Federal Register, Volume 76 Issue 217 (Wednesday, November 9, 2011)

[Federal Register Volume 76, Number 217 (Wednesday, November 9, 2011)]
[Rules and Regulations]
[Pages 69648-69653]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-28945]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2011-0456; FRL-8890-1]

Trifloxystrobin; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
trifloxystrobin in or on alfalfa, forage and alfalfa, hay. Bayer
CropScience requested these tolerances under the Federal Food, Drug,
and Cosmetic Act (FFDCA).

DATES: This regulation is effective November 9, 2011. Objections and
requests for hearings must be received on or before January 9, 2012,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2011-0456. 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; email address: Maignan.Tawanda@epa.gov.

SUPPLEMENTARY INFORMATION:

[[Page 69649]]

I. General Information

A. Does this action apply to me?

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

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

You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR site at http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2011-0456 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
January 9, 2012. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket. Information not marked confidential pursuant to 40 CFR part 2
may be disclosed publicly by EPA without prior notice. Submit a copy of
your non-CBI objection or hearing request, identified by docket ID
number EPA-HQ-OPP-2011-0456, 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 July 20, 2011 (76 FR 43231) (FRL-8880-
1), 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
0F7713) by Bayer CropScience, P.O. Box 12014, 2 T.W. Alexander Dr.,
Research Triangle Park, NC 27709. The petition requested that 40 CFR
180.555 be amended by establishing tolerances for residues of the
fungicide trifloxystrobin, benzeneacetic acid, (E,E)-[alpha]-
(methoxyimino)-2-[[[[1-[3- (trifluoromethyl)
phenyl]ethylidene]amino]oxy]methyl]-methyl ester), in or on alfalfa,
forage at 0.01 parts per million (ppm) and alfalfa, hay at 0.01 ppm.
That notice referenced a summary of the petition prepared by Bayer
CropScience, the registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the
notice of filing.

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 trifloxystrobin
including exposure resulting from the tolerances established by this
action. EPA's assessment of exposures and risks associated with
trifloxystrobin 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. Trifloxystrobin exhibits very low toxicity following single
oral, dermal and inhalation exposures. It is a strong dermal
sensitizer. In repeated dose tests in rats, the liver is the target
organ for trifloxystrobin; toxicity is induced following oral and
dermal exposure for 28 days. There is no evidence of increased
susceptibility following prenatal exposure to rats and rabbits and
postnatal exposures to rats. Trifloxystrobin was determined not to be
carcinogenic in mice or rats following long-term dietary
administration. Trifloxystrobin is positive for mutagenicity in Chinese
Hamster V79 cells, albeit at cytotoxic dose levels. However,
trifloxystrobin is negative in the remaining mutagenicity studies.
Specific information on the studies received and the nature of the
adverse effects caused by trifloxystrobin as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies are discussed in the final rule
published in the Federal

[[Page 69650]]

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 trifloxystrobin used
for human risk assessment is discussed in Unit III.B. of the final rule
published in the Federal Register of June 11, 2010 (75 FR 33190).

C. Exposure Assessment

1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to trifloxystrobin, EPA considered exposure under the
petitioned-for tolerances as well as all existing trifloxystrobin
tolerances in 40 CFR 180.555. EPA assessed dietary exposures from
trifloxystrobin in food as follows:
i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure.
Such effects were identified for trifloxystrobin. In estimating
acute dietary exposure for females 13-49 years old, EPA conducted an
analysis using the Dietary Exposure Evaluation Model (DEEM\TM\ 7.81),
which used food consumption information from the United States
Department of Agriculture (USDA) 1994-1996 and 1998, Nationwide
Continuing Surveys of Food Intake by Individuals (CSFII). EPA used
tolerance level residues. EPA assumed all commodities with established
or proposed tolerances were treated with trifloxystrobin.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 1994-1996
and 1998, CSFII to be included in DEEM. As to residue levels in food,
EPA used tolerance level residues for all commodities with the
exception of apples, oranges and grapes. For these commodities EPA used
anticipated residues from field residue trials. EPA assumed all
commodities with established or proposed tolerances were treated with
trifloxystrobin.
iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that trifloxystrobin does not pose a cancer risk to humans.
Therefore, a dietary exposure assessment for the purpose of assessing
cancer risk is unnecessary.
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 trifloxystrobin in drinking water. These simulation
models take into account data on the physical, chemical, and fate/
transport characteristics of trifloxystrobin. 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 Pesticide Root Zone Model/Exposure Analysis Modeling
System (PRZM/EXAMS), GENeric Estimated Exposure Concentration (GENEEC),
and/or Screening Concentration in Ground Water (SCI-GROW) models, the
estimated drinking water concentrations (EDWCs) of trifloxystrobin plus
its major degradation product, CGA-321113 for the proposed alfalfa use
are less than those previously estimated in the revised EDWCs for turf
use.
Acute and chronic exposures are estimated to be 47.99 parts per
billion (ppb) and 47.31 ppb for surface water, respectively. Modeled
estimates of drinking water concentrations were directly entered into
the dietary exposure model.
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).
Trifloxystrobin is currently registered for the following uses that
could result in residential exposures: Ornamentals and turfgrass. EPA
assessed residential exposure under the following exposure scenarios:
Adult post-application dermal exposure; and children's post-application
dermal and/or hand to mouth exposure. Further information regarding EPA
standard assumptions and generic inputs for residential exposures may
be found at http://www.epa.gov/pesticides/trac/science/trac6a05.pdf.
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 trifloxystrobin to share a common mechanism of
toxicity with any other substances, and trifloxystrobin does not appear
to produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
trifloxystrobin 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.

[[Page 69651]]

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 Food Quality
Protection Act Safety Factor (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 indication of
increased susceptibility of rat or rabbits to trifloxystrobin. In the
prenatal developmental study in rats, there was no developmental
toxicity at the limit dose. In the prenatal developmental study in
rabbits, developmental toxicity was seen at a dose that was higher than
the dose that caused maternal toxicity. In the 2-generation
reproduction study, there was no offspring toxicity at the highest dose
tested.
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 trifloxystrobin is complete except for
neurotoxicity and immunotoxicity testing. Recent changes to 40 CFR part
158 make neurotoxicity and immunotoxicity testing required for
pesticide registration; however, the existing data are sufficient for
endpoint selection for exposure/risk assessment scenarios, and for
evaluation of the requirements under the FQPA. Although acute and
subchronic neurotoxicity and immunotoxicity studies are needed to
complete the database, there are no concerns for immunotoxicity or
neurotoxicity based on the results of the existing studies. The
toxicological database for trifloxystrobin does not show any evidence
of treatment-related effects on the immune system. There was a decrease
in the incidence of hemosiderosis in the spleen of F0 and F1 parental
males and females in the 2-generation reproduction study. The effect
was not seen in any other toxicity studies, and it was not a primary
effect on the spleen. This decrease may indicate a decrease of red
blood cell turnover; but it is not an effect on the immune system.
Further, there was no evidence of neurotoxicity at the limit dose in an
unacceptable acute neurotoxicity study or in the other subchronic and
chronic studies in the database. EPA does not believe that conducting
neurotoxicity or immunotoxicity studies will result in a dose less than
the points of departure already used in this risk assessment and an
additional database uncertainty factor (UF) for potential neurotoxicity
and/or immunotoxicity does not need to be applied.
ii. There is no indication that trifloxystrobin 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 trifloxystrobin 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 acute and chronic dietary food exposure assessments
utilize existing and proposed tolerance level residues and 100 PCT
information for all commodities, except for apples, oranges, and grapes
which utilized anticipated residues for the chronic dietary assessment.
By using these screening-level assessments with minor refinement,
actual exposures/risks from residues in food will not be
underestimated. EPA made conservative (protective) assumptions in the
ground water and surface water modeling used to assess exposure to
trifloxystrobin in drinking water. EPA used similarly conservative
assumptions to assess postapplication exposure of children as well as
incidental oral exposure of toddlers. These assessments will not
underestimate the exposure and risks posed by trifloxystrobin.

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. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary consumption of food and
drinking water. With the exception of the sub-population females 13-49
years, no adverse effect resulting from a single oral exposure was
identified and no acute dietary endpoint was selected. Therefore, using
the exposure assumptions discussed in this unit for acute exposure, the
acute dietary exposure from food and water to trifloxystrobin will
occupy <2% of the aPAD for females 13-49 years old.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
trifloxystrobin from food and water will utilize 34% of the cPAD for
the general U.S. population and 64% of the cPAD for children 1-2 years
old, the population group receiving the greatest exposure. Based on the
explanation in Unit III.C.3., regarding residential use patterns,
chronic residential exposure to residues of trifloxystrobin is not
expected.
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).
Trifloxystrobin is currently registered for uses that could result
in short-term residential exposure, and the Agency has determined that
it is appropriate to aggregate chronic exposure through food and water
with short-term residential exposures to trifloxystrobin.
Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water,
and residential exposures result in aggregate MOEs of 1,100 for adults
(dermal residential + dietary food and drinking water exposures); 650
for children 1-2 years (dermal residential + dietary food and drinking
water exposures); and 120 for children 1-2 years (incidental oral +
dietary food and drinking water exposures). Because EPA's level of
concern for trifloxystrobin is a MOE of 100 or below, these MOEs are
not of concern.
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). Trifloxystrobin is not expected to pose an intermediate-term
risk based on a short soil half-life (approximately 2 days).

[[Page 69652]]

5. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, trifloxystrobin is not expected to pose a cancer risk to
humans.
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 trifloxystrobin residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

Adequate enforcement methodologies (gas chromatography with
nitrogen phosphorus detection (GC/NPD), Method AG-659A and liquid
chromatography with tandem mass spectrometry detection (LC/MS/MS),
Method No. 200177) are 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 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 trifloxystrobin in or on
alfalfa forage or alfalfa hay. Also, since Canada does not establish
tolerances for livestock feed items, no Canadian MRLs have been
established for these commodities.

V. Conclusion

Therefore, tolerances are established for residues of
trifloxystrobin, benzeneacetic acid, (E,E)-[alpha]-(methoxyimino)-2-
[[[[1-[3-(trifluoromethyl) phenyl]ethylidene]amino]oxy]methyl]-methyl
ester), in or on alfalfa, forage at 0.01 ppm and alfalfa, hay at 0.01
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: October 4, 2011.
Daniel J. Rosenblatt,
Acting Director, Registration Division, Office of Pesticide Programs.

Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

0
2. Section 180.555 is amended by alphabetically adding the following
commodities to the table in paragraph (a) to read as follows:

Sec. 180.555 Trifloxystrobin; tolerance of residues.

(a) * * *

------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Alfalfa, forage........................................... 0.01
Alfalfa, hay.............................................. 0.01

* * * * *
------------------------------------------------------------------------

[[Page 69653]]

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[FR Doc. 2011-28945 Filed 11-8-11; 8:45 am]
BILLING CODE 6560-50-P