intended to facilitate plan development by setting
forth certain critical control points, critical limits, controls, and
records that, if incorporated into or prepared under a HACCP plan,
would be acceptable to the agency for the types of products mentioned.
To further facilitate the development of HACCP plans, FDA intends to
issue separate HACCP guidance for seafood that will provide information
on hazards and appropriate controls by species and by product type.
The guidance will provide a broad spectrum of information from
which firms will be able to identify likely hazards and critical
control points that apply to them. The agency believes that the number
of critical control points will range, roughly, between 2 and 12 per
product.
The guidance will also contain a fill-in-the-blank type of HACCP
plan with instructions on how to complete the plan based on information
in the guidance. The agency has tentatively concluded that a plan that
follows this model is likely to be acceptable to FDA. The agency is
including samples of the guidance it is developing in Appendix 1 to
this document. FDA intends to issue a separate draft guidance document
for public comment and to make the completed guidance available to the
public at the time that the regulations are finalized.
In addition, seafood trade associations, university Sea Grant
extension offices, and others have already developed work sheets and
other aids to facilitate HACCP planning for seafood. Industry members
are encouraged to contact their trade associations and state
universities or Sea Grant extension offices on such matters.
3. Effective Date
Even with these forms of assistance, however, FDA recognizes that
HACCP plans cannot be written and implemented overnight. As has already
been discussed, the HACCP system of controls can involve new ways of
thinking and performing on a routine basis. Consequently, FDA is
proposing that these regulations will become effective 1 year after
issuance of the final rule in this proceeding. The agency has
tentatively concluded that this period of time is sufficient to permit
the development and implementation of HACCP plans by the industry. FDA
specifically invites comment on whether 1 year will be adequate. The
agency's objective is to provide enough time to permit processors and
importers to understand HACCP, analyze the relevant hazards, and
develop an appropriate HACCP plan, but also to avoid unnecessary delay.
After the proposed effective date, inspection of HACCP plans will
occur as part of routine, mandatory plant inspections and import
examinations. FDA is not proposing to require that HACCP plans be
submitted to FDA in advance, or that preapproval by FDA be a condition
of their adoption or implementation. FDA is not requiring preapproval
for two reasons. First, HACCP plans can only properly be judged in the
context of the facility itself. Thus, while FDA investigators will
consider the adequacy of the plan during their inspections, preapproval
does not seem warranted. Second, the agency simply does not have the
resources to make preapproval a requirement. Given the protections that
are built into the HACCP approach, FDA tentatively finds that
preapproval is not necessary to ensure that fish and fishery products
are not produced under conditions whereby they may be adulterated under
section 402(a)(4) of the act.
4. Location and Product Type
FDA is proposing in Sec. 123.6(a) to require that every processor
and importer have and implement an HACCP plan that is specific both to
each location where that processor engages in processing and to each
kind of fish and fishery product being processed. A plan should be
specific to each location because the likely hazards, critical control
points, critical limits, and monitoring procedures can vary from one
facility to the next depending on such factors as type of equipment,
conditions and procedures, and location. A plan also should be specific
to each type of fish and fishery product for the same kinds of reasons.
Hazards can vary depending on species, location of catch, and other
factors.
FDA does not intend, however, to require a processor or importer to
write a separate plan, or separate part of a plan, for each fish and
fishery product it handles if the likely hazards, critical control
points, critical limits, and monitoring procedures are identical for
each of them. For example, the preventive controls necessary to ensure
safety for most deep water species of finfish from the north Atlantic
may be virtually identical. The agency has tentatively concluded that,
in such cases, a processor or importer may group the fish or fish
products together in an HACCP plan.
5. Safety Hazards Only
FDA is proposing to require at Sec. 123.6(b)(1) that HACCP plans
identify the human food safety hazards that must be controlled for each
fish and fishery product being processed by a processor or importer.
There exists a range of opinion on whether HACCP should apply solely to
safety hazards, as this provision proposes to require, or whether HACCP
should apply to other types of hazards, such as decomposition not
normally associated with illness in humans. One school of thought holds
that HACCP should apply to safety hazards only in order to keep it
focused and to not overwhelm operators with an unnecessarily large
number of critical control points that have no bearing on the primary
concern of safety. Another view holds that, for seafood at least,
HACCP-type controls can be applied to various consumer risks without
generating an excessive number of critical control points. The Codex
Committee on Food Hygiene came to the latter conclusion (Ref. 46), as
did NOAA as a result of its experiences during the MSSP (Ref. 35, p.
70). Partly for that reason, the FDA/NOAA HACCP pilot programs involved
HACCP controls for safety and HACCP-type controls for other hazards as
well.
For purposes of these proposed regulations, however, FDA's
application of HACCP is intended for the efficient enforcement of
section 402(a)(1) and 402(a)(4) of the act, which applies to products
that contain substances that may render the product injurious to health
and to processing conditions that are insanitary and that could render
a product injurious to health. Consequently, FDA is proposing to
require that HACCP plans include identification of hazards that could
affect human food safety only. To facilitate the production of such
plans, FDA has listed in proposed Sec. 123.6(b)(1) the types of hazards
that have been associated with seafood (see section II.C. of this
document for a discussion of these hazards). All of these hazards are
identified and discussed in the NAS report on seafood safety (Ref. 7).
Processors and importers should identify in their written plans
only those safety hazards that are reasonably likely to occur, rather
than every conceivable hazard no matter how theoretical or remote. This
view is in keeping with NACMCF's recommendation that firms conduct a
hazard analysis and then give no further consideration to hazards that
are unlikely to occur (Ref. 34, p. 189). FDA has tentatively concluded
that processors and importers should not be required to establish
controls and regularly monitor for hazards that are highly unlikely to
occur in the absence of those controls. If, for example, chemical
contaminants have never been found, or have only been found in amounts
significantly below levels of public health concern in a species from a
particular location, processors and importers need not identify
chemical contaminants as a hazard that must be controlled for that
fish.
As indicated earlier in this preamble, FDA intends to issue a
guidance document that will cover possible environmental and processing
hazards for fish and fishery products as well as types of controls that
can be applied to those hazards. The agency anticipates that it will
update that guidance periodically as new controls (or new hazards) are
identified or established.
FDA cannot reasonably expect processors and importers to exercise
controls for hazards that are beyond the scope of current scientific
knowledge. The agency does expect processors and importers to
demonstrate that they are taking precautions that are reasonable in
light of available information, and that they are adopting new controls
as those controls are developed and accepted.
For example, the controls for Vibrio bacteria in raw molluscan
shellfish, which can cause serious illness and death in certain at-risk
populations, are the subject of continuing research at FDA and
elsewhere. Short of a complete ban on harvesting, there is no known
control that would prevent the presence of Vibrios in molluscan
shellfish. Moreover, the infectious dose, that is, the number of
Vibrios necessary to cause illness, is unknown. Because these bacteria
occur naturally in the environment and are ubiquitous, controls that
are employed to prevent sewage-related viruses from entering molluscan
shellfish are not relevant to Vibrios. It is known, however, that
proper temperature controls from the time of harvest onward can at
least limit the growth of these bacteria (Ref. 49). FDA believes that
such controls are reasonable and should be applied now. (In fact,
temperature controls have long been a feature of the National Shellfish
Sanitation Program (NSSP).)
Of the hazards listed in proposed Sec. 123.6(b), pesticides and
drug residues (proposed Sec. 123.6(b)(1)(iv) and (b)(1)(v)) are forms
of chemical contaminants (proposed Sec. 123.6(b)(1)(iii)) but are
listed separately because they can be of special concern in
aquaculture-raised species. These fish generally have a greater
likelihood of being exposed to agricultural run-off than wild ocean
stocks (Ref. 50, pp. 11 and 12). Aquaculture-raised fish are known to
be fed drugs for various purposes. Drug residues in edible tissues can
be a public health concern.
Decomposition, listed in proposed Sec. 123.6(b)(1)(vi), is a known
hazard in those species that can generate scombrotoxin when they
decompose; otherwise, it is regarded as a quality problem. Parasites
(proposed Sec. 123.6(b)(1)(vii)) are not a hazard if killed during
cooking but can be a hazard in finfish consumed raw, unless that fish
is commercially frozen. Unapproved direct and indirect food and color
additives (proposed Sec. 123.6(b)(1)(viii)) are a potential hazard with
most any food.
6. Critical Control Points
Consistent with the HACCP principles identified by NACMCF, FDA is
proposing to require in Sec. 123.6(b)(2) that critical control points
be identified for each of the hazards that the processor or importer
has identified. Hazards may be caused by improper processing or by
events outside the processor's or importer's direct control. To control
the latter type of hazard, that is, environmental hazards and hazards
that may be caused by poor handling prior to receipt of fish or fishery
products by the processor or importer, the point of receipt by the
processor or importer represents a critical control point. As indicated
previously in this preamble, the processor or importer may need to
ensure that it obtains imported shipments or raw materials only from
harvesters, transporters, and others who can demonstrate that they also
have exercised appropriate controls. The hazards that may be caused by
both improper processing and events outside the plant are controlled by
the critical limits, monitoring, control procedures, and recordkeeping
that are done as part of HACCP.
7. Critical Limits
In Sec. 123.6(b)(3), consistent with NACMCF principles, FDA is
proposing that processors and importers identify critical limits in the
plan that must be met at each critical control point. Critical limits
must be met to ensure that the relevant hazard is avoided. Thus, some
critical limits can be set to reflect regulatory levels established by
FDA in the form of action levels, regulatory limits, and tolerances for
such contaminants as pesticides, histamine, and other contaminants. FDA
intends to compile all such levels in the guidance document described
earlier.
Other critical limits can be set in consultation with outside
experts, in keeping with the longstanding practice for low acid canned
foods. For example, as explained later in this preamble with respect to
cooked, ready-to-eat products, there exist a range of possible cooking
time-temperature combinations that will deactivate pathogens during the
cooking step, depending on the type of equipment being used by the
processor and the size and species of fish being cooked. The existence
of a range of effective cooking time-temperature combinations convinced
FDA not to establish specific cooking time-temperatures for industry in
the regulations for low acid canned foods. Rather, FDA decided to rely
on outside experts and on research within the scientific community to
establish cooking times and temperatures for these products. FDA is not
proposing specific cooking time-temperature requirements for most
seafood products (although FDA is providing guidance on time,
temperature, and salinity parameters for smoked and smoke-flavored
fish, as is fully explained in Appendix 1 to this document) for the
same reason.
8. Monitoring and Control Procedures
Proposed Sec. 123.6(b)(4) requires that the processor or importer
identify in the HACCP plan the procedures that it will use to control
and monitor each critical control point. Monitoring steps are necessary
to ensure that the critical control point is in fact under control and
to produce an accurate record of what has occurred at the critical
control point (Ref. 34, p. 197). Among the procedures that are to be
used under proposed Sec. 123.6(b)(4) is monitoring of the consumer
complaints received by the processor. While the goal of an HACCP system
is to prevent all likely hazards from occurring, no system is
foolproof. Consumer complaints may be the first alert that a processor
has that deviations are occurring that are not being prevented or
uncovered by the processor's HACCP controls. FDA has tentatively
concluded, therefore, that each HACCP system should take advantage of
consumer complaints as they relate to the operation of critical control
points.
Proposed Sec. 123.6(b)(4) also requires that procedures for
controlling and monitoring critical control points must include
calibration of process control instruments and validation of software
for computer control systems, as appropriate. For a processor's
preventive controls to work, the instruments and equipment that it
relies upon in monitoring critical control points, such as
thermometers, temperature-recording devices, and computer software,
must be accurate and reliable. FDA has tentatively concluded that the
best way to ensure such accuracy and reliability is to require that the
processor's monitoring procedures include steps necessary to verify the
reliability of these instruments and devices.
9. Recordkeeping
As explained above, a HACCP system will not work unless records are
generated during the operation of the HACCP plan, and these records are
maintained and are available for review (see section IV.A.6. of this
document). Thus, FDA is requiring in proposed Sec. 123.6(b)(5) that the
HACCP plan provide for a recordkeeping system that will document the
processor's or importer's monitoring of the critical control points.
Proposed Sec. 123.6(b)(5) also requires that HACCP records contain the
actual values obtained during monitoring, such as the actual
temperatures and times. FDA has tentatively concluded that it is not
possible for the processor to derive the full benefits of its HACCP
system, nor is it possible for FDA to verify the operation of the
system, without actual values. Notations that refrigeration
temperatures are satisfactory or unsatisfactory, without recording the
actual temperatures, are vague and subject to varying interpretation
and thus will not ensure that preventive controls are working. Also, it
is not possible to discern trends without actual values.
In addition, proposed Sec. 123.6(b)(5) requires that HACCP records
include the actual consumer complaints that may have been received by
the processor or importer relating to the operation of critical control
points or possible critical limit deviations. FDA has tentatively
concluded that it may be necessary on occasion for it to review these
complaints in order to be able to validate whether the firm is taking
necessary steps to review controls and correct deviations as necessary
in response to consumer complaints.
It is not FDA's intent to gain unlimited access to industry's
consumer complaint files through this proposal or to engage in
``fishing expeditions'' through consumer complaint files. Only those
consumer complaints relating to the operation of the HACCP critical
control points need be included as HACCP records. FDA's interest is
solely in verifying that the HACCP system is working as it should. The
agency understands the sensitivities associated with consumer complaint
records and invites comments on this aspect of the proposal.
10. Nonsafety Hazards
Proposed Sec. 123.6(c) encourages, but does not require, processors
and importers to include in their plans controls for hazards other than
hazards to health. Examples listed in Sec. 123.6(c)(1)(i) and (ii) are
decomposition not associated with human illness and economic
adulteration. FDA is not requiring processors and importers to include
nonsafety hazards in their HACCP plans for reasons stated previously.
However, the agency is encouraging processors and importers to apply
HACCP principles to these nonsafety hazards, and to control them in the
same manner that processors and importers control safety hazards (see
proposed Sec. 123.6(c)(2)), because they are common problems in the
seafood industry. FDA has included a guideline on economic adulteration
with these proposed regulations (see Appendix D).
Despite the fact that these proposed regulations do not require
HACCP controls for nonsafety hazards, such hazards as economic
adulteration, decomposition not normally associated with human illness,
general unfitness for food, and misbranding, constitute violations of
the act and are subject to regulatory action by FDA (see sections
402(a)(3) and 403 of the act (21 U.S.C. 343). Inspections by FDA
investigators will continue to consider and enforce these provisions of
the act.
D. Corrective Actions
FDA is proposing in Sec. 123.7 to require that deviations from
critical limits trigger a prescribed series of actions by a processor
or importer, including determining the significance of the deviation,
taking appropriate remedial action, and documenting the actions taken.
This proposed provision is consistent with the HACCP principles
enunciated by NACMCF (Ref. 34). First, under proposed Sec. 123.7(a)(1),
any critical limit deviation will require the segregation and holding
of the affected product until the significance of the deviation can be
determined. This step is necessary to ensure that products that may be
injurious to health do not enter commerce until the impact of the
deviation on safety has been determined, and the safety of the product
assured. Second, under proposed Sec. 123.7(a)(2), the processor or
importer must actually determine the effect of the deviation on safety,
and third, under proposed Sec. 123.7(a)(3), it must take whatever
corrective actions are necessary with respect to both the affected
product and the critical control point at which the deviation occurred,
based on that determination.
Some deviations, especially if they are caught quickly, will not
adversely affect safety. For example, if a refrigeration unit fails,
but product being stored there is moved to a functioning unit before
any appreciable warming of the product can occur, safety will not have
been affected.
FDA is proposing to require in Sec. 123.7(a)(2) that the safety
determination be made by an individual who has successfully completed
training in HACCP principles (see proposed Sec. 123.9). FDA has
tentatively concluded that this requirement is necessary to ensure that
the person who is reviewing the significance of the deviation
understands the possible consequences of a processing deviation and
knows how to take appropriate measures in response to a deviation. FDA
does not expect that a processor or importer will be able, without
assistance, to determine the public health consequences of every
possible deviation. The required training will, however, provide the
processor or importer with information about when and how to obtain the
assistance of an analytical laboratory, outside expert, State
regulatory authority, or FDA district office in determining the proper
course of action.
FDA is proposing to require in Sec. 123.7(a)(4) and (a)(5) that the
processor or importer review the process and the HACCP plan to
determine whether the deviation reveals the need to modify the process
or the plan, or both, and to make such modifications as may be needed.
It is critically important that a processor or importer learn as much
as possible from the occurrence of a deviation and take steps to ensure
that it will not be repeated. The plan should be a living document that
the processor or importer should modify and update as circumstances
warrant. These proposed requirements will ensure that the processor and
importer connect day-to-day processing and other operations to the
plan. Each modification is required to be noted, dated, and maintained
as part of their HACCP records.
FDA is proposing to require in Sec. 123.7(b) that when a processor
or importer receives a consumer complaint that may be related to the
performance of a critical control point or that may reflect a critical
limit deviation, it take appropriate steps to determine whether a
deviation or other system failure has occurred that warrants remedial
action and take such remedial action that appears to be warranted under
Sec. 123.7(a). The importance of consumer complaints has been discussed
above.
FDA recognizes that segregation and holding of the affected product
will not always be feasible or warranted in response to a consumer
complaint. In many cases, there will be no product to hold because all
of the product in question will already be in commerce. In other cases,
a processor or importer may be able to determine very quickly whether a
deviation has actually occurred.
FDA is proposing in Sec. 123.7(c) to require that processors and
importers clearly document all of the steps that they take in response
to a critical limit deviation or a consumer complaint and include that
documentation as part of their HACCP records. FDA has tentatively
concluded that the processor, the importer, and FDA will benefit from
this requirement. Documentation helps processors and importers to think
the whole process through in a thorough and methodical way and to
establish to their own satisfaction that they have taken proper steps.
Documentation enables the regulatory agency to determine whether the
processor or importer is able to regain control once a deviation occurs
and to ensure that potentially unsafe products are being prevented from
entering commerce or at least quickly removed from commerce.
The documentation that FDA is proposing to require of the
processor's or importer's response to the consumer complaints covered
by Sec. 123.7(b) will enable the processor, the importer, and FDA
reviewers to determine whether those consumer complaints are receiving
appropriate attention in a timely manner. The documentation should be
clear enough to allow a determination of the nature of the complaint
and of the time it took from the receipt of the complaint for processor
or importer to review it and to take any necessary corrective actions.
FDA may choose on occasion to review a limited number of consumer
complaints to match against the documentation maintained by the
processor or the importer.
There is a strong view in the HACCP literature (see e.g., Ref. 51),
which is reflected in one of NACMCF's seven principles listed above,
that processors should actually have a plan describing how they will
handle deviations, and that this plan should be part of the overall
HACCP plan. FDA believes that there is merit in this view and
encourages processors and importers to think through how they will
handle deviations that may occur. The agency has tentatively concluded,
however, that the proposed requirements in Sec. 123.7 represent the
minimum requirements necessary to ensure that processors and importers
respond effectively to deviations that could affect safety, and that
given these provisions, it is not necessary to require that a specific
plan be formulated and adopted. FDA requests comments on this tentative
conclusion.
E. Records
As discussed above, maintenance of appropriate records is
fundamental to the success of an HACCP system (see section IV.A.6. of
this document). In recognition of this fact, FDA is proposing to
require in Sec. 123.8 that HACCP records contain certain necessary
information; that processors review records of monitoring and related
activities before distributing the products to which the records
pertain; that processors and importers retain records for specific
periods of time; and that FDA investigators be given access to HACCP
records.
FDA is proposing in Sec. 123.8(a) that records involving
observations or measurements during processing, corrective actions, and
related activities, contain the identity of the product, product code,
and date that the record was made. The purpose of this provision is to
ensure that both the processor or importer and the regulator can
readily link a record to a product and to the timeframe in which the
product was manufactured. The linkage of the record to product is
especially important when there has been a deviation at a critical
control point. The agency has tentatively concluded that including the
identity of the product, product code, and date of the activity that
the record reflects provide the minimum necessary information to enable
the processor or the importer and, ultimately, the regulator to
determine what product may have been affected and to take appropriate
action, such as withholding the product from distribution or recalling
it from distribution. Dates also help discern trends over time. Even
when no deviation has occurred, the information will enable both the
processor and the regulator to identify factors that may help prevent
problems in the future.
In Sec. 123.8(a), FDA is also proposing to require that information
be recorded at the time that it is observed, and that each record be
signed by the operator or observer. It is important that information
relating to observations be recorded immediately to ensure accuracy.
The record should be signed by the individual who made the observation
to ensure responsibility and accountability. Also, if there is a
question about the record, a signature ensures that the source of the
record will be known.
FDA is proposing to require in Sec. 123.8(b) that records receive a
second review by an individual trained in accordance with Sec. 123.9,
for verification purposes, before the product is distributed into
commerce. The purpose of this review is to ensure that the processor or
importer verifies that employees are recording data in HACCP records,
and that deviations from critical limits are being caught before
products that may have been affected can enter commerce. The agency is
proposing to require that this records verification be performed by a
trained individual to ensure that the records are reviewed by a person
who understands the HACCP system, understands the significance of a
processing deviation, and knows how to respond if a deviation occurs.
FDA is proposing in Sec. 123.8(c) to require that HACCP records be
retained for at least 1 year after they are prepared for refrigerated
products and for at least 2 years after they are prepared for frozen or
preserved (i.e., shelf-stable) products. These timeframes are based on
the length of time that these products can be expected to be in
commercial distribution (Ref. 52; Ref. 53, pp. 72-73) plus a reasonable
time thereafter to ensure that the records are there when the FDA
inspector performs the next inspection. They are the same timeframes as
now provided for in the Manual of Operations of the NSSP for the
retention of records for raw molluscan shellfish.
Similarly, FDA is also proposing to require in Sec. 123.8(c) that
the processor retain any records relating to the general adequacy of
the equipment or processes being used by the processor, including the
results of scientific studies and evaluations to determine adequacy,
for 1 year beyond the applicability of these records to refrigerated
products being produced by the processor, and for 2 years beyond the
applicability of the records to frozen or preserved products being
produced by the processor. The processor may need to obtain a written
scientific evaluation of a process, such as a cooking, pasteurization,
or cooling process, to ensure that the process it is using is adequate
to destroy pathogens or to prevent their growth. Such an evaluation may
also be necessary to ensure the adequacy of the cooking, pasteurizing,
or refrigerating equipment that the processor is using. (See the
preamble discussion on cooked, ready-to-eat fishery products.) As with
processing records, these records should be retained for a period of
time that reflects the period that the products to which they relate
can be expected to be in commercial distribution.
FDA recognizes that some processing plants may be closed on a
seasonal basis. Given the nature of the HACCP system, however, FDA may
choose to inspect at least the records of a plant even if the plant is
not in operation. Therefore, FDA is providing in proposed Sec. 123.8(c)
that if a processing facility is closed between seasonal packs, the
records may be transferred to some reasonably accessible location
during the period of closure.
FDA is proposing to require in Sec. 123.8(d) that HACCP plans and
records be available for review and copying by authorized agency
employees at reasonable times. As already discussed, the agency's
access to HACCP records is essential to ensure that the HACCP system is
working, and that the safety of seafood is being ensured by design.
FDA's authority to require maintenance of these records, and to provide
for agency access to them, is fully supported by the holding in
National Confectioners Association v. Califano, 569 F.2d 694-95 (D.C.
Cir. 1978). In this case, the court recognized FDA's authority to
impose recordkeeping requirements on firms that process foods when such
requirements effectuate the goals of the act. See also Toilet Goods
Association v. Gardner, 387 U.S. 158, 163-164 (1967). The importance of
the records in ensuring that fish and fishery products will not be
rendered injurious to health has been fully discussed. FDA access to
these records will expedite the agency's efforts to ensure that the
fish and fishery products in interstate commerce are not adulterated
and to identify any such products that are.
FDA is aware that there is substantial public interest in the
extent to which industry-generated HACCP records could or should be
publicly available. As FDA understands it, the argument in favor of
availability is that where an inspection system to protect the public
health relies heavily on records, those records should be public to the
maximum extent possible. The arguments in favor of protection of
records, on the other hand, are based on concerns about advantages to
competitors from disclosure and on the risk that the records will be
otherwise misused if they become public. FDA invites comment on the
general question of public disclosure of HACCP records and on the
agency's preliminary analysis of their availability, as follows.
FDA has longstanding explicit statutory access to certain industry
records during inspections involving infant formula, drugs, and devices
and has access by regulation to certain processing records during
inspections of low acid canned food processors. The agency has the
right to copy and take possession of these records but does not
routinely do so. FDA typically copies and takes possession of records
only when they may be needed for regulatory purposes. As a preliminary
matter, FDA expects to continue that practice with regard to seafood
HACCP records.
The public availability of those HACCP records that FDA would
possess as a result of copying during an inspection would be governed
by section 301(j) of the act and by the Freedom of Information Act
(FOIA) and regulations issued pursuant to it by the Department of
Health and Human Services (DHHS) and FDA. Section 301(j) of the act
expressly prohibits FDA from disclosing trade secret information
obtained during the course of an inspection. The FOIA regulations also
say that FDA will not divulge either trade secret or commercial
confidential information. As a preliminary matter, HACCP plans and
monitoring records appear to fall within these two categories of
protected records. As a consequence, FDA may well have little
discretion in this area. Moreover, under DHHS' FOIA regulations,
processors may be entitled to challenge in court a pending disclosure
of records on the grounds that the records to be disclosed are
commercial confidential or trade secret.
As an additional matter, there are significant legal and practical
questions as to whether FDA has the authority to require disclosure of
industry records that are not in FDA's possession. As discussed
elsewhere in this document, FDA does not contemplate the submission of
HACCP plans or other records to FDA under these proposed regulations.
The preapproval of HACCP plans by FDA (and thus the submission of HACCP
plans to FDA) is simply not practical. The agency has tentatively
concluded that HACCP plans and monitoring records will be reviewed on
site by agency investigators as part of FDA's normal inspection regime.
FDA is proposing in Sec. 123.8(e) to exempt tags as defined in
Sec. 123.3(t) from the recordkeeping requirements of Sec. 123.8. While
the information on tags must be saved in accordance with the proposed
requirements of this section and Sec. 123.28(d), the agency has
tentatively concluded that it would be burdensome for processors to be
required to retain the tags themselves for extended periods of time.
NSSP now provides that processors are to retain tags for 90 days.
F. Training
Proposed Sec. 123.9 requires that each processor and importer
employ at least one individual who has successfully completed a
training course on the application of HACCP to fish and fishery
products processing. The agency has tentatively concluded that training
is critical to the successful implementation of HACCP systems in the
seafood industry. Based on experience obtained during the FDA/NOAA
HACCP pilot programs in 1991-92, the agency believes that a significant
portion of the seafood industry will be unprepared to meet the
requirements of a mandatory HACCP program without some training. As
discussed earlier, the pilot program revealed a general lack of
understanding of the preventive nature of HACCP, including
misunderstandings about how to establish critical limits, control
measures, corrective actions, and recordkeeping procedures (Ref. 40).
A similar concern that the industry did not understand the
application of HACCP principles formed the basis for the training
requirements in the agency's regulations for low acid canned foods.
Improvements in canning operations can be attributed in significant
measure to the success of the training programs that were established
to implement that requirement (Ref. 54). NAS concluded that the
successful application of HACCP principles to low acid canned foods was
substantially the result of the training requirement in the regulations
for those products (Ref. 36, p. 309). The CGMP regulations for foods in
part 110 also call for training in appropriate food protection
principles (Sec. 110.10(c)).
The often seasonal nature, remote location, and small size of many
seafood processors also support the need for formalized training. All
of these conditions result in difficulty recruiting highly qualified
management and supervisory staff. Thus, FDA has tentatively concluded
that proposed Sec. 123.9 is necessary to ensure that seafood processors
and importers employ at least one person who is familiar with HACCP.
These regulations propose to require at Sec. 123.9 that the person
or persons at each importing and processing establishment who has
received training be responsible for reviewing records of critical
control point monitoring, recognizing critical limit deficiencies, and
assessing the need for corrective actions relative to the product in
question and the HACCP plan itself. While it is the intent of the
agency to provide as much guidance as possible to assist processors and
importers, these activities require specialized training in the
principles of HACCP, various aspects of food science, and the criteria
of existing regulations and guidelines.
The agency anticipates that 2- or 3-day training sessions, modeled
after the Better Process Control Schools currently in place for low
acid canned food and acidified food manufacturers, will be provided by
various public and semiprivate institutions. The uniformity of this
training can be assured by a review of their contents and by periodic
onsite monitoring by the agency. Thus, FDA is proposing to require that
the program of instruction be approved by the agency.
While 2- or 3-day courses may well become the norm, FDA invites
comment on whether the training requirement could be satisfied by
different gradations of training, depending on the complexity or size
of the operation, or on the degree of risk posed by the product being
produced, without compromising the purposes for which training is
proposed to be required. For example, could training for a small
business with few hazards be accomplished in a shorter time and at a
lower cost through the use of a video? FDA also invites comment on
whether training in HACCP received before these proposed regulations
become effective as final regulations should be ``grandfathered'' as
fulfilling the training requirement.
G. Sanitation Control Procedures
1. General
FDA is proposing to require in Sec. 123.10 that processors and
importers that engage in processing perform sanitation inspections at
specified frequencies and maintain sanitation control records that
document the results and frequency of those inspections. If these
regulations are adopted, the sanitation control records will be subject
to the recordkeeping requirements in Sec. 123.8, including review by
FDA investigators.
For seafood, sanitary practices affect most directly the safety of
those products that do not receive any further cooking by the consumer.
These products include raw molluscan shellfish; finfish destined to be
consumed as sushi; cooked, ready-to-eat products; and certain smoked
and salted products. Both finfish and shellfish are regarded as
microbiologically sensitive foods based on the potential presence of
pathogens, notably L. monocytogenes (Ref. 55, pp. 31 and 32).
L. monocytogenes is a pathogenic bacterium that is widespread in
the environment. Thus, the likelihood of finding it on the exterior
surfaces and viscera of fish is high. Since 1983, several large
outbreaks of human listeriosis have been linked to contaminated foods.
Although it is a relatively rare illness, the exceptionally high
mortality rate among susceptible individuals makes this illness one of
the leading fatal foodborne diseases in the United States.
Numerous seafood products have been shown to support growth of L.
monocytogenes (Refs. 56 and 57), and seafoods have been
epidemiologically linked to two outbreaks and one sporadic case of
listeriosis (Ref. 58). Furthermore, several cooked seafood products
have been recalled from the market in North America because of
contamination with L. monocytogenes (Ref. 27). Seven of nine smoked
fish processing facilities recently inspected by FDA in New York State
had L. monocytogenes in the environment or in the products (Ref. 59).
Good sanitation practices are critical to the prevention of
listeriosis and other microbiologically related foodborne illnesses.
FDA's CGMP regulations for food in part 110 set out general principles
of sanitation that should be followed in plants that manufacture,
package, label, or hold human food. They address such matters as
personal hygiene and cleanliness among workers who handle food, the
suitability of the plant design to sanitary operations, and the
cleaning of food-contact surfaces. FDA inspections of seafood
processors apply the principles in part 110.
Nearly half of the consumer complaints relating to seafood that FDA
receives in a typical year are related to plant or food hygiene (Ref.
60). The reasons, while not entirely clear, appear to be related to
factors such as the age of processing facilities, the seasonal nature
of operations that affect training, and the turnover of personnel.
A representative cross section of those FDA establishment
inspection reports (EIR's) for domestic seafood manufacturers that
revealed CGMP deficiencies for fiscal years 1988-90 demonstrates this
point (Ref. 61). The cross section involves 795 EIR's covering 561
facilities. (The number of EIR's exceeds the number of facilities
because followup visits were made to check on the status of corrective
actions.) The following percentages refer to EIR's with deficiencies
where at least some of the deficiencies involved sanitation:
(1) Twenty-three percent documented receiving area facilities that
were not clean/orderly or in good repair.
(2) Twenty-six percent documented facilities lacking effective
insect and rodent control measures in the receiving area.
(3) Sixteen percent documented failure to handle ice in a sanitary
manner and to protect it properly.
(4) Thirty-five percent documented lack of adequate cleaning or
sanitizing of processing equipment.
(5) Twenty-one percent documented processing equipment that was not
constructed so that it could be easily cleaned and sanitized.
(6) Eighteen percent documented processing equipment that was not
made of suitable materials.
(7) Fifteen percent documented hand sanitizers that were not kept
at proper sanitizing levels.
(8) Eighteen percent documented failure to have hand sanitizers
available in the processing area.
(9) Thirty percent documented processing areas that were not
maintained in a clean and sanitary manner.
(10) Forty-two percent documented processing areas with exterior
openings that were not sealed/covered properly to prevent the entrance
of pests or insects.
(11) Sixteen percent documented waste material not being collected/
covered in suitable containers or not being disposed of properly.
(12) Twenty-three percent documented handling of finished product
in a manner that did not preclude contamination.
(13) Twenty-two percent documented employees not taking necessary
precautions to avoid food contamination.
During fiscal years 1991-92, FDA conducted abbreviated inspections
of nearly all domestic manufacturers in its seafood establishment
inventory. These inspections provide data on sanitation practices and
conditions that are generally consistent with the above findings (Ref.
62). Examples of these data are:
(1) Sixteen percent of firms had problems with the general
sanitation condition of their processing areas. (This percentage is
lower than for item 9 above because the universe is all firms, not just
firms with deficiencies.)
(2) Nineteen percent of firms did not clean and sanitize their
processing areas or equipment throughout the day's production. (This
matches most closely with item 4 above but is lower, presumably for the
reason stated in the previously numbered paragraph.)
(3) Twenty-eight percent of firms had employees that were not
following proper sanitation practices in processing activities. (This
figure does not precisely match any of the items listed above because
the EIR's break employee practices down into specific categories, such
as the wearing of hair nets. Some categories involve relatively minor
matters, others are more significant. Findings with respect to these
employee practices were not listed above for the sake of brevity.)
(4) Twenty percent had employees that were not following proper
sanitation practices for packaging and finished product storage. (The
parenthetical observations in the previously numbered paragraph apply
here as well.)
(5) Thirty-six percent of firms either lacked hand sanitizers in
their processing areas or had sanitizers that were not kept at proper
sanitizing levels. (This finding is equivalent to a combination of
items 7 and 8 above. Surprisingly, this finding is roughly the same as
7 and 8 added together, even though it includes all processors rather
than processors with deficiencies.)
Sanitation problems found by NMFS during the operation of its fee-
for-service inspection program for seafood manufacturers, as described
earlier, are generally consistent with FDA's findings. Entrants into
the NMFS program undergo initial sanitation surveys by NMFS and are
checked for sanitation practices thereafter. NMFS' data show
significant sanitation deficiencies during the initial surveys (Ref.
35, p. 40). Some of the most common for 1989 include:
(1) Sixty-four percent of plants had discrepancies relating to
proper cleaning and sanitizing of product contact surfaces or
equipment, containers, or utensils after use.
(2) Fifty-one percent of plants had discrepancies relating to
design, materials, or construction that prevented their being
maintained in a sanitary manner.
(3) Forty-five percent of plants had discrepancies relating to
design of equipment, containers, and utensils so that they did not
provide protection from contaminants and could not be readily cleaned
and effectively sanitized.
(4) Forty-three percent of plants had discrepancies relating to
improper storage of equipment, litter, waste, uncut weeds, and grass.
(5) Forty percent had discrepancies relating to storage facilities
that were not clean, sanitary, or in good repair.
For established participants in the NMFS program (as opposed to
entrants), the percentages with discrepancies in the above areas for
1989 were: 49 percent; 47 percent; 25 percent; 49 percent; and 33
percent (Ref. 35, p. 42).
FDA has tentatively concluded on the basis of all of these findings
that HACCP-type controls for sanitation as proposed below are needed.
The sanitation measures required under proposed Sec. 123.10 are
fundamental to good sanitation practices and can have a bearing on
human safety. The agency recognizes, however, that depending on the
conditions in a facility, additional measures may be necessary (see,
e.g., part 110). FDA will expect processors to include those measures
in their sanitation practices but tentatively concludes that it is not
necessary to include them in the fundamental core of required steps.
FDA acknowledges the conclusion of the MSSP project that, for
seafood at least, it is possible to include sanitation within an HACCP
system without unduly overburdening that system with large numbers of
critical control points. The FDA/NOAA HACCP-based seafood pilot program
included critical control points for sanitation. For these regulations,
however, FDA has tentatively decided to propose specific HACCP-type
requirements for sanitation, rather than require that processors
identify critical control points for sanitation in their HACCP plans.
The proposed requirements in Sec. 123.10 potentially relate to an
entire facility, not just to a limited number of critical control
points. FDA tentatively concludes that this step is necessary to fully
implement section 402(a)(4) of the act and yet at the same time not
overload the HACCP system. FDA invites comments on this approach.
In particular, FDA invites comment on whether sanitation
requirements should be enumerated as in proposed Sec. 123.10. The
logical alternative would be to leave sanitation as one of the
procedures that is to be identified and addressed in HACCP plans for
the control of microbiological and physical hazards (see proposed
Sec. 123.6(b)(1)(ii), (b)(1)(ix), and (b)(4)), but not to have specific
provisions in the regulations as to how sanitation is to be achieved.
Good sanitation blocks avenues for the introduction of pathogens,
harmful chemicals, and physical objects and is an essential preventive
control for safety. Even if a product is to be cooked by the consumer,
the load of microbiological pathogens on that product when received by
the consumer is still relevant to safety. FDA's prescriptive approach
to sanitation in proposed Sec. 123.10 is intended to assist processors
to provide the greatest protection for consumers. Nonetheless, FDA
invites comment on whether an alternative approach as described above
would ensure this protection at less cost.
FDA is proposing in Sec. 123.10(a) to require that processors
conduct sanitation inspections to ensure that the sanitation conditions
in Sec. 123.10(a)(1) through (a)(17) are met. FDA recognizes that the
nature of the operations conducted by a processor affects the hazards
that may be presented by the product. Processing other than storing
usually involves manipulation of exposed, i.e., unpackaged, fish and
fishery products. Both the manipulation and the exposure subject the
product to all the hazards that can occur from unsanitary practices.
Storage, on the other hand, can subject the product to some, but
nowhere near all, of the hazards associated with insanitation.
Consequently, FDA is proposing to require that processors of fish and
fishery products inspect for those conditions in Sec. 123.10(a)(1)
through (a)(17) that are appropriate to their circumstances. FDA
expects that, at a minimum, in, for example, storage facilities, such
inspections will include ensuring against the presence of vermin,
because this is a frequent problem in warehouses that can affect
products even when they are being stored in a packaged state.
In Sec. 123.10(a)(1), the agency is proposing to require that
processors ensure that water that contacts the product or food-contact
surfaces, or that is used in the manufacture of ice, is derived from a
safe and sanitary source or is treated to render it of safe and
sanitary quality. Water is used in virtually all fish and fishery
product processing facilities for washing raw materials, product
contact surfaces, and employees' hands. It is used to transport fish
through the plant in water flumes. In addition, water is often an
ingredient, as in soups and glazes. Contaminated water can serve as a
vehicle for contamination of the product, both directly and indirectly
(Refs. 63, 64; 65, p. 49; 66, 67, and 68, pp. 1 and 2). It can also
serve as a vehicle for contamination as the ice in which the product is
stored.
The safety and sanitary quality of water from United States and
some foreign public water systems is generally ensured through public
water treatment, chlorination, or monitoring and control by local
health authorities. Where this assurance exists, FDA does not
anticipate that processors will need to implement any additional
controls.
Private sources of water, particularly surface waters or water from
shallow wells, may be subject to microbiological, chemical, or
radiological contamination attributable to the source itself or to
surface contamination at the well head or intake. Private sources are
also frequently untreated or minimally treated (Refs. 69, p. 15; and
70). Where the processor uses a private source of water, it will need
to take steps to ensure that the water is of a safe and sanitary
quality. These steps may include retaining a copy of the initial local
health authority well design approval and copies of the local health
authority fecal coliform test results; obtaining and maintaining copies
of private coliform test results; performing and recording periodic
inspections of the sanitary condition of the well head or source
intake; and performing and monitoring appropriate water treatment
procedures, including filtration, sedimentation, and chlorination.
The type and frequency of controls exercised by the processor
should be based upon the type of source water and its historic safety
and sanitary quality. Consequently, the agency is proposing to require,
in Sec. 123.10(c)(3), that such controls be performed and documented at
such frequency as necessary to ensure control. In Sec. 123.10(a)(2), as
a means of ensuring that potable water does not become contaminated,
the agency is proposing to require that the processor ensure that there
are no cross connections between the potable water system and any
nonpotable systems. Nonpotable systems include waste water and sewage.
Cross connections, which include situations that allow for back
siphonage into a potable system from a nonpotable system under negative
pressure conditions, can result in the chemical or microbiological
contamination of the potable water system (Refs. 64; 65, pp. 50 and 51;
68, 71, and 72). For example, if a hose from a potable water system is
left in a thawing tank with water and frozen fish, and if negative
pressure occurs that draws water from the tank back through the hose to
the potable water system, both the potable water line and the water
source itself, i.e., the municipal or private water system, can become
contaminated.
Cross connections can best be controlled by performing periodic
inspections of the potable and nonpotable systems. These inspections
should be performed at least every time that there is a change in the
plumbing of the systems and with sufficient additional frequency to
ensure that unintentional cross connections do not develop.
Consequently, in Sec. 123.10(c)(3), the agency is proposing to require
that such inspections be performed and documented at such frequency as
necessary to ensure control.
FDA is proposing in Sec. 123.10(a)(3) to require that the processor
ensure that all food-contact surfaces are designed, constructed, and
maintained in a manner that minimizes the potential for chemical and
microbiological contamination of the product. Utensils and equipment
can be vehicles for microbial contamination of both the raw and
finished products. Utensils, equipment, and other food-contact surfaces
that are made of corrosive material or wood, or that contain breaks,
pits, cuts, or grooves, may harbor pathogenic microorganisms that can
migrate to the product and contaminate it. These kinds of surfaces are
difficult to clean, with the pores and crevices shielding the
microorganisms from the action of cleaning and sanitizing agents (Refs.
65, pp. 20, 36-48; 72, pp. 166 and 167; and 73).
Additionally, where food-contact surfaces are constructed of toxic
materials (e.g., lead shucking blocks), the product may be directly
contaminated with the toxic material (Ref. 74). Therefore, FDA
tentatively concludes that it is necessary to require that processors
take affirmative steps to minimize the possibility that any risks will
be created by the utensils and equipment they use.
Proper construction of the equipment should be ensured at the time
it is received, and whenever it is modified or repaired. The frequency
of subsequent inspections necessary to ensure that the sanitary
condition of the equipment has not declined with time will depend on
the frequency of its use, the materials and construction methods, and
the nature of its use. In Sec. 123.10(c)(3) the agency is proposing to
require that such controls be performed and documented with such
frequency as is necessary to ensure control.
In Sec. 123.10(a)(4), the agency is proposing to require that the
processor ensure that food-contact surfaces are regularly cleaned and
sanitized with cleaning and sanitizing preparations that are suitable
for this purpose. Surfaces that are not adequately cleaned and
sanitized can be a source of filth to subsequent products produced on
the equipment, an attractant for vermin, and a reservoir for pathogenic
microorganisms. Infrequent cleaning of equipment can result in the
formation of biofilms, microscopic films in which microorganisms can be
entrapped, shielded from the action of sanitizers, and physically bound
to the food-contact surface of the equipment.
An effective cleaning compound is one that will lower the surface
tension of water so that spills can be lifted and flushed away.
Ordinary soap is generally ineffective for equipment washing because of
its limited ability to solubilize fats, oils, and proteins. Mildly
alkaline detergents are generally suitable for cleaning seafood
processing plants, but high alkaline detergents are often necessary for
heavy buildups of fats and proteins. Mineral deposits will frequently
require the use of acid cleaners.
An effective sanitizing agent is one that has a good bacteriocidal
effect on the types of pathogens normally present in the plant
environment and is safe, stable, and convenient for use. Examples
include hypochlorites, iodophors, and quaternary ammonium compounds
(Refs. 73, 74, 75, 76, and 77).
To eliminate the product residue that accumulates on product
contact surfaces during production, FDA is proposing in
Sec. 123.10(a)(4)(i) to require that utensils and surfaces of equipment
that contact food during processing be thoroughly washed at the end of
the day's operations. FDA is also proposing in Sec. 123.10(a)(4)(iii)
that sanitizing be performed on the same utensils and equipment
immediately before the beginning of production, so that any
recontamination that occurs between cleaning and production can be
eliminated.
FDA is proposing to require in Sec. 123.10(a)(4)(ii) that, in those
operations in which microbiological contamination can adversely affect
the safety of the product (e.g., the processing of cooked, ready-to-eat
products), the equipment also be washed and sanitized at least every 4
hours during processing. Washing and sanitizing with this frequency is
necessary to inactivate mesophilic pathogens, such as Salmonella spp.,
before they leave the lag phase of growth and enter the rapid log phase
(Ref. 23). Temperatures in fish and fishery product processing plants
are generally not low enough to control the growth of such
microorganisms and are certainly not low enough to control the growth
of such psychrotropic pathogens as L. monocytogenes (Refs. 23, 78, 79,
and 80). Therefore, FDA tentatively finds that washing and sanitizing
equipment every 4 hours is necessary.
