[Federal Register Volume 73, Number 233 (Wednesday, December 3, 2008)]
[Proposed Rules]
[Pages 73632-73637]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-28593]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2007-1106; FRL-8390-1]
Chlorothalonil; Proposed Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: This document proposes to establish tolerances for combined
residues of chlorothalonil and its 4-hydroxy metabolite in or on lychee
and starfruit under the Federal Food, Drug, and Cosmetic Act (FFDCA).
DATES: Comments must be received on or before February 2, 2009.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2007-1106, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is (703) 305-5805.
Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2007-1106. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line at
http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The regulations.gov website is an ``anonymous access'' system,
which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through regulations.gov,
your e-mail address will be automatically captured and included as part
of the comment that is placed in the docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
Docket: All documents in the docket are listed in the docket index
available at http://www.regulations.gov. Although listed in the index,
some information is not publicly available, e.g., CBI or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, is not placed on the Internet
and will be publicly available only in hard copy form. Publicly
available docket materials are available either in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The hours of
operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday
through Friday, excluding legal holidays. The Docket Facility telephone
number is (703) 305-5805.
FOR FURTHER INFORMATION CONTACT: Susan Stanton, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave, NW., Washington, DC 20460-0001; telephone
number: (703) 305-5218; 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 entities may include, but are not limited to:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
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 this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.
B. What Should I Consider as I Prepare My Comments for EPA?
1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or e-mail. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
2. Tips for preparing your comments. When submitting comments,
remember to:
i. Identify the document by docket ID number and other identifying
[[Page 73633]]
information (subject heading, Federal Register date and page number).
ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
iv. Describe any assumptions and provide any technical information
and/or data that you used.
v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
viii. Make sure to submit your comments by the comment period
deadline identified.
II. Background
EPA on its own initiative, under section 408(e) of FFDCA, 21 U.S.C.
346a(e), is proposing to establish tolerances for combined residues of
the fungicide, chlorothalonil, tetrachloroisophthalonitrile, and its
metabolite, 4-hydroxy-2,5,6-trichloroisophthalonitrile, in or on lychee
at 15 parts per million (ppm) and starfruit at 3.0 ppm. The United
States Department of Agriculture (USDA) requested that EPA establish
these tolerances. Because USDA did not submit a petition in support of
establishing these tolerances, EPA did not publish a Notice of Filing
of a petition for these tolerances.
III. Aggregate Risk Assessment and Determination of Safety
Section 408(b)(2)(A)(i) of 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) of FFDCA 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) of FFDCA 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. * *
*''
Consistent with section 408(b)(2)(D) of FFDCA, and the factors
specified in section 408(b)(2)(D) of FFDCA, 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 for tolerances for combined
residues of chlorothalonil and its 4-hydroxy metabolite on lychee at 15
ppm and starfruit at 3.0 ppm. EPA's assessment of exposures and risks
associated with establishing these tolerances 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.
Chlorothalonil has low acute toxicity by the oral and dermal routes
of exposure and is moderately toxic by the inhalation route. It is
severely irritating to the eye and moderately irritating to the skin
but is not a skin sensitizer.
Chlorothalonil causes gastric irritation upon ingestion. In a
subchronic dog study, both males and females exhibited decreased body
weights, body-weight gains and food consumption. In a chronic dog
study, there was one death (female), decreased body-weight gain and
food consumption, macroscopic and microscopic pathological findings in
the stomach (including thickened appearance of the stomach and intra-
epithelial nuclear pyknosis in the mucosal epithelium of the antrum of
the stomach) and a very slight hypertrophy of the cells in the zona
fasciculata of the adrenal glands. In a second chronic dog study,
vacuolated epithelium of the kidney was observed. In a subchronic mouse
study, chlorothalonil produced hyperplasia and hyperkeratosis of the
squamous epithelium of the stomach. In a subchronic rat study,
chlorothalonil increased relative kidney weights and produced dilated
renal medullary tubules as well as hyperplasia and hyperkeratosis of
the non-glandular area of the stomach. In rodent chronic toxicity
studies, there was an increased incidence of epithelial hyperplasia of
the limiting ridge and non-glandular region of the stomach in rats and
mice.
There are two toxicology data sets, submitted by different basic
registrants, available for chlorothalonil. There was no indication of a
carcinogenic response in the rat chronic toxicity/carcinogenicity study
from the newer data set; however, an increased incidence of renal
adenomas and carcinomas and an increased incidence of papillomas and/or
carcinomas of the forestomach were observed in both sexes of rats and
mice with the older data set. The new carcinogenicity study in mice
also demonstrates that chlorothalonil produces similar papillomas of
the forestomach. Based on the increased incidence of renal adenomas and
carcinomas observed in both sexes of rats and mice, the rarity of the
tumor response in the kidney, and the increased incidence of papillomas
and/or carcinomas of the forestomach in rats and mice, EPA classified
chlorothalonil as a ``likely'' human carcinogen by all routes of
exposure.
Several studies are available that address the mechanism of
carcinogenicity of chlorothalonil. Based on the mechanistic data
submitted for the kidney tumor response demonstrating a toxic response
of the kidney and forestomach to repeated dietary administration of
chlorothalonil, the mode of action for tumor induction of
chlorothalonil is likely to be non-linear. With regard to the
forestomach tumors, data submitted by the registrant showing cell
proliferation and non-neoplastic pathology at doses near those
producing a tumorigenic response also support a non-linear mode of
action for chlorothalonil. Based on the weight of the evidence
presented to the Agency, EPA has concluded that a non-linear risk
assessment using a Margin of Exposure (MOE) approach is appropriate for
chlorothalonil.
No developmental toxicity was observed in two rat developmental
toxicity studies or in one of the two rabbit developmental toxicity
studies available for chlorothalonil. In the other rabbit study, there
was an increased incidence of thirteen ribs and reduced sternebrae in
the absence of maternal toxicity. There was no evidence of reproductive
toxicity in either rat reproduction study available for chlorothalonil.
There is no evidence that chlorothalonil causes neurotoxicity.
There was no evidence of neuropathology, and there were no central
nervous system (CNS) malformations, effects on brain weights, abnormal
behavior or effects on offspring sexual maturation observed in the
toxicity studies available for
[[Page 73634]]
chlorothalonil, including a subchronic neurotoxicity study in rats.
In a 90-day oral toxicity study in rats, a slight decrease in
thymus weight was observed at the highest dose tested (HDT), a possible
indication of immunotoxicity. However, since there were no
histopathological findings noted in the thymus and no effects on the
thymus observed in other subchronic or chronic/carcinogenicity studies
in rats, EPA has concluded that the slight effect on thymus weight seen
in this study is a spurious effect and not indicative of
immunotoxicity.
4-hydroxy-2,5,6-trichloroisophthalonitrile is a major metabolite of
chlorothalonil in plants and the predominant residue in animals.
Toxicology data available for this metabolite include acute oral and
subchronic toxicity studies in rats, developmental toxicity studies in
rats and rabbits, a reproduction toxicity study in rats, a chronic
toxicity study in dogs and chronic/carcinogenicity studies in rats and
mice. The results of these studies indicate that the toxicity of the 4-
hydroxy metabolite is similar to that of parent chlorothalonil. Based
on this determination, EPA has concluded that the chlorothalonil risk
assessment adequately accounts for potential toxicity resulting from
exposure to 4-hydroxy chlorothalonil, and a separate risk assessment is
not needed.
Specific information on the studies received and the nature of the
adverse effects caused by chlorothalonil and 4-hydroxy chlorothalonil,
as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-
observed-adverse-effect-level (LOAEL) from the toxicity studies can be
found at http://www.regulations.gov in the document Chlorothalonil.
Petition For Tolerances on Brassica Head and Stem Subgroup 5A, Cucurbit
Vegetable Group 9, Fruiting Vegetable Group 8, Ginseng, Horseradish,
Lentil, Lupin, Okra, Persimmon, Rhubarb, Yam, Lychee, and Starfruit.
Human-Health Risk Assessment, page 15 in docket ID number EPA-HQ-OPP-
2007-1106.
