Document ID: EPA-HQ-OPP-2008-0478-0003
Agency: epa
Document Type: Rule
Title: Pyrimethanil; Pesticide Tolerances
Posted Date: 2009-07-08T04:00Z

[Federal Register: July 8, 2009 (Volume 74, Number 129)]
[Rules and Regulations]               
[Page 32443-32448]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08jy09-17]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2008-0478; FRL-8423-6]

 
Pyrimethanil; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation replaces existing tolerances for residues of 
pyrimethanil on fruit, citrus, group 10 postharvest; and fruit, stone, 
group 12, except cherry with tolerances for residues of pyrimethanil in 
or on fruit, citrus, group 10, except lemon, postharvest; fruit, stone, 
group 12; and lemon, preharvest and postharvest. Interregional Research 
Project Number 4 (IR-4) requested these tolerances under the Federal 
Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective July 8, 2009. Objections and 
requests for hearings must be received on or before September 8, 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-2008-0478. 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., 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 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 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 
http://www.regulations.gov, you may access this Federal Register 
document electronically through the EPA Internet under the ``Federal 
Register'' listings at http://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 cite 
at http://www.gpoaccess.gov/ecfr. To access the OPPTS Harmonized 
Guidelines referenced in this document, go directly to the guidelines 
at http://www.epa.gpo/opptsfrs/home/guidelin.htm.

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

[[Page 32444]]

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-2008-0478 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 September 8, 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-2008-0478, 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.

II. Petition for Tolerance

    In the Federal Register of July 9, 2008 (73 FR 39289) (FRL-8371-2), 
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 8E7353) 
by IR-4, 500 College Road East, Suite 201W, Princeton, NJ 08540. The 
petition requested that 40 CFR 180.518 be amended by establishing 
tolerances for residues of the fungicide pyrimethanil, 4,6-dimethyl-N-
phenyl-2-pyrimidinamine, in or on fruit, citrus, (except lemon), group 
10 (postharvest) at 10 parts per million (ppm); lemon at 11 ppm; and 
fruit, stone, group 12 at 10 ppm; and removing existing tolerances for 
residues of pyrimethanil on fruit, citrus, group 10 postharvest at 10 
ppm; and fruit stone, group 12, except cherry at 3.0 ppm. That notice 
referenced a summary of the petition prepared by Bayer CropScience, the 
registrant, on behalf of IR-4, which is available to the public in the 
docket, http://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 made 
minor changes to the citrus commodity definitions. The reason for these 
changes is 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 residues of pyrimethanil on fruit, citrus, group 10, 
except lemon, postharvest at 11 ppm; fruit, stone, group 12 at 10 ppm; 
and lemon, preharvest and postharvest at 11 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.
    Pyrimethanil is of low acute toxicity by the oral, inhalation, and 
dermal routes of exposure. It is slightly irritating to the eyes and 
non-irritating to the skin in rabbit studies. Pyrimethanil is not a 
dermal sensitizer. Subchronic and chronic repeated oral toxicity 
studies in rats, mice, and dogs primarily resulted in decreased body 
weight and body-weight gains, often accompanied by decreased food 
consumption. The major target organs in rats and mice were the liver 
and thyroid. In subchronic studies in rats and mice, liver toxicity was 
manifested as increased absolute and relative liver weights. 
Histopathological changes in the liver were primarily associated with 
increased evidence of hypertrophy in centrilobular hepatocytes. In a 
subchronic toxicity study in mice, increases in absolute thyroid weight 
were observed, associated with exfoliative necrosis and pigmentation of 
follicular cells. In a subchronic toxicity study in rats, thyroid 
effects were manifested as an increased incidence and severity of 
follicular epithelial hypertrophy and follicular epithelial brown 
pigment.
    EPA classified pyrimethanil as a Group C (possible human) 
carcinogen, based on an increased incidence of thyroid follicular cell 
tumors observed in the chronic/carcinogenicity study in rats. There was 
no evidence of carcinogenicity in mice; however, the dosing in this 
study was not considered to be adequate to assess the potential 
carcinogenicity. Therefore, EPA is requesting a repeat of the mouse 
carcinogenicity study. Based on the presence of thyroid tumors in rats, 
EPA has determined that a margin of exposure (MOE) approach is 
appropriate for quantification of risk. This determination is based on 
evidence that pyrimethanil appears to induce thyroid tumors through a 
disruption in the thyroid-pituitary status and thus may have a 
threshold for tumor development. This decision was supported by the 
weight of the evidence, considering the neoplastic, related 
nonneoplastic and/or hormonal effects in the male rat thyroid and 
liver. A point of departure (POD) of 17 milligrams/kilograms/day (mg/
kg/day), based on the thyroid precursor lesions is used for 
establishing the chronic population adjusted dose (cPAD) for 
pyrimethanil. The cPAD will be protective of any potential cancer and 
non-cancer effects from exposure to pyrimethanil. At this time, there 
is less concern for the lack of a repeat mouse carcinogenicity study, 
since no toxicologically significant effects were

