82_FR_14674 82 FR 14620 - Cloquintocet-mexyl; Pesticide Tolerances

82 FR 14620 - Cloquintocet-mexyl; Pesticide Tolerances

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 82, Issue 54 (March 22, 2017)

Page Range14620-14623
FR Document2017-05705

This regulation establishes tolerances for residues of Cloquintocet-mexyl (acetic acid [5-chloro-8-quinolinyl) oxy]-1- methylhexyl ester) in or on teff when cloquintocet-mexyl is used as an inert ingredient (herbicide safener) in pesticide formulations containing pyroxsulam. Dow AgroSciences LLC requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA) in order to cover residues of cloquintocet-mexyl in imported teff commodities.

Federal Register, Volume 82 Issue 54 (Wednesday, March 22, 2017)
[Federal Register Volume 82, Number 54 (Wednesday, March 22, 2017)]
[Rules and Regulations]
[Pages 14620-14623]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-05705]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2016-0299; FRL-9959-11]


Cloquintocet-mexyl; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This regulation establishes tolerances for residues of 
Cloquintocet-mexyl (acetic acid [5-chloro-8-quinolinyl) oxy]-1-
methylhexyl ester) in or on teff when cloquintocet-mexyl is used as an 
inert ingredient (herbicide safener) in pesticide formulations 
containing pyroxsulam. Dow AgroSciences LLC requested these tolerances 
under the Federal Food, Drug, and Cosmetic Act (FFDCA) in order to 
cover residues of cloquintocet-mexyl in imported teff commodities.

DATES: This regulation is effective March 22, 2017. Objections and 
requests for hearings must be received on or before May 22, 2017, and 
must be filed in accordance with the instructions provided in 40 CFR 
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2016-0299, 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

[[Page 14621]]

20460-0001. The Public Reading Room is open from 8:30 a.m. to 4:30 
p.m., Monday through Friday, excluding legal holidays. The telephone 
number for the Public Reading Room is (202) 566-1744, and the telephone 
number for the OPP Docket is (703) 305-5805. Please review the visitor 
instructions and additional information about the docket available at 
http://www.epa.gov/dockets.

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

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

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

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

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

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2016-0299 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 
May 22, 2017. Addresses for mail and hand delivery of objections and 
hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing (excluding any Confidential Business Information (CBI)) for 
inclusion in the public docket. Information not marked confidential 
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without 
prior notice. Submit the non-CBI copy of your objection or hearing 
request, identified by docket ID number EPA-HQ-OPP-2016-0299, 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 August 29, 2016 (81 FR 59165) (FRL-9950-
22), 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# 
5E8432) by Dow AgroSciences LLC, 9330 Zionsville Road, Indianapolis, IN 
46268. The petition requested that 40 CFR part 180.560 be amended by 
establishing tolerances without U.S registrations for residues of the 
cloquintocet-mexyl for use as an inert ingredient (safener) in 
combination with the herbicide pyroxulam in or on the raw agricultural 
commodities teff, forage at 0.2 parts per million (ppm); teff, grain at 
0.1 ppm; teff hay at 0.5 ppm; teff straw at 0.1ppm. That document 
referenced a summary of the petition prepared by Dow AgroSciences, LLC, 
the registrant, which is available in the docket EPA-HQ-OPP-2016-0299 
at http://www.regulations.gov. There were no comments received in 
response to the notice of filing.

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), 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 cloquintocet-mexyl in or 
on teff forage, grain, hay and straw, consistent with FFDCA section 
408(b)(2).
    In the Federal Register of August 2, 2016 (81 FR 50630) (FRL-9947-
78), EPA established tolerances for residues of cloquintocet-mexyl and 
its acid metabolite (5-chloro-8-quinolinoxyacetic acid) when used in 
pesticide formulations containing the active ingredient halauxifen-
methyl, in or on barley grain, barley hay, barley straw, and wheat 
forage, wheat grain, wheat hay, and wheat straw. EPA is relying upon 
the risk assessments that supported the findings made in the August 2, 
2016, Federal Register document in support of this action. The toxicity 
profile of cloquintocet-mexyl has not changed, and the previous risk 
assessments that supported the establishment of those tolerances remain 
valid.
    The Agency evaluated the request to establish tolerances in or on 
teff forage, grain, hay, and straw. Teff is prepared like other whole 
grains, such as rice and barley, and may also be used to make flour in 
a manner similar to wheat and other cereal grains. In considering 
likely residue levels on teff, EPA concludes that because of the 
similarity in application rates for pesticides containing cloquintocet-
mexyl between

