[Federal Register Volume 83, Number 176 (Tuesday, September 11, 2018)]
[Rules and Regulations]
[Pages 45841-45844]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-19757]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2017-0591; FRL-9980-90]


Cloquintocet-mexyl; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of the 
inert ingredient cloquintocet-mexyl (CAS Reg. No. 99607-70-2) in or on 
teff commodities when used in formulations with the active ingredients 
florasulam and fluroxypyr 1-methylhelptyl ester. The Interregional 
Research Project Number 4 requested these tolerances under the Federal 
Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective September 11, 2018. Objections and 
requests for hearings must be received on or before November 13, 2018 
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-2017-0591, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 
1301 Constitution Ave. NW, Washington, DC 20460-0001. The Public 
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through 
Friday, excluding legal holidays. The telephone number for the Public 
Reading Room is (202) 566-1744, and the telephone number for the OPP 
Docket is (703) 305-5805. Please review the visitor instructions and 
additional information about the docket available at http://www.epa.gov/dockets.

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

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document 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-2017-0591 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 
November 13, 2018. Addresses for mail and hand delivery of objections 
and hearing requests are provided in 40 CFR 178.25(b).

[[Page 45842]]

    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-2017-0591, by one of 
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be CBI or other 
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-for Tolerance

    In the Federal Register of March 21, 2018 (83 FR 12311) (FRL-9974-
76), 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 
IN-11030) by the Interregional Research Project No. 4 (IR-4), Rutgers, 
The State University of New Jersey, 500 College Road East, Suite 201 W, 
Princeton, NJ 08540. The petition requested that 40 CFR 180.560 be 
amended by establishing tolerances for residues of the 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-
quinlinoxyacetic acid), for use as an inert ingredient (safener) in 
combination with the active ingredients florasulam, fluroxypyr 1-
methylhelptyl ester and 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 parts per million (ppm). That document referenced a summary of the 
petition prepared by the Interregional Research Project No. 4 (IR-4), 
the petitioner, which is available in the docket, http://www.regulations.gov. There were no relevant comments received in 
response to the notice of filing.
    Based upon the fact that tolerances for cloquintocet-mexyl when 
used with the active ingredient pyroxsulam have previously been 
established under 40 CFR 180.560, the Agency's evaluation of the 
subject tolerance petition is limited to the use of cloquintocet-mexyl 
with the active ingredients florasulam and fluroxypyr 1-methylhelptyl 
ester on teff only.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue. . . 
.''
    Consistent with FFDCA section 408(b)(2)(D), and the factors 
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available 
scientific data and other relevant information in support of this 
action. EPA has sufficient data to assess the hazards of and to make a 
determination on aggregate exposure for cloquintocet-mexyl (acetic 
acid, [(5-chloro-8-quinolinyl)oxy]-, 1-methylhexyl ester) and its acid 
metabolite (5-chloro-8-quinolinoxyacetic acid) 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 teff and wheat, the likely decline in residue levels as 
teff moves through commerce, and the similarities to other 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

[[Page 45843]]

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, chromatography with ultraviolet 
detection (HPLC-UV for cloquintocet-mexyl and its acid metabolite, are 
available to enforce the tolerance expression.
    The method may be requested from: Chief, Analytical Chemistry 
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 
20755-5350; telephone number: (410) 305-2905; email address: 
residuemethods@epa.gov.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as 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 (acetic 
acid, [(5-chloro-8-quiniolinyl)oxy]-, 1-methylhexyl ester) and its acid 
metabolite (5-chloro-8-quinlinoxyacetic acid) on teff.

V. Conclusion

    Therefore, tolerances are established for residues of cloquintocet-
mexyl (acetic acid, [(5-chloro-8-quiniolinyl)oxy]-, 1-methylhexyl 
ester) and its acid metabolite (5-chloro-8-quinlinoxyacetic acid), for 
use as an inert ingredient (safener) when used in formulations with the 
active ingredients florasulam and fluroxypyr 1-methylhelptyl ester 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), nor is it a regulatory action 
under Executive Order 13771, entitled ``Reducing Regulations and 
Controlling Regulatory Costs'' ((82 FR 9339, February 3, 2017). 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 tolerance in this 
final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.), do not apply.
    This action directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled ``Federalism'' (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
``Consultation and Coordination with Indian Tribal Governments'' (65 FR 
67249, November 9, 2000) do not apply to this action. In addition, this 
action does not impose any enforceable duty or contain any unfunded 
mandate as described under Title II of the Unfunded Mandates Reform Act 
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

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

List of Subjects in 40 CFR Part 180

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

    Dated: August 28, 2018.
Michael L. 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, revise the introductory text of paragraph (a) to 
read as follows:


Sec.  180.560  Cloquintocet-mexyl; tolerances for residues.

    (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), pyroxsulam (wheat or teff), florasulam 
(teff), or fluroxypyr 1-methylheptyl ester (teff). Compliance with the 
tolerance levels specified is to be determined by measuring the 
combined residues of cloquintocet-

[[Page 45844]]

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:
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[FR Doc. 2018-19757 Filed 9-10-18; 8:45 am]
 BILLING CODE 6560-50-P