80 FR 75426 - Etoxazole; Pesticide Tolerances

ENVIRONMENTAL PROTECTION AGENCY

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

Page Range		75426-75430
FR Document		2015-30513

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 Issue 231 (Wednesday, December 2, 2015)

[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: 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

[[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
----------------------------------------------------------------------------------------------------------------
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:
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

[[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

75430 Federal Register / Vol. 80, No. 231 / Wednesday, December 2, 2015 / Rules and Regulations

required by FFDCA section 408(b)(4). Risks and Safety Risks’’ (62 FR 19885, Register. This action is not a ‘‘major
The Codex Alimentarius is a joint April 23, 1997). This action does not rule’’ as defined by 5 U.S.C. 804(2).
United Nations Food and Agriculture contain any information collections
List of Subjects in 40 CFR Part 180
Organization/World Health subject to OMB approval under the
Organization food standards program, Paperwork Reduction Act (PRA) (44 Environmental protection,
and it is recognized as an international U.S.C. 3501 et seq.), nor does it require Administrative practice and procedure,
food safety standards-setting any special considerations under Agricultural commodities, Pesticides
organization in trade agreements to Executive Order 12898, entitled and pests, Reporting and recordkeeping
which the United States is a party. EPA ‘‘Federal Actions to Address requirements.
may establish a tolerance that is Environmental Justice in Minority Dated: November 23, 2015.
different from a Codex MRL; however, Populations and Low-Income Susan Lewis,
FFDCA section 408(b)(4) requires that Populations’’ (59 FR 7629, February 16, Director, Registration Division, Office of
EPA explain the reasons for departing 1994). Pesticide Programs.
from the Codex level. Since tolerances and exemptions that
The Codex has established MRLs for Therefore, 40 CFR chapter I is
are established on the basis of a petition amended as follows:
etoxazole in or on citrus fruits at 0.1 under FFDCA section 408(d), such as
ppm. EPA is establishing a tolerance for the tolerances in this final rule, do not PART 180—[AMENDED]
residues in or on orange of 0.10 ppm in require the issuance of a proposed rule,
order to harmonize with the Codex the requirements of the Regulatory ■ 1. The authority citation for part 180
MRL. Flexibility Act (RFA) (5 U.S.C. 601 et continues to read as follows:
C. Revisions to Petitioned-For seq.), do not apply. Authority: 21 U.S.C. 321(q), 346a and 371.
Tolerances This action directly regulates growers,
■ 2. In § 180.593, add alphabetically the
EPA has revised the proposed food processors, food handlers, and food
following commodities and footnote 2 to
tolerance levels for orange and orange retailers, not States or tribes, nor does
the table in paragraph (a) to read as
oil from 0.08 and 1.8 ppm to 0.10 and this action alter the relationships or
follows:
1.0 ppm, respectively. EPA is distribution of power and
establishing a tolerance of 0.10 ppm for responsibilities established by Congress § 180.593 Etoxazole; tolerances for
orange in order to harmonize with the in the preemption provisions of FFDCA residues.
Codex MRL. Additionally, based on the section 408(n)(4). As such, the Agency (a) * * *
orange raw agricultural commodity has determined that this action will not
highest-average field-trial residue of have a substantial direct effect on States Commodity Parts per
or tribal governments, on the million
0.048 ppm and the median orange oil
processing factor of 20x, EPA is relationship between the national
establishing a tolerance for orange, oil at government and the States or tribal * * * * *
1.0 ppm. In addition, EPA is revising governments, or on the distribution of Orange 2 ...................................... 0.10
the commodity terms for orange oil to power and responsibilities among the Orange, oil 2 ................................ 1.0
read as orange, oil to be consistent with various levels of government or between
the Agency’s commodity vocabulary. the Federal Government and Indian * * * * *
tribes. Thus, the Agency has determined 2 There
V. Conclusion are no U.S. registrations for orange
that Executive Order 13132, entitled and orange, oil as of December 2, 2015.
Therefore, tolerances are established ‘‘Federalism’’ (64 FR 43255, August 10,
1999) and Executive Order 13175, * * * * *
for residues of etoxazole (2-(2,6- [FR Doc. 2015–30513 Filed 12–1–15; 8:45 am]
difluorophenyl)-4-[4-(1,1- entitled ‘‘Consultation and Coordination
with Indian Tribal Governments’’ (65 FR BILLING CODE 6560–50–P
dimethylethyl)-2-ethoxyphenyl]-4,5-
dihydrooxazole), in or on orange and 67249, November 9, 2000) do not apply
orange, oil at 0.10 ppm and 1.0 ppm, to this action. In addition, this action
does not impose any enforceable duty or ENVIRONMENTAL PROTECTION
respectively. AGENCY
contain any unfunded mandate as
VI. Statutory and Executive Order described under Title II of the Unfunded
Reviews 40 CFR Part 180
Mandates Reform Act (UMRA) (2 U.S.C.
This action establishes tolerances 1501 et seq.). [EPA–HQ–OPP–2014–0804; FRL–9937–02]
under FFDCA section 408(d) in This action does not involve any
response to a petition submitted to the Hexythiazox; Pesticide Tolerances;
technical standards that would require
Agency. The Office of Management and Technical Correction
Agency consideration of voluntary
Budget (OMB) has exempted these types consensus standards pursuant to section AGENCY: Environmental Protection
of actions from review under Executive 12(d) of the National Technology Agency (EPA).
Order 12866, entitled ‘‘Regulatory Transfer and Advancement Act ACTION: Final rule; technical correction.
Planning and Review’’ (58 FR 51735, (NTTAA) (15 U.S.C. 272 note).
October 4, 1993). Because this action SUMMARY: EPA issued a final rule in the
VII. Congressional Review Act Federal Register of August 14, 2015,
has been exempted from review under
Executive Order 12866, this action is Pursuant to the Congressional Review concerning the establishment of
jstallworth on DSK7TPTVN1PROD with RULES

not subject to Executive Order 13211, Act (5 U.S.C. 801 et seq.), EPA will tolerances with regional registrations for
entitled ‘‘Actions Concerning submit a report containing this rule and residues of hexythiazox in or on wheat.
Regulations That Significantly Affect other required information to the U.S. This document corrects a technical
Energy Supply, Distribution, or Use’’ (66 Senate, the U.S. House of error, specifically, the omission of
FR 28355, May 22, 2001) or Executive Representatives, and the Comptroller regions in the commodity definitions.
Order 13045, entitled ‘‘Protection of General of the United States prior to DATES: This final rule correction is
Children from Environmental Health publication of the rule in the Federal effective December 2, 2015.

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Document Created: 2015-12-14 13:48:36
Document Modified: 2015-12-14 13:48:36

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Rules and Regulations
Action		Final rule.
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).
Contact		Susan Lewis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone
FR Citation		80 FR 75426
CFR Associated		Environmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements