[Federal Register Volume 80, Number 145 (Wednesday, July 29, 2015)]
[Rules and Regulations]
[Pages 45073-45078]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-18544]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2012-0638; FRL-9930-73]


Fluxapyroxad; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
fluxapyroxad in or on cotton, gin byproducts and cotton, undelinted 
seed. BASF Corporation requested these tolerances under the Federal 
Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective July 29, 2015. Objections and 
requests for hearings must be received on or before September 28, 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-2012-0638, 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. To access the OCSPP 
test guidelines referenced in this document electronically, please go 
to http://www.epa.gov/ocspp and select ``Test Methods and Guidelines.''

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

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2012-0638 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 
September 28, 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-2012-0638, 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),

[[Page 45074]]

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 4F8270) 
by BASF Corporation, 26 Davis Drive, Research Triangle Park, NC 27709. 
The petition requested that 40 CFR 180.666 be amended by establishing 
tolerances for residues of the fungicide fluxapyroxad (BAS 700 F), 3-
(difluoromethyl)-1-methyl-N-(3',4',5'-trifluoro[1,1'-biphenyl]-2-yl)-
1H-pyrazole-4-carboxamide, its metabolites, and degradates, in or on 
cotton, gin byproducts at 20 parts per million (ppm); cotton undelinted 
seed at 0.30 ppm. That document referenced a summary of the petition 
prepared by BASF Corporation, the registrant, which is available in the 
docket, http://www.regulations.gov. There were no comments received in 
response to the notice of filing

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 fluxapyroxad including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with fluxapyroxad 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.
    Fluxapyroxad is of low acute toxicity by the oral, dermal and 
inhalation routes, is not irritating to the eyes and skin, and is not a 
dermal sensitizer. The primary target organ for fluxapyroxad exposure 
via the oral route is the liver with secondary toxicity in the thyroid 
for rats only. Liver toxicity was observed in rats, mice, and dogs, 
with rats as the most sensitive species for all durations of exposure. 
In rats, adaptive effects of hepatocellular hypertrophy and increased 
liver weights and changes in liver enzyme activities were first 
observed. As the dose or duration of exposure to fluxapyroxad 
increased, clinical chemistry changes related to liver function also 
occurred, followed by hepatocellular necrosis, neoplastic changes in 
the liver, and tumors. Thyroid effects were observed only in rats. 
These effects were secondary to changes in liver enzyme regulation, 
which increased metabolism of thyroid hormone, resulting in changes in 
thyroid hormones, thyroid follicular hypertrophy and hyperplasia, and 
thyroid tumor formation. Tumors were not observed in species other than 
rats or in organs other than the liver and thyroid.
    Fluxapyroxad is classified as ``Not likely to be Carcinogenic to 
Humans'' based on convincing evidence that carcinogenic effects are not 
likely below a defined dose range. There is no mutagenicity concern 
from in vivo or in vitro assays. The hypothesized mode of action (i.e., 
a non-genotoxic) for treatment related tumors (i.e., the liver and 
thyroid) was supported by a full panel of in vitro and in vivo studies 
that showed no evidence of genotoxicity, together with mechanistic 
studies in the liver and thyroid of rats that satisfied stringent 
criteria for establishing tumorgenic modes of action. The studies 
clearly identified the sequence of key events, dose-response 
concordance and temporal relationship to the tumor types. The Agency 
has determined that the chronic population adjusted dose (PAD) will 
adequately account for all chronic effects, including carcinogenicity 
that could result from exposure to fluxapyroxad because the points of 
departure (POD) for the chronic population adjusted dose (cPAD) is 
based on the most sensitive endpoint, liver effects. Effects in the 
liver preceded liver tumors and the effects observed in the thyroid (in 
rats only) were believed to be secondary to the liver effects.
    No evidence of neurotoxicity was observed in response to repeated 
administration of fluxapyroxad. An acute neurotoxicity study showed 
decreased rearing and motor activity. This occurred on the day of 
dosing only and in the absence of histopathological effects or 
alterations in brain weights. This indicated that any neurotoxic 
effects of fluxapyroxad are likely to be transient and reversible due 
to alterations in neuropharmacology and not from neuronal damage. There 
were no neurotoxic effects observed in the subchronic dietary toxicity 
study. No evidence of reproductive toxicity was observed. Developmental 
effects observed in both rats and mice (thyroid follicular hypertrophy 
and hyperplasia in rats and decreased defecation, food consumption, 
body weight/body weight gain, and increased litter loss in rabbits) 
occurred at the same doses as those that caused adverse effects in 
maternal animals, indicating no quantitative susceptibility. Since the 
maternal toxicities of thyroid hormone perturbation in rats and 
systemic toxicity in rabbits likely contributed to the observed 
developmental effects there is low concern for qualitative 
susceptibility. An immunotoxicity study in mice showed no evidence of 
immunotoxic effects from fluxapyroxad.
    Subchronic oral toxicity studies in rats, developmental toxicity 
studies in rabbits, and in vitro and in vivo genotoxicity studies were 
performed for fluxapyroxad metabolites F700F001, M700F002, and 
M700F048. Like fluxapyroxad, no genotoxic effects were observed for any 
of these metabolites. All three metabolites displayed lower subchronic 
toxicity via the oral route than fluxapyroxad, with evidence of non-
specific toxicity (decreased body weight) observed only for M700F0048 
at the limit dose. Only M700F0048 exhibited developmental toxicity at 
doses similar to those that caused developmental effects in rabbits 
with fluxapyroxad treatment. However, these effects (abortions and 
resorptions) were of a different nature than for fluxapyroxad (paw 
hyperflexion) and are considered secondary to maternal toxicity. The 
Agency considers these studies sufficient for hazard identification and 
characterization and concludes that these metabolites do not have 
hazards that exceed those of fluxapyroxad in nature, severity, or 
potency.
    Specific information on the studies received and the nature of the 
adverse effects caused by fluxapyroxad as well as the no-observed-
adverse-effect-level

