
[Federal Register Volume 81, Number 87 (Thursday, May 5, 2016)]
[Rules and Regulations]
[Pages 27019-27025]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-10581]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2015-0324; FRL-9945-48]


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 multiple commodities which are identified and 
discussed later in this document. BASF Corporation requested these 
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective May 5, 2016. Objections and 
requests for hearings must be received on or before July 5, 2016, and 
must be filed in accordance with the instructions provided in 40 CFR 
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2015-0324, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 
1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public 
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through 
Friday, excluding legal holidays. The telephone number for the Public 
Reading Room is (202) 566-1744, and the telephone number for the OPP 
Docket is (703) 305-5805. Please review the visitor instructions and 
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Susan Lewis, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone 
number: (703) 305-7090; email address: RDFRNotices@epa.gov.

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's 
tolerance regulations at 40 CFR part 180 through the Government 
Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. 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-2015-0324 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 
July 5, 2016. Addresses for mail and hand delivery of objections and 
hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing (excluding any Confidential Business Information (CBI)) for 
inclusion in the public docket. Information not marked confidential 
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without 
prior notice. Submit the non-CBI copy of your objection or hearing 
request, identified by docket ID number EPA-HQ-OPP-2015-0324, 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

[[Page 27020]]

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 August 26, 2015 (80 FR 51759) (FRL-9931-
74), 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 
5F8344) 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, in 
or on citrus, dried pulp at 2.7 parts per million (ppm); citrus oil at 
19 ppm; fruit, citrus group 10-10 at 1.0 ppm; grass forage, fodder and 
hay group 17 at 30 ppm; non-grass animal feed, group 18 at 30 ppm; and 
poultry, fat at 0.005 ppm. The petition also requested that the 
existing tolerance for residues of fluxapyroxad on egg be amended from 
0.002 ppm to 0.01 ppm and that the tolerance for inadvertent residues 
of fluxapyroxad on nongrass animal feeds, group 18 at 0.3 ppm be 
removed upon establishment of the superceding group 18 tolerance. 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.
    Based upon review of the data supporting the petition, EPA has 
recommended tolerances for poultry meat, poultry meat byproduct, and 
milk fat for which there were no established tolerances previously due 
to low dietary burden and falling under category 3 of CFR 180.6(a). The 
reason for these changes are explained in Unit IV.D.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the 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 tumorigenic 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

[[Page 27021]]

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 (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 Fluxaproxad on Citrus Crop Group 10-10, Grass Crop Group 17, and 
Non-Grass Crop Group 18.'' on pp. 56 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 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.
    Summary of the toxicological endpoints for 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 Dietary, Residential and Non-
                                   Occupational Human Health Risk Assessments
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                                                  Uncertainty/   RfD, PAD, level
      Exposure/scenario            Point of       FQPA safety     of concern for      Study and toxicological
                                  departure         factors      risk assessment              effects
----------------------------------------------------------------------------------------------------------------
Acute Dietary (General         NOAEL = 125 mg/  UFA = 10x        Acute RfD =      Acute neurotoxicity study in
 Population, including          kg/day.         UFH = 10x......   1.25 mg/kg/day.  rats.
 Infants and Children and                       FQPA SF = 1x...  aPAD = 1.25 mg/  LOAEL = 500 mg/kg/day based on
 Females 13-49 years of age).                                     kg/day.          decreased motor activity
                                                                                   (both sexes) and decreased
                                                                                   rearing (males only).
----------------------------------------------------------------------------------------------------------------
Chronic Dietary (All           NOAEL = 2.1 mg/  UFA = 10x        Chronic RfD =    Chronic toxicity/
 Populations).                  kg/day.         UFH = 10x......   0.021 mg/kg/     carcinogenicity study in
                                                FQPA SF = 1x...   day.             rats.
                                                                 cPAD = 0.021 mg/ LOAEL = 11 mg/kg/day based on
                                                                  kg/day.          non-neoplastic changes in the
                                                                                   liver (foci, masses).
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Incidental Oral Short-Term (1- NOAEL = 7.3mg/   UFA = 10x        Residential LOC  90-day dietary study in rats.
 30 days).                      kg/day.         UFH = 10x......   for MOE = 100.  MIRD 47923567.
                                                FQPA SF = 1x...                   LOAEL = 35.1 mg/kg/day based
                                                                                   on thyroid follicular
                                                                                   hypertrophy/hyperplasia.
----------------------------------------------------------------------------------------------------------------
Dermal Short- and                                            No hazard identified.
 Intermediate-Term.
----------------------------------------------------------------------------------------------------------------
Inhalation, Short-Term (1-30   NOAEL = 7.3 mg/  UFA = 10x        Residential LOC  90-day dietary study in rats.
 days) and Intermediate-term    kg/day.         UFH = 10x......   for MOE = 100.  MIRD 47923567.
 (1-6 months).                                  FQPA SF = 1x...                   LOAEL = 35.1 mg/kg/day based
                                                                                   on thyroid follicular
                                                                                   hypertrophy/hyperplasia.
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal,             Classification: Not likely to be carcinogenic to humans below a defined dose
 inhalation).                                                        range.
----------------------------------------------------------------------------------------------------------------
Point of Departure (POD) = A data point or an estimated point that is derived from observed dose-response data
  and used to mark the beginning of extrapolation to determine risk associated with lower environmentally
  relevant human exposures. NOAEL = no observed adverse effect level. LOAEL = lowest observed adverse effect
  level. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential
  variation in sensitivity among members of the human population (intraspecies). FQPA SF = FQPA Safety Factor.
  PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. MOA = mode of action.


