Fluxapyroxad; Pesticide Tolerances, 28270-28276 [2012-11602]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 77, Number 93 (Monday, May 14, 2012)]
[Rules and Regulations]
[Pages 28270-28276]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-11602]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2010-0421; FRL-9346-7]


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 14, 2012. Objections and 
requests for hearings must be received on or before July 13, 2012, 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: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2010-0421. All documents in the 
docket are listed in the docket index available at https://www.regulations.gov. Although listed in the index, some information is 
not publicly available, e.g., Confidential Business Information (CBI) 
or other information whose disclosure is restricted by statute. Certain 
other material, such as copyrighted material, is not placed on the 
Internet and will be publicly available only in hard copy form. 
Publicly available docket materials are available in the electronic 
docket at https://www.regulations.gov, or, if only available in hard 
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac 
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket 
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The Docket Facility telephone number is (703) 
305-5805.

FOR FURTHER INFORMATION CONTACT: Olga Odiott, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone 
number: (703) 308-9369; email address: odiott.olga@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. 
Potentially affected entities may include, but are not limited to those 
engaged in the following activities:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather to 
provide a guide for readers regarding entities likely to be affected by 
this action. Other types of entities not listed in this unit could also 
be affected. The North American Industrial Classification System 
(NAICS) codes have been provided to assist you and others in 
determining whether this action might apply to certain entities. If you 
have any questions regarding the applicability of this action to a 
particular entity, consult the person listed under FOR FURTHER 
INFORMATION CONTACT.

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 https://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. To access the 
OCSPP test guidelines referenced in this document electronically, 
please go https://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-2010-0421 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 13, 2012. Addresses for mail and hand delivery of objections and 
hearing requests are provided in 40 CFR 178.25(b).

[[Page 28271]]

    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 that does not contain any 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 a copy of 
your non-CBI objection or hearing request, identified by docket ID 
number EPA-HQ-OPP-2010-0421, by one of the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the online instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave. 
NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket Facility's normal hours of operation (8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays). 
Special arrangements should be made for deliveries of boxed 
information. The Docket Facility telephone number is (703) 305-5805.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of June 23, 2010 (75 FR 35803) (FRL-8831-
3), EPA issued a notice pursuant to FFDCA section 408(d)(3), 21 U.S.C. 
346a(d)(3), announcing the filing of a pesticide petition (PP 0F7709) 
by BASF Corporation, 26 Davis Drive, Research Triangle Park, NC 27709-
3528. The petition requested that 40 CFR part 180 be amended by 
establishing tolerances for residues of the fungicide fluxapyroxad, 3-
(difluoromethyl)-1-methyl-N-(3',4',5'-trifluoro[1,1'-biphenyl]-2-yl)-
1H-pyrazole-4-carboxamide, in or on multiple commodities. That notice 
referenced a summary of the petition prepared by BASF Corporation, the 
registrant, which is available in the docket, https://www.regulations.gov. There were no comments received in response to the 
notice of filing. Based on EPA's review of the data supporting the 
petition, BASF Company revised their petition (PP 0F7709) by:
    1. Proposing tolerances for corn, pop, grain; corn, sweet kernels 
plus cobs with husks removed; and wheat, grain;
    2. Decreasing or increasing the proposed tolerances for various 
commodities;
    3. Deleting the proposed tolerance for vegetable, root, subgroup 1A 
and proposing a tolerance for beet, sugar; and
    4. Proposing a tolerance for oilseeds, group 20.
    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 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 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.
    In accordance with the EPA's Final Guidelines for Carcinogen Risk 
Assessment (March, 2005), 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:
     No treatment-related tumors were seen in male or female 
mice when tested at doses that were adequate to assess carcinogenicity 
(including the Limit Dose);
     Treatment-related liver tumors were seen in male rats at 
doses >=250 parts per million (ppm) (11 milligrams/kilogram/day (mg/kg/
day)) and in female rats at doses >=1,500 ppm (82 mg/kg/day);
     Treatment-related thyroid follicular cell tumors were seen 
in male rats only at doses >=1,500 ppm (68 mg/kg/day);
     There is no mutagenicity concern from in vivo or in vitro 
assays;
     The hypothesized mode of action (i.e., a non-genotoxic) 
for each tumor type (i.e., the liver and thyroid) was supported by 
adequate studies that clearly identified the sequence of key events, 
dose-response concordance and temporal relationship to the tumor types. 
The mode of action met the criteria established by the Agency.
    The Agency has determined that the chronic population adjusted dose 
(cPAD) will adequately account for all chronic effects, including 
carcinogenicity, that could result from exposure to fluxapyroxad.
    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.

[[Page 28272]]

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 (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at https://www.regulations.gov in document ``Fluxapyroxad: Human Health Risk 
Assessment for Use of New Active Ingredient on Cereal Grains, Legume 
Vegetables (Succulent and Dry), Oil Seed Crops (Canola and Sunflower), 
Peanuts, Pome Fruit, Stone Fruit, Root and Tuber Vegetables (Potatoes 
and Sugar Beets), Fruiting Vegetables, and Cotton,'' at page 39 in 
docket ID number EPA-HQ-OPP-2010-0421-0005.