[[Page 32445]]

noted up to the highest dose tested (HDT) (254 mg/kg/day) in the 
existing mouse study, and the new study will be tested at higher doses. 
Consequently EPA does not believe that the new study will yield a POD 
lower than the current POD (17 mg/kg/day) used for risk assessment.
    Signs of potential neurotoxicity (ataxia, decreased motor activity, 
decreased body temperature, decreased hind limb grip strength in males, 
and dilated pupils in females) were observed at the HDT (1,000 mg/kg/
day) in the acute neurotoxicity study in rats. No signs of 
neurotoxicity were evident at doses up to 392 mg/kg/day in the 
subchronic neurotoxicity study in rats; and there was no evidence of 
neuropathology in either the acute or subchronic neurotoxicity study or 
in any of the subchronic and chronic toxicity studies in mice, rats and 
dogs.
    There was no quantitative or qualitative evidence of increased 
susceptibility of fetuses in the developmental toxicity studies in rats 
and rabbits or of offspring in the 2-generation reproduction toxicity 
study in rats. In the rat developmental toxicity study, maternal 
effects (decreased body weight and weight gain) and fetal effects 
(decreases in mean litter weight and mean fetal weight) were observed 
at the same dose. Similarly, in the rabbit developmental toxicity 
study, fetal effects (decreased body weight, weight gain, food 
consumption, and production and size of fecal pellets; increase in 
fetal runts; retarded ossification; 13 thoracic vertebrae and pairs of 
ribs; and deaths) occurred at a dose that produced similar maternal 
toxicity (decreased body weight, weight gain, food consumption, and 
production and size of fecal pellets, and deaths). There were no 
effects on fertility or reproduction in the 2-generation reproduction 
study in rats. In this study, adverse effects (decreased body weight/
weight gain) also occurred at the same dose in parental animals and 
pups.
    Specific information on the studies received and the nature of the 
adverse effects caused by pyrimethanil 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 Pyrimethanil Human-Health Risk 
Assessment for Proposed Uses on Stone Fruits and Citrus Fruits, page 39 
in docket ID number EPA-HQ-OPP-2008-0478.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no 
appreciable risk, a toxicological POD is identified as the basis for 
derivation of reference values for risk assessment. The POD may be 
defined as the highest dose at which no adverse effects are observed 
(the NOAEL) in the toxicology study identified as appropriate for use 
in risk assessment. However, if a NOAEL cannot be determined, the 
lowest dose at which adverse effects of concern are identified (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 cPAD. The aPAD and 
cPAD are calculated by dividing the POD by all applicable UFs. 
Aggregate short-, intermediate-, 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 http://www.epa.gov/
pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for pyrimethanil used for 
human risk assessment can be found at http://www.regulations.gov in the 
document Pyrimethanil Human-Health Risk Assessment for Proposed Uses on 
Stone Fruits and Citrus Fruits, page 20 in docket ID number EPA-HQ-OPP-
2008-0478.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to pyrimethanil, EPA considered exposure under the petitioned-
for tolerances as well as all existing pyrimethanil tolerances in 40 
CFR 180.518. EPA assessed dietary exposures from pyrimethanil 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. EPA identified such effects 
for the general population (decreased motor activity, ataxia, decreased 
body temperature, hind limb grip strength, and dilated pupils observed 
in the acute neurotoxicity study) and for females 13 to 49 years old 
(increase in fetuses with 13 thoracic vertebrae and 13 pairs of ribs 
observed in the rabbit developmental toxicity study that are presumed 
to occur after a single exposure). The aPAD for the general population 
has been established at 1 mg/kg/day; whereas, the aPAD for females 13 
to 49 years old is lower (0.45 mg/kg/day) due to the more sensitive 
endpoint on which it is based.
    In estimating acute dietary exposure, EPA used food consumption 
information from the United States Department of Agriculture (USDA) 
1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by 
Individuals (CSFII). As to residue levels in food, EPA assumed that 
pyrimethanil residues are present in all commodities at tolerance 
levels and that 100% of all crops are treated.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA 1994-1996 
and 1998 CSFII. As to residue levels in food, EPA assumed that 
pyrimethanil residues are present in all commodities at tolerance 
levels and that 100% of all crops are treated.
    iii. Cancer. EPA classified pyrimethanil as a Group C (possible 
human) carcinogen but determined that the chronic dietary risk 
assessment based on the cPAD would be protective of any potential 
cancer effects. Therefore, a separate exposure assessment to evaluate 
cancer risk is unnecessary. The weight of the evidence supporting this 
determination is discussed in unit III.A.
    iv. Anticipated residue and percent crop treated (PCT) information. 
EPA did not use anticipated residue or PCT information in the dietary 
assessment for pyrimethanil. Tolerance level residues and 100 PCT were 
assumed for all food commodities.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for pyrimethanil in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of pyrimethanil. Further information regarding EPA 
drinking water models

