[Federal Register Volume 66, Number 48 (Monday, March 12, 2001)]
[Rules and Regulations]
[Pages 14330-14342]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-6087]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-301088; FRL-6759-4]
RIN 2070-AB78
Chlorothalonil; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for combined residues
of chlorothalonil and its metabolite, 4-hydroxy-2,5,6-
trichloroisophthalonitrile (SDS-3701) in or on almonds (nutmeats),
almond hulls, asparagus, mangoes, non-bell peppers, and pistachios. In
addition, tolerances for the metabolite SDS-3701 are established for
milk and meat commodities. ISK Biosciences Corporation and the
Interregional Research Project Number 4 (IR-4) requested this tolerance
under the Federal Food, Drug, and Cosmetic Act, as amended by the Food
Quality Protection Act of 1996.
DATES: This regulation is effective March 12, 2001. Objections and
requests for hearings, identified by docket control number OPP-301088,
must be received by EPA on or before May 11, 2001.
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 VI. of the SUPPLEMENTARY
INFORMATION. To ensure proper receipt by EPA, your objections and
hearing requests must identify docket control number OPP-301088 in the
subject line on the first page of your response.
FOR FURTHER INFORMATION CONTACT: By mail: Cynthia Giles-Parker,
Registration Division (7505C), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave.,
NW.,Washington, DC 20460; telephone number: 703-305-7740; and e-mail
address: [email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be 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 potentially
Categories NAICS 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.
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/.
2. In person. The Agency has established an official record for
this action under docket control number OPP-301088. 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, Crystal 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
In the Federal Register of February 13, 1997 (PP 5F4558) (62 FR
6780) (FRL-5587-3), April 2, 1997 (PP 6F4676) (62 FR 15700) (FRL-5594-
9), July 11, 1997 (PP 6F4611) (62 FR 37246) (FRL-5723-1), and September
17, 1997 (PP 2E4042, 2E4018 and 6E4672) (62 FR 48849) (FRL-5735-8), EPA
issued notices pursuant to section 408 of the Federal Food, Drug, and
Cosmetic Act (FFDCA), 21 U.S.C. 346a as amended by the Food Quality
Protection Act of 1996 (FQPA) (Public Law 104-170) announcing the
filing of pesticide petitions (PP) for tolerances by ISK Biosciences
Corporation, 15966 Heisley Road, P.O. Box 8000, Mentor, OH 44061-8000
and Interregional Research Project Number 4 (IR-4), New Jersey
Agricultural Experimental Station, P.O. box 231, Rutgers University,
New Brunswick, NJ 08903. These notices included a summary of the
petition prepared by ISK Biosciences Corporation and IR-4, the
registrants. The active ingredient has since been transferred to GB
Biosciences Corporation, 1800 Concord Pike, P.O. Box 15458, Wilmington,
DE 19850-5458. There were no comments received in response to the
notices of filing.
The petitions requested that 40 CFR 180.275 be amended by
establishing tolerances for combined residues of the fungicide
chlorothalonil, tetrachloroisophthalonitrile and its metabolite, 4-
hydroxy-2,5,6-trichloroisopthalonitrile (SDS-3701), in or on almonds
(nutmeats) at 0.05 part per million (ppm), almond hulls at 1.0 ppm,
asparagus at 0.1 ppm, mangoes at 1.0 ppm, non-bell peppers at 5 ppm,
and pistachios at 0.2 ppm, and for residues of the metabolite SDS-3701
in or on the following milk and meat commodities: fat of cattle, hogs,
goats, horses, and sheep at 0.1 ppm; kidney of cattle, hogs, goats,
horses and sheep at 0.5 ppm; meat byproducts (mbyp) (except kidney) of
cattle, goats, hogs, horses and sheep at 0.05 ppm and meat of cattle,
goats, hogs, horses, and sheep at 0.03 ppm and milk at 0.1 ppm.
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
[[Page 14331]]
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....''
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).