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 https://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for fluxapyroxad used for 
human risk assessment is shown in the following Table.

  Table--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/    aRfD = 1.25 mg/kg/   Acute neurotoxicity study in rats.
 including infants and children,    day.                  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 (both
                                   UFH = 10x...........   day.                 sexes) and decreased rearing
                                   FQPA SF = 1x........                        (males only)
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Chronic dietary (All               NOAEL= 2.1 mg/kg/day  cRfD = 0.021 mg/kg/  Chronic toxicity/carcinogenicity
 populations)..                    UFA = 10x...........   day..                study in rats.
                                   UFH = 10x...........  cPAD = 0.021 mg/kg/  LOAEL = 11 mg/kg/day based on non-
                                   FQPA SF = 1x........   day.                 neoplastic changes in the liver
                                                                               (foci, masses)
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Cancer (Oral, dermal,              Classification: Not likely to be carcinogenic to humans at doses sufficient
 inhalation)..                      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.
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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). 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 fluxapyroxad, EPA considered exposure under the petitioned-
for tolerances. EPA assessed dietary exposures from fluxapyroxad in 
food as follows:

[[Page 28273]]

    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 U.S. 
Department of Agriculture (USDA) 1994-1996 and 1998 Nationwide 
Continuing Surveys of Food Intake by Individuals (CSFII). As to residue 
levels in food, tolerance level residues adjusted to account for 
metabolites of concern, 100 percent crop treated (PCT) assumptions, and 
Dietary Exposure Evaluation Model (DEEM) default and empirical 
processing factors were used.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA 1994-1996 
and 1998 CSFII. 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. Highest average field trial (HAFT) 
residues for parent plus metabolite were used for all plant 
commodities. For livestock commodities, tolerance level residues 
adjusted to account for metabolites of concern were used.
    iii. Cancer. EPA determines whether quantitative cancer exposure 
and risk assessments are appropriate for a food-use pesticide based on 
the weight of the evidence from cancer studies and other relevant data. 
Cancer risk is quantified using a linear or nonlinear approach. If 
sufficient information on the carcinogenic mode of action is available, 
a threshold or nonlinear approach is used and a cancer RfD is 
calculated based on an earlier noncancer key event. If carcinogenic 
mode of action data are not available, or if the mode of action data 
determines a mutagenic mode of action, a default linear cancer slope 
factor approach is utilized. 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. 
EPA did not use anticipated residue or PCT information in the acute 
dietary assessment for fluxapyroxad. Tolerance level residues and 100 
PCT information were assumed for all food commodities. For the chronic 
dietary assessment tolerance level residues and 100 PCT information 
were assumed for livestock commodities. HAFT residues for parent plus 
metabolite were used for all plant commodities.
    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 https://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the First Index Reservoir Screening Tool (FIRST), and the 
Screening Concentration in Ground Water (SCI-GROW) models, the 
estimated drinking water concentrations (EDWCs) of fluxapyroxad for 
acute exposures are estimated to be 14.1 parts per billion (ppb) for 
surface water and 0.087 ppb for ground water. For chronic exposures the 
EDWCs are estimated to be 6.7 ppb for surface water and 0.087 ppb for 
ground water. Modeled estimates of drinking water concentrations were 
directly entered into the dietary exposure model. The EDWCs of 14.1 ppb 
for surface water and 0.087 ppb for ground water were used for the 
acute and the chronic dietary assessments, respectively.
    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 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.''
    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 https://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 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

[[Page 28274]]

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 prenatal 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. Neither the acute or 
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. 
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 6% 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 48% of the cPAD for 
children 1-2 years old, the population group receiving the greatest 
exposure. There are no residential uses for fluxapyroxad.
    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 not registered for any use patterns that would result in short-term 
residential exposure and chronic dietary exposure has already been 
assessed under the appropriately protective cPAD.
    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). Fluxapyroxad is not registered for any use patterns that would 
result in intermediate-term residential exposure and chronic dietary 
exposure has already been assessed under the appropriately protective 
cPAD.
    5. Aggregate cancer risk for U.S. population. In accordance with 
the EPA's Final Guidelines for Carcinogen Risk Assessment (March 2005), 
EPA 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 48% of the cPAD for 
children 1-2 years 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 
and the metabolites M700F008 and M700F048, so the method also serves as 
the confirmatory method.
    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.
    The Codex has not established MRLs for fluxapyroxad.

