[Federal Register Volume 84, Number 70 (Thursday, April 11, 2019)]
[Rules and Regulations]
[Pages 14617-14622]
[FR Doc No: 2019-07173]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2017-0673; FRL-9990-02]

Fenazaquin; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

DATES: This regulation is effective April 11, 2019. Objections and
requests for hearings must be received on or before June 10, 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-2017-0673, 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<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>. 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:<PHONE_NUMBER>; 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
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-2017-0673 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
June 10, 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-2017-0673, 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 March 6, 2018 (83 FR 9471) (FRL-9973-
27), 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
7F8618) by Gowan Company, LLC, P.O. Box 556, Yuma, AZ 85364. The
petition requested that 40 CFR 180.632 be amended by establishing
tolerances for residues of the miticide/insecticide fenazaquin, 4-[2-
[4-(1,1-dimethylethyl)phenyl]ethoxy]quinazoline, in or on alfalfa,
forage at 4.0 parts per million (ppm); alfalfa, hay at 15 ppm; avocado
at 0.15 ppm; bushberry, subgroup 13-07B at 0.8 ppm; caneberry, subgroup
13-07A at 0.7 ppm;

fruit, citrus, group 10-10 at 0.4 ppm; fruit, low growing berry,
subgroup 13-07G at 2.0 ppm; corn, field, grain at 0.09 ppm; corn,
field, forage at 7.0 ppm; corn, field, stover at 40 ppm; corn, field,
aspirated grain fractions at 3.0 ppm; corn, field, refined oil at 0.2
ppm; corn, sweet, forage at 9.0 ppm; corn, sweet, grain at 0.03 ppm;
cotton, gin byproducts at 15.0 ppm; cotton, undelinted seed at 0.4 ppm;
fruit, pome, group 11-10 at 0.4 ppm; fruit, small fruit vine climbing,
except fuzzy kiwifruit, subgroup 13-07F at 0.7 ppm; fruit, stone, group
12-12 at 1.5 ppm; grape, raisins at 0.8 ppm; mint at 10.0 ppm;
vegetable, cucurbit, group 9 at 0.3 ppm; vegetable, fruiting, group 8-
10 at 0.3 ppm; vegetable, legume, edible podded, subgroup 6A at 0.4
ppm; vegetables, legumes, dried shelled pea and bean (except soybean)
subgroup 6C at 0.3 ppm; vegetables, legumes, succulent shelled pea and
bean subgroup 6B at 0.02 ppm; beef, fat at 0.05 ppm; pork, fat at 0.05
ppm; sheep, fat at 0.05 ppm; milk at 0.01 ppm; liver at 0.02 p.m.; and
kidney at 0.01 ppm. That document referenced a summary of the petition
prepared by Gowan Company, LLC, the registrant, which is available in
the docket, http://www.regulations.gov. EPA received one favorable
comment in response to the Notice of Filing from the Northwest
Horticultural Council in support of establishing tolerances for fruit,
pome, group 11-10 and fruit, stone, group 12-12.
    Based upon review of the data supporting the petition, EPA has
modified the commodity definitions and the tolerance levels for many of
the proposed uses. Additionally, EPA is increasing the current
tolerance level for citrus, oil and is not establishing tolerances on
alfalfa, cotton, corn, and livestock commodities. The reasons for the
changes and modifications are further explained in Unit IV.C.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.''
    Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for fenazaquin including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with fenazaquin 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 most consistently observed effects of fenazaquin exposure
across species, sexes, and treatment durations were decreases in body
weight, food consumption, and food efficiency. The effects on body
weight and food consumption were consistent with the commonly observed
effects for compounds that disrupt mitochondrial respiration. Other
effects noted were mild dehydration and certain clinical signs seen at
relatively high dose levels in the acute activity, sluggish arousal,
unusual posture, abnormal gait, and altered response to auditory
stimuli were seen in the absence of any neuropathological changes and
were not considered to be related to neurotoxicity. In a 90-day study
in hamsters, treated animals had an increased incidence of testicular
hypospermatogenesis and reduced testicular and prostate weight;
however, these findings were not replicated in the hamster
carcinogenicity study which suggest the effects were transient or
reversible.
    Fenazaquin did not cause any developmental or reproductive toxicity
at the doses tested in rats and rabbits. In the rat study,
developmental toxicity was not observed in the presence of maternal
toxicity (i.e. decreases in body weight gain, food consumption, and
food efficiency). In the rabbit study, no developmental or maternal
toxicity was seen. In the reproduction study, systemic toxicity
manifested in parental animals as excessive salivation and decreased
body weight and food intake; and in offspring as decreased body weight
gain; and there was no observed reproductive toxicity. Therefore, there
is no developmental toxicity or reproductive susceptibility with
respect to fetal and developing young animals with in utero and
postnatal exposures.
    Carcinogenicity was evaluated in the hamster instead of the mouse
because the hamster was found to be more sensitive to the effects of
fenazaquin than mice due to slower elimination kinetics for hamster. In
a three-month feeding study in the mouse, it was found that 6-22x
higher dose levels were required to elicit a comparable effect in mice
than in the hamster. The results of the rat and hamster carcinogenicity
studies demonstrated no increase in treatment-related tumor incidence.
Therefore, fenazaquin was classified as ``not likely to be carcinogenic
to humans.''
    Fenazaquin did not cause mutagenicity, genotoxicity, neurotoxicity,
or immunotoxicity. Fenazaquin did not demonstrate any systemic toxicity
in a 21-day dermal toxicity study in rabbits up to the limit dose
(1,000 milligram/kilogram/day (mg/kg/day)).
    Specific information on the studies received and the nature of the
adverse effects caused by fenazaquin 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 ``Fenazaquin: Human Health Risk
Assessment in Support of Proposed Uses on Avocado, Bushberry Subgroup
13-07B, Caneberry Subgroup 13-07A, Citrus Fruit Group 10-10, Cucurbit
Vegetables Group 9, Fruiting Vegetables Group 8-10, Edible-Podded
Legume Vegetable Subgroup 6A, Succulent Pea And Bean Subgroup 6B, Dried
Shelled Pea And Bean (Except Soybean) Subgroup 6C, Low Growing Berry
Subgroup 13-07G, Mint, Pome Fruit Group 11-10, Small Fruit Vine
Climbing Subgroup, Except Fuzzy Kiwifruit 13-07F, and Stone Fruit Group
12-12'' in pages 11-17 in docket ID number EPA-HQ-OPP-2017-0673.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human

