82 FR 14620 - Cloquintocet-mexyl; Pesticide Tolerances

ENVIRONMENTAL PROTECTION AGENCY

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

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, 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.

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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