[Federal Register Volume 80, Number 222 (Wednesday, November 18, 2015)]
[Rules and Regulations]
[Pages 71947-71952]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-29462]


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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2015-0179; FRL-9933-61]


Flutriafol; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes a tolerances for residues of 
flutriafol in or on hop, dried cones. Cheminova A/S, c/o Cheminova, 
Inc. requested this tolerances under the Federal Food, Drug, and 
Cosmetic Act (FFDCA). Additionally, tolerances are being removed that 
were inadvertently returned from an earlier Final rule.

DATES: This regulation is effective November 18, 2015. Objections and 
requests for hearings must be received on or before January 19, 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-2015-0179, 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-2015-0179 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 
January 19, 2016. 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-2015-0179, 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.

[[Page 71948]]

II. Summary of Petitioned-for Tolerance and This Action

    In the Federal Register of April 22, 2015 (80 FR 22466) (FRL-9925-
79), 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 
4F8294) by Cheminova Inc., c/o Cheminova A/S, 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, (()-[alpha]-(2-fluorophenyl)-[alpha]-
(4-fluorophenyl)-1H-1,2,4-triazole-1-ethanol), in or on hops, dried 
cones at 20 parts per million (ppm). That document referenced a summary 
of the petition prepared by Cheminova Inc., c/o Cheminova A/S, the 
registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the 
notice of filing. For purposes of accuracy, the Agency notes that a 
harmless error was made in the notice of filing publication and is 
correcting that misstatement here: The petition was actually filed by 
Cheminova A/S, c/o Cheminova, Inc.
    Additionally, in the Federal Register of February 4, 2015 (80 FR 
5946) (FRL-9922-06) EPA established tolerances for residues of 
flutriafol, in or on several commodities, including cotton, gin 
byproducts at 6.0 ppm and cotton, undelinted seed at 0.50 ppm. When 
establishing the general tolerances in paragraph (a) for cotton, gin 
byproducts at 6.0 ppm and cotton, undelinted seed at 0.50 ppm, EPA 
inadvertently forgot to remove the existing tolerances for cotton, gin 
byproducts at 0.02 ppm and cotton, undelinted seed at 0.01 ppm from the 
table in paragraph (d) for Indirect or inadvertent residues. These 
indirect tolerances were made redundant by the establishment of the 
tolerances in the General section at a higher level for the same 
commodities. Therefore, EPA is removing the cotton, gin byproducts and 
cotton, undelinted seed tolerances established in Sec.  180.629(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 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. Consistent with the mammalian toxicity profiles of the other 
triazole fungicides, the prevalent adverse effects following oral 
exposure to flutriafol were in the liver. Effects consisted of 
increases in liver enzyme release (alkaline phosphatase), liver 
weights, and histopathology findings (hepatocyte vacuolization to 
centrilobular hypertrophy and slight increases in hemosiderin-laden 
Kupffer cells, minimal to severe fatty changes, and bile duct 
proliferation/cholangiolar fibrosis). Progression of toxicity occurred 
with time as some effects were only observed at chronic durations.
    Slight indications of effects in the hematopoietic system were 
sporadically seen in all species consisting of slight anemia, increased 
platelets, white blood cells, neutrophils, and lymphocytes. The effects 
in the neurotoxicity screening batteries were observed only at higher 
doses and were considered secondary effects (decreased motor activity 
and hindlimb grip strength, ptosis, lost righting reflex, hunched 
posture, and ataxia). Flutriafol showed no evidence of dermal toxicity, 
or immunotoxicity. Flutriafol showed no evidence of carcinogenicity in 
rodents or in vitro.
    There is evidence of increased quantitative and qualitative pre- 
and postnatal susceptibility for flutriafol in rats and rabbits. In the 
first of two rat developmental toxicity studies, developmental effects 
(delayed ossification or non-ossification of the skeleton in the 
fetuses) were observed at a lower dose than that where maternal effects 
were observed. In the second rat developmental study, 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 
at the same dose. For rabbits, intrauterine deaths occurred at a dose 
level that also caused adverse effects in maternal animals. In the 2-
generation reproduction studies, 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) observed at the same dose.
    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.
    Flutriafol is considered to be ``Not likely to be Carcinogenic to 
Humans'' based on the results of the carcinogenicity studies in rats 
and mice. The results of the rat chronic toxicity/carcinogenicity study 
and the mouse carcinogenicity study are negative for carcinogenicity. 
All genotoxicity studies on flutriafol showed no evidence of 
clastogenicity or mutagenicity.
    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).

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

[[Page 71949]]

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 the NOAEL and the 
LOAEL are identified. 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 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 raisin and tomato paste tolerances 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.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA NHANES/
WWEIA conducted from 2003-2008. As to residue levels in food, EPA made 
the following 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 raisin and tomato paste tolerances 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.
    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 percent crop treated (PCT) information. 
EPA did not use anticipated residue and/or PCT information in the 
dietary assessment for flutriafol. Tolerance-level residues and/or 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 in drinking water. 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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
    Based on the First Index Reservoir Screening Tool (FIRST), and 
Pesticide Root Zone Model Ground Water (PRZM GW), the estimated 
drinking water concentrations (EDWCs) of flutriafol for acute exposures 
are estimated to be 15.9 parts per billion (ppb) for surface water and 
193 ppb for ground water.
    For chronic exposures assessments the EDWC's are estimated to be 
5.39 ppb for surface water and 165 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 193 ppb was used to assess 
the contribution to drinking water. For chronic dietary risk 
assessment, the water concentration of value 165 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

[[Page 71950]]

from substances found to have a common mechanism of toxicity, see EPA's 
Web site at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.
    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 risk 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.
    The most recent update to that aggregate human health risk 
assessment for free traizoles and its conjugates was conducted on April 
9, 2015. This assessment considered all proposed/registered triazole 
derived pesticides uses with the resulting risk less than the Agency's 
level of concern. 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-2015-0179-0014 entitled, 
``Common Triazole Metabolites: Updated Aggregate Human Health Risk 
Assessment to Address The New Section 3 Registrations for Use of 
Propiconazole on Tea, Dill, Mustard Greens, Radish, and Watercress; Use 
of Difenoconazole on Globe Artichoke, Ginseng and Greenhouse Grown 
Cucumbers and Conversation of the Established Foliar Uses/Tolerances 
for Stone Fruit and Tree Nut Crop Groups to Fruit, Stone, Group 12-12 
and the Nut, Tree, Group 14-12.; and Use of Flutriafol on Hops.''

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 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. 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 residual 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: (1) clear NOAELs and LOAELs were established in the fetuses/
offspring for each of these studies; (2) the dose-response for these 
effects are well-defined and characterized; (3) 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; (4) the acute reference dose for 
females 13-49 is 1,000 fold lower than the dose at which quantitative 
susceptibility in the first developmental rat study was observed; and 
(5) 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. 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.

[[Page 71951]]

    1. Acute risk. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food and water 
to flutriafol will occupy 39% of the aPAD for females 13-49 years, the 
population group receiving the greatest % aPAD.
    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 96% of the cPAD for 
children 1-2 years old, the population group receiving the greatest 
exposure. There are no residential uses for flutriafol.
    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 
is no short-term residential exposure, and chronic dietary exposure has 
already been assessed under the appropriately protective cPAD (which is 
at least as protective as the POD used to assess short-term risk), no 
further assessment of short-term risk is necessary, and EPA relies on 
the chronic dietary risk assessment for evaluating short-term risk for 
flutriafol.
    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 is no intermediate-term residential exposure, and 
chronic dietary exposure has already been assessed under the 
appropriately protective cPAD (which is at least as protective as the 
POD used to assess short-term risk), no further assessment of 
intermediate-term risk is necessary, and EPA relies on the chronic 
dietary risk assessment for evaluating intermediate-term risk for 
flutriafol.
    5. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, flutriafol 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 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 is available to enforce 
the tolerance expression.
    The method may be requested from: Chief, Analytical Chemistry 
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 
20755-5350; telephone number: (410) 305-2905; email address: 
[email protected].

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint United Nations 
Food and Agriculture Organization/World Health Organization food 
standards program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level.
    The Codex has not established a MRL for flutriafol.

V. Conclusion

    Therefore, tolerances are established for residues of flutriafol, 
(()-[alpha]-(2-fluorophenyl)-[alpha]-(4-fluorophenyl)-1H-
1,2,4-triazole-1-ethanol), in or on hop, dried cones at 20 ppm. 
Additionally, the tolerances for cotton, gin byproducts, and cotton, 
undelinted seed established in 180.629(d) are being removed.

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 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

[[Page 71952]]

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: November 10, 2015.
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.  180.629:
0
a. Add alphabetically the commodity ``Hop, dried cones'' to the table 
in paragraph (a).
0
b. Remove the commodities ``Cotton, gin byproducts,'' and ``Cotton, 
undelinted seed'' from the table in paragraph (d).
    The addition reads as follows:


Sec.  180.629  Flutriafol; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                            Parts per
                       Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Hop, dried cones.......................................              20
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2015-29462 Filed 11-17-15; 8:45 am]
 BILLING CODE 6560-50-P