[Federal Register Volume 80, Number 231 (Wednesday, December 2, 2015)]
[Rules and Regulations]
[Pages 75426-75430]
[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<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>. 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:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document

applies to them. Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

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

    You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. 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

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
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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.
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Cancer (Oral, dermal, inhalation)..  EPA classified etoxazole as ``not likely to be carcinogenic to humans.
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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

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:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
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 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


[Federal Register Volume 81, Number 183 (Wednesday, September 21, 2016)]
[Notices]
[Pages 64969-64970]
[FR Doc No: 2016-22729]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-78851; File No. SR-FINRA-2016-036]

Self-Regulatory Organizations; Financial Industry Regulatory
Authority, Inc.; Notice of Filing and Immediate Effectiveness of a
Proposed Rule Change To Adopt NASD Interpretive Material 2210-2 as
FINRA Rule 2211 (Communications With the Public About Variable Life
Insurance and Variable Annuities) in the Consolidated FINRA Rulebook

September 15, 2016.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on August 31, 2016, Financial Industry Regulatory Authority, Inc.
(``FINRA'') filed with the Securities and Exchange Commission (``SEC''
or ``Commission'') the proposed rule change as described in Items I,
II, and III below, which Items have been prepared by FINRA. FINRA has
designated the proposed rule change as constituting a ``non-
controversial'' rule change under paragraph (f)(6) of Rule 19b-4 under
the Act,\3\ which renders the proposal effective upon receipt of this
filing by the Commission. The Commission is publishing this notice to
solicit comments on the proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 17 CFR 240.19b-4(f)(6).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    FINRA is proposing to adopt NASD Interpretive Material 2210-2
(Communications with the Public About Variable Life Insurance and
Variable Annuities) as FINRA Rule 2211 (Communications with the Public
About Variable Life Insurance and Variable Annuities) in the
consolidated FINRA rulebook without any substantive changes. FINRA also
proposes to update cross-references within other FINRA rules
accordingly.
    The text of the proposed rule change is available on FINRA's Web
site at http://www.finra.org, at the principal office of FINRA and at
the Commission's Public Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, FINRA included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. FINRA has prepared summaries, set forth in sections A,
B, and C below, of the most significant aspects of such statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    As part of the process of developing a new consolidated rulebook
(``Consolidated FINRA Rulebook''),\4\ FINRA is proposing to transfer
NASD Interpretive Material 2210-2 (Communications with the Public About
Variable Life Insurance and Variable Annuities) (``NASD IM-2210-2'')
into the Consolidated FINRA Rulebook as FINRA Rule 2211 (Communications
with the Public About Variable Life Insurance and Variable Annuities)
without any substantive changes.
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    \4\ The current FINRA rulebook consists of: (1) FINRA Rules; (2)
NASD Rules; and (3) rules incorporated from New York Stock Exchange
LLC (``NYSE'') (``Incorporated NYSE Rules'') (together, the NASD
Rules and Incorporated NYSE Rules are referred to as the
``Transitional Rulebook''). While the NASD Rules generally apply to
all FINRA members, the Incorporated NYSE Rules apply only to those
members of FINRA that are also members of the NYSE (``Dual
Members''). The FINRA Rules apply to all FINRA members, unless such
rules have a more limited application by their terms. For more
information about the rulebook consolidation process, see
Information Notice, March 12, 2008 (Rulebook Consolidation Process).
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    As with NASD IM-2210-2, proposed FINRA Rule 2211 provides a set of
guidelines (``Guidelines'') that must be considered--in addition to the
standards governing communications with the public under FINRA Rule
2210 (Communications with the Public)--in preparing communications
about variable life insurance and variable annuities.
    NASD IM-2210-2 states that the Guidelines are applicable to
``advertisements'' and ``sales literature'' as defined in NASD Rule
2210, as well as ``individualized communications such as personalized
letters and computer generated illustrations, whether printed or made
available on-screen.'' The proposed rule change makes technical changes
to NASD IM-2210-2 by replacing references to ``advertisements,''
``sales literature,'' and ``individualized communications'' with the
current corresponding terms defined in FINRA Rule 2210. In adopting
FINRA Rule 2210, FINRA updated the definitions under NASD Rule 2210 by
adopting the defined terms ``retail communication,'' for written
communications that are distributed or made available to more than 25
retail investors within any 30 calendar-day period, and
``correspondence'' for written communications that are distributed or
made available to 25 or fewer retail investors within any 30 calendar-
day period.'' \5\ Accordingly, the proposed rule change would replace
references in NASD IM-2210-2, where applicable, to the terms (1)
``advertisements'' and ``sales literature'' with the term ``retail
communications,'' \6\ (2) ``individualized communications'' with the
term ``correspondence,'' and (3) ``communications'' with the term
``retail communications and correspondence,'' as such terms are defined
in FINRA Rule 2210. The proposed rule change also would amend paragraph
(b)(5) of NASD IM-2210-2 by replacing the heading ``sales literature
and personalized illustrations'' with ``retail communications and
correspondence,'' and by replacing the term ``sales literature'' in
paragraph (b)(5)(B) with the term ``retail communications and
correspondence,'' to reflect the current intent and scope of this
provision to include communications containing personalized
illustrations that are sent to retail investors irrespective of whether
a member distributes or makes them available to more than 25 retail
investors within any 30 calendar-day period (qualifying the
communication as a ``retail communication'') or 25 or

fewer retail investors within any 30 calendar-day period (qualifying
the communication as ``correspondence'').
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    \5\ See Securities Exchange Act Release No. 66681 (March 29,
2012), 77 FR 20452 (April 4, 2012) (Order Approving File No. SR-
FINRA-2011-035). In addition, to the extent that a member
distributed or made available a communication that qualified as an
independently prepared reprint to more than 25 retail investors
within a 30 calendar-day period, the communication also would fall
under the definition of ``retail communication.''
    \6\ See Securities Exchange Act Release No. 64984 (July 28,
2011), 76 FR 46870 (August 3, 2011) (Notice of Filing File No. SR-
FINRA-2011-035) (stating that communications that qualified as
advertisements and sales literature generally would fall within the
term ``retail communication'').
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    In addition, proposed FINRA Rule 2211 closely tracks the language
of IM-2210-2 and makes only non-substantive, technical changes to the
text of the NASD rule by, for instance, replacing the reference to a
legacy NASD rule with the applicable FINRA rule.\7\
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    \7\ FINRA previously solicited comment on a proposal to move IM-
2210-2 to the Consolidated FINRA Rulebook with substantive changes.
See Regulatory Notice 08-39 (July 2008); see also Securities
Exchange Act Release No. 61107 (December 3, 2009), 74 FR 65180
(December 9, 2009) (Notice of Filing File No. SR-FINRA-2009-070)
(withdrawn on April 27, 2012). Given that FINRA would like to
proceed with the rulebook consolidation process expeditiously to
provide greater clarity and regulatory efficiency to FINRA members,
FINRA is proposing to move IM-2210-2 to the Consolidated FINRA
Rulebook without substantive changes at this time, but FINRA may
consider proposing substantive changes to the rule as part of future
rulemaking.
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    These proposed rule changes would correct references in IM-2210-2
for purposes of adopting it as a FINRA rule without changing the
substantive meaning.
    The proposed rule change also would replace all references to IM-
2210-2 in FINRA Rules 0150 (Application of Rules to Exempted Securities
Except Municipal Securities) and 9217 (Violations Appropriate for
Disposition Under Plan Pursuant to SEA Rule 19d-1(c)(2)) with
references to FINRA Rule 2211, accordingly.
    FINRA has filed the proposed rule change for immediate
effectiveness. The implementation date will be 30 days after the date
of filing.
2. Statutory Basis
    FINRA believes that the proposed rule change is consistent with the
provisions of Section 15A(b)(6) of the Act,\8\ which requires, among
other things, that FINRA rules must be designed to prevent fraudulent
and manipulative acts and practices, to promote just and equitable
principles of trade, and, in general, to protect investors and the
public interest. FINRA believes that the proposed rule change, which
does not substantively change the rule, is consistent with the Act
because it is being undertaken pursuant to the rulebook consolidation
process, which is designed to provide additional clarity and regulatory
efficiency to FINRA members by consolidating the applicable NASD,
Incorporated NYSE, and FINRA rules into one rule set.
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    \8\ 15 U.S.C. 78o-3(b)(6).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    FINRA does not believe that the proposed rule change will result in
any burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act. As noted above, the proposed
rule change will not substantively change either the text or
application of the rule. FINRA would like to proceed with the rulebook
consolidation process expeditiously, which it believes will provide
additional clarity and regulatory efficiency to members.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    Written comments were neither solicited nor received with respect
to the proposed rule change to transfer IM-2210-2 into the Consolidated
FINRA Rulebook without any substantive changes.\9\
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    \9\ But see supra note 7.
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III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    Because the foregoing proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate, it has become
effective pursuant to Section 19(b)(3)(A) of the Act \10\ and Rule 19b-
4(f)(6) thereunder.\11\
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    \10\ 15 U.S.C. 78s(b)(3)(A).
    \11\ 17 CFR 240.19b-4(f)(6).
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    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings to
determine whether the proposed rule should be approved or disapproved.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-FINRA-2016-036 on the subject line.

Paper Comments

     Send paper comments in triplicate to Robert W. Errett,
Deputy Secretary, Securities and Exchange Commission, 100 F Street NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-FINRA-2016-036. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of such filing also will be available for
inspection and copying at the principal office of FINRA. All comments
received will be posted without change; the Commission does not edit
personal identifying information from submissions. You should submit
only information that you wish to make available publicly. All
submissions should refer to File Number SR-FINRA-2016-036 and should be
submitted on or before October 12, 2016.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\12\
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    \12\ 17 CFR 200.30-3(a)(12).
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Brent J. Fields,
Secretary.
[FR Doc. 2016-22729 Filed 9-20-16; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 82, Number 124 (Thursday, June 29, 2017)]
[Proposed Rules]
[Pages 29469-29470]
[FR Doc No: 2017-13478]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 52 and 81

[EPA-R06-OAR-2009-0750; FRL-9963-46-Region-6]

Approval and Promulgation of Air Quality Implementation Plans;
Texas; Redesignation of the Collin County Area to Attainment the 2008
Lead Standard

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) is proposing to
determine the Collin County Lead (Pb) Nonattainment Area (comprising
the part of Collin County bounded to the north by latitude 33.153
North, to the east by longitude 96.822 West, to the south by latitude
33.131 North, and to the West by longitude 96.837 West, which surrounds
the Exide Technologies property), hereinafter referenced to as Non-
Attainment Area or NAA, as attainment for the 2008 Pb NAAQS. We are
also proposing to approve two SIP revision requests made by the TCEQ in
2009 and 2012. These two requests include one made in 2009 requesting
approval of the state's second 10-year maintenance plan for the 1978 Pb
National Ambient Air Quality Standard (NAAQS) and one made in 2012 to
approve the state's plan to demonstrate compliance with the 2008 Pb
NAAQS. These two revisions represent a change in the Texas State
Implementation Plan (SIP) for Pb. The details of all three proposals,
and our complete analysis of the requirements for each and how the
state's submission meets those requirements can be found in the
accompanying direct final notice and technical support document (TSD)
to this proposal. The TSD is available in the docket at http://www.regulations.gov, Docket ID No. EPA-R06-OAR-2009-0750.

DATES: Written comments should be received on or before July 31, 2017.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R06-
OAR-2009-0750, at http://www.regulations.gov or via email to
<EMAIL_ADDRESS>For additional information on how to submit
comments see the detailed instructions in the ADDRESSES section of the
direct final rule located in the rules section of this Federal
Register.

FOR FURTHER INFORMATION CONTACT: Robert M. Todd,<PHONE_NUMBER>,
<EMAIL_ADDRESS>

SUPPLEMENTARY INFORMATION: In the final rules section of this Federal
Register, the EPA is approving the State's SIP submittal as a direct
rule without prior proposal because the Agency views this as
noncontroversial submittal and anticipates no adverse comments. A
detailed rationale for the approval is set forth in the direct final
rule. If no relevant adverse comments are received in response to this
action no further activity is contemplated. If the EPA receives
relevant adverse comments, the direct final rule will be withdrawn and
all public comments received will be addressed in a subsequent final
rule based on this proposed rule. The EPA will not institute a second
comment period. Any parties interested in commenting on this action
should do so at this time.
    For additional information, see the direct final rule which is
located in the rules section of this Federal Register.

    Dated: June 14, 2017.
Samuel Coleman,
Acting Regional Administrator, Region 6.
[FR Doc. 2017-13478 Filed 6-28-17; 8:45 am]
 BILLING CODE 6560-50-P