81_FR_9810 81 FR 9772 - Trifloxystrobin; Pesticide Tolerances

81 FR 9772 - Trifloxystrobin; Pesticide Tolerances

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 81, Issue 38 (February 26, 2016)

Page Range9772-9777
FR Document2016-04070

This regulation establishes tolerances for residues of trifloxystrobin in or on multiple commodities which are identified and discussed later in this document. Bayer CropScience requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

Federal Register, Volume 81 Issue 38 (Friday, February 26, 2016)
[Federal Register Volume 81, Number 38 (Friday, February 26, 2016)]
[Rules and Regulations]
[Pages 9772-9777]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-04070]


-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2014-0709; FRL-9941-92]


Trifloxystrobin; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This regulation establishes tolerances for residues of 
trifloxystrobin in or on multiple commodities which are identified and 
discussed later in this document. Bayer CropScience requested these 
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective February 26, 2016. Objections and 
requests for hearings must be received on or before April 26, 2016, 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-2014-0709, 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), West William Jefferson Clinton 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: Susan Lewis, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone 
number: (703) 305-7090; email address: [email protected].

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. 
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://www.ecfr.gov/cgi-bin/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-2014-0709 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 
April 26, 2016. Addresses for

[[Page 9773]]

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 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-2014-0709, 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 
20460-0001.
     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.html.
    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 February 11, 2015 (80 FR 7559) (FRL-
9921-94), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
4F8288) by Bayer CropScience, 2 T.W. Alexander Drive, P.O. Box 12014, 
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, and the free form of its acid 
metabolite CGA-321113, (E,E)-methoxyimino-[2-[1-(3-trifluoromethyl-
phenyl)-ethylideneaminooxymethyl]-phenyl]acetic acid, calculated as the 
stoichiometric equivalent of trifloxystrobin, in or on leafy greens 
(crop subgroup 4A) at 30 parts per million (ppm); herb (crop subgroup 
19A) at 200 ppm; spice (crop subgroup 19B), except black pepper) at 30 
ppm; head and stem brassica (crop subgroup 5A) at 2 ppm; leafy brassica 
greens (crop subgroup 5B) at 30 ppm; tuberous and corm vegetables (crop 
subgroup 1C) at 0.04 ppm; small fruit vine climbing (except fuzzy 
kiwifruit) (crop subgroup 13-07F) at 2.0 ppm; and low growing berry 
(crop subgroup 13-07G) at 1.5 ppm. Bayer CropScience, also requested 
that the existing tolerance for leafy petioles (subgroup 4B) be amended 
from 3.5 ppm to 9 ppm. That document 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.
    Based upon review of the data supporting the petition, EPA has 
modified the commodity terms for several tolerances to reflect the 
correct commodity definition. The reason for these changes are 
explained in Unit IV.C.

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 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 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 and a 
mild dermal and eye irritant. 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. Liver effects characterized by an 
increase in liver weights and an increased incidence of hepatocellular 
hypertrophy and/or hepatocellular necrosis were seen in rats, mice, and 
dogs. There is no concern for neurotoxicity or immunotoxicity in the 
database. In the rabbit developmental toxicity study, an increase in 
the incidence of fused sternabrae was seen at a dose 10 times higher 
than the maternal lowest observed adverse effect level (LOAEL). In the 
rat reproduction study, both parents and offspring showed decreases in 
body weight during lactation. The rat and rabbit developmental and the 
rat reproduction toxicity data do not demonstrate an increase in 
susceptibility in the fetus or other offspring. Trifloxystrobin is 
classified as: ``Not likely to be Carcinogenic to Humans'' based on 
both the negative results in the battery of mutagenicity tests (except 
at a cytoxic dose in one in vitro test), and from the long-term 
carcinogenicity studies in rats and mice. 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 document ``Trifloxystrobin. Aggregate 
Human Health Risk Assessment for the Proposed New Uses on Leafy Greens 
(Crop Subgroup 4A), Head and Stem Brassica Vegetables (Crop Subgroup 
5A), Leafy Brassica Greens (Crop Subgroup 5B), Herbs (Crop Group 19A), 
and Spices, Except Black Pepper (Crop Subgroup 19B); to Amend the 
Current Tolerance on Leafy Petioles (Crop Subgroup 4B); and to Convert 
the Potato Tolerance to the Tuberous and Corm Vegetables Subgroup (Crop 
Subgroup 1C), Convert the Grape Tolerance to the Small Fruit Vine 
Climbing (Subgroup 13-07F), and Convert the Strawberry Tolerance to the 
Low Growing Berries (Subgroup 13-07G).,'' dated December 1, 2015.

[[Page 9774]]

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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
    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. However, subsequent 
to that Federal Register publication, EPA reassessed the liver effects 
seen in the 28-day dermal toxicity study according to current policy, 
and determined that since these effects should not be considered 
adverse, no toxicity endpoint was identified. The NOAEL for the 28-day 
dermal study was set at 1,000 mg/kg/day and the LOAEL was not 
established. Therefore, the endpoints assessed as part of this action 
exclude the endpoint for dermal exposure identified in the table 
published in the above-referenced Federal Register on June 11, 2010.

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 EPA conducted 
an analysis using the Dietary Exposure Evaluation Model (DEEM-FCID) 
Version 3.16. This model uses 2003-2008 food consumption data from the 
U.S. Department of Agriculture's (USDA's) National Health and Nutrition 
Examination Survey, What We Eat in America (NHANES/WWEIA). An acute 
dietary assessment was conducted assuming tolerance level residues and 
100 percent crop treated (PCT) for all commodities.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the Dietary Exposure Evaluation Model (DEEM-FCID) 
Version 3.16. This model uses 2003-2008 food consumption data from the 
U.S. Department of Agriculture's (USDA's) National Health and Nutrition 
Examination Survey, What We Eat in America (NHANES/WWEIA). As to 
residue levels in food, EPA assumed 100% crop treated, tolerance level 
residues, anticipated residues for some crops, and default processing 
factors.
    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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
    Based on the Pesticide Root Zone Model/Exposure Analysis Modeling 
System (PRZM/EXAMS) and Pesticide Root Zone Model Ground Water (PRZM 
GW) models, the estimated drinking water concentrations (EDWCs) of 
trifloxystrobin and its major degradation product for acute exposures 
are estimated to be 29 parts per billion (ppb) for surface water, and 
427 ppb for ground water. For chronic non-cancer exposure assessments, 
EDWCs are estimated to be 23 ppb for surface water and 365 ppb for 
ground water. Modeled estimates of drinking water concentrations were 
directly entered into the acute (427 ppb) and chronic (365 ppb) dietary 
assessments in the Dietary Exposure Evaluation Model--Food Commodity 
Intake Database (DEEM-FCID) food categories of ``water, direct, all 
sources'' and ``water, indirect, all sources.''
    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: Ornamental plants and turfgrass. 
EPA assessed residential exposure from relevant registered 
trifloxystrobin products using the Agency's 2012 Residential Standard 
Operating Procedures (SOPs) along with updates in dermal risk 
assessment hazard and policy regarding body weight in addition to the 
following assumptions:
    i. Residential handler exposures. Residential handler exposure is 
expected to be short-term only. Intermediate-term exposures are not 
likely because of the intermittent nature of applications by 
homeowners. Dermal handler exposures were not assessed since no adverse 
systemic dermal hazard was identified for trifloxystrobin.
    ii. Residential post-application exposures. Because dermal hazard 
has not been identified for trifloxystrobin, a quantitative post-
application assessment for dermal exposure is not necessary and the 
only exposure scenarios quantitatively assessed are for children

[[Page 9775]]

