[Federal Register Volume 75, Number 232 (Friday, December 3, 2010)]
[Rules and Regulations]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-30363]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
Metrafenone; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
SUMMARY: This regulation establishes tolerances for residues of
methylphenyl)methanone in or on grapes. BASF Corporation requested
these tolerances under the Federal Food, Drug, and Cosmetic Act
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)
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: email@example.com.
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
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
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
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
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
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-
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
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).
Chronic dietary (All populations,.. NOAEL = 24.9 mg/kg/day Chronic RfD = 0.249 mg/ Combined Chronic/
including infants and children). UFA = 10x cPAD = 0.249 mg/kg/day LOAEL = 260 mg/kg/day
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
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
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
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
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
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
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
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
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
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
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
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:
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
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-
methylphenyl)methanone in or on the commodities.
Therefore, tolerances are established for residues of metrafenone,
methylphenyl)methanone, in or on grape at 4.5 ppm and grape, raisin at
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
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
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
Dated: November 24, 2010.
Director, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
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, raisin........................................ 17
* * * * *
[FR Doc. 2010-30363 Filed 12-2-10; 8:45 am]
BILLING CODE 6560-50-P