18802 Federal Register / Vol. 79, No. 65 / Friday, April 4, 2014 / Rules and Regulations 

have a significant impact on a 

substantial number of small entities. 

V. Paperwork Reduction Act of 1995 

This final rule contains information 

collection provisions that are subject to 

the Paperwork Reduction Act of 1995 

(44 U.S.C. 3501–3520). We conclude 

that these information collection 

provisions are exempt from OMB review 

under 44 U.S.C. 3518(c)(1)(B)(ii) and 5 

CFR 1320.4(a)(2) as collections of 

information obtained during the 

conduct of a civil action to which the 

United States or any official or Agency 

thereof is a party, or during the conduct 

of an administrative action, 

investigation, or audit involving an 

Agency against specific individuals or 

entities. The regulations in 5 CFR 

1320.3(c) provide that the exception in 

5 CFR 1320.4(a)(2) applies during the 

entire course of the investigation, audit, 

or action, but only after a case file or 

equivalent is opened with respect to a 

particular party. Such a case file would 

be opened as part of the request to 

access records under 21 CFR 1.361. 

VI. Analysis of Environmental Impact 

The Agency has carefully considered 

the potential environmental effects of 

this action. FDA has concluded under 

21 CFR 25.30(h) that this action is of a 

type that does not individually or 

cumulatively have a significant effect on 

the human environment. Therefore, 

neither an environmental assessment 

nor an environmental impact statement 

is required. 

VII. Federalism 

FDA has analyzed this final rule in 

accordance with the principles set forth 

in Executive Order 13132. FDA has 

determined that the rule does not 

contain policies that have substantial 

direct effects on the States, on the 

relationship between the National 

Government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government. Accordingly, the 

Agency has concluded that the rule does 

not contain policies that have 

federalism implications as defined in 

the Executive Order and, consequently, 

a federalism summary impact statement 

is not required. 

List of Subjects in 21 CFR Part 1 

Cosmetics, Drugs, Exports, Food 

labeling, Imports, Labeling, Reporting 

and recordkeeping requirements. 

PART 1—GENERAL ENFORCEMENT 

REGULATIONS 

■ Accordingly, the interim rule 

amending 21 CFR part 1, which was 

published at 77 FR 10658 (February 23, 

2012), is adopted as a final rule without 

change. 

Dated: April 1, 2014. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2014–07550 Filed 4–3–14; 8:45 am] 

BILLING CODE 4160–01–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 52 

[EPA–R05–OAR–2013–0646; FRL–9908–72– 

Region 5] 

Approval and Promulgation of Air 

Quality Implementation Plans; 

Michigan; PSD Rules for PM2.5

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Direct Final Rule. 

SUMMARY: The Environmental Protection 

Agency (EPA) is approving revisions to 

Michigan’s Prevention of Significant 

Deterioration (PSD) Program rules and 

definitions, including revisions to Parts 

1 and 18 of Michigan’s Air Pollution 

Control Rules into Michigan’s State 

Implementation Plan (SIP). The revised 

rules address the Federal requirements 

for significant emission levels, and 

definitions for fine particulate matter 

(PM2.5). The Michigan Department of 

Environmental Quality (MDEQ) 

submitted these revisions to EPA on 

August 9, 2013, and September 19, 

2013. 

DATES: This direct final rule is effective 

June 3, 2014, unless EPA receives 

adverse comments by May 5, 2014. If 

adverse comments are received, EPA 

will publish a timely withdrawal of the 

direct final rule in the Federal Register 

informing the public that the rule will 

not take effect. 

ADDRESSES: Submit your comments, 

identified by Docket ID No. EPA–R05– 

OAR–2013–0646, by one of the 

following methods: 

1. www.regulations.gov: Follow the 

on-line instructions for submitting 

comments. 

2. Email: damico.genevieve@epa.gov. 

3. Fax: (312) 886–0968. 

4. Mail: Genevieve Damico, Chief, Air 

Permits Section, Air Programs Branch 

(AR–18J), U.S. Environmental 

Protection Agency, 77 West Jackson 

Boulevard, Chicago, Illinois 60604. 

5. Hand Delivery: Genevieve Damico, 

Chief, Air Permits Section, Air Programs 

Branch (AR–18J), U.S. Environmental 

Protection Agency, 77 West Jackson 

Boulevard, Chicago, Illinois 60604. 

Such deliveries are only accepted 

during the Regional Office normal hours 

of operation, and special arrangements 

should be made for deliveries of boxed 

information. The Regional Office official 

hours of business are Monday through 

Friday, 8:30 a.m. to 4:30 p.m., excluding 

Federal holidays. 

Instructions: Direct your comments to 

Docket ID No. EPA–R05–OAR–2013– 

0646. EPA’s policy is that all comments 

received will be included in the public 

docket without change and may be 

made available online at 

www.regulations.gov, including any 

personal information provided, unless 

the comment includes information 

claimed to be Confidential Business 

Information (CBI) or other information 

whose disclosure is restricted by statute. 

Do not submit information that you 

consider to be CBI or otherwise 

protected through www.regulations.gov 

or email. The www.regulations.gov Web 

site is an ‘‘anonymous access’’ system, 

which means EPA will not know your 

identity or contact information unless 

you provide it in the body of your 

comment. If you send an email 

comment directly to EPA without going 

through www.regulations.gov your email 

address will be automatically captured 

and included as part of the comment 

that is placed in the public docket and 

made available on the Internet. If you 

submit an electronic comment, EPA 

recommends that you include your 

name and other contact information in 

the body of your comment and with any 

disk or CD–ROM you submit. If EPA 

cannot read your comment due to 

technical difficulties and cannot contact 

you for clarification, EPA may not be 

able to consider your comment. 

Electronic files should avoid the use of 

special characters, any form of 

encryption, and be free of any defects or 

viruses. 

Docket: All documents in the docket 

are listed in the www.regulations.gov 

index. Although listed in the index, 

some information is not publicly 

available, e.g., CBI or other information 

whose disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, will be publicly 

available only in hard copy. Publicly 

available docket materials are available 

either electronically in 

www.regulations.gov or in hard copy at 

the Environmental Protection Agency, 

Region 5, Air and Radiation Division, 77 

West Jackson Boulevard, Chicago, 

Illinois 60604. This facility is open from 

8:30 a.m. to 4:30 p.m., Monday through 

Friday, excluding Federal holidays. We 

recommend that you telephone 

Constantine Blathras, Environmental 


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Engineer, at (312) 886–0671 before 

visiting the Region 5 office. 

FOR FURTHER INFORMATION CONTACT: 

Constantine Blathras, Environmental 

Engineer, Air Permits Section, Air 

Programs Branch (AR–18J), 

Environmental Protection Agency, 

Region 5, 77 West Jackson Boulevard, 

Chicago, Illinois 60604, (312) 886–0671, 

Blathras.constantine@epa.gov. 

SUPPLEMENTARY INFORMATION: 

Throughout this document whenever 

‘‘we,’’ ‘‘us,’’ or ‘‘our’’ is used, we mean 

EPA. This supplementary information 

section is arranged as follows: 

I. Background 

II. What action is EPA taking? 

III. Statutory and Executive Order Reviews. 

I. Background 

On August 9, 2013, MDEQ submitted 

revisions to Michigan rules R 336.2801, 

Definitions; R 336.2803, Ambient air 

increments; and R 336.2816, Sources 

impacting Federal Class I areas, 

additional requirements, which reflect 

changes to Federal rules on PM2.5 and 

ozone precursors. MDEQ also submitted 

various revisions to Michigan rule R 

336.2809 to allow for the exemption 

from permitting requirements of 

minimal air quality impacts from new 

sources; however, MDEQ has requested 

that EPA not act on subsection R 

336.2809(5)(a)(iii), which creates a 

significant monitoring concentration 

(SMC) for PM2.5. Michigan had 

promulgated this subsection before the 

U.S. Court of Appeals for the District of 

Columbia Circuit vacated the Federal 

PM2.5 SMC on January 22, 2013. On 

September 19, 2013, MDEQ submitted 

revisions to definitions in Michigan 

rules R 336.1116, R 336.1119, and R 

336.1122 to address additional changes 

to Federal rules. The revisions to rules 

R 336.1116 and R 336.1119 add 

significance levels and definitions for 

PM2.5 and account for PM2.5 and PM10

condensables in applicability 

determinations and in establishing 

emissions limits. The revision to R 

336.1122(f) updates the definition of 

volatile organic compounds to exclude 

additional compounds with negligible 

reactivity in the formation of ozone that 

have been approved by EPA. However, 

MDEQ has asked EPA not to act on the 

revision to the definition of 

‘‘significant’’ in rule R 336.1119 at this 

time. Michigan will resubmit revisions 

to that definition at a later date. 

II. What action is EPA taking? 

EPA is approving the submitted 

revisions to Michigan’s Part 1 

definitions, with the exception of the 

definition of ‘‘significant’’ in rule R 

336.1119. EPA has determined that the 

revised rules comply with the revisions 

to the Federal requirements found in 40 

CFR 51.100, 51.165, and 51.166, 

pertaining to new definitions and 

provisions for PM2.5. 

EPA is approving the submitted 

revisions to Michigan’s Part 18 PSD 

rules into the Michigan SIP, with the 

exception of R 336.2809(5)(a)(iii), on 

which we are taking no action. EPA has 

determined that the revised rules 

comply with the revisions to the Federal 

definitions and provisions pertaining to 

PM2.5 found at 40 CFR 51.100, 51.165, 

and 51.166. 

We are publishing this action without 

prior proposal because we view this as 

a noncontroversial amendment and 

anticipate no adverse comments. 

However, in the proposed rules section 

of this Federal Register publication, we 

are publishing a separate document that 

will serve as the proposal to approve the 

state plan if relevant adverse written 

comments are filed. This rule will be 

effective June 3, 2014 without further 

notice unless we receive relevant 

adverse written comments by May 5, 

2014. If we receive such comments, we 

will withdraw this action before the 

effective date by publishing a 

subsequent document that will 

withdraw the final action. We then will 

address all public comments in a 

subsequent final rule based on the 

proposed action. EPA will not institute 

a second comment period. Any parties 

interested in commenting on this action 

should do so at this time. Please note 

that if EPA receives adverse comment 

on an amendment, paragraph, or section 

of this rule that may be severed from the 

remainder of the rule, EPA may adopt 

as final those provisions of the rule that 

are not the subject of the adverse 

comment. If we do not receive any 

adverse comments, this action will be 

effective June 3, 2014. 

III. Statutory and Executive Order 

Reviews 

Under the Clean Air Act, the 

Administrator is required to approve a 

SIP submission that complies with the 

provisions of the Clean Air Act and 

applicable Federal regulations. 42 

U.S.C. 7410(k); 40 CFR 52.02(a). Thus, 

in reviewing SIP submissions, EPA’s 

role is to approve state choices, 

provided that they meet the criteria of 

the Clean Air Act. Accordingly, this 

action merely approves state law as 

meeting Federal requirements and does 

not impose additional requirements 

beyond those imposed by state law. For 

that reason, this action: 

• Is not a ‘‘significant regulatory 

action’’ subject to review by the Office 

of Management and Budget under 

Executive Order 12866 (58 FR 51735, 

October 4, 1993); 

• Does not impose an information 

collection burden under the provisions 

of the Paperwork Reduction Act (44 

U.S.C. 3501 et seq.); 

