[Federal Register Volume 77, Number 234 (Wednesday, December 5, 2012)]
[Rules and Regulations]
[Pages 72226-72232]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-29250]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2010-0458; FRL-9370-8]


Picoxystrobin; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
picoxystrobin in or on multiple commodities which are identified and 
discussed later in this document. E.I. du Pont de Nemours & Company 
requested these tolerances under the Federal Food, Drug, and Cosmetic 
Act (FFDCA).

DATES: This regulation is effective December 5, 2012. Objections and 
requests for hearings must be received on or before February 4, 2013, 
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-2010-0458, 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), EPA West 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: Grant Rowland, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone 
number: (703) 347-0254; 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. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather

[[Page 72227]]

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://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-2010-0458 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 
February 4, 2013. 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-2010-0458, 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.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 June 23, 2010 (75 FR 35801) (FRL-8831-
3), 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 0F7722) 
by E.I. du Pont de Nemours & Company 1007 Market Street, Wilmington, DE 
19898, proposed to establish tolerances in 40 CFR part 180 for residues 
of the fungicide picoxystrobin, in or on the cereal grains crop group 
(crop group 15) except rice at 0.2 parts per million(ppm); the cereal 
forage and fodder crop group (crop group 16) except rice at 13.0 ppm; 
cereal grain aspirated grain fractions at 4.5 ppm; cereal grain oil at 
1.5 ppm; the dry legume vegetables crop subgroup (crop group 6, 
subgroup C) except soybean at 0.1 ppm; the legume vegetable foliage 
crop group (crop group 7) at 18.0 ppm; soybean seed at 0.05 ppm; 
soybean forage at 0.8 ppm; soybean hay at 2.5 ppm; soybean aspirated 
grain fractions at 3.2 ppm; soybean hulls at 10.0 ppm; soybean oil at 
0.05 ppm; canola seed at 0.05 ppm; meat and meat byproducts except 
liver of cattle, goat, hog, horse, and sheep at 0.01 ppm; fat of 
cattle, goat, hog, horse, and sheep at 0.05 ppm; liver of cattle, goat, 
hog, horse, and sheep at 0.8 ppm; meat, meat byproducts, fat, and eggs 
of poultry at 0.01 ppm; milk at 0.01 ppm, and cream, at 0.03 ppm. That 
notice referenced a summary of the petition prepared by E.I. du Pont de 
Nemours & Company, 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 
revised the proposed tolerance levels for several commodities. The 
reasons for these changes are explained in Unit IV.C.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue * * 
*.''
    Consistent with 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 picoxystrobin, including 
exposure resulting from the tolerances established by this action. 
EPA's assessment of exposures and risks associated with picoxystrobin 
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 most consistently observed effects of picoxystrobin exposure 
across species, genders, and treatment durations were decreased body 
weight, body weight gain and food consumption, and diarrhea. The 
effects on body weight and food consumption were consistent with the 
commonly observed findings for compounds which disrupt mitochondria 
respiration system and the resulting disruption of energy production. 
Similar to some other strobilurins, picoxystrobin causes intestinal 
disturbance as indicated by increased incidence of diarrhea or duodenum 
mucosal thickening. These intestinal effects appeared to be related to 
the irritating action on the mucus membranes as demonstrated by the 
severe eye irritation effect seen in the primary eye irritation study 
on picoxystrobin.
    Picoxystrobin caused changes in behavioral effects in both the 
acute and subchronic neurotoxicity studies with no neuropathological 
findings. The effects observed with acute exposure

[[Page 72228]]

were transient (i.e. lasted for a day) and consisted of low arousal and 
decreased motor activities in males and decreased rearing in females, 
and, with subchronic exposure, included decreased male forelimb grip 
and increased female hindlimb splay. In the absence of any 
neuropathological findings, the behavioral effects were attributed to 
general malaise (probably related to energy production perturbations) 
as evidenced by the associated decreased body weight and body weight 
gain.
    In the rat and rabbit developmental toxicity studies, developmental 
toxicity was expressed as skeletal variations at doses causing maternal 
toxicity (i.e. diarrhea, decreased body weight, body weight gain, food 
consumption, and clinical signs of toxicity). In the reproduction 
study, parental/systemic toxicity manifested as decreased body weight 
and body weight gain in both the parents and offspring; no reproductive 
toxicity was seen.
    Picoxystrobin induced a treatment-related increase in testicular 
interstitial cell benign tumors only in the high dose male rats. No 
tumors were seen in females; no treatment related-increase in any type 
of tumor incidence was seen in male and female mice at doses that were 
considered to be adequate for the assessment of carcinogenicity of 
picoxystrobin. There is no mutagenic concern. Based on these data, EPA 
has concluded that quantification of cancer risk based on a non-linear 
approach (i.e., reference dose (RfD) will adequately account for all 
chronic toxicity, including carcinogenicity, that which could result 
from exposure to picoxystrobin. Specific information on the studies 
received and the nature of the adverse effects caused by picoxystrobin 
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, ``Picoxystrobin: Human 
Health Risk Assessment for Proposed Uses on Canola, Cereal Grains 
Except Rice, Dried Shelled Peas and Beans, and Soybeans.'' at pages 17-
22 in docket ID number EPA-HQ-OPP-2010-0458.

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 picoxystrobin used for human risk assessment is shown in 
Table 1 of this unit.

 Table 1--Summary of Toxicological Doses and Endpoints for Picoxystrobin 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 of   There were no appropriate toxicological effects attributable to a single
 age).                                    exposure (dose) observed in available toxicity studies. Therefore, a
                                             dose and endpoint were not identified for this risk assessment.
----------------------------------------------------------------------------------------------------------------
Acute dietary (General population      LOAEL = 200 mg/kg/day..  aRfD = 0.2 mg/kg/day...  Acute Neurotoxicity--
 including infants and children).      UFA = 10x..............  aPAD = 0.2 mg/kg/day...   Rat
                                       UFH = 10x..............                           LOAEL = 200 mg/kg/day
                                       FQPA SF = 10x..........                            based on low arousal
                                                                                          and decreased motor
                                                                                          activities in males,
                                                                                          decreased rearing in
                                                                                          females, in addition
                                                                                          to decreased
                                                                                          bodyweight gain and
                                                                                          food consumption in
                                                                                          both sexes on Day 1.
Chronic dietary (All populations)....  NOAEL= 4.6 mg/kg/day...  cRfD = 0.046 mg/kg/day.  Chronic Toxicity--Dog
                                       UFA = 10x..............  cPAD = 0.046 mg/kg/day.  LOAEL = 15.7 mg/kg/day
                                       UFH = 10x..............                            based on decreased
                                       FQPA SF = 1x...........                            body weights, weight
                                                                                          gains, and food
                                                                                          consumption in both
                                                                                          sexes.
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)....   Classification: ``Suggestive evidence of Carcinogenic Potential'' based
                                          on tumors in one species and one sex: A treatment-related increase in
                                           testicular interstitial cell benign tumors in high dose male rats.
                                         Quantification of cancer is based on a non-linear (i.e. RfD) approach.
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern mg/kg/day = milligram/kilogram/day. 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 picoxystrobin, EPA considered exposure under the 
petitioned-for tolerances. EPA assessed dietary exposures from 
picoxystrobin 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

[[Page 72229]]