[[Page 27022]]

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 Nationwide Continuing Surveys of Food 
Intake by Individuals (CSFII). As to residue levels in food, EPA used 
tolerance-level residues adjusted to account for the metabolites of 
concern (M700F008, and M700F010 (milk only)) and 100 percent crop 
treated (PCT) assumptions were used. DEEM default and empirical 
processing factors were used to modify the tolerance values.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA 2003-2008 
CSFII. As to residue levels in food, a moderately refined chronic 
dietary exposure analysis was performed for the general U.S. population 
and various population subgroups. Combined average residue for parent 
and highest residue for metabolite M700F008 and 100 PCT assumptions 
were used. For livestock commodities tolerance-level residues adjusted 
to account for the metabolites of concern (M700F008, M700F010) were 
used. An assumption of 100 PCT was also used for the chronic dietary 
analysis. DEEM default and empirical processing factors were used to 
modify the tolerance values.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that fluxapyroxad does not pose a cancer risk to humans. 
Therefore, a dietary exposure assessment for the purpose of assessing 
cancer risk is unnecessary.
    iv. Anticipated residue and percent crop treated (PCT) information. 
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.
    The Agency did not use PCT information in the dietary assessment 
for fluxapyroxad; 100 PCT was assumed for all food commodities.
    2. Dietary exposure from drinking water. The Agency used screening-
level water exposure models in the dietary exposure analysis and risk 
assessment for 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 Pesticide Root Zone Model Ground Water (PRZM GW), the 
estimated drinking water concentrations (EDWCs) of fluxapyroxad for 
acute exposures are 127 ppb parts per billion (ppb) for surface water 
and 203 ppb for ground water. The EDWCs for chronic exposures for non-
cancer assessments are 127 ppb for surface water and 188 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 value of 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).
    There are no residential exposure associated with the proposed uses 
in this action; however, there are existing turf uses that were 
previously assessed for fluxapyroxad. Although the Agency had conducted 
a residential exposure assessment for previous fluxapyroxad actions, 
the Agency completed an updated turf assessment to reflecting an update 
in the single maximum application rate from 2.47 pounds active 
ingredient/gallon (lb ai/gallon) to 0.005 lb ai/gallon. The present 
assessment assumed the following exposure scenarios:
     Residential handler: The Agency assessed inhalation 
exposures to adults from applications only because fluxapyroxad does 
not pose a dermal risk. Residential handler exposure is expected to be 
short-term in duration. Intermediate-term exposures are not likely 
because of the intermittent nature of applications by homeowners.
     Post-application exposures: Dermal exposures were not 
assessed because there is no identified systemic dermal hazard for 
fluxapyroxad. Post-application inhalation exposure while engaged in 
activities on or around previously treated turf is generally not 
quantitatively assessed. The combination of low vapor pressure for 
chemicals typically used as active ingredients in outdoor residential 
pesticide products and dilution in outdoor air is likely to result in 
minimal inhalation exposure. Incidental oral exposure for children is 
anticipated. The quantitative oral exposure/risk assessment for 
residential post-application exposures is based on the incidental oral 
scenario for children 1<2.
    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

