Federal Register Vol. 83, No.31,

I. Obtaining Information and Submitting Comments A. Obtaining Information

Please refer to Docket ID NRC-2017-0081 when contacting the NRC about the availability of information for this action. You may obtain publicly-available information related to this action by any of the following methods:

• Federal Rulemaking Website: Go to https://www.regulations.gov and search for Docket ID NRC-2017-0081.

• NRC's Agencywide Documents Access and Management System (ADAMS): You may obtain publicly-available documents online in the ADAMS Public Documents collection at https://www.nrc.gov/reading-rm/adams.html. To begin the search, select “ADAMS Public Documents” and then select “Begin Web-based ADAMS Search.” For problems with ADAMS, please contact the NRC's Public Document Room (PDR) reference staff at 1-800-397-4209, 301-415-4737, or by email to [email protected].

• NRC's PDR: You may examine and purchase copies of public documents at the NRC's PDR, Room O1-F21, One White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852.

Please include Docket ID NRC-2017-0081 in the subject line of your comment submission, in order to ensure that the NRC is able to make your comment submission available to the public in this docket. If your comment contains proprietary or sensitive information, please contact the individual listed in the FOR INFORMATION CONTACT section of this document to determine the most appropriate method for submitting your comment.

The NRC cautions you not to include identifying or contact information that you do not want to be publicly disclosed in your comment submission. The NRC will post all comment submissions at https://www.regulations.gov as well as enter the comment submissions into ADAMS, and the NRC does not routinely edit comment submissions to remove identifying or contact information.

If you are requesting or aggregating comments from other persons for submission to the NRC, then you should inform those persons not to include identifying or contact information that they do not want to be publicly disclosed in their comment submission. Your request should state that the NRC does not routinely edit comment submissions to remove such information before making the comment submissions available to the public or entering the comment into ADAMS.

On December 22, 2015, the Commission, in Staff Requirements Memorandum (SRM)-SECY-15-0094, “Historical and Current Issues Related to Disposal of GTCC Low Level Radioactive Waste (LLRW)” (ADAMS Accession No. ML15356A623), directed the NRC staff to develop a regulatory basis for disposal of GTCC and transuranic waste through means other than a deep geologic disposal, including near surface disposal, within six months of the completion of the final rule for part 61 of title 10 of the Code of Federal Regulations (10 CFR), “Low-Level Radioactive Waste Disposal,” RIN 3150-AI92; Docket ID NRC-2011-0012. The Commission also directed the staff to conduct a public workshop during the development of the regulatory basis to receive input from stakeholders. On September 8, 2017, the Commission, in SRM-SECY-16-0106, “Final Rule: Low-Level Radioactive Waste Disposal (10 CFR part 61) (RIN 3150-AI92)” (ADAMS Accession No. ML17251B147), revised its earlier directions regarding the development of the GTCC and transuranic waste regulatory basis. The Commission directed the staff to develop the regulatory basis six months after the publication of the supplemental proposed rule for the 10 CFR part 61 rulemaking.

The NRC staff is in the initial phase of implementing the Commission's directions in SRM-SECY-15-0094 and SRM-SECY-16-0106. The process of potentially amending the NRC's regulations is very thoughtful and deliberative because it can have significant impacts on members of the public, States, licensees, and other stakeholders. The regulatory basis describes the various scientific, technical, and legal issues associated with a potential rulemaking. Therefore, as a part of the initial steps in implementing the Commission's directions, the staff has planned a public meeting with stakeholders to identify the various technical issues that should be considered in the development of a regulatory basis for the disposal of GTCC and transuranic waste. The staff is also requesting that stakeholders respond to the questions discussed in Section IV, “Specific Request for Comments,” of this notice. When this initial phase is completed, staff plans to develop a regulatory basis, which will be provided for public review. Staff plans to hold public meetings on the draft regulatory basis as well. After which, the staff will develop a final regulatory basis.

The NRC's “Licensing Requirements for Land Disposal of Radioactive Waste” are provided in 10 CFR part 61. Section 10 CFR 61.2, “Definitions,” provides that waste as used in part 61 means those low-level radioactive wastes containing source, special nuclear, or byproduct material that are acceptable for disposal in a land disposal facility. The definition also indicates that low-level radioactive waste means radioactive waste not classified as high-level radioactive waste, transuranic waste, spent nuclear fuel, or byproduct material as defined in paragraphs (2), (3), and (4) of the definition of byproduct material in § 20.1003.

The Statements of Consideration (SOC) for the 10 CFR part 61 proposed rule explained that not all waste may be suitable for disposal in the near surface. Specifically, Section IV Purpose and Scope of the SOC (46 FR 38082; July 24, 1981) indicates that, while 10 CFR part 61 was intended to deal with the disposal of most LLRW defined by the Low-Level Radioactive Waste Policy Act, the 10 CFR part 61`waste classification system identified some LLRW that are not suitable for disposal under its regulatory framework, and alternative methods would have to be used.

In § 61.55, “Waste classification,” the NRC developed a classification system for waste for near surface disposal, which categorizes waste as Class A, B, or C. This provision also describes waste that is not generally acceptable for near-surface disposal, whose disposal methods must be more stringent than those specified for Class C waste. This waste is referred to as GTCC waste.

The GTCC waste is generated by nuclear power reactors, facilities supporting the nuclear fuel cycle, and other facilities and licensees outside of the nuclear fuel cycle. This class of wastes include (1) plutonium-contaminated nuclear fuel cycle wastes; (2) activated metals; (3) sealed sources; and (4) radioisotope product manufacturing wastes (i.e., wastes “occasionally generated as part of manufacture of sealed sources, radiopharmaceutical products and other materials used for industrial, education, and medical applications”).

With regards to transuranic waste, as mentioned earlier, transuranic waste is not included in the § 61.2 definition of LLRW. In a 1988 amendment to the Atomic Energy Act of 1954, as amended, a definition for transuranic was added. Transuranic waste 1 is defined as “material contaminated with elements that have an atomic number greater than 92, including neptunium, plutonium, americium, and curium, and that are in concentrations greater than 10 nanocuries per gram [(nCi/g)], or in such other concentrations as the [U.S.] Nuclear Regulatory Commission may prescribe to protect the public health and safety.” Transuranic waste is a byproduct of nuclear research and power production and is primarily produced from spent fuel recycling, medical isotope production, or nuclear weapons fabrication. The waste may consist of rags, tools, and laboratory equipment contaminated with organic and inorganic residues.

The identification and evaluation of regulatory concerns associated with land disposal of GTCC and transuranic waste will largely depend on the characteristics of the wastes (e.g., isotopes, concentrations and volumes of waste, physical and chemical properties). The variable characteristics of the waste can influence the decision regarding the appropriate regulatory approach to use for management and disposal of these wastes. Overly conservative assumptions for the inventory and characteristics could significantly limit disposal options, whereas, overly optimistic assumptions with respect to characteristics could lead to a disposal facility that may not provide adequate protection of public health and safety, and security.

The NRC is seeking stakeholder participation and involvement in identifying the various technical issues that should be considered in the development of a draft regulatory basis for the disposal of GTCC and transuranic radioactive waste through means other than a deep geologic disposal, including near surface disposal. To assist in this process, the NRC staff is requesting that stakeholders respond to the questions below. In addition, the NRC staff has conducted some initial technical analyses to assist its understanding of potential hazards with near surface disposal of GTCC and transuranic wastes, which are contained in draft “NRC Staff Analyses Identifying Potential Issues Associated with the Disposal of Greater-Than-Class C Low-Level Radioactive Waste,” (ADAMS Accession No. ML17362A012). The draft analyses should assist in providing responses to the following questions:

Question 1: What are the important radionuclides that need to be considered for the disposal of the GTCC and transuranic wastes?

The U.S. Department of Energy has described three broad categories of GTCC wastes, including a range of transuranic radionuclides, in its “Final Environmental Impact Statement for the Disposal of Greater-Than-Class C (GTCC) Low-Level Radioactive Waste and GTCC-Like Waste” (http://www.gtcceis.anl.gov/documents/index.cfm). The three categories are entitled activated metals, sealed sources, and other wastes. The attributes (e.g., radionuclide concentrations, heat generation, and waste form) vary significantly between the three categories. Certain waste streams represent a very specific waste form (e.g., stainless steel for most activated metals; very concentrated amounts in sealed sources) that may require specific treatment to mitigate potential safety, security and criticality concerns. Some waste streams may contain sufficient quantities of specific radionuclides that will present a significant thermal output and/or gas generation through radiolysis. Still other waste streams may contain a significant quantity of fissile radionuclides (e.g., some isotopes of uranium and plutonium). The NRC is interested in identifying those radionuclides that could be important for evaluating the safety and security of: (1) Storage associated with the operational period at a disposal facility, and (2) the post-closure period, including inadvertent intruder protection. Additionally, the NRC is interested in obtaining available data and information to support the characteristics of GTCC and transuranic wastes.

Question 2: How might GTCC and transuranic wastes affect the safety and security of a disposal facility during operations (i.e., pre-closure period)?

The presence of sufficient quantities of high activity radionuclides and/or fissile radionuclides in GTCC and transuranic wastes may impact the design and operational activities associated with a disposal facility prior to disposal. The NRC is interested in identifying those design and operational activities at a disