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[Federal Register Volume 75, Number 232 (Friday, December 3, 2010)]
[Rules and Regulations]
[Pages 75389-75393]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-30363]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2008-0732; FRL-8854-6]

Metrafenone; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
metrafenone (3-bromo-6-methoxy-2-methylphenyl)(2,3,4-trimethoxy-6-
methylphenyl)methanone in or on grapes. BASF Corporation requested 
these tolerances under the Federal Food, Drug, and Cosmetic Act 
(FFDCA).

DATES: This regulation is effective December 3, 2010. Objections and 
requests for hearings must be received on or before February 1, 2011, 
and must be filed in accordance with the instructions provided in 40 
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2008-0732. All documents in the 
docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is 
not publicly available, e.g., Confidential Business Information (CBI) 
or other information whose disclosure is restricted by statute. Certain 
other material, such as copyrighted material, is not placed on the 
Internet and will be publicly available only in hard copy form. 
Publicly available docket materials are available in the electronic 
docket at http://www.regulations.gov, or, if only available in hard 
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac 
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket 
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The Docket Facility telephone number is (703) 
305-5805.

FOR FURTHER INFORMATION CONTACT: Tawanda Maignan, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 308-8050; e-mail address: maignan.tawanda@epa.gov.

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to those 
engaged in the following activities:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather to 
provide a guide for readers regarding entities likely to be affected by 
this action. Other types of entities not listed in this unit could also 
be affected. The North American Industrial Classification System 
(NAICS) codes have been provided to assist you and others in 
determining whether this action might apply to certain entities. If you 
have any questions regarding the applicability of this action to a 
particular entity, consult the person listed under FOR FURTHER 
INFORMATION CONTACT.

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

    You may access a frequently updated electronic version of EPA's 
tolerance regulations at 40 CFR part 180 through the Government 
Printing Office's e-CFR site at http://www.gpoaccess.gov/ecfr. To 
access the harmonized test guidelines referenced in this document 
electronically, please go http://www.epa.gov/ocspp and select ``Test 
Methods and Guidelines.''

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-2008-0732 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 1, 2011. 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 
your non-CBI objection or hearing request, identified by docket ID 
number EPA-HQ-OPP-2008-0732, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket Facility's normal hours of operation (8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays). 
Special arrangements should be made for deliveries of boxed 
information. The Docket Facility telephone number is (703) 305-5805.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of October 7, 2009 (74 FR 51599) (FRL-8792-
7), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
8F7371) by BASF Corporation, 26 Davis Drive, P.O. Box 13528, Research 
Triangle Park, NC 27709. The petition requested that 40 CFR 180.624 be 
amended by establishing tolerances for residues of the fungicide 
metrafenone, (3-bromo-6-methoxy-2-methylphenyl)(2,3,4-trimethoxy-6-
methylphenyl) methanone, in or on table and wine grapes at 4.5 parts 
per million (ppm), juice grapes at 0.45 ppm, and raisin grapes at 17 
ppm. That notice

[[Page 75390]]

