83 FR 45841 - Cloquintocet-mexyl; Pesticide Tolerances

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 83, Issue 176 (September 11, 2018)

Page Range		45841-45844
FR Document		2018-19757
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).
Federal Register, Volume 83 Issue 176 (Tuesday, September 11, 2018)
[Federal Register Volume 83, Number 176 (Tuesday, September 11, 2018)]
[Rules and Regulations]
[Pages 45841-45844]
From the Federal Register Online  [www.thefederalregister.org]
[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:
* * * * *
[FR Doc. 2018-19757 Filed 9-10-18; 8:45 am]
 BILLING CODE 6560-50-P
Federal Register / Vol. 83, No. 176 / Tuesday, September 11, 2018 / Rules and Regulations 45841

described under Title II of the Unfunded General of the United States prior to PART 180—[AMENDED]
Mandates Reform Act (UMRA) (2 U.S.C. publication of the rule in the Federal
1501 et seq.). Register. This action is not a ‘‘major ■ 1. The authority citation for part 180
This action does not involve any rule’’ as defined by 5 U.S.C. 804(2). continues to read as follows:
technical standards that would require
List of Subjects in 40 CFR Part 180 Authority: 21 U.S.C. 321(q), 346a and 371.
Agency consideration of voluntary
consensus standards pursuant to section Environmental protection, ■ 2. In § 180.960, alphabetically add the
12(d) of the National Technology Administrative practice and procedure, following polymer ‘‘2-Propenoic acid, 2-
Transfer and Advancement Act Agricultural commodities, Pesticides methyl-, 2-oxiranylmethyl ester,
(NTTAA) (15 U.S.C. 272 note). and pests, Reporting and recordkeeping polymer with butyl 2-propenoate,
requirements. ethenylbenzene and 2-ethylhexyl 2-
XI. Congressional Review Act
Dated: August 28, 2018. propenoate, minimum number average
Pursuant to the Congressional Review molecular weight (in amu), 3,600’’ to the
Michael Goodis,
Act (5 U.S.C. 801 et seq.), EPA will table to read as follows:
submit a report containing this rule and Director, Registration Division, Office of
Pesticide Programs. § 180.960 Polymers; exemptions from the
other required information to the U.S.
Senate, the U.S. House of Therefore, 40 CFR chapter I is requirement of a tolerance.
Representatives, and the Comptroller amended as follows: * * * * *

Polymer CAS No.

* * * * * * *
2-Propenoic acid, 2-methyl-, 2-oxiranylmethyl ester, polymer with butyl 2-propenoate, ethenylbenzene and 2-ethylhexyl 2-
propenoate, minimum number average molecular weight (in amu), 3,600 ..................................................................................... 58499–26–6

