[Federal Register Volume 66, Number 216 (Wednesday, November 7, 2001)]
[Rules and Regulations]
[Pages 56233-56245]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-27602]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-301188; FRL-6807-1]
RIN 2070-AB78
Chlorothalonil; Pesticide Tolerances for Emergency Exemptions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation re-establishes a time-limited tolerance for
combined residues of chlorothalonil and its metabolite, 4-hydroxy-
2,5,6- trichloroisophthalonitrile in or on ginseng. This action is in
response to EPA's granting of an emergency exemption under section 18
of the Federal Insecticide, Fungicide, and Rodenticide Act authorizing
use of the pesticide on ginseng. This regulation re-establishes a
maximum permissible level for residues of chlorothalonil and its
metabolite, 4-hydroxy-2,5,6-trichloroisophthalonitrile (SDS-3701) in
this food commodity. The tolerance will expire and is revoked on
December 31, 2003.
DATES: This regulation is effective November 7, 2001. Objections and
requests for hearings, identified by docket control number OPP-301188,
must be received by EPA on or before January 7, 2002.
ADDRESSES: Written objections and hearing requests may be submitted by
mail, in person, or by courier. Please follow the detailed instructions
for each method as provided in Unit VII. of the SUPPLEMENTARY
INFORMATION. To ensure proper receipt by EPA, your objections and
hearing requests must identify docket control number OPP-301188 in the
subject line on the first page of your response.
FOR FURTHER INFORMATION CONTACT: By mail: Dan Rosenblatt, Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460;
telephone number:(703) 308-9375; and e-mail address:
[email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected categories and entities may include, but are not
limited to:
------------------------------------------------------------------------
Examples of
Categories NAICS codes potentially
affected entities
------------------------------------------------------------------------
Industry 111 Crop production
112 Animal production
311 Food manufacturing
32532 Pesticide
manufacturing
------------------------------------------------------------------------
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in the table could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether or not this action might apply to certain entities. If you have
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.
[[Page 56234]]
B. How Can I Get Additional Information, Including Copies of This
Document and Other Related Documents?
1. Electronically.You may obtain electronic copies of this
document, and certain other related documents that might be available
electronically, from the EPA Internet Home Page at http://www.epa.gov/.
To access this document, on the Home Page select ``Laws and
Regulations,'' ``Regulations and Proposed Rules,'' and then look up the
entry for this document under the ``Federal Register--Environmental
Documents.'' You can also go directly to the Federal Register listings
at http://www.epa.gov/fedrgstr/. A frequently updated electronic
version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr180._00.html, a beta site currently
under development.
2. In person. The Agency has established an official record for
this action under docket control number OPP-301188. The official record
consists of the documents specifically referenced in this action, and
other information related to this action, including any information
claimed as Confidential Business Information (CBI). This official
record includes the documents that are physically located in the
docket, as well as the documents that are referenced in those
documents. The public version of the official record does not include
any information claimed as CBI. The public version of the official
record, which includes printed, paper versions of any electronic
comments submitted during an applicable comment period is available for
inspection in the Public Information and Records Integrity Branch
(PIRIB), Rm. 119, Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA,
from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal
holidays. The PIRIB telephone number is (703) 305-5805.
II. Background and Statutory Findings
EPA, on its own initiative, in accordance with sections 408(e) and
408 (l)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21
U.S.C. 346a, is re-establishing a tolerance for combined residues of
the fungicide chlorothalonil and its metabolite, 4-hydroxy-2,5,6-
trichloroisophthalonitrile, in or on ginseng at 0.10 part per million
(ppm). This tolerance will expire and is revoked on December 31, 2003.
EPA will publish a document in the Federal Register to remove the
revoked tolerance from the Code of Federal Regulations.
Section 408(l)(6) of the FFDCA requires EPA to establish a time-
limited tolerance or exemption from the requirement for a tolerance for
pesticide chemical residues in food that will result from the use of a
pesticide under an emergency exemption granted by EPA under section 18
of FIFRA. Such tolerances can be established without providing notice
or period for public comment. EPA does not intend for its actions on
section 18 related tolerances to set binding precedents for the
application of section 408 and the new safety standard to other
tolerances and exemptions. Section 408(e) of the FFDCA allows EPA to
establish a tolerance or an exemption from the requirement of a
tolerance on its own initiative, i.e., without having received any
petition from an outside party.
Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) defines ``safe'' to mean that ``there is a reasonable
certainty that no harm will result from aggregate exposure to the
pesticide chemical residue, including all anticipated dietary exposures
and all other exposures for which there is reliable information.'' This
includes exposure through drinking water and in residential settings,
but does not include occupational exposure. Section 408(b)(2)(C)
requires EPA to give special consideration to exposure of infants and
children to the pesticide chemical residue in establishing a tolerance
and to ``ensure that there is a reasonable certainty that no harm will
result to infants and children from aggregate exposure to the pesticide
chemical residue. . . .''
Section 18 of the Federal Insecticide, Fungicide, and Rodenticide
Act (FIFRA) authorizes EPA to exempt any Federal or State agency from
any provision of FIFRA, if EPA determines that ``emergency conditions
exist which require such exemption.'' This provision was not amended by
the Food Quality Protection Act (FQPA). EPA has established regulations
governing such emergency exemptions in 40 CFR part 166.
III. Emergency Exemption for Chlorothalonil on Ginseng and FFDCA
Tolerances
Ginseng is a valuable root crop that is used as a health supplement
in a variety of foods such as teas, wine, herbal medicines and gum.
Ginseng is grown over multiple growing seasons, so disease control is
necessary to ensure that the harvested roots and seeds are not damaged
by intensifying disease pressure over successive seasons. Roots are not
harvested until the plants are four years old. Growers are concerned
about the damage that the fungal disease Alternaria panax causes to
ginseng gardens. The fungus can produce leaf and stem blight which
defoliates and diminishes the overall vigor of effected ginseng. These
blights can result in high or complete yield loss of the harvested
ginseng root.
Growers have typically relied upon mancozeb treatments to protect
gardens against Alternaria panax. However, during the 2001 growing
season, Wisconsin experienced significant precipitation and also hot
humid conditions. This weather cycle further heightened the probability
of significant disease pressure. At the same time, the rain events
negated the effectiveness of the traditional control means, mancozeb.
If applied prior to rain events, mancozeb will wash off of the ginseng
plants. The Applicant identified a weather-stick formulation of
chlorothalonil that has the characteristic of adhering strongly to the
ginseng plants. Thus, on June 15, 2001, the Wisconsin Department of
Agriculture, Trade, and Consumer Protection availed itself of its
authority to declare a crisis situation under section 18, thereby
permitting growers to immediately use a weather-stick formulation of
chlorothalonil on ginseng.
EPA acknowledges that there are not sufficient registered
alternatives and concurred on the crisis declaration by the State to
control leaf and stem blight in ginseng.
As part of its assessment of this emergency exemption, EPA assessed
the potential risks presented by residues of chlorothalonil in or on
ginseng. In doing so, EPA considered the safety standard in FFDCA
section 408(b)(2), and EPA decided that the necessary tolerance under
FFDCA section 408(l)(6) would be consistent with the safety standard
and with FIFRA section 18. Consistent with the need to move quickly on
the emergency exemption in order to address an urgent non-routine
situation and to ensure that the resulting food is safe and lawful, EPA
is issuing this tolerance without notice and opportunity for public
comment as provided in section 408(l)(6). Although this tolerance will
expire and is revoked on December 31, 2003, under FFDCA section
408(l)(5), residues of the pesticide not in excess of the amounts
specified in the tolerance remaining in or on ginseng after that date
will not be unlawful, provided the pesticide is applied in a manner
that was lawful under FIFRA, and the residues do not
[[Page 56235]]
exceed a level that was authorized by this tolerance at the time of
that application. EPA will take action to revoke this tolerance earlier
if any experience with, scientific data on, or other relevant
information on this pesticide indicate that the residues are not safe.
Because this tolerance is being approved under emergency
conditions, EPA has not made any decisions about whether chlorothalonil
meets EPA's registration requirements for use on ginseng or whether a
permanent tolerance for this use would be appropriate. Under these
circumstances, EPA does not believe that this tolerance serves as a
basis for registration of chlorothalonil by a State for special local
needs under FIFRA section 24(c). Nor does this tolerance serve as the
basis for any State other than Wisconsin to use this pesticide on this
crop under section 18 of FIFRA without following all provisions of
EPA's regulations implementing section 18 as identified in 40 CFR part
166. For additional information regarding the emergency exemption for
chlorothalonil, contact the Agency's Registration Division at the
address provided under FOR FURTHER INFORMATION CONTACT.
IV. Aggregate Risk Assessment and Determination of Safety
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 and a complete description of
the risk assessment process, see the final rule on Bifenthrin Pesticide
Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7) .
Consistent with section 408(b)(2)(D), EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of
chlorothalonil and to make a determination on aggregate exposure,
consistent with section 408(b)(2), for a time-limited tolerance for
combined residues of chlorothalonil and its metabolite, 4-hydroxy-
2,5,6-trichloroisophthalonitrile in or on ginseng at 0.10 ppm. EPA's
assessment of the dietary exposures and risks associated with
establishing the tolerance follows.
A. Toxicological Endpoints
The dose at which no adverse effects are observed (the NOAEL) from
the toxicology study identified as appropriate for use in risk
assessment is used to estimate the toxicological endpoint. However, the
lowest dose at which adverse effects of concern are identified (the
LOAEL) is sometimes used for risk assessment if no NOAEL was achieved
in the toxicology study selected. An uncertainty factor (UF) is applied
to reflect uncertainties inherent in the extrapolation from laboratory
animal data to humans and in the variations in sensitivity among
members of the human population as well as other unknowns. An UF of 100
is routinely used, 10x to account for interspecies differences and 10x
for intra species differences.
For dietary risk assessment (other than cancer) the Agency uses the
UF to calculate an acute or chronic reference dose (acute RfD or
chronic RfD) where the RfD is equal to the NOAEL divided by the
appropriate UF (RfD = NOAEL/UF). Where an additional safety factor is
retained due to concerns unique to the FQPA, this additional factor is
applied to the RfD by dividing the RfD by such additional factor. The
acute or chronic Population Adjusted Dose (aPAD or cPAD) is a
modification of the RfD to accommodate this type of FQPA Safety Factor.
For non-dietary risk assessments (other than cancer) the UF is used
to determine the level of concern (LOC). For example, when 100 is the
appropriate UF (10x to account for interspecies differences and 10x for
intraspecies differences) the LOC is 100. To estimate risk, a ratio of
the NOAEL to exposures (margin of exposure (MOE) = NOAEL/exposure) is
calculated and compared to the LOC.
The linear default risk methodology (Q*) is the primary method
currently used by the Agency to quantify carcinogenic risk. The Q*
approach assumes that any amount of exposure will lead to some degree
of cancer risk. A Q* is calculated and used to estimate risk which
represents a probability of occurrence of additional cancer cases
(e.g., risk is expressed as 1 x10-6 or one in a million).
Under certain specific circumstances, MOE calculations will be used for
the carcinogenic risk assessment. In this non-linear approach, a
``point of departure'' is identified below which carcinogenic effects
are not expected. The point of departure is typically a NOAEL based on
an endpoint related to cancer effects though it may be a different
value derived from the dose response curve. To estimate risk, a ratio
of the point of departure to exposure (MOEcancer = point of
departure/exposures) is calculated. A summary of the toxicological
endpoints for chlorothalonil used for human risk assessment is shown in
the following Table 1.
Table 1.--Summary of Toxicological Dose and Endpoints for Chlorothalonil for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
FQPA SF* and Level of
Exposure Scenario Dose Used in Risk Concern for Risk Study and Toxicological
Assessment, UF Assessment Effects
----------------------------------------------------------------------------------------------------------------
Acute dietary general population LOAEL = 175 mg/kg/day FQPA SF = 1X Subchronic Dietary -
including infants and children UF = 300 Acute RfD aPAD = acute RfD/FQPA Rats
=0.58 mg/kg/day. SF= 0.58 mg/kg/day. LOAEL = 175 mg/kg/day
based on increased
cell proliferation
correlated with
histopathological
lesions of
degeneration of the
proximal convoluted
tubules and epithelial
hyperplasia.
----------------------------------------------------------------------------------------------------------------
Chronic dietary all populations NOAEL = 2 mg/kg/day FQPA SF = 1X Chronic Toxicity/
UF = 100............... cPAD =................. Carcinogenicity Study
Chronic RfD = 0.02 mg/ chronic RfD/FQPA SF= Rats
kg/day. 0.02 mg/kg/day. LOAEL = 4 mg/kg/day
based on increased
kidney weights and
hyperplasia of the
proximal convoluted
tubules in the kidneys
as well asulcers and
forestomach
hyperplasia.
----------------------------------------------------------------------------------------------------------------
[[Page 56236]]
Short-term dermal (1 to 7 days) dermal (or oral) study LOC for MOE = 100 21-Day Dermal Toxicity
(Residential)........................ NOAEL= 600 mg/kg/day (Residential).......... Study - Rats
(dermal absorption rate LOAEL = 600 mg/kg/day
= 0.15%). based on no treatment-
related systemic
toxicity in the
highest dose tested.
----------------------------------------------------------------------------------------------------------------
Intermediate-termdermal (1 week to dermal (or oral) study LOC for MOE = 100 21-Day Dermal Toxicity
several months) NOAEL = 600 mg/kg/day (Residential).......... Study - Rats
(Residential)........................ (dermal absorption LOAEL = 600 mg/kg/day
rate = 0.15% based on no treatment-
related systemic
toxicity in the
highest dose tested.
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal,inhalation) Q* = 7.66 x 10-3 (mg/kg/ Chronic toxicity/
day)-1 carcinogenicity study
in rats. Findings
based on evidence of
increased incidence of
renal adenomas,
carcinomas and
adenomas/carcinomas
combined in rats and
mice following chronic
dosing at 15 and 175
milligram/kilograms/
day (mg/kg/day), as
well as increased
incidence of
forestomach carcinomas
in CD-1 mice and
papillomas and/or
carcinomas combined in
Fisher 344 rats. A 3/4
scaling factor was
applied to the Q*.
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation) NOAEL = 1.5 mg/kg/day LOC for MOE = 9,500 Cell proliferation
study in rats;
LOAEL = 15 mg/kg/day
based on toxic
response of the kidney
and forestomach.
----------------------------------------------------------------------------------------------------------------
* The reference to the FQPA Safety Factor refers to any additional safety factor retained due to concerns unique
to the FQPA.
1. Mechanistic data. In a cell proliferation study, 28 male Fischer
344 rats received technical chlorothalonil (97.9%) in the diet at 175
mg/kg/day for up to 91 days. Mean labeling index was statistically
increased in the kidneys of male rats treated with 175 mg/kg/day
chlorothalonil at all scheduled sacrifice times. From Day 7 to Day 28,
the increase in labeling index was relatively stable (approximately 10-
fold over control), with a decrease to approximately 3.5-fold over
control on Day 91. Increased cell proliferation correlated with
histopathological lesions of degeneration of the proximal convoluted
tubules and epithelial hyperplasia. The results of this study
demonstrate a sustained cell proliferative response as a result of
dietary administration of technical chlorothalonil at a dose of 175 mg/
kg/day.
In another study, 96 male SPR rats were divided into test groups of
6 animals per group. Rats received technical chlorothalonil (98.98%
a.i.) in the diet at dose levels of 0, 1.5, 15, or 175 mg/kg/day for
either 7, 14, 21, or 28 days (total of 24 rats per time point).
Histological examination of kidney and stomach tissue was performed for
each group after the appropriate exposure. In addition, kidneys were
subjected to PCNA staining and stomachs to BrdU staining, and the
labeling index and labeling count of cell nuclei were performed.
Duodenum was used as a negative control for PCNA and BrdU staining.
Increased absolute and relative weight of the kidneys was observed at
175 mg/kg/day at all time points, and, in one animal, at 15 mg/kg/day
on Day 28. Increased incidence of vacuolization of the epithelium of
the proximal convoluted tubules was observed at all time points at 175
mg/kg/day on Days 7, 14, and 21 at 15 mg/kg/day. PCNA immunostaining of
the proximal convoluted tubule epithelial cells showed increased
labeling of cells at the 175 mg/kg/day dose level at all time points,
and increased labeling at 15 mg/kg/day on Days 7, 14 and 21. BrdU
labeling of the rat forestomach showed marked labeling at 175 mg/kg/day
at all time points, and increased labeling on Day 28 at 15 mg/kg/day.
The results of this study demonstrate a toxic response of the kidney
and forestomach to repeated dietary administration of chlorothalonil at
doses of 15 and 175 mg/kg/day.
2. Summary of toxicological dose and levels of concern for SDS-3701
for use in human risk assessment. There is no evidence of
carcinogenicity for the SDS-3701 metabolite in either rats or mice. For
the acute and chronic non-cancer exposure assessments, residues of SDS-
3701 were combined with residues of chlorothalonil and the sum compared
to chlorothalonil levels of concern (the LOAEL for acute dietary risk
and the RfD for chronic non-dietary risk).
3. Summary of toxicological dose and levels of concern for HCB for
use in human risk assessment. A summary of the toxicological endpoints
for HCB used for human risk assessment is shown in the following Table
2.
Table 2.--Summary of Toxicological Dose and Endpoints for HCB for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
FQPA SF* and Level of
Exposure Scenario Dose used in Risk Concern for Risk Study and Toxicological
Assessment, UF Assessment Effects
----------------------------------------------------------------------------------------------------------------
Chronic dietary all populations NOAEL = 0.08 mg/kg/day Chronic RfD = 0.0008 mg/ 130-week study in rats.
UF = 100............... kg/day Effects observed were
hepatic centrilobular
basophilic
chromogenesis.
----------------------------------------------------------------------------------------------------------------
[[Page 56237]]
Cancer (oral, dermal, inhalation) Q* = 1.02 (mg/kg/day)-1 Carcinogenicity study
in rodents. Based on
increased tumor
incidences in hamsters
and rats. A 3/4
scaling factor was
applied to the Q*.
----------------------------------------------------------------------------------------------------------------
B. Exposure Assessment
1. Dietary exposure from food and feed uses. Tolerances have been
established (40 CFR 180.275) for the combined residues of
chlorothalonil and its metabolite 4-hydroxy-2,5,6-
trichloroisophthalonitrile, in or on a variety of raw agricultural
commodities. Because it is a low consumption specialty crop, ginseng is
not uniquely identified in the dietary exposure system the Agency uses
to estimate food consumption behaviors in the U.S. Thus, there is not
likely to be a measurable difference in the exposures and risks from
chlorothalonil when ginseng is added into the exposure scenario. Also,
there are not likely to be implications for livestock as ginseng is not
a feed item. However, in connection with another registration action
involving chlorothalonil, EPA recently completed a comprehensive risk
assessment for chlorothalonil. These risk assessments were conducted by
EPA to assess dietary exposures from chlorothalonil and its metabolite
in food as follows:
i. Acute exposure. Acute dietary risk assessments are performed for
a food-use pesticide if a toxicological study has indicated the
possibility of an effect of concern occurring as a result of a 1 day or
single exposure. The Dietary Exposure Evaluation Model
(DEEMTM) analysis evaluated the individual food consumption
as reported by respondents in the USDA 1977-1978-nationwide Continuing
Surveys of Food Intake by Individuals (CSFII) and accumulated exposure
to the chemical for each commodity. The following assumptions were made
for the acute exposure assessments: Each analysis assumes uniform
distribution of chlorothalonil in the commodity supply. Acute dietary
exposure was estimated based on the theoretical maximum residue
contribution (TMRC) or anticipated residues for combined residues of
chlorothalonil and SDS-3701. Percent crop treated and anticipated
residue refinements were used.
ii. Chronic exposure. In conducting this chronic dietary risk
assessment the Dietary Risk Evaluation System (DRES) was used. The
following assumptions were made for the chronic exposure assessments:
Tolerance level residues and percent of crop treated information were
used in the analysis for chlorothalonil and SDS-3701. Anticipated
residues were used in the chronic dietary exposure analysis from food
for HCB.
iii. Cancer. In this analysis, dietary exposure from chlorothalonil
was estimated based on anticipated residues (excluding meat and milk,
eggs and poultry). Meat and milk, eggs and poultry were not included in
this analysis since chlorothalonil residues are not expected in these
commodities. SDS-3701 was not included in this analysis since it is not
carcinogenic. The dietary exposure from food from HCB was estimated
based on anticipated residues (includes meat and milk, eggs, and
poultry). Since HCB is a contaminant in several other pesticides, an
aggregate exposure assessment for HCB was conducted with food uses of
chlorothalonil, pentachlorobenzene, picloram, and dacthal. HCB is
present in five other food-use pesticides but at low levels which do
not significantly add to the aggregate dietary exposure.
Pentachlorobenzene (PCB) is also present in PCNB, and the Agency has
concluded that the carcinogenic potential of PCB is comparable to HCB.
In estimating dietary carcinogenic risk from HCB in these four
pesticides, the Q* for PCB is assumed to be equal to that for HCB. The
assumption was made that the impurities would occur on food commodities
at the same ratio to the active ingredient as was present in the
formulation applied to these crops. It is also assumed that the
impurity would dissipate from the food commodity at an equal or greater
rate than the active ingredient. The Agency believes these are
reasonable assumptions because there are data from studies with
chlorothalonil, picloram, and dacthal which support this approach.
iv. Anticipated residue and percent crop treated information.
Section 408(b)(2)(E) authorizes EPA to use available data and
information on the anticipated residue levels of pesticide residues in
food and the actual levels of pesticide chemicals that have been
measured in food. If EPA relies on such information, EPA must require
that data be provided 5 years after the tolerance is established,
modified, or left in effect, demonstrating that the levels in food are
not above the levels anticipated. Following the initial data
submission, EPA is authorized to require similar data on a time frame
it deems appropriate. As required by section 408(b)(2)(E), EPA will
issue a data call-in for information relating to anticipated residues
to be submitted no later than 5 years from the date of issuance of this
tolerance.
Section 408(b)(2)(F) states that the Agency may use data on the
actual percent of food treated for assessing chronic dietary risk only
if the Agency can make the following findings: Condition 1, that the
data used are reliable and provide a valid basis to show what
percentage of the food derived from such crop is likely to contain such
pesticide residue; Condition 2, that the exposure estimate does not
underestimate exposure for any significant subpopulation group; and
Condition 3, if data are available on pesticide use and food
consumption in a particular area, the exposure estimate does not
understate exposure for the population in such area. In addition, the
Agency must provide for periodic evaluation of any estimates used. To
provide for the periodic evaluation of the estimate of percent crop
treated (PCT) as required by section 408(b)(2)(F), EPA may require
registrants to submit data on PCT.
The Agency used percent crop treated (PCT) information as shown in
the following Table 3.
[[Page 56238]]
Table 3.--Estimation of Percentage of Crops Treated With Chlorothalonil
--------------------------------------------------------------------------------------------------------------------------------------------------------
Anticipated Residues (ppm)
Commodity Processing Factors ------------------------------------------------------------ % Crop Treated
Chlorothalonil HCB
--------------------------------------------------------------------------------------------------------------------------------------------------------
Apricots None 0.0078 3.9 x 10-6 35
--------------------------------------------------------------------------------------------------------------------------------------------------------
Banana pulp None 0.0005 0.3 x 10-6 10
--------------------------------------------------------------------------------------------------------------------------------------------------------
Beans, dry None 0.0087 4.4 x 10-6 2
--------------------------------------------------------------------------------------------------------------------------------------------------------
Beans, snap 0.05 for all 0.0133 6.7 x 10-6 40
cooked canned or
frozen beans
--------------------------------------------------------------------------------------------------------------------------------------------------------
Broccoli None 0.0015 0.8 x 10-6 15
--------------------------------------------------------------------------------------------------------------------------------------------------------
Brussels sprouts None 0.0135 6.8 x 10-6 42
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cabbage 0.2 for all food 0.0137 6.9 x 10-6 50
forms
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cabbage, Chinese 0.2 for all food 0.0116 5.8 x 10-6 100
forms
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cattle fat None 0 1.65 x 10-4 None
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cattle meat None 0 1.24 x 10-5 None
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cattle liver None 0 8 x 10-6 None
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cattle kidney None 0 8 x 10-6 None
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cocoa 0.1 for all food 0.05 2.5 x 10-6 100
forms
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cantaloupe None 0.0191 9.6 x 10-6 30
--------------------------------------------------------------------------------------------------------------------------------------------------------
Carrots 0.005 for all 0.0036 1.8 x 10-6 35
cooked or
processed food
forms
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cauliflower None 0.0115 5.8 x 10-6 20
--------------------------------------------------------------------------------------------------------------------------------------------------------
Celery None 0.0874 43.7 x 10-6 85
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cherries 0.05 for all 0.002 1 x 10-6 40
processed food
forms
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cranberries None 0.4125 206 x 10-6 60
--------------------------------------------------------------------------------------------------------------------------------------------------------
Coffee 0.1 for all food 0.20 1 x 10-4 100
forms
--------------------------------------------------------------------------------------------------------------------------------------------------------
Corn, sweet None 0.0002 0.1 x 10-6 5
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cucumber 0.2 for cold- 0.0062 3.1 x 10-6 35
canned pickles;
0.04 for hot-
canned pickles
--------------------------------------------------------------------------------------------------------------------------------------------------------
Garlic None 0.0005 0.3 x 10-6 10
--------------------------------------------------------------------------------------------------------------------------------------------------------
Honeydew None 0.0033 1.7 x 10-6 20
--------------------------------------------------------------------------------------------------------------------------------------------------------
Nectarines None 0.00175 0.9 x 10-6 35
--------------------------------------------------------------------------------------------------------------------------------------------------------
Onions, bulb None 0.0033 1.7 x 10-6 65
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 56239]]
Onions, green and leeks None 0.0262 13.1 x 10-6 65
--------------------------------------------------------------------------------------------------------------------------------------------------------
Papayas None 0.005 2.5 x 10-6 100
--------------------------------------------------------------------------------------------------------------------------------------------------------
Parsnips None 0.0052 2.6 x 10-6 10
--------------------------------------------------------------------------------------------------------------------------------------------------------
Passion fruit None 3 1.5 x 10-3 100
--------------------------------------------------------------------------------------------------------------------------------------------------------
Peaches 0.02 for all 0.0018 0.9 x 10-6 35
cooked or canned
food forms
--------------------------------------------------------------------------------------------------------------------------------------------------------
Peanuts 0.5 for peanut oil 0.0045 2.3 x 10-6 90
--------------------------------------------------------------------------------------------------------------------------------------------------------
Plums 0.33 for dried 0.0005 0.3 x 10-6 10
prunes
--------------------------------------------------------------------------------------------------------------------------------------------------------
Potatoes None 0.0030 1.5 x 10-6 30
--------------------------------------------------------------------------------------------------------------------------------------------------------
Poultry fat None 0 2.2 x 10-6 None
--------------------------------------------------------------------------------------------------------------------------------------------------------
Pumpkins 0.002 for raw 0.0065 3.3 x 10-6 30
pumpkin
--------------------------------------------------------------------------------------------------------------------------------------------------------
Soybeans 0.5 for soybean 0.00005 2.5 x 10-8 1
oil
--------------------------------------------------------------------------------------------------------------------------------------------------------
Squash None for summer 0.0058 2.9 x 10-6 15
squash; 0.002 for
raw winter
squash; 0.001 for
cooked winter
squash
--------------------------------------------------------------------------------------------------------------------------------------------------------
Tomatoes 0.25 for juice; 0.0716 35.8 x 10-6 70
0.02 for paste,
puree and catsup
--------------------------------------------------------------------------------------------------------------------------------------------------------
Watermelons None 0.0228 11.4 x 10-6 55
--------------------------------------------------------------------------------------------------------------------------------------------------------
The Agency believes that the three conditions listed above have
been met. With respect to Condition 1, PCT estimates are derived from
Federal and private market survey data, which are reliable and have a
valid basis. EPA uses a weighted average PCT for chronic dietary
exposure estimates. This weighted average PCT figure is derived by
averaging State-level data for a period of up to 10 years, and
weighting for the more robust and recent data. A weighted average of
the PCT reasonably represents a person's dietary exposure over a
lifetime, and is unlikely to underestimate exposure to an individual
because of the fact that pesticide use patterns (both regionally and
nationally) tend to change continuously over time, such that an
individual is unlikely to be exposed to more than the average PCT over
a lifetime. For acute dietary exposure estimates, EPA uses an estimated
maximum PCT. The exposure estimates resulting from this approach
reasonably represent the highest levels to which an individual could be
exposed, and are unlikely to underestimate an individual's acute
dietary exposure. The Agency is reasonably certain that the percentage
of the food treated is not likely to be an underestimation. As to
Conditions 2 and 3, regional consumption information and consumption
information for significant subpopulations is taken into account
through EPA's computer-based model for evaluating the exposure of
significant subpopulations including several regional groups. Use of
this consumption information in EPA's risk assessment process ensures
that EPA's exposure estimate does not understate exposure for any
significant subpopulation group and allows the Agency to be reasonably
certain that no regional population is exposed to residue levels higher
than those
[[Page 56240]]
estimated by the Agency. Other than the data available through national
food consumption surveys, EPA does not have available information on
the regional consumption of food to which chlorothalonil may be applied
in a particular area.
2. Dietary exposure from drinking water--i. Ground water exposure
- chlorothalonil and SDS-3701. Exposure to chlorothalonil in drinking
water is derived from the monitoring data. The metabolites (SDS-46851,
SDS-47525, SDS-3701, and SDS-19221) were measured at a combined
concentration of approximately 16 parts per billion (ppb) in Suffolk
County, Long Island in 1981. Chlorothalonil itself has been detected in
the Sates of California, Florida, Massachusetts, and Maine at levels
typically below 1 ppb. These observations are predictable based on
laboratory mobility studies and evidence of metabolite persistence. It
is expected that the levels of chlorothalonil metabolites detected in
the ground water in New York are relatively high compared to the
country as a whole, because (a) they were the highest values reported
in the data base, (b) potatoes are a major crop on Long Island, and (c)
Long Island ground water is generally shallow and vulnerable. The Long
Island values were used to represent a high-end potential exposure. In
the absence of data demonstrating otherwise, this assessment is based
on the conservative assumption that the detected metabolites of
chlorothalonil have the same toxicity as the parent. As indicated
above, this assessment relies on other conservative factors.
ii. Surface water exposure chlorothalonil and SDS-3701.
Chlorothalonil can contaminate surface water at application via spray
drift or after application through runoff and erosion. The intermediate
soil/water partitioning of chlorothalonil indicates that its
concentration is suspended and bottom sediment will be substantially
greater than its concentration in water. The major degradate of
chlorothalonil in the soil under aerobic conditions is SDS-3701. SDS-
3701 appears to be more persistent and mobile than chlorothalonil,
based on ground water detections. Substantial amounts of SDS-3701 could
be available for runoff for longer periods than chlorothalonil, and
SDS-3701 may be more persistent in water/sediment systems than
chlorothalonil. The apparent greater mobility of SDS-3701 suggests that
it exhibits lower soil/water partitioning than chlorothalonil.
Therefore, the ratio of SDS-3701 runoff loss via dissolution in runoff
to runoff loss via adsorption to eroding soil for SDS-3701 may be
greater than for chlorothalonil. In addition, the ratios of
concentrations dissolved in the water column to concentrations adsorbed
to suspended and bottom sediment may be higher for SDS-3701 than for
chlorothalonil. The Agency has be unable to calculate drinking water
risk for SDS-3701 in surface water because no monitoring data were
available.
The South Florida Water Management District (SFWMD) summarized
chlorothalonil detections in samples collected every 2 to 3 months from
surface water sites within the SFWMD from November 1988 through
November 1993. Approximately 810 samples (30 sampling intervals x 27
sites sampled/interval) were collected during that time. Chlorothalonil
was detected in 25 samples at concentrations ranging from 0.003 ppb to
0.35 ppb. Six of the samples had concentrations greater than 0.01 ppb.
iii. Ground and surface water exposure HCB and PCB. HCB and
pentachlorobenzene are present in ground water and surface water from
sources other than current usage of contaminated pesticides, including
manufacturer of solvents and tires, incineration of wastes, and coal
combustion. HCB and PCB are persistent and relatively immobile in the
environment; the major route of dissipation is through sorption to
soil, sediment, and suspended particulates in water. HCB and PCB
contamination of ground water sources is relatively unlikely due to the
high binding potential of both compounds. Detections of HCB in ground
water generally have ranged between 0.0002 to 0.100 ppb. Based on
monitoring data and fate properties, it seems unlikely that long-term
HBC and PCB concentration in surface water would exceed 10 parts per
trillion (ppt) (0.01 ppb).
Surface water detection shows much more variability than
concentrations in ground water and have been measured at up to 750 ppb.
These values appear to include sorbed HCB. The HCB concentration which
actually appear to be dissolved in the water are generally less than
0.001 ppb. Great Lakes region concentrations generally ranged from
0.00002 to 0.0001 ppb. When concentrations exceeded this range, they
appeared to be related to industrial areas or areas of historic
contamination (more than 20 years ago). Concentrations of PCB in
surface water have ranged between 0.00002 and 0.0001 ppb.
Concentrations of HCB and PCB in drinking water can be greatly reduced
through treatment with activated granular charcoal.
Higher concentrations of HCB and PCB have been reported in surface
and ground water, but tend to be related to hazardous waste, landfill
sites, and suspended sediment. The U.S. Department of Health and Human
Services in 1996 estimated that the average exposure in the United
States from drinking HCB contaminated water is 0.00085 g/kg/
year (-0.000082 ppb). Since potential exposures are generally so low,
and because pesticides are just one source of HCB and PCB in drinking
water, the Agency concluded that there are insufficient data to
quantify risk and that drinking water risk estimates from HCB in
pesticides do not exceed the Agency's level of concern.
3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
Chlorothalonil is currently registered for use on the following
residential non-dietary sites: Home vegetable gardens, ornamentals,
paint, stain, and wood preservatives. The risk assessment was conducted
using the following exposure assumptions: The Agency completed an
exposure assessment for uses of chlorothalonil as an additive contained
40.4% active ingredient for use in caulks, sealants, polymer lattices,
grouts, joint compounds, and paper coatings. All relevant occupational
and residential exposures were considered. Data were not available to
estimate application and post application exposure and risk for primary
and secondary homeowner exposure. Primary homeowner exposure occurs in
individuals who use or install chlorothalonil-containing material;
secondary residential exposure occurs when other individuals live and
work in places where chlorothalonil-containing materials have been
used. For these exposures, no risk assessment could be conducted, but
the Agency believes that secondary and homeowner exposures to these
products by themselves are generally lower than primary occupational
application exposures.
Since other residential risks could not be quantified, risk
concerns and uncertainties about exposure resulted in the following
agreements with the registrants. To mitigate potential residential
exposure concerns and uncertainties about the packaging and
concentration of chlorothalonil additives for paint, the registrants
have agreed that chlorothalonil mildewicidal additives must be labeled
to prohibit sale over-the-counter in retail outlets. The registrants
have committed to
[[Page 56241]]
working with the Agency to develop measures for the protection of
employees of paint sales outlets who mix mildewicidal additives into
paint for sale. To mitigate potential residential exposure concerns and
uncertainties about the in-container preservative use of
chlorothalonil, particularly because the chlorothalonil content of
products in which the preservative is used may not be known to the
purchaser, and because such preservatives may be used in paints
intended for use by children, the registrants have agreed that the in-
container preservative use of chlorothalonil is prohibited.
The contact rate for activities with ornamentals (5,800
cm2/hr) is based on a study by Brouwer et al., in which
chlorothalonil was applied to carnation sprays and carnations grown for
cut flowers. Rates for dermal contact with treated turf by adults
(1,000 cm2/hr)and toddlers (8,700 cm2/hr) are
based on EPA estimates for low exposure activities. Contact rates for
hand-to-mouth transfer by toddlers (1.56 events/hour), ingestion of
treated grass by toddlers (25 cm2/day, and ingestion of soil
from treated areas by children (100 mg/day) are default values which
originate with high-end exposure scenarios. For the cancer risk
estimates, the Agency assumed that activities with ornamentals occur 4
days per year for 50 years, and that an application is made once a
year, for adults in dermal contact with treated turf, that contact
occurred 40 days per year for 50 years, and that three applications
were made each year. The Agency also assumed that reentry occurred on
the day of treatment.
For residential post-application exposures related to the use of
chlorothalonil on turf and ornamentals, short- and intermediate-term
MOEs ranged from 14 to 26,000. Only the MOEs for toddlers exposed to
treated turf were at a risk level of concern at which the EPA typically
takes regulatory action. To address this risk, the registrants have
agreed to delete the home lawn use from their manufacturing-use and
end-use products registered solely for this use. When considering the
elimination of the home lawn use of chlorothalonil, EPA had determined
that residential post-application exposures to toddlers exposed to
treated turf do not exceed EPA's level of concern.
A summary of the residential post-application scenarios and cancer
risks from chlorothalonil is shown in the following table 4.
Table 4.--Surrogate Residential Post-application Scenarios and Cancer Risks from Chlorothalonil
----------------------------------------------------------------------------------------------------------------
Application Rate DFR (g/ LADD* (mg/kg/ Cancer Risk
Exposure Activity/Crop or Target (lb ai/acre) cm2) day) (Based on Q*)
----------------------------------------------------------------------------------------------------------------
Ornamentals (Transplanting/ 0.183 0.41 2.5E-6 2.0E-9
Pruning/Bundling Flowers)
----------------------------------------------------------------------------------------------------------------
8.7 20 1.3E-5 9.6E-8
----------------------------------------------------------------------------------------------------------------
15.7 35 2.3E-5 1.8E-7
----------------------------------------------------------------------------------------------------------------
Vegetables (Harvesting) 0.183 0.41 4.6E-7 3.5E-9
----------------------------------------------------------------------------------------------------------------
0.74 1.7 1.9E-6 1.4E-8
----------------------------------------------------------------------------------------------------------------
8.7 20 2.2E-5 1.7E-7
----------------------------------------------------------------------------------------------------------------
Adult Dermal Contact with Turf 8.7 20 3.3E-5 2.5E-7
----------------------------------------------------------------------------------------------------------------
11.8 26 4.4E-5 3.4E-7
----------------------------------------------------------------------------------------------------------------
15.7 35 5.5E-5 4.2E-7
----------------------------------------------------------------------------------------------------------------
* Lifetime average daily dose.
4. Cumulative exposure to substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) requires that, when considering
whether to establish, modify, or revoke a tolerance, the Agency
consider ``available information'' concerning the cumulative effects of
a particular pesticide's residues and ``other substances that have a
common mechanism of toxicity.''
EPA does not have, at this time, available data to determine
whether chlorothalonil has a common mechanism of toxicity with other
substances or how to include this pesticide in a cumulative risk
assessment. Unlike other pesticides for which EPA has followed a
cumulative risk approach based on a common mechanism of toxicity,
chlorothalonil does not appear to produce a toxic metabolite produced
by other substances. For the purposes of this tolerance action,
therefore, EPA has not assumed that chlorothalonil has a common
mechanism of toxicity with other substances. For information regarding
EPA's efforts to determine which chemicals have a common mechanism of
toxicity and to evaluate the cumulative effects of such chemicals, see
the final rule for Bifenthrin Pesticide Tolerances (62 FR 62961,
November 26, 1997).
C. Safety Factor for Infants and Children
1. In general. FFDCA section 408 provides that EPA shall apply an
additional tenfold margin of safety for infants and children in the
case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the data base on toxicity and exposure
unless EPA determines that a different margin of safety will be safe
for infants and children. Margins of safety are incorporated into EPA
risk assessments either directly through use of a margin of exposure
(MOE) analysis or through using uncertainty (safety) factors in
calculating a dose level that poses no appreciable risk to humans.
2. Prenatal and postnatal sensitivity. The developmental and
reproductive data for chlorothalonil indicate that there is no evidence
of increased sensitivity to chlorothalonil from prenatal and postnatal
exposures. In the rat developmental toxicity study, the developmental
NOAEL and LOAEL were based on an increase in total resoprtions per dam
with a related increase in post-implantation loss. These observations
occurred at a dose (400 mg/kg/day) which produced increased mortality
and reduced body weight gain in maternal animals. No developmental
toxicity was observed in
[[Page 56242]]
the rabbit developmental toxicity study, and no maternal toxicity was
observed at the highest dose tested (20 mg/kg/day).
iii. Conclusion. There is a complete toxicity data base for
chlorothalonil and exposure data are complete or are estimated based on
data that reasonably accounts for potential exposures. EPA determined
that the 10X safety factor to protect infants and children should be
removed. The FQPA factor is removed because no reproductive effects
were observed in any study and developmental effects occurred only in
the presence of significant maternal toxicity. HCB was not considered
in this evaluation of the special sensitivity of infants and children.
HCB will be considered at a future date when the Agency is better
equipped to understand the implications of FQPA for HCB, which is a
common contaminant of at lest nine other pesticides and which also
enters the environment from non-pesticidal sources.
D. Aggregate Risks and Determination of Safety
1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the estimated MOEs from exposure to
chlorothalonil and SDS-3701 residues from food and water do not exceed
the Agency's LOC. A summary of the aggregate risk assessment for acute
exposure to chlorothalonil is shown in the following Table 5.
Table 5.--Aggregate Risk Assessment for Acute Exposure to Chlorothalonil and SDS-3701
----------------------------------------------------------------------------------------------------------------
Population Subgroup LOC for MOE MOE
----------------------------------------------------------------------------------------------------------------
Food - U.S. Population 300 1,166
----------------------------------------------------------------------------------------------------------------
Food - Infants <1 year old 300 875
----------------------------------------------------------------------------------------------------------------
Food - Children (1-6 years) 300 875
----------------------------------------------------------------------------------------------------------------
Food - Females (13+ years) 300 1,750
----------------------------------------------------------------------------------------------------------------
Food - Males (13+ years) 300 1,750
----------------------------------------------------------------------------------------------------------------
Drinking water (ground water) - 300 110,000
Children
----------------------------------------------------------------------------------------------------------------
Drinking water (ground water) - 300 380,000
Adults
Drinking water (surface water) 300 50,000,000
- Children
----------------------------------------------------------------------------------------------------------------
Drinking water (surface water) 300 175,000,000
- Adults
----------------------------------------------------------------------------------------------------------------
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
chlorothalonil and SDS-3701 from food will utilize 34% of the cPAD for
the U.S. population and 68% of the cPAD for children. Based on the use
pattern, chronic residential exposure to residues of chlorothalonil is
not expected. EPA does not have chronic non-cancer concerns for HCB in
chlorothalonil. EPA does not expect the aggregate exposure to exceed
100% of the cPAD.