1 to <2 years old who may experience short-term incidental oral 
exposure to trifloxystrobin from treated turf. Incidental oral granule 
ingestion is not applicable because there is no endpoint identified for 
the acute dietary duration for infants and children. Intermediate-term 
incidental oral post-application exposures are not expected because 
trifloxystrobin is not persistent in soil or water; furthermore, the 
short-term incidental oral risk estimates would be protective of the 
possible intermediate-term incidental oral exposures because the POD 
for both durations is the same. Post-application inhalation exposure is 
expected to be negligible for the proposed residential uses.
    Further information regarding EPA standard assumptions and generic 
inputs for residential exposures may be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.
    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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

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 and up to the limit dose. In the 
prenatal developmental study in rabbits, developmental toxicity was 
seen at a dose that was higher than the dose causing 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.
    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 exposure databases are complete or are estimated based 
on data that reasonably account for potential exposures. The exposure 
assessments will not underestimate the potential dietary (food and 
drinking water) or non-dietary exposures for infants and children from 
the use of trifloxystrobin. The acute and chronic dietary food exposure 
assessment was conservatively based on 100 PCT assumptions and 
conservative ground water drinking water modeling estimates. The 
dietary drinking water assessment utilizes water concentration values 
generated by models and associated modeling parameters which are 
designed to provide conservative, health protective, high-end estimates 
of water concentrations, and are not likely to be exceeded. In 
addition, the residential post-application assessment is based upon the 
residential SOPs employing surrogate study data and reasonable ``worst-
case'' assumptions. These data and assessments are reliable and are not 
expected to underestimate exposure and risk posed by trifloxystrobin to 
adults or children as well as incidental oral exposure of young 
children (1-2 years old).

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. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food and water 
to trifloxystrobin will occupy 3.1% 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 71% of the cPAD for 
infants (<1 year 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 300 for adults 
and 120 for children 1 to < 2 years old. 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

[[Page 9776]]

exposure to food and water (considered to be a background exposure 
level). Although the Agency identified an intermediate-term endpoint, 
the Agency does not expect trifloxystrobin to result in intermediate-
term residential exposure, due to the intermittent nature of homeowner 
applications and its short soil half-life (about 2 days). Therefore, 
the Agency relies on the chronic risk assessment to account for 
intermediate-term risk and concludes that trifloxystrobin does not pose 
an intermediate-term aggregate risk.
    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 methodology (gas chromatography with nitrogen 
phosphorus detection (GC/NPD), Method AG-659A) is available to enforce 
the tolerance expression for the combined residues of trifloxystrobin 
and CGA-321113 in plant and livestock commodities. The lowest level of 
method validation (LLMV) is equivalent to the limit of quantitation 
(LOQ) which was 0.010 ppm for each analyte in/on all matrices.
    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 MRLs for trifloxystrobin in or on 
lettuce, head at 15 ppm; celery at 1 ppm; brussel sprouts at 0.1 ppm; 
cabbage at 0.5 ppm; flower head Brassicas (includes broccoli; broccoli, 
Chinese; and cauliflower) at 0.5 ppm; potato at 0.2 ppm; grape at 3 
ppm; and strawberry at 1 ppm. These MRLs are different than the 
tolerances established for trifloxystrobin in the United States.
    These tolerances, with exception to grape and potato, cannot be 
harmonized with the Codex MRLs because the MRLs for those commodities 
are expressed in terms of trifloxystrobin (parent only) while U.S. 
tolerances are based on the combined residues of trifloxystrobin and 
its acid metabolite CGA-321113, expressed in parent equivalents. 
Therefore, harmonization is not possible for these commodities as the 
Codex MRLs are too low based on the U.S. residue definition for 
tolerance enforcement. For grape and potato, the U.S. is establishing 
MRLs for the requested representative crop groups; fruit, small vine 
climbing, except fuzzy kiwifruit, subgroup 13-07F and vegetable, 
tuberous and corm, subgroup 1C. These MRLs will be lower than Codex, 
but identical to Canadian MRLs (for grape and potato). This will permit 
harmonization with the existing Canadian MRLs as requested by the 
petitioner and facilitate trade with Canada.

C. Revisions to Petitioned-For Tolerances

    The Agency is revising the commodity terms for the requested 
tolerances to reflect the common commodity vocabulary currently used by 
the Agency. Specifically, head and stem Brassica subgroup 5A was 
changed to Brassica, head and stem, subgroup 5A; leafy Brassica 
subgroup 5B was changed to Brassica, leafy greens, subgroup 5B; 
tuberous and corm vegetable subgroup 1C was changed to vegetable, 
tuberous and corm, subgroup 1C. small fruit vine climbing subgroup 
(except fuzzy kiwifruit), subgroup 13-07F was changed to fruit, small 
vine climbing, except fuzzy kiwifruit, subgroup 13-07F and low growing 
berry, subgroup 13-07G was changed to berry, low growing, subgroup 13-
07G. Bayer requested a tolerance for spice (crop subgroup 19B), except 
black pepper. As black pepper is the representative commodity for spice 
subgroup 19B, it may not be excepted from a tolerance. 40 CFR 
180.40(h). Without sufficient data to establish the subgroup tolerance, 
the Agency is establishing an individual tolerance for the crop for 
which data was submitted--dill, seed.

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, and the free form of its acid metabolite CGA-321113, 
(E,E)-methoxyimino-[2-[1-(3-trifluoromethyl-phenyl)-
ethylideneaminooxymethyl]-phenyl]acetic acid, calculated as the 
stoichiometric equivalent of trifloxystrobin, in or on Brassica, head 
and stem, subgroup 5A at 2 ppm; Brassica, leafy greens, subgroup 5B at 
30 ppm; herb subgroup 19A at 200 ppm; dill, seed at 30 ppm; vegetable, 
tuberous and corm, subgroup 1C at 0.04 ppm; fruit, small vine climbing, 
except fuzzy kiwifruit, subgroup 13-07F at 2.0 ppm; berry, low growing, 
subgroup 13-07G at 1.5 ppm; and leaf petioles, subgroup 4A at 30 ppm.
    The existing tolerance for leaf petioles subgroup 4B, is amended 
from 3.5 ppm to 9 ppm based on new celery residue data at zero day 
(pre-harvest interval) PHI. The existing tolerance for potato at 0.04 
ppm is being removed because it is included with the new tolerance 
being established for tuberous and corm vegetables (crop subgroup 1C) 
at 0.04 ppm. Similarly, the current tolerances for grape at 2.0 ppm and 
strawberry at 1.1 ppm are being removed as they are included in the new 
tolerances for the small fruit vine climbing (subgroup 13-07F) at 2.0 
ppm, and low growing berries (subgroup 13-07G) at 1.5 ppm, 
respectively.

VI. Statutory and Executive Order Reviews

    This action 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 action has been 
exempted from review under Executive Order 12866, this action 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

[[Page 9777]]

Children from Environmental Health Risks and Safety Risks'' (62 FR 
19885, April 23, 1997). This action 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 action 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 action. In addition, this 
action does not impose any enforceable duty or contain any unfunded 
mandate as described under Title II of the Unfunded Mandates Reform Act 
(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 (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: February 11, 2016.
Susan Lewis,
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. In Sec.  180.555, is amended:
0
a. By alphabetically adding the commodities to the table in paragraph 
(a);
0
b. By removing ``Grape'', ``Potato'', and ``Strawberry'' from the table 
in paragraph (a);
0
c. By revising ``Leaf petioles subgroup 4B'' in the table in paragraph 
(a).
    The additions and revision read as follows:


Sec.  180.555  Trifloxystrobin; tolerances for residues.

    (a) General. * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
 
                              * * * * * * *
Berry, low growing subgroup 13-07G.........................          1.5
Brassica, head and stem, subgroup 5A.......................          2.0
Brassica, leafy greens, subgroup 5B........................           30
 
                              * * * * * * *
Dill, seed.................................................           30
 
                              * * * * * * *
Fruit, small vine climbing, except fuzzy kiwifruit,                  2.0
 subgroup 13-07F...........................................
 
                              * * * * * * *
Herbs, subgroup 19A........................................          200
 
                              * * * * * * *
Leaf petioles subgroup 4B..................................          9.0
Leafy greens, subgroup 4A..................................           30
 
                              * * * * * * *
Vegetable, tuberous and corm, subgroup 1C..................         0.04
 
                              * * * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2016-04070 Filed 2-25-16; 8:45 am]
BILLING CODE 6560-50-P



                                                9772              Federal Register / Vol. 81, No. 38 / Friday, February 26, 2016 / Rules and Regulations

                                                ■ a. Adding entries (110) and (111) in                    ■ b. Adding new entry (42) in numerical                     § 52.820   Identification of plan.
                                                numerical order to table (d); and                         order to table (e) to read as follows:                      *       *    *     *      *
                                                                                                                                                                          (d) * * *

                                                                                          EPA-APPROVED IOWA SOURCE-SPECIFIC ORDERS/PERMITS
                                                                                                                                                        State effective
                                                       Name of source                                  Order/Permit No.                                                       EPA Approval date            Explanation
                                                                                                                                                             date


                                                          *                      *                   *                  *                                       *                      *                     *
                                                (110) Griffin Pipe Products     Administrative Consent Order No. 2015–AQ–02 .......                            1/29/15    2/26/16 [Insert Federal
                                                  Co., LLC.                                                                                                                 Register citation].
                                                (111) Alter Metal Recy-         Permit No. 14–A–521 .................................................           9/2/14    2/26/16 [Insert Federal
                                                  cling.                                                                                                                    Register citation].



                                                    (e) * * *

                                                                                               EPA-APPROVED IOWA NONREGULATORY PROVISIONS
                                                    Name of nonregulatory                                                                               State submittal
                                                                                      Applicable geographic or nonattainment area                                             EPA Approval date            Explanation
                                                       SIP provision                                                                                         date


                                                         *                       *                    *                        *                                *                      *                     *
                                                (42) Lead attainment SIP        Portions of Pottawattamie County ..............................                1/30/15    2/26/16 [Insert Federal           [EPA–R07–
                                                                                                                                                                            Register citation].             OAR–2015–
                                                                                                                                                                                                            0582; FRL–
                                                                                                                                                                                                              9942–79–
                                                                                                                                                                                                             Region 7].



                                                [FR Doc. 2016–04082 Filed 2–25–16; 8:45 am]               Public Docket (OPP Docket) in the                           applies to them. Potentially affected
                                                BILLING CODE 6560–50–P                                    Environmental Protection Agency                             entities may include:
                                                                                                          Docket Center (EPA/DC), West William                          • Crop production (NAICS code 111).
                                                                                                          Jefferson Clinton Bldg., Rm. 3334, 1301                       • Animal production (NAICS code
                                                ENVIRONMENTAL PROTECTION                                  Constitution Ave. NW., Washington, DC                       112).
                                                AGENCY                                                    20460–0001. The Public Reading Room                           • Food manufacturing (NAICS code
                                                                                                          is open from 8:30 a.m. to 4:30 p.m.,                        311).
                                                40 CFR Part 180                                           Monday through Friday, excluding legal                        • Pesticide manufacturing (NAICS
                                                                                                          holidays. The telephone number for the                      code 32532).
                                                [EPA–HQ–OPP–2014–0709; FRL–9941–92]
                                                                                                          Public Reading Room is (202) 566–1744,                      B. How can I get electronic access to
                                                Trifloxystrobin; Pesticide Tolerances                     and the telephone number for the OPP                        other related information?
                                                                                                          Docket is (703) 305–5805. Please review                        You may access a frequently updated
                                                AGENCY:  Environmental Protection                         the visitor instructions and additional
                                                Agency (EPA).                                                                                                         electronic version of EPA’s tolerance
                                                                                                          information about the docket available                      regulations at 40 CFR part 180 through
                                                ACTION: Final rule.                                       at http://www.epa.gov/dockets.                              the Government Printing Office’s e-CFR
                                                                                                          FOR FURTHER INFORMATION CONTACT:                            site at http://www.ecfr.gov/cgi-bin/text-
                                                SUMMARY:   This regulation establishes
                                                tolerances for residues of trifloxystrobin                Susan Lewis, Registration Division                          idx?&c=ecfr&tpl=/ecfrbrowse/Title40/
                                                in or on multiple commodities which                       (7505P), Office of Pesticide Programs,                      40tab_02.tpl.
                                                are identified and discussed later in this                Environmental Protection Agency, 1200
                                                                                                                                                                      C. How can I file an objection or hearing
                                                document. Bayer CropScience requested                     Pennsylvania Ave. NW., Washington,
                                                                                                                                                                      request?
                                                these tolerances under the Federal Food,                  DC 20460–0001; main telephone
                                                                                                          number: (703) 305–7090; email address:                        Under FFDCA section 408(g), 21
                                                Drug, and Cosmetic Act (FFDCA).                                                                                       U.S.C. 346a, any person may file an
                                                                                                          RDFRNotices@epa.gov.
                                                DATES: This regulation is effective                                                                                   objection to any aspect of this regulation
                                                February 26, 2016. Objections and                         SUPPLEMENTARY INFORMATION:
                                                                                                                                                                      and may also request a hearing on those
                                                requests for hearings must be received                    I. General Information                                      objections. You must file your objection
                                                on or before April 26, 2016, and must                                                                                 or request a hearing on this regulation
                                                be filed in accordance with the                           A. Does this action apply to me?
                                                                                                                                                                      in accordance with the instructions
                                                instructions provided in 40 CFR part                         You may be potentially affected by                       provided in 40 CFR part 178. To ensure
                                                178 (see also Unit I.C. of the                            this action if you are an agricultural                      proper receipt by EPA, you must
mstockstill on DSK4VPTVN1PROD with RULES




                                                SUPPLEMENTARY INFORMATION).                               producer, food manufacturer, or                             identify docket ID number EPA–HQ–
                                                ADDRESSES: The docket for this action,                    pesticide manufacturer. The following                       OPP–2014–0709 in the subject line on
                                                identified by docket identification (ID)                  list of North American Industrial                           the first page of your submission. All
                                                number EPA–HQ–OPP–2014–0709, is                           Classification System (NAICS) codes is                      objections and requests for a hearing
                                                available at                                              not intended to be exhaustive, but rather                   must be in writing, and must be
                                                http://www.regulations.gov or at the                      provides a guide to help readers                            received by the Hearing Clerk on or
                                                Office of Pesticide Programs Regulatory                   determine whether this document                             before April 26, 2016. Addresses for


                                           VerDate Sep<11>2014   17:33 Feb 25, 2016   Jkt 238001   PO 00000     Frm 00032     Fmt 4700    Sfmt 4700     E:\FR\FM\26FER1.SGM   26FER1


                                                                  Federal Register / Vol. 81, No. 38 / Friday, February 26, 2016 / Rules and Regulations                                          9773

                                                mail and hand delivery of objections                    5A) at 2 ppm; leafy brassica greens (crop             completeness, and reliability as well as
                                                and hearing requests are provided in 40                 subgroup 5B) at 30 ppm; tuberous and                  the relationship of the results of the
                                                CFR 178.25(b).                                          corm vegetables (crop subgroup 1C) at                 studies to human risk. EPA has also
                                                  In addition to filing an objection or                 0.04 ppm; small fruit vine climbing                   considered available information
                                                hearing request with the Hearing Clerk                  (except fuzzy kiwifruit) (crop subgroup               concerning the variability of the
                                                as described in 40 CFR part 178, please                 13–07F) at 2.0 ppm; and low growing                   sensitivities of major identifiable
                                                submit a copy of the filing (excluding                  berry (crop subgroup 13–07G) at 1.5                   subgroups of consumers, including
                                                any Confidential Business Information                   ppm. Bayer CropScience, also requested                infants and children.
                                                (CBI)) for inclusion in the public docket.              that the existing tolerance for leafy                    Trifloxystrobin exhibits very low
                                                Information not marked confidential                     petioles (subgroup 4B) be amended from                toxicity following single oral, dermal
                                                pursuant to 40 CFR part 2 may be                        3.5 ppm to 9 ppm. That document                       and inhalation exposures. It is a strong
                                                disclosed publicly by EPA without prior                 referenced a summary of the petition                  dermal sensitizer and a mild dermal and
                                                notice. Submit the non-CBI copy of your                 prepared by Bayer CropScience, the                    eye irritant. In repeated dose tests in
                                                objection or hearing request, identified                registrant, which is available in the                 rats, the liver is the target organ for
                                                by docket ID number EPA–HQ–OPP–                         docket, http://www.regulations.gov.                   trifloxystrobin; toxicity is induced
                                                2014–0709, by one of the following                      There were no comments received in                    following oral and dermal exposure for
                                                methods:                                                response to the notice of filing.                     28 days. Liver effects characterized by
                                                  • Federal eRulemaking Portal: http://                   Based upon review of the data                       an increase in liver weights and an
                                                www.regulations.gov. Follow the online                  supporting the petition, EPA has                      increased incidence of hepatocellular
                                                instructions for submitting comments.                   modified the commodity terms for
                                                                                                                                                              hypertrophy and/or hepatocellular
                                                Do not submit electronically any                        several tolerances to reflect the correct
                                                                                                                                                              necrosis were seen in rats, mice, and
                                                information you consider to be CBI or                   commodity definition. The reason for
                                                                                                                                                              dogs. There is no concern for
                                                other information whose disclosure is                   these changes are explained in Unit
                                                                                                                                                              neurotoxicity or immunotoxicity in the
                                                restricted by statute.                                  IV.C.
                                                  • Mail: OPP Docket, Environmental                                                                           database. In the rabbit developmental
                                                Protection Agency Docket Center (EPA/                   III. Aggregate Risk Assessment and                    toxicity study, an increase in the
                                                DC), (28221T), 1200 Pennsylvania Ave.                   Determination of Safety                               incidence of fused sternabrae was seen
                                                NW., Washington, DC 20460–0001.                            Section 408(b)(2)(A)(i) of FFDCA                   at a dose 10 times higher than the
                                                  • Hand Delivery: To make special                      allows EPA to establish a tolerance (the              maternal lowest observed adverse effect
                                                arrangements for hand delivery or                       legal limit for a pesticide chemical                  level (LOAEL). In the rat reproduction
                                                delivery of boxed information, please                   residue in or on a food) only if EPA                  study, both parents and offspring
                                                follow the instructions at http://                      determines that the tolerance is ‘‘safe.’’            showed decreases in body weight
                                                www.epa.gov/dockets/contacts.html.                      Section 408(b)(2)(A)(ii) of FFDCA                     during lactation. The rat and rabbit
                                                  Additional instructions on                            defines ‘‘safe’’ to mean that ‘‘there is a            developmental and the rat reproduction
                                                commenting or visiting the docket,                      reasonable certainty that no harm will                toxicity data do not demonstrate an
                                                along with more information about                       result from aggregate exposure to the                 increase in susceptibility in the fetus or
                                                dockets generally, is available at http://              pesticide chemical residue, including                 other offspring. Trifloxystrobin is
                                                www.epa.gov/dockets.                                    all anticipated dietary exposures and all             classified as: ‘‘Not likely to be
                                                                                                        other exposures for which there is                    Carcinogenic to Humans’’ based on both
                                                II. Summary of Petitioned-For                                                                                 the negative results in the battery of
                                                Tolerance                                               reliable information.’’ This includes
                                                                                                        exposure through drinking water and in                mutagenicity tests (except at a cytoxic
                                                   In the Federal Register of February                  residential settings, but does not include            dose in one in vitro test), and from the
                                                11, 2015 (80 FR 7559) (FRL–9921–94),                    occupational exposure. Section                        long-term carcinogenicity studies in rats
                                                EPA issued a document pursuant to                       408(b)(2)(C) of FFDCA requires EPA to                 and mice. Specific information on the
                                                FFDCA section 408(d)(3), 21 U.S.C.                      give special consideration to exposure                studies received and the nature of the
                                                346a(d)(3), announcing the filing of a                  of infants and children to the pesticide              adverse effects caused by trifloxystrobin
                                                pesticide petition (PP 4F8288) by Bayer                 chemical residue in establishing a                    as well as the no-observed-adverse-
                                                CropScience, 2 T.W. Alexander Drive,                    tolerance and to ‘‘ensure that there is a             effect-level (NOAEL) and the lowest-
                                                P.O. Box 12014, Research Triangle Park,                 reasonable certainty that no harm will                observed-adverse-effect-level (LOAEL)
                                                NC 27709. The petition requested that                   result to infants and children from                   from the toxicity studies are discussed
                                                40 CFR 180.555 be amended by                            aggregate exposure to the pesticide                   in the document ‘‘Trifloxystrobin.
                                                establishing tolerances for residues of                 chemical residue. . . .’’                             Aggregate Human Health Risk
                                                the fungicide trifloxystrobin,                             Consistent with FFDCA section                      Assessment for the Proposed New Uses
                                                benzeneacetic acid, (E, E)-a-                           408(b)(2)(D), and the factors specified in            on Leafy Greens (Crop Subgroup 4A),
                                                (methoxyimino)-2-[[[[1-[3-                              FFDCA section 408(b)(2)(D), EPA has                   Head and Stem Brassica Vegetables
                                                (trifluoromethyl)phenyl]ethylidene]                     reviewed the available scientific data                (Crop Subgroup 5A), Leafy Brassica
                                                amino]oxy]methyl]-, methyl ester, and                   and other relevant information in                     Greens (Crop Subgroup 5B), Herbs (Crop
                                                the free form of its acid metabolite CGA-               support of this action. EPA has                       Group 19A), and Spices, Except Black
                                                321113, (E,E)-methoxyimino-[2-[1-(3-                    sufficient data to assess the hazards of              Pepper (Crop Subgroup 19B); to Amend
                                                trifluoromethyl-phenyl)-                                and to make a determination on                        the Current Tolerance on Leafy Petioles
                                                ethylideneaminooxymethyl]-                              aggregate exposure for trifloxystrobin                (Crop Subgroup 4B); and to Convert the
                                                phenyl]acetic acid, calculated as the                   including exposure resulting from the                 Potato Tolerance to the Tuberous and
mstockstill on DSK4VPTVN1PROD with RULES




                                                stoichiometric equivalent of                            tolerances established by this action.                Corm Vegetables Subgroup (Crop
                                                trifloxystrobin, in or on leafy greens                  EPA’s assessment of exposures and risks               Subgroup 1C), Convert the Grape
                                                (crop subgroup 4A) at 30 parts per                      associated with trifloxystrobin follows.              Tolerance to the Small Fruit Vine
                                                million (ppm); herb (crop subgroup                                                                            Climbing (Subgroup 13–07F), and
                                                19A) at 200 ppm; spice (crop subgroup                   A. Toxicological Profile                              Convert the Strawberry Tolerance to the
                                                19B), except black pepper) at 30 ppm;                     EPA has evaluated the available                     Low Growing Berries (Subgroup 13–
                                                head and stem brassica (crop subgroup                   toxicity data and considered its validity,            07G).,’’ dated December 1, 2015.


                                           VerDate Sep<11>2014   17:33 Feb 25, 2016   Jkt 238001   PO 00000   Frm 00033   Fmt 4700   Sfmt 4700   E:\FR\FM\26FER1.SGM   26FER1


                                                9774              Federal Register / Vol. 81, No. 38 / Friday, February 26, 2016 / Rules and Regulations

                                                B. Toxicological Points of Departure/                   exposures from trifloxystrobin in food                for trifloxystrobin in drinking water.
                                                Levels of Concern                                       as follows:                                           These simulation models take into
                                                                                                           i. Acute exposure. Quantitative acute              account data on the physical, chemical,
                                                   Once a pesticide’s toxicological                     dietary exposure and risk assessments                 and fate/transport characteristics of
                                                profile is determined, EPA identifies                   are performed for a food-use pesticide,               trifloxystrobin. Further information
                                                toxicological points of departure (POD)                 if a toxicological study has indicated the            regarding EPA drinking water models
                                                and levels of concern to use in                         possibility of an effect of concern                   used in pesticide exposure assessment
                                                evaluating the risk posed by human                      occurring as a result of a 1-day or single            can be found at http://www2.epa.gov/
                                                exposure to the pesticide. For hazards                  exposure. Such effects were identified                pesticide-science-and-assessing-
                                                that have a threshold below which there                 for trifloxystrobin. In estimating acute              pesticide-risks/about-water-exposure-
                                                is no appreciable risk, the toxicological               dietary exposure EPA conducted an                     models-used-pesticide.
                                                POD is used as the basis for derivation                 analysis using the Dietary Exposure                      Based on the Pesticide Root Zone
                                                of reference values for risk assessment.                Evaluation Model (DEEM–FCID)                          Model/Exposure Analysis Modeling
                                                PODs are developed based on a careful                   Version 3.16. This model uses 2003–                   System (PRZM/EXAMS) and Pesticide
                                                analysis of the doses in each                           2008 food consumption data from the                   Root Zone Model Ground Water (PRZM
                                                toxicological study to determine the                    U.S. Department of Agriculture’s                      GW) models, the estimated drinking
                                                dose at which no adverse effects are                    (USDA’s) National Health and Nutrition                water concentrations (EDWCs) of
                                                observed (the NOAEL) and the lowest                     Examination Survey, What We Eat in                    trifloxystrobin and its major degradation
                                                dose at which adverse effects of concern                America (NHANES/WWEIA). An acute                      product for acute exposures are
                                                are identified (the LOAEL). Uncertainty/                dietary assessment was conducted                      estimated to be 29 parts per billion
                                                safety factors are used in conjunction                  assuming tolerance level residues and                 (ppb) for surface water, and 427 ppb for
                                                with the POD to calculate a safe                        100 percent crop treated (PCT) for all                ground water. For chronic non-cancer
                                                exposure level—generally referred to as                 commodities.                                          exposure assessments, EDWCs are
                                                a population-adjusted dose (PAD) or a                      ii. Chronic exposure. In conducting                estimated to be 23 ppb for surface water
                                                reference dose (RfD)—and a safe margin                  the chronic dietary exposure assessment               and 365 ppb for ground water. Modeled
                                                of exposure (MOE). For non-threshold                    EPA used the Dietary Exposure                         estimates of drinking water
                                                risks, the Agency assumes that any                      Evaluation Model (DEEM–FCID)                          concentrations were directly entered
                                                amount of exposure will lead to some                    Version 3.16. This model uses 2003–                   into the acute (427 ppb) and chronic
                                                degree of risk. Thus, the Agency                        2008 food consumption data from the                   (365 ppb) dietary assessments in the
                                                estimates risk in terms of the probability              U.S. Department of Agriculture’s                      Dietary Exposure Evaluation Model—
                                                of an occurrence of the adverse effect                  (USDA’s) National Health and Nutrition                Food Commodity Intake Database
                                                expected in a lifetime. For more                        Examination Survey, What We Eat in                    (DEEM–FCID) food categories of ‘‘water,
                                                information on the general principles                   America (NHANES/WWEIA). As to                         direct, all sources’’ and ‘‘water, indirect,
                                                EPA uses in risk characterization and a                 residue levels in food, EPA assumed                   all sources.’’
                                                complete description of the risk                        100% crop treated, tolerance level                       3. From non-dietary exposure. The
                                                assessment process, see http://                         residues, anticipated residues for some               term ‘‘residential exposure’’ is used in
                                                www2.epa.gov/pesticide-science-and-                     crops, and default processing factors.                this document to refer to non-
                                                assessing-pesticide-risks/assessing-                       iii. Cancer. Based on the data                     occupational, non-dietary exposure
                                                human-health-risk-pesticides.                           summarized in Unit III.A., EPA has                    (e.g., for lawn and garden pest control,
                                                                                                        concluded that trifloxystrobin does not               indoor pest control, termiticides, and
                                                   A summary of the toxicological                       pose a cancer risk to humans. Therefore,              flea and tick control on pets).
                                                endpoints for trifloxystrobin used for                  a dietary exposure assessment for the                    Trifloxystrobin is currently registered
                                                human risk assessment is discussed in                   purpose of assessing cancer risk is                   for the following uses that could result
                                                Unit III B of the final rule published in               unnecessary.                                          in residential exposures: Ornamental
                                                the Federal Register of June 11, 2010.                     iv. Anticipated residue and percent                plants and turfgrass. EPA assessed
                                                However, subsequent to that Federal                     crop treated (PCT) information. Section               residential exposure from relevant
                                                Register publication, EPA reassessed the                408(b)(2)(E) of FFDCA authorizes EPA                  registered trifloxystrobin products using
                                                liver effects seen in the 28-day dermal                 to use available data and information on              the Agency’s 2012 Residential Standard
                                                toxicity study according to current                     the anticipated residue levels of                     Operating Procedures (SOPs) along with
                                                policy, and determined that since these                 pesticide residues in food and the actual             updates in dermal risk assessment
                                                effects should not be considered                        levels of pesticide residues that have                hazard and policy regarding body
                                                adverse, no toxicity endpoint was                       been measured in food. If EPA relies on               weight in addition to the following
                                                identified. The NOAEL for the 28-day                    such information, EPA must require                    assumptions:
                                                dermal study was set at 1,000 mg/kg/                    pursuant to FFDCA section 408(f)(1)                      i. Residential handler exposures.
                                                day and the LOAEL was not established.                  that data be provided 5 years after the               Residential handler exposure is
                                                Therefore, the endpoints assessed as                    tolerance is established, modified, or                expected to be short-term only.
                                                part of this action exclude the endpoint                left in effect, demonstrating that the                Intermediate-term exposures are not
                                                for dermal exposure identified in the                   levels in food are not above the levels               likely because of the intermittent nature
                                                table published in the above-referenced                 anticipated. For the present action, EPA              of applications by homeowners. Dermal
                                                Federal Register on June 11, 2010.                      will issue such data call-ins as are                  handler exposures were not assessed
                                                C. Exposure Assessment                                  required by FFDCA section 408(b)(2)(E)                since no adverse systemic dermal
                                                                                                        and authorized under FFDCA section                    hazard was identified for trifloxystrobin.
mstockstill on DSK4VPTVN1PROD with RULES




                                                  1. Dietary exposure from food and                     408(f)(1). Data will be required to be                   ii. Residential post-application
                                                feed uses. In evaluating dietary                        submitted no later than 5 years from the              exposures. Because dermal hazard has
                                                exposure to trifloxystrobin, EPA                        date of issuance of these tolerances.                 not been identified for trifloxystrobin, a
                                                considered exposure under the                              2. Dietary exposure from drinking                  quantitative post-application assessment
                                                petitioned-for tolerances as well as all                water. The Agency used screening level                for dermal exposure is not necessary
                                                existing trifloxystrobin tolerances in 40               water exposure models in the dietary                  and the only exposure scenarios
                                                CFR 180.555. EPA assessed dietary                       exposure analysis and risk assessment                 quantitatively assessed are for children


                                           VerDate Sep<11>2014   17:33 Feb 25, 2016   Jkt 238001   PO 00000   Frm 00034   Fmt 4700   Sfmt 4700   E:\FR\FM\26FER1.SGM   26FER1


                                                                  Federal Register / Vol. 81, No. 38 / Friday, February 26, 2016 / Rules and Regulations                                          9775

                                                1 to <2 years old who may experience                    FQPA Safety Factor (SF). In applying                  risk posed by trifloxystrobin to adults or
                                                short-term incidental oral exposure to                  this provision, EPA either retains the                children as well as incidental oral
                                                trifloxystrobin from treated turf.                      default value of 10X, or uses a different             exposure of young children (1–2 years
                                                Incidental oral granule ingestion is not                additional safety factor when reliable                old).
                                                applicable because there is no endpoint                 data available to EPA support the choice
                                                                                                                                                              E. Aggregate Risks and Determination of
                                                identified for the acute dietary duration               of a different factor.
                                                                                                           2. Prenatal and postnatal sensitivity.             Safety
                                                for infants and children. Intermediate-
                                                term incidental oral post-application                   There is no indication of increased                      EPA determines whether acute and
                                                exposures are not expected because                      quantitative or qualitative susceptibility            chronic dietary pesticide exposures are
                                                trifloxystrobin is not persistent in soil or            to trifloxystrobin in rats or rabbits. In             safe by comparing aggregate exposure
                                                water; furthermore, the short-term                      the prenatal developmental study in                   estimates to the acute PAD (aPAD) and
                                                incidental oral risk estimates would be                 rats, there was no developmental                      chronic PAD (cPAD). For linear cancer
                                                protective of the possible intermediate-                toxicity at and up to the limit dose. In              risks, EPA calculates the lifetime
                                                term incidental oral exposures because                  the prenatal developmental study in                   probability of acquiring cancer given the
                                                the POD for both durations is the same.                 rabbits, developmental toxicity was seen              estimated aggregate exposure. Short-,
                                                Post-application inhalation exposure is                 at a dose that was higher than the dose               intermediate-, and chronic-term risks
                                                expected to be negligible for the                       causing maternal toxicity. In the                     are evaluated by comparing the
                                                proposed residential uses.                              multigeneration study, offspring and                  estimated aggregate food, water, and
                                                   Further information regarding EPA                    parental LOAELs are at the same dose                  residential exposure to the appropriate
                                                standard assumptions and generic                        level.                                                PODs to ensure that an adequate MOE
                                                inputs for residential exposures may be                    3. Conclusion. EPA has determined                  exists.
                                                found at http://www2.epa.gov/pesticide-                 that reliable data show the safety of                    1. Acute risk. Using the exposure
                                                science-and-assessing-pesticide-risks/                  infants and children would be                         assumptions discussed in this unit for
                                                standard-operating-procedures-                          adequately protected if the FQPA SF                   acute exposure, the acute dietary
                                                residential-pesticide.                                  were reduced to 1X. That decision is                  exposure from food and water to
                                                   4. Cumulative effects from substances                based on the following findings:                      trifloxystrobin will occupy 3.1% of the
                                                with a common mechanism of toxicity.                       i. The toxicity database for                       aPAD for females 13–49 years old, the
                                                Section 408(b)(2)(D)(v) of FFDCA                        trifloxystrobin is complete.                          population group receiving the greatest
                                                requires that, when considering whether                    ii. There is no indication that                    exposure.
                                                to establish, modify, or revoke a                       trifloxystrobin is a neurotoxic chemical                 2. Chronic risk. Using the exposure
                                                tolerance, the Agency consider                          and there is no need for a                            assumptions described in this unit for
                                                ‘‘available information’’ concerning the                developmental neurotoxicity study or                  chronic exposure, EPA has concluded
                                                cumulative effects of a particular                      additional UFs to account for                         that chronic exposure to trifloxystrobin
                                                pesticide’s residues and ‘‘other                        neurotoxicity.                                        from food and water will utilize 71% of
                                                substances that have a common                              iii. There is no evidence that                     the cPAD for infants (<1 year old), the
                                                mechanism of toxicity.’’                                trifloxystrobin results in increased                  population group receiving the greatest
                                                   EPA has not found trifloxystrobin to                 susceptibility in in utero rats or rabbits            exposure.
                                                share a common mechanism of toxicity                    in the prenatal developmental studies or                 Based on the explanation in Unit
                                                with any other substances, and                          in young rats in the 2-generation                     III.C.3., regarding residential use
                                                trifloxystrobin does not appear to                      reproduction study.                                   patterns, chronic residential exposure to
                                                produce a toxic metabolite produced by                     iv. There are no residual uncertainties            residues of trifloxystrobin is not
                                                other substances. For the purposes of                   identified in the exposure databases.                 expected.
                                                this tolerance action, therefore, EPA has               The exposure databases are complete or                   3. Short-term risk. Short-term
                                                assumed that trifloxystrobin does not                   are estimated based on data that                      aggregate exposure takes into account
                                                have a common mechanism of toxicity                     reasonably account for potential                      short-term residential exposure plus
                                                with other substances. For information                  exposures. The exposure assessments                   chronic exposure to food and water
                                                regarding EPA’s efforts to determine                    will not underestimate the potential                  (considered to be a background
                                                which chemicals have a common                           dietary (food and drinking water) or                  exposure level).
                                                mechanism of toxicity and to evaluate                   non-dietary exposures for infants and                    Trifloxystrobin is currently registered
                                                the cumulative effects of such                          children from the use of trifloxystrobin.             for uses that could result in short-term
                                                chemicals, see EPA’s Web site at                        The acute and chronic dietary food                    residential exposure, and the Agency
                                                http://www2.epa.gov/pesticide-science-                  exposure assessment was conservatively                has determined that it is appropriate to
                                                and-assessing-pesticide-risks/                          based on 100 PCT assumptions and                      aggregate chronic exposure through food
                                                cumulative-assessment-risk-pesticides.                  conservative ground water drinking                    and water with short-term residential
                                                                                                        water modeling estimates. The dietary                 exposures to trifloxystrobin.
                                                D. Safety Factor for Infants and                        drinking water assessment utilizes water                 Using the exposure assumptions
                                                Children                                                concentration values generated by                     described in this unit for short-term
                                                  1. In general. Section 408(b)(2)(C) of                models and associated modeling                        exposures, EPA has concluded the
                                                FFDCA provides that EPA shall apply                     parameters which are designed to                      combined short-term food, water, and
                                                an additional tenfold (10X) margin of                   provide conservative, health protective,              residential exposures result in aggregate
                                                safety for infants and children in the                  high-end estimates of water                           MOEs of 300 for adults and 120 for
                                                case of threshold effects to account for                concentrations, and are not likely to be              children 1 to < 2 years old. Because
mstockstill on DSK4VPTVN1PROD with RULES




                                                prenatal and postnatal toxicity and the                 exceeded. In addition, the residential                EPA’s level of concern for
                                                completeness of the database on toxicity                post-application assessment is based                  trifloxystrobin is a MOE of 100 or
                                                and exposure unless EPA determines                      upon the residential SOPs employing                   below, these MOEs are not of concern.
                                                based on reliable data that a different                 surrogate study data and reasonable                      4. Intermediate-term risk.
                                                margin of safety will be safe for infants               ‘‘worst-case’’ assumptions. These data                Intermediate-term aggregate exposure
                                                and children. This additional margin of                 and assessments are reliable and are not              takes into account intermediate-term
                                                safety is commonly referred to as the                   expected to underestimate exposure and                residential exposure plus chronic


                                           VerDate Sep<11>2014   17:33 Feb 25, 2016   Jkt 238001   PO 00000   Frm 00035   Fmt 4700   Sfmt 4700   E:\FR\FM\26FER1.SGM   26FER1


                                                9776              Federal Register / Vol. 81, No. 38 / Friday, February 26, 2016 / Rules and Regulations

                                                exposure to food and water (considered                  which the United States is a party. EPA               subgroup 19B, it may not be excepted
                                                to be a background exposure level).                     may establish a tolerance that is                     from a tolerance. 40 CFR 180.40(h).
                                                Although the Agency identified an                       different from a Codex MRL; however,                  Without sufficient data to establish the
                                                intermediate-term endpoint, the Agency                  FFDCA section 408(b)(4) requires that                 subgroup tolerance, the Agency is
                                                does not expect trifloxystrobin to result               EPA explain the reasons for departing                 establishing an individual tolerance for
                                                in intermediate-term residential                        from the Codex level.                                 the crop for which data was submitted—
                                                exposure, due to the intermittent nature                   The Codex has established MRLs for                 dill, seed.
                                                of homeowner applications and its short                 trifloxystrobin in or on lettuce, head at
                                                                                                        15 ppm; celery at 1 ppm; brussel sprouts              V. Conclusion
                                                soil half-life (about 2 days). Therefore,
                                                the Agency relies on the chronic risk                   at 0.1 ppm; cabbage at 0.5 ppm; flower                   Therefore, tolerances are established
                                                assessment to account for intermediate-                 head Brassicas (includes broccoli;                    for residues of trifloxystrobin,
                                                term risk and concludes that                            broccoli, Chinese; and cauliflower) at                benzeneacetic acid, (E,E)-a-
                                                trifloxystrobin does not pose an                        0.5 ppm; potato at 0.2 ppm; grape at 3                (methoxyimino)-2-[[[[1-[3-
                                                intermediate-term aggregate risk.                       ppm; and strawberry at 1 ppm. These                   (trifluoromethyl) phenyl]ethylidene]
                                                   5. Aggregate cancer risk for U.S.                    MRLs are different than the tolerances                amino]oxy]methyl]-, methyl ester, and
                                                population. Based on the lack of                        established for trifloxystrobin in the                the free form of its acid metabolite
                                                evidence of carcinogenicity in two                      United States.                                        CGA–321113, (E,E)-methoxyimino-[2-[1-
                                                adequate rodent carcinogenicity studies,                   These tolerances, with exception to                (3-trifluoromethyl-phenyl)-
                                                trifloxystrobin is not expected to pose a               grape and potato, cannot be harmonized                ethylideneaminooxymethyl]-
                                                cancer risk to humans.                                  with the Codex MRLs because the MRLs                  phenyl]acetic acid, calculated as the
                                                   6. Determination of safety. Based on                 for those commodities are expressed in                stoichiometric equivalent of
                                                these risk assessments, EPA concludes                   terms of trifloxystrobin (parent only)                trifloxystrobin, in or on Brassica, head
                                                that there is a reasonable certainty that               while U.S. tolerances are based on the                and stem, subgroup 5A at 2 ppm;
                                                no harm will result to the general                      combined residues of trifloxystrobin                  Brassica, leafy greens, subgroup 5B at 30
                                                population, or to infants and children                  and its acid metabolite CGA–321113,                   ppm; herb subgroup 19A at 200 ppm;
                                                from aggregate exposure to                              expressed in parent equivalents.                      dill, seed at 30 ppm; vegetable, tuberous
                                                trifloxystrobin residues.                               Therefore, harmonization is not possible              and corm, subgroup 1C at 0.04 ppm;
                                                                                                        for these commodities as the Codex                    fruit, small vine climbing, except fuzzy
                                                IV. Other Considerations                                MRLs are too low based on the U.S.                    kiwifruit, subgroup 13–07F at 2.0 ppm;
                                                A. Analytical Enforcement Methodology                   residue definition for tolerance                      berry, low growing, subgroup 13–07G at
                                                                                                        enforcement. For grape and potato, the                1.5 ppm; and leaf petioles, subgroup 4A
                                                   Adequate enforcement methodology                     U.S. is establishing MRLs for the                     at 30 ppm.
                                                (gas chromatography with nitrogen                       requested representative crop groups;                    The existing tolerance for leaf petioles
                                                phosphorus detection (GC/NPD),                          fruit, small vine climbing, except fuzzy              subgroup 4B, is amended from 3.5 ppm
                                                Method AG–659A) is available to                         kiwifruit, subgroup 13–07F and                        to 9 ppm based on new celery residue
                                                enforce the tolerance expression for the                vegetable, tuberous and corm, subgroup                data at zero day (pre-harvest interval)
                                                combined residues of trifloxystrobin                    1C. These MRLs will be lower than                     PHI. The existing tolerance for potato at
                                                and CGA–321113 in plant and livestock                   Codex, but identical to Canadian MRLs                 0.04 ppm is being removed because it is
                                                commodities. The lowest level of                        (for grape and potato). This will permit              included with the new tolerance being
                                                method validation (LLMV) is equivalent                  harmonization with the existing                       established for tuberous and corm
                                                to the limit of quantitation (LOQ) which                Canadian MRLs as requested by the                     vegetables (crop subgroup 1C) at 0.04
                                                was 0.010 ppm for each analyte in/on                    petitioner and facilitate trade with                  ppm. Similarly, the current tolerances
                                                all matrices.                                           Canada.                                               for grape at 2.0 ppm and strawberry at
                                                   The method may be requested from:                                                                          1.1 ppm are being removed as they are
                                                Chief, Analytical Chemistry Branch,                     C. Revisions to Petitioned-For
                                                                                                                                                              included in the new tolerances for the
                                                Environmental Science Center, 701                       Tolerances
                                                                                                                                                              small fruit vine climbing (subgroup 13–
                                                Mapes Rd., Ft. Meade, MD 20755–5350;                      The Agency is revising the                          07F) at 2.0 ppm, and low growing
                                                telephone number: (410) 305–2905;                       commodity terms for the requested                     berries (subgroup 13–07G) at 1.5 ppm,
                                                email address: residuemethods@                          tolerances to reflect the common                      respectively.
                                                epa.gov.                                                commodity vocabulary currently used
                                                                                                        by the Agency. Specifically, head and                 VI. Statutory and Executive Order
                                                B. International Residue Limits                         stem Brassica subgroup 5A was changed                 Reviews
                                                  In making its tolerance decisions, EPA                to Brassica, head and stem, subgroup                    This action establishes tolerances
                                                seeks to harmonize U.S. tolerances with                 5A; leafy Brassica subgroup 5B was                    under FFDCA section 408(d) in
                                                international standards whenever                        changed to Brassica, leafy greens,                    response to a petition submitted to the
                                                possible, consistent with U.S. food                     subgroup 5B; tuberous and corm                        Agency. The Office of Management and
                                                safety standards and agricultural                       vegetable subgroup 1C was changed to                  Budget (OMB) has exempted these types
                                                practices. EPA considers the                            vegetable, tuberous and corm, subgroup                of actions from review under Executive
                                                international maximum residue limits                    1C. small fruit vine climbing subgroup                Order 12866, entitled ‘‘Regulatory
                                                (MRLs) established by the Codex                         (except fuzzy kiwifruit), subgroup 13–                Planning and Review’’ (58 FR 51735,
                                                Alimentarius Commission (Codex), as                     07F was changed to fruit, small vine                  October 4, 1993). Because this action
                                                required by FFDCA section 408(b)(4).                    climbing, except fuzzy kiwifruit,                     has been exempted from review under
mstockstill on DSK4VPTVN1PROD with RULES




