	Information Collection Request 	for Revised Interpretation of Clean Water Act Tribal Provision (Final Interpretive Rule)

	 	 	March 2016

	EPA ICR Number 2515.02                           OMB Control Number 2040-NEW

	U.S. Environmental Protection Agency 	Office of Water/Office of Science and Technology 	1200 Pennsylvania Avenue, NW 	Washington, D.C. 20460

	CONTENTS

	Page

1. IDENTIFICATION OF THE INFORMATION COLLECTION	3 1.1 Title of the Information Collection	3 1.2 Short Characterization/Abstract	3

2. NEED FOR AND USE OF THE COLLECTION	4 2.1 Need and Authority for the Collection	4 2.2 Practical Utility/Users of the Data	4

3. NON-DUPLICATION, CONSULTATIONS, AND OTHER  	COLLECTION CRITERIA	5 3.1 Non-duplication	5 3.2 Public Notice Required Prior to ICR Submission to OMB	5 3.3 Consultations	5 3.4 Effects of Less Frequent Collection	6 3.5 General Guidelines	6 3.6 Confidentiality and Sensitive Questions	6

4. THE RESPONDENTS AND THE INFORMATION REQUESTED	6 4.1 Respondents/NAICS Codes	6 4.2 Information Requested	6 4.3 Respondent Activities	7

5. THE INFORMATION COLLECTED - AGENCY ACTIVITIES, COLLECTION METHODOLOGY, AND INFORMATION MANAGEMENT	7 5.1 Agency Activities	7 5.2 Collection Methodology and Management	8 5.3 Small Entity Flexibility	8 5.4 Collection Schedule	8

6. ESTIMATING THE BURDEN AND COST OF THE COLLECTION	8 6.1 Estimating Respondent Burden	8 6.2 Estimating Respondent Costs	9 6.3 Estimating Agency Burden and Cost	9 6.4 Reasons for Change in Burden	9       6.5 Burden Statement	10

Attachment: Derivation of Burden Estimates	11

1. 	IDENTIFICATION OF THE INFORMATION COLLECTION

1.1 	Title of the Information Collection

The title of this Information Collection Request (ICR) is Revised Interpretation of Clean Water Act Tribal Provision (Final Interpretive Rule).

1.2 	Short Characterization/Abstract

      The U.S. Environmental Protection Agency (EPA) developed this ICR to evaluate how the final interpretive rule, Revised Interpretation of Clean Water Act Tribal Provision, would affect the paperwork burden on tribal applicants.       The reinterpretation streamlines how tribes apply for treatment in a similar manner as a state (TAS) for the water quality standards (WQS) program and other Clean Water Act (CWA) regulatory programs. In the reinterpretation EPA concludes definitively that section 518 includes an express delegation of authority by Congress to eligible Indian tribes to administer regulatory programs over their entire reservations. This reinterpretation eliminates the need for applicant tribes to demonstrate inherent authority to regulate under the CWA, thus allowing tribes to implement the congressional delegation of authority unhindered by requirements not specified in the statute. The reinterpretation reduces the burden on applicant tribes and facilitates tribal involvement in the protection of reservation water quality as intended by Congress.       Based on input from eight tribes with relevant TAS experience, EPA developed burden and cost estimates for the tribes to develop their TAS applications. The results discussed in this ICR show that the reinterpretation would reduce the burden by an estimated 583 staff hours (27%) for a typical tribe, and reduce the cost to a typical tribe for salaries and contractor support by an estimated $70,956 (39%).               These estimates may overstate actual burden because (a) EPA used a liberal estimate of the number of tribal applications, (b) EPA used a simplifying steady-state assumption in estimating annualized costs, and (c) EPA included all costs associated with a TAS application even if some costs might not be strictly information collection costs. EPA and the eight tribes were unable to differentiate the information collection costs consistently and reliably from other costs such as program development costs.        	As described in section 6 and the Appendix, EPA has assumed that all tribal costs and burden associated with the rule are information collection burden. Therefore, EPA has not conducted a separate Economic Analysis.

2. 		NEED FOR AND USE OF THE COLLECTION

2.1 	Need and Authority for the Collection

       In 1987, through the Water Quality Act (P. L. 100-4), Congress made substantial additions to the CWA. The Water Quality Act added section 518 which requires EPA to promulgate regulations specifying how Indian tribes would qualify to administer certain specified CWA programs. EPA published such regulations for CWA regulatory programs from 1991 through 1994 in 40 CFR sections 131.4(c), 131.8, 123.31-34, 223.60-62, and related sections.               The CWA does not require tribes to administer these programs. However, tribes seeking to be authorized must apply for and be found eligible for TAS through the procedures described in the regulations. The information a tribe submits represents a collection of information that is necessary for EPA to fulfill the Agency's responsibilities under CWA section 518(e) in a reasonable and timely manner.

      The statute and regulations specify four criteria for an Indian tribe to qualify to administer a CWA regulatory program: (a) the tribe must be federally recognized, (b) the tribe must have a governing body carrying out substantial governmental duties and powers, (c) the functions to be administered by the tribe pertain to water resources within the borders of an Indian reservation or legal equivalent, and (d) the tribe must be reasonably expected to be capable of carrying out the functions to be exercised consistent with the terms and purposes of the CWA and all applicable regulations.               The regulations cited above specify the information a tribe must submit in order for EPA to review and approve the tribe for TAS. The required information is summarized in section 4.2 below.

2.2 	Practical Utility/Users of the Data

            EPA uses the information supplied by an interested tribe to determine whether it qualifies to administer the CWA program which it seeks. EPA must assess the tribe's information to determine whether the tribe meets the requirements specified in section 518(e) of the CWA and EPA's implementing regulations listed in section 2.1 above.

	If these information collection activities were not carried out, interested and otherwise qualified tribes would be unable to administer CWA regulatory programs, such as WQS, water quality certifications, and the National Pollutant Discharge Elimination System permit program. This would not be consistent with the CWA or federal Indian policy.

3. 	NON-DUPLICATION, CONSULTATIONS, AND OTHER COLLECTION CRITERIA

3.1 	Non-Duplication

      Under EPA's regulations, a tribe must submit a separate TAS application for each program it wishes to administer. To avoid requiring tribes to submit duplicate information, EPA's regulations specify that a tribe need only provide the required information which has not been submitted in a previous application. For example, in evaluating whether a tribe qualifies to administer WQS, EPA does not require a tribe to resubmit information from its previously-approved TAS application under section 106.        3.2 	Public Notice Required Prior to ICR Submission to OMB

      In compliance with the 1995 Paperwork Reduction Act, EPA solicited comments on the January 2015 draft of this ICR for a 60-day period concurrently with the comment period for the proposed rule, Revised Interpretation of Clean Water Act Tribal Provision. No comments were received. This final ICR incorporates minor technical revisions.

3.3 	Consultations

	In developing the interpretive rule, EPA made a substantial effort to involve key stakeholders. In multiple meetings, EPA consulted and coordinated with tribes, states, and organizations representing tribes and states.

      To help develop the burden estimate for this ICR, EPA identified eight tribes that were willing to provide quantitative information about the resources they expended in obtaining approval for TAS to administer the WQS program. The tribes and the year in which their TAS approval occurred are:         Hoopa Valley Tribe (CA) (1996)  Hualapai Indian Tribe (AZ) (2004)  Ute Mountain Ute (CO) (2005)  Navajo Nation (AZ, NM, UT) (2006)  Northern Cheyenne (MT) (2006)  Lac du Flambeau Band of Chippewa (WI) (2008)  Bad River Band of the Lake Superior Tribe of Chippewa Indians of the Bad River Reservation (WI) (2009)  Blackfeet Tribe (MT) (2012)       The tribes provided the resource information in interviews conducted by EPA staff members in the respective regional offices.

3.4 	Effects of Less Frequent Collection

      Application by Indian tribes to obtain TAS to administer a CWA regulatory program is a one-time collection of information per respondent, initiated voluntarily by interested tribes.

3.5 	General Guidelines

      EPA reviewed this ICR for compliance with OMB's information collection guidelines in 5 CFR 1320.5(d)(2)(iv) and concluded it is in compliance.

3.6 	Confidentiality And Sensitive Questions

        Tribal program applications under this ICR will contain no confidential or sensitive information.

4. 	THE RESPONDENTS AND THE INFORMATION REQUESTED

4.1 	Respondents/NAICS Codes              The following describes the universe of potential respondents. The number of annual respondents is estimated in section 6.

      Any federally recognized tribe with a reservation may apply to administer a regulatory program under the CWA, unless prohibited by another federal law. Over 300 tribes have reservation lands. From 1991 through March 2016, over 70 tribes have submitted such an application, all of which are for the WQS program. Of these, EPA has approved TAS for 51 tribes; the remaining applications are in various stages of development.               The respondents affected by this collection activity are in NAICS code 92411 "Administration of Air and Water Resources and Solid Waste Management Programs."  	 4.2 	Information Requested

      EPA's regulations listed in section 2.1 specify the information a tribe must provide in its application to administer a CWA regulatory program. Specifically, an interested tribe must submit:

      (1) A statement that the tribe is recognized by the Secretary of the Interior;

      (2) A descriptive statement demonstrating that the tribal governing body is currently carrying out substantial governmental duties and powers over a defined area;

      (3) A descriptive statement of the Indian tribe's authority to regulate water quality, including a map or legal description of the area over which the Indian tribe asserts       authority; a statement by the tribe's legal counsel (or equivalent official) which describes the basis for the tribe's assertion of authority; a copy of documents that support the tribe's assertion of authority; and an identification of the surface waters for which the tribe proposes to administer the program;.