[[Page 32446]]

used in pesticide exposure assessment can be found at http://
www.epa.gov/oppefed1/models/water/index.htm.
    Based on 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 
pyrimethanil for acute exposures are estimated to be 37.8 parts per 
billion (ppb) for surface water and 4.8 ppb for ground water. EDWCs of 
pyrimethanil for chronic exposures for non-cancer assessments are 
estimated to be 5.1 ppb for surface water and 4.8 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For acute dietary risk 
assessment, the water concentration value of 37.8 ppb was used to 
assess the contribution to drinking water. For chronic dietary risk 
assessment, the water concentration of value 5.1 ppb was used to assess 
the contribution to 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). Pyrimethanil is not 
registered for any specific use patterns that would result in 
residential exposure.
    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.''
    EPA has not found pyrimethanil to share a common mechanism of 
toxicity with any other substances, and pyrimethanil does not appear to 
produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
pyrimethanil 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 Food Quality 
Protection Act of 1996 (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 
toxicology database for pyrimethanil includes rat and rabbit 
developmental toxicity studies and a 2-generation reproduction toxicity 
study in rats. As discussed in unit III.A., there was no evidence of 
increased quantitative or qualitative susceptibility of fetuses or 
offspring following exposure to pyrimethanil in these studies.
    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 pyrimethanil is adequate to assess the 
prenatal and postnatal toxicity of pyrimethanil. In accordance with 40 
CFR part 158's toxicological data requirements, an immunotoxicity 
testing study (OPPTS Guideline 870.7800) is required for pyrimethanil. 
The evidence for immunotoxicity in the existing database is limited to 
a slight decrease in thymus weight observed at the HDT (529 mg/kg/day) 
in the subchronic study in rats. There were no corroborative 
histopathological findings noted in the thymus in this study, and there 
were no effects on the thymus in the chronic/carcinogenicity study in 
rats at doses up to and including 221 mg/kg/day or in any other study 
with pyrimethanil. Since the observed thymus weight increase is an 
isolated finding, EPA does not believe that conducting immunotoxicity 
testing will result in a POD lower than the POD already selected for 
evaluating chronic exposures to pyrimethanil (17 mg/kg/day), and an 
additional database UF is not needed to account for potential 
immunotoxicity.
    ii. Although there were signs of potential neurotoxicity (ataxia, 
decreased motor activity, decreased body temperature, decreased hind 
limb grip strength in males, and dilated pupils in females) observed at 
the HDT (1,000 mg/kg/day) in the acute neurotoxicity study, there were 
no signs of neurotoxicity at doses up to 392 mg/kg/day in the 
subchronic neurotoxicity study; and there was no evidence of 
neuropathology in either the acute or subchronic neurotoxicity study or 
in any of the subchronic and chronic toxicity studies in mice, rats and 
dogs. Based on these findings, EPA has determined that there is no need 
for a developmental neurotoxicity study or additional UFs to account 
for neurotoxicity.
    iii. There is no evidence that pyrimethanil results in increased 
susceptibility in in utero rats or rabbits in the prenatal 
developmental studies or in offspring in the 2-generation reproduction 
study. There are no residual uncertainties for prenatal and/or 
postnatal toxicity.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on 100 PCT and tolerance-level residues. EPA made conservative 
(protective) assumptions in the ground and surface water modeling used 
to assess exposure to pyrimethanil in drinking water. Pyrimethanil is 
not registered for any uses that would result in residential exposures 
to the pesticide. These assessments will not underestimate the exposure 
and risks posed by pyrimethanil.

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-, intermediate-, 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. Using the exposure assumptions discussed in this unit 
for acute exposure, EPA performed two different acute risk assessments-
one focusing on females 13 to 49 years old and designed to protect 
against prenatal effects and the other focusing on acute effects

[[Page 32447]]

relevant to all other population groups. For females 13 to 49 years 
old, the acute dietary exposure to pyrimethanil from food and water 
will occupy 13% of the aPAD addressing prenatal effects. As to acute 
effects other than prenatal effects, the acute dietary exposure to 
pyrimethanil from food and water will occupy 35% of the aPAD for 
infants less than 1-year old, the population group with the highest 
estimated acute dietary exposure to pyrimethanil.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
pyrimethanil from food and water will utilize 63% of the cPAD for 
children 1 to 2 years old, the population group receiving the greatest 
exposure. There are no residential uses for pyrimethanil.
    3. Short-term risk. Short-term aggregate exposure takes into 
account short-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level). Pyrimethanil 
is not registered for any use patterns that would result in residential 
exposure. Therefore, the short-term aggregate risk is the sum of the 
risk from exposure to pyrimethanil through food and water and will not 
be greater than the chronic aggregate risk.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level). Pyrimethanil is not registered for any use patterns that would 
result in intermediate-term residential exposure. Therefore, the 
intermediate-term aggregate risk is the sum of the risk from exposure 
to pyrimethanil through food and water, which has already been 
addressed, and will not be greater than the chronic aggregate risk.
    5. Aggregate cancer risk for U.S. population. The Agency has 
determined that the chronic risk assessment based on the established 
cPAD is protective of potential cancer effects from exposure to 
pyrimethanil. Based on the results of the chronic risk assessment 
discussed in Unit III.E.2. EPA concludes that pyrimethanil is not 
expected to pose a cancer risk.
    6. 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 pyrimethanil residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (High Performance Liquid 
Chromatography (HPLC)) 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: 
residuemethods@epa.gov.

B. International Residue Limits

    Codex maximum residue limits (MRLs) have been established for 
pyrimethanil per se in/on plant commodities associated with this 
petition, including citrus fruit at 7 ppm (postharvest); cherry 
(postharvest), peach and nectarine at 4 ppm; apricot at 3 ppm; and plum 
at 2 ppm. Due to differences in application rates and use patterns, 
harmonization of U.S. tolerances with the lower Codex MRLs is not 
possible at this time.

C. Revisions to Petitioned-For Tolerances

    IR-4 petitioned for tolerances for residues of pyrimethanil on 
``fruit, citrus, (except lemon), group 10, (postharvest)'' and on 
``lemon.'' EPA revised the group tolerance to read ``fruit, citrus, 
group 10, except lemon, postharvest'' to agree with the accepted 
nomenclature in the Agency's Food and Feed Vocabulary Database. The 
tolerance for lemon was revised to read ``lemon, preharvest and 
postharvest'' to comply with the regulation at 40 CFR 180.1(h), which 
requires EPA to specify those tolerances intended to cover postharvest 
use of a pesticide.

V. Conclusion

    Therefore, tolerances are established for residues of pyrimethanil, 
4,6-dimethyl-N-phenyl-2-pyrimidinamine, in or on fruit, citrus, group 
10, except lemon, postharvest at 10 ppm; fruit, stone, group 12 at 10 
ppm; and lemon, preharvest and postharvest at 11 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

[[Page 32448]]

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: June 26, 2009.
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. The table in paragraph (a)(1) of Sec.  180.518 is amended by 
removing the commodities ``Fruit, citrus, group 10 postharvest'' and 
``Fruit, stone, group 12, except cherry'' and alphabetically adding the 
following commodities to read as follows:

Sec.  180.518  Pyrimethanil; tolerances for residues.

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

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
                                * * * * *
Fruit, citrus, group 10, except lemon, postharvest.........           10
                                * * * * *
Fruit, stone, group 12.....................................           10
                                * * * * *
Lemon, preharvest and postharvest..........................           11
                                * * * * *
------------------------------------------------------------------------

* * * * *

[FR Doc. E9-15942 Filed 7-7-09; 8:45 am]

BILLING CODE 6560-50-S