occurring as a result of a 1-day or single exposure.
    Such effects were identified for picoxystrobin. In estimating acute 
dietary exposure for the general population, including infants and 
children, EPA used food consumption information from the U.S. 
Department of Agriculture (USDA) National Health and Nutrition 
Examination Survey, What We Eat in America, (NHANES/WWEIA). As to 
residue levels in food, EPA's assumption of this dietary assessment 
included total highest field trial total residues (parent and 
metabolite) for all proposed crops. In addition, 100 percent crop 
treated (PCT) was assumed. Dietary Exposure Evaluation Model (DEEM) 
version 7.81 default processing factors were assumed except for where 
tolerances were established for processed commodities or when 
processing studies showed no concentration. A separate tolerance was 
set for wheat bran, wheat germ, barley bran and corn oil. Tolerance 
levels were used for livestock commodities.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA 1994-1996 
and 1998 Continuing Survey of Food Intake by Individuals (CSFII). As to 
residue levels in food, EPA used total highest average field trial 
total residues (parent and metabolite) for all proposed crops. In 
addition, 100 PCT was assumed. DEEM version 7.81 default processing 
factors were assumed except for where tolerances were established for 
processed commodities. Tolerance levels were used for livestock 
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 is 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 for picoxystrobin. Cancer risk was assessed 
using the same exposure estimates as discussed in Unit III.C.1.ii., 
chronic exposure.
    iv. Anticipated residue and percent crop treated (PCT) information. 
Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and 
information on the anticipated residue levels of pesticide residues in 
food and the actual levels of pesticide residues that have been 
measured in food. If EPA relies on such information, EPA must require 
pursuant to FFDCA section 408(f)(1) that data be provided 5 years after 
the tolerance is established, modified, or left in effect, 
demonstrating that the levels in food are not above the levels 
anticipated. For the present action, EPA will issue such data call-ins 
as are required by FFDCA section 408(b)(2)(E) and authorized under 
FFDCA section 408(f)(1). Data will be required to be submitted no later 
than 5 years from the date of issuance of these tolerances.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for picoxystrobin in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of picoxystrobin. 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.
    The drinking water assessment used a total toxic residue approach 
to include parent and the major environmental degradates: Compound 2, 
Compound 3, Compound 7, and Compound 8. Based on the Pesticide Root 
Zone Model/Exposure Analysis Modeling System and Screening 
Concentration in Ground Water models, the estimated drinking water 
concentrations of picoxystrobin for:
     Acute exposures are estimated to be 7.95 parts per billion 
(ppb) for surface water and 0.041 ppb for ground water.
     Chronic exposures for non-cancer assessments are estimated 
to be 2.41 ppb for surface water and 0.041 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 7.95 ppb was used to 
assess the contribution to drinking water. For chronic dietary risk 
assessment, the water concentration of value 2.41 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). Picoxystrobin 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 picoxystrobin to share a common mechanism of 
toxicity with any other substances, and picoxystrobin does not appear 
to produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
picoxystrobin 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 
toxicity studies include rat and rabbit prenatal development studies, 
in addition to reproduction and fertility effects studies in rats. No 
evidence of increased qualitative or quantitative susceptibility/
sensitivity was seen in any of these studies.
    3. Conclusion. EPA has determined that reliable data show the 
safety of infants and children would be adequately protected if the 
FQPA Safety factor were reduced to 1X for chronic dietary exposure. For 
acute dietary exposures for the general population, including infants 
and children where the acute neurotoxicity is study used as an endpoint 
for risk assessment, EPA is

[[Page 72230]]

retaining a 10X FQPA safety factor. That decision is based on the 
following findings:
    i. Although all required toxicity studies for picoxystrobin have 
been submitted, the acute neurotoxicity study used for acute dietary 
risk assessment did not demonstrate a NOAEL, and a LOAEL was used as an 
endpoint. Therefore, the 10X FQPA safety factor was retained for use of 
a LOAEL to extrapolate a NOAEL.
    ii. There is no indication that picoxystrobin is a neurotoxic 
chemical and there is no need for a developmental neurotoxicity study 
or additional UFs to account for neurotoxicity.
    iii. There is no evidence that picoxystrobin 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, total highest field trial total residues for acute 
exposures, total highest average field trial total residues for chronic 
exposures, and tolerance levels for livestock commodities. EPA made 
conservative (protective) assumptions in the ground and surface water 
modeling used to assess exposure to picoxystrobin in drinking water. 
These assessments will not underestimate the exposure and risks posed 
by picoxystrobin.

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 picoxystrobin will occupy 1.3% of the aPAD for children 1-2 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 
picoxystrobin from food and water will utilize 2.8% of the cPAD for 
children 1-2 years old, the population group receiving the greatest 
exposure. There are no residential uses for picoxystrobin.
    3. Short- and intermediate--term risks. Short- and intermediate-- 
term risk aggregate exposures take into account residential exposure 
plus chronic exposure to food and water (considered to be a background 
exposure level). Because no short-term or intermediate-term adverse 
effects were identified, picoxystrobin is not expected to pose a short- 
or intermediate-- term risk.
    4. Aggregate cancer risk for U.S. population. The Agency considers 
the chronic aggregate risk assessment, making use of the cPAD, to be 
protective of any aggregate 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 picoxystrobin residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology, (a liquid chromatography tandem 
mass spectrometry method (LC/MS/MS), 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. No Codex MRLs have been 
established for picoxystrobin.

