Federal Register / Vol. 79, No. 163 / Friday, August 22, 2014 / Proposed Rules 49731 

determined that the proposed rule, if 

finalized, would not contain policies 

that would 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 tentatively 

concludes that the proposed rule does 

not contain policies that have 

federalism implications as defined in 

the E.O. and, consequently, a federalism 

summary impact statement is not 

required. 

X. Request for Comments 

Interested persons may submit either 

electronic comments regarding this 

document to http://www.regulations.gov 

or written comments to the Division of 

Dockets Management (see ADDRESSES). It 

is only necessary to send one set of 

comments. Identify comments with the 

docket number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday, and 

will be posted to the docket at http://

www.regulations.gov. 

XI. Reference 

FDA has placed the following 

reference on display in the Division of 

Dockets Management (see ADDRESSES) 

and may be seen by interested persons 

between 9 a.m. and 4 p.m., Monday 

through Friday and are available 

electronically at http://

www.regulations.gov. 

1. Anderson, J. F., ‘‘The Influence of 

Concentration (Gibson’s Method) On the 

Presence of Tetanus Toxin in Blood 

Serum,’’ Journal of Experimental 

Medicine: 1909 September 2; 11(5): 656– 

658. 

List of Subjects 

21 CFR Part 610 

Biologics, Labeling, Reporting and 

recordkeeping requirements. 

21 CFR Part 680 

Biologics, Blood, Reporting and 

recordkeeping requirements. 

Therefore under the Federal Food, 

Drug, and Cosmetic Act, the Public 

Health Service Act, and under authority 

delegated to the Commissioner of Food 

and Drugs, it is proposed that 21 CFR 

parts 610 and 680 be amended as 

follows: 

PART 610—GENERAL BIOLOGICAL 

PRODUCTS STANDARDS 

■ 1. The authority citation for 21 CFR 

part 610 continues to read as follows: 

Authority: 21 U.S.C. 321, 331, 351, 352, 

353, 355, 360, 360c, 360d, 360h, 360i, 371, 

372, 374, 381; 42 U.S.C. 216, 262, 263, 263a, 

264. 

§ 610.11 [Removed and Reserved] 

■ 2. Remove and reserve § 610.11. 

§ 610.11a [Removed and Reserved] 

■ 3. Remove and reserve § 610.11a. 

PART 680—ADDITIONAL STANDARDS 

FOR MISCELLANEOUS PRODUCTS 

■ 4. The authority citation for 21 CFR 

part 680 continues to read as follows: 

Authority: 21 U.S.C. 321, 351, 352, 353, 

355, 360, 371; 42 U.S.C. 216, 262, 263, 263a, 

264. 

§ 680.3 [Amended] 

■ 5. Remove and reserve paragraph (b). 

Dated: August 18, 2014. 

Peter Lurie, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. 2014–19888 Filed 8–21–14; 8:45 am] 

BILLING CODE 4164–01–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 52 

[EPA–R03–OAR–2014–0522; FRL–9915–48- 

Region 3] 

Approval and Promulgation of Air 

Quality Implementation Plans; Virginia; 

Infrastructure Requirements for the 

2010 Sulfur Dioxide National Ambient 

Air Quality Standards 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Proposed rule. 

SUMMARY: The Environmental Protection 

Agency (EPA) is proposing to approve a 

State Implementation Plan (SIP) 

revision submitted by the 

Commonwealth of Virginia pursuant to 

the Clean Air Act (CAA). Whenever new 

or revised National Ambient Air Quality 

Standards (NAAQS) are promulgated, 

the 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 Commonwealth of 

Virginia has made a submittal 

addressing the infrastructure 

requirements for the 2010 sulfur dioxide 

(SO2) NAAQS. 

DATES: Written comments must be 

received on or before September 22, 

2014. 

ADDRESSES: Submit your comments, 

identified by Docket ID Number EPA– 

R03–OAR–2014–0522 by one of the 

following methods: 

A. www.regulations.gov. Follow the 

on-line instructions for submitting 

comments. 

B. Email: fernandez.cristina@epa.gov. 

C. Mail: EPA–R03–OAR–2014–0522, 

Cristina Fernandez, Associate Director, 

Office of Air Program Planning, Air 

Protection Division, Mailcode 3AP30, 

U.S. Environmental Protection Agency, 

Region III, 1650 Arch Street, 

Philadelphia, Pennsylvania 19103. 

D. Hand Delivery: At the previouslylisted EPA Region III address. Such 

deliveries are only accepted during the 

Docket’s normal hours of operation, and 

special arrangements should be made 

for deliveries of boxed information. 

Instructions: Direct your comments to 

Docket ID No. EPA–R03–OAR–2014– 

0522. 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 

electronic docket are listed in the 


tkelley on DSK3SPTVN1PROD with PROPOSALS
49732 Federal Register / Vol. 79, No. 163 / Friday, August 22, 2014 / Proposed Rules 

1For example: Section 110(a)(2)(E)(i) provides 

that states must provide assurances that they have 

adequate legal authority under state and local law 

to carry out the SIP; Section 110(a)(2)(C) provides 

that states must have a SIP-approved program to 

address certain sources as required by part C of title 

I of the CAA; and Section 110(a)(2)(G) provides that 

states must have legal authority to address 

emergencies as well as contingency plans that are 

triggered in the event of such emergencies. 

www.regulations.gov index. 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 either 

electronically in www.regulations.gov or 

in hard copy during normal business 

hours at the Air Protection Division, 

U.S. Environmental Protection Agency, 

Region III, 1650 Arch Street, 

Philadelphia, Pennsylvania 19103. 

Copies of the State submittal are 

available at the Virginia Department of 

Environmental Quality, 629 East Main 

Street, Richmond, Virginia 23219. 

FOR FURTHER INFORMATION CONTACT: 

Ellen Schmitt, (215) 814–5787, or by 

email at schmitt.ellen@epa.gov. 

SUPPLEMENTARY INFORMATION: On June 

23, 2014, the Commonwealth of Virginia 

through the Virginia Department of 

Environmental Quality (VADEQ) 

submitted a revision to the 

Commonwealth’s SIP to satisfy the 

requirements of Section 110(a)(2) of the 

CAA for the 2010 SO2 NAAQS. 

I. Background 

On June 22, 2010, (75 FR 35520), EPA 

promulgated a revised NAAQS for the 1- 

hour primary SO2 at a level of 75 parts 

per billion (ppb), based on a 3-year 

average of the annual 99th percentile of 

1-hour daily maximum concentrations. 

Section 110(a) of the CAA requires 

states to submit SIPs to provide for the 

implementation, maintenance, and 

enforcement of a new or revised 

NAAQS. Specifically, Section 110(a)(1) 

requires states to submit SIPs meeting 

the applicable requirements of Section 

110(a)(2) within three years following 

the promulgation of such NAAQS, or 

within such shorter period as EPA may 

prescribe, and Section 110(a)(2) requires 

states to address specific elements for 

monitoring, basic program requirements 

and legal authority that are designed to 

assure attainment and maintenance of 

the newly established or revised 

NAAQS. The contents of a submission 

may vary depending upon the facts and 

circumstances. In particular, the data 

and analytical tools available at the time 

the state develops and submits the SIP 

for a new or revised NAAQS affects the 

content of the submission. The contents 

of such SIP submissions may also vary 

depending upon what provisions the 

state’s existing SIP already contains. 

II. Summary of SIP Revision 

On June 23, 2014, VADEQ provided a 

SIP revision to satisfy certain Section 

110(a)(2) requirements of the CAA for 

the 2010 SO2 NAAQS. This revision 

addressed the following infrastructure 

elements which EPA is proposing to 

approve: Section 110(a)(2)(A), (B), (C), 

(D)(i)(II) (prevention of significant 

deterioration), (D)(ii), (E)(i), (E)(iii), (F), 

(G), (H), (J) (consultation, public 

notification, and prevention of 

significant deterioration), (K), (L), and 

(M). A detailed summary of EPA’s 

review and rationale for approving 

Virginia’s submittal may be found in the 

Technical Support Document (TSD) for 

this rulemaking action which is 

available on line at 

www.regulations.gov, Docket ID Number 

EPA–R03–OAR–2014–0522. 

This rulemaking action does not 

include any proposed action on Section 

110(a)(2)(I) of the CAA which pertains 

to the nonattainment requirements of 

part D, Title I of the CAA, because 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. This 

rulemaking action also does not include 

proposed action on Section 

110(a)(2)(D)(i)(I) of the CAA because 

Virginia’s submittal did not include a 

submittal for this element; therefore, 

EPA will take later, separate action on 

Section 110(a)(2)(D)(i)(I) for the 2010 

SO2 NAAQS for Virginia. At this time, 

EPA is not proposing action on Section 

110(a)(2)(D)(i)(II) or (J) for visibility 

protection for the 2010 SO2 NAAQS. 

Although Virginia’s infrastructure SIP 

submittal for the 2010 SO2 NAAQS 

referred to Virginia’s regional haze SIP 

for addressing requirements in Section 

110(a)(2)(D)(i)(II) and (J) for visibility 

protection, EPA intends to take separate 

action on Virginia’s submittal for these 

elements at a later date as explained in 

the TSD. Finally, EPA will take later, 

separate action with respect to Section 

110(a)(2)(E)(ii) regarding CAA Section 

128 requirements for State Boards for 

the 2010 SO2 NAAQS. EPA is soliciting 

public comments on the issues 

discussed in this document. These 

comments will be considered before 

taking final action. 

III. EPA’s Approach To Review 

Infrastructure SIPs 

EPA is acting upon the SIP 

submission from Virginia that addresses 

the infrastructure requirements of 

Section 110(a)(1) and (2) of the CAA for 

the 2010 SO2 NAAQS. The requirement 

for states to make a SIP submission of 

this type arises out of Section 110(a)(1). 

