[Federal Register Volume 80, Number 87 (Wednesday, May 6, 2015)]
[Rules and Regulations]
[Pages 25953-25958]
[FR Doc No: 2015-10375]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2006-0075; FRL-9925-97]

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 almonds and cherries. Gowan Company requested these
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective May 6, 2015. Objections and
requests for hearings must be received on or before July 6, 2015, 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-2006-0075, 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: Susan Lewis, 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_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Publishing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/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-2006-0075 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
July 6, 2015. 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-2006-0075, 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 April 20, 2011 (76 FR 22067) (FRL-8869-
7), 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
1F7825) by Gowan Company, P.O. Box 5569, Yuma, AZ 85366. The petition
requested that 40 CFR 180.632 be amended by establishing tolerances for
residues of the insecticide fenazaquin, 4-[2-[4-(1,1-
dimethylethyl)phenyl]ethoxy]quinazoline, in or on fruit, pome group at
0.35 parts per million (ppm); cucurbit group at 0.25 ppm; almond, hulls
at 4.5 ppm; apple, wet pomace at 0.6 ppm; berry fruit group at 0.6 ppm;

vegetable, fruiting group at 0.25 ppm; grape at 0.9 ppm; hop at 2.0
ppm; mint at 6.0 ppm; stone fruit group at 1.5 ppm; strawberry at 1.5
ppm; tree nut group at 0.02 ppm; alfalfa, forage at 4.5 ppm; alfalfa,
hay at 8.0 ppm; avocado at 0.15 ppm; citrus fruit group at 0.3 ppm;
citrus, oil at 2.5 ppm; cotton, seed (undelinted) at 0.5 ppm; cotton,
gin byproducts at 12.0 ppm; bean, shelled dry subgroup at 0.2 ppm;
bean, edible podded subgroup at 0.3 ppm; beans and pea, succulent
subgroup at 0.02 ppm; corn, field, grain at 0.15 ppm; corn, field,
forage at 9.0 ppm; corn, field, stover at 30 ppm; corn, field,
aspirated grain fractions at 9.0 ppm; corn, field, refined oil at 0.6
ppm; corn, sweet at 0.04 ppm; and corn, sweet, forage at 9.0 ppm. That
document referenced a summary of the petition prepared by Gowan
Company, the registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the
notice of filing.
    Based upon EPA review of the data supporting the petition, Gowan
Company, the registrant, revised their petition by limiting their
request for tolerances to almond and cherry. The reason for these
changes are 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, genders, and treatment durations were decreases in body
weight, food consumption, and food efficiency. Other effects noted were
mild dehydration and certain clinical signs seen at relatively high
dose levels in the acute neurotoxicity study. These clinical signs,
which included increased foot splay, decreased motor 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; 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.''
    The database for fenazaquin shows no evidence of 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)).
    Fenazaquin has high acute oral toxicity, low acute toxicity by
dermal and inhalation routes of exposure, is not a skin irritant, is
minimally irritating to the eye, and is considered to be a dermal
sensitizer.
    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 for Proposed New Uses on Almonds and Cherries on page 30 in
docket ID number EPA-HQ-OPP-2006-0075.

