83 FR 60366 - Pyrifluquinazon; Pesticide Tolerances

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 83, Issue 227 (November 26, 2018)

Page Range		60366-60372
FR Document		2018-25690

This regulation establishes tolerances for residues of pyrifluquinazon in or on multiple commodities that are identified and discussed later in this document. Nichino America, Inc. requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

Federal Register, Volume 83 Issue 227 (Monday, November 26, 2018)

[Federal Register Volume 83, Number 227 (Monday, November 26, 2018)]
[Rules and Regulations]
[Pages 60366-60372]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2018-25690]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2011-0971; FRL-9977-14]

Pyrifluquinazon; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
pyrifluquinazon in or on multiple commodities that are identified and
discussed later in this document. Nichino America, Inc. requested these
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective November 26, 2018. Objections and
requests for hearings must be received on or before January 25, 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-2011-0971, 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, Director, 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-2011-0971 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
January 25, 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-2011-0971, 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 Tolerances

In the Federal Register of December 9, 2016 (81 FR 89036) (FRL-
9953-69) and September 15, 2017 (82 FR 43352) (FRL-9965-43), EPA issued
a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3),
announcing the filing of pesticide petitions (PP 6F8502 and PP 7E8578,
respectively) by Nichino America, Inc., 4550 New Linden Hill Road,
Suite 501, Wilmington, DE 19808. The petitions requested that 40 CFR
part 180 be amended by establishing tolerances for residues of the
insecticide pyrifluquinazon, (1-acetyl-3,4-dihydro-3-[(3-
pyridinylmethyl)amino]-6-[1,2,2,2-tetrafluoro-1-
(trifluoromethyl)ethyl]-2(1H)-quinazolinone), as follows: PP 6F8502
requested tolerances for residues in or on Almond, hulls at 0.4 parts
per million (ppm); Brassica head and stem vegetables (crop group 5-16)
at 0.4 ppm; Cattle, fat at 0.01 ppm; Cattle, meat at 0.01 ppm; Cattle,
meat byproducts at 0.01 ppm; Citrus fruits (crop group 10-10) at 0.5
ppm; Citrus, oil at 14 ppm; Cotton, gin byproducts at 4.0 ppm; Cotton,
undelinted seed at 0.2 ppm; Cucurbit vegetables (crop group 9)

[[Page 60367]]

at 0.06 ppm; Fruiting vegetables, tomato subgroup 8-10A at 0.20 ppm;
Fruiting vegetables, pepper/eggplant subgroup 8-10B at 0.15 ppm; Goat,
fat at 0.01 ppm; Goat, meat at 0.01 ppm; Goat, meat byproducts at 0.01
ppm; Horse, fat at 0.01 ppm; Horse, meat at 0.01 ppm; Horse, meat
byproducts at 0.01 ppm; Leafy vegetables (crop group 4-16) at 5 ppm;
Leaf petiole vegetables (crop subgroup 22B) at 1.5 ppm; Milk at 0.01
ppm; Pome fruits (crop group 11-10) at 0.04 ppm; Sheep, fat at 0.01
ppm; Sheep, meat at 0.01 ppm; Sheep, meat byproducts at 0.01 ppm; Small
fruit vine climbing subgroup (crop subgroup 13-07F) except fuzzy
kiwifruit at 0.6 ppm; Stone fruits, cherry subgroup 12-12A at 0.2 ppm;
Stone fruits, peach subgroup 12-12B at 0.03 ppm; Stone fruits, plum
subgroup 12-12C at 0.015 ppm; Tree nuts (crop group 14-12) at 0.01 ppm;
and Tuberous and corm vegetables (crop subgroup 1C) at 0.01 ppm and PP
7E8578 requested a tolerance for residues in or on imported tea at 20
ppm. Those documents referenced summaries of the petitions prepared by
Nichino America, Inc., the registrant, which are available in the
docket, http://www.regulations.gov. Comments were received in response
to the first notice of filing, and EPA's response can be found in Unit
IV.C.
Consistent with the authority in section 408(d)(4)(A)(i), EPA is
establishing tolerances that vary from what the petitioner sought. The
reasons 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 pyrifluquinazon including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with pyrifluquinazon
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.
The effects observed following dietary exposure to pyrifluquinazon,
primarily targeted the liver, thyroid, kidney, hematopoietic system,
and the male and female reproductive organs. Nasal toxicity was
observed following chronic oral exposures to rats, mice, and dogs, but
was not observed following inhalation exposure to rats. Inhalation
exposure for 28 days in rats resulted in portal-of-entry effects in the
form of terminal airway inflammation in the lungs of males at an
equivalent oral dose that was higher than those causing nasal effects
in dogs (the most sensitive species for nasal toxicity). Systemic
effects following inhalation exposure to pyrifluquinazon consisted of
clinical signs including palpebral closure, splayed gait, hunched
posture, ataxia, piloerection, lethargy, and ocular effects. No adverse
effects were seen in rats following dermal exposure. Pyrifluquinazon
showed no signs of immunotoxicity.
Pyrifluquinazon showed signs of increased pre- and postnatal
quantitative susceptibility in rats. In the rat developmental toxicity
study, maternal effects (decreased body weights, and mean gravid
uterine weights) were seen at a higher dose than fetal effects
(decreased anogenital distances (AGD) in males, increased incidences of
skeletal variations, and increased incidences of supernumerary ribs).
In the two-generation reproduction study in rats, systemic parental
effects were consistent with the general systemic toxic effects in rats
and occurred at doses higher than those eliciting offspring and
reproductive effects. Offspring effects included decreased body weights
and decreased AGD in the male pups, which is also considered a
reproductive effect. In the rabbit developmental toxicity study, a
decreased number of live fetuses per doe was observed, which is
considered a maternal and developmental adverse effect since it is
unknown whether the effect occurred from toxicity to maternal animals
or the fetuses. In addition, effects were observed in reproductive
organs (epididymides, testes, uterus).
Signs of neurotoxicity were observed in the acute neurotoxicity
(ACN) study, and consisted of: Decreased motor activity, prostrate,
ataxia, hyporeactivity, hunched posture, loss of the righting reflex,
coldness to touch, lacrimation, bradyapnea, piloerection, and ptosis.
Signs of neurotoxicity were also observed in the subchronic oral study
and the inhalation study in rats at doses that caused portal-of-entry
effects.
Exposure to pyrifluquinazon resulted in increased incidences of
testicular interstitial cell tumors (Leydig tumors) in both male rats
and mice. Based on its review of the available data, EPA has concluded
that pyrifluquinazon is ``not likely to be carcinogenic to humans at
levels that do not alter rodent hormone homeostasis.'' This conclusion
is based on the following: (1) The Agency was only able to conclude
that one type of Leydig cell tumor (in the male mice) is treatment-
related because the type of rat tested has a high background rate for
this tumor type; (2) the suggested mode of action is supported by the
available data and indicates that the tumors are not likely to occur
below doses that trigger androgen receptor degradation in sex-specific
tissues leading to changes in circulating androgen related hormones;
and (3) neither the parent molecule nor its metabolites showed evidence
of genotoxicity or mutagenicity. For these reasons and because the
level that triggers tumor development is higher than 70.1 mg/kg/day and
the chronic reference dose is 0.06 mg/kg/day, EPA has determined that
quantification of cancer risk using a non-linear approach (i.e.,
chronic reference dose) will adequately account for all chronic
toxicity, including carcinogenicity that could result from exposure to
pyrifluquinazon.
Specific information on the studies received and the nature of the
adverse effects caused by pyrifluquinazon 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 ``Pyrifluquinazon: Human Health Risk
Assessment for the Proposed Use on Tuberous and Corm Vegetables, Leafy

[[Page 60368]]

Vegetables (including greenhouse-grown lettuce), Brassica Head and Stem
Vegetables, Fruiting Vegetables (including greenhouse-grown pepper and
tomato), Cucurbit Vegetables (including greenhouse-grown cucumber),
Citrus Fruits, Pome Fruits, Stone Fruits, Small Vine Climbing Fruit
(excluding fuzzy kiwifruit), Tree Nuts, Leaf Petiole Vegetables, and
Cotton, and for the Establishment of a Tolerance without a U.S.
Registration for Residues in/on Imported Tea'' on pages 16-24 in docket
ID number EPA-HQ-OPP-2011-0971.

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 pyrifluquinazon used
for human risk assessment is shown in Table 1 of this unit.

Table--Summary of Toxicological Doses and Endpoints for Pyrifluquinazon 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 (Females 13-49 NOAEL = 5 mg/kg/day. Acute RfD = 0.05 mg/ Developmental Toxicity Study (rat)
years of age). UFA = 10X........... kg/day. LOAEL = 10 mg/kg/day based on
UFH = 10X........... aPAD = 0.05 mg/kg/ decreased AGD in males, increased
FQPA SF = 1X........ day. incidences of skeletal variations
(total), and increased incidences
of supernumerary ribs.
Acute dietary (General population NOAEL = 100 mg/kg/ Acute RfD = 1 mg/kg/ Acute Neurotoxicity Screening
including infants and children). day. day. Battery
UFA = 10X........... aPAD = 1 mg/kg/day. LOAEL = 300 mg/kg/day based on
UFH = 10X........... increased incidences of clinical
FQPA SF = 1X........ signs and effects on functional
observational parameters,
dehydration, decreased motor
activity, prostrate, ataxia,
hyporeactivity, scant or no
feces, hunched posture, lost
righting reflex, decreased body
temperatures, lacrimation,
bradyapnea, piloerection, ptosis,
and decreased grip strength),
decreased body weights and body-
weight gains, decreased food
consumption, and decreased brain
weights.
Chronic dietary (All populations) NOAEL= 6.25 mg/kg/ Chronic RfD = 0.06 Carcinogenicity (mouse)
day. mg/kg/day. LOAEL = 27.1/25.0 mg/kg/day (M/F)
UFA = 10X........... cPAD = 0.06 mg/kg/ based on decreased mean body
UFH = 10X........... day. weight in males; and increased
FQPA SF = 1X........ incidences of tactile hair loss
in males, endometrial hyperplasia
of the uterine horn in females,
follicular cell hypertrophy of
the thyroid in males, and
subcapsular cell hyperplasia of
the adrenal in males.
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation) Classification: ``Not likely to be carcinogenic to humans at levels that do
not alter rodent hormone homeostasis.''
----------------------------------------------------------------------------------------------------------------

FQPA SF = Food Quality Protection Act Safety Factor. LOAEL =
lowest-observed-adverse-effect-level. LOC = level of concern. mg/kg/day
= milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-
observed-adverse-effect-level. PAD = population-adjusted dose (a =
acute, c = chronic). RfD = reference dose. UF = uncertainty factor.
UFA = extrapolation from animal to human (interspecies).
UFDB = to account for the absence of data or other data
deficiency. 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 pyrifluquinazon, EPA considered exposure under the
petitioned-for tolerances. EPA assessed dietary exposures from
pyrifluquinazon 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 pyrifluquinazon. In estimating acute dietary exposure, EPA used the
Dietary Exposure Evaluation Model software with the Food Commodity
Intake Database (DEEM-FCID) Version 3.16. This software uses 2003-2008
food consumption data from the U.S. Department of Agriculture's
(USDA's) National Health and Nutrition Examination Survey, What We Eat
in America, (NHANES/WWEIA). As to residue levels in food, EPA assumed
tolerance level residues, default processing factors, and 100 percent
crop treated (PCT) for all proposed uses.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment

[[Page 60369]]

EPA used DEEM-FCID, Version 3.16 software with 2003-2008 food
consumption data from the USDA's NHANES/WWEIA. As to residue levels in
food, EPA assumed tolerance level residues, default processing factors,
and 100 PCT for all proposed and registered uses.
iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that pyrifluquinazon would not pose a cancer risk to humans
at dose levels below the chronic reference dose. Therefore, a separate
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 pyrifluquinazon. Tolerance-level residues and/or
100% CT 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 pyrifluquinazon in drinking water. These simulation
models take into account data on the physical, chemical, and fate/
transport characteristics of pyrifluquinazon. 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.
Based on the Pesticides in Water Calculator (PWC) and Pesticide
Root Zone Model Ground Water (PRZM GW), the estimated drinking water
concentrations (EDWCs) of pyrifluquinazon for acute exposures are
estimated to be 7.52 parts per billion (ppb) for surface water and 10.3
ppb for ground water; for chronic exposures for non-cancer assessments
are estimated to be 3.99 ppb for surface water and 9.02 ppb for ground
water.
Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For acute dietary risk
assessment, the water concentration value of 10.3 ppb was used to
assess the contribution to drinking water. For chronic dietary risk
assessment, the water concentration of value 9.02 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). Pyrifluquinazon is
not registered for any specific use patterns that would result in
residential exposure.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
EPA has not found pyrifluquinazon to share a common mechanism of
toxicity with any other substances, and pyrifluquinazon does not appear
to produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
pyrifluquinazon 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. Pyrifluquinazon showed signs
of increased pre- and postnatal quantitative susceptibility in the
developmental toxicity study and in the two-generation reproduction
study in rats. In the rabbit developmental toxicity study, observed
maternal and developmental effects were considered adverse since it is
unknown whether the effects occurred from toxicity to maternal animals
or the fetuses.
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 pyrifluquinazon is complete.
ii. Evidence of potential neurotoxicity was observed for
pyrifluquinazon; however, the concern is low since there were no
neuropathological changes in any tissue, clear NOAELs were established
for the observed effects, and the endpoints selected are protective. No
additional UFs were required to account for neurotoxicity.
iii. Although there is evidence of increased quantitative fetal
susceptibility following in utero exposure to pyrifluquinazon in rats
and quantitative postnatal susceptibility in the two-generation
reproduction study, the concern for all observed effects is low
because: (1) The effects are well characterized, (2) clear NOAELs were
established, and (3) risk assessment endpoints used were from the
developmental rat and 2-generation reproduction studies.
iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100% CT and tolerance-level residues. EPA made conservative
(protective) assumptions in the ground and surface water modeling used
to assess exposure to pyrifluquinazon in drinking water. These
assessments will not underestimate the exposure and risks posed by
pyrifluquinazon.

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 (food plus water) risk for
the U.S. population utilizes 1.2% of the acute population-adjusted dose
(aPAD) and 2.5% for children 1-2 years old, who had the highest
exposure estimate. For females 13 to 49 years old, for which the Agency
used a different endpoint, the acute risk utilized 23% of the aPAD.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded

[[Page 60370]]

that chronic risk from pyrifluquinazon in food and water will utilize
13% of the cPAD for children 1-2 years old, the population subgroup
receiving the greatest exposure. There are no residential uses for
pyrifluquinazon.
3. Short- and intermediate-term risk. The Agency's assessment of
short- and intermediate-term risk aggregates short- and intermediate-
term residential exposure plus chronic exposure to food and water
(considered to be a background exposure level). Short- and
intermediate-term adverse effects were identified; however,
pyrifluquinazon is not registered for any use patterns that would
result in short- or intermediate-term residential exposure. Because
there is no 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- and intermediate-term risk is necessary,
and EPA relies on the chronic dietary risk assessment for evaluating
short- and intermediate-term risk for pyrifluquinazon.
4. Aggregate cancer risk for U.S. population. Based on the
information referenced in Unit III.A., EPA has concluded that exposure
to pyrifluquinazon is unlikely to cause cancer effects at doses that do
not alter rodent hormone homeostasis. Because the chronic reference
doses is protective of those alterations and the Agency's assessment
concludes that aggregate exposure to pyrifluquinazon does not pose a
chronic risk, EPA has determined that aggregate exposure to
pyrifluquinazon is unlikely to pose a cancer risk to the U.S.
population.
5. 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 pyrifluquinazon residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

Adequate enforcement methodology, high-performance liquid
chromatography with tandem mass-spectrometry detection (HPLC-MS/MS) is
available to enforce the tolerance expression for crop commodities. For
livestock commodities, the method used is a modified QuEChERS LC/MS/MS
method. These 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:
residuemethods@epa.gov.

B. International Residue Limits

In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. Section
408(b)(4) of the FFDCA specifically requires that EPA determine whether
the Codex Alimentarius Commission (Codex) has established a maximum
residue level (MRL) for the commodity and to explain the reasons for
departing from the Codex level when establishing tolerances at a
different level. 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 also take into account MRLs established by
other countries when determining what tolerance levels to set
domestically.
The Codex has not established a MRL for residues of
pyrifluquinazon. EPA is establishing the tolerance for residues of
pyrifluquinazon in or on tea to harmonize with Japan.

C. Response to Comments

EPA received two comments, only one of which was specific to the
petition for pyrifluquinazon tolerances. The specific comment opposed
``allowing such high residues'' but did not provide any information
relevant to the safety of the pesticide. The Agency recognizes that
some individuals believe that pesticides should be banned on
agricultural crops; however, the existing legal framework provided by
section 408 of the FFDCA states that tolerances may be set when persons
seeking such tolerances or exemptions have demonstrated that the
pesticide meets the safety standard imposed by that statute. The
comment appears to be directed at the underlying statute and not EPA's
implementation of it; the citizen has made no contention that EPA has
acted in violation of the statutory framework.

