Document ID: EPA-HQ-OPP-2015-0012-0005
Agency: epa
Document Type: Rule
Title: Pesticide Tolerances: Pyrimethanil
Posted Date: 2015-10-21T04:00Z

[Federal Register Volume 80, Number 203 (Wednesday, October 21, 2015)]
[Rules and Regulations]
[Pages 63686-63691]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-26596]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2015-0012; FRL-9935-11]

Pyrimethanil; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
pyrimethanil in or on multiple commodities which are identified and 
discussed later in this document. Interregional Research Project Number 
4 (IR-4) requested the tolerances associated with pesticide petition 
number (PP 4E8302), and Bayer CropScience requested the tolerances 
associated with PP 4F8291, under the Federal Food, Drug, and Cosmetic 
Act (FFDCA).

DATES: This regulation is effective October 21, 2015, except for the 
amendment to Sec.  180.661 in amendatory instruction number 3, which is 
effective April 21, 2016. Objections and requests for hearings must be 
received on or before December 21, 2015, 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: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2015-0012, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 
1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public 
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through 
Friday, excluding legal holidays. The telephone number for the Public 
Reading Room is (202) 566-1744, and the telephone number for the OPP 
Docket is (703) 305-5805. Please review the visitor instructions and 
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Susan Lewis, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone 
number: (703) 305-7090; email address: RDFRNotices@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. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may 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 http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 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-2015-0012 in the subject line on the first 
page of your submission. All objections and requests for a hearing must 
be in writing, and must be received by the Hearing Clerk on or before 
December 21, 2015. Addresses for mail and hand delivery of objections 
and hearing requests are provided in 40 CFR 178.25(b).
    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 (excluding any Confidential Business Information (CBI)) for 
inclusion in the public docket. Information not marked confidential 
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without 
prior notice. Submit the non-CBI copy of your objection or hearing 
request, identified by docket ID number EPA-HQ-OPP-2015-0012, by one of 
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be CBI or other 
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of December 17, 2014 (79 FR 75107) (FRL-
9918-90), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 
U.S.C. 346a(d)(3), announcing the filing of (PP 4E8302) by IR-4, 500 
College Road East, Suite 201 W, Princeton, NJ 08540. The petition 
requested that 40 CFR part 180 be amended by establishing tolerances 
for residues of the fungicide pyrimethanil, (4,6-dimethyl-N-phenyl-2-
pyrimidinamine), in or on cucumber at 1.5 parts per million (ppm); 
fruit, pome, group 11-10 at 14 ppm; fruit, stone, group 12-12 at 10 
ppm; grapefruit subgroup 10-10C at 10 ppm; lemon subgroup 10-10B at 11 
ppm; orange subgroup 10-10A at 10 ppm; and tomato subgroup 8-10A at 0.5 
ppm. Upon approval of the tolerances in this petition, the petition 
requested that the tolerances for fruit, citrus, group 10 except lemon, 
postharvest; fruit, pome, group 11 (preharvest and post-harvest); 
fruit, stone, group 12; lemon (preharvest and postharvest); and tomato 
be removed as they are superseded. This petition additionally requested 
that 40 CFR 180.518 be amended by revising the existing tolerance for 
onion, bulb, subgroup 3-07A from 2.0 ppm to 0.20 ppm. That document 
referenced a summary of the petition prepared on behalf of IR-4 by 
Bayer CropScience,

[[Page 63687]]