Pursuant to Section 110(a)(1), states 

must make SIP submissions ‘‘within 3 

years (or such shorter period as the 

Administrator may prescribe) after the 

promulgation of a national primary 

ambient air quality standard (or any 

revision thereof),’’ and these SIP 

submissions are to provide for the 

‘‘implementation, maintenance, and 

enforcement’’ of such NAAQS. The 

statute directly imposes on states the 

duty to make these SIP submissions, 

and the requirement to make the 

submissions is not conditioned upon 

EPA’s taking any action other than 

promulgating a new or revised NAAQS. 

Section 110(a)(2) includes a list of 

specific elements that ‘‘[e]ach such 

plan’’ submission must address. 

EPA has historically referred to these 

SIP submissions made for the purpose 

of satisfying the requirements of Section 

110(a)(1) and (2) as ‘‘infrastructure SIP’’ 

submissions. Although the term 

‘‘infrastructure SIP’’ does not appear in 

the CAA, EPA uses the term to 

distinguish this particular type of SIP 

submission from submissions that are 

intended to satisfy other SIP 

requirements under the CAA, such as 

‘‘nonattainment SIP’’ or ‘‘attainment 

plan SIP’’ submissions to address the 

nonattainment planning requirements of 

part D of title I of the CAA, ‘‘regional 

haze SIP’’ submissions required by EPA 

rule to address the visibility protection 

requirements of CAA Section 169A, and 

nonattainment new source review 

permit program submissions to address 

the permit requirements of CAA, title I, 

part D. 

Section 110(a)(1) addresses the timing 

and general requirements for 

infrastructure SIP submissions and 

Section 110(a)(2) provides more details 

concerning the required contents of 

these submissions. The list of required 

elements provided in Section 110(a)(2) 

contains a wide variety of disparate 

provisions, some of which pertain to 

required legal authority, some of which 

pertain to required substantive program 

provisions, and some of which pertain 

to requirements for both authority and 

substantive program provisions.1 EPA 

therefore believes that while the timing 

requirement in Section 110(a)(1) is 

unambiguous, some of the other 

statutory provisions are ambiguous. In 

particular, EPA believes that the list of 


tkelley on DSK3SPTVN1PROD with PROPOSALS
Federal Register / Vol. 79, No. 163 / Friday, August 22, 2014 / Proposed Rules 49733 

2See, e.g., ‘‘Rule To Reduce Interstate Transport 

of Fine Particulate Matter and Ozone (Clean Air 

Interstate Rule); Revisions to Acid Rain Program; 

Revisions to the NOX SIP Call; Final Rule,’’ 70 FR 

25162, at 25163–65 (May 12, 2005) (explaining 

relationship between timing requirement of Section 

110(a)(2)(D) versus Section 110(a)(2)(I)). 

3EPA notes that this ambiguity within Section 

110(a)(2) is heightened by the fact that various 

subparts of part D set specific dates for submission 

of certain types of SIP submissions in designated 

nonattainment areas for various pollutants. Note, 

e.g., that Section 182(a)(1) provides specific dates 

for submission of emissions inventories for the 

ozone NAAQS. Some of these specific dates are 

necessarily later than three years after promulgation 

of the new or revised NAAQS. 

4See, e.g., ‘‘Approval and Promulgation of 

Implementation Plans; New Mexico; Revisions to 

the New Source Review (NSR) State 

Implementation Plan (SIP); Prevention of 

Significant Deterioration (PSD) and Nonattainment 

New Source Review (NNSR) Permitting,’’ 78 FR 

4339 (January 22, 2013) (EPA’s final action 

approving the structural PSD elements of the New 

Mexico SIP submitted by the State separately to 

meet the requirements of EPA’s 2008 PM2.5 NSR 

rule), and ‘‘Approval and Promulgation of Air 

Quality Implementation Plans; New Mexico; 

Infrastructure and Interstate Transport 

Requirements for the 2006 PM2.5 NAAQS,’’ 78 FR 

4337 (January 22, 2013) (EPA’s final action on the 

infrastructure SIP for the 2006 PM2.5 NAAQS). 

5On December 14, 2007, the State of Tennessee, 

through the Tennessee Department of Environment 

and Conservation, made a SIP revision to EPA 

demonstrating that the State meets the requirements 

of Sections 110(a)(1) and (2). EPA proposed action 

for infrastructure SIP elements (C) and (J) on 

January 23, 2012 (77 FR 3213) and took final action 

on March 14, 2012 (77 FR 14976). On April 16, 

2012 (77 FR 22533) and July 23, 2012 (77 FR 

42997), EPA took separate proposed and final 

actions on all other Section 110(a)(2) infrastructure 

SIP elements of Tennessee’s December 14, 2007 

submittal. 

6For example, implementation of the 1997 PM2.5

NAAQS required the deployment of a system of 

new monitors to measure ambient levels of that new 

indicator species for the new NAAQS. 

7EPA notes, however, that nothing in the CAA 

requires EPA to provide guidance or to promulgate 

Continued 

required elements for infrastructure SIP 

submissions provided in Section 

110(a)(2) contains ambiguities 

concerning what is required for 

inclusion in an infrastructure SIP 

submission. 

