Fenazaquin; Pesticide Tolerances, 24067-24071 [2017-10751]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 82, Number 100 (Thursday, May 25, 2017)]
[Rules and Regulations]
[Pages 24067-24071]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-10751]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2016-0029 FRL-9961-99]


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 hop, dried cones; nuts, tree, group 14-12; 
pineapple; and tea, dried. Gowan Company requested these tolerances 
under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective May 25, 2017. Objections and 
requests for hearings must be received on or before July 24, 2017, 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-2016-0029, is available at https://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 https://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: RDFRNotices@epa.gov.

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

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

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

    You may access a frequently updated electronic version of EPA's 
tolerance regulations at 40 CFR part 180 through the Government 
Printing Office's e-CFR site at https://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-2016-0029 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 24, 2017. 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-2016-0029, by one of 
the following methods:
     Federal eRulemaking Portal: https://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 https://www.epa.gov/dockets/contacts.html. Additional 
instructions on commenting or visiting the docket, along with more 
information about dockets generally, is available at https://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerances

    In the Federal Registers of March 16, 2016 (81 FR 14030) (FRL-9942-
86); May 19, 2016 (81 FR 31581) (FRL-9946-02); and August 12, 2016 (81 
FR 53379) (FRL-9949-53) EPA issued documents pursuant to FFDCA section 
408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of pesticide 
petitions (PP 6F8442, PP 5F8429, and PP 6E8466) by Gowan Company, P.O. 
Box 5569, Yuma, AZ 85366-5569. The petitions 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 hops at 30 parts per 
million (ppm) (PP 6F8442); nuts, tree, group 14-12 at 0.02 ppm (PP 
5F8429); pineapple at 0.2 ppm (PP 6E8466); and tea at 9 ppm (PP 
6E8466). The petitions also requested that the existing tolerance for 
almond at 0.2 ppm be removed upon establishment of the above tolerance 
for nut, tree group 14-12. Those documents referenced summaries of the 
petitions prepared by Gowan Company, the registrant, which are 
available in the docket, https://www.regulations.gov. Comments were 
received on the Notices of Filing. EPA's response to these comments is 
discussed 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

[[Page 24068]]

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. These effects were 
consistent with the commonly observed effects for compounds that 
disrupt mitochondrial electron transport system. Fenazaquin is a member 
of this class of chemicals.
    Fenazaquin did not produce developmental effects in rats and 
rabbits with prenatal exposure. It also did not cause reproductive 
effects, although it produced decreased body weight in the offspring at 
a dose where maternal body reduction also occurred in the reproduction 
study. The available data did not demonstrate clear neurotoxicity, 
immunotoxicity, or genotoxicity. The data in the immunotoxicity study 
showed an increased incidence of ataxia/hypo-activity with gavage 
dosing, but the effects were judged to be resulting from general 
malaise. Fenazaquin is also classified as not likely to be carcinogenic 
to humans, based on a lack of treatment-related cancer effects in two 
carcinogenicity studies.
    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 https://www.regulations.gov in document, ``Fenazaquin (044501); Human Health 
Risk Assessment in Support of Proposed Uses on tree nuts, group 14-12, 
and Hops, Dried Cones'' in pp. 11-17 in docket ID number EPA-HQ-OPP-
2016-0029.

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 https://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, default 
processing factors, and 100 percent crop treated (PCT) for all proposed 
and registered uses.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used DEEM-FCID, Version 3.16 software with 2003-2008 
food consumption data from the USDA's NHANES/WWEIA. As to residue 
levels in food, EPA assumed tolerance level residues, default 
processing factors, and 100 PCT for all proposed and registered uses.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that 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 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. 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. The Agency used 
screening-level water exposure models in the dietary exposure analysis 
and risk assessment for fenazaquin in drinking water. These

[[Page 24069]]

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 https://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
    Based on the Pesticide in Water Calculator (PWC version 1.52), the 
estimated drinking water concentrations (EDWCs) of fenazaquin and its 
metabolites of concern for acute exposures are estimated to be 23.8 
parts per billion (ppb) for surface water and 1.112 ppb for ground 
water, for chronic exposures for non-cancer assessments are estimated 
to be 3.19 ppb for surface water and 0.891 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For acute dietary risk 
assessment, the water concentration value of 23.8 ppb was used to 
assess the contribution to drinking water. For chronic dietary risk 
assessment, the water concentration of value 3.19 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 handler (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 https://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.''
    Unlike other pesticides, for which EPA followed a cumulative risk 
approach based on a common mechanism of toxicity, EPA has not made a 
common mechanism of toxicity finding as to fenazaquin and 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 not assumed that fenazaquin has 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 https://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 fetuses or young animals. 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. The available data do not provide evidence 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 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. 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 11% of the aPAD for children 1-2 years old, 
the population group receiving the greatest exposure.

