Document ID: EPA-HQ-OPP-2014-0482-0005
Agency: epa
Document Type: Rule
Title: Pesticide Tolerances: Flutriafol
Posted Date: 2015-02-04T05:00Z

[Federal Register Volume 80, Number 23 (Wednesday, February 4, 2015)]
[Rules and Regulations]
[Pages 5946-5952]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-02177]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2014-0482; FRL-9922-06]

Flutriafol; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

[[Page 5947]]

ACTION: Final rule.

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SUMMARY: This regulation establishes, amends, and removes tolerances 
for residues of flutriafol in or on multiple commodities which are 
identified and discussed later in this document. Cheminova A/S c/o 
Cheminova, Inc. requested these tolerances under the Federal Food, 
Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective February 4, 2015. Objections and 
requests for hearings must be received on or before April 6, 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-2014-0482, 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: RDFRNotices@epa.gov.

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-2014-0482 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 6, 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-2014-0482, 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 December 17, 2014 (79 FR 75107) (FRL-
9918-90), 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 
3F8199) by Cheminova A/S, c/o Cheminova Inc., 1600 Wilson Blvd., Suite 
700, Arlington, VA 22209-2510. The petition requested that 40 CFR 
180.629 be amended by establishing tolerances for residues of the 
fungicide flutriafol, in or on Brassica, head and stem, subgroup 5A at 
1.5 parts per million (ppm); Brassica, head and stem, subgroup 5A, at 
1.5 ppm; Brassica, leafy greens, subgroup 5B at 7.0 ppm; egg at 0.01 
ppm; hog, liver at 0.05 ppm; hog, meat by products, except liver at 
0.02 ppm; hog, muscle at 0.01 ppm; leaf petioles, subgroup 4B at 3.0 
ppm; leafy greens, subgroup 4A except head lettuce at 10 ppm; lettuce, 
head at 1.5 ppm; poultry, meat byproducts at 0.02 ppm; radicchio at 1.5 
ppm; sorghum, grain, forage at 2.0 ppm; sorghum, grain, grain at 1.5 
ppm and sorghum, grain, stover at 6.0 ppm. The petition requested that 
40 CFR 180.629 amend the current established tolerances for residues of 
the fungicide flutriafol in or on cotton, gin byproducts from 0.5 ppm 
to 5.0 ppm; cotton, undelinted seed from 0.35 ppm to 0.5 ppm; grain, 
aspirated fractions from 2.2 ppm to 6.0 ppm. The petition also 
requested that 40 CFR 180.629 delete the current established tolerances 
for residues of the fungicide flutriafol in or on cotton, meal at 0.5 
ppm; cotton, refined oil at 0.5 ppm; and hog, meat byproducts at 0.02 
ppm. That document referenced a summary of the petition prepared by 
Cheminova A/S, c/o Cheminova, Inc., the registrant, which is available 
in the docket, http://www.regulations.gov. One comment was received on 
the notice of filing. EPA's response to this comment is discussed in 
Unit IV.C.
    Based upon review of the data supporting the petition, EPA is 
issuing some tolerances that vary from what the petitioner requested. 
The reason 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

[[Page 5948]]

