Food and Drug Administration: Carrageenan Food Additive from the
Philippines Conforms to Regulations (Letter Report, 08/02/94,
GAO/HEHS-94-141).
Questions have arisen as to whether a less refined, less expensive
carrageenan--a food additive derived from red seaweed--manufactured in
the Philippines should be imported and sold in the United States. U.S.
carrageenan manufacturers estimate that their revenue losses to the
Philippines could exceed $170 million over four years. On the basis of
its food additive regulations for traditionally refined carrageenan, the
Food and Drug Administration (FDA) classified Philippine natural grade
carrageenan as carrageenan, which is an approved food additive. As a
result, Philippine manufacturers were not required to submit a food
additive petition to FDA. A new food additive petition would have
required FDA to approve conditions under which the Philippine product
could be used in foods. In determining that the Philippine carrageenan
complied with its food additive regulations, FDA concluded that there
were no major qualitative differences between Philippine natural grade
carrageenan and traditionally refined carrageenan, including the safety
of processing. However, allegations of illegal pesticide use have
prompted FDA to test Philippine natural grade carrageenan for unapproved
pesticide residues, specifically ethylene oxide.
--------------------------- Indexing Terms -----------------------------
REPORTNUM: HEHS-94-141
TITLE: Food and Drug Administration: Carrageenan Food Additive
from the Philippines Conforms to Regulations
DATE: 08/02/94
SUBJECT: Food additives
Food industry
Safety regulation
Federal regulations
Product safety
Pesticides
Testing
Safety standards
Investigations by federal agencies
IDENTIFIER: Philippines
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Cover
================================================================ COVER
Report to Congressional Requesters
August 1994
FOOD AND DRUG ADMINISTRATION -
CARRAGEENAN FOOD ADDITIVE FROM THE
PHILIPPINES CONFORMS TO
REGULATIONS
GAO/HEHS-94-141
Classifying PNG as Carrageenan
Abbreviations
=============================================================== ABBREV
AIM - acid-insoluble matter
ECH - ethylene chlorohydrin
EPA - Environmental Protection Agency
EtO - ethylene oxide
FCC - Food Chemicals Codex
FDA - Food and Drug Administration
JECFA - Joint Expert Committee on Food Additives
PES - processed Eucheuma seaweed
PNG - Philippine natural grade
SIAP - Seaweed Industry Association of the Philippines
USDA - U.S. Department of Agriculture
Letter
=============================================================== LETTER
B-255635
August 2, 1994
Congressional Requesters
This report responds to your joint request for information on the
Food and Drug Administration's (FDA) regulation of carrageenan--a
food additive derived from red seaweed. (Requesters are listed at
the end of this letter.) At issue is whether a less refined, less
expensive carrageenan manufactured in the Philippines should be
imported and sold in the United States as carrageenan. U.S.
carrageenan manufacturers estimate that their revenue losses to
Philippine carrageenan could exceed $170 million over 4 years.
Commercial food manufacturers use carrageenan to control moisture and
modify texture in products such as ham, deli meats and turkey
products, ice cream, and chocolate milk. FDA first approved the use
of carrageenan in foods in 1961. During the late 1970s, processed
Eucheuma seaweed\1 (PES) was introduced for use as carrageenan. The
major difference between traditionally refined carrageenan and PES is
the way in which it is processed. Traditionally refined carrageenan
is produced by extracting the carrageenan from the seaweed and
filtering the carrageenan extract to remove the cellulose and other
substances, a process used for more than 3 decades. To produce PES,
the process is modified in that the other substances are extracted
and the remaining seaweed containing carrageenan and cellulose is
processed as PES. In 1990, FDA determined that PES (now called
Philippine natural grade (PNG) carrageenan) meets its criteria to be
classified as carrageenan in the United States. (We are using the
term PNG in our response to distinguish between PNG carrageenan and
traditionally refined carrageenan.)
Congressional concerns have been heightened by allegations that PNG
is different from traditionally refined carrageenan because of the
way in which it is processed and by safety considerations arising
from the difference in processing. You asked us to provide
information on FDA's basis for (1) classifying PNG as carrageenan and
(2) determining that PNG is safe for use in foods. In subsequent
discussions with your offices, you also asked us to provide
information on FDA's plans to investigate recent allegations that
some PNG could be unsafe because it is processed with an illegal
pesticide.
The results of our work are summarized in the following sections and
discussed more fully in appendix I.
--------------------
\1 Eucheuma cottonii and Eucheuma spinosum are FDA-approved red
seaweed sources for carrageenan that abound in the warm waters
surrounding the Philippines.
RESULTS IN BRIEF
------------------------------------------------------------ Letter :1
Based on FDA's food additive regulations for traditionally refined
carrageenan, FDA classified PNG as carrageenan. Because FDA
determined that PNG is carrageenan--an approved food additive, PNG
manufacturers were not required to submit a food additive petition to
FDA. A new food additive petition would have required FDA to approve
conditions under which PNG could be used in foods.
FDA's determination that PNG complied with its food additive
regulations included a determination that there were no significant
qualitative differences between PNG and traditionally refined
carrageenan, including the safety of processing procedures. Based on
FDA's original evaluation of the safety of traditional carrageenan
and information about PNG, FDA looked at the safety of PNG processing
and concluded that there is no inherent safety difference between PNG
and traditionally refined carrageenan. Allegations about illegal
pesticide use on PNG have led FDA to begin testing carrageenan for
the presence of unapproved pesticide residues of ethylene oxide.
BACKGROUND
------------------------------------------------------------ Letter :2
FDA's food additive regulations (21 C.F.R. 172.620) define
carrageenan as a "refined hydrocolloid that is prepared by aqueous
extraction from" specific red seaweeds.\2
Carrageenan must be processed from one of eight red seaweeds listed
in the regulations. Carrageenan has been produced in the United
States and Europe for more than 30 years by chemically extracting the
carrageenan from red seaweeds. Traditionally refined carrageenan is
produced through a process that extracts the carrageenan from the
seaweed, discarding the cellulose, impurities, and other substances
along with the seaweed. In producing PNG, however, the impurities
and other substances are extracted, and the carrageenan and cellulose
are retained in the seaweed, which is processed as PNG. While PNG
has a high level of cellulose, according to FDA officials, cellulose
is not considered a safety concern.
Manufacturers of "new" food additives must submit a petition to
obtain FDA's approval before the additives can be used in foods. In
response to a petition for approval of a proposed use of a new food
additive, the Federal Food, Drug, and Cosmetic Act requires FDA to
establish regulations prescribing conditions for the additive's safe
use in food or to deny its use. Once FDA has approved a food
additive, manufacturers or importers are generally free to use or
modify any process to produce the ingredient without notifying FDA.
The final ingredient must, however, comply with FDA's regulations and
may not introduce contaminants that could render the food injurious
to health or otherwise cause the adulteration of the food.
Manufacturers or importers who are not certain whether a food
additive complies with a relevant regulation may seek FDA's advice.
The Federal Food, Drug, and Cosmetic Act prohibits distribution in
the United States, or importation, of food additives that are
adulterated. To ensure that food additives are not adulterated, FDA
relies on postmarket surveillance of domestic establishments and
imported products. To conduct postmarket surveillance, FDA (1)
inspects domestic food establishments to ensure compliance with
federal laws, regulations, and good manufacturing practices; and (2)
inspects imported food products at the port of entry to ensure
compliance with the same safety and labeling requirements established
for domestic foods. Under the act, a food additive is adulterated
if, among other things, it contains either (1) any pesticide residue
that is not subject to a tolerance (i.e., a legal limit for residues
established by the Environmental Protection Agency (EPA) for use on
or in that food or (2) a pesticide residue in an amount greater than
the tolerance level established by EPA for that food.\3
--------------------
\2 Hydrocolloids, also known as industrial gums, thickeners,
stabilizers, and gelling agents, have a variety of uses in food,
beverages, and pharmaceuticals. The primary function of
hydrocolloids is to control moisture within a product or substance.
\3 A food substance is found adulterated if it is filthy, is produced
under insanitary conditions, or contains unapproved food additives,
unapproved color additives, or certain unapproved pesticide residues.
FDA shares responsibility with EPA for regulating pesticide residues
in food. EPA determines the pesticide residue levels (tolerances)
allowed on food, and FDA monitors and enforces these levels.
PRINCIPAL FINDINGS
------------------------------------------------------------ Letter :3
FDA DETERMINED THAT PNG
CONFORMED TO CARRAGEENAN
REGULATIONS
---------------------------------------------------------- Letter :3.1
FDA's classification of PNG as carrageenan is based on the
carrageenan standards contained in FDA's food additive regulations.
In 1990, FDA classified PNG as carrageenan because, first, it
determined that (1) the modified process used to produce PNG met the
aqueous extraction requirement in its regulations and (2) PNG
conformed with FDA's food additive specifications for carrageenan.
