[Federal Register Volume 79, Number 242 (Wednesday, December 17, 2014)]
[Rules and Regulations]
[Pages 75059-75065]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-29480]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2013-0662; FRL-9918-99]


Fluopyram; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
fluopyram in or on multiple commodities that 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 December 17, 2014, except for the 
amendment to Sec.  180.661 in amendatory instruction number 3, which is 
effective June 17, 2015. Objections and requests for hearings must be 
received on or before February 17, 2015, 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-2013-0662, 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

[[Page 75060]]

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: <a href="/cdn-cgi/l/email-protection#095b4d4f5b47667d606a6c7a496c7968276e667f"><span class="__cf_email__" data-cfemail="86d4c2c0d4c8e9f2efe5e3f5c6e3f6e7a8e1e9f0">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
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:
    <bullet> Crop production (NAICS code 111).
    <bullet> Animal production (NAICS code 112).
    <bullet> Food manufacturing (NAICS code 311).
    <bullet> 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. To access the OCSPP 
test guidelines referenced in this document electronically, please go 
to http://www.epa.gov/ocspp and select ``Test Methods and Guidelines.''

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

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2013-0662 in the subject line on the first 
page of your submission. All objections and requests for a hearing must 
be in writing, and must be received by the Hearing Clerk on or before 
February 17, 2015. Addresses for mail and hand delivery of objections 
and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing (excluding 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-2013-0662, by one of 
the following methods:
    <bullet> 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.
    <bullet> Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 
20460-0001.
    <bullet> 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 May 23, 2014 (79 FR 29729) (FRL-9910-
29), 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 
3F8190) by Bayer CropScience, P.O. Box 12014, 2 T.W. Alexander Dr., 
Research Triangle Park, NC 27709. The petition requested that 40 CFR 
180.661 be amended by establishing tolerances for residues of the 
fungicide fluopyram, N-[2-[3-chloro-5-(trifluoromethyl)-2-
pyridinyl]ethyl]-2-(trifluoromethyl)benzamide, including its 
metabolites and degradates in or on the following commodities: Beef, 
byproducts at 0.70 parts per million (ppm); beef, fat at 0.10 ppm; 
beef, meat at 0.10 ppm; grain, cereal, forage, group 16 at 1.5 ppm; 
cotton, gin by-products at 0.80 ppm; cotton, seed at 0.01 ppm; egg at 
0.15 ppm; grain, cereal group 15, except rice at 0.03 ppm; grain, 
cereal, fodder, hay and straw, group 16 at 2.0 ppm; hog, fat at 0.05 
ppm; hog, meat at 0.10 ppm; hog, meat byproducts at 0.70 ppm; milk at 
0.10 ppm; peanuts at 0.09 ppm; poultry, fat at 0.10 ppm; poultry, meat 
at 0.10 ppm; poultry, meat byproducts at 0.20 ppm; and soybean, seed at 
0.04 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. Comments were received on the notice of 
filing. EPA's response to these comments is discussed in Unit IV.C.
    Based upon review of the data supporting the petition, EPA is 
issuing some tolerances that vary from the fluopyram tolerances as 
requested. The reasons for these changes are explained in Unit IV.D.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue . . 
.''
    Consistent with 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 fluopyram including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with fluopyram 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

[[Page 75061]]