[[Page 24070]]

    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 9.6% of the cPAD for 
children 1-2 years old, the population group receiving the greatest 
exposure, when the additional uses for hops, dried cones and nuts, 
tree, group 14-12 are considered. The chronic exposure will increase to 
9.9% of the cPAD for children 1-2 years old, when tea and pineapple are 
also assessed (See ``Fenazaquin, Acute and Chronic Aggregate Dietary 
(Food and Drinking Water) Exposure and Risk Assessments to Support Use 
of the Insecticide (Without Section 3 Registration) on Imported Tea and 
Imported Pineapple'' in docket ID number EPA-HQ-OPP-2016-0029). 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). Because there 
is no dermal endpoint and no potential short-term residential 
inhalation or incidental oral exposure to fenazaquin, a short-term risk 
is not expected.
    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). Because there is no dermal endpoint and no potential 
intermediate-term inhalation or oral residential exposure to 
fenazaquin, an intermediate-term risk is not expected.
    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 with positive ion electrospray ionization with tandem 
mass spectrometric detection (LC-MS/MS), is available to enforce the 
tolerance expression. However, for tea, residues were analyzed using 
gas chromatography with mass spectrometry (GC-MS) in selected ion 
monitoring mode.
    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: 
residuemethods@epa.gov.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. 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 in/on hop, dried 
cones; nuts, tree, group 14-12; pineapple; or tea, dried.

C. Response to Comments

    The majority of comments submitted to this docket concerned 
chemicals or actions not associated with the fenazaquin petitions. One 
comment was submitted by the Center for Biological Diversity (CBD) in 
response to the Notice of Filing for PP 6F8442 and PP 5F8429 and was 
primarily concerned about environmental risks and Agency compliance 
with any relevant obligations under the Endangered Species Act. This 
comment is not relevant to the Agency's evaluation of safety of the 
fenazaquin tolerances; section 408 of the FFDCA focuses on potential 
harms to human health, not effects on the environment.
    The three remaining comments were anonymous public comments 
submitted in response to the Notice of Filing, which stated, in part, 
to ``Deny this petition. It is harmful and is a toxic chemical''; 
``there is insufficient information on all facets of hazard from this 
toxic chemical''; and ``We, as Americans, do not need or want any more 
EPA regulations.'' The Agency recognizes that some individuals believe 
that pesticides should be banned on agricultural crops; however, these 
comments provide no supporting information upon which to evaluate the 
safety of pesticide. The existing legal framework provided by section 
408 of the FFDCA states that tolerances may be set when persons seeking 
such tolerances or exemptions have demonstrated that the pesticide 
meets the safety standard imposed by that statute. The Agency has 
evaluated the available information and determined that these 
tolerances are safe.

V. Conclusion

    Therefore, tolerances are established for residues of fenazaquin, 
including its metabolites and degradates, in or on hop, dried cones at 
30 ppm; nuts, tree, group 14-12 at 0.02 ppm; pineapple at 0.20 ppm; and 
tea, dried at 9.0 ppm. In addition, the Agency is removing the separate 
tolerance for almonds as it is unnecessary because almond is a 
commodity covered by the crop group tolerances for nuts, tree, group 
14-12.

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

[[Page 24071]]

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: May 1, 2017.
Michael Goodis,
Director, Registration Division, Office of Pesticide Programs.

0
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, amend the table in paragraph (a) as follows:
0
a. Remove the entry for ``Almond''.
0
b. Add alphabetically the entries for ``hop, dried cones''; ``nuts, 
tree, group 14-12''; ``pineapple''; and ``tea, dried''.
0
c. Add a footnote at the end of the table.
    The additions read as follows:


Sec.  180.632  Fenazaquin; Tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                              million
------------------------------------------------------------------------
 
                                * * * * *
Hop, dried cones.............................................       30.0
------------------------------------------------------------------------
 
                                * * * * *
Pineapple \1\................................................       0.20
Nuts, Tree, Group 14-12......................................       0.02
Tea, dried \1\...............................................        9.0
------------------------------------------------------------------------
\1\ There are no U.S. registrations as of May 25, 2017 for use on
  pineapple and tea.

* * * * *
[FR Doc. 2017-10751 Filed 5-24-17; 8:45 am]
BILLING CODE 6560-50-P