[Federal Register Volume 77, Number 211 (Wednesday, October 31, 2012)]
[Rules and Regulations]
[Pages 65827-65831]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-26757]



40 CFR Part 180

[EPA-HQ-OPP-2012-0225; FRL-9360-9]

Trifloxystrobin; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.


SUMMARY: This regulation amends tolerances for residues of 
trifloxystrobin in or on almond hulls; and Vegetable, root, except 
sugarbeet, subgroup 1B, except radish. Bayer CropScience requested 
amendments to these tolerances under the Federal Food, Drug, and 
Cosmetic Act (FFDCA).

DATES: This regulation is effective October 31, 2012. Objections and 
requests for hearings must be received on or before December 31, 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: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2012-0225, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), EPA West Bldg., Rm. 3334, 1301 Constitution 
Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open 
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal 
holidays. The telephone number for the Public Reading Room is (202) 
566-1744, and the telephone number for the OPP Docket is (703) 305-
5805. Please review the visitor instructions and additional information 
about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Dominic Schuler, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone 
number: (703) 347-0260; email address: [email protected].


I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

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

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

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

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2012-0225 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 
December 31, 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 (excluding

[[Page 65828]]

any Confidential Business Information (CBI)) for inclusion in the 
public docket. Information not marked confidential pursuant to 40 CFR 
part 2 may be disclosed publicly by EPA without prior notice. Submit 
the non-CBI copy of your objection or hearing request, identified by 
docket ID number EPA-HQ-OPP-2012-0225, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be CBI or other 
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.htm.

Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of July, 25 2012 (77 FR 43565) (FRL-9353-
6), EPA issued a notice pursuant to FFDCA section 408(d)(3), 21 U.S.C. 
346a(d)(3), announcing the filing of a pesticide petition (PP 1F7930) 
by Bayer CropScience, 2 TW Alexander Dr., RTP, NC 27709. The petition 
requested that 40 CFR 180.555 be amended by increasing tolerances for 
residues of the fungicide trifloxystrobin, (benzeneacetic acid, (E,E)-
(trifluoromethyl)phenyl]ethylidene]amino]oxy] methyl]-methyl ester), in 
or on almond hulls at 9.0 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. Bayer CropScience's petition also requested that EPA 
delete the trifloxystrobin tolerance for ``Vegetable, root, except 
sugar beet, subgroup 1B, except radish.'' This tolerance was superseded 
by the establishment of the tolerance ``Vegetable, root, except sugar 
beet, subgroup 1B'' in the Federal Register of January 2, 2008 (73 FR 
52). Inadvertently, EPA failed to remove the ``Vegetable, root, except 
sugar beet, subgroup 1B, except radish'' tolerance when it established 
the broader ``Vegetable, root, except sugar beet, subgroup 1B'' 
    In addition to the petitioner's requests EPA has deleted the 
tolerance for almond. The reason for this change is explained in Unit 

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to amend 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 amending a tolerance and to ``ensure that there is 
a reasonable certainty that no harm will result to infants and children 
from aggregate exposure to the pesticide chemical residue * * *.''
    Consistent with FFDCA section 408(b)(2)(D), and the factors 
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available 
scientific data and other relevant information in support of this 
action. EPA has sufficient data to assess the hazards of and to make a 
determination on aggregate exposure for trifloxystrobin including 
exposure resulting from the tolerances amended by this action. EPA's 
assessment of exposures and risks associated with trifloxystrobin 

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 
    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 Register of June 11, 2010 (75 FR 33190) (FRL-
8829-2), and at http://www.regulations.gov in the document 
``Trifloxystrobin. Human Health Risk Assessment for a Section 3 
Petition Proposing Increased Tolerances for Residues in/on Field, Sweet 
and Pop Corn,'' pp. 17-21 in docket ID number EPA-HQ-OPP-2009-0278.

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

[[Page 65829]]

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). As to residue levels in food, 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. 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 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 
    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), and Screening Concentration in Ground Water (SCI-
GROW) models, the estimated drinking water concentrations (EDWCs) of 
trifloxystrobin plus its major degradation product, are estimated to be 
47.98 parts per billion (ppb) and 47.31 ppb for surface water for acute 
and chronic exposures, respectively. Modeled estimates of drinking 
water concentrations were directly entered into the dietary exposure 
    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/science/residential-exposure-sop.html.
    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 
    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 
    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 database is complete except for an inhalation study. An 
immunotoxicity study has been submitted; preliminary examination of the 
data found no evidence of immunotoxicity. In addition, the entire 
trifloxystrobin toxicity database was examined and there was no 
indication that this chemical directly targets the immune system. EPA 
does not believe that the immunotoxicity study 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 

[[Page 65830]]

does not need to be applied. Regarding the requirement for an 
inhalation toxicity study, the Agency has increased its focus on the 
uncertainties associated with route-to-route extrapolation (i.e., the 
use of oral toxicity studies for inhalation risk assessment) and is 
presently requiring inhalation toxicity studies more frequently. 
Although an inhalation toxicity study is now required for 
trifloxystrobin based on the current weight of the evidence approach, 
residential inhalation exposure is not anticipated; therefore, there 
are no uncertainties with respect to residential inhalation exposures 
to trifloxystrobin and no need to retain an additional database 
uncertainty factor for this safety finding.
    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. A waiver for a 
subchronic neurotoxicity study has been granted. There is no evidence 
of neurotoxicity in subchronic and chronic toxicity studies (rats, 
dogs, mice), in developmental toxicity studies (rats, rabbits), or in a 
reproductive toxicity study (rats). There is no concern for 
neurotoxicity for trifloxystrobin based on the available database, 
limited findings in an acute neurotoxicity study, and lack of 
neurotoxicity in other fungicides of the strobilurin class.
    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 
    iv. There are no residual uncertainties identified in the exposure 
databases. The acute dietary exposure assessment was unrefined, and the 
chronic dietary exposure assessment was partially refined, assuming 
100% crop treated and tolerance-level residues for all commodities 
except for apples, grapes, and oranges where the average field trial 
residues were used. 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 post-application 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 population adjusted dose (aPAD) and chronic population adjusted 
dose (cPAD). For linear cancer risks, EPA calculates the lifetime 
probability of acquiring cancer given the estimated aggregate exposure. 
Short-, intermediate-, and chronic-term risks are evaluated by 
comparing the estimated aggregate food, water, and residential exposure 
to the appropriate PODs to ensure that an adequate MOE exists.
    1. Acute risk. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food and water 
to trifloxystrobin will occupy 1.9% of the aPAD for females 13-49 years 
old, the population group receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
trifloxystrobin from food and water will utilize 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 130 for children 1-2 years (incidental oral 
residential + dietary food and drinking water exposures). Because EPA's 
level of concern for trifloxystrobin is a MOE of 100 or less, 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 
    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 methodology (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) 
is available to enforce the tolerance expression.
    The method may be requested from: Chief, Analytical Chemistry 
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 
20755-5350; telephone number: (410) 305-2905; email address: 
[email protected].

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint United Nations 
Food and Agriculture Organization/World Health Organization food 
standards program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level.
    The Codex has established an MRL for trifloxystrobin in or on 
almond hulls at 3.0 ppm. This MRL is different than the proposed 
amended tolerance at 9.0 ppm for trifloxystrobin in the United States.

[[Page 65831]]

    Previously, the domestic tolerance and Codex MRL of trifloxystrobin 
were harmonized at 3.0 ppm. The proposed amendment, to reduce the 
preharvest interval of almond hulls from 60 days to 14 days requires an 
increase in the tolerance level from 3.0 ppm to 9.0 ppm.

C. Revisions to Petitioned-For Tolerances

    EPA is deleting the existing tolerance for almonds. The removal of 
the specific tolerance for almonds is a result of the coverage of 
almonds within the established tolerance for nut, tree, group 14 at 
0.04 ppm.

V. Conclusion

    Therefore, the tolerance is amended for residues of 
trifloxystrobin, (benzeneacetic acid, (E,E)-[alpha]-(methoxyimino)-2-
[[[[1-[3(trifluoromethyl)phenyl]ethylidene]amino] oxy]methyl]-methyl 
ester), in or on almond, hulls from 3.0 ppm to 9.0 ppm. EPA is also 
granting the petitioner's request to remove the tolerance for 
Vegetable, root, except sugar beet, subgroup 1B, except radish. This 
tolerance should have been removed by EPA in its January 2, 2008 
rulemaking, (73 FR 52) (FRL-8342-6), that added a tolerance for 
``Vegetable, root, except sugar beet, subgroup 1B.'' The ``Vegetable, 
root, except sugar beet, subgroup 1B'' tolerance was intended as a 
replacement for the tolerance ``Vegetable, root, except sugar beet, 
subgroup 1B, except radish.'' EPA is correcting that error in this 
action. Finally, the specific tolerance is removed for almonds because 
this commodity is covered by crop group tolerances.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under FFDCA section 408(d) 
in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled ``Regulatory Planning and 
Review'' (58 FR 51735, October 4, 1993). Because this final rule has 
been exempted from review under Executive Order 12866, this final rule 
is not subject to Executive Order 13211, entitled ``Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
``Protection of Children from Environmental Health Risks and Safety 
Risks'' (62 FR 19885, April 23, 1997). This final rule does not contain 
any information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any 
special considerations under Executive Order 12898, entitled ``Federal 
Actions to Address Environmental Justice in Minority Populations and 
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under FFDCA section 408(d), such as the tolerance in this 
final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.), do not apply.
    This final rule directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled ``Federalism'' (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
``Consultation and Coordination with Indian Tribal Governments'' (65 FR 
67249, November 9, 2000) do not apply to this final rule. In addition, 
this final rule does not impose any enforceable duty or contain any 
unfunded mandate as described under Title II of the Unfunded Mandates 
Reform Act of 1995 (UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act of 1995 (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
EPA will submit a report containing this rule and other required 
information to the U.S. Senate, the U.S. House of Representatives, and 
the Comptroller General of the United States prior to publication of 
the rule in the Federal Register. This action is not a ``major rule'' 
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: October 15, 2012.
Lois Rossi,
Director, Registration Division, 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. In Sec.  180.555, in the table in paragraph (a), remove the entries 
for ``Almond'' and ``Vegetable, root, except sugar beet, subgroup 1B, 
except radish'' and revise the entry for ``Almond, hulls'' to read as 

Sec.  180.555  Trifloxystrobin; tolerances for residues.

    (a) * * *

                                                              Parts per
                         Commodity                             million
                                * * * * *
Almond, hulls..............................................          9.0
                                 * * * *

* * * * *
[FR Doc. 2012-26757 Filed 10-30-12; 8:45 am]