                                                The Codex Alimentarius is a joint                       subgroup 13–07F and low growing                       Executive Order 12866, this action is
                                                United Nations Food and Agriculture                     berry, subgroup 13–07G was changed to                 not subject to Executive Order 13211,
                                                Organization/World Health                               berry, low growing, subgroup 13–07G.                  entitled ‘‘Actions Concerning
                                                Organization food standards program,                    Bayer requested a tolerance for spice                 Regulations That Significantly Affect
                                                and it is recognized as an international                (crop subgroup 19B), except black                     Energy Supply, Distribution, or Use’’ (66
                                                food safety standards-setting                           pepper. As black pepper is the                        FR 28355, May 22, 2001) or Executive
                                                organization in trade agreements to                     representative commodity for spice                    Order 13045, entitled ‘‘Protection of


                                           VerDate Sep<11>2014   17:33 Feb 25, 2016   Jkt 238001   PO 00000   Frm 00036   Fmt 4700   Sfmt 4700   E:\FR\FM\26FER1.SGM   26FER1


                                                                          Federal Register / Vol. 81, No. 38 / Friday, February 26, 2016 / Rules and Regulations                                                                                                    9777

                                                Children from Environmental Health                                           governments, or on the distribution of                                       List of Subjects in 40 CFR Part 180
                                                Risks and Safety Risks’’ (62 FR 19885,                                       power and responsibilities among the
                                                                                                                                                                                                            Environmental protection,
                                                April 23, 1997). This action does not                                        various levels of government or between
                                                                                                                                                                                                          Administrative practice and procedure,
                                                contain any information collections                                          the Federal Government and Indian
                                                                                                                             tribes. Thus, the Agency has determined                                      Agricultural commodities, Pesticides
                                                subject to OMB approval under the
                                                                                                                             that Executive Order 13132, entitled                                         and pests, Reporting and recordkeeping
                                                Paperwork Reduction Act (PRA) (44
                                                                                                                             ‘‘Federalism’’ (64 FR 43255, August 10,                                      requirements.
                                                U.S.C. 3501 et seq.), nor does it require
                                                any special considerations under                                             1999) and Executive Order 13175,                                               Dated: February 11, 2016.
                                                Executive Order 12898, entitled                                              entitled ‘‘Consultation and Coordination                                     Susan Lewis,
                                                ‘‘Federal Actions to Address                                                 with Indian Tribal Governments’’ (65 FR                                      Director, Registration Division, Office of
                                                Environmental Justice in Minority                                            67249, November 9, 2000) do not apply                                        Pesticide Programs.
                                                Populations and Low-Income                                                   to this action. In addition, this action
                                                                                                                                                                                                            Therefore, 40 CFR chapter I is
                                                Populations’’ (59 FR 7629, February 16,                                      does not impose any enforceable duty or
                                                                                                                                                                                                          amended as follows:
                                                1994).                                                                       contain any unfunded mandate as
                                                   Since tolerances and exemptions that                                      described under Title II of the Unfunded                                     PART 180—[AMENDED]
                                                are established on the basis of a petition                                   Mandates Reform Act (UMRA) (2 U.S.C.
                                                under FFDCA section 408(d), such as                                          1501 et seq.).                                                               ■ 1. The authority citation for part 180
                                                                                                                                This action does not involve any                                          continues to read as follows:
                                                the tolerance in this final rule, do not
                                                                                                                             technical standards that would require
                                                require the issuance of a proposed rule,                                                                                                                      Authority: 21 U.S.C. 321(q), 346a and 371.
                                                                                                                             Agency consideration of voluntary
                                                the requirements of the Regulatory
                                                                                                                             consensus standards pursuant to section                                        2. In § 180.555, is amended:
                                                Flexibility Act (RFA) (5 U.S.C. 601 et                                                                                                                    ■
                                                                                                                             12(d) of the National Technology
                                                seq.), do not apply.                                                                                                                                      ■ a. By alphabetically adding the
                                                                                                                             Transfer and Advancement Act
                                                   This action directly regulates growers,                                   (NTTAA) (15 U.S.C. 272 note).                                                commodities to the table in paragraph
                                                food processors, food handlers, and food                                                                                                                  (a);
                                                retailers, not States or tribes, nor does                                    VII. Congressional Review Act                                                ■ b. By removing ‘‘Grape’’, ‘‘Potato’’,
                                                this action alter the relationships or                                         Pursuant to the Congressional Review                                       and ‘‘Strawberry’’ from the table in
                                                distribution of power and                                                    Act (5 U.S.C. 801 et seq.), EPA will                                         paragraph (a);
                                                responsibilities established by Congress                                     submit a report containing this rule and                                     ■ c. By revising ‘‘Leaf petioles subgroup
                                                in the preemption provisions of FFDCA                                        other required information to the U.S.                                       4B’’ in the table in paragraph (a).
                                                section 408(n)(4). As such, the Agency                                       Senate, the U.S. House of                                                       The additions and revision read as
                                                has determined that this action will not                                     Representatives, and the Comptroller                                         follows:
                                                have a substantial direct effect on States                                   General of the United States prior to
                                                or tribal governments, on the                                                publication of the rule in the Federal                                       § 180.555 Trifloxystrobin; tolerances for
                                                relationship between the national                                            Register. This action is not a ‘‘major                                       residues.
                                                government and the States or tribal                                          rule’’ as defined by 5 U.S.C. 804(2).                                            (a) General. * * *

                                                                                                                                                                                                                                                                Parts per
                                                                                                                                             Commodity                                                                                                           million


                                                          *                   *                           *                                 *                                 *                                *                                                *
                                                Berry, low growing subgroup 13–07G .....................................................................................................................................................                               1.5
                                                Brassica, head and stem, subgroup 5A ..................................................................................................................................................                                2.0
                                                Brassica, leafy greens, subgroup 5B ......................................................................................................................................................                              30

                                                          *                                *                                 *                                 *                                 *                                *                             *
                                                Dill, seed ..................................................................................................................................................................................................           30

                                                          *                     *                      *                     *                                 *                                *                                                               *
                                                Fruit, small vine climbing, except fuzzy kiwifruit, subgroup 13–07F .......................................................................................................                                            2.0

                                                         *                       *                                 *                                 *                                 *                                *                                       *
                                                Herbs, subgroup 19A ...............................................................................................................................................................................                    200

                                                          *                    *                                 *                                 *                                 *                                *                                         *
                                                Leaf petioles subgroup 4B .......................................................................................................................................................................                      9.0
                                                Leafy greens, subgroup 4A .....................................................................................................................................................................                        30

                                                         *                  *                      *                                 *                                 *                                *                                                       *
                                                Vegetable, tuberous and corm, subgroup 1C .........................................................................................................................................                                   0.04

                                                              *                                *                                *                                *                                *                                *                            *
mstockstill on DSK4VPTVN1PROD with RULES




                                                *        *         *         *         *
                                                [FR Doc. 2016–04070 Filed 2–25–16; 8:45 am]
                                                BILLING CODE 6560–50–P




                                           VerDate Sep<11>2014          17:55 Feb 25, 2016         Jkt 238001       PO 00000        Frm 00037        Fmt 4700        Sfmt 4700      E:\FR\FM\26FER1.SGM               26FER1



Document Created: 2018-02-02 14:36:48
Document Modified: 2018-02-02 14:36:48
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionRules and Regulations
ActionFinal rule.
DatesThis regulation is effective February 26, 2016. Objections and requests for hearings must be received on or before April 26, 2016, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ContactSusan Lewis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone
FR Citation81 FR 9772 
CFR AssociatedEnvironmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements

2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR