Federal Register / Vol. 80, No. 183 / Tuesday, September 22, 2015 / Proposed Rules 57141 

Coordinator (HFS–618), Center for Food 

Safety and Applied Nutrition, Food and 

Drug Administration, 5100 Paint Branch 

Pkwy., College Park, MD 20740. These 

forms also are available on the Food and 

Drug Administration’s Web site at 

http://www.fda.gov/Food/FoodSafety/

Product-SpecificInformation/

AcidifiedLow-AcidCanned/Foods/

default.htm. For electronic submission 

go to FDA’s Industry Systems Web site 

at www.access.fda.gov. Commercial 

processors duly registered in accordance 

with this section shall notify the Food 

and Drug Administration not later than 

90 days after such commercial processor 

ceases or discontinues the manufacture, 

processing, or packing of thermally 

processed foods in any establishment: 

Provided, That such notification shall 

not be required as to the temporary 

cessation necessitated by the seasonal 

character of the particular 

establishment’s production or caused by 

temporary conditions including but not 

limited to strikes, lockouts, fire, or acts 

of God. 

(2) Process filing. A commercial 

processor engaged in the thermal 

processing of low-acid foods packaged 

in hermetically sealed containers shall, 

not later than 60 days after registration 

and prior to the packing of a new 

product, provide the Food and Drug 

Administration information as to the 

scheduled processes including but not 

limited to the processing method, type 

of retort or other thermal processing 

equipment employed, minimum initial 

temperatures, times and temperatures of 

processing, sterilizing value (Fo), or 

other equivalent scientific evidence of 

process adequacy, critical control 

factors affecting heat penetration, and 

source and date of the establishment of 

the process, for each such low-acid food 

in each container size: Provided, That 

the filing of such information does not 

constitute approval of the information 

by the Food and Drug Administration, 

and that information concerning 

processes and other data so filed shall 

be regarded as trade secrets within the 

meaning of 21 U.S.C. 331(j) and 18 

U.S.C. 1905. This information shall be 

submitted on the following forms as 

appropriate: Form FDA 2541d (Food 

Process Filing for Low-Acid Retorted 

Method), Form FDA 2541f (Food 

Process Filing for Water Activity/

Formulation Control Method), or Form 

FDA 2541g (Food Process Filing for 

Low-Acid Aseptic Systems). These 

forms are available from the LACF 

Registration Coordinator (HFS–303), 

Center for Food Safety and Applied 

Nutrition, Food and Drug 

Administration, 5100 Paint Branch 

Pkwy., College Park, MD 20740, or at 

any Food and Drug Administration 

district office. The completed form(s) 

shall be submitted to the LACF 

Registration Coordinator (HFS–303), 

Center for Food Safety and Applied 

Nutrition, Food and Drug 

Administration, 5100 Paint Branch 

Pkwy., College Park, MD 20740. These 

forms also are available on the Food and 

Drug Administration’s Web site at 

http://www.fda.gov/Food/FoodSafety/

Product-SpecificInformation/

AcidifiedLow-AcidCannedFoods/

default.htm. For electronic submission, 

go to FDA’s Industry Systems Web site 

at www.access.fda.gov. 

* * * * * 

(ii) If a packer intentionally makes a 

change in a previously filed scheduled 

process by reducing the initial 

temperature or retort temperature, 

reducing the time of processing, or 

changing the product formulation, the 

container, or any other condition basic 

to the adequacy of scheduled process, 

he shall prior to using such changed 

process obtain substantiation by 

qualified scientific authority as to its 

adequacy. Such substantiation may be 

obtained by telephone, telegram, or 

other media, but must be promptly 

recorded, verified in writing by the 

authority, and contained in the packer’s 

files for review by the Food and Drug 

Administration. Within 30 days after 

first use, the packer shall submit to the 

LACF Registration Coordinator (HFS– 

303), Center for Food Safety and 

Applied Nutrition, Food and Drug 

Administration, 5100 Paint Branch 

Pkwy., College Park, MD 20740 a 

complete description of the 

modifications made and utilized, 

together with a copy of his file record 

showing prior substantiation by a 

qualified scientific authority as to the 

safety of the changed process. Any 

intentional change of a previously filed 

scheduled process or modification 

thereof in which the change consists 

solely of a higher initial temperature, a 

higher retort temperature, or a longer 

processing time, shall not be considered 

a change subject to this paragraph, but 

if that modification is thereafter to be 

regularly scheduled, the modified 

process shall be promptly filed as a 

scheduled process, accompanied by full 

information on the specified forms as 

provided in this paragraph. 