D. Revisions to Petitioned-For Tolerances

Almost all the tolerances being established in this rule differ
from the petitioner requested in minor ways. For crop subgroups
``vegetable, tuberous and corm, subgroup 1C,'' ``stone fruits, plum
subgroup 12-12C,'' and crop group ``nut, tree, group 14-12,'' the
appropriate tolerance level (0.02 ppm) is based on the sum of the LOQs
for pyrifluquinazon and metabolite IV-01, rather than on the LOQ for
one analyte (0.01 ppm), as requested. In addition, EPA determined that
a tolerance is needed for residues in or on the processed commodity
citrus dried pulp, so EPA is establishing that tolerance in accordance
with 40 CFR 180.40(f)(1)(i)(A). Based on the dietary burden
calculations and the residue profile in the cattle feeding study, EPA
concluded that tolerances are not needed for pyrifluquinazon residues
of concern in milk, livestock meat, fat, or meat byproducts as expected
secondary residues are less than 1/10th the combined LOQs. However, a
tolerance for livestock liver is needed at the LOQ (pyrifluquinazon,
metabolite IV-01, and metabolite IV-203) corresponding to a tolerance
of 0.04 ppm. The combined LOQs for pyrifluquinazon, metabolite IV-01,
and metabolite IV-203 in parent equivalents corresponded to 0.035 ppm;
therefore, a tolerance of 0.04 ppm is required for the liver of cattle,
goat, horse, and sheep. For the remainder of tolerances being
established, EPA used corrected commodity names, and adjusted
tolerances levels based on available residue data, proportionality
adjustments to the crop field trial data. and correcting for potential
decline during frozen storage, which resulted in increased recommended
tolerances. Finally, EPA notes that although the notice of filing
indicated that the petition requested a tolerance for almond, hulls at
0.01 ppm, the petition itself requested a tolerance at 0.4 ppm.
Nevertheless, based on available residue data, the Agency has
determined that a tolerance of 0.60 ppm is necessary to cover residues
from this use.

V. Conclusion

Therefore, tolerances are established for residues of
pyrifluquinazon, (1-acetyl-3,4-dihydro-3-[(3-pyridinylmethyl)amino]-6-
[1,2,2,2-tetrafluoro-1-(trifluoromethyl)ethyl]-2(1H)-quinazolinone),
and its metabolites in or on Almond, hulls at 0.60 ppm; Cherry subgroup
12-12A at 0.30 ppm; Citrus, dried pulp at 2.0 ppm; Citrus, oil at 30
ppm; Cotton, gin byproducts at 6.0 ppm; Cotton, undelinted seed at 0.30
ppm; Fruit, citrus, group 10-10 at 0.70 ppm; Fruit, pome, group 11-10
at 0.07 ppm; Fruit small vine climbing, except fuzzy kiwifruit,
subgroup 13-07F at 0.30 ppm; Leaf petiole vegetable, subgroup 22B at
1.5 ppm; Peach subgroup 12-12B at 0.04 ppm; Plum subgroup 12-12C at
0.02 ppm; Nut, tree, group 14-12 at 0.02 ppm; Tea, dried at 20 ppm;
Vegetable,

[[Page 60371]]

brassica, head and stem, group 5-16 at 0.60 ppm; Vegetable, cucurbit,
group 9 at 0.07 ppm; Vegetable, fruiting, group 8-10 at 0.30 ppm;
Vegetable, leafy, group 4-16 at 5.0 ppm; Vegetable, tuberous and corm,
subgroup 1C at 0.02 ppm; Cattle, liver at 0.04 ppm; Goat, liver at 0.04
ppm; Horse, liver at 0.04 ppm; and Sheep, liver at 0.04 ppm. For the
plant commodities, compliance with the tolerance is determined by
measuring residues of the parent compound and the IV-01 metabolite; for
the livestock commodities, compliance is determined by measuring
residues of the parent compound and the free and conjugated forms of
IV-01 and IV-203 metabolites.

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); Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997); or 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 tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This action directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined 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 9, 2018.
Michael Goodis,
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. 180.701 to subpart C to read as follows:

Sec. 180.701 Pyrifluquinazon; tolerances for residues.

(a) General. (1) Tolerances are established for residues of the
insecticide pyrifluquinazon, 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 pyrifluquinazon (1-acetyl-3,4-dihydro-3-[(3-
pyridinylmethyl)amino]-6-[1,2,2,2-tetrafluoro-1-
(trifluoromethyl)ethyl]-2(1H)-quinazolinone) and its metabolite IV-01
(3-[(pyridin-3-ylmethyl)amino]-6-[1,2,2,2-tetrafluoro-1-
(trifluoromethyl)ethyl]-3,4-dihydro-1H-quinazolin-2-one), calculated as
the stoichiometric equivalent of pyrifluquinazon.

------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Almond, hulls............................................... 0.60
Cherry subgroup 12-12A...................................... 0.30
Citrus, dried pulp.......................................... 2.0
Citrus, oil................................................. 30
Cotton, gin byproducts...................................... 6.0
Cotton, undelinted seed..................................... 0.30
Fruit, citrus, group 10-10.................................. 0.70
Fruit, pome, group 11-10.................................... 0.07
Fruit, small vine climbing, except fuzzy kiwifruit, subgroup 0.30
13-07F.....................................................
Leaf petiole vegetable, subgroup 22B........................ 1.5
Peach subgroup 12-12B....................................... 0.04
Plum subgroup 12-12C........................................ 0.02
Nut, tree, group 14-12...................................... 0.02
Tea, dried\1\............................................... 20
Vegetable, brassica, head and stem, group 5-16.............. 0.60
Vegetable, cucurbit, group 9................................ 0.07
Vegetable, fruiting, group 8-10............................. 0.30
Vegetable, leafy, group 4-16................................ 5.0
Vegetable, tuberous and corm, subgroup 1C................... 0.02
------------------------------------------------------------------------
\1\ There are no U.S. registrations as of November 26, 2018 for use on
tea.

(2) Tolerances are established for residues of the insecticide
pyrifluquinazon, 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
pyrifluquinazon (1-acetyl-3,4-dihydro-3-[(3-pyridinylmethyl)amino]-6-
[1,2,2,2-tetrafluoro-1-(trifluoromethyl)ethyl]-2(1H)-quinazolinone) and
the free and conjugated forms of its metabolites IV-01 (3-[(pyridin-3-
ylmethyl)amino]-6-[1,2,2,2-tetrafluoro-1-(trifluoromethyl)ethyl]-3,4-
dihydro-1H-quinazolin-2-one) and IV-203 (6-[1,2,2,2-tetrafluoro-1-
trifluoromethyl)ethyl]-1H-quinazolin-2,4-dione), calculated as the
stoichiometric equivalent of pyrifluquinazon.

[[Page 60372]]

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

[FR Doc. 2018-25690 Filed 11-23-18; 8:45 am]
BILLING CODE 6560-50-P

60366 Federal Register / Vol. 83, No. 227 / Monday, November 26, 2018 / Rules and Regulations

Name of non-regulatory SIP State submittal
Applicable geographic area EPA approval date Additional explanation
revision date

* * * * * * *
Regional Haze Five-Year Statewide ............................... 8/09/2017 11/26/2018, [Insert Federal
Progress Report. Register citation].

[FR Doc. 2018–25556 Filed 11–23–18; 8:45 am] SUPPLEMENTARY INFORMATION: Information not marked confidential
BILLING CODE 6560–50–P pursuant to 40 CFR part 2 may be
I. General Information
disclosed publicly by EPA without prior
A. Does this action apply to me? notice. Submit the non-CBI copy of your
ENVIRONMENTAL PROTECTION You may be potentially affected by objection or hearing request, identified
AGENCY this action if you are an agricultural by docket ID number EPA–HQ–OPP–
producer, food manufacturer, or 2011–0971, by one of the following
40 CFR Part 180 methods:
pesticide manufacturer. The following
[EPA–HQ–OPP–2011–0971; FRL–9977–14] list of North American Industrial • Federal eRulemaking Portal: http://
Classification System (NAICS) codes is www.regulations.gov. Follow the online
Pyrifluquinazon; Pesticide Tolerances not intended to be exhaustive, but rather instructions for submitting comments.
provides a guide to help readers Do not submit electronically any
AGENCY: Environmental Protection
determine whether this document information you consider to be CBI or
Agency (EPA).
applies to them. Potentially affected other information whose disclosure is
ACTION: Final rule.
entities may include: restricted by statute.
SUMMARY: This regulation establishes • Crop production (NAICS code 111). • Mail: OPP Docket, Environmental
tolerances for residues of • Animal production (NAICS code Protection Agency Docket Center (EPA/
pyrifluquinazon in or on multiple 112). DC), (28221T), 1200 Pennsylvania Ave.
commodities that are identified and • Food manufacturing (NAICS code NW, Washington, DC 20460–0001.
discussed later in this document. 311). • Hand Delivery: To make special
Nichino America, Inc. requested these • Pesticide manufacturing (NAICS arrangements for hand delivery or
tolerances under the Federal Food, code 32532). delivery of boxed information, please
Drug, and Cosmetic Act (FFDCA). follow the instructions at http://
B. How can I get electronic access to www.epa.gov/dockets/contacts.html.
DATES: This regulation is effective other related information? Additional instructions on
November 26, 2018. Objections and commenting or visiting the docket,
You may access a frequently updated
requests for hearings must be received along with more information about
electronic version of EPA’s tolerance
on or before January 25, 2019, and must dockets generally, is available at http://
regulations at 40 CFR part 180 through
be filed in accordance with the www.epa.gov/dockets.
the Government Printing Office’s e-CFR
instructions provided in 40 CFR part
site at http://www.ecfr.gov/cgi-bin/text- II. Summary of Petitioned-For
178 (see also Unit I.C. of the
idx?&c=ecfr&tpl=/ecfrbrowse/Title40/ Tolerances
SUPPLEMENTARY INFORMATION).
40tab_02.tpl.
ADDRESSES: The docket for this action, In the Federal Register of December 9,
identified by docket identification (ID) C. How can I file an objection or hearing 2016 (81 FR 89036) (FRL–9953–69) and
number EPA–HQ–OPP–2011–0971, is request? September 15, 2017 (82 FR 43352)
available at http://www.regulations.gov Under FFDCA section 408(g), 21 (FRL–9965–43), EPA issued a document
or at the Office of Pesticide Programs U.S.C. 346a, any person may file an pursuant to FFDCA section 408(d)(3), 21
Regulatory Public Docket (OPP Docket) objection to any aspect of this regulation U.S.C. 346a(d)(3), announcing the filing
in the Environmental Protection Agency and may also request a hearing on those of pesticide petitions (PP 6F8502 and PP
Docket Center (EPA/DC), West William objections. You must file your objection 7E8578, respectively) by Nichino
Jefferson Clinton Bldg., Rm. 3334, 1301 or request a hearing on this regulation America, Inc., 4550 New Linden Hill
Constitution Ave. NW, Washington, DC in accordance with the instructions Road, Suite 501, Wilmington, DE 19808.
20460–0001. The Public Reading Room provided in 40 CFR part 178. To ensure The petitions requested that 40 CFR part
is open from 8:30 a.m. to 4:30 p.m., proper receipt by EPA, you must 180 be amended by establishing
Monday through Friday, excluding legal identify docket ID number EPA–HQ– tolerances for residues of the insecticide
holidays. The telephone number for the OPP–2011–0971 in the subject line on pyrifluquinazon, (1-acetyl-3,4-dihydro-
Public Reading Room is (202) 566–1744, the first page of your submission. All 3-[(3-pyridinylmethyl)amino]-6-[1,2,2,2-
and the telephone number for the OPP objections and requests for a hearing tetrafluoro-1-(trifluoromethyl)ethyl]-
Docket is (703) 305–5805. Please review must be in writing, and must be 2(1H)-quinazolinone), as follows: PP
the visitor instructions and additional received by the Hearing Clerk on or 6F8502 requested tolerances for
information about the docket available before January 25, 2019. Addresses for residues in or on Almond, hulls at 0.4
at http://www.epa.gov/dockets. mail and hand delivery of objections parts per million (ppm); Brassica head
FOR FURTHER INFORMATION CONTACT: and hearing requests are provided in 40 and stem vegetables (crop group 5–16)
Michael Goodis, Director, Registration CFR 178.25(b). at 0.4 ppm; Cattle, fat at 0.01 ppm;
Division (7505P), Office of Pesticide In addition to filing an objection or Cattle, meat at 0.01 ppm; Cattle, meat
Programs, Environmental Protection hearing request with the Hearing Clerk byproducts at 0.01 ppm; Citrus fruits
Agency, 1200 Pennsylvania Ave. NW, as described in 40 CFR part 178, please (crop group 10–10) at 0.5 ppm; Citrus,
Washington, DC 20460–0001; main submit a copy of the filing (excluding oil at 14 ppm; Cotton, gin byproducts at
telephone number: (703) 305–7090; any Confidential Business Information 4.0 ppm; Cotton, undelinted seed at 0.2
email address: RDFRNotices@epa.gov. (CBI)) for inclusion in the public docket. ppm; Cucurbit vegetables (crop group 9)