      (4) A narrative statement describing the capability of the Indian tribe to administer an effective program; and

      (5) Any additional documentation required by the Regional Administrator to support the application.

      Approvals for tribes to administer a CWA regulatory program are valid unless rescinded. Therefore, an interested tribe usually needs to apply only once for a program. Where a tribe has previously qualified for TAS under another program, the tribe need only provide the required information which has not been submitted in a previous application.

4.3 	Respondent Activities

      Respondent activities include reading the regulatory requirements and EPA guidance, obtaining any necessary background understanding, obtaining clarifications from EPA, assembling information required for the application, analyzing the assembled information, analyzing any issues identified by the tribe or EPA, writing the application and transmittal documents, responding to comments from EPA or others, and transmitting the draft and final application to EPA. The activities also include establishing a permanent file of the TAS application that can be referenced when applying for other CWA programs at a later date.               These activities are generally carried out by tribal staff members, with support in some instances from contractors and consultants hired by the tribe.

5. 	THE INFORMATION COLLECTED  -  AGENCY ACTIVITIES, COLLECTION METHODOLOGY, AND INFORMATION MANAGEMENT

5.1 	Agency Activities

      After a tribe submits an application to administer a CWA regulatory program, EPA reviews the application and uses the submitted information to determine whether the tribe meets the criteria under CWA section 518(e) and EPA's regulations to administer the program. Under the regulations, EPA also provides an opportunity for appropriate governmental entities and the public to comment on the application. EPA considers any comments received when it makes a decision concerning the tribe's TAS eligibility.

5.2 	Collection Methodology and Management

      An interested tribe submits its application in hardcopy and/or electronic form to the EPA regional office. EPA has delegated to Regions the responsibility to review and approve tribal TAS eligibility; EPA headquarters must concur on the first application submitted to each Region. Regional office staff members work closely with the tribes in this process. EPA headquarters staff members provide support to the regional offices in the reviews.

5.3 	Small Entity Flexibility              The reporting requirements discussed in this ICR do not place a burden on any small entities.         5.4 	Collection Schedule

      There are no scheduling requirements for Indian tribes to apply for authorization to administer CWA regulatory programs.

6. 	ESTIMATING THE BURDEN AND COST OF THE COLLECTION

6.1 	Estimating Respondent Burden

	In order to develop the burden estimates in this section, EPA assembled and evaluated information collected from eight tribes with experience in developing TAS applications for CWA regulatory programs, as described in section 3.3. EPA's methodology and results are described in detail in Appendix A, Derivation of Burden Estimates.              Pre-rule tribal burden: EPA estimates that a typical tribe expends 2,190 staff hours and $90,000 on contractor costs to develop a TAS application. Based on the past ten years, there have been approximately 4 new tribal TAS applications for CWA regulatory programs per year. Thus the pre-rule baseline burden comprises (4 tribes) * (2,190 hours) = 8,760 staff hours, and (4 tribes) * ($90,000) = $360,000 in contractor costs.        	Post-rule tribal burden: EPA estimates that a typical tribe would expend 1,607 staff hours and $43,920 on contract costs to develop a TAS application pursuant to the reinterpretation. Further, EPA estimates that an average of 6 tribes would for TAS to administer CWA regulatory programs per year, a 50% increase that is expected to continue for the first few years. Thus the post-rule burden would comprise (6 tribes) * (1,607 hours) = 9,642 staff hours and (6 tribes) * ($43,920) = $263,520 in contractor costs. The pace of applications could increase as tribes become more familiar with the new post-rule process.

6.2 	Estimating Respondent Costs

      The above burden estimates have been converted to dollar cost estimates using the following assumption:

      Tribal employee costs were estimated assuming an average hourly salary of $26.67, which is equivalent to the salary of a GS-9, Step 10 federal employee. Overhead costs for tribal employees are expected to be 60 percent, or $16.00 per hour, yielding a total hourly rate of $42.67.

      Pre-rule annual tribal costs: Cost per application = (2,190 hours/application) * ($42.67/hour) + $90,000 contractor costs = $183,447. Total annual cost = (4 tribes) * ($183,447/application) = $733,788.              Post-rule annual tribal costs: Cost per application = (1,607 hours/application) * ($42.67/hour) + $43,920 contractor costs = $112,491. Total annual cost = (6 tribes) * ($112,491/application) = $674,946.

6.3 	Estimating Agency Burden and Cost

      Annual burden and costs to the federal government are detailed below. EPA employee costs were estimated assuming a GS-12 Step 1 federal employee earning $29.76 per hour. Overhead costs for federal employees are expected to be 60 percent, or $17.86 per hour, yielding a total hourly rate of $47.62.               Pre-rule agency burden:  EPA estimates that reviewing a typical application requires approximately 348 agency staff hours from regional and headquarters offices. The pre-rule agency cost is 348 staff hours * $47.62 = $16,572 per application reviewed. Thus the total pre-rule Agency burden is 4 * 348 = 1,392 staff hours or 4 * $16,572 = $66,288.               Post-rule agency burden: EPA estimates that the agency staff burden would reduce by 41% to 205 staff hours or 205 * $47.62 = $9,762 per application reviewed. Thus the total post-rule agency burden would be 6 * 205 = 1,230 staff hours or 6 * $9,762 = $58,572.

      There are no Capital Expenses and no O&M costs associated with this ICR.

6.4 	Reasons for Change in Burden

The programmatic changes associated with the interpretive rule would result in a reduction in total burden and cost to tribes and EPA for developing and processing TAS applications.

6.5 	Burden Statement

      The annual public reporting and recordkeeping burden for this collection of information is estimated to average 1,607 hours plus $43,920 in contract support per response for a typical applicant tribe.               Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information.              An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations are listed in 40 CFR part 9 and 48 CFR chapter 15.              To comment on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including the use of automated collection techniques, EPA has established a public docket for this ICR under Docket ID No. EPA-HQ-OW-2014-0461, which is available for online viewing at http://www.regulations.gov, or in person viewing at the Water Docket in the EPA Docket Center (EPA/DC), EPA West, Room 3334, 1301 Constitution Ave., NW, Washington, DC. The EPA Docket Center Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Reading Room is<PHONE_NUMBER>, and the telephone number for the Water Docket is<PHONE_NUMBER>. An electronic version of the public docket is available online for viewing at http://www.regulations.gov. This site can be used to submit or view public comments, access the index listing of the contents of the public docket, and to access those documents in the public docket that are available electronically. When in the system, select "search," then key in the docket ID number identified above. Also, you can send comments to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street, NW, Washington, DC 20503, Attention: Desk Officer for EPA. Please include the EPA Docket ID (EPA-HQ-OW-2014-0461) and OMB Control Number (2040-NEW) in any correspondence.

                                                                     ATTACHMENT                                                                                Derivation of Burden Estimates                                                                                Methodology              In order to evaluate the burden under this interpretive rule, EPA obtained quantitative resource information from the eight tribes listed in section 3.3 that have experience in applying for TAS for the WQS program. From interviews with tribal staff members, EPA obtained tribal estimates of the staff hours and contractor funds the tribes actually expended in preparing their TAS applications, and an estimate of the portion of this burden that would be eliminated under the rule.              Utility and Limitations              The estimates based on tribal input reflect the best available information. EPA selected the tribes because of their knowledge of the TAS process and willingness to participate. The staff members interviewed were either direct participants or observers at the time the applications were developed. They were knowledgeable about how their tribes demonstrated inherent authority and were able to discern how the level of effort would have differed if such a demonstration had not been required.              The information obtained from the tribes has certain limitations. First, some of the information may lack precision and accuracy because it depends largely on personal recollections of events from 3 to 20 years ago, depending on the tribe.        	Second, in many cases it was difficult to distinguish which tribal efforts represented solely information collection activities  -  that is, "reporting and recordkeeping" as these terms are defined and used under the Paperwork Reduction Act. In many cases, such efforts could not be distinguished from program development costs, program implementation costs, management oversight, or other costs that are not strictly "reporting and recordkeeping."