* * * * * 

(i) This section shall not apply to the 

commercial processing of any food 

processed under the continuous 

inspection of the meat and poultry 

inspection program of the Food Safety 

Inspection Service of the Department of 

Agriculture under the Federal Meat 

Inspection Act (34 Stat. 1256, as 

amended by 81 Stat. 584 (21 U.S.C. 601 

et seq.)) and the Poultry Products 

Inspection Act (71 Stat. 441, as 

amended by 82 Stat. 791 (21 U.S.C. 451 

et seq.)). 

* * * * * 

Dated: September 15, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–23614 Filed 9–21–15; 8:45 am] 

BILLING CODE 4164–01–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 52 

[EPA–R04–OAR–2015–0444; FRL–9934–42– 

Region 4] 

Air Plan Approval; KY; Emissions 

Statements for the 2008 8-Hour Ozone 

NAAQS 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Proposed rule. 

SUMMARY: The Environmental Protection 

Agency (EPA) is proposing to approve 

the portion of a draft state 

implementation plan (SIP) revision 

submitted by the Commonwealth of 

Kentucky, through the Kentucky 

Division of Air Quality (DAQ) on April 

15, 2015, for parallel processing, that 

addresses the emissions statement 

requirements for Kentucky’s portion of 

the Cincinnati, Ohio-Kentucky-Indiana 

(Cincinnati, OH-KY-IN) 2008 8-hour 

ozone national ambient air quality 

standards (NAAQS) nonattainment area 

(hereinafter referred to as the 

‘‘Cincinnati, OH-KY-IN Area’’ or 

‘‘Area’’). Annual emissions reporting 

(i.e., emissions statements) is required 

for all ozone nonattainment areas. The 

Area is comprised of Butler, Clermont, 

Clinton, Hamilton and Warren Counties 

in Ohio; portions of Boone, Campbell, 

and Kenton Counties in Kentucky; and 

a portion of Dearborn County in 

Indiana. EPA will consider and take 

action on the Ohio and Indiana 

submissions addressing the emissions 

statements requirements for their 

portions of this Area in separate actions. 

This action is being taken pursuant to 

the Clean Air Act (CAA or Act) and its 

implementing regulations. 

DATES: Written comments must be 

received on or before October 22, 2015. 

ADDRESSES: Submit your comments, 

identified by Docket ID No. EPA–R04– 

OAR–2015–0444, by one of the 

following methods: 


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57142 Federal Register / Vol. 80, No. 183 / Tuesday, September 22, 2015 / Proposed Rules 

1. www.regulations.gov: Follow the 

on-line instructions for submitting 

comments. 

2. Email: R4–ARMS@epa.gov. 

3. Fax: (404) 562–9019. 

4. Mail: ‘‘EPA–R04–OAR–2015– 

0444,’’ Air Regulatory Management 

Section, (formerly the Regulatory 

Development Section), Air Planning and 

Implementation Branch (formerly the 

Air Planning Branch), Air, Pesticides 

and Toxics Management Division, U.S. 

Environmental Protection Agency, 

Region 4, 61 Forsyth Street SW., 

Atlanta, Georgia 30303–8960. 

5. Hand Delivery or Courier: Lynorae 

Benjamin, Chief, Air Regulatory 

Management Section, Air Planning and 

Implementation Branch, Air, Pesticides 

and Toxics Management Division, U.S. 

Environmental Protection Agency, 

Region 4, 61 Forsyth Street SW., 

Atlanta, Georgia 30303–8960. Such 

deliveries are only accepted during the 

Regional Office’s normal hours of 

operation. The Regional Office’s 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–R04–OAR–2015– 

0444. 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 through 

www.regulations.gov or email, 

information that you consider to be CBI 

or otherwise protected. 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 information 

about EPA’s public docket visit the EPA 

Docket Center homepage at http://

www.epa.gov/epahome/dockets.htm. 

Docket: All documents in the 

electronic docket are listed in the 

www.regulations.gov index. Although 

listed in the index, some information 

may not be 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 either 

electronically in www.regulations.gov or 

in hard copy at the Air Regulatory 

Management Section, Air Planning and 

Implementation Branch, Air, Pesticides 

and Toxics Management Division, U.S. 

Environmental Protection Agency, 

Region 4, 61 Forsyth Street SW., 

Atlanta, Georgia 30303–8960. EPA 

requests that if at all possible, you 

contact the person listed in the FOR

FURTHER INFORMATION CONTACT section to 

schedule your inspection. The Regional 

Office’s official hours of business are 

Monday through Friday, 8:30 a.m. to 

4:30 p.m., excluding Federal holidays. 

FOR FURTHER INFORMATION CONTACT: 

Tiereny Bell, Air Regulatory 

Management Section, Air Planning and 

Implementation Branch, Air, Pesticides 

and Toxics Management Division, U.S. 

Environmental Protection Agency, 

Region 4, 61 Forsyth Street SW., 

Atlanta, Georgia 30303–8960. Ms. Bell 

can be reached at (404) 562–9088 and 

via electronic mail at bell.tiereny@

epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. What is parallel processing? 

Consistent with EPA regulations 

found at 40 CFR part 51, Appendix V, 

section 2.3.1, for purposes of expediting 

review of a SIP submittal, parallel 

processing allows a state to submit a 

plan to EPA prior to actual adoption by 

the state. Generally, the state submits a 

copy of the proposed regulation or other 

revisions to EPA before conducting its 

public hearing. EPA reviews this 

proposed state action and prepares a 

notice of proposed rulemaking. EPA’s 

notice of proposed rulemaking is 

published in the Federal Register 

during the same time frame that the 

state is holding its public process. The 

state and EPA then provide for 

concurrent public comment periods on 

both the state action and federal action. 

If the revision that is finally adopted 

and submitted by the state is changed in 

aspects other than those identified in 

the proposed rulemaking on the parallel 

process submission, EPA will evaluate 

those changes and if necessary and 

appropriate, issue another notice of 

proposed rulemaking. The final 

rulemaking action by EPA will occur 

only after the SIP revision has been 

adopted by the state and submitted 

formally to EPA for incorporation into 

the SIP. 

On April 15, 2015, the State of 

Kentucky, through Kentucky DAQ, 

submitted a formal letter request for 

parallel processing of a draft SIP 

revision that the Commonwealth was 

already taking through public comment. 

Kentucky DAQ requested parallel 

processing so that EPA could begin to 

take action on its draft SIP revision in 

advance of the Commonwealth’s 

submission of the final SIP revision, 

should that be necessary. As stated 

above, the final rulemaking action by 

EPA will occur only after the SIP 

revision has been: (1) Adopted by 

Kentucky; (2) submitted formally to EPA 

for incorporation into the SIP; and (3) 

evaluated by EPA, including any 

changes made by the State after the 

April 15, 2015, draft was submitted to 

EPA. 

II. Background 

On March 12, 2008, EPA promulgated 

a revised 8-hour ozone NAAQS of 0.075 

parts per million (ppm). See 73 FR 

16436 (March 27, 2008). Under EPA’s 

regulations at 40 CFR part 50, the 2008 

8-hour ozone NAAQS is attained when 

the 3-year average of the annual fourthhighest daily maximum 8-hour average 

ambient air quality ozone 

concentrations is less than or equal to 

0.075 ppm. See 40 CFR 50.15. Ambient 

air quality monitoring data for the 3- 

year period must meet a data 

completeness requirement. The ambient 

air quality monitoring data 

completeness requirement is met when 

the average percent of days with valid 

ambient monitoring data is greater than 

90 percent, and no single year has less 

than 75 percent data completeness as 

determined in Appendix I of part 50. 

Upon promulgation of a new or 

revised NAAQS, the CAA requires EPA 

to designate as nonattainment any area 

that is violating the NAAQS, based on 

the three most recent years of ambient 

air quality data at the conclusion of the 

designation process. The Cincinnati, 

OH-KY-IN Area was designated 

nonattainment for the 2008 8-hour 

ozone NAAQS on April 30, 2012 

(effective July 20, 2012) using 2008– 

2010 ambient air quality data. See 77 FR 

30088. At the time of designation, the 

Cincinnati, OH-KY-IN Area was 

classified as a marginal nonattainment 

area for the 2008 8-hour ozone NAAQS. 


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Federal Register / Vol. 80, No. 183 / Tuesday, September 22, 2015 / Proposed Rules 57143 

1The SIP Requirements Rule addresses a range of 

nonattainment area SIP requirements for the 2008 

ozone NAAQS, including requirements pertaining 

to attainment demonstrations, reasonable further 

progress (RFP), reasonably available control 

technology, reasonably available control measures, 

major new source review, emission inventories, and 

the timing of SIP submissions and of compliance 

with emission control measures in the SIP. The rule 

also revokes the 1997 ozone NAAQS and 

establishes anti-backsliding requirements. 

2A state may waive the emissions statements 

requirement for any class or category of stationary 

sources which emit less than 25 tons per year of 

VOCs or NOX if the state meets the requirements 

of section 182(a)(3)(B)(ii). 

3 Kentucky’s requirement for an emissions 

statement program is listed within its permitting 

regulations. Kentucky does not have a stand-alone 

regulation addressing the emissions statement 

requirements of section 182(a)(3)(B). 

On March 6, 2015, EPA finalized a rule 

entitled ‘‘Implementation of the 2008 

National Ambient Air Quality Standards 

for Ozone: State Implementation Plan 

Requirements’’ (SIP Requirements Rule) 

that establishes the requirements that 

state, tribal, and local air quality 

management agencies must meet as they 

develop implementation plans for areas 

where air quality exceeds the 2008 8- 

hour ozone NAAQS.1 See 80 FR 12264. 

This rule establishes nonattainment area 

attainment dates based on Table 1 of 

section 181(a) of the CAA, including an 

attainment date three years after the July 

20, 2012, effective date, for areas 

classified as marginal for the 2008 8- 

hour ozone NAAQS. Therefore, the 

attainment date for the Cincinnati, OHKY-IN Area is July 20, 2015. 

Based on the nonattainment 

designation, Kentucky is required to 

develop a nonattainment SIP revision 

addressing certain CAA requirements. 

Specifically, pursuant to CAA section 

182(a)(3)(B), Kentucky is required to 

submit a SIP revision addressing 

emissions statements requirements. 

Ground level ozone is not emitted 

directly into the air, but is created by 

chemical reactions between oxides of 

nitrogen (NOX) and volatile organic 

compounds (VOC) in the presence of 

sunlight. Emissions from industrial 

facilities and electric utilities, motor 

vehicle exhaust, gasoline vapors, and 

chemical solvents are some of the major 

sources of NOX and VOC. Section 

182(a)(3)(B) of the CAA requires each 

state with ozone nonattainment areas to 

submit a SIP revision requiring annual 

emissions statements to be submitted to 

the state by the owner or operator of 

each NOX or VOC stationary source 2

located within a nonattainment area 

showing the actual emissions of NOX

and VOC from that source. The first 

statement is due three years from the 

area’s nonattainment designation, and 

subsequent statements are due at least 

annually thereafter. 

On April 15, 2015, Kentucky 

submitted a draft SIP revision, for 

parallel processing, containing 

emissions statements requirements 

related to its portion of the Cincinnati, 

OH-KY-IN Area. EPA is now taking 

action to propose approval of this SIP 

revision as meeting the requirements of 

section 182(a)(3)(B) of the CAA. More 

information on EPA’s analysis of 

Kentucky’s SIP revision is provided 

below. 

III. Analysis of the Commonwealth’s 

Submittal 

Kentucky’s April 15, 2015, draft 

submission seeks to include the specific 

sections of 401 Kentucky 

Administrative Regulations (KAR) 

52.020—Title V permits, 401 KAR 

52:030 Federally-enforceable permits for 

non-major sources, 401 KAR 52:040— 

State-Origin Permits, and 401 KAR 

52:070—Registration of designated 

sources identified on pages 8 and 9 of 

its submittal into the SIP to meet the 

emissions statements requirements of 

CAA section 182(a)(3)(B). EPA has 

preliminarily determined that the 

specific regulatory sections identified 

on pages 8 and 9 of the SIP submission, 

collectively, meet the emissions 

statement requirements of section 

182(a)(3)(B) because they require 

sources that emit 25 tons per year or 

more of VOCs or NOX within the 

Kentucky portion of the Area to submit 

annual certified statements showing 

actual VOC and NOX emissions.3

Consequently, EPA is proposing to 

approve the portion of Kentucky’s April 

15, 2015, draft SIP submission that 

addresses the emissions statements 

requirements for the Kentucky portion 

of the Area. 

IV. Incorporation By Reference 

In this proposed rule, EPA is 

proposing to finalize regulatory text that 

includes incorporation by reference. In 

accordance with requirements of 1 CFR 

51.5, EPA is proposing to finalize the 

incorporate by reference of 401 KAR 

52:020—Title V permits, Section 22 

entitled ‘‘Annual Emissions 

Certification’’, first sentence only and 

Section 23 entitled ‘‘Certification by 

Responsible Official’’, introductory 

paragraph text and subsection (4) only; 

401 KAR 52:030—Federally-enforceable 

permits for nonmajor sources, Section 3 

entitled ‘‘General Provisions’’, 

subsection (4) only, Section 22 entitled 

‘‘Certification by Responsible Official’’, 

introductory text and subsection (4) 

only, and Section 25 entitled ‘‘Sources 

Subject to Title V’’, subsection (1) 

introductory text, subsection (1)(c), and 

subsection (2) introductory text only; 

401 KAR 52:040—State-Origin Permits, 

Section 3 entitled ‘‘General Provisions’’, 

subsection (2) introductory text, 

subsection (2)(c), and subsection (3) 

only, Section 20 entitled ‘‘Annual 

Emissions Certification for Specified 

Sources’’, subsection (1) only, and 

Section 21 entitled ‘‘Certification by 

Responsible Official’’, introductory text 

and subsection (4) only; and 401 KAR 

52:070—Registration of designated 

sources, Section 3 entitled ‘‘General 

Provisions’’, subsection (2) introductory 

text, subsection (2)(a)(1), and subsection 

(2)(a)(2) first sentence only. EPA has 

made, and will continue to make, these 

documents generally available 

electronically through 

www.regulations.gov and/or in hard 

copy at the Region 4 EPA office (see the 

ADDRESSES section of this preamble for 

more information). 

V. Proposed Action 

EPA is proposing to approve the 

portion of a draft SIP revision submitted 

by Kentucky on April 15, 2015, that 

addresses the CAA section 182(a)(3)(B) 

emissions statements requirements for 

the Kentucky portion of the Cincinnati, 

OH-KY-IN Area. EPA has preliminarily 

concluded that this portion of the 

Commonwealth’s draft submission 

meets the requirements of sections 110 

and 182 of the CAA. 

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 

Act and applicable federal regulations. 

See 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.); 


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57144 Federal Register / Vol. 80, No. 183 / Tuesday, September 22, 2015 / Proposed Rules 

• 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 as specified by 

Executive Order 13175 (65 FR 67249, 

November 9, 2000), nor will it impose 

substantial direct costs on tribal 

governments or preempt tribal law. 

List of Subjects in 40 CFR Part 52 

Environmental protection, Air 

pollution control, Incorporation by 

reference, Intergovernmental relations, 

Nitrogen dioxide, Ozone, Reporting and 

recordkeeping requirements, Volatile 

organic compounds. 

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

Dated: September 10, 2015. 

Heather McTeer Toney, 

Regional Administrator, Region 4. 

[FR Doc. 2015–23657 Filed 9–21–15; 8:45 am] 

BILLING CODE 6560–50–P 


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