[[Page 27023]]

an additional tenfold (10X) margin of safety for infants and children 
in the case of threshold effects to account for prenatal and postnatal 
toxicity and the completeness of the database on toxicity and exposure 
unless EPA determines based on reliable data that a different margin of 
safety will be safe for infants and children. This additional margin of 
safety is commonly referred to as the FQPA Safety Factor (SF). In 
applying this provision, EPA either retains the default value of 10X, 
or uses a different additional safety factor when reliable data 
available to EPA support the choice of a different factor.
    2. Prenatal and postnatal sensitivity. 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.
    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. Although an acute 
neurotoxicity study showed decreased rearing and motor activity, this 
occurred on the day of dosing only 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. 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 residue database is adequate. The dietary risk 
assessment is conservative and will not underestimate dietary exposure 
to fluxapyroxad. There are residential uses proposed for fluxapyroxad 
and the assessment will not underestimate residential exposure via 
handler for adults and incidental oral for children. 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 post application 
exposure of children as well as incidental oral exposure of toddlers. 
There are residential uses proposed for fluxapyroxad and the assessment 
will not underestimate residential exposure via handler for adults and 
incidental oral for children.

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 1-2 years old, 
the population group receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
fluxapyroxad from food and water will utilize 66% 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 1139 for adults and 431 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. Because the Agency has determined fluxapyroxad will not 
cause a chronic risk, the Agency concludes that fluxapyroxad will not 
pose a cancer risk for the U.S. population.
    6. Determination of safety. Based on these risk assessments, EPA 
concludes

[[Page 27024]]

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

    There are suitable residue analytical methods available for 
enforcement of fluxapyroxad tolerances (BASF Methods L0137/01 for 
plants and L0140/02 for animal matrices) which have been radio-
validated and have underwent successful validation by an independent 
laboratory. These are liquid chromatography with tandem mass 
spectrometry (LC/MS/MS) methods and monitor two ion transitions. The 
Limit of Quantitation (LOQ) for BASF method L0137/01 is 0.01 ppm for 
various matrices. The LOQ for BASF method L0140/02 is 0.01 ppm for 
liver and muscle, and 0.001 ppm for milk and eggs.
    The method may be requested from: Chief, Analytical Chemistry 
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 
20755-5350; telephone number: (410) 305-2905; email address: 
residuemethods@epa.gov.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint United Nations 
Food and Agriculture Organization/World Health Organization food 
standards program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level.
    There are no Codex MRLs for citrus or grass and non-grass animal 
feed at present. US and Codex use different dietary burden evaluations 
and calculations which result in US tolerances for residues in ruminant 
meat byproduct, milk, and milk fat generally much lower than 
corresponding Codex MRLs.

C. Revisions to Petitioned-for Tolerances

    EPA is establishing tolerances for milk fat and poultry meat, and 
meat byproduct that the applicant did not request. There have been no 
established tolerances for poultry tissues because residues were not 
expected to be found in those tissues due to the low dietary burden; 
i.e., category 3 of 40 CFR 180.6(a) applied for those poultry matrices 
previously. However, because of expectation of higher residues on the 
feed items associated with the proposed uses (mainly grass and non-
grass), the livestock dietary burdens have increased, and residues are 
now expected to be transferred to poultry tissues. Consequently, the 
Agency is establishing poultry tolerances. Similarly, due to the higher 
livestock dietary burdens, EPA is establishing a new tolerance for 
residues in milk fat, and increasing current tolerances on milk, 
ruminant fat and meat byproduct (to include fat and meat byproduct of 
cattle, goat, horse and sheep). EPA is also establishing higher 
tolerances than what the applicant proposed for grass (group 17), 
citrus oil, dried pulp, and poultry fat. The difference in the group 17 
grass tolerance is due to the fact that EPA is using residues from 0-
day postharvest interval (PHI) from grass samples (instead of 14-day 
PHI used by the applicant). With regard to citrus oil, the difference 
between the petitioned-for and established tolerance is due to the use 
of the highest average field trial (HAFT) data by EPA (instead of 
median used by the applicant), times processing factor. Dried pulp 
tolerance difference is due to EPA rounding of the calculated 
tolerance. Lastly, the difference in the tolerance in poultry fat is 
due to recalculating dietary burden for livestock, taking into account 
residues on feed commodities from (0-day PHI) grass, alfalfa and clover 
which resulted in higher than previously calculated dietary burdens and 
therefore higher tolerances.