concerning the variability of the sensitivities of major identifiable 
subgroups of consumers, including infants and children.
    Decreased body weight and liver effects were the common and 
frequent findings in the fluopyram subchronic and chronic oral toxicity 
studies in rats, mice, and dogs, and they appeared to be the most 
sensitive effects. Liver effects were characterized by increased liver 
weight, hepatocellular hypertrophy, hepatocellular vacuolation, 
increased mitosis and hepatocellular necrosis. Thyroid effects were 
found at dose levels similar to those that produced liver effects in 
rats and mice; these effects consisted of follicular cell hypertrophy, 
increased thyroid weight and hyperplasia at dose levels greater than or 
equal to 100 milligrams/kilogram/day (mg/kg/day). Changes in thyroid 
hormone levels were also seen in a subchronic toxicity study. In male 
mice, there was an increased incidence of thyroid adenomas.
    Although increased liver tumors were observed in female rats in the 
carcinogenicity study, EPA has concluded that fluopyram is ``Not Likely 
to be Carcinogenic to Humans'' at doses that do not induce cellular 
proliferation in the liver or thyroid glands. This classification was 
based on convincing evidence that non-genotoxic modes of action for 
liver tumors in rats and thyroid tumors in mice have been established 
and that the carcinogenic effects have been demonstrated as a result of 
a mode of action dependent on activation of the CAR/PXR receptors. 
Moreover, fluopyram is not genotoxic or mutagenic.
    Fluopyram is not a developmental toxicant, nor did it adversely 
affect reproductive parameters. No evidence of qualitative or 
quantitative susceptibility was observed in developmental studies in 
rats and rabbits or in a multi-generation study in rats.
    In an acute neurotoxicity study, transient decreased motor activity 
was seen only on the day of treatment, but no other findings 
demonstrating neurotoxicity were observed. In addition, no 
neurotoxicity was observed in the subchronic neurotoxicity study in the 
presence of other systemic adverse effects. Fluopyram did not produce 
treatment-related effects on the immune system.
    Fluopyram has low acute toxicity via the oral, dermal, and 
inhalation routes of exposure. Fluopyram is not a skin or eye irritant 
or sensitizer under the conditions of the murine lymph node assay.
    Specific information on the studies received and the nature of the 
adverse effects caused by fluopyram as well as the no-observed-adverse-
effect-level (NOAEL) and the lowest-observed-adverse-effect-level 
(LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document entitled ``Fluopyram: Human Health Risk 
Assessment for Proposed New Use as a Soil/In-Furrow Treatment for 
Cotton and Peanut, and as a Seed Treatment to Cotton and Soybean, Plus 
a Proposal for Amended Inadvertent Tolerances for the Crop Group 15 
Cereal Grains and Crop Group 16 Forage, Fodder, and Straw of Cereal 
Grains'' in docket ID number EPA-HQ-OPP-2013-0662.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (POD) and levels of 
concern to use in evaluating the risk posed by human exposure to the 
pesticide. For hazards that have a threshold below which there is no 
appreciable risk, the toxicological POD is used as the basis for 
derivation of reference values for risk assessment. PODs are developed 
based on a careful analysis of the doses in each toxicological study to 
determine the dose at which no adverse effects are observed (the NOAEL) 
and the lowest dose at which adverse effects of concern are identified 
(the LOAEL). Uncertainty/safety factors are used in conjunction with 
the POD to calculate a safe exposure level--generally referred to as a 
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe 
margin of exposure (MOE). For non-threshold risks, the Agency assumes 
that any amount of exposure will lead to some degree of risk. Thus, the 
Agency estimates risk in terms of the probability of an occurrence of 
the adverse effect expected in a lifetime. For more information on the 
general principles EPA uses in risk characterization and a complete 
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    The details for selecting toxicity endpoints and points of 
departure for various exposure scenarios can be found at http://www.regulations.gov in the document entitled ``Fluopyram: Human Health 
Risk Assessment for Proposed New Use as a Soil/In-Furrow Treatment for 
Cotton and Peanut, and as a Seed Treatment to Cotton and Soybean, Plus 
a Proposal for Amended Inadvertent Tolerances for the Crop Group 15 
Cereal Grains and Crop Group 16 Forage, Fodder, and Straw of Cereal 
Grains'' in docket ID number EPA-HQ-OPP-2013-0662.
    A summary of the toxicological endpoints for fluopyram used for 
human risk assessment is shown in Table 1 of this unit.

   Table 1--Summary of Toxicological Doses and Endpoints for Fluopyram for Use in Human Health Risk Assessment
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                                    Point of departure
        Exposure/scenario            and uncertainty/     RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
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Acute dietary (Females 13-50       An endpoint attributable to a single dose exposure has not been identified
 years of age).                     for this subpopulation.
                                  ------------------------------------------------------------------------------
Acute dietary (General population  NOAEL = 50 mg/kg/day  Acute RfD = 0.50 mg/ Acute Neurotoxicity Study in Rats.
 including infants and children).  UFA = 10x...........   kg/day.             LOAEL = 100 mg/kg/day based on
                                   UFH = 10x...........  aPAD = 0.50 mg/kg/    decreased motor and locomotor
                                   FQPA SF = 1x........   day.                 activity in females. The LOAEL in
                                                                               males was 125 mg/kg/day.
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Chronic dietary (All populations)  NOAEL = 1.2 mg/kg/    Chronic RfD = 0.012  Combined Chronic/Carcinogenicity
                                    day.                  mg/kg/day.           in Rats.
                                   UFA = 10x...........  cPAD = 0.012 mg/kg/  LOAEL = 6.0 mg/kg/day based on
                                   UFH = 10x...........   day.                 follicular cell hypertrophy in
                                   FQPA SF = 1x........                        the thyroid, and increased liver
                                                                               weight with gross pathological
                                                                               and histopathological findings.
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[[Page 75062]]