C. Revisions to Petitioned-for Tolerances

    The Agency has revised several of the commodity definitions and 
modified the levels for which tolerances are being established as 
follows: Vegetable, legume, dried shelled, except soybean, (group 6C) 
at 0.1 ppm is revised to pea and bean, dried shelled, except soybean, 
subgroup 6C at 0.06 ppm; soybean forage at 0.08 ppm is revised to 
soybean, forage at 1.0 ppm; soybean hay at 2.5 ppm is revised to 
soybean, hay at 3.0 ppm; soybean hulls at 10 ppm is revised to soybean, 
hulls at 0.2 ppm; canola, seed at 0.05 ppm is revised to rapeseed 
subgroup 20A at 0.08 ppm; barley, grain which was proposed as crop 
group 15 at 0.2 ppm is revised to barley, grain at 0.3 ppm. Tolerance 
for soybeans oil was proposed at 0.8 ppm, but EPA has determined that a 
tolerance is not needed. These tolerances have been revised based on 
the use of the Organization for Economic Co-operation and development 
tolerance calculation procedure (OECD TCP). Further, EPA determined 
that the proposed tolerance for crop group 15 (grain, cereal, except 
rice), and crop subgroup 7A group/subgroup (vegetable, foliage of 
legume) each be modified and established as follows: Grain, cereal, 
group 15, except rice and barley at 0.04 ppm; vegetable, foliage of 
legume, except soybean, subgroup 7A at 40.0 ppm. Crop group 16 (grain, 
cereal, forage and fodder except rice) however, should each be broken 
up and established with individual tolerances. These tolerances are 
revised as follows: Grain, cereal, forage, fodder, and straw, group 16, 
straw at 2.0 ppm; grain, cereal, forage fodder, and straw, group 16, 
stover at 10.0 ppm; grain, cereal, forage, fodder and straw group 16, 
hay at 5.0 ppm; grain, cereal forage, fodder, and straw, group 16, 
forage at 15.0 ppm;
    Based on the corn processing study, the proposed tolerance for 
cereal grain oil at 1.5 ppm is revised to corn, field, refined oil at 
0.07 ppm.
    The proposed tolerance for cereal (wheat), aspirated grain 
fractions at 4.5 ppm is being established as grain, aspirated grain 
fractions at 10 ppm; soybean, aspirated grain fractions at 3.2 ppm is 
revised to grain, aspirated grain fractions at 10 ppm as well.
    Though not proposed, the Agency has determined it was appropriate 
to establish tolerances for wheat, bran at 0.06 ppm; wheat, germ at 
0.09 ppm; and barely, bran at 0.5 ppm.
    EPA also revised livestock tolerances as follows, based on the 
calculated dietary burden to account for the transfer of residues to 
livestock matrices (tissues and milk): Cattle, fat from 0.05

[[Page 72231]]

ppm to 0.01 ppm; goat, fat from 0.05 ppm to 0.01 ppm; hog, fat from 
0.05 ppm to 0.01 ppm. horse, fat from 0.5 ppm to 0.01 ppm; sheep, fat 
from 0.05 ppm to 0.01 ppm; horse, liver at 0.8 ppm and horse, meat 
byproduct, except liver at 0.01 ppm were combined as horse, meat 
byproduct at 0.01 ppm. Sheep, liver at 0.8 ppm and sheep, meat 
byproducts, except liver at 0.01 ppm were combined as sheep, meat 
byproducts, at 0.01 ppm. Goat, liver at 0.8 ppm and goat, meat 
byproducts, except liver at 0.01 ppm were combined as goat, meat 
byproducts at 0.01 ppm.; hog, liver at 0.8 ppm and hog, meat 
byproducts, except liver at 0.01 were combined as hog, meat byproducts 
at 0.01 ppm. Cattle, liver at 0.8 ppm and cattle, meat byproduct, 
except liver at 0.01 ppm were combined as cattle, meat byproducts at 
0.01 ppm. Finally a tolerance was proposed on cream at 0.03 ppm; 
however EPA has determined that no tolerance is needed.

V. Conclusion

    Therefore, tolerances are established for residues of 
picoxystrobin, methyl ([alpha]E)-[alpha]-(methoxymethylene)-2-[[[6-
(trifluoromethyl)-2-pyridinyl]oxy]methyl]benzeneacetate in or on 
barley, bran at 0.5 ppm; barley, grain at 0.3 ppm; rapeseed subgroup 
20A at 0.08 ppm; cattle, fat at 0.01 ppm; cattle, meat at 0.01 ppm; 
cattle, meat byproducts, at 0.01 ppm; corn, field, refined oil at 0.07 
ppm; goat, fat at 0.01 ppm; goat, meat at 0.01 ppm; goat meat 
byproduct, at 0.01 ppm; grain, aspirated grain fractions at 10 ppm; 
grain, cereal, group 15, except rice and barely at 0.04 ppm; grain, 
cereal, forage, fodder, and straw, group 16, hay at 5.0 ppm; grain, 
cereal, forage, fodder, and straw, group 16, forage at 15 ppm; grain, 
cereal, forage, fodder, and straw group 16, stover at 10 ppm; grain, 
cereal, forage, fodder, and straw, group 16, straw at 2 ppm; hog, fat 
at 0.01 ppm; hog, meat at 0.01 ppm; hog, meat byproducts, at 0.01 ppm; 
horse, fat at 0.01 ppm; horse, meat at 0.01 ppm; horse, meat 
byproducts, at 0.01 ppm; milk at 0.01 ppm; pea and bean, dried shelled, 
except soybean, subgroup 6C at 0.06 ppm; eggs at 0.01 ppm; poultry, fat 
at 0.01 ppm; poultry, meat at 0.01 ppm; poultry, meat byproducts at 
0.01 ppm; sheep, fat at 0.01 ppm; sheep, meat at 0.01 ppm; sheep, meat 
byproducts, at 0.01 ppm; soybean, forage at 1 ppm; soybean, hay at 3 
ppm; soybean, hulls at 0.2 ppm; soybean, seed at 0.05 ppm; vegetable, 
foliage of legume, except soybean, subgroup 7A at 40 ppm; wheat, bran 
at 0.06 ppm; and wheat, germ at 0.09 ppm.

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 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) (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 of 1995 (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.

    Dated: November 26, 2012.
Steven Bradbury,
Director, Office of Pesticides 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. Add Sec.  180.669 to subpart C to read as follows:


Sec.  180.669  Picoxystrobin; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
fungicide picoxystrobin, including its metabolites and degradates, in 
or on the commodities listed below. Compliance with the tolerance 
levels specified below is to be determined by measuring only 
picoxystrobin, methyl ([alpha]E)-[alpha]-(methoxymethylene)-2-[[[6-
(trifluoromethyl)-2-pyridinyl]oxy]methyl]benzeneacetate.

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Barley, bran..............................................          0.5
Barley, grain.............................................          0.3
Cattle, fat...............................................          0.01
Cattle, meat..............................................          0.01
Cattle, meat byproducts...................................          0.01
Corn, field, refined oil..................................          0.07
Eggs......................................................          0.01
Goat, fat.................................................          0.01
Goat, meat................................................          0.01

[[Page 72232]]

 
Goat, meat byproducts.....................................          0.01
Grain, aspirated grain fractions..........................         10
Grain, cereal, forage, fodder, and straw, group 16, forage         15
Grain, cereal, forage, fodder, and straw, group 16, hay...          5
Grain, cereal, forage, fodder, and straw, group 16, stover         10
Grain, cereal, forage, fodder, and straw, group 16, straw.          2
Grain, cereal, group 15, except rice and barley...........          0.04
Hog, fat..................................................          0.01
Hog, meat.................................................          0.01
Hog, meat byproducts......................................          0.01
Horse, fat................................................          0.01
Horse, meat...............................................          0.01
Horse, meat byproducts....................................          0.01
Milk......................................................          0.01
Pea and bean, dried shelled, except soybean, subgroup 6C..          0.06
Poultry, fat..............................................          0.01
Poultry, meat.............................................          0.01
Poultry, meat byproducts..................................          0.01
Rapeseed subgroup 20A.....................................          0.08
Sheep, fat................................................          0.01
Sheep, meat...............................................          0.01
Sheep, meat byproducts....................................          0.01
Soybean, forage...........................................          1
Soybean, hay..............................................          3
Soybean, hulls............................................          0.2
Soybean, seed.............................................          0.05
Vegetable, foliage of legume, except soybean, subgroup 7A.         40
Wheat, bran...............................................          0.06
Wheat, germ...............................................          0.09
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[FR Doc. 2012-29250 Filed 12-4-12; 8:45 am]
BILLING CODE 6560-50-P