[Federal Register Volume 79, Number 109 (Friday, June 6, 2014)]
[Rules and Regulations]
[Pages 32666-32673]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-13223]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2013-0654 and EPA-HQ-OPP-2013-0655; FRL-9910-38]


Flutriafol; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

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 June 6, 2014. Objections and 
requests for hearings must be received on or before August 5, 2014, 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-2013-0654 and EPA-HQ-OPP-2013-
0655, 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

[[Page 32667]]

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: Lois Rossi, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; 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 
the appropriate docket ID number, EPA-HQ-OPP-2013-0654 and/or EPA-HQ-
OPP-2013-0655, for the pesticide petition of interest 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 August 5, 2014. 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 the appropriate docket ID number, EPA-HQ-OPP-
2013-0654 and/or EPA-HQ-OPP-2013-0655, for the pesticide petition of 
interest 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 October 25, 2013 (78 FR 63938) (FRL-
9901-96), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 
U.S.C. 346a(d)(3), announcing the filing of pesticide petitions (PP 
3F8156; EPA-HQ-OPP-2013-0654) and (PP 3F8174; EPA-HQ-OPP-2013-0655) by 
Cheminova A/S, c/o Cheminova, Inc., 1600 Wilson Blvd., Suite 700, 
Arlington, VA 22209-2510. The petitions requested that 40 CFR 180.629 
amend the current established tolerances for residues of the fungicide 
flutriafol, including its metabolites and degradates, in or on corn, 
field, forage to 5 parts per million (ppm); corn, field, stover to 15 
ppm; corn, pop, stover to 15 ppm (PP 3F8156). The petitions also 
requested that the 40 CFR part 180 be amended by establishing 
tolerances for residues of the fungicide flutriafol, including its 
metabolites and degradates, in or on cattle, liver at 1.0 ppm; cattle, 
meat byproducts, except liver at 0. 10 ppm; cattle, muscle at 0.03 ppm; 
goat, liver at 1.0 ppm; goat, meat byproducts, except liver at 0.10 
ppm; goat, muscle at 0.03 ppm; horse, liver at 1.0 ppm; horse, meat 
byproducts, except liver at 0.10 ppm; horse, muscle at 0.03 ppm; milk 
at 0.01 ppm; sheep, liver at 1.0 ppm; sheep, meat byproducts, except 
liver at 0.10 ppm; sheep, muscle at 0.03 ppm (PP 3F8156); african tree 
nut at 0.015 ppm; almond, nutmeat at 0.6 ppm; almond, hulls at 15 ppm; 
brazil nut at 0.015 ppm; bur oak at 0.015 ppm; butternut at 0.015 ppm; 
cajon at 0.015 ppm; cashew at 0.015 ppm; castanha-do-maranhao at 0.015 
ppm; coconut at 0.015 ppm; coquito nut at 0.015 ppm; dika nut at 0.015 
ppm; guiana chestnut at 0.015 ppm; hazelnut at 0.015 ppm; heartnut at 
0.015 ppm; hickory nut at 0.015 ppm; Japanese horse-chestnut at 0.015 
ppm; macadamia nut at 0.015 ppm; mongongo nut at 0.015 ppm; monkey-pot 
at 0.015 ppm; pachira nut at 0.015 ppm; peanut, hay at 15 ppm; pecan at 
0.015 ppm; sapucaia nut at 0.015 ppm; strawberry at 1.5 ppm; tomato, 
paste at 1.5 ppm; triticale, grain at 0.10 ppm; vegetable, cucurbit, 
Group 9 at 0.20 ppm; vegetable, fruiting, Group 8-10 at 0.60 ppm; 
walnut, black at 0.015 ppm; walnut, English at 0.015 ppm; wheat, forage 
at 30 ppm; wheat, grain at 0.10 ppm; wheat, hay at 15 ppm; and wheat, 
straw at 9 ppm (PP 3F8174). The documents referenced a summary of the 
petitions prepared by Cheminova, Inc., the registrant, which is 
available in the docket, http://www.regulations.gov. There was one 
comment received in response to the notice of filings and is discussed 
in Unit IV.D.
    Based upon review of the data supporting the petitions, proposed 
tolerances for cattle, liver; cattle, meat by products, except liver; 
goat, liver; goat, meat by products, except liver; horse, liver; horse, 
meat by products, except liver; sheep, liver; and sheep, meat by 
products, except liver were lowered. The proposed tolerances for wheat, 
grain; pecan; african tree nut; brazil nut; bur oak, butternut, cajou; 
cashew; castanha-do-maranhao; coconut; coquito nut; dika nut; guiana 
chestnut; hazelnut; heartnut; hickory nut; japanese horse-chestnut; 
macadamia nut; mongongo nut; monkey-pot; pachira nut; sapucaia nut; 
walnut, black; walnut, english; vegetable, cucurbit, group 9; 
vegetable, fruiting, group 8-10; cattle, muscle; goat, muscle; horse, 
muscle; and sheep, muscle were increased. A tolerance for triticale, 
grain is not needed and so is not being established. On the other hand, 
EPA has determined that tolerances are needed for hog, fat and hog, 
muscle and accordingly are being established. The established 
tolerances for cattle, meat by products; goat, meat