III. Aggregate Risk Assessment and Determination of Safety
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 and to
make a determination on aggregate exposure, consistent with section
408(b)(2), for tolerances for combined residues of chlorothalonil and
its metabolite SDS-3701 in or on almonds (nutmeats) at 0.05 ppm, almond
hulls at 1.0 ppm, asparagus at 0.1 ppm, mangoes at 1.0 ppm, non-bell
peppers at 5 ppm, and pistachios at 0.2 ppm, and for residues of the
metabolite SDS-3701 in or on the following milk and meat commodities:
fat of cattle, hogs, goats, horses, and sheep at 0.1 ppm; kidney of
cattle, hogs, goats, horses and sheep at 0.5 ppm; meat byproducts
(mbyp) (except kidney) of cattle, goats, hogs, horses and sheep at 0.05
ppm and meat of cattle, goats, hogs, horses, and sheep at 0.03 ppm and
milk at 0.1 ppm. EPA's assessment of exposures and risks associated
with establishing the tolerance follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. The nature of the toxic effects caused by chlorothalonil,
SDS-3701, the major metabolite of chlorothalonil, and hexachlorobenzene
(HCB), an impurity in chlorothalonil and other pesticide products, are
discussed in the following Table 1 as well as the no observed adverse
effect level (NOAEL) and the lowest observed adverse effect level
(LOAEL) from the toxicity studies reviewed.
Table 1.--Subchronic, Chronic and Other Toxicity; Chlorothalonil and SDS-
3701
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Study Type Results
------------------------------------------------------------------------
21-Day dermal toxicity in rats- Dermal NOAEL = <60 mg/kg/day based
chlorothalonil on dermal irritation and lesions;
Systemic LOAEL = 600 mg/kg/day.
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Prenatal developmental in rodents - Maternal NOAEL = 100 mg/kg/day;
chlorothalonil LOAEL = 400 mg/kg/day based on
increased mortality and reduced
body weight gain. Developmental
LOAEL = 400 mg/kg/day based on an
increase total resorptions and
resorptions per dam with a related
increase in post-implantation loss.
No decrease in litter size was
reported.
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Prenatal developmental in Maternal NOAEL = 1 mg/kg/day; LOAEL
nonrodents - SDS-3701 = 2.5 mg/kg/day based on increase
in maternal death and abortion.
Developmental NOAEL = 5 mg/kg/day,
the highest dose tested. No
developmental toxicity observed.
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Reproduction and fertility effects Parental/Systemic NOAEL = <38 mg/kg/
- chlorothalonil day; LOAEL = 38 mg/kg/day based on
hyperplasia of renal and
forestomach tissues. Offspring
toxicity NOAEL = 115 mg/kg/day;
LOAEL = 234 mg/kg/day based on
lower neonatal body weights by day
21.
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Carcinogenicity rats - NOAEL = 2 mg/kg/day; LOAEL = 4 mg/kg/
chlorothalonil day based on increased kidney
weights as well as ulcers and
forestomach hyperplasia. Renal
tubular adenomas and carcinomas
were seen in male Fisher 344 rats
at 15 and 175 mg/kg/day and in
females at 175 mg/kg/day. The
incidence of forestomach papillomas
and carcinomas was increased at 175
mg/kg/day in males and at both 15
and 175 mg/kg/day in females.
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Carcinogenicity rats - NOAEL = <40 mg/kg/day; Chronic
chlorothalonil hyperplasia of cortical tubules and
pelvic/papillary epithelium,
tubular cysts were found at all
dose levels. Renal adenomas and
carcinomas as well as stomach
papillomas were also present at all
dose levels. Female rat renal
(adenomas and/or carcinomas) tumor
rates were 0/60 in the control, 2/
60 at 40 mg/kg/day, 7/61 at 80 mg/
kg/day, and 19/59 at 175 mg/kg/day.
------------------------------------------------------------------------
Carcinogenicity mice - NOAEL = <112.5 mg/kg/day; Bone
chlorothalonil marrow and spleen red pulp
hyperplasia, increased kidney
weights with surface
irregularities, pelvic dilation,
cysts and nodules, and stomach /
esophageal hyperplasia were found
at all dose levels (equivalent to
112.5, 225, or 450 mg/kg/day) in CD-
1 mice.
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Carcinogenicity rats - SDS-3701 NOAEL = 3.0 mg/kg/day; LOAEL = 10 mg/
kg/day based on reduced body
weight. There was no evidence of
carcinogenicity in either sex of
Sprague-Dawley rats.
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Carcinogenicity mice - SDS-3701 LOAEL = <54 mg/kg/day based on
increased liver-to-body weight
ratios in males. There was no
evidence of carcinogenicity in
either sex of CD-1 mice.
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[[Page 14332]]
Gene Mutation In light of considerable body of
evidence from acceptable whole
animal testing, it is concluded
that chlorothalonil is also not
calstogenic or aneugenic in rats,
mice or Chinese hamsters.
------------------------------------------------------------------------
Cytogenetics A weak positive response was seen
under non-activated conditions in
an in vivo cytogenetic CHO assay
and in the subchronic phase of an
in vivo bone marrow Chinese hamster
cytogenetic assay.
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Metabolism and pharmacokinetics Oral absorption was low
(approximately 33% of the
administered dose). Peak blood
levels were considered low (less
than 1% of the dose present in
blood). Elimination was primarily
by the gastrointestinal tract, with
80 - 90% in feces and approximately
15 - 20% was observed in bile.
------------------------------------------------------------------------
Dermal penetration An upper limit of 0.15% of
chlorothalonil that contacts the
skin during a workday is estimated
to be absorbed. The dermal
absorption rate is calculated using
the lowest LOAEL from the
subchronic oral dosing studies in
rats, the oral absorption rate
obtained from the rat metabolism
study and the LOAEL from the 21-day
dermal toxcity study.
------------------------------------------------------------------------
Cell proliferation study in male LOAEL = 175 mg/kg/day based on
Fisher 344 rats - chlorothalonil increased cell proliferation
correlated with histopathological
lesions of degeneration of the
proximal convoluted tubules and
epithelial hyperplasia.
------------------------------------------------------------------------
B. 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 level of concern
(LOC). 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
ariations 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 intraspecies differences. In the
case of acute dietary risk, effects were seen at the only dose tested
in the subchronic dietary toxicity study in rats; therefore, no NOAEL
was identified. Since the LOAEL was used for acute dietary risk
assessment, an additional UF of 3X was added to the conventional UF of
100X for a total UF of 300X.
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 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 x
10-\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 2:
Table 2.--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
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Acute Dietary general population LOAEL = 175 mg/kg/day FQPA SF = 1 aPAD = Subchronic dietary
including infants and children UF = 300 Acute RfD = acute RfD/FQPA SF = toxicity study in rats
0.58 mg/kg/day 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.
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[[Page 14333]]
Chronic Dietary general population NOAEL= 2 mg/kg/day; UF FQPA SF = 1 cPAD = Chronic toxicity/
including infants and children = 100; Chronic RfD = chronic RfD/FQPA SF = carcinogenicity study
0.02 mg/kg/day 0.02 mg/kg/day in rats LOAEL = 4 mg/
kg/day based on
increased kidney
weights and
hyperplasia of the
proximal convoluted
tubules in the kidneys
as well as ulcers and
forestomach
hyperplasia.
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Short-Term Dermal (1 to 7 days) dermal NOAEL = 600 mg/ LOC for MOE = 100 21-day dermal toxicity
(Residential) kg/day (dermal (Residential) study in rats; LOAEL =
absorption rate = 600 mg/kg/day based on
0.15%) No treatment-related
systemic toxicity in
the highest dose
tested.
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Intermediate-Term Dermal (1 week to dermal NOAEL = 600 mg/ LOC for MOE = 100 21-day dermal toxicity
several months) (Residential) kg/day (dermal (Residential) study in rats; LOAEL =
absorption rate = 600 mg/kg/day based on
0.15% no treatment-related
systemic toxicity in
the highest dose
tested.
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Short-, Intermediate, Long-Term Oral NOAEL = 2 mg/kg/ LOC for MOE = 100 Chronic toxicity/
Inhalation (Residential) day (inhalation (Residential) carcinogenicity study
absorption rate = in rats; LOAEL = 4 mg/
100%) kg/day based on
increased kidney
weights and
hyperplasia of the
proximal convoluted
tubules in the kidneys
as well as ulcers and
forestomach
hyperplasia.
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Cancer (oral, dermal, inhalation) Q* = 7.66 x 10-3 (mg/ Chronic toxicity/
kg/day)-1 carcinogenicity study
in rats 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
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*.
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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
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\*\ 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 SPF 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
3:
[[Page 14334]]
Table 3.--Summary of Toxicological Dose and Endpoints for HCB for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
Dose Used in Risk FQPA SF* and Endpoint Study and
Exposure Scenario Assessment, UF for Risk Assessment Toxicological Effects
----------------------------------------------------------------------------------------------------------------
Chronic Dietary all populations NOAEL= 0.08 mg/kg/day Chronic RfD = 0.0008 130-week feeding study
UF = 100 mg/kg/day in rats. Effects
observed were hepatic
centrilobular
basophilic
chromogenesis.
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation) Q* = 1.02 (mg/kg/day)- Carcinogenicity study
1 in rodents. Based on
increased tumor
incidences in hamsters
and rats. A 3/4
scaling factor was
applied to the Q*.
----------------------------------------------------------------------------------------------------------------
C. 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 SDS-3701, in or on a variety of raw
agricultural commodities. At levels ranging from 0.05 ppm in cocoa
beans and bananas, edible pulp to 15 ppm in celery and papayas. Risk
assessments were conducted by EPA to assess dietary exposures from
chlorothalonil and its metabolite SDS-3701 in food as follows:
Food uses evaluated in the dietary (food) risk assessments were
the published uses of chlorothalonil in 40 CFR 180.275 and pending
uses. U.S. Food and Drug Administration monitoring data (1988-1993),
USDA Pesticide Data Program (PDP) (1992-1994 partial), and field trial
data are types of anticipated residue data provided for chlorothalonil
and HCB. Anticipated residues were used for pending tolerances for
pistachios (0.068 ppm), mangoes (0.3 ppm), asparagus (0.03 ppm) and
non-bell peppers (5 ppm). Percent of crop treated information was used
for most crops with established tolerances. Residues of HCB in plant
commodities were estimated to be present at 0.05% of the residues of
chlorothalonil. This level is equivalent to the maximum level of HCB
that is allowed in formulations of chlorothalonil. In meat products,
anticipated residues were estimated based on HCB feeding studies.
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 one day
or single exposure. The following assumptions were made for the acute
exposure assessments: The computerized modeling system (Dietary Risk
Evaluation System (DRES) was used to estimate acute dietary exposure.
The analysis evaluates individual food consumption as reported by
respondents in the USDA 1977-1978 Nationwide Food Consumption Survey
(NFCS) and accumulates exposure to chlorothalonil for each commodity.
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.