B. Toxicological Endpoints
For hazards that have a threshold below which there is no
appreciable risk, a toxicological point of departure (POD) is
identified as the basis for derivation of reference values for risk
assessment. The POD may be defined as the NOAEL in the toxicology study
identified as appropriate for use in risk assessment. However, if a
NOAEL cannot be determined, the LOAEL or a Benchmark Dose (BMD)
approach is sometimes used for risk assessment. Uncertainty/safety
factors (UFs) are used in conjunction with the POD to take into account
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. Safety is assessed for
acute and chronic dietary risks by comparing aggregate food and water
exposure to the pesticide to the acute population adjusted dose (aPAD)
and chronic population adjusted dose (cPAD). The aPAD and cPAD are
calculated by dividing the POD by all applicable UFs. Aggregate short-
term, intermediate-term, and chronic-term risks are evaluated by
comparing food, water, and residential exposure to the POD to ensure
that the margin of exposure (MOE) called for by the product of all
applicable UFs is not exceeded. This latter value is referred to as the
Level of Concern (LOC).
For non-threshold risks, the Agency assumes that any amount of
exposure will lead to some degree of risk. Thus, the Agency estimates
risk in terms of the probability of an occurrence of the adverse effect
greater than that expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
A summary of the toxicological endpoints for chlorothalonil used
for human risk assessment can be found at http://www.regulations.gov in
the document Chlorothalonil. Petition For Tolerances on Brassica Head
and Stem Subgroup 5A, Cucurbit Vegetable Group 9, Fruiting Vegetable
Group 8, Ginseng, Horseradish, Lentil, Lupin, Okra, Persimmon, Rhubarb,
Yam, Lychee, and Starfruit. Human-Health Risk Assessment, page 36 in
docket ID number EPA-HQ-OPP-2007-1106.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to chlorothalonil and its 4-hydroxy metabolite, EPA considered
exposure under the proposed tolerances as well as all existing
chlorothalonil tolerances in 40 CFR 180.275. EPA assessed dietary
exposures from chlorothalonil and its metabolite in food as follows:
i. Acute exposure. Quantitative acute dietary exposure and 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. No such effects were
identified in the toxicological studies for chlorothalonil; therefore,
a quantitative acute dietary exposure assessment is unnecessary.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 1994-1996
and 1998 Nationwide Continuing Surveys of Food Intakes by Individuals
(CSFII). As to residue levels in food, EPA assumed 100% crop treated,
tolerance-level residues and default processing factors for all foods
except tomatoes (average field-trial residues and empirical processing
factors used), peppers (average field-trial residues used) and snap
beans (average field-trial residues used).
iii. Cancer. Because chlorothalonil's cancer effects are the result
of chronic exposure, EPA is using the chronic exposure assessment to
assess chlorothalonil's cancer risk.
iv. Anticipated residue information. Section 408(b)(2)(E) of FFDCA
authorizes EPA to use available data and information on the anticipated
residue levels of pesticide residues in food and the actual levels of
pesticide residues that have been measured in food. If EPA relies on
such information, EPA must require pursuant to FFDCA section 408(f)(1)
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. For the present action, EPA will
issue such data call-ins as are required by FFDCA section 408(b)(2)(E)
and authorized under FFDCA section 408(f)(1). Data will be required to
be submitted no later than 5 years from the date of issuance of these
tolerances.
2. Dietary exposure from drinking water. The residues of concern in
drinking water include parent chlorothalonil and its 4-hydroxy
metabolite. The Agency used screening level water exposure models in
the dietary exposure analysis and risk assessment for chlorothalonil
and 4-hydroxy chlorothalonil in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of chlorothalonil and 4-hydroxy chlorothalonil. Further
information regarding EPA drinking water models used in pesticide
exposure assessment can be found at http://www.epa.gov/oppefed1/models/water/index.htm.
Based on the Pesticide Root Zone Model/Exposure Analysis Modeling
System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-
GROW) models, the estimated drinking water concentrations (EDWCs) of
chlorothalonil and its 4-hydroxy
[[Page 73635]]
metabolite for chronic exposures are estimated to be 68.2 parts per
billion (ppb) for surface water and 3.2 ppb for ground water.
Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For chronic dietary risk
assessment, the water concentration of value 68.2 ppb was used to
assess the contribution from drinking water.
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 the following uses that
could result in residential exposures: As a fungicide on golf courses
and as a preservative in paints. EPA assessed residential exposure
using the following assumptions: There is potential for short-term or
intermediate-term dermal exposure of adults and children on golf
courses that have been treated with chlorothalonil. There is also
potential for short-term/intermediate-term dermal and inhalation
exposure of handlers of paints containing chlorothalonil and potential
for short-term/intermediate-term postapplication dermal exposure of
adults, as well as short-/intermediate-term postapplication dermal and
episodic incidental oral exposures of children from the use of
chlorothalonil-treated paints in residential buildings. Postapplication
inhalation exposures to chlorothalonil on treated golf courses and in
buildings from treated paint are expected to be negligible, and the
Agency has not identified a hazard of concern for short-term or
intermediate-term dermal exposures; therefore, EPA assessed only short-
term and intermediate-term inhalation exposures of handlers using
chlorothalonil-treated paints and episodic postapplication incidental
oral exposures of children from the use of chlorothalonil-treated
paints in residential buildings.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA 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.''
Chlorothalonil is a polychlorinated fungicide. Other members of
this class include hexachlorobenzene (HCB), pentachlorophenol (PCP) and
pentachloronitrobenzene (PCNB). This is a very loose classification of
compounds related only in being polychlorinated and acting as
fungicides. Available data do not support a finding for a common
mechanism of toxicity for chlorothalonil and the other pesticides in
the polychlorinated fungicide class. Chlorothalonil produces renal
(kidney) tubular adenomas and carcinomas and papillomas of the stomach
in rats. Chlorothalonil also produces gastric lesions and kidney
toxicity due to perturbation of mitochondrial respiration. The other
pesticides in the class do not have the same toxic effects and do not
have the same mode of action. For the purposes of this tolerance
action, therefore, EPA has assumed that chlorothalonil does not have 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 EPA's website at http://www.epa.gov/pesticides/cumulative.
D. Safety Factor for Infants and Children
1. In general. Section 408(b)(2)(c) of FFDCA provides that EPA
shall apply an additional tenfold (10X) 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 based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA safety
factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
2. Prenatal and postnatal sensitivity. The prenatal and postnatal
toxicity database for chlorothalonil includes rat and rabbit
developmental toxicity studies (two of each) and two reproduction
toxicity studies in rats, as well as a subchronic neurotoxicity study
in rats. In addition, there are developmental toxicity studies in rats
and rabbits and reproduction toxicity studies in rats available for the
4-hydroxy metabolite as well as the major soil degradate, SDS-46851.
There was no evidence of increased qualitative or quantitative
susceptibility of fetuses or offspring in any of the submitted
developmental or reproduction studies for chlorothalonil or its
metabolites, except in one of the chlorothalonil developmental toxicity
studies in rabbits. In the newer of the two rabbit studies, there was a
slight increase in the incidence of two variations (13th rib and
reduced sternebrae) in fetuses in the high-dose group. No maternal
effects occurred at any dose in this study. EPA's concern for this
equivocal evidence of quantitative susceptibility is low, and there are
no residual uncertainties with regard to prenatal and postnatal
susceptability, for the following reasons: The variations were only
observed in one of the two developmental toxicity studies conducted in
the same strain of rabbit at the same dose levels; these variations are
known to occur spontaneously within this strain (New Zealand White) of
rabbit, as evidenced by the fact that the concurrent controls had high
incidences of both variations; and there is a well-defined NOAEL for
the study that is protective of these effects.
3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X. That decision is based on the following
findings:
i. The toxicity database for chlorothalonil is complete, except for
acute neurotoxicity and immunotoxicity studies, and EPA has determined
that an additional uncertainty factor is not required to account for
potential neurotoxicity or immunotoxicity. The reasons for this
determination are explained as follows:
a. EPA began requiring functional immunotoxicity testing of all
food and non-food use pesticides on December 26, 2007. Since this
requirement went into effect after the tolerance petition was
submitted, these studies are not yet available for chlorothalonil. In
the absence of specific immunotoxicity studies, EPA has evaluated the
available chlorothalonil toxicity data to determine whether an
additional database uncertainty factor is needed to account for
potential immunotoxicity. In a 90-day oral toxicity study in rats, a
slight decrease in thymus weight was observed at the HDT, a possible
indication of immunotoxicity. However, since there were no
histopathological findings noted in the thymus and no effects on the
thymus observed in other subchronic or chronic/carcinogenicity studies
in rats, EPA has concluded that the slight effect on thymus weight seen
in this study is a spurious effect and not indicative of
immunotoxicity. Due to the lack of evidence of immunotoxicity for
chlorothalonil, EPA does not believe that conducting immunotoxicity
testing will result in a NOAEL less than the NOAEL of 2 milligrams/
kilogram/day
[[Page 73636]]
(mg/kg/day) already established for chlorothalonil, and an additional
factor (UFDB) for database uncertainties is not needed to account for
potential immunotoxicity.
b. Acute neurotoxicity testing is also required as a result of
changes made to the pesticide data requirements in December of 2007.
Although an acute study has not yet been submitted, there is no
evidence of neurotoxicity in any study in the toxicity database for
chlorothalonil, including a subchronic neurotoxicity study. Therefore,
EPA has concluded that an additional uncertainty factor is not needed
to account for the lack of these data.
ii. Although there was equivocal evidence of increased quantitative
susceptibility of fetuses to chlorothalonil exposure in one of two
rabbit developmental toxicity studies, the Agency did not identify any
residual uncertainties after establishing toxicity endpoints and
traditional UFs to be used in the risk assessment.
iii. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments utilized tolerances or
anticipated residues that are based on reliable field trial data. EPA
made conservative (protective) assumptions in the ground and surface
water modeling used to assess exposure to chlorothalonil in drinking
water. EPA used similarly conservative assumptions to assess
postapplication incidental oral exposure of toddlers. These assessments
will not underestimate the exposure and risks posed by chlorothalonil.
E. Aggregate Risks and Determination of Safety
EPA determines whether acute and chronic pesticide exposures are
safe by comparing aggregate exposure estimates to the aPAD and cPAD.
The aPAD and cPAD represent the highest safe exposures, taking into
account all appropriate SFs. EPA calculates the aPAD and cPAD by
dividing the POD by all applicable UFs. For linear cancer risks, EPA
calculates the probability of additional cancer cases given the
estimated aggregate exposure. Short-term, intermediate-term, and
chronic-term risks are evaluated by comparing the estimated aggregate
food, water, and residential exposure to the POD to ensure that the MOE
called for by the product of all applicable UFs is not exceeded.
1. Acute risk. An acute aggregate risk assessment takes into
account exposure estimates from acute dietary consumption of food and
drinking water. No adverse effect resulting from a single-oral exposure
was identified and no acute dietary endpoint was selected. Therefore,
chlorothalonil is not expected to pose an acute risk.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
chlorothalonil from food and water will utilize 94% of the cPAD for
children, 1 to 2 years old, the population group receiving the greatest
exposure. Based on the explanation in Unit III.C.3., regarding
residential use patterns, chronic residential exposure to residues of
chlorothalonil is not expected.
3. Short-term/intermediate-term risk. Short-term or intermediate-
term aggregate exposure takes into account short-term or intermediate-
term residential exposure plus chronic exposure from food and water
(considered to be a background exposure level).
Chlorothalonil is currently registered for uses that could result
in short-term and intermediate-term residential exposure and the Agency
has determined that it is appropriate to aggregate chronic exposure
through food and water with short-term and intermediate-term
residential exposures to chlorothalonil. Since the doses and endpoints
selected for chlorothalonil to assess short-term and intermediate-term
exposure are identical, the short-term and intermediate-term risk
estimates for chlorothalonil are the same.
Using the exposure assumptions described in this unit for short-
term/intermediate-term exposures, EPA has concluded the combined short-
term/intermediate-term food, water, and residential exposures
aggregated result in an aggregate MOE of 270 for adults. The MOE for
adults includes food, drinking water and short-/intermediate-term
inhalation exposure of individuals mixing, loading and applying
chlorothalonil-treated paint with an airless sprayer, the handler
exposure scenario resulting in the highest estimated exposure to
chlorothalonil.
As discussed in Unit III.C.3., there is potential for short and
intermediate-term post-application dermal exposure of children on golf
courses and in residential areas where chlorothalonil-treated paints
have been used; however, EPA has not identified a toxicological
endpoint of concern for short or intermediate-term dermal exposures.
Therefore, for children, the short and intermediate-term aggregate risk
is the sum of the risk from food and water, which does not exceed the
Agency's level of concern.
EPA did assess incidental oral exposures of children from ingestion
of paint chips containing chlorothalonil. The estimated incidental oral
MOE for children is 1,200. Ingestion of paint chips is considered to be
an episodic, rather than a routine behavior; therefore, EPA has
determined that it is not appropriate to aggregate incidental oral
exposures with chronic exposures from food and drinking water.
4. Aggregate cancer risk for U.S. population. As discussed in Unit
III.A., EPA classified chlorothalonil as a ``likely'' human carcinogen
by all routes of exposure, based on the increased incidence of renal
adenomas and carcinomas observed in both sexes of rats and mice, the
rarity of the tumor response in the kidney, and the increased incidence
of papillomas and/or carcinomas of the forestomach in rats and mice.
EPA has determined that the mechanism of carcinogenicity of
chlorothalonil is non-linear (i.e. not a non-threshold effect) and that
the Point of Departure used in calculating the cPAD is protective of
the cancer effects. Since there are no uses of chlorothalonil expected
to result in chronic residential exposure, and since chronic dietary
exposure for the overall U.S. population is less than the cPAD (43% of
the cPAD), EPA concludes that aggregate cancer risk from exposure to
chlorothalonil is below the level of concern.
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, or to infants and children from aggregate
exposure to chlorothalonil residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (gas chromatography (GC) method
with electron-capture detection (ECD)) is available to enforce the
tolerance expression. The method may be requested from: Chief,
Analytical Chemistry Branch, Environmental Science Center, 701 Mapes
Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; e-mail
address: [email protected].
B. International Residue Limits
There are no established or proposed Codex MRLs for residues of
chlorothalonil on lychee or starfruit.
V. Conclusion
A tolerance is proposed for combined residues of chlorothalonil,
tetrachloroisophthalonitrile, and its metabolite, 4-hydroxy-2,5,6-
trichloroisophthalonitrile, in or on lychee at 15 ppm and starfruit at
3.0 ppm.
[[Page 73637]]
VI. Statutory and Executive Order Reviews
This proposed rule establishes a tolerance under section 408(d) of
FFDCA 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). Because this proposed rule has
been exempted from review under Executive Order 12866 due to its lack
of significance, this proposed rule is not subject to Executive Order
13211, entitled Actions Concerning Regulations That Significantly
Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001).
This proposed 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). Pursuant to the Regulatory Flexibility Act (RFA)
(5 U.S.C. 601 et seq.), the Agency hereby certifies that this proposed
action will not have significant negative economic impact on a
substantial number of small entities. Establishing a pesticide
tolerance or an exemption from the requirement of a pesticide tolerance
is, in effect, the removal of a regulatory restriction on pesticide
residues in food and thus such an action will not have any negative
economic impact on any entities, including small entities. 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 proposed 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 section 408(n)(4) of the FFDCA. For these same reasons, the Agency
has determined that this proposed 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 9, 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 proposed 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 proposed rule.
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: November 13, 2008.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
Therefore, it is proposed that 40 CFR chapter I be 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 alphabetically adding the
following commodities to the table in paragraph (a)(1) to read as
follows:
Sec. 180.275 Chlorothalonil; tolerances for residues.
(a) * * *
(1) * * *
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
* * * * *
Lychee............................................... 15
* * * * *
Starfruit............................................ 3.0
* * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. E8-28593 Filed 12-2-08; 8:45 am]
BILLING CODE 6560-50-S