Federal Register / Vol. 83, No. 176 / Tuesday, September 11, 2018 / Rules and Regulations 45841 

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). 

XI. 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 Goodis, 

Director, Registration Division, Office of 

Pesticide Programs. 

Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. In § 180.960, alphabetically add the 

following polymer ‘‘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’’ to the 

table to read as follows: 

§ 180.960 Polymers; exemptions from the 

requirement of a tolerance. 

* * * * * 

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] 

BILLING CODE 6560–50–P 

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. 

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/textidx?&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). 


daltland on DSKBBV9HB2PROD with RULES
45842 Federal Register / Vol. 83, No. 176 / Tuesday, September 11, 2018 / Rules and Regulations 

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 cloquintocetmexyl (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, ‘‘Cloquintocetmexyl-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 cloquintocetmexyl as well as the no-observedadverse-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 


daltland on DSKBBV9HB2PROD with RULES
Federal Register / Vol. 83, No. 176 / Tuesday, September 11, 2018 / Rules and Regulations 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 cloquintocetmexyl 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] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. In § 180.560, revise the introductory 

text of paragraph (a) to read as follows: 

§ 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), flucarbazonesodium (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 cloquintocetVerDate Sep<11>2014 16:11 Sep 10, 2018 Jkt 244001 PO 00000 Frm 00033 Fmt 4700 Sfmt 4700 E:\FR\FM\11SER1.SGM 11SER1

daltland on DSKBBV9HB2PROD with RULES
45844 Federal Register / Vol. 83, No. 176 / Tuesday, September 11, 2018 / Rules and Regulations 

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 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2017–0505; FRL–9982–21] 

Spiromesifen; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes a 

tolerance for residues of spiromesifen in 

or on coffee. Bayer CropScience 

requested this tolerance 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–2017–0505, 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 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/textidx?&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–2017–0505 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). 

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– 

2017–0505, 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 February 

27, 2018 (83 FR 8408) (FRL–9972–17), 

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 7E8584) by Bayer 

CropScience, 2 T.W. Alexander Drive, 

Research Triangle Park, NC 27709. The 

petition requested that 40 CFR part 180 

be amended by establishing tolerances 

for residues of spiromesifen; 2-oxo-3- 

(2,4,6-trimethylphenyl)-1- 

oxaspiro[4.4]non-3-en-4-yl 3,3- 

dimethylbutanoate, and its enol 

metabolite (4-hydroxy-3-(2,4,6- 

trimethylphenyl)-1-oxaspiro[4.4]non-3- 

en-2-one calculated as the 

stoichiometric equivalent of 

spiromesifen in or on the raw 

agricultural commodities: Coffee bean, 

green at 0.20 parts per million (ppm); 

coffee, instant at 0.20 ppm; and coffee 

bean, roasted at 0.20 ppm. That 

document referenced a summary of the 

petition prepared by Bayer CropScience, 

the registrant, which is available in the 

docket, http://www.regulations.gov. 

Comments were received on the notice 

of filing. EPA’s response to these 

comments is discussed in Unit IV.C. 

Based upon review of the data 

supporting the petition, EPA has 

modified the commodities for which 

tolerances are being established. The 

reason for these changes is explained in 

Unit IV.D. 

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 


daltland on DSKBBV9HB2PROD with RULES