[[Page 32668]]

by products; horse, meat by products; and sheep, meat by products are 
being removed. The reasons for these changes are explained in Unit 
IV.C.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue. . . 
.''
    Consistent with FFDCA section 408(b)(2)(D), and the factors 
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available 
scientific data and other relevant information in support of this 
action. EPA has sufficient data to assess the hazards of and to make a 
determination on aggregate exposure for 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 has high oral acute toxicity in the mouse. It has 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 any of the species tested. After over 1 year of 
exposure, hepatotoxicity in rats, dogs, and mice took the form of 
minimal to severe fatty changes; bile duct proliferation/
cholangiolarfibrosis; 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 were 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.
    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 most 
recent risk assessment, ``Flutriafol: Human-Health Risk Assessment for 
Tolerances in/on Field Corn, Popcorn, Peanut, Wheat, Strawberries, 
Cucurbit, Vegetables, Fruiting Vegetables, and Tree Nuts,'' which can 
be found at http://www.regulations.gov, under document ID number EPA-
HQ-OPP-2013-0654-0005 and EPA-HQ-2013-0655-0007.

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 shown in the following table.

   Table--Summary of Toxicological Doses and Endpoints for Flutriafol 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 13-49       NOAEL = 7.5 mg/kg/    Acute RfD = 0.075    Developmental Study--rabbit.
 years of age).                     day.                  mg/kg/day.          LOAEL = 15 mg/kg/day based on
                                   UFA = 10x...........  aPAD = 0.075 mg/kg/   decreased number of live fetuses,
                                   UFH = 10x...........   day.                 complete litter resorptions and
                                   FQPA SF = 1x........                        increased post-implantation loss.

[[Page 32669]]

 
Acute dietary (General population  NOAEL = 250 mg/kg/    Acute RfD = 2.5 mg/  Neurotoxicity screening battery--
 including infants and children).   day.                  kg/day.              rat.
                                   UFA = 10x...........  aPAD = 2.5 mg/kg/    LOAEL = 750 mg/kg/day based on
                                   UFH = 10x...........   day.                 decreased body weight, body-
                                   FQPA SF = 1x........                        weight gain, absolute and
                                                                               relative food consumption, and
                                                                               clinical signs of toxicity in
                                                                               both sexes: Dehydration, urine-
                                                                               stained abdominal fur, ungroomed
                                                                               coat, ptosis, decreased motor
                                                                               activity, prostration, limp
                                                                               muscle tone, muscle flaccidity,
                                                                               hypothermia, hunched posture,
                                                                               impaired or lost righting reflex,
                                                                               scant feces; in males: Red or tan
                                                                               perioral substance,
                                                                               chromodacryorrhea,
                                                                               chromorhinorrhea and labored
                                                                               breathing, and in females:
                                                                               Piloerection and bradypnea.
Chronic dietary (All populations)  NOAEL = 5 mg/kg/day   Chronic RfD = 0.05   Chronic toxicity--dog.
                                   UFA = 10x...........   mg/kg/day.          LOAEL = 20 mg/kg/day based on
                                   UFH = 10x...........  cPAD = 0.05 mg/kg/    adverse liver findings (increased
                                   FQPA SF = 1x........   day.                 liver weights, increased
                                                                               centrilobular hepatocyte lipid in
                                                                               the liver, and increases in
                                                                               alkaline phosphatase, albumin,
                                                                               and triglycerides), increased
                                                                               adrenal cortical vacuolation of
                                                                               the zona fasciculata, and marked
                                                                               hemosiderin pigmentation in the
                                                                               liver and spleen in both sexes;
                                                                               mild anemia (characterized by
                                                                               decreased hemoglobin, hematocrit,
                                                                               and red blood cell count) in the
                                                                               males; and initial body weight
                                                                               losses, decreased cumulative body-
                                                                               weight gains, and increased
                                                                               adrenal weights in the females.
Dermal short (1 to 30 days) and    NOAEL = 7.5 mg/kg/    Occupational LOC     Developmental toxicity--rabbit.
 Intermediate (1-6 months) Term.    day.                  for MOE = 100.      Developmental LOAEL = 15 mg/kg/day
                                    Dermal absorption                          based on decreased number of live
                                    factor = 21%\1\.                           fetuses, complete litter
                                   UFA = 10x...........                        resorptions, and increased post-
                                   UFH = 10x...........                        implantation loss.
Inhalation short (1 to 30 days)    NOAEL= 7.5 mg/kg/day  Occupational LOC     Developmental toxicity--rabbit.
 and Intermediate (1-6 months)     Inhalation toxicity    for MOE = 100.      Developmental LOAEL = 15 mg/kg/day
 Term.                              assumed to be                              based on decreased number of live
                                    equivalent to oral                         fetuses, complete litter
                                    toxicity.                                  resorptions, and increased post-
                                    Inhalation-                                implantation loss.
                                    absorption factor =
                                    100% \2\.
                                   UFA = 10x...........
                                   UFH = 10x...........
                                  ------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)  Classification: ``Not likely to be Carcinogenic to Humans'' based on the
                                    carcinogenicity studies in rats and mice.
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\1\ Dermal absorption factor was derived from the dermal penetration study.
\2\ Inhalation absorption factor is considered the worst-case scenario for inhalation exposure using an oral
  NOAEL.
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. 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 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's (USDA) National 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/recommended, the default 
processing factors for these commodities were reduced to 1. The 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 the 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

