[Federal Register Volume 83, Number 233 (Tuesday, December 4, 2018)]
[Rules and Regulations]
[Pages 62479-62485]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-26348]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2016-0538; FRL-9982-42]


Bixafen; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of bixafen 
in or on multiple commodities which are identified and discussed later 
in this document. FMC Corporation requested these tolerances under the 
Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective December 4, 2018. Objections and 
requests for hearings must be received on or before February 4, 2019 
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-2016-0538, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 
1301 Constitution Ave. NW, Washington, DC 20460-0001. The Public 
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through 
Friday, excluding legal holidays. The telephone number for the Public 
Reading Room is (202) 566-1744, and the telephone number for the OPP

[[Page 62480]]

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:  Michael Goodis, 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.

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-2016-0538 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 
February 4, 2019. 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-2016-0538, 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 November 30, 2016 (81 FR 86312) (FRL-
9954-06), 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 
6F8475) by FMC Corporation. The petition requested that 40 CFR part 180 
be amended by establishing tolerances for residues of the fungicide 
bixafen, N-(3',4'-dichloro-5-fluoro[1,1'-biphenyl]-2-yl)-3-
(difluoromethyl)-1-methyl-1H-pyrazole-4-carboxamide, in or on cattle, 
fat at 0.5 parts per million (ppm); cattle, kidney at 0.3 ppm; cattle, 
liver at 1.5 ppm; cattle, muscle at 0.15 ppm; grain, aspirated 
fractions at 80 ppm; grain, cereal, forage, fodder and straw, group 16 
(except rice), forage at 4.0 ppm; grain, cereal, forage, fodder and 
straw, group 16 (except rice), hay at 5.0 ppm; grain, cereal, forage, 
fodder and straw, group 16 (except rice), stover at 6.0 ppm; grain, 
cereal, forage, fodder and straw, group 16 (except rice), straw at 7.0 
ppm; grain, cereal, group 15 (except rice and sorghum) at 0.15 ppm; 
milk at 0.1 ppm; oilseed, rapeseed subgroup 20A at 0.15 ppm; peanut, 
hay at 10.0 ppm; peanut, nutmeat at 0.02 ppm; peanut, refined oil at 
0.04 ppm; poultry, eggs at 0.02 ppm; poultry, fat at 0.02 ppm; poultry, 
liver at 0.02 ppm; poultry, muscle at 0.02 ppm; sorghum, grain at 3.0 
ppm; soybean, hulls at 0.15 ppm; soybean, seed at 0.06 ppm; sugar beet, 
dried pulp at 1.0 ppm; vegetable, root subgroup 1A at 0.2 ppm and 
vegetable, tuberous and corm subgroup 1C at 0.02 ppm. That document 
referenced a summary of the petition prepared by FMC 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 is 
establishing tolerances that vary from those proposed. 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 bixafen including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with bixafen 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

[[Page 62481]]

subgroups of consumers, including infants and children.
    Following repeated oral administration of bixafen, the liver was 
the primary target organ in mice, rats and dogs. Increased liver 
weights and hepatocellular hypertrophy were observed in all species 
tested and were considered to reflect hepatic microsomal enzyme 
induction. Also, in several studies, there was evidence for liver 
toxicity based on clinical chemistry changes (increased serum alkaline 
phosphatase and cholesterol, decreased serum albumin) and 
histopathological changes (hepatocellular pigmentation, degeneration 
and necrosis). In mice and rats, the thyroid was an additional target 
in the subchronic and chronic studies, with effects such as increased 
thyroid weight, follicular cell hypertrophy and follicular cell 
hyperplasia observed. Thyroid toxicity was seen only in the presence of 
liver effects, either adverse effects (such as hepatocellular single-
cell degeneration/necrosis) or adaptive effects (such as increased 
liver weights with enzyme changes, hepatocellular hypertrophy). This 
correlation suggested they thyroid effects are secondary to the liver 
effects via enhanced hepatic clearance of thyroid hormones. This 
suggestion was supported by a 14-day mechanistic study in rats in which 
a marked induction of phase I and II hepatic enzymes, a slight 
reduction of thyroid hormone (T3, T4) levels and a significant increase 
of TSH levels were observed at 150 mg/kg bodyweight per day, the only 
dose tested. Since thyroid toxicity was seen in the absence of adverse 
liver effects in studies such as the subchronic and chronic rat 
studies, a primary adverse effect on the thyroid cannot be ruled out. 
However, no studies are available to address potential susceptibility 
in the young to potential thyroid toxicity. As a result, the need for a 
Comparative Thyroid Assay (CTA) was considered. However, given risk 
estimates are well below the Agency's level of concern (LOC) even when 
using conservative exposure assumptions, the Agency concluded that a 
CTA is not required at this time. This conclusion, however, may be 
revisited should the use pattern change or if updated risk estimates 
reach a point where the PODs used in the risk assessment are no longer 
protective of potential life-stage susceptibility.
    From the prenatal developmental studies, it is apparent that 
evidence of increased quantitative susceptibility in offspring was 
observed in the database. The prenatal developmental study in the rat 
showed decreased fetal body weights at a dose that produced no adverse 
effects in the dam. Similarly, the prenatal developmental study in the 
rabbit showed decreased fetal body weight in the absence of maternal 
toxicity. In the rat 2-generation reproduction study, however, parental 
toxicity (decreased body weight and increased liver weight with 
centrilobular and diffuse hypertrophy) and offspring toxicity 
(decreased F1 and F2 pup body weights) occurred 
at the same dose level.
    An acute neurotoxicity study in the adult rat indicated decreased 
motor activity in both sexes and decreased rearing counts in females at 
a high dose level (1,000 mg/kg/day). A subchronic neurotoxicity study 
was not available, and no evidence of neurotoxicity was observed in 
other studies in the database.
    Bixafen did not produce evidence of mutagenicity or clastogenicity 
in the required battery of studies. The available mouse carcinogenicity 
study produced no treatment-related tumors in the presence of other 
toxicity such as organ weight changes with histopathology in both the 
liver and thyroid. Thus, bixafen is classified as ``not likely to be 
carcinogenic to humans.''
    Bixafen has low acute oral, dermal, and inhalation toxicity. 
Bixafen is not an acute eye irritant and is neither a dermal irritant 
nor a dermal sensitizer. Specific information on the studies received 
and the nature of the adverse effects caused by bixafen 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 the document Bixafen. Human Health Risk 
Assessment for Section 3 Registration and Tolerance Requests for a New 
Active Ingredient Proposed for Use on Cereal Grains, Group 15 (Except 
Rice); Forage, Fodder and Straw of Cereal Grains, Group 16 (Except 
Rice); Peanut; Soybean; Root Vegetable Subgroup 1A; and Tuberous and 
Corm Vegetable Subgroup 1C at pages 14--23 in docket ID number EPA-HQ-
OPP-2016-0538.

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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
    A summary of the toxicological endpoints for bixafen used for human 
risk assessment is shown in Table 1 of this unit.

    Table 1--Summary of Toxicological Doses and Endpoints for Bixafen for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                    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 = 250 mg/kg/    Acute RfD = 2.5 mg/  Acute Neurotoxicity Study in rats;
 including infants and children).   day.                  kg/day.              MRID 49877279.
                                   UFA = 10x...........  aPAD = 2.5 mg/kg/    LOAEL = 1,000 mg/kg/day based on
                                   UFH = 10x...........   day.                 statistically significant
                                   FQPA SF = 1x........                        decreases in motor activity in
                                                                               both sexes and decreased rearing
                                                                               counts in females approximately 4
                                                                               hours following a single oral
                                                                               dose.

[[Page 62482]]

 
Chronic dietary (All populations)  NOAEL = 2.8 mg/kg/    Chronic RfD = 0.03   Chronic/Carcinogenicity Studies in
                                    day.                  mg/kg/day.           Rats; MRIDs 49877272, 49877273.
                                   UFA = 10x...........  cPAD = 0.03 mg/kg/   LOAEL = 17.4 mg/kg/day based on
                                   UFH = 10x...........   day.                 thyroid effects (follicular cell
                                   FQPA SF = 1x........                        hypertrophy, alteration of the
                                                                               thyroid colloid at interim and
                                                                               terminal sacrifice).
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)     Classification: ``Not likely to be carcinogenic to humans'' based on an
                                     absence of tumors in the rat chronic/oncogenicity and mouse carcinogenicity
                                                                      studies.
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. mg/kg/day = milligram/kilogram/day. 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 bixafen, EPA considered exposure under the petitioned-for 
tolerances. EPA assessed dietary exposures from bixafen 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 bixafen. In estimating acute 
dietary exposure, EPA used food consumption information from the United 
States Department of Agriculture (USDA) Nationwide Health and Nutrition 
Examination Survey, What We Eat in America (NHANES/WWEIA) conducted 
from 2003-2008. As to residue levels in food, the acute dietary 
analysis was obtained from the Dietary Exposure Evaluation Model using 
the Food Commodity Intake Database (DEEM-FCID; version 3.16). The 
assessment is based on tolerance-level residues and 100% crop treated 
(100 PCT) estimates for all commodities.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA NHANES/
WWEIA conducted from 2003-2008. As to residue levels in food, the 
chronic dietary analysis was obtained from the Dietary Exposure 
Evaluation Model using the Food Commodity Intake Database (DEEM-FCID; 
version 3.16). The assessment is based on tolerance-level residues and 
100 PCT estimates for all commodities.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that bixafen does not pose a cancer risk to humans. 
Therefore, a dietary exposure assessment for the purpose of assessing 
cancer risk is unnecessary.
    iv. Anticipated residue and percent crop treated (PCT) information. 
EPA did not use anticipated residue and/or PCT information in the 
dietary assessment for bixafen. Tolerance-level residues and 100 PCT 
were assumed for all food commodities.
    2. Dietary exposure from drinking water. The Agency used screening-
level water exposure models in the dietary exposure analysis and risk 
assessment for bixafen in drinking water. These simulation models take 
into account data on the physical, chemical, and fate/transport 
characteristics of bixafen. Further information regarding EPA drinking 
water models used in pesticide exposure assessment can be found at 
http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
    The Tier II Pesticide in Water Calculator (PWC version 1.52) and 
Tier I Pesticide Root Zone Model Ground Water (PRZM GW) was used for 
calculating surface water and ground water EDWCs respectively. The 
driver for drinking water exposure is from surface water and the EDWC 
of bixafen for acute exposure is estimated to be 16.3 parts per billion 
(ppb). For chronic exposure for non-cancer assessment, it is estimated 
to be 15.2 ppb for surface 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 16.3 ppb was used to 
assess the contribution to drinking water. For chronic dietary risk 
assessment, the water concentration of value 15.2 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).
    Bixafen is not proposed nor is it 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 bixafen to share a common mechanism of toxicity 
with any other substances, and bixafen does not appear to produce a 
toxic metabolite produced by other substances. For the purposes of this 
tolerance action, therefore, EPA has assumed that bixafen 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 website at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

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

[[Page 62483]]

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. The prenatal developmental 
toxicity studies showed effects in the fetus (decreased body weights) 
at dose levels that were lower than that of the observed maternal 
toxicity (decreased body weights). However, concerns for potential pre- 
and postnatal susceptibility from the developmental and reproduction 
studies are low because clear NOAELs and LOAELs exist for these 
developmental effects, and the PODs and endpoints selected for risk 
assessment are protective of potential toxicity in offspring.
    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 bixafen is considered complete at this 
time. The following acceptable studies are available to support this 
determination: A prenatal developmental toxicity study in rabbits, a 
prenatal developmental toxicity study in rats, a two-generation 
reproduction study in rats and an acute neurotoxicity study. The 
following study waivers were accepted, and it was determined that these 
studies are not required at this time: subchronic inhalation, 
subchronic neurotoxicity, and an immunotoxicity study. As summarized in 
Unit III.A., EPA determined that the CTA study is not required at this 
time.
    ii. An acute neurotoxicity study in the adult rat indicated 
decreased motor activity in both sexes and decreased rearing counts in 
females at a high dose level (1,000 mg/kg/day). A subchronic 
neurotoxicity study was not available, and no evidence of neurotoxicity 
was observed in other studies in the database. Concern for 
neurotoxicity is low, and thus no developmental neurotoxicity study or 
FQPA 10X SF is necessary, because (1) signs of neurotoxicity in the 
database occur only at a high dose level, do not include 
neuropathology; (2) a clear and well-defined NOAEL has been 
established; and (3) the PODs used for risk assessment are protective 
of neurotoxicity seen in the database.
    iii. There is evidence of increased prenatal quantitative 
susceptibility of the developing offspring in the toxicology database 
for bixafen. Developmental toxicity (reduced fetal body weight) was 
seen at doses that caused no maternal toxicity in both rats and 
rabbits. However, clear NOAELs and LOAELs exist for these developmental 
effects, and the endpoints and PODs selected for risk assessment are 
protective of these effects. In the 2-generation reproduction toxicity 
study, toxicity in the offspring (decreased F1 and 
F2 pup body weights) occurred at the same level where 
parental toxicity (decreased body weight) was observed, and 
susceptibility was not demonstrated. The subchronic and chronic rat 
studies in the database indicate thyroid toxicity (epithelial cell 
hypertrophy) at the LOAELs, and no studies are available to address 
potential susceptibility in the young to potential thyroid toxicity. As 
a result, the need for a CTA was considered. However, given risk 
estimates are well below the Agency's level of concern even when using 
conservative exposure assumptions and that further refinement of 
exposure estimates would yield even greater margins of safety, the 
Agency concluded that a CTA is not required at this time.
    iv. There are no residual uncertainties identified in the exposure 
databases. The unrefined dietary risk assessments are based on high-end 
assumptions such as tolerance-level residues, 100PCT assumptions, and 
modeled, high-end estimates of residues in drinking water. EPA made 
conservative (protective) assumptions in the ground and surface water 
modeling used to assess exposure to bixafen in drinking water. These 
assessments will not underestimate the exposure and risks posed by 
bixafen.

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 bixafen will occupy <1% of the aPAD for children 1-2 years of age, 
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 
bixafen from food and water will utilize 20% of the cPAD for children 
1-2 years of age the population group receiving the greatest exposure.
    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). A short-term 
adverse effect was identified; however, bixafen is not proposed for any 
use patterns that would result in short-term residential exposure. 
Short-term risk is assessed based on short-term residential exposure 
plus chronic dietary exposure. Because there is no short-term 
residential exposure and chronic dietary exposure has already been 
assessed under the appropriately protective cPAD (which is at least as 
protective as the POD used to assess short-term risk), no further 
assessment of short-term risk is necessary, and EPA relies on the 
chronic dietary risk assessment for evaluating short-term risk for 
bixafen.
    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, 
bixafen is not proposed 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 
bixafen.
    5. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, bixafen is not expected to pose a cancer risk to humans.
    6. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, or to infants and children from aggregate 
exposure to bixafen residues.

[[Page 62484]]

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (Analytical Methods 00983 and 
01063, high- performance liquid chromatography methods with tandem mass 
spectrometry detection (LC/MS/MS)) is available as an enforcement 
method for determination of residues of bixafen and its metabolite 
bixafen-desmethyl.

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 established MRLs for bixafen in or on barley and oats 
at 0.4 ppm; the U.S. tolerance for grain, cereal, group 15, except rice 
and grain sorghum at 0.40 ppm is harmonized with those MRLs. Codex has 
also established MRLs for rye, wheat, and wheat bran at 0.05 ppm, which 
is not harmonized with the U.S. tolerances for group 15 because use 
consistent with approved labeling could result in exceedances. Codex 
has also established MRLs for barley straw and fodder, dry at 20 ppm; 
oat straw and fodder, dry at 20 ppm; rye straw and fodder, dry at 20 
ppm; and wheat straw and fodder, dry at 20 ppm. The U.S. tolerance for 
grain, cereal, forage, fodder and straw, group 16, except rice at 20 
ppm is harmonized with those Codex MRLs.
    Additionally, the Codex has established MRLs for bixafen in or on 
cattle, fat at 2 ppm; cattle, meat byproducts at 4 ppm; cattle, muscle 
at 2 ppm; goat, fat at 2 ppm; goat, meat byproducts at 4 ppm; goat, 
muscle at 2 ppm; horse, fat at 2 ppm; horse, meat byproducts at 4 ppm; 
horse, muscle at 2 ppm; milk at 0.2 ppm; sheep, fat at 2 ppm; sheep, 
meat byproducts at 4 ppm; and sheep, muscle at 2 ppm. These MRLs are 
significantly higher than the tolerances being established for bixafen 
on the same commodities in the United States. The U.S. tolerances are 
based on calculated dietary burden that supports a lower residue level 
in fat, muscle, and meat byproducts commodities. Therefore, these 
tolerances are not harmonized because such high tolerances could mask 
instances of misuse by U.S. growers. As noted in the next section, the 
Agency is not establishing tolerances for milk fats and poultry 
commodities in harmony with Codex MRLs for milk fats, poultry, edible 
offal, poultry fats, and poultry meat because the Agency has determined 
that use consistent with the approved pesticide will not result in 
residues in milk fats and poultry commodities.

C. Revisions to Petitioned-For Tolerances

    Several proposed tolerances requested by the petitioner are 
different from those being established by EPA. For soybean seed; 
peanut; peanut, hay; vegetable, tuberous and corm (subgroup 1C); and 
vegetable, root, subgroup 1A, tolerance values were calculated using 
the Organization for Economic Cooperation and Development (OECD) 
tolerance calculation procedures and field trial residue data. The 
combination provided a different tolerance value than the proposed 
values. EPA is establishing a tolerance for grain, cereal, group 15, 
except rice and grain sorghum at 0.40 ppm instead of 0.15 ppm and for 
grain, cereal, forage, fodder and straw, group 16, except rice at 20 
ppm, rather than the requested tolerances for forage at 4.0 ppm, hay at 
5.0 ppm, stover at 6.0 ppm, straw at 7.0 ppm in order to harmonize with 
Codex MRLs. Since the tolerance of 20 ppm for group 16 covers the 
residues on forage, hay, stover, and straw forms of the group 16 
commodities, EPA has determined that separate tolerances are 
unnecessary.
    Additionally, while tolerances were proposed on liver and kidney 
for livestock commodities, EPA is establishing tolerances on meat 
byproducts, which are inclusive of kidney and liver. EPA is further 
establishing lower tolerances for residues in fat, muscle and meat 
byproducts in cattle, based on the calculated dietary burdens paired 
with low residue transfer rates into ruminant commodities. The 
tolerance on milk is also established at a lower level (0.04 ppm versus 
the 0.10 ppm proposed tolerance). This recommendation is also based on 
the calculated dietary burdens paired with low residue transfer rates 
into ruminant commodities.
    Under EPA's regulations (40 CFR 180.6), EPA assessed whether 
residues on raw agricultural commodities would result in possible 
residues entering the diet of man through the ingestion of milk, eggs, 
meat, and/or poultry produced by animals fed agricultural products 
bearing such residues. As a result of that assessment, EPA determined 
that quantifiable residues are expected in commodities from cattle, 
horses, goats, and sheep and is establishing tolerances for residues in 
fat, muscle and meat byproducts in horse, goat and sheep. EPA also 
determined that there is no reasonable expectation of residues in or on 
milk fats and poultry products; therefore, no tolerances on milk fats 
and poultry commodities are needed.
    Additionally, the proposed use and associated tolerance on Rapeseed 
subgroup 20A (canola) was subsequently withdrawn by the petitioner; 
therefore, the Agency is not establishing a tolerance on that subgroup 
because it is not needed.
    The Agency is not establishing a tolerance for peanut, refined oil 
as requested because the residue data indicate that anticipated 
residues in the peanut, refined oil are lower than, and will be covered 
by, the tolerance for peanut.
    Finally, the Agency is establishing a tolerance for radish, tops, 
even though it was not requested by the petitioner. Under EPA's 
regulations (40 CFR 180.40(f)(1)(i)(B)), EPA will not establish a crop 
group tolerance unless all necessary tolerances are established, 
including tolerances for raw commodities not covered by the crop group 
and derivative of commodities in the group. In this case, EPA is 
establishing a tolerance for root vegetables, subgroup 1A, which 
includes radish. Due to the presence of residues on radish tops, EPA is 
establishing a necessary tolerance on radish tops to facilitate the 
establishment of the subgroup 1A tolerance.

V. Conclusion

    Therefore, tolerances are established for residues of bixafen in or 
on beet, sugar, dried pulp at 1.0 ppm; cattle, fat at 0.08 ppm; cattle, 
meat byproducts at 0.40 ppm; cattle, muscle at 0.08 ppm; goat, fat at 
0.08 ppm; goat, meat byproducts at 0.40 ppm; goat, muscle at 0.08 ppm; 
grain, aspirated grain fractions at 80 ppm; grain, cereal, forage, 
fodder, and straw, group 16, except rice at 20 ppm; grain, cereal, 
group 15, except rice and grain sorghum at 0.40 ppm; horse, fat at 0.08 
ppm; horse, meat byproducts at 0.40 ppm; horse, muscle

[[Page 62485]]

at 0.08 ppm; milk at 0.04 ppm; peanut at 0.01 ppm; peanut, hay at 8.0 
ppm; radish, tops at 3.0 ppm; sheep, fat at 0.08 ppm; sheep, meat 
byproducts at 0.40 ppm; sheep, muscle at 0.08 ppm; sorghum, grain, 
grain at 3.0 ppm; soybean, hulls at 0.15 ppm; soybean, seed at 0.04 
ppm; vegetable, root subgroup 1A at 0.30 ppm; and vegetable, tuberous 
and corm subgroup 1C at 0.01 ppm.

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), nor is it considered a 
regulatory action under Executive Order 13771, entitled ``Reducing 
Regulations and Controlling Regulatory Costs'' (82 FR 9339, February 3, 
2017). 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: November 13, 2018.
Donna Davis,
Acting 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. Add Sec.  180.702 to subpart C to read as follows:


Sec.  180.702  Bixafen; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of the 
fungicide bixafen, including its metabolites and degradates, in or on 
the commodities in the table below. Compliance with the tolerance 
levels specified below is to be determined by measuring only bixafen, 
N-(3,4-dichloro-5-fluorobiphenyl-2-yl)-3-(difluoromethyl)-1-
methylpyrazole-4-carboxamide, in or on the commodity.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Beet, sugar, dried pulp.....................................         1.0
Grain, aspirated grain fractions............................          80
Grain, cereal, forage, fodder, and straw, group 16, except            20
 rice.......................................................
Grain, cereal, group 15, except rice and grain sorghum......        0.40
Peanut......................................................        0.01
Peanut, hay.................................................         8.0
Radish, tops................................................         3.0
Sorghum, grain, grain.......................................         3.0
Soybean, hulls..............................................        0.15
Soybean, seed...............................................        0.04
Vegetable, root, subgroup 1A................................        0.30
Vegetable, tuberous and corm, subgroup 1C...................        0.01
------------------------------------------------------------------------

    (2) Tolerances are established for residues of the fungicide 
bixafen, including its metabolites and degradates, in or on the 
commodities in the table below. Compliance with the tolerance levels 
specified below is to be determined by measuring only the sum of 
bixafen, N-(3,4-dichloro-5-fluorobiphenyl-2-yl)-3-(difluoromethyl)-1-
methylpyrazole-4-carboxamide, and its desmethyl metabolite, N-(3',4'-
dichloro-5-fluoro[1,1'-biphenyl]-2-yl)-3-(difluoromethyl)-1H-pyrazole-
4-carboxamide, calculated as the stoichiometric equivalent of bixafen, 
in or on the commodity.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Cattle, fat.................................................        0.08
Cattle, meat byproducts.....................................        0.40
Cattle, muscle..............................................        0.08
Goat, fat...................................................        0.08
Goat, meat byproducts.......................................        0.40
Goat, muscle................................................        0.08
Horse, fat..................................................        0.08
Horse, meat byproducts......................................        0.40
Horse, muscle...............................................        0.08
Milk........................................................        0.04
Sheep, fat..................................................        0.08
Sheep, meat byproducts......................................        0.40
Sheep, muscle...............................................        0.08
------------------------------------------------------------------------

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

[FR Doc. 2018-26348 Filed 12-3-18; 8:45 am]
 BILLING CODE 6560-50-P