[Federal Register Volume 77, Number 42 (Friday, March 2, 2012)]
[Rules and Regulations]
[Pages 12727-12731]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-4977]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2011-0138; FRL-9336-5]


Trifloxystrobin; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for residues of 
trifloxystrobin in or on coffee, green bean. Bayer CropScience 
requested these tolerances under the Federal Food, Drug, and Cosmetic 
Act (FFDCA).

DATES: This regulation is effective March 2, 2012. Objections and 
requests for hearings must be received on or before May 1, 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-2011-0138. 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: Rosemary Kearns, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone 
number: (703) 305-5611; email address: <a href="/cdn-cgi/l/email-protection#076c626675697429756874626a66757e4762776629606871"><span class="__cf_email__" data-cfemail="016a6460736f722f736e72646c607378416471602f666e77">[email protected]</span></a>.

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:
    <bullet> Crop production (NAICS code 111).
    <bullet> Animal production (NAICS code 112).
    <bullet> Food manufacturing (NAICS code 311).
    <bullet> 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-2011-0138 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 
May 1, 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-2011-0138, by one of the following methods:

[[Page 12728]]

    <bullet> Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
    <bullet> Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave. 
NW., Washington, DC 20460-0001.
    <bullet> 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 December 30, 2011 (76 FR 82238) (FRL-
9331-1), 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 
0E7789) by Bayer CropScience Corporation, 2 T.W. Alexander Drive, 
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)-a-(methoxyimino)-
2-[[[[1-[3-(trifluoromethyl)phenyl]ethylidene]amino]oxy]methyl]-methyl 
ester] and the free form of its acid metabolite CG-321113 [(E,E)-
(methoxyimino)-[2-[1-(3-(trifluoromethylphenyl)-
ethylideneaminooxymethyl]-phenyl]acetic acid, in or on imported coffee, 
green bean at 0.02 parts per million (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 low acute 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. There is no evidence of increased 
susceptibility following pre-natal exposure to rats and rabbits and 
post-natal 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 can be found at http://www.regulations.gov in document ``Trifloxystrobin Human Health Risk 
Assessment for Proposed New Use on Imported Coffee,'' p.11 in docket ID 
number EPA-HQ-OPP-2011-0138.

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 33192) (FRL-
8829-2).

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 part 180. 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

[[Page 12729]]

United States Department of Agriculture (USDA) 1994-1996 and 1998, 
Nationwide Continuing Surveys of Food Intake by Individuals (CSFII). As 
to residue levels in food, EPA assumed all commodities with established 
or proposed tolerances were treated with trifloxystrobin and contained 
trifloxystrobin at the tolerance level.
    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 
data 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.
    For acute and chronic exposures are estimated to be 47.98 parts per 
billion (ppb) and 47.31 ppb for surface water. The ground water EDWC 
(1.9 [mu]g/L, or 1.9 ppb) represents the combined residues of 
trifloxystrobin plus CGA-321113, 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: 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 postapplication 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. EPA assessed 
residential exposure using the following assumptions:
    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.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10x) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the FQPA Safety 
Factor (SF). In applying this provision, EPA either retains the default 
value of 10x, or uses a different additional safety factor when 
reliable data available to EPA support the choice of a different 
factor.
    2. Prenatal and postnatal sensitivity. There is no indication of 
increased quantitative or qualitative susceptibility to trifloxystrobin 
in rats or rabbits. 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 multigeneration study, offspring and parental LOAELs are at the 
same dose level.
    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 
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

[[Page 12730]]

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. The 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 field trial residue levels 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 surface 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. 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 1100 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 130 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).
    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: 
<a href="/cdn-cgi/l/email-protection#ee9c8b9d878a9b8b838b9a86818a9dae8b9e8fc0898198"><span class="__cf_email__" data-cfemail="0a786f79636e7f6f676f7e62656e794a6f7a6b246d657c">[email protected]</span></a>.

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. There are currently no 
established Mexican, Canadian, or Codex maximum residue limits (MRLs) 
or tolerances for trifloxystrobin on coffee. Therefore, harmonization 
is not an issue at this time.

V. Conclusion

    Therefore, a tolerance is established for residues of 
[benzeneacetic acid, (E, E)-a-(methoxyimino)-2-[[[[1-[3-
(trifluoromethyl)phenyl]ethylidene]amino]oxy]methyl]-methyl ester] and

[[Page 12731]]

the free form of its acide metabolite CG-321113 [(E,E)-(methoxyimino)-
[2-[1-(3-(trifluoromethylphenyl)-ethylideneaminooxymethyl]-
phenyl]acetic acid, in or on imported coffee, green bean at 0.02 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: February 17, 2012.
Lois Rossi,
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 
commodity and footnote 2 to the table in paragraph (a) to read as 
follows:


Sec.  180.555  Trifloxystrobin; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Coffee, green bean \2\.....................................         0.02
 
                                * * * * *
------------------------------------------------------------------------
* * * * *
\2\ There are no U.S. registrations as of January 18, 2012 for use on
  coffee, green bean.
 
* * * * *

[FR Doc. 2012-4977 Filed 3-1-12; 8:45 am]
BILLING CODE 6560-50-P


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