[[Page 32670]]

assessment and 100 PCT. Since adequate processing studies have been 
submitted which indicate that tolerances for residues in/on apple 
juice, dried prunes, grape juice, and tomato puree are unnecessary and 
since tolerances for residues in/on raisin and tomato paste tolerances 
are established/recommended, the default processing factors for these 
commodities were reduced to 1. The 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 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 flutriafol dietary exposure analysis 
and risk assessment. 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), 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 for cancer 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 and chronic dietary 
risk assessment, the water concentration value of 310 ppb and 202 ppb, 
respectively, were 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 (UFs)) 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-2013-0295 
entitled ``Common Triazole Metabolites: Updated Dietary (Food + Water) 
Exposure and Risk Assessment to Address the Revised Tolerance for 
Residues of Fenbuconazole in Peppers.'' Based on the triazole residue 
estimates resulting from the proposed uses for flutriafol, a revised 
triazole risk assessment is unnecessary.

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 two 
multi-generation reproduction toxicity studies in rats. In the first of 
two rat developmental toxicity studies, a quantitative susceptibility 
was observed (delayed ossification or non-ossification of the skeleton 
in the fetuses) at a lower dose than maternal effects. In the second 
rat developmental study, a qualitative susceptibility was noted. 
Although the developmental toxicity occurred at the same dose level 
that elicited maternal toxicity, the developmental effects (external, 
visceral, and skeletal malformations; embryo lethality

[[Page 32671]]

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, 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 studies in rats, mice, and 
dogs, or in the 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 in 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 31% 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 51% 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 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 from exposure 
to flutriafol through food and water and will not be greater than the 
chronic aggregate 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.
    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 Chromatography/Nitrogen/
Phosphorus detector (GC/NPD) for proposed tolerances) 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.
    There are no Canadian or Mexican MRLs for flutriafol in/on the 
proposed commodities with the exception for peanut hay; dried chili 
peppers; sweet peppers; wheat straw; wheat grain and wheat bran. The 
Codex has established MRLs for flutriafol in or on dried chili peppers 
at 10 ppm; peanut, hay at 20 ppm; sweet peppers at 1 ppm; wheat, bran 
at 0.3 ppm; wheat, grain at 0.15 ppm; and wheat, straw at 8 ppm. Wheat, 
bran and wheat, grain MRLs are the same as the tolerances being 
established for flutriafol in the United States. The Agency is 
establishing tolerances for vegetable, fruiting, group 8-10 at 1.0 ppm 
to harmonize with the Codex sweet pepper MRL.

[[Page 32672]]

    Harmonization of the peanut, hay and wheat, straw tolerances were 
determined to be unnecessary as these commodities do not normally enter 
international commerce.

C. Revisions to Petitioned-For Tolerances

    Based on an analysis of feeding studies and on the livestock 
maximum reasonable dietary burdens, EPA is establishing tolerances for 
hog, fat and hog, muscle and establishing lower tolerances than those 
proposed by the petitioner for cattle, liver; cattle, meat by products, 
except liver; goat, liver; goat, meat by products, except liver; horse, 
liver; horse, meat by products, except liver; sheep, liver; and sheep, 
meat by products, except liver. For the same reason EPA is establishing 
higher tolerance than those proposed by the petitioner for cattle, 
muscle; goat, muscle; horse, muscle; and sheep, muscle.
    EPA established higher tolerance than those proposed by the 
petitioner for African tree nut; brazil nut; bur oak, butternut, cajou; 
cashew; castanha-do-maranhao; coconut; coquito nut; dika nut; guiana 
chestnut; hazelnut; heartnut; hickory nut; Japanese horse-chestnut; 
macadamia nut; mongongo nut; monkey-pot; pachira nut; sapucaia nut; 
vegetable, cucurbit, group 9; walnut, black; walnut, english and wheat, 
grain based upon the analysis of residue levels from crop field trial 
data and the Organization for Economic Cooperation Development (OECD) 
tolerance calculation procedure. The proposed tolerance for triticale 
is unnecessary because triticale is covered by the wheat tolerances. As 
the petitioned for tolerances for liver and meat byproducts of cattle, 
goat, horse, and sheep, replace meat byproducts tolerances for cattle, 
goat, horse, and sheep, the latter tolerances are being removed.

D. Response to Comments

    EPA received one comment to the Notice of Filing that stated, in 
part, that no residues or increase in residues should be allowed for 
flutriafol. No additional data was provided by the commenter for Agency 
review. 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. As is the case 
with almost all conventional pesticides, numerous tests have been 
performed to study the toxicological effects of flutriafol. The various 
tests use doses that range from quite low to many times higher than 
virtually any member of the population of the United States could ever 
be exposed to. The highest doses are, in fact, deliberately chosen to 
try to elicit toxicological symptoms because a description of these 
symptoms and the dose levels at which they occur is one of the desired 
outcomes of the studies. Virtually any chemical (vitamins, for example) 
is toxic if taken in excessively large doses. Risk, however, is a 
function of the exposure levels that actually occur in the population 
in comparison to the threshold exposure level at which adverse symptoms 
begin to be elicited. For a toxicologically average person, if actual 
exposure is less than the adverse symptom exposure threshold, no such 
symptoms are expected to be seen. However, in order to make the 
reasonable certainty of no harm determination the Agency requires more 
assurance than this that the use of animals (instead of humans) for 
testing, variations in susceptibility among members of the U.S. 
population, greater sensitivity of infants and children, etc., has been 
accounted for in the risk assessment process. Therefore, safety factors 
are used in conjunction with dosing levels at which no or only the 
first symptoms of exposure to the pesticide were seen to provide a 
substantial additional margin of safety. This mechanism helps assure 
that toxicological symptoms will not be elicited in members of the U.S. 
population by beneficial, labeled uses of the pesticide. The fact that 
very high doses of a pesticide cause toxicological symptoms is not, by 
itself, enough to make approval of uses of that pesticide unreasonable.

V. Conclusion

    Therefore, tolerances are established for residues of flutriafol, 
in or on African tree nut at 0.02 ppm; Almond at 0.60 ppm; Almond hull 
at 15 ppm; Brazil nut at 0.02 ppm; Butternut at 0.02 ppm; Bur oak at 
0.02 ppm; Cajou at 0.02 ppm; Cashew at 0.02 ppm; Castanha-Do-Maranhao 
at 0.02 ppm; Cattle, fat at 0.05 ppm; Cattle, liver at 0.80 ppm; 
Cattle, meat by products, except liver at 0.05 ppm; Cattle, muscle at 
0.05 ppm; Coconut at 0.02 ppm; Coquito nut at 0.02 ppm; Corn, field, 
forage at 5.0 ppm; Corn, field, stover to 15 ppm; Corn, pop, stover to 
15 ppm; Dika nut at 0.02 ppm; Guiana chestnut at 0.02 ppm; Goat, fat at 
0.05 ppm; Goat liver at 0.80 ppm; Goat, meat byproducts, except liver 
at 0.05 ppm; Goat, muscle at 0.05 ppm; Hazelnut at 0.02 ppm; Heartnut 
at 0.02 ppm; Hickory nut at 0.02 ppm; Hog, fat at 0.01 ppm; Hog, muscle 
at 0.01 ppm; Horse, fat at 0.05 ppm; Horse, liver at 0.80 ppm; Horse, 
meat byproducts, except liver at 0.05 ppm; Horse, muscle at 0.05 ppm; 
Japanese horse-chestnut at 0.02 ppm; Macadamia nut at 0.02 ppm; Milk at 
0.01 ppm; Mongongo nut at 0.02 ppm; Monkey-pot at 0.02 ppm; Pachira nut 
at 0.02 ppm; Peanut, hay at 15 ppm; Pecan at 0.02 ppm; Sapucaia nut at 
0.02 ppm; Sheep, fat at 0.05 ppm; Sheep, liver at 0.80 ppm; Sheep, meat 
byproducts, except liver at 0.05 ppm; Sheep, muscle at 0.05 ppm; 
Strawberry at 1.5ppm; Tomato, paste at 1.5 ppm; Vegetable, cucurbit, 
group 9 at 0.30 ppm; Vegetable, fruiting, group 8-10 at 1.0 ppm; 
Walnut, black at 0.02 ppm; Walnut, English at 0.02 ppm; Wheat, bran at 
0.30 ppm; Wheat, forage at 30 ppm; Wheat, germ at 0.25 ppm; Wheat, 
grain at 0.15 ppm; Wheat, hay at 15 ppm; and Wheat, straw at 9.0 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 tolerance in this 
final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory

[[Page 32673]]

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: June 2, 2014.
Lois Rossi,
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, revise the table in paragraph (a) to read as 
follows:


Sec.  180.629  Flutriafol; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
African tree nut...........................................         0.02
Almond.....................................................         0.60
Almond, hull...............................................        15
Banana \1\.................................................         0.30
Beet sugar.................................................         0.08
Brazil nut.................................................         0.02
Bur oak....................................................         0.02
Butternut..................................................         0.02
Cajou......................................................         0.02
Cashew.....................................................         0.02
Castanha-do-maranhao.......................................         0.02
Cattle, fat................................................         0.05
Cattle, liver..............................................         0.80
Cattle, meat byproducts, except liver......................         0.05
Cattle, muscle.............................................         0.05
Coconut....................................................         0.02
Coffee, green, bean \1\....................................         0.15
Coffee, instant \1\........................................         0.30
Coquito nut................................................         0.02
Corn, field, forage........................................         5.0
Corn, field, grain.........................................         0.01
Corn, field, refined oil...................................         0.02
Corn, field, stover........................................        15
Corn, pop..................................................         0.01
Corn, pop, stover..........................................        15
Dika nut...................................................         0.02
Fruit, pome, group 11-09...................................         0.40
Fruit, stone, group 12-10..................................         1.5
Goat, fat..................................................         0.05
Goat, liver................................................         0.80
Goat, meat byproducts, except liver........................         0.05
Goat, muscle...............................................         0.05
Grain, aspirated fractions.................................         2.2
Grape......................................................         1.5
Grape, raisin..............................................         2.4
Guiana chestnut............................................         0.02
Hazelnut...................................................         0.02
Heartnut...................................................         0.02
Hickory nut................................................         0.02
Hog, fat...................................................         0.01
Hog, muscle................................................         0.01
Horse, fat.................................................         0.05
Horse, liver...............................................         0.80
Horse, meat byproducts, except liver.......................         0.05
Horse, muscle..............................................         0.05
Japanese horse-chestnut....................................         0.02
Macadamia nut..............................................         0.02
Milk.......................................................         0.01
Mongongo nut...............................................         0.02
Monkey-pot.................................................         0.02
Pachira nut................................................         0.02
Peanut.....................................................         0.09
Peanut, hay................................................        15
Pecan......................................................         0.02
Sapucaia nut...............................................         0.02
Sheep, fat.................................................         0.05
Sheep, liver...............................................         0.80
Sheep, meat byproducts, except liver.......................         0.05
Sheep, muscle..............................................         0.05
Soybean, seed..............................................         0.35
Strawberry.................................................         1.5
Tomato, paste..............................................         1.5
Vegetable, cucurbit, group 9...............................         0.30
Vegetable, fruiting, group 8-10............................         1.0
Walnut, black..............................................         0.02
Walnut, English............................................         0.02
Wheat, bran................................................         0.30
Wheat, forage..............................................        30
Wheat, germ................................................         0.25
Wheat, grain...............................................         0.15
Wheat, hay.................................................        15
Wheat, straw...............................................         9.0
------------------------------------------------------------------------
\1\ There are no U.S. registrations as of October 22, 2013.

* * * * *
[FR Doc. 2014-13223 Filed 6-5-14; 8:45 am]
BILLING CODE 6560-50-P