### 80719 Federal Register / Vol. 80, No. 248 / Monday, December 28, 2015 / Proposed Rules

in response to requests for an extension to allow interested persons additional time to submit comments.

**DATES :**  FDA is extending the comment period for a docket to receive information and comments on the use of the term ‘‘natural’’ in the labeling of human food products. We established the docket in a notice published on November 12, 2015 (80 FR 69905). Submit either electronic or written comments to the docket by May 10,

2016.

**ADDRESSES :**  You may submit comments by any of the following methods:

Electronic Submissions

Submit electronic comments in the following way:

• Federal eRulemaking Portal: http:// www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http:// www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov.

• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). Written/Paper Submissions

Submit written/paper submissions as follows:

• Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

• For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ‘‘Instructions.’’

Instructions: All submissions received must include the Docket No. FDA– 2014–N–1207 for ‘‘Use of the Term ‘Natural’ in the Labeling of Human Food Products; Request for Information and Comments.’’ Received comments will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ‘‘THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.’’ The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ‘‘confidential.’’ Any information marked as ‘‘confidential’’ will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/ regulatoryinformation/dockets/ default.htm.

Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http:// www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ‘‘Search’’ box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

**FOR FURTHER INFORMATION CONTACT :**  Margaret-Hannah Emerick, Center for Food Safety and Applied Nutrition (HFS–820), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240–

402–2371.

**SUPPLEMENTARY INFORMATION :**  In the Federal Register of November 12, 2015 (80 FR 69905), we published a notice announcing the establishment of a docket to receive information and comments on the use of the term ‘‘natural’’ in the labeling of human food products, including foods that are genetically engineered or contain ingredients produced through the use of genetic engineering. The notice discussed FDA’s position regarding the use of the term ‘‘natural’’, the events that prompted us to establish a docket to request comment on this issue, and specific questions. We provided a 90- day comment period that was scheduled to end on February 10, 2016.

We received requests for a 90-day extension of the comment period. The requests conveyed concern that the current 90-day comment period does not allow sufficient time to develop meaningful or thoughtful comments to the questions and issues we presented in the notice.

FDA has considered the requests and is extending the comment period for 90 days, until May 10, 2016. We believe that a 90-day extension allows adequate time for interested persons to submit

comments.

Dated: December 21, 2015. Leslie Kux, Associate Commissioner for Policy.

[FR Doc. 2015–32471 Filed 12–24–15; 8:45 am]

**BILLING CODE 4164–01–P**

**ENVIRONMENTAL PROTECTION AGENCY** 

**40 CFR Part 52**

**[EPA–R05–OAR–2015–0074; FRL–9940–58– Region 5]** 

**Air Plan Approval; Indiana; Temporary Alternate Opacity Limits for American**  **Electric Power, Rockport**

**AGENCY :**  Environmental Protection Agency (EPA).

**ACTION :**  Proposed rule.

**SUMMARY :**  The Environmental Protection Agency (EPA) is proposing to approve a revision to the Indiana State Implementation Plan (SIP), authorizing temporary alternate opacity limits (TAOLs) at the American Electric Power, Rockport (AEP Rockport) facility during periods of unit startup and shutdown. This action is consistent with the Clean Air Act (CAA) and EPA policy regarding emissions during periods of startup and shutdown. Indiana has provided an air quality analysis demonstrating that this revision will continue to protect the applicable National Ambient Air Quality Standards (NAAQS) for fine particulate matter (PM2.5 ) in Spencer County.


### 80720 Federal Register / Vol. 80, No. 248 / Monday, December 28, 2015 / Proposed Rules

1 These facilities are identified in the attachment to the October 10, 2001, letter from Janet McCabe, IDEM Assistant Commissioner to Stephen Rothblatt, US EPA Region 5 Air Programs Branch Chief. They are: Alcoa Generating, AEP Tanners Creek, Crawfordsville Electric, Hoosier Energy Merom, Hoosier Energy Ratts, IKEC Clifty Creek, IPL Perry ‘‘K’’, IPL Stout, IPL Pritchard, IPL Petersburg units 1–3, NIPCCO Bailly, NIPSCO Michigan City, NIPSCO Schahfer, PSI Cayuga, PSI Edwardsport, PSI Gallagher, PSI Gibson, PSI Noblesville, PSI Wabash River, Richmond Power & Light, SIGECO Brown unit 1, and SIGECO Culley. **DATES :**  Comments must be received on or before January 27, 2016.