Second, FDA determined that PNG conformed with its detailed
specifications for carrageenan adopted in 1979.\4 Third, FDA
determined that the uses and functions of PNG are similar to those of
traditionally refined carrageenan. Some U.S. manufacturers contend
that PNG should not be classified as carrageenan because the modified
process used to produce PNG is not an aqueous extraction as FDA
regulations require. Chemists from several scientific associations
we contacted, however, agreed with FDA that the modified process used
to produce PNG involves an aqueous extraction.\5
FDA followed its regulations in classifying PNG as carrageenan
without requiring a food additive petition. Because FDA determined
that PNG conformed to the food additive regulations for carrageenan,
FDA did not require a food additive petition for PNG. In the absence
of an existing regulation covering a particular additive, a
manufacturer or importer is required to submit a food additive
petition to FDA containing adequate data, including the results of
animal studies where necessary, to demonstrate that a food additive
is safe and will accomplish its intended function.
FDA officials told us that in the absence of sufficient information
about PNG, the agency initially requested additional data in the form
of a food additive petition. When FDA received additional
information about PNG, it decided that the information at hand was
sufficient to classify PNG as carrageenan. Although manufacturers of
traditionally refined carrageenan characterized this as a reversal of
FDA's position, because FDA had determined that PNG conformed to its
existing food additive regulations, FDA decided to rescind its
earlier request for a food additive petition for PNG.
--------------------
\4 FDA adopted the detailed specifications for carrageenan contained
in the Food Chemicals Codex, second edition, as amended by the second
supplement (1975).
\5 We discussed FDA's interpretation of aqueous extract with chemists
from the National Institute of Standards and Technology, the
Association of Official Analytical Chemists, and the American
Chemical Society.
FDA CONCLUDED PNG WAS SAFE
BASED ON ITS CLASSIFICATION
AS CARRAGEENAN
---------------------------------------------------------- Letter :3.2
FDA concluded that PNG conformed with its carrageenan food additive
regulations and was safe. More specifically, FDA had determined that
carrageenan was safe when it approved a new food additive petition
for traditionally refined carrageenan in 1961. FDA determined that
PNG was safe because PNG is produced from approved seaweed sources
for carrageenan that have been considered safe without toxicological
testing because these seaweeds have been used as food for many
decades. Later, in the 1990s FDA reviewed PNG's modified
manufacturing process and determined that it was effective in
eliminating bacteria normally found in seaweed and was not expected
to introduce contaminants that could render the food injurious to
health.
After manufacturers of traditionally refined carrageenan raised
questions about the propriety of FDA's classification of PNG as
carrageenan and about PNG's safety, FDA reexamined its classification
of PNG as carrageenan with particular attention to PNG's safety.\6 To
facilitate its reexamination, FDA requested the trade associations
representing traditional carrageenan and PNG manufacturers and their
respective members to submit data on the safety of PNG. After
reviewing the information provided, in August 1992, FDA reaffirmed
its classification of PNG as carrageenan. Based on the results of
assays of PNG, FDA determined that PNG was safe for use in food and
that PNG's modified refining process does not affect the safety of
the final product. Specifically, FDA determined that the only
significant difference between PNG and traditional carrageenan is
that PNG contains more cellulose as compared to traditionally refined
carrageenan. FDA considers the cellulose contained in PNG to be
generally recognized as safe and does not consider it to represent a
safety concern.
--------------------
\6 Further, the Joint Explanatory Statement of the Committee of
Conference to H.R. 5268, appropriations for Rural Development,
Agriculture and Related Agencies for Fiscal Year 1991, said it
"expected FDA to reexamine its decision on PNG carrageenan as a
substitute for highly refined processed carrageenan in accordance
with 21 CFR 172.620."
INFORMATION ON PENDING
PETITIONS AND ALLEGED SAFETY
VIOLATIONS
------------------------------------------------------------ Letter :4
PETITIONS TO AMEND FDA'S
CARRAGEENAN REGULATIONS ARE
PENDING
---------------------------------------------------------- Letter :4.1
Despite FDA's reaffirmation of its decision, manufacturers of
traditionally refined carrageenan continue their efforts to have FDA
rescind its determination that PNG should be classified as
carrageenan and that PNG is safe for use in foods. Manufacturers of
traditionally refined carrageenan have petitioned FDA to amend its
carrageenan regulations. The petitions would permit PNG to be
marketed as a food ingredient, but under a separate regulation and a
different name that would clearly distinguish it from carrageenan.
FDA also received results of a study performed by an independent
chemist indicating that, among other things, PNG may contain
contaminants from its manufacture or processing that may affect its
safety for food. As of April 1994, FDA was in the process of
reviewing the petitions and study results before making its final
decision.