[[Page 28275]]

C. Revisions to Petitioned-For Tolerances

    Based on EPA's review, BASF Company revised their petition (PP 
0F7709) by:
    1. Proposing tolerances for corn, pop, grain; corn, sweet kernels 
plus cobs with husks removed; and wheat, grain. Tolerances for these 
commodities were originally proposed as part of the respective crop 
group tolerances, but the Agency determined that separate tolerances 
are needed because of differences between the needed tolerances and the 
proposed crop group tolerances.
    2. Decreasing or increasing the proposed tolerances for various 
commodities.
    3. Deleting the proposed tolerance for vegetable, root, subgroup 1A 
and proposing a tolerance for beet, sugar. The submitted data are not 
sufficient to support a tolerance for the proposed subgroup 1A, but it 
supports a tolerance for beet, sugar.
    4. Deleting tolerances that the Agency determined are not needed 
and/or are covered by other proposed tolerances.
    5. Proposing a tolerance for oilseeds, group 20. The registrant had 
proposed tolerances for all the representative commodities for crop 
group 20 and the submitted data supports establishment of the group 
tolerance.
    The Agency concluded that based on the residue data these changes 
are required to support the proposed uses. The Agency analyzed the 
field trial data for the respective commodities using the Organization 
for Economic Cooperation and Development tolerance calculation 
procedures to determine the appropriate tolerances.

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, as requested in the revised petition.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under FFDCA section 408(d) 
in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled ``Regulatory Planning and 
Review'' (58 FR 51735, October 4, 1993). Because this final rule has 
been exempted from review under Executive Order 12866, this final rule 
is not subject to Executive Order 13211, entitled ``Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
``Protection of Children from Environmental Health Risks and Safety 
Risks'' (62 FR 19885, April 23, 1997). This final rule does not contain 
any information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any 
special considerations under Executive Order 12898, entitled ``Federal 
Actions to Address Environmental Justice in Minority Populations and 
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under FFDCA section 408(d), such as the tolerance in this 
final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply.
    This final rule directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled ``Federalism'' (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
``Consultation and Coordination with Indian Tribal Governments'' (65 FR 
67249, November 9, 2000) do not apply to this final rule. In addition, 
this final rule does not impose any enforceable duty or contain any 
unfunded mandate as described under Title II of the Unfunded Mandates 
Reform Act of 1995 (UMRA) (Pub. L. 104-4).
    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), Public Law 104-113, section 12(d) (15 U.S.C. 272 
note).

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report to each House of the Congress and to 
the Comptroller General of the United States. 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 this final rule in the Federal 
Register. This final rule 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: May 2, 2012.
Steven Bradbury,
Director, 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. Add Sec.  180.666 to subpart C to read as follows:


Sec.  180.666  Fluxapyroxad; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
fungicide fluxapyroxad, including its metabolites and degradates, in or 
on the commodities listed in the table below. Compliance with the 
tolerance levels specified below is to be determined by measuring only 
fluxapyroxad, 3-(difluoromethyl)-1-methyl-N-(3',4',5'-trifluoro[1,1'-
biphenyl]-2-yl)-1H-pyrazole-4-carboxamide in or on the commodity.

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Apple, wet pomace..........................................        2.0
Beet, sugar................................................        0.1
Beet, sugar, dried pulp....................................        0.1
Beet, sugar, tops..........................................        7.0
Cattle, fat................................................        0.05
Cattle, meat...............................................        0.01
Cattle, meat byproducts....................................        0.03
Corn, field, grain.........................................        0.01
Corn, oil..................................................        0.03
Corn, pop, grain...........................................        0.01
Corn, sweet, kernels plus cobs with husks removed..........        0.15
Cotton, gin byproducts.....................................        0.01
Cotton, undelinted seed....................................        0.01
Egg........................................................        0.002
Fruit, pome, group 11......................................        0.8
Fruit, stone, group 12.....................................        2.0
Goat, fat..................................................        0.05

[[Page 28276]]

 
Goat, meat.................................................        0.01
Goat, meat byproducts......................................        0.03
Grain, aspirated fractions.................................       20.0
Grain, cereal, group 15, (except corn, field, grain; except        3.0
 corn, pop, grain; except corn, kernels plus cobs with
 husks removed; except wheat)..............................
Grain, cereal, forage, fodder and straw, group 16..........       20
Horse, fat.................................................        0.05
Horse, meat................................................        0.01
Horse, meat byproducts.....................................        0.03
Milk.......................................................        0.005
Oilseeds, group 20.........................................        0.9
Pea and bean, dried shelled except soybean, subgroup 6C....        0.4
Pea and bean, succulent shelled, subgroup 6B...............        0.5
Peanut.....................................................        0.01
Peanut, refined oil........................................        0.02
Plum, prune................................................        3.0
Potato, wet peel...........................................        0.1
Rice, bran.................................................        4.5
Rice, hulls................................................        8.0
Sheep, fat.................................................        0.05
Sheep, meat................................................        0.01
Sheep, meat byproducts.....................................        0.03
Soybean, hulls.............................................        0.3
Soybean, seed..............................................        0.15
Vegetable, foliage of legume, group 7......................       30
Vegetables, fruiting, group 8..............................        0.7
Vegetable, legume, edible podded, subgroup 6A..............        2.0
Vegetable, tuberous and corm, subgroup 1C..................        0.02
Wheat, bran................................................        0.6
Wheat, grain...............................................        0.3
------------------------------------------------------------------------

     (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[FR Doc. 2012-11602 Filed 5-11-12; 8:45 am]
BILLING CODE 6560-50-P