 
Cancer (Oral, dermal, inhalation)  Classification: Not likely to be carcinogenic to humans at doses that do not
                                    induce cellular proliferation in the liver or thyroid glands.
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FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
  level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor.
  UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among
  members of the human population (intraspecies).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to fluopyram, EPA considered exposure under the petitioned-for 
tolerances as well as all existing fluopyram tolerances in 40 CFR 
180.661. EPA assessed dietary exposures from fluopyram 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 fluopyram. In estimating acute dietary exposure, EPA used food 
consumption information from the United States Department of 
Agriculture (USDA) 2003-2008 National Health and Nutrition Examination 
Survey/What We Eat in America (NHANES/WWEIA). As to residue levels in 
food, EPA included tolerance residue levels, the assumption of 100 
percent crop treated (PCT), and processing factors (empirical and 
default).
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA 2003-2008 
NHANES/WWEIA. As to residue levels in food, EPA included average field-
trial residue levels, the assumption of 100 PCT, and processing factors 
(empirical and default).
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that fluopyram does not pose a cancer risk to humans at doses 
that do not induce cellular proliferation in the liver or thyroid 
glands. The chronic RfD is derived using the NOAEL of 1.2 mg/kg/day as 
the ``point of departure'' which is below the dose of 11 mg/kg/day that 
caused cell proliferation in the liver (i.e., a key event in tumor 
formation) and the subsequent liver tumors at a higher dose (89 mg/kg/
day). Therefore, the Agency believes the chronic assessment will be 
protective of any cancer risk; therefore, a separate dietary exposure 
assessment for the purpose of assessing cancer risk is unnecessary.
    iv. Anticipated residue and PCT information. EPA did not use 
anticipated residue and/or PCT information in the dietary assessment 
for fluopyram. Tolerance level residues or average field-trial residues 
and 100 PCT were assumed for all food commodities.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for fluopyram in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of fluopyram. Further information regarding EPA 
drinking water models used in pesticide exposure assessment can be 
found at http://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the Pesticide Root Zone Model/Exposure Analysis Modeling 
System (PRZM/EXAMS) and Pesticide Root Zone Model Ground Water (PRZM 
GW), the estimated drinking water concentrations (EDWCs) of fluopyram 
for acute exposures are estimated to be 19.4 parts per billion (ppb) 
for surface water and 87.5 ppb for ground water. The chronic exposures 
for non-cancer assessments are estimated to be 4.9 ppb for surface 
water and 76.8 ppb for ground water. Modeled estimates of drinking 
water concentrations were directly entered into the dietary exposure 
model. For acute dietary risk assessment, the water concentration value 
of 87.5 ppb was used to assess the contribution to drinking water. For 
chronic dietary risk assessment, the water concentration of value 76.8 
ppb was used to assess the contribution to drinking water.
    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). Fluopyram is not 
registered for any specific use patterns that would result in 
residential exposure.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.'' EPA has not found fluopyram 
to share a common mechanism of toxicity with any other substances, and 
fluopyram does not appear to produce a toxic metabolite produced by 
other substances. For the purposes of this tolerance action, therefore, 
EPA has assumed that fluopyram does not have a common mechanism of 
toxicity with other substances. For information regarding EPA's efforts 
to determine which chemicals have a common mechanism of toxicity and to 
evaluate the cumulative effects of such chemicals, see EPA's Web site 
at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the Food Quality 
Protection Act Safety Factor (FQPA SF). In applying this provision, EPA 
either retains the default value of 10X, or uses a different additional 
safety factor when reliable data available to EPA support the choice of 
a different factor.
    2. Prenatal and postnatal sensitivity. The available developmental 
toxicity studies in rats and rabbits and the multi-generation 
reproduction in rats