ALLEGATIONS OF ILLEGAL
PESTICIDE USE IN SOME PNG
---------------------------------------------------------- Letter :4.2
In June 1993 and February 1994, FDA received allegations from
manufacturers of traditionally refined carrageenan that some PNG
could be adulterated because it is processed with an illegal
pesticide. Specifically, they alleged that a leading manufacturer of
PNG used ethylene oxide as a pesticide on its product. Ethylene
oxide is not approved for use on carrageenan.\7 When foods are
decontaminated with ethylene oxide gas, the chemical ethylene
chlorohydrin is formed. One of the traditional carrageenan
manufacturers also alleged that certain hams were contaminated with
ethylene chlorohydrin. The traditional carrageenan manufacturer
stated that because the hams were processed with PNG that had been
treated with ethylene oxide, they too contained residues of ethylene
chlorohydrin.
FDA first received allegations of this illegal practice in June 1993.
In August 1993, the leading manufacturer of PNG acknowledged in a
letter to FDA that it had used ethylene oxide to process PNG, but
that it ceased this practice once it learned ethylene oxide was not
approved for use on carrageenan. FDA officials admitted that they
did not follow the agency's standard procedures for handling industry
allegations in that they did not refer the allegation to an FDA
district office for follow-up. In February 1994, another
manufacturer of traditionally refined carrageenan presented test
results to FDA showing that PNG from the same manufacturer had been
decontaminated with ethylene oxide because the PNG contained ethylene
chlorohydrin. The traditional carrageenan manufacturer also provided
test results showing that certain hams were contaminated with
ethylene chlorohydrin because they were processed with PNG that had
been treated with ethylene oxide. Although FDA has not completed its
determination of whether ethylene oxide was used on PNG, FDA
officials told us in May 1994 that based on its preliminary
evaluation, they have determined that ethylene chlorohydrin, at the
levels reported by the traditional carrageenan manufacturer, does not
represent a safety concern.
The manufacturer of PNG stands by its earlier statement that it no
longer uses ethylene oxide. The manufacturer speculates that the PNG
tested could have been manufactured prior to August 1993 before it
ceased using ethylene oxide. To avoid further use of adulterated
PNG, in February 1994, the manufacturer recalled all PNG that was
treated with ethylene oxide.
FDA has the authority under the Federal Food, Drug, and Cosmetic Act
to identify an imported food product containing an illegal pesticide
residue as adulterated and to detain and subsequently refuse entry of
that shipment into the United States. To determine if some PNG
contains an illegal pesticide residue, FDA is collecting samples of
imported carrageenan, both traditionally refined carrageenan and PNG,
to test for ethylene chlorohydrin, the residue of ethylene oxide. If
FDA's surveillance activities identify any imported carrageenan that
contains the illegal pesticide residue ethylene chlorohydrin, FDA
will consider the product adulterated and take appropriate regulatory
action.
Since the U.S. Department of Agriculture (USDA) is responsible for
inspecting meat and poultry products, USDA tested processed hams for
ethylene chlorohydrin. USDA found ethylene chlorohydrin in some
hams, but decided not to recall the hams because it believes the
levels found do not represent a safety concern.
--------------------
\7 EPA regulations permit using ethylene oxide as a fumigant to
decontaminate some food products, namely spices, herbs, and black
walnuts.
AGENCY COMMENTS
------------------------------------------------------------ Letter :5
We discussed the information in this report with officials in FDA and
have included their comments where appropriate.
---------------------------------------------------------- Letter :5.1
To obtain information used in this report, we reviewed FDA
regulations relating to food additives in general and to carrageenan
specifically. We also reviewed FDA records on its decision to
classify PNG as carrageenan and on its determination concerning the
safety of PNG. We discussed the basis for these decisions with FDA
officials. We also discussed FDA's decisions with manufacturers of
both traditional carrageenan and PNG as well as representatives of
trade associations, the World Health Organization, and the National
Academy of Sciences to obtain their perspectives on the issues
involved. We discussed FDA's interpretation of aqueous extraction
with scientists from the National Institute of Standards and
Technology, the Association of Official Analytical Chemists, and the
American Chemical Society. In addition, we discussed FDA and USDA
plans for sampling and testing to assure that carrageenan and hams
processed with carrageenan, respectively, do not contain illegal
pesticide residues. We also discussed with EPA officials the health
implications of potential pesticide contamination of carrageenan.
We conducted our work from October 1993 to March 1994 in accordance
with generally accepted government auditing standards.
As we arranged with your offices, we will send copies of this report
to appropriate congressional committees and subcommittees, the
Secretary of Health and Human Services, and the Commissioner of Food
and Drugs. We will also make copies available to other interested
parties upon request.
If you or your staffs have any questions about this report, please
call me on (202) 512-7119. Other major contributors to this report
are listed in appendix II.