* * * * * * *

[FR Doc. 2018–19758 Filed 9–10–18; 8:45 am] or at the Office of Pesticide Programs • Crop production (NAICS code 111).
BILLING CODE 6560–50–P Regulatory Public Docket (OPP Docket) • Animal production (NAICS code
in the Environmental Protection Agency 112).
Docket Center (EPA/DC), West William • Food manufacturing (NAICS code
ENVIRONMENTAL PROTECTION Jefferson Clinton Bldg., Rm. 3334, 1301 311).
AGENCY Constitution Ave. NW, Washington, DC
20460–0001. The Public Reading Room • Pesticide manufacturing (NAICS
40 CFR Part 180 is open from 8:30 a.m. to 4:30 p.m., code 32532).
[EPA–HQ–OPP–2017–0591; FRL–9980–90] Monday through Friday, excluding legal B. How can I get electronic access to
holidays. The telephone number for the other related information?
Cloquintocet-mexyl; Pesticide Public Reading Room is (202) 566–1744,
Tolerances and the telephone number for the OPP You may access a frequently updated
Docket is (703) 305–5805. Please review electronic version of EPA’s tolerance
AGENCY: Environmental Protection the visitor instructions and additional regulations at 40 CFR part 180 through
Agency (EPA). information about the docket available the Government Printing Office’s e-CFR
ACTION: Final rule. at http://www.epa.gov/dockets. site at http://www.ecfr.gov/cgi-bin/text-
idx?&c=ecfr&tpl=/ecfrbrowse/Title40/
SUMMARY: This regulation establishes FOR FURTHER INFORMATION CONTACT:
40tab_02.tpl.
tolerances for residues of the inert Michael L. Goodis, Registration Division
ingredient cloquintocet-mexyl (CAS (7505P), Office of Pesticide Programs, C. How can I file an objection or hearing
Reg. No. 99607–70–2) in or on teff Environmental Protection Agency, 1200 request?
commodities when used in formulations Pennsylvania Ave. NW, Washington, DC
20460–0001; main telephone number: Under FFDCA section 408(g), 21
with the active ingredients florasulam U.S.C. 346a, any person may file an
and fluroxypyr 1-methylhelptyl ester. (703) 305–7090; email address:
RDFRNotices@epa.gov. objection to any aspect of this regulation
The Interregional Research Project and may also request a hearing on those
Number 4 requested these tolerances SUPPLEMENTARY INFORMATION:
objections. You must file your objection
under the Federal Food, Drug, and or request a hearing on this regulation
I. General Information
Cosmetic Act (FFDCA). in accordance with the instructions
DATES: This regulation is effective A. Does this action apply to me? provided in 40 CFR part 178. To ensure
September 11, 2018. Objections and You may be potentially affected by proper receipt by EPA, you must
requests for hearings must be received this action if you are an agricultural identify docket ID number EPA–HQ–
on or before November 13, 2018 and producer, food manufacturer, or OPP–2017–0591 in the subject line on
must be filed in accordance with the pesticide manufacturer. The following the first page of your submission. All
instructions provided in 40 CFR part list of North American Industrial objections and requests for a hearing
daltland on DSKBBV9HB2PROD with RULES

178 (see also Unit I.C. of the Classification System (NAICS) codes is must be in writing, and must be
SUPPLEMENTARY INFORMATION). not intended to be exhaustive, but rather received by the Hearing Clerk on or
ADDRESSES: The docket for this action, provides a guide to help readers before November 13, 2018. Addresses
identified by docket identification (ID) determine whether this document for mail and hand delivery of objections
number EPA–HQ–OPP–2017–0591, is applies to them. Potentially affected and hearing requests are provided in 40
available at http://www.regulations.gov entities may include: CFR 178.25(b).

VerDate Sep<11>2014 16:11 Sep 10, 2018 Jkt 244001 PO 00000 Frm 00031 Fmt 4700 Sfmt 4700 E:\FR\FM\11SER1.SGM 11SER1
Federal Register / Vol. 83, No. 176 / Tuesday, September 11, 2018 / Rules and Regulations 45843