[[Page 14622]]

teff and wheat, the likely decline in residue levels as teff moves 
through commerce, and the similarities to the small grains in terms of 
morphology, taxonomy and cultural practices, residue levels of 
cloquintocet-mexyl on teff will be similar to residue levels on wheat. 
The lack of teff consumption data being reported in the available food 
consumption data indicates a very low overall consumption of teff in 
the United States. When teff is consumed in the U.S., it is typically 
consumed in place of wheat. Using these assumptions regarding likely 
residue levels and consumption, EPA concludes that aggregate exposure 
and risk estimates resulting from cloquintocet-mexyl residues in/on 
teff would not be substantially different than those presented in the 
most recent human health risk assessment and published in the August 2, 
2016 final rule. As those risk estimates were not of concern to the 
Agency, 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 cloquintocet-mexyl residues.
    For a detailed discussion of the aggregate risk assessments and 
determination of safety for these tolerances, please refer to the 
August 2, 2016, Federal Register document and its supporting documents, 
available at http://www.regulations.gov in docket ID number EPA-HQ-OPP-
2012-0843. Further information about EPA's determination that an 
updated risk assessment was not necessary may be found in the document, 
``Cloquintocet-mexyl--Human Health Risk Assessment of Tolerances 
without a U.S. Registration for Use on Teff'' in docket ID number EPA-
HQ-OPP-2016-0299.
    For specific information on the studies received and the nature of 
the adverse effects caused by cloquintocet-mexyl as well as the no-
observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-
effect-level (LOAEL) from the toxicity studies, the reader is referred 
to the final rule published in the Federal Register of December 16, 
2005 (70 FR 74679) (FRL-7753-4); Docket ID number EPA-HQ-OPP-2005-0234.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology, high performance liquid 
chromatography with ultraviolet detection (HPLC-UV); method REM 
138.01for the cloquintocet-mexyl (parent) and the HPLC-UV Method RED 
138.10 for its acid metabolite, are available to enforce the tolerance 
expression.
    The methods may be requested from: Chief, Analytical Chemistry 
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 
20755-5350; telephone number: (410) 305-2905; email address: 
[email protected].

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint United Nations 
Food and Agriculture Organization/World Health Organization food 
standards program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level.
    The Codex has not established a MRL for cloquintocet-mexyl.

V. Conclusion

    Therefore, tolerances are established for combined residues of 
cloquintocet-mexyl (acetic acid [(5-chloro-8-quinolinyl) oxy]-1-
methylhexyl ester) and its acid metabolite (5-chloro-8-quinlinoxyacetic 
acid), expressed as cloquintocet-mexyl, for use as an inert ingredient 
(safener) in combination with the herbicide pyroxsulam in or on teff, 
forage at 0.2 ppm; teff, grain at 0.1 ppm; teff, hay at 0.5 ppm; and 
teff, straw at 0.1 ppm.

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

[[Page 14623]]

publication of the rule in the Federal Register. This action is not a 
``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

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

    Dated: March 6, 2017.
Michael Goodis,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority:  21 U.S.C. 321(q), 346a and 371.


0
2. In Sec.  180.560:
0
a. Revise paragraph (a) introductory text; and
0
b. Add alphabetically entries for ``teff, forage,'' ``teff, grain,'' 
``teff, hay,'' and ``teff, straw'' to the table in paragraph (a).
    The revision and additions read as follows:


Sec.  180.560   Cloquintocet-mexyl; pesticide tolerances.

    (a) General. Tolerances are established for residues of the inert 
ingredient cloquintocet-mexyl, including its metabolites and 
degradates, in or on the commodities in the following table when used 
as a safener in pesticide formulations containing the active 
ingredients clodinafop-propargyl (wheat only), dicamba (wheat only), 
flucarbazone-sodium (wheat only), halauxifen-methyl (wheat or barley), 
pinoxaden (wheat or barley), or pyroxsulam (wheat or teff). Compliance 
with the tolerance levels specified is to be determined by measuring 
the combined residues of cloquintocet-mexyl, (acetic acid [(5-chloro-8-
quinolinyl)oxy]-, 1-methylhexyl ester; CAS Reg. No. 99607-70-2) and its 
acid metabolite (5-chloro-8-quinolinoxyacetic acid), expressed as 
cloquintocet-mexyl, in or on the following commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Teff, forage \1\............................................         0.2
Teff, grain \1\.............................................         0.1
Teff, hay \1\...............................................         0.5
Teff, straw \1\.............................................         0.1
 
                                * * * * *
------------------------------------------------------------------------
\1\ There are no U.S. registrations for use on this commodity as of
  March 22, 2017.

* * * * *
[FR Doc. 2017-05705 Filed 3-21-17; 8:45 am]
 BILLING CODE 6560-50-P



                                                14620               Federal Register / Vol. 82, No. 54 / Wednesday, March 22, 2017 / Rules and Regulations

                                                VI. Conclusions                                                  Populations’’ (59 FR 7629, February 16,                          consensus standards pursuant to section
                                                                                                                 1994).                                                           12(d) of the National Technology
                                                  Therefore, an exemption from the                                  Since tolerances and exemptions that                          Transfer and Advancement Act
                                                requirement of a tolerance is established                        are established on the basis of a petition                       (NTTAA) (15 U.S.C. 272 note).
                                                under 40 CFR 180.910 for isoamyl                                 under FFDCA section 408(d), such as
                                                acetate (CAS Reg. No. 123–92–2) when                             the exemption in this final rule, do not                         VIII. Congressional Review Act
                                                used as an inert ingredient (buffering                           require the issuance of a proposed rule,                           Pursuant to the Congressional Review
                                                agent) in pesticide formulations applied                         the requirements of the Regulatory                               Act (5 U.S.C. 801 et seq.), EPA will
                                                to growing crops and raw agricultural                            Flexibility Act (RFA) (5 U.S.C. 601 et                           submit a report containing this rule and
                                                commodities after harvest.                                       seq.), do not apply.                                             other required information to the U.S.
                                                VII. Statutory and Executive Order                                  This action directly regulates growers,                       Senate, the U.S. House of
                                                Reviews                                                          food processors, food handlers, and food                         Representatives, and the Comptroller
                                                                                                                 retailers, not States or tribes, nor does                        General of the United States prior to
                                                   This action establishes an exemption                          this action alter the relationships or                           publication of the rule in the Federal
                                                from the requirement of a tolerance                              distribution of power and                                        Register. This action is not a ‘‘major
                                                under FFDCA section 408(d) in                                    responsibilities established by Congress                         rule’’ as defined by 5 U.S.C. 804(2).
                                                response to a petition submitted to the                          in the preemption provisions of FFDCA
                                                Agency. The Office of Management and                             section 408(n)(4). As such, the Agency                           List of Subjects in 40 CFR Part 180
                                                Budget (OMB) has exempted these types                            has determined that this action will not                           Environmental protection,
                                                of actions from review under Executive                           have a substantial direct effect on States                       Administrative practice and procedure,
                                                Order 12866, entitled ‘‘Regulatory                               or tribal governments, on the                                    Agricultural commodities, Pesticides
                                                Planning and Review’’ (58 FR 51735,                              relationship between the national                                and pests, Reporting and recordkeeping
                                                October 4, 1993). Because this action                            government and the States or tribal                              requirements.
                                                has been exempted from review under                              governments, or on the distribution of
                                                Executive Order 12866, this action is                                                                                               Dated: February 13, 2017.
                                                                                                                 power and responsibilities among the
                                                not subject to Executive Order 13211,                            various levels of government or between                          Michael Goodis,
                                                entitled ‘‘Actions Concerning                                    the Federal Government and Indian                                Director, Registration Division, Office of
                                                Regulations That Significantly Affect                            tribes. Thus, the Agency has determined                          Pesticide Programs.
                                                Energy Supply, Distribution, or Use’’ (66                        that Executive Order 13132, entitled                               Therefore, 40 CFR chapter I is
                                                FR 28355, May 22, 2001) or Executive                             ‘‘Federalism’’ (64 FR 43255, August 10,                          amended as follows:
                                                Order 13045, entitled ‘‘Protection of                            1999) and Executive Order 13175,
                                                Children from Environmental Health                               entitled ‘‘Consultation and Coordination                         PART 180—[AMENDED]
                                                Risks and Safety Risks’’ (62 FR 19885,                           with Indian Tribal Governments’’ (65 FR
                                                April 23, 1997). This action does not                            67249, November 9, 2000) do not apply                            ■ 1. The authority citation for part 180
                                                contain any information collections                              to this action. In addition, this action                         continues to read as follows:
                                                subject to OMB approval under the                                does not impose any enforceable duty or                              Authority: 21 U.S.C. 321(q), 346a and 371.
                                                Paperwork Reduction Act (PRA) (44                                contain any unfunded mandate as
                                                U.S.C. 3501 et seq.), nor does it require                                                                                         ■ 2. In § 180.910, add alphabetically the
                                                                                                                 described under Title II of the Unfunded
                                                any special considerations under                                                                                                  inert ingredient to the table to read as
                                                                                                                 Mandates Reform Act (UMRA) (2 U.S.C.
                                                Executive Order 12898, entitled                                                                                                   follows:
                                                                                                                 1501 et seq.).
                                                ‘‘Federal Actions to Address                                        This action does not involve any                              § 180.910 Inert ingredients used pre- and
                                                Environmental Justice in Minority                                technical standards that would require                           post-harvest; exemptions from the
                                                Populations and Low-Income                                       Agency consideration of voluntary                                requirement of a tolerance.

                                                                                                          Inert ingredients                                                                           Limits                    Uses


                                                                *               *                       *                             *                             *                             *                         *
                                                Isoamyl acetate (CAS Reg. No. 123–92–2) ...................................................................................................    .....................   Buffering Agent.

                                                                     *                        *                       *                        *                        *                         *                         *



                                                [FR Doc. 2017–05701 Filed 3–21–17; 8:45 am]                      SUMMARY:   This regulation establishes                           before May 22, 2017, and must be filed
                                                BILLING CODE 6560–50–P                                           tolerances for residues of Cloquintocet-                         in accordance with the instructions
                                                                                                                 mexyl (acetic acid [5-chloro-8-                                  provided in 40 CFR part 178 (see also
                                                                                                                 quinolinyl) oxy]-1-methylhexyl ester) in                         Unit I.C. of the SUPPLEMENTARY
                                                ENVIRONMENTAL PROTECTION                                         or on teff when cloquintocet-mexyl is                            INFORMATION).
                                                AGENCY                                                           used as an inert ingredient (herbicide
                                                                                                                 safener) in pesticide formulations                               ADDRESSES:   The docket for this action,
                                                40 CFR Part 180                                                  containing pyroxsulam. Dow                                       identified by docket identification (ID)
                                                [EPA–HQ–OPP–2016–0299; FRL–9959–11]                              AgroSciences LLC requested these                                 number EPA–HQ–OPP–2016–0299, is
jstallworth on DSK7TPTVN1PROD with RULES