The following examples of 

ambiguities illustrate the need for EPA 

to interpret some Section 110(a)(1) and 

Section 110(a)(2) requirements with 

respect to infrastructure SIP 

submissions for a given new or revised 

NAAQS. One example of ambiguity is 

that Section 110(a)(2) requires that 

‘‘each’’ SIP submission must meet the 

list of requirements therein, while EPA 

has long noted that this literal reading 

of the statute is internally inconsistent 

and would create a conflict with the 

nonattainment provisions in part D of 

title I of the CAA, which specifically 

address nonattainment SIP 

requirements.2 Section 110(a)(2)(I) 

pertains to nonattainment SIP 

requirements and part D addresses 

when attainment plan SIP submissions 

to address nonattainment area 

requirements are due. For example, 

Section 172(b) requires EPA to establish 

a schedule for submission of such plans 

for certain pollutants when the 

Administrator promulgates the 

designation of an area as nonattainment, 

and Section 107(d)(1)(B) allows up to 

two years or in some cases three years, 

for such designations to be 

promulgated.3 This ambiguity illustrates 

that rather than apply all the stated 

requirements of Section 110(a)(2) in a 

strict literal sense, EPA must determine 

which provisions of Section 110(a)(2) 

are applicable for a particular 

infrastructure SIP submission. 

Another example of ambiguity within 

Section 110(a)(1) and (2) with respect to 

infrastructure SIPs pertains to whether 

states must meet all of the infrastructure 

SIP requirements in a single SIP 

submission, and whether EPA must act 

upon such SIP submission in a single 

action. Although Section 110(a)(1) 

directs states to submit ‘‘a plan’’ to meet 

these requirements, EPA interprets the 

CAA to allow states to make multiple 

SIP submissions separately addressing 

infrastructure SIP elements for the same 

NAAQS. If states elect to make such 

multiple SIP submissions to meet the 

infrastructure SIP requirements, EPA 

can elect to act on such submissions 

either individually or in a larger 

combined action.4 Similarly, EPA 

interprets the CAA to allow it to take 

action on the individual parts of one 

larger, comprehensive infrastructure SIP 

submission for a given NAAQS without 

concurrent action on the entire 

submission. For example, EPA has 

sometimes elected to act at different 

times on various elements and subelements of the same infrastructure SIP 

submission.5

Ambiguities within Section 110(a)(1) 

and (2) may also arise with respect to 

infrastructure SIP submission 

requirements for different NAAQS. 

Thus, EPA notes that not every element 

of Section 110(a)(2) would be relevant, 

or as relevant, or relevant in the same 

way, for each new or revised NAAQS. 

The states’ attendant infrastructure SIP 

submissions for each NAAQS therefore 

could be different. For example, the 

monitoring requirements that a state 

might need to meet in its infrastructure 

SIP submission for purposes of Section 

110(a)(2)(B) could be very different for 

different pollutants, for example 

because the content and scope of a 

state’s infrastructure SIP submission to 

meet this element might be very 

different for an entirely new NAAQS 

than for a minor revision to an existing 

NAAQS.6

EPA notes that interpretation of 

Section 110(a)(2) is also necessary when 

EPA reviews other types of SIP 

submissions required under the CAA. 

Therefore, as with infrastructure SIP 

submissions, EPA also has to identify 

and interpret the relevant elements of 

Section 110(a)(2) that logically apply to 

these other types of SIP submissions. 

For example, Section 172(c)(7) requires 

that attainment plan SIP submissions 

required by part D have to meet the 

‘‘applicable requirements’’ of Section 

110(a)(2). Thus, for example, attainment 

plan SIP submissions must meet the 

requirements of Section 110(a)(2)(A) 

regarding enforceable emission limits 

and control measures and Section 

110(a)(2)(E)(i) regarding air agency 

resources and authority. By contrast, it 

is clear that attainment plan SIP 

submissions required by part D would 

not need to meet the portion of Section 

110(a)(2)(C) that pertains to the 

prevention of significant deterioration 

(PSD) program required in part C of title 

I of the CAA, because PSD does not 

apply to a pollutant for which an area 

is designated nonattainment and thus 

subject to part D planning requirements. 

As this example illustrates, each type of 

SIP submission may implicate some 

elements of Section 110(a)(2) but not 

others. 

Given the potential for ambiguity in 

some of the statutory language of 

Section 110(a)(1) and Section 110(a)(2), 

EPA believes that it is appropriate to 

interpret the ambiguous portions of 

Section 110(a)(1) and Section 110(a)(2) 

in the context of acting on a particular 

SIP submission. In other words, EPA 

assumes that Congress could not have 

intended that each and every SIP 

submission, regardless of the NAAQS in 

question or the history of SIP 

development for the relevant pollutant, 

would meet each of the requirements, or 

meet each of them in the same way. 

Therefore, EPA has adopted an 

approach under which it reviews 

infrastructure SIP submissions against 

the list of elements in Section 110(a)(2), 

but only to the extent each element 

applies for that particular NAAQS. 