**ADDRESSES :**  Submit your comments, identified by Docket ID No. EPA–R05– OAR–2015–0074, by one of the following methods:

1. www.regulations.gov: Follow the on-line instructions for submitting

comments.

2. Email: blakley.pamela@epa.gov.

3. Fax: (312) 692–2490.

4. Mail: Pamela Blakley, Chief, Control Strategies Section, Air Programs Branch (AR–18J), U.S. Environmental Protection Agency, 77 West Jackson Boulevard, Chicago, Illinois 60604.

5. Hand Delivery: Pamela Blakley, Chief, Control Strategies 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–2015– 0074. 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. For additional instructions on submitting comments, go to Section I of the **SUPPLEMENTARY INFORMATION** section of this document.

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 Matt Rau, Environmental Engineer, at (312) 886–6524 before visiting the Region 5 office.

**FOR FURTHER INFORMATION CONTACT :**  Matt Rau, Environmental Engineer, Control Strategies Section, Air Programs Branch (AR–18J), Environmental Protection Agency, Region 5, 77 West Jackson Boulevard, Chicago, Illinois 60604, (312) 886–6524, rau.matthew@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. What should I consider as I prepare my comments for EPA? II. What is the background for this action? III. What is EPA’s analysis? IV. What action is EPA taking? V. Incorporation by Reference VI. Statutory and Executive Order Reviews I. What should I consider as I prepare my comments for EPA?

When submitting comments, remember to:

1. Identify the rulemaking by docket number and other identifying information (subject heading, Federal Register date and page number).

2. Follow directions—EPA may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations (CFR) part or section number.

3. Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes.

4. Describe any assumptions and provide any technical information and/ or data that you used.

5. If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced.

6. Provide specific examples to illustrate your concerns, and suggest alternatives.

7. Explain your views as clearly as possible, avoiding the use of profanity or personal threats.

8. Make sure to submit your comments by the comment period deadline identified. II. What is the background for this action?

On July 16, 2002 (67 FR 46589), EPA approved a revision to Indiana’s SIP to include 326 Indiana Administrative Code (IAC) 5–1–3, which provides a mechanism to establish TAOLs. The rule is consistent with the criteria contained in EPA’s September 20, 1999, ‘‘State Implementation Plans: Policy Regarding Excess Emissions During Malfunctions, Startup, and Shutdown’’ memorandum. The criteria requires that: The frequency and duration of operation in startup or shutdown mode must be minimized to the extent possible; and the state must analyze the potential worst-case emissions that could occur during startup and shutdown to ensure that the NAAQS are protected. Indiana initially submitted TAOLs for 22 power plants with coal-fired boilers that use electrostatic precipitators (ESPs). 1

326 IAC 5–1–3(d) provides for a TAOL, upon EPA approval, if the following criteria are met: (1) The source burns any combination of coal, wood, fuel oil, tire-derived fuel, or petroleum coke, (2) the source demonstrates that the TAOL is needed during periods of startup and shutdown and a demonstration is made that the TAOL will not interfere with the NAAQS, (3) Indiana determines that acceptable operating and maintenance procedures are being used, be based on information provided to the commissioner, (4) the commissioner may require the source to install a continuous opacity monitor (COM), (5) the TAOL shall be reviewed by the commissioner after two years of monitoring, (6) the commissioner may deny a request for a TAOL limit if economically and technically feasible


### 80721 Federal Register / Vol. 80, No. 248 / Monday, December 28, 2015 / Proposed Rules

2 The requirement in 326 IAC 5–1–3(d)(5) related to Indiana review of monitoring data does not apply in this case because AEP has previously installed COMs and provided the necessary data. means are available to meet a more stringent opacity limit, and (7) the TAOL must be submitted to and approved by EPA.

On January 13, 2015, Indiana requested a SIP revision to add 326 IAC 5–1–8, which provides a mechanism to establish site-specific TAOLs. This provision was used to establish AEP Rockport Units #1 and #2 a TAOL during unit startup and shutdown. These two coal-fired boilers are each controlled by an ESP.

The TAOL for unit startup is only allowed until the exhaust temperature reaches 250 °F at the ESP inlet, up to a maximum of two hours (20 six-minute averaging periods). The TAOL for unit shutdown is only allowed when the exhaust temperature declines below

250 °F at the ESP inlet, up to a maximum of one and one-half (1.5) hours (15 six-minute averaging periods). III. What is EPA’s analysis?

