80 FR 75426 - Etoxazole; Pesticide Tolerances

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 80, Issue 231 (December 2, 2015)

This regulation establishes tolerances for residues of etoxazole in or on orange and orange oil. Sumitomo Chemical Latin America through Valent USA Corporation requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

[Federal Register Volume 80, Number 231 (Wednesday, December 2, 2015)]
[Rules and Regulations]
[Pages 75426-75430]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-30513]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2014-0681; FRL-9934-60]


Etoxazole; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
etoxazole in or on orange and orange oil. Sumitomo Chemical Latin 
America through Valent USA Corporation requested these tolerances under 
the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective December 2, 2015. Objections and 
requests for hearings must be received on or before February 1, 2016, 
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-2014-0681, 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

[[Page 75427]]

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. To access the OCSPP 
test guidelines referenced in this document electronically, please go 
to http://www.epa.gov/ocspp and select ``Test Methods and Guidelines.''

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-2014-0681 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 
February 1, 2016. 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-2014-0681, 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 4, 2015 (80 FR 11611) (FRL-9922-
68), 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 
4E8304) by Sumitomo Chemical Latin America through Valent USA 
Corporation, 1600 Riviera Avenue, Suite 200, Walnut Creek, CA 94596. 
The petition requested that 40 CFR 180.593 be amended by establishing 
tolerances for residues of the insecticide etoxazole (2-(2,6-
difluorophenyl)-4-[4-(1,1-dimethylethyl)-2-ethoxyphenyl]-
4,5dihydrooxazole), in or on orange and orange oil at 0.08 and 1.8 
parts per million (ppm), respectively. That document referenced a 
summary of the petition prepared by Valent USA Corporation on behalf of 
Sumitomo Chemical Latin America, the registrant, which is available in 
the docket, http://www.regulations.gov.
    EPA received one comment to the Notice of Filing concerning another 
chemical (azoxystrobin) and not etoxazole. The commenter stated, in 
part, that zero residues should be allowed for pesticide residues. The 
Agency understands the commenter's concerns and recognizes that some 
individuals believe that pesticides should be banned on agricultural 
crops. However, 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. This citizen's comment appears 
to be directed at the underlying statute and not EPA's implementation 
of it; the citizen has made no contention that EPA has acted in 
violation of the statutory framework.
    Based upon review of the data supporting the petition, EPA has 
revised the petitioned-for tolerance levels of 0.08 and 1.8 ppm for 
orange and orange, oil to 0.10 and 1.0 ppm, respectively. The reasons 
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 etoxazole including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with etoxazole 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 effects in the etoxazole database show liver toxicity in all 
species tested (enzyme release, hepatocellular swelling, and 
histopathological indicators), and the severity does not appear to 
increase with time. In rats only, there were effects on incisors 
(elongation, whitening, and partial loss of upper and/or lower 
incisors). There is no evidence of neurotoxicity or immunotoxicity. No 
toxicity was seen at the limit dose in a 28-day dermal toxicity study 
in rats. Etoxazole was not mutagenic. No increased quantitative or 
qualitative susceptibilities were observed following in utero exposure 
to

[[Page 75428]]

rats or rabbits in the developmental studies; however, offspring 
toxicity was more severe (increased pup mortality) than maternal 
toxicity (increased liver and adrenal weights) at the same dose (158.7 
milligram/kilogram/day (mg/kg/day)) in the rat reproduction study 
indicating increased qualitative susceptibility. Etoxazole is not 
likely to be carcinogenic based on the lack of carcinogenicity effects 
in the database.
    Specific information on the studies received and the nature of the 
adverse effects caused by etoxazole 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, ``Etoxazole: Human Health Risk 
Assessment in Support of the Proposed Tolerances for Residues in/on 
Imported Oranges and Orange Oil'' at pp. 16-18 in docket ID number EPA-
HQ-OPP-2014-0681.

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 the NOAEL and the LOAEL are identified. 
Uncertainty/safety factors are used in conjunction with the POD to 
calculate a safe exposure level--generally referred to as a population-
adjusted dose (PAD) or a reference dose (RfD)--and a safe margin of 
exposure (MOE). For non-threshold risks, the Agency assumes that any 
amount of exposure will lead to some degree of risk. Thus, the Agency 
estimates risk in terms of the probability of an occurrence of the 
adverse effect expected in a lifetime. For more information on the 
general principles EPA uses in risk characterization and a complete 
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for etoxazole used for 
human risk assessment is shown in Table 1 of this unit.