[[Page 45075]]

(NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the 
toxicity studies can be found at http://www.regulations.gov in 
document, ``Human Health Risk Assessment for Use of Fluxapyroxad on 
Numerous Crops'' at pp. 52 in docket ID number EPA-HQ-OPP-2012-0638.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological 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 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 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 chemical name used for 
human risk assessment is shown in Table 1 of this unit.

 Table 1--Summary of Toxicological Doses and Endpoints for Fluxapyroxad 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 (General population  NOAEL = 125 mg/kg/    Acute RfD = 1.25 mg/ Acute neurotoxicity study in rats
 including infants and children,    day.                  kg/day.             LOAEL = 500 mg/kg/day based on
 and females 13-49 years of age).  UFA = 10x...........  aPAD = 1.25 mg/kg/    decreased motor activity and
                                   UFH = 10x...........   day.                 decreased rearing.
                                   FQPA SF = 1x........
Chronic dietary (All populations)  NOAEL = 2.1 mg/kg/    Chronic RfD = 0.021  Chronic toxicity/carcinogenicity
                                    day.                  mg/kg/day.           study in rats
                                   UFA = 10x...........  cPAD = 0.021 mg/kg/  LOAEL = 11 mg/kg/day based on non-
                                   UFH = 10x...........   day.                 neoplastic changes in the liver
                                   FQPA SF = 1x........                        (foci, masses).
Incidental oral short-term (1 to   NOAEL = 9 mg/kg/day.  LOC for MOE = 100..  28-day oral toxicity study in rats
 30 days).                         UFA = 10x...........                       LOAEL = 176 mg/kg/day based on
                                   UFH = 10x...........                        changes in thyroid hormones and
                                   FQPA SF = 1x........                        thyroid follicular hypertrophy/
                                                                               hyperplasia.
Inhalation short-term (1 to 30     NOAEL= 9 mg/kg/day..  LOC for MOE = 100..  28-day oral toxicity study in rats
 days).                            UFA = 10x...........                       LOAEL = 176 mg/kg/day based on
                                   UFH = 10x...........                        changes in thyroid hormones and
                                   FQPA SF = 1x........                        thyroid follicular hypertrophy/
                                                                               hyperplasia.
                                  ------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)  Classification: Not likely to be carcinogenic to humans at doses sufficient
                                    to induce liver and/or thyroid tumors. Quantification of risk using a non-
                                    linear approach (i.e., RfD) will adequately account for all chronic
                                    toxicity, including carcinogenicity.
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
  level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor.
  UFA = extrapolation from animal to human (interspecies). UFDB = to account for the absence of data or other
  data deficiency. UFH = potential variation in sensitivity among members of the human population
  (intraspecies). UFL = use of a LOAEL to extrapolate a NOAEL. UFS = use of a short-term study for long-term
  risk assessment.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to fluxapyroxad, EPA considered exposure under the petitioned-
for tolerances as well as all existing fluxapyroxad tolerances in 40 
CFR 180.666. EPA assessed dietary exposures from fluxapyroxad 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 fluxapyroxad. In estimating acute dietary exposure, EPA used food 
consumption information from the United States Department of 
Agriculture (USDA) 2003-2008 National Health and Nutrition Examination 
Survey, What We Eat in America (NHANES/WWEIA). As to residue levels in 
food, EPA used tolerance-level residues adjusted upward to account for 
metabolites of concern not included in the tolerance expression, 100 
percent crop treated (PCT) assumptions, and dietary exposure evaluation 
model (DEEM) default and empirical processing factors.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA 2003-2008 
NHANES/WWEIA. As to residue levels in food, a moderately refined 
chronic dietary exposure analysis was performed. An assumption of 100 
PCT and DEEM default and empirical processing factors were used for the 
chronic dietary analysis. Combined average field-trial residues for 
parent and highest field-trial residues for metabolites of concern were 
used for all plant commodities. For livestock commodities tolerance-
level residues adjusted upward to account for