referenced a summary of the petition prepared by BASF Corporation, 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 
determined that the proposed tolerances for wine and juice grapes are 
not needed. The reason for this change is explained in Unit IV.D.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue. * * 
*''
    Consistent with section 408(b)(2)(D) of FFDCA, and the factors 
specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the 
available scientific data and other relevant information in support of 
this action. EPA has sufficient data to assess the hazards of and to 
make a determination on aggregate exposure for metrafenone including 
exposure resulting from the tolerances established by this action. 
EPA's assessment of exposures and risks associated with metrafenone 
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.
    Metrafenone has low acute toxicity via oral, inhalation and dermal 
routes. It is not a dermal sensitizer, or a skin or eye irritant. 
Subchronic and chronic studies showed that the liver was the primary 
organ affected in toxicity studies with mice, rats and rabbits, along 
with impacts on body weights and body weight gains. After chronic 
durations, the liver and body weight effects were accompanied by kidney 
effects. In the subchronic and chronic toxicity studies in dogs, no 
effects were seen at any dose, up to 500 milligrams/kilogram/day (mg/
kg/day). In developmental toxicity studies in rats and rabbits, there 
were no effects observed in fetuses at any dose level up to 700 mg/kg/
day in rabbits and 1,000 mg/kg/day in rats. The maternal effects in the 
rabbit developmental study consisted of liver effects as well as 
decreased body weight gains and food consumption. In the rat 
developmental toxicity study, no effects were observed in the maternal 
animals. In the 2-generation reproduction study, there was no evidence 
of reproductive effects or any impacts on the endocrine system. Effects 
in parental animals and offspring consisted of decreased body weights 
and body weight gains, and these were observed at similar doses. In 
addition, in the parental animals liver effects and decreased thymus 
weights were observed at the same high doses that resulted in decreased 
body weight gains.
    Based on a battery of mutagenicity studies, metrafenone is not 
considered to be genotoxic. In accordance with the EPA's Final 
Guidelines for Carcinogen Risk Assessment (March, 2005), metrafenone is 
classified as ``Suggestive Evidence of Carcinogenicity,'' and concluded 
that human risk to liver tumorgenesis would not be expected at exposure 
levels that do not cause tumors in mice. The no-observed-adverse-
effect-level (NOAEL) and the lowest-observed-adverse-effect-level 
(LOAEL) selected for the chronic reference dose (cRfD) are based on 
hepatotoxicity and nephrotoxicity observed at doses lower than the 
liver tumor response dose. Thus, the cRfD is protective of the cancer 
effects. The weight of evidence considerations can be found in the 
Federal Register of September 20, 2006 (71 FR 54915) (FRL-8093-7).
    Specific information on the studies received and the nature of the 
adverse effects caused by metrafenone as well as the NOAEL and the 
LOAEL from the toxicity studies can be found at http://www.regulations.gov in document Metrafenone: Human Health Risk 
Assessment for Foliar Use on Grapes in docket ID number EPA-HQ-OPP-
2008-0732.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (POD) and levels of 
concern to use in evaluating the risk posed by human exposure to the 
pesticide. For hazards that have a threshold below which there is no 
appreciable risk, the toxicological POD is used as the basis for 
derivation of reference values for risk assessment. PODs are developed 
based on a careful analysis of the doses in each toxicological study to 
determine the dose at which the NOAEL and the LOAEL. Uncertainty/safety 
factors (U/SF) are used in conjunction with the POD to calculate a safe 
exposure level--generally referred to as a population-adjusted dose 
(PAD) (a = acute c = chronic) 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 Metrafenone used for 
human risk assessment is shown in Table 1 of this unit.

  Table 1--Summary of Toxicological Doses and Endpoints for Metrafenone for Use in Human Health Risk Assessment
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                                     Point of departure and
         Exposure/scenario              uncertainty/safety   RfD, PAD, LOC for risk    Study and toxicological
                                             factors                assessment                 effects
----------------------------------------------------------------------------------------------------------------
Acute dietary (All populations,           No appropriate endpoint attributable to a single dose identified.
 including infants and children).
----------------------------------------------------------------------------------------------------------------

[[Page 75391]]

 
Chronic dietary (All populations,..  NOAEL = 24.9 mg/kg/day  Chronic RfD = 0.249 mg/ Combined Chronic/
                                                              kg/day.                 Carcinogenicity-Rat
 including infants and children).    UFA = 10x               cPAD = 0.249 mg/kg/day   LOAEL = 260 mg/kg/day
                                                                                      based on
                                     UFH = 10x                                        hepatotoxicity and
                                                                                      nephrotoxicity in both
                                     FQPA SF = 1x                                     sexes.
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)..  Suggestive evidence of carcinogenicity. Quantification of cancer risk using
                                      a cancer potency factor is not required. The chronic reference dose is
                                      protective of potential cancer risk.
----------------------------------------------------------------------------------------------------------------
UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members
  of the human population (intraspecies). UFL = use of a LOAEL to extrapolate a NOAEL. UFS = use of a short-term
  study for long-term risk assessment. UFDB = to account for the absence of data or other data deficiency. FQPA
  SF = Food Quality Protection Act Safety Factor. LOC = level of concern.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to metrafenone, EPA considered exposure under the petitioned-
for tolerances. EPA assessed dietary exposures from metrafenone 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.
    No such effects were identified in the toxicological studies for 
Metrafenone; therefore, a quantitative acute dietary exposure 
assessment is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the Dietary Exposure Evaluation Model software with 
the Food Commodity Intake Database (DEEM-FCID, Version 2.03), which 
incorporates food consumption data as reported by respondents in the 
U.S. Department of Agriculture (USDA) 1994-1996 and 1998 Nationwide 
Continuing Surveys of Food Intake by Individuals (CSFII). No Percent 
Crop Treated (PCT) information was incorporated into the dietary 
exposure and risk assessment; it was assumed that 100 PCT for grapes. 
As to residue levels, EPA assumed treated commodities would contain 
tolerance level residues 2X higher than the proposed tolerances to 
account for additional residues of potential concern with respect to 
toxicity which were not included in the proposed tolerance for 
enforcement purposes.
    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 non-linear 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 and 
referenced in Unit III.A., EPA has concluded that metrafenone is 
classified as ``Suggestive Evidence of Carcinogenicity.'' Cancer risk 
was assessed using the same exposure estimates as discussed in Unit 
III.C.1.ii.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for metrafenone in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of metrafenone. Further information regarding EPA 
drinking water models used in pesticide exposure assessment can be 
found at http://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the First Index Reservoir Screening Tool (FIRST), 
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 metrafenone for 
chronic exposures for non-cancer assessments are estimated to be 22.82 
parts per billion (ppb) for surface water and 0.097 ppb for ground 
water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For chronic (non-cancer) 
dietary risk assessment, the water concentration of value 22.82 ppb was 
used to assess the contribution to drinking water because the Tier II 
PRZM/EXAMS value was higher than the Tier I FIRST and groundwater 
values.
    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).
    Metrafenone 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 metrafenone to share a common mechanism of 
toxicity with any other substances, and metrafenone does not appear to 
produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
metrafenone 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

[[Page 75392]]

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 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. There is no evidence of 
increased susceptibility following in utero and/or postnatal exposure 
in the developmental toxicity studies in rats or rabbits, and in the 2-
generation rat reproduction study.
    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 toxicity database for metrafenone is complete with the 
exception of an immunotoxicity study. In accordance with the updated 40 
CFR part 158 toxicity data requirements for conventional pesticides, an 
immunotoxicity study is required for metrafenone. EPA has evaluated the 
available metrafenone toxicity data to determine whether an additional 
UFDB is needed to account for the lack of the study. 
Decreased thymus weight, a potential immunotoxic effect, was observed 
only in adults and solely in a 2-generation reproduction study in rats. 
Because this effect was observed in only one species (rats) in one 
study, at the highest dose tested, and the NOAEL for this effect is 3X 
higher than the NOAEL for liver toxicity on which the cPAD is based, 
EPA believes the NOAEL for liver toxicity is protective of this effect, 
and an additional UFDB is not needed to account for 
potential immunotoxicity.
    ii. There is no indication that metrafenone 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 metrafenone 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 based on assuming 
100 PCT and residues 2X higher than the proposed tolerance residue 
levels. EPA made conservative (protective) assumptions in the ground 
and surface water modeling used to assess exposure to metrafenone in 
drinking water. These assessments will not underestimate the exposure 
and risks posed by metrafenone.

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 
aPAD and 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. An acute aggregate risk assessment takes into 
account acute exposure estimates from dietary consumption of food and 
drinking water. No adverse effect resulting from a single oral exposure 
was identified and no acute dietary endpoint was selected. Therefore, 
metrafenone is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
metrafenone from food and water will utilize 1% of the cPAD for the 
general U.S. population and 5% of the cPAD for children 1-2 years old, 
the population group receiving the greatest exposure. There are no 
residential uses for metrafenone.
    3. Short-term risk. Short-term aggregate exposure takes into 
account short-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level). Because there 
is no residential exposure, metrafenone is not expected to pose a 
short-term risk.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level). Because there is no residential exposure, metrafenone is not 
expected to pose an intermediate-term risk.
    5. Aggregate cancer risk for U.S. population. Based on the data 
summarized and referenced in Unit III.A., EPA has concluded that the 
cRfD/cPAD for metrafenone is protective of the cancer effects. As noted 
above, the chronic exposure for the general U.S. population utilizes 
only 1% of the cPAD.
    6. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population or to infants and children from aggregate 
exposure to metrafenone residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    An adequate gas chromatography (GC) method with electron capture 
(ECD) and mass spectrometry (MS) detection, Method FAMS 105-01, is 
available to enforce the tolerance expression for grapes. However, EPA 
requires radiovalidation data for any future tolerances on other 
commodities. Such data were being generated at the time EPA was 
reviewing the grape submission.
    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; e-mail 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 U.N. 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 not established a MRL for metrafenone. Although there 
has been an agreement to harmonize the proposed grape MRL with Canada, 
the MRL has yet to be harmonized between member states.

C. Revisions to Petitioned-for Tolerances

    EPA is not establishing the proposed tolerances for wine and juice 
grapes. Tolerances on raw agricultural commodities (such as grapes) are 
applicable to food processed from those commodities (such as grape 
juice and wine). Because the processing data indicate that residues of 
metrafenone do not concentrate in grape juice or wine, a tolerance on 
the raw agricultural commodity is all that is necessary.
    EPA is revising the requested tolerance expression to clarify the 
chemical moieties that are covered by

[[Page 75393]]

the tolerances and specify how compliance with the tolerances is to be 
measured. The revised tolerance expression makes clear that the 
tolerances cover residues of the fungicide metrafenone, including its 
metabolites and degradates, but that compliance with the specified 
tolerance levels is to be determined by measuring only metrafenone (3-
bromo-6-methoxy-2-methylphenyl)(2,3,4-trimethoxy-6-
methylphenyl)methanone in or on the commodities.

V. Conclusion

    Therefore, tolerances are established for residues of metrafenone, 
(3-bromo-6-methoxy-2-methylphenyl)(2,3,4-trimethoxy-6-
methylphenyl)methanone, in or on grape at 4.5 ppm and grape, raisin at 
17 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under section 408(d) of 
FFDCA in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993). Because this final rule has been 
exempted from review under Executive Order 12866, this final rule is 
not subject to Executive Order 13211, entitled Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
Protection of Children from Environmental Health Risks and Safety Risks 
(62 FR 19885, April 23, 1997). This final rule does not contain any 
information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any 
special considerations under Executive Order 12898, entitled Federal 
Actions to Address Environmental Justice in Minority Populations and 
Low-Income Populations (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under section 408(d) of FFDCA, such as the tolerance in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply.
    This final rule directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of FFDCA. As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled Federalism (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
Consultation and Coordination with Indian Tribal Governments (65 FR 
67249, November 9, 2000) do not apply to this final rule. In addition, 
this final rule does not impose any enforceable duty or contain any 
unfunded mandate as described under Title II of the Unfunded Mandates 
Reform Act of 1995 (UMRA) (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: November 24, 2010.
Steven Bradbury,
Director, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority:  21 U.S.C. 321(q), 346a and 371.

0
2. Section 180.624 paragraph (a) is revised to read as follows:

Sec.  180.624  Metrafenone; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
fungicide metrafenone, including its metabolites and degradates, in or 
on the commodities in the table below. Compliance with the tolerance 
levels specified in the following table is to be determined by 
measuring only metrafenone (3-bromo-6-methoxy-2-methylphenyl)(2,3,4-
trimethoxy-6-methylphenyl)methanone in or on the following commodities:

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
Grape................................................                4.5
Grape, raisin........................................               17
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[FR Doc. 2010-30363 Filed 12-2-10; 8:45 am]
BILLING CODE 6560-50-P
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