[[Page 75063]]

demonstrate no evidence of increased susceptibility in the developing 
or young animals, which were exposed during prenatal or postnatal 
periods. Decreased fetal body weight was observed at levels equal to or 
greater than the maternal LOAEL in both rat and rabbit developmental 
studies. Likewise, body-weight effects were seen in offspring at levels 
equal to the parental LOAEL in the rat 2-generation reproductive 
toxicity study.
    3. Conclusion. EPA has determined that reliable data show the 
safety of infants and children would be adequately protected if the 
FQPA SF were reduced to 1X. That decision is based on the following 
findings:
    i. The toxicity database for fluopyram is complete.
    ii. The fluopyram toxicology database did not demonstrate evidence 
of neurotoxicity. Although transient decreases in motor and locomotor 
activities in the acute neurotoxicity study on the day of treatment and 
limited use of hind-limbs and reduced motor activity in the rat 
chronic/carcinogenicity study were seen, there were no other associated 
neurobehavioral or histopathology changes found in other studies in the 
fluopyram toxicity database. The effects seen in the chronic/
carcinogenicity study were in the presence of increased mortality and 
morbidity such as general pallor and appearance. Therefore, the reduced 
motor activity and limited use of hind-limbs seen in these two studies 
were judged to be the consequence of the systemic effects and not 
direct neurotoxicity. Therefore, there is no need for a developmental 
neurotoxicity study or additional uncertainty factors (UFs) to account 
for neurotoxicity.
    iii. There is no evidence that fluopyram results in increased 
susceptibility in in utero rats or rabbits in the prenatal 
developmental studies or in young rats in the 2-generation reproduction 
study.
    iv. There are no residual uncertainties identified in the exposure 
databases. The acute and chronic dietary exposure assessment was 
performed using tolerance level residues or average field-trial 
residues for all crops. Both acute and chronic assessments assumed 100 
PCT and incorporated empirical or default processing factors. The 
dietary exposure assessment also assumed that all drinking water will 
contain fluopyram at the highest EDWC levels modeled by the Agency for 
ground or surface water. Residential exposures are not expected. EPA 
made conservative (protective) assumptions in the ground and surface 
water modeling used to assess exposure to fluopyram in drinking water. 
These assessments will not underestimate the exposure and risks posed 
by fluopyram.

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 fluopyram will occupy 4.4% of the aPAD for children 1-2 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 
fluopyram from food and water will utilize 38% of the cPAD for all 
infants, the population group receiving the greatest exposure. There 
are no residential uses for fluopyram. Based on the explanation in Unit 
III.C.3., regarding residential use patterns, chronic residential 
exposure to residues of fluopyram 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). Because there 
are no residential uses, short-term residential exposures are not 
likely to occur, and therefore fluopyram is not expected to pose a 
short-term aggregate risk.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level). Because there are no residential uses, intermediate-term 
residential exposures are not likely to occur, and therefore fluopyram 
is not expected to pose an intermediate-term aggregate risk.
    5. Aggregate cancer risk for U.S. population. Based on the data 
summarized in Unit III.A. and the lack of a chronic risk, fluopyram 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 fluopyram residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    The German multi-residue method DFG Method S 19, a gas 
chromatography with mass selective detection (GC/MSD) method, is 
adequate for the enforcement of tolerances for fluopyram residues in or 
on crop commodities, and a high performance liquid chromatography 
method with tandem mass spectrometry detection (HPLC/MS/MS), Method 
01079, is adequate for the enforcement of tolerances for residues of 
fluopyram and its metabolite, AE C656948-benzamide, in livestock 
commodities. The validated limit of quantitation (LOQ) is 0.01 ppm for 
each analyte in each matrix. The enforcement methods for plant 
commodities (DFG Method S19) and livestock commodities (Method 01079) 
are deemed adequate as enforcement methods. Adequate HPLC/MS/MS methods 
were used for data collection for crop and livestock commodities. Thus, 
adequate enforcement methodologies (DFG Method S 19 and Method 01079) 
are available to enforce the tolerance expression.

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. As required 
by FFDCA section 408(b)(4), EPA considers the international maximum 
residue limits (MRLs) established by the Codex Alimentarius Commission 
(Codex) in its tolerance decisions. 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 MRL for peanut is 0.03 mg/kg, which is lower than the 
U.S. tolerance as amended for peanuts at 0.09 ppm. The U.S. peanut 
tolerance cannot be harmonized at 0.03 because following the approved 
label directions could result in residues above 0.03 ppm.

[[Page 75064]]

    There are Codex MRLs for the livestock commodities that are higher 
than the U.S. tolerances for livestock commodities. The lowering of the 
tolerances for the cereal grains (group 15), and cereal grains forages, 
stovers, and straws (group 16), all as rotational crops, resulted in 
considerably less fluopyram in the livestock diets than under the 
previous tolerances. As a result, the tolerances for the livestock 
commodities were lowered. Calculated values were adjusted slightly to 
harmonize with Canada for all livestock commodity tolerances/MRLs but 
could not be harmonized with Codex MRLs, which are generally higher 
(5X-60X), because they are based on a different residue definition, do 
not reflect the North American Free Trade Agreement (NAFTA) plant 
commodity use patterns, and do not consider the Maximum Reasonably 
Based Diet.