the registrant, which is available in the docket EPA-HQ-OPP-2014-0590 
at http://www.regulations.gov. There were no comments received in 
response to this notice of filing.
    In the Federal Register of May 20, 2015 (80 FR 28925) (FRL-9927-
39), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 
U.S.C. 346a(d)(3), announcing the filing of PP 4F8291 by Bayer 
CropScience, 2 T.W. Alexander Drive, P.O. Box 12014, Research Triangle 
Park, NC 27709. The petition requested that 40 CFR part 180 be amended 
by establishing tolerances for residues of the fungicide pyrimethanil, 
in or on in or on caneberry (subgroup 13-07A) at 15.0 ppm and bushberry 
(subgroup 13-07B) at 8.0 ppm. That document referenced a summary of the 
petition prepared by Bayer CropScience, the registrant, which is 
available in the docket, http://www.regulations.gov. A comment was 
received on the notice of filing. EPA's response to the comment is 
discussed in Unit IV.C.
    Based upon review of the data supporting the petitions, EPA has 
revised the petitioned-for tolerance in or on fruit, pome, group 11-10. 
The Agency has also determined that the separate subgroup tolerances 
proposed in or on orange subgroup 10-10A, lemon subgroup 10-10B, and 
grapefruit subgroup 10-10C should be established in or on fruit, 
citrus, group 10-10. The reasons for these changes are 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 FFDCA section 408(b)(2)(D), and the factors 
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available 
scientific data and other relevant information in support of this 
action. EPA has sufficient data to assess the hazards of and to make a 
determination on aggregate exposure for pyrimethanil including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with pyrimethanil follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children.
    The major target organs of repeated oral exposure to pyrimethanil 
were the liver, kidney and thyroid. By the oral route of exposure, the 
rat was the most sensitive species to pyrimethanil toxicity, followed 
by the dog and then the mouse. Effects observed including clinical 
signs (for example, vomiting, diarrhea and salivation in the dog), 
changes in clinical chemical parameters (liver enzymes), changes in 
organ weights (mostly relative), and macroscopic and microscopic organ 
changes. These effects were accompanied by decreased body weight. 
Clinical signs of neurotoxicity including ataxia and dilated pupils, 
and decreases in motor activity, hind limb grip strength and body 
temperature were observed in an acute neurotoxicity study in rats 
(females only) at the highest dose tested (HDT). However, there was no 
evidence of neurotoxicity with repeated dosing in a subchronic 
neurotoxicity study in rats.
    Special short-term exposure studies conducted for pyrimethanil 
demonstrated increased liver uridine diphosphate glucuronosyl 
transferase activity, leading to decreases in thyroid hormones (T3, T4) 
and compensatory increases in thyroid-stimulating hormone (TSH) in 
adult rats. Although the effects on the thyroid raise a potential 
concern for thyroid toxicity in the young, EPA concluded there is no 
concern for thyroid toxicity in the young based on the following: (1) 
The effects are not severe in nature and; (2) the wide dose spread 
(i.e., more than 10-fold difference between the no observed adverse 
effect levels (NOAELs) and the lowest-observed-adverse-effect-levels 
(LOAELs) in each of the studies showing effects on thyroid hormone 
levels (as well as the studies the Agency is using for its points of 
departure) provides a measure of protection for any potential effects 
linked to decreased thyroid hormone levels in offspring. Moreover, 
reproductive toxicity was not observed following pyrimethanil 
administration, and developmental effects (e.g., decreased fetal 
weight, retarded ossification, extra ribs) were observed only at doses 
that caused maternally toxic effects (e.g., death, decreased body 
weight and body-weight gain); therefore, pyrimethanil is not expected 
to result in increased quantitative or qualitative susceptibility for 
infants and children.
    Thyroid adenomas were seen in rats following long-term exposure, 
and it was concluded that they were mediated via disruption of the 
thyroid/pituitary axis. There were no concerns for mutagenicity. The 
EPA has classified pyrimethanil as ``not likely to be carcinogenic to 
humans at doses that do not alter rat thyroid hormone homeostasis.'' 
This decision was based on the following:
    1. There were treatment-related increases in thyroid follicular 
cell tumors in male and female Sprague-Dawley rats at doses which were 
considered adequate to assess carcinogenicity; however, rats are 
substantially more sensitive than humans to the development of thyroid 
follicular cell tumors in response to thyroid hormone imbalance.
    2. There were no treatment-related tumors seen in male or female 
CD-1 mice at doses which were considered adequate to assess 
carcinogenicity.
    3. There is no mutagenicity concern and there is no evidence for 
thyroid carcinogenesis mediated through a mutagenic mode of action.
    4. The non-neoplastic toxicological evidence (i.e., thyroid growth, 
thyroid hormonal changes) indicated that pyrimethanil was inducing a 
disruption in the thyroid-pituitary hormonal status. The overall 
weight-of-evidence was considered sufficient to indicate that 
pyrimethanil induced thyroid follicular tumors through a non-linear, 
antithyroid mode of action.
    For these reasons, EPA determined that quantification of 
carcinogenic risk is not required and that the NOAEL established for 
deriving the chronic reference dose (cRfD) would be protective of 
cancer effects. Due to the non-linear mode of action of pyrimethanil, 
exposure at the NOAEL is not expected to alter thyroid hormone 
homeostasis nor result in thyroid tumor formation.
    Specific information on the studies received and the nature of the 
adverse effects caused by pyrimethanil as well

