Chlorothalonil; Pesticide Tolerances, 73580-73586 [E8-28597]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 73, Number 233 (Wednesday, December 3, 2008)]
[Rules and Regulations]
[Pages 73580-73586]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-28597]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2007-1106; FRL-8387-9]


Chlorothalonil; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for combined residues 
of chlorothalonil and its 4-hydroxy metabolite in or on Brassica, head 
and stem, subgroup 5A; ginseng; horseradish; lentil; okra; rhubarb; 
vegetable, cucurbit, group 9; vegetable, fruiting, group 8, except 
tomato; and yam, true. It also establishes a tolerance with regional 
registration for combined residues of chlorothalonil and its metabolite 
on persimmon and removes existing tolerances for combined residues of 
chlorothalonil and its metabolite on broccoli, brussels sprouts, 
cabbage, cauliflower, cucumber, melon, non-bell pepper, pumpkin, summer 
squash, and winter squash; as well as the time-limited tolerance on 
ginseng. These tolerances are no longer needed, since they are 
superseded by the new tolerances on Brassica, cucurbit and fruiting 
vegetables and the permanent tolerance on ginseng. Interregional 
Research Project Number 4 (IR-4) requested these tolerances under the 
Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective December 3, 2008. Objections and 
requests for hearings must be received on or before February 2, 2009, 
and must be filed in accordance with the instructions provided in 40 
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2007-1106. All documents in the 
docket are listed in the docket index available at https://
www.regulations.gov. Although listed in the index, some information is 
not publicly available, e.g., Confidential Business Information (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 in the electronic 
docket at https://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 Docket 
Facility is open 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: stanton.susan@epa.gov.

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 those 
engaged in the following activities:
     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 to 
provide 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. How Can I Access Electronic Copies of this Document?

    In addition to accessing electronically available documents at 
https://www.regulations.gov, you may access this Federal Register 
document electronically through the EPA Internet under the ``Federal 
Register'' listings at https://www.epa.gov/fedrgstr. You may also access 
a frequently updated electronic version of EPA's tolerance regulations 
at 40 CFR part 180 through the Government Printing Office's e-CFR site 
at https://www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, 21 U.S.C. 346a, any person may file 
an objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2007-1106 in the subject line on the first 
page of your submission. All requests must be in writing, and must be 
mailed or delivered to the Hearing Clerk as required by 40 CFR part 178 
on or before February 2, 2009.
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing that does not contain any CBI for inclusion in the public 
docket that is described in ADDRESSES. Information not marked 
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA 
without prior notice. Submit this copy, identified by docket ID number 
EPA-HQ-OPP-2007-1106, by one of the following methods:
     Federal eRulemaking Portal: https://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.

II. Petition for Tolerance

    In the Federal Register of January 23, 2008 (73 FR 3964) (FRL-8345-
7), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
7E7270) by Interregional Research Project Number 4 (IR-4), 500 College 
Road East, Suite 201W, Princeton, NJ 08540. The petition requested that 
40 CFR 180.275 be amended by establishing tolerances for combined 
residues of the fungicide chlorothalonil, tetrachloroisophthalonitrile, 
and its

[[Page 73581]]

metabolite, 4-hydroxy-2,5,6-trichloroisophthalonitrile, in or on 
vegetables, fruiting, group 8 at 5.0 parts per million (ppm); okra at 
5.0 ppm; persimmon at 1.9 ppm; horseradish at 4.0 ppm; rhubarb at 5.0 
ppm; ginseng at 3.0 ppm; yam at 5.0 ppm; lupine at 0.1 ppm; lentil at 
0.1 ppm; vegetable, cucurbit, group 9 at 5.0 ppm; and Brassica, head 
and stem, subgroup 5A at 5.0 ppm. That notice referenced a summary of 
the petition prepared by GB Biosciences Corporation, the registrant, on 
behalf of IR-4, which is available to the public in the docket, https://
www.regulations.gov. There were no comments received in response to the 
notice of filing.
    Based upon review of the data supporting the petition, EPA has 
revised the tolerance levels for ginseng, okra, persimmon, rhubarb, and 
yam. EPA has also determined that a tolerance is not needed for lupine 
and that the proposed tolerance for vegetable, fruiting, group 8 should 
exclude tomato and be set slightly higher than proposed. The reasons 
for these changes are explained in Unit IV.C.

