54502 Federal Register / Vol. 81, No. 158 / Tuesday, August 16, 2016 / Rules and Regulations 

machines, or who voluntarily register 

with FDA to be covered, to declare 

calories for those vending machine 

foods for which the Nutrition Facts label 

cannot be examined before purchase or 

for which visible nutrition information 

is not otherwise provided at the point of 

purchase. Covered vending machine 

operators must comply with the rule by 

December 1, 2016. However, in the 

Federal Register of August 1, 2016 (81 

FR 50303), we issued a final rule 

entitled ‘‘Food Labeling; Calorie 

Labeling of Articles of Food in Vending 

Machines; Extension of Compliance 

Date.’’ This rule provides that the 

compliance date for type size front-ofpack labeling requirements 

(§ 101.8(b)(2) (21 CFR 101.8(b)(2))) and 

calorie disclosure requirements 

(§ 101.8(c)(2)) for certain gums, mints, 

and roll candy products in glass-front 

machines in the final rule published 

December 1, 2014 (79 FR 71259) is 

extended to July 26, 2018. The 

compliance date for all other 

requirements in the final rule (79 FR 

71259) remains December 1, 2016. 

II. Paperwork Reduction Act of 1995 

This draft guidance refers to 

previously approved collections of 

information found in FDA regulations. 

These collections of information are 

subject to review by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995 

(44 U.S.C. 3501–3520). The collections 

of information in 21 CFR 101.8 have 

been approved under OMB Control No. 

0910–0782. 

III. Electronic Access 

Persons with access to the Internet 

may obtain the draft guidance at either 

http://www.fda.gov/FoodGuidances or 

http://www.regulations.gov. Use the 

FDA Web site listed in the previous 

sentence to find the most current 

version of the guidance. 

Dated: August 11, 2016. 

Jeremy Sharp, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2016–19493 Filed 8–15–16; 8:45 am] 

BILLING CODE 4164–01–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 52 

[EPA–R07–OAR–2014–0213; FRL–9950–65– 

Region 7] 

Approval and Promulgation of 

Implementation Plans; State of Iowa; 

Infrastructure State Implementation 

Plan (SIP) Requirements for the 1997 

and 2006 Fine Particulate Matter 

(PM2.5) National Ambient Air Quality 

Standards (NAAQS), and the Adoption 

of the 1997 PM2.5 Standard 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: The Environmental Protection 

Agency (EPA) is approving elements of 

two State Implementation Plan (SIP) 

submissions from the State of Iowa for 

the Infrastructure SIP Requirements for 

the 1997 and 2006 Fine Particulate 

Matter (PM2.5) National Ambient Air 

Quality Standards (NAAQS). 

Infrastructure SIPs address the 

applicable requirements of Clean Air 

Act (CAA) section 110, which requires 

that each state adopt and submit a SIP 

for the implementation, maintenance, 

and enforcement of each new or revised 

NAAQS promulgated by the EPA. The 

infrastructure requirements are designed 

to ensure that the structural components 

of each state’s air quality management 

program are adequate to meet the state’s 

responsibilities under the CAA. This 

action also approves the adoption of the 

1997 PM2.5 standard. 

On September 8, 2011, EPA issued a 

Finding of Failure to Submit a Complete 

State Implementation Plan for several 

states, including Iowa. With respect to 

Iowa, the Finding of Failure to Submit 

included the following 2006 PM2.5

NAAQS infrastructure requirements: 

110(a)(2)(A)–(C), (D)(i)(II) (prong 3 

only), (E)–(H) and (J)–(M). This approval 

of Iowa’s infrastructure SIP for the 2006 

PM2.5 NAAQS addresses the September 

8, 2011 finding. 

DATES: This final rule is effective on 

September 15, 2016. 

ADDRESSES: EPA has established a 

docket for this action under Docket ID 

No. EPA–R07–OAR–2014–0213. All 

documents in the docket are listed on 

the www.regulations.gov Web site. 

Although listed in the index, some 

information is not publicly available, 

i.e., CBI or other information whose 

disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available electronically at 

www.regulations.gov and at EPA Region 

7, 11201 Renner Boulevard, Lenexa, 

Kansas 66219. Please schedule an 

appointment during normal business 

hours with the contact listed in the FOR

FURTHER INFORMATION CONTACT section. 

FOR FURTHER INFORMATION CONTACT: 

Heather Hamilton, Environmental 

Protection Agency, Air Planning and 

Development Branch, 11201 Renner 

Boulevard, Lenexa, Kansas 66219 at 

(913) 551–7039, or by email at 

Hamilton.heather@epa.gov. 

SUPPLEMENTARY INFORMATION: 

Throughout this document ‘‘we,’’ ‘‘us,’’ 

or ‘‘our’’ refer to EPA. This section 

provides additional information by 

addressing the following: 

I. What is being addressed in this document? 

II. EPA’s Response to Comments 

III. Final Action 

IV. Statutory and Executive Order Reviews 

I. What is being addressed in this 

document? 

The EPA is approving two 

submissions from the State of Iowa: The 

infrastructure SIP submissions for the 

1997 and 2006 PM2.5 NAAQS received 

on March 31, 2008 and July 29, 2013. 

The SIP submissions from Iowa 

addressed the requirements of CAA 

sections 110(a)(1) and (2) as applicable 

to the 1997 and 2006 PM2.5 NAAQS. 

The March 31, 2008 SIP submission also 

included the state adoption of the 1997 

PM2.5 standard. The EPA is also 

approving the 1997 PM2.5 standard in 

today’s action. 

For the 1997 PM2.5 NAAQS, the EPA 

took previous action to address section 

110(a)(2)(D)(i)(I)—prongs 1 and 2 for 

Iowa. (72 FR 10380, March 8, 2007, as 

revised in 76 FR 48208, August 8, 2011). 

Therefore, in this final action, we are 

not acting on these portions since they 

have already been acted upon by the 

EPA. 

A Technical Support Document is 

included as part of the docket to discuss 

the details of this final action. 

II. EPA’s Response to Comment 

The public comment period on EPA’s 

proposed regulation opened June 23, 

2016, the date of its publication in the 

Federal Register, and closed on July 25, 

2016. 81 FR 40825. During this period, 

EPA received one comment that is 

addressed as follows: 

Comment: The commenter stated that 

EPA must disapprove the Prevention of 

Significant Deterioration (PSD) portions 

of the infrastructure SIP, 110(a)(2)(C), 

(D)(i)(II) (prong 3) and (J), because the 

local air agencies in Iowa with their 


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Federal Register / Vol. 81, No. 158 / Tuesday, August 16, 2016 / Rules and Regulations 54503 

own PSD programs lack the PM2.5

increment or do not treat NOX as a 

precursor for ozone. 

Response to comment: Iowa has a 

delegated PSD program (see 72 FR 

27056) that is not delegated to local air 

agencies. PSD permits are only issued 

by the Iowa Department of Natural 

Resources. 81 FR 44795, 44796. 

Therefore, no changes will be made in 

response to this comment. 

III. What action is EPA taking? 

The EPA is approving two 

submissions from the State of Iowa: The 

infrastructure SIP submissions for the 

1997 and 2006 PM2.5 NAAQS received 

on March 31, 2008 and July 29, 2013. 

The SIP submissions from Iowa address 

the requirements of CAA sections 

110(a)(1) and (2) as applicable to the 

1997 and 2006 PM2.5 NAAQS. Today’s 

action also approves the adoption of the 

1997 PM2.5 standard. 

The EPA’s analysis of these 

submissions is addressed in a TSD as 

part of the docket. 

IV. Statutory and Executive Order 

Reviews 

Under the CAA, the Administrator is 

required to approve a SIP submission 

that complies with the provisions of the 

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 CAA. 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 Orders 12866 (58 FR 51735, 

October 4, 1993) and 13563 (76 FR 3821, 

January 21, 2011); 

• 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 (Pub. L. 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 CAA; 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). 

The SIP is not approved to apply on 

any Indian reservation land or in any 

other area where EPA or an Indian tribe 

has demonstrated that a tribe has 

jurisdiction. In those areas of Indian 

country, the rule does not have tribal 

implications and will not impose 

substantial direct costs on tribal 

governments or preempt tribal law as 

specified by Executive Order 13175 (65 

FR 67249, November 9, 2000). 

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. 

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

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

Under section 307(b)(1) of the CAA, 

petitions for judicial review of this 

action must be filed in the United States 

Court of Appeals for the appropriate 

circuit by October 17, 2016. 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. This action may not 

be challenged later in proceedings to 

enforce its requirements. (See section 

307(b)(2).) 

Statutory Authority 

The statutory authority for this action 

is provided by section 110 of the CAA, 

as amended (42 U.S.C. 7410). 

List of Subjects in 40 CFR Part 52 

Environmental protection, Air 

pollution control, Prevention of 

significant deterioration, Incorporation 

by reference, Intergovernmental 

relations, Particulate matter, Reporting 

and recordkeeping requirements. 

Dated: August 1, 2016. 

Mike Brincks, 

Acting Regional Administrator, Region 7. 

For the reasons stated in the 

preamble, EPA to amends 40 CFR part 

52 as set forth below: 

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. 

Subpart Q—Iowa 

■ 2. Section 52.820 is amended by 

adding (e)(45) and (46) to read as 

follows: 

§ 52.820 Identification of plan. 

* * * * * 

(e) * * * 


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54504 Federal Register / Vol. 81, No. 158 / Tuesday, August 16, 2016 / Rules and Regulations 

EPA-APPROVED IOWA NONREGULATORY SIP PROVISIONS

Name of 

non-regulatory 

SIP revision 

Applicable 

geographic or 

nonattainment 

area 

State submittal 

date EPA Approval date Explanation 

*******

(45) Sections 

110(a)(1) and (2) 

Infrastructure Requirements 1997 

PM2.5 NAAQS.

Statewide ............................ 3/21/08 8/16/16 [Insert Federal 

Register citation].

This action addresses the following CAA 

elements: 110(a)(2)(A), (B), (C), 

(D)(i)(II), prong 3, (E), (F), (G), (H), (J), 

(K), (L), and (M). 110(a)(2)(I) is not applicable. 

(46) Sections 

110(a)(1) and (2) 

Infrastructure Requirements 2006 

PM2.5 NAAQS.

Statewide ............................ 7/23/13 8/16/16 [Insert Federal 

Register citation].

This action addresses the following CAA 

elements: 110(a)(2)(A), (B), (C), 

(D)(i)(II), prong 3, (E), (F), (G), (H), (J), 

(K), (L), and (M). 110(a)(2)(I) is not applicable. 

[FR Doc. 2016–19386 Filed 8–15–16; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 52 

[EPA–R03–OAR–2016–0350; FRL–9950–73– 

Region 3] 

Air Plan Approval; DC; Infrastructure 

Requirements for the 2012 PM2.5

NAAQS 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Direct final rule. 

SUMMARY: The Environmental Protection 

Agency (EPA) is taking direct final 

action to approve a revision to the 

District of Columbia (the District) state 

implementation plan (SIP). Whenever 

new or revised national ambient air 

quality standards (NAAQS) are 

promulgated, the Clean Air Act (CAA) 

requires states to submit a plan for the 

implementation, maintenance, and 

enforcement of such NAAQS. The plan 

is required to address basic program 

elements including, but not limited to, 

regulatory structure, monitoring, 

modeling, legal authority, and adequate 

resources necessary to assure attainment 

and maintenance of the standards. 

These elements are referred to as 

infrastructure requirements. The District 

has made a submittal addressing the 

infrastructure requirements for the 2012 

annual fine particulate matter (PM2.5) 

NAAQS. EPA is approving these 

revisions addressing the infrastructure 

requirements for the 2012 PM2.5 NAAQS 

in accordance with the requirements of 

the CAA. 

DATES: This rule is effective on October 

17, 2016 without further notice, unless 

EPA receives adverse written comment 

by September 15, 2016. If EPA receives 

such comments, it will publish a timely 

withdrawal of the direct final rule in the 

Federal Register and inform the public 

that the rule will not take effect. 

ADDRESSES: Submit your comments, 

identified by Docket ID No. EPA–R03– 

OAR–2016–0350 at http://

www.regulations.gov, or via email to 

Fernandez.cristina@epa.gov. For 

comments submitted at Regulations.gov, 

follow the online instructions for 

submitting comments. Once submitted, 

comments cannot be edited or removed 

from Regulations.gov. For either manner 

of submission, the EPA may publish any 

comment received to its public docket. 

Do not submit electronically any 

information you consider to be 

confidential business information (CBI) 

or other information whose disclosure is 

restricted by statute. Multimedia 

submissions (audio, video, etc.) must be 

accompanied by a written comment. 

The written comment is considered the 

official comment and should include 

discussion of all points you wish to 

make. The EPA will generally not 

consider comments or comment 

contents located outside of the primary 

submission (i.e. on the web, cloud, or 

other file sharing system). For 

additional submission methods, please 

contact the person identified in the FOR

FURTHER INFORMATION CONTACT section. 

For the full EPA public comment policy, 

information about CBI or multimedia 

submissions, and general guidance on 

making effective comments, please visit 

http://www2.epa.gov/dockets/

commenting-epa-dockets. 

FOR FURTHER INFORMATION CONTACT: 

Ruth Knapp, (215) 814–2191, or by 

email at knapp.ruth@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. Summary of SIP Revision 

On December 28, 2015, the District 

submitted a formal SIP revision to its 

SIP. The District’s SIP revision 

submittal addresses the following 

infrastructure elements for the 

implementation of the 2012 annual 

PM2.5 NAAQS: section 110(a)(2)(A), (B), 

(C), (D)(i)(I), (D)(i)(II), (D)(ii), (E), (F), 

(G), (H), (J), (K), (L), and (M) of the CAA. 

The infrastructure SIP submittal does 

not address section 110(a)(2)(I) which 

pertains to the nonattainment 

requirements of part D, title I of the 

CAA, since this element is not required 

to be submitted by the 3-year 

submission deadline of CAA section 

110(a)(1), and will be addressed in a 

separate process. 

II. Summary of EPA’s Rationale for 

Proposing Approval 

In accordance with 40 CFR part 51, 

appendix V, EPA found that the 

District’s December 28, 2015 

infrastructure SIP submittal is 

technically incomplete for the portions 

addressing the infrastructure elements 

in section 110(a)(2)(C), (D)(i)(II), (D)(ii), 

and (J) relating to the permitting 

program for prevention of significant 

deterioration (PSD), because the District 

has not adequately addressed the 

requirements of part C of title I of the 

CAA for having a SIP approved PSD 

permit program. EPA found the 

remainder of the SIP submittal to be 

administratively and technically 

complete. On May 11, 2016, EPA sent a 

letter to the District Department of 

Environment and Energy (DDOEE) 

notifying the District of this 

determination. 

As a result of this incompleteness 

finding, EPA is not taking rulemaking 

action on the PSD related portions of 

section 110(a)(2)(C), (D)(i)(II), (D)(ii), 

and (J) for the 2012 annual PM2.5

NAAQS, until the District through 

DDOEE submits a SIP to address the 

PSD permit program requirements of 

part C of title I of the CAA. EPA 

recognizes, however, that the District is 


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