	Because of this inherent limitation, EPA has chosen to include all costs identified by the tribal staff members as associated with the TAS application as ICR "burden," regardless of whether the costs meet a strict definition of "reporting and recordkeeping." The estimates of burden in this document therefore likely overstate the actual ICR burden by an unknown amount, but provide a reasonable estimate of the total costs. Because of the interview process used, EPA has confidence that the tribes' estimates of the relative proportion of work that the rule would eliminate are fairly accurate.              Finally, the sample of eight tribes is small relative to the number of tribes with approved TAS for the WQS program (51) from which they were drawn, or the total number of tribes with reservations (over 300). As a result, there is inherent variability in the data.               Assumptions for estimates              This analysis assumes that all post-rule applications would be first-time applications for a CWA regulatory program, thus unable to rely on materials from previous applications for different regulatory programs. Therefore, to the extent that some tribes that have applied previously for one CWA regulatory program seek a subsequent approval for a different regulatory program, the post-rule estimates of burden in this document will likely overstate the actual burden.               ICR burdens are stated as annualized burdens. In the analysis below, EPA has used a steady-state assumption to simplify the calculations of annual burden. Specifically, the analysis assumes that the rates of new tribal applications for CWA regulatory programs are steady at the same number from one year to the next. This assumption enables EPA to assume that the entire burden for a tribe occurs within the first year when calculating annual burden rates, even though in reality all applications by the eight participating tribes have required multiple years. This is because in a steady-state situation, assuming all burden occurs within one year is mathematically equivalent to, say, a two-year application process with one-half of the burden occurring in each year, or a three-year process with one-third burden each year. To the extent that the rate of applications rises from year to year (thereby deviating from steady state) and any tribes' application processes take more than one year, the post-rule estimates of burden in this document will likely overstate the actual burden.                       Estimates of total pre-rule burden               Table 1 shows the estimates provided by the tribes for the work done to prepare TAS applications, including providing additional information EPA requested in the course of the application process. Based on this information, EPA estimates that the pre-rule burden for a typical tribe would be 2,190 burden hours and $90,000 of contractor support.              Table 1: Per-tribe burden estimates, pre-rule                                      Tribe                                   Staff hours                               Contractor support                                        A 	1,295 	$90,000                                        B 	1,611 	$102,000                                        C 	1,640 	$10,000                                        D 	2,190 	$8,100                                        E 	3,605 	$96,300                                        F 	9,736 	$90,000                                        G 	12,298 	$2,700                                        H 	20,800 	$270,000 Median* 	2,190 	$90,000       *Excluding Tribe H, considered an outlier because of unique processes used in developing its TAS application.              EPA data for the past 10 years shows that between one and five tribes have been applying for TAS for a CWA regulatory program each year, with a 75[th] percentile of 4.0. EPA chose to use the 75[th] percentile value to ensure the ICR does not underestimate the total burden to tribes. Therefore, EPA's estimate of the pre-rule rate of new applications submitted is four tribes per year, resulting in a total pre-rule burden estimate of 4 x 2,190 = 8,760 total burden hours and 4 x $90,000 = $360,000 contractor support costs.                Estimates of total post-rule burden              Table 2 shows the estimates provided by the tribes for the percentage of the work done to prepare TAS applications that would be eliminated by the interpretive rule. Based on this information, EPA estimates that the effect of the rule would be to reduce tribal staff hours to prepare TAS application by an average of 26.6%, and to reduce contractor support costs by an average of 51.2%.         	Table 2: Percentage of burden eliminated by the interpretive rule                                      Tribe                                % of Staff hours                             % of Contractor support                                        A 	5.5% 	33.3%                                        B 	33.3% 	29.4%                                        C 	15.9% 	32.5%                                        D 	14.7% 	37.1%                                        E 	11.5% 	44.1%                                        F 	15.6% 	33.3%                                        G 	50.0% 	100.0%                                        H 	66.7% 	100.0% Average 	26.6% 	51.2%

	Table 3 shows the estimated post-rule burden per tribe, developed by applying the average percentage reductions in Table 2 to the typical tribal pre-rule burden estimates in Table 1. From this information, EPA estimates the rule would eliminate 583 staff burden hours and $46,080 contractor support costs for the typical tribe applying for TAS for a CWA regulatory program.

	Table 3: Estimated post-rule burden per tribe                                                                           Staff hours                               Contractor support (a) Pre-rule burden estimates (from Table 1) 	2,190 	$90,000 (b) Percentage eliminated by the proposed rule (from Table 2)  	26.6% 	51.2% (c) Amount eliminated by the proposed rule [(a)*(b)] 	583 	$46,080 (d) Post rule burden [(a)  -  (c)] 	1,608 	$43,920

	Also from Table 3, EPA estimates that the post-rule burden to develop TAS applications would be 1,607 staff hours and $43,920 contractor support costs for a typical tribe. This may not necessarily result in a similar reduction in the total annual burden, however, because the lower per-tribe burden could encourage more tribes to apply for TAS than in the past. Taking this into consideration, EPA estimates that in the first three years the proposed rule could increase the rate of new applications from the previous rate of 4 per year to a new rate of approximately 6 per year. Based on these factors, EPA estimates that the total annual post-rule burden for the next few years would comprise (6 tribes) * (1,607 hours) = 9,642 staff hours and (6 tribes) * ($43,920) = $263,520 in contractor costs. After that time, EPA expects the pace of applications could increase as tribes become more familiar with the post-rule process.


[Federal Register Volume 85, Number 136 (Wednesday, July 15, 2020)]
[Notices]
[Pages 42887-42888]
[FR Doc No: 2020-15239]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-D-1401]

Adaptive and Other Innovative Designs for Effectiveness Studies
of New Animal Drugs; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry (GFI) #268 entitled
``Adaptive and Other Innovative Designs for Effectiveness Studies of
New Animal Drugs.'' The draft guidance, if finalized, will describe
FDA's current thinking with respect to assisting sponsors in
incorporating complex adaptive and other novel investigation designs
into proposed clinical investigation protocols and applications for new
animal drugs under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

DATES: Submit either electronic or written comments on the draft
guidance by October 13, 2020 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://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 https://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): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, 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-2020-D-1401 for ``Adaptive and Other Innovative Designs for
Effectiveness Studies of New Animal Drugs.'' Received comments will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday,<PHONE_NUMBER>.
     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 https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. 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: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.

    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the guidance to the
Policy and Regulations Staff (HFV-6), Center for Veterinary Medicine,
Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855.
Send one self-addressed adhesive label to assist that office in
processing your requests. See the SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Susan Storey, Center for Veterinary
Medicine (HFV-131), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of draft GFI #268 entitled
``Adaptive and Other Innovative Designs for Effectiveness Studies of
New Animal Drugs.'' Section 305 of the Animal Drug and Animal Generic
Drug User Fee Amendments of 2018 (Pub. L. 115-234), among other things,
directed FDA to hold a public meeting for interested parties to discuss
innovative animal drug investigation designs and to issue guidance
addressing the incorporation of the use of such elements of
investigations as complex adaptive and other novel investigation
designs, data from foreign countries, real-world evidence (including
ongoing surveillance activities, observational studies, and registry
data), biomarkers, and surrogate endpoints into proposed clinical
investigation protocols and applications for new animal drugs.
    In the Federal Register of July 9, 2019 (84 FR 32749), FDA's Center
for Veterinary Medicine (CVM) published a notice of a public meeting
entitled ``Incorporating Alternative Approaches in Clinical
Investigations for New Animal Drugs'' giving interested persons until
August 17, 2019, to comment on the topics discussed at the public
meeting and the questions published in the meeting notice (84 FR 32749
at 32750-32751).\1\ On August 13, 2019, we published a notice
announcing the extension of the comment period to September 16, 2019
(84 FR 40071). CVM received numerous comments on the topics discussed
at the public meeting and the questions published in the meeting notice
and those comments were considered as the draft GFI #268 entitled
``Adaptive and Other Innovative Designs for Effectiveness Studies of
New Animal Drugs'' was developed.
---------------------------------------------------------------------------

    \1\ https://www.fda.gov/animal-veterinary/workshops-conferences-meetings/public-meeting-incorporating-alternative-approaches-clinical-investigations-new-animal-drugs.
---------------------------------------------------------------------------

    This draft guidance describes principles for designing, conducting,
and reporting the results for investigations or studies, including
adaptive design features, when they are incorporated into clinical
investigations submitted to CVM to demonstrate substantial evidence of
effectiveness for new animal drug applications or a reasonable
expectation of effectiveness for applications for conditional approval
of a new animal drug. It also provides information about how sponsors
may obtain feedback from CVM on technical issues related to the use of
adaptive and innovative designs before the submission of an
application.
    This level 1 draft guidance is being issued consistent with FDA's
good guidance practices regulation (21 CFR 10.115). The draft guidance,
if finalized, will represent the current thinking of FDA regarding the
use of complex adaptive and other novel investigation designs to
support the effectiveness of new animal drugs. It does not establish
any rights for any person and is not binding on FDA or the public. You
can use an alternative approach if it satisfies the requirements of the
applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    FDA tentatively concludes that this draft guidance contains no
collection of information. Therefore, clearance by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act of 1995
(PRA) (44 U.S.C. 3501-3521) is not required.
    However, this draft guidance refers to previously approved FDA
collections of information found in FDA regulations. These collections
of information are subject to review by the OMB under the PRA. The
collections of information in 21 CFR part 514 have been approved under
OMB control number 0910-0032.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at either https://www.fda.gov/animal-veterinary/guidance-regulations/guidance-industry or https://www.regulations.gov.

    Dated: July 9, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-15239 Filed 7-14-20; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 81, Number 91 (Wednesday, May 11, 2016)]
[Proposed Rules]
[Pages 29247-29248]
[FR Doc No: 2016-11119]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF TRANSPORTATION

Pipeline and Hazardous Materials Safety Administration

49 CFR Parts 190, 191, 192, 195, and 199

[Docket No. PHMSA-2016-0032]

Pipeline Safety: Meeting of the Gas Pipeline Safety Advisory
Committee and the Liquid Pipeline Safety Advisory Committee

AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA),
DOT.

ACTION: Notice of advisory committee meeting.

-----------------------------------------------------------------------

SUMMARY: This notice announces a public meeting of the Gas Pipeline
Advisory Committee (GPAC), also known as the Technical Pipeline Safety
Standards Committee, and the Liquid Pipeline Advisory Committee (LPAC),
also known as the Technical Hazardous Liquid Pipeline Safety Standards
Committee. The GPAC will meet to discuss a proposed rulemaking to
address regulatory requirements involving plastic piping systems used
in gas services and both committees will meet jointly to discuss a
proposed rulemaking to strengthen the federal pipeline safety
regulations and to address sections 9 (accident and incident reporting)
and 13 (cost recovery for design-review work) of the Pipeline Safety,
Regulatory Certainty, and Job Creation Act of 2011 (2011 Act). Both
committees will also be briefed on the ``Pipeline Safety: Safety of Gas

Transmission and Gathering Pipelines'' proposed rulemaking.