[[Page 63688]]

as the NOAEL and the LOAEL from the toxicity studies can be found at 
http://www.regulations.gov in document, ``Pyrimethanil. Human Health 
Risk Assessment for Proposed Uses on Greenhouse-Grown Cucumbers, Tomato 
Subgroup 8-10A, Lemon Subgroup 10-10B, Orange Subgroup 10-10A, 
Grapefruit Subgroup 10-10C, Pome Fruit Group 11-10, Stone Fruit Group 
12-12 Caneberry Subgroup 13-07A, and Bushberry Subgroup 13-07B,'' in 
pp. 29-31 in docket ID number EPA-HQ-OPP-2015-0012.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (POD) and levels of 
concern to use in evaluating the risk posed by human exposure to the 
pesticide. For hazards that have a threshold below which there is no 
appreciable risk, the toxicological POD is used as the basis for 
derivation of reference values for risk assessment. PODs are developed 
based on a careful analysis of the doses in each toxicological study to 
determine the dose at which the NOAEL and the LOAEL are identified. 
Uncertainty/safety factors are used in conjunction with the POD to 
calculate a safe exposure level--generally referred to as a population-
adjusted dose (PAD) or a reference dose (RfD)--and a safe margin of 
exposure (MOE). 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 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 is discussed 
in Table 1 in Unit III.B. of the final rule published in the Federal 
Register of August 1, 2012 (77 FR 45499) (FRL-9354-7).

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.
    Such effects were identified for pyrimethanil. In estimating acute 
dietary exposure, EPA used food consumption information from the United 
States Department of Agriculture (USDA) 2003-2008 National Health and 
Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA). 
As to residue levels in food, EPA assumed default processing factors, 
empirical processing factors for orange and apple juice, tolerance-
level residues, and 100 percent crop treated (PCT) for all commodities.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA 2003-2008 
NHANES/WWEIA. As to residue levels in food, EPA assumed default 
processing factors, empirical processing factors for orange and apple 
juice, tolerance-level residues, and 100 PCT for all commodities.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that pyrimethanil is not likely to be carcinogenic to humans 
at doses that do not alter rat thyroid hormone homeostasis. Therefore, 
a dietary exposure assessment for the purpose of assessing cancer risk 
was not performed.
    iv. Anticipated residue and percent crop treated (PCT) information. 
EPA did not use anticipated residue and/or PCT information in the 
dietary assessment for pyrimethanil. Tolerance-level residues and/or 
100 PCT were assumed for all food commodities.
    2. Dietary exposure from drinking water. In drinking water, 
residues of concern are pyrimethanil and the degradate 2-amino-4,6-
dimethylpyrimidine. The Agency used screening-level water exposure 
models in the dietary exposure analysis and risk assessment for 
pyrimethanil and its degradate in drinking water. These simulation 
models take into account data on the physical, chemical, and fate/
transport characteristics of pyrimethanil and its degradate. 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 Surface Water Concentration Calculator (SWCC) 
models, the estimated drinking water concentrations (EDWCs) of 
pyrimethanil and its degradate for acute exposures are estimated to be 
156 parts per billion (ppb) for surface water and 128 ppb for ground 
water. For chronic exposures for non-cancer assessments, they are 
estimated to be 27.9 ppb for surface water and 117 ppb for ground 
water.
    Current EPA policy typically recommends the EDWCs for use in 
dietary assessments be derived from the water source with the highest 
EDWCs, which for pyrimethanil is surface water for acute exposure and 
groundwater for chronic exposure. However, due to generally low 
leaching (EDWCs and incomplete breakthrough) identified in the 100-year 
simulation in groundwater, the surface water EDWCs are recommended for 
both acute and chronic exposure assessments. Therefore, for acute 
dietary risk assessment, the water concentration value of 156 ppb was 
used to assess the contribution to drinking water. For chronic dietary 
risk assessment, the water concentration of value 27.9 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 Web site 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

[[Page 63689]]

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 
Safety Factor (FQPA 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 1X. That decision is based on the following 
findings:
    i. The toxicity database for pyrimethanil is complete.
    ii. Clinical signs of neurotoxicity (ataxia, decreased motor 
activity, decreased body temperature, decreased hind limb grip strength 
in males, and dilated pupils) were observed only in females in the 
acute neurotoxicity study in rats and only at the HDT (1,000 milligram/
kilogram (mg/kg)). Although the limit dose was not tested in the 
subchronic neurotoxicity study, no clinical signs, behavioral changes, 
or neuropathology were seen at one-half of the limit dose (up to 430 
milligram/kilogram/day (mg/kg/day)). In addition, no neurotoxic signs 
were seen in the rest of the toxicity database for pyrimethanil and the 
target organ for toxicity is the thyroid. The selected endpoints for 
pyrimethanil will be protective of any potential signs of 
neurotoxicity. Therefore, the concern for neurotoxicity is low, and 
there is no need for a developmental neurotoxicity study or additional 
uncertainty factors (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 young rats in the 2-generation reproduction 
study.
    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 surface water modeling used to assess 
exposure to pyrimethanil in drinking water. 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 dietary pesticide 
exposures are safe by comparing aggregate exposure estimates to the 
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA 
calculates the lifetime probability of acquiring cancer 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 appropriate PODs to ensure that an 
adequate MOE exists.
    1. Acute risk. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food and water 
to pyrimethanil will occupy 40% of the aPAD for children one to two 
years 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 80% of the cPAD for 
children one to two years old, the population group receiving the 
greatest exposure. There are no residential uses for pyrimethanil.
    3. Short- and intermediate-term risk. Short- and intermediate-term 
aggregate exposures take into account short- and intermediate-term 
residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level). Short- and 
intermediate-term adverse effects were identified; however, 
pyrimethanil is not registered for any use patterns that would result 
in short- or intermediate-term residential exposures. Short- and 
intermediate-term risk is assessed based on short- or intermediate-term 
residential exposure plus chronic dietary exposure. Because there is no 
short- or intermediate-term residential exposures and chronic dietary 
exposure has already been assessed under the appropriately protective 
cPAD (which is at least as protective as the POD used to assess short-
term risk), no further assessment of short- or intermediate-term risk 
is necessary, and EPA relies on the chronic dietary risk assessment for 
evaluating short-term risk for pyrimethanil.
    4. Aggregate cancer risk for U.S. population. EPA has determined 
that the thyroid tumors seen in rat studies arise through a non-linear 
mode of action and the NOAEL (17 mg/kg/day) established for deriving 
the cRfD is not expected to alter thyroid hormone homeostasis nor 
result in thyroid tumor formation. Thus, the chronic risk assessment 
addresses any cancer risk. Based on the results of chronic risk 
assessment, EPA concludes that aggregate exposure to pyrimethanil will 
not cause a cancer risk.
    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 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; email address: 
residuemethods@epa.gov.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint United Nations 
Food and Agriculture Organization/World Health Organization food 
standards program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level.
    There are no Codex MRLs established for residues of pyrimethanil in 
or on cucumber or bushberry subgroup 13-07B or caneberry subgroup 13-
07A commodities. A U.S. tolerance in or on pome fruit group 11-10 was 
petitioned-

[[Page 63690]]

for at 14 ppm; however, the EPA is establishing a tolerance at 15 ppm 
in order to harmonize with Codex MRLs established on associated pome 
fruit commodities at 15 ppm. The U.S. tolerance in or on bulb onion 
subgroup 3-07A at 0.20 ppm is harmonized with a Codex MRL on bulb 
onion. Although there is a Codex MRL at 0.7 ppm for tomato, EPA is 
establishing a tolerance for the tomato subgroup 8-10A at 0.50 ppm in 
order to harmonize with the Canadian MRL to facilitate trade with 
Canada. The U.S. tolerances for citrus fruit group 10-10 at 10 ppm and 
stone fruit group 12-12 at 10 ppm cannot be harmonized with Codex MRLs 
on the same commodities because the residue data supporting these uses 
result in tolerance calculations that are higher than the Codex MRLs 
for citrus (7 ppm) and the range of MRLs for stone fruit commodities (2 
ppm to 4 ppm), which precludes harmonization.

C. Response to Comments

    One comment was received to the Notice of Filing for PP 4F8291, 
which provided general support for the proposed tolerances. There were 
no concerns identified in this public comment.

D. Revisions to Petitioned-For Tolerances

    Based upon review of the data supporting the petitions, EPA has 
revised the petitioned-for tolerance in or on fruit, pome, group 11-10 
from 14 ppm to 15 ppm, in order to harmonize with the Codex MRL on 
associated pome fruit commodities. The Agency has also determined that 
the separate subgroup tolerances petitioned-for in or on orange 
subgroup 10-10A at 10 ppm, lemon subgroup 10-10B at 11 ppm, and 
grapefruit subgroup 10-10C at 10 ppm should be established in or on 
fruit, citrus, group 10-10 at 10 ppm. A citrus group 10-10 tolerance at 
10 ppm is supported by available data and harmonizes the U.S. tolerance 
with the Canadian MRL.