Historically, EPA has elected to use 

guidance documents to make 

recommendations to states for 

infrastructure SIPs, in some cases 

conveying needed interpretations on 

newly arising issues and in some cases 

conveying interpretations that have 

already been developed and applied to 

individual SIP submissions for 

particular elements.7 EPA most recently 


tkelley on DSK3SPTVN1PROD with PROPOSALS
49734 Federal Register / Vol. 79, No. 163 / Friday, August 22, 2014 / Proposed Rules 

regulations for infrastructure SIP submissions. The 

CAA directly applies to states and requires the 

submission of infrastructure SIP submissions, 

regardless of whether or not EPA provides guidance 

or regulations pertaining to such submissions. EPA 

elects to issue such guidance in order to assist 

states, as appropriate. 

8 ‘‘Guidance on Infrastructure State 

Implementation Plan (SIP) Elements under Clean 

Air Act Sections 110(a)(1) and 110(a)(2),’’ 

Memorandum from Stephen D. Page, September 13, 

2013. 

9EPA’s September 13, 2013, guidance did not 

make recommendations with respect to 

infrastructure SIP submissions to address Section 

110(a)(2)(D)(i)(I). EPA issued the guidance shortly 

after the U.S. Supreme Court agreed to review the 

DC Circuit decision in EME Homer City, 696 F.3d 

7 (D.C. Cir. 2012) which had interpreted the 

requirements of Section 110(a)(2)(D)(i)(I). In light of 

the uncertainty created by ongoing litigation, EPA 

elected not to provide additional guidance on the 

requirements of Section 110(a)(2)(D)(i)(I) at that 

time. As the guidance is neither binding nor 

required by statute, whether EPA elects to provide 

guidance on a particular section has no impact on 

a state’s CAA obligations. 

10By contrast, EPA notes that if a state were to 

include a new provision in an infrastructure SIP 

submission that contained a legal deficiency, such 

as a new exemption for excess emissions during 

SSM events, then EPA would need to evaluate that 

provision for compliance against the rubric of 

applicable CAA requirements in the context of the 

action on the infrastructure SIP. 

issued guidance for infrastructure SIPs 

on September 13, 2013 (2013 

Guidance).8 EPA developed this 

document to provide states with up-todate guidance for infrastructure SIPs for 

any new or revised NAAQS. Within this 

guidance, EPA describes the duty of 

states to make infrastructure SIP 

submissions to meet basic structural SIP 

requirements within three years of 

promulgation of a new or revised 

NAAQS. EPA also made 

recommendations about many specific 

subsections of Section 110(a)(2) that are 

relevant in the context of infrastructure 

SIP submissions.9 The guidance also 

discusses the substantively important 

issues that are germane to certain 

subsections of Section 110(a)(2). 

Significantly, EPA interprets Section 

110(a)(1) and (2) such that infrastructure 

SIP submissions need to address certain 

issues and need not address others. 

Accordingly, EPA reviews each 

infrastructure SIP submission for 

compliance with the applicable 

statutory provisions of Section 110(a)(2), 

as appropriate. 

As an example, Section 

110(a)(2)(E)(ii) is a required element of 

Section 110(a)(2) for infrastructure SIP 

submissions. Under this element, a state 

must meet the substantive requirements 

of Section 128, which pertain to state 

boards that approve permits or 

enforcement orders and heads of 

executive agencies with similar powers. 

Thus, EPA reviews infrastructure SIP 

submissions to ensure that the state’s 

SIP appropriately addresses the 

requirements of Section 110(a)(2)(E)(ii) 

and Section 128. The 2013 Guidance 

explains EPA’s interpretation that there 

may be a variety of ways by which states 

can appropriately address these 

substantive statutory requirements, 

depending on the structure of an 

individual state’s permitting or 

enforcement program (e.g., whether 

permits and enforcement orders are 

approved by a multi-member board or 

by a head of an executive agency). 

However they are addressed by the 

state, the substantive requirements of 

Section 128 are necessarily included in 

EPA’s evaluation of infrastructure SIP 

submissions because Section 

110(a)(2)(E)(ii) explicitly requires that 

the state satisfy the provisions of 

Section 128. 

As another example, EPA’s review of 

infrastructure SIP submissions with 

respect to the PSD program 

requirements in Section 110(a)(2)(C), 

(D)(i)(II), and (J) focuses upon the 

structural PSD program requirements 

contained in part C and EPA’s PSD 

regulations. Structural PSD program 

requirements include provisions 

necessary for the PSD program to 

address all regulated sources and NSR 

pollutants, including Green House 

Gases (GHGs). By contrast, structural 

PSD program requirements do not 

include provisions that are not required 

under EPA’s regulations at 40 CFR 

51.166 but are merely available as an 

option for the state, such as the option 

to provide grandfathering of complete 

permit applications with respect to the 

2013 PM2.5 NAAQS. Accordingly, the 

latter optional provisions are types of 

provisions EPA considers irrelevant in 

the context of an infrastructure SIP 

action. 

For other Section 110(a)(2) elements, 

however, EPA’s review of a state’s 

infrastructure SIP submission focuses 

on assuring that the state’s SIP meets 

basic structural requirements. For 

example, Section 110(a)(2)(C) includes, 

inter alia, the requirement that states 

have a program to regulate minor new 

sources. Thus, EPA evaluates whether 

the state has an EPA-approved minor 

new source review program and 

whether the program addresses the 

pollutants relevant to that NAAQS. In 

the context of acting on an 

infrastructure SIP submission, however, 

EPA does not think it is necessary to 

conduct a review of each and every 

provision of a state’s existing minor 

source program (i.e., already in the 

existing SIP) for compliance with the 

requirements of the CAA and EPA’s 

regulations that pertain to such 

programs. 

With respect to certain other issues, 

EPA does not believe that an action on 

a state’s infrastructure SIP submission is 

necessarily the appropriate type of 

action in which to address possible 

deficiencies in a state’s existing SIP. 

These issues include: (i) Existing 

provisions related to excess emissions 

from sources during periods of startup, 

shutdown, or malfunction that may be 

contrary to the CAA and EPA’s policies 

addressing such excess emissions 

(SSM); (ii) existing provisions related to 

‘‘director’s variance’’ or ‘‘director’s 

discretion’’ that may be contrary to the 

CAA because they purport to allow 

revisions to SIP-approved emissions 

limits while limiting public process or 

not requiring further approval by EPA; 

and (iii) existing provisions for PSD 

programs that may be inconsistent with 

current requirements of EPA’s ‘‘Final 

NSR Improvement Rule,’’ 67 FR 80186 

(December 31, 2002), as amended by 72 

FR 32526 (June 13, 2007) (NSR Reform). 

Thus, EPA believes it may approve an 

infrastructure SIP submission without 

scrutinizing the totality of the existing 

SIP for such potentially deficient 

provisions and may approve the 

submission even if it is aware of such 

existing provisions.10 It is important to 

note that EPA’s approval of a state’s 

infrastructure SIP submission should 

not be construed as explicit or implicit 

re-approval of any existing potentially 

deficient provisions that relate to the 

three specific issues just described. 

EPA’s approach to review of 

infrastructure SIP submissions is to 

identify the CAA requirements that are 

logically applicable to that submission. 

EPA believes that this approach to the 

review of a particular infrastructure SIP 

submission is appropriate, because it 

would not be reasonable to read the 

general requirements of Section 

110(a)(1) and the list of elements in 

Section 110(a)(2) as requiring review of 

each and every provision of a state’s 

existing SIP against all requirements in 

the CAA and EPA regulations merely for 

purposes of assuring that the state in 

question has the basic structural 

elements for a functioning SIP for a new 

or revised NAAQS. Because SIPs have 

grown by accretion over the decades as 

statutory and regulatory requirements 

under the CAA have evolved, they may 

include some outmoded provisions and 

historical artifacts. These provisions, 

while not fully up to date, nevertheless 

may not pose a significant problem for 

the purposes of ‘‘implementation, 

maintenance, and enforcement’’ of a 

new or revised NAAQS when EPA 

evaluates adequacy of the infrastructure 

SIP submission. EPA believes that a 


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11For example, EPA issued a SIP call to Utah to 

address specific existing SIP deficiencies related to 

the treatment of excess emissions during SSM 

events. See ‘‘Finding of Substantial Inadequacy of 

Implementation Plan; Call for Utah State 

Implementation Plan Revisions,’’ 74 FR 21639 

(April 18, 2011). 

12EPA has used this authority to correct errors in 

past actions on SIP submissions related to PSD 

programs. See ‘‘Limitation of Approval of 

Prevention of Significant Deterioration Provisions 

Concerning Greenhouse Gas Emitting-Sources in 

State Implementation Plans; Final Rule,’’ 75 FR 

82536 (December 30, 2010). EPA has previously 

used its authority under CAA Section 110(k)(6) to 

remove numerous other SIP provisions that the 

Agency determined it had approved in error. See, 

e.g., 61 FR 38664 (July 25, 1996) and 62 FR 34641 

(June 27, 1997) (corrections to American Samoa, 

Arizona, California, Hawaii, and Nevada SIPs); 69 

FR 67062, November 16, 2004 (corrections to 

California SIP); and 74 FR 57051 (November 3, 

2009) (corrections to Arizona and Nevada SIPs). 

13See, e.g., EPA’s disapproval of a SIP submission 

from Colorado on the grounds that it would have 

included a director’s discretion provision 

inconsistent with CAA requirements, including 

Section 110(a)(2)(A). See, e.g., 75 FR 42342 at 42344 

(July 21, 2010) (proposed disapproval of director’s 

discretion provisions); 76 FR 4540 (January 26, 

2011) (final disapproval of such provisions). 

better approach is for states and EPA to 

focus attention on those elements of 

Section 110(a)(2) of the CAA most likely 

to warrant a specific SIP revision due to 

the promulgation of a new or revised 

NAAQS or other factors. 