C. Response to Comments

    Two comments were received in response to the notice of filing of 
Bayer CropScience's application. Both commenters objected to the 
increase of chemical residues generally and one commenter expressed 
additional concerns about the carcinogenic effects of chemicals in 
general on humans. The Agency understands the commenters' concerns 
regarding toxic chemicals and their potential effects on humans. 
Pursuant to its authority under the FFDCA, and as discussed further in 
this preamble, EPA conducted a comprehensive assessment of fluopyram, 
which included an assessment on the carcinogenic potential of 
fluopyram. Based on its assessment of the available data, the Agency 
has concluded that fluopyram is not likely to be a carcinogen and that 
there is a reasonable certainty that no harm will result from aggregate 
exposure to residues of fluopyram.

D. Revisions to Petitioned-For Tolerances

    EPA is establishing tolerances for cotton gin byproducts and for 
cereal grain forage group 16 that differ from the petitioned-for 
tolerances. The petitioned-for tolerances differ from the tolerances 
for cotton gin byproducts and for cereal grain forage group 16. The 
petition requested a tolerance of 0.80 ppm for cotton gin byproducts, 
but based on residue data provided and using the Organization for 
Economic Cooperation and Development (OECD) statistical calculation, 
EPA is establishing a tolerance level of 0.70 ppm. The petition also 
requested two different tolerances for the cereal grain forage, fodder, 
stover, and straw group 16: 1.5 ppm for forage and 2.0 ppm for hay, 
fodder, and straw. Only one tolerance is possible for the group, so the 
Agency is establishing the tolerance at 2.0 ppm to cover residues 
within that crop group.
    EPA is establishing tolerances for fat, meat, and meat byproducts 
of cattle, hog, and poultry; egg; and milk lower than the petition 
requested based on a recalculation of the livestock dietary burdens and 
adjusted upwards to harmonize with Canada. The Agency is revising the 
commodity terms to ``cattle, fat''; ``cattle, meat''; and ``cattle, 
meat byproducts'' to be consistent with the food commodity vocabulary 
used for tolerances.

E. Trade Considerations

    A few of the tolerance actions result in reductions of existing 
tolerance levels; therefore, EPA is delaying the effective date of the 
following tolerance actions for 6 months to allow a reasonable interval 
for producers in exporting member countries of the World Trade 
Organization's Sanitary and Phytosanitary Measures Agreement to adapt 
to the requirements of these modified tolerances. The tolerance actions 
subject to the 6-month delay are effective June 17, 2015 are as 
follows: Modifying tolerances in Sec.  180.661(a)(2) for cattle, fat at 
0.05 ppm; cattle, meat at 0.05 ppm; cattle, meat byproducts at 0.40 
ppm; egg at 0.06 ppm; hog, fat at 0.02 ppm; hog, meat at 0.02 ppm; hog, 
meat byproducts at 0.03 ppm; milk at 0.06 ppm; poultry, fat at 0.03 
ppm; poultry, meat at 0.03 ppm; and poultry, meat byproducts at 0.10 
ppm; modifying tolerances in Sec.  180.661(d) for grain, cereal, group 
15, except rice at 1.5 ppm to grain, cereal, except rice, group 15 at 
0.03 ppm; establishing tolerances in Sec.  180.661(d) for grain, 
cereal, forage, fodder and straw, group 16 at 2.0 ppm; and removing 
tolerances from Sec.  180.661(d) for grain, cereal, forage, fodder and 
straw, group 16, except rice; forage at 4.0 ppm; grain, cereal, forage, 
fodder and straw, group 16, except rice; hay, straw and stover at 7.0 
ppm; and soybean, seed at 0.10 ppm.

V. Conclusion

    Therefore, tolerances are established for residues of fluopyram, N-
[2-[3-chloro-5-(trifluoromethyl)-2-pyridinyl]ethyl]-2-
(trifluoromethyl)benzamide, including its metabolites and degradates in 
or on the following commodities: Cattle, fat at 0.05 ppm; cattle, meat 
at 0.05 ppm; cattle, meat byproducts at 0.40 ppm; cotton, gin 
byproducts at 0.70 ppm; cotton, undelinted seed at 0.01 ppm; egg at 
0.06 ppm; grain, cereal, except rice, group 15 at 0.03 ppm; grain, 
cereal, forage, fodder and straw, group 16 at 2.0 ppm; hog, fat at 0.02 
ppm; hog, meat at 0.02 ppm; hog, meat byproducts at 0.03 ppm; milk at 
0.06 ppm; peanuts at 0.09 ppm; poultry, fat at 0.03 ppm; poultry, meat 
at 0.03 ppm; poultry, meat byproducts at 0.10; and soybean, seed at 
0.04 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under FFDCA section 408(d) 
in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled ``Regulatory Planning and 
Review'' (58 FR 51735, October 4, 1993). Because this final rule has 
been exempted from review under Executive Order 12866, this final rule 
is not subject to Executive Order 13211, entitled ``Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
``Protection of Children from Environmental Health Risks and Safety 
Risks'' (62 FR 19885, April 23, 1997). This final rule does not contain 
any information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any 
special considerations under Executive Order 12898, entitled ``Federal 
Actions to Address Environmental Justice in Minority Populations and 
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under FFDCA section 408(d), such as the tolerances in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.), do not apply.
    This final rule directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined

[[Page 75065]]

that Executive Order 13132, entitled ``Federalism'' (64 FR 43255, 
August 10, 1999) and Executive Order 13175, entitled ``Consultation and 
Coordination with Indian Tribal Governments'' (65 FR 67249, November 9, 
2000) do not apply to this final rule. In addition, this final rule 
does not impose any enforceable duty or contain any unfunded mandate as 
described under Title II of the Unfunded Mandates Reform Act of 1995 
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act of 1995 (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

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

List of Subjects in 40 CFR Part 180

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

    Dated: December 9, 2014.
G. Jeffrey Herndon,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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


0
2. In Sec.  180.661 (effective December 17, 2014):
0
a. Add alphabetically ``Cotton, gin by-products''; ``Cotton, undelinted 
seed''; and ``Soybean, seed'' to the table in paragraph (a)(1).
0
b. Revise the entry for ``Peanut'' in the table in paragraph (a)(1).
0
c. Remove the entries ``Cotton, gin byproducts'' and ``Cotton, 
undelinted seed,'' in the table in paragraph (d).
    The additions and revision read as follows:


Sec.  180.661  Fluopyram; tolerances for residues.

    (a) * * *
    (1) * * *

 
                                                              Parts per
                         Commodity                             million
 
 
                                * * * * *
Cotton, gin byproducts.....................................         0.70
Cotton, undelinted seed....................................         0.01
 
                                * * * * *
Peanut.....................................................         0.09
 
                                * * * * *
Soybean, seed..............................................         0.04
 
                                * * * * *
 

* * * * *

0
3. In Sec.  180.661 (effective June 17, 2015):
0
a. Revise in the table in paragraph (a)(2) the following entries listed 
in the table below.
0
b. Add alphabetically ``Grain, cereal, except rice, group 15'' and 
``Grain, cereal, forage, fodder and straw, group 16'' to the table in 
paragraph (d).
0
c. Remove the entries ``Grain, cereal, forage, fodder and straw, group 
16, except rice; forage''; ``Grain, cereal, forage, fodder and straw, 
group 16, except rice; hay, straw and stover''; and ``Grain, cereal, 
group 15, except rice'' in the table in paragraph (d).
    The additions and revisions read as follows:


Sec.  180.661  Fluopyram; tolerances for residues.

    (a) * * *
    (2) * * *

 
                                                              Parts per
                         Commodity                             million
 
Cattle, fat................................................         0.05
Cattle, meat...............................................         0.05
Cattle, meat byproducts....................................         0.40
Egg........................................................         0.06
 
                                * * * * *
Hog, fat...................................................         0.02
Hog, meat..................................................         0.02
Hog, meat byproducts.......................................         0.03
 
                                * * * * *
Milk.......................................................         0.06
Poultry, fat...............................................         0.03
Poultry, meat..............................................         0.03
Poultry, meat byproducts...................................         0.10
 
                                * * * * *
 

* * * * *
    (d) * * *

 
                                                              Parts per
                         Commodity                             million
 
 
                                * * * * *
Grain, cereal, except rice, group 15.......................         0.03
Grain, cereal, forage, fodder and straw, group 16..........          2.0
 
                                * * * * *
 

[FR Doc. 2014-29480 Filed 12-16-14; 8:45 am]
BILLING CODE 6560-50-P


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