[Federal Register Volume 83, Number 233 (Tuesday, December 4, 2018)]
[Rules and Regulations]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-26348]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
Bixafen; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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
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.
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
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
(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
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-
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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.
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
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
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.
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
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
Dated: November 13, 2018.
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
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,
methylpyrazole-4-carboxamide, in or on the commodity.
Beet, sugar, dried pulp..................................... 1.0
Grain, aspirated grain fractions............................ 80
Grain, cereal, forage, fodder, and straw, group 16, except 20
Grain, cereal, group 15, except rice and grain sorghum...... 0.40
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
methylpyrazole-4-carboxamide, and its desmethyl metabolite, N-(3',4'-
4-carboxamide, calculated as the stoichiometric equivalent of bixafen,
in or on the commodity.
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
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