For example, EPA’s 2013 Guidance 

gives simpler recommendations with 

respect to carbon monoxide than other 

NAAQS pollutants to meet the visibility 

requirements of Section 

110(a)(2)(D)(i)(II), because carbon 

monoxide does not affect visibility. As 

a result, an infrastructure SIP 

submission for any future new or 

revised NAAQS for carbon monoxide 

need only state this fact in order to 

address the visibility prong of Section 

110(a)(2)(D)(i)(II). 

Finally, EPA believes that its 

approach with respect to infrastructure 

SIP requirements is based on a 

reasonable reading of Section 110(a)(1) 

and (2) because the CAA provides other 

avenues and mechanisms to address 

specific substantive deficiencies in 

existing SIPs. These other statutory tools 

allow EPA to take appropriately tailored 

action, depending upon the nature and 

severity of the alleged SIP deficiency. 

Section 110(k)(5) authorizes EPA to 

issue a ‘‘SIP call’’ whenever the Agency 

determines that a state’s SIP is 

substantially inadequate to attain or 

maintain the NAAQS, to mitigate 

interstate transport, or to otherwise 

comply with the CAA.11 Section 

110(k)(6) authorizes EPA to correct 

errors in past actions, such as past 

approvals of SIP submissions.12

Significantly, EPA’s determination that 

an action on a state’s infrastructure SIP 

submission is not the appropriate time 

and place to address all potential 

existing SIP deficiencies does not 

preclude EPA’s subsequent reliance on 

provisions in Section 110(a)(2) as part of 

the basis for action to correct those 

deficiencies at a later time. For example, 

although it may not be appropriate to 

require a state to eliminate all existing 

inappropriate director’s discretion 

provisions in the course of acting on an 

infrastructure SIP submission, EPA 

believes that Section 110(a)(2)(A) may 

be among the statutory bases that EPA 

relies upon in the course of addressing 

such deficiency in a subsequent 

action.13

IV. Proposed Action 

EPA is proposing to approve the 

following elements of Virginia’s June 23, 

2014 SIP revision for the 2010 SO2

NAAQS: Section 110(a)(2)(A), (B), (C), 

(D)(i)(II) (prevention of significant 

deterioration), (D)(ii), (E)(i), (E)(iii), (F), 

(G), (H), (J) (consultation, public 

notification, and prevention of 

significant deterioration), (K), (L), and 

(M). Virginia’s SIP revision provides the 

basic program elements specified in 

Section 110(a)(2) necessary to 

implement, maintain, and enforce the 

2010 SO2 NAAQS. This proposed 

rulemaking action does not include 

action on Section 110(a)(2)(I) which 

pertains to the nonattainment planning 

requirements of part D, Title I of the 

CAA, because this element is not 

required to be submitted by the 3-year 

submission deadline of Section 

110(a)(1) of the CAA, and will be 

addressed in a separate process. 

Additionally, EPA will take later, 

separate action on Section 

110(a)(2)(D)(i)(I) (interstate transport of 

emissions), (D)(i)(II) (visibility 

protection), (J) (visibility protection) and 

(E)(ii) (Section 128, ‘‘State Boards’’) for 

the 2010 SO2 NAAQS as discussed 

above and in the TSD. EPA is soliciting 

public comments on the issues 

discussed in this document. These 

comments will be considered before 

taking final action. 

V. General Information Pertaining to 

SIP Submittals From the 

Commonwealth of Virginia 

In 1995, Virginia adopted legislation 

that provides, subject to certain 

conditions, for an environmental 

assessment (audit) ‘‘privilege’’ for 

voluntary compliance evaluations 

performed by a regulated entity. The 

legislation further addresses the relative 

burden of proof for parties either 

asserting the privilege or seeking 

disclosure of documents for which the 

privilege is claimed. Virginia’s 

legislation also provides, subject to 

certain conditions, for a penalty waiver 

for violations of environmental laws 

when a regulated entity discovers such 

violations pursuant to a voluntary 

compliance evaluation and voluntarily 

discloses such violations to the 

Commonwealth and takes prompt and 

appropriate measures to remedy the 

violations. Virginia’s Voluntary 

Environmental Assessment Privilege 

Law, Va. Code Sec. 10.1–1198, provides 

a privilege that protects from disclosure 

documents and information about the 

content of those documents that are the 

product of a voluntary environmental 

assessment. The Privilege Law does not 

extend to documents or information 

that: (1) Are generated or developed 

before the commencement of a 

voluntary environmental assessment; (2) 

are prepared independently of the 

assessment process; (3) demonstrate a 

clear, imminent and substantial danger 

to the public health or environment; or 

(4) are required by law. 

On January 12, 1998, the 

Commonwealth of Virginia Office of the 

Attorney General provided a legal 

opinion that states that the Privilege 

law, Va. Code Sec. 10.1–1198, precludes 

granting a privilege to documents and 

information ‘‘required by law,’’ 

including documents and information 

‘‘required by Federal law to maintain 

program delegation, authorization or 

approval,’’ since Virginia must ‘‘enforce 

Federally authorized environmental 

programs in a manner that is no less 

stringent than their Federal 

counterparts. . .’’ The opinion 

concludes that ‘‘[r]egarding § 10.1–1198, 

therefore, documents or other 

information needed for civil or criminal 

enforcement under one of these 

programs could not be privileged 

because such documents and 

information are essential to pursuing 

enforcement in a manner required by 

Federal law to maintain program 

delegation, authorization or approval.’’ 