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 flutriafol including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with flutriafol 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.
    Flutriafol is categorized as having high oral acute toxicity in the 
mouse. It is categorized as having low acute toxicity via the oral, 
dermal and inhalation routes in rats. Flutriafol is minimally 
irritating to the eyes and is not a dermal irritant. Flutriafol was not 
shown to be a skin sensitizer when tested in guinea pigs.
    Short-term, subchronic, and chronic toxicity studies in rats, mice, 
and dogs identified the liver as the primary target organ of 
flutriafol. Hepatotoxicity was first evident in the subchronic studies 
(rats and dogs) in the form of increases in liver enzyme release 
(alkaline phosphatase), and liver weights, and histopathology findings 
ranging from hepatocyte vacuolization to centrilobular hypertrophy and 
slight increases in hemosiderin-laden Kupffer cells. It is noteworthy 
that with chronic exposures, there are no indications of progression of 
liver toxicity in all species. After over one year of exposure, 
hepatotoxicity in rats, dogs, and mice took the form of minimal to 
severe fatty changes; bile duct proliferation/cholangiolar fibrosis; 
hemosiderin accumulation in Kupffer cells; centrilobular hypertrophy, 
and increases in alkaline phosphatase release. Slight indications of 
effects in the hematopoietic system are sporadically seen in the 
database. These effects are manifested in the form of slight anemia 
(rats and dogs) and increased platelet, white blood cell, neutrophil, 
and lymphocyte counts (mice). These effects, however, were minimal in 
severity.
    Specific information on the studies received and the nature of the 
adverse effects caused by flutriafol as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies are discussed in the final rule 
published in the Federal Register of June 6, 2014 (79 FR 32666) (FRL-
9910-38) under the docket ID numbers EPA-HQ-OPP-2013-0654-0005 and EPA-
HQ-OPP-2013-0655-0008.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (POD) and levels of 
concern to use in evaluating the risk posed by human exposure to the 
pesticide. For hazards that have a threshold below which there is no 
appreciable risk, the toxicological POD is used as the basis for 
derivation of reference values for risk assessment. PODs are developed 
based on a careful analysis of the doses in each toxicological study to 
determine the dose at which no adverse effects are observed (the NOAEL) 
and the lowest dose at which adverse effects of concern are identified 
(the LOAEL). Uncertainty/safety factors are used in conjunction with 
the POD to calculate a safe exposure level--generally referred to as a 
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe 
margin of exposure (MOE). For non-threshold risks, the Agency assumes 
that any amount of exposure will lead to some degree of risk. Thus, the 
Agency estimates risk in terms of the probability of an occurrence of 
the adverse effect expected in a lifetime. For more information on the 
general principles EPA uses in risk characterization and a complete 
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for flutriafol used for 
human risk assessment is discussed in Unit III.B. of the final rule 
published in the Federal Register of June 6, 2014.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to flutriafol, EPA considered exposure under the petitioned-
for tolerances as well as all existing flutriafol tolerances in 40 CFR 
180.629. EPA assessed dietary exposures from flutriafol 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 flutriafol. In estimating acute dietary exposure, EPA used food 
consumption information from the United States Department of 
Agriculture (USDA) Nationwide Health and Nutrition Examination Survey, 
What We Eat In America (NHANES/WWEIA) conducted from 2003-2008. As to 
residue levels in food, EPA made the following assumptions for the 
acute exposure assessment: Tolerance-level residues or tolerance-level 
residues adjusted to account for the residues of concern for risk 
assessment and 100 percent crop treated (PCT). Since adequate 
processing studies have been submitted which indicate that tolerances 
for residues in/on apple juice, grape juice, dried prunes, and tomato 
puree are unnecessary and since tolerances for residues in/on raisins 
and tomato paste are established, the Dietary Exposure Evaluation Model 
(DEEM) (ver. 7.81) default processing factors for these commodities 
were reduced to 1. The DEEM (ver. 7.81) default processing factors were 
retained for the remaining relevant commodities.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA's (NHANES/
WWEIA) conducted from 2003-2008 as well. As to residue levels in food, 
EPA made the follow assumptions for the chronic exposure assessment: 
Tolerance-level residues or tolerance-level residues adjusted to 
account for the residues of concern for risk assessment and 100 PCT. 
Since adequate processing studies have been submitted which indicate 
that tolerances for residues in/on apple juice, grape juice, dried 
prunes, and tomato puree are unnecessary and since tolerances for 
residues in/on raisins and tomato paste are established, the DEEM (ver. 
7.81) default processing factors for these commodities were reduced to 
1. The DEEM (ver. 7.81) default processing factors were retained for 
the remaining relevant commodities.

[[Page 5949]]