Mark V. Nadel
Associate Director, National
and Public Health Issues
LIST OF REQUESTERS
---------------------------------------------------------- Letter :5.2
The Honorable William V. Roth, Jr.
United States Senate
The Honorable Robert E. Andrews
House of Representatives
The Honorable Roscoe G. Bartlett
House of Representatives
The Honorable Sherwood L. Boehlert
House of Representatives
The Honorable Frederick C. Boucher
House of Representatives
The Honorable Michael N. Castle
House of Representatives
The Honorable Bill Emerson
House of Representatives
The Honorable Vic Fazio
House of Representatives
The Honorable Elizabeth Furse
House of Representatives
The Honorable Dean A. Gallo
House of Representatives
The Honorable Benjamin A. Gilman
House of Representatives
The Honorable Robert W. Goodlatte
House of Representatives
The Honorable James V. Hansen
House of Representatives
The Honorable Steny H. Hoyer
House of Representatives
The Honorable Don Johnson
House of Representatives
The Honorable Jack Kingston
House of Representatives
The Honorable Richard H. Lehman
House of Representatives
The Honorable Jerry Lewis
House of Representatives
The Honorable John Linder
House of Representatives
The Honorable Robert T. Matsui
House of Representatives
The Honorable John T. Myers
House of Representatives
The Honorable Bill Orton
House of Representatives
The Honorable Richard J. Santorum
House of Representatives
The Honorable Karen Shepherd
House of Representatives
The Honorable Norman Sisisky
House of Representatives
The Honorable Joe Skeen
House of Representatives
The Honorable Robert G. Torricelli
House of Representatives
The Honorable Fred Upton
House of Representatives
The Honorable Curt Weldon
House of Representatives
INFORMATION ON THE FOOD AND DRUG
ADMINISTRATION'S REGULATION OF
CARRAGEENAN
=========================================================== Appendix I
FDA'S BASIS FOR CLASSIFYING PNG
AS CARRAGEENAN
--------------------------------------------------------- Appendix I:1
The Food and Drug Administration determined that Philippine natural
grade carrageenan complied with its regulations and should be
classified as carrageenan. While the extraction processes used to
produce PNG and traditionally refined carrageenan are different, FDA
determined that the process used for PNG meets the extraction
requirement called for in FDA regulations and that the function of
both products is similar.
The following chronology describes FDA's approval of traditionally
refined carrageenan for use in food and its classification of PNG as
carrageenan.
In October 1961, in response to a petition for approval of a "new"
food additive, FDA issued regulations permitting the use of
carrageenan in foods. The regulations provided standards for
the description and use of carrageenan. FDA regulations also
restricted the seaweed sources of carrageenan to eight red
seaweeds that were determined to be safe.\8
In July 1979, FDA stated in a Federal Register notice that all
food-grade carrageenan must comply with FCC's carrageenan
standards.\9 The specifications in the FCC standards effectively
precluded degraded carrageenan for use in food.\10
In 1984, FCC drafted revised standards for carrageenan. The
extraction process described in the revised standards is the one
used to extract traditionally refined carrageenan from seaweeds
and is different from the process used for producing PNG. The
standard would also allow the use of seaweeds that are not
authorized in the FDA regulations and would require that
carrageenan not include more than 2 percent acid-insoluble
matter (AIM).\11 JECFA standards that were also revised were
similar to FCC standards. Before 1984, FCC and JECFA standards
did not address the AIM content of carrageenan. In 1986, FCC
and JECFA issued their revised standards.
PNG does not comply with the revised FCC or JECFA standards for
carrageenan because its manufacturing process does not follow the
process used to extract traditionally refined carrageenan, and PNG
contains as much as 18 percent AIM (consisting mainly of fibrous
cellulose).\12
FDA did not adopt either the FCC or JECFA revised standards for
carrageenan because they would allow the use of seaweeds that
were not approved by FDA.\13
In 1985, concerned that FDA would adopt FCC and JECFA
specifications, representatives from the Embassy of the
Philippines asked FDA's opinion on whether PNG complied with
FDA's carrageenan regulations. Since FDA lacked data on PNG,
agency officials advised the embassy to submit a food additive
petition containing information on the identity and safety of
the PNG.
In July 1989, the Philippine embassy requested FDA to review a
protocol prepared by the Seaweed Industry Association of the
Philippines (SIAP) to study the effects of PNG fed to rats for
90 days.\14 According to FDA, however, the protocol was
submitted because SIAP apparently believed that review of the
protocol was the initial step to gain both JECFA and FDA
clearance for the use of PNG.