[[Page 45076]]

metabolites of concern not included in the tolerance expression were 
used.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that a nonlinear RfD approach is appropriate for assessing 
cancer risk to fluxapyroxad. Cancer risk was assessed using the same 
exposure estimates as discussed in Unit III.C.1.ii., chronic exposure.
    iv. Anticipated residue and percent crop treated (PCT) information. 
Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and 
information on the anticipated residue levels of pesticide residues in 
food and the actual levels of pesticide residues that have been 
measured in food. If EPA relies on such information, EPA must require 
pursuant to FFDCA section 408(f)(1) that data be provided 5 years after 
the tolerance is established, modified, or left in effect, 
demonstrating that the levels in food are not above the levels 
anticipated. For the present action, EPA will issue such data call-ins 
as are required by FFDCA section 408(b)(2)(E) and authorized under 
FFDCA section 408(f)(1). Data will be required to be submitted no later 
than 5 years from the date of issuance of these tolerances.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for fluxapyroxad in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of fluxapyroxad. 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 Tier 1 Rice Model and the Pesticide Root Zone Model 
Ground Water (PRZM GW), the estimated drinking water concentrations 
(EDWCs) of fluxapyroxad for acute exposures are estimated to be 127 
parts per billion (ppb) for surface water and 203 ppb for ground water. 
The EDWCs for chronic exposures for non-cancer assessments are 
estimated to be 127 ppb for surface water and 184 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 203 ppb was used to assess 
the contribution to drinking water. For chronic dietary risk 
assessment, the water concentration of value 184 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). Fluxapyroxad is 
currently registered for the following uses that could result in 
residential exposures: Residential turf. EPA assessed residential 
exposure using the following assumptions: Residential handler exposures 
are expected to be short-term (1 to 30 days) via either the dermal or 
inhalation routes of exposures. Intermediate-term exposures are not 
likely because of the intermittent nature of applications by 
homeowners. Since no dermal hazard was identified for fluxapyroxad, 
MOEs were calculated for the inhalation route of exposure only.
    Both adults and children may be exposed to fluxapyroxad residues 
from contact with treated lawns. Adult post-application exposures were 
not quantitatively assessed since no dermal hazard was identified for 
fluxapyroxad and inhalation exposures are typically negligible in 
outdoor settings. The exposure assessment for children included 
incidental oral exposure resulting from transfer of residues from the 
hands or objects to the mouth, and from incidental ingestion of soil. 
Post-application hand-to-mouth and object-to-mouth exposures are 
expected to be short-term (1 to 30 days) in duration due to the 
intermittent nature of applications in residential environments. 
Further information regarding EPA standard assumptions and generic 
inputs for residential exposures may be found at http://www.epa.gov/pesticides/trac/science/trac6a05.pdf.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    EPA has not found fluxapyroxad to share a common mechanism of 
toxicity with any other substances, and fluxapyroxad does not appear to 
produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
fluxapyroxad does not have a common mechanism of toxicity with other 
substances. For information regarding EPA's efforts to determine which 
chemicals have a common mechanism of toxicity and to evaluate the 
cumulative effects of such chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.