FDA is proposing to require both cleaning and sanitizing because
neither step is fully effective without the other. When sanitizing
occurs without benefit of cleaning, pathogenic microorganisms can be
protected from the action of the sanitizer by food residue. Conversely,
while cleaning can effectively remove product residue and a portion of
the microorganisms, sanitizing is generally needed to remove the
remaining microorganisms (Refs. 81 and 82).
FDA is proposing to require in Sec. 123.10(c)(2) that the processor
inspect the condition of the utensils and surfaces of equipment that
contact food immediately after each cleaning and sanitizing. The
purpose of the inspection is to ensure the adequacy of the cleaning and
sanitizing operations, and to ensure that the equipment is in a
condition that is suitable for further operations.
The agency is also proposing in Sec. 123.10(c)(2) that the
processor document the time of each cleaning and sanitizing, the
concentration of the sanitizer, and the condition of the equipment.
Documentation of the time of each cleaning and sanitizing will
facilitate an assessment of compliance with the frequency requirement
of Sec. 123.10(a)(4). Documentation of the concentration of the
sanitizer will facilitate an assessment of the adequacy of the
sanitizing operation. Sanitizers must be of sufficient strength to be
effective, while excessive sanitizer concentrations can contaminate the
product with indirect food additives (21 CFR part 178) (Ref. 82).
Documentation of the condition of the equipment is necessary to ensure
that it is examined after cleaning and sanitizing to make sure that
these processes were done properly.
The agency is proposing in Sec. 123.10(a)(5) to require that the
processor ensure that gloves and outer garments that contact the food
or food-contact surfaces are made of an impermeable material and are
maintained in a clean and sanitary condition. Gloves or aprons that are
made of cloth or other porous materials are difficult to clean and may
serve as a reservoir for pathogenic microorganisms that can migrate to
the food during processing, in much the same manner as previously
described for processing equipment (Refs. 65 and 83). Gloves and aprons
that are not maintained in a clean and sanitary condition can also
house pathogens that can migrate to the food. Therefore, FDA
tentatively finds that it is appropriate to require the measures set
out in Sec. 123.10(a)(5).
At Sec. 123.10(c), the agency is proposing to require that, like
most of the other sanitation measures that FDA is proposing, the
sanitary condition and impermeability of gloves and outer garments that
may contact the food or food-contact surfaces be checked at least daily
while processing operations are occurring. Such checking will ensure
that employees arriving for work are equipped with gloves and outer
garments that will not serve as a source of contamination to the
product. It will also ensure that employees are never using personally
owned gloves and garments that are made of materials that are
unsuitable for the processing environment. Proposed Sec. 123.10(c) also
requires that such checking be documented on a daily basis to provide a
record that such checking has occurred.
Under proposed Sec. 123.10(a)(6), the processor must ensure that
employees' hands, gloves, outer garments, utensils, and food-contact
surfaces that come into contact with insanitary objects are thoroughly
cleaned and sanitized before contacting fish or fishery products. Under
proposed Sec. 123.10(a)(7), the processor must also ensure that
employees' hands, gloves, outer garments, utensils, and food-contact
surfaces that contact raw products are thoroughly cleaned and sanitized
before they contact cooked product.
Employees and food-contact surfaces can serve as vectors in the
transmission of filth and pathogenic microorganisms to the food. Filth
and pathogenic microorganisms can be brought into the processing
environment on the employees' hands from outside areas, restrooms,
contaminated raw materials, waste or waste receptacles, floors, and
other insanitary objects (Refs. 63, 64, 73, 74, 84, and 85).
Bacteria naturally present on fresh fish skin and gills and in the
gastrointestinal tract reflect the microbial content of the water from
which the fish were harvested. Typical microorganisms found on and in
fresh fish include C. botulinum, enteric bacteria, Vibrio
parahaemolyticus, salmonella, shigella, hepatitis A, and other
microorganisms that pollute harvest waters (Ref. 7). These
microorganisms contaminate the environment in processing plants and
cannot, using reasonable methods, be completely eliminated.
Proper precautions, such as proper hand and equipment cleaning and
sanitizing, must be taken to minimize opportunities for contamination
of the finished product (Refs. 63, 64, 73, 74, and 84). Therefore, FDA
is proposing in Sec. 123.10 (a)(6) and (a)(7) that such precautions be
taken with respect to hands, gloves, garments, utensils, and food-
contact surfaces.
The agency recognizes that not all processing activities will
require hand washing and sanitizing. Activities that would not require
such steps include the handling of raw fish and fishery products prior
to the initial washing step (i.e., directly from the fisherman) and the
handling of finished products in shipping cases. These activities are
exceptions, however, to the general rule that employees must thoroughly
wash and sanitize their hands after each contact with an insanitary
surface. Additionally, when insanitary objects come into contact with
product contact surfaces, they must be thoroughly cleaned and
sanitized.
In the processing of cooked products, the raw material may also
serve as a reservoir of pathogenic microorganisms. For this reason,
employees or equipment that handle or touch the raw material must be
cleaned and sanitized before being used with cooked product or ice, or
they could convey the microorganisms to these foods (Refs. 63, 64, 73,
74, 84, 87, and 88).
In Sec. 123.10(c)(1), the agency is proposing to require that the
sanitary practices of the employees, especially as they relate to hand
washing, sanitizing practices, and the potential for cross
contamination, be checked and recorded at least every 4 hours during
processing. This monitoring will ensure that employees arriving for
work and returning from the midshift break have properly washed and
sanitized their hands. The concentration of hand sanitizing solutions
tends to be reduced over the course of a production day because of the
reaction of the sanitizer with organic matter and dissipation as a gas
(Ref. 82). It will also cause a regular assessment of the adequacy of
the normal operating procedures. Finally, recording will provide
assurance that appropriate procedures are being followed.
In Sec. 123.10(a)(8)(i), FDA is proposing to require that hand
washing facilities be located in all processing areas in which washing
and sanitizing is required by CGMP's so that these facilities are
readily accessible to employees who work in processing areas. The
agency has tentatively concluded that proper sanitization is such an
important part of preventing the spread of disease as to warrant a
requirement that hand washing equipment be conveniently located to
facilitate their use. Where these facilities are not conveniently
located, they may not be frequented by the employees.
FDA is proposing to require in Sec. 123.10(a)(8)(ii) that these
facilities be equipped with hand cleaning and effective sanitizing
preparations and single-service towels or suitable hand drying devices.
Ordinary soap is acceptable for hand washing. Hand sanitizers need to
be fast acting because of the short contact time involved. In contrast
to the sanitizing of equipment, which can involve leaving a sanitizing
spray on the equipment for extended periods of time, hand sanitizing
usually involves a quick dip in and out of the sanitizer. Of the
sanitizers described previously (see discussion of proposed
Sec. 123.10(a)(4)), quaternary ammonium is not fast acting and is not
suitable as a hand sanitizer. The others are appropriate as hand
sanitizers.
The agency is proposing to require single-service towels or
suitable hand drying devices to ensure that microbiological
contamination does not occur though the repeated use of the same towel
by several individuals. A hot-air blower is an example of a suitable
hand drying device because contamination from individual to individual
is eliminated.
In Sec. 123.10(c)(3), the agency is proposing to require that
inspection and documentation of the location of hand washing facilities
be performed at sufficient frequency to ensure that there is compliance
with Sec. 123.10(a)(8)(i). Generally, this procedure will be necessary
only after construction or any significant building or process
modification.
FDA is proposing to require in Sec. 123.10(c) that the processor
inspect, and document that it has inspected, the hand washing and hand
sanitizing facilities to ensure that they are properly equipped no less
than once per day. This procedure will ensure that cleaning and
sanitizing preparations, as well as towels or hand drying devices, are
present whenever needed by employees.
FDA is proposing to require at Sec. 123.10 (a)(9) and (a)(10) that
the processor protect the food, food-contact surfaces, and food
packaging materials against adulteration by chemical and physical
contaminants. Such protection is necessary to ensure that the food
produced by the processor is safe. The use of toxic compounds (e.g.,
pesticides, cleaning and sanitizing agents, and lubricants) is
frequently necessary in the processing environment. For example,
lubricants and fuel are necessary to operate equipment. Improper use of
these compounds is a frequent cause of product adulteration throughout
the food industry (Ref. 74). Thus, it is necessary to ensure that food,
food-contact surfaces, and food packaging materials are not
contaminated by these toxic compounds. Food and food packaging material
should be protected or removed from areas where pesticides are used,
and caustic cleaning compounds should be thoroughly removed from food-
contact surfaces before processing begins. Finally, as an additional
protection, FDA is proposing to require in Sec. 123.10(a)(10) that
toxic compounds be labeled, held, and used in a manner that minimizes
the risk of contamination of the product.
FDA is proposing to require in Sec. 123.10(c) that the processing
plant be inspected daily to ensure that the food is protected from
toxic compounds, and that this inspection be documented. This check
should normally be performed before the start of operations, at a time
when the equipment can be effectively inspected, and in time to prevent
adulteration of the product. Because processing conditions vary on a
day-to-day basis, FDA has tentatively concluded that daily inspection
is necessary.
FDA is proposing to require at Sec. 123.10(a)(11) that the
processor ensure that products are not exposed to contaminants that may
drip, drain, or be drawn into the food. An example of such a
contaminant is condensate, which may form on the ceilings and equipment
in a processing plant. If the condensate forms on an insanitary surface
and then falls on the product, it may carry with it filth and
microbiological contaminants from that surface to the food (Ref. 65,
pp. 24 and 25).
In Sec. 123.10(c), the agency is proposing to require that the
processing plant be inspected daily to ensure that the potential for
such contamination is minimized, and that this inspection be
documented. This check should normally be performed during the actual
operations, at a time when condensate or other such contaminating
conditions are likely to be present. As explained above, the agency has
tentatively concluded that daily variations in processing and climatic
conditions necessitate daily inspection.
In Sec. 123.10(a)(12), the agency is proposing to require that the
processor ensure that compressed gases that contact food or food-
contact surfaces of equipment are filtered or treated in such a way
that the food is not contaminated with unapproved indirect food
additives or other chemical, physical, or microbiological contaminants.
Compressed gases can be contaminated with oil from the compressor,
filth and microbiological contaminants from the air intake, and rust or
other physical contaminants from the compression, storage, and
distribution equipment. Filtration at the air intake and after
compression, storage, and distribution is an effective means of
reducing the risk of such contaminants entering the food (Ref. 89).
FDA is proposing to require in Sec. 123.10(c)(3) that the
filtration and other equipment used to protect the food from such
contaminants be inspected, and the inspection documented, with such
frequency as is necessary to ensure control. Normally, this frequency
will be directed by the manufacturer of the filtration equipment. FDA
is not proposing to require daily inspection because the filter and
related equipment do not normally need cleaning or replacement on a
daily basis.
FDA is proposing to require in Sec. 123.10(a)(13) that the
processor take action to ensure that unprotected cooked, ready-to-eat
fishery products, smoked fishery products, raw molluscan shellfish, and
raw fish and fishery products are physically separated from each other
during refrigerated storage. Cooked, ready-to-eat products are products
that will not normally receive a cooking by the consumer adequate
enough to kill pathogens. Therefore, any microbiological
recontamination of the product after cooking can subject the consumer
to health risks. Raw molluscan shellfish may contain pathogens that can
cause severe illness to certain at-risk individuals, e.g., those who
are immunocompromised. These individuals might know to avoid eating raw
molluscan shellfish but would not expect the same health risk from
cooked, ready-to-eat products. Similarly, raw fish and fishery products
may contain filth and pathogenic microorganisms not normally associated
with raw molluscan shellfish or cooked, ready-to-eat products (Refs. 63
and 84).
In Sec. 123.10(c), the agency is proposing to require that
refrigerated storage areas be inspected at least daily to ensure that
the three types of products are physically separated from each other.
This check should normally be performed during actual operations, at a
time when commingling of these products is likely to take place. The
agency has tentatively concluded that daily inspection is necessary
because products are normally moved in and out of refrigerated storage
areas on a regular basis, creating an ongoing threat that problems will
occur.
FDA is proposing to require in Sec. 123.10(a)(14) that refrigerated
storage units operate at 40 deg.F (4.4 deg.C) or below when storing
raw materials, in-process or finished cooked, ready-to-eat fishery
products, smoked fishery products, and fish and fishery products made
in whole or in part of scombroid toxin forming species. The purpose of
this requirement is to ensure that processors control microbiological
hazards associated with refrigerated storage for these products (Refs.
85 and 86). Cooked, ready-to-eat products as defined in proposed
Sec. 123.3(b) and smoked fishery products (see Appendix 1) are not
shelf-stable and must be kept refrigerated to retard the growth of
microorganisms. As stated above, these products will not normally be
cooked by the consumer at a sufficient temperature to destroy any
pathogens that may be present. Scombroid toxin forming species are
addressed in considerable detail later in this document. These species
can form a toxin harmful to humans if subjected to time/temperature
abuse after capture.
Proper refrigeration is essential for fish and fishery products
that include these species. Maintaining product temperatures during
storage in a range that will minimize the growth of mesophilic and
psychrotropic pathogens is necessary to ensure product safety
throughout the shelf life of these products (Ref. 85). It is uniformly
more convenient to control refrigeration unit temperatures than to
control and monitor the internal temperatures of the various products
under refrigerated storage, particularly when these products are in
sealed containers. For these reasons, FDA is proposing that
refrigeration units be operated at or below 40 deg.F (4.4 deg.C). FDA
tentatively finds that this temperature is appropriate because it is
adequate to minimize the growth of pathogens (Refs. 85 and 86.) The
agency also strongly recommends this temperature or lower for all fish
and fishery products that need refrigeration, regardless of whether
safety is an issue. The agency is also especially interested in
obtaining comment on the appropriateness of this temperature.
In Sec. 123.10(c)(4) the agency is proposing to require that the
processor use instruments that monitor the temperature of refrigeration
units on a continuous basis. The measurements from those instruments
must be checked and documented with such frequency as is necessary to
ensure control.
Continuous monitoring ensures that temperature fluctuations above
40 deg.F (4.4 deg.C), if any, as a result of circumstances such as
heavy cooler loading, frequent cooler entry, or power failures, are
quickly detected. The guideline for cooked, ready-to-eat products, in
Appendix A, section 6, describes alternative ways to continuously
monitor the temperature. A temperature-recording device can show both
the high temperature and the length of time that refrigeration unit was
operating at that temperature. Maximum-indicating thermometers and high
temperature alarms also show that the critical limit has been exceeded
but cannot show the duration of the deviation. Consequently, when a
maximum-indicating thermometer or high temperature alarm reveals a
deviation, the processor will need to assume loss of control since the
last time that the measurements displayed by the instruments were
checked, unless reasonable evidence exists to the contrary. The more
frequent such checks are made, the lower the risk to which the
processor is exposed. During periods when the refrigeration unit is not
frequently entered and the load is constant, such as overnight, it is
reasonable to reduce the frequency. However, during periods of heavy
use and frequent entry, the frequency should be increased.
FDA is proposing to require in Sec. 123.10(a)(15) that the
processor ensure that persons with sores or illnesses that present an
increased risk for product contamination are excluded from those areas
of processing where such contamination is likely. Employees can serve
as a reservoir of foodborne diseases, such as salmonellosis,
shigellosis, and hepatitis, that can be passed on to the consumer
through the fecal-oral route. Additionally, open sores, boils, or
infected wounds present the potential for contamination of the food
with such pathogenic microorganisms as Staphylococcus aureus. Employees
with suspicious illnesses or sores can be effectively screened upon
arrival at the processing facility with minimal personal intrusion
(Refs. 22, 74, and 84).
In Sec. 123.10(c), the agency is proposing to require that such
screening, and documentation of the screening, take place daily. This
frequency will ensure that changing health conditions of the employees
are not missed.
In Sec. 123.10(a)(16), the agency is proposing to require that the
processor ensure that toilet facilities are available and maintained in
a sanitary condition and in good repair, and that these facilities
provide for proper disposal of the sewage. Toilet facilities eliminate
from the processing environment pathogenic microorganisms shed in fecal
material. Where fecal material is not properly conveyed from the
processing plant to an acceptable treatment facility, restroom floors
and grounds around the processing facility can become contaminated with
pathogens. Foot traffic over the affected areas can introduce pathogens
to the processing room and cause product contamination. Insanitary
toilet facilities can also increase the potential for contamination of
employees' hands and, ultimately, the product (Refs. 64 and 74).
FDA is proposing to require at Sec. 123.10(c) that the toilet
facilities be inspected, and the inspection be documented, to ensure
that they function properly and are in a sanitary condition at least
every day. Ordinarily this inspection should be performed before each
day's operation to ensure that the facility is ready at the beginning
of the day.
In Sec. 123.10(a)(17), the agency is proposing to require that the
processor ensure that no pests are present in the processing area.
Pests, such as rodents, birds, and insects carry a variety of human
disease agents, which they can introduce to the processing environment
(Refs. 63, 64, 73, and 84). Additionally, their feces constitutes filth
which can contaminate the food. A daily inspection of the processing
facility, as proposed in Sec. 123.10(c), serves to assess the
effectiveness of the processor's pest control activities and redirect
them where necessary.
In Sec. 123.10(a)(18), the agency is proposing to require that the
processor ensure that the plant is designed to minimize risk of
contamination of the food. Proper construction is essential if the
other sanitary measures that FDA is proposing to require are to be
successful. It includes the isolation of incompatible operations, such
as the handling of raw materials and the processing of cooked products
(Refs. 71, 74, 87, and 88). A periodic inspection of the facility for
structural defects, product flow, and general building condition is
necessary to ensure that these attributes do not pose an increased
potential for product contamination. In Sec. 123.10(c)(3), the agency
is proposing to require that such controls be performed and documented
with sufficient frequency to ensure control.
FDA is proposing to require at Sec. 123.10(b) that processors
maintain sanitation control records that document the occurrence and
findings of the inspections required by Sec. 123.10(a) as well as the
frequency required by Sec. 123.10(c). FDA is also proposing to require
that the problems found during these inspections be corrected, and the
corrections recorded in accordance with proposed Sec. 123.10(d). Such
corrections are essential to the proper working of the HACCP system.
The records that are produced are subject to the recordkeeping
requirements of proposed Sec. 123.8, including being subject to
inspection by FDA investigators. FDA has tentatively concluded that
HACCP-type preventive controls, including recordkeeping, will ensure
that the hazards caused by insanitation are controlled by design.
Recordkeeping is the key to an HACCP-type system. The agency's access
to these records is essential to ensuring that the system is working.
In addition to these proposed requirements, FDA is encouraging
processors in Sec. 123.10(e) to have a written standard operating
procedure for sanitation. The details of many sanitation procedures can
differ from plant to plant depending upon the type of operation and
other conditions. For example, how a piece of equipment should be
cleaned can differ from plant to plant. In one plant, it may be
necessary to disassemble all or part of the equipment in order to clean
it. In other plants, breaking down the equipment may not be necessary.
Likewise, different cleaning compounds may be needed from one plant to
another in order to solve specialized problems such as buildups of
mineral deposits. FDA is therefore encouraging each processor to study
its own plant and develop a procedure that is tailored to that
processor's needs and circumstances.
2. Evisceration of Raw Fish
In 1988, following botulism outbreaks traced to consumption of
kapchunka, FDA published compliance policy guide (CPG) 7108.17 for
salt-cured, air-dried, uneviscerated fish (53 FR 44949 November 7,
1988). In this CPG, FDA stated that the processing and sale of smoked
and salted uneviscerated fish products pose a potential health hazard,
and that it would consider such products to be adulterated under
section 402(a)(4) of the act in that they have been prepared, packed,
or held under insanitary conditions whereby they may have been rendered
injurious to health (Ref. 175). FDA issued this CPG in an effort to
prevent further outbreaks, as well as other potential health hazards,
related to the consumption of ungutted fish products. The agency
recognized only two exceptions: (1) Small species, such as anchovies
and herring pieces (sprats), provided that they are processed by a
method that will ensure a water-phase salt content of at least 10
percent, a water activity below 0.85, or a pH of 4.6 or less; and (2)
fish that are fully cooked before further processing.
As previously noted, C. botulinum, as well as other microorganisms,
are naturally present in the intestinal tract of both fresh-water fish
and marine fish. Therefore, it is essential not only to remove the
viscera but to do so in a manner that does not contaminate the fish
flesh with viscera contents. It is the viscera that can contain the
majority of the hazardous microorganisms (e.g., C. botulinum and L.
monocytogenes) that pose the potential health hazard (Refs. 165 through
167). After the viscera is removed, it must be discarded immediately to
a segregated area, using a method that minimizes the potential for
contamination or cross-contamination of utensils, equipment, raw
materials, and other processed products.
Uneviscerated fish that have been smoked, smoke-flavored, or
salted, and that are intended to be filleted after processing, pose the
same potential health hazard as those products sold as uneviscerated
whole fish. The potential health hazard is created when the viscera is
removed after processing. As the fish are being filleted, the viscera
may be cut, and its contents may spill out, contaminating the processed
fish. As a result, the opportunity arises for C. botulinum spore
outgrowth and toxin production as well as for growth of other food
spoilage microorganisms in these types of products.
Therefore, the agency is proposing to require in Sec. 123.10(f)
that, subject to the same limitations that were set forth in the CPG:
(1) All fish for smoking or salting be eviscerated prior to processing,
and (2) the process of evisceration must be performed in an area that
is segregated and separate from other processing operations.
H. Imported Seafood
As stated earlier, imports make up over half of the seafood
consumed in this country, in sharp contrast to meat and poultry, which
are primarily domestically produced. Many of the hazards that can
affect imported seafood are likely to occur before it enters the United
States. These hazards include those that can be acquired from the
environment before harvest and those that are process-induced.
Detection of these hazards is the focus of the current regulatory
system, and thus FDA tries to ensure safety by testing imported
product.
However, product testing places a substantial burden on the agency.
The system currently is overburdened because of limits on the number of
government personnel available to collect and analyze samples of
imported product. In addition, FDA is concerned because this system
does not promote industry responsibility and accountability the way an
HACCP-based problem prevention system would. Given when most problems
with imported seafood occur, these problems can be more efficiently
controlled if the seafood is subject to HACCP controls before it is
offered for import into this country than if the product is simply
tested at the time that it is offered for sale. Therefore, FDA has
tentatively concluded that these HACCP regulations should cover
imported products in the same manner, to the extent possible, that they
cover domestic products.
Accordingly, FDA is proposing to make importers subject to the
general provisions of subpart A. Thus, FDA is proposing in
Sec. 123.11(a) to require that products that are offered for import be
produced under the same HACCP and sanitation controls that it is
proposing to apply to domestically produced seafood. FDA is proposing
to require that importers adopt an HACCP plan that includes the
criteria for how they will decide to purchase and then handle seafood
while it is under their control. They must also establish ways to
determine that these requirements are being met.
More specifically, the plan must include hazard analysis, critical
control points, and critical limits for each type of product imported
as well as a copy of each supplier's HACCP plan for those products, as
required in Sec. 123.11(b). Under proposed Sec. 123.11(b), these plans
must be available on file at the importer's U.S. place of business. As
stated above, the agency is developing a hazard analysis book to assist
importers, as well as processors, in designing their individual plans.
Because of the proposed requirement of Sec. 123.11(b) that
importers must have on file an HACCP plan from each of their foreign
suppliers, foreign processors who wish to offer their products for
import into the United States after the implementation of this
regulation will have to operate under valid HACCP plans and sanitation
control procedures and furnish copies of those plans to the U.S.
importers. The foreign processors should maintain appropriate
monitoring records, as dictated by the principles of HACCP already
discussed. These records should be kept at the foreign processors'
places of business.
Importers will be required under proposed Sec. 123.11(c) to take
affirmative steps to monitor that their suppliers are in fact operating
under their HACCP plans. Thus, under this proposal, the importer will
need to take such steps as: (1) Obtaining records from the foreign
processors' facilities; (2) obtaining certification from foreign
governments that the suppliers are operating under valid HACCP plans or
obtain certification lot by lot; (3) visiting the facilities to inspect
them on a regular basis; or (4) taking some similar type of action,
e.g., end product testing.
For example, importers of swordfish may specify to their suppliers
that the mercury level in the swordfish that they purchase cannot
exceed FDA's action level of 1 part per million methyl mercury. The
importers may decide to require certificates of analysis for methyl
mercury on a regular basis from their suppliers as a means of ensuring
that the swordfish that they offer for import into the United States is
not adulterated.
Section 123.11(d) provides an option for those importing from a
country that has an active memorandum of understanding (MOU) or similar
agreement with FDA. If the MOU is current, and if there is equivalency
between the inspection system of the foreign country and the U.S.
system, the importer will be able to rely on the MOU in lieu of the
actions required under Sec. 123.11(c). An active MOU must accurately
reflect the current situation between the signing parties and be
functioning and enforceable in its entirety. It is the importer's
responsibility to determine whether the MOU is in fact active, and
whether it covers the products that the importer intends to receive
from that country.
Finally, the agency strongly encourages importers (as reflected in
proposed Sec. 123.11(e)) to require their suppliers to obtain HACCP
training such as is required in Sec. 123.9.
Proposed Sec. 123.12 provides that there must be evidence that
seafood offered for import has been produced in accordance with part
123, subpart A. As stated previously, FDA is including this requirement
to ensure that there is equivalent treatment of imported and domestic
products. FDA can ensure that domestic product is being produced in
accordance with the HACCP plan and the sanitation controls in
Sec. 123.10 through direct observation and review of records. Similar
inspection of foreign processors would be prohibitively expensive.
However, FDA tentatively finds that mere reliance on the existence of
an HACCP plan is not enough, and that additional evidence of compliance
must be provided. FDA tentatively finds that this evidence can be
provided by the means listed in proposed Sec. 123.12(a).
One of the ways that the agency contemplates obtaining this
evidence would be by inspecting, at the importers' U.S. place of
business, the importers' and foreign suppliers' HACCP plans, sanitation
procedures, and records associated with the importers' plans. If these
records demonstrate that the foreign processor and the importer are
operating in accordance with adequate HACCP plans, agency will have
assurance that the food is not adulterated under section 402(a)(4) of
the act.
FDA also intends to pursue MOU's with countries that demonstrate
that their inspection systems are and continue to be substantially
equivalent to those in the United States (proposed Sec. 123.12(a)(2)).
The existence of an active MOU between FDA and the country of origin
covering the seafood products being offered for import will provide
assurance that these products covered by the MOU are being produced
under appropriate conditions.
If there is no MOU, the agency will take into consideration, for
purposes of verifying the compliance of imported seafood, knowledge
that a foreign country has an advanced seafood inspection system that
provides for plans that are HACCP based, as provided in proposed
Sec. 123.12(a)(3). The existence of such a regulatory system and its
enforcement will provide assurance about the conditions under which
products exported from that country are being produced.
Proposed Sec. 123.12(a)(4) provides that inspection of foreign
processors by the agency or other organization designated by FDA may
also be used to establish compliance with these regulations.
Finally, the agency intends to use other measures as it finds
appropriate to make determinations about the acceptability of the
product being offered for import, including but not limited to end
product testing, as in proposed Sec. 123.12(a)(5).
If assurances do not exist, as described in Sec. 123.12(a), that
the product has been produced under an HACCP plan and under sanitation
controls that are equivalent to those required of domestic processors,
the agency will deny entry to the products as provided in proposed
Sec. 123.12(b) because the product will appear to be adulterated (see
section 801(a) of the act).
I. Raw Molluscan Shellfish
FDA is proposing to require in part 123, subpart C that processors
of raw molluscan shellfish include in their HACCP plans how they
control the origin of the molluscan shellfish that they process.
Proposed Sec. 123.28 requires that these controls include obtaining raw
shellfish only from approved growing waters through harvesters or
processors licensed by a shellfish control authority. FDA is proposing
to require that processors maintain records to document that each lot
of raw molluscan shellfish meets these requirements. Under this
proposal, these records will constitute HACCP records subject to the
requirements of proposed Sec. 123.8.
The agency is also proposing to establish a system of tagging or
other labeling that provides information about the origin of all
shellstock and shucked molluscan shellfish received by a processor. FDA
is proposing to amend Sec. 1240.60 (21 CFR 1240.60) to provide for such
a tagging system.
Raw molluscan shellfish are molluscan shellfish that have not been
subject to a treatment sufficient to kill pathogens of public health
significance. Shellfish that have been subjected to any form of
treatment, such as steam, hot water, or dry heat, for a short period of
time before shucking to facilitate removal of the meat from the shell
are still considered to be raw.
Molluscan shellfish consumed raw or partially cooked pose unique
public health risks. They probably cause the majority of all seafood-
related illnesses in the United States (Refs. 6; and 7, p. 330). The
safety of raw molluscan shellfish directly reflects the cleanliness of
its aquatic environment. Of all edible species of fish, molluscan
shellfish are unique in that they are nonmotile, filter feeding
organisms. They pump large quantities of water through their bodies
during the normal feeding process (Refs. 7, p. 331; and 90, p. c-4).
The positive relationship between harvesting areas contaminated by
sewage pollution and shellfish-borne enteric disease has been
demonstrated many times (Refs. 7, p. 76; 91 and 92). During feeding,
the shellfish may concentrate pathogenic microorganisms, deadly toxins
associated with naturally occurring marine plankton (Ref. 93), or forms
of agricultural and industrial pollution (Ref. 94). Among the
pathogenic microorganisms is the Norwalk virus, probably the most
common cause of seafood-borne illness. This virus commonly occurs in
waters contaminated by sewage effluent (Refs. 7, p. 76; 91, 92, and
95).
Before the adoption of the current public health controls in the
United States, shellfish commonly transmitted many serious communicable
diseases. Consumption of raw or undercooked seafood from polluted
waters can be a mode of transmission for typhoid fever, infectious
hepatitis, and cholera (Ref. 67). These diseases are still commonly
associated with raw shellfish consumption in lesser developed countries
(Ref. 7, p. 73). However, the incidence of these diseases in the United
States has been largely controlled under section 361 of the PHS Act (42
U.S.C. 264). This statute was enacted to prevent the introduction,
transmission, and spread of communicable disease. Under provisions of
the PHS Act, FDA is empowered to accept assistance from the States to
protect public health. Accordingly, FDA participates in a Federal/State
cooperative program called NSSP.
Established in 1925, the NSSP provides water quality criteria for
assessing the safety of shellfish growing areas. These criteria are
applied by the States under the authority of their own laws. The NSSP
``Manual of Operations'' provides the basis (Refs. 90 and 96) for State
regulation in 23 shellfish-producing States and 6 nations. Each
participating State or nation classifies and monitors its shellfish
growing waters, controls harvesting, inspects shellfish packing and
shucking facilities, and issues certificates to individual shellfish
processors that meet the State or foreign government's shellfish
control criteria.
To assist themselves in the implementation of their shellfish laws,
the States have formed the ISSC. The ISSC is an organization of State
officials, representatives of Federal agencies, and representatives of
the shellfish industry. It provides guidance to the States and provides
a forum for them to discuss their problems in attempting to ensure the
sanitary control of shellfish handling and production (Ref. 97, p. 3).
FDA evaluates State and international shellfish sanitation programs
(Ref. 98, part I, p. 2). When it finds that the program is consistent
with the NSSP, FDA accepts the State's or country's shipper
certifications. FDA publishes the ``Interstate Certified Shellfish
Shippers List'' monthly, in which it lists the approximately 2,000
shellfish dealers that have been certified by participating States.
While FDA continues to believe in the cooperative partnership that
it has established with the States, there is evidence that this system
is not protecting the public health as well as it might (Refs. 7, p.
331; 99, p. iii; and 100). Problems can originate anywhere. As
explained in the discussion above of the term ``lot of molluscan
shellfish,'' the water from which shellfish are harvested plays a
significant role in determining their safety. If they are harvested
from unclassified or polluted waters, shellfish can be a vector of
communicable disease. Problems can also occur as a result of conditions
under which the shellfish are held on the harvest vessel, in the
processing plant, or by subsequent handlers or repackers of shucked
products.
Given the current situation, FDA has tentatively determined that it
is necessary for it to take steps to strengthen and provide additional
support for the existing cooperative program. Thus, FDA is proposing
two measures.
First, FDA is proposing to add Sec. 1240.60(b), which will require
that all shellfish offered for transport or transported in interstate
commerce bear a tag that lists the date, place, type, and quantity of
shellfish, and by whom it was harvested, including the harvester's
identification number. FDA is proposing this requirement because it has
determined that a tag is the only means by which the agency can ensure
that it will be possible to determine whether the shellfish have been
taken from safe water. FDA is proposing to require that the place where
the shellfish were harvested be listed because it will enable a
processor who receives the shellfish, or a regulatory official who
inspects them, to determine whether they were taken from safe water.
FDA is proposing to require that the date when the shellfish were
harvested be listed because, as discussed above, the shifting
conditions in shellfish harvesting waters make shellfish safety
virtually a day-to-day proposition. Therefore, when the shellfish are
harvested becomes a critical factor.
FDA is proposing that the type of shellfish e.g., oysters, clams,
mussels, or scallops, and quantity be shown on the tag or bill of
lading to ensure that the tag is applied only to the product to which
it was initially affixed. Information on type and quantity of shellfish
describes that product. FDA is proposing to require that the person by
whom the shellfish were harvested be listed because that person has the
most direct knowledge of where and when the shellfish were harvested
and should be readily identifiable in case there are problems with the
shellfish, so that quick action can be taken to meet the effect of any
problem.
Finally, FDA is proposing that the harvester identification number
issued by the shellfish control authority be included to provide a
means to confirm the harvester's identity and to obtain the harvester's
local address in case of an illness investigation or followup to
tagging and labeling discrepancies.
FDA is proposing this tagging requirement under section 361 of the
PHS Act. Under this section, the Surgeon General and, by delegation,
FDA, is authorized to make and enforce such regulations as in FDA's
judgment are necessary to prevent the introduction, transmission, or
spread of communicable disease. FDA tentatively finds that requiring a
tag is a measure necessary to prevent the spread of communicable
diseases because the tag will readily permit identification of those
raw shellfish that were harvested from properly classified waters, and
thus that will not be vectors of communicable disease in interstate
commerce, and those that were not harvested from properly classified
waters and thus that may be vectors of disease.
Under the PHS Act, FDA is also authorized to provide for such
measures which in its judgment may be necessary to enforce the
regulations that it adopts to prevent the spread of communicable
diseases (section 361(a) of the PHS Act). Therefore, FDA is proposing
to provide in Sec. 1240.60(b) for the seizure and destruction of any
shellfish that are not properly tagged. Without the assurances provided
by the tag, the shellfish may bear a microorganism that may render them
injurious to health. Thus, they are unfit for consumption and must be
removed from the food supply.
FDA recognizes that all shellfish-producing States have laws that
require the tagging of shellfish. This proposal is intended to support
those laws, not supersede them. The proposed tagging requirement is
necessary for two reasons. First, there is no assurance that untagged
shellfish come from safe waters. Illegal harvesting of molluscan
shellfish from contaminated or unclassified waters is known to occur
(Ref. 7, p. 331). It is also known that illegally harvested shellfish
find their way into commercial channels. States and FDA find untagged
or improperly tagged shellfish during their inspections of shellfish
processors under the cooperative program (Refs. 101 through 109). FDA
frequently lacks a basis for taking action against untagged shellfish
(Ref. 110). Proposed Sec. 1240.60 will provide a basis. Second, State
tagging requirements and sanctions are not uniform, and the sanctions
provided under some State laws have little deterrent effect (Refs. 102,
103, and 109). The establishment of a Federal sanction will provide
illegal harvesters with sure knowledge that if their catch enters
interstate commerce and comes to the attention of FDA, it will be
destroyed.
If Sec. 1240.60(b) is adopted, as a practical matter, product
identification will begin at the harvesting site. FDA is proposing to
amend Sec. 1240.60 to require that the first handler of live molluscan
shellfish, be it the licensed harvester, licensed aquaculturist, or
certified shellfish shipper, affix a tag to each container of
shellfish. The tag will then provide the means for processors to ensure
that the shellfish that they buy is from properly classified water.
Moreover, the tag will provide all information that is necessary to
trace the product to its source, e.g., date of harvest, location of
harvest, quantity and type of shellfish, and the harvester's name and
identification number assigned by the shellfish control authority. The
product traceability that results will enhance epidemiological
investigations in the event of shellfish-borne illness. It will also
facilitate prompt remedial actions necessary to reestablish public
health controls.
The safety concerns about shucked molluscan shellfish are
substantially the same as those discussed above for in-shell molluscan
shellfish. Because shucked shellfish are packaged in a container that
can be labeled, the agency is proposing to require in Sec. 1240.60(c)
that for these shellfish, a label may be substituted that bears
information equivalent to that found on the tag. Another reason for
allowing labeling in lieu of a tag is the fact that one bag of
unshucked molluscan shellfish bearing a single tag can typically be
processed into more than one container of shucked molluscan shellfish.
The second measure that FDA is proposing is based on its experience
with the NSSP and the ISSC. FDA has tentatively concluded that the
system for protecting the safety of shellfish can be significantly
strengthened if the agency were to require that certain limited steps
be taken as part of the processing of shellfish that are intended for
interstate commerce. FDA believes that these measures, like the
proposed tagging requirement, will serve to strengthen the Federal-
State cooperative program as well as the shellfish safety programs of
each of the States and countries that participate in NSSP.
Many of the pathogens in shellfish, such as the Norwalk virus, are
virtually undetectable. Moreover, from a technical and practical
perspective, end product testing cannot be used in the processing of
shellfish to ensure that they are not contaminated with one of the
myriad of possible domestic, industrial, and agricultural contaminants
that have been found in shellfish harvesting areas. Therefore, State
classification of growing waters is a necessary first step to ensure
the safety of shellfish. These classifications, as detailed in NSSP,
address all actual and potential pollutants in deciding whether an area
is suitable for harvesting (Ref. 90, pp. c-5 and c-6).
FDA is proposing in Sec. 123.28(a) that each processor of shellfish
have an HACCP plan that ensures that the molluscan shellfish that it
processes come only from areas that have been classified by a shellfish
control authority as satisfactory for harvesting. As noted above, the
safety of molluscan shellfish consumed raw or partly cooked is
predicated on the cleanliness of the growing area waters from which
they are obtained. Ensuring that shellfish come from properly
classified growing areas is where shellfish safety begins.
Under proposed Sec. 123.28(b), processors are to process only
shellfish that originate from growing waters that have been approved
for harvesting by a shellfish control authority as shown by product
tags or labels with specific information that establishes that they
were harvested from appropriate waters. FDA is proposing this
requirement under both section 361 of the PHS Act, to prevent the
spread of communicable disease, and sections 402(a)(1), 402(a)(4), and
701(a) of the act to ensure that the food does not contain any added
substances that may render it injurious to health and is not prepared,
packed, or held under insanitary conditions whereby it may be rendered
injurious to health.
Under proposed Sec. 123.28(b)(2) and (b)(3), the shellstock tag
from a licensed harvester or certified processor, or the bill of lading
accompanying bulk shipments, will contain the information required
under proposed Sec. 1240.60(b) and thus document whether the shellfish
are from an acceptable source.
The proposed requirement Sec. 123.28(b) that only shellfish drawn
from such acceptable sources can be processed will place a premium on
properly tagged products from shellfish dealers that States or nations
that participate in NSSP have certified.
The agency is further proposing to require in Sec. 123.28(c) that
shucked products be subject to the same requirements that apply to
shellstock. FDA is doing so because the safety of shucked shellfish
products, like shellstock, depends on the quality of the water where
they are grown. Therefore, the same requirements are needed.
FDA is further proposing to require in Sec. 123.28(d) that the
processor maintain records that document that each lot of shellfish
meets the tagging or labeling requirements in Sec. 123.28 (b) or (c)
(see Refs. 104 and 108). The information that FDA is proposing to
require to be maintained in records simply reflects these requirements.
Permanent records are needed to demonstrate that processors are
controlling the origin of the shellfish they process. In addition,
permanent records will facilitate epidemiological investigations by
allowing complete product traceability to the source of origin.
The protection of shellfish consumers also requires that domestic
and imported products be treated equally. While imported raw molluscan
shellfish are subject to the same standards as domestic shellfish with
regard to adulteration and misbranding, Federal law does not require
that imported shellfish come from waters that were classified by a
public health authority. This double standard is unfair to domestic
processors, and both ISSC and industry representatives have urged the
Federal Government to address this problem (Refs. 111 and 112). While
virtually all States have chosen to reject imported shellfish that are
not tagged as coming from classified waters (Ref. 113), it is known
that such shellfish nonetheless enter interstate commerce (Ref. 107).
Untagged imports originating from uncertified producers compromise the
effectiveness of seafood safety programs (Ref. 7, p. 73) and product
traceability. Therefore, FDA is proposing that all raw shellfish
products either from domestic or foreign origin must comply with the
requirements in part 123 and Sec. 1240.60.
Thus, if Sec. 123.28(b), for example, is adopted, it will mean that
only those molluscan shellfish that are harvested in a foreign country
that has a program that incorporates the type of measures set out in
the NSSP for approving growing waters will be appropriate for
processing. Such a program will need to include measures that provide
for water classification, monitoring, and other related activities if
it is to ensure that the growing waters that it approves are safe, and
thus that the shellfish that are drawn from such waters are not
adulterated. FDA has found that the best way to establish that a
foreign country's program meets this standard is through the
development of an MOU between the agency and that country. Currently,
such agreements exist with Australia, Canada, Chile, England, Iceland,
Japan, Republic of Korea, Mexico, and New Zealand.
In summary, FDA anticipates that these proposed requirements will
improve the safety of raw molluscan shellfish by establishing uniform
requirements for domestic and imported products and prohibiting
interstate movement of shellfish that is not properly tagged to
demonstrate that it came from an appropriate harvesting area.
The effectiveness of State shellfish sanitation programs and the
NSSP will be strengthened by the proposed mandatory tagging, labeling,
and recordkeeping requirements, which will allow complete product
traceability to its source of origin. Should illnesses occur, product
traceability will facilitate a rapid determination of when a problem
occurred and allow immediate remedial actions to restore public health
controls. Also, requiring proper tagging or labeling will place a
premium on State and foreign shellfish sanitation and processor
certification programs.
J. Guideline for Cooked, Ready-to-Eat Fishery Products
FDA is proposing a guideline in Appendix A for cooked, ready-to-eat
fishery products. These products possess an elevated microbiological
risk relative to most other seafood products because they are cooked as
part of processing and do not normally receive any additional cooking
by consumers before consumption. Consequently, to be safe, these
products must be essentially pathogen-free by the time they leave the
processing facility. Immediate refrigeration at proper temperatures to
prevent the growth of pathogens is also essential for these products,
which are not shelf-stable.
The guideline addresses critical control points that apply to these
products as a class and that thus will typically be identified in the
HACCP plans of most processors of cooked, ready-to-eat products. The
guideline also addresses ways of controlling hazards at each critical
control point. Processors of cooked, ready-to-eat products that are
also smoked and smoke-flavored fishery products should apply the
controls set forth in Appendix 1. If FDA adopts that regulation, it
will codify it in reserved subpart B of part 123.
This guideline is not relevant to most of the cooked, ready-to-eat
products that are processed as low acid canned foods under part 113.
However, the recommendations in Appendix A, section 4. a., b., and d.
for cooling, processing after cooking, and refrigerated storage, will
apply to those low acid canned foods that are cooked, processed, and
then cooked again.
The guideline provides information on how to control the growth of
S. aureus during the processing step between cooks. It also addresses
the control of microbiological hazards that can occur within the
processing environment for cooked, ready-to-eat products. It does not
address nonprocessing hazards, because they are not relevant to this
class of products. FDA intends to publish separate guidance that will,
among other things, address nonprocessing hazards. Likewise, this
guideline will not address the nonsafety hazards, such as decomposition
that is not associated with human illness and economic adulteration,
that FDA has suggested in proposed Sec. 123.6(c) should be covered by
the HACCP plan. These hazards will also be covered in the separately
published guidance. Economic adulteration, for example, is addressed in
Appendix D.
FDA has tentatively decided to address the processing controls for
cooked, ready-to-eat products in a guideline, rather than by
regulation, to permit flexibility in the face of changing processing
technologies and knowledge. As stated earlier in this preamble, the
guidelines are intended to advise processors about what FDA believes
will be acceptable in a HACCP plan. The agency acknowledges, however,
that there are basic processing norms to which conscientious processors
adhere, and that these norms are not likely to change for the
foreseeable future. FDA therefore invites comments on whether any or
all of the guideline on the cooked, ready-to-eat products ought to be
codified as requirements in part 123 if it is adopted as a final
regulation.
1. Thermal Processing: Cooking and Pasteurization Processes and
Equipment
The proposed guideline in Appendix A, section 4 advises processors
on how to ensure that: (1) Their cooking and pasteurization processes
are adequate to inactivate pathogens; and (2) their cooking and
pasteurization equipment is adequate to deliver their cooking and
pasteurization processes. A cooking process is, in essence, the
temperature and time at that temperature that will both kill pathogens
and create a marketable product. A pasteurization process is the
temperature and time at temperature that is necessary to reduce the
numbers of pathogens to the point where they will not cause harm over
the shelf life of a refrigerated product. It is essential that C.
botulinum type E not survive the pasteurization process for cooked,
ready-to-eat products that are packed in hermetically sealed containers
and held at refrigerated temperatures (Ref. 52). Such containers are
typically vacuum or modified atmosphere packaged and thus can provide a
good environment for the growth of C. botulinum type E.
To meet the requirements in part 123, subpart A, processors must
have assurance that their cooking and pasteurization processes are
adequate to inactivate pathogens and must document this assurance in
their HACCP records. This approach is similar to that in the
regulations for low acid canned foods, which require that processors of
those products know that their thermal processes are adequate to
destroy C. botulinum. The low acid canned food regulations do not
specify to processors what their time/temperature parameters must be in
order to destroy those pathogens. There are simply too many variables
and possibilities with regard to thermal processing parameters for this
kind of specificity in those regulations to be practical or
appropriate. Rather, the regulations require that processors use a
thermal process that is at least equivalent to one established by a
competent process authority, i.e., a third party who has the expertise
to determine the parameters of a thermal process that will destroy
pathogens (Ref. 85).
This approach has served the consuming public, the agency, and the
industry well over the years. FDA is therefore recommending in proposed
Appendix A, section 4. a.1. and b.1. that processors utilize the
services of process authorities to establish the parameters of their
cooking and pasteurization processes.
A process authority could be a private individual, a member of
academia, or an agency of government. Processors can find competent
process authorities through their trade associations, local Sea Grant
extension offices, or State universities.
The procedures that are used in establishing a cooking or
pasteurization process should be generally recognized and accepted.
Such procedures may include thermal death time, heat penetration, and
inoculated pack studies, as necessary, to establish the minimum process
necessary to destroy pathogens. In cases where the cooking process or
pasteurization process is standardized and not unique to a specific
processor, articles in journals; Federal, State, or local regulations
and guidelines; or other appropriate vehicles could provide process
parameters (Ref. 52). Whatever the source, processors must retain the
documentation from the process authority that the process will be
effective as part of their HACCP records, in accordance with proposed
Sec. 123.8(c).
The process established by a process authority should include
values for those aspects of the process that can affect the destruction
of pathogens. The most notable of these are cooking times and
temperatures. Others may include the initial internal temperature of
the cooking medium before the cooking, the product size and species,
and the viscosity of formulated products such as soups.
FDA is already aware that the cooking processes necessary to create
a marketable product for several types of cooked, ready-to-eat products
are many times more lethal than necessary to inactivate pathogens (Ref.
114). The products are the several types of crabs listed in the
guidelines at proposed Appendix A, section 4.a.4. FDA has tentatively
concluded that, for these products, the adequacy of both the cooking
process and cooking equipment can be assumed.
It is likely that other products could be added to this list. The
agency invites comments on this point. Comments should be accompanied
by data that will enable the agency to determine that the minimum
cooking process necessary to achieve a marketable product, e.g., heat
penetration data and data on the range of cooking processes (times and
temperatures) applied to that product, will produce a safe product.
The same general principles also apply to the design of the cooking
and pasteurization equipment. It is necessary that this equipment be
designed and operated so that every unit of product receives the
established minimum cooking or pasteurization process proposed
(Appendix A, section 4. a.2. and b.2.) (Ref. 85). FDA recommends that
the equipment be evaluated for design and operation by a process
authority who is familiar with the dynamics of temperature distribution
in processing equipment. In some instances, temperature distribution
studies may be necessary to establish the adequacy of the equipment. In
other instances, existing literature should be sufficient. Processors
must obtain and retain documentation that the equipment will provide
the minimum process as part of their HACCP records in accordance with
Sec. 123.8.
2. Container Integrity
The proposed guidelines advise in Appendix A, section 3. c. and d.
that HACCP plans prepared in accordance with part 123, subpart A will
normally identify finished product container sealing for pasteurized
products and postpasteurizing cooling as critical control points.
Contamination with C. botulinum type E during the postpasteurization
cooling step is a special food safety hazard that must be controlled
for pasteurized products. Two potential causes of recontamination are
poor container seams and contaminated cooling water. Consequently, the
guidelines, at Appendix A, section 5, recommend controls that
processors can utilize that are likely to meet the requirements of
subpart A. Appendix A, section 5.a. advises processors how to inspect
finished product containers of pasteurized products for container
integrity to ensure a consistently reliable hermetic seal. At proposed
Appendix A, section 5.b., the guidelines advise about testing for the
presence of sanitizer in cooling water.
Seam inspections should determine whether the seams conform to the
manufacturer's guidelines. Additionally, because of variations from
seaming head to seaming head, from closing machine to closing machine,
and over time for any one machine or head, FDA recommends that
processors conduct inspections for each machine and head at least every
4 hours. Visual seam inspections are not adequate to fully assess the
integrity of the seam. Physical testing and, in the case of double
seams, seam teardown and measurement, are necessary parts of the
inspection, as presently required for low acid canned foods in part
113.
The presence of sanitizer in cooling water provides a control for
the risk of microbiologically contaminated water being drawn into the
can. A vacuum created by a collapse in the cooling vat of the steam
head in the container, generated during the heating step, can draw in a
minute amount of cooling water and any pathogens contained in that
cooling water. Seams are in a particularly stressed condition at that
time. Sanitizer strength levels should be checked periodically because
there is a tendency for variation in strength to occur, particularly in
batch-type systems.
3. Time and Temperature
The guidelines advise, in proposed Appendix A, section 3. e., f.,
g., and h., that HACCP plans prepared in accordance with subpart A of
part 123 will normally identify cooling after cooking, processing after
cooking, final product cooling, and refrigerated storage, as critical
control points. The potential exists for some pathogenic microorganisms
to survive the cooking process, regardless of the controls that are in
place at that step. Likewise, despite a processor's efforts to minimize
recontamination of the cooked product with pathogens, the potential
exists for some pathogens to be reintroduced. For these reasons, it is
imperative that exposure of the product after the cooking process to
temperatures that permit the growth of pathogens be kept to a minimum,
since larger numbers are frequently associated with a greater potential
for disease.
To control hazards as required by part 123, subpart A, the process
must take steps to restrict time/temperature abuse of the cooked
product to the point that pathogens such as Salmonella spp. do not
enter the rapid (logarithmic) phase of growth. By restricting pathogen
growth to the slow (lag) phase, pathogen numbers should remain constant
or increase only slightly.
Proposed Appendix A, section 6.a. provides a way to control the
growth of pathogens immediately after cooking. It advises that, after
cooking, the product should be cooled from 140 deg.F (60 deg.C) to 70
deg.F (21.1 deg.C) within two hours. This time/temperature
combination is based on the upper limit for growth (i.e., 140 deg.F)
and the lower limit for rapid growth (i.e., 70 deg.F) of such
mesophilic pathogens as Salmonella spp. and S. aureus, and the typical
length of the lag phase for the former microorganism (Refs. 23, 85, and
115). However, 70 deg.F (21.1 deg.C) will not fully control the
growth of psychrotrophic pathogens. Consequently, further cooling from
70 deg.F (21.1 deg.C) to 40 deg.F (4.4 deg.C) within 4 additional
hours is advisable, based on the minimum growth temperatures of such
psychrotropic pathogens as L. monocytogenes, Salmonella spp., and S.
aureus, and the lag time of Salmonella spp. (Refs. 23, 78, and 79).
These cooling recommendations are generally consistent with those
of the Food Safety and Inspection Service (FSIS) of USDA (Ref. 115) and
the National Food Processors Association (NFPA) (Ref. 78). FDA invites
comments on the specifics in App. A, section 6.a.
In those instances where further processing takes place before the
achievement of the 70 deg.F (21.1 deg.C) or the 40 deg.F (4.4
deg.C) temperatures, further reduction in temperature need not take
place. There is no need for production delays when in-process storage
times are normally less than the 2 or 6 hours needed to achieve each of
these temperatures.
The time/temperature parameters employed to control the
microbiological hazards associated with cooling after cooking can be
confirmed by a program of routine time and temperature monitoring
(Appendix A, section 6.a.1.). Real time documentation of this
monitoring should be done to facilitate management and regulatory
review.
Alternately, the ability of the firm's processing procedures to
consistently achieve the appropriate time/temperature parameters can be
confirmed through scientifically conducted time/temperature studies
that take into consideration the range of processing variations
encountered at the firm. Examples of processing variations include
product size, e.g., the range of shrimp sizes that the firm typically
processes; the temperature of the cooling medium, e.g., the highest
temperature normally experienced in the firm's cooling unit; and the
amount of product normally placed in the cooling unit.
In some instances in-process time/temperature monitoring may be
impractical or needlessly redundant, particularly in continuous
processing systems. A scientifically conducted study is especially
appropriate for such situations, where it can be assured that in all
plausible situations the time/temperature parameters will be met.
Documentation and retention of the conduct and results of this study is
required by Sec. 123.8.
Appendix A, section 6.b. advises how processors can ensure that
microbiological hazards associated with postcooking processing can be
controlled. It advises that products not be exposed to ambient
temperatures of 40 deg.F (4.4 deg.C) or higher for more than 4 hours
during postcooking processing, again based on the minimum growth
temperature of such psychrotropic pathogens as L. monocytogenes and on
the normal lag phase of such mesophilic pathogens as Salmonella spp.
The agency recognizes that, for many products, manipulation of the
product after cooking, while undesirable from the standpoint of
microbiological recontamination, is necessary for many cooked, ready-
to-eat products. It is often impractical to perform this manipulation
under refrigerated conditions. Consequently, the product will be
exposed to some combination of time and temperature that may allow for
microbiological growth. The recommended conditions will minimize the
growth of pathogenic microorganisms and the production of heat stable
toxins (e.g., staphylococcal enterotoxin).
The ability of the firm's processing procedures to consistently
achieve its time/temperature parameters can be confirmed by monitoring
the length of time that the product is exposed to such ambient
temperatures. Documentation of time/temperature monitoring must be in
accordance with Sec. 123.8. to facilitate management and regulatory
review.
Appendix A, section 6.c. advises how processors can ensure that
microbiological hazards associated with final product cooling can be
controlled. Following the manipulation of the product during
postcooking processing, it will be necessary for the processor to cool
the product to a temperature that will not support the further growth
of mesophilic or psychrotropic pathogens. This result can be achieved
by cooling the finished product to an internal temperature of 40 deg.F
(4.4 deg.C) within 4 hours of either placing it in the finished
product container or completing pasteurization. Again, the
recommendation is based on the minimum growth temperature of such
psychrotropic pathogens as L. monocytogenes and on the normal lag phase
of such mesophilic pathogens as Salmonella spp. Of specific concern to
the pasteurization process is the reduction of the internal temperature
of the product to a level that will not support the growth of any
surviving spores of C. botulinum, type E.
The ability of the firm's processing procedures to consistently
achieve its time/temperature parameters can be confirmed by a program
of routine time and temperature monitoring designed to address the
particulars of the firm's processing system. Real time documentation of
this monitoring should be done to facilitate management and regulatory
review.
Alternately, the firm's ability to consistently meet its parameters
can be confirmed through scientifically conducted time/temperature
studies that take into consideration the range of processing variations
encountered at the firm. Examples of these processing variations
include container size, the temperature of the cooling medium, and the
amount of product normally placed in the cooling unit. In many
instances, in-process time/temperature monitoring may be impractical
and expensive for sealed finished product containers. A scientifically
conducted study is especially appropriate in such situations, where it
can be assured that in all plausible situations the time/temperature
constraints will be met. Documentation of the conduct and results of
the study is required under proposed Sec. 123.8 to facilitate
management and regulatory review.
Temperature control during refrigerated storage is best achieved
through the use of temperature indicating and recording devices and
recordkeeping, as stated in Appendix A, section 6.d.2. (Ref. 85).
However, FDA recognizes that some processors may desire to manually
monitor the temperature of the refrigeration unit, using only a
temperature-indicating device and a logbook. When coupled with a high
temperature alarm or a maximum-indicating thermometer, the agency feels
that this practice represents an acceptable alternative.
The guideline advises, in Appendix A, section 3.i., that HACCP
plans prepared in accordance with subpart A of part 123 will normally
identify distribution as a critical control point. Distribution of
perishable products encompasses the same hazards as associated with
refrigerated storage. For this reason, in Appendix A, section 6.e., the
agency is recommending a critical limit of an internal temperature
maximum of 40 deg.F (4.4 deg.C) and is encouraging the shipper and
consignee to arrange for appropriate control measures.
The agency recognizes that distribution patterns vary considerably
from single shipments to pooled and multiple delivery shipments, from
iced shipments to refrigerated shipments, and from shipments on the
consignee's truck to shipments on the shipper's truck to common carrier
shipments. Each mode presents different opportunities and impediments
for control.
4. Temperature Monitoring Equipment
Processors must monitor and control the temperature of their
refrigeration units in order to ensure that microorganisms of public
health concern do not increase in numbers. Likewise, processors must
control the times and temperatures of their thermal processes in order
to ensure that the minimum thermal process is consistently delivered to
the product. The guidelines address the outfitting of cooking,
pasteurization, and refrigeration equipment with temperature indicating
and recording devices (Appendix A, sections 4. a.2.ii. and b.2.ii., and
section 6.d.2., respectively). A temperature-recording device provides
a complete history of the temperature throughout the thermal process by
continuously recording it on a chart. As has been demonstrated for low
acid canned foods, the chart itself provides an excellent HACCP record
for the benefit of both processor and regulator. For this record to be
meaningful, it is critical that the temperature-recording device sensor
be installed so as to accurately represent the temperature of the
heating or cooling medium.
Temperature-recording devices are easily jarred and rendered
inaccurate. They can be calibrated and corrected against a temperature-
indicating device (e.g., a thermometer) quite easily, however.
Processors should do so at least at the beginning and end of each
production day in order to determine whether the instrument was
accurate throughout the day's production. In this situation, the
temperature-indicating device serves as reference instrument since it
is much more reliable. Consequently, the temperature-recording device
should never show a higher temperature than the temperature-indicating
device.
Temperature-indicating devices are generally reliable and need only
be calibrated upon installation and annually thereafter. Calibration
should be against a standardized (i.e., traceable to the National
Bureau of Standards) thermometer that is not subject to the rigors of
the processing environment (Ref. 85). Temperature-indicating devices
must often be read under less than ideal plant conditions, so they
should be installed in a location that facilitates easy reading. As
with the temperature-recording device, the sensor on the temperature-
indicating device should be installed so as to accurately represent the
temperature of the heating or cooling medium.
5. Corrective Actions
Appendix A, section 8. advises processors about corrective action
steps that they should consider to comply with the proposed corrective
action requirements in Sec. 123.7 of subpart A. Because the evaluation
of critical limit failures relating to the cooking step and the
terminal heat treatment step of cooked, ready-to-eat products may well
require an understanding of the technical aspects of thermal process
calculations, Appendix A, section 8. recommends additional controls to
those required by Sec. 123.7 in this regard. Of primary importance is
the recommendation that any corrective action other than processing to
eliminate the hazard or destruction must be assessed by a competent
process authority. For this purpose, a process authority may be a
representative of the firm or may be an outside source, so long as the
process authority has a scientific background that is adequate to make
the assessment.
6. Sanitary Zones
Section 123.10 of subpart A establishes requirements for all
processors for sanitation within the processing environment. In
addition to these requirements, this guideline recommends in Appendix
A, section 8. that processors of cooked, ready-to-eat products
establish sanitary zones in their facilities. The agency invites
comments on the merits of this concept and on whether it should be
codified in the regulations.
The importance of good sanitation in the processing of cooked,
ready-to-eat products cannot be overemphasized. While, as has been
stated earlier, plant sanitation has no real bearing on human food
safety for many foods, the safety of cooked, ready-to-eat products can
be easily jeopardized by pathogens that are introduced through poor
sanitation practices. Consequently, FDA is recommending that processors
establish sanitary zones around areas where products that have already
been cooked are being handled or stored. The primary purpose of a
sanitary zone is to physically separate insanitary objects from cooked
products. Sanitary zones can also minimize the likelihood of airborne
contamination through proper filtration and positive air pressure in
the zone.
A sanitary zone is a separation of operations by location,
partition, air flow, or enclosed systems. In most cases, it requires
procedural changes to minimize the risk of contamination but not large-
scale structural changes. Canada has successfully incorporated the
concept of sanitary zones for seafood processing as part of its HACCP-
based inspection program (Ref. 116).
K. Guideline For Scombroid Toxin Forming Species
FDA is proposing a guideline in Appendix B for handling of the
species in which scombroid toxin can form. This problem is primarily,
but not exclusively, associated with members of the family Scombridae.
The fish involved contain significant levels of naturally occurring
free histidine in their flesh, which certain bacteria can decarboxylate
into histamine. Significant histamine levels occur when the fish are
exposed after death to times and temperatures that permit the growth of
these bacteria. Histamine can result in a mild to severe allergic
response in humans. Scombrotoxin poisoning is one of the three most
common seafood-related illnesses (Ref. 5, p. 24). The scombrotoxic
species that have been associated with foodborne illness include tuna,
bluefish, mahi, mackerel, sardines, herring, kahawai, anchovies, and
marlin.
This HACCP guidance is intended to maximize the use of controls to
ensure proper handling of scombrotoxic species and thus to minimize the
possibility of a problem. It also recognizes the often complex pathways
of movement and ownership through which such fish may pass. Failure to
ensure safe handling at any point in the chain may render the fish
injurious to health.
There is a basis for concern about the safety of the fish as soon
as histamine begins to form. Once the histamine-forming process has
begun, it is like a chain reaction. Lowering the temperature of, or
freezing, the fish will slow or arrest the process, but only cooking
and prevention of recontamination can stop it (Refs. 9 and 117).
The guideline describes a HACCP system that emphasizes reliance
upon accurate recordkeeping to show continuity of proper handling.
Accurate knowledge of the time/temperature history of the fish is very
important in determining the likelihood that the fish are unsafe or may
become unsafe. The guideline also calls for more stringent processor
controls to be applied to lots for which records are inadequate. While
this guideline is designed to prevent problems, nothing in it should be
construed as meaning that the agency will not take regulatory action if
it finds decomposed fish.
The guideline in Appendix B, section 2. identifies receipt of raw
materials, which include imported shipments, as a critical control
point for processors of scombroid toxin forming species. Time/
temperature abuse by the fisherman can result in decomposition and the
resultant production of histamine.
Decomposition can also occur before the fish are removed from the
harvest water if the fish dies in capture nets or on long lines. In
such an event, the degree of decomposition will reflect the sea
temperature, time in the water, and particular species (Ref. 118). It
is not uncommon to encounter water temperatures of 80 deg.F to 90
deg.F in tropical waters, which can produce rapid decomposition.
Thus, rapid cooling of fish when they are captured is very
important to prevent initiation of the process by which histamine is
produced. Fish subjected to 68 deg.F for periods as short as one day,
a practice which can happen in warm climates on fishing vessels, will
yield high levels of histamine, even if the fish are later stored at
refrigerated temperatures (Ref. 117).
For these reasons, the guideline advises that processors of fish
and fishery products from scombroid toxin forming species must ensure
that their raw materials are essentially free of decomposition and
histamine as a result of time/temperature abuse that occurred before
the processor received them. The guideline provides for three
interrelated controls for the processor to apply with regard to raw
materials. For the first processor that takes ownership after harvest,
these are: (1) Time/temperature records from the harvesting vessel
(Appendix B, section 3.a.1.); (2) organoleptic examination of the fish
from the harvesting vessel for decomposition (Appendix B, section
3.a.2.); and (3) histamine analysis, if warranted by the time/
temperature history of the fish as revealed by the time/temperature
record from the vessel or by the results of the organoleptic
examination (Appendix B, section 3.a.3.), or both. Time/temperature
records from the vessel indicate whether entire lots from the vessel
may be suspect, and thus in need of a histamine examination, because of
unusual events on the vessel. Such records would not normally reveal,
however, whether there are individual fish in the lot that may have
decomposition. An organoleptic examination for decomposition serves to
screen individual fish. It also serves as a way to verify the time/
temperature records from the vessel with regard to an entire lot. If
organoleptic examination reveals an unusually high number of fish with
decomposition, the entire lot should be considered suspect and
subjected to histamine analysis.
Appendix B, section 3.a.1. provides for how the first processor can
take measures to determine whether the fish were properly harvested and
handled on board the harvesting vessel. Certification of the mode of
capture, including information on the time between physical capture and
bringing the fish on board, handling techniques, and the use of
temperature logs onboard the vessel that record that time/temperature
history of the fish (for example, catch date and time, means and rate
of cooling, storage temperature, and refrigerated brine or seawater
temperature) provide documentation to the processor and to regulatory
authorities that the fish were properly handled. Such records on the
handling of the fish should be part of an HACCP system and can be used
in the specific HACCP plans of processors.
The harvester's goal should be to bring the fish to an internal
temperature of 40 deg.F (4.4 deg.C) or below as soon as possible
after the fish dies to minimize the risk of histamine production.
Cooling fish below 59 deg.F (15 deg.C), and preferably below 50
deg.F (10 deg.C), greatly reduces the growth of populations of the
bacteria that are most likely to cause histamine formation (Ref. 7, p.
95). Once bacterial growth has begun, temperature at or below 41 deg.F
(5 deg.C) halts bacterial growth, although enzymatic histamine
formation may slowly continue (Ref. 7, p. 95). Consequently, in
proposed Appendix B, section 3.a.1., the agency is recommending a
slightly lower flesh temperature of 40 deg.F (4.4 deg.C) or below.
This temperature is consistent with recommendations of safe
temperatures in other sections of the proposed regulation. Nonetheless,
FDA specifically invites comments on the appropriateness of this
temperature.
Appendix B, section 3.a.1. recommends that the time/temperature
history from the vessel be on a lot-by-lot basis and defines a lot as a
discrete storage compartment on the vessel in keeping with industry
practice. A lot typically reflects a day's catch. Because a boat's
catch can be subject to varying conditions and treatment from day-to-
day, the time/temperature records should be specific to each lot.
If the time/temperature records suggest that, for a particular lot,
the conditions on the vessel were likely to cause, or significantly
contribute to, the formation of histamine in the fish, or if no
adequate time/temperature records exist for that lot, the guideline
provides that a representative sample of fish from the lot be analyzed
for histamine Appendix B, section 3.a.2.ii.B.). The samples should be
collected on a statistically valid sample schedule because variations
in time/temperature abuse are likely at various points in a ship's
hold.
The second control, organoleptic examination by the processor for
decomposition, should be performed regardless of what the time/
temperature records show (Appendix B, section 3.a.2.). First,
decomposition is a form of adulteration under 403(a)(3) of the act.
Second, as indicated earlier, an organoleptic examination provides a
screening mechanism for individual fish. It is possible for the
conditions on the vessel to be good but for some fish to develop
decomposition anyway. Third, also as stated earlier, an examination for
decomposition provides a way to verify the time/temperature records.
FDA recognizes that an organoleptic examination of each fish can be
highly impractical. Consequently, the guideline calls for an
examination of a representative number of fish to achieve a 95 percent
certainty that the total number of fish in the lot that exhibit
decomposition does not exceed 2.5 percent. (The significance of 2.5
percent is addressed in the preamble discussion of Appendix B, section
3. a.2.iii. and a.2.iv.) Using this approach, the number of fish
examined will be reasonably close to the total number of fish, so that
the goal of screening individual fish is preserved to the maximum
extent practicable. Additionally, FDA expects that this representative
sample will be large enough so as to provide a sufficient verification
of the time/temperature records for the entire lot.
Appendix B, section 3.a.2.i. provides that no fish flesh that
exhibits any organoleptically detectable decomposition should be used
for food. Aside from the clear violation of 402(a)(3) of the act
presented by such decomposition, the public health risk presented by
decomposition in scombrotoxin forming species is unacceptable. While
the existence of decomposition does not mean that scombrotoxin is
present, it does mean that a process has begun that can lead to the
presence of scombrotoxin over the shelf life of the fish or fishery
product.
In some instances, e.g., large fish such as tuna, isolated parts of
the fish will exhibit decomposition but other parts will be free of
decomposition. FDA recognizes that it is possible to remove those parts
of a fish that have decomposition and salvage the remainder. Appendix
B, section 3.a.2.i. provides for such reconditioning so long as a
histamine examination is performed on the flesh that is free of
decomposition. FDA believes that a histamine test is prudent under such
circumstances to verify that scombrotoxin forming processes are not at
work in that flesh.
The guideline also provides for how the processor should use
organoleptic examination and time/temperature records in tandem to
determine whether fish or fishery products from scombroid forming
species are fit for further processing or should first be subject to a
histamine examination. If no decomposition is found, and the time/
temperature records show that conditions on the vessel were unlikely to
cause, or significantly contribute to, the formation of histamine in
the fish, all the fish from that lot may be further processed or
directly entered into commerce (Appendix B, section 3.a.2.ii.). If, as
stated earlier, the time/temperature records are inadequate or indicate
conditions that could cause histamine, the processor should always
conduct a histamine analysis on a representative sample regardless of
the decomposition findings.
If decomposition is found in less than 2.5 percent of the lot, and
the time/temperature records show that conditions on the vessel were
unlikely to cause, or significantly contribute to, the formation of
histamine in the fish, Appendix B, section 3.a.2.iii. provides that the
decomposed fish should be removed in accordance with the procedure
outlined in Appendix B, section 3.a.2.i., but that it is not necessary
to subject the lot to a histamine examination. The agency has
tentatively concluded that decomposition below 2.5 percent is not
significant in terms of the acceptability of the entire lot. Under the
best conditions, it is possible that some fish in a large lot will
experience some minimal decomposition. Under these circumstances, so
long as the fish with decomposition are culled from the lot, there is
no reason to suspect that the lot has been subject to unusual
conditions that could cause histamine or scombrotoxin to form. The
agency is aware that the canned tuna industry uses the 2.5 percent
value to determine whether special handling of a lot is warranted (Ref.
119). The canned tuna industry has concluded, just as FDA tentatively
concludes, that levels above 2.5 percent represent likely exposure of
the fish in a lot to conditions that are out of the ordinary and
potentially dangerous.
For these reasons, if the processor finds decomposition in more
than 2.5 percent of the fish from a lot, those fish must be removed
from the lot, and a histamine examination needs to be performed on a
representative sample of the remaining fish in that lot (Appendix B,
section 3.a.2.iv.).
It is important to recognize that where the time/temperature
records are inadequate for all the fish on a vessel, or show poor
conditions for all the fish from a vessel, histamine analyses should be
performed on representative samples from each lot on the vessel.
Although an appropriate number of fish for sampling could possibly be
provided from a single lot, the results would not be representative of
the vessel as a whole.
Appendix B, section 3.a.3. describes how fish should be disposed of
depending on the results of a histamine examination. In keeping with
current policy, the agency expects that any fish that is found to have
histamine above a defect action level or other regulatory level or
limit for histamine established by FDA will not be used for food.
Moreover, the agency expects, as reflected in Appendix B, section
3.a.3.i., that a finding of histamine over such level or limit in any
fish in a lot from the vessel will result in the destruction of that
entire lot, regardless of the percentage of decomposition that was
organoleptically detected or the conditions on the vessel as indicated
by the time/temperature records. Such a histamine finding strongly
indicates that neither the records from the vessel nor the
decomposition test (if the results were below 2.5 percent) are
reliable. Histamine may be present in the absence of organoleptically
detectable decomposition.
Similarly, the agency expects, as reflected in Appendix B, section
3.a.3.ii., that a finding of histamine below the action level, but
higher than is normally found in fresh fish (Refs. 120 and 121), in any
fish in a lot will result in the immediate cooking of all the fish in
the lot to ensure that scombrotoxin will not form over the shelf life
of the fish. Cooking stops the histamine forming process once it has
started. Without this cooking, any elevated temperatures later in the
distribution system or in the home can result in a rapid elevation of
histamine levels to hazardous levels (Ref. 117, p. 341).
Appendix B, section 3.b. addresses raw materials controls that can
be exercised by subsequent processors, i.e., those other than the first
processor to take possession of scombroid toxin forming fish and fish
products from a harvester. Assuming that the first processor has met
its responsibilities with regard to raw materials as explained above,
and has not caused a problem through improper handling during
processing, subsequent processors should determine whether
decomposition occurred during transfer from the previous processor.
Consequently, the guideline provides, at Appendix B, section 3.b.1.,
that subsequent processors that do processing other than simply
storing, should subject a representative sample of fish or fish
products from each lot to an organoleptic examination. Any finding of
decomposition in that sample should lead to organoleptic examination of
the entire lot. If decomposition is found in more than 2.5 percent of
the fish in the lot, the processor should perform a histamine
examination on a representative sample of fish from the lot. These
gradations are consistent with the expectations reflected in the
guidelines for first processors.
FDA has tentatively concluded these measures need not be taken by
those who only store fish and fishery products. While time/temperature
abuse can occur during storage, and thus scombroid toxin forming
species must be held at appropriate temperatures (40 deg.F (4.4
deg.C) or below), the hazard of scombrotoxin in the finished product
can be controlled by those who own the product or manipulate it during
processing.
As suggested above, time/temperature abuse can occur during
processing as well as before the raw materials are received. It is
important that processors identify critical control points and suitable
controls that will protect fish and fish products that can form
scombrotoxin from time/temperature abuse. As the guideline for
scombrotoxin states in Appendix B, section 5., many of the controls for
time and temperature in the guideline for cooked, ready-to-eat products
should be applicable to the processing of scombrotoxin forming species.
Such handling conditions are necessary to control histamine production.
In addition, Appendix B, section 4. provides that products that are
undergoing processing not be exposed to ambient temperatures of 40
deg.F (4.4 deg.C) or higher for more than 4 hours during that
processing. The agency recognizes that for many products, manipulation
under unrefrigerated conditions is necessary. The processor must be
aware, however, that during such periods the product will be exposed to
conditions that can lead to histamine formation. Appendix B, section 4.
describes how to minimize this possibility.
To comply with Appendix B, section 4., the processor should monitor
the length of time that the product is exposed to ambient temperatures
of 40 deg.F or higher. Documentation of the time/temperature
monitoring controls will facilitate management and regulatory review.
L. Guideline for Product Integrity
1. Economic Adulteration
Economic adulteration occurs when a consumer is misled about the
worth, amount, or identity of a food product and, therefore,
unknowingly pays for value not received. Economically deceptive
practices in the representation of a food's value may occur in a number
of ways. Sections 402(b) and 403 of the act define the conditions and
practices that result, respectively, in the economic adulteration and
misbranding of a food. In addition, the Fair Packaging and Labeling
Act, 15 U.S.C. 1451 et seq., requires that food packages and their
labeling provide consumers with accurate information about the identity
and net quantity of the contents, so that consumers can make fair value
comparisons among products.
While any food may be subjected to economic adulteration or to
misbranding, fish and fishery products present distinctive
characteristics and processing procedures that make them more
susceptible to abusive economic practices than most foods. The great
variety of finfish, shellfish, and crustacean species, as well as the
multiplicity of products prepared from them, including fabricated
surimi-based products that imitate actual seafoods, provide ample
opportunity for both inadvertent and deliberate economic adulteration
and misbranding practices that result in economic loss to the consumer.
Most important among the characteristics that make seafoods
vulnerable to abuse is the similar appearance of many finfish, in the
whole, raw state, in the form of fillets, or as ingredients. Unlike the
situation with the limited types of red meats and fowl, it is very
difficult for most consumers to detect the substitution of an
economically inferior species for a more valuable one that is declared
on the label or in labeling (e.g., the substitution of rockfish for red
snapper).
Irrespective of the relative economic value of the substitute
species, section 403(a)(1) of the act states that a food shall be
deemed to be misbranded if its labeling is false and misleading in any
particular. More specifically, a food is misbranded under section
403(b) of the act if it is offered for sale under the name of another
food. If the substituted fish is less valuable than the species
represented on the label or labeling, the product is also adulterated
under section 402(b)(2) of the act, which states that a food shall be
deemed to be adulterated if any substance has been substituted wholly
or in part therefor. Consequently, it is a clear violation of the act
when a finfish, shellfish, or crustacean is not correctly identified on
its label or in its labeling.
Furthermore, the misidentification of species may also have adverse
public health consequences. Should an illness or outbreak occur from a
seafood product, it is essential for proper diagnoses and treatment
that public health investigators not be prevented from quickly
identifying the exact cause or agent responsible in the food, and from
tracing it back to the correct source of the food to prevent further
sale and consumption.
For example, in a seafood related incident that occurred in 1982,
in New York, two men became ill shortly after eating a fish dinner in a
restaurant. Species substitution caused investigators to erroneously
suspect that the illnesses were caused by ciguatoxin because the food
was identified as being red snapper, a species which could cause that
illness. The food actually was mahi, a fish which is often associated
with scombroid poisoning (Ref. 122). Scombroid poisoning is associated
with high levels of histamine.
FDA found that the fish mislabeled as red snapper had been shipped
from Ecuador and processed in Panama. Had the fish been labeled as
mahi, it would not have been permitted entry into the United States
because FDA had an automatic detention for mahi from Ecuador at the
time because of problems with high levels of histamine.
Another instance involving species substitution resulting in a
negative public health consequence occurred in Hawaii in 1987. Fifty
illnesses, 32 of which required medical attention, were attributed to
the consumption of limpets misbranded as ``Baby Abalone.'' The symptoms
displayed were those of a histamine-type reaction. Because abalone is
not one of the species expected to form histamine, substituting limpets
for abalone put consumers at risk from a food that they had not
intended to eat. Thus, accurate identification of species is essential
to public health protection and prompt accurate diagnosis and treatment
of illness when that protection fails.
Processing practices traditionally used in the seafood industry
also are easily abused to increase a product's weight, in the form of
ice or water. For instance, frozen fillets, shrimp, crab legs, and
other products are normally protected from dehydration (freezer burn)
while frozen by the application of a light glaze of ice. A packer then
includes added product in the package to compensate for the weight of
the glaze. Excessive amounts of glaze, however, not compensated for in
this manner, can deliberately be used to increase the apparent weight,
and therefore the apparent value, of the product delivered. Percentage
weight increases from overglazing are most dramatic for foods with high
surface area to volume ratios, such as shrimp. Overglazing is a
practice that violates section 402(b)(4) of the act because a substance
has been added to increase a food's weight or to make it appear of
greater value than it is.
A similar type of fraud frequently results from oversoaking fish
and shellfish meats in dip solutions. Dip solutions are customarily
used to retard the natural loss of moisture (drip loss) from products
such as scallops, which are particularly susceptible to drip loss.
However, exposure to the dip may deliberately be prolonged to add
weight in the form of water. Dip solutions may contain chemicals, such
as sodium tripolyphosphate, that can greatly enhance the amount of
water absorbed by the scallops. The net effect of such practices is to
mislead the consumer into purchasing added water at scallop prices.
Seafoods generally represent a high dollar value per unit weight
compared with other foods, particularly crab, lobster, shrimp, and
certain shellfish. Thus, even relatively modest percentage weight
increases from abusive glazing or water uptake from dip solutions
represent a substantial loss of value to the consumer.
For the same reason, the potential fraudulent profit from similar
practices of adding less valuable ingredients, such as breading on
shrimp and fish sticks or water to shucked oysters, to increase the
size or weight of products are enticing to unscrupulous processors.
The agency believes that economic adulteration occurs with
sufficient frequency in various seafood products to result in
substantial losses to the consumer. Evidence of such economic
adulteration usually comes to light indirectly, as a result of
investigations that are carried out for other purposes.
Fourteen and one-half percent of the samples of seafoods reported
in 1986 as having adverse findings by eight FDA district offices were
so listed because of product misrepresentation (Ref. 123).
Similarly, FDA found that in fiscal years 1991 and 1992, 14.8 and
11.7 percent, respectively, of all consumer complaints involved
complaints of economic problems (Ref. 60).
Imported seafood products also are subject to significant levels of
economic misrepresentation. In 1992, approximately 13 percent of all
detentions of imported seafood involved some form of misbranding, such
as false or misleading labeling, short fill, short weight, standard of
identity, and omitted labeling (Ref. 124).
Specific data on species substitution are available from The
National Seafood Inspection Laboratory (NSIL) of NMFS, Department of
Commerce. Data gathered for the 3-year period of 1990-1992 by the
laboratory in conducting species verification tests requested by
industry show that 59 percent of the samples labeled as cod, 57 percent
of the product labeled as haddock, 56 percent of the product labeled as
flounder or sole, and 51 percent of the product labeled as red snapper
were not the species claimed on the label. While these data cannot be
regarded as representative of industry-wide misbranding practices
because the testing was not random, the results indicate a remarkably
high incidence of species substitution. Moreover, these findings are
consistent with other surveys (Ref. 35, p. 45).
For example, a survey conducted in Florida to determine the extent
of retail species substitution in the case of red snapper found that 64
percent of the fish fillets labeled for retail sale as red snapper were
misbranded (Ref. 125). The prevalence of misbranding just this one
desirable species is underscored by the observation: ``If all of the
red snapper sold in the United States were genuine, the seas would long
since have been swept absolutely clean of this species'' (Ref. 126, p.
41).
While most States' regulations follow FDA nomenclature policy and
regulations, misbranding practices are exacerbated by the failure of
some States to require these common names for some species sold within
the State. Red snapper again provides a case study in the extent of
variation in acceptable nomenclature allowed for a species. Although
not permitted when sold in interstate commerce, California regulations
allow 12 species of rockfish to be labeled as ``Pacific red snapper''
within the State. Similarly, Oregon and Washington regulations also
allow rockfish to be called ``snapper'' (Ref. 126, p. 305). Moreover,
an even greater variety of imported species may be misrepresented as
``red snapper.''
Many in the seafood industry believe that economic abuse is one its
most significant problems. A survey conducted by the National Fisheries
Institute found that the Institute's membership supported mandatory
inspection as a means of overcoming practices that pose a threat to the
reputation of processors and packers adhering to scrupulous practices
in the representation of their products (Ref. 127). General agreement
was found to exist among processors, distributors, and importers, as
well as retailers and restaurateurs, that abusive economic practices
are widespread, including overglazing and overbreading of fishery
products, inaccurate net weight measurement, and the substitution of
inferior species for more valuable fish.
In a similar industry study by the Southeastern Fisheries
Association, members ranked problems with economic fraud (such as
species identification, overglazing, and the use of phosphates) above
all other seafood industry problems, except vessel handling practices
(Ref. 128).
2. Recommended Adoption of HACCP-Based Methods
Although the agency recognizes that HACCP was developed primarily
to address safety, FDA believes that the proposed requirement in
Sec. 123.6, for seafood processors to adopt HACCP methods to ensure the
safety of seafoods provides an opportunity for processors to develop
and apply effective control point procedures that they can use to
ensure that seafoods comply with the provisions of sections 402(b) and
403 of the act, The Fair Packaging and Labeling Act, the seafood
standards of identity promulgated in 21 CFR, and applicable compliance
policy guides issued by the agency (Compliance Policy Guides 7108.01,
7108.03, 7108.04, 7108.12, 7108.13, 7108.14, 7108.21, and 7108.23).
Consequently, the agency is proposing in Appendix D to establish a
guideline for HACCP-based procedures to avoid economic adulteration and
misbranding of seafoods. Following this guideline will enable
processors to develop procedures and records that will establish that
they are not engaged in any practices that would render their products
economically adulterated. Clearly, however, guidelines cannot prevent
economic fraud.
The following guideline for product integrity lists critical
control points covering raw material receipt, processing, and labels
and labeling that processors and importers can incorporate in their
HACCP plans. The agency believes that proper control begins with
verification of the raw materials received by a processor. Therefore,
in Appendix D, section 2.a., the agency is suggesting that, as part of
their HACCP plan, processors and importers should include critical
control points beginning with the receipt of raw materials. Ensuring
that raw materials meet critical limits (e.g., correct species
identification, net weight, additive identification) at the point they
enter a processor's or importer's control is crucial.
There are a number of ways to ensure that species are properly
identified. Physical examination, as indicated in Appendix D, section
2.a.1. is the typical method of determining the identity of a species.
The agency believes that most seafood processors and importers are
knowledgeable about the species that they handle and would have
personnel available at the point of receipt who could monitor the
incoming shipments for species substitution. Expert consultation is
another option for correctly identifying species.
Processors or importers can also check the identity of seafood by
employing laboratory services, as provided for in Appendix D, section
2.a.2. Protein chromatography is a laboratory method that can
accurately establish the species of fish and fishery products (Ref.
50). Another option, Appendix D, section 2.a.3., is to receive raw
materials certified by suppliers under either limited or general and
continuing guaranties (section 303(c)(2) of the act (21 U.S.C.
333(c)(2)) and 21 CFR 7.12 and 7.13).
In Appendix D, section 2.b., the agency points out that processors
must ensure that the labels, labeling, and invoices of their finished
products accurately list weight, count, size, and product identity, as
well as the content of valuable constituents (i.e., that ingredient
that the consumer identifies as providing the reason to purchase the
product, for example, the shrimp in breaded shrimp). The content of the
valuable constituents must be maintained as required by FDA's standards
of identity regulations (21 CFR part 161, including: oysters, Pacific
salmon, canned wet packed shrimp in transparent or nontransparent
containers, frozen raw breaded shrimp, frozen raw lightly breaded
shrimp, and canned tuna) or in accordance with FDA's compliance policy
guides.
More specifically, as in Appendix D, section 2.b.1., the species
must be correctly identified by its common or usual name and be so
represented on the label and labeling. To assist processors and
consumers, FDA has developed both printed and database versions of the
``FDA Fish List'' to provide such guidance. Also specific requirements
for such labeling are listed in Standards of Identity and the Common or
Usual Name regulations (21 CFR, parts 161 and 102).
Appendix D, sections 2.b.2. through b.5. are based on section
402(b) of the act. Under Appendix D, section 2.b.2., the processor
needs to ensure that valuable constituents of the product are not
omitted or abstracted. For example, breaded shrimp must contain the
required weight ratio of shrimp to breading. Similarly, shrimp must be
of the size and/or weight specified on the label or labeling.
Under Appendix D, section 2.b.3., the processor needs to ensure
that no substance is substituted wholly or in part for a valuable
constituent. For example, substitution of crab flavored surimi cannot
be used in whole or in part instead of crab meat in a product labeled
as crab cake.
Under Appendix D, section 2.b.4., the processor needs to ensure
that damage or inferiority is not concealed in any manner. This means,
for example, that bleaching or coloring of product to conceal its true
nature or condition of wholesomeness is not acceptable.
M. Additional Guidance--FDA Fish and Fishery Products Hazards and
Controls Guide Including Specific Guidance on Smoked Fishery Products
As an adjunct to its rulemaking to require HACCP procedures in the
seafood industry, FDA is drafting an extensive guidance for processors
to use in understanding and implementing HACCP principles for their
operations. This guidance will provide information that processors and
importers can use in the development of their HACCP plans. This
information consists largely of an identification of hazards that can
affect the safety of seafood and a review of control measures that can
keep the hazards from actually occurring, or that can at least minimize
the likelihood of their occurrence.
FDA has included selected portions of the draft HACCP guidance as
Appendix 1 to this proposal, so as to better inform the public about
how this guidance will be structured and about the kinds of assistance
that will be available to processors and importers who implement HACCP.
The agency emphasizes, however, that this guidance is a work-in-
progress and still being developed by FDA. Nonetheless, the agency
seeks comment on the need for this guidance and the usefulness of the
format the agency proposes to adopt.
In addition, FDA is including in Appendix 1 specific guidance on
time-temperature and salinity parameters and other matters for use in
the HACCP plans of processors of smoked and smoke-flavored fishery
products. While FDA is seeking comment on the guidance generally, it
particularly seeks comment on the guidance on smoked and smoke-flavored
fishery products. Material relevant to the safe processing of smoked
and smoke-flavored fishery products is found in various sections of the
HACCP guidance because this general guidance is primarily organized by
hazard rather than by commodity type. However, the agency has gathered
the materials relating to smoked and smoke-flavored fishery products
into a single section of the guidance to facilitate use of this
guidance by this industry, and to facilitate obtaining public comment
on it. As stated above, FDA seeks public comment on the appropriateness
of the materials relating to smoked and smoke-flavored fishery products
as guidance, on their validity as guidelines, and on whether they
should be made mandatory by incorporating them into any final
regulation that results from this rulemaking.
While no known outbreaks of botulism attributed to smoked fish have
been reported since 1963, FDA believes that the failure by
manufacturers to obtain information about the composition of hot- and
cold-process products represents a potential health hazard. Without
analytical results from the testing for water-phase salt and sodium
nitrite levels, a manufacturer cannot determine whether the fish have
been adequately processed to inhibit C. botulinum spore outgrowth and
toxin production. The agency's concerns are underscored by the
diversity of processing temperatures and salt levels used in the
manufacture of these products, particularly the lower range
temperatures and water-phase salt levels (Ref. 24).
Finally, as stated above, the use of modified atmosphere and vacuum
packaging with smoked and smoke-flavored fish products is also a source
of concern. These types of packaging provide an anaerobic environment
in which C. botulinum spores can grow out and produce botulin, the
causative agent in botulism. When consumed, the toxin attacks the
central nervous system and may cause death if untreated within 3 to 6
days.
For all these reasons, FDA has tentatively concluded that some type
of guidance that defines the procedures for the safe processing of
smoked and smoke-flavored fish is necessary.
Historically, fish have been smoked in order to preserve them.
Today, the primary reason for smoking is to impart certain taste and
texture qualities to the fish. There are essentially two types of
smoked fish: (1) Those that are subjected to a ``cold process'' that
leaves the fish soft and moist, with a delicate smoke flavor, such as
lox, and (2) those that are subjected to a ``hot process'' that
produces a less moist, firmer product with heavier smoke flavor, such
as smoked whitefish.
The processing of these fish basically involves: (1) Cleaning and
gutting followed by (2) immersion in a brine solution or dry salt in
order to salt them, (3) drying in a cool temperature to avoid bacterial
growth, (4) smoking in a smoking chamber at a temperature and for a
time necessary to achieve the desired ``cold process'' or ``hot
process'' effect, and (5) packaging and cooling. The taste and texture
qualities attributable to ``cold process'' smoked fish require much
lower temperatures during the smoking phase of the process than those
attributable to ``hot process.'' Salted fish may not be smoked at all.
As with virtually all fish, the species used to make smoked fish
are exposed during their lives to C. botulinum, a spore- forming
bacterium that is ubiquitous in the marine and freshwater environment.
Type E is the predominant type of C. botulinum found in fish, other
aquatic animals, water, and sediment, although other types such as A,
proteolytic and nonproteolytic B, C, D, and F also have been found in
fish (Refs. 148 through 152). The concentration of C. botulinum spores
that may be expected in and on a naturally contaminated fish is
unknown, although it is reported to vary from one spore per 16 g of
fish to one spore per 200 g (Refs. 153 and 180).
Under certain conditions, C. botulinum can produce a toxin that
causes botulism, a disease that attacks the central nervous system of
humans and can cause death within 3 to 6 days of ingestion if not
properly treated (Ref. 193). C. botulinum's ability to form spores
means that in a dormant state, it can survive environments that are
otherwise hostile to it. C. botulinum is ``anaerobic,'' meaning that
air constitutes a hostile environment. When conditions become
favorable, that is, when no air is present, the spores experience
``outgrowth'' during which toxin can be produced. In fish, C. botulinum
spores are found in the intestines and can also adhere to the surface
of fish.
For these reasons, C. botulinum can be found in the environment of
most any fish processor and cannot be totally eliminated using
reasonable means. Moreover, even though a fish might be cleaned,
gutted, and air packaged, some risk will still exist because C.
botulinum spores can find their way into muscle tissue during
processing. Muscle tissue below the surface of the fish can provide an
anaerobic environment where outgrowth and toxin production can occur if
time and temperature permit.
Although the processing procedures in Appendix 1 are based on
studies of the time-temperature and salinity conditions required to
prevent the outgrowth of botulinum spores, these practices are also
effective in the elimination of risk from other pathogenic bacteria
such as L. monocytogenes. L. monocytogenes is a pathogenic bacterium
that is widespread in the environment and that is commonly isolated
from surface waters and other environmental samples. Thus the
likelihood of finding this pathogen on the exterior surfaces and
viscera of fish is high. Since 1983, several large outbreaks of human
listeriosis have been linked to the consumption of contaminated foods
(Refs. 130, 131, and 132), thereby demonstrating the etiologic
importance of foodborne transmission of this disease in humans.
Although listeriosis is a relatively rare illness (approximately
2,000 reported cases per year in the United States), the exceptionally
high mortality rate, as high as 34 percent, makes this illness one of
the leading fatal foodborne diseases in the United States. The highest
incidence of listeriosis generally occurs in neonates, the elderly,
pregnant women, and individuals suffering from compromised immune
systems. However, there are instances in which apparently healthy
individuals have contracted listeriosis (Refs. 130 and 133).
The incidence of Listeria species (including L. monocytogenes) in
frozen raw and cooked seafood products is reportedly as high as 61
percent (Ref. 136). Indeed, numerous seafood products have been shown
to support growth of L. monocytogenes (Refs. 137 and 138). L.
monocytogenes is capable of prolific growth on smoked salmon stored at
4 deg.C, even when test inocula as low as 6 organisms per gram (g) are
applied to the surface of fish samples (Ref. 139). Seafoods other than
smoked or smoke-flavored fish have been epidemiologically linked to two
outbreaks and one sporadic case of listeriosis (Ref. 140). Furthermore,
several cooked seafood products have been recalled from the market in
North America because of contamination with L. monocytogenes, but these
crises did not involve smoked or smoke- flavored fish products.
A recent survey of smoked fish and smoked fish products in Iceland
has shown that 29 percent of samples tested were contaminated with
Listeria species, including L. monocytogenes (Ref. 141). Another survey
revealed that 8.9 percent and 13.6 percent of hot- and cold-smoked
fish, respectively, were contaminated with L. monocytogenes (Ref. 142).
Cold-smoked fish may pose a significant health risk, particularly when
stored for extended periods. When raw salmon was inoculated with known
populations of L. monocytogenes and smoked at 78.8 to 86 deg.F (26 to
30 deg.C) for 6 hours, and the finished product stored at 39.2 and 50
deg.F (4 and 10 deg.C) for up to 30 days, investigators observed
substantial increases in L. monocytogenes populations at both
incubation temperatures (Ref. 143). No known cases of listeriosis have
been linked to smoked seafood consumption in the United States.
In contrast, studies have shown that properly controlled hot-
smoking processes effectively eliminate L. monocytogenes contamination
(Ref. 144). In raw trout inoculated with high doses of L.
monocytogenes, stored for 12 hours in a marinade containing 10 percent
NaCl, and then subjected to a hot-smoke process (dried for 30 minutes
at 140 deg.F (60 deg.C), cooked at 230 deg.F (110 deg.C) until an
internal temperature of 149 deg.F (65 deg.C) was maintained for 20
minutes, and finally smoked for 45 minutes at 140 deg.F), L.
monocytogenes did not survive the smoking process. However, when fish
were inoculated after smoking and stored at 46.4 to 50 deg.F (8 to 10
deg.C), a significant increase in L. monocytogenes populations was
observed after up to 20 days of storage. These findings further
emphasize the importance of preventing the contamination of processed
fish.
Studies have also shown the importance of controlling the salt
concentration in smoked fish. Although L. monocytogenes can survive in
environments containing up to 20 percent NaCl (Ref. 145), it has been
demonstrated that the organism becomes increasingly more sensitive to
NaCl when it is exposed to heat processing (Ref. 146).
Because of the prevalence of L. monocytogenes in the environment,
it may be impossible to completely eliminate the organism from all
foods. However, use of the sanitary practices and processing practices
proposed in this document should prevent cross-contamination and growth
of the organism in smoked and smoke-flavored seafoods.
Smoking fish is a delicate process, involving a number of
interrelated variables including times, temperatures, and exposure to
smoke, salt, and sodium nitrite, when used. However, FDA believes that,
by its very nature, this process involves certain inherent risks, risks
that, if not attended to, can have very significant consequences.
For example, the times/temperatures involved in the ``hot process''
can injure but not kill C. botulinum spores while killing spoilage
microorganisms. Thus, during the period when the spoilage
microorganisms are becoming reestablished, surviving C. botulinum
spores would be presented with an optimum growth environment because of
the lack of competition. Yet, because of the absence of spoilage
microorganisms, spoilage odors that would warn consumers away from
potentially dangerous products would not be present. Botulism toxin
alone is not detectable by sensory examination.
In addition, because of the number and types of steps involved, the
processing of smoked fish involves an unusual amount of handling of the
product relative to other seafood processing procedures. Increased
handling presents increased opportunities for contamination during the
process than would otherwise be the case.
The finished product also is inherently more risky than most other
seafood products because it is a ready-to-eat product that is generally
not cooked before eating. However, the present evidence indicates that
smoked fish has caused no more cases of botulism in the United States
than any other type of seafood product. In contrast, fresh fillets that
are not smoked are intended to be cooked before consumption. Cooking is
lethal to bacteria and will deactivate botulism toxin. Thus, smoked
fish products usually do not get the benefit of an additional
processing step that protects against most bacteriological risks.
In addition to these inherent characteristics, FDA believes that
smoked fish present special risks because both domestic and foreign
processors are now using vacuum packaging to a substantial extent--much
more so than are other segments of the seafood industry. A 1988-1989
FDA and New York State survey of domestic processing plants, for
example, showed that 45 percent of the firms visited vacuum-packaged
smoked fish. However, there is no evidence to show a linkage between
vacuum packaging of smoked fish and illness in the 5 years since this
survey was completed.
An economic incentive for use of vacuum packaging is the extended
shelf-life of the product, made possible by the anaerobic environment
in the package that prevents the growth of some spoilage microorganisms
and slows the growth of others. Because this anaerobic environment
cannot prevent spoilage altogether, vacuum-packaged products must still
be refrigerated.
Unfortunately, the anaerobic environment greatly favors the
outgrowth of any C. botulinum spores that may be present over the
development of telltale spoilage microorganisms. Thus, C. botulinum
outgrowth can occur before spoilage if a vacuum-packaged product is
temperature abused, i.e., not refrigerated. Moreover, as discussed
elsewhere in this document, the growth of L. monocytogenes and C.
botulinum type E and nonproteolytic type B is possible even at
refrigeration temperatures below 40 deg.F (4.4 deg.C). FDA believes
that strict controls are needed to overcome this risk.
In 1970, FDA issued a final rule for smoked fish in response to
outbreaks of botulism attributed to vacuum-packaged smoked fish
products (35 FR 17401, November 13, 1970). Among other things, the rule
attempted to control the risk of botulism by setting conservative
processing parameters for time, temperature, and salinity that would
minimize the opportunity for C. botulinum spore outgrowth. These
parameters were based on the relatively limited research that had been
conducted up to that time with one species of fish. Many processors
claimed that these parameters would have resulted in a product that was
too salty and too dry in texture to be marketable.
The rule was overturned in court due to procedural problems (United
States v. Nova Scotia Food Products Corp., 568 F.2d 240 (2d Cir.
1977)). However, in rethinking this rule after the remand, FDA decided
that research was needed into the relationships among time,
temperature, and salinity to develop processing parameters that would
provide safety without producing an undesirable product that consumers
would not buy.
This research has been successfully conducted by FDA, the National
Marine Fisheries Service, and the industry. FDA has prepared the time,
temperature, and salinity parameters in the Hazard Assessment Guide
based on the results of this research.
1. Need for Guidance
FDA routinely inspects smoked fish processing establishments for
sanitary conditions using the guidance in 21 CFR part 110, ``Current
Good Manufacturing Practice in Manufacturing, Packing, or Holding Human
Food'' (Ref. 196) and in the FDA Inspection Operations Manual, Chapter
5, Establishment Inspection and section 616.6 Smoked Fish inspection
methods (Ref. 197). In addition to the Establishment Inspection Reports
(EIR's) discussed in section G, EIR's for smoked fish processing
establishments over the past few years (1985 to the present) show
evidence that the use of manufacturing procedures are not in line with
CGMP's. The EIR's also show that processing parameters and controlled
processing and storage techniques, commonly recognized as appropriate
in the industry (Ref. 182) are not being used (Ref. 169).
Typical observations by FDA officials in these inspections include:
(1) Live flies in production areas providing a vehicle for
contamination and recontamination of products; (2) standing water in
production rooms providing a medium for microbial growth and
contamination from splashed water; (3) utensils not sanitized prior to
use; (4) open bags of raw materials in storage areas exposing products
to flying insects and potential microbial contamination; (5) smoke
racks encrusted with pieces of fish from previous processes, thus
providing an opportunity for microbial growth; (6) refrigerators being
used for both raw and finished products, thus providing an environment
for microbial growth through cross-contamination between unprocessed
and processed products; (7) overcrowded fish in brine tanks, whereby
some fish are not fully submerged in brine, resulting in lower and
uneven levels of salt uptake that would not be effective in inhibiting
spore outgrowth; (8) salinity and microbiologic testing not performed
on products; (9) low minimum water-phase salt levels (0.88 to 1.79
percent) that would not inhibit C. botulinum spore outgrowth and toxin
production; and (10) poor employee practices that foster microbial
contamination, including spitting into sinks adjacent to sinks used to
thaw product, not washing or sanitizing hands, and street clothes in
contact with product (Ref. 169). (See also Ref. 200.)
As part of its Fiscal Year (FY) 91 Domestic Fish and Fishery
Products Inspection Assignment, FDA conducted food safety inspections
of smoked fish establishments. These inspections revealed a continuing
pattern of problems in these facilities. In over half of these
inspections FDA found violations that required action, ranging from
minor violations, which are normally handled by informing the firm's
official during the inspection, to more serious violations that
prompted some form of official agency action (Ref. 200).
In addition, several States, working through AFDO, have expressed
concern that a potential health hazard exists with smoked and smoke-
flavored fish products and have stated that a Federal regulation is
necessary for uniform regulation of the production and distribution of
these foods (Refs. 170 and 189). AFDO is an organization of Federal,
State, and local regulatory officials with membership representing all
50 states, as well as FDA and other Federal agencies. AFDO's Central
States Regional organization held a meeting in 1988, attended by public
health officials from 6 states in which the smoked fish industry is
concentrated, Canada, and NMFS, to discuss a Federal regulation
governing the processing, storage, and distribution of smoked and
smoke-flavored fish products. In December, 1989, AFDO first passed a
resolution requesting that FDA expedite the rulemaking process to
establish uniform Federal regulations to ensure that safe smoked fish
processing methods are utilized for fish products sold in the United
States. In December, 1990, AFDO passed resolution 8, which strongly
encouraged FDA to ``accelerate the promulgation of smoked fish CGMP's
so that concerned States can move forward with their efforts to ensure
the safety of smoked fish'' (Ref. 170). FDA recognizes the need to
address the hazards associated with smoked and smoke-flavored fishery
products and therefore is setting forth the procedures in Appendix 1 in
the interest of protecting the public health.
The need for some type of agency guidance on smoked fish is also
evidenced by several other factors. First, the 1970 final rule, which
covered only hot-process smoked and smoke-flavored fish and the
processing parameters that they required, is still being used as a
guideline by some States. These earlier parameters could result in
commercially undesirable products. These parameters ought to be updated
with the current technological understanding and processing flexibility
for both hot and cold smoked products. The guidance in this document
can provide the basis on which such updating can occur.
Second, the manufacture or sale of cold-processed fish products is
not permitted in at least two States because there are no regulations
or regulatory guidelines for these products (Ref. 170). There is some
pressure, however, to permit the sale of these products. The Canadian
Government, for example, has urged these States, Minnesota and
Michigan, to permit the sale of these products so that Canadian
products may be exported to the United States (Ref. 170). Some type of
guidance that helps to define the processing parameters and techniques
that reduce human health risks from cold-process smoked and smoke-
flavored fish products would provide State, as well as federal, public
health officials with the tools necessary to evaluate the safety of
cold processed products manufactured in the United States, as well as
those imported into the United States.
Third, in 1988 FDA conducted a survey of processing parameters used
by fish smoking plants in the United States. Seventy five percent of
the firms surveyed did not do final product testing to ascertain
whether their products met commonly recognized (Ref. 182) parameters
for their products (Ref. 24). The information collected in this survey
augmented information obtained from the New York State Department of
Agriculture and Marketing (Ref. 24), which had conducted a similar
survey of fish smoking establishments in that State at approximately
the same time. A total of 64 establishments were surveyed by FDA and
New York State, representing over 90 percent of the smoked fish
manufacturers in the United States. Among the species of fish included
in the survey were chubs, bluefish, trout, carp, salmon, whitefish, and
herring. Processing information was collected from manufacturers, and
samples were collected for laboratory analysis.
The following chart summarizes the results of these surveys and
compares them to proposed processing parameters:
1988-1989 Domestic Survey Data
--------------------------------------------------------------------------------------------------------------------------------------------------------
Characteristic FDA New York Proposal
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cold-Smoked Products:
Temperature range....... 38 to 180 deg.F.............. 34 to 90 deg.F............... 50 deg.F for 24 hours or 90 deg.F for 20 hours.
Water-phase salt........ 1.33 to 18.1 percent.......... 1.4 to 7.4 percent............ 2.5 to 3.5 percent.\1\
Nitrite range........... 3.75 to 994 ppm............... .............................. 100 to 200 ppm.
Percentage of firms that 40 percent.................... 50 percent.................... ..........................................................
do not know water-phase
salt level.
Hot-Smoked Products:
Temperature range....... 90 to 210 deg.F.............. 128 to 240 deg.F............. 145 deg.F.
Water-phase salt........ 0.88 to 27.5 percent.......... 1.3 to 7.0 percent............ 3.0 percent.\1\
Nitrite range........... 15 to 239 ppm................. .............................. ..........................................................
Percentage of firms that 39 percent.................... 72 percent.................... ..........................................................
do not know water-phase
salt level.
Total number of firms 76 percent.................... 74 percent.................... ..........................................................
that do not test their
products (for 1 or more
processing parameter).
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\Actual level depends on other processing factors.
Oven temperatures for hot processing ranged from 90 to 240 deg.F
(32 to 116 deg.C) and from 38 to 125 deg.F (4.4 to 52 deg.C) for
cold processing. Water-phase salt content in hot-process products
ranged from 0.88 to 27.5 percent and in cold-process products from 1.33
to 18.1 percent. Twenty-eight firms (43.7 percent) vacuum packed cold-
process products, but 60.7 percent of those firms did not test final
products for water-phase salt content or for residual sodium nitrite.
Twenty-five firms (39.1 percent) vacuum packed hot-process products,
but 68 percent of those firms did not test final products for water-
phase salt content or for residual sodium nitrite. Seventy-five percent
of the firms surveyed did not test final products for water-phase salt
content or for residual sodium nitrite, where used. Since this survey
was conducted, the frequency of FDA inspections of smoked fish
establishments has been increased over 50 percent each year.
Therefore, FDA is providing guidance on the appropriate parameters
for processing smoked fishery products in Appendix 1 to this document.
The guidance addresses critical control points that apply to these
products as a class and that will typically be identified in the HACCP
plans of most processors of smoke and smoke-flavored products. The
guidance also addresses ways of controlling hazards at these critical
control points.
The key processing parameters that must be controlled to ensure the
safety of these products involve time, temperature, and salinity. While
a range of time-temperature-salinity (TTS) values will provide a safe
product, there are now known safety minimums for these values that have
been developed through years of research. Processors whose TTS values
fall below these minimums do not produce a safe product and shift much
of the burden of preventing botulism toxin outgrowth to those who take
possession of these products after they leave the processing plant,
including the ultimate consumer. This burden includes, among other
things, maintaining strict temperature control at 40 deg.F or lower
even though it is known that many commercial and home refrigerators are
unable to maintain this temperature (Ref. 201).
These TTS minimums are known to produce a marketable product,
because there are processors that operate in conformance with them.
Moreover, because they are minimums, these values allow for the
production of a variety of products, such as different types of lox
with varying amounts of saltiness, to suit different tastes.
These minimum TTS values provide the only scientifically valid way
developed to date of ensuring that no botulism toxin will be produced
over the shelf life of the product under proper refrigeration
conditions or under conditions of moderate temperature abuse. The
minimum values, coupled with the sanitation practices proposed in this
document, should also ensure against the presence of detectable L.
monocytogenes.
These minimum TTS values are being issued at this time as proposed
guidance to ensure maximum flexibility. If these values are reflected
in the HACCP plans that are required by proposed subpart A of 21 CFR
part 123, and are being effectively implemented by the processor, the
agency is likely to find that the plan and its implementation are
adequate with regard to those critical limits and critical control
points. The same holds true for the other types of controls recommended
in the guidance.
The agency is requesting comment on this approach, and on the
following alternatives:
(1) Issue all or part of the materials relating to smoked and
smoke-flavored fishery products in Appendix 1 as regulations, rather
than guidance. Given the public health concerns associated with these
products and the scientific basis for the TTS minimums, it may well be
appropriate to issue them as regulations. Such regulations would take
into account advances in knowledge and technology by allowing
processors to use alternative processing parameters so long as these
alternatives were scientifically demonstrated to produce an equivalent
level of safety. (Section 11 of the guidance relating to smoked and
smoke-flavored fishery products in Appendix 1 contains such a feature.)
(2) Issue a performance standard as a regulation, while leaving the
materials in Appendix 1 as guidelines on how processors could meet the
performance standard. The likely performance standard would be, as
suggested above (and included in section 11 of the guidance relating to
smoked and smoke- flavored fishery products in Appendix 1): (a) for
botulism, zero toxin production in the product during a time period
through--and slightly beyond--the shelf life of the product,
demonstrated through inoculated pack studies under normal and moderate
abuse conditions; and (b) no detectable L. monocytogenes in the final
product.
(3) Maintain the guidance relating to smoked and smoke-flavored
fishery products in the FDA Fish and Fishery Products Hazards and
Controls Guide and control safety through the HACCP requirements for
all seafood in proposed subpart A.
FDA requests comment on which of these alternatives is most likely
to ensure that smoked fish will be safe and is most consistent with the
agency's obligations under the act. In the absence of a regulation or
guideline, how can the agency best ensure that the results of the
research that it has conducted will be available for use by the
industry? FDA solicits comments on these and the matters raised above.
N. Verification Issues
As described in section IV.A. of this document, one of the NACMCF's
seven HACCP principles involves verification that the HACCP system is
working. NACMCF recommends that HACCP plans include procedures for
verification of the HACCP system (Ref. 34, p. 200). FDA advises
processors to consider adopting this recommendation, but has not
proposed to require it because the agency expects verification to occur
through: (1) A firm's consistency with the controls and limits to be
provided by FDA in the HACCP guidance described in section VII.C. and
M. of this document; (2) third-party technical assistance provided
through trade associations, universities and government agencies; and
(3) review of all HACCP monitoring records by trained individuals
before distribution of product (see proposed Sec. 123.8(b)); the
proposed corrective action requirements (see proposed Sec. 123.7),
especially the provision for assessment of HACCP plans as a consequence
of deviations (Sec. 123.7(a)(4)); the recommended use of process
authorities for cooked, ready-to-eat products (see Appendix A); the
proposed general training requirements (see proposed Sec. 123.9); and
inspector review during routine agency inspections. FDA invites comment
on whether this approach is adequate to ensure that the NACMCF
verification principle is being properly addressed, both for individual
firms and for the overall HACCP program.
For individual firms, NACMCF specifically discourages the sole
reliance on end-product sampling for verification purposes (Ref. 34, p.
201). FDA also has questions concerning the efficacy of end-product
sampling as the only way to measure the success of HACCP. These caveats
notwithstanding, FDA invites comment on what tests should be used to
measure success, both in terms of individual firms and the program as a
whole, and how frequently such tests should be administered.
VIII. Other Approaches to HACCP
This preamble has described in great detail the HACCP system that
is being proposed and the reasoning behind each proposed provision.
While the agency is inviting comment on the merits of each provision,
FDA also invites comment on the overall system, including whether some
other approach to HACCP or some variation of the proposed approach
might be preferable. Variations on the proposed approach include, but
are not limited to: (1) Requiring HACCP only for higher risk seafood
products; (2) exempting small firms from HACCP requirements; (3)
staggering the effective date for implementation based on size of firm
or risk; and (4) deleting or altering some of the requirements in this
proposal in order to facilitate implementation and lower costs. A brief
discussion of each of these variations follows:
A. Higher Risk Only
An alternative to requiring HACCP for all commercial seafood
products would be to require it for products or processes that have
been linked to significant numbers reported seafood-borne illnesses. As
section II.B. of this document explains in detail, many of the reported
illnesses from seafood involve raw molluscan shellfish and certain
species of finfish that can accumulate scombrotoxin and ciguatoxin.
Other seafood products cause illness but are not as commonly reported.
FDA invites comment on whether this proposed regulation should apply
only to molluscan shellfish and the species responsible for
scombrotoxin and ciguatoxin poisonings.
A variation on this approach would be to have the proposed
regulation apply to those species and processes with a higher potential
for harm, even if actual illnesses from them cannot be documented from
the foodborne illness reporting system. As described earlier in the
preamble, the fact that the system is not recording illnesses from a
particular food does not mean that illnesses are not occurring. Also,
potential for harm need not always be measured in terms of the number
of illnesses that are actually occurring. For example, some problems,
like botulism, may occur infrequently, but when they do, the
consequences can be devastating. Based on the potential for harm, other
candidates for inclusion would be: (1) Hot-process smoked and hot-
process smoke-flavored fish, cold-process smoked and cold-process
smoke- flavored fish, because of the hazards of botulism and listeria;
(2) cooked, ready-to-eat products, because of the microbiological
hazards associated with products that are not intended to be cooked by
the consumer; (3) low acid canned foods, because of the hazard of
botulism and general complexity of the processing operation; (4) raw,
ready-to-eat products, because of the risk of parasites; and (5)
species that require a judgment as to appropriate location of harvest
to avoid unsafe pesticide or industrial contaminant levels.
FDA also invites comment on the effect of using a modified approach
on the regulation of imports, especially with regard to the types of
products described in item (5) above.
B. Exempting Small Firms
FDA invites comment on whether small firms should be exempt from
the proposed regulation. Even if exempted, these firms would still be
subject to the requirements of current food safety law and to
inspection by FDA and State authorities.
As stated earlier in this preamble, small operations are the norm
in the seafood industry. A significant majority of processors have
total revenues of under 1 million dollars. If small firms are to be
exempted, FDA invites comment on the criteria that should be used for
exempting them, including how a small firm should be defined for
purposes of an exemption.
The implementation of HACCP may be more burdensome for small firms
than for large firms. Large firms tend to have quality control
personnel already in place. In addition, many regulatory requirements
are less burdensome for a large firm in proportion to output than they
are for a small firm. On the other hand, FDA is taking steps, such as
the preparation of its HACCP guidance, to minimize the cost of these
regulations for small businesses. Thus, such an exemption may not be
needed.
The agency also points out that, because many large firms already
have quality control systems, an exemption for small business would
appear to result in requiring HACCP for that segment of the industry
(i.e., large firms) that needs it the least. Large processors,
moreover, tend to process relatively low risk products, such as breaded
fish and shrimp and raw fish blocks. Many high-risk processors, such as
processors of cooked, ready-to-eat products, tend to be small, and
processors of raw molluscan shellfish tend to be very small.
Nonetheless, an exemption for small business could be limited to
those small businesses that produce low risk products, and FDA invites
comment on this approach. As stated earlier, however, the criteria for
determining low as well as high risk are not clear, due largely to the
limitations of the U.S. foodborne illness reporting system. Moreover, a
case can be made that risk also relates to the margin for error in a
processing operation and to the consequences of failure as well as to
the actual occurrence of illness.
With these points in mind, FDA invites comment on how to define
``low risk.'' FDA also invites comment on what the nature of the
exemption should be. Should a firm be exempt from all or part of the
HACCP requirements? As circumstances change, a HACCP-based analysis of
risk by a firm might reveal that the firm has become a high risk
processor rather than a low risk processor. In addition, FDA invites
comment on whether such an exemption should be obtained by petitioning
the agency.
Finally, even if an exemption were to be adopted in the final rule
based on the comments received, the agency would still encourage
voluntary adoption of HACCP systems by exempted firms. The advantages
that HACCP is expected to provide in terms of consumer confidence,
control of process, and access to international markets warrant
adoption of this system.
FDA also invites comment on the effect of a small business
exemption on the regulation of imports. How would HACCP be applied to
imports under a tiered approach? Would it be possible to treat domestic
and imported products equally under such an approach?
C. Staggered Phase-in
The proposed regulations include an effective date of 1 year from
the publication of a final rule. FDA has explained the reasoning behind
this proposed effective date and has invited comment on it elsewhere in
this preamble. In addition, comments are invited on the merits of a
staggered phase-in instead of a single implementation date for all
affected entities.
The two most obvious ways of accomplishing a staggered phase-in
would be to differentiate on the basis of size or on the basis of risk.
Differentiating on the basis of size would presumably allow small
businesses to have a longer time or times for implementation than would
be allowed for larger firms. As suggested earlier, large firms are
probably much more able to implement a HACCP system than are small
firms. Theoretically, the longer lead time for small firms would allow
the private sector to develop an infrastructure that could help small
firms implement HACCP. Such an infrastructure could include process
authorities (see the preamble discussion on cooked, ready-to-eat
products), testing facilities, and consulting services from trade
associations, academia, and others.
As an additional consideration, FDA will likely learn lessons from
its experiences in implementing the regulation that it could apply to
the benefit of those that would have to implement it at a later date.
For example, FDA is considering whether it should make the first review
of HACCP plans by agency investigators a nonregulatory evaluation to
facilitate plan development by the processor (although the overall
inspection of the plant would be regulatory). The agency invites
comment on this approach. Presumably, the more experience the agency
has, the better this evaluation will be.
On the other hand, as noted above, small firms are involved in the
processing of higher risk products. How does this fact bear on the
possibility of longer implementation times for small firms?
Differentiation solely on the basis of risk appears to be more
complex than differentiation on the basis of size. If high risk
products were to be phased in first, it would appear that those with
the most complex plans to develop and implement would receive the
shortest lead time, while those with the simplest plans would receive
the longest lead time.
Also, the criteria for determining risk would have to be carefully
considered. FDA asks for comment on whether a staggered start should
begin with raw molluscan shellfish and certain species of finfish that
can accumulate scombrotoxin and ciguatoxin, or whether other criteria
should apply, as discussed previously.
FDA invites comment on all these matters. FDA also invites comment
on the effect of a phase-in approach on the regulation of imports. How
could this approach be applied to imported products?
D. Deleting or Modifying Aspects of This Proposal, or Taking Some Other
Step, to Reduce the Burden of Implementation
As has already been explained in this preamble, FDA has proposed
only the basics of HACCP in order to keep the regulatory burden to a
minimum. Several features of HACCP included within the NACMCF's seven
principles, such as flow charts and the establishment of ``HACCP
teams,'' are noted in this preamble, but FDA has not proposed to
require them. Nonetheless, FDA acknowledges that, theoretically, there
are a number of ways in which this proposal could be scaled back even
further. FDA invites comments on whether such scaling back would be
desirable, and, if so, how it could be done. Possible areas for scale-
back include, but are not limited to:
(1) Requiring only negative, rather than positive records. Negative
records note only deviations from critical limits and how they are
corrected. If a critical control point is under control, no record is
made. Admittedly, FDA has reservations about such an approach. For
example, it is virtually impossible for firms or for FDA to spot trends
that could lead to problems if only negative records are being kept.
Nonetheless, FDA invites comment on this approach.
(2) Developing generic plans by FDA that list critical control
points and contain other information for various industry segments.
(3) Deleting some or all of the proposed specific sanitation
requirements.
(4) Requiring HACCP only for the domestic industry. The HACCP
requirements would become the basis for negotiating agreements with
other countries relating to the equivalency of regulatory programs.
(5) Deleting or modifying the proposed training requirements.
(6) Requiring HACCP for processing hazards only. The Canadian HACCP
system does not involve species-related safety hazards.
(7) Exempting warehouses.
(8) Although only in guidelines (Appendix B, Scombroid Toxin-
Forming Species), sanctioning the receipt by a processor from a
harvester of an assurance of good handling practices, rather than
detailed time/temperature records. Such an assurance, without further
verification, would be acceptable only from harvesters with histories
of delivering acceptable products.
These four alternative approaches to implementing these regulations
are not necessarily mutually exclusive. Comments are invited on them in
combination as well as on them individually.
E. Information and Consumer Awareness
In addition to requesting comment on alternative approaches to
HACCP, FDA is taking the opportunity to invite comment on the general
subject of complementary risk reduction activities, primarily directed
toward postprocessing handling. Elsewhere in this document, FDA invited
comment on the advisability of applying HACCP or alternative regulatory
approaches to commercial entities that are not directly subject to
these proposed regulations, i.e., harvesting vessels, common carriers,
and retail establishments (although not necessarily doing so as part of
this rulemaking). In addition, FDA seeks comment on appropriate
education and information that should be directed toward consumers and
recreational fishermen. The commercial application of HACCP principles
can mitigate somewhat the effects of poor consumer handling practices
by helping to ensure that a safe product reaches the home, but no such
program can prevent illnesses caused by improper home handling.
Similarly, HACCP practiced by processors can have no effect on
recreational fishermen who consume their own catch.
Education has always been an important part of FDA's comprehensive
seafood safety program, but the agency believes that more can be done.
Recent FDA education projects include the initiation of a seafood
hotline, which has been consulted by over 26,000 individuals on a wide
range of seafood safety issues since it began in October 1992. (The
hotline can be reached by calling toll-free, 1-800-FDA-4010.) FDA also
recently developed brochures aimed at advising certain medically
compromised populations that they should not eat molluscan shellfish
without adequate cooking. FDA invites comment on other types of
education and information activities that might be useful, including
more information that might be made available through grocery stores,
pharmacies, and other establishments, through the media, and through
other means, including labeling. FDA is considering the merits of
labeling information for consumers of molluscan shellfish, and will
address this issue in proceedings separate from these regulations. FDA
notes that several states have already mandated, or are in the process
of mandating, point- of-purchase information for raw molluscan
shellfish.
The agency also invites comment on whether FDA should consider
proposing to require handling instructions for consumers on the
labeling of seafood. The Department of Agriculture has proposed such
requirements for meat and poultry (58 FR 58922, November 4, 1993).
FDA has a longstanding program to control the levels of
microorganisms of public health concern in seafood. This program
includes compliance policies on such levels, including zero levels
(i.e., none detectable based upon official methods) for such pathogens
as Listeria monocytogenes in cooked, ready-to-eat products and
Salmonella in all foods. These proposed regulations require control of
microbial pathogens through HACCP principles, including specific
sanitation controls. Even so, FDA recognizes that no system can reduce
all risks to zero. Because all foods in the home, including seafood,
are subject to mishandling and cross contamination from other sources,
FDA invites comment on the general subject of handling instructions.
Should FDA decide to propose handling instructions, it would do so as a
regulatory proposal separate from the proposed HACCP requirements for
seafood.
IX. Paperwork Reduction Act
This proposed rule contains requirements for information
collections which are subject to review by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1980. The title,
description, and respondent description of the information collection
are shown below with an estimate of the annual reporting and
recordkeeping burden. Included in the estimate is the time for
reviewing instructions, searching existing data sources, gathering and
maintaining the data needed, and completing and reviewing the
collection of information.
Title: Procedures for the Safe Processing and Importing of Fish and
Fishery Products.
Description: The information requirements in this proposed rule are
essentially monitoring and recordkeeping requirements encompassing
critical control points in the production and inspection of fish and
fishery products as established in the HACCP plans of processors and
importers. The specific information collected and the frequency of
collection will depend on such factors as the species and the
processing conditions. It will include observations of processing
parameters such as the time and temperature of processing and storage;
the condition of raw materials; the results of chemical and
microbiological tests; the sanitation conditions in a processing
facility; the corrective actions taken in response to processing
deviations, etc. Records identifying production lot codes and date of
manufacture will also be maintained. Records will be maintained by the
processing facility or at an importer's place of business for 1 year
after the date of preparation in the case of refrigerated products and
at least 2 years for frozen products.
This information will be used by FDA investigators during regularly
scheduled inspections of processing plants, or at the time of entry of
imports, to determine whether products were processed under sanitary
conditions and processed, packaged, stored, and distributed using HACCP
control techniques to avoid hazards that might cause the products to be
adulterated. The information will also be used when necessary to trace
and remove potentially hazardous products from the marketplace.
Records of processing conditions will also provide a means for
processors to monitor the quality of their products and to alert them
when a deviation from the critical limits established in the HACCP plan
has occurred that may create a potential public health hazard in the
final product.
The figures provided below reflect an FDA estimate of the annual
hours of monitoring and recordkeeping based upon currently available
data and assumptions about the effects of the requirements in proposed
part 123. The estimate is based on data used to develop cost estimates
for the economic impact analysis required by Executive Order 12866 and
thus is subject to the same types of uncertainties described elsewhere
in this preamble. For example, the agency has anecdotal evidence that
the burden on firms that are operating under a mandatory HACCP system
established by the State of Alaska is more nominal. Consequently, FDA
acknowledges the possibility that the estimates provided here are
conservatively high, indicating recordkeeping burdens that are higher
than would customarily be the case. FDA specifically invites comments
on this point.
Description of Respondents: Businesses.
Estimated Annual Reporting and Recordkeeping Burden
------------------------------------------------------------------------
Average annual burden
Number of respondents per respondent Total burden all
(hours) respondents (hours)
------------------------------------------------------------------------
4,349................. 650 2,826,850
------------------------------------------------------------------------
The agency has submitted a copy of this proposed rule to OMB for
its review of this information collection. Interested persons are
requested to send comments regarding this burden estimate or any other
aspect of this collection of information, including suggestions for
reducing this burden to FDA's Dockets Management Branch (address
above), and to the Office of Information and Regulatory Affairs, OMB
rm. 3208, New Executive Office Bldg., Washington, DC 20503, Attn: Desk
Officer for FDA.
X. Economic Impact
FDA has examined the impacts of the proposed rule under Executive
Order 12866 and the Regulatory Flexibility Act (Pub. L. 96-354).
Executive Order 12866 compels agencies to use cost-benefit analysis as
a component of decisionmaking. The Regulatory Flexibility Act requires
regulatory relief for small businesses where feasible. FDA finds that
this proposed rule constitutes a major rule under both Executive Order
12866 and the Regulatory Flexibility Act. A summary of the preliminary
regulatory impact analysis (PRIA), which may be obtained from Dockets
Management Branch (address above), is presented below.
Executive Order 12866 requires Federal agencies to justify the need
for regulations by demonstrating that the problem that the regulation
is designed to remedy cannot be adequately addressed by measures other
than Federal regulation. In its review of such alternatives, FDA finds
that the current system (periodic inspection plus sampling of a small
proportion of seafood), coupled with the uncertainty in estimating the
illnesses related to seafood, has not adequately ensured consumers that
a minimum level of safety has been established. Although the tort
system is not able to provide remedies for unsafe seafood, the price
system provides some differentiation between products based on brands
and retail reputation. However, the price system works in conjunction
with current Federal regulation which signals consumers as to a minimum
level of seafood safety. As is argued in the preamble, countless public
arguments and attempts at legislation imply that the minimum levels
that some consumers believe they are getting (those that do not search
for higher levels) is probably higher than the actual levels of seafood
safety.
The tort system fails because consumers are often unable to trace
either the source of their foodborne illness to seafood, and even where
that is possible, it is often difficult to trace seafood to a specific
company.
A. Regulatory Options
FDA has evaluated multiple options to address the compelling public
interest in further ensuring seafood safety. These options include: (1)
Maintaining the existing approach--``snapshot'' inspections and
sampling; (2) significantly increasing the frequency of both snapshot
inspections and sampling under the existing approach; (3) beginning a
voluntary HACCP program in addition to the existing approach; (4)
beginning mandatory HACCP for high risk products only, in addition to
the existing approach; (5) beginning mandatory HACCP for all seafood
(the proposed approach); (6) beginning a more comprehensive mandatory
HACCP program than that proposed, similar to the Model Seafood
Surveillance Project (MSSP), which would include all CGMP's, quality
factors, and economic fraud as critical control points; and (7)
beginning a mandatory water-to-table HACCP program which would include
all vessels, carriers, and retail food operators.
The existing approach does not adequately address the compelling
public interest in further ensuring seafood safety because sampling the
large volume of seafood with FDA's limited resources cannot detect many
violative products. Increasing the frequency of sampling and
inspections is also unlikely to resolve this problem without
significant increases in funding. These options are discussed
extensively in the preamble to the proposed regulations and in the
PRIA. The third option, voluntary HACCP, has been in existence at NOAA
and has very few participants. The forth option, risk-based HACCP, has
been evaluated in the PRIA in several forms, including HACCP only for
the highest risk products from a historical perspective and HACCP only
for those products with the potential for catastrophic risk. For
example, one possibility evaluated under this option would be to
implement HACCP solely for molluscan shellfish, which NAS and other
groups have concluded constitute most of the risk from seafood. The
sixth option is more costly than the proposed option and includes more
reliance on CGMP's. Finally, the last option involves mandatory HACCP
for nearly 1 million establishments.
The options evaluated in the PRIA have both lower and higher costs
than the proposed option. However, the benefits of all options are not
equal to the proposed option. FDA has quantified net benefits of some
of the high risk options and has found them to have been positive net
benefits for those costs and benefits which have been quantified.
These options are not all equal in terms of costs and benefits.
They differ significantly from one another in this regard, as well as
from the option that FDA has selected to propose as new part 123. They
are also not equal in their ability to meet all the regulatory
objectives stated in the preamble, including effective treatment of
imports and an appropriate alignment of industry and government
responsibilities. FDA seeks comment on the costs and benefits as well
as on the general pros and cons of all the stated options and on any
options that the agency may have overlooked. It is extremely important
that FDA's evaluation of regulatory options be as thorough as possible
for purposes of developing a final rule, and that the agency be able to
fully articulate the distinctions among them and the significance of
those distinctions.
B. Costs
There is no single source of data that FDA has found to be entirely
satisfactory for developing a preliminary estimate of the costs of the
proposed regulations. Consequently, FDA has considered two sources of
information, each with its own strengths and weaknesses. The results
provide a range of possibilities, and FDA invites comment on them.
The first source is U.S. seafood processors that have actually
implemented HACCP systems. The number of such firms may exceed 100.
Understandably, many firms are reluctant to make public detailed
information about the costs of operation; consequently, the information
available to FDA from this source is incomplete. On the other hand,
there is enough information from which some preliminary conclusions can
be drawn that are relevant to an economic assessment.
The second source is a study of the costs of implementing a form of
HACCP that was developed by the Department of Commerce for the
congressionally mandated MSSP. That study was performed by an
independent contractor for the National Fisheries Education and
Research Foundation, Inc., and commissioned under a grant from NMFS.
While these data are the most detailed available, fitting them to the
proposed regulations required extensive adjustments and extrapolations.
Thus, these data also fail to eliminate the considerable uncertainty of
the results as they relate to these proposed regulations.
1. Costs: Actual Industry Experience
FDA has some information relevant to the actual costs of
implementing HACCP experienced by a number of seafood firms. While this
information is neither detailed nor complete enough to definitively
answer the question of how much the proposed regulations will cost the
industry, it does provide insight into the costs of the proposed
regulations.
This information includes responses to a 1991 evaluation
questionnaire from four of the eight firms that participated in the
FDA/NOAA seafood HACCP pilot in 1990-1991 (Ref. 40). It also includes
information more recently provided to FDA from seven firms through the
assistance of NFPA, and from two trade associations. The trade
associations, the NFI and the New England Fisheries Development
Association (NEFDA) provided FDA with summary information about member
firms that were implementing HACCP systems. NEFDA has operated a HACCP
pilot with member firms through a Federal grant. The two trade
associations provided information on 16 firms. The seven firms that
provided information about themselves through NFPA operate a total of
44 processing plants, so FDA has information on at least 64 plants
(Ref. 129).
The firms represent a good cross section of processing operation
types, including canned, fresh, frozen, smoked/salted, and cooked,
ready-to-eat products as well as molluscan shellfish. The majority of
firms were involved in HACCP as participants in either pilot programs,
the NOAA fee-for-service program, or the State of Alaska program, and
therefore have been subject to some form of third party verification of
their HACCP systems. Virtually all of them developed HACCP plans, and
the majority of these included critical control points for quality or
economic fraud or both in addition to safety. In this respect, the
majority of firms implemented a more extensive form of HACCP than is
being proposed by FDA.
Presumably, start-up costs for HACCP are normally higher than
operating costs in subsequent years. The majority of firms that could
estimate their own start-up costs indicated costs in the $1,000 to
$5,000 range. The remaining minority appear to be roughly equally
divided between lower and higher costs. A few firms indicated costs in
the $20,000 or higher range. These may be firms that decided to hire
additional personnel in order to install or implement HACCP.
It should be noted that the cost figures that come from firms that
operate more than one plant are for the total costs of their plants
collectively; in order to calculate the average start-up cost per plant
for these firms, their costs would have to be divided by the number of
plants.
Nearly twice as many firms did not hire additional personnel or did
not anticipate hiring additional personnel as a result of operating
HACCP systems as those who did or felt the need to do so. The
overwhelming majority of firms reported that they believed that the
advantages they derived from HACCP were worth the costs to them in
terms of better control over their operations, better sanitation, and
greater efficiencies, such as reduced waste. Virtually all foresaw
long-term benefits from operating under HACCP.
FDA notes that there are several uncertainties with this data. The
first is that FDA does not know the extent of previous HACCP-type
activities in these firms so that they may have different incremental
costs than the industry average. In addition, these firms may have been
relatively larger firms so that they may not be fully representative of
the industry. Also, FDA does not know whether or not these firms would
necessarily be in full compliance with the proposed regulations so that
additional costs might have to be expended.
2. Costs: MSSP Study
The MSSP study provides FDA with survey data from which detailed
cost estimates have been made in the PRIA, subject to numerous
uncertainties. As this is the largest and only randomly selected data
base available to FDA, the PRIA relied primarily on estimates based on
these data. The contractor in the MSSP study sent teams into 130
processing plants, none of which were operating under HACCP systems, to
project the costs to each plant to implement and operate a form of
HACCP chosen for that study.
In areas where FDA had better data than that used in the contractor
reports, the agency has used information available from its field
surveys on current practices or conditions in the industry in general,
and it has substituted that information for the information gathered
from the sample plants in the contractor reports. Where gaps in the
contractor estimates exist that could not be filled in by information
from FDA field surveys, a number of assumptions have been made for the
purposes of this economic assessment. FDA views the cost estimates
extrapolated from the contractor reports and other sources as
preliminary and requests comments on them.
From FDA's 1992 official establishment inventory, FDA has estimated
that there are 4,846 domestic seafood manufacturing plants that will be
affected by the proposed rule. Thirty-three percent of the first year
costs can be attributed to expenditures necessary to comply with the
HACCP-based sanitation provisions of the proposed rule. Another 36
percent are attributable to monitoring and recordkeeping requirements.
In addition, approximately 31 percent of the first year costs are for
equipment such as temperature indicators, temperature recorders, and
can seam tear-down machines. Additional costs are for HACCP training,
consulting by processing authorities, writing HACCP plans, instituting
operational changes, responding to critical limit deviations, and
analytical testing. The average expected cost of the proposed rule per
domestic manufacturing plant is estimated to be $23,900 in the first
year ($24,000 for small plants, $23,400 for large plants) and $15,000
in the following years ($14,700 for small plants and $15,700 for large
plants). Total costs of the proposed rule for domestic manufacturers
are estimated to be $117 million in the first year and $65 million in
the following years.
In addition, FDA estimates that 924 importers will bear start-up
costs of approximately $8 million, and 1,571 repackers and warehouses
will bear annual recurring costs of $14 million. Therefore, based on
these data, FDA estimates domestic costs for this rule to be $139
million in the first year and $79 million in succeeding years.
Discounted domestic costs are estimated to be $676 million over 10
years (6 percent). FDA also estimates that 8,125 foreign processors
will have initial costs of $96 million and recurring costs of $44
million.
Should smoked fish products be required to bear refrigeration
statements on their labels, the maximum possible cost to this industry
segment would be estimated to be $2.5 million for a label redesign for
all products. A label redesign would be likely only in the case of
extensive refrigeration instructions. If a simple statement such as
``keep refrigerated'' were to be required, then the cost to the smoked
fish industry would be approximately $168,000 because approximately 75
percent of the products currently bear such statements.
These estimates are considerably higher than the estimates from
data submitted to FDA from seafood plants as discussed above. These
differences may be attributable to several factors. For example, the
MSSP-based estimates also include estimated costs of compliance by
processors with pre-existing sanitation requirements in part 110 and
costs of complying with guidelines that are appended to these proposed
regulations. Although these costs are not inherent to the operation of
a HACCP system, they represent one-third of the total MSSP-based
estimates. As indicated earlier in this document, compliance with
CGMP's for sanitation has been a continuing problem across the
industry. For this reason, FDA is proposing specific sanitation
requirements in subpart A of part 123.
Moreover, the estimate of costs associated with complying with
guidelines in the appendices may be overstated because, in actuality,
FDA may find industry practices other than those stated in the
guidelines to be acceptable. The guidelines are intended to provide the
industry with information on how it could implement HACCP, not how it
must do so.
Costs to importers and to foreign processors that ship to the
United States were also estimated. In the absence of reliable data for
estimating costs to foreign processors, FDA estimated the number of
plants that export seafood to the United States and based their costs
of implementing HACCP on MSSP- generated data on the costs to U.S.
plants.
It is important to recognize that many of the United States major
seafood trading partners are using, or have opted for, HACCP programs.
For example, the EC will soon require HACCP or an equivalent system
from over 100 nations that export to it. Consequently, with the current
trend toward HACCP worldwide, the costs to many foreign processors of
implementing HACCP may be incurred regardless of whether FDA issued
these proposed regulations. Moreover, in the near future, U.S.
importers subject to this proposed rule should have little difficulty
finding products produced under HACCP. FDA specifically invites comment
on the estimated costs of the proposed regulations to importers and
foreign processors, e.g., whether they are high due to the worldwide
move toward HACCP or whether they are low due to other factors that
have not been considered, and the potential effect on U.S. consumers of
requiring that imports be produced under HACCP systems.
The PRIA presumes that most of the cost of compliance of the
proposed regulations will be passed on to consumers. Estimating the
magnitude of these price increases is difficult. U.S. consumers spent
about $16.5 billion on domestically produced seafood in 1991 (Ref. 42).
If the domestic industry passed on all of the estimated annual costs to
consumers, prices for domestically produced seafood would increase by
less than 1 percent in the first year and less than one-half of 1
percent in succeeding years. Price changes of such magnitude are
unlikely to have a major impact on general seafood purchases. However,
some regional price increases may considerably exceed this. In
addition, this estimation of change in price does not address potential
concentration effects. It is worth noting that the contractor that
performed the MSSP study estimated a range of cost increases from
negligible to 1.3 percent, depending on the type of product.
The effect on prices of imported products is impossible to
estimate. While the PRIA uses MSSP data and a number of assumptions to
estimate possible costs to foreign processors of complying with the
proposed regulations, those costs will be spread among the consumers
from all nations to which these processors export. FDA is unable to
estimate what percentage of these costs would be passed on to U.S.
consumers.
On the other side of the ledger, the MSSP-based estimates were not
able to include costs associated with some features of the proposed
rules because data were lacking. An inventory of these features is
provided in the PRIA, and FDA invites comment on possible costs
associated with them. They include prevention of cross contamination by
the separation of food contact surfaces, storage at 40 deg.F of
cooked, ready-to-eat products and products that are made in whole or in
part of scombroid toxin forming species, and the costs of following the
approach presented in the guidelines at Appendix B for scombroid toxin
forming species.
C. Benefits
This proposed action will reduce the amount of illness that derives
from consumption of seafood (safety benefits) and may have significant
nutrition benefits that result from increased consumption of seafood.
The increased consumption will result from a decrease in consumer
anxiety associated with the consumption of seafood. In addition, there
may be significant cost savings (benefits) in other areas as a result
of adoption of this proposed rule.
The existence of a national, mandatory, HACCP-based inspection
system for seafood should have a beneficial, although nonquantifiable
effect on both the industry and the Federal government. FDA knows from
experience that continuing concerns about the adequacy of the current
Federal regulatory system for seafood place a financial stress on
industry, which must constantly defend itself from criticism, and on
regulatory agencies such as FDA, which must divert resources in order
to respond to the Congress and the media. While public interest in food
safety is healthy and desirable, the extreme interest in seafood
safety, which has manifested itself in over 10 congressional hearings
and over 20 pieces of legislation in the past 5 years, demonstrates how
a system that is less than fully adequate from the public's standpoint
can cause a steady diversion of both public and private resources that
is likely to continue in the absence of a system that overcomes current
inefficiencies and shortcomings.
Finally, there will be an additional benefit to firms wishing to
export seafood to those countries which require federally monitored
HACCP. The latter two benefits have not been quantified, and FDA
requests comments on how this might be done.
The agency followed three steps to quantify the safety benefits of
HACCP for processors: (1) Identify all significant hazards associated
with seafood safety and establish the baseline number of incidents of
each hazard in the U.S. population; (2) estimate the reduction in the
number of incidents of each hazard that HACCP is expected to
accomplish; and (3) quantify the benefit of the reduced illnesses and
deaths. In all three steps, FDA acknowledges that there is substantial
uncertainty.
First, to establish a baseline number of illnesses, FDA reviewed
both reported data to the CDCP, which provides a lower bound on the
actual number of cases, and an earlier FDA risk assessment that
estimated an upper-bound number of cases. Using information about the
probable amount of underreporting for each type of illness, FDA
constructed a likely baseline number for each type of illness by
inflating these numbers between zero and 1,000 times the amount
reported. Thus, for example, while it is likely that nearly all cases
of neurotoxic shellfish poisoning (NSP) are reported to CDCP, it is
likely that Campylobacter jejuni is underreported by approximately 100
times the actual number of cases. This approach for estimating cases
yielded an estimated 33,000 cases of illness from seafood per year.
However, FDA acknowledges that even a reasonably precise estimate of
the number of illnesses cannot be determined with the existing
foodborne disease reporting mechanisms in this country.
In the second step, FDA used a panel of internal experts to
determine the number of illnesses the proposed regulations are likely
to reduce.\1\ For example, it is not likely to reduce any cases of NSP
because they are primarily associated with recreational fishing. On the
other hand, it is likely to reduce over 50 percent of scombroid
poisoning because most of the mishandling of seafood comes either at
the catch or processing stages. This action will not reduce any cases
that are a result of consumer or retailer mishandling but, as explained
earlier in this document, problems at the retail level are addressed
through mechanisms outside of this proposed regulation. FDA has
estimated that between 5,000 and 19,000 cases of seafood illness and
death will be reduced by the proposed action annually.
---------------------------------------------------------------------------
\1\Memorandum to Richard A. Williams, Jr., November 17, 1993.
---------------------------------------------------------------------------
In the third step, FDA used economic valuation techniques to
quantify the effect of reducing the range of cases of seafood illness.
This technique combines costs of illness, such as hospital costs, with
the costs of pain and suffering in a reduced health state to estimate
the cost of each hazard. Thus, for example, NSP, with very mild
symptoms, has a low cost per case ($270), whereas Vibrio vulnificus,
with a high probability of death, has a very high cost ($1.3 million
per case). Using this methodology, the total safety benefits of the
proposed option are valued between $15 and $75 million per year.
FDA has also evaluated the potential health benefits associated
with increased consumption of seafood. Because of the negative
publicity concerning water pollution and seafood safety, consumer
perception of seafood safety may overestimate actual risk. In addition,
contamination scares cause drastic short-term drops in consumer demand
for seafood products and undoubtedly contribute to the chronic level of
consumer concern about seafood safety. Thus, safety concerns about
seafood are a likely factor preventing wider consumer acceptance of
seafood as part of the U.S. diet.
If this proposal is finalized, consumer concerns about seafood
safety may be reduced which may, in turn, lead to increased consumption
of seafood. FDA has evaluated the possibility that consumers may switch
from higher fat flesh protein, such as meat and poultry, to seafood.
The resulting reduced dietary fat in the diet of the general population
would result in reduced incidence of coronary heart disease and cancer.
Using the same methodology employed in an earlier analysis of the
Nutrition Labeling and Education Act of 1990 (Pub. L. 101-535), FDA
analyzed the benefits of a 1- and 5-pound per capita increase in
consumption of seafood. These were estimated to decrease deaths by 673
and 2,782, respectively, over a 10-year period. The resulting benefits
are valued at $3 and $14 billion.
D. Small Business Impact
The proposed rule will have a substantial impact on small seafood
processors as defined by the Regulatory Flexibility Act. Eighty percent
of the seafood processors covered by this proposed regulation are
small, where small is defined for nonshrimp firms as less than $1
million in annual gross revenue and less than $2 million for shrimp
firms. The provisions of this rule, such as monitoring and
recordkeeping, are largely fixed costs (costs which do not vary
significantly with the amount of the product produced) which will
impose larger per unit costs on small rather than on large businesses.
In addition, small firms may have as many critical control points as
large firms because critical control points tend to be related to the
complexity of the operation, not the size of the business. However, it
may be that smaller firms are less complex than large firms, although
the agency does not have sufficient data to determine if this is so.
In some cases the increase in cost will be large enough to cause
some firms to go out of business. For example, estimates of firm
failure have been as low as 2 percent (96 firms) of all firms (from the
Canadian experience) to 334 firms (estimated for compliance with MSSP).
However, FDA does not have enough information to estimate the number of
firms that will close if the proposed rule becomes final.
There are several factors that affect the ability of small
processors to comply with the proposed regulations. First, the basic
HACCP requirements proposed in subpart A of part 123 deliberately
include only the essentials of HACCP in order to keep fixed costs to a
minimum. Second, FDA is developing considerable guidance in the form of
a hazard guide and model HACCP plans to enable small processors to
implement an effective HACCP system at the lowest possible cost. Third,
FDA is also aware that academia and trade associations are available to
assist processors to implement HACCP. Finally, for those small
processors that have very simple operations requiring few critical
control points, an inherent feature of HACCP is that it adjusts to the
complexity and risks of an operation.
While any closure is regrettable, the agency strongly believes that
firms that are unable to identify the likely hazards associated with
their products and take reasonable preventive controls to prevent those
hazards from occurring should not be selling food in interstate
commerce. As described in the preamble, FDA is keenly interested in
keeping the costs of implementing HACCP to a minimum and is issuing
guidance documents and model HACCP plans to facilitate such
implementation.
FDA is specifically requesting comment in areas where costs and
benefit estimates are either very uncertain or potentially large. FDA
will utilize answers received on these comments along with all other
comments to help formulate the final rule.
1. Costs
FDA specifically requests comments on:
(1) The expected cost to retrofit plants as necessary for the
proper operation of HACCP controls (e.g., enhance refrigerator
capacity, water supply changes, etc.).
(2) The cost of taking corrective actions to respond to critical
limit deviations on an annual basis. FDA has estimated an average of
$1,000 per firm to take such actions as discarding product, buying new
equipment, and changing the processing practice.
(3) The cost of training employees. FDA has estimated that there
will be a cost per plant of $900 to train an employee to manage HACCP.
This will include the cost of training, travel expenses, and loss of
several days of productivity for that employee. Not all of these costs
may be borne by manufacturers, however, because some training may be
sponsored by academia, trade associations, and others.
(4) The cost of ensuring that cooking and pasteurizing equipment
and processes are achieving the desired safety results (i.e.,
destroying microbiological pathogens). This ensurance may be obtained
by having equipment and processes that are equivalent to those found
effective by a processing authority. FDA estimated that this would cost
$1,000 per plant in the first year and, on average, half that amount in
the following years as processors change their processes and equipment.
This cost may be offset, however, by reliance on literature that
contains the necessary information from a processing authority.
(5) The cost of temperature indicators and thermometers for plants
who do not now have this equipment. FDA estimated that the cost would
be $1,000 per plant, initially, with replacement as necessary.
(6) The cost of creating a HACCP plan from the guidance provided by
FDA. FDA estimated that it will take processors with simpler processes
24 hours of managerial time to adapt the guidance into a HACCP plan.
FDA estimated that it will take processors with more complex processes
72 hours of managerial time to adapt the guidance into a HACCP plan.
(7) FDA requests comment on the recordkeeping burden associated
with the proposed sanitation requirements in Sec. 123.10 (b) and (c).
If possible, such estimates should be provided in terms of hours spent
and translated into dollars if staff compensation rates are known.
In addition, FDA was unable to provide cost estimates of the
following provisions and requests specific comments on these areas:
(1) Section 123.10(a)(7), prevention of cross-contamination by the
separation of food-contact surfaces;
(2) Section 123.10(a)(14), storage at 40 deg.F or below;
(3) Appendix A.6., cooling after cooking;
(4) Appendix B., scombroid toxin forming species;
(5) Appendix 1., specifically, the guidance on smoked and smoke-
flavored fishery products;
(6) Increased short-term recall potential, if any, due to
heightened industry awareness;
(7) Increasing time spent escorting Federal inspectors,
particularly in the initial phases;
(8) The cost of restricting catch in certain areas and seasons if
processors find it necessary.
2. Benefits
(1) FDA is reprinting two tables from the PRIA and requests
comments on both the baseline number of illnesses due to seafood and
the likelihood that HACCP for processors will reduce those illnesses.
The baseline number of illnesses reflects an estimate of all cases
(from any source, including recreational harvest, retail, and consumer
mishandling). FDA considers the estimates in both tables as preliminary
estimates.
Table 1.--Significant Hazards Associated With Seafood
[All Seafood Sources Combined--Recreational and Commercial]
------------------------------------------------------------------------
Reported Upper-bound Estimated
Hazards cases cases cases
(annual) (annual) (annual)
------------------------------------------------------------------------
Anasakis......................... 1 100 100
Campylobacter jejuni............. 2 200 200
Ciguatera........................ 800 8,000 800
Clostridium botulinum............ 4 4 4
Clostridium perfringens.......... 7 70 70
Diphyllobothrium latum........... (\1\) 1,000 1,000
Giardia.......................... 3 50 30
Hepatitis A virus................ 9.2 6,700 92
Neurotoxic shellfish poisoning... 48 48 48
Norwalk virus.................... 12.4 30,000 12,400
Other Vibrios.................... 43 10,000 10,000
Paralytic shellfish poisoning.... 13.4 13.4 13.4
Salmonella nontyphi.............. 2 2,750 200
Scombrotoxin..................... 796 21,500 7,960
Shigella......................... 7 100 70
Vibrio vulnificus................ 24 48 48
--------------------------------------
Total........................ 1,772 80,389 33,035
------------------------------------------------------------------------
\1\Unknown.
Table 2.--Projected Number of Cases Averted Using HACCP Approach
------------------------------------------------------------------------
FDA best
estimate Number of Number of
Hazards of the cases cases
number of averted averted
cases (lower)* (upper)**
------------------------------------------------------------------------
Anasakis............................ 100 10 75
Campylobacter jejuni................ 200 100 150
Ciguatera........................... 800 50 100
Clostridium botulinum............... 4 0 1
Clostridium perfringens............. 70 53 70
Diphyllobothrum latum............... 1,000 250 750
Giardia............................. 30 0 7.5
Hepatitis A virus................... 92 15 46
Neurotoxic shellfish poisoning...... 48 0 0
Norwalk virus....................... 12,400 1,000 6,200
Other Vibrios....................... 10,000 1,000 5,000
Paralytic shellfish poisoning....... 13 0 0
Salmonella nontyphi................. 200 100 150
Scombrotoxin........................ 7,960 3,980 5,970
Shigella............................ 70 18 35
Vibrio vulnificus................... 48 0 24
-----------------------------------
Total........................... 33,035 6,575 18,679
------------------------------------------------------------------------
*Estimates by Klontz and Altekruse.
**Estimates by Archer.
\1\Memorandum to Richard A. Williams, Jr., November 16, 1993.
(2) FDA also specifically requests comments on the number of cases
of illness included in the baseline estimate (33,035) that may be due
to factors outside the processors' control, such as those due to
recreational harvests (that are not eventually sent to processors),
those due to restaurants and supermarkets, and those due to consumer
mishandling.
(3) As mentioned above, FDA has also estimated potential benefits
associated with increased seafood consumption. These benefits will only
be realized if the price increase resulting from this rule does not
offset the effect of increased demand for seafood which will result
from reduced consumer anxiety. FDA requests specific comment on the
likelihood that seafood consumption will be increased as a result of
this rule.
(4) FDA has identified but not quantified benefits to seafood
exporters as well as reduced public anxiety associated with the safety
of seafood. FDA requests comments on these benefits (including how to
quantify them) as well as other potential benefits such as how HACCP
will help firms gain better control over their operations, better
sanitation and greater efficiencies such as reduced product waste.
E. Tribal Governments
FDA is aware that some tribal governments are involved in the
processing of seafood for interstate commerce. The agency expects that
the proposed regulations will apply to them in such cases. Executive
Order 12875 of October 26, 1993, requires, among other things,
consultation with tribal governments before the formal promulgation of
regulations containing unfunded Federal mandates. While FDA does not
believe that the proposed regulations would impose an unfunded Federal
mandate, the agency wishes to foster consultation on matters that might
significantly affect tribal communities. Consequently, FDA specifically
requests comment on the economic effect of the proposed regulations on
tribal governments.
F. Availability of PRIA/RFA
FDA acknowledges considerable uncertainty in both cost and benefit
estimates of the proposed regulations and requests comment on all
aspects of the PRIA and the RFA. The full PRIA/RIA is available at the
Dockets Management Branch (address above).
XI. Environmental Impact
The agency has carefully considered the potential environmental
effects of this action. FDA has concluded that the action will not have
a significant impact on the human environment, and that an
environmental impact statement is not required. The agency's finding of
no significant impact and the evidence supporting that finding,
contained in an environmental assessment, may be seen in the Dockets
Management Branch (address above) between 9 a.m. and 4 p.m., Monday
through Friday.
XII. Request for Comments
Interested persons may, on or before April 28, 1994, submit to the
Dockets Management Branch (address above) written comments regarding
this proposal. Two copies of any comments are to be submitted, except
that individuals may submit one copy. Comments are to be identified
with the docket number found in brackets in the heading of this
document. Received comments may be seen in the office above between 9
a.m. and 4 p.m., Monday through Friday.
XIII. References
The following references have been placed on display in the Dockets
Management Branch (address above) and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday through Friday.
1. Committee on Diet and Health, Food and Nutrition Board,
Commission on Life Sciences, National Research Council, ``Diet and
Health: Implications for Reducing Chronic Disease Risk,'' National
Academy Press, Washington, DC, 1989.
2. National Heart, Lung, and Blood Institute, DHHS, ``National
Cholesterol Education Program: Report of the Expert Panel on
Population Strategies for Blood Cholesterol Reduction, Executive
Summary,'' NIH Publication No. 90-3047, National Institutes of
Health, Bethesda, MD, 1990.
3. Hackney, C., and D. Ward, ed., ``Microbiology of Marine Food
Products,'' Van Nostrand Reinhold, 1991.
4. Roper, W.L. Director, Centers for Disease Control, letter to
the Honorable John D. Dingell, May 2, 1990.
5. Otwell, W.S., ``Seafood Safety in Question,'' MTS Journal,
25(1):23-29.
6. FDA, DHHS, ``Seafood Safety,'' May 10, 1993.
7. Ahmed, F.E. ed., Committee on Evaluation of the Safety of
Fishery Products, Food and Nutrition Board, Institute of Medicine,
NAS, Seafood Safety, National Academy Press, 1991.
8. Rhodehamel, E.J., ``Overview of Biological, Chemical, and
Physical Hazards,'' HACCP: Principles and Applications, Van Nostrand
Reinhold, 1992.
9. Colwell, R.R. ed., ``Natural Toxins and Human Pathogens in
the Marine Environment,'' Report of a Sea Grant-Sponsored Workshop,
A Maryland Sea Grant Publication, undated.
10. Stone, R., ed., ``Single-Celled Killer in Monterey Bay,''
Science, November 22, 1991.
11. Letter to John A. Sandor from Thomas J. Billy, March 22,
1993.
12. Bier, J.W., T.L. Deardorff, G.J. Jackson, and R.B.
Raybourne, ``Human Anisakiasis,'' Bailliere's Clinical Tropical
Medicine and Communicable Diseases, 2(3):723-733, 1987.
13. Liston, J., Statement before the Senate Committee on
Commerce, Science, and Transportation, U.S. Senate, June 30, 1992.
14. Mayer, B.K., and D.R. Ward, ``Microbiology of Finfish and
Finfish Processing,'' Microbiology of Marine Food Processing, Van
Nostrand Reinhold, 1991.
15. Spitzig, P., memorandum, ``Decomposition Data From the
Seafood Regulatory Action Database,'' May 14, 1992.
16. FDA, DHHS, ``The Fish List: FDA Guide to Acceptable Market
Names for Food Fish Sold in Interstate Commerce,'' 1988.
17. Letter From Skip Widtfeldt, Seafood Permit Coordinator,
State of Alaska Department of Environmental Conservation, to Alaska
Seafood Processors, January 17, 1992.
18. Nardi, G., ``HACCP: A View From the Inside,'' American
Seafood Institute Report, April 1992.
19. Coons, K., ``HACCP is Here,'' Seafood Supplier, May/June
1992.
20. Kraemer, D.W., memorandum, ``Unique Nature of Seafood
Processing Industry,'' May 6, 1993.
21. Kraemer, D.W., memorandum, ``High Risk Survey--Cooked Ready
to Eat Results,'' March 1, 1993.
22. Bryan, F.L., ``What the Sanitarian Should Know About
Staphylococci and Salmonellae in Non-Dairy Products: I.
Staphylococci,'' Journal of Milk and Food Technology, 31(4):110-116,
April 1968.
23. Golden, D.A., E.J. Rhodehamel, and D.A. Kautter, ``Growth of
Salmonella spp. in Cantaloupe, Watermelon, and Honeydew Melons,''
Journal of Food Protection, 56(3):194-196, 1993.
24. FDA Smoked or Salted Fish Assignment (FY 89), and
compilation of data, dated December 19, 1988.
25. New York State Good Manufacturing Practices Regulation for
Smoked Fish Products, 1990.
26. Eklund, M.W. et al., ``Inhibition of Clostridium Botulinum
Types A and E Toxin Production by Liquid Smoke and NaCl in Hot-
Process Smoke-Flavored Fish,'' Journal of Food Protection,
45(10):935, 1982.
27. Program Evaluation Branch, Office of Regulatory Affairs,
FDA, DHHS, ``Field Summary Seafood Accomplishments/Expenditures FY
1984-FY 1992,'' November 1992.
28. FSIS, USDA, ``Meat and Poultry Inspection 1991: Report of
the Secretary of Agriculture to the U.S. Congress.''
29. Snyder, M.I., memorandum, ``FDA Rejection Insurance,'' May
7, 1993.
30. Sunde, S., ``A Sea of Uncertainties,'' Seattle Post-
Intelligencer, February 25, 1993.
31. Wilms, H.G., memorandum, ``State Seafood Resources,'' May
17, 1993.
32. Spencer, H., ``The Role of Government in a Mandatory HACCP
Based Program,'' Dairy, Food and Environmental Sanitation, July
1992.
33. Bauman, H.E., ``Introduction to HACCP,'' HACCP: Principles
and Applications, Van Nostrand Reinhold, 1992.
34. NACMCF, ``National Advisory Committee on Microbiological
Criteria for Foods, Hazard Analysis and Critical Control Point
System Adopted March 20, 1992,'' HACCP: Principles and Applications,
Van Nostrand Reinhold, 1992.
35. NMFS, NOAA, U.S. Department of Commerce, ``The Report of the
Model Seafood Surveillance Project: A Report to the Congress,''
draft dated February 5, 1993.
36. Subcommittee on Microbiological Criteria, Committee on Food
Protection, Food and Nutrition Board, National Research Council, An
Evaluation of the Role of Microbiological Criteria for Foods and
Food Ingredients, National Academy Press, 1985.
37. Lee, J.S., and K.S. Hilderbrand, Jr., ``Hazard Analysis &
Critical Control Point Applications to the Seafood Industry,''
Oregon Sea Grant, ORESU-H-92-001, 1992.
38. Weddig, L.J., letter to the Honorable Donna E. Shalala,
February 25, 1993.
39. Iani, L.J., letter to Tom Billy, April 1, 1993.
40. Peeler, T., ``Review of the FDA/NOAA Seafood Pilot,''
undated.
41. Food and Agriculture Organization of the United Nations,
``Fishery Statistics: Commodities 1990,'' vol. 71, Rome, 1992.
42. NMFS, NOAA, U.S. Department of Commerce, ``Fisheries of the
United States, 1991,'' Silver Spring, MD, 1992.
43. NMFS, NOAA, U.S. Department of Commerce, ``Current Fisheries
Statistics No. 9202: Imports and Exports of Fishery Products Annual
Summary, 1992.''
44. The Council of the European Communities, ``Council Directive
of 22 July 1991 Laying Down the Health Conditions for the Production
and the Placing on the Market of Fishery Products,'' Official
Journal of the European Communities, No. L 268/15.
45. GATT Secretariat, ``Draft Final Act Embodying the Results of
the Uruguay Round of Multilateral Trade Negotiations,'' December 20,
1991.
46. Codex Alimentarius Commission, Food and Agriculture
Organization of the United Nations, ``Joint FAO/WHO Food Standards
Programme, Codex Alimentarius Commission, 20th Session, Geneva 28
June-7 July 1993, Report of the 25th Session of the Codex Committee
on Food Hygiene Washington D.C., 28 October-1 November 1991.''
47. ``Communication From The President of the United States
Transmitting the Final Legal Text of the U.S.-Canada Free-Trade
Agreement, The Proposed U.S.-Canada Free- Trade Agreement
Implementation Act of 1988, and a Statement of Administrative
Action, Pursuant to 19 U.S.C. 2112(e)(2), 2212(a),'' House Document
100-216, July 26, 1988.
48. Rhodehamel, E.J., ``FDA's Concerns With Sous Vide
Processing,'' Food Technology, 46(12) 73-76, 1992.
49. Cook, D.W., and Ruple, A.D., ``Vibrio Vulnificus and
Indicator Bacteria in Shellstock and Commercially Processed Oysters
From the Gulf Coast,'' Journal of Food Protection, 55(9):667-671,
1992.
50. FDA, DHHS, ``Food and Drug Administration Pesticide Program:
Residue Monitoring 1991,'' Journal of the Association of Official
Analytical Chemists International, Vol. 75, September/October 1992.
51. Corlett, D.A., Jr., and Pierson, M.D., ed., HACCP:
Principles and Applications, Van Nostrand Reinhold, 1991.
52. Duersch, J.W., Paparella, M.W., and Cockey, R.R.,
``Processing Recommendations for Pasteurizing Meat from the Blue
Crab,'' Advisory Report, Maryland Sea Grant Program, Publication No.
UM-SG-MAP-81- 02, 1981.
53. Gorga, C., and Ronsivalli, L.J., ``Quality Assurance of
Seafood,'' Van Nostrand Reinhold, New York.
54. Schaffner, R.M., ``Introduction to Canned Foods: Principles
of Thermal Process Control, Acidification and Container Closure
Evaluation'' The Food Processors Institute, 1982.
55. Corlett, D.A., Jr., and Pierson, M.D., ``Hazard Analysis and
Assignment of Risk Categories,'' HACCP: Principles and Applications,
Van Nostrand Reinhold, 1991.
56. Farber, J.M., ``Listeria Monocytogenes in Fish Products,''
Journal of Food Protection, 54:922-924, 1991.
57. Lovett, J., Francis, D.W., and Bradshaw, J.G., ``Outgrowth
of Listeria Monocytogenes in Foods,'' Foodborne Listeriosis, Society
for Industrial Microbiology, Elsevier Science Publishers, New York,
1990.
58. Farber, J.M., and Peterkin, P.I., ``Listeria Monocytogenes,
a Food-borne Pathogen,'' Microbiology Reviews, 55:476-511, 1991.
59. Warner, E.T., memorandum, ``New York District Smoked Fish
Inspection Results,'' May 24, 1993.
60. Wilson, B.F., memorandum, ``Seafood Consumer Complaint
Data,'' April 15, 1993.
61. Data summary sheets.
62. Wilson, B., memorandum, ``Sanitation Data from 1991-1992
Abbreviated Inspections,'' April 13, 1993.
63. Bryan, F.L., ``Microbiological Food Hazards Today--Based on
Epidemiological Information,'' Food Technology, pp. 52-64, September
1974.
64. FDA, DHHS, ``FDA Fact Sheet: Shigella in Food,'' December
1969.
65. FDA, DHHS, ``Food Service Sanitation Manual Including a
Model Food Service Sanitation Ordinance,'' DHEW Publication No.
(FDA) 78-2081, 1976.
66. Koren, H., ``Handbook of Environmental Health and Safety
Principles and Practices,'' Vol. I, 2d ed., Lewis Publishers, pp.
116-117, 1991.
67. Benenson, A.S., ed., ``Control of Communicable Diseases in
Man,'' 15th ed., American Public Health Association, pp. 170-177,
197-8, 210-11, 491-2, 1991.
68. Cross Connection Control Committee, Pacific Northwest
Section, American Water Works Association, With the Assistance of
EPA, ``Cross Connection Control Manual, Accepted Procedures and
Practice,'' 5th Ed., May, 1990.
69. National Sanitation Foundation, ``Reference Guide:
Sanitation Aspects of Food Service Facility Plan Preparation and
Review,'' January 1978.
70. EPA, ``Drinking Water; Substitution of Contaminants and
Priority List of Additional Substances which May Require Regulation
under the Safe Drinking Water Act,'' 52 FR 25720, July 8, 1987.
71. National Sanitation Foundation, Ann Arbor, Michigan,
``Sanitation Aspects of Installation of Food Service Equipment,''
undated.
72. The National Food Safety Certification Program, Applied Food
Service Sanitation, A Certification Coursebook, 4th ed., John Wiley
& Sons, Inc., pp. 176-179, 1992.
73. Surkiewicz, B.F., Hyndman, J.B., and Yancey, M.V.,
``Bacteriological Survey of the Frozen Prepared Foods Industry: II.
Frozen Breaded Raw Shrimp,'' Applied Microbiology, 15(1):1-9,
January 1967.
74. Bryan, F.L., ``Emerging Foodborne Diseases: II. Factors that
Contribute to Outbreaks and Their Control,'' Journal of Milk and
Food Technology, 35(11):632-638, November 1972.
75. Brown, J.L., ``Fundamentals of Cleaning Multi-Use
Utensils,'' National Sanitation Foundation Testing Laboratory, Ann
Arbor, Michigan, undated.
76. ``Carbon Dioxide Treatment Destroys Biofilms: NFPA Food
Chemical News, p. 22, November 11, 1991.
77. Surkiewicz, B.F., Groomes, R.J., and Shelton, L.R. Jr.,
``Bacteriological Survey of the Frozen Prepared Foods Industry: IV.
Frozen Breaded Fish,'' Applied Microbiology, 16(1): 147-150, January
1968.
78. Food Safety Committee, NFPA, ``Guidelines for the
Development of Refrigerated Foods,'' NFPA Bulletin 42-L, 1989.
79. Kornacki, J.L., and Gabis, D.A., ``Microorganisms and
Refrigeration Temperatures,'' Dairy, Food and Environmental
Sanitation, 10(4):192-195, April 1990.
80. Phillips, F.A., and Peeler, J.T., ``Bacteriological Survey
of the Blue Crab Industry,'' Applied Microbiology, pp. 958-966,
December 1972.
81. Moody, M.W., ``How Cleaning Compounds Do the Job,'' Seafood
Technology Cooperative Extension Service, Louisiana State
University, undated.
82. Lentsch. S., ``Sanitizers for an Effective Cleaning
Program,'' Klenzade Division, Economics Laboratories, St. Paul, MN.
83. Codex Alimentarius Commission, Food and Agriculture
Organization of the United Nations, ``Recommended International Code
of Practice for Fresh Fish,'' 2d ed., CAC/RCP 9-1976.
84. Bryan, F.L., ``Emerging Foodborne Diseases: I. Their
Surveillance and Epidemiology,'' Journal of Milk and Food
Technology, 35(10):618-625, October 1972.
85. Refrigerated Foods and Microbiological Committee, NFPA,
``Factors to be Considered in Establishing Good Manufacturing
Practices for the Production of Refrigerated Foods,'' Dairy and Food
Sanitation, 8(6):288-291, June 1988.
86. Schmidt, C.F., Lechowich, R.V., and Folinazzo, J.F.,
``Growth and Toxin Production by Type E Clostridium Botulinum Below
40 deg.F,'' Journal of Food Science, 26:626, 1961.
87. Bott, T.L. et al., ``Clostridium Botulinum Type E in Fish
from the Great Lakes,'' Journal of Bacteriology, 91(3):919, 1966.
88. Bott, T.L., et al., ``Possible Origin of the High Incidence
of Clostridium Botulinum Type E in an Inland Bay (Green Bay of Lake
Michigan), Journal of Bacteriology,
95(5):1542, 1968.
89. Milk Safety Branch, Center for Food Safety and Applied
Nutrition, FDA, ``FDA's Dairy Product Safety Initiatives:
Preliminary Status Report,'' September 1986.
90. FDA, DHHS, ``National Shellfish Sanitation Program--Manual
of Operations Part I Sanitation of Shellfish Growing Areas,'' 1992.
91. Richards, G.P., ``Outbreaks of Shellfish-Associated Enteric
Virus Illness In The United States: Requisite For Development Of
Viral Guidelines,'' Journal of Food Protection, 48:815-823; 1985.
92. Richards, G.P., 1987, ``Shellfish-associated Enteric Virus
Illness in the United States,'' 1934-1984, Estuaries 10(1):84-85.
93. McFarren, E.C., et al., 1960, ``Public Health Significance
of Paralytic Shellfish Poison,'' Advances in Food Research, 10:135-
179.
94. Farrington, J.W., et al., ``U.S. `Mussel Watch' 1976-1978:
An Overview Of The Trace-Metal, DDE, PCB, Hydrocarbon, And
Artificial Radionuclide Data,'' Environmental Science Technology,
17:490-496; 1983.
95. Kaplan, J.E., et al., 1982, ``Epidemiology of Norwalk
Gastroenteritis and the Role of Norwalk Virus in Outbreaks of Acute
Nonbacterial Gasteroenteritis,'' Annals of Internal Medicine,
96(1):756-761.
96. FDA, PHHS ``National Shellfish Sanitation Program--Manual of
Operations, Part II, Sanitation of The Harvesting, Processing and
Distribution of Shellfish, 1992.''
97. FDA, Compliance Policy Guide, Chapter 58--Non-Government
Agreements, 7158.04, April 1, 1984.
98. FDA, Compliance Program Guidance Manual, Compliance Program
7318.004 (TN 92-41, 01/01/92), 1992.
99. General Accounting Office, ``Problems in Protecting
Consumers From Illegally Harvested Shellfish (Clams, Mussels, and
Oysters),'' HRD-84-36, Report to the Honorable Thomas J. Downey,
House of Representatives, 1984, U.S. Government Printing Office,
Washington, DC.
100. New York Department of Environmental Conservation,
``Improved Procedures for Source Identification of Shellfish by
State Government,'' 1988.
101. Goza, M., memorandum, ``Arizona Ban of Shellfish,''
February 19, 1993.
102. Veazey, J., memorandum, ``Louisiana and Mississippi
Seizures for Tagging Violations,'' March 29, 1993.
103. Steele, E.A., memorandum, ``Shellfish Summons and Arrests--
South Carolina,'' April 9, 1992.
104. Letter from David G. Field, Director, State Program Branch,
Northeast Region, FDA, to Mr. John Volk, Director, Aquaculture
Division, Connecticut Department of Agriculture, December 10, 1992.
105. Letter from David G. Field, Director, State Program Branch,
Northeast Region, FDA to Mr. John Volk, Director, Aquaculture
Division, Connecticut Department of Agriculture, December 18, 1992.
106. Letter from David G. Field, Director, State Program Branch,
Northeast Region, FDA, to Mr. John Volk, Director, Aquaculture
Division, Connecticut Department of Agriculture, December 31, 1992.
107. Hesselman, D., memorandum, ``Imported Shucked Frozen
Mussels from Thailand,'' March 4, 1993.
108. Letter from Donald M. Hesselman, Shellfish Specialist,
Southeast Region, FDA, to Mr. Robert G. Benton, Chief, Shellfish
Sanitation Program, North Carolina Department of Environment, Health
and Natural Resources, February 11, 1993.
109. Glatzer, M., memorandum, ``Tagging/Labeling Violations/
Actions,'' March 24, 1993.
110. Letter from Joseph P. Hile, Associate Commissioner for
Regulatory Affairs, FDA, to Dr. Robert L. Flentge, Chief, Division
of Food, Drugs and Dairies, State of Illinois, November 5, 1985.
111. Moore, K., Statement before the House Merchant Marine and
Fisheries Committee, Subcommittee on Fisheries and Wildlife
Conservation and the Environment, U.S. House of Representatives, May
15, 1991.
112. Smith, T., Statement before the House Merchant Marine and
Fisheries Committee, Subcommittee on Fisheries and Wildlife
Conservation and the Environment, U.S. House of Representatives, May
15, 1991.
113. Banks, A., memorandum, ``Model Food Codes Provisions
Requiring that Shellfish be Obtained from U.S. PHS Listed Sources,
and Status of Adoptions,'' May 17, 1993.
114. Kraemer, D.W., ``Processing Methods for Ready-To-Eat
Seafood Products and Control and Inactivation of Listeria
monocytogenes,'' December 1989.
115. FSIS, USDA, ``Time/Temperature Guidelines for Cooling
Heated Products,'' FSIS Directive 7110.3.
116. Department of Fisheries and Oceans, Canada, ``Good
Manufacturing Practices, Lobster Processing, Annex A: Sanitary
Zone(s),'' Revision No. 1 900601, pp. 49-51.
117. Stratton, J.E., and Taylor, S.L., ``Scombroid Poisoning,''
Microbiology of Marine Food Products, Van Nostrand Reinhold, pp.
331-351, 1991.
118. Frank, H.A., and Yoshinaga, D.H., ``Histamine Formation in
Tuna,'' Seafood Toxins, Regelis, E.P., ed., ACS Symposium Series No.
262, American Chemical Society, Washington, D.C., pp. 443-451, 1984.
119. Barnett, J.D., memorandum, ``Scombrotoxin Regulation,'' May
14, 1993.
120. Yoshinaga, D.H., and Frank, H.A., ``Histamine-Producing
Bacteria in Decomposing Skipjack Tuna (Katsuwonus pelamis)'' Applied
and Environmental Microbiology. 44(2):447-452, 1982.
121. Baranowski, J.D., Frank, H.A., Brust, P.A.,
Chongsiriwatana, M., and Premaratne, R.J., ``Decomposition and
Histamine Content in Mahimahi (Coryphaena Hippurus),'' Journal of
Food Protection, 53(3):217-222, 1990.
122. Association of Food and Drug Officials Quarterly Bulletin,
49(3):129, July 1985.
123. General Accounting Office, ``Seafood Safety: Seriousness of
Problems and Efforts to Protect Consumers,'' GAO/RCED-88-135, 1988.
124. Brunetti, A.P., memorandum, ``Import Detentions Related to
Misbranding for FY 1992,'' May 26, 1993.
125. Hsieh, Y., Kirsh, P., and Woodward, B., ``Species
identification of retail snapper fillets in Florida,'' Proceedings
of the 14th Annual Conference of the Tropical and Subtropical
Fisheries Technological Society of the Americas, Florida Sea Grant
Program, SGR-101, University of Florida, Gainesville, September,
1990.
126. Ian Dore, ``Fresh Seafood, The Commercial Buyers Guide,''
Van Nostrand Reinhold, New York, 1984.
127. National Fisheries Institute, Inc., ``Seafood Quality:
Inspecting the Issue: A Study of the U.S. Fisheries Inspection
System Conducted by the National Fisheries Institute in Cooperation
With the National Marine Fisheries Service,'' Washington, DC, 1985.
128. Jones, B., and Doolin, C., ``Industry and Regulatory
Interface to Address Concerns for Seafood Product Quality and
Safety,'' Federal Saltonstall-Kennedy Project NA88-WC-H-06065,
Southeast Fisheries Association, Inc., Tallahassee, FL, June, 1990.
129. Spiller, P., Memorandum, ``Industry Costs of HACCP,''
September 13, 1993.
130. Schlech, W.F. et al., ``Epidemic Listeriosis--Evidence for
Transmission by Food,'' New England Journal of Medicine, 308:203-
206, 1983.
131. Fleming, D.W. et al., ``Pasteurized Milk as a Vehicle of
Infection in an Outbreak of Listeriosis,'' New England Journal of
Medicine, 312:404-407, 1985.
132. James, S.M. et al., ``Listeriosis Outbreak Associated With
Mexican-style Cheese--California,'' Morbidity and Mortality Weekly
Report, 34:358-359, 1985.
133. Azadian, B.S., G.T. Finnerty, and A.D. Pearson,
``Cheeseborne Lister Meningitis in Immunocompetent Patient,'' The
Lancet, i:322-323, 1989.
134. Buchanan, R.L., H.G. Stahl, M.M. Bencivengo, and F. Del
Corral, ``Comparison of Lithium Chloride-Phenylethanol-Moxalactam
and Retail-Level Meats, Poultry, and Seafood,'' Applied and
Environmental Microbiology, 55:599-603, 1989.
135. Johnson, J.L., M.P. Doyle, and R.G. Cassens, ``Listeria
Monocytogenes and Other Listeria Spp. in Meat and Meat products: A
Review,'' Journal of Food Protection, 53:81-91, 1990.
136. Weagant, S.D. et al., ``The Incidence of Listeria Species
in Frozen Seafood Products,'' Journal of Food Protection, 51:655-
657, 1988.
137. Farber, J.M., ``Listeria Monocytogenes in Fish Products,''
Journal of Food Protection, 54:922-924, 1991.
138. Lovett, J., D.W. Francis, and J.G. Bradshaw, ``Outgrowth of
Listeria Monocytogenes in Foods,'' p. 183-187, In A.J. Miller, J.L.
Smith, and G.A. Somkuti (eds.), ``Foodborne Listeriosis,'' Society
for Industrial Microbiology, Elsevier Science Publishers, New York,
1990.
139. Rorvik, L.M., M. Yndestad, and E. Skjerve, ``Growth of
Listeria Monocytogenes in Vacuum-packed, Smoked Salmon, During
Storage At 4 deg.C, International Journal of Food Microbiology,
14:111-118, 1991.
140. Farber, J.M., and P.I. Peterkin, ``Listeria Monocytogenes,
a Food-borne Pathogen, Microbiology Reviews, 55:476-511, 1991.
141. Hartemink, R., and F. Georgsson, ``Incidence of Listeria
Species in Seafood and Seafood Salads,'' International Journal of
Food Microbiology, 12:189-196, 1991.
142. Jemmi, T., ``Occurrence of Listeria Monocytogenes in
Imported Smoked and Fermented Fish,'' Food Science and Technology
Abstracts, 23(9):226, 1990.
143. Guyer, S., and T. Jemmi, ``Behavior of Listeria
Monocytogenes During Fabrication and Storage of Experimentally
Contaminated Smoked Salmon, Applied Environmental Microbiology,
57:1523-1527, 1991.
144. Jemmi, T., and A. Keusch, ``Behavior of Listeria
Monocytogenes During Processing and Storage of Experimentally
Contaminated Hot-smoked Trout,'' International Journal of Food
Microbiology, 15:339-346, 1992.
145. Shahamat, M., A. Seaman, and M. Woodbine, ``The Survival of
Listeria Monocytogenes in High Salt Concentrations,'' Zentral Blatt
for Bakteriologie, Mikrobiologie and Hygiene I.ABT.Originate, A,
246:506-511, 1980.
146. Golden, D.A., L.R. Beuchat, and R.E. Brackett,
``Inactivation and Injury of Listeria Monocytogenes as Affected by
Heating and Freezing,'' Food Microbiology, 5:17-23, 1988.
147. Pace, P.J., and E.R. Krumbiegel, ``Clostridium Botulinum
and Smoked Fish Production: 1963-1972,'' Journal of Milk and Food
Technology, 36(1):42, 1973.
148. Craig, J.M., and K.S. Pilcher, ``Clostridium Botulinum Type
F: Isolation From Salmon From the Columbia River,'' Science,
153:311, 1966.
149. Kautter, D.A. et al., ``Incidence of Clostridium Botulinum
in Crabmeat From the Blue Crab,'' Applied Microbiology, 28(4):722,
1974.
150. Ward, B.Q. et al., ``Survey of the U.S. Atlantic Coast and
Estuaries From Key Largo to Staten Island for the Presence of
Clostridium Botulinum,'' Applied Microbiology, 15(4):964, 1970.
151. Ward, B.Q. et al., ``Survey of the U.S. Gulf Coast for the
Presence of Clostridium Botulinum,'' Applied Microbiology,
15(3):629, 1970.
152. Huss, H.H., A. Pedersen, and D.C. Cann, ``The Incidence of
Clostridium Botulinum in Danish Trout Farms,'' Journal of Milk and
Food Technology, 9(4):445, 1974.
153. Pace, P.J., E.R. Krumbiegel, and H.J. Wisniewski,
``Interrelationship of Heat and Relative Humidity in the Destruction
of Clostridium Botulinum Type E Spores on Whitefish Chubs,'' Applied
Microbiology, 23(4):750, 1972.
154. Graikoski, J.T., ``Effect of Heat and Environmental
Conditions on the Survival and Outgrowth of Clostridium Botulinum
Type E in Smoked Fish,'' unpublished, May 12, 1967.
155. Bott, T.L. et al., ``Clostridium Botulinum Type E in Fish
From the Great Lakes,'' Journal of Bacteriology, 91(3):919, 1966.
156. Bott, T.L. et al., ``Possible Origin of the High Incidence
of Clostridium Botulinum Type E in an Inland Bay (Green Bay of Lake
Michigan),'' Journal of Bacteriology, 95(5):1542, 1968.
157. Craig, J.M., and K.S. Pilcher, ``The Natural Distribution
of Cl. Botulinum Type E in the Pacific Coast Areas of the United
States'' In M. Ingram, and T.A. Roberts, (eds.), ``Botulism 1966,
Proceedings of the Fifth International Symposium on Food
Microbiology: Moscow, July 1966,'' Chapman and Hall Ltd., London,
1967.
158. Craig, J.M., S. Hayes, and K.S. Pilcher, ``Incidence of
Clostridium Botulinum Type E in Salmon and Other Marine Fish in the
Pacific Northwest,'' Applied Microbiology, 16(4):553, 1968.
159. Eklund, M.W., and F. Poysky, ``Incidence of Cl. Botulinum
Type E From the Pacific Coast of the United States,'' In M. Ingram,
and T.A. Roberts, (eds.), ``Botulism 1966, Proceedings of the Fifth
International Symposium on Food Microbiology: Moscow, July 1966,''
Chapman and Hall Ltd., London, 1967.
160. Hayes, S., J.M. Craig, and K.S. Pilcher, ``The Detection of
Clostridium Botulinum Type E in Smoked Fish Products in the Pacific
Northwest,'' Canadian Journal of Microbiology, 16(3):207, 1970.
161. U.S. Department of the Interior and U.S. Department of
Health, Education, and Welfare, ``Sanitation Standards for Smoked-
Fish Processing; 1967 Recommendations,'' Public Health Service
Publication No. 1587, 1967.
162. Guthrie, R.K., ``Sanitation in Food Production and
Processing,'' In R.K. Guthrie, ``Food Sanitation,'' p. 131, AVI
Publishing Co., Inc., Westport, CT, 1980.
163. Christiansen, L.N. et al., ``Survival and Outgrowth of
Clostridium Botulinum Type E Spores in Smoked Fish,'' Applied
Microbiology, 16(1):133, 1968.
164. United States v. Nova Scotia Food Products Corp., U.S.
Court of Appeals, Second Circuit, 1977, 568 F.2d 240.
165. Anonymous, Monthly Epidemiological Bulletin, State of
Israel Ministry of Health, December 1987.
166. Centers for Disease Control, ``International Outbreak of
Type E Botulism Associated With Ungutted, Salted Whitefish,''
Morbidity and Mortality Weekly Report, 36(49):812, 1987.
167. Centers for Disease Control, ``Botulism Associated With
Commercially Distributed Kapchunka--New York City,'' Morbidity and
Mortality Weekly Report, 34(35):546, 1985.
168. Badhey, H. et al., ``Two Fatal Cases of Type E Adult Food-
borne Botulism With Early Symptoms and Terminal Neurologic Signs,''
Journal of Clinical Microbiology, 23(3):616, 1986.
169. EIR's conducted by FDA.
170. Letter to D.A. Kautter from Alan L. Hoeting, July 31, 1987.
171. Codex Alimentarius Commission, ``Thirteenth Session of the
Codex Committee on Fish and Fishery Products, RCP-25, Recommended
International Code of Practice for Smoked Fish,'' 1979.
172. Codex Alimentarius Commission, ``Thirteenth Session of the
Codex Committee on Fish and Fishery Products, RCP-26, Recommended
International Code of Practice for Salted Fish,'' 1979.
173. Eklund, M.W., ``Significance of Clostridium Botulinum in
Fishery Products Preserved Short of Sterilization,'' Food
Technology, 35(12):107, 1982.
174. Schmidt, C.F., R.V. Lechowich, and J.F. Folinazzo, ``Growth
and Toxin Production by Type E Clostridium Botulinum Below 40
deg.F,'' Journal of Food Science, 26:626, 1961.
175. CPG No. 7108.17; Salt-cured, Air-Dried, Uneviscerated Fish
(53 FR 44949, November 7, 1988), Docket No. 88D-0306.
176. Graham, P.P., R.S. Hamilton, and M. D. Pierson, ``Influence
of Bringing Procedures on Salt Content and Distribution in Smoked
Whitefish Chubs,'' Journal of Food Processing and Preserving,
10:295, 1986.
177. Deng, J., R.T. Toledo, and D.A. Lillard, ``Effect of
Smoking Temperatures on Acceptability and Storage Stability of
Smoked Spanish Mackerel,'' Journal of Food Science, 39:596, 1974.
178. Chan, W.S., R.T. Toledo, and J. Deng, ``Effect of
Smokehouse Temperature, Humidity, and Air Flow on Smoke Penetration
into Fish Muscle,'' Journal of Food Science, 40:240, 1975.
179. Pelroy, G.A. et al., ``Inhibition of Clostridium Botulinum
Types A and E Toxin Formation by Sodium Nitrite and Sodium Chloride
in Hot-process (Smoked) Salmon,'' Journal of Food Protection,
45(9):833, 1982.
180. Eklund, M.W., testimony presented at New York State
Department of Agriculture and Markets' hearing, May 13, 1989.
181. Newberry, R.E., Letter to City Smoked Fish Co., Use of
Colors in Smoked Salmon, March 11, 1985.
182. National Fisheries Institute, Inc., ``Techniques For
Smoking Fish,'' Washington, DC.
183. Borgstrom, G., ``Smoking,'' in ``Fish as Food, Processing:
Part I, Vol. 3,'' p. 88, Academic Press, New York, 1965.
184. Kautter, D.A., memorandum, ``Aqueous Phase Salt
Concentration for Vacuum Packaged Cold-smoked Fish,'' April 6, 1990.
185. Eklund, M.W. et al., ``Feasibility of a Heat-pasteurization
Process for the Inactivation of Nonproteolytic Clostridium Botulinum
Types B and E in Vacuum-packaged, Hot-process Smoked Fish,'' Journal
of Food Protection, 51(9):720, 1988.
186. Eklund, M.W., D.I. Wieler, and F.T. Poysky, ``Outgrowth and
Toxin Production of Nonproteolytic Type B Clostridium Botulinum at
3.3 to 5.6 deg.C,'' Journal of Bacteriology, 93(4):1461, 1967.
187. Solomon, H.M. et al., ``Effect of Low Temperatures on
Growth of Clostridium Botulinum Spores in Meat of the Blue Crab,''
Journal of Food Protection, 40(1):5, 1977.
188. Ohye, D.F., and W.J. Scott, ``Studies in the Physiology of
Clostridium Botulinum Type E,'' Australian Journal of Biological
Science, 10:85, 1956.
189. National Research Council, ``An Evaluation of the Role of
Microbiological Criteria for Foods and Food Ingredients,'' p. 249,
National Academy Press, Washington, DC.
190. Federal Standard, ``Sanitation Standards For Fish Plants,''
FED-STD-369, Academy of Health Sciences, U.S. Army, Fort Sam
Houston, Houston, TX, August 2, 1977.
191. Masso T.W., letters to T. Schwarz With AFDO Resolution No.
8, June 8, 1990.
192. Bryan, F.L., ``Application of HACCP to Ready-to-eat Chilled
Foods,'' Food Technology, 44(7):70, 1990.
193. Tartakow, I.J., and J.H. Vorperian, (eds.), ``Foodborne and
Waterborne Diseases: Their Epidemiologic Characteristics,'' p. 50-
52, AVI Publishing Co., Westport, CN, 1981.
194. Rhodehamel, J.E., N.R. Reddy, and M.D. Pierson, ``Botulism:
The Causative Agent and its Control in Foods: A Review,'' Food
Control, 3(3):125-143, 1992.
195. FDA, ``Human Foods; Current Good Manufacturing Practice
(Sanitation) in Manufacturing, Processing, Packing, or Holding
Smoked Fish,'' 34 FR 17176, October 23, 1969.
196. FDA, Part 110--Current Good Manufacturing Practice in
Manufacturing, Packing, or Holding Human Food (21 CFR part 110).
197. FDA, FDA Inspections Manual, Chapter 5, Establishment
Inspection, Subchapter 530, Food.
198. Center for Disease Control, ``Fish Botulism--Hawaii,
1990,'' Morbidity and Mortality Weekly, 40(24):412-414, June 21,
1991.
199. FDA, ``Studies in Food Sanitation Control--Year Five,
Contract No. 223-80-2295, Task XVI, Effect of Controlled Humidity of
Processing Ovens at High Operating Temperatures on Production of
Smoked Fish,'' June 14, 1984.
200. Printout of FDA FY 90/91 Domestic Fish and Fishery Products
Assignment Inspection Data as of August 6, 1991.
201. Daniels, Richard W., ``Applying HACCP to New Generation
Refrigerated Foods at Retail and Beyond,'' Food Technology, June
1991.
List of Subjects
21 CFR Part 123
Fish, Fishery products, Imports, Reporting and recordkeeping
requirements, Seafood.
21 CFR Part 1240
Communicable diseases, Public health, Travel restrictions, Water
supply.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, it is
proposed that 21 CFR chapter I be amended as follows:
1. Part 123 is added to read as follows:
PART 123--FISH AND FISHERY PRODUCTS
Subpart A--General Provisions
Sec.
123.3 Definitions.
123.5 Current good manufacturing practice (sanitation).
123.6 Hazard Analysis Critical Control Point (HACCP) plan.
123.7 Corrective actions.
123.8 Records.
123.9 Training.
123.10 Sanitation control procedures.
123.11 Obligations of importers.
123.12 Imports--determination of compliance.
Subpart B--[Reserved]
Subpart C--Raw Molluscan Shellfish
123.20 General.
123.28 Source controls and records.
Appendix A to Part 123--Cooked, Ready-to-eat Fishery Products
Appendix B to Part 123--Scombroid Toxin Forming Species
Appendix C to Part 123--[Reserved]
Appendix D to Part 123--Product Integrity
Authority: Secs. 201, 402, 403, 406, 409, 701, 704, 721, 801 of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 342, 343,
346, 348, 371, 374, 379e, 381); secs. 301, 307, 361, 1702 of the
Public Health Service Act (42 U.S.C. 241, 242l, 264, 300u-1).
Subpart A--General Provisions
Sec. 123.3 Definitions.
The definitions and interpretations of terms in section 201 of the
Federal Food, Drug, and Cosmetic Act and in part 110 of this chapter
are applicable to such terms when used in this part. The following
definitions shall also apply:
(a) Certification number means a unique combination of letters and
numbers assigned by a shellfish control authority to a molluscan
shellfish processor.
(b) Cooked, ready-to-eat fishery product means a fishery product
that is subjected by a commercial processor to either a cooking process
before being placed in a final container, or to pasteurization in the
final container, or to both.
(c) Critical control point means a point in a food process where
there is a high probability that improper control may cause, allow, or
contribute to a hazard in the final food.
(d) Critical limit means the maximum or minimum value to which a
physical, biological, or chemical parameter must be controlled at a
critical control point to minimize the risk of occurrence of the
identified hazard.
(e) Fish means fresh or saltwater finfish, molluscan shellfish,
crustaceans, and other forms of aquatic animal life other than birds or
mammals.
(f) Fishery product means any edible human food product derived in
whole or in part from fish, including fish that has been processed in
any manner.
(g) Harvester means a person who has an identification number
issued by a shellfish control authority for commercially taking
molluscan shellfish by any means from a growing area.
(h) Importer means a person, or his representative in the United
States, who is responsible for ensuring that goods being offered for
entry into the United States are in compliance with all laws affecting
the importation.
(i) Lot of molluscan shellfish means a collection of shellstock or
containers of shellstock of no more than 1 day's harvest from a single,
defined growing area harvested by one or more harvesters.
(j) Molluscan shellfish means any edible species of fresh or frozen
oysters, clams, mussels and scallops or edible portions thereof, except
when the scallop product consists entirely of the shucked adductor
muscle.
(k) Potable water means water which meets the U.S. Environmental
Protection Agency's Primary Drinking Water Regulations as set forth in
40 CFR part 141.
(l) Process control instrument means an instrument or device used
to monitor conditions during processing at a critical control point.
(m) Processing means, with respect to fish or fishery products,
handling, storing, preparing, heading, gutting, shucking, freezing,
changing into different market forms, manufacturing, preserving,
packing, labeling, or holding. Practices such as heading or gutting
intended solely to prepare a fish for holding on board a harvest vessel
are excluded. This regulation does not cover the operation of a retail
establishment.
(n) Processor means any person engaged in commercial, custom, or
institutional processing of fish or fishery products, either in the
United States or in a foreign country. Persons engaged in the
production of foods that are to be used in market or consumer tests are
also included. Persons who only harvest or transport seafood, without
otherwise engaging in processing, are not covered by these regulations.
(o) Shall is used to state mandatory requirements.
(p) Shellfish control authority means a Federal or State health
authority, or foreign government health authority, legally responsible
for the administration of a program that includes classification of
molluscan shellfish growing areas, enforcement of harvesting controls,
and certification of molluscan shellfish processors.
(q) Shellstock means raw, in-shell molluscan shellfish.
(r) Should is used to state recommended or advisory procedures or
to identify recommended equipment.
(s) Shucked shellfish means molluscan shellfish that have one or
both shells removed.
(t) Tag means a record of harvesting information attached to a
container of shellstock by the harvester or processor.
Sec. 123.5 Current good manufacturing practice (sanitation).
(a) The criteria in part 110 of this chapter apply in determining
whether the facilities, methods, practices, and controls used to
process fish and fishery products are safe, and whether these products
have been processed under sanitary conditions.
(b) The purpose of subpart A of this part is to set forth
requirements specific to the processing of fish and fishery products.
Sec. 123.6 Hazard Analysis Critical Control Point (HACCP) plan.
(a) Every processor and importer shall have and implement a written
HACCP plan that is specific to:
(1) Each location where fish and fishery products are processed by
that processor; and
(2) Each kind of fish and fishery product processed by the
processor. The plan may group kinds of fish and fishery products
together if the hazards, critical control points, critical limits, and
procedures required to be identified in paragraph (b) of this section
are identical for all fish and fishery products so grouped.
(b) The HACCP plan shall:
(1) Identify the safety hazards that are reasonably likely to occur
and that thus must be controlled for each fish and fishery product,
including, as appropriate:
(i) Natural toxins;
(ii) Microbiological contamination;
(iii) Chemical contamination;
(iv) Pesticides;
(v) Drug residues;
(vi) Decomposition;
(vii) Parasites;
(viii) Unapproved direct and indirect food and color additives; and
(ix) Physical hazards;
(2) Identify the critical control points for each of the identified
hazards;
(3) Identify the critical limits that must be met at each of the
critical control points;
(4) Identify the procedures, and frequency thereof, including the
use of consumer complaints received by the processor or importer, that
will be used to control and monitor each of the critical control points
to ensure compliance with the critical limits. Such procedures shall
include the calibration of process control instruments and validation
of software for computer control systems as appropriate;
(5) Provide for a recordkeeping system that will document the
monitoring of the critical control points. The records shall contain
the actual values obtained during monitoring. The records shall also
include consumer complaints that relate to the operation of critical
control points or possible critical limit deviations.
(c) In addition, the HACCP plan should:
(1) Identify other consumer hazards not related to the safety of
the product, including, but not necessarily limited to:
(i) Decomposition not associated with human illness; and
(ii) Economic adulteration.
(2) Provide for control of these hazards in the manner described by
paragraphs (b)(2) through (b)(5) of this section.
(d) Failure of a processor or importer to have and implement an
HACCP plan that complies with this section or to operate in accordance
with the requirements of this part, shall render the products of that
processor or importer adulterated under section 402(a)(4) of the
Federal Food, Drug, and Cosmetic Act.
Sec. 123.7 Corrective actions.
(a) Any critical limit deviation shall require:
(1) Segregation and holding of the affected product, at least until
the requirements of paragraphs (a)(2) and (a)(3) of this section are
met;
(2) Immediate review by an individual or individuals who have been
trained in accordance with Sec. 123.9, to determine the acceptability
of the lot in question for distribution, based on a judgment as to
whether the deviation may have rendered the product in that lot
injurious to health or otherwise adulterated;
(3) Corrective action, when necessary, with respect to the affected
product and the critical control point at which the deviation occurred;
(4) Timely assessment by an individual or individuals who have been
trained in accordance with Sec. 123.9, to determine whether the process
or Hazard Analysis Critical Control Point (HACCP) plan needs to be
modified to reduce the risk of recurrence of the deviation; and
(5) Modification when necessary as it applies to the process or
HACCP plan.
(b) When a processor or importer receives a consumer complaint that
may be related to the performance of a critical control point or that
may reflect a critical limit deviation, it shall determine whether
corrective action as described by paragraph (a) of this section is
appropriate and, if so, it shall take such action.
(c) All actions required by paragraphs (a) and (b) of this section
shall be documented in records that are subject to the requirements of
Sec. 123.8.
Sec. 123.8 Records.
(a) Records required by this part that involve observations or
measurements during processing or related activities, including
corrective actions taken in accordance with Sec. 123.7, shall include
the identity of the product, product code, and date of activity that
the record reflects. Processing and other information shall be entered
at the time that it is observed. Each record shall be signed by the
operator or observer, except that corrective action records need only
be signed in accordance with paragraph (b) of this section.
(b) Records required by this part shall be reviewed, signed, and
dated by an individual who has been trained in accordance with
Sec. 123.9, before distribution of the product for completeness and
compliance with the established critical limits.
(c) The records required by this part shall be retained at the
processing facility or the importer's place of business in the United
States for at least 1 year after the date they were prepared in the
case of refrigerated products and for at least 2 years after the date
they were prepared in the case of frozen or preserved products. Records
that relate to the general adequacy of equipment or processes being
used by a processor, including the results of scientific studies and
evaluations, shall be retained at the processing facility for at least
2 years after their applicability to the product being produced at the
facility. If the processing facility is closed between seasonal packs,
the records may be transferred to some other reasonably accessible
location during the period of closure.
(d) All records required by this part, including HACCP plans
required in Sec. 123.6 and consumer complaints that may be related to a
critical limit deviation, shall be available for review and copying at
reasonable times by duly authorized officers and employees.
(e) Tags as defined in Sec. 123.3(t) are not subject to the
requirements of this section.
Sec. 123.9 Training.
Each processor and importer shall employ at least one individual
who has successfully completed a prescribed course of instruction in
the application of Hazard Analysis Critical Control Point (HACCP)
principles to fish and fishery product processing at a program of
instruction approved by the Food and Drug Administration. At a minimum,
this individual shall be responsible for developing and modifying the
plan as required by Sec. 123.6, evaluating critical limit deviations
and corrective actions as required by Sec. 123.7, and performing record
review as required by Sec. 123.8(b).
Sec. 123.10 Sanitation control procedures.
(a) Every processor and importer who takes physical possession of
fish or fishery products and engages in the processing of such fish or
fishery products, including storing such products, shall perform
sanitation inspections and ensure at a minimum that, to the extent
applicable to the operations conducted by the processor or importer,
the following conditions apply:
(1) Water that directly comes into contact with a product or with
food contact surfaces, or is used in the manufacture of ice, is derived
from a safe and sanitary source or is being treated to render it of
safe and sanitary quality.
(2) There are no cross connections between the potable water system
and any nonpotable system.
(3) All food contact surfaces of plant equipment and utensils,
including equipment used for ice production and storage, are so
designed and of such material and workmanship as to be easily
cleanable, and are maintained in a sanitary condition. Such surfaces
shall be constructed of nontoxic materials and designed to withstand
the environment of its intended use and the action of the food,
cleaning compounds, and sanitizing agents.
(4) All utensils and surfaces of equipment that contact food during
processing are cleaned and sanitized with effective cleaning and
sanitizing preparations with the following frequency:
(i) Cleaned at the end of the day's operations;
(ii) Cleaned and sanitized at least every 4 hours during the
processing of cooked, ready-to-eat fishery products; and
(iii) Sanitized before the beginning of the day's operations.
(5) Gloves and outer garments that contact food or food contact
surfaces are made of an impermeable material and are maintained in a
clean and sanitary condition.
(6) Employees' hands, gloves, outer garments, utensils and food
contact surfaces of equipment that come into contact with waste, the
floor, or other insanitary objects, do not contact fish or fishery
products without first being adequately cleaned and sanitized.
(7) Where applicable, employee's hands, gloves, outer garments,
utensils and food contact surfaces of equipment that come into contact
with raw product shall not contact cooked product or ice used on cooked
product, without first being adequately cleaned and sanitized.
(8) Hand washing and hand sanitizing facilities are:
(i) Located in all processing areas in which good sanitary practice
requires employees to wash and sanitize their hands; and
(ii) Equipped with hand-cleaning and effective sanitizing
preparations and single service towels or suitable hand drying devices.
(9) Food, food contact surfaces, and food-packaging materials shall
be protected from adulteration with lubricants, fuel, pesticides,
cleaning compounds, sanitizing agents, metal fragments, or other
chemical or physical contaminants.
(10) Toxic compounds shall be identified, held, used, and stored in
a manner that protects against contamination of food, food-contact
surfaces, or food-packaging materials.
(11) Food, food-contact surfaces, and food-packaging materials
shall be protected from contaminants that may drip, drain, or be drawn
into the food.
(12) Compressed gases that contact food or food contact surfaces of
equipment shall be filtered or treated in a way that ensures that they
will not contaminate the food with unapproved indirect food additives
or other chemical, physical, or microbiological contaminants.
(13) Unprotected cooked, ready-to-eat fishery products, smoked
fishery products, raw molluscan shellfish, and raw fish and fishery
products shall be physically separated from each other during
refrigerated storage.
(14) Refrigeration units that store raw materials, in-process, or
finished fish or fishery products that are cooked, ready-to-eat,
smoked, or made in whole or in part from scombroid toxin forming
species shall be operated at a temperature of 40 deg.F (4.4 deg.C) or
below.
(15) Any person who, by medical examination or supervisory
observation, is shown to have, or appears to have, an illness, open
lesion, including boils, sores, or infected wounds, or any other source
of microbial contamination by which there is a reasonable possibility
that food, food-contact surfaces, or food-packaging materials will
become contaminated, shall be excluded from any operations that may be
expected to result in such contamination until the condition is
corrected.
(16) Adequate, readily accessible toilet facilities that provide
for proper sewage disposal shall be available and maintained in a
sanitary condition and in good repair.
(17) No pests are in any area of a food plant.
(18) The plant is designed to minimize the risk of contamination of
the food, food-contact surfaces, and food-packaging material.
(b) Each processor shall maintain sanitation control records that
document that the steps required under paragraph (a) of this section
are performed with requisite frequency.
(c) Sanitation control measures shall be taken on a daily basis,
and the sanitation control records shall be prepared according to the
requirements of paragraph (a) of this section, except that:
(1) The hand sanitizer strength and sanitary practices of the
processing employees, especially as these relate to hand washing and
sanitizing practices and the potential for cross contamination, shall
be checked and recorded at least every 4 hours during processing.
(2) All utensils and food-contact surfaces of equipment shall be
inspected immediately after each cleaning and sanitizing operation
under paragraph (a)(4)(ii) of this section. Each such cleaning and
sanitizing shall be documented, and such documentation shall at a
minimum record the time of each cleaning, the concentration of the
sanitizer, and the condition of the equipment.
(3) The requirements of paragraphs (a)(1), (a)(2), (a)(3),
(a)(8)(i), (a)(12), and (a)(18) of this section shall be performed and
documented with such frequency as is necessary to ensure control.
(4) The requirement of paragraph (a)(14) of this section shall be
ensured by the continuous monitoring of the refrigeration unit with an
accurate process control instrument. The instrument shall be checked
and the measurements documented with such frequency as is necessary to
ensure control.
(d) Where deviations from the requirements of paragraph (a) of this
section are noted during these inspections, appropriate corrective
actions shall be taken and documented on the sanitation control record.
(e) Every plant should have a written standard operating procedure
(SOP) for assuring the maintenance of proper sanitary conditions and
practices during processing that is specific to each fish and fishery
product produced at that location. The SOP should include, at a
minimum, requirements as described in paragraph (a) of this section.
(f)(1) All fish to be smoked or salted shall be eviscerated and
free of residual viscera, except for:
(i) Small species of fish, such as anchovies and herring sprats,
provided that they are processed in a fashion so that they contain a
water-phase salt level of at least 10 percent, a water activity below
0.85, or a pH of 4.6 or less; and
(ii) Fish that are fully cooked before further processing.
(2) Evisceration shall be conducted in an area that is segregated
and separate from other processing operations. Evisceration shall be
performed with minimal disturbance of the intestinal tract contents.
The fish, including the body cavity, shall be washed thoroughly with a
vigorous water spray or a continuous water flow system.
Sec. 123.11 Obligations of importers.
This section sets forth the specific obligations of importers of
fish and fishery products into the United States.
(a) An importer of fish or fishery products shall have and
implement a Hazard Analysis Critical Control Point (HACCP) plan in
accordance with Sec. 123.6 that describes how the fish will be
prepared, packed, or held while it is in the control of the importer.
(b) The importer of fish or fishery products shall have on file the
HACCP plans of each of its foreign processors.
(c) The importer shall take affirmative steps to ensure that the
fish and fishery products that it offers for import were produced under
the HACCP plan that it has in its possession and subject to the
sanitation controls listed in Sec. 123.10. Such steps may include, but
would not be limited to:
(1) Obtaining from the foreign processor the HACCP monitoring
records that relate to the specific fish or fishery products being
offered for import.
(2) Obtaining a certificate from a foreign government inspection
authority certifying that the firm is operating under a valid HACCP
plan or certification on a lot-by-lot basis.
(3) Regularly inspecting its suppliers' facilities to ensure that
they are being operated in compliance with the applicable HACCP plan
and Sec. 123.10.
(4) Periodic end-product testing by the importer or a private
laboratory hired by the importer; or
(5) Other such verification measures as appropriate.
(d) An importer's obligation under paragraph (c) of this section
will be satisfied if the importer imports product from a country that
has an active memorandum of understanding (MOU), or similar agreement,
with FDA that documents the equivalency of the inspection system of the
foreign country with the U.S. system. The active MOU will be expected
to accurately reflect the current situation between the signing parties
and be functioning and enforceable in its entirety.
(e) Importers should encourage foreign processors to obtain HACCP
training similar to that required by Sec. 123.9.
Sec. 123.12 Imports--determination of compliance.
(a) There must be evidence that seafood that is offered for import
has been produced under conditions that comply with subpart A of this
part. Such evidence can be provided by:
(1) Examination, at the U.S. importer's place of business, of the
importer's Hazard Analysis Critical Control Point (HACCP) plan, the
foreign processor's HACCP plan and sanitation procedures and records
associated with the importer's plan that demonstrate that the plan and
procedures were followed.
(2) An active memorandum of understanding (as defined in
Sec. 123.11(d)) with an exporting country that provides that the
country will impose regulatory controls equivalent to those established
in this part for domestic processors.
(3) Evidence that an exporting country has in place and is
enforcing an HACCP-based regulatory system.
(4) Inspection of foreign processors by FDA or some other
organization designated by FDA.
(5) Any other measures that FDA deems appropriate, including, but
not limited to, end-product testing.
(b) If assurances do not exist that the product has been produced
under an HACCP plan and sanitation controls that are equivalent to
those required of domestic processors, the product will appear to be
adulterated and will be denied entry.
Subpart B--[Reserved]
Subpart C--Raw Molluscan Shellfish
Sec. 123.20 General.
This subpart augments subpart A of this part by setting forth
specific requirements for processing fresh or frozen molluscan
shellfish.
Sec. 123.28 Source controls and records.
(a) In order to meet requirements of subpart A of this part as they
apply to microbiological contamination, natural toxins, and related
hazards, processors shall include in their Hazard Analysis Critical
Control Point (HACCP) plans how they are controlling the origin of the
molluscan shellfish they process.
(b) Processors shall only process molluscan shellfish that
originate from growing waters approved for harvesting by a shellfish
control authority. To meet this requirement, processors shall only
receive shellstock:
(1) From a harvester that is licensed or a processor that is
certified by a shellfish control authority; and
(2) That has affixed a tag on each container of shellstock received
by the processor that bears, at a minimum, the information required in
Sec. 1240.60(b) of this chapter.
(3) Bulk shellstock shipments may be identified by a bill of lading
or similar document that contains the same information.
(c) The same requirements that apply to shellstock shall apply to
shucked molluscan shellfish received by a processor except that, in
lieu of a tag, the body of the container of shucked molluscan shellfish
shall bear a label that complies with Sec. 1240.60(c) of this chapter.
(d) Processors shall maintain records that document that each lot
of molluscan shellfish meet the requirements of paragraphs (b) and (c)
of this section.
(1) For shellstock these records shall document:
(i) The date of harvest;
(ii) The location of harvest by State and site;
(iii) The quantity and type of shellfish;
(iv) The date of receipt by the processor; and
(v) The name of the harvester and identification number.
(2) For shucked shellfish these records shall document:
(i) The date of receipt;
(ii) The quantity and type of shellfish; and
(iii) The name and certification number of the shipper.
Appendix A to Part 123--Cooked, Ready-to-Eat Fishery Products
1. General guidelines for cooked, ready-to- eat fishery
products.
2. Definitions in Appendix A.
3. Critical control points.
4. Thermal processing critical control points.
5. Container integrity critical control points.
6. Time and temperature critical control points.
7. Temperature monitoring equipment.
8. Corrective actions.
9. Sanitary zones.
1. General Guidelines for Cooked, Ready-to-Eat Fishery Products
This Appendix provides guidance on how to meet the requirements
of 21 CFR part 123, subpart A for the processing of cooked, ready-
to-eat fishery products. Cooked, ready-to-eat fishery products are
those that are subjected by a commercial processor to either a
cooking process before being placed in a final container, or to
pasteurization in the final container, or to both. This guidance
involves processing procedures that are common to most of these
products for the control of the microbiological hazards to which
they are particularly susceptible. The guidance does not apply to
environmental or other hazards that might occur before the processor
takes possession of the product or raw materials. (Guidance on these
hazards may be found in a separate guidance document for all fish
and fishery products to be issued by FDA.) This guidance also does
not apply to cooked, ready-to-eat fishery products covered by 21 CFR
part 123, subpart B.
2. Definitions in Appendix A
a. Cooking process means the application of sufficient heat for
a sufficient period of time to a fish or fishery product to
coagulate the protein throughout the product.
b. Hermetically sealed package means a container that is
designed and intended to be secure against the entry of
microorganisms.
c. Microorganisms of public health significance means bacteria,
fungi, and viruses capable of producing illness if they or their
toxins are ingested by humans.
d. Pasteurization means a process applied to a fish or fishery
product after that fish or fishery product has been placed in a
final, hermetically sealed package, which involves the application
of sufficient heat or other processes for a sufficient period of
time to result in the reduction of microorganisms of public health
concern to levels that, under normal conditions of storage, are
unlikely to cause disease.
e. Process authority means a person having expert knowledge of
commercial processing of fish and fishery products based on a
combination of education, training and experience.
f. Raw materials means fish and fishery products that are
received for processing and include fishery products that have been
processed elsewhere and that are received for further processing.
g. Temperature-indicating device means a mercury-in-glass
thermometer or equivalent device, such as a resistance temperature
device or thermocouple.
h. Temperature-recording device means a device that is capable
of providing a continuous record of the temperature conditions being
monitored.
3. Critical Control Points
Hazard Analysis Critical Control Point (HACCP) plans prepared in
accordance with 21 CFR part 123, subpart A will typically identify
and address the following critical control points:
a. Cooking;
b. Pasteurization;
c. Finished product container sealing for pasteurized products;
d. Post-pasteurization cooling;
e. Cooling after cooking;
f. Processing after cooking;
g. Final product cooling;
h. Refrigerated storage; and
i. Distribution.
In accordance with 21 CFR part 123, subpart A, processors shall
identify in their HACCP plans how they will control hazards at
critical control points. The measures in sections 4. through 6. of
this Appendix are suitable for HACCP plans.
4. Thermal Processing Critical Control Points
a. Cooking
1. The Cooking Process. The processor must be able to
demonstrate to itself and to FDA that its cooking process ensures
the destruction of vegetative cells of microorganisms of public
health concern. This may be accomplished by having a cooking process
that is at least equivalent to a process established by a process
authority. To demonstrate equivalence, a processor should have on
file in its Hazard Analysis Critical Control Point (HACCP) records a
document that:
i. Describes the results of a scientific evaluation, conducted
by a process authority, of the adequacy of the cooking process; and
ii. Identifies and establishes values for key aspects of the
process or of the product that may affect the adequate destruction
of microorganisms of public health concern. At a minimum, these
values should include cooking times and temperatures.
Such a document may consist of, but should not be limited to, a
letter from a process authority, articles in scientific journals, or
Federal, State, or local government regulations or advisories.
Failure to have documentation that the cooking process will achieve
its goal will violate 21 CFR 123.8 and will mean that the product
produced by the processor will be produced under insanitary
conditions whereby it may be rendered injurious to health.
2. Cooking Equipment Design.
i. The processor must be able to demonstrate to itself and to
FDA that its cooking equipment can deliver the cooking process that
ensures the destruction of vegetative cells of microorganisms of
public health concern. One way to accomplish this is for the
processor to have on file in its HACCP records a document that
describes the results of a scientific evaluation, conducted by a
process authority, of the design and operation of the type of
equipment and the operational procedures used by the processor. The
engineering specifications for the equipment used by the processor
(e.g., pipe sizes, flow rates, loading configuration, and, whenever
a steam process is used, venting parameters) should meet or exceed
those for the equipment evaluated by the process authority. Failure
to have documentation that the cooking equipment will achieve its
goal will violate 21 CFR 123.8 and will mean that the product
produced by the processor will be produced under insanitary
conditions whereby it may be rendered injurious to health.
ii. Cooking equipment should be equipped with both a
temperature-indicating device and temperature-recording device. The
temperature-indicating device should be the reference instrument for
determining conformance to the established process temperatures.
3. Records.
Monitoring records made by the processor should record both the
actual values that are occurring for those key aspects of the
process identified by the process authority in section 4.a.1. of
this Appendix and the actual values that are occurring for
operational procedures identified by the process authority in
section 4.a.2.i. of this Appendix.
4. Special Considerations.
For the cooking of blue crab (Callinectes sapidus), dungeness
crab (Cancer magister), or king crab (Paralithodes camtschatica),
the known lethality of the cooking process necessary to make the
product generally acceptable for human consumption, or to enable
further processing, is sufficient so that the adequacy of the
process and the equipment can normally be assumed.
b. Pasteurization
1. The Pasteurization Process. The processor must be able to
demonstrate to itself and to FDA that its pasteurization process
ensures the adequate reduction of numbers of viable spores of
microorganisms of public health concern. One way to accomplish this
is to have a pasteurization process that is equivalent to a process
established by a process authority. To demonstrate equivalence, a
processor should have on file in its HACCP records a document that:
i. Describes the results of a scientific evaluation conducted by
a process authority of the adequacy of the pasteurization process;
and that
ii. Identifies and establishes values for those key aspects of
the process, or of the product, that may affect the adequate
reduction in numbers of microorganisms of public health concern. At
a minimum, these values should include pasteurization times and
temperatures.
Such document may consist of, but should not be limited to, a
letter from a process authority, articles in scientific journals, or
Federal, State or local government regulations or advisories.
Failure to have documentation that the pasteurization process will
achieve its goal will violate 21 CFR 123.8 and will mean that the
product produced by the processor will be produced under insanitary
conditions whereby it may be rendered injurious to health.
2. Pasteurization Equipment Design.
i. The processor must be able to demonstrate to itself and to
FDA that its pasteurization equipment can deliver the pasteurization
process that ensures the adequate reduction of viable spores of
microorganisms of public health concern. One way to accomplish this
is to have on file a document that describes the results of a
scientific evaluation conducted by a process authority, of the
design and operation of the type of equipment used by the processor.
The engineering specifications for the equipment used by the
processor (e.g., pipe sizes, flow rates, loading configuration)
should meet or exceed those for the equipment evaluated by the
process authority. Failure to have documentation that the
pasteurization equipment will achieve its goals will violate 21 CFR
123.8 and will mean that the product produced by the processor will
be produced under insanitary conditions whereby it may be rendered
injurious to health.
ii. Pasteurization equipment should be equipped with both a
temperature-indicating device and temperature-recording device. The
temperature-indicating device should be the reference instrument for
determining conformance to the established process temperatures.
3. Records. Monitoring records made by the processor should
record the actual values that are occurring for those key aspect of
the process identified by the process authority in section 4.b.1.ii
of this Appendix.
5. Container Integrity Critical Controls Points
a. Finished Product Container Sealing
Finished product containers must be inspected, and the results
recorded, for container integrity to assure a consistently reliable
hermetic seal. FDA recommends that:
1. Visual seam inspection of one container from each seaming
head occur every 30 minutes; and
2. Testing by qualified personnel of one container from each
seaming head occur at least every 4 hours. As applicable, these
tests should be performed in accordance with 21 CFR 113.60(a)(1) and
(a)(2).
b. Post-pasteurization Cooling
Container cooling water must contain a measurable residual of
chlorine or other sanitizer. Tests to determine the presence of a
measurable residual of chlorine or other sanitizer in the container
cooling water should be made, and the results recorded, at
sufficient frequency to ensure control.
6. Time and Temperature Critical Control Points
a. Cooling After Cooking
After cooking, the product must be rapidly cooled to minimize
recontamination. Continuous cooling from 140 deg.F (60 deg.C) to
achieve an internal temperature of 70 deg.F (21.1 deg.C) or below
within 2 hours and an internal temperature of 40 deg.F (4.4 deg.C)
or below within an additional 4 hours, unless processing after
cooking, as described in section 6.b. of this Appendix, occurs
during either of these time periods, will effectively minimize
recontamination. Other time/temperature parameters may also be
effective. Processors should ensure that the cooling parameters are
met by either:
1. Monitoring. Monitoring and recording internal product
temperatures at least every 2 hours; or
2. Studies.
i. Conducting or obtaining a study that establishes that
appropriate cooling temperatures are always met under prescribed
processing conditions. The study should establish the limits of
significant variables that could affect the rate of cooling. These
variables may include product size, ambient air temperature, and
amount of product in the cooler. An adequate study should consist of
at least three processing runs under the prescribed processing
conditions; and
ii. Monitoring and recording the prescribed processing
conditions as identified by the study in section 6.a.2.i. of this
Appendix at least every 2 hours.
b. Processing After Cooking
Products that will receive processing after cooking should not
be exposed to ambient temperatures of 40 deg.F (4.4 deg.C) or
higher for longer than a cumulative total of 4 hours after cooking.
If they are exposed to such temperatures for more than 4 hours,
unacceptable recontamination is the likely result. Processors are
required to regularly monitor and record the length of time that the
product is exposed to temperatures above 40 deg.F (4.4 deg.C)
under 21 CFR 123.8. FDA recommends that such monitoring and
recording be done at least every 2 hours.
c. Final Product Cooling
To avoid microbiological hazards for perishable finished
products, the internal temperature of the finished product should be
40 deg.F (4.4 deg.C) or below within 4 hours of either placement
in a finished product container or the completion of pasteurization.
Processors should either conduct:
1. Monitoring. Monitor and record internal product temperatures
at least every 2 hours; or
2. Studies.
i. Conduct or obtain a study that establishes that the internal
temperature of the finished product will always be 40 deg.F (4.4
deg.C) or below within 4 hours of either placement in a finished
product container or completion of pasteurization under prescribed
processing conditions. The study should establish the limits of
significant variables that could affect the rate of cooling. These
variables may include product size, ambient air temperature, and
amount of product in the cooler. An adequate study should consist of
at least three processing runs under the prescribed processing
conditions; and
ii. Monitoring and recording the prescribed processing
conditions as identified by the study in section 6.c.2.i. of this
Appendix at least every 2 hours.
d. Refrigerated Storage
1. In-process products. Refrigeration units that are being used
to store in-process products or finished products shall operate at a
temperature of 40 deg.F (4.4 deg.C) or below in accordance with 21
CFR 123.10(a)(14).
2. Temperature devices. Units should be equipped with both a
temperature-indicating device and a temperature-recording device. In
lieu of a temperature-recording device, a processor may equip a
refrigeration unit with a high temperature alarm or a maximum-
indicating thermometer and maintain a temperature log that notes
temperature with such frequency as is necessary to achieve control.
e. Distribution
All perishable finished products should be distributed in a
manner that ensures that the internal temperature is maintained at
40 deg.F (4.4 deg.C) or below.
7. Temperature Monitoring Equipment
Where reference is made in this Appendix to temperature-
indicating devices and temperature-recording devices, the following
conditions should apply:
a. Temperature-Indicating Devices
Temperature-indicating devices should be installed where they
can be easily read and located to ensure that they accurately
measure the warmest temperature of the refrigeration equipment and
the coldest temperature of the heating equipment, as appropriate.
Temperature-indicating devices should be calibrated at the routine
operating temperature of the refrigeration, cooling, or heating
equipment against a known accurate standard thermometer upon
installation and at least once a year thereafter, or more
frequently, if necessary, to ensure their accuracy. Records required
to be maintained under 21 CFR 123.8 of accuracy checks for
temperature-indicating devices should specify the date, standard
used, method used, results, and person performing the test. A
temperature-indicating device that has a divided fluid column or
that cannot be adjusted to the standard should be immediately
repaired or replaced.
b. Temperature-Recording Devices
Temperature-recording devices should be installed where they can
be easily read and the sensors for such devices should be installed
to ensure that they accurately measure the warmest temperature of
the refrigeration equipment and the coldest temperature of the
heating equipment, as appropriate. Computerized storage of
temperature data may be used in place of recorder thermometer charts
if the use of such a system has been validated and can be shown to
be substantially equivalent to the use of a temperature-recording
device. Each temperature-recording device should be checked for
accuracy at the beginning and end of each production day and
adjusted as necessary to agree as nearly as possible with the
reference temperature-indicating device. A record of these accuracy
checks should be maintained that specifies the time, date,
temperatures indicated by both devices before adjustment, corrective
action taken, where applicable, and person performing the accuracy
check.
8. Corrective Actions
Under 21 CFR 123.7, whenever a deviation occurs at a critical
control point, the processor shall segregate and hold the product
until a review can be made to determine the effect of that
deviation, and shall take corrective action as necessary. For
cooked, ready-to-eat products, when a deviation occurs at a cooking
or pasteurization critical control point, the processor should meet
the requirements of Sec. 123.7 either by destroying the product; by
fully reprocessing, where possible, that portion of the production
involved, keeping full records of the reprocessing conditions; or by
setting aside that portion of the product involved for further
evaluation as to any potential public health significance. Such an
evaluation should be made by a process authority and should be in
accordance with procedures recognized by process authorities as
being adequate to detect any unacceptable hazard to public health.
Unless this evaluation demonstrates that the product had been given
a thermal process that rendered it free of microorganisms of
potential public health significance or, in the case of
pasteurization, that resulted in the adequate reduction in numbers
of microorganisms, the product set aside should be either fully
reprocessed to correct the deficiency or destroyed. A record should
be made of the evaluation procedures used and the results. Either
upon completion of full reprocessing or after the determination that
no significant public health hazard exists, that portion of the
product involved may be shipped in normal distribution. Otherwise,
the portion of the product involved should be destroyed.
9. Sanitary Zones
In addition to the requirements of 21 CFR 123.10, sanitary zones
should be established around areas in which cooked product is
handled or stored. In such areas, objects and employees that have
come into contact with waste, raw product, or other insanitary
objects are excluded. Packaging material, equipment, employees, and
in-process materials that enter a sanitary zone should be treated in
a manner that will minimize the risk of the introduction of
microorganisms. Air handling systems should be designed to minimize
the risk of airborne contamination and to provide positive air
pressure in the sanitary zone relative to the surrounding areas.
Appendix B to Part 123--Scombroid Toxin Forming Species
1. General guidelines for Scombroid Toxin Forming Species.
2. Critical control points.
3. Receipt of raw materials critical control point.
4. Processing critical control point.
5. Additional critical control points.
1. General Guidelines for Scombroid Toxin Forming Species
This Appendix provides guidance on how to meet the requirements
of 21 CFR part 123, subpart A for fish and fishery products that
consist in whole or in part of scombroid toxin forming species.
These include tuna, bluefish, mahi mahi, mackerel, sardines,
herring, kahawai, anchovies, marlin, and other species, whether or
not of the family Scombridae, in which significant levels of
histamine may be produced in the fish flesh by decarboxylation of
free histidine as a result of exposure of the fish after capture to
temperatures that permit the growth of mesophilic bacteria. The
guidance focuses on preventing the formation of scombrotoxin, which
can be harmful to humans, as a consequence of improper handling
after capture, i.e., time and temperature abuse.
2. Critical Control Points
Every processor who engages in processing other than, or in
addition to, storing of fish or fishery products that consist in
whole or in part of scombroid forming species, must ensure that
neither decomposition leading to histamine formation, nor histamine
formation, has occurred before receipt of such fish or fishery
products. Processors must also ensure that neither decomposition
leading to histamine formation, nor histamine formation, occurs as a
result of inadequate handling practices by the processor. In order
to prevent these hazards from occurring, Hazard Analysis Critical
Control Point (HACCP) plans prepared in accordance with 21 CFR part
123, subpart A will typically identify and address the receipt of
raw materials, as well as processing, as critical control points. In
accordance with 21 CFR part 123, subpart A, processors shall
identify in their HACCP plans how they will control hazards at
critical control points. This appendix provides guidance on how to
do so with respect to scombroid toxin forming species.
3. Receipt of Raw Materials Critical Control Point
a. First Processor
1. On-board handling. The first processor to take ownership
after harvest of fish and fishery products of scombroid toxin
forming species should ensure that vessels supplying such fish have
in place measures to ensure that the fish were rapidly brought to,
and maintained at, an internal temperature of 40 deg.F (4.4 deg.C)
or below, and were not held for a period of time sufficient to allow
histamine formation to begin at the temperature at which they were
held. The processor may determine the time and temperature history
of the fish by requiring certification of the fishing method and on-
board handling practices, and a time/temperature log from the
harvesting vessel. The time/temperature log should record, for each
lot of fish, the date of harvest, fishing method, temperature of the
harvest water, and temperature history of the fish relating to the
lowering of the internal temperature. The temperature history of the
fish may be documented by controlling and recording the key aspects
of the cooling and storage operation (e.g., refrigerated brine or
seawater temperature, fish size, and container packing). For
purposes of this guideline, a lot of fish is the fish in a vessel
storage compartment (i.e., well, tote, or other container). The log
should be sufficient to enable the processor to determine whether
the fish were subject to conditions in the water after capture, on
the harvesting vessel, or in storage, that could cause, or
significantly contribute to, the formation of histamine in the fish.
2. Sampling and examination. The first processor, as described
in section 3.a.1. of this Appendix, should subject a representative
sample of fish in each lot from the vessel to an external
organoleptic examination for decomposition and should record the
results of the examination. A representative sample should provide
at least 95 percent confidence that decomposition does not exist in
more than 2.5 percent of the fish in the lot. If the number of fish
from a vessel is small enough to permit an examination of each fish,
e.g., because the weight of each fish is typically greater than 10
pounds, the processor is encouraged to examine each fish.
i. Any fish that exhibits decomposition should either be
rejected and not used for food, or reconditioned according to the
processor's established procedures. Reconditioning should include,
at a minimum, removal of all parts of the fish that exhibit any
decomposition, organoleptic reexamination of the remaining fish
flesh, and the performance of a histamine analysis on the remaining
fish flesh.
ii. If no decomposition in any fish in a lot is detected through
organoleptic examination, the following should apply:
A. If the time/temperature log as described in section 3.a.1. of
this Appendix indicates that the conditions on the vessel were
unlikely to cause, or significantly contribute to, the formation of
histamine in the fish, all the fish from that lot may be further
processed or enter commerce.
B. If the time/temperature log as described in section 3.a.1. of
this Appendix indicates that the conditions on the vessel were
likely to cause, or significantly contribute to, the formation of
histamine in the fish in a lot, or if no adequate time/temperature
log is available, a histamine analysis should be made on a
representative sample of fish from that lot.
iii. If decomposition is detected in less than 2.5 percent of
the fish from a lot, the following should apply:
A. If the time/temperature log as described in section 3.a.1. of
this Appendix indicates that the conditions on the vessel were
unlikely to cause, or significantly contribute to, the formation of
histamine in the fish in a particular lot, those fish from that lot
found to have decomposition should be treated in accordance with
section 3.a.2.i. of this Appendix. Other fish from that lot may be
further processed or enter commerce.
B. If the time/temperature log as described in section 3.a.1. of
this Appendix indicates that the conditions on the vessel were
likely to cause, or significantly contribute to, the formation of
histamine in the fish in a particular lot, or if no adequate time/
temperature log is available, the processor should perform a
histamine analysis on a representative sample of organoleptically
acceptable fish from that lot. (However, if the processor elects to
perform a histamine analysis on a representative sample of each lot
of fish from the vessel before conducting an organoleptic analysis
for decomposition because, for example, the processor received the
fish in a frozen state, the histamine analysis does not have to be
repeated based on results of subsequent organoleptic analysis.)
iv. If decomposition is detected in more than 2.5 percent of the
fish from a particular lot, the processor should perform a histamine
analysis on a representative sample of organoleptically acceptable
fish from that lot.
3. Histamine Findings.
i. If any fish from a particular lot is found to have histamine
above a defect action level or other regulatory level or limit for
histamine established by FDA, the fish in that lot may not be used
for food.
ii. If any fish from a particular lot is found to have histamine
below the defect action level or other regulatory level or limit for
histamine established by FDA but above levels expected of fresh
fish, the fish from that lot should enter commerce only if first
immediately cooked to prevent histamine from increasing to
unacceptable levels.
b. Subsequent Processors
1. Processor evaluations. All subsequent processors who take
ownership of fish and fish products of scombroid toxin forming
species and who engage in processing other than, or in addition to,
storage, should subject a representative sample each lot of such
fish and fishery products to organoleptic evaluation for
decomposition to determine whether decomposition occurred during
transfer from the previous processor. Any fish that exhibits
decomposition should be treated in accordance with section 3.a.2.i.
of this Appendix.
2. Decomposition. A finding of any organoleptically detectable
decomposition should result in the organoleptic examination of the
entire lot. If decomposition is detected in more than 2.5 percent of
the fish in the lot, the processor should perform a histamine
analysis on a representative sample of fish from the lot. The
results should be treated in accordance with section 3.a.3. of this
Appendix.
4. Processing Critical Control Point.
Products that are undergoing processing should not be exposed to
ambient temperatures of 40 deg.F (4.4 deg.C) or higher for more
than a cumulative total of 4 hours. Processors should ensure that
this requirement is met by monitoring and recording, at least every
2 hours, the length of time that the product is exposed to
temperatures of 40 deg.F (4.4 deg.C) or higher.
5. Additional Critical Control Points.
The guidelines relating to cooked ready to eat fish and fishery
products specified by Appendix A, sections 6 and 7 should also be
applied to scombroid toxin forming species, where applicable.
Appendix C to Part 123--[Reserved]
Appendix D to Part 123--Product Integrity
1. General guidelines for product integrity.
2. Product integrity critical control points.
1. General Guidelines for Product Integrity
This Appendix provides guidance on how a processor can use an
HACCP-based approach to ensure that all fish and fishery products
are in compliance with the economic adulteration and misbranding
provisions of the Federal Food, Drug, and Cosmetic Act (sections
402(b) and 403, respectively). This guidance applies to controlling
economic factors including the identity of species, weight, count
and size, and the percentage of valuable constituents. These factors
must be accurately represented on the label and labeling of a food.
2. Product Integrity Critical Control Points
Hazard Analysis Critical Control Point (HACCP) plans prepared in
accordance with subpart A of 21 CFR part 123 will typically include
the following critical control points, as appropriate, that can be
used to ensure the economic integrity of the product:
a. Receipt of Raw Material
A processor must ensure that the fish and fishery products that
it receives are correctly identified as to species at the point of
receipt into its processing facility. Methods used for
identification upon receipt may include, but are not limited to:
1. Exams. Physical examination of the seafood species by
qualified personnel;
2. Evaluations. Laboratory evaluation (e.g., protein
chromatography); and
3. Acceptance of species identity as certified by a supplier
under either a Limited or a General and Continuing Guaranty, as
provided for by section 303(c)(2) of the Federal Food, Drug, and
Cosmetic Act (21 CFR 7.12 and 7.13).
b. Labeling-Economic Value
A processor must ensure that the finished product labels,
labeling, and invoices accurately represent the weight, count, and
size of the product, as well as the presence and amount of any
valuable constituents. An example would be the handling of shrimp
and breading material to make breaded shrimp. The processor must
ensure that the shrimp has not been adulterated by the addition of
water, and that the valuable constituents are present at levels that
are consistent with FDA standards of identity (21 CFR part 161) and
compliance policy guides. The processor thus should provide for
monitoring of the level of the valuable constituents throughout
receipt, processing, and distribution to ensure that:
1. Identification. The species is correctly identified by its
common or usual name and is so represented on the label and
labeling. Guidance in selecting the correct common or usual name of
a species is provided by the FDA Fish List. Specific requirements
are given in 21 CFR 101.18 and 21 CFR part 161.
2. Valuable constituents. The valuable constituents of the
product are not omitted or abstracted from the product (e.g.,
breaded shrimp contains the required weight ratio of shrimp to
breading and, if appropriate, shrimp of the size and weight
specified on the label or labeling).
3. Substitution. No substance is substituted wholly or in part
for the valuable constituent (e.g., through added water or glazing,
or substitution of crab flavored surimi for crab meat in a product
labeled as crab cake).
4. Damage or inferiority. Damage or inferiority is not concealed
in any manner (e.g., through bleaching or coloring of product to
conceal its true nature or condition of wholesomeness).
5. Product adulteration. No substance is added to, or mixed
with, the product to increase its bulk or weight or to reduce its
quality, or make it appear of better or greater value than it is
(e.g., through adding water to a product by chemical or other
means).
PART 1240--CONTROL OF COMMUNICABLE DISEASES
2. The authority citation for 21 CFR part 1240 continues to read as
follows.
Authority: Secs. 215, 311, 361, 368 of the Public Health Service
Act (42 U.S.C. 216, 243, 264, 271).
3. Section 1240.3 is amended by revising paragraph (p) to read as
follows:
Sec. 1240.3 General definitions.
* * * * *
(p) Molluscan shellfish. Any edible species of fresh or frozen
oysters, clams, mussels, and scallops or edible portions thereof,
except when the scallop or scallop product consists entirely of the
shucked adductor muscle.
4. Section 1240.60 is amended by revising the section heading; by
designating the existing text as paragraph (a) and adding the word
``molluscan'' before the word ``shellfish'' the two times that it
appears; and by adding new paragraphs (b) and (c) to read as follows:
Sec. 1240.60 Molluscan shellfish.
* * * * *
(b) All unshucked raw molluscan shellfish, that is all unshucked
molluscan shellfish that has not been subject to a treatment sufficient
to kill pathogens of public health significance, shall bear a tag that
discloses the date and place they were harvested, type and quantity of
shellfish, and by whom they were harvested, including the number
assigned to the harvester by the shellfish control authority. Any raw
molluscan shellfish that are found by FDA in interstate commerce
without such a tag or label, or with a tag or label that does not bear
all the required information, will be subject to seizure and
destruction.
(c) Shucked molluscan shellfish shall be subject to the same
requirements as apply to molluscan shellfish that has not been shucked
as provided in paragraph (b) of this section, except that, in lieu of a
tag, the body of the container of shucked molluscan shellfish, shall
bear a label that identifies the name, address, and certification
number of the processor of the molluscan shellfish.
Dated: January 21, 1994.
David A. Kessler,
Commissioner of Food and Drugs.
Donna E. Shalala,
Secretary of Health and Human Services.
Note: The following appendix will not appear in the annual Code
of Federal Regulations.
Appendix 1--FDA Fish Fishery Products Hazard and Controls Guide
Including Guidance on Smoked Fish
FDA is in the process of developing guidance to, among other
things, assist the seafood industry develop and implement HACCP
systems. The guidance will be titled the ``FDA Fish and Fishery
Products Hazard and Controls Guide.'' When a draft of the entire
Guide is completed in the near future, FDA will publish a notice of
availability in the Federal Register and invite public comment. FDA
will revise the draft as warranted and then issue the first edition
of the Guide.
I. The Information Presented
The selected portions of the draft Guide that are provided below
are:
Example 1. The Table of Contents.
Example 2. One page each from the ``Vertebrate'' and
``Invertebrate Hazard and Control Lists.'' Together, these lists
contain about 350 species of commercially marketed fish. Each list
is in the form of a chart that directs the reader to one or more of
the 10 numbered hazard and control descriptions elsewhere in the
Guide for species-related hazards. For purposes of the Guide,
species-related hazards are those that can occur in the environment
or during harvest. Processors should find in the appropriate list
the species they handle, then turn to those numbered hazard and
control descriptions that are relevant to that species.
Example 3. A sample of a species-related hazard and control
description (Species-related Hazard and Control #1 (Chemical
Contamination)). Each description explains a hazard and the measures
available to control it, with an emphasis on HACCP controls such as
critical control points, critical limits, monitoring procedures and
frequencies, recordkeeping, and corrective actions. Some
descriptions contain several control options.
Example 4. One page from the ``Process-related Hazards and
Controls List.'' For purposes of this Guide, process-related hazards
are those that can occur because of the nature of the processing
procedures and the finished product form. This list includes 20
types of finished products (e.g., cooked shrimp) and directs the
reader to one or more of the 22 process-related hazard and control
descriptions, which are located in the next part of the Guide.
The process-related hazard and control descriptions are
numbered. Some of them are further subdivided into lettered
portions. Where the reader need only refer to a portion of a
process-related hazard and control description, the list directs the
reader to that portion by referring to a lettered part of the
description. See below.
Example 5. A sample of a process-related hazard and control
description (``Process-related Hazard and Control #11'' (pathogen
survival during pasteurization)). As with the species-related
descriptions discussed above, each process-related description
explains a hazard and the measures available to control it, with an
emphasis on HACCP controls. Some of these descriptions are
subdivided. For example, ``Process-related Hazard and Control No.
8,'' which is about temperature abuse, is subdivided into ``8a:
Histamine,'' ``8b: Pathogens,'' and ``8c: Decomposition.'' Where the
list in 4. above directs a reader to a number-letter combination,
e.g., ``8b,'' it is to one of the subdivided portions of a
description, in this case to the ``Pathogens'' material in Process-
related Hazards and Controls #8.
Example 6. A consolidated section for smoked and smoke-flavored
fishery products.
Example 7. A model HACCP plan. This is essentially a fill-in-
the-blank model. Processors can use the materials in the hazards and
controls descriptions and this model plan, to develop much if not
all of their HACCP plans, depending on their circumstances.
It must be remembered that these materials reflect a work in
progress and are published to provide the public with a preview of
the document. When the entire document is made available to the
public in the near future, the selected portions published here may
have been revised.
To help processors and other interested persons to understand
the guidance presented in the consolidated section on smoked fishery
products, FDA will explain that guidance in the section that
follows.
II. Smoked Fishery Products
Research conducted since FDA proposed the 1970 final rule shows
that less stringent processing temperatures and lower water-phase
salt content, with or without use of other inhibiting factors such
as sodium nitrite, can provide an adequate margin of safety for hot-
process products held in refrigerated storage (40 deg.F (4.4
deg.C) or lower). FDA has considered this research, and based on it,
the agency is proposing a guidance setting forth what it tentatively
finds are the minimum time, temperature, and salinity requirements
to make a safe and marketable smoked fish product. Proposed TTS
parameters are found in example 6 of this appendix.
A. Raw Materials/Handling of Unprocessed Fish.
The presence of microorganisms, including C. botulinum and L.
monocytogenes, cannot be avoided in fresh-water fish and marine fish
because they are present in the aquatic environment. Under certain
conditions, the potential exists for the outgrowth of C. botulinum
spores and toxin production (Refs. 148 through 152), as well as for
an increase in the L. monocytogenes population (Ref. 143).
To minimize microbial growth, fresh fish should be maintained at
refrigerated temperatures close to 38 deg.F (3.3 deg.C) (Refs. 173
and 175). Although certain strains of C. botulinum are capable of
growth at temperatures as low as 38 deg.F (3.3 deg.C), favorable
growth media are necessary for a significant growth rate to occur at
this temperature. For example, it has been shown that C. botulinum
Type E requires 31 to 35 days before outgrowth and toxin production
occurs in a beef stew media held at 38 deg.F. However, outgrowth
and toxin production in a cooked meat medium held at 41 deg.F does
not occur until after 56 days, demonstrating that less favorable
growth media can significantly lower the rate of growth. Even in
those cases where C. botulinum does grow and produce toxin, the
laboratory conditions are generally more ideally suited to growth
than those found in nonexperimental situations where less favorable
growth environments prevail. Thus, while the growth of C. botulinum
is not completely inhibited at 40 deg.F (4.4 deg.C), under the
less than ideal conditions for its growth that are generally
encountered in the processing of smoked fish, FDA has tentatively
concluded that maintaining fresh fish at a maximum temperature of 40
deg.F, only 2 degrees above the temperature of complete growth
inhibition, before and during processing will provide adequate
protection against C. botulinum outgrowth. Moreover, 40 deg.F (4.4
deg.C) is consistent with the maximum temperature FDA has proposed
in various guidelines, such as the Unicode (now called the Food
Code) (53 FR 16472, May 9, 1988). Therefore, under proposed
Sec. 123.10(a)(14), all raw fish that is to be smoked must be
refrigerated until needed for processing (Ref. 175).
Similarly, fish that are initially frozen need to remain in the
frozen state until needed for processing (Refs. 161 and 25). When
frozen fish are needed for processing, the thawing procedure must be
carried out in a way that minimizes the opportunity for microbial
growth (Refs. 161 and 171). The method used to thaw the fish must
provide an environment that will inhibit the growth of C. botulinum
and other microorganisms that pose a potential health hazard (Refs.
171 and 172). Thus, the fish should be thawed in a way that ensures
that the internal temperature at the core of the fish does not
exceed 40 deg.F (4.4 deg.C) (Refs. 171 and 172). Therefore,
section 4.a. of Example 6 of this appendix, the agency suggests that
this procedure be used in the thawing process.
B. Manufacturing Operations
Reduction of the potential health hazard from C. botulinum spore
outgrowth and toxin production in smoked and smoke-flavored fish
relies on the interrelationship of processing time, processing
temperature, water-phase salt concentration in the loin muscle, and
smoke (or constituents of smoke) deposition, combined with
refrigerated storage (40 deg.F (4.4 deg.C) or lower) (see proposed
Sec. 123.10(a)(14)) (Ref. 173). At one time, smoking and associated
brining may have been an effective preservation method. With the
changes in processing techniques that have occurred since the advent
of refrigeration and in response to consumers' demands for products
with certain organoleptic qualities, however, smoked fish products,
either hot- or cold-process, have become perishable products that
must be refrigerated and cannot be considered preserved foods (Ref.
173). The changes that have occurred, both in processing techniques
and in organoleptic qualities, have resulted in products that are
more moist and contain less salt. As a result, the two critical
processing factors that affect the overall preservation and safety
of the product have been altered. The processing time-temperature
parameters have been decreased, and the water-phase salt content has
been reduced (Ref. 173). Therefore, these products need to be
maintained at refrigerated temperatures (40 deg.F (4.4 deg.C) or
lower) or frozen immediately after processing to ensure the overall
quality of these products (Ref. 173).
1. Brining/dry salting. Salt, as a preservative in smoked and
smoke-flavored fish, is somewhat limited in its effectiveness
because of the variability in salt uptake by fish flesh, even among
fish in the same brining tank. Ventral muscle, which is thin,
absorbs high levels of salt, while the thicker dorsal muscles absorb
less salt, limiting the effectiveness of salt as a deterrent against
spore outgrowth in that part of the fish. Equilibration techniques,
such as two-stage brining, reduce variation in salt content within a
fish and increase the preservative effect (Ref. 176).
It is possible that salt-tolerant microorganisms of public
health concern (such as strains of Staphylococcus) may grow during
brining or after the dry salting process. Therefore, FDA is
providing in section 5.c. and 5.e. in example 6 of this appendix
that the brining and dry salting of fish be carried out at
refrigerated temperatures, i.e., 40 deg.F (4.4 deg.C) or lower.
Doing so will ensure that the environment in which brining is done,
and in which fish are held after dry-salting, will inhibit the
growth of salt-tolerant microorganisms that can cause a potential
health hazard (Ref. 173).
FDA recognizes that when fish are initially added to the brine,
the temperature of the brine may increase. It is essential to this
process that the brine be returned to refrigerated temperatures 40
deg.F (4.4 deg.C) or lower to reduce the opportunity of microbial
growth and to ensure the overall quality of the product during the
brining process (Refs. 175 and 182). Therefore, the agency is
suggesting in section 5.d. of Example 6 of this appendix that the
temperature of the brine not exceed 60 deg.F (16 deg.C) at the
start of brining.
To minimize the variation in salt content of the fish, the
agency is recommending in section 5.f. of Example 6 of this appendix
that only fish of the same species and of similar size and similar
weight be brined in the same tank (Refs. 171 and 199). Because reuse
of brine solutions is a possible route of microbial contamination of
raw fish, the agency is providing in section 5.g. of Example 6 of
this appendix that brines not be reused unless they have been
processed in some way to return them to a microbiological quality
equivalent to the original, unused brine made with potable water and
food-grade salt. The agency is also providing in section 5.h. of
Example 6 of this appendix that a processor may rinse the brined
fish with fresh water to remove any unwanted excess salt on the
exterior of the fish.
2. Drying. Fish that are to be processed as smoked or smoke-
flavored fish are dried after brining to remove excess water and
prevent dripping during smoking. The drying process, usually of
several hours in duration, provides another opportunity for
microbial growth. Therefore, to minimize the opportunity for
microbial growth by reducing those conditions that would provide a
favorable environment for such growth, the agency is providing in
section 5.i. of Example 6 of this appendix that the presmoking
drying step should be conducted in a refrigerated room (Ref. 46).
3. Smoking. Smoke deposition, like water-phase salt content, is
very difficult to control. Constituents of smoke called ``inhibitory
compounds'' (such as phenolic compounds) are reported to have a
bactericidal effect (Ref. 177). Factors that affect the quantity of
inhibitory compounds deposited on the fish surface and the degree of
penetration by those compounds into the fish are the humidity in the
smoking chamber, the temperature of smoking, and the air flow in the
smoking chamber (Ref. 178). Decreased levels of inhibitory compounds
reduce the preservative effect of the smoke and make dependence on
these compounds inadvisable (Ref. 178). In general, smoked products
are not shelf stable and must be either refrigerated at a
temperature of 40 deg.F (4.4 deg.C) or lower or frozen immediately
after processing (Refs. 43, 45, and 178).
To promote uniform deposition of smoke, heat exposure, and
dehydration, and to ensure that on completion of these processes,
the fish do not contain any raw or wet sections that would create an
environment favorable for microbial growth and spoilage, the agency
is providing in section 5.j. of Example 6 of this appendix that fish
should be arranged in the smokehouse chamber or oven so that they
are not overcrowded or touching each other, and that only fish of
like size and weight should be included in a single batch of fish
for smoking.
Liquid smoke, a solution of wood smoke that, when diluted, may
be used to impart a smoke flavor to fish products, is often used as
an alternative to generated smoke. Liquid smoke has been reported to
have similar antibacterial properties to, and some advantages over,
generated smoke (Ref. 26). It is easier to apply uniformly, and the
inhibitory compounds penetrate further into the fish flesh (Ref.
26). Liquid smoke, generated smoke, or a combination of liquid smoke
and generated smoke needs to be applied to all surfaces of fish to
be smoked. Liquid smoke may be applied to the product before, at the
commencement of, or during the process, while generated smoke needs
to be applied to the fish during the first half of the process and
longer if necessary (Refs. 178 and 179). If a combination of liquid
smoke and generated smoke is used, the method for use of liquid
smoke may be followed, and the generated smoke may be applied at any
stage of the process (Ref. 26). The agency is providing for the use
of liquid smoke alone or in combination with generated smoke in
section 3.c.2. of Example 6 of this appendix to impart smoke flavor
and antibacterial properties to the products.
4. Use of sodium nitrite. Use of sodium nitrite in smoked and
smoke-flavored fish products is limited to the species listed in
Sec. 172.175 (21 CFR 172.175) and to chubs in Sec. 172.177 (21 CFR
172.177). Section 172.175 permits the use of sodium nitrite as a
preservative and color fixative in cured, smoked sablefish, salmon,
and shad. However, it requires that the level of sodium nitrite in
the final product not exceed 200 ppm. Use of sodium nitrite
substantially reduces the level of salt necessary to inhibit
outgrowth of C. botulinum type A and type E spores, although the
levels vary because of the difference in heat resistance between the
two types of spores (Ref. 179). The quantity of sodium nitrite
necessary to achieve inhibition is affected by both the level of
contamination and the resistance of the spores (Refs. 179 and 180).
Refrigeration of the finished product at temperatures of 40 deg.F
(4.4 deg.C) or below is necessary to retain the inhibitory
characteristic gained through use of sodium nitrite (Ref. 179).
Therefore, in accordance with the provisions of Secs. 172.175 and
172.177, the agency is proposing to provide for the use of sodium
nitrite in the processing and packaging of smoked and smoke-flavored
fish in section 5.a. and section 5.b. of Example 6 of this appendix.
5. Vacuum- and modified atmosphere-packaging. Vacuum packaging
and other types of modified atmosphere-packaging (those in which the
air in the package or container is replaced by one or more gases, in
various concentrations, before the package is sealed) extend the
shelf life of foods markedly. However, the anaerobic environment
created in these types of packaging favors the outgrowth of C.
botulinum spores and subsequent toxin production, and it inhibits
growth of aerobic microorganisms that might otherwise serve as
organoleptic indicators of spoilage (Refs. 180 and 182).
Consequently, use of vacuum- or modified atmosphere-packaging
demands strict adherence to temperature-controlled storage and
distribution to reduce the opportunity for spore outgrowth and toxin
production and to reduce the potential growth of other
microorganisms of public health significance (such as L.
monocytogenes).
Two methods of reducing the potential public health hazard of
vacuum or modified atmosphere packaged smoked, smoke-flavored, and
salted fish products are: (1) To store and distribute the products
frozen or, alternatively, (2) to use in-package heat processing
followed by refrigeration. At freezer temperatures, outgrowth of
spores of C. botulinum types B, E, and F is retarded (Refs. 171,
173, and 180). Type A does not grow below 50 deg.F (10 deg.C)
(Refs. 179 and 180). Storage and distribution in the frozen state
reduces the possibility that temperature abuse will occur.
In-package heat processing, sometimes referred to as ``heat
pasteurization,'' at temperatures in the range of 185 deg.F (85
deg.C) for 85 minutes to 198 deg.F (92 deg.C) for 55 minutes,
inhibits outgrowth and toxin production by type E spores (Ref. 185).
Longer exposure to processing temperatures is required for more heat
resistant spores, such as types B and A (Ref. 185). In a study
examining this method of packaging, samples of hot-process salmon
steaks were injected with spores of nonproteolytic strains of C.
botulinum types B and E (Ref. 185). The steaks were vacuum packaged,
heat pasteurized, then incubated using different time-temperature
combinations. The results of this research showed that closely
controlled in-package heat processing extends the shelf life of the
product, inactivates nonproteolytic C. botulinum types B, E, and F
and other vegetative pathogens, and maintains product quality
attributes. However, this process is more suitable for pieces,
fillets, and steaks than for whole eviscerated fish because this
process causes the flesh to separate from the backbone (Ref. 185).
C. Specific Processing Conditions
The various processing techniques used to produce smoked and
smoke-flavored fish are affected by the interrelationship of the
smoking, the method of smoke application, the time-temperature
combinations used, and the water-phase salt content. A critical
factor in determining alternative processing methods is the type of
packaging utilized, specifically whether the product is air-packaged
or vacuum-packaged. The following discussion sets out the various
processing procedures that the agency has tentatively concluded will
ensure the safety of hot-process smoked and smoke-flavored fish, and
cold-process smoked and smoke-flavored fish.
1. Hot-process smoked and smoke-flavored fish. a. Air-packaged.
Research data and industry practice show that a lower minimum water-
phase salt content (3.5 percent or lower), in combination with lower
processing temperatures (lower than 180 deg.F (82 deg.C)) than
cited in the 1970 final rule for hot-process products are effective
in inhibiting spore outgrowth and toxin production when the products
are not vacuum-packaged and are held at refrigerated temperatures
(40 deg.F (4.4 deg.C) or lower) (Refs. 24, 163, and 177). Research
studies from the National Marine Fisheries Service and testimony
presented at a public hearing held by the New York State Department
of Agriculture and Markets on May 3, 1989, to establish a CGMP for
the manufacture of smoked and smoke-flavored fish products, show
that C. botulinum type E is inhibited in air-packaged smoked fish
products when the water-phase salt content is at least 3.0 percent,
and the processing internal temperature of the product is maintained
at a minimum of 145 deg.F (63 deg.C) for at least 30 minutes (Ref.
180). In light of these findings, FDA is setting forth these
processing parameters in Example 6 of this appendix to provide
guidance on the safe manufacturing of these products.
The agency is setting forth the following minimum T-T-S
parameters for air-packed, hot-process smoked and smoke-flavored
fish in section 5.a.1. of Example 6 of this appendix: Heating at an
internal temperature of 145 deg.F (63 deg.C) for 30 minutes with a
water-phase salt content of 3.0 percent in the finished product.
b. Vacuum-packaged/modified atmosphere. For vacuum-packaged
products, National Marine Fisheries Service research shows that
processing temperatures in the range of 145 to 175 deg. F (63 to 80
deg.C) for hot-process smoked fish will inhibit C. botulinum type E
when the water-phase salt content is greater than 3.5 percent (Refs.
26, 173, and 180). Based on this evidence, New York's CGMP included
a procedure for processing vacuum-packaged smoked fish that
specifies heating the fish to an internal temperature of 145 deg.F
(63 deg.C) for 30 minutes, with a water-phase salt content of 3.5
percent (Ref. 25).
The use of sodium nitrite in combination with sodium chloride
significantly inhibits the outgrowth and toxin production of C.
botulinum type E. Research data show that when the water-phase salt
content and sodium nitrite content are at least 3.1 percent and 100
ppm, respectively, and the internal temperature of the fish is not
less than 145 deg.F, the inhibitory effect on C. botulinum growth
and toxin production greatly increases (Refs. 173 and 179). At
higher processing temperatures, e.g., 180 deg.F (82 deg.C), a
water-phase salt content of 3.0 percent or more inhibits toxin
formation by C. botulinum type E (Ref. 163).
Based on this information, the agency is setting forth the
following T-T-S parameters for vacuum-packaged hot-process smoked
and smoke-flavored fish in section 5.a.2. of Example 6 of this
appendix: (1) Heating at an internal temperature of at least 145
deg.F (63 deg.C) for 30 minutes with a minimum water-phase salt
content of 3.5 percent in the finished product, or (2) heating at an
internal temperature of at least 145 deg.F (63 deg.C) for 30
minutes, with a minimum water-phase salt content of 3.0 percent, and
a sodium nitrite content of 100 to 200 ppm (as permitted by the food
additive regulations in Sec. 172.175) in the finished product, or
(3) as described in Sec. 172.177 for smoked chub containing sodium
nitrite.
The agency points out that these processing parameters for
vacuum-packaged hot-process smoked and smoke-flavored fish are
minimums. Unless the comments on Example 6 of this appendix convince
the agency otherwise, fish that have been processed at a lower
temperature or with a lower water-phase salt level could provide the
basis for regulatory action on the grounds that the product has been
processed under conditions whereby it may have been reduced
injurious to health and thus could represent a hazard for consumers.
2. Cold-process smoked and smoke-flavored fish. Cold-process
smoked and smoke-flavored fish, by virtue of the temperatures used
in processing, are not cooked because they are processed at
temperatures lower than those that coagulate protein, i.e., 100
deg.F (38 deg.C) or lower. Because these temperatures are not high
enough to inactivate C. botulinum spores, and because they provide a
favorable environment for other food spoilage microorganisms, other
inhibitive factors, such as higher salt content and sodium nitrite
(where permitted by food additive regulations in Sec. 172.175) need
to be used.
The time and temperature relationship in the processing of cold-
smoked and smoke-flavored fish is a critical factor in yielding a
microbiologically safe and high quality finished product (Ref. 182).
Modern establishments that cold-smoked fish generally process
between 40 deg.F (5 deg.C) and 100 deg.F (38 deg.C) for 18 to 24
hours (Refs. 171 and 182). Based on the research data that are
available and the requirements in the New York CGMP, the agency is
proposing the following requirements for air-packaged and vacuum-
packaged/modified atmosphere cold-process smoked and smoke-flavored
fish (Refs. 25, 180, and 184).
a. Air-packaged products. The agency is providing in section
5.a.3. of Example 6 of this appendix that air-packed, cold-process
smoked and smoke-flavored fish should have a minimum water-phase
salt content of: (1) 3.5 percent, or (2) 3.0 percent and contain 100
to 200 ppm of sodium nitrite in the finished product, or (3) 2.5
percent in the finished product if the product is frozen immediately
after processing and cooling and is kept frozen throughout holding
and distribution. The agency is providing that the finished product
that contains a water-phase salt content of 2.5 percent should be
frozen immediately and kept frozen to ensure the microbiological
safety of the product, as well as to maintain the shelf-life of the
finished product.
As stated above, because these products are not cooked and
contain a low water-phase salt content, these products may present a
potential public health hazard because they provide an ideal
environment for the outgrowth of C. botulinum spores and toxin
production. Therefore, based on the discussion above, the agency is
suggesting that air-packaged cold-process smoked and smoke-flavored
fish be processed under one of the following sets of conditions: (1)
A maximum 20-hour drying and smoking period with the temperature in
the smoking chamber not exceeding 90 deg.F (32 deg.C) (section
5.a.3.i. of Example 6 of this appendix), or (2) a maximum 24-hour
drying and smoking period with the temperature in the smoking
chamber not exceeding 50 deg.F (10 deg.C) (section 5.a.3.ii. of
Example 6 of this appendix) except that sablefish needs to be heated
to a temperature not to exceed 120 deg.F (49 deg.C) for a period
not to exceed 6 hours (section 5.a.3.iii. of example 6 of this
appendix) (Refs. 25, 180, and 184).
b. Vacuum-/modified atmosphere-packaged products. FDA is
providing in section 5.a.4. of Example 6 of this appendix that cold-
process smoked and smoke-flavored fish to be vacuum- or modified
atmosphere-packaged should have a minimum water-phase salt content
of: (1) 3.0 percent and contain 100 to 200 ppm of sodium nitrite in
the finished product, or (2) 3.5 percent in the finished product
when no sodium nitrite is used. The agency is also providing that
vacuum-/modified atmosphere-packaged cold-process smoked and smoke-
flavored fish should be processed under one of the following sets of
conditions: (1) A maximum 20-hour drying and smoking period with the
temperature in the smoking chamber not exceeding 90 deg.F (32
deg.C) (section 5.a.3.i. of Example 6 of this appendix), or (2) a
maximum 24-hour drying and smoking period with the temperature in
the smoking chamber not exceeding 50 deg.F (10 deg.C) (section
5.a.3.ii. of Example 6 of this appendix) (Refs. 25, 180, and 184).
The agency again points out that these processing parameters for
vacuum-/modified atmosphere-packaged cold-process smoked and smoke-
flavored fish are minimums. Failure to adhere to these parameters
could provide the basis for regulatory action because the product
that results may be injurious to health and thus could represent a
hazard to consumers.
The agency believes that the proposed processing requirements
for cold-process smoked and smoke-flavored products, air-packed and
vacuum- or modified atmosphere-packaged, will produce a safe and
commercially acceptable product. However, because less data and
information are available for these products than for hot-process
products, the agency is requesting specific comments, data, and
information about these processing parameters and any alternative
processing parameters that should be included in the guideline.
3. Cooling and storage of finished products. Rapid cooling and
storage at temperatures of 40 deg.F (4.4 deg.C) or below are
essential for all smoked, smoke-flavored, and salted fish products
to minimize microbial growth. The exceptions are cold-process air-
packaged products that contain a water-phase salt content of 2.5
percent, which should be frozen immediately after processing and
remain frozen throughout distribution because of the lower water-
phase salt content and lower processing temperatures that may
provide an opportunity for food spoilage microorganisms to flourish
during storage (see section 5.a.3. of Example 6 of this appendix)
and the discussion above).
Outgrowth of C. botulinum spores, types A and proteolytic B, and
toxin production are inhibited at temperatures of 50 deg.F (10
deg.C) and lower. Spore types E and nonproteolytic B are completely
inhibited at temperatures of 38 deg.F (3.3 deg.C) and lower (Refs.
174 and 185 through 188).
At section 6 of Example 6 of the appendix, the agency is
recommending specific time/temperature controls for processing after
smoking. These proposed controls are the same as those proposed for
after cooking in the cooked, ready-to-eat section of this document
(Appendix A, section 6). A full discussion of the controls is
provided in section VII.J.3. of this document.
4. Alternative processing parameters. As this preamble
indicates, FDA has tentatively concluded that the TTS processing
parameters reflected in this appendix are the minimum necessary to
ensure that these products are free from botulinum toxin over their
shelf life. FDA has also tentatively concluded that the T-T-S
parameters, coupled with good sanitation practices, will also render
these products listeria free. Nonetheless, the agency does not wish
to discourage the development and use of alternative procedures that
are capable of achieving the same outcome.
Consequently, section 11 of Example 6 of this appendix calls for
the use of alternative processing parameters when the user can
demonstrate the following: (1) For botulism, zero toxin production
slightly beyond the expected shelf life of the product, demonstrated
through inoculated pack studies under normal and moderate abuse
conditions and (2) for listeria, no detectable L. monocytogenes in
the final product. The data demonstrating these outcomes would have
to be available to FDA to enable the agency to determine whether
they have been achieved.
Example 6 of this appendix states that those data should be part
of a processor's HACCP records. FDA asks for comment on whether a
third-party scientific expert, or processing authority, should be
involved in the development of the data that demonstrate the
effectiveness of the alternative procedure.
5. Use of vacuum- and modified atmosphere-packaging. As
explained above, vacuum- or modified atmosphere-packaged smoked,
smoke-flavored, and salted fish products represent an increased
public health hazard over conventionally packaged products because
these types of packaging provide the ideal environment for spore
outgrowth and toxin production. Based on the discussion above, the
agency states in section 3 of Example 6 of this appendix that these
types of packaging should be used only when: (1) As provided in
section 5.a.2. of Example 6 of this appendix the product is a hot-
process smoked or smoke-flavored product, is vacuum-packed or
modified atmosphere-packed, and contains at least 3.5 percent water-
phase salt in the finished product, or 3.0 percent salt and 100 to
200 ppm of sodium nitrite in the finished product (section 4.a.1. of
Example 6 of this appendix); (2) as provided in section 5.a.4. of
Example 6 of this appendix, the product is a cold-process smoked or
smoke-flavored product, is vacuum-packed or modified atmosphere-
packed, and contains at least 3.5 percent water-phase salt in the
finished product or 3.0 percent salt and 100 to 200 ppm of sodium
nitrite.
The agency is providing in Appendix C, section 8.a. that all
vacuum- or modified atmosphere-packaging should be conducted within
the processing plant where the product is manufactured (Ref. 180).
FDA considers this limitation appropriate to prevent any
postprocessing contamination of the product from bacterial pathogens
and to ensure that the fish will be packaged immediately after
processing to protect its overall quality.
6. Process monitoring. Section 7 of Example 6 of this appendix,
the agency is recommending specifications for temperature indicating
and recording devices where they are recommended elsewhere in this
appendix. These proposed specifications are the same as those
proposed in Appendix A for cooked, ready-to-eat fishery products
(Appendix A, section 7). A full discussion of these controls is
provided in section VII.J.4. of the preamble to this document.
Temperature indicating and recording devices are specifically
recommended in section 5.j. and 5.k. of Example 6 of this appendix
for the control of the smoking temperature.
At section 5.b. of Example 6 of this appendix, the agency is
recommending specific controls to ensure that the appropriate water-
phase salt and sodium nitrate levels are achieved. The significance
of these attributes has already been discussed in this document. In
section 5.b. of Example 6 of this appendix, the agency recommends
that a processor perform or obtain a study that shows that under
certain processing conditions the desired water phase salt or sodium
nitrite level will reliably be achieved. The processor should
monitor those processing conditions identified by the study as
having an impact on the ability of the product to achieve the
desired level. The study should provide critical limits for each of
the relevant processing conditions (e.g. maximum fish size, minimum
soak time, minimum salt to product ratio).
Because of the existence of numerous variables that affect the
ability of fish to uniformly take up salt and sodium nitrite, it may
be appropriate for a processor to perform periodic finished product
water phase salt or sodium nitrite analyses as a verification step.
The purpose of such analyses would be to identify any variables that
have an impact on salt or nitrite absorption that were not
identified by the study.
7. Corrective actions. At section 9 of Example 6 of this
appendix, the agency is recommending corrective action procedures.
These proposed procedures are the same as those proposed in the
cooked, ready-to-eat section of this document (Appendix A, section
8). A full discussion of the procedures is provided in section
VII.J.5 of the preamble to this document.
8. Sanitary zones. At section 10 of Example 6 of this appendix,
the agency is recommending the institution of sanitary zones. This
proposed control procedure is the same as that proposed in the
cooked, ready-to-eat section of this document (Appendix A, section
9). A full discussion of the control procedure is provided in
section VII.J.6 of the preamble to this document.
To further ensure the safety of the product during distribution
and storage, FDA is considering adopting specific package labeling
requirements for smoked and smoke-flavored fish products to reduce
the opportunity of temperature abuse of the finished product. The
agency requests comments on whether it should require that the label
of all shipping containers and retail packages state that the
product is perishable, and, more specifically, that the product must
be kept refrigerated. FDA tentatively finds that such labeling is
extremely important to ensuring the safe handling of these products,
and, therefore, it considers it likely that it will require this
labeling in the final rule. The agency requests comment on whether
it should do so. The agency also requests comment on whether, if it
decides to require such a label statement, the statement should
specify a temperature at which the product should be refrigerated
(e.g. 40 deg.F (4.4 deg.C) or below). The agency is also
considering requiring that the label of all frozen smoked products
state that the product must remain frozen, that if the product needs
to be thawed, it must be thawed at refrigerated temperatures, and
that the product must not be refrozen.
FDA has authority to adopt these labeling requirements under
sections 201(n), 403(a), and 701(a) of the act because these
sections require the inclusion of facts on the food label that are
material with respect to consequences that may result from use of
the product under conditions of use prescribed in the label or that
are otherwise customary or usual. The agency requests comments on
whether it is necessary to do so.
EXAMPLE 1.--FDA Fish And Fishery Products Hazards And Controls Guide
Table of Contents
Section I:
Status
Purpose
HACCP
This Guide and How to Use It
Section II:
Table 1--Vertebrate Hazard and Control List
Table 2--Invertebrate Hazard and Control List
Species Related Hazards and Controls Nos. 1-10
No. 1 (Safety)--Chemical contamination other than methyl mercury
No. 2 (Safety)--Methyl mercury
No. 3 (Safety)--Natural toxins
3a Paralytic shellfish poisoning (PSP)
3b Neurotoxic shellfish poisoning (NSP)
3c Diarrheic shellfish poisoning (DSP)
3d Amnesic shellfish poisoning (ASP)
3e Ciguatera food poisoning (CFP)
3f Clupeotoxin
3g Chondrichthytoxin
3h Tetrodotoxin
3i Gempylotoxin
No. 4 (Nonsafety)--Filth, extraneous materials or noxious
substances
No. 5 (Nonsafety)--Decomposition
No. 6 (Safety)--Histamine
No. 7 (Safety)--Food and color additives
No. 8 (Nonsafety/safety): Parasites
No. 9 (Safety)--Animal drugs
No. 10 (Safety)--Pathogenic Microorganisms
Section III:
Table 3--Process Related Hazards and Controls List
Process Related Hazards and Controls Nos. 1-22
No. 1 (Nonsafety)--Filth in dry ingredients
No. 2 (Nonsafety)--Processing of dead crustaceans and mollusks
No. 3 (Nonsafety)--Temperature abuse during raw material storage
No. 4 (Safety)--Excessive water activity
No. 5 (Safety)--Inadequate salt, sugar, and/or nitrite
concentration
No. 6 (Safety)--Pathogen survival during cook
No. 7 (Safety)--Cross-contamination
No. 8 (Safety/nonsafety)--Temperature abuse during processing of
cooked products and raw molluscan shellfish
No. 9 (Safety/nonsafety)--Temperature abuse during processing of
noncooked products
No. 10 (Safety)--Microbiological growth in batter
No. 11 (Safety)--Pathogen survival during pasteurization
No. 12 (Safety): Recontamination after pasteurization
No. 13 (Safety/nonsafety)--Temperature abuse during final
cooling
No. 14 (Safety/nonsafety)--Temperature abuse during finished
product storage
No. 15 (Safety/Nonsafety)--Temperature abuse during finished
product distribution
No. 16 (Safety)--Metal inclusion
No. 17 (Safety)--Food and color additives
No. 18 (Nonsafety)--Short weight
No. 19 (Nonsafety)--Species substitution
No. 20 (Nonsafety)--Grade size misrepresentation
No. 21 (Nonsafety)--Incorrect proportions
No. 22 (Nonsafety)--Over breading
Section IV:
Finished Product Standards for Use in Verification
Section V:
Smoked and Smoke-Flavored Fishery Products
Cooked, Ready-to-Eat Fishery Products
Scombroid Toxin Forming Species
Section VI:
Model HACCP Plan
Example 2.--Section II
[Table 1--Vertebrate Hazard and Control List]
------------------------------------------------------------------------
Safety Non safety
Market names Scientific names hazards hazards\1\
------------------------------------------------------------------------
Aholehole................ Kuhlia spp. ....... 4, 5
Alewife/river herring.... Alosa spp. 1 4, 5, 8
Alfonsino/red bream...... Beryx spp. ....... 4, 5
Trachichthodes spp. ....... 4, 5
Amberjacks/yellowtail.... Seriola spp. 3e, 6 4, 5, 8
Anchovy/anchoveta........ Anchova spp. 1, 3f, 4, 5
Anchoviella spp. 6 4, 5
Cetengraulis spp. 1, 6 4, 5
Engraulis spp. 1, 6 4, 5
Stolephorus spp. 1, 6 4, 5
Aquaculture species...... Aquatic species, 1, 7, 4, 5, 8
(Including 8, 9
invertebrates, fishes,
amphibians and
reptiles)
Angelfish................ Holacanthus spp. 3e 4, 5
Pomacanthus spp. ....... 4, 5
Argentine/queenfish...... Argentina elongata ....... 4, 5
Barracouta............... Thrysites atun ....... 4, 5
Barracuda................ Sphyraena spp. 3e 4, 5
Bass..................... Ambloplites spp. 1, 9 4, 5, 8
Micropterus spp. 1, 9 4, 5, 8
Morone spp. 1, 9 4, 5, 8
Stereolepis gigas 1, 9 4, 5, 8
Synagrops bellus 1, 9 4, 5, 8
Bass, sea................ Acanthistius 8 4, 5, 8
Brasilianus ....... 4, 5, 8
Centropristis spp. ....... 4, 5, 8
Dicentrachus labrax ....... 4, 5, 8
Lateolabrax ....... 4, 5, 8
Japonicus ....... 4, 5, 8
Paralabrax spp. ....... 4, 5, 8
Pranthias furcifer ....... ..........
Polyprion spp. ....... ..........
------------------------------------------------------------------------
\1\See Table of Contents for key to hazards.
Reminder: See process hazard tables beginning on p. 70 for hazards that
apply to your product.
TABLE 2.--Invertebrate Hazard and Control List
----------------------------------------------------------------------------------------------------------------
Market names Scientific names Safety hazards\1\ Non safety hazards\1\
----------------------------------------------------------------------------------------------------------------
Abalone...................... Haliotis spp................. 1, 3a, 3b, 3c, 3d....... 4, 5
Aquacultured invertebrates... All species (Coelenterates, 1, 3a, 3b, 3c, 3d, 7, 9, 4, 5, 8
Molluscs, Crustacea, and 10.
Echinoderms).
Arkshell..................... Anadara subcrenata Arca spp.. 1, 3a, 3b, 3c, 3d, 10... 4, 5
Clam, Carpet Shell........... Tapes spp.................... 1, 3a, 3b, 3c, 3d, 10... 4, 5
Clam, Bentnose............... Macoma nasuta,............... 1, 3a, 3b, 3c, 3d, 10... 4, 5
Clam, Butter................. Saxidomus spp................ 1, 3a, 3b, 3c, 3d, 10... 4, 5
Clam, Calico................. Macrocallista maculata....... 1, 3a, 3b, 3c, 3d, 10... 4, 5
Clam, Clovis................. Tapes virginea............... 1, 3a, 3b, 3c, 3d, 10... 4, 5
Clam, Geoduck................ Panopea spp.................. 1, 3a, 3b, 3c, 3d, 10... 4, 5
Clam, Hard................... Arctica islandica, 3a, 3b, 3c, 3d, 10...... 4, 5
Meretricinae spp. Venus
mortoni.
Clam, Hardshell/Quahog....... Protothaca thaca............. 1, 3a, 3b, 3c, 3d, 10... 4, 5
Clam, Littleneck............. Protothaca staminea 1, 3a, 3b, 3c, 3d, 10... 4, 5
Protothaca tenerrima, Tapes
philippinarum.
Clam, Manila................. Tapes semidecussata.......... 1, 3a, 3b, 3c, 3d, 10... 4, 5
Clam, Pismo.................. Tivela stultorum............. 1, 3a, 3b, 3c, 3d, 10... 4, 5
----------------------------------------------------------------------------------------------------------------
\1\See Table of Contents for key to hazards.
Reminder: See process hazard tables beginning on p. 70 for hazards that apply to your product.
Example 3
Species-Related Hazards and Controls No. 1
Hazard No. 1 (Safety)--Chemical Contamination Other Than Methyl Mercury
Contamination of Raw Material at Receipt with Pesticides,
Radioactivity, Toxic Elements, and Industrial Chemicals, Derived
From the Harvest Area.
Hazard Statement
Fish and molluscan shellfish may be harvested from waters that
are exposed to varying amounts of environmental contaminants.
Industrial chemicals, pesticides, and many toxic elements may
accumulate in fish at levels that can cause public health problems.
Concern for these contaminants primarily focuses on fish and
shellfish harvested from fresh water, estuaries, and near-coastal
waters rather than from the open ocean. Pesticides and herbicides
used near aquaculture operations or for other purposes may
contaminate fish and fishery products.
Federal tolerances or action levels are established for some of
the most toxic and persistent contaminants that are found in fish
and fishery products shipped in interstate commerce. (These
contaminants and their corresponding limits are listed below.) When
products exceed these limits, FDA can seize the contaminated fish
and fishery products.
States often use the limits for deciding whether to issue
consumption advisories or to close or classify waters for
harvesting. Molluscan shellfish waters are controlled by the State
Shellfish Control Agency (SSCA) or the equivalent in foreign
countries that have Memoranda of Understanding with the United
States that permit them to export molluscan shellfish to this
country. If local or regional contaminants are not covered by
federal limits, contact local health departments to decide if
contaminant levels in fish and fishery products are of public health
concern.
The control measures provided in this section are appropriate
for the control of methyl mercury contamination in fish, where such
contamination is the result of industrial contamination in a harvest
area. Recommended controls for the problem of open ocean species,
such as swordfish and shark, concentrating methyl mercury from their
diet and its diffuse presence in the environment are provided in the
``Mercury'' hazard section.
Critical Control Point: Receiving
There are five options for control at this critical control
point.
Option 1
Where the firm receives wild caught fish, other than molluscan
shellfish, directly from the fisher or from a supplier that has
credible knowledge of the harvest area location (e.g., a tender or
related company that pools fish from various fishers), the following
applies:
Control Measures
1. Find out the harvest area location for each lot or batch from
the fisher upon receipt.
2. Find out whether the harvest area is closed to fishing by
foreign, Federal, State or local health authorities due to known
instances of chemical contamination.
3. Reject fish that have been caught in a closed area.
Example
ABC Fish Co. has contacted the State Department of Health and
learned that the Long River is closed to commercial harvest above
Lookout Point, including its tributaries, due to the presence of
chlordecone (KeponeTM). The species affected are croaker,
bluefish, and striped bass. ABC Fish Co., which processes these
species, will reject any of the listed species originating from the
area.
Frequency
1. For finding out the location: each lot or batch.
2. For finding out whether the harvest area is closed: before
accepting fish from a new area and after that at least quarterly.
3. For rejecting fish: each lot or batch that does not meet the
critical limit.
Critical Limits
Zero tolerance for fish (i.e., accept no fish) harvested from
areas closed by foreign, State, or local health authorities due to
chemical contamination.
Records
A record for each lot or batch that shows the harvest area for
the fish. Record may be the receipt from the fisher, if it shows the
harvest area, or it may be a notation on another record of the
location of harvest for each lot or batch. The description of the
location should be clear enough to show that the fish were harvested
from an area that is open to harvesting. Longitude and latitude may
be necessary (e.g., for open ocean harvesting).
Corrective Actions
Destroy or recall product that fails to meet the critical limit.
Any critical limit deviation should cause a timely assessment by
management to: Decide whether the process or HACCP plan needs
changing to reduce the risk of recurrence of the deviation, and to
take appropriate followup action.
Option 2
Where the firm receives raw fish, other than molluscan
shellfish, directly from the aquacultural or maricultural producer
or from a supplier that has credible knowledge of the harvest area
location (e.g., a tender or related company that pools fish from
various aquaculturists), the following applies:
Control Measures
1. Find out the harvest area location for each lot or batch of
aquacultured fish.
2. Find out the potential for chemical contamination before
receipt of the product. This can be done by obtaining or reviewing
the results of analysis of soil, water, and raw fish samples, as
needed. Monitor agricultural and industrial practices in the
aquacultural or maricultural production area.
3. Reject fish that have been grown in an area where uses of
agricultural or industrial chemicals are likely to have caused
contamination of the growing and harvesting environment or where
soil, water, or fish sample results show chemical contamination.
Example
ABC Fish Co., which receives pond-raised catfish from the Long
River delta area, screens potential pond sites either directly or by
obtaining results of the aquaculturists' analyses of soil and water
samples.
The samples are analyzed for pesticides, PCB's, dioxins, and
petrochemicals. Either ABC Fish Co. representatives visit each pond
to assess the potential for ongoing chemical contamination, or
information is obtained from the U.S. Department of Agriculture
Extension Service about the use of pesticides and herbicides near
each pond. Where there is a potential for pond contamination, annual
samples are collected and analyzed for the same contaminants. Fish
that come from contaminated or suspect ponds are rejected.
Frequency
1. For finding out the location: each lot or batch.
2. For learning the potential for contamination: before
accepting fish from a new growing area, and annually, after that if
there is a potential for ongoing contamination of the growing area.
3. For rejecting fish: each lot or batch that does not meet the
critical limit.
Critical Limits
Zero tolerance for fish (i.e., accept no fish) produced in an
area where uses of agricultural or industrial chemicals are likely
to have caused contamination of the growing and harvesting
environment.
Records
Record that shows the production area for each lot of raw
material. Records describing the assessed risk of chemical
contamination for all producers.
Corrective Actions
Destroy or recall product that fails to meet the critical limit.
Any critical limit deviation should cause a timely assessment by
management to: Learn whether the process or HACCP plan needs
modification to reduce the risk of recurrence of the deviation, and
take appropriate followup action.
Option 3
Where the firm receives fish, other than molluscan shellfish,
from someone other than the fisher, aquacultural producer, or a
supplier that has credible knowledge of the harvest area location
(e.g., a transportation company that pools fish from various fishers
or aquaculturists), the following applies:
Control Measures
1. Periodically monitor the incoming fish for environmentally
persistent organochlorine pesticides which have the potential to be
present in the fish. These should include, but are not limited to:
DDT and its degradation products (DDE, TDE), chlordane, and
heptachlor, also similar chlorinated industrial chemicals, such as
PCB's and dioxins. Sampling should represent all suppliers (i.e.,
three samples per supplier per year).
2. Reject all shipments from suppliers that provide fish that
exceed the critical limits unless convincing evidence can be
obtained that only acceptable harvest or growing areas are now being
used.
Example
ABC Fish Co. receives brown shrimp from an interstate seafood
transportation company. The carrier, which buys the shrimp directly
from the fishers, makes no effort to learn the harvest location. ABC
Fish Co. collects three samples per supplier per year and sends them
to a contract laboratory for pesticide screening. When positive test
results are obtained, the firm stops using that supplier.
Frequency
1. For sampling incoming fish: three times per supplier per
year.
2. For rejecting fish: each lot or batch that does not meet the
critical limit.
Critical Limits
All limits are for the edible portion of the fish product, and
are based on wet weight:
Aldrin plus dieldrin, chlordane, endrin, heptachlor
plus heptachlor epoxide, and chlordecone (KeponeTM): 0.3 ppm in
edible portion (except chlordecone in crabmeat 0.4 parts per
million(ppm)) (CPG 7141.01);
DDT plus TDE plus DDE: 5 ppm (CPG 7141.01);
Mirex: 0.1 ppm (CPG 7141.01);
Toxaphene: 5.0 ppm in edible portion (CPG 7141.01);
PCB's: 2 ppm [CPG 7108.19 and CFR 109. 30 (A)];
Methyl mercury: 1 ppm (CPG 7108.07).
Records
Records of analytical results from the firm's own laboratory or
contract laboratory(s).
Corrective Actions
Destroy or recall product that fails to meet the critical limit.
Any critical limit deviation should cause a timely assessment by
management to: Learn whether the process or HACCP plan needs
changing to reduce the risk of recurrence of the deviation, and take
appropriate followup action.
Option 4
Where the firm receives inshell molluscan shellfish, the
following applies:
Control Measures
1. Find out the harvest area location from the harvester's tag
on the containers of shellfish for each lot or batch of shellfish.
2. Check the harvester's state commercial fishing license or
compare the dealer's certification number to those listed in the
most current edition of the ``Interstate Certified Shellfish
Shippers List (ICSSL).'' If the dealer is not listed, check for
certification with the SSCA or equivalent.
3. Find out whether the harvest area is closed (i.e. classified
as prohibited) to fishing by a SSCA or equivalent due to chemical
contamination.
4. Reject molluscan shellfish harvested from a closed (i.e.,
classified as prohibited) area, or delivered by an unlicensed
harvester or uncertified dealer, or those not properly tagged.
Example
The ABC Fish Co. distributes clams, muscles, and oysters to
restaurants. The shellfish are received from other processors. The
firm examines the labels of the containers in each lot to learn the
name, address, and certification number of the last processor. This
information is compared to the ICSSL to confirm that the product is
from a certified processor. Containers from uncertified processors
and inadequately labeled containers are rejected. Contact the State
Department of Health to confirm certification for unlisted
processors.
Frequency
1. For finding out the location: each lot or batch.
2. For checking licenses and certification: each lot or batch.
3. For finding out whether the harvest area is closed: before
accepting shellfish from a new area and as often after that as
necessary to ensure accuracy.
4. For rejecting molluscan shellfish: each lot or batch that
does not meet the critical limit.
Critical Limits
Zero tolerance for molluscan shellfish (i.e., accept no
molluscan shellfish) harvested from areas closed (i.e. classified as
prohibited) by a SSCA or equivalent due to chemical contamination.
Zero tolerance for molluscan shellfish (i.e., accept no
molluscan shellfish) delivered by a harvester that is unlicensed or
a processor that is not certified by a SSCA or equivalent.
Zero tolerance for molluscan shellfish (i.e., accept no
molluscan shellfish) that do not bear a tag on each container that
contains the following information, at a minimum: harvester's name,
address, the harvester number assigned by the SSCA or equivalent;
date of harvest; location of harvest by state and site; type and
quantity of shellfish. Bulk shipments should be identified by a
bill-of-lading that contains the same information.
Records
A record for each lot or batch that shows the information from
the harvester tag or bill of lading, including: name of harvester,
address, identification number, the date of harvest, location of
harvest by state and site, quantity and type of shellfish.
Corrective Actions
Destroy or recall product which fails to meet the critical
limit.
Any critical limit deviation should cause a timely assessment by
management to: learn whether the process or HACCP plan needs
changing to reduce the risk of recurrence of the deviation, and take
appropriate followup action.
Option 5
Where the firm receives shucked molluscan shellfish, the
following applies:
Control Measures
1. Find out the name, address, and certification number of the
last processor from the containers of shucked molluscan shellfish in
each lot or batch.
2. Compare the dealer's certification number to those listed in
the most current edition of the ``Interstate Certified Shellfish
Shippers List'' (ICSSL), which is published monthly. If the dealer
is not listed, check for certification with the SSCA or equivalent.
3. Reject molluscan shellfish not from a dealer certified by a
SSCA or equivalent, packed in containers not bearing the name,
address, and certification number of the last processor.
Example
ABC Fish Co. receives shucked oysters from other processors. The
firm examines the labels of the containers in each lot to learn the
name, address, and certification number of the last processor. This
information is compared to the current ICSSL to confirm that the
product is from a certified processor. Containers from uncertified
processors and inadequately labeled containers are rejected. The
firm contacts the State Department of Health to confirm
certification for unlisted processors.
Frequency
1. For finding the certification number: each lot or batch.
2. For finding out if the processor is certified: each lot or
batch.
3. For rejecting uncertified molluscan shellfish: each batch
that does not meet the critical limit.
Critical Limits
Zero tolerance for molluscan shellfish (i.e., accept no
molluscan shellfish) from an uncertified processor.
Zero tolerance for molluscan shellfish (i.e., accept no
molluscan shellfish) packed in containers that do not list the name,
address, and certification number of the last processor.
Records
Record for each lot or batch that shows the date of receipt,
type and quantity of shellfish, and name and certification number of
the last processor.
Corrective Actions
Destroy or recall product that does not meet the critical limit.
Any critical limit deviation should cause a timely assessment by
management to: Learn whether the process or HACCP plan needs
changing to reduce the risk of recurrence of the deviation, and take
appropriate followup action.
Example 4
Section III
Table 3.--Process-Related Hazards and Controls List Products
----------------------------------------------------------------------------------------------------------------
Finished product Safety hazards Nonsafety hazards
----------------------------------------------------------------------------------------------------------------
Cooked crustacean meat, cooked crustacean 3b\1\, 6\2\, 7, 8b, 13b, 14b, 15b 2\4\, 3c\1\, 8c, 13c, 14c,
sections, whole crustaceans (except shrimp). 16\3\, 17. 15c, 18, 19
Cooked shrimp................................ 6, 7, 8b, 13b, 14b, 15b, 16\3\, 3c, 8c, 13c, 14c, 15c, 18, 20
17.
Surimi-based analog products................. 6, 7, 8b, 13b, 14b, 15b, 16, 17.. 1, 8c, 13c, 14c, 15c, 18, 21
Pasteurized crustacean meat and pasteurized
surimi-based analog products (in addition to
hazards identified above).
11, 12........................... ..............................
Coldsmoked fish (including spreads and dips). 3a\5\b, 5, 7, 9a\5\b, 13a\5\b, 3c, 9c, 13c, 14c, 15c, 18, 19
14a\5\b, 15a\5\b, 16\3\, 17.
Hotsmoked fish (including spreads, dips, 3a\5\, 5, 6, 7, 8a\5\b, 13a\5\b, 3c, 8c, 13c, 14c, 15c, 18, 19
sausages, and jerkies). 14a\5\b, 15a\5\b, 16\3\, 17.
----------------------------------------------------------------------------------------------------------------
\1\This hazard applies only if a cooked raw material or molluscan shellfish is used.
\2\This hazard does not apply to blue crab (Callinectes sapidus), dungeness crab (Cancer magister), or king crab
(Paralithodes spp.) and golden crab (Lithodes aequispina).
\3\This hazard applies only to those products that are mechanically produced.
\4\This hazard applies only to live raw material.
\5\This hazard applies only for scombriod-type species. See Vertebrate Hazard List (Hazard 6-Histamine).
Example 5
Process-Related Hazard and Control No. 11
Hazard No. 11 (Safety)--Pathogen Survival During Pasteurization
Hazard Statement
Survival of Clostridium botulinum (C. botulinum type E) or other
microorganisms of public health concern, through the pasteurization
process is a food safety hazard for cooked, ready-to-eat products
packed in hermetically sealed containers and held refrigerated.
Pasteurization is a process applied to a fish or fishery product
after that fish or fishery product has been placed in a final,
hermetically sealed package. The process involves the application of
sufficient heat (or other processes) for a sufficient time to cause
the reduction of microorganisms of public health concern to levels
that, under normal conditions of storage, are unlikely to cause
disease. C. botulinum type E is a pathogenic microorganism that may
be found in fish and fishery products.
Botulism is a severe type of food poisoning caused by the
ingestion of foods containing the potent neurotoxin formed during
the growth of C. botulinum. C. botulinum type E can grow and produce
toxin at temperatures as low as 3.3 deg.C (38 deg.F), and must,
therefore, be eliminated from the hermetically sealed container
during the pasteurization process. Pasteurized products that are
stored, distributed, and displayed in the frozen state, and are so
labeled, are not similarly at risk, and need not be subjected to the
constraints of these control measures.
For there to be assurance that the pasteurization step
effectively eliminates the microorganisms of public health
significance (e.g., C. botulinum type E), a minimum acceptable
process should be scientifically established. This requires expert
knowledge of thermal process calculations. Procedures used in
establishing the minimum thermal process should be those that are
generally recognized and accepted. Sometimes, thermal death time,
heat penetration, and inoculated pack studies will be necessary to
establish the minimum process. In other instances, existing
literature is sufficient to provide the processor with a minimum
process.
In either case, characteristics of the process and/or the
product will necessarily affect the ability of the cook step to
effectively eliminate the microorganisms of public health
significance. Such factors should be considered in the establishment
of the process. Where control of those factors is necessary to
consistently achieve that goal, the process authority should specify
these to the processor.
It is necessary that the pasteurizing equipment be designed and
operated so that every unit of product receives the established
minimum process. This will require that a competent process
authority, who is thoroughly familiar with the dynamics of heat
transfer in processing equipment, evaluate the design and operation
of the type of equipment used by the processor. Sometimes
temperature distribution studies will be necessary to establish the
adequacy of the equipment. In other instances existing literature
will be sufficient to establish the adequacy of the equipment.
Critical Control Point: Pasteurization Control Measures
1. Make sure that the pasteurization process that is being used
was designed to ensure an appropriate reduction in the numbers of
viable microorganisms of public health concern. The adequacy of the
pasteurization process should be established by a process authority.
The pasteurization process that is being used should meet any
factors of the process or of the product that are identified by the
process authority as critical to achieving pathogen destruction. At
a minimum, these critical factors should include pasteurizing times
and temperatures.
2. Make sure that the pasteurization equipment being used is
properly designed and operated to deliver the process established by
the process authority. The engineering specifications of the
equipment being used (e.g., pipe sizes, flow rates, loading pattern)
should meet or exceed that of the equipment evaluated by a process
authority.
3. Deliver the pasteurization process in a way that there is no
deviation from the minimum established pasteurization critical
factors.
4. Monitor the pasteurization temperature with a temperature
recording device (i.e., temperature recorder). The temperature
recorder should be installed where it can be easily read and the
sensor for the device should be installed to ensure that it
accurately measures the coldest temperature of the pasteurizing
equipment. The temperature recorder must show a continuous record of
the process. Computerized storage of temperature data may be used
for a temperature recorder chart if the use of such a system has
been validated and can be shown to be equivalent to the use of a
temperature recorder.
5. Check the accuracy of each temperature recorder at the
beginning and end of each production day and adjust it as necessary
to agree as nearly as possible with a temperature indicating device
(mercury-in-glass thermometer or equivalent device). The thermometer
should be installed where it can be easily read and placed to ensure
that it accurately measures the coldest temperature of the
pasteurizing equipment.
6. Calibrate the thermometer at the pasteurizing temperature
against an accurate standard thermometer. This should be done when
the thermometer is installed and at least once a year after that, or
more frequently, if necessary, to ensure its accuracy.
7. Monitor the length of the pasteurization cycle.
8. Monitor other critical factors (e.g., initial temperature,
container size, product formulation) at the start of each shift or
when the product changes during a shift.
Example
The ABC Crab Co. produces pasteurized crabmeat. The
pasteurization process being used has been established by the
university extension service (a process authority). The process
provided by the extension service includes limits on how to stack
the canned product into the pasteurizer, the process temperature,
and the length of time needed to achieve proper pasteurization.
The pasteurization equipment being used by ABC Crab Co. is at
least equivalent to that described by the information received from
the extension service. It is equipped with both a mercury-in-glass
thermometer and a recording thermometer. The recording thermometer
is compared to the mercury-in-glass thermometer during each
pasteurization cycle. It is adjusted as necessary to meet the
critical limit. The mercury-in-glass thermometer is calibrated at an
independent laboratory every 6 months. The temperature of each
pasteurization cycle is controlled to meet the critical limits using
the mercury-in-glass thermometer and the length of each cycle is
controlled using a wall clock. The loading of the cans is checked
before starting each batch.
Frequency
1. For making sure that the pasteurization process was properly
established: before using a pasteurization process.
2. For making sure that the pasteurizing equipment is properly
designed: before using pasteurizing equipment.
3. For properly delivering the process: each lot or batch.
4. For monitoring the temperature: each lot or batch.
5. For checking the accuracy of the temperature recorder: at the
beginning and end of each production day.
6. For calibrating the thermometer: at installation and at least
annually after that.
7. For monitoring the length of the pasteurizing cycle: each lot
or batch.
8. For monitoring other critical factors: as often as necessary
to achieve control.
Critical Limits
Zero tolerance for product produced with a deviation from the
minimum established pasteurization process, including such critical
factors as time, temperature, initial temperature, container size,
and product formulation.
The temperature-indicating device should agree within 1 deg.C
(2 deg.F) of the National Institute of Standards and
Technology (NIST) traceable thermometer.
The temperature recording device should be adjusted to agree as
nearly as possible, but never to be higher, than the temperature
indicating device.
Records
A record that describes the results of a scientific evaluation,
conducted by a process authority, of the adequacy of the
pasteurizing process. Such document may consist of, but is not
limited to, a letter from a process authority, articles in
scientific journals, or Federal, State, or local government
regulations or advisories.
A record that describes the results of a scientific evaluation,
conducted by a process authority, which applies to the design and
operation of the type of equipment used by the processor.
A record for each lot or batch that shows the results of the
pasteurization process. The records should include: the time of day
that the pasteurization temperature is achieved; the time of day
that the pasteurization cycle ends; the time of day that the product
is placed in the water; and, as appropriate, the product size, belt
speed (continuous pasteurizer), the temperature at the time that the
processing starts, and any other factors of the process or of the
product that are identified by the process authority as being
critical to achieving pathogen reduction.
Temperature recorder charts or computerized temperature data
storage. A record of calibration for thermometers that specify the
date, standard against which the thermometers were compared (NIST-
traceable thermometer), procedure used, results, and person
performing the test.
A record of accuracy checks for the temperature recorder that
specifies the time, date, temperatures shown by the thermometer and
temperature recorder before adjustment, the corrective action taken,
and person performing the accuracy check.
Records of process evaluation by the process authority, where
deviations from critical limits occurred.
Corrective Actions
When there has been a failure to maintain appropriate
temperature, time, or other critical factors of the process or of
the product, within the critical limits, the affected product should
be:
destroyed;
reprocessed to eliminate the hazard, keeping full
records of the processing conditions; or,
segregated and held until an evaluation can be made to
determine the effect of a deviation. The evaluation should be made
by a process authority following recognized procedures. Unless the
evaluation shows that the product has received adequate
pasteurization, the product should be destroyed or reprocessed to
eliminate the hazard.
Indicating or recording thermometers that cannot be adjusted to
within the critical limits should be repaired or replaced. A
thermometer that has a divided fluid column should be immediately
repaired or replaced.
Any critical limit deviation should cause a timely assessment by
management to: Learn whether the process or HACCP plan needs
changing to reduce the risk of recurrence of the deviation, and take
appropriate followup action.
Example 6
General Guidance for Smoked and Smoke-Flavored Fishery Products
1. General guidance for smoked and smoke-flavored fishery
products
2. Definitions
3. Critical control points
4. Thawing
5. Brining and smoking
6. Post-smoking
7. Temperature monitoring equipment
8. Packaging
9. Corrective actions
10. Sanitary zones
11. Alternative parameters
1. General guidance for smoked and smoke-flavored fishery products
This section provides consolidated guidance on how to meet the
requirements of subpart A of 21 CFR part 123, for the processing of
smoked and smoke-flavored fishery products. This guidance involves
processing procedures for the control of the microbiological hazards
to which these products are particularly susceptible. The guidance
does not apply to finnan haddie, smoked cod fillets, smoked scotch
kippers, or other smoked fish that are cooked before being consumed,
because these products will be heated to destroy any potential
toxins or pathogens. The guidance also does not apply to smoked
fishery products that are packaged in hermetically sealed
containers, processed to destroy spores of nonproteolytic C.
botulinum types B, E, and F, and stored and distributed
refrigerated, in the same container. These products are covered by
Appendix A relating to Cooked, Ready-to-Eat fishery products. In
addition, the guidance does not cover environmental or other hazards
that might occur before the processor takes possession of its
product or raw materials. (Guidance on these hazards may be found in
a separate guidance document for all fish and fishery products
issued by FDA.)
2. Definitions
a. Cold-process smoked or cold-process smoked-flavored fish
means the finished food prepared by subjecting forms of smoked fish
and smoke-flavored fish to heat for a period of time that does not
coagulate the protein.
b. Hot-process smoked or hot-process smoke-flavored fish means
the finished food prepared by subjecting forms of smoked fish and
smoke-flavored fish to sufficient heat for a sufficient period of
time to coagulate protein throughout the fish.
c. Liquid smoke means an aqueous solution of wood smoke which,
when suitably diluted, may be used to impart a smoke flavor to fish
products.
d. Loin muscle means the longitudinal quarter of the great
lateral muscle of the fish that is free from skin, scales, visible
blood clots, bones, gills, and from the nonstriated part of such
muscle, which part is known anatomically as ``the median superficial
muscle.''
e. Modified atmosphere-packaging means the food-packaging
technique in which the air in a package or container is replaced by
one or more gases, in various concentrations, before sealing. The
purpose of this type of packaging is to extend the refrigerated
shelf life of the product by limiting microbial growth or
detrimental chemical changes in the food.
f. Smoked-flavored fish means fish that is prepared by treating
it with salt (sodium chloride) and then imparting to it the flavor
of smoke by other than the direct action of smoke, such as immersing
it in a solution of liquid smoke. This paragraph does not alter the
labeling requirements under Sec. 101.22 of this chapter.
g. Smoked fish means fish that is prepared by treating it with
salt (sodium chloride) and then subjecting it to the direct action
of smoke from burning wood, sawdust, or similar material.
h. Sodium nitrite content means the concentration in parts per
million of sodium nitrite in the loin muscle of the finished product
as determined by the method of analysis for sodium nitrite in the
``Official Methods of Analysis of the Association of Official
Analytical Chemists,'' 15th ed. (1990).
i. Vacuum-packaged means the food-packaging technique in which
the air in a package or container is removed before sealing.
j. Water-phase salt content means the percent salt (sodium
chloride) in the finished product as determined by the method of
analysis for water-phase salt on the ``Official Methods of Analysis
of the Association of Official Analytical Chemists,'' 15th ed.
(1990). It is measured in the loin muscle of whole, dressed fish and
in the thickest part of cuts of fish.
3. Critical Control Points
Hazards Analysis Critical Control Point (HACCP) plans prepared
in accordance with subpart A of 21 CFR part 123, will typically
identify and address the following critical control points:
a. Raw material thawing
b. Brining or dry salting
c. Drying
d. Smoking
e. Cooling after smoking
f. Post-smoke processing, if any
g. Final product cooling
h. Refrigerated storage
i. Distribution
In accordance with subpart A of 21 CFR part 123, processors
shall identify in their HACCP plans how they will control hazards at
critical control points. The measures in sections 4 through 11 of
this guidance are suitable for HACCP plans.
4. Thawing
Thawing should be carried out in as rapid a manner as possible,
so that the internal temperature at the core of the fish does not
exceed 40 deg.F (4.4 deg.C).
5. Brining and smoking
a. Products covered by this guidance should be subjected to one
of the following processes:
(1) Hot-process smoked or hot-process smoke-flavored fish to be
air packaged needs to be heated to a continuous internal temperature
of at least 145 deg.F (63 deg.C) throughout each fish for a
minimum of 30 minutes, and brined to contain not less than 3.0
percent water-phase salt in the finished product (except that smoked
chub containing sodium nitrite as provided for in Sec. 172.177 of
this chapter must be processed as described in that section); or
(2) Hot-process smoked or hot-process smoked-flavored fish to be
vacuum packaged, modified atmosphere packaged, or controlled
atmosphere packaged, needs to be heated to a continuous internal
temperature of at least 145 deg.F (63 deg.C) throughout each fish
for a minimum of 30 minutes. It also needs to be brined to contain
not less than 3.5 percent water-phase salt in the finished product.
However, where sodium nitrite is present at not less than 100 parts
per million (as permitted by Secs. 172.175 and 172.177 of this
chapter) the water-phase salt content in the finished product should
not be less than 3.0 percent; or
(3) Cold-process smoked fish and cold-process smoke-flavored
fish to be air-packaged should be brined or dry salted to contain at
least 3.5 percent water-phase salt in the finished product. However,
when such fish contains not less than 100 parts per million sodium
nitrite, it should contain not less than 3.0 percent water-phase
salt in the finished product. When cold-process smoked fish or cold-
process smoked-flavored fish to be air-packaged is frozen
immediately after smoking and cooling, and remains frozen throughout
subsequent storage and distribution, it should contain not less than
2.5 percent water-phase salt in the finished product. Cold smoked
and cold smoke-flavored fish to be air packaged should be processed
under one of the following sets of conditions:
(i) The temperature in the smoking chamber does not exceed 90
deg.F (32 deg.C) during a drying and smoking period that does not
exceed 20 hours, or
(ii) The temperature in the smoking chamber does not exceed 50
deg.F (10 deg.C) during a drying and smoking period that does not
exceed 24 hours.
(iii) For sablefish, the temperature in the smoking chamber does
not exceed 120 deg.F (49 deg.C) during a drying and smoking period
that does not exceed 6 hours; or
(4) Cold-process smoked fish and cold-process smoke-flavored
fish, to be vacuum packaged, modified atmosphere packaged, or
controlled atmosphere packaged should be brined to contain at least
3.0 percent water-phase salt in the finished product and not less
than 100 parts per million of sodium nitrite (where permitted by
Secs. 172.175 and 172.177 of this chapter) and should be processed
as described in section 5(a)(3)(i) or (a)(3)(ii) of this Appendix.
If sodium nitrite is not used, the water-phase salt content in the
finished product should be at least 3.5 percent.
b. Brining and dry salting operations should be conducted in a
manner that will consistently result in the water phase salt content
or sodium nitrite level (where permitted by Secs. 172.175 and
172.177 of this chapter) recommended by section 5.a. of this
Appendix. This should be achieved by conducting or obtaining a study
that establishes that the appropriate salt content or sodium nitrite
level is always met under prescribed processing conditions. The
study should establish the limits of significant variables that
could affect the ability of the product to reach the appropriate
levels. These variables may include product size, product condition,
soak time, soak temperature, salt-to-water ratio, and product-to-
brine ratio. An adequate study should consist of at least three
processing runs under the prescribed processing conditions. In this
case, the processor should monitor and record the prescribed
processing conditions identified by the study at least every 2
hours.
c. The brining of all fish should take place in a refrigerated
area at 40 deg.F (4.4 deg.C) or lower.
d. The temperature of the brine should not exceed 60 deg.F
(15.6 deg.C) at the start of brining. The temperature of the brine
at the start of the each brining process should be determined and
recorded.
e. For dry salting, the fish should be returned to a
refrigerated area of 40 deg.F (4.4 deg.C) or lower immediately
after the application of the salt.
f. Different species of fish and fish of dissimilar size and
weight should not be mixed in the same brining tank.
g. Brines should not be reused unless they are subject to a
process that effectively returns them to a microbiological condition
equivalent to the original, unused brine made with potable water and
food-grade salt.
h. Fish may be rinsed with potable water after brining.
i. Drying of a product to be cold-smoked should be carried out
in a refrigerated area at 40 deg.F (4.4 deg.C) or below.
j. Smoking operation.
(1) Fish should be arranged without overcrowding and without
touching each other within the smokehouse oven or chamber to permit
uniform smoke absorption, heat exposure, and dehydration. Fish
smoked in the same smoke chamber load should be of relatively
uniform size and weight.
(2) Liquid smoke, generated smoke, or a combination of liquid
smoke and generated smoke needs to be applied to all surfaces of the
product. Liquid smoke may be applied to the product before, at the
beginning, or during the process. If only generated smoke is to be
used, it needs to be applied to the fish during the first half of
the process. If a combination of liquid smoke and generated smoke is
used, the generated smoke may be applied at any stage of the
process.
k. Each smoking chamber should be equipped with a temperature
recording device to indicate the temperature of the air and of the
fish within the smoking chamber. Additionally, each chamber should
be equipped with a temperature indicating device to indicate the
temperature of the air within the smoking chamber.
l. During hot-smoking or cold-smoking, a temperature recording
device should be used to monitor both the internal temperature of
the fish and the ambient temperature of the smoking chamber. The
internal temperature readings should be obtained by inserting probes
from the temperature recording device into the thickest flesh
portion of three or more of the largest fish in the smoking chamber.
The temperature from the slowest heating fish should be considered
the processing temperature.
6. Post-Smoking
a. Cooling after smoking. After smoking, the product needs to be
rapidly cooled to minimize recontamination. Continuous cooling from
140 deg.F (60 deg.C) to achieve an internal temperature of 70
deg.F (21.1 deg.C) or below within 2 hours and an internal
temperature of 40 deg.F (4.4 deg.C) or below within an additional
4 hours, unless processing after smoking as described in section
6.b. of this Appendix, occurs during either of these time periods,
will effectively minimize recontamination. Other time/temperature
parameters may also be effective. Processors should ensure that the
cooling parameters are met by either:
(1) Monitoring. Monitoring and recording internal product
temperatures at least every 2 hours; or
(2) Studies.
i. Conducting or obtaining a study that establishes that
appropriate cooling temperatures are always met under prescribed
processing conditions. The study should establish the limits of
significant variables that could affect the rate of cooling. These
variables may include product size, ambient air temperature, and
amount of product in the cooler. An adequate study should consist of
at least three processing runs under the prescribed processing
conditions; and
ii. Monitoring and recording the prescribed processing
conditions as identified by the study in section 6.a.2.i. of this
Appendix at least every 2 hours.
b. Processing after smoking. Products that will receive
processing after smoking should not be exposed to ambient
temperatures of 40 deg.F (4.4 deg.C) or higher for longer than a
cumulative total of 4 hours after smoking. If they are exposed to
such temperatures for more than 4 hours, unacceptable
recontamination is the likely result. Processors are required to
regularly monitor and record the length of time that the product is
exposed to temperatures above 40 deg.F (4.4 deg.C) under 21 CFR
123.8. FDA recommends that such monitoring and recording be done at
least every 2 hours.
c. Final product cooling. To avoid microbiological hazards for
perishable finished products, the internal temperature of the
finished product should be 40 deg.F (4.4 deg.C) or below within 4
hours of placement in a finished product container. Processors
should either conduct:
(1) Monitoring. Monitor and record internal product temperatures
at least every 2 hours; or
(2) Studies.
i. Conduct or obtain a study that establishes that the internal
temperature of the finished product will always be 40 deg.F (4.4
deg.C) or below within 4 hours of placement in a finished product
container under prescribed processing conditions. The study should
establish the limits of significant variables that could affect the
rate of cooling. These variables may include product size, ambient
air temperature, and amount of product in the cooler. An adequate
study should consist of at least three processing runs under the
prescribed processing conditions; and
ii. Monitoring and recording the prescribed processing
conditions as identified by the study in section 6.c.2.i. of this
Appendix at least every 2 hours.
d. Refrigerated storage.
(1) In-process products. Refrigeration units that are being used
to store in-process products or finished products must operate at a
temperature of 40 deg.F (4.4 deg.C) or below in accordance with 21
CFR 123.10(a)(14).
(2) Temperature devices. Units should be equipped with both a
temperature-indicating device and a temperature-recording device. In
lieu of a temperature-recording device, a processor may equip a
refrigeration unit with a high temperature alarm or a maximum-
indicating thermometer and maintain a temperature log that notes
temperature with such frequency as is necessary to achieve control.
e. Distribution. All perishable finished products should be
distributed in a manner that ensures that the internal temperature
is maintained at 40 deg.F (4.4 deg.C) or below.
7. Temperature Monitoring Equipment
Where reference is made in this Appendix to temperature-
indicating devices and temperature-recording devices, the following
conditions should apply:
a. Temperature-indicating devices. Temperature-indicating
devices should be installed where they can be easily read and
located to ensure that they accurately measure the warmest
temperature of the refrigeration equipment and the coldest
temperature of the smoking equipment, as appropriate. Temperature-
indicating devices should be calibrated at the routine operating
temperature of the refrigeration, cooling, or smoking equipment
against a known accurate standard thermometer upon installation and
at least once a year thereafter, or more frequently, if necessary,
to ensure their accuracy. Records of accuracy checks for
temperature-indicating devices required to be maintained under 21
CFR 123.8 should specify the date, standard used, method used,
results, and person performing the test. A temperature-indicating
device that has a divided fluid column or that cannot be adjusted to
the standard should be immediately repaired or replaced.
b. Temperature-recording devices. Temperature-recording devices
should be installed where they can be easily read and the sensors
for such devices should be installed to ensure that they accurately
measure the warmest temperature of the refrigeration equipment and
the coldest temperature of the smoking equipment, as appropriate.
Computerized storage of temperature data may be used in place of
recorder thermometer charts if the use of such a system has been
validated and can be shown to be substantially equivalent to the use
of a temperature-recording device. Each temperature-recording device
should be checked for accuracy at the beginning and end of each
production day and adjusted as necessary to agree as nearly as
possible with the reference temperature-indicating device. A record
of these accuracy checks should be maintained that specifies the
time, date, temperatures indicated by both devices before
adjustment, corrective action taken, where applicable, and person
performing the accuracy check.
8. Packaging
a. Vacuum- or modified atmosphere-packaging should be conducted
only within the facilities in which the product is produced.
b. Permanently legible code marks should be placed on each
finished product package and shipping container. These marks should
identify the plant where the product was packed and the date of
packing.
9. Corrective Action
Under 21 CFR 123.7, whenever a deviation occurs at a critical
control point, the processor is required to segregate and hold the
product until a review can be made to determine the effect of that
deviation and take corrective action as necessary. For smoked and
smoke-flavored fishery products, when a deviation occurs at a
brining or smoking critical control point, the processor should meet
the requirements of Sec. 123.7 either by destroying the product; by
fully reprocessing, where possible, that portion of the production
involved, keeping full records of the reprocessing conditions; or by
setting aside that portion of the product involved for further
evaluation as to any potential public health significance. Such an
evaluation should be made by a process authority and should be in
accordance with procedures recognized by process authorities as
being adequate to detect any unacceptable hazard to public health.
Unless this evaluation demonstrates that the product had been
rendered safe for its intended use, the product set aside should be
either fully reprocessed to correct the deficiency or destroyed. A
record should be made of the evaluation procedures used and the
results. Either upon completion of full reprocessing or after the
determination that no significant public health hazard exists, that
portion of the product involved may be shipped in normal
distribution. Otherwise, the portion of the product involved should
be destroyed.
10. Sanitary Zones
In addition to the requirements of 21 CFR 123.10, sanitary zones
should be established around areas in which a smoked product is
handled or stored. In such areas, objects and employees that have
come into contact with waste, raw product, or other insanitary
objects are excluded. Packaging material, equipment, employees, and
in-process materials that enter a sanitary zone should be treated in
a manner that will minimize the risk of the introduction of
microorganisms. Air handling systems should be designed to minimize
the risk of airborne contamination into sanitary zones and to
provide positive air pressure in the sanitary zone relative to the
surrounding areas.
11. Alternative Parameters
A processor of smoked or smoke-flavored fishery products may use
parameters other than those provided in Appendix C, section 5.a., if
those parameters will achieve the following, as demonstrated by
adequate scientific studies:
(1) For botulism, zero toxin production in the product through a
time period slightly beyond the shelf life of the product,
demonstrated through inoculated pack studies under normal and
moderate abuse conditions, and
(2) For listeria, no detectable Listeria monocytogenes in the
final product. A processor using alternative parameters should have
on file, subject to the requirements of 21 CFR 123.8(d), a
description, including the results of, the scientific studies.
Example 7
Section VI
Model HACCP Plan
Establishment Name-----------------------------------------------------
Establishment Address--------------------------------------------------
Mailing Address--------------------------------------------------------
Date and Authorization of HACCP Plan(s) Activation:
Product----------------------------------------------------------------
Critical Control Point-------------------------------------------------
1. What is the hazard at this critical control point?
2. Describe your control measures.
3. What is your frequency of control?
4. What are your critical limits?
5. What records are kept of control measures?
6. What corrective action will you take when the product fails
to meet the critical limits?
[FR Doc. 94-1592 Filed 1-21-94; 4:31 pm]
BILLING CODE 4160-01-P