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

  Table 1--Summary of Toxicological Doses and Endpoints for Fenazaquin for Use in Human Health Risk Assessment
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                                    Point of departure
        Exposure/scenario            and  uncertainty/    RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
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Acute dietary (General population  NOAEL = 15 mg/kg/day  Acute RfD = 0.15 mg/ [Immunotoxicity--Rat].
 including infants and children    UFA = 10x...........   kg/day.             LOAEL = 30 mg/kg/day based on
 and females 13-50 years of age).  UFH = 10x...........  aPAD = 0.15 mg/kg/    clinical signs (general ataxia/
                                   FQPA SF = 1x........   day.                 hypoactivity) observed in 1
                                                                               animal on Day 02 and 3 animals on
                                                                               Day 03 of dosing.
Chronic dietary (All populations)  NOAEL = 5 mg/kg/day.  Chronic RfD = 0.05   Co-Critical: Subchronic Toxicity--
                                   UFA = 10x...........   mg/kg/day.           Dog.
                                   UFH = 10x...........  cPAD = 0.05 mg/kg/   LOAEL = 15 mg/kg/day based on
                                   FQPA SF = 1x........   day.                 decreased body weight and food
                                                                               consumption/efficiency.
                                                                              Chronic Toxicity--Dog.
                                                                              LOAEL = 12 mg/kg/day based on
                                                                               decreased body weight and food
                                                                               consumption/efficiency.
Incidental oral short-term (1 to   NOAEL = 5 mg/kg/day.  LOC for MOE = 100..  Co-Critical: Subchronic and
 30 days).                         UFA = 10x...........                        Chronic Toxicity--Dog.
                                   UFH = 10x...........                       Same as Chronic Dietary.
                                   FQPA SF = 1x........
Inhalation short-term (1 to 30     Inhalation (or oral)  LOC for MOE = 100..  Co-Critical: Subchronic and
 days) and Intermediate Term (1     study NOAEL = 5 mg/                        Chronic Toxicity--Dog.
 to 6 months).                      kg/day (inhalation                        Same as Chronic Dietary.
                                    absorption rate =
                                    100%).
                                   UFA = 10x...........
                                   UFH = 10x...........
                                   FQPA SF = 1x........
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)  Classification: ``Not likely to be Carcinogenic to Humans'' based on the
                                    absence of significant tumor increases in two adequate rodent
                                    carcinogenicity studies.
----------------------------------------------------------------------------------------------------------------
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 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 food consumption information from the United
States Department of Agriculture (USDA) 2003-2008 National Health and
Nutrition Examination Survey, What We Eat in America (NHANS/WWEIA). As
to residue levels in food, EPA included tolerance level residues for
all registered and proposed crops and 100 percent crop treated (PCT).
Default processing factors were used for all processed commodities.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 2003-2008
National Health and Nutrition Examination Survey, What We Eat in
America (NHANES/WWEIA). As to residue levels in food, EPA included
tolerance level residues for all registered and proposed crops and 100
PCT. Default processing factors were used for all processed
commodities.
    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 100 PCT
were assumed for all food commodities.
    2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for fenazaquin in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of fenazaquin. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at http://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the Tier II Pesticide Root Zone Model/Exposure Analysis
Modeling System (PRZM/EXAMS) for surface water, the estimated drinking
water concentrations (EDWCs) of fenazaquin for acute and chronic
exposures were estimated to be 5.74 parts per billion (ppb) and 2.09
ppb,

respectively, and were entered directly into the dietary exposure
model. The groundwater EDWC from the screening concentration in ground
water (SCI-GROW) model was estimated to be 0.704 ppb. The modeled
estimates were corrected for the default percent cropped area of 0.87.
The drinking water assessment was conducted using the total toxic
residue (TTR) approach. The residues considered in the assessment
include fenazaquin (parent), Metabolite 1, and Metabolite 29.
    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 uses. EPA assessed
residential exposure using the following assumptions: EPA assessed
potential exposures for residential handlers using several application
methods including handwand and backpack sprayers to treat ornamental
plants. MOEs were calculated for the inhalation route of exposure only
since no systemic toxicity associated with dermal exposure to
fenazaquin was observed. Adult post-applications exposures were not
quantitatively assessed since no dermal hazard was identified for
fenazaquin and inhalation exposures are typically negligible in outdoor
settings. Furthermore, the inhalation exposure assessment performed for
residential handlers is representative of worst case inhalation
exposures and is considered protective for post-application inhalation
scenarios. Since there is no residential incidental oral exposure
expected for children 1<2 years old on ornamental plants, a post-
application exposure assessment was not conducted and the aggregate
assessment for children will only include exposure from food and water.
    Further information regarding EPA standard assumptions and generic
inputs for residential exposures may be found at http://www.epa.gov/pesticides/trac/science/trac6a05.pdf.
    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 Web site at http://www.epa.gov/pesticides/cumulative.

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 sensitivity/
susceptibility in the developing or young animal. Clear NOAELs and
LOAELs are available for all the parental and offspring effects.
Therefore, there are no residual prenatal or postnatal concerns.
    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 considered complete and
sufficient for assessing susceptibility to infants and children.
    ii. There is no indication that fenazaquin is a neurotoxic chemical
and there is no need for a developmental neurotoxicity study or
additional UFs to account for neurotoxicity.
    iii. There is no evidence that fenazaquin results in increased
susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in young rats in the 2-generation reproduction
study.
    iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100 PCT and tolerance-level residues. EPA made conservative
(protective) assumptions in the ground and surface water modeling used
to assess exposure to fenazaquin in drinking water. EPA also made
conservative assumptions in the non-dietary residential exposures
estimates including maximum application rates and standard values for
unit exposures, amount handled. 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 10% 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 10% of the cPAD for
children 1-2 years old the population group receiving the greatest
exposure. Based on the explanation in Unit III.C.3., regarding
residential use patterns, chronic residential exposure to residues of
fenazaquin is not expected.
    3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level). Fenazaquin is
currently registered for uses that could result in short-term
residential exposure, and the Agency has determined that it is
appropriate to aggregate chronic exposure through food and water with
short-term residential exposures to fenazaquin.

    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water,
and residential exposures result in aggregate MOEs of 5,200 for adults.
Because EPA's level of concern for fenazaquin is a MOE of 100 or below,
the MOE is not of concern. Since there is no residential exposure
expected for children, there is no potential that a short-term
aggregate risk for children could be higher than the dietary (food and
drinking water) risk.
    4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level).
    An intermediate-term adverse effect was identified; however,
fenazaquin is not registered for any use patterns that would result in
intermediate-term residential exposure.
    Intermediate-term risk is assessed based on intermediate-term
residential exposure plus chronic dietary exposure. Because there is no
intermediate-term residential exposure and chronic dietary exposure has
already been assessed under the appropriately protective cPAD (which is
at least as protective as the POD used to assess intermediate-term
risk), no further assessment of intermediate-term risk is necessary,
and EPA relies on the chronic dietary risk assessment for evaluating
intermediate-term risk for fenazaquin.
    5. 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.
    6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to fenazaquin residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (high performance liquid
chromatography and tandem mass spectrometry (HPLC-MS/MS)) is available
to enforce the tolerance expression.
    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_ADDRESS>
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 a MRL for fenazaquin.

C. Revisions to Petitioned-For Tolerances

    EPA's review of the data supporting the petition, showed that there
was not sufficient data to support some of the tolerances originally
proposed by the registrant. Gowan Company, the registrant, revised
their petition by limiting their request for tolerances to almond and
cherry, which are supported by the available data. The Organization of
Economic Cooperation and Development (OECD) tolerance derivation
procedures indicates the need for the following changes in the proposed
tolerances: Cherries from 1.5 ppm to 2.0 ppm and almond hull from 0.6
ppm to 4.0 ppm. The Agency is also revising the tolerance expression to
clarify that (1) as provided in FFDCA section 408(a)(3), the tolerance
covers metabolites and degradates of fenazaquin not specifically
mentioned and (2) compliance with the specified tolerance levels is to
be determined by measuring only the specific compounds mentioned in the
tolerance expression.

V. Conclusion

    Therefore, tolerances are established for residues of fenazaquin,
4-[2-[4-(1,1-dimethylethyl)phenyl]ethoxy]quinazoline, in or on almond
at 0.02 ppm, almond hulls at 4.0 ppm, and cherry at 2.0 ppm.

VI. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA section 408(d) in
response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this action has been
exempted from review under Executive Order 12866, this action is not
subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). 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: April 27, 2015.
Susan Lewis,
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, the section heading and paragraph (a) are revised
to read as follows:

Sec.  180.632  Fenazaquin; Tolerances for residues.

    (a) General. Tolerances are established for residues of the
insecticide fenazaquin, 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
fenazaquin, or 4-[2-[4-(1,1-dimethylethyl)phenyl]ethoxy]quinazoline.

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Almond.....................................................         0.02
Almond, hulls..............................................         4.0
Apple......................................................         0.2
Cherry.....................................................         2.0
Citrus Oil.................................................        10
Fruit, Citrus, Group 10 except Grape fruit.................         0.5
Pear.......................................................         0.2
------------------------------------------------------------------------

* * * * *

[FR Doc. 2015-10375 Filed 5-5-15; 8:45 am]
BILLING CODE 6560-50-P