V. Conclusion

    Therefore, tolerances are established for residues of fluxapyroxad, 
in or on cattle, fat at 0.06 ppm; cattle, meat byproduct at 0.04 ppm; 
citrus, dried pulp at 3.0 ppm; citrus, oil at 40 ppm; fruit, citrus, 
group 10-10 at 1.0 ppm; goat, fat at 0.06 ppm; goat, meat byproduct at 
0.04 ppm; grass, forage, fodder, and hay, group 17 at 40 ppm; horse, 
fat at 0.06 ppm; horse, meat byproduct at 0.04 ppm; milk at 0.01 ppm; 
milk, fat at 0.15 ppm; non-grass animal feeds, group 18 at 30 ppm; 
poultry, fat, poultry, meat and meat byproduct, each at 0.01 ppm; 
sheep, fat at 0.06 ppm; and sheep, meat byproduct at 0.04 ppm. Finally, 
the Agency is removing the tolerance for inadvertent residues of 
fluxapyroxad on non-grass animal feeds, group 18 contained in paragraph 
(d) of section 180.666, as it is subsumed by the tolerance for non-
grass animal feeds, group 18 being established in paragraph (a) of the 
same section.

VI. Statutory and Executive Order Reviews

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

[[Page 27025]]

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: April 26, 2016.
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, amend the table in paragraph (a) as follows:
0
i. Add alphabetically the entries ``Citrus, dried pulp'', ``Citrus, 
oil'', ``Fruit, citrus, group 10-10'', ``Grass forage, fodder and hay, 
group 17'', ``Milk, fat'', ``Non-grass animal feed, group 18'', 
``Poultry, fat'', ``Poultry, meat'' and ``Poultry, meat byproduct''.
0
ii. Revise the following entries ``Cattle, fat'', ``Cattle, meat 
byproduct'', ``Egg'', ``Goat, fat'', ``Goat, meat byproduct'', ``Horse, 
fat'', ``Horse, meat byproduct'', ``Milk'', ``Sheep, fat,'' and 
``Sheep, meat byproduct''.
0
iii. Remove from the table in paragraph (d) the entry ``non-grass 
animal feeds, group 18''.
    The amendments read as follows:


Sec.  180.666  Fluxapyroxad; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Cattle, fat.............................................            0.06
 
                                * * * * *
Cattle, meat byproduct..................................            0.04
Citrus, dried pulp......................................             3.0
Citrus, oil.............................................              40
 
                                * * * * *
Egg.....................................................            0.01
Fruit, citrus, group 10-10..............................             1.0
 
                                * * * * *
Grass, forage, fodder and hay, group 17.................              40
Goat, fat...............................................            0.06
 
                                * * * * *
Goat, meat byproduct....................................            0.04
 
                                * * * * *
Horse, fat..............................................            0.06
 
                                * * * * *
Horse, meat byproduct...................................            0.04
Milk....................................................            0.01
Milk, fat...............................................            0.15
Non-grass animal feed, group 18.........................              30
 
                                * * * * *
Poultry, fat............................................            0.01
Poultry, meat...........................................            0.01
Poultry, meat byproduct.................................            0.01
 
                                * * * * *
Sheep, fat..............................................            0.06
 
                                * * * * *
Sheep, meat byproduct...................................            0.04
 
                                * * * * *
------------------------------------------------------------------------

* * * * *

[FR Doc. 2016-10581 Filed 5-4-16; 8:45 am]
 BILLING CODE 6560-50-P


