[Federal Register Volume 77, Number 234 (Wednesday, December 5, 2012)]
[Rules and Regulations]
[Pages 72226-72232]
From the Federal Register Online via the Government Printing 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: rowland.grant@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
[[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
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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.
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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.
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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:
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. 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