exposure to the pesticide. For hazards that have a threshold below
which there is no appreciable risk, the toxicological POD is used as
the basis for derivation of reference values for risk assessment. PODs
are developed based on a careful analysis of the doses in each
toxicological study to determine the dose at which no adverse effects
are observed (the NOAEL) and the lowest dose at which adverse effects
of concern are identified (the LOAEL). Uncertainty/safety factors are
used in conjunction with the POD to calculate a safe exposure level--
generally referred to as a population-adjusted dose (PAD) or a
reference dose (RfD)--and a safe margin of exposure (MOE). For non-
threshold risks, the Agency assumes that any amount of exposure will
lead to some degree of risk. Thus, the Agency estimates risk in terms
of the probability of an occurrence of the adverse effect expected in a
lifetime. For more information on the general principles EPA uses in
risk characterization and a complete description of the risk assessment
process, see http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
    A summary of the toxicological endpoints for fenazaquin used for
human risk assessment is discussed in Unit III.B. of the final rule
published in the Federal Register of May 6, 2015 (80 FR 25953) (FRL-
9925-97).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to fenazaquin, EPA considered exposure under the petitioned-
for tolerances as well as all existing fenazaquin tolerances in 40 CFR
180.632. EPA assessed dietary exposures from fenazaquin 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 fenazaquin. 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, DEEM default processing factors for tomato
(paste and juice), dried apple, dried pear, dried apricot, cherry
juice, plum/prune juice, and dried coconut, and 100 percent crop
treated (PCT) for all proposed and registered uses.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the DEEM-FCID Version 3.16. This software uses
USDA's NHANES/WWEIA. As to residue levels in food, EPA assumed
tolerance-level residues, DEEM default processing factors for tomato
(paste and juice), dried apple, dried pear, dried apricot, cherry
juice, plum/prune juice, and dried coconut, and 100 percent crop
treated (PCT) for all proposed and registered uses.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that fenazaquin does not pose a cancer risk to humans.
Therefore, a dietary exposure assessment for the purpose of assessing
cancer risk is unnecessary.
    iv. Anticipated residue and percent crop treated (PCT) information.
EPA did not use anticipated residue and/or PCT information in the
dietary assessment for fenazaquin. Tolerance-level residues and/or 100%
CT were assumed for all food commodities.
    2. Dietary exposure from drinking water. In drinking water, the
residues of concern are fenazaquin (parent) and two metabolites:
Metabolite M29 or 2-(4-{2-[(2-hydroxyquinazolin-4-
yl)oxy]ethyl{time} phenyl)-2-methylpropanoic acid and its tautomer 2-
methyl-2-(4-{2-[(2-oxo-1,2-dihydroquinazolin-4-
yl)oxy]ethyl{time} phenyl)propanoic acid; and Metabolite 1 or 4-[2-(4-
tert-butyl-phenyl)-ethoxy]-quinazolin-2-ol and its tautomer 4-[2-(4-
tert-butylphenyl)ethoxy]quinazolin-2(1H)-one..
    Although a screening level drinking water assessment (DWA) was
conducted, EPA used the solubility limit of fenazaquin at 20 [deg]C,
102 parts per billion (ppb), in place of EDWCs from the modeling that
are well below the solubility limit of fenazaquin, for the proposed new
uses and rate increases in the human health risk assessment. This
concentration is not representative of anticipated exposures in
drinking water, but is used as an upper bound limit to represent the
potential exposure to fenazaquin and the two additional residues of
concern.
    The solubility limit of fenazaquin at 20 [deg]C, 102 ppb, was
directly entered into the dietary exposure model. For acute dietary
risk assessment, the water concentration value of 102 ppb was used to
assess the contribution to drinking water. For chronic dietary risk
assessment, the water concentration of value 102 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).
    Fenazaquin is currently registered for the following uses that
could result in residential exposures: Ornamental plants. There is a
potential for exposure associated with handling (i.e., mixing, loading
and applying), as well as post-application exposure from the use of
fenazaquin on ornamental plants. However, for residential exposure
associated with handlers, all registered fenazaquin product labels with
residential use sites (e.g., ornamental plants) require that handlers
wear specific clothing (e.g., long-sleeve shirt/long pants/chemical
resistant gloves) and/or use personal protective equipment (PPE).
Therefore, the Agency has made the assumption that these products are
not for homeowner use, and has not conducted a quantitative residential
handler assessment. With respect to the potential residential post-
application exposure from the use of fenazaquin on ornamental plants,
since there is (1) no adverse systemic hazard via the dermal route of
exposure; (2) inhalation exposures are typically negligible in outdoor
settings; and (3) there is no incidental oral exposure expected from
fenazaquin use on ornamental plants, a residential post-application
assessment is unnecessary. Furthermore, since the extent to which young
children engage in activities associated with these areas or utilize
these areas for prolonged periods of play is low, significant non-
dietary ingestion exposure is not expected. 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
fenazaquin to share a common mechanism of toxicity with any other
substances, and fenazaquin does not