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 the petitioned-for 
tolerances for combined residues of chlorothalonil and its 4-hydroxy 
metabolite on Brassica, head and stem, subgroup 5A at 5.0 ppm; ginseng 
at 4.0 ppm; horseradish at 4.0 ppm; lentil at 0.10 ppm; okra at 6.0 
ppm; persimmon at 1.5 ppm; rhubarb at 4.0 ppm; vegetable, cucurbit, 
group 9 at 5.0 ppm; vegetable, fruiting, group 8, except tomato at 6.0 
ppm; and yam, true at 0.10 ppm. EPA's assessment of exposures and risks 
associated with establishing 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 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, 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,

[[Page 73582]]

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 https://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 at 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 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 https://www.epa.gov/
pesticides/factsheets/riskassess.htm.
    The endpoint used to establish the cPAD for chlorothalonil has 
changed since EPA conducted its previous risk assessment, described in 
the Federal Register of July 27, 2007 (72 FR 41224) (FRL-8127-9). 
Previously, the cPAD was based on forestomach lesions observed in the 
mouse carcinogenicity study. EPA has reconsidered this endpoint and 
concluded that it is not appropriate for use in human risk assessment 
because of differences in the physiological characteristics of the 
forestomach in rodents compared to other species, including humans. 
Therefore, EPA has selected another endpoint (kidney lesions observed 
in the rat chronic toxicity/carcinogenicity study) as the basis for the 
cPAD.
    The dose used to assess risk from short-term and intermediate-term 
incidental oral exposure to chlorothalonil has also changed. 
Previously, EPA assessed incidental oral exposures based on forestomach 
and kidney effects observed in the 2-generation reproduction study 
(LOAEL = 30.8 milligrams/kilograms/day (mg/kg/day)). EPA is now 
assessing incidental oral exposures to chlorothalonil based on kidney 
effects observed in a different study, the 90-day rat feeding study 
(LOAEL = 10 mg/kg/day). This study provides the lowest NOAEL (3.0 mg/
kg/day) and LOAEL in the database for short-term/intermediate-term 
exposures, and the study length is the most appropriate to assess 
exposures of these durations.
    A summary of the toxicological endpoints for chlorothalonil used 
for human risk assessment can be found at https://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 at 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 petitioned-for 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 United States 
Department of Agriculutre (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 (CT), 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

[[Page 73583]]

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 https://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 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-term/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 https://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 pre- 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 (13\th\ 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 (UF) is not required to account 
for potential neurotoxicity or immunotoxicity. The reasons for this 
determination are explained below:

[[Page 73584]]

    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 UF 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 highest dose tested, 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 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 UF 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-term/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 this unit, EPA also assessed incidental oral 
exposure 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 LOC.
    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

[[Page 73585]]

Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone 
number: (410) 305-2905; e-mail address: residuemethods@epa.gov.

B. International Residue Limits

    The Codex Alimentarius Commission has established maximum residue 
limits (MRLs) for chlorothalonil per se on several commodities 
associated with this petition: 7 ppm for sweet pepper; 5 ppm each for 
broccoli, brussels sprouts, cucumber, and squash (summer and winter); 2 
ppm for melons (except watermelon); and 1 ppm each for cabbage, heads 
and cauliflower. Some of these MRLs are set at the same nominal value 
as the U.S. tolerances (broccoli and brussels sprouts from the Brassica 
group; cucumber and squash from the cucurbit group). However, since the 
U.S. tolerance definition includes the 4-hydroxy metabolite, 
harmonization with CODEX is not possible at this time.

C. Revisions to Petitioned-For Tolerances

    Based upon review of the data supporting the petition, EPA has 
revised the tolerance levels for ginseng, okra, persimmon, rhubarb, and 
yam. EPA has also determined that a tolerance is not needed for lupine 
and that the proposed tolerance for fruiting vegetable group 8 should 
exclude tomato and be set slightly higher than proposed. EPA revised 
the tolerance levels for ginseng from 3.0 to 4.0 ppm, rhubarb from 5.0 
to 4.0 ppm, persimmon from 1.9 to 1.5 ppm, and vegetable, fruiting, 
group 8 and okra from 5.0 to 6.0 ppm, based on analyses of the residue 
field trial data using the Agency's Tolerance Spreadsheet in accordance 
with the Agency's Guidance for Setting Pesticide Tolerances Based on 
Field Trial Data. The Agency determined that a tolerance is not needed 
for lupine, since residues on lupine are covered by the existing 
tolerance on dry bean seed. Tomato was excluded from fruiting vegetable 
group 8 based on differences in the use pattern for tomatoes and the 
other members of this group. The tolerance for yam was reduced from 5.0 
to 0.1 ppm, based on data translated from potato. The 5.0 ppm level 
proposed by the petitioner appears to have been a typographical error 
in the petition, since the 0.1 ppm level was discussed elsewhere in the 
text of the petition.

V. Conclusion

    Therefore, tolerances are established for combined residues of 
chlorothalonil, tetrachloroisophthalonitrile, and its metabolite, 4-
hydroxy-2,5,6-trichloroisophthalonitrile, in or on Brassica, head and 
stem, subgroup 5A at 5.0 ppm; ginseng at 4.0 ppm; horseradish at 4.0 
ppm; lentil at 0.10 ppm; okra at 6.0 ppm; persimmon at 1.5 ppm; rhubarb 
at 4.0 ppm; vegetable, cucurbit, group 9 at 5.0 ppm; vegetable, 
fruiting, group 8, except tomato at 6.0 ppm; and yam, true at 0.10 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances 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 final rule has been 
exempted from review under Executive Order 12866, this final 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) or Executive Order 13045, entitled 
Protection of Children from Environmental Health Risks and Safety Risks 
(62 FR 19885, April 23, 1997). 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., 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).
    Since tolerances and exemptions that are established on the basis 
of a petition under section 408(d) of FFDCA, 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.
    This final rule directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of FFDCA. As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled Federalism (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
Consultation and Coordination with Indian Tribal Governments (65 FR 
67249, November 9, 2000) do not apply to this final rule. In addition, 
this final rule does not 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).
    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).

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report 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: November 13, 2008.
 Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. Section 180.275 is amended by:
0
i. Removing the entries for Broccoli; Brussels sprouts; Cabbage; 
Cauliflower; Cucumber; Melon; Pepper, nonbell (and its associated 
footnote); Pumpkin; Squash, summer; and Squash, winter from the table 
in paragraph (a)(1).
0
ii. Alphabetically adding commodities to the table in paragraph (a)(1).
0
iii. Revising paragraph (b).
0
iv. Alphabetically adding commodities to the table in paragraph (c) to 
read as follows:

[[Page 73586]]

Sec.  180.275  Chlorothalonil; tolerances for residues.

    (a) * * *
    (1) * * *

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
                                * * * * *
    Brassica, head and stem, subgroup 5A.............                5.0
                                * * * * *
Ginseng..............................................                4.0
Horseradish..........................................                4.0
Lentil...............................................               0.10
                                * * * * *
Okra.................................................                6.0
                                * * * * *
Rhubarb..............................................                4.0
                                * * * * *
Vegetable, cucurbit, group 9.........................                5.0
Vegetable, fruiting, group 8, except tomato..........                6.0
Yam, true............................................               0.10
------------------------------------------------------------------------

* * * * *
    (b) Section 18 emergency exemptions. [Reserved]
    (c) * * *

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
                                * * * * *
Persimmon............................................                1.5
------------------------------------------------------------------------

* * * * *
[FR Doc. E8-28597 Filed 12-2-08; 8:45 am]
BILLING CODE 6560-50-S