   Table 1--Summary of Toxicological Doses and Endpoints for Etoxazole for Use in Human Health Risk Assessment
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                                     Point of departure and
         Exposure/scenario              uncertainty/safety   RfD, PAD, LOC for risk    Study and toxicological
                                             factors               assessment                  effects
----------------------------------------------------------------------------------------------------------------
Acute dietary (all populations)....  N/A...................  N/A...................  A dose and endpoint
                                                                                      attributable to a single
                                                                                      dose were not identified
                                                                                      in the database including
                                                                                      the hazard database. An
                                                                                      acute dietary assessment
                                                                                      was not performed.
Chronic dietary (all populations)..  NOAEL = 4.62 mg/kg/day  Chronic RfD = 0.046 mg/ Chronic Oral Toxicity
                                     UFA = 10x.............   kg/day.                 Study--Dog. LOAEL = 23.5
                                     UFH = 10x.............  cPAD = 0.046 mg/kg/day   mg/kg/day based upon
                                     FQPA SF = 1x..........                           increased alkaline
                                                                                      phosphatase activity,
                                                                                      increased liver weights,
                                                                                      liver enlargement
                                                                                      (females), and incidences
                                                                                      of centrilobular
                                                                                      hepatocellular swelling in
                                                                                      the liver.
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)..  EPA classified etoxazole as ``not likely to be carcinogenic to humans.
----------------------------------------------------------------------------------------------------------------
Point of departure (POD) = A data point or an estimated point that is derived from observed dose-response data
  and used to mark the beginning of extrapolation to determine risk associated with lower environmentally
  relevant human exposures. NOAEL = no-observed adverse-effect level. LOAEL = lowest-observed adverse-effect
  level. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential
  variation in sensitivity among members of the human population (intraspecies). Food Quality Protection Act
  Safety Factor = FQPA SF. PAD = population-adjusted dose (a = acute, c = chronic). RfD = reference dose. N/A =
  not applicable.

    Since the current proposal pertains to an import tolerance (no 
occupational exposure for workers in the U.S.) and since residential 
exposure is not anticipated from the proposed/registered uses, only 
dietary toxicological endpoints are listed in Table 1.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to etoxazole, EPA considered exposure under the petitioned-for 
tolerances as well as all existing etoxazole tolerances in 40 CFR 
180.593. EPA assessed dietary exposures from etoxazole 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.
    No such effects were identified in the toxicological studies for 
etoxazole; therefore, a quantitative acute dietary exposure assessment 
is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA National 
Health and Nutrition Examination Survey, What We Eat in America 
(NHANES/WWEIA; 2003-2008). As to residue levels in food, EPA assumed 
tolerance-level residues, 100% crop treated (PCT), and in the absence 
of empirical data, DEEM (ver 7.81) default processing factors. In 
addition, based on EPA's conclusion that etoxazole has a high potential 
to bioaccumulate, residue estimates for fish/shellfish were included.
    iii. Cancer. EPA classified etoxazole as ``not likely to be 
carcinogenic 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 etoxazole. Tolerance-level residues and/or 100 
PCT were assumed for all food commodities.
    2. Dietary exposure from drinking water. Although the orange and 
orange, oil tolerances will not result in residues in drinking water, 
as those uses are not

[[Page 75429]]

associated with a U.S. registration, the Agency used screening-level 
water exposure models in the dietary exposure analysis and risk 
assessment to assess etoxazole in drinking water resulting from 
existing U.S. registrations. These simulation models take into account 
data on the physical, chemical, and fate/transport characteristics of 
etoxazole. 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 First Index Reservoir Screening Tool (FIRST), and 
Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/
EXAMS), the estimated drinking water concentrations (EDWCs) of 
etoxazole for chronic exposures for non-cancer assessments are 
estimated to be 4.761 parts per billion (ppb) for surface water and 
<0.1 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model.
    For chronic dietary risk assessment, the water concentration of 
value 4.761 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).
    Etoxazole is not registered for any specific use patterns that 
would result in residential exposure.
    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 etoxazole to share a common mechanism of toxicity 
with any other substances, and etoxazole does not appear to produce a 
toxic metabolite produced by other substances. For the purposes of this 
tolerance action, therefore, EPA has assumed that etoxazole 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. No increased quantitative or 
qualitative susceptibilities were observed following in utero exposure 
to rats or rabbits in the developmental studies. There is evidence of 
increased qualitative offspring susceptibility in the rat reproduction 
study, but the concern is low since: (1) The effects in pups are well-
characterized with a clear NOAEL; (2) the selected endpoints are 
protective of the doses where the offspring toxicity is observed; and 
(3) offspring effects occur in the presence of parental toxicity. There 
are no residual uncertainties for pre-/post-natal toxicity.
    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 etoxazole is complete.
    ii. There is no indication that etoxazole is a neurotoxic chemical 
and there is no need for a developmental neurotoxicity study or 
additional uncertainty factors (UFs) to account for neurotoxicity.
    iii. The observed qualitative postnatal susceptibility is protected 
for by the selected endpoints.
    iv. There are no residual uncertainties identified in the exposure 
databases.
    EPA made conservative (protective) assumptions in the ground and 
surface water modeling used to assess exposure to etoxazole in drinking 
water. These assessments will not underestimate the exposure and risks 
posed by etoxazole.

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. An acute aggregate risk assessment takes into 
account acute exposure estimates from dietary consumption of food and 
drinking water. No adverse effect resulting from a single oral exposure 
was identified and no acute dietary endpoint was selected. Therefore, 
etoxazole is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
etoxazole from food and water will utilize 15% of the cPAD for children 
1-2 years old the population group receiving the greatest exposure. 
There are no residential uses for etoxazole.
    3. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, etoxazole is not expected to pose a cancer risk to humans.
    4. 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 etoxazole residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology gas chromatography/nitrogen 
phosphorus detector (GC/NPD) is available to enforce the recommended 
tolerances.
    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

[[Page 75430]]

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 established MRLs for etoxazole in or on citrus fruits 
at 0.1 ppm. EPA is establishing a tolerance for residues in or on 
orange of 0.10 ppm in order to harmonize with the Codex MRL.

C. Revisions to Petitioned-For Tolerances

    EPA has revised the proposed tolerance levels for orange and orange 
oil from 0.08 and 1.8 ppm to 0.10 and 1.0 ppm, respectively. EPA is 
establishing a tolerance of 0.10 ppm for orange in order to harmonize 
with the Codex MRL. Additionally, based on the orange raw agricultural 
commodity highest-average field-trial residue of 0.048 ppm and the 
median orange oil processing factor of 20x, EPA is establishing a 
tolerance for orange, oil at 1.0 ppm. In addition, EPA is revising the 
commodity terms for orange oil to read as orange, oil to be consistent 
with the Agency's commodity vocabulary.

 V. Conclusion

    Therefore, tolerances are established for residues of etoxazole (2-
(2,6-difluorophenyl)-4-[4-(1,1-dimethylethyl)-2-ethoxyphenyl]-4,5-
dihydrooxazole), in or on orange and orange, oil at 0.10 ppm and 1.0 
ppm, respectively.

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 tolerances in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.), do not apply.
    This action directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled ``Federalism'' (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
``Consultation and Coordination with Indian Tribal Governments'' (65 FR 
67249, November 9, 2000) do not apply to this action. In addition, this 
action does not impose any enforceable duty or contain any unfunded 
mandate as described under Title II of the Unfunded Mandates Reform Act 
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
EPA will submit a report containing this rule and other required 
information to the U.S. Senate, the U.S. House of Representatives, and 
the Comptroller General of the United States prior to publication of 
the rule in the Federal Register. This action is not a ``major rule'' 
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: November 23, 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.  180.593, add alphabetically the following commodities and 
footnote 2 to the table in paragraph (a) to read as follows:


Sec.  180.593  Etoxazole; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Orange \2\..................................................        0.10
Orange, oil \2\.............................................         1.0
 
                                * * * * *
------------------------------------------------------------------------
\2\ There are no U.S. registrations for orange and orange, oil as of
  December 2, 2015.

* * * * *
[FR Doc. 2015-30513 Filed 12-1-15; 8:45 am]
 BILLING CODE 6560-50-P