VerDate Sep<11>2014 16:13 Nov 23, 2018 Jkt 247001 PO 00000 Frm 00034 Fmt 4700 Sfmt 4700 E:\FR\FM\26NOR1.SGM 26NOR1

$60368 Federal Register / Vol. 83, No. 227 / Monday, November 26, 2018 / Rules and Regulations Vegetables (including greenhouse-grown toxicological points of departure (POD) reference dose (RfD)—and a safe margin lettuce), Brassica Head and Stem and levels of concern to use in of exposure (MOE). For non-threshold Vegetables, Fruiting Vegetables evaluating the risk posed by human risks, the Agency assumes that any (including greenhouse-grown pepper exposure to the pesticide. For hazards amount of exposure will lead to some and tomato), Cucurbit Vegetables that have a threshold below which there degree of risk. Thus, the Agency (including greenhouse-grown is no appreciable risk, the toxicological estimates risk in terms of the probability cucumber), Citrus Fruits, Pome Fruits, POD is used as the basis for derivation of an occurrence of the adverse effect Stone Fruits, Small Vine Climbing Fruit of reference values for risk assessment. expected in a lifetime. For more (excluding fuzzy kiwifruit), Tree Nuts, PODs are developed based on a careful information on the general principles Leaf Petiole Vegetables, and Cotton, and analysis of the doses in each EPA uses in risk characterization and a for the Establishment of a Tolerance toxicological study to determine the complete description of the risk without a U.S. Registration for Residues dose at which no adverse effects are assessment process, see http:// in/on Imported Tea’’ on pages 16–24 in docket ID number EPA–HQ–OPP–2011– observed (the NOAEL) and the lowest www.epa.gov/pesticides/factsheets/ 0971. dose at which adverse effects of concern riskassess.htm. are identified (the LOAEL). Uncertainty/ A summary of the toxicological B. Toxicological Points of Departure/ safety factors are used in conjunction endpoints for pyrifluquinazon used for Levels of Concern with the POD to calculate a safe human risk assessment is shown in Once a pesticide’s toxicological exposure level—generally referred to as Table 1 of this unit. profile is determined, EPA identifies a population-adjusted dose (PAD) or a TABLE—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR PYRIFLUQUINAZON FOR USE IN HUMAN HEALTH RISK ASSESSMENT Point of departure RfD, PAD, LOC for and Exposure/scenario risk Study and toxicological effects uncertainty/safety assessment factors Acute dietary (Females 13–49 NOAEL = 5 mg/kg/ Acute RfD = 0.05 Developmental Toxicity Study (rat) years of age). day. mg/kg/day. LOAEL = 10 mg/kg/day based on decreased AGD in males, in- UFA = 10X aPAD = 0.05 mg/kg/ creased incidences of skeletal variations (total), and in- UFH = 10X day creased incidences of supernumerary ribs. FQPA SF = 1X Acute dietary (General popu- NOAEL = 100 mg/ Acute RfD = 1 mg/ Acute Neurotoxicity Screening Battery lation including infants and kg/day. kg/day. LOAEL = 300 mg/kg/day based on increased incidences of children). UFA = 10X aPAD = 1 mg/kg/day clinical signs and effects on functional observational param- UFH = 10X eters, dehydration, decreased motor activity, prostrate, atax- FQPA SF = 1X ia, hyporeactivity, scant or no feces, hunched posture, lost righting reflex, decreased body temperatures, lacrimation, bradyapnea, piloerection, ptosis, and decreased grip strength), decreased body weights and body-weight gains, decreased food consumption, and decreased brain weights. Chronic dietary (All populations) NOAEL= 6.25 mg/ Chronic RfD = 0.06 Carcinogenicity (mouse) kg/day. mg/kg/day. LOAEL = 27.1/25.0 mg/kg/day (M/F) based on decreased UFA = 10X cPAD = 0.06 mg/kg/ mean body weight in males; and increased incidences of tac- UFH = 10X day tile hair loss in males, endometrial hyperplasia of the uterine FQPA SF = 1X horn in females, follicular cell hypertrophy of the thyroid in males, and subcapsular cell hyperplasia of the adrenal in males. Cancer (Oral, dermal, inhala- Classification: ‘‘Not likely to be carcinogenic to humans at levels that do not alter rodent hormone homeo- tion). stasis.’’ FQPA SF = Food Quality Protection C. Exposure Assessment dietary exposure, EPA used the Dietary Act Safety Factor. LOAEL = lowest- Exposure Evaluation Model software 1. Dietary exposure from food and observed-adverse-effect-level. LOC = with the Food Commodity Intake feed uses. In evaluating dietary level of concern. mg/kg/day = exposure to pyrifluquinazon, EPA Database (DEEM–FCID) Version 3.16. milligram/kilogram/day. MOE = margin considered exposure under the This software uses 2003–2008 food of exposure. NOAEL = no-observed- petitioned-for tolerances. EPA assessed consumption data from the U.S. adverse-effect-level. PAD = population- dietary exposures from pyrifluquinazon Department of Agriculture’s (USDA’s) adjusted dose (a = acute, c = chronic). in food as follows: National Health and Nutrition RfD = reference dose. UF = uncertainty i. Acute exposure. Quantitative acute Examination Survey, What We Eat in factor. UFA = extrapolation from animal dietary exposure and risk assessments America, (NHANES/WWEIA). As to to human (interspecies). UFDB = to are performed for a food-use pesticide, residue levels in food, EPA assumed account for the absence of data or other if a toxicological study has indicated the tolerance level residues, default data deficiency. UFH = potential possibility of an effect of concern processing factors, and 100 percent crop variation in sensitivity among members occurring as a result of a 1-day or single treated (PCT) for all proposed uses. of the human population (intraspecies). exposure. Such effects were identified ii. Chronic exposure. In conducting for pyrifluquinazon. In estimating acute the chronic dietary exposure assessment VerDate Sep<11>2014 16:13 Nov 23, 2018 Jkt 247001 PO 00000 Frm 00036 Fmt 4700 Sfmt 4700 E:\FR\FM\26NOR1.SGM 26NOR1$

