[Federal Register Volume 84, Number 177 (Thursday, September 12, 2019)]
[Rules and Regulations]
[Pages 48071-48077]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-19662]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2018-0514; FRL-9998-98]
Pyraflufen-ethyl; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for residues of
pyraflufen-ethyl in or on multiple commodities which are identified and
discussed later in this document. In addition, certain existing
tolerances are removed as they are superseded by this action.
Interregional Research Project Number 4 (IR-4) requested these
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective September 12, 2019. Objections and
requests for hearings must be received on or before November 12, 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-2018-0514, 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: [email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
B. How can I get electronic access to other related information?
You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Publishing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/
[[Page 48072]]
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-2018-0514 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
November 12, 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-2018-0514, 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 October 18, 2018, 83 FR 52787 (FRL-9984-
21), 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
8E8684) by Interregional Research Project Number 4, IR-4 Headquarters,
Rutgers, The State University of New Jersey, 500 College Road East,
Suite 201 W, Princeton, New Jersey 08540. The petition requests the
establishment of tolerances in 40 CFR 180.585 for residues of the
herbicide pyraflufen-ethyl in or on the following commodities:
cottonseed subgroup 20C at 0.04 ppm; fruit, small, vine climbing,
except fuzzy kiwifruit, subgroup 13-07F at 0.01 ppm; fruit, stone,
group 12-12 at 0.01 ppm; hop, dried cones at 0.02 ppm; nut, tree, group
14-12 at 0.01 ppm; tropical and subtropical, small fruit, edible peel,
subgroup 23A at 0.01 ppm; and vegetable, tuberous and corm, subgroup 1C
at 0.02 ppm. Upon establishment of the above tolerances, the petitioner
proposes to remove the existing tolerances for residues of pyraflufen-
ethyl in or on cotton, undelinted seed at 0.04 ppm; fruit, stone, group
12 at 0.01 ppm; grape at 0.01 ppm; nut, tree, group 14 at 0.01 ppm;
olive at 0.01 ppm; and pistachio at 0.01 ppm. That document referenced
a summary of the petition prepared by Nichino America, Inc., the
registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the
notice of filing.
III. Aggregate Risk Assessment and Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue . .
. .''
Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for pyraflufen-ethyl including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with pyraflufen-
ethyl follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered their
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.
Pyraflufen-ethyl exhibits relatively low acute toxicity for oral,
dermal, and inhalation exposure. It is moderately irritating to the eye
but is not a skin irritant or a dermal sensitizer.
In repeat-dose oral studies, the liver, kidney, and hematopoietic
system are the target organs for pyraflufen-ethyl in the rat and the
mouse. Adverse effects were not noted in the dog following oral
exposure nor in the rat following dermal exposure. There is no evidence
of neurotoxicity following acute and subchronic dosing. In the
submitted immunotoxicity study, an immunosuppressant response was
observed only at dose levels approaching the limit dose of 1,000 mg/kg/
day. There was no evidence of increased susceptibility following pre-
natal exposure to rats and rabbits in the developmental toxicity
studies, nor following pre- and post-natal exposure to rats in the
multi-generation reproduction study.
Pyraflufen-ethyl is classified as ``Likely to be Carcinogenic to
Humans'' based on the presence of liver tumors (hepatocellular
adenomas, carcinomas, and/or hepatoblastomas) in male and female mice.
A linear low-dose extrapolation approach (Q1* of 3.32 x
10-2 (milligram/kilogram/day (mg/kg/day))-1) is
used to estimate human cancer risk.
Specific information on the studies received and the nature of the
adverse effects caused by pyraflufen-ethyl as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document ``SUBJECT: Pyraflufen-ethyl. Human
Health Risk Assessment for a Section 3 Registration of New Food Use on
Hops and Conversions and Expansions of the Following Crop Groups: Nut,
Tree, Group 14-12, Fruit, Stone, Group 12-12, Fruit, Small, Vine
Climbing, Except Fuzzy Kiwifruit, Subgroup 13-07F, Vegetable, Tuberous
and Corm,
[[Page 48073]]
Subgroup lC, Tropical and Subtropical, Small Fruit, Edible Peel
Subgroup 23A and Cottonseed Subgroup 20C'' at pages 28-35 in docket ID
number EPA-HQ-OPP-2018-0514.
B. Toxicological Points of Departure/Levels of Concern
Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
A summary of the toxicological endpoints for pyraflufen-ethyl used
for human risk assessment is discussed in Unit III of the final rule
published in the Federal Register of February 27, 2013 (78 FR 13257)
(FRL-9379-6).
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to pyraflufen-ethyl, EPA considered exposure under the
petitioned-for tolerances as well as all existing pyraflufen-ethyl
tolerances in 40 CFR 180.585. EPA assessed dietary exposures from
pyraflufen-ethyl 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.
No such effects were identified in the toxicological studies for
pyraflufen-ethyl; therefore, a quantitative acute dietary exposure
assessment is unnecessary.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the U.S. Department
of Agriculture's (USDA) 2003-2008 National Health and Nutrition
Examination Survey, What We Eat in America (NHANES/WWEIA).
A highly refined chronic non-cancer exposure assessment was
conducted. The Agency used residue estimates of 0.02 ppm for cottonseed
oil (\1/2\ tolerance); residue values of \1/2\ LOQ (limit of
quantitation) (supported by field trial and monitoring data) for all
other crops; and anticipated residues for livestock commodities
calculated using updated dietary burdens based on field trial data for
the livestock feed items. Percent crop treated (PCT) estimates and 2018
DEEM default processing factors were incorporated into the assessment.
iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that pyraflufen-ethyl should be classified as ``Likely to be
Carcinogenic to Humans'' and a linear approach has been used to
quantify cancer risk.
A linear low-dose extrapolation approach is used to estimate human
cancer risk (Q1* of 3.32 x 10-\2\ (mg/kg/day)-1). The
exposure inputs for the cancer assessment were quantified using the
same estimates as discussed in Unit III.C.1.ii., chronic exposure, and
a drinking water estimate of 0.672 ppb was used.
iv. Anticipated residue and percent crop treated (PCT) information.
Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and
information on the anticipated residue levels of pesticide residues in
food and the actual levels of pesticide residues that have been
measured in food. If EPA relies on such information, EPA must require
pursuant to FFDCA section 408(f)(1) that data be provided 5 years after
the tolerance is established, modified, or left in effect,
demonstrating that the levels in food are not above the levels
anticipated. For the present action, EPA will issue such data call-ins
as are required by FFDCA section 408(b)(2)(E) and authorized under
FFDCA section 408(f)(1). Data will be required to be submitted no later
than 5 years from the date of issuance of these tolerances.
Section 408(b)(2)(F) of FFDCA states that the Agency may use data
on the actual percent of food treated for assessing chronic dietary
risk only if:
Condition a: The data used are reliable and provide a
valid basis to show what percentage of the food derived from such crop
is likely to contain the pesticide residue.
Condition b: The exposure estimate does not underestimate
exposure for any significant subpopulation group.
Condition c: Data are available on pesticide use and food
consumption in a particular area, and the exposure estimate does not
understate exposure for the population in such area.
In addition, the Agency must provide for periodic evaluation of any
estimates used. To provide for the periodic evaluation of the estimate
of PCT as required by FFDCA section 408(b)(2)(F), EPA may require
registrants to submit data on PCT.
The Agency used the following average percent crop treated
estimates for the chronic non-cancer and cancer analyses: 1% for
barley, beans (snap, bush, pole, and string), celery, corn, dry beans
and peas, onions, peanuts, pecans, potatoes, pumpkins, sorghum,
soybeans, squash, sunflowers, tomatoes, and walnuts; 2.5% for almonds,
apples, canola, cherries, lettuce, olive, and peach; 5% for cotton,
garlic, table grape, raisin, kiwi, pistachio, plum and prune; 10% for
wine grape, and pear; 20% for apricot, and fig; and 40% for
pomegranate. For all other commodities, 100% crop treated was used.
In most cases, EPA uses available data from United States
Department of Agriculture/National Agricultural Statistics Service
(USDA/NASS), proprietary market surveys, and California Department of
Pesticide Regulation (CalDPR) Pesticide Use Reporting (PUR) for the
chemical/crop combination for the most recent 10 years. EPA uses an
average PCT for chronic dietary risk analysis and a maximum PCT for
acute dietary risk analysis. The average PCT figure for each existing
use is derived by combining available public and private market survey
data for that use, averaging across all observations, and rounding up
to the nearest 5%, except for those situations in which the average PCT
is less than 1% or less than 2.5%. In those cases, the Agency would use
less than 1% or less than 2.5% as the average PCT value, respectively.
The maximum PCT figure is the highest observed maximum value reported
within the most recent 10 years of available public and private market
survey data for the existing use and rounded up to the nearest multiple
of 5%, except where the maximum PCT is less than 2.5%, in which case,
the Agency uses less than 2.5% as the maximum PCT.
The Agency believes that the three conditions discussed in Unit
III.C.1.iv. have been met. With respect to
[[Page 48074]]
Condition a, PCT estimates are derived from Federal and private market
survey data, which are reliable and have a valid basis. The Agency is
reasonably certain that the percentage of the food treated is not
likely to be an underestimation. As to Conditions b and c, regional
consumption information and consumption information for significant
subpopulations is taken into account through EPA's computer-based model
for evaluating the exposure of significant subpopulations including
several regional groups. Use of this consumption information in EPA's
risk assessment process ensures that EPA's exposure estimate does not
understate exposure for any significant subpopulation group and allows
the Agency to be reasonably certain that no regional population is
exposed to residue levels higher than those estimated by the Agency.
Other than the data available through national food consumption
surveys, EPA does not have available reliable information on the
regional consumption of food to which pyraflufen-ethyl may be applied
in a particular area.
2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for pyraflufen-ethyl in drinking water. These simulation
models take into account data on the physical, chemical, and fate/
transport characteristics of pyraflufen-ethyl. 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 Pesticide in Water Calculator (PWC version 1.52) was utilized
to calculate all Estimated Drinking Water Concentrations (EDWCs). The
EDWCs were incorporated directly into this dietary exposure assessment.
Water residues were incorporated in the DEEM-FCID into the food
categories ``water, direct, all sources'' and ``water, indirect, all
sources.''
Drinking water concentrations were estimated separately for chronic
and cancer durations. The highest EDWCs resulted from groundwater for
these durations.
For chronic exposures for non-cancer assessments are estimated to
be 0.295 ppb for surface water and 0.672 ppb for ground water. For
chronic exposures for cancer assessments are estimated to be 0.268 ppb
for surface water and 0.672 ppb for ground water.
Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For both chronic and cancer
assessments, the highest EDWC of 0.672 ppb was used to assess the
dietary contribution from 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).
Pyraflufen-ethyl is currently registered for use by residential and
commercial applicators on several residential/non-agricultural use
sites; i.e., established ornamental turf lawns, parks, cemeteries,
athletic fields, golf courses, sod farms, nurseries and ornamental
plantings, and Christmas trees. There is the potential for residential
(post-application) exposure pathways via the oral, dermal, and
inhalation routes of exposure. Post-application dermal exposure (adults
and children 1 to <2 years old) was not assessed for non-cancer effects
since no toxicity was observed at the limit dose (1,000 mg/kg/day) in a
28-day dermal toxicity study in rats.
Residential exposure is expected to be short-term (1 to 30 days) in
duration. The quantitative exposure assessment for residential non-
cancer post-application exposures is based on incidental (hand-to-
mouth) oral exposure (children 1 to <2 years old) from contact with
residues on lawns and turf scenario. While not the only lifestage
potentially exposed for these post-application scenarios, the lifestage
that is included in the quantitative assessment is health protective
for the exposures and risk estimates for any other potentially exposed
lifestage. The registered application rate for pyraflufen-ethyl on
lawns and turf was utilized in the assessing exposure.
A dermal and inhalation cancer exposure assessment was performed
because dermal and inhalation exposure contributes to the overall
cancer risk for pyraflufen-ethyl. Further information regarding EPA
standard assumptions and generic inputs for residential exposures may
be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.
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 pyraflufen-ethyl to share a common mechanism of
toxicity with any other substances, and pyraflufen-ethyl does not
appear to produce a toxic metabolite produced by other substances. For
the purposes of this tolerance action, therefore, EPA has assumed that
pyraflufen-ethyl 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
factor.
2. Prenatal and postnatal sensitivity. There is no evidence of
increased susceptibility of rat or rabbit fetuses following in utero
exposure in the developmental studies with pyraflufen-ethyl.
Developmental effects for both rats and rabbits occurred at either the
same dose levels or were above the NOAELs and LOAELs for maternal
toxicity. Similarly, there is no evidence of increased susceptibility
of young rats in the pyraflufen-ethyl 2-generation rat reproduction
study. The NOAEL for offspring effects was identical to that of the
parental animals. There are no residual uncertainties for pre- and/or
postnatal exposure.
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 pyraflufen-ethyl is complete.
ii. There is no indication that pyraflufen-ethyl is a neurotoxic
chemical based on results of acute and
[[Page 48075]]
subchronic neurotoxicity studies, and no neurotoxic effect was seen in
other toxicity studies. Therefore, there are no concerns for
neurotoxicity and no need for a developmental neurotoxicity study or
additional UFs to account for neurotoxicity.
iii. Developmental studies with pyraflufen-ethyl show no evidence
of increased susceptibility of rat or rabbit fetuses following in utero
exposure. Similarly, there is no evidence of increased susceptibility
of young rats in the pyraflufen-ethyl 2-generation rat reproduction
study.
iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed using
PCT data, where available; refined residue concentrations (generally
\1/2\ LOQ); anticipated residues in livestock commodities; and default
and empirical processing factors. EPA made conservative (protective)
assumptions in the ground and surface water modeling used to assess
exposure to pyraflufen-ethyl in drinking water. EPA used similarly
conservative assumptions to assess post-application exposure of adults
and children as well as incidental oral exposure of children. In
addition, the residential exposure assessment used surrogate study
data, including conservative exposure assumptions based on Day 0
dermal/oral contact to turf and surfaces treated at the maximum
application rate. These data are reliable and are not expected to
underestimate risks to adults or children.
E. Aggregate Risks and Determination of Safety
EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
1. Acute risk. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary consumption of food and
drinking water. No adverse effect resulting from a single oral exposure
was identified and no acute dietary endpoint was selected. Therefore,
pyraflufen-ethyl is not expected to pose an acute risk.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
pyraflufen-ethyl from food and water will utilize <1% of the cPAD for
the general U.S. population and all population subgroups, including
children 1 to 2 years old, the most highly exposed population subgroup.
Based on the explanation in Unit III.C.3., regarding residential use
patterns, chronic residential exposure to residues of pyraflufen-ethyl
is not expected.
3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level). Pyraflufen-
ethyl is currently registered for uses that could result in short-term
residential exposure, and the Agency has determined that it is
appropriate to aggregate chronic exposure through food and water with
short-term residential exposures to pyraflufen-ethyl.
Using the exposure assumptions described in this unit for short-
term exposures, EPA concluded there is potential short-term exposure to
pyraflufen-ethyl via dietary and residential exposure pathways. For
adults, these pathways lead to exposure via oral and inhalation routes.
EPA chose the most conservative scenario, children 1 to 2 years old
with hand-to-mouth exposure from treated turf as well as the
subpopulation with the highest chronic dietary exposure resulting in an
aggregate MOE of 69,000. Because EPA's level of concern for pyraflufen-
ethyl is a MOE of 100 or below, this MOE is not of concern.
4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level). An intermediate-term adverse effect was identified; however,
pyraflufen-ethyl is not registered for any use patterns that would
result in intermediate-term residential exposure. Intermediate-term
risk is assessed based on intermediate-term residential exposure plus
chronic dietary exposure. Because there is no intermediate-term
residential exposure and chronic dietary exposure has already been
assessed under the appropriately protective cPAD (which is at least as
protective as the POD used to assess intermediate-term risk), no
further assessment of intermediate-term risk is necessary, and EPA
relies on the chronic dietary risk assessment for evaluating
intermediate-term risk for pyraflufen-ethyl.
5. Aggregate cancer risk for U.S. population. The aggregate cancer
risk assessment for the general U.S. population considers exposure
estimates from dietary consumption of pyraflufen-ethyl in food and
drinking water and exposure through residential uses of pyraflufen-
ethyl. Exposures from residential uses are based on the lifetime
average daily dose and assume an exposure period of 2 days per year and
35 years of exposure over a 78-year lifetime. Average food and water
exposure to pyraflufen-ethyl was used in the aggregate cancer
assessment. Estimated cancer risk for the general U.S. population
includes infants and children; therefore, a children's cancer risk
estimate was not reported separately. For a description of the
residential exposure scenarios considered in the aggregate assessment,
see section 6.3. The aggregate cancer risk estimate for pyraflufen-
ethyl is 1.1 x 10-6. The Agency generally considers risks up
to 3 x 10-6 to be within the negligible risk range and below
the Agency's LOC. Therefore, the aggregate cancer risk estimate from
pyraflufen-ethyl residues in food and drinking water is not of concern
to EPA for the general U.S. population. This is a conservative estimate
of pyraflufen-ethyl exposure based on the inputs to the dietary and
residential exposure assessments.
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 pyraflufen-ethyl residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methods are available. Gas chromatography/mass
spectroscopy (GC/MS) analytical methods determine Metabolite E-1 as its
methyl ester (E-15) and monitor two ion transitions each for
pyraflufen-ethyl and the E-15 analyte. The methods also contain
appendices that provide parameters for other detection schemes such as
GC/electron-capture detection (ECD), GC/nitrogen-phosphorus detection
(NPD), and GC/MS/MS.
The methods may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350; telephone number: (410) 305-2905; email address:
[email protected].
B. International Residue Limits
In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food
[[Page 48076]]
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 any MRLs for pyraflufen-ethyl.
V. Conclusion
Therefore, tolerances are established for residues of pyraflufen-
ethyl, ethyl 2-[2-chloro-5-(4-chloro-5-difluoromethoxy)-1-methyl-1H-
pyrazol-3-yl]-4-fluorophenoxy] acetate, including its metabolites and
degradates. Compliance with these tolerances is to be determined by
measuring only the sum of the parent pyraflufen-ethyl, and its acid
metabolite, E-1,2-chloro-5-(4-chloro-5-difluoromethoxy-1-methyl-1H-
pyrazol-3-yl)-4-fluorophenoxyacetic acid, calculated as the
stoichiometric equivalent of pyraflufen-ethyl in or on commodities:
Cottonseed subgroup 20C at 0.04 ppm; Fruit, small, vine climbing,
except fuzzy kiwifruit, subgroup 13-07F at 0.01 ppm; Fruit, stone,
group 12-12 at 0.01 ppm; Hop, dried cones at 0.02 ppm; Nut, tree, group
14-12 at 0.01 ppm; Tropical and subtropical, small fruit, edible peel,
subgroup 23A at 0.01 ppm and Vegetable, tuberous and corm, subgroup 1C
at 0.02 ppm. In addition, existing tolerances on Cotton, undelinted
seed; Fruit, stone, group 12; Grape; Nut, tree, group 14; Olive;
Pistachio; and Potato are removed as they are superseded by this
regulation.
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: August 30, 2019.
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. In Sec. 180.585, amend the table in paragraph (a) as follows:
0
i. Add alphabetically the entries ``Cottonseed subgroup 20C''; ``Fruit,
small, vine climbing, except fuzzy kiwifruit, subgroup 13-07F'';
``Fruit, stone, group 12-12''; ``Hop, dried cones''; ``Nut, tree, group
14-12''; ``Tropical and subtropical, small fruit, edible peel, subgroup
23A''; and ``Vegetable, tuberous and corm, subgroup 1C''.
0
ii. Remove the entries for ``Cotton, undelinted seed''; ``Fruit, stone,
group 12''; ``Grape''; ``Nut, tree, group 14''; ``Olive'';
``Pistachio''; and ``Potato''.
The additions and revisions read as follows:
Sec. 180.585 Pyraflufen-ethyl; tolerances for residues.
(a) * * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Cottonseed subgroup 20C................................. 0.04
* * * * *
Fruit, small, vine climbing, except fuzzy kiwifruit, 0.01
subgroup 13-07F........................................
* * * * *
Fruit, stone, group 12-12............................... 0.01
* * * * *
Hop, dried cones........................................ 0.02
[[Page 48077]]
* * * * *
Nut, tree, group 14-12.................................. 0.01
* * * * *
Tropical and subtropical, small fruit, edible peel, 0.01
subgroup 23A...........................................
Vegetable, tuberous and corm, subgroup 1C............... 0.02
* * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 2019-19662 Filed 9-11-19; 8:45 am]
BILLING CODE 6560-50-P