DATES: The committees will meet as follows:
     Wednesday, June 1, 2016, from 1:00 p.m. to 5:00 p.m., ET--
GPAC only
     Thursday, June 2, 2016, from 8:30 a.m. to 5:00 p.m., ET--
Joint Meeting (GPAC/LPAC)
     Friday, June 3, 2016, from 8:30 a.m. to 12:30 p.m., ET.--
LPAC only
The meetings will not be webcast; however, presentations will be
available on the meeting Web site and posted on the E-Gov Web site:
http://www.regulations.gov under docket number PHMSA-2016-0032 within
30 days following the meeting.

ADDRESSES: The meeting will be held at a location yet to be determined
in the Washington, DC Metropolitan area. The meeting location, agenda
and any additional information will be published on the following
pipeline advisory committee meeting and registration page at https://primis.phmsa.dot.gov/meetings/MtgHome.mtg?mtg=113.

Public Participation

    This meeting will be open to the public. Members of the public who
wish to attend in person are asked to RSVP to<EMAIL_ADDRESS>with your name and affiliation no later than May 23, 2016, in order to
facilitate entry and guarantee seating. Members of the public who
attend in person will also be provided an opportunity to make a
statement during the meeting.
    Services for Individuals with Disabilities: The public meeting is
physically accessible to people with disabilities. Individuals
requiring accommodations, such as sign language interpretation or other
ancillary aids, are asked to notify Cheryl Whetsel at
<EMAIL_ADDRESS>by May 23, 2016.
    Written comments: Persons who wish to submit written comments on
the meeting may be submitted to the docket in the following ways:
    E-Gov Web site: http://www.regulations.gov. This site allows the
public to enter comments on any Federal Register notice issued by any
agency.
    Fax: 1-202-493-2251.
    Mail: Docket Management Facility; U.S. Department of Transportation
(DOT), 1200 New Jersey Avenue SE., West Building, Room W12-140,
Washington, DC 20590-001.
    Hand Delivery: Room W12-140 on the ground level of the DOT West
Building, 1200 New Jersey Avenue SE., Washington, DC, between 9:00 a.m.
and 5:00 p.m., Monday through Friday, except on Federal holidays.
    Instructions: Identify the docket number PHMSA-2016-0032 at the
beginning of your comments. Note that all comments received will be
posted without change to http://www.regulations.gov, including any
personal information provided. You should know that anyone is able to
search the electronic form of all comments received into any of our
dockets by the name of the individual submitting the comment (or
signing the comment, if submitted on behalf of an association,
business, labor union, etc.). Therefore, you may want to review DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000, (65 FR 19477) or view the Privacy Notice at http://www.regulations.gov before submitting any such comments.
    Docket: For access to the docket or to read background documents or
comments, go to http://www.regulations.gov at any time or to Room W12-
140 on the ground level of the DOT West Building, 1200 New Jersey
Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday through
Friday, except Federal holidays.
    If you wish to receive confirmation of receipt of your written
comments, please include a self-addressed, stamped postcard with the
following statement: ``Comments on PHMSA-2016-0032.'' The Docket Clerk
will date stamp the postcard prior to returning it to you via the U.S.
mail. Please note that due to delays in the delivery of U.S. mail to
federal offices in Washington, DC, we recommend that persons consider
an alternative method (Internet, fax, or professional delivery service)
of submitting comments to the docket and ensuring their timely receipt
at DOT.

Privacy Act Statement

    In accordance with 5 U.S.C. 553(c), DOT solicits comments from the
public to better inform its rulemaking process. DOT posts these
comments, without edit, including any personal information the
commenter provides, to www.regulations.gov, as described in the system
of records notice (DOT/ALL-14 FDMS), which can be reviewed at
www.dot.gov/privacy.

FOR FURTHER INFORMATION CONTACT: For information about the meeting,
contact Cheryl Whetsel by phone at<PHONE_NUMBER> or by email at
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Meeting Details and Agenda

    The Pipeline and Hazardous Materials Safety Administration will
hold meetings of the GPAC and LPAC. The GPAC will be considering and
voting on the notice of proposed rulemaking (NPRM) titled: Pipeline
Safety: Plastic Pipe Rule (80 FR 29263; May 21, 2015), and in a joint
meeting of the GPAC and LPAC, members will consider and vote on the
NPRM titled: Pipeline Safety: Operator Qualification, Cost Recovery,
Accident and Incident Notification, and Other Pipeline Safety Proposed
Changes (80 FR 39916; July 10, 2015). Other topics of discussion will
include the regulatory agenda and agency and stakeholder priorities. A
briefing on the NPRM, titled: Pipeline Safety: Safety of Gas
Transmission and Gathering Pipelines (81 FR 20722; April 8, 2016), will
also be presented to both committees and the public.
    The agenda will be published to include committee discussions and
votes on the two rules mentioned above. PHMSA staff will also brief the
committees on several regulatory and policy initiatives.

II. Committee Background

    The GPAC and LPAC are statutorily-mandated advisory committees that
advise PHMSA on proposed safety standards, risk assessments, and safety
policies for natural gas pipelines and for hazardous liquid pipelines.
Both committees were established under the Federal Advisory Committee
Act (Pub. L. 92-463, 5 U.S.C. App. 1) and the Pipeline Safety Law (49
U.S.C. Chap. 601). Each committee consists of 15 members--with
membership evenly divided among the federal and state government, the
regulated industry, and the public. The committees advise PHMSA on the
technical feasibility, practicability, and cost-effectiveness of each
proposed pipeline safety standard.

    Issued in Washington, DC, on May 6, 2016, under authority
delegated in 49 CFR 1.97.
Alan K. Mayberry,
Acting Associate Administrator for Pipeline Safety.
[FR Doc. 2016-11119 Filed 5-10-16; 8:45 am]
 BILLING CODE 4910-60-P


[Federal Register Volume 81, Number 56 (Wednesday, March 23, 2016)]
[Notices]
[Pages 15587-15588]
[FR Doc No: 2016-06455]

-----------------------------------------------------------------------

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-77395; File No. 4-533]

Joint Industry Plan; Order Approving Amendment No. 3 to the
National Market System Plan for the Selection and Reservation of
Securities Symbols Submitted by Financial Industry Regulatory
Authority, Inc., BATS Exchange, Inc., BOX Options Exchange, LLC,
Chicago Board Options Exchange, Incorporated, Chicago Stock Exchange,
Inc., EDGA Exchange, Inc., EDGX Exchange, Inc., International
Securities Exchange, LLC, NASDAQ OMX BX, Inc., NASDAQ OMX PHLX, Inc.,
The Nasdaq Stock Market LLC, National Stock Exchange, Inc., New York
Stock Exchange, LLC, NYSE MKT, LLC, and NYSE Arca, Inc.

March 17, 2016.

I. Introduction

    On August 24, 2015, Financial Industry Regulatory Authority, Inc.
(``FINRA''), on behalf of itself and the following parties to the
National Market System (``NMS'') Plan for the Selection and Reservation
of Securities Symbols (the ``Plan''): BATS Exchange, Inc., BOX Options
Exchange, LLC, Chicago Board Options Exchange, Incorporated, Chicago
Stock Exchange, Inc., EDGA Exchange, Inc., EDGX Exchange, Inc.,
International Securities Exchange, LLC, NASDAQ OMX BX, Inc., NASDAQ OMX
PHLX, Inc., The Nasdaq Stock Market LLC, National Stock Exchange, Inc.,
New York Stock Exchange, LLC, NYSE MKT, LLC, and NYSE Arca, Inc. (each
a ``Party'' and collectively with FINRA, the ``Parties''), filed with
the Securities and Exchange Commission (``Commission''), pursuant to
Section 11A of the Securities Exchange Act of 1934 (``Act'') \1\ and
Rule 608 thereunder,\2\ an amendment (``Amendment No. 3'') to the
Plan.\3\ Amendment No. 3 was published for comment in the Federal
Register on February 18, 2016.\4\ The Commission received no comment
letters on this proposal. This Order approves Amendment No. 3 to the
Plan.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78k-1.
    \2\ 17 CFR 242.608.
    \3\ The Plan is an NMS plan approved by the Commission pursuant
to Section 11A of the Act and Rule 608 thereunder. See Securities
Exchange Act Release No. 58904 (November 6, 2008), 73 FR 67218
(November 13, 2008).
    \4\ See Securities Exchange Act Release No. 77123 (February 11,
2016), 81 FR 8264 (February 18, 2016) (``Amendment No. 3 Notice'').
---------------------------------------------------------------------------

II. Background and Description of the Proposal

A. Background

    The Plan was created to establish a uniform system for the
selection and reservation of securities symbols and sets forth, among
other things, the process for securing perpetual and limited-time
reservations (``List A and List B''), the use of a waiting list, the
right to reuse a symbol, and the ability to request the release of a
symbol. Currently, Section IV(d) of the Plan outlines the procedures
with respect to reuse of a symbol, and requires that in the event a
Party ceases to use a symbol, such symbol will be automatically
reserved by that Party for a period of 24 months, notwithstanding any
other limits on the number of reserved symbols specified in the Plan.
However, in the event that the Party ceasing to use the symbol neither:
(1) Places the symbol on its List A or (2) uses the symbol within 24
months, the symbol will be released for use pursuant to Section
IV(b)(5) (Non-Use or Release of Symbols Within Time Period). In such
instances, the symbol may be reused by a different Party to identify a
new security in accordance with the procedures set forth in the Plan,
but in no event may a symbol be reused to identify a new security if
such use would cause investor confusion in the judgment of the party
seeking to reuse the symbol.