ii. Chronic exposure.In conducting this chronic dietary risk
assessment the computerized modeling system (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
[[Page 14335]]
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 described
in the following Table 4:
Table 4.--Estimation of Percentage of Crops Treated with Chlorothalonil
----------------------------------------------------------------------------------------------------------------
Anticipated Residues (ppm)
Commodity Processing factors -------------------------------- % crop
Chlorothalonil HCB treated
----------------------------------------------------------------------------------------------------------------
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 cooked, 0.0133 6.7 x 10-\6\ 40
canned or frozen beans
----------------------------------------------------------------------------------------------------------------
Broccoli None 0.0015 0.8 10-\6\ 15
----------------------------------------------------------------------------------------------------------------
Brussels sprouts None 0.0135 6.8 x 10-\6\ 42
----------------------------------------------------------------------------------------------------------------
Cabbage 0.2 for all food forms 0.0137 6.9 x 1010- 50
\6\
----------------------------------------------------------------------------------------------------------------
Cabbage, Chinese 0.2 for all food forms 0.0116 5.8 x 10-\6\ 100
----------------------------------------------------------------------------------------------------------------
Cattle fat None 0 1.65 x 10- None
\4\
----------------------------------------------------------------------------------------------------------------
Cattle meat None 0 1.24 x 10- None
\5\
----------------------------------------------------------------------------------------------------------------
Cattle liver None 0 8 x 10-\6\ None
----------------------------------------------------------------------------------------------------------------
Cattle kidney None 0 8 x 10-\6\ None
----------------------------------------------------------------------------------------------------------------
Cocoa 0.1 for all food forms 0.05 2.5 x 10-\6\ 100
----------------------------------------------------------------------------------------------------------------
Cantaloupe None 0.0191 9.6 x 10-\6\ 30
----------------------------------------------------------------------------------------------------------------
Carrots 0.005 for all cooked or 0.0036 1.8 x 10-\6\ 35
processed food forms
----------------------------------------------------------------------------------------------------------------
Cauliflower None 0.0115 5.8 x 10-\6\ 20
----------------------------------------------------------------------------------------------------------------
Celery None 0.0874 43.7 x 10- 85
\6\
----------------------------------------------------------------------------------------------------------------
Cherries 0.05 for all processed 0.002 1 x 10-\6\ 40
food forms
----------------------------------------------------------------------------------------------------------------
Cranberries None 0.4125 206 x 10-\6\ 60
----------------------------------------------------------------------------------------------------------------
Coffee 0.1 for all food forms 0.20 1 x 10-\4\ 100
----------------------------------------------------------------------------------------------------------------
Corn, sweet None 0.0002 0.1 x 10-\6\ 5
----------------------------------------------------------------------------------------------------------------
Cucumbers 0.2 for cold-canned 0.0062 3.1 x 10-\6\ 35
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
----------------------------------------------------------------------------------------------------------------
Onions, green and leeks None 0.0262 13.1 x 10- 65
\6\
----------------------------------------------------------------------------------------------------------------
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 cooked or 0.0018 0.9 x 10-\6\ 35
canned food forms
----------------------------------------------------------------------------------------------------------------
Peanuts 0.5 for peanut oil 0.0045 2.3 x 10-\6\ 90
----------------------------------------------------------------------------------------------------------------
[[Page 14336]]
Plums 0.33 for dried prunes 0.0005 0.3 x 10-\6\ 10
----------------------------------------------------------------------------------------------------------------
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 pumpkin 0.0065 3.3 x 10-\6\ 30
----------------------------------------------------------------------------------------------------------------
Soybeans 0.5 for soybean oil 0.00005 2.5 x 10-\8\ 1
----------------------------------------------------------------------------------------------------------------
Squash None for summer squash; 0.0058 2.9 x 10-\6\ 15
0.002 for raw winter
squash; 0.001 for cooked
winter squash
----------------------------------------------------------------------------------------------------------------
Tomatoes 0.25 for juice; 0.02 for 0.0716 35.8 x 10- 70
paste, puree and catsup \6\
----------------------------------------------------------------------------------------------------------------
Watermelon None 0.0228 11.4 x 10- 55
\6\
----------------------------------------------------------------------------------------------------------------
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 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 of
chlorothalonil have been found in ground water in Long Island, New
York, and have been attributed to potato use. These 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 States 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 database, (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--chlorothlonil 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 was 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
27
[[Page 14337]]
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 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
HCB and PCB concentrations in surface water would exceed 10 parts per
trillion (ppt) (0.01 ppb).
Surface water detections show much more variability than
concentrations in ground water and have been measured at up to 750 ppb.
These high values appear to include sorbed HCB. The HCB concentrations
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 residential exposure assumptions: The Agency
completed an exposure assessment for uses of chlorothalonil as an
additive containing 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 occur 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 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 product labels and have requested voluntary cancellation of
their 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 5:
[[Page 14338]]
Table 5.--surrogate Residential Post-application Scenarios and Cancer Risks from Chlorothalonil
----------------------------------------------------------------------------------------------------------------
Application Rate DFR (g/ Cancer Risk
Exposure Activity/Crop or Target (lb ai/acre) cm2) LADD* (mg/kg/day) (based on Q*)
----------------------------------------------------------------------------------------------------------------
Ornamentals (Transplanting/Pruning/ 0.183 0.41 2.6E-7 2.0E-9
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).
D. Safety Factor for Infants and Children
1. Safety factor for infants and children--i. 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
database 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.
ii. Prenatal and postnatal sensitivity. The developmental and
reproductive data for chlorothalonil indicate that there is no evidence
of increased sensitivity to chlorothalonil from pre- or post-natal
exposures. In the rat developmental toxicity study, the developmental
NOAEL and LOAEL were based on an increase in total resorptions 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 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 database 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 least nine other pesticides and which also
enters the environment from non-pesticidal sources.
E. 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 aggregrate risk assessment for acute
exposure to chlorothalonil is shown in the following Table 6:
[[Page 14339]]
Table 6.--Aggregate Risk Assessment for Acute Exposure to Chlorothalonil
and SDS-3701
------------------------------------------------------------------------
Population Subgroup LOC for MOE MOE
------------------------------------------------------------------------
Food - U.S. Population 300 1166
------------------------------------------------------------------------
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 1750
------------------------------------------------------------------------
Drinking water (ground water) - Children 300 110,000
------------------------------------------------------------------------
Drinking water (ground water) - Adults 300 380,000
Drinking water (surface water) - 300 50,000,000
Children
------------------------------------------------------------------------
Drinking water (surface water) - Adults 300 175,000,000
------------------------------------------------------------------------
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to combined
residues of chlorothalonil and SDS-3701 from food and water 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 62.1 g/L.
Based on monitoring data and fate properties, its 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 follow equation:
HCB Upper Bound Cancer Risk = Dietary Exposure (ARC) x
Q*
Based on 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 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 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 estimating 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 the 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 pesticidal 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 7:
[[Page 14340]]
Table 7.--Cancer Risks For Chlorothalonil, HCB, and PCB
--------------------------------------------------------------------------------------------------------------------------------------------------------
Upperbound Upperbound
Chemical Q* cancer risk Cancer MOE for Cancer Risk Cancer MOE for
(food) Food (Water) Water
--------------------------------------------------------------------------------------------------------------------------------------------------------
Chlorothalonil 0.00766 1.2 - 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 point in 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 manufacuring-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.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology is available in PAM II for non-
bell peppers and almonds. Residue analytical methods are available for
purposes of reregistration. The Pesticide Analytical Manual (PAM) Vol.
II lists Method I, a gas chromatography method with electron capture
detection (ECD), for the enforcement of tolerances for plant
commodities. Residue data for plant commodities were collected using
methods based on the enforcement method. An acceptable enforcement
method for residues of SDS-3701 tolerances for peanuts, potatoes, and
tomatoes which is a modification of the current enforcement method is
available. This method underwent successful validation and is suitable
for enforcement of tolerances for SDS-3710 in meat and milk.
B. International Residue Limits
There are no Codex, Mexican or Canadian MRLs for almonds, almond
hulls, asparagus, mango, and pistachio.
C. Conditions
All data pertaining to rotational crops have been evaluated and
deemed adequate. In response to Agency evaluations of confined
rotational crop data, there is a 12-month rotational crop restriction
on all pertinent product labels. Available data indicate that only
residue that was detected in rotated crops was the soil metabolite
(SDS-46851). Because of the low toxicity of this metabolite, an
exemption for the requirement of a tolerance for residues of the soil
metabolite 2-carbamyl-2,4,5-trichlorobenzoic acid (SDS-46851) as
inadvertent residues in rotated crops has been established (40 CFR
180.110).
V. Conclusion
Therefore, tolerances are established for combined residues of
chlorothalonil, chlorothalonil and its metabolite SDS-3701, in or on
almonds (nutmeats) at 0.05 ppm, almond hulls at 1.0 ppm, asparagus at
0.1 ppm, mangoes at 1.0 ppm, non-bell peppers at 5 ppm, and pistachios
at 0.2 ppm, and for residues of the metabolite, 4-hydroxy-2,5,6
trichloroisopthalonitrile (SDS-3701), in or on the following milk and
meat commodities: fat of cattle, hogs, goats, horses, and sheep at 0.1
ppm,; kidney of cattle, hogs, goats, horses and sheep at 0.5 ppm; mbyp
(except kidney) of cattle, goats, hogs, horses and sheep at 0.05 ppm,
meat of cattle, goats, hogs, horses, and sheep at 0.03 ppm and milk at
0.1 ppm.
VI. 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-301088 in the subject line on the
first page of your submission. All requests must be in writing, and
must be
[[Page 14341]]
mailed or delivered to the Hearing Clerk on or before May 11, 2001.
1. Filing the request. Your objection must specify the specific
provisions in 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 VI.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 docket control number OPP-301088, 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).
VII. Regulatory Assessment Requirements
This final rule establishes a tolerance under FFDCA section 408(d)
in response to a petition submitted to the Agency. 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). This final rule does not contain
any information collections subject to OMB approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et 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
petition under FFDCA section 408(d), 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 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
[[Page 14342]]
``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.
VIII. 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: January 24, 2001.
James Jones,
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), (346a) and 371.
2. Section 180.275 is amended by revising paragraph (a)
introductory text and redesignating it as paragraph (a)(1); by adding
in alphabetical order entries for ``almonds (nutmeat)''; ``almond
hulls''; ``mango''; ``peppers, non-bell''; and ``pistachio'' to the
table in newly designated paragraph (a)(1), and by adding new paragraph
(a) (2) to read as follows:
Sec. 180.275 Chlorothalonil; tolerances for residues.
(a) General. (1) Tolerances are established for the fungicide
chlorothalonil (tetrachloroisophthalonitrile) and its metabolite 4-
hydroxy-2,5,6-trichloroisophthalonitrile in or on the following food
commodities.
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Almonds (nutmeats)......................................... 0.05
Almond hulls............................................... 1.0
Asparagus.................................................. 0.1
* * * * *
Mango...................................................... 1.0
* * * * *
Peppers, (non-bell\1\)..................................... 5
* * * * *
Pistachio.................................................. 0.2
* * * * *
------------------------------------------------------------------------
\1\There are no U.S. registrations as of January, 2001.
(2) Tolerances are established for the metabolite 4-hydroxy-2,5,6-
trichloroisophthalonitrile in or on the following food commodities.
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Cattle, fat................................................ 0.1
Cattle, kidney............................................. 0.5
Cattle, mbyp (except kidney)............................... 0.05
Cattle, meat............................................... 0.03
Goat, fat.................................................. 0.1
Goat, kidney............................................... 0.5
Goat, mbyp, (except kidney)................................ 0.05
Goat, meat................................................. 0.03
Hog, fat................................................... 0.1
Hog, kidney................................................ 0.5
Hog, mbyp (except kidney).................................. 0.05
Hog, meat.................................................. 0.03
Horses, fat................................................ 0.1
Horses, kidney............................................. 0.5
Horses, mbyp (except kidney)............................... 0.05
Horses, meat............................................... 0.03
Milk....................................................... 0.1
Sheep, fat................................................. 0.1
Sheep, kidney.............................................. 0.5
Sheep, mbyp (except kidney)................................ 0.05
Sheep, meat................................................ 0.03
------------------------------------------------------------------------
* * * * *
[FR Doc. 01-6087 Filed 3-9-01; 8:45 am]
BILLING CODE 6560-50-S