 D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the Food Quality 
Protection Act Safety Factor (FQPA SF). In applying this provision, EPA 
either retains the default value of 10X, or uses a different additional 
safety factor when reliable data available to EPA support the choice of 
a different factor.
    2. Prenatal and postnatal sensitivity. No evidence of quantitative 
susceptibility was observed in a reproductive and developmental 
toxicity study in rats or in developmental toxicity studies in rats and 
rabbits. Developmental toxicity data in rats showed decreased body 
weight and body weight gain in the offspring at the same dose levels 
that caused thyroid follicular hypertrophy/hyperplasia in parental 
animals. Effects in rabbits were limited to paw hyperflexion, a 
malformation that is not considered to result from a single exposure 
and that usually reverses as the animal matures. Developmental effects 
observed in both rats and rabbits occurred at the same doses as those 
that caused adverse effects in maternal animals, indicating no 
quantitative susceptibility. The Agency has low concern for 
developmental toxicity because the observed effects were of low 
severity, were likely secondary to maternal toxicity, and demonstrated 
clear NOAELs. Further, the NOAELs for these effects were at dose levels 
higher than the points of departure selected for risk assessment for 
repeat-exposure scenarios. Therefore, based on the available data and 
the selection of risk assessment endpoints that are protective of 
developmental effects, there are no residual uncertainties with regard 
to pre- and/or postnatal 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 fluxapyroxad is complete. Although no 
subchronic inhalation data is available,

[[Page 45077]]

EPA has waived that data requirement based on, among other things, its 
conclusion that even if an additional 10X safety factor was applied, 
inhalation exposure would not raise a risk of concern.
    ii. There is no indication that fluxapyroxad is a neurotoxic 
chemical and there is no need for a developmental neurotoxicity study 
or additional UFs to account for neurotoxicity. Neither the acute nor 
the subchronic neurotoxicity studies indicated specific neurotoxicity 
responses to fluxapyroxad. Because fluxapyroxad can disrupt thyroid 
hormone levels, the Agency considered the potential for fluxapyroxad to 
cause developmental neurotoxicity as a result of thyroid hormone 
disruption, which is more sensitive endpoint than the endpoints used in 
a developmental neurotoxicity study. Based on its evaluation of thyroid 
hormone data submitted for fluxapyroxad and the ontogeny of thyroid 
hormone metabolism, the Agency has determined that adverse thyroid 
hormone disruptions in the young are unlikely to occur at dose levels 
as low as the points of departure chosen for risk assessment. The 
Agency has low concern for neurotoxic effects of fluxapyroxad at any 
life stage.
    iii. Based on the developmental and reproductive toxicity studies 
discussed in Unit III.D.2., there are no residual uncertainties with 
regard to prenatal and/or postnatal toxicity.
    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 or field trial residue data. 
The dietary risk assessment is based on reliable data, is conservative 
and will not underestimate dietary exposure to fluxapyroxad. EPA made 
conservative (protective) assumptions in the ground and surface water 
modeling used to assess exposure to fluxapyroxad in drinking water. EPA 
used similarly conservative assumptions to assess postapplication 
exposure of children as well as incidental oral exposure of toddlers. 
These assessments will not underestimate the exposure and risks posed 
by fluxapyroxad.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide 
exposures are safe by comparing aggregate exposure estimates to the 
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA 
calculates the lifetime probability of acquiring cancer given the 
estimated aggregate exposure. Short-, intermediate-, and chronic-term 
risks are evaluated by comparing the estimated aggregate food, water, 
and residential exposure to the appropriate PODs to ensure that an 
adequate MOE exists.
    1. Acute risk. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food and water 
to fluxapyroxad will occupy 12% of the aPAD for children 3-5 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 
fluxapyroxad from food and water will utilize 64% of the cPAD for 
infants (< 1 year old). Based on the explanation in Unit III.C.3., 
regarding residential use patterns, chronic residential exposure to 
residues of fluxapyroxad is not expected.
    3. Short-term risk. Short-term aggregate exposure takes into 
account short-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level). Fluxapyroxad 
is currently registered for uses that could result in short-term 
residential exposure, and the Agency has determined that it is 
appropriate to aggregate chronic exposure through food and water with 
short-term residential exposures to fluxapyroxad. Using the exposure 
assumptions described in this unit for short-term exposures, EPA has 
concluded the combined short-term food, water, and residential 
exposures result in aggregate MOEs of 320 for adults and 560 for 
children. Because EPA's level of concern for fluxapyroxad is a MOE of 
100 or below, these MOEs are not of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level). An intermediate-term adverse effect was identified; however, 
fluxapyroxad is not registered for any use patterns that would result 
in intermediate-term residential exposure. Intermediate-term risk is 
assessed based on intermediate-term residential exposure plus chronic 
dietary exposure. 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 intermediate-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 
fluxapyroxad.
    5. Aggregate cancer risk for U.S. population. As discussed in Unit 
III.A., EPA has classified fluxapyroxad as ``Not likely to be 
Carcinogenic to Humans'' based on convincing evidence that carcinogenic 
effects are not likely below a defined dose range. The Agency has 
determined that the quantification of risk using the cPAD for 
fluxapyroxad will adequately account for all chronic toxicity, 
including carcinogenicity that could result from exposure to 
fluxapyroxad. As noted above, chronic exposure to fluxapyroxad from 
food and water will utilize 64% of the cPAD for infants (< 1year old) 
the population group receiving the greatest exposure.
    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 fluxapyroxad residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    A Liquid Chromatography-Mass Spectrometer/Mass Spectrometer (LC/MS/
MS) method is available as an enforcement method. This method uses 
reversed-phase High Pressure Liquid Chromatography (HPLC) with gradient 
elution, and includes 2 ion transitions to be monitored for the parent 
fluxapyroxad.
    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,

[[Page 45078]]

FFDCA section 408(b)(4) requires that EPA explain the reasons for 
departing from the Codex level.
    There is a Codex MRL for cotton, undelinted seed at 0.01 ppm. 
However, this MRL is based on seed treatment of cotton, and not foliar 
applications (which is the proposed use for the U.S. registration and 
which results in higher residues). Therefore, there is no ground for 
harmonization of U.S. tolerance and Codex MRL.

V. Conclusion

    Therefore, tolerances are established for residues of fluxapyroxad 
[3-(difluoromethyl)-1-methyl-N-(3',4',5'-trifluoro[1,1'-biphenyl]-2-
yl)-1H-pyrazole-4-carboxamide], including its metabolites and 
degradates, in or on cotton, gin byproducts at 20 ppm and cotton 
undelinted seed at 0.30 ppm.

VI. Statutory and Executive Order Reviews

    This action amends existing 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 tolerances in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.), do not apply.
    This action directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled ``Federalism'' (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
``Consultation and Coordination with Indian Tribal Governments'' (65 FR 
67249, November 9, 2000) do not apply to this action. In addition, this 
action does not impose any enforceable duty or contain any unfunded 
mandate as described under Title II of the Unfunded Mandates Reform Act 
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

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

List of Subjects in 40 CFR Part 180

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

    Dated: July 22, 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.  180.666, revise the entries for ``Cotton, gin byproducts'' 
and ``Cotton, undelinted seed'' in the table in paragraph (a) to read 
as follows:


Sec.  180.666  Fluxapyroxad; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
 
                              * * * * * * *
Cotton, gin byproducts..................................           20
Cotton, undelinted seed.................................            0.30
 
                              * * * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2015-18544 Filed 7-28-15; 8:45 am]
 BILLING CODE 6560-50-P