                                                                                                                 tolerances under the Federal Food,                               available at http://www.regulations.gov
                                                Cloquintocet-mexyl; Pesticide                                    Drug, and Cosmetic Act (FFDCA) in                                or at the Office of Pesticide Programs
                                                Tolerances                                                       order to cover residues of cloquintocet-                         Regulatory Public Docket (OPP Docket)
                                                                                                                 mexyl in imported teff commodities.                              in the Environmental Protection Agency
                                                AGENCY:  Environmental Protection
                                                Agency (EPA).                                                    DATES: This regulation is effective                              Docket Center (EPA/DC), West William
                                                                                                                 March 22, 2017. Objections and requests                          Jefferson Clinton Bldg., Rm. 3334, 1301
                                                ACTION: Final rule.
                                                                                                                 for hearings must be received on or                              Constitution Ave. NW., Washington, DC


                                           VerDate Sep<11>2014      14:52 Mar 21, 2017     Jkt 241001    PO 00000      Frm 00020     Fmt 4700      Sfmt 4700   E:\FR\FM\22MRR1.SGM            22MRR1


                                                                 Federal Register / Vol. 82, No. 54 / Wednesday, March 22, 2017 / Rules and Regulations                                         14621

                                                20460–0001. The Public Reading Room                     before May 22, 2017. Addresses for mail               III. Aggregate Risk Assessment and
                                                is open from 8:30 a.m. to 4:30 p.m.,                    and hand delivery of objections and                   Determination of Safety
                                                Monday through Friday, excluding legal                  hearing requests are provided in 40 CFR                  Section 408(b)(2)(A)(i) of FFDCA
                                                holidays. The telephone number for the                  178.25(b).                                            allows EPA to establish a tolerance (the
                                                Public Reading Room is (202) 566–1744,                    In addition to filing an objection or               legal limit for a pesticide chemical
                                                and the telephone number for the OPP                    hearing request with the Hearing Clerk                residue in or on a food) only if EPA
                                                Docket is (703) 305–5805. Please review                 as described in 40 CFR part 178, please               determines that the tolerance is ‘‘safe.’’
                                                the visitor instructions and additional                 submit a copy of the filing (excluding                Section 408(b)(2)(A)(ii) of FFDCA
                                                information about the docket available                  any Confidential Business Information                 defines ‘‘safe’’ to mean that ‘‘there is a
                                                at http://www.epa.gov/dockets.                          (CBI)) for inclusion in the public docket.            reasonable certainty that no harm will
                                                FOR FURTHER INFORMATION CONTACT:                        Information not marked confidential                   result from aggregate exposure to the
                                                Michael L. Goodis, P.E., Registration                   pursuant to 40 CFR part 2 may be                      pesticide chemical residue, including
                                                Division (7505P), Office of Pesticide                   disclosed publicly by EPA without prior               all anticipated dietary exposures and all
                                                Programs, Environmental Protection                      notice. Submit the non-CBI copy of your               other exposures for which there is
                                                Agency, 1200 Pennsylvania Ave. NW.,                     objection or hearing request, identified              reliable information.’’ This includes
                                                Washington, DC 20460–0001; main                         by docket ID number EPA–HQ–OPP–                       exposure through drinking water and in
                                                telephone number: (703) 305–7090;                       2016–0299, by one of the following                    residential settings, but does not include
                                                email address: RDFRNotices@epa.gov.                     methods:                                              occupational exposure. Section
                                                SUPPLEMENTARY INFORMATION:                                • Federal eRulemaking Portal: http://               408(b)(2)(C) of FFDCA requires EPA to
                                                                                                        www.regulations.gov. Follow the online                give special consideration to exposure
                                                I. General Information                                  instructions for submitting comments.                 of infants and children to the pesticide
                                                A. Does this action apply to me?                        Do not submit electronically any                      chemical residue in establishing a
                                                                                                        information you consider to be CBI or                 tolerance and to ‘‘ensure that there is a
                                                   You may be potentially affected by                   other information whose disclosure is
                                                this action if you are an agricultural                                                                        reasonable certainty that no harm will
                                                                                                        restricted by statute.                                result to infants and children from
                                                producer, food manufacturer, or
                                                                                                          • Mail: OPP Docket, Environmental                   aggregate exposure to the pesticide
                                                pesticide manufacturer. The following
                                                                                                        Protection Agency Docket Center (EPA/                 chemical residue. . . .’’
                                                list of North American Industrial
                                                                                                        DC), (28221T), 1200 Pennsylvania Ave.                    Consistent with FFDCA section
                                                Classification System (NAICS) codes is
                                                                                                        NW., Washington, DC 20460–0001.                       408(b)(2)(D), EPA has reviewed the
                                                not intended to be exhaustive, but rather
                                                                                                          • Hand Delivery: To make special                    available scientific data and other
                                                provides a guide to help readers
                                                                                                        arrangements for hand delivery or                     relevant information in support of this
                                                determine whether this document
                                                                                                        delivery of boxed information, please                 action. EPA has sufficient data to assess
                                                applies to them. Potentially affected
                                                                                                        follow the instructions at http://                    the hazards of and to make a
                                                entities may include:
                                                   • Crop production (NAICS code 111).                  www.epa.gov/dockets/contacts.html.                    determination on aggregate exposure for
                                                   • Animal production (NAICS code                        Additional instructions on                          cloquintocet-mexyl in or on teff forage,
                                                112).                                                   commenting or visiting the docket,                    grain, hay and straw, consistent with
                                                   • Food manufacturing (NAICS code                     along with more information about                     FFDCA section 408(b)(2).
                                                311).                                                   dockets generally, is available at http://               In the Federal Register of August 2,
                                                   • Pesticide manufacturing (NAICS                     www.epa.gov/dockets.                                  2016 (81 FR 50630) (FRL–9947–78),
                                                code 32532).                                                                                                  EPA established tolerances for residues
                                                                                                        II. Summary of Petitioned-For
                                                                                                                                                              of cloquintocet-mexyl and its acid
                                                B. How can I get electronic access to                   Tolerance
                                                                                                                                                              metabolite (5-chloro-8-
                                                other related information?                                In the Federal Register of August 29,               quinolinoxyacetic acid) when used in
                                                   You may access a frequently updated                  2016 (81 FR 59165) (FRL–9950–22),                     pesticide formulations containing the
                                                electronic version of EPA’s tolerance                   EPA issued a document pursuant to                     active ingredient halauxifen-methyl, in
                                                regulations at 40 CFR part 180 through                  FFDCA section 408(d)(3), 21 U.S.C.                    or on barley grain, barley hay, barley
                                                the Government Printing Office’s e-CFR                  346a(d)(3), announcing the filing of a                straw, and wheat forage, wheat grain,
                                                site at http://www.ecfr.gov/cgi-bin/text-               pesticide petition (PP# 5E8432) by Dow                wheat hay, and wheat straw. EPA is
                                                idx?&c=ecfr&tpl=/ecfrbrowse/Title40/                    AgroSciences LLC, 9330 Zionsville                     relying upon the risk assessments that
                                                40tab_02.tpl.                                           Road, Indianapolis, IN 46268. The                     supported the findings made in the
                                                                                                        petition requested that 40 CFR part                   August 2, 2016, Federal Register
                                                C. How can I file an objection or hearing               180.560 be amended by establishing                    document in support of this action. The
                                                request?                                                tolerances without U.S registrations for              toxicity profile of cloquintocet-mexyl
                                                  Under FFDCA section 408(g), 21                        residues of the cloquintocet-mexyl for                has not changed, and the previous risk
                                                U.S.C. 346a, any person may file an                     use as an inert ingredient (safener) in               assessments that supported the
                                                objection to any aspect of this regulation              combination with the herbicide                        establishment of those tolerances
                                                and may also request a hearing on those                 pyroxulam in or on the raw agricultural               remain valid.
                                                objections. You must file your objection                commodities teff, forage at 0.2 parts per                The Agency evaluated the request to
                                                or request a hearing on this regulation                 million (ppm); teff, grain at 0.1 ppm; teff           establish tolerances in or on teff forage,
                                                in accordance with the instructions                     hay at 0.5 ppm; teff straw at 0.1ppm.                 grain, hay, and straw. Teff is prepared
                                                provided in 40 CFR part 178. To ensure                  That document referenced a summary of                 like other whole grains, such as rice and
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                                                proper receipt by EPA, you must                         the petition prepared by Dow                          barley, and may also be used to make
                                                identify docket ID number EPA–HQ–                       AgroSciences, LLC, the registrant,                    flour in a manner similar to wheat and
                                                OPP–2016–0299 in the subject line on                    which is available in the docket EPA–                 other cereal grains. In considering likely
                                                the first page of your submission. All                  HQ–OPP–2016–0299 at http://                           residue levels on teff, EPA concludes
                                                objections and requests for a hearing                   www.regulations.gov. There were no                    that because of the similarity in
                                                must be in writing, and must be                         comments received in response to the                  application rates for pesticides
                                                received by the Hearing Clerk on or                     notice of filing.                                     containing cloquintocet-mexyl between


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                                                14622            Federal Register / Vol. 82, No. 54 / Wednesday, March 22, 2017 / Rules and Regulations

                                                teff and wheat, the likely decline in                   available to enforce the tolerance                    Order 13045, entitled ‘‘Protection of
                                                residue levels as teff moves through                    expression.                                           Children from Environmental Health
                                                commerce, and the similarities to the                      The methods may be requested from:                 Risks and Safety Risks’’ (62 FR 19885,
                                                small grains in terms of morphology,                    Chief, Analytical Chemistry Branch,                   April 23, 1997). This action does not
                                                taxonomy and cultural practices,                        Environmental Science Center, 701                     contain any information collections
                                                residue levels of cloquintocet-mexyl on                 Mapes Rd., Ft. Meade, MD 20755–5350;                  subject to OMB approval under the
                                                teff will be similar to residue levels on               telephone number: (410) 305–2905;                     Paperwork Reduction Act (PRA) (44
                                                wheat. The lack of teff consumption                     email address: residuemethods@                        U.S.C. 3501 et seq.), nor does it require
                                                data being reported in the available food               epa.gov.                                              any special considerations under
                                                consumption data indicates a very low                                                                         Executive Order 12898, entitled
                                                                                                        B. International Residue Limits
                                                overall consumption of teff in the                                                                            ‘‘Federal Actions to Address
                                                United States. When teff is consumed in                   In making its tolerance decisions, EPA              Environmental Justice in Minority
                                                the U.S., it is typically consumed in                   seeks to harmonize U.S. tolerances with               Populations and Low-Income
                                                place of wheat. Using these assumptions                 international standards whenever                      Populations’’ (59 FR 7629, February 16,
                                                regarding likely residue levels and                     possible, consistent with U.S. food                   1994).
                                                consumption, EPA concludes that                         safety standards and agricultural                        Since tolerances and exemptions that
                                                aggregate exposure and risk estimates                   practices. EPA considers the                          are established on the basis of a petition
                                                resulting from cloquintocet-mexyl                       international maximum residue limits                  under FFDCA section 408(d), such as
                                                residues in/on teff would not be                        (MRLs) established by the Codex                       the tolerances in this final rule, do not
                                                substantially different than those                      Alimentarius Commission (Codex), as                   require the issuance of a proposed rule,
                                                presented in the most recent human                      required by FFDCA section 408(b)(4).                  the requirements of the Regulatory
                                                health risk assessment and published in                 The Codex Alimentarius is a joint                     Flexibility Act (RFA) (5 U.S.C. 601 et
                                                the August 2, 2016 final rule. As those                 United Nations Food and Agriculture                   seq.), do not apply.
                                                risk estimates were not of concern to the               Organization/World Health                                This action directly regulates growers,
                                                Agency, EPA concludes that there is a                   Organization food standards program,                  food processors, food handlers, and food
                                                reasonable certainty that no harm will                  and it is recognized as an international              retailers, not States or tribes, nor does
                                                result to the general population, or to                 food safety standards-setting                         this action alter the relationships or
                                                infants and children from aggregate                     organization in trade agreements to                   distribution of power and
                                                exposure to cloquintocet-mexyl                          which the United States is a party. EPA               responsibilities established by Congress
                                                residues.                                               may establish a tolerance that is                     in the preemption provisions of FFDCA
                                                   For a detailed discussion of the                     different from a Codex MRL; however,                  section 408(n)(4). As such, the Agency
                                                aggregate risk assessments and                          FFDCA section 408(b)(4) requires that                 has determined that this action will not
                                                determination of safety for these                       EPA explain the reasons for departing                 have a substantial direct effect on States
                                                tolerances, please refer to the August 2,               from the Codex level.                                 or tribal governments, on the
                                                2016, Federal Register document and its                   The Codex has not established a MRL                 relationship between the national
                                                supporting documents, available at                      for cloquintocet-mexyl.                               government and the States or tribal
                                                http://www.regulations.gov in docket ID                                                                       governments, or on the distribution of
                                                                                                        V. Conclusion                                         power and responsibilities among the
                                                number EPA–HQ–OPP–2012–0843.
                                                                                                           Therefore, tolerances are established              various levels of government or between
                                                Further information about EPA’s
                                                                                                        for combined residues of cloquintocet-                the Federal Government and Indian
                                                determination that an updated risk
                                                                                                        mexyl (acetic acid [(5-chloro-8-                      tribes. Thus, the Agency has determined
                                                assessment was not necessary may be
                                                                                                        quinolinyl) oxy]-1-methylhexyl ester)                 that Executive Order 13132, entitled
                                                found in the document, ‘‘Cloquintocet-
                                                                                                        and its acid metabolite (5-chloro-8-                  ‘‘Federalism’’ (64 FR 43255, August 10,
                                                mexyl—Human Health Risk Assessment
                                                                                                        quinlinoxyacetic acid), expressed as                  1999) and Executive Order 13175,
                                                of Tolerances without a U.S.
                                                                                                        cloquintocet-mexyl, for use as an inert               entitled ‘‘Consultation and Coordination
                                                Registration for Use on Teff’’ in docket
                                                                                                        ingredient (safener) in combination with              with Indian Tribal Governments’’ (65 FR
                                                ID number EPA–HQ–OPP–2016–0299.
                                                                                                        the herbicide pyroxsulam in or on teff,               67249, November 9, 2000) do not apply
                                                   For specific information on the
                                                                                                        forage at 0.2 ppm; teff, grain at 0.1 ppm;            to this action. In addition, this action
                                                studies received and the nature of the
                                                                                                        teff, hay at 0.5 ppm; and teff, straw at              does not impose any enforceable duty or
                                                adverse effects caused by cloquintocet-
                                                                                                        0.1 ppm.                                              contain any unfunded mandate as
                                                mexyl as well as the no-observed-
                                                adverse-effect-level (NOAEL) and the                    VI. Statutory and Executive Order                     described under Title II of the Unfunded
                                                lowest-observed-adverse-effect-level                    Reviews                                               Mandates Reform Act (UMRA) (2 U.S.C.
                                                (LOAEL) from the toxicity studies, the                                                                        1501 et seq.).
                                                                                                          This action establishes tolerances                     This action does not involve any
                                                reader is referred to the final rule                    under FFDCA section 408(d) in                         technical standards that would require
                                                published in the Federal Register of                    response to a petition submitted to the               Agency consideration of voluntary
                                                December 16, 2005 (70 FR 74679) (FRL–                   Agency. The Office of Management and                  consensus standards pursuant to section
                                                7753–4); Docket ID number EPA–HQ–                       Budget (OMB) has exempted these types                 12(d) of the National Technology
                                                OPP–2005–0234.                                          of actions from review under Executive                Transfer and Advancement Act
                                                IV. Other Considerations                                Order 12866, entitled ‘‘Regulatory                    (NTTAA) (15 U.S.C. 272 note).
                                                                                                        Planning and Review’’ (58 FR 51735,
                                                A. Analytical Enforcement Methodology                   October 4, 1993). Because this action                 VII. Congressional Review Act
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                                                  Adequate enforcement methodology,                     has been exempted from review under                     Pursuant to the Congressional Review
                                                high performance liquid                                 Executive Order 12866, this action is                 Act (5 U.S.C. 801 et seq.), EPA will
                                                chromatography with ultraviolet                         not subject to Executive Order 13211,                 submit a report containing this rule and
                                                detection (HPLC–UV); method REM                         entitled ‘‘Actions Concerning                         other required information to the U.S.
                                                138.01for the cloquintocet-mexyl                        Regulations That Significantly Affect                 Senate, the U.S. House of
                                                (parent) and the HPLC–UV Method RED                     Energy Supply, Distribution, or Use’’ (66             Representatives, and the Comptroller
                                                138.10 for its acid metabolite, are                     FR 28355, May 22, 2001) or Executive                  General of the United States prior to


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                                                                       Federal Register / Vol. 82, No. 54 / Wednesday, March 22, 2017 / Rules and Regulations                                                   14623

                                                publication of the rule in the Federal                                                                           Parts per   number: (703) 305–7090; email address:
                                                                                                                                   Commodity
                                                Register. This action is not a ‘‘major                                                                            million    RDFRNotices@epa.gov.
                                                rule’’ as defined by 5 U.S.C. 804(2).                                                                                        SUPPLEMENTARY INFORMATION:
                                                                                                                         *           *          *           *         *
                                                List of Subjects in 40 CFR Part 180                                                                                          I. General Information
                                                                                                                       1 There
                                                                                                                            are no U.S. registrations for use on
                                                  Environmental protection,                                        this commodity as of March 22, 2017.                      A. Does this action apply to me?
                                                Administrative practice and procedure,                             *          *      *      *       *
                                                Agricultural commodities, Pesticides                                                                                            You may be potentially affected by
                                                                                                                   [FR Doc. 2017–05705 Filed 3–21–17; 8:45 am]               this action if you are an agricultural
                                                and pests, Reporting and recordkeeping
                                                requirements.
                                                                                                                   BILLING CODE 6560–50–P                                    producer, food manufacturer, or
                                                                                                                                                                             pesticide manufacturer. The following
                                                  Dated: March 6, 2017.                                                                                                      list of North American Industrial
                                                Michael Goodis,                                                    ENVIRONMENTAL PROTECTION                                  Classification System (NAICS) codes is
                                                Director, Registration Division, Office of                         AGENCY                                                    not intended to be exhaustive, but rather
                                                Pesticide Programs.                                                                                                          provides a guide to help readers
                                                                                                                   40 CFR Part 180
                                                  Therefore, 40 CFR chapter I is                                                                                             determine whether this document
                                                amended as follows:                                                [EPA–HQ–OPP–2014–0357; FRL–9958–53]                       applies to them. Potentially affected
                                                                                                                                                                             entities may include:
                                                PART 180—[AMENDED]                                                 Cyantraniliprole; Pesticide Tolerances                       • Crop production (NAICS code 111).
                                                                                                                                                                                • Animal production (NAICS code
                                                ■ 1. The authority citation for part 180                           AGENCY:  Environmental Protection                         112).
                                                continues to read as follows:                                      Agency (EPA).                                                • Food manufacturing (NAICS code
                                                                                                                   ACTION: Final rule.                                       311).
                                                    Authority: 21 U.S.C. 321(q), 346a and 371.
                                                                                                                                                                                • Pesticide manufacturing (NAICS
                                                ■  2. In § 180.560:                                                SUMMARY:  This regulation establishes                     code 32532).
                                                ■  a. Revise paragraph (a) introductory                            tolerances for residues of
                                                                                                                   cyantraniliprole in or on multiple                        B. How can I get electronic access to
                                                text; and
                                                                                                                   commodities which are identified and                      other related information?
                                                ■ b. Add alphabetically entries for ‘‘teff,
                                                forage,’’ ‘‘teff, grain,’’ ‘‘teff, hay,’’ and                      discussed later in this document. E.I.                       You may access a frequently updated
                                                ‘‘teff, straw’’ to the table in paragraph                          DuPont de Nemours & Company and                           electronic version of EPA’s tolerance
                                                (a).                                                               Syngenta Crop Protection, LLC                             regulations at 40 CFR part 180 through
                                                   The revision and additions read as                              requested these tolerances under the                      the Government Printing Office’s e-CFR
                                                follows:                                                           Federal Food, Drug, and Cosmetic Act                      site at http://www.ecfr.gov/cgi-bin/text-
                                                                                                                   (FFDCA).                                                  idx?&c=ecfr&tpl=/ecfrbrowse/Title40/
                                                § 180.560 Cloquintocet-mexyl; pesticide                            DATES:  This regulation is effective                      40tab_02.tpl.
                                                tolerances.
                                                                                                                   March 22, 2017. Objections and requests                   C. How can I file an objection or hearing
                                                  (a) General. Tolerances are                                      for hearings must be received on or                       request?
                                                established for residues of the inert                              before May 22, 2017, and must be filed
                                                ingredient cloquintocet-mexyl,                                     in accordance with the instructions                         Under FFDCA section 408(g), 21
                                                including its metabolites and                                      provided in 40 CFR part 178 (see also                     U.S.C. 346a, any person may file an
                                                degradates, in or on the commodities in                            Unit I.C. of the SUPPLEMENTARY                            objection to any aspect of this regulation
                                                the following table when used as a                                 INFORMATION).                                             and may also request a hearing on those
                                                safener in pesticide formulations                                                                                            objections. You must file your objection
                                                containing the active ingredients                                  ADDRESSES:   The docket for this action,                  or request a hearing on this regulation
                                                clodinafop-propargyl (wheat only),                                identified by docket identification (ID)                   in accordance with the instructions
                                                dicamba (wheat only), flucarbazone-                               number EPA–HQ–OPP–2014–0357 is                             provided in 40 CFR part 178. To ensure
                                                sodium (wheat only), halauxifen-methyl                            available at http://www.regulations.gov                    proper receipt by EPA, you must
                                                (wheat or barley), pinoxaden (wheat or                            or at the Office of Pesticide Programs                     identify docket ID number EPA–HQ–
                                                barley), or pyroxsulam (wheat or teff).                           Regulatory Public Docket (OPP Docket)                      OPP–2014–0357 in the subject line on
                                                Compliance with the tolerance levels                              in the Environmental Protection Agency                     the first page of your submission. All
                                                specified is to be determined by                                  Docket Center (EPA/DC), West William                       objections and requests for a hearing
                                                measuring the combined residues of                                Jefferson Clinton Bldg., Rm. 3334, 1301                    must be in writing, and must be
                                                cloquintocet-mexyl, (acetic acid [(5-                             Constitution Ave. NW., Washington, DC                      received by the Hearing Clerk on or
                                                chloro-8-quinolinyl)oxy]-, 1-                                     20460–0001. The Public Reading Room                        before May 22, 2017. Addresses for mail
                                                methylhexyl ester; CAS Reg. No. 99607–                            is open from 8:30 a.m. to 4:30 p.m.,                       and hand delivery of objections and
                                                70–2) and its acid metabolite (5-chloro-                          Monday through Friday, excluding legal                     hearing requests are provided in 40 CFR
                                                8-quinolinoxyacetic acid), expressed as                           holidays. The telephone number for the                     178.25(b).
                                                cloquintocet-mexyl, in or on the                                  Public Reading Room is (202) 566–1744,                       In addition to filing an objection or
                                                following commodities:                                            and the telephone number for the OPP                       hearing request with the Hearing Clerk
                                                                                                                  Docket is (703) 305–5805. Please review                    as described in 40 CFR part 178, please
                                                                                                     Parts per    the visitor instructions and additional                    submit a copy of the filing (excluding
                                                                Commodity                                         information about the docket available
                                                                                                      million                                                                any Confidential Business Information
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                                                                                                                  at http://www.epa.gov/dockets.                             (CBI)) for inclusion in the public docket.
                                                                                                                  FOR FURTHER INFORMATION CONTACT:                           Information not marked confidential
                                                   *              *              *               *          *
                                                Teff,   forage 1 ...............................              0.2
                                                                                                                  Michael Goodis, Registration Division                      pursuant to 40 CFR part 2 may be
                                                Teff,   grain 1 .................................             0.1 (7505P), Office of Pesticide Programs,                     disclosed publicly by EPA without prior
                                                Teff,   hay 1 ....................................            0.5 Environmental Protection Agency, 1200                      notice. Submit the non-CBI copy of your
                                                Teff,   straw 1 .................................             0.1 Pennsylvania Ave. NW., Washington,                         objection or hearing request, identified
                                                                                                                  DC 20460–0001; main telephone                              by docket ID number EPA–HQ–OPP–


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Document Created: 2017-03-22 03:58:53
Document Modified: 2017-03-22 03:58:53
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionRules and Regulations
ActionFinal rule.
DatesThis regulation is effective March 22, 2017. Objections and requests for hearings must be received on or before May 22, 2017, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ContactMichael L. Goodis, P.E., Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-
FR Citation82 FR 14620 
CFR AssociatedEnvironmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements

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