E. International Trade Considerations

    In this rulemaking, EPA is reducing the tolerance for the onion, 
bulb, subgroup 3-07A from 2.0 ppm to 0.20 ppm. The petitioner requested 
this reduction because it was a typographical error when the previous 
rule for pyrimethanil was published. EPA had assessed the tolerance at 
0.20 ppm, but the rule was printed as 2.0 ppm. The reduction is 
appropriate based on available data and residue levels resulting from 
registered use patterns. In accordance with the World Trade 
Organization's Sanitary and Phytosanitary Measures Agreement, EPA is 
allowing the existing higher tolerance to remain in effect for 6 months 
following the publication of this rule in order to allow a reasonable 
interval for producers in the exporting countries to adapt to the 
requirements of these modified tolerances. On April 21, 2016, the new 
reduced tolerance for subgroup 3-07A will go into effect. At that time, 
residues of pyrimethanil on commodities contained in subgroup 3-07A 
will need to comply with the new tolerance of 0.20 ppm. This reduction 
in tolerance is not discriminatory; the same food safety standard 
contained in the FFDCA applies equally to domestically produced and 
imported foods.

V. Conclusion

    Therefore, tolerances are established for residues of pyrimethanil 
(4,6-dimethyl-N-phenyl-2-pyrimidinamine) in or on bushberry subgroup 
13-07B at 8.0 ppm; caneberry subgroup 13-07A at 15 ppm; cucumber at 1.5 
ppm; fruit, citrus, group 10-10 at 10 ppm; fruit, pome, group 11-10 at 
15 ppm; fruit, stone group 12-12 at 10 ppm; and tomato subgroup 8-10A 
at 0.50 ppm. This regulation additionally revises the tolerance in or 
on onion, bulb, subgroup 3-07A from 2.0 ppm to 0.20 ppm. Finally, this 
regulation removes tolerances in or on fruit, citrus, group 10, except 
lemon, postharvest; fruit, pome, group 11 (pre-harvest and post-
harvest); fruit, stone, group 12; lemon, preharvest and postharvest; 
and tomato.

VI. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA section 408(d) in 
response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled ``Regulatory Planning and 
Review'' (58 FR 51735, October 4, 1993). Because this action has been 
exempted from review under Executive Order 12866, this action 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 action 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 FFDCA section 408(d), such as the tolerances 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 action 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 FFDCA section 408(n)(4). 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 action. In addition, this 
action does not impose any enforceable duty or contain any unfunded 
mandate as described under Title II of the Unfunded Mandates Reform Act 
(UMRA) (2 U.S.C. 1501 et seq.).
    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 (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
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 
the rule in the Federal Register. This action 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.

[[Page 63691]]

    Dated: October 13, 2015.
Susan Lewis,
Director, Registration Division, Office of Pesticide Programs.

    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. In Sec.  180.518, the table in paragraph (a)(1):
0
a. Remove the commodities ``fruit, citrus, group 10, except lemon, 
postharvest''; ``fruit, pome, group 11 (pre-harvest and post-
harvest)''; ``fruit, stone, group 12''; ``lemon, preharvest and 
postharvest''; and ``tomato''; and
0
b. Add alphabetically the following commodities to the table.
    The additions read as follows:

Sec.  180.518  Pyrimethanil; tolerances for residues.

    (a) General. (1) * * *

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Bushberry subgroup 13-07B...................................         8.0
Caneberry subgroup 13-07A...................................          15
 
                                * * * * *
Cucumber....................................................         1.5
Fruit, citrus, group 10-10..................................          10
Fruit, pome, group 11-10....................................          15
 
                                * * * * *
Fruit, stone, group 12-12...................................          10
 
                                * * * * *
Tomato subgroup 8-10A.......................................        0.50
 
                                * * * * *
------------------------------------------------------------------------

* * * * *

0
3. In Sec.  180.518, in the table in paragraph (a)(1), effective April 
21, 2016, revise the existing tolerance ``Onion, bulb, subgroup 3-07A'' 
to read as follows:

Sec.  180.518  Pyrimethanil; tolerances for residues.

    (a) General.
    (1) * * *

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Onion, bulb, subgroup 3-07A.................................         0.2
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2015-26596 Filed 10-20-15; 8:45 am]
 BILLING CODE 6560-50-P