3. Short- and intermediate-term risk. Short- and intermediate-term
aggregate exposure takes into account residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level). The estimated MOEs from residential uses ranged from 310 for
adults transplanting, pruning or bundling flowers to 110,000 for
infants ingesting paint chips. Though residential exposure could occur
with the use of chlorothalonil, the potential short- and intermediate-
term exposure were not aggregated with chronic food and water exposures
because the toxic effects are different. Therefore, based on the best
available data and current policies, potential risks do not exceed the
Agency's level of concern.
4. Aggregate cancer risk for U.S. population. HCB and
pentachlorobenzene are present in ground water and surface water from
sources other than current usage of contaminated pesticides, including
manufacturing of solvents and tires, incineration of wastes, and coal
combustion. Both are persistent and relatively immobile in the
environment; the major route of dissipation is through sorption to
soil, sediment, and suspended particulates in water.
HCB and PCB contamination of ground water sources is relatively
unlikely due to the high binding potential of both compounds.
Detections of HCB in ground water generally have ranged between 0.0002
to 0.100 g/L. PCB levels in ground water at a hazardous waste
site ranged from 0.001 to 62 g/L.
Based on monitoring data and fate properties, it seems unlikely
that long-term HCB and PCB concentrations in surface water would exceed
10 ppt (0.01 g/L). As discussed previously, surface water
detections show much more variability than concentrations in ground
water but concentrations which actually appear to be dissolved in the
water are generally less than 0.001 g/L.
The upper bound carcinogenic risk from food uses of HCB for the
general U.S. population was calculated using the following equation:
HCB Upper Bound Cancer Risk = Dietary Exposure (ARC) x Q*, where the Q*
of 1.02 mg/kg/day)-\1\, the upper bound cancer risk was calculated to
be 2.4 x 10-\7\, contributed through all the published, pending and new
uses for chlorothalonil.
The upper bound risk for HCB in chlorothalonil is in the range the
Agency generally considers negligible for excess lifetime cancer risk.
The exposure assessment for carcinogenic risk from HCB in
chlorothalonil includes many a assumptions and uncertainties which
impact the Agency's confidence in the calculated risk.
HCB is also a contaminant in several other pesticides, and an
aggregate risk assessment for HCB from chlorothalonil and these other
sources has been conducted. The exposure assessment for aggregate risk
is subject to the same kinds of uncertainties and assumptions as the
risk assessment for HCB in chlorothalonil. For some of the individual
pesticide contributors, these
[[Page 56243]]
limitations impact the assessment to an even greater extent.
Four pesticides that are used on food/feed crops have been assessed
for cancer risk due to contamination with HCB -- chlorothalonil,
dacthal, picloram, and pentachlornitrobenzene (PCNB).
Pentachlorobenzene (PCB) is also present in PCNB, and the Agency has
concluded that the carcinogenic potential of PCB is comparable to HCB,
based on the similarities of the chemical structures and toxicities of
HCB and PCB. In estimated dietary risk from HCB in these four
pesticides, the Q* for PCB is assumed to be equal to that for HCB.
HCB is also present in pentachlorophenol, but pentachlorophenol is
not a food use pesticide and so that contaminant in pentachlorophenol
does not contribute to aggregate dietary risk (the contribution to
drinking water risk is discussed below). HCB and/or PCB is present in
five other food-use pesticides, but at low levels which do not
significantly add to the aggregate dietary exposure.
The estimated aggregate dietary cancer risk from HCB from all known
pesticide sources is 1.34 x 10-\6\. An additional 0.46 x 10-\6\ may be
attributed to PCB for a total of 1.8 x 10-\6\.
A summary of the cancer risks for chlorothalonil, HCB, and PCB are
shown in the following Table 6.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Upperbound Cancer Risk Upper Bound Cancer
Chemical Q* (Food) Cancer MOE for food Risk (Water) Cancer MOE for Water
--------------------------------------------------------------------------------------------------------------------------------------------------------
Chlorothalonil 0.00766 1.2 x 10-\6\ 9,500 8 x 10-\9\ <1.5 million
--------------------------------------------------------------------------------------------------------------------------------------------------------
HCB from Chlorothalonil 2.4 x 10-\7\ Not applicable 5 x 10-\9\ Not applicable
--------------------------------------------------------------------------------------------------------------------------------------------------------
HCB and PCB - all pesticide sources 1.8 x 10-\6\ Not applicable Does not exceed Not applicable
Agency's level of
concern
--------------------------------------------------------------------------------------------------------------------------------------------------------
EPA has estimated cancer risk using both the Q* and MOE approaches.
Under the MOE approach, cancer risk is estimated at MOE = 9,500. At
this time, EPA is not able to conclusively determine that
chlorothalonil is a non-linear carcinogen nor to apply approved policy
determinations on non-linear carcinogens to chlorothalonil, and so
cannot determine whether the MOE of 9,500 represents an excess lifetime
risk. Under the Q* approach, cancer risk is estimated at 1.2 x 10-\6\.
This figure is at a level which the EPA considers negligible for excess
lifetime cancer risk estimates.
Cancer risk for HCB is estimated at 2.4 x 10-\7\, and EPA does not
have cancer risk concerns for chlorothalonil alone. Although subject to
considerable uncertainty, cancer risk from HCB from chlorothalonil and
other pesticides, combined with cancer risk from the related
contaminate PCB present in other pesticides, is estimated at 1.8 x 10-
\6\. a level at which the EPA typically takes regulatory action. To
address this risk, the registrants of chlorothalonil have agreed that
the level of HCB in all chlorothalonil products must be reduced to no
greater than 0.004% (40 ppm). This is the lowest level that has been
shown to be technologically feasible for chlorothalonil. All
registrations are conditional on achieving this level, and failure to
achieve this level will result in a suspension of manufacture or import
of the subject products. In addition, registrants of chlorothalonil
products will maintain approximately historic levels of production and
import of chlorothalonil manufacturing use product to assure that
chlorothalonil with higher levels of HCB will not be stockpiled and
formulated. When this decrease in the amount of HCB is considered, EPA
has determined that the cancer risk estimates do not exceed the level
for regulatory action.
5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, and to infants and children from aggregate
exposure to combined residues of chlorothalonil and SDS-3701 or from
residues of the contaminant HCB.
V. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology using gas chromotography is
available to enforce the established tolerance expressions. The
Pesticide Analytical Manual (PAM) vol. II lists Method I, a gas
chromatography method with electron capture detection (ECD), for
enforcement of tolerances for plant commodities. An acceptable
enforcement method for residues of SDS-3701, a modification of the
method for chlorothalonil, is also available.
B. International Residue Limits
There are no Canadian, Mexican, or Codex tolerances for
chlorothalonil on ginseng.
VI. Conclusion
Therefore, the tolerance is re-established for combined residues of
chlorothalonil and its metabolite, 4-hydroxy-2,5,6-
trichloroisophthalonitrile, in or on ginseng at 0.10 ppm.
VII. Objections and Hearing Requests
Under section 408(g) of the FFDCA, as amended by the FQPA, any
person may file an objection to any aspect of this regulation and may
also request a hearing on those objections. The EPA procedural
regulations which govern the submission of objections and requests for
hearings appear in 40 CFR part 178. Although the procedures in those
regulations require some modification to reflect the amendments made to
the FFDCA by the FQPA of 1996, EPA will continue to use those
procedures, with appropriate adjustments, until the necessary
modifications can be made. The new section 408(g) provides essentially
the same process for persons to ``object'' to a regulation for an
exemption from the requirement of a tolerance issued by EPA under new
section 408(d), as was provided in the old FFDCA sections 408 and 409.
However, the period for filing objections is now 60 days, rather than
30 days.
A. What Do I Need To Do To File an Objection or Request a Hearing?
You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in this unit
and in 40 CFR part 178. To ensure proper receipt by EPA, you must
identify docket control number OPP-301188 in the subject line on the
first page of your submission. All requests must be in writing, and
must be mailed or delivered to the Hearing Clerk on or before January
7, 2002.
1. Filing the request. Your objection must specify the specific
provisions in
[[Page 56244]]
the regulation that you object to, and the grounds for the objections
(40 CFR 178.25). If a hearing is requested, the objections must include
a statement of the factual issues(s) on which a hearing is requested,
the requestor's contentions on such issues, and a summary of any
evidence relied upon by the objector (40 CFR 178.27). Information
submitted in connection with an objection or hearing request may be
claimed confidential by marking any part or all of that information as
CBI. Information so marked will not be disclosed except in accordance
with procedures set forth in 40 CFR part 2. A copy of the information
that does not contain CBI must be submitted for inclusion in the public
record. Information not marked confidential may be disclosed publicly
by EPA without prior notice.
Mail your written request to: Office of the Hearing Clerk (1900),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460. You may also deliver your request to the Office
of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW.,
Washington, DC 20460. The Office of the Hearing Clerk is open from 8
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Office of the Hearing Clerk is (202) 260-4865.
2. Tolerance fee payment. If you file an objection or request a
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must
mail the fee to: EPA Headquarters Accounting Operations Branch, Office
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please
identify the fee submission by labeling it ``Tolerance Petition Fees.''
EPA is authorized to waive any fee requirement ``when in the
judgement of the Administrator such a waiver or refund is equitable and
not contrary to the purpose of this subsection.'' For additional
information regarding the waiver of these fees, you may contact James
Tompkins by phone at (703) 305-5697, by e-mail at [email protected],
or by mailing a request for information to Mr. Tompkins at Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
If you would like to request a waiver of the tolerance objection
fees, you must mail your request for such a waiver to: James Hollins,
Information Resources and Services Division (7502C), Office of
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460.
3. Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit VII.A., you
should also send a copy of your request to the PIRIB for its inclusion
in the official record that is described in Unit I.B.2. Mail your
copies, identified by the docket control number OPP-301188, to: Public
Information and Records Integrity Branch, Information Resources and
Services Division (7502C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
In person or by courier, bring a copy to the location of the PIRIB
described in Unit I.B.2. You may also send an electronic copy of your
request via e-mail to: [email protected]. Please use an ASCII file
format and avoid the use of special characters and any form of
encryption. Copies of electronic objections and hearing requests will
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format.
Do not include any CBI in your electronic copy. You may also submit an
electronic copy of your request at many Federal Depository Libraries.
B. When Will the Agency Grant a Request for a Hearing?
A request for a hearing will be granted if the Administrator
determines that the material submitted shows the following: There is a
genuine and substantial issue of fact; there is a reasonable
possibility that available evidence identified by the requestor would,
if established resolve one or more of such issues in favor of the
requestor, taking into account uncontested claims or facts to the
contrary; and resolution of the factual issues(s) in the manner sought
by the requestor would be adequate to justify the action requested (40
CFR 178.32).
VIII. Regulatory Assessment Requirements
This final rule establishes a time-limited tolerance under FFDCA
section 408. The Office of Management and Budget (OMB) has exempted
these types of actions from review under Executive Order 12866,
entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993).
Because this rule has been exempted from review under Executive Order
12866 due to its lack of significance, this rule is not subject to
Executive Order 13211, Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355,
May 22, 2001). This final rule does not contain any information
collections subject to OMB approval under the Paperwork Reduction Act
(PRA), 44 U.S.C. 3501et seq., or impose any enforceable duty or contain
any unfunded mandate as described under Title II of the Unfunded
Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor does it
require any special considerations under Executive Order 12898,
entitled Federal Actions to Address Environmental Justice in Minority
Populations and Low-Income Populations (59 FR 7629, February 16, 1994);
or OMB review or any Agency action under Executive Order 13045,
entitled Protection of Children from Environmental Health Risks and
Safety Risks (62 FR 19885, April 23, 1997). This action does not
involve any technical standards that would require Agency consideration
of voluntary consensus standards pursuant to section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (NTTAA),
Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since
tolerances and exemptions that are established on the basis of a FIFRA
section 18 exemption under FFDCA section 408, such as the tolerance in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply. In addition, the Agency has determined that this
action will not have a substantial direct effect on States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government, as specified in Executive Order 13132, entitled Federalism
(64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to
develop an accountable process to ensure ``meaningful and timely input
by State and local officials in the development of regulatory policies
that have federalism implications.'' ``Policies that have federalism
implications'' is defined in the Executive Order to include regulations
that have ``substantial direct effects on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government.'' This final rule directly regulates growers, food
processors, food handlers and food retailers, not States. This action
does not alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). For these same reasons, the Agency has
determined that this rule does not have any ``tribal implications'' as
described in Executive Order 13175, entitled
[[Page 56245]]
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 6, 2000). Executive Order 13175, requires EPA to
develop an accountable process to ensure ``meaningful and timely input
by tribal officials in the development of regulatory policies that have
tribal implications.'' ``Policies that have tribal implications'' is
defined in the Executive Order to include regulations that have
``substantial direct effects on one or more Indian tribes, on the
relationship between the Federal government and the Indian tribes, or
on the distribution of power and responsibilities between the Federal
government and Indian tribes.'' This rule will not have substantial
direct effects on tribal governments, on the relationship between the
Federal government and Indian tribes, or on the distribution of power
and responsibilities between the Federal government and Indian tribes,
as specified in Executive Order 13175. Thus, Executive Order 13175 does
not apply to this rule.
IX. Submission to Congress and the Comptroller General
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of this final rule in the Federal Register. This final
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: October 20, 2001.
Peter Caulkins,
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
1. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 321(q), 346(a) and 371.
2. Section 180.275 is amended by revising the entry for the
commodity in the table in paragraph (b) to read as follows:
Sec. 180.275 Chlorothalonil; tolerances for residues.
* * * * *
(b)* * *
------------------------------------------------------------------------
Expiration/Revocation
Commodity Parts per million Date
------------------------------------------------------------------------
Ginseng..................... 0.10 12/31/03
------------------------------------------------------------------------
* * * * *
[FR Doc. 01-27602 Filed 11-6-01; 8:45 am]
BILLING CODE 6560-50-S