December 16, 2005 (70 FR 74679) (FRL– VI. Statutory and Executive Order 67249, November 9, 2000) do not apply
7753–4); Docket ID number EPA–HQ– Reviews to this action. In addition, this action
OPP–2005–0234. This action establishes tolerances does not impose any enforceable duty or
under FFDCA section 408(d) in contain any unfunded mandate as
IV. Other Considerations described under Title II of the Unfunded
response to a petition submitted to the
A. Analytical Enforcement Methodology Agency. The Office of Management and Mandates Reform Act (UMRA) (2 U.S.C.
Budget (OMB) has exempted these types 1501 et seq.).
Adequate enforcement methodology, of actions from review under Executive This action does not involve any
chromatography with ultraviolet Order 12866, entitled ‘‘Regulatory technical standards that would require
detection (HPLC–UV for cloquintocet- Planning and Review’’ (58 FR 51735, Agency consideration of voluntary
mexyl and its acid metabolite, are October 4, 1993). Because this action consensus standards pursuant to section
available to enforce the tolerance has been exempted from review under 12(d) of the National Technology
expression. Executive Order 12866, this action is Transfer and Advancement Act
not subject to Executive Order 13211, (NTTAA) (15 U.S.C. 272 note).
The method may be requested from:
Chief, Analytical Chemistry Branch, entitled ‘‘Actions Concerning VII. Congressional Review Act
Environmental Science Center, 701 Regulations That Significantly Affect Pursuant to the Congressional Review
Mapes Rd., Ft. Meade, MD 20755–5350; Energy Supply, Distribution, or Use’’ (66 Act (5 U.S.C. 801 et seq.), EPA will
telephone number: (410) 305–2905; FR 28355, May 22, 2001) or Executive submit a report containing this rule and
email address: residuemethods@ Order 13045, entitled ‘‘Protection of other required information to the U.S.
epa.gov. Children from Environmental Health Senate, the U.S. House of
Risks and Safety Risks’’ (62 FR 19885, Representatives, and the Comptroller
B. International Residue Limits April 23, 1997), nor is it a regulatory General of the United States prior to
action under Executive Order 13771, publication of the rule in the Federal
In making its tolerance decisions, EPA
entitled ‘‘Reducing Regulations and Register. This action is not a ‘‘major
seeks to harmonize U.S. tolerances with
Controlling Regulatory Costs’’ ((82 FR rule’’ as defined by 5 U.S.C. 804(2).
international standards whenever
9339, February 3, 2017). This action
possible, consistent with U.S. food List of Subjects in 40 CFR Part 180
does not contain any information
safety standards and agricultural collections subject to OMB approval
practices. EPA considers the Environmental protection,
under the Paperwork Reduction Act Administrative practice and procedure,
international maximum residue limits (PRA) (44 U.S.C. 3501 et seq.), nor does
(MRLs) established by the Codex Agricultural commodities, Pesticides
it require any special considerations and pests, Reporting and recordkeeping
Alimentarius Commission (Codex), as under Executive Order 12898, entitled
required by FFDCA section 408(b)(4). requirements.
‘‘Federal Actions to Address
The Codex Alimentarius is a joint Environmental Justice in Minority Dated: August 28, 2018.
United Nations Food and Agriculture Populations and Low-Income Michael L. Goodis,
Organization/World Health Populations’’ (59 FR 7629, February 16, Director, Registration Division, Office of
Organization food standards program, 1994). Pesticide Programs.
and it is recognized as an international Since tolerances and exemptions that Therefore, 40 CFR chapter I is
food safety standards-setting are established on the basis of a petition amended as follows:
organization in trade agreements to under FFDCA section 408(d), such as
which the United States is a party. EPA the tolerance in this final rule, do not PART 180—[AMENDED]
may establish a tolerance that is require the issuance of a proposed rule,
different from a Codex MRL; however, the requirements of the Regulatory ■ 1. The authority citation for part 180
FFDCA section 408(b)(4) requires that Flexibility Act (RFA) (5 U.S.C. 601 et continues to read as follows:
EPA explain the reasons for departing seq.), do not apply. Authority: 21 U.S.C. 321(q), 346a and 371.
from the Codex level. This action directly regulates growers, ■ 2. In § 180.560, revise the introductory
The Codex has not established a MRL food processors, food handlers, and food text of paragraph (a) to read as follows:
for cloquintocet-mexyl (acetic acid, [(5- retailers, not States or tribes, nor does
chloro-8-quiniolinyl)oxy]-, 1- this action alter the relationships or § 180.560 Cloquintocet-mexyl; tolerances
distribution of power and for residues.
methylhexyl ester) and its acid
metabolite (5-chloro-8-quinlinoxyacetic responsibilities established by Congress (a) General. Tolerances are
in the preemption provisions of FFDCA established for residues of the inert
acid) on teff.
section 408(n)(4). As such, the Agency ingredient cloquintocet-mexyl,
V. Conclusion has determined that this action will not including its metabolites and
have a substantial direct effect on States degradates, in or on the commodities in
Therefore, tolerances are established or tribal governments, on the the following table when used as a
for residues of cloquintocet-mexyl relationship between the national safener in pesticide formulations
(acetic acid, [(5-chloro-8- government and the States or tribal containing the active ingredients
quiniolinyl)oxy]-, 1-methylhexyl ester) governments, or on the distribution of clodinafop-propargyl (wheat only),
and its acid metabolite (5-chloro-8- power and responsibilities among the dicamba (wheat only), flucarbazone-
quinlinoxyacetic acid), for use as an various levels of government or between sodium (wheat only), halauxifen-methyl
inert ingredient (safener) when used in the Federal Government and Indian (wheat or barley), pinoxaden (wheat or
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formulations with the active ingredients tribes. Thus, the Agency has determined barley), pyroxsulam (wheat or teff),
florasulam and fluroxypyr 1- that Executive Order 13132, entitled florasulam (teff), or fluroxypyr 1-
methylhelptyl ester in or on teff, forage ‘‘Federalism’’ (64 FR 43255, August 10, methylheptyl ester (teff). Compliance
at 0.2 ppm; teff, grain at 0.1 ppm; teff, 1999) and Executive Order 13175, with the tolerance levels specified is to
hay at 0.5 ppm; and teff, straw at 0.1 entitled ‘‘Consultation and Coordination be determined by measuring the
ppm. with Indian Tribal Governments’’ (65 FR combined residues of cloquintocet-

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45844 Federal Register / Vol. 83, No. 176 / Tuesday, September 11, 2018 / Rules and Regulations

mexyl, (acetic acid [(5-chloro-8- I. General Information • Federal eRulemaking Portal: http://
quinolinyl)oxy]-, 1-methylhexyl ester; www.regulations.gov. Follow the online
A. Does this action apply to me?
CAS Reg. No. 99607–70–2) and its acid instructions for submitting comments.
metabolite (5-chloro-8- You may be potentially affected by Do not submit electronically any
quinolinoxyacetic acid), expressed as this action if you are an agricultural information you consider to be CBI or
cloquintocet-mexyl, in or on the producer, food manufacturer, or other information whose disclosure is
following commodities: pesticide manufacturer. The following restricted by statute.
* * * * * list of North American Industrial • Mail: OPP Docket, Environmental
[FR Doc. 2018–19757 Filed 9–10–18; 8:45 am] Classification System (NAICS) codes is Protection Agency Docket Center (EPA/
BILLING CODE 6560–50–P not intended to be exhaustive, but rather DC), (28221T), 1200 Pennsylvania Ave.
provides a guide to help readers NW, Washington, DC 20460–0001.
determine whether this document • Hand Delivery: To make special
ENVIRONMENTAL PROTECTION applies to them. arrangements for hand delivery or
AGENCY Potentially affected entities may delivery of boxed information, please
include: follow the instructions at http://
40 CFR Part 180 • Crop production (NAICS code 111). www.epa.gov/dockets/contacts.html.
Additional instructions on
• Animal production (NAICS code
[EPA–HQ–OPP–2017–0505; FRL–9982–21] commenting or visiting the docket,
112).
along with more information about
• Food manufacturing (NAICS code
Spiromesifen; Pesticide Tolerances dockets generally, is available at http://
311).
www.epa.gov/dockets.
AGENCY: Environmental Protection • Pesticide manufacturing (NAICS
Agency (EPA). code 32532). II. Summary of Petitioned-For
ACTION: Final rule. Tolerance
B. How can I get electronic access to
other related information? In the Federal Register of February
SUMMARY: This regulation establishes a 27, 2018 (83 FR 8408) (FRL–9972–17),
tolerance for residues of spiromesifen in You may access a frequently updated EPA issued a document pursuant to
or on coffee. Bayer CropScience electronic version of EPA’s tolerance FFDCA section 408(d)(3), 21 U.S.C.
requested this tolerance under the regulations at 40 CFR part 180 through 346a(d)(3), announcing the filing of a
Federal Food, Drug, and Cosmetic Act the Government Printing Office’s e-CFR pesticide petition (PP 7E8584) by Bayer
(FFDCA). site at http://www.ecfr.gov/cgi-bin/text- CropScience, 2 T.W. Alexander Drive,
DATES: This regulation is effective idx?&c=ecfr&tpl=/ecfrbrowse/Title40/ Research Triangle Park, NC 27709. The
September 11, 2018. Objections and 40tab_02.tpl. petition requested that 40 CFR part 180
requests for hearings must be received C. How can I file an objection or hearing be amended by establishing tolerances
on or before November 13, 2018, and request? for residues of spiromesifen; 2-oxo-3-
must be filed in accordance with the (2,4,6-trimethylphenyl)-1-
Under FFDCA section 408(g), 21 oxaspiro[4.4]non-3-en-4-yl 3,3-
instructions provided in 40 CFR part
U.S.C. 346a, any person may file an dimethylbutanoate, and its enol
178 (see also Unit I.C. of the
objection to any aspect of this regulation metabolite (4-hydroxy-3-(2,4,6-
SUPPLEMENTARY INFORMATION).
and may also request a hearing on those trimethylphenyl)-1-oxaspiro[4.4]non-3-
ADDRESSES: The docket for this action, objections. You must file your objection
identified by docket identification (ID) en-2-one calculated as the
or request a hearing on this regulation stoichiometric equivalent of
number EPA–HQ–OPP–2017–0505, is in accordance with the instructions
available at http://www.regulations.gov spiromesifen in or on the raw
provided in 40 CFR part 178. To ensure agricultural commodities: Coffee bean,
or at the Office of Pesticide Programs proper receipt by EPA, you must
Regulatory Public Docket (OPP Docket) green at 0.20 parts per million (ppm);
identify docket ID number EPA–HQ– coffee, instant at 0.20 ppm; and coffee
in the Environmental Protection Agency OPP–2017–0505 in the subject line on
Docket Center (EPA/DC), West William bean, roasted at 0.20 ppm. That
the first page of your submission. All document referenced a summary of the
Jefferson Clinton Bldg., Rm. 3334, 1301 objections and requests for a hearing
Constitution Ave. NW, Washington, DC petition prepared by Bayer CropScience,
must be in writing, and must be the registrant, which is available in the
20460–0001. The Public Reading Room received by the Hearing Clerk on or
is open from 8:30 a.m. to 4:30 p.m., docket, http://www.regulations.gov.
before November 13, 2018. Addresses Comments were received on the notice
Monday through Friday, excluding legal for mail and hand delivery of objections
holidays. The telephone number for the of filing. EPA’s response to these
and hearing requests are provided in 40 comments is discussed in Unit IV.C.
Public Reading Room is (202) 566–1744, CFR 178.25(b).
and the telephone number for the OPP Based upon review of the data
In addition to filing an objection or supporting the petition, EPA has
Docket is (703) 305–5805. Please review hearing request with the Hearing Clerk
the visitor instructions and additional modified the commodities for which
as described in 40 CFR part 178, please tolerances are being established. The
information about the docket available submit a copy of the filing (excluding
at http://www.epa.gov/dockets. reason for these changes is explained in
any Confidential Business Information Unit IV.D.
FOR FURTHER INFORMATION CONTACT: (CBI)) for inclusion in the public docket.
Michael Goodis, Registration Division Information not marked confidential III. Aggregate Risk Assessment and
(7505P), Office of Pesticide Programs, pursuant to 40 CFR part 2 may be Determination of Safety
daltland on DSKBBV9HB2PROD with RULES

Environmental Protection Agency, 1200 disclosed publicly by EPA without prior Section 408(b)(2)(A)(i) of FFDCA
Pennsylvania Ave. NW, Washington, DC notice. Submit the non-CBI copy of your allows EPA to establish a tolerance (the
20460–0001; main telephone number: objection or hearing request, identified legal limit for a pesticide chemical
(703) 305–7090; email address: by docket ID number EPA–HQ–OPP– residue in or on a food) only if EPA
RDFRNotices@epa.gov. 2017–0505, by one of the following determines that the tolerance is ‘‘safe.’’
SUPPLEMENTARY INFORMATION: methods: Section 408(b)(2)(A)(ii) of FFDCA

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Document Created: 2018-09-11 01:02:31
Document Modified: 2018-09-11 01:02:31
Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Rules and Regulations
Action		Final rule.
Dates		This regulation is effective 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).
Contact		Michael L. Goodis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
FR Citation		83 FR 45841
CFR Associated		Environmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements