[Federal Register Volume 84, Number 70 (Thursday, April 11, 2019)]
[Rules and Regulations]
[Pages 14617-14622]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 (202) 566-1744, and the telephone number for the OPP 
Docket is (703) 305-5805. Please review the visitor instructions and 
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Michael Goodis, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; main telephone 
number: (703) 305-7090; email address: [email protected].

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

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

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

    You may access a frequently updated electronic version of EPA's 
tolerance regulations at 40 CFR part 180 through the Government 
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;

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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

[[Page 14619]]

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

[[Page 14620]]

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: (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 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

[[Page 14621]]

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

[[Page 14622]]

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