[Federal Register Volume 80, Number 87 (Wednesday, May 6, 2015)]
[Rules and Regulations]
[Pages 25953-25958]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 (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: Susan Lewis, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone 
number: (703) 305-7090; email address: [email protected].

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

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

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

    You may access a frequently updated electronic version of EPA's 
tolerance regulations at 40 CFR part 180 through the Government 
Publishing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/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;

[[Page 25954]]

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

[[Page 25955]]

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
----------------------------------------------------------------------------------------------------------------
                                    Point of departure
        Exposure/scenario            and  uncertainty/    RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
----------------------------------------------------------------------------------------------------------------
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,

[[Page 25956]]

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.

[[Page 25957]]

    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: (410) 305-2905; email address: 
[email protected].

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food 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

[[Page 25958]]

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