Federal Register / Vol. 83, No. 227 / Monday, November 26, 2018 / Rules and Regulations 60371

brassica, head and stem, group 5–16 at in the preemption provisions of FFDCA insecticide pyrifluquinazon, including
0.60 ppm; Vegetable, cucurbit, group 9 section 408(n)(4). As such, the Agency its metabolites and degradates, in or on
at 0.07 ppm; Vegetable, fruiting, group has determined that this action will not the commodities in the table below.
8–10 at 0.30 ppm; Vegetable, leafy, have a substantial direct effect on States Compliance with the tolerance levels
group 4–16 at 5.0 ppm; Vegetable, or tribal governments, on the specified below is to be determined by
tuberous and corm, subgroup 1C at 0.02 relationship between the national measuring only the sum of
ppm; Cattle, liver at 0.04 ppm; Goat, government and the States or tribal pyrifluquinazon (1-acetyl-3,4-dihydro-3-
liver at 0.04 ppm; Horse, liver at 0.04 governments, or on the distribution of [(3-pyridinylmethyl)amino]-6-[1,2,2,2-
ppm; and Sheep, liver at 0.04 ppm. For power and responsibilities among the tetrafluoro-1-(trifluoromethyl)ethyl]-
the plant commodities, compliance with various levels of government or between 2(1H)-quinazolinone) and its metabolite
the tolerance is determined by the Federal Government and Indian IV–01 (3-[(pyridin-3-ylmethyl)amino]-6-
measuring residues of the parent tribes. Thus, the Agency has determined [1,2,2,2-tetrafluoro-1-
compound and the IV–01 metabolite; for that Executive Order 13132, entitled (trifluoromethyl)ethyl]-3,4-dihydro-1H-
the livestock commodities, compliance ‘‘Federalism’’ (64 FR 43255, August 10, quinazolin-2-one), calculated as the
is determined by measuring residues of 1999) and Executive Order 13175, stoichiometric equivalent of
the parent compound and the free and entitled ‘‘Consultation and Coordination pyrifluquinazon.
conjugated forms of IV–01 and IV–203 with Indian Tribal Governments’’ (65 FR
metabolites. 67249, November 9, 2000) do not apply Parts per
to this action. In addition, this action Commodity
VI. Statutory and Executive Order million
does not impose any enforceable duty or
Reviews
contain any unfunded mandate as Almond, hulls .............................. 0.60
This action establishes tolerances described under Title II of the Unfunded Cherry subgroup 12–12A ........... 0.30
under FFDCA section 408(d) in Mandates Reform Act (UMRA) (2 U.S.C. Citrus, dried pulp ........................ 2.0
response to a petition submitted to the 1501 et seq.). Citrus, oil ..................................... 30
Agency. The Office of Management and This action does not involve any Cotton, gin byproducts ............... 6.0
Budget (OMB) has exempted these types technical standards that would require Cotton, undelinted seed ............. 0.30
of actions from review under Executive Agency consideration of voluntary Fruit, citrus, group 10–10 ........... 0.70
Order 12866, entitled ‘‘Regulatory consensus standards pursuant to section Fruit, pome, group 11–10 ........... 0.07
Planning and Review’’ (58 FR 51735, 12(d) of the National Technology Fruit, small vine climbing, except
October 4, 1993). Because this action Transfer and Advancement Act fuzzy kiwifruit, subgroup 13–
has been exempted from review under (NTTAA) (15 U.S.C. 272 note). 07F .......................................... 0.30
Executive Order 12866, this action is Leaf petiole vegetable, subgroup
not subject to Executive Order 13211, VII. Congressional Review Act 22B .......................................... 1.5
entitled ‘‘Actions Concerning Pursuant to the Congressional Review Peach subgroup 12–12B ............ 0.04
Regulations That Significantly Affect Act (5 U.S.C. 801 et seq.), EPA will Plum subgroup 12–12C .............. 0.02
Energy Supply, Distribution, or Use’’ (66 submit a report containing this rule and Nut, tree, group 14–12 ............... 0.02
FR 28355, May 22, 2001); Executive other required information to the U.S. Tea, dried1 .................................. 20
Order 13045, entitled ‘‘Protection of Senate, the U.S. House of Vegetable, brassica, head and
Children from Environmental Health Representatives, and the Comptroller stem, group 5–16 .................... 0.60
General of the United States prior to Vegetable, cucurbit, group 9 ...... 0.07
Risks and Safety Risks’’ (62 FR 19885,
publication of the rule in the Federal Vegetable, fruiting, group 8–10 .. 0.30
April 23, 1997); or Executive Order
Register. This action is not a ‘‘major Vegetable, leafy, group 4–16 ..... 5.0
13771, entitled ‘‘Reducing Regulations
rule’’ as defined by 5 U.S.C. 804(2). Vegetable, tuberous and corm,
and Controlling Regulatory Costs’’ (82
subgroup 1C ........................... 0.02
FR 9339, February 3, 2017). This action List of Subjects in 40 CFR Part 180
does not contain any information 1 There
are no U.S. registrations as of No-
collections subject to OMB approval Environmental protection, vember 26, 2018 for use on tea.
under the Paperwork Reduction Act Administrative practice and procedure,
(PRA) (44 U.S.C. 3501 et seq.), nor does Agricultural commodities, Pesticides (2) Tolerances are established for
it require any special considerations and pests, Reporting and recordkeeping residues of the insecticide
under Executive Order 12898, entitled requirements. pyrifluquinazon, including its
‘‘Federal Actions to Address Dated: November 9, 2018.
metabolites and degradates, in or on the
Environmental Justice in Minority commodities in the table below.
Michael Goodis,
Populations and Low-Income Compliance with the tolerance levels
Director, Registration Division, Office of
Populations’’ (59 FR 7629, February 16, specified below is to be determined by
Pesticide Programs.
1994). measuring only the sum of
Therefore, 40 CFR chapter I is
Since tolerances and exemptions that pyrifluquinazon (1-acetyl-3,4-dihydro-3-
amended as follows:
are established on the basis of a petition [(3-pyridinylmethyl)amino]-6-[1,2,2,2-
under FFDCA section 408(d), such as PART 180—[AMENDED] tetrafluoro-1-(trifluoromethyl)ethyl]-
the tolerance in this final rule, do not 2(1H)-quinazolinone) and the free and
require the issuance of a proposed rule, ■ 1. The authority citation for part 180 conjugated forms of its metabolites IV–
the requirements of the Regulatory continues to read as follows: 01 (3-[(pyridin-3-ylmethyl)amino]-6-
Flexibility Act (RFA) (5 U.S.C. 601 et Authority: 21 U.S.C. 321(q), 346a and 371. [1,2,2,2-tetrafluoro-1-
seq.), do not apply. (trifluoromethyl)ethyl]-3,4-dihydro-1H-
■ 2. Add § 180.701 to subpart C to read
This action directly regulates growers, quinazolin-2-one) and IV–203 (6-
as follows:
food processors, food handlers, and food [1,2,2,2-tetrafluoro-1-
retailers, not States or tribes, nor does § 180.701 Pyrifluquinazon; tolerances for trifluoromethyl)ethyl]-1H-quinazolin-
this action alter the relationships or residues. 2,4-dione), calculated as the
distribution of power and (a) General. (1) Tolerances are stoichiometric equivalent of
responsibilities established by Congress established for residues of the pyrifluquinazon.

VerDate Sep<11>2014 16:13 Nov 23, 2018 Jkt 247001 PO 00000 Frm 00039 Fmt 4700 Sfmt 4700 E:\FR\FM\26NOR1.SGM 26NOR1

$60372 Federal Register / Vol. 83, No. 227 / Monday, November 26, 2018 / Rules and Regulations Parts per portion of its 2018 commercial summer concurrence of the NMFS Greater Commodity million flounder quota to the Commonwealth of Atlantic Regional Administrator, can Massachusetts. This quota adjustment is transfer or combine summer flounder Cattle, liver .................................. 0.04 necessary to comply with the Summer commercial quota under § 648.102(c)(2). Goat, liver ................................... 0.04 Flounder, Scup, and Black Sea Bass The Regional Administrator is required Horse, liver ................................. 0.04 Sheep, liver ................................. 0.04 Fishery Management Plan quota transfer to consider the criteria in provisions. This announcement informs § 648.102(c)(2)(i)(A) through (C) in the (b) Section 18 emergency exemptions. the public of the revised commercial evaluation of requests for quota transfers [Reserved] quotas for Maryland and Massachusetts. or combinations. (c) Tolerances with regional DATES: Effective November 23, 2018, Maryland is transferring 3,169 lb registrations. [Reserved] through December 31, 2018. (1,437 kg) of summer flounder (d) Indirect or inadvertent residues. FOR FURTHER INFORMATION CONTACT: commercial quota to Massachusetts [Reserved] Cynthia Ferrio, Fishery Management through mutual agreement of the states. [FR Doc. 2018–25690 Filed 11–23–18; 8:45 am] Specialist, (978) 281–9180. This transfer was requested to repay BILLING CODE 6560–50–P SUPPLEMENTARY INFORMATION: landings by a Maryland-permitted Regulations governing the summer vessel that landed in Massachusetts flounder fishery are found in 50 CFR under a safe harbor agreement. Based on DEPARTMENT OF COMMERCE 648.100 through 648.110. These the initial quotas published in the 2018 regulations require annual specification Summer Flounder, Scup, and Black Sea National Oceanic and Atmospheric of a commercial quota that is Bass Specifications and subsequent Administration apportioned among the coastal states adjustments, the revised summer from Maine through North Carolina. The flounder quotas for calendar year 2018 50 CFR Part 648 process to set the annual commercial are now: Maryland, 128,070 lb (58,092 quota and the percent allocated to each kg); and Massachusetts, 413,361 lb [Docket No. 170828822–70999–04] state is described in § 648.102, and the (187,497 kg). RIN 0648–XG633 initial 2018 allocations were published Classification on December 22, 2017 (82 FR 60682), Fisheries of the Northeastern United and corrected January 30, 2018 (83 FR This action is taken under 50 CFR States; Summer Flounder Fishery; 4165). part 648 and is exempt from review Quota Transfer The final rule implementing under Executive Order 12866. AGENCY: National Marine Fisheries Amendment 5 to the Summer Flounder Authority: 16 U.S.C. 1801 et seq. Service (NMFS), National Oceanic and Fishery Management Plan, as published in the Federal Register on December 17, Dated: November 19, 2018. Atmospheric Administration (NOAA), Commerce. 1993 (58 FR 65936), provided a Karen H. Abrams, ACTION: Temporary rule; quota transfer. mechanism for transferring summer Acting Director, Office of Sustainable flounder commercial quota from one Fisheries, National Marine Fisheries Service. SUMMARY: NMFS announces that the state to another. Two or more states, [FR Doc. 2018–25566 Filed 11–23–18; 8:45 am] State of Maryland is transferring a under mutual agreement and with the BILLING CODE 3510–22–P VerDate Sep<11>2014 16:13 Nov 23, 2018 Jkt 247001 PO 00000 Frm 00040 Fmt 4700 Sfmt 9990 E:\FR\FM\26NOR1.SGM 26NOR1$

Document Created: 2018-11-24 00:51:42
Document Modified: 2018-11-24 00:51:42

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Rules and Regulations
Action		Final rule.
Dates		This regulation is effective November 26, 2018. Objections and requests for hearings must be received on or before January 25, 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).
Contact		Michael Goodis, Director, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
FR Citation		83 FR 60366
CFR Associated		Environmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements