Document ID: EPA-HQ-OPP-2008-0609-0004
Agency: epa
Document Type: Rule
Title: Pyrimethanil; Pesticide Tolerances
Posted Date: 2008-10-29T04:00Z

[Federal Register: October 29, 2008 (Volume 73, Number 210)]
[Rules and Regulations]               
[Page 64246-64252]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29oc08-17]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2008-0609; FRL-8384-7]

 
Pyrimethanil; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation amends the tolerances in the 40 CFR 180.518 
for residues of the fungicide, pyrimethanil, 4,6-dimethyl-N-phenyl-2-
pyrimidinamine, in or on pome fruit crop group 11, establishes 
tolerances for the residues of pyrimethanil in or on apple wet pomace, 
and amends the tolerances for residues of pyrimethanil

[[Page 64247]]

and its metabolites in or on milk, kidney of cattle, goat, horse and 
sheep. Pace International, LLC requested these tolerances under the 
Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective October 29, 2008. Objections and 
requests for hearings must be received on or before December 29, 2008, 
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-2008-0609. 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: Tamue L. Gibson, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-9096; e-mail address: gibson.tamue@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 pilot e-CFR 
site at http://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-2008-0609 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 December 29, 2008.
    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-2008-0609, 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 August 13, 2008 (73 FR 47164) (FRL-8377-
9), 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 
7F7250) by Pace International, LLC, 5661 Branch Road, Wapato, WA 98951. 
The petition requested that 40 CFR 180.518 be amended by increasing 
tolerances for residues of the fungicide pyrimethanil, 4,6-dimethyl-N-
phenyl-2-pyrimidinamine, in or on pome fruit crop group, namely apples, 
crabapple, loquat, mayhaw, pear, including oriental pear, and quince to 
14 parts per million (ppm), and pome fruit wet pomace to 56 ppm. The 
petitioner also proposed to increase the tolerances for the combined 
residues of the fungicide pyrimethanil, [4,6-dimethyl-N-phenyl-2-
pyrimidinamine] and its metabolite 4-[4,6-dimethyl-2-(pyrimidinyl) 
amino]phenol in or on kidney of cattle, goat, horse, and sheep to 0.6 
ppm, and to increase the tolerances for the combined residues of the 
fungicide pyrimethanil, 4, 6-dimethyl-N-phenyl-2-pyrimidinamine and its 
metabolite 4,6-dimethyl-2-(phenylamino)-5-pyrimidinol in milk to 0.06 
ppm. That notice referenced a summary of the petition prepared by Pace 
International, LLC, the registrant, which is available to the public in 
the docket, http://www.regulations.gov. Comments were received on the 
notice of filing. EPA's response to these comments is discussed in Unit 
IV.C.
    Pace International is seeking a tolerance increase for pyrimethanil 
to support the use of thermofogging as a viable method of application. 
It is generally recognized that thermofogging may result in variable 
residues dependent on a wide range of factors, and field studies on 
apples have demonstrated residue levels of pyrimethanil up to 9.47 ppm, 
which is greater than the existing pome fruit tolerance.
    Based upon review of the data supporting the petition, EPA is 
establishing a lower tolerance for pome

[[Page 64248]]

fruit wet pomace and milk and a higher tolerance for kidney of cattle, 
goat, horse, and sheep than were proposed. The reason for these changes 
is explained in Unit IV.D.

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 
increased tolerances for residues of the fungicide pyrimethanil, 4,6-
dimethyl-N-phenyl-2-pyrimidinamine, in or on pome fruit group 11 at 14 
ppm, apple, wet pomace at 40 ppm, cattle, goat, horse and sheep, kidney 
at 2.5 ppm and milk at 0.05 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. 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 body 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. There 
was no quantitative or qualitative evidence of increased susceptibility 
following prenatal exposure (in rats and rabbits), or postnatal 
exposure (in rats). There were no effects on fertility or reproduction 
in the 2-generation reproduction study in rats.
    No signs of neurotoxicity were evident at doses up to 392 
milligrams/kilograms/day (mg/kg/day) in the subchronic neurotoxicity 
study in rats. No evidence of neuropathology was seen in neurotoxicity 
studies, subchronic or chronic studies in mice, rats, and dogs.
    In a carcinogenicity study in mice, there was no increase in the 
incidence of any tumor types in either sex. In a carcinogenicity study 
in rats, the thyroid was the only tissue showing a higher incidence of 
tumors than those seen in the control group. In this study, benign 
follicular cell adenomas were seen in both sexes. A pair-wise 
comparison of the incidence in the high-dose treated males was not 
statistically significant when compared to the control group, while the 
high-dose females were determined to be statistically significant. EPA 
classified pyrimethanil as a Group C- possible human carcinogen; EPA is 
using a threshold or MOE approach to estimate cancer risk to humans 
based on its conclusion that the thyroid tumors associated with 
administration of pyrimethanil in Sprague-Dawley rats are likely to be 
due to a disruption in the thyroid-pituitary status. The mode of action 
for thyroid carcinogens such as pyrimethanil is a threshold effect that 
is well understood by the Agency. There is no concern for mutagenicity 
resulting from exposures to pyrimethanil.
    In a 90-day oral toxicity study with rats, a slight decrease in 
thymus weight was observed at 529 mg/kg/day (highest dose tested; 
(HDT)). There were no histopathological findings noted in the thymus. 
There were no effects on the thymus in the chronic carcinogenicity 
study in rats at doses up to and including 221 mg/kg/day HDT. 
Therefore, decreases in thymus weight in the 90-day study are 
considered equivocal and not a trigger for immunotoxicity study.
    Specific information on the studies received and the nature of the 
adverse effects caused by pyrimethanil, [4,6-dimethyl-N-phenyl-2-
pyrimidinamine] 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 document 
Pyrimethanil. Application for Amended Section 3 Registration of 
Xedathane A for Postharvest Use on Pome Fruits by Thermafog 
Application. Human-Health Risk Assessment, page 17 in docket ID number 
EPA-HQ-OPP-2008-0609.

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 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 chronic 
population adjusted dose (cPAD). The aPAD and cPAD are calculated by 
dividing the POD by all applicable UFs. Aggregate short-term, 
intermediate-, 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).

[[Page 64249]]

    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 
document Pyrimethanil. Application for Amended Section 3 Registration 
of Xedathane A for Postharvest Use on Pome Fruits by Thermafog 
Application, page 17 in docket ID number EPA-HQ-OPP-2008-0609.

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.
    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 Intakes by 
Individuals (CSFII). As to residue levels in food, EPA assumed 
tolerance-level residues, 100% crop treated (PCT), default processing 
factors as necessary, and empirical processing factors for orange and 
apple juice.
    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 tolerance-
level residues, 100 PCT, default processing factors as necessary, and 
empirical processing factors for orange and apple juice.
    iii. Cancer. The Agency has classified pyrimethanil as a Group C 
carcinogen based on thyroid follicular cell tumors in both sexes of the 
2-year rat study. A non-linear approach was used to assess cancer risk 
using the same exposure estimates as discussed in Unit III.C.1.ii, 
chronic exposure.
    iv. Anticipated residue and PCT information. EPA did not use 
anticipated residues and 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 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 
pyrimethanil and its major metabolite (2-amino-4,6-dimethylpyrimidine) 
for acute exposures are estimated to be 37.8 parts per billion (ppb) 
for surface water and 4.8 ppb for ground water and for chronic 
exposures 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 value of 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 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. Based on the results in 
developmental toxicity studies in rats and rabbits, there is no 
quantitative or qualitative evidence of increased susceptibility of rat 
or rabbit fetuses to in utero exposure to pyrimethanil. There were no 
effects on fertility or reproduction in the 2-generation reproduction 
study in rats. In a 90-day oral toxicity study with rats, a slight 
decrease in thymus weight was observed at 529 mg/kg/day HDT. There were 
no histopathological findings noted in the thymus. There were no 
effects on thymus in the chronic carcinogenicity study in rats at doses 
up to and including 221 mg/kg/day HDT. Therefore, decreases in thymus 
weight in the 90-day study are considered equivocal and not a trigger 
for an immunotoxicity study. Since an immunotoxicity study is now a 
data requirement in the revised 40 CFR part 158, it will be required as 
a condition of registration. However, a database uncertainty factor is 
not warranted since the effects (decreased thymus weight) were seen 
only in the 90-day study and not in a chronic study and the decrease in 
thymus weight was not associated with any histopathological finding. In 
addition, the current NOAEL of 17 mg/kg/day selected for cRfD would be 
protective of any potential immunotoxicity seen at a dose level of 529 
mg/kg/day.

[[Page 64250]]

    3. Conclusion. EPA has determined that reliable data show the 
safety of infants and children would be adequately protected if the 
FQPA SF was reduced to 1X. That decision is based on the following 
findings:
    i. The toxicity database for pyrimethanil is adequate. EPA 
classified the submitted subchronic neurotoxicity study as unacceptable 
because it was not conducted at doses up to 1,000 mg/kg/day (limit-
dose). Nonetheless, EPA determined that no additional data is needed on 
neurotoxicity because, given that no signs of neurotoxicity were 
evident at doses up to 392 mg/kg/day in the subchronic neurotoxicity 
study in rats and no evidence of neuropathology was seen in 
neurotoxicity studies, subchronic or chronic studies in mice, rats, and 
dogs, the results of a repeat study are not likely to impact the 
current endpoints used for risk assessment. EPA began requiring 
functional immunotoxicity testing (series 870.7800) of all food and 
non-food use pesticides on December 26, 2007. These studies are not yet 
available for pyrimethanil. In the absence of specific immunotoxicity 
studies, EPA has evaluated the available toxicity data for pyrimethanil 
and determined that an additional database uncertainty factor is not 
needed to account for potential immunotoxicity. In a 90-day oral 
toxicity study with rats, a slight decrease in thymus weight was 
observed at 529 mg/kg/day HDT. There were no histopathological findings 
noted in the thymus and a NOAEL of 54.5 mg/kg/day was established. 
There were no effects on thymus in the chronic carcinogenicity study in 
rats at doses up to and including 221 mg/kg/day HDT. Therefore, 
decreases in thymus weight in the 90-day study are considered equivocal 
and not a trigger for an immunotoxicity study. Since an immunotoxicity 
study is now a data requirement in the revised 40 CFR part 158, it will 
be required as a condition of registration. However, a database 
uncertainty factor is not warranted since the effects (decreased thymus 
weight) were seen only in the 90-day study and not in a chronic study, 
the effects were only seen at a relatively high dose, and the decrease 
in thymus weight was not associated with any histopathological finding.
    ii. Based on the weight of evidence, a developmental neurotoxicity 
study is not required for pyrimethanil since there is no evidence of 
neuropathology and no neurotoxic signs up to 392 mg/kg/day in a 
subchronic neurotoxicity study in rats where the only evidence of 
neurotoxicity occurs after an acute dose level (1,000 mg/kg) much 
higher than the doses used to establish endpoints for risk assessment.
    iii. There is no evidence that pyrimethanil results in increased 
susceptibility in in utero rats or rabbits in the prenatal 
developmental studies or in young rats in the 2-generation reproduction 
study.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessment utilizes tolerance-
level residues and 100 PCT for all proposed/established commodities. By 
using these assumptions, the acute and chronic exposures/risks will not 
be underestimated. The dietary drinking water assessment utilizes water 
concentration values generated by models and associated modeling 
parameters which are designed to provide conservative, health-
protective, high-end estimates of water concentrations which will not 
likely be exceeded. EPA made conservative (protective) assumptions in 
the ground and surface water modeling used to assess exposure to 
pyrimethanil in drinking water.