In September 1989, to determine whether toxicity testing was
required for approval of PNG as a food additive, FDA requested
the Philippine embassy to provide data on (1) the seaweeds from
which PNG is obtained, (2) the process used to isolate or
extract the carrageenan, (3) the procedures used to assure the
purity and quality of PNG produced, and (4) the uses and
specifications for PNG. FDA advised embassy representatives
that the extent of the similarity between PNG and traditionally
refined carrageenan would determine if a new food additive
regulation would be needed for PNG.
In January 1990, the Philippine embassy submitted the data FDA
requested.
Based on its review of the information submitted, FDA determined
that PNG was produced from approved seaweeds and that the
product conformed with the description for carrageenan in FDA
regulations. Because FDA determined that PNG should be
classified as carrageenan and was not a new food additive, the
Philippines believed it did not need to submit a food additive
petition for FDA's approval.
In July 1990, FDA informed SIAP and the Philippine embassy that PNG
satisfied the requirements of FDA's carrageenan regulations and
could be used in food.
Traditional carrageenan manufacturers and trade associations
representing the manufacturers questioned FDA's decision to
classify PNG as carrageenan. One issue raised by traditional
carrageenan manufacturers was that the production process used
to produce PNG is not an aqueous extraction and therefore does
not conform to FDA's regulations.
The Joint Explanatory Statement of the Committee of Conference to
H.R. 5268, appropriations for Rural Development, Agriculture
and Related Agencies for Fiscal Year 1991, expected FDA to
reexamine its July 1990 decision concerning PNG. In conducting
a review of its decision, FDA requested all interested parties
to submit any information relevant to the decision.
In July 1991, based on FDA's review of information submitted in
response to its request, FDA affirmed its previous decision.
FDA determined that PNG was, as specified in the FDA
regulations, "a refined hydrocolloid prepared by aqueous
extraction" from FDA-approved red seaweeds. FDA's rationale for
its classification is that (1) PNG meets the functional
definition of a "hydrocolloid" in that the functions of PNG are
the same as those of traditionally refined carrageenan, i.e.,
they are used in foods as thickeners, stabilizers, and gelling
agents; (2) the process by which PNG is prepared (extracting the
impurities and soluble material while retaining the carrageenan
in the seaweed) constitutes one form of aqueous extraction;\15
and (3) PNG is "refined" because water and soluble materials are
removed from the seaweed. FDA also determined that the only
significant difference between PNG and traditional carrageenan
is that PNG contains more cellulose (as much as 18 percent),
compared to the traditional carrageenan product that is expected
to contain less than 2-percent cellulose.
At various times in 1991, in accordance with agency regulations
that set out procedures for review of agency decisions,
carrageenan trade associations again requested that FDA review
its decision to classify PNG as carrageenan. In August 1992,
FDA reaffirmed its decision.
Since FDA's decision, traditional carrageenan manufacturers have
filed three petitions with FDA. The petitions request that FDA
amend its regulations for carrageenan. Petitions range from
requests to exclude PNG from use in human food to permitting PNG
to be marketed as a food ingredient, but under a separate
regulation and a different name that would clearly distinguish
it from traditionally refined carrageenan. FDA is in the
process of reviewing the various petitions and does not have an
estimate on when it will complete its review and make its
decision.
--------------------
\8 In addition to the standards in FDA regulations, the Committee on
Food Chemicals Codex (FCC) and the Joint Expert Committee on Food
Additives (JECFA) each have standards for carrageenan. FCC is an
activity of the National Academy of Sciences' Institute of Medicine
and works under a contract with FDA. FCC's objective is to develop
minimum identity and purity requirements for food-grade chemicals
based on safety and good manufacturing practices that are published
in the "Food Chemicals Codex." JECFA is an activity of the World
Health Organization and the Foreign and Agriculture Organization of
the United Nations. JECFA is composed of an international group of
experts and assists in developing International Food Standards (the
Codex Alimentarius) for the purity and identity of food additives and
contaminants. However, the marketing and use of carrageenan in the
United States is subject only to FDA regulations. FCC and JECFA
standards do not have the force of regulations in the United States
unless they are adopted by FDA.
\9 Food Chemicals Codex, second edition, as amended by the second
supplement (1975).
\10 FDA considers carrageenan whose composition does not conform to
certain chemical specifications to be degraded.
\11 AIM is insoluble seaweed residue (primarily cellulose (crude
fiber), sand, and shells) that does not dissolve during the chemical
extraction process employed in producing traditionally refined
carrageenan. In producing traditionally refined carrageenan, the
carrageenan extract is filtered to remove all insoluble seaweed
residues.
\12 FCC has formed an ad hoc group to review its monograph for
carrageenan and plans to publish any needed revision in July 1995.
JECFA has temporarily given PNG a separate monograph, under the name
"processed Eucheuma seaweed," and an identification number that is
distinct from carrageenan. JECFA plans to reconsider its
classification of PES (PNG) at its next meeting in February 1995.
\13 The Food Chemicals Codex, second edition, third supplement
(1978), list of red seaweeds was expanded to include additional red
seaweeds as sources of carrageenan. FDA did not agree with the
expansion because FCC standards allow the use of seaweeds for which a
history of safe use as food has not been demonstrated and which are
not approved in the United States. FDA has not adopted any Food
Chemicals Codex edition published after 1975.
\14 SIAP is the trade association representing seaweed manufacturers
in the Philippines. SIAP's members represent 95 percent of the
worldwide production of PNG carrageenan.
\15 There is no standard definition of "aqueous extraction." We
contacted scientists from the National Institute of Standards and
Technology, the Association of Official Analytical Chemists, and the
American Chemical Society. They agreed that the process used to
produce PNG involves an aqueous extraction.
FDA HAS DETERMINED THAT PNG IS
SAFE FOR USE IN FOODS
--------------------------------------------------------- Appendix I:2
FDA has acknowledged that there are differences in the extraction
processes used to manufacture PNG and traditionally refined
carrageenan but has concluded that these differences have no
significance with respect to the safety of the final products. In
July 1991, based on information submitted to FDA for its use in
reexamining its classification of PNG as carrageenan, including the
safety of PNG, FDA was not given any evidence that PNG contains
contaminants from its manufacture or processing that would affect its
suitability for food use.
In February 1993, however, FDA received study results as part of the
comments on the petitions indicating that PNG may contain
contaminants from its manufacture or processing that may affect its
suitability for food. A study done by Dr. D.M.W. Anderson of the
University of Edinburgh, United Kingdom, has raised concerns about
the safety of PNG. SIAP disagrees with Dr. Anderson's study.
SIAP's assays and an animal toxicity study of PNG, which were
submitted to FDA, did not find any harmful substances in PNG or raise
any toxicity concerns with the product. Based on the assays and
animal study, JECFA, like FDA, has determined that PNG is safe for
human consumption.
Dr. Anderson tested six samples of PNG and found that two samples
contained contaminants, including coliforms and faecal
streptococci as well as large (up to 25 percent) quantities of
unidentified impurities. The results of Dr. Anderson's study
are part of the comments on the petitions that are before FDA to
amend its carrageenan regulations. They will be considered in
FDA's disposition of the petitions.
SIAP speculates that the characteristics of the PNG that was tested
could indicate that it was a grade of PNG that is used for pet
food or that the PNG was contaminated during shipping and
handling after it was manufactured.
FDA's determination that PNG is safe is supported by the results of
assays conducted by SIAP. SIAP conducted assays of 30 samples
of PNG to obtain JECFA clearance of PNG for use in foods. The
assays showed that none of the samples contained harmful
contaminants.
Additionally, SIAP conducted a 90-day toxicity study involving the
feeding of PNG to rats. The results of SIAP's study did not
find evidence of toxicity.
FDA is not alone in permitting the use of PNG as a food additive.
Based on the assays and animal toxicity study, in February 1993
JECFA determined that PNG was safe for human consumption. JECFA
allocated a temporary acceptable daily intake to PES. The
acceptable daily intake was made temporary pending submission of
the complete details from the 90-day toxicity study in rats.
JECFA will consider allocating a permanent acceptable daily
intake to PES after reviewing the requested data when JECFA
reconvenes in 1995.
Canada also is currently reviewing PNG's use as a food additive.
Canada adopted the Food Chemicals Codex as part of its food
additive regulations. Since PNG does not comply with the AIM
requirement for carrageenan contained in FCC, PNG was not
authorized for use in food. Subsequently, SIAP has petitioned
the Canadian government to approve PNG as a food additive.
Pending the completion of its review, the Canadian government
agreed to allow manufacturers to use PNG until all stocks were
exhausted. Although the agreement expired, the government is
not rigorously enforcing its ban on the use of PNG in foods.
FDA'S PLANS TO DETECT ILLEGAL
PESTICIDE USE IN PNG
--------------------------------------------------------- Appendix I:3
Recently, FDA received allegations from the industry that a leading
PNG manufacturer was distributing PNG that had been processed with an
illegal pesticide that could cause the food additive to be
adulterated. Specifically, in February 1994, a manufacturer of
traditionally refined carrageenan provided test results indicating
that PNG had been treated with an illegal pesticide, ethylene oxide
(EtO). It was alleged that treatment by EtO resulted in a chemical
residue, ethylene chlorohydrin (ECH), in PNG. Furthermore, the
manufacturer's test results showed that certain hams were
contaminated with ECH. The manufacturer stated that the hams were
contaminated because they had been processed with PNG that had been
treated with EtO.
