[Federal Register Volume 77, Number 148 (Wednesday, August 1, 2012)]
[Rules and Regulations]
[Pages 45498-45503]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-18388]


-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2011-0477; FRL-9354-7]


Pyrimethanil; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

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 these tolerances under the Federal Food, Drug, and 
Cosmetic Act (FFDCA).

DATES: This regulation is effective August 1, 2012. Objections and 
requests for hearings must be received on or before October 1, 2012, 
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-2011-0477, is available at http://www.regulations.gov or at the OPP Docket in the Environmental 
Protection Agency Docket Center (EPA/DC), located in EPA West, 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: Andrew Ertman, Registration Division 
(7509P) Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone 
number: (703) 308-9367; email address: [email protected].

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to 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 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://ecfr.gpoaccess.gov/cgi/t/text/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-2011-0477 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 
October 1, 2012. 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 that does not contain any 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 a copy of

[[Page 45499]]

your non-CBI objection or hearing request, identified by docket ID 
number EPA-HQ-OPP-2011-0477, 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 Confidential Business 
Information (CBI) or other information whose disclosure is restricted 
by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), Mail Code: 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.htm.

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 July 20, 2011 (76 FR 43231) (FRL-8880-
1), EPA issued a notice pursuant to FFDCA section 408(d)(3), 21 U.S.C. 
346a(d)(3), announcing the filing of a pesticide petition (PP 1E7861) 
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 the raw agricultural commodities 
onion, bulb, subgroup 03-07A at 0.1 parts per million (ppm), onion, 
green, subgroup 03-07B at 2.0 ppm, berry and small fruit, small fruit 
vine climbing subgroup, except fuzzy kiwifruit 13-07F at 5.0 ppm, berry 
and small fruit, low growing berry subgroup 13-07G at 3.0 ppm and 
ginseng at 2.5 ppm. That notice referenced a summary of the petition 
prepared by Bayer CropScience, the registrant, which is available 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 
modified the levels at which tolerances are being established for some 
of the commodities. The reason for this change 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 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.
    Pyrimethanil is of low acute lethality by the oral, dermal, and 
inhalation routes. It is a slight eye irritant, is not irritating to 
the skin, and it is not a dermal sensitizer. A single oral dose of 
1,000 milligrams/kilogram (mg/kg) produced a number of acute signs of 
neurotoxicity, including ataxia, dilated pupils, and decreases in motor 
activity, hind limb grip strength, and body temperature. However, there 
was no evidence of neurotoxicity with repeated dosing in a subchronic 
neurotoxicity study in rats. Exposure to pyrimethanil in oral toxicity 
studies primarily resulted in decreased body weights and body-weight 
gain, often accompanied by decreases in food consumption. The major 
target organs of repeated oral exposure were the liver and the thyroid. 
No reproductive toxicity was observed, and developmental effects (e.g., 
decreased fetal weight, retarded ossification, extra ribs) were 
observed only at maternally toxic doses. Special short-term exposure 
studies demonstrated increased liver uridine diphosphate glucuronosyl 
transferase (UDPGT) activity leading to decreases in thyroid hormones 
(T3, T4) and compensatory increases in thyroid stimulating hormone 
(TSH) in adult rats. 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.
    2. There were no treatment-related tumors were 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 an antithyroid 
mode of action.
    5. Rats are substantially more sensitive than humans to the 
development of thyroid follicular cell tumors in response to thyroid 
hormone imbalance. EPA determined that quantification of carcinogenic 
risk is not required since the thyroid tumors arise through a non-
linear mode of action and the no observed adverse effect level (NOAEL) 
(17 mg/kg/day) established for deriving the chronic reference dose 
(cRfD) 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 as the NOAEL and the 
lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies 
can be found at http://www.regulations.gov in the document titled 
``Pyrimethanil Human-Health Risk Assessment for Proposed Uses on

[[Page 45500]]

Ginseng, Bulb Onion Subgroups 3-07A and B, and Small Berry Subgroups 
13-07F and G,'' pp. 32-34 in docket ID number EPA-HQ-OPP-2011-0477.

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 no adverse effects are observed (the NOAEL) 
and the lowest dose at which adverse effects of concern are identified 
(the LOAEL). 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 shown in the Table of this unit.

 Table 1.--Summary of Toxicological Doses and Endpoints for Pyrimethanil for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                     Point of departure and
         Exposure/scenario              uncertainty/safety   RfD, PAD, LOC for risk    Study and toxicological
                                             factors                assessment                 effects
----------------------------------------------------------------------------------------------------------------
Acute dietary (Females 13-49 years   NOAEL = 45 mg/kg/day..  Acute RfD = 0.45 mg/kg/ Developmental Toxicity--
 of age).                            UFA = 10X.............   day.                    Rabbit:
                                     UFH = 10X.............  aPAD = 0.45 mg/kg/day.  LOAEL = 300 mg/kg/day based
                                     FQPA SF = 1X..........                           on increases in fetuses
                                                                                      with 13 thoracic vertebrae
                                                                                      and 13 pairs of ribs.
Acute dietary (General population    NOAEL = 100 mg/kg/day.  Acute RfD = 1 mg/kg/    Acute Neurotoxicity--Rat:
 including infants and children).    UFA = 10X.............   day.                   LOAEL = 1,000 mg/kg/day
                                     UFH = 10X.............  aPAD = 1 mg/kg/day....   based on decreased motor
                                     FQPA SF = 1X..........                           activity, ataxia,
                                                                                      decreased body
                                                                                      temperature, hind limb
                                                                                      grip strength, and dilated
                                                                                      pupils.
Chronic dietar (All populations)...  NOAEL= 17 mg/kg/day...  Chronic RfD = 0.17 mg/  Chronic Toxicity--Rat:
                                     UFA = 10X.............   kg/day.                LOAEL = 221 mg/kg/day based
                                     UFH = 10X.............  cPAD = 0.17 mg/kg/day.   on decreased body-weight
                                     FQPA SF = 1X..........                           gains; increased serum
                                                                                      cholesterol and GGT,
                                                                                      increased relative liver/
                                                                                      body weight ratios,
                                                                                      necropsy and
                                                                                      histopathological findings
                                                                                      in the liver and thyroid.
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
  level. PAD = population-adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor.
  UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among
  members of the human population (intraspecies).

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) 1994-1996 and 1998 Nationwide 
Continuing Surveys of Food Intake by Individuals (CSFII). As to residue 
levels in food, EPA assumed default processing factors (as necessary), 
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 1994-1996 
and 1998 CSFII. As to residue levels in food, EPA assumed default 
processing factors (as necessary), empirical processing factors for 
orange and apple juice, tolerance level residues and 100 PCT for all 
commodities.
    iii. Cancer. EPA determines whether quantitative cancer exposure 
and risk assessments are appropriate for a food-use pesticide based on 
the weight of the evidence from cancer studies and other relevant data. 
Cancer risk is quantified using a linear or nonlinear approach. If 
sufficient information on the carcinogenic mode of action is available, 
a threshold or nonlinear approach is used and a cancer RfD is 
calculated based on an earlier noncancer key event. If carcinogenic 
mode of action data are not available, or if the mode of action data 
determines a mutagenic mode of action, a default linear cancer slope 
factor approach is utilized. Based on the data summarized in Unit 
III.A., EPA has concluded that a nonlinear RfD approach is appropriate 
for assessing cancer risk to pyrimethanil. Cancer risk was assessed 
using the same exposure estimates as discussed in Unit III.C.1.ii.
    iv. Anticipated residue and PCT information. EPA did not use 
anticipated residue and/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 used in pesticide exposure assessment

[[Page 45501]]

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 for acute exposures are estimated to be 86.5 parts per 
billion (ppb) for surface water and 4.8 ppb for ground water. For 
chronic exposures for non-cancer assessments, they are estimated to be 
29.4 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 
86.5 ppb was used to assess the contribution to drinking water.
    For chronic dietary risk assessment, the water concentration of 
value 29.4 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 an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the FQPA Safety 
Factor (SF). In applying this provision, EPA either retains the default 
value of 10X, or uses a different additional safety factor when 
reliable data available to EPA support the choice of a different 
factor.
    2. Prenatal and postnatal sensitivity. The prenatal and postnatal 
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 toxicology database for pyrimethanil is complete.
    ii A guideline immunotoxicity study has been submitted, and there 
is no evidence for immunotoxicity due to pyrimethanil treatment. 
Evidence of neurotoxicity was observed at a very high dose (the limit 
dose) in the acute neurotoxicity study in rats. However, the study has 
a clear NOAEL, which is being utilized as the POD for the acute dietary 
exposure scenario, and there was no evidence of neurotoxicity observed 
in the subchronic neurotoxicity study in rats up to the highest dose 
tested in that study (430 mg/k/day). A developmental neurotoxicity 
(DNT) study is not required.
    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. Thyroid has been shown to be one of the target organs in adult 
animals for pyrimethanil-induced toxicity thus raising a potential 
concern for thyroid toxicity in the young. EPA, however, concluded that 
there is no concern for thyroid toxicity in the young based on the 
following weight of evidence considerations: the effects seen on the 
thyroid and the liver in the database, while treatment-related, are not 
severe in nature; and in each of the studies that show an effect on 
thyroid hormone levels, as well as in all studies chosen for PODs 
selection, there is a wide dose spread (~10-fold difference between 
NOAELs and LOAELs) which provides a measure of protection for any 
potential effects linked to decreased thyroid hormone levels in 
offspring.
    v. There are no residual uncertainties with respect to exposure 
data. The dietary food exposure assessment utilizes tolerance-level 
residues (established or recommended) 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 that are designed to 
provide conservative, health-protective, high-end estimates of water 
concentrations that will not likely be exceeded. 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 population adjusted dose (aPAD) and chronic population adjusted 
dose (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 35% 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 64% of the cPAD for 
children 1-2 years old, the population group receiving the greatest 
exposure. There are no residential uses for pyrimethanil.
    3. Short-and intermediate-term risk. Short-term and intermediate-
term aggregate exposure takes into account short-and intermediate-term 
residential exposure plus chronic exposure to food

[[Page 45502]]

and water (considered to be a background exposure level). A short-and 
intermediate-term adverse effect was identified; however, pyrimethanil 
is not registered for any use patterns that would result in short- and/
or intermediate-term residential exposure. Short-and intermediate-term 
risk is assessed based on short-and intermediate-term residential 
exposure plus chronic dietary exposure. Because there is no short-and 
intermediate-term residential exposure 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-and 
intermediate-term risk), no further assessment of short-and 
intermediate-term risk is necessary, and EPA relies on the chronic 
dietary risk assessment for evaluating short-and intermediate-term risk 
for pyrimethanil.
    4. Aggregate cancer risk for U.S. population. The Agency 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.
    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: 
[email protected].

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.
    The Codex has established MRLs for pyrimethanil in or on strawberry 
at 3 ppm, bulb onions at 0.2 ppm, and spring onion at 3 ppm. These MRLs 
are the same as the tolerances established by this rule for 
pyrimethanil on the low growing berry subgroup 13-07G, the bulb onion 
subgroup 3-07A, and the green onion subgroup 3-07B in the United 
States.
    The Codex has established an MRL for pyrimethanil in or on grapes 
at 4 ppm which is less than tolerance of 5.0 ppm set on the small vine 
climbing fruit subgroup 13-07F of which grape is a member. The reason 
for this is due to the fact that the European PHI is 21 days and the 
U.S. PHI is 7 days. Residues are thus higher in U.S. residue trials, 
necessitating a higher tolerance.

C. Revisions to Petitioned-For Tolerances

    Using the Organization for Economic Co-operation and Development 
(OECD) tolerance calculation procedures for the residue data set 
indicates that the requested tolerance of 2.5 ppm for residues of 
pyrimethanil in/on ginseng is too high and that a tolerance of 1.5 ppm 
is appropriate. Also, the tolerance levels for the bulb onion subgroup 
3-07A and green onion subgroup 3-07B were modified to harmonize with 
existing Codex Maximum Residue Levels (MRLs). Lastly, EPA has revised 
the tolerance expressions to clarify:
    1. That, as provided in FFDCA section 408(a)(3), the tolerance 
covers metabolites and degradates of pyrimethanil not specifically 
mentioned; and
    2. That compliance with the specified tolerance levels is to be 
determined by measuring only the specific compounds mentioned in the 
tolerance expression.

V. Conclusion

    Therefore, tolerances are established for residues of pyrimethanil 
(4,6-dimethyl-N-phenyl-2-pyrimidinamine) in or on onion, bulb, subgroup 
03-07A at 0.20 ppm; onion, green, subgroup 03-07B at 3.0 ppm; fruit, 
small, vine climbing subgroup 13-07F, except fuzzy kiwifruit 13-07F at 
5.0 ppm; berry, low growing, subgroup 13-07G at 3.0 ppm and ginseng at 
1.5 ppm.
    Also, due to the tolerances established in this unit by this 
document, the following existing tolerances are removed as unnecessary; 
strawberry; grape; onion, bulb; and onion, green.

VI. Statutory and Executive Order Reviews

    This final rule 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 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 FFDCA section 408(d), 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 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

[[Page 45503]]

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) (Pub. L. 
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: July 18, 2012.
Daniel J. Rosenblatt,
Acting 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. Section 180.518 is amended as follows:
0
a. Revising the introductory text to paragraph (a)(1);
0
b. Removing the entries for ``Grape''; ``Onion, bulb''; and ``Onion, 
green; and ``Strawberry'' from the table in paragraph (a)(1);
0
c. Alphabetically adding the following commodities to the table in 
paragraph (a)(1); and
0
d. Revising the introductory text for paragraphs (a)(2) and (3).
    The amendments read as follows:


Sec.  180.518  Pyrimethanil; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of the 
fungicide pyrimethanil, including its metabolites and degradates, in or 
on the commodities in the following table Compliance with the tolerance 
levels specified in the following table is to be determined by 
measuring only pyrimethanil (4,6-dimethyl-N-phenyl-2-pyrimidinamine).

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Berry, low growing, subgroup 13-07G.........................         3.0
 
                                * * * * *
Fruit, small, vine climbing, subgroup 13-07F, except fuzzy           5.0
 kiwifruit..................................................
 
                                * * * * *
Ginseng.....................................................         1.5
 
                                * * * * *
Onion, bulb, subgroup 3-07A.................................         2.0
Onion, green, subgroup 3-07B................................         3.0
 
                                * * * * *
------------------------------------------------------------------------

     (2) Tolerances are established for residues of the fungicide 
pyrimethanil, including its metabolites and degradates, in or on the 
commodities in the following table. Compliance with the tolerance 
levels specified in the following table is to be determined by 
measuring only the sum of pyrimethanil and its metabolite 4-[4,6-
dimethyl-2-pyrimidinyl)amino]phenol, calculated as the stoichiometric 
equivalent of pyrimethanil.
* * * * *
    (3) Tolerances are established for residues of the fungicide 
pyrimethanil, including its metabolites and degradates, in or on the 
commodities in the following table. Compliance with the tolerance 
levels specified in the following table is to be determined by 
measuring only the sum of pyrimethanil and its metabolite 4,6-dimethyl-
2-(phenylamino)-5-pyrimidinol, calculated as the stoichiometric 
equivalent of pyrimethanil.
* * * * *
[FR Doc. 2012-18388 Filed 7-31-12; 8:45 am]
BILLING CODE 6560-50-P