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, the acute dietary exposure from food and water to 
pyrimethanil will occupy 33% of the aPAD for (all infants < 1 year old) 
the population group receiving the greatest exposure.
    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 59% of the cPAD for 
(children 1-2 years old) the population group receiving the greatest 
exposure and 12% of the aPAD for the U.S. population as a whole. 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. A separate cancer 
dietary assessment was not conducted for pyrimethanil as the chronic 
assessment is considered protective for carcinogenic effects. Based 
upon chronic food plus water exposure of the general U.S. population, 
the MOE for cancer assessment is 830. For threshold cancer effects 
where the mode of action is well understood, like thyroid carcinogens 
such as pyrimethanil, the MOE that indicates a reasonable certainty of 
no harm would be 100 or greater (representing 2 factors of 10 for 
inter-species and intra-species extrapolation). Therefore, the 
aggregate cancer risk does not exceed the Agency's level of concern.
    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 and liquid chromatography-mass spectrometry (HPLC and 
LC-MS/MS) are available to enforce the tolerance expression. The method 
may be required from: Chief, Analytical Chemistry Branch,

[[Page 64251]]

Environmental Science Center, 701 Mapes Rd., Ft. Mead, 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 or on plant commodities. Codex MRLs have also 
been established for milk in terms of the sum of pyrimethanil and 2-
anilino-4,6-dimethylpyrimidin-5-ol, expressed as pyrimethanil, and for 
livestock tissues (excluding poultry) as the sum of pyrimethanil and 2-
(4-hydroxyanilino)-4,6-dimethylpyrimidine, expressed as pyrimethanil. 
Codex MRLs are listed for pome fruit at 7 ppm (postharvest), milk at 
0.05 ppm, dry apple pomace at 40 ppm, and edible offal at 0.1 ppm. 
Except for apple pomace and milk, harmonization is not feasible at this 
time, presumably due to differences in good agricultural practices.
    A Canadian MRL for pome fruit is established at 3 ppm. There are no 
Mexican MRLs established for residues of pyrimethanil on the crops 
associated with this tolerance petition.

C. Response to Comments

    One comment was received from an anonymous commenter objecting to 
increasing the tolerances. The comments contained no scientific data or 
evidence to rebut the Agency's conclusions that there is reasonable 
certainty that no harm will result from aggregate exposure to 
pyrimethanil.

D. Revisions to Petitioned-For Tolerances

    Based upon review of the dietary exposure levels and the residue 
data from an available ruminant feeding study, the existing 
pyrimethanil tolerances have been reassessed and the Agency has 
determined that the tolerances for residues in cattle, goat, horse, and 
sheep kidney should be increased to 2.5 ppm and the tolerance for 
residues in milk should be lowered to 0.05 ppm. Additionally, the 
apple, wet pomace residue tolerance should be lowered to 40 ppm.

V. Conclusion

    Therefore, tolerances are amended to increase the residues of the 
fungicide, pyrimethanil, 4,6-dimethyl-N-phenyl-2-pyrimidinamine, in or 
on pome fruit group 11 at 14 ppm, apple, wet pomace at 40 ppm, cattle, 
goat, horse and sheep, kidney at 2.5 ppm and milk at 0.05 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: October 9, 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 180.518 is amended by revising the following entries in the 
table in paragraphs (a)(1), (a)(2), and (a)(3) to read as follows:

Sec.  180.518  Pyrimethanil; tolerances for residues.

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

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
                                * * * * *
Apple, wet pomace....................................                 40
                                * * * * *
Fruit, pome, group 11 (pre-harvest and post-harvest).                 14
                                * * * * *
------------------------------------------------------------------------

    (2) * * *

[[Page 64252]]

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
                                * * * * *
Cattle, kidney.......................................                2.5
                                * * * * *
Goat, kidney.........................................                2.5
                                * * * * *
Horse, kidney........................................                2.5
                                * * * * *
Sheep, kidney........................................                2.5
                                * * * * *
------------------------------------------------------------------------

    (3) * * *

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
Milk.................................................               0.05
------------------------------------------------------------------------

* * * * *
[FR Doc. E8-25676 Filed 10-28-08; 8:45 am]

BILLING CODE 6560-50-S