B. Description of the Proposal

    In Amendment No. 3,\5\ the Parties propose to modify the Plan to
revise Section IV(d) to provide that, where a Party ceases to use a
symbol, such party may: (1) Elect to release the symbol, and (2) that
such symbol may not be reused to identify a new security within 90
calendar days from the last day of its use, without the consent of the
Party that released the symbol. In addition, Amendment No. 3 proposes
that a Party may not reuse (or consent to the reuse of) a symbol to
identify a new security unless such Party reasonably determines that
such use would not cause investor confusion.\6\
---------------------------------------------------------------------------

    \5\ See Amendment No. 3 Notice, supra note 4, for a more
detailed description of the proposed changes.
    \6\ In making a reasonable determination as to whether the reuse
of a symbol would cause investor confusion, Parties would consider
factors such as the level of recent activity in the old security,
including trading frequency, volume and the number of market maker
quotes. See Amendment No. 3 Notice, supra note 4, at 5.
---------------------------------------------------------------------------

    Separately, Amendment No. 3 also includes several technical and
ministerial proposed changes to provide current information about the
name and

principal place of business of certain parties to the Plan.

III. Discussion

    After careful review, the Commission finds that Amendment No. 3 is
appropriate in the public interest, for the protection of investors and
the maintenance of fair and orderly markets, and to remove impediments
to, and perfect the mechanisms of, a national market system. By
allowing a Party to elect to release a symbol immediately after its
discontinued use, Amendment No. 3 would encourage the efficient use of
symbols to the benefit of the Parties and potential issuers.
Additionally, the proposed symbol reuse process, which includes a
presumptive 90-day waiting period as well as the requirement that a
Party may not reuse (or consent to the reuse of) a symbol to identify a
new security unless such Party reasonably determines that such use
would not cause investor confusion, would help ensure that the reuse of
symbols would not cause investor confusion. The Commission notes that
the Parties have also stated that the amendment provides for a fair and
orderly approach that would be applied consistently by all Parties to
facilitate investor protection. Finally, the Commission believes that
the proposed technical and ministerial changes should be adopted to
reflect updated Party names and addresses to the Plan.

IV. Conclusion

    For the reasons discussed above, the Commission finds that
Amendment No. 3 is appropriate in the public interest, for the
protection of investors and the maintenance of fair and orderly
markets, and to remove impediments to, and perfect the mechanisms of, a
national market system, or otherwise in furtherance of the purposes of
the Act.
    It is therefore ordered, pursuant to Section 11A of the Act, and
the rules and regulations thereunder, that Amendment No. 3 to the Plan
(File No. 4-553) be, and it hereby is, approved.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\7\
---------------------------------------------------------------------------

    \7\ 17 CFR 200.30-3(a)(29).
---------------------------------------------------------------------------

Robert W. Errett,
Deputy Secretary.
[FR Doc. 2016-06455 Filed 3-22-16; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 86, Number 73 (Monday, April 19, 2021)]
[Notices]
[Page 20395]
[FR Doc No: 2021-07945]

-----------------------------------------------------------------------

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4582-DR; Docket ID FEMA-2021-0001]

Navajo Nation; Amendment No. 2 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: This notice amends the notice of a major disaster declaration
for the Navajo Nation (FEMA-4582-DR), dated February 2, 2021, and
related determinations.

DATES: This amendment was issued February 2, 2021.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Notice is hereby given that, pursuant to the
President's Memorandum to Extend Federal Support to Governors' Use of
the National Guard to Respond to COVID-19 and to Increase Reimbursement
and Other Assistance Provided to States, dated January 21, 2021 and the
President's Memorandum on Maximizing Assistance from the Federal
Emergency Management Agency, dated February 2, 2021 FEMA is amending
the cost-sharing arrangements regarding Federal funds provided under
the authority of the Robert T. Stafford Disaster Relief and Emergency
Assistance Act, 42 U.S.C. 5121-5207 (the ``Stafford Act'') for all of
the COVID-19 emergency and major disaster declarations. FEMA is
amending this declaration as follows:

    Federal funds for emergency protective measures (Category B),
including direct Federal assistance, under the Public Assistance
program (Section 403) are authorized at 100 percent of total
eligible costs for work performed from January 20, 2020 through
September 30, 2021.

(The following Catalog of Federal Domestic Assistance Numbers (CFDA)
are to be used for reporting and drawing funds: 97.030, Community
Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling;
97.033, Disaster Legal Services; 97.034, Disaster Unemployment
Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048,
Disaster Housing Assistance to Individuals and Households In
Presidentially Declared Disaster Areas; 97.049, Presidentially
Declared Disaster Assistance--Disaster Housing Operations for
Individuals and Households; 97.050, Presidentially Declared Disaster
Assistance to Individuals and Households--Other Needs; 97.036,
Disaster Grants--Public Assistance (Presidentially Declared
Disasters); 97.039, Hazard Mitigation Grant.)

Robert J. Fenton,
Senior Official Performing the Duties of the Administrator, Federal
Emergency Management Agency.
[FR Doc. 2021-07945 Filed 4-16-21; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 88, Number 73 (Monday, April 17, 2023)]
[Rules and Regulations]
[Pages 23356-23361]
[FR Doc No: 2023-07615]

-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R03-OAR-2022-0956; FRL-10885-02-R3]

Air Plan Disapproval; West Virginia; Revision to the West
Virginia State Implementation Plan To Add the Startup, Shutdown,
Maintenance Rule 45CSR1--Alternative Emission Limitations During
Startup, Shutdown, and Maintenance Operations

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final action.

-----------------------------------------------------------------------

SUMMARY: The Environmental Protection Agency (EPA) is disapproving a
state implementation plan (SIP) revision submitted by the State of West
Virginia on June 13, 2017. The revision pertains to a new rule setting
forth the requirements to establish, at the discretion of the Secretary
of the West Virginia Department of Environmental Protection, an
alternative emission limitation (AEL) for a source that requests an
AEL. This SIP revision was submitted subsequent to a finding of
substantial inadequacy and SIP call published on June 12, 2015, for
provisions in the West Virginia SIP related to excess emissions during
startup, shutdown, and malfunction (SSM) events. EPA is disapproving
this revision to the West Virginia SIP because it does not comply with
the requirements of the Clean Air Act (CAA). EPA will also be issuing a
finding of failure to submit (FFS) in a separate action, published
elsewhere in this issue of the Federal Register, to address West
Virginia's failure to correct the deficiencies identified in the June
12, 2015, SIP call.

DATES: This final action is effective on May 17, 2023.

ADDRESSES: EPA has established a docket for this action under Docket ID
Number EPA-R03-OAR-2022-0956. All documents in the docket are listed on
the www.regulations.gov website. Although listed in the index, some
information is not publicly available, e.g., confidential business
information (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 through
www.regulations.gov, or please contact the person identified in the FOR
FURTHER INFORMATION CONTACT section for additional availability
information.

FOR FURTHER INFORMATION CONTACT: Serena Nichols, Planning &
Implementation Branch (3AD30), Air & Radiation Division, U.S.
Environmental Protection Agency, Region III, 1600 John F. Kennedy
Boulevard, Philadelphia, Pennsylvania 19103. The telephone number is
(215) 814-2053. Ms. Nichols can also be reached via electronic mail at
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    On June 12, 2015, pursuant to CAA section 110(k)(5), the EPA
finalized ``State Implementation Plans: Response to Petition for
Rulemaking; Restatement and Update of EPA's SSM Policy Applicable to
SIPs; Findings of Substantial Inadequacy; and SIP Calls to Amend
Provisions Applying to Excess Emissions During Periods of Startup,
Shutdown and Malfunction,'' \1\ hereafter referred to as the ``2015 SSM
SIP Action.'' The 2015 SSM SIP Action clarified, restated, and updated
the EPA's interpretation that SSM exemptions (whether automatic or
discretionary) and affirmative defense SIP provisions are inconsistent
with CAA requirements. The 2015 SSM SIP Action found that certain SIP
provisions in 36 states were substantially inadequate to meet CAA
requirements and issued a SIP call to those states to submit SIP
revisions to address the inadequacies. EPA established an 18-month
deadline by which the affected states had to submit such SIP revisions.
States were required to submit corrective revisions to their SIPs in
response to the SIP calls by November 22, 2016. With respect to the
West Virginia SIP, in the 2015 SSM SIP Action, EPA determined that 14
provisions were substantially inadequate to meet CAA requirements.
---------------------------------------------------------------------------

    \1\ 80 FR 33839, June 12, 2015.
---------------------------------------------------------------------------

    On June 13, 2017, West Virginia submitted a SIP revision requesting
the approval of a new state rule into the West Virginia SIP that sets
forth the requirements to establish an AEL for a source that may
require an AEL. The new West Virginia regulation, found at 45 Code of
State Rules (CSR) 1, is referred to as ``Rule 1'' in West Virginia's
SIP submission, and will be referred to the same way here.
    On December 22, 2022, EPA published a notice of proposed rulemaking
(NPRM) related to West Virginia's June 13, 2017 submittal.\2\ In that
document, EPA proposed disapproval of West Virginia's submittal for
multiple reasons. These reasons included: (1) the SIP revision did not
remove any of the existing West Virginia SSM exemptions identified as
substantially inadequate in the 2015 SSM SIP Action; (2) the new AEL
regulations did not specify that any AELs granted by the state would be
submitted to EPA as SIP revisions; (3) the AEL regulations allowed
sources to request AELs on a case-by-case basis, rather than adopting
AELs for a narrow category of sources with similar characteristics and
controls; (4) the AEL regulations did not allow for AELs for
malfunctions; and (5) sources subject to the new source performance
standard (NSPS) or national emission standard for hazardous air
pollutants (NESHAPS) with startup and shutdown provisions could not
obtain AELs and instead had to comply with the startup or shutdown
standards in the applicable NSPS and/or NESHAP. A more complete
explanation of the reasons for the proposed disapproval can be found in
the December 22, 2022 NPRM.
---------------------------------------------------------------------------

    \2\ 87 FR 78617, December 22, 2022.
---------------------------------------------------------------------------

    In response to the NPRM, West Virginia submitted comments claiming
that EPA failed to understand that the SIP revision allowing for AELs
was only a first step in responding to the 2015 SSM SIP Action, and
that therefore the AEL SIP revision should be judged solely on its own
approvability under the Clean Air Act. Given this new information,
which was not clearly stated in the documents included in the AEL SIP
revision package, EPA is now assessing this AEL SIP revision
independently of the state SIP provisions identified as the basis for
West Virginia's inclusion in the 2015 SSM SIP Action. That is, EPA has
reviewed the SIP submission solely on the basis of whether it meets the
requirements of the Clean Air Act, rather than assessing whether it
also addresses the deficiencies cited in the 2015 SSM SIP Action.
However, when reviewed solely on this basis, and as discussed in
response to West Virginia's comments below, the AEL SIP revision is not
approvable as a SIP revision under section 110 of the CAA. In addition,
based on West Virginia's clarification, EPA is also taking a separate
action, published elsewhere in this issue of the Federal Register,
making a FFS for West Virginia's failure to submit any SIP revision
addressing the 14 State regulatory provisions identified in the 2015
SSM SIP Action.

II. EPA's Response to Comments Received

    EPA received two sets of comments on the December 22, 2022 NPRM.
The full text of the comments is in the

docket for this action. A summary of the comments and EPA's responses
are provided herein.

A. Summary of Comments From the Sierra Club and the Environmental
Integrity Project.

    Comment: These commenters agree with EPA's proposed disapproval of
West Virginia's SSM SIP submittal, and offer three major reasons why
EPA should disapprove West Virginia's SIP submission: (1) West
Virginia's SIP call response did not remove the unlawful SSM SIP
provisions, (2) West Virginia's proposed AEL rule would unilaterally
amend its SIPs through permits without undergoing the SIP revision
process, and (3) West Virginia's proposed AEL rule does not comply with
the CAA and the SSM SIP call guidance on AELs. As a result, these
commenters urge EPA to propose a FIP to remove the unlawful SSM SIP
provisions.
    Response: The first three points raised by this commenter are
similar to reasons EPA cited for proposing to disapprove West
Virginia's SIP revision. In response to the request that EPA promulgate
a FIP if West Virginia does not promptly submit a SIP revision
addressing this disapproval, EPA notes that the states are not required
to adopt and submit to EPA SIP revisions creating AELs for periods of
SSM. States may choose to remove SSM exemptions, director's discretion
provisions, and affirmative defense provisions and not provide
alternative limits for periods of SSM. Thus, following this
disapproval, West Virginia could choose to not create new AEL
regulations and submit those as a SIP revision, and instead rely upon
their enforcement discretion should a source exceed an emission limit
which is part of the EPA-approved SIP. In a separate action, published
elsewhere in this issue of the Federal Register, EPA is issuing an FFS
for West Virginia's failure to address the issues cited in the 2015 SSM
SIP Action, and that FFS will provide deadlines, in accordance with CAA
sections 110(c) and 179(a).

B. Summary of Comments From the West Virginia Department of
Environmental Protection (WVDEP).

    WVDEP objects to the proposed disapproval for multiple reasons,
with the most important being that the SIP submittal was not intended
to be a full remedy to the 2015 SSM SIP call. West Virginia also claims
that EPA's lack of communication with West Virginia deprived the State
of an opportunity to remedy the issues cited in the disapproval prior
to the proposed disapproval. In addition, West Virginia also requests
that EPA not take final action on this SIP revision until a decision is
issued by the U.S. Court of Appeals for the D.C. Circuit in a lawsuit
challenging EPA's SIP call. West Virginia's concerns are set forth with
more specificity below.
    Comment: West Virginia asks that EPA delay final action on this SIP
submission until the United States Court of Appeals for the D.C.
Circuit issues its ruling on the lawsuits seeking to challenge EPA's
issuance of the 2015 SSM SIP Action.\3\
---------------------------------------------------------------------------

    \3\ Environ. Comm. Fl. Elec. Power v. EPA, et al, No. 15-1239
(D.C. Cir.) (and consolidated cases).
---------------------------------------------------------------------------

    Response: EPA is under a court-ordered deadline to take final
action on West Virginia's AEL SIP submittal.\4\ Given this deadline,
EPA cannot wait to take final action on West Virginia's AEL SIP
submittal until the D.C. Circuit rules on the lawsuits challenging the
2015 SSM SIP Call. The judicial consent decree requires EPA to take
final action on the West Virginia AEL SIP submittal within 240 days of
the Court's entry of the final decree. Public notice and opportunity to
comment upon this consent decree was published on April 11, 2022. No
comments were received from West Virginia. The consent decree was
entered on June 27, 2022, and as such the 240-day deadline for taking
final action was February 22, 2023, but was extended to April 12, 2023
by court order.
---------------------------------------------------------------------------

    \4\ Sierra Club, et. al., v. Michael S. Regan, Case No. 4:21-cv-
6956-SBA (N.D. Ca., Sept. 8, 2021).
---------------------------------------------------------------------------

    Even if there were not a court-ordered deadline for EPA to take
action, it would not be appropriate or necessary to wait until the D.C.
Circuit rules on the lawsuits challenging the 2015 SSM SIP Call. EPA's
disapproval of West Virginia's AEL SIP submission is based on other CAA
legal deficiencies that are unrelated to the deficiencies and Agency
policies underlying the 2015 SSM SIP Call (for example, the fact that
West Virginia's submission would allow for changes to West Virginia's
SIP without appropriate procedures), and thus are irrelevant to the
D.C. Circuit's eventual decision.
    Comment: West Virginia states that the only purpose of the 2017
West Virginia SIP revision was to add Rule 1 into the West Virginia
SIP, and that nothing in the 2017 SIP revision states that the revision
was intended to be a complete response to the 2015 SSM SIP Action. West
Virginia further states that it was considering revising or removing
requirements identified in the 2015 SSM SIP Action through subsequent
legislative rulemaking after sources had a SIP-approved mechanism to
obtain AELs, but that EPA's failure to take timely action on the 2017
SIP revision prevented West Virginia from doing so. Therefore, West
Virginia argues that this SIP revision should have been evaluated on
its own merits, and EPA's reliance on West Virginia's failure to remove
the provisions allowing exemptions from emission limits during SSM
events cited in the 2015 SSM SIP Call is irrelevant.
    Response: EPA notes that West Virginia's 2017 SIP submission did
not specifically state that it was only a first step in addressing the
2015 SSM SIP Call. EPA reviewed the SIP submission and found that, in
response to a comment submitted by the Sierra Club, West Virginia
stated that ``Division of Air Quality (DAQ) intends to propose removal
of the provisions identified in the SSM SIP Call after 45 CSR1 is
effective.'' West Virginia's own comments do not cite to this statement
in its SIP submission. In the absence of a specific statement directed
to EPA in the SIP submittal noting that this was DAQ's plan, it is easy
to see how EPA misunderstood DAQ's intent.
    In response to this clarification by West Virginia, EPA is no
longer identifying the AEL submission's failure to fully address the
SIP call as a basis for its disapproval. Instead, in a separate action
published elsewhere in the ``Rules'' section of this issue of the
Federal Register, EPA is issuing a FFS for West Virginia's failure to
submit SIP revisions addressing the other deficiencies identified in
the 2015 SSM SIP Action.\5\ The reasons for issuing a FFS will be
discussed in that separate action and therefore are not discussed here.
---------------------------------------------------------------------------

    \5\ See Docket ID No. EPA-R03-OAR-2023-0179.
---------------------------------------------------------------------------

    Regarding West Virginia's claim that it was hampered by a lack of
communication from EPA, the Region and Agency has publicly recognized
that there were changes to the Agency's SSM policy in 2020 and 2021 \6\
which could have caused confusion and delay in the submission of SIP
revisions. However, the policy changes occurred well after the November
2016 deadline for submitting SIP revisions set by the 2015 SSM SIP
Call, which is still in place, and was never lifted. Indeed, the 2020
Memorandum specifically noted that it ``[did] not alter in any way the
determinations made in the 2015 SSM SIP Action that identified specific
state

SIP provisions that were substantially inadequate to meet the
requirements of the Act.'' \7\
---------------------------------------------------------------------------

    \6\ October 9, 2020, Memorandum ``Inclusion of Provisions
Governing Periods of Startup, Shutdown, and Malfunctions in State
Implementation Plans,'' from Andrew R. Wheeler, Administrator.
September 30, 2021; Memorandum ``Withdrawal of the October 9, 2020,
Memorandum Addressing Startup, Shutdown, and Malfunctions in State
Implementation Plans and Implementation of the Prior Policy,'' from
Janet McCabe, Deputy Administrator.
    \7\ October 9, 2020 Memorandum at 3.
---------------------------------------------------------------------------

    Finally, based on EPA's new understanding of West Virginia's
intention in submitting the AEL SIP revision, EPA has analyzed the 2017
AEL SIP revision on its own merits, but nevertheless finds that the AEL
SIP revision is not approvable for two reasons that are independent of
the 2015 SSM SIP Action. First, as noted in the NPRM, the AEL SIP
revision cannot be approved because it does not specify that any AEL
granted by West Virginia must be submitted to EPA as a SIP revision for
approval. Instead, West Virginia's comments note that the submitted AEL
regulations require that any AEL granted by West Virginia must be
incorporated into a permit under West Virginia Rule 13, Rule 14, or
Rule 19, and that each of these permitting programs are approved by EPA
as part of the SIP. West Virginia cites to its original response to
EPA's 2016 comments when Rule 1 was proposed at the State level:

    These permitting rules are all SIP approved and are an integral
part of the State air program designed to address compliance with
the NAAQS [National Ambient Air Quality Standard]. By virtue of
their SIP approval, it is immaterial whether an AEL is directly
approved into the SIP because it will be embodied in a permit under
a SIP approved program and is therefore fully federally enforceable.