    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that flutriafol 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 PCT information. EPA did not use 
anticipated residue and/or PCT information in the dietary assessment 
for flutriafol. Tolerance level residues or tolerance level residues 
adjusted to account for the residues of concern for risk assessment 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 flutriafol. These simulation models take into account 
data on the physical, chemical, and fate/transport characteristics of 
flutriafol. 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 Food Quality Protection Act (FQPA): First Index 
Reservoir Screening Tool (FIRST) and the Pesticide Root Zone Model/
Ground Water (PRZM/GW), the estimated drinking water concentrations 
(EDWCs) of flutriafol for acute exposures are estimated to be 40.55 
parts per billion (ppb) for surface water and 310 ppb for ground water.
    For chronic exposures assessments the EDWC's are estimated to be 
4.03 ppb for surface water and 202 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 310 ppb was used to assess 
the contribution to drinking water. For chronic dietary risk 
assessment, the water concentration of value 202 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). Flutriafol 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.''
    Flutriafol is a member of the triazole-containing class of 
pesticides. Although conazoles act similarly in plants (fungi) by 
inhibiting ergosterol biosynthesis, there is not necessarily a 
relationship between their pesticidal activity and their mechanism of 
toxicity in mammals. Structural similarities do not constitute a common 
mechanism of toxicity. Evidence is needed to establish that the 
chemicals operate by the same, or essentially the same, sequence of 
major biochemical events. In conazoles, however, a variable pattern of 
toxicological responses is found; some are hepatotoxic and 
hepatocarcinogenic in mice. Some induce thyroid tumors in rats. Some 
induce developmental, reproductive, and neurological effects in 
rodents. Furthermore, the conazoles produce a diverse range of 
biochemical events including altered cholesterol levels, stress 
responses, and altered DNA methylation. It is not clearly understood 
whether these biochemical events are directly connected to their 
toxicological outcomes. Thus, there is currently no evidence to 
indicate that conazoles share common mechanisms of toxicity and EPA is 
not following a cumulative risk approach based on a common mechanism of 
toxicity for the conazoles. For information regarding EPA's procedures 
for cumulating effects from substances found to have a common mechanism 
of toxicity, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.
    Triazole-derived pesticides can form the metabolite 1,2,4-triazole 
(T) and two triazole conjugates triazolylalanine (TA) and 
triazolylacetic acid (TAA). To support existing tolerances and to 
establish new tolerances for triazole-derivative pesticides, EPA 
conducted an initial human-health risk assessment for exposure to T, 
TA, and TAA resulting from the use of all current and pending uses of 
any triazole-derived fungicide as of September 1, 2005. The risk 
assessment was a highly conservative, screening-level evaluation in 
terms of hazards associated with common metabolites (e.g., use of a 
maximum combination of uncertainty factors) and potential dietary and 
non-dietary exposures (i.e., high-end estimates of both dietary and 
non-dietary exposures). In addition, the Agency retained the additional 
10X Food Quality Protection Act (FQPA) safety factor (SF) for the 
protection of infants and children. The assessment included evaluations 
of risks for various subgroups, including those comprised of infants 
and children. The Agency's complete risk assessment can be found in the 
propiconazole reregistration docket at http://www.regulations.gov, 
docket ID number EPA-HQ-OPP-2005-0497 and an update to the aggregate 
human health risk assessment for free triazoles and its conjugates may 
be found in this current docket, docket ID number EPA-HQ-OPP-2013-0653-
0006 entitled ``Common Triazole Metabolites: Updated Aggregate Human 
Health Risk Assessment to Address The New Section 3 Registrations For 
Use of Propiconazole on Rapeseed Crop Subgroup 20 A; Use of 
Difenoconazole on Rapeseed Crop Subgroup 20 A; and Use of Tebuconazole 
on Imported Oranges.''

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. The potential impact of in 
utero and perinatal flutriafol exposure was investigated in three 
developmental toxicity studies (two in rats, one in rabbits) and 2 
multi-generation reproduction toxicity studies in rats. In the first of 
two rat developmental toxicity studies, increased quantitative 
susceptibility was observed with developmental effects (delayed 
ossification or non-ossification of the skeleton in the fetuses) seen 
at a lower dose than maternal effects. In the second rat developmental 
study, a qualitative susceptibility was noted. Although developmental 
toxicity occurred at the same dose level that elicited maternal 
toxicity, the developmental effects (external, visceral, and skeletal 
malformations; embryo lethality; skeletal variations; a generalized 
delay in fetal development; and fewer live fetuses) were more severe 
than the decreased food consumption and body-weight gains observed in 
the dams. For rabbits, there was in increased qualitative fetal 
susceptibly.

[[Page 5950]]

Intrauterine deaths occurred at a dose level that also caused adverse 
effects in maternal animals. In the 2-generation reproduction studies, 
a qualitative susceptibility was also seen. Effects in the offspring 
decreased litter size and percentage of live births (increased pup 
mortality) and liver toxicity can be attributed to the systemic 
toxicity of the parental animals (decreased body weight and food 
consumption and liver toxicity).
    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 flutriafol is complete.
    ii. There is no indication that flutriafol is a neurotoxic chemical 
and there is no need for a developmental neurotoxicity study or 
additional UFs to account for neurotoxicity. Signs of neurotoxicity 
were reported in the acute and subchronic neurotoxicity studies at the 
highest dose only; however, these effects were primarily seen in 
animals that were agonal (at the point of death) and, thus, are not 
indicative of neurotoxicity. In addition, there was no evidence of 
neurotoxicity in any additional short-term or long-term toxicity 
studies in rats, mice, and dogs.
    iii. There are no concerns or residential uncertainties for 
prenatal and/or postnatal toxicity. Although there is evidence for 
increased quantitative and qualitative susceptibility in the prenatal 
study in rats and rabbits and the 2-generation reproduction study rats, 
there are no concerns for the offspring toxicity observed in the 
developmental and reproductive toxicity studies for the following 
reasons:
     Clear NOAELs and LOAELs were established in the fetuses/
offspring for each of these studies:
     The dose-response for these effects are well-defined and 
characterized.
     Developmental endpoints are used for assessing acute 
dietary risks to the most sensitive population (females 13-49 years 
old) as well as all other short-and intermediate-term exposure 
scenarios.
     The chronic reference dose is greater than 300-fold lower 
than the dose at which the offspring effects were observed in the 2-
generation reproduction studies.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on 100 PCT and tolerance-level residues. EPA made conservative 
(protective) assumptions in the ground and surface water modeling used 
to assess exposure to flutriafol in drinking water. These assessments 
will not underestimate the exposure and risks posed by flutriafol.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide 
exposures are safe by comparing aggregate exposure estimates to the 
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA 
calculates the lifetime probability of acquiring cancer given the 
estimated aggregate exposure. Short-, intermediate-, and chronic-term 
risks are evaluated by comparing the estimated aggregate food, water, 
and residential exposure to the appropriate PODs to ensure that an 
adequate MOE exists.
    1. Acute risk. An acute aggregate risk assessment takes into 
account acute exposure estimates from dietary consumption of food and 
drinking water. Using the exposure assumptions discussed in this unit 
for acute exposure, the acute dietary exposure from food and water to 
flutriafol will occupy 44% 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 
flutriafol from food and water will utilize 74% of the cPAD for 
children 1-2 years old, the population group receiving the greatest 
exposure. Because there are no residential uses for flutriafol, the 
chronic aggregate risk includes food and drinking water only.
    3. Short-term and intermediate-term risk. Short- and intermediate-
term aggregate exposure takes into account short- and intermediate-term 
residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level). Since flutriafol is not 
registered for any use patterns that would result in residential 
exposure, the short- and intermediate-term aggregate risk is the sum of 
the risk.
    4. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, flutriafol is classified as ``not likely to be carcinogenic to 
humans.'' EPA does not expect flutriafol to pose a cancer risk.
    5. 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 flutriafol residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology gas chromotography/nitrogen/
phosphorus detector (GC/NPD) for the proposed tolerances is available 
to enforce the tolerances recommended herein. The method may be 
requested from: Chief, Analytical Chemistry Branch, Environmental 
Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone 
number: (410) 305-2905; email address: residuemethods@epa.gov.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint 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.
    There are no Codex MRLs for flutriafol in/on the proposed 
commodities.

C. Response to Comments

    EPA received one comment to the Notice of Filing that stated, in 
part, that no residue should be allowed for flutriafol. The Agency 
understands the commenter's concerns and recognizes that some 
individuals believe that pesticides should be banned on agricultural 
crops. However, the existing legal framework provided by FFDCA section 
408 states that tolerances may be set when persons seeking such 
tolerances or exemptions have demonstrated that the pesticide meets the 
safety standard imposed by that statute. This citizen's comment appears 
to be directed at the underlying statute and not EPA's implementation 
of it; the citizen has made no contention that EPA has acted in 
violation of the statutory framework.

[[Page 5951]]

D. Revisions to Petitioned-for Tolerances

    Based on the analysis of available field trial data and the 
Organisation for Economic Co-operation and Development (OECD) tolerance 
calculation procedure, EPA established a higher tolerance for cotton, 
gin byproducts than requested. For the same reason, EPA is granting a 
tolerance for vegetable, leafy, except Brassica, crop group 4, except 
head lettuce and radicchio and is not granting separate subgroup 
tolerances for leafy greens (subgroup 4A) except head lettuce and leaf 
petioles (subgroup 4B). Based on the proposed uses and the resulting 
livestock dietary burdens, EPA is setting a poultry, fat tolerance and 
is increasing tolerances for cattle, liver; goat, liver; horse, liver; 
sheep, liver; and milk. Based upon the previous explanation, EPA is 
establishing tolerances for poultry, meat byproducts below the level 
requested. Since residues in hog tissue were near the Limit of 
Quantification (LOQ), EPA determined that separate tolerances in or on 
hog liver and hog meat byproducts except liver were unnecessary and is 
establishing a tolerance in or on hog meat byproducts only. Although 
the petition requested that EPA remove a tolerance for hog meat 
byproducts, no such tolerance existed before this rule, so EPA could 
not remove it. A tolerance in or on hog, muscle was not established as 
it was granted as part of a previous tolerance petition (PP 3F8174) 
under docket ID numbers EPA-HQ-OPP-2013-0654 and EPA-HQ-OPP-2013-0655.

V. Conclusion

    Therefore, tolerances are established for residues of flutriafol, 
in or on Brassica, head and stem (subgroup 5A) at 1.5 ppm; Brassica, 
leafy greens (subgroup 5B) at 7.0 ppm; cotton, gin byproducts at 6.0 
ppm; cotton, undelinted seed at 0.50 ppm; egg at 0.01 ppm; grain, 
aspirated fractions at 6.0 ppm; hog, meat by products at 0.05 ppm; 
lettuce, head at 1.5 ppm; liver (cattle, goat, horse, sheep) at 1.0 
ppm; milk at 0.02 ppm; poultry, fat at 0.01 ppm; poultry, meat 
byproducts at 0.01 ppm; radicchio at 1.5 ppm; sorghum, grain forage at 
2.0 ppm; sorghum, grain, grain at 1.5 ppm; sorghum, grain, stover at 
6.0 ppm and vegetable, leafy, except Brassica, crop group 4, except 
head lettuce and radicchio at 10 ppm.
    Also, as a housekeeping measure, this regulation removes the 
entries for the tolerances contained in paragraph (b) of Sec.  180.629 
as those tolerances expired on December 31, 2014.

VI. Statutory and Executive Order Reviews

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

VII. Congressional Review Act

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

List of Subjects in 40 CFR Part 180

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

    Dated: January 28, 2015.
Susan T. 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.  180.629:
0
i. Add alphabetically the entries for ``Brassica, head and stem 
(subgroup 5A)''; ``Brassica, leafy greens (subgroup 5B)''; ``Cotton, 
gin byproducts''; ``Cotton, undelinted seed''; ``Egg''; ``Hog, meat 
byproducts''; ``Lettuce, head''; ``Poultry, fat''; ``Poultry, meat 
byproducts''; ``Radicchio''; ``Sorghum, grain, forage''; ``Sorghum, 
grain, grain''; ``Sorghum, grain, stover'' and ``Vegetable, leafy, 
except Brassica, crop group 4, except head lettuce and radicchio'' to 
the table in paragraph (a).
0
ii. Revise the entries for ``Cattle, liver''; ``Goat, liver''; ``Grain, 
aspirated fractions''; ``Horse, liver''; ``Milk''; and ``Sheep, liver'' 
in the table in paragraph (a).
0
iii. Revise paragraph (b).
    The amendments read as follows:

Sec.  180.629  Flutriafol; tolerances for residues.

    (a) General. * * *

[[Page 5952]]

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Brassica, head and stem (subgroup 5A)...................            1.5
Brassica, leafy greens (subgroup 5B)....................            7.0
 
                                * * * * *
Cattle, liver...........................................            1.0
 
                                * * * * *
Cotton, gin byproducts..................................            6.0
Cotton, undelinted seed.................................            0.50
 
                                * * * * *
Egg.....................................................            0.01
 
                                * * * * *
Goat, liver.............................................            1.0
 
                                * * * * *
Grain, aspirated fractions..............................            6.0
 
                                * * * * *
Hog, meat byproducts....................................            0.05
 
                                * * * * *
Horse, liver............................................            1.0
 
                                * * * * *
Lettuce, head...........................................            1.5
 
                                * * * * *
Milk....................................................            0.02
 
                                * * * * *
Poultry, fat............................................            0.01
Poultry, meat byproducts................................            0.01
Radicchio...............................................            1.5
 
                                * * * * *
Sheep, liver............................................            1.0
 
                                * * * * *
Sorghum, grain, forage..................................            2.0
Sorghum, grain, grain...................................            1.5
Sorghum, grain, stover..................................            6.0
 
                                * * * * *
Vegetable, leafy, except Brassica, crop group 4, except            10
 head lettuce and radicchio.............................
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
    (b) Section 18 emergency exemptions. [Reserved]
* * * * *
[FR Doc. 2015-02177 Filed 2-3-15; 8:45 am]
BILLING CODE 6560-50-P