The chemical ECH is formed when PNG is decontaminated using EtO gas.
At certain exposure levels, ECH is toxic when it is ingested orally,
inhaled, or comes in contact with skin. Although U.S. Environmental
Protection Agency regulations permit using EtO in manufacturing some
food products, the regulations do not permit using EtO to manufacture
carrageenan. EPA has not established a tolerance level for ECH
residue in carrageenan. FDA has evaluated the relevant toxicity
tests on ECH and the analytical and exposure data on the PNG that the
traditional carrageenan manufacturer provided in February 1994. FDA
has determined that the levels of ECH residues in PNG reported by the
traditional carrageenan manufacturer do not represent a safety
concern.
FDA TESTS OF CARRAGEENAN
------------------------------------------------------- Appendix I:3.1
To determine if some PNG contains an illegal pesticide residue, FDA
is collecting samples of imported carrageenan, both traditionally
refined carrageenan and PNG, to test for ECH residues and other
contaminants. Because it was alleged that PNG could also become
contaminated with ECH through further processing after it is
imported, FDA also will be collecting samples of carrageenan for
analysis from domestic firms that process or repackage carrageenan or
who may be importers or distributors of the product.
FDA will use the test results as a basis to determine what action to
take. If FDA identifies that an imported food product contains an
illegal pesticide residue, FDA will consider the product adulterated.
FDA has the authority to detain and subsequently refuse entry of that
shipment into the United States. In this case, for example, if FDA
identifies an import shipment of carrageenan containing ECH, FDA has
the authority to deny entry of that shipment.
USDA TESTED HAMS
------------------------------------------------------- Appendix I:3.2
Because the U.S. Department of Agriculture has responsibility for
regulating the safety of meat and poultry products, and the
allegations were against hams processed with PNG, USDA tested hams
for the ECH residue. The allegations stated that processed hams had
been manufactured using the ECH-contaminated PNG. USDA collected
samples of processed hams from retailers in several states to test
for ECH residue. However, USDA agreed with FDA that ECH in hams at
the levels reported by the traditional carrageenan manufacturer is
not a safety concern. In April 1994, USDA decided not to recall the
hams containing ECH residues.
FDA RECEIVED EARLIER
ALLEGATIONS
------------------------------------------------------- Appendix I:3.3
In June 1993, FDA received allegations from a carrageenan
manufacturer that the same PNG manufacturer identified in the 1994
allegations was using an illegal pesticide to decontaminate PNG; the
decontamination resulted in ECH residue. The allegations stated the
manufacturer was using an illegal pesticide, EtO, but did not
indicate that use of EtO caused public health concerns.
According to FDA officials, FDA receives many "trade complaints,"
i.e., complaints from one manufacturer alleging that another
manufacturer has not complied with FDA regulations. FDA's standard
procedure in handling trade complaints that do not involve immediate
public health implications is to refer the case to the relevant
district office for follow-up. In this case, FDA did not have any
reason to believe the trade complaint had public health implications.
Due to reorganization and office moves within FDA, these allegations
were inadvertently not referred to a district office.
In August 1993, the PNG manufacturer accused of using EtO submitted a
written statement to FDA stating that it had used EtO to process PNG.
The manufacturer agreed to stop using EtO to manufacture PNG sold in
the United States. Under standard FDA procedures for handling
illegal actions, FDA would issue a warning letter to the company in
violation. If the company acknowledged that it would cease the
violative actions, then FDA would allow time for the company to
comply with the regulations and would follow up to ensure that the
company was no longer in violation. In this case, FDA did not issue
a warning letter.
As previously discussed, in February 1994 FDA received further
allegations that this manufacturer had continued to use EtO to
decontaminate PNG. At this time, FDA sent a letter to the
manufacturer stating that EtO is not approved in the United States
for manufacturing carrageenan and acknowledging the manufacturer's
claim to cease U.S. distribution of PNG processed with EtO. FDA, in
conjunction with the PNG importer, is taking steps to ensure that the
adulterated PNG is removed from the U.S. market.
MAJOR CONTRIBUTORS TO THIS REPORT
========================================================== Appendix II
Sarah F. Jaggar, Director, Health Financing and Policy Issues
Albert B. Jojokian, Assistant Director (Retired)
Gloria E. Taylor, Evaluator-in-Charge, (202) 512-7160
Linda S. Lootens, Senior Evaluator
Paul C. Wright, Evaluator