    West Virginia's comment does not address the most important element
of EPA's concern, which is that these regulations creating AELs do not
require that the AELs, when issued, be submitted to EPA for approval as
a SIP revision. While inclusion of the AEL limits in a permit issued
under an EPA-approved permitting program in the SIP does make the limit
federally enforceable, it does not provide a SIP mechanism for assuring
that SIP limits would not be changed without first going through the
CAA's SIP revision process. To the contrary, it creates a non-SIP
mechanism for amending the SIP by creating alternatives to it. It also
creates the potential for confusion because the associated AEL would
not be contained in the SIP with the SIP limits that it amends, and it
allows for the possibility of non-SIP AELs that conflict with the SIP
limits. Moreover, it does so without opportunity for EPA review or
disapproval where the AEL fails to meet CAA requirements. Any AEL which
revises a limit that is EPA-approved as part of the West Virginia SIP
must go through the process of being submitted as a SIP revision in
accordance with CAA section 110. EPA's SIP call makes clear that AELs
that modify SIP-approved emissions limitations, whether adopted on a
case-by-case basis or as an AEL generally applicable to a narrow
category of similar sources, must be presented to EPA for approval as a
SIP revision, and go through the SIP revision process. This is because
the AELs at issue here would be changes to a state emission regulation
adopted as part of the state's SIP to implement the CAA, and as such
must be approved as a SIP revision by EPA. States cannot unilaterally
make changes to SIP-approved emission limits without the requirements
of CAA section 110 being met, including a public comment process and
EPA approval.
    EPA specifically addressed this concern in the 2015 SSM SIP Action,
at 80 FR 33918, June 12, 2015:

    Pursuant to the EPA's own responsibilities under sections
110(k)(3), 110(l) and 193 . . ., it would be inappropriate for the
Agency to approve a SIP provision that automatically preauthorized
the state unilaterally to revise the SIP emission limitation without
meeting the applicable procedural and substantive statutory
requirements for a SIP revision.
    The 2015 SSM SIP Action also stated--
    It is a fundamental tenet of the CAA that states cannot
unilaterally change SIP provisions, including the emission
limitations within SIP provisions, without the EPA's approval of the
change through the appropriate process.

Thus, the fact that an AEL must be incorporated into a permit that is
part of the EPA-approved West Virginia SIP does not do away with this
requirement that the AEL be submitted as a SIP revision and go through
the SIP revision process.
    The second reason for disapproving the AEL SIP submission which is
unrelated to the deficiencies in the 2015 SSM SIP Action is that the
AEL prohibits a source from obtaining an AEL if that source is subject
to a CAA section 111 Federal new source performance standard (NSPS)
and/or a national emission standard for hazardous air pollutants
(NESHAP) under section 112, and that NSPS or NESHAP has a startup or
shutdown provision. The regulation at 45CSR1-1.5.b specifically states
that persons subject to NSPS in 45CSR16 or to NESHAPS in 45CSR34
``shall meet the applicable startup and shutdown provisions of the
applicable Federal rule and are not eligible for an alternative
emission limit under this rule for affected sources.'' As EPA explained
in the 2015 SSM SIP Action and in the NPRM for this action, those NSPS
and NESHAPS adopted before 2008 but not yet updated may contain
problematic exemptions for startups and shutdowns that have not yet
been corrected to comply with the 2008 Sierra Club v. Johnson
decision.\8\ West Virginia's 45CSR1-1-5.b does not distinguish between
the updated standards and not-yet-updated standards. For those not-yet-
updated, the Agency cannot approve as a SIP revision a regulation that
allows these NSPS and/or NESHAP-related SSM provisions to continue to
exist in State-issued permits, nor can it approve a blanket provision
preventing the State from issuing or revising permits to address the
problematic provisions.\9\ In addition, West Virginia's blanket rule
requiring sources to follow applicable NSPS or NESHAP startup and
shutdown provisions assumes that emission limitation requirements in
recent NESHAP and NSPS are appropriate for all pollutants and sources
regulated by the SIP. That is, the NSPS or NESHAP may not be designed
to address the excess emission of NAAQS pollutants, which the SIPs seek
to control, and as such may not adequately address excess emission of
NAAQS pollutants during startup or shutdown. West Virginia's regulation
assumes, without support, that NSPS and/or NESHAP startup and shutdown
provisions are directed at controlling emissions of NAAQS pollutants,
which may not be the case. Thus, a source's compliance with an NSPS or
NESHAP startup or shutdown provision is not guaranteed to address
excessive emissions of NAAQS pollutants or precursors. Therefore, the
particular emissions limitation which any particular NSPS or NESHAP
adopts for a startup or shutdown event as part of a continuously
applicable emission limitation would still need to be evaluated on a
case-by-case basis as to their applicability and appropriateness as
AELs for SIP purposes.
---------------------------------------------------------------------------

    \8\ 87 FR 78617, at 78620, December 22, 2022.
    \9\ Id.
---------------------------------------------------------------------------

    Comment: Rule 1 does not establish limits for sources. West
Virginia objects to EPA citing as one reason for the disapproval the
fact that the SIP submittal setting AEL requirements did not address
those provisions of West Virginia's regulations granting sources an
automatic or discretionary exemption during SSM events that were
specifically cited by EPA in the 2015 SSM SIP Action. West Virginia
notes that states are allowed some discretion in how they establish
programs to meet CAA requirements, and they chose to adopt the guidance
and codify the requirements for sources to establish AELs. West
Virginia also seems to

believe that EPA's comments ``suggest that West Virginia should have
conducted a detailed technical analysis for each distinct category of
sources . . .''.
    Response: As noted above, in response to West Virginia's claim that
the AEL SIP revision was not intended to address all of the
deficiencies cited in the 2015 SSM SIP Action, EPA is evaluating the
AEL SIP submission solely as to whether it meets the requirements for
approvability under the CAA, without regard to whether it addresses all
the 2015 SSM SIP Action deficiencies. Thus, whether the AEL SIP
submission addresses all the SIP Action deficiencies is no longer
relevant to this action.
    Regarding the claim that EPA's proposal suggests that West Virginia
should have conducted an analysis for each distinct category of
sources, EPA believes that West Virginia is misinterpreting the
discussion in the proposed disapproval at 87 FR 78620 (87 FR 78617,
December 22, 2022). That discussion points out that some NSPS and
NESHAP regulate pollutants other than criteria pollutants. Therefore,
controls, operational standards and other measures in those regulations
that are meant to address non-criteria pollutants may not work for
criteria pollutants. As such, reliance by a state on the NSPS or NESHAP
control requirements may not address the emission of pollutants
regulated by a state's SIP.
    Comment: WVDEP did not and does not now consider it necessary to
require all sources to apply for an AEL, nor is it necessary for the
DEP to conduct a detailed analysis to review every permit for every
source to make that determination.
    Response: EPA agrees that it may not be necessary for all sources
to apply for an AEL. However, the EPA statement quoted in West
Virginia's comments does not say or imply that every source must apply
for an AEL. As noted above, EPA also did not state that West Virginia
must conduct a detailed analysis of every permit for every source.
    Comment: The WVDEP disagrees with the EPA's concern regarding the
first of the seven criteria set forth in the 2015 SSM SIP Action
because the criterion for narrowly defined source categories using
specific control strategies is embodied in the West Virginia case-by-
case approach codified in Rule 1. WVDEP argues that the EPA has been
unable to define alternatives for narrowly defined source categories in
the almost eight years since it finalized the 2015 SSM SIP Call and
objects to EPA's expectation that the states do the same in a much
shorter time frame and without EPA assistance.
    Response: EPA agrees that West Virginia's case-by-case approach to
AELs embodies the idea of granting AELs narrowly to specific types of
sources using specific controls. However, EPA continues to believe that
the case-by-case approach could prove to be a resource-intensive
endeavor for WVDEP. As such, EPA reiterates that West Virginia could
meet the requirements of the 2015 SSM SIP Action by removing the cited
SSM exemptions from its SIP. There is no requirement that West Virginia
adopt an AEL regulation to address the SIP call. This approach would
avoid West Virginia having to undertake the potentially difficult task
of creating AELs. If West Virginia nevertheless decides to proceed with
a case-by-case AEL approach, the important point is that the regulation
allowing for AELs must make it clear that each AEL must be submitted as
a SIP revision to EPA for approval in accordance with section 110 of
the CAA. In addition, as EPA explained in the proposed disapproval,
West Virginia's case-by-case approach could lead to inconsistent
alternative limits for sources that, based on similar operating
characteristics, fuels, and other similar traits, should have similar
AELs, and makes it difficult to consider any cumulative impact of
source-specific emission limitations on West Virginia's air quality.
Moreover, consistent with the court decision in Sierra Club v. EPA, 551
F.3d 1019 (D.C. Cir. (2008)) and provisions set forth in CAA section
302(k), EPA is revising NESHAP and NSPS regulations, which generally
apply to defined source categories and require specific emission
controls or other standards, as they come up for statutorily required
review to eliminate SSM exemptions and ensure that standards apply at
all times.
    Comment: The fact that malfunctions are not included in the scope
of 45CSR1 is not a reason for the SIP to be disapproved.
    Response: EPA agrees. In the NPRM, EPA specifically points out that
states are not required to establish an AEL for malfunction.\10\
---------------------------------------------------------------------------

    \10\ 87 FR 78620, December 22, 2022.
---------------------------------------------------------------------------

    Comment: WVDEP does not agree that an AEL developed by the EPA
under the NESHAP program for an overlapping source category would not
be relevant for sources covered by Rule 1. The WVDEP is confused by the
EPA's argument that West Virginia should rely on a case-by-case
analysis regarding the use of alternative limits allowed under a
particular NSPS or NESHAP, which contradicts EPA's previous concern
regarding WVDEP use of case-by-case analysis under Rule 1.
    Response: EPA has reviewed the NPRM and cannot identify an EPA
statement suggesting that an AEL developed by EPA under the NESHAP
program for an overlapping source category \11\ would not be relevant
for sources seeking an AEL under Rule 1. EPA believes that West
Virginia is conflating EPA's concern that existing SSM exemptions in
NESHAPS should not be relied upon with EPA's other expressed concern
that NESHAPS may not be focused on addressing criteria pollutants (or
criteria pollutant pre-cursors), so reliance on limits in such NESHAP
limits addressing periods of SSM for these other pollutants may not
control certain criteria pollutants, which are the focus of SIPs. The
discussion of these issues, at 87 FR 78620 of EPA's NPRM, was in the
context of 45CSR1-1-5.b, which states that sources subject to NSPS, as
incorporated into 45CSR16, and NESHAPS, as incorporated into 45CSR34,
shall follow any startup or shutdown provisions set forth in an
applicable NSPS and/or NESHAP and is not eligible for an AEL. EPA has
been clear that state reliance on NSPS or NESHAPs with ``legacy'' SSM
exemptions is not an acceptable alternative to the removal of the
specific SSM provisions cited in the 2015 SSM SIP Call. EPA is
separately working to remove these SSM exemptions, and if EPA develops
AELs for emissions of certain NAAQS pollutants when removing these SSM
provisions from NSPS and NESHAPS, those AELs may be relevant for
purposes of the state if it elects to set an AEL for the same NAAQS
pollutants when removing SSM provisions from its SIP. If EPA has not
yet removed such SSM exemption, the state may, in conjunction with
removing its SIP-based SSM exemption, elect to establish an AEL. If so,
it would need to perform a ``case-by-case'' analysis of the particular
source category at issue to determine what would constitute an
appropriate AEL. EPA also notes, again, that West Virginia could
resolve the CAA violations detailed in the 2015 SSM SIP Call without
implementing any AELs, but simply by removing the violating provisions
from the State's SIP.
---------------------------------------------------------------------------

    \11\ EPA interprets ``overlapping source category'' as a source
category currently granted an SSM exemption by state regulations
which is also regulated as a NESHAP source category.
---------------------------------------------------------------------------

    Comment: At multiple places, West Virginia notes that EPA did not
comment on certain issues when it

submitted comments to the state during the 2016 public comment period.
    Response: EPA's relevant comments, dated July 28, 2016, addressed
seven submitted West Virginia proposed air quality rules, including
Rule 1. These rules were submitted by WVDEP to EPA on or about June 29,
2016. At that time, EPA identified four issues, one being an issue
cited in this disapproval, that the AEL limitations must be submitted
for EPA approval into West Virginia's SIP for SIP compliance purposes.
EPA's failure to identify all of its concerns with Rule 1 at that time
is not a waiver of its responsibility to do so now, and EPA notes that
it must also address comments submitted by commenters in response to
EPA's NPRM. Commenter Sierra Club has identified many of the same
issues with Rule 1 as EPA, so even if EPA had not raised these issues
in the NPRM, the issues would need to be addressed.

III. Final Action

    EPA is disapproving West Virginia's June 13, 2017 submittal as a
revision to the West Virginia SIP.

IV. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, the EPA's role is to review state choices,
and approve those choices if they meet the minimum criteria of the Act.
Accordingly, this final action disapproving West Virginia's new rule
related to AELs as a SIP revision merely ascertains that this State law
does not meets Federal requirements and therefore does not impose
additional requirements beyond those imposed by State law.
    Additional information about these statutes and Executive orders
can be found at www.epa.gov/laws-regulations/laws-and-executive-orders.

A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulation and Regulatory Review

    This action is not a significant regulatory action and was
therefore not submitted to the Office of Management and Budget (OMB)
for review.

B. Paperwork Reduction Act (PRA)

    This action does not impose an information collection burden under
the PRA, because this SIP disapproval does not in-and-of itself create
any new information collection burdens, but simply disapproves certain
State requirements for inclusion in the SIP.

C. Regulatory Flexibility Act (RFA)

    I certify that this action will not have a significant economic
impact on a substantial number of small entities under the RFA. This
action will not impose any requirements on small entities. This SIP
disapproval does not in-and-of itself create any new requirements but
simply disapproves certain pre-existing State requirements for
inclusion in the SIP.

D. Unfunded Mandates Reform Act (UMRA)

    This action does not contain any unfunded mandate as described in
UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect
small governments. This action does not impose additional requirements
beyond those imposed by state law. Accordingly, no additional costs to
state, local, or tribal governments, or to the private sector, will
result from this action.

E. Executive Order 13132: Federalism

    This action does not have federalism implications. It will not 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.

F. Executive Order 13175: Coordination With Indian Tribal Governments

    This action does not have tribal implications, as specified in
Executive Order 13175, because the SIP EPA is disapproving would not
apply on any Indian reservation land or in any other area where the EPA
or an Indian tribe has demonstrated that a tribe has jurisdiction and
will not impose substantial direct costs on tribal governments or
preempt tribal law. Thus, Executive Order 13175 does not apply to this
action.

G. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks

    The EPA interprets Executive Order 13045 as applying only to those
regulatory actions that concern environmental health or safety risks
that the EPA has reason to believe may disproportionately affect
children, per the definition of ``covered regulatory action'' in
section 2-202 of the Executive order. This action is not subject to
Executive Order 13045 because this SIP disapproval does not in-and-of
itself create any new regulations, but simply disapproves certain pre-
existing State requirements for inclusion in the SIP.

H. Executive Order 13211: Actions That Significantly Affect Energy
Supply, Distribution, or Use

    This action is not subject to Executive Order 13211, because it is
not a significant regulatory action under Executive Order 12866.

I. National Technology Transfer and Advancement Act (NTTAA)

    Section 12(d) of the NTTAA directs the EPA to use voluntary
consensus standards in its regulatory activities unless to do so would
be inconsistent with applicable law or otherwise impractical. The EPA
believes that this action is not subject to the requirements of section
12(d) of the NTTAA because application of those requirements would be
inconsistent with the CAA.

J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations

    Executive Order 12898 (Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations, 59 FR 7629,
February 16, 1994) directs Federal agencies to identify and address
``disproportionately high and adverse human health or environmental
effects'' of their actions on minority populations and low-income
populations to the greatest extent practicable and permitted by law.
EPA defines environmental justice (EJ) as ``the fair treatment and
meaningful involvement of all people regardless of race, color,
national origin, or income with respect to the development,
implementation, and enforcement of environmental laws, regulations, and
policies.'' EPA further defines the term fair treatment to mean that
``no group of people should bear a disproportionate burden of
environmental harms and risks, including those resulting from the
negative environmental consequences of industrial, governmental, and
commercial operations or programs and policies.''
    The air agency did not evaluate environmental justice
considerations as part of its SIP submittal; the CAA and applicable
implementing regulations neither prohibit nor require such an
evaluation. EPA did not perform an EJ analysis and did not consider EJ
in this action. Consideration of EJ is not required as part of this
action, and there is no information in the record inconsistent with the
stated goal of E.O. 12898 of achieving environmental

justice for people of color, low-income populations, and Indigenous
peoples.

K. Congressional Review Act (CRA)

    This action is subject to the CRA, and the EPA will submit a rule
report to each House of the Congress and to the Comptroller General of
the United States. This action is not a ``major rule'' as defined by 5
U.S.C. 804(2).

L. Petitions for Judicial Review

    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by June 16, 2023. Filing a petition for
reconsideration by the Administrator of this final action does not
affect the finality of this action for the purposes of judicial review
nor does it extend the time within which a petition for judicial review
may be filed, and shall not postpone the effectiveness of such action.
This action pertaining to the disapproval of West Virginia's June 13,
2017 submittal, may not be challenged later in proceedings to enforce
its requirements. (See section 307(b)(2).)

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Carbon monoxide,
Incorporation by reference, Intergovernmental relations, Nitrogen
dioxide, Ozone, Particulate matter, Reporting and recordkeeping
requirements, Sulfur oxides, Volatile organic compounds.

Adam Ortiz,
Regional Administrator, Region III.
[FR Doc. 2023-07615 Filed 4-14-23; 8:45 am]
BILLING CODE 6560-50-P