appear to produce a toxic metabolite produced by other substances. For
the purposes of this tolerance action, therefore, EPA has assumed that
fenazaquin 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 Food Quality
Protection Act Safety Factor (FQPA 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. Susceptibility/sensitivity
in the developing animals was evaluated in developmental toxicity
studies in rats and rabbits as well as a reproduction and fertility
study in rats. The data showed no evidence of increased sensitivity/
susceptibility in the developing or young animal. Clear NOAELs and
LOAELs are available for all the parental and offspring effects.
    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 fenazaquin is complete.
    ii. There is no indication that fenazaquin is a neurotoxic chemical
and there is no need for a developmental neurotoxicity study or
additional Uncertainty Factors (UFs) to account for neurotoxicity.
    iii. There is no concern for susceptibility in infants and young
children.
    iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were based on 100% CT
and tolerance level residues for both the acute and chronic dietary
exposure. EPA made conservative (protective) assumptions when using the
solubility limit of fenazaquin to account for exposure to fenazaquin in
drinking water. These assessments will not underestimate the exposure
and risks posed by fenazaquin.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
    1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to fenazaquin will occupy 31% of the aPAD for children 1-2 years old,
the population group receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
fenazaquin from food and water will utilize 37% of the cPAD for
children 1-2 years old, the population group receiving the greatest
exposure. There are no residential uses for fenazaquin which contribute
to the aggregate exposure.
    3. Short-term and intermediate-term risk. Short-term and
intermediate-term aggregate exposure takes into account short-term and
intermediate-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level). Because there
is no toxicological hazard via the dermal route of exposure for
fenazaquin, short-term and intermediate-term aggregate exposure
consists solely of chronic exposure to food and water, which is below
the Agency's level of concern.
    4. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, fenazaquin is not expected to pose a cancer risk to humans.
    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 fenazaquin residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate analytical methods are available for enforcing fenazaquin
tolerances on plant commodities. The high-performance liquid
chromatography (HPLC) method with tandem mass spectrometry detection
(HPLC/MS-MS) method is the same as that used for data collection and
has been shown to be acceptable over a range of commodities. The method
has undergone successful independent laboratory confirmation and radio
validation. The ion transitions monitored for fenazaquin are m/z 307.0
[rarr] 161.2 for (quantitation) and m/z 307.0 [rarr] 147.2
(confirmation). The LOQ of the method was determined to be 0.01 ppm for
fenazaquin. The method may be requested from: Chief, Analytical
Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft.
Meade, MD 20755-5350; telephone number:<PHONE_NUMBER>; 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 safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
    The Codex has not established MRLs for fenazaquin.

C. Revisions to Petitioned-for Tolerances

    Based upon review of the data supporting the petition, EPA is
establishing tolerances for the following commodities requested using
the Agency's preferred commodity terminology: Instead of establishing a
tolerance for grape, raisins as requested, the Agency is establishing a
tolerance for grape, raisin; revising fruit, low

growing berry, subgroup 13-07G to berry, low growing, subgroup 13-07G;
revising the requested mint to peppermint, fresh leaves and spearmint,
fresh leaves; revising the requested vegetables, legumes, succulent
shelled pea and bean subgroup 6B to pea and bean, succulent shelled,
subgroup 6B; revising vegetables, legumes, dried shelled pea and bean
(except soybean) subgroup 6C to pea and bean, dried shelled, except
soybean, subgroup 6C. In addition, based on supporting data, the Agency
is establishing tolerance levels higher than requested for fruit,
stone, group 12-12 at 2 ppm and for fruit, pome, group 11-10 at 0.6
ppm. In addition, because the current residue data supporting fruit,
citrus, group 10-10 indicates that residues concentrate in citrus, oil,
EPA is establishing a tolerance for fruit, citrus, group 10-10, oil
consistent with the requirements in 40 CFR 180.40(f)(1). This tolerance
supersedes the existing tolerance for citrus, oil, so EPA is removing
that tolerance. The Agency is also establishing tolerances and revising
current tolerance levels consistent the Organization for Economic
Cooperation and Development (OECD) maximum residue limits calculator.
Finally, due to a lack of supporting data, EPA is not establishing any
tolerances for alfalfa, forage; alfalfa, hay; corn, field, forage;
corn, field, aspirated grain fractions; corn, field, grain; corn,
field, refined oil; corn, field, stover; corn, sweet, forage; corn,
sweet, grain; cotton, gin byproducts; cotton, undelinted seed; beef,
fat; pork, fat; sheep, fat; liver; kidney; and milk.