Virginia’s Immunity law, Va. Code 

Sec. 10.1–1199, provides that ‘‘[t]o the 

extent consistent with requirements 

imposed by Federal law,’’ any person 

making a voluntary disclosure of 

information to a state agency regarding 

a violation of an environmental statute, 

regulation, permit, or administrative 

order is granted immunity from 

administrative or civil penalty. The 

Attorney General’s January 12, 1998 

opinion states that the quoted language 

renders this statute inapplicable to 

enforcement of any Federally authorized 

programs, since ‘‘no immunity could be 

afforded from administrative, civil, or 

criminal penalties because granting 


tkelley on DSK3SPTVN1PROD with PROPOSALS
49736 Federal Register / Vol. 79, No. 163 / Friday, August 22, 2014 / Proposed Rules 

such immunity would not be consistent 

with Federal law, which is one of the 

criteria for immunity.’’ 

Therefore, EPA has determined that 

Virginia’s Privilege and Immunity 

statutes will not preclude the 

Commonwealth from enforcing its 

program consistent with the Federal 

requirements. In any event, because 

EPA has also determined that a state 

audit privilege and immunity law can 

affect only state enforcement and cannot 

have any impact on Federal 

enforcement authorities, EPA may at 

any time invoke its authority under the 

CAA, including, for example, Sections 

113, 167, 205, 211 or 213, to enforce the 

requirements or prohibitions of the state 

plan, independently of any state 

enforcement effort. In addition, citizen 

enforcement under Section 304 of the 

CAA is likewise unaffected by this, or 

any, state audit privilege or immunity 

law. 

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 proposed 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 (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, this proposed rule, which 

satisfies certain infrastructure 

requirements of Section 110(a)(2) of the 

CAA for the 2010 SO2 NAAQS for the 

Commonwealth of Virginia, 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. 

List of Subjects in 40 CFR Part 52 

Environmental protection, Air 

pollution control, Incorporation by 

reference, Reporting and recordkeeping 

requirements, Sulfur oxides. 

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

Dated: August 5, 2014. 

William C. Early, 

Acting, Regional Administrator, Region III. 

[FR Doc. 2014–20032 Filed 8–21–14; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 52 

[EPA–R04–OAR–2012–0694; FRL–9915–64– 

Region 4] 

Approval and Promulgation of 

Implementation Plans; South Carolina; 

Infrastructure Requirements for the 

2008 8-Hour Ozone National Ambient 

Air Quality Standards 

AGENCY: Environmental Protection 

Agency. 

ACTION: Proposed rule. 

SUMMARY: The Environmental Protection 

Agency (EPA) is proposing to approve 

the July 17, 2012, State Implementation 

Plan (SIP) submission, provided by the 

South Carolina Department of Health 

and Environmental Control (SC DHEC) 

for inclusion into the South Carolina 

SIP. This proposal pertains to the Clean 

Air Act (CAA or the Act) infrastructure 

requirements for the 2008 8-hour ozone 

national ambient air quality standards 

(NAAQS). The CAA requires that each 

state adopt and submit a SIP for the 

implementation, maintenance, and 

enforcement of each NAAQS 

promulgated by EPA, which is 

commonly referred to as an 

‘‘infrastructure’’ SIP. SC DHEC certified 

that the South Carolina SIP contains 

provisions that ensure the 2008 8-hour 

ozone NAAQS is implemented, 

enforced, and maintained in South 

Carolina (hereafter referred to as an 

‘‘infrastructure SIP submission’’). With 

the exception of provisions pertaining to 

prevention of significant deterioration 

(PSD) permitting, interstate transport, 

and visibility protection requirements, 

EPA is proposing to determine that 

South Carolina’s infrastructure SIP 

submission, provided to EPA on July 17, 

2012, addresses the required 

infrastructure elements for the 2008 8- 

hour ozone NAAQS. 

DATES: Written comments must be 

received on or before September 22, 

2014. 

ADDRESSES: Submit your comments, 

identified by Docket ID No. EPA–R04– 

OAR–2012–0694, by one of the 

following methods: 

1. http://www.regulations.gov: Follow 

the on-line instructions for submitting 

comments. 

2. Email: R4–RDS@epa.gov. 

3. Fax: (404) 562–9019. 

4. Mail: ‘‘EPA–R04–OAR–2012– 

0694,’’ Regulatory Development Section, 

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, Regulatory 

Development Section, Air Planning 

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–2012– 

0694. EPA’s policy is that all comments 

received will be included in the public 

docket without change and may be 

made available online at http:// 

www.regulations.gov, including any 

personal information provided, unless 

the comment includes information 


tkelley on DSK3SPTVN1PROD with PROPOSALS