To support the SIP revision request, Indiana evaluated COMs data for Units #1 and #2, and air dispersion modeling. Air dispersion modeling was conducted using the AERMOD regulatory dispersion model with five years of meteorological data. The analysis included conservative suppositions for stack temperature and flow rate. Indiana used worst-case emission rates to predict the highest hourly emissions during a cold startup. The modeling results yielded an eighth high 24-hour PM2.5 value of 22.2 micrograms per cubic meter (mg/m 3 )

, well below the 24- hour PM2.5 standard of 35 mg/m 3 . The air quality in the area will remain protected when Units #1 and #2 are operating with TOALs at the AEP Rockport facility.

EPA has reviewed the COMs data provided in Indiana’s submission on AEP Rockport’s startups and shutdowns from 2001 until the first quarter of 2004. The AEP Rockport TAOLs appear to be set at appropriate levels, minimizing the TAOL duration. The startup TAOL for AEP Rockport is limited to two hours. The shutdown TAOL is limited to one hour, 30 minutes. Both are less than the three-hour TAOL periods allowed under 326 IAC 5–1–3(e)(2). Indiana has provided the facility’s operation and maintenance procedures for its ESPs, which support the expectation that AEP Rockport will operate in a manner that will minimize emissions with well operating emission control. In addition, because the ESP exhaust must be warm enough for it to be safely operated, it is impractical to require operating the ESPs during startup and shutdown periods. Further, EPA reviewed the AEP Rockport COMs data from 2009 to 2013, which shows that it was in compliance with the opacity standards 99.81 percent of the time. This indicates that the facility is generally in compliance with the opacity rule, even during the startup and shutdown periods covered by the TAOLs.

EPA has determined the AEP Rockport TAOL meets the criteria contained in 326 IAC 5–1–3(d) as follows: (1) The AEP Rockport facility burns coal, (2) AEP Rockport has demonstrated that the TAOL is needed during periods of startup and shutdown, and that the TAOL will not interfere with the maintenance of the national ambient air quality standards, (3) Indiana has determined that acceptable operating and maintenance procedures are being used, based on information AEP Rockport provided, (4) AEP Rockport currently operates a COM for each boiler, (5) Indiana has determined that no economically and technically feasible controls are available to meet a more stringent limit, and (6) the TAOLs were submitted to EPA. 2 IV. What action is EPA taking?

EPA is proposing to approve the addition of 326 IAC 5–1–8 to the Indiana SIP. The rule provides AEP Rockport Units #1 and Unit #2 with TAOLs during unit startup and shutdown periods. This action is consistent with the Clean Air Act (CAA) and EPA policy regarding emissions during periods of startup and shutdown. Indiana has provided an air quality analysis demonstrating that this revision will continue to protect the applicable National Ambient Air Quality Standards (NAAQS) for PM2.5 in Spencer County. V. Incorporation by Reference

In this rule, EPA is proposing to include in a final EPA rule regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, EPA is proposing to incorporate by reference Indiana Regulation 326 IAC 5–1–8 entitled ‘‘Site-specific temporary alternative opacity limitations’’, effective December 6, 2014. EPA has made, and will continue to make, these documents generally available electronically through www.regulations.gov and/or in hard copy at the appropriate EPA office (see the **ADDRESSES** section of this preamble for more information). VI. Statutory and Executive Order Reviews

Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the CAA 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).

In addition, 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


### 80722 Federal Register / Vol. 80, No. 248 / Monday, December 28, 2015 / Proposed Rules

governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000). List of Subjects in 40 CFR Part 52

Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Particulate matter, Reporting and recordkeeping requirements.

Dated: December 14, 2015. Susan Hedman, Regional Administrator, Region 5.

[FR Doc. 2015–32509 Filed 12–24–15; 8:45 am]

**BILLING CODE 6560–50–P**

**ENVIRONMENTAL PROTECTION AGENCY** 

**40 CFR Parts 271 and 272**

**[EPA–R06–RCRA–2015–0110; FRL–9939– 50–Region 6]** 

**Texas: Final Authorization of State initiated Changes and Incorporation by**  **Reference of State Hazardous Waste Management Program** 

**AGENCY :**  Environmental Protection Agency (EPA).

**ACTION :**  Proposed rule.

**SUMMARY :**  During a review of Texas’ regulations, the Environmental Protection Agency (EPA) identified a variety of State-initiated changes to Texas’ hazardous waste program under the Resource Conservation and Recovery Act, as amended (RCRA), for which the State had not previously sought authorization. The EPA proposes to authorize the State for the program changes. In addition, the EPA proposes to codify in the regulations entitled ‘‘Approved State Hazardous Waste Management Programs, ‘‘Texas’ authorized hazardous waste program’’. The EPA will incorporate by reference into the Code of Federal Regulations (CFR) those provisions of the State regulations that are authorized and that the EPA will enforce under RCRA.

**DATES :**  Send your written comments by January 27, 2016.

**ADDRESSES :**  Submit any comments identified by Docket ID No. EPA–R06– RCRA–2015–0110 by one of the following methods:

1. Federal eRulemaking Portal: http:// www.regulations.gov. Follow the on-line instructions for submitting comments.

2. Email: patterson.alima@epa.gov. 3. Mail: Alima Patterson, Region 6, Regional Authorization Coordinator, State/Tribal Oversight Section (6PD–O), Multimedia Planning and Permitting Division, EPA Region 6, 1445 Ross Avenue, Dallas, Texas 75202–2733. 4. Hand Delivery or Courier. Deliver your comments to Alima Patterson, Region 6, Regional Authorization Coordinator, State/Tribal Oversight Section (6PD–O), Multimedia Planning and Permitting Division, EPA Region 6, 1445 Ross Avenue, Dallas, Texas 75202–

2733.

Instructions: Do not submit information that you consider to be CBI or otherwise protected through regulations.gov, or email. Direct your comment to Docket No. EPA–R06– RCRA–2015–0109. The Federal regulations.gov Web site is an ‘‘anonymous access’’ system, which means the 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 the EPA without going through 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, the 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 the EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, the 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. You can view and copy Texas’ application and associated publicly available materials from 8:30 a.m. to 4 p.m. Monday through Friday at the following location: EPA, Region 6, 1445 Ross Avenue, Dallas, Texas 75202– 2733, phone number (214) 665–8533. Interested persons wanting to examine these documents should make an appointment with the office at least two weeks in advance.

**FOR FURTHER INFORMATION CONTACT :**  Alima Patterson at (214) 665–8533 or Julia Banks at (214) 665–8178, State/ Tribal Oversight Section (6PD–O), Multimedia Planning and Permitting Division, EPA Region 6, 1445 Ross Avenue, Dallas, Texas 75202–2733, (214) 665–8533) and Email address patterson.alima@epa.gov and bank.julia@epa.gov.

**SUPPLEMENTARY INFORMATION :**  In the ‘‘Rules and Regulations’’ section of this Federal Register , EPA is authorizing the changes by direct final rule. EPA did not make a proposal prior to the direct final rule because we believe this action is not controversial and do not expect comments that oppose it. We have explained the reasons for this authorization in the preamble to the direct final rule. Unless we get written comments which oppose this authorization during the comment period, the direct final rule will become effective 60 days after publication and we will not take further action on this proposal. If we receive comments that oppose this action, we will withdraw the direct final rule and it will not take effect. We will then respond to public comments in a later final rule based on this proposal. You may not have another opportunity for comment. If you want to comment on this action, you must do so at this time.

The purpose of this Federal Register document is to codify Texas’ base hazardous waste management program and its revisions to that program through RCRA Cluster XXI (see 79 FR 52220; September 3, 2014). The EPA provided notices and opportunity for comments on the Agency’s decisions to authorize the Texas program, and the EPA is not now reopening the decisions, nor requesting comments, on the Texas authorizations as published in FR notices specified in Section I.F of the direct final rule FR document.

This document incorporates by reference Texas’ hazardous waste statutes and regulations and clarifies which of these provisions are included in the authorized and federally enforceable program. By codifying Texas’ authorized program and by amending the Code of Federal Regulations, the public will be more easily able to discern the status of federally approved requirements of the Texas hazardous waste management

program.

Dated: October 1, 2015. Ron Curry, Regional Administrator, Region 6.

[FR Doc. 2015–31876 Filed 12–24–15; 8:45 am]

**BILLING CODE 6560–50–P**

**FEDERAL COMMUNICATIONS COMMISSION** 

**47 CFR Parts 20 and 68**

**[CG Docket Nos. 12–32 and 13–46 and WT Docket Nos. 07–250 and 10–254; FCC 15–**  **144]**

**Hearing Aid Compatibility Standards**

**AGENCY :**  Federal Communications Commission.

**ACTION :**  Proposed rule.

**SUMMARY :**  In this document, the Commission proposes to amend its hearing aid compatibility (HAC) rules to enhance equal access to the national