D. International Trade Considerations

    In this rule, EPA is revising the commodity definition of and
reducing the existing tolerance for citrus commodities as follows:
Fruit, citrus, group 10 except grapefruit will become fruit, citrus,
group 10-10 and the tolerance will be revised from 0.5 ppm to 0.4 ppm.
The Agency is reducing this tolerance based on review of available
data. This reduction in tolerance level is not discriminatory; the same
food safety standard contained in the FFDCA applies equally to
domestically produced and imported foods.
    In accordance with the World Trade Organization's (WTO) Sanitary
and Phytosanitary Measures (SPS) Agreement, EPA will notify the WTO of
its tolerance revision. In addition, the SPS Agreement requires that
Members provide a ``reasonable interval'' between the publication of a
regulation subject to the Agreement and its entry into force in order
to allow time for producers in exporting Member countries to adapt to
the new requirement. At this time, EPA is establishing an expiration
date for the existing tolerances to allow those tolerances remain in
effect for a period of six months after the effective date of this
final rule, in order to address this requirement. Prior to the
expiration date, residues of fenazaquin up to the existing tolerance
level will be permitted; after the expiration date, residues will need
to be compliant with the reduced tolerance level.

V. Conclusion

    Therefore, tolerances are established for residues of fenazaquin,
4-[2-[4-(1,1-dimethylethyl)phenyl]ethoxy]quinazoline, in or on avocado
at 0.15 ppm; berry, low growing, subgroup 13-07G at 2 ppm; bushberry,
subgroup 13-07B at 0.8 ppm; caneberry, subgroup 13-07A at 0.7 ppm;
fruit, citrus, group 10-10, oil at 20 ppm; fruit, citrus, group 10-10
at 0.4 ppm; fruit, pome, group 11-10 at 0.6 ppm; fruit, small fruit
vine climbing, except fuzzy kiwifruit, subgroup 13-07F at 0.7 ppm;
fruit, stone, group 12-12 at 2 ppm; grape, raisin at 0.8 ppm; pea and
bean, dried shelled, except soybean, subgroup 6C at 0.3 ppm; pea and
bean, succulent shelled, subgroup 6B at 0.03 ppm; peppermint, fresh
leaves at 10 ppm; spearmint, fresh leaves at 10 ppm; vegetable,
cucurbit, group 9 at 0.3 ppm; vegetable, fruiting, group 8-10 at 0.3
ppm; and vegetable, legume, edible podded, subgroup 6A at 0.4 ppm. In
addition, EPA is removing the following tolerances: (1) Individual
tolerances for apple, pear, and cherry because they are superseded by
the new tolerances for pome fruit group 11-10 and stone fruit group 12-
12; (2) the group tolerance for fruit, citrus, group 10, except
grapefruit because it is superseded by a new group tolerance for fruit,
citrus, group 10-10; and (3) the tolerance for citrus, oil because it
is superseded by the new group tolerance for fruit, citrus, group 10-
10, oil. The Agency is setting a 6-month expiration date on the current
group tolerance for fruit, citrus, group 10, except grapefruit to
provide a reasonable interval for exporting countries to adjust to the
lower fruit, citrus, group 10-10 tolerance.

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: March 28, 2019.
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. In Sec.  180.632, revise the table in paragraph (a) to read as
follows:

Sec.  180.632  Fenazaquin; Tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Almond, hulls...............................................           4
Avocado.....................................................        0.15
Berry, low growing, subgroup 13-07G.........................           2
Bushberry, subgroup 13-07B..................................         0.8
Caneberry, subgroup 13-07A..................................         0.7
Fruit, Citrus, Group 10 except Grapefruit \2\...............         0.5
Fruit, citrus, group 10-10..................................         0.4
Fruit, citrus, group 10-10, oil.............................          20
Fruit, pome, group 11-10....................................         0.6
Fruit, small vine climbing, except fuzzy kiwifruit, subgroup         0.7
 13-07F.....................................................
Fruit, stone, group 12-12...................................           2
Grape, raisin...............................................         0.8
Hop, dried cones............................................          30
Nuts, Tree, Group 14-12.....................................        0.02
Pea and bean, dried shelled, except soybean, subgroup 6C....         0.3
Pea and bean, succulent shelled, subgroup 6B................        0.03
Peppermint, fresh leaves....................................          10
Pineapple \1\...............................................         0.2
Spearmint, fresh leaves.....................................          10
Tea, dried \1\..............................................           9
Vegetable, cucurbit, group 9................................         0.3
Vegetable, fruiting, group 8-10.............................         0.3
Vegetable, legume, edible podded, subgroup 6A...............         0.4
------------------------------------------------------------------------
\1\ There are no U.S. registrations as of May 25, 2017 for use on
  pineapple and tea.
\2\ This tolerance expires on October 11, 2019.

* * * * *
[FR Doc. 2019-07173 Filed 4-10-19; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 86, Number 240 (Friday, December 17, 2021)]
[Rules and Regulations]
[Page 71573]
[FR Doc No: 2021-27334]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2021-0901]

Safety Zone; Military Ocean Terminal Concord Safety Zone, Suisun
Bay, Military Ocean Terminal Concord, CA

AGENCY: Coast Guard, DHS.

ACTION: Notification of enforcement of regulation.

-----------------------------------------------------------------------

SUMMARY: The Coast Guard will enforce the safety zone in the navigable
waters of Suisun Bay, off Concord, CA, in support of explosive off and
on-loading to Military Ocean Terminal Concord (MOTCO). This safety zone
is necessary to protect personnel, vessels, and the marine environment
from potential explosion within the explosive arc. The safety zone is
open to all persons and vessels for transitory use, but vessel
operators desiring to anchor or otherwise loiter within the safety zone
must obtain the permission of the Captain of the Port San Francisco or
a designated representative. All persons and vessels operating within
the safety zone must comply with all directions given to them by the
Captain of the Port San Francisco or a designated representative.

DATES: The regulations in 33 CFR 165.1198 will be enforced from 12:01
a.m. on December 17, 2021, until 11:59 p.m. on December 21, 2021.

FOR FURTHER INFORMATION CONTACT: If you have questions about this
notification of enforcement, call or email LT Anthony Solares, Sector
San Francisco Waterways Management, U.S. Coast Guard; telephone 415-
399-3585, email [email protected].

SUPPLEMENTARY INFORMATION: The Coast Guard will enforce the safety zone
in 33 CFR 165.1198 for the Military Ocean Terminal Concord regulated
area from December 17, 2021 from 12:01 a.m., until December 21, 2021,
at 11:59 p.m., or as announced via marine local broadcasts. This safety
zone is necessary to protect personnel, vessels, and the marine
environment from potential explosion within the explosive arc. Our
regulation for this safety zone, Sec.  165.1198, specifies the location
of the safety zone which encompasses the navigable waters in the area
between 500 yards of MOTCO Pier 2 in position 38[deg]03'30'' N,
122[deg]01'14'' W and 3,000 yards of the pier. During the enforcement
periods, as reflected in Sec.  165.1198(d), if you are the operator of
a vessel in the regulated area you must comply with the instructions of
the COTP or the designated on-scene patrol personnel. Vessel operators
desiring to anchor or otherwise loiter within the safety zone must
contact Sector San Francisco Vessel Traffic Service at<PHONE_NUMBER> or
VHF Channel 14 to obtain permission.
    In addition to this notification of enforcement in the Federal
Register, the Coast Guard plans to provide notification of this
enforcement period via the Local Notice to Mariners, and marine
information broadcasts.

    Dated: December 13, 2021.
Taylor Q. Lam,
Captain, U.S. Coast Guard, Captain of the Port San Francisco.
[FR Doc. 2021-27334 Filed 12-16-21; 8:45 am]
BILLING CODE 9110-04-P