• Is certified as not having a 

significant economic impact on a 

substantial number of small entities 

under the Regulatory Flexibility Act (5 

U.S.C. 601 et seq.); 

• Does not contain any unfunded 

mandate or significantly or uniquely 

affect small governments, as described 

in the Unfunded Mandates Reform Act 

of 1995 (Public Law 104–4); 

• Does not have Federalism 

implications as specified in Executive 

Order 13132 (64 FR 43255, August 10, 

1999); 

• Is not an economically significant 

regulatory action based on health or 

safety risks subject to Executive Order 

13045 (62 FR 19885, April 23, 1997); 

• Is not a significant regulatory action 

subject to Executive Order 13211 (66 FR 

28355, May 22, 2001); 

• Is not subject to requirements of 

Section 12(d) of the National 

Technology Transfer and Advancement 

Act of 1995 (15 U.S.C. 272 note) because 

application of those requirements would 

be inconsistent with the Clean Air Act; 

and 

• Does not provide EPA with the 

discretionary authority to address, as 

appropriate, disproportionate human 

health or environmental effects, using 

practicable and legally permissible 

methods, under Executive Order 12898 

(59 FR 7629, February 16, 1994). 

In addition, this rule does not have 

tribal implications as specified by 

Executive Order 13175 (65 FR 67249, 

November 9, 2000), because the SIP is 

not approved to apply in Indian country 

located in the state, and EPA notes that 

it will not impose substantial direct 

costs on tribal governments or preempt 

tribal law. 

The Congressional Review Act, 5 

U.S.C. 801 et seq., as added by the Small 

Business Regulatory Enforcement 

Fairness Act of 1996, generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report, which includes a 

copy of the rule, to each House of the 

Congress and to the Comptroller General 

of the United States. EPA will submit a 

report containing this action 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. A major rule 

cannot take effect until 60 days after it 

is published in the Federal Register. 


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18804 Federal Register / Vol. 79, No. 65 / Friday, April 4, 2014 / Rules and Regulations 

This action is not a ‘‘major rule’’ as 

defined by 5 U.S.C. 804(2). 

Under section 307(b)(1) of the Clean 

Air Act, petitions for judicial review of 

this action must be filed in the United 

States Court of Appeals for the 

appropriate circuit by June 3, 2014. 

Filing a petition for reconsideration by 

the Administrator of this final rule does 

not affect the finality of this action for 

the purposes of judicial review nor does 

it extend the time within which a 

petition for judicial review may be filed, 

and shall not postpone the effectiveness 

of such rule or action. Parties with 

objections to this direct final rule are 

encouraged to file a comment in 

response to the parallel notice of 

proposed rulemaking for this action 

published in the proposed rules section 

of today’s Federal Register, rather than 

file an immediate petition for judicial 

review of this direct final rule, so that 

EPA can withdraw this direct final rule 

and address the comment in the 

proposed rulemaking. This action may 

not be challenged later in proceedings to 

enforce its requirements. (See section 

307(b)(2).) 

List of Subjects in 40 CFR Part 52 

Environmental protection, Air 

pollution control, Carbon monoxide, 

Incorporation by reference, 

Intergovernmental relations, Lead, 

Nitrogen dioxide, Ozone, Particulate 

matter, Reporting and recordkeeping 

requirements, Sulfur oxides, Volatile 

organic compounds. 

Dated: March 17, 2014. 

Susan Hedman, 

Regional Administrator, Region 5. 

40 CFR part 52 is amended as follows: 

PART 52—APPROVAL AND 

PROMULGATION OF 

IMPLEMENTATION PLANS 

■ 1. The authority citation for part 52 

continues to read as follows: 

Authority: 42 U.S.C. 7401 et seq. 

■ 2. In § 52.1170 the table in paragraph 

(c) is amended by: 

■ i. Revising the entries in ‘‘Part 1. 

General Provisions’’ for R 336.1116 and 

R 336.1122; and 

■ ii. Revising the entries in ‘‘Part 18. 

Prevention of Significant Deterioration 

of Air Quality’’ for R 336.2801, R 

336.2803, R 336.2809, and R 336.2816. 

The revised text reads as follows: 

§ 52.1170 Identification of plan. 

* * * * * 

(c) * * * 

EPA-APPROVED MICHIGAN REGULATIONS

Michigan citation Title State effective 

date EPA approval date Comments 

*******

Part 1. General Provisions 

*******

R 336.1116 .................................. Definitions; P ............................... 11/30/2012 4/4/14, [INSERT PAGE 

NUMBER WHERE THE 

DOCUMENT BEGINS].

* * * * * * * 

R 336.1122 .................................. Definitions; V ............................... 11/30/2012 4/4/14, [INSERT PAGE 

NUMBER WHERE THE 

DOCUMENT BEGINS].

* * * * * * * 

Part 18. Prevention of Significant Deterioration of Air Quality 

R 336.2801 .................................. Definitions .................................... 11/30/2012 4/4/14, [INSERT PAGE 

NUMBER WHERE THE 

DOCUMENT BEGINS].

* * * * * * * 

R 336.2803 .................................. Ambient Air Increments ............... 11/30/2012 4/4/14, [INSERT PAGE 

NUMBER WHERE THE 

DOCUMENT BEGINS].

* * * * * * * 

R 336.2809 .................................. Exemptions .................................. 11/30/2012 4/4/14, [INSERT PAGE 

NUMBER WHERE THE 

DOCUMENT BEGINS].

All except for section 

(5)(a)(iii) 

* * * * * * * 

R 336.2816 .................................. Sources impacting federal class I 

areas; additional requirements.

11/30/2012 4/4/14, [INSERT PAGE 

NUMBER WHERE THE 

DOCUMENT BEGINS].

* * * * * * * 

[FR Doc. 2014–06825 Filed 4–3–14; 8:45 am] 

BILLING CODE 6560–50–P 


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ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2013–0258; FRL–9907–67] 

Metaflumizone; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of metaflumizone 

in or on eggplant, pepper, tomato, and 

tomato, paste. BASF Corporation 

requested these tolerances under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA). 

DATES: This regulation is effective April 

4, 2014. Objections and requests for 

hearings must be received on or before 

June 3, 2014, 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–2013–0258, 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), EPA West 

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: Lois 

Rossi, Registration Division (7505P), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; 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–2013–0258 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 June 3, 2014. 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– 

2013–0258, 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.htm. 

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 June 5, 2013 

(78 FR 33785) (FRL–9386–2), 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 3E8146) by BASF 

Corporation, P.O. Box 13528, Research 

Triangle Park, NC 27790. The petition 

requested that 40 CFR 180.657 be 

amended by establishing tolerances for 

residues of the insecticide 

metaflumizone, (E and Z isomers; 2-[2- 

(4-cyanophenyl)-1-[3-(trifluoromethyl) 

phenyl]ethylidene]-N-[4- 

(trifluoromethoxy)phenyl] 

hydrazinecarboxamide), and its 

metabolite (4-{2-oxo-2-[3- 

(trifluoromethyl) phenyl]ethyl}- 

benzonitrile), in or on eggplant at 0.6 

parts per million (ppm); pepper at 0.6 

ppm; and tomato at 0.6 ppm. That 

document referenced a summary of the 

petition prepared by BASF Corporation, 

the registrant, which is available in the 

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

There were no comments received in 

response to the notice of filing. 

Based upon review of the data 

supporting the petition, EPA has 

determined that the tolerances for 

eggplant and pepper should each be 

established at 1.5 ppm, the tolerance for 

tomato should be established at 0.60 

ppm, and that an additional tolerance 

for tomato, paste should be established 

at 1.2 ppm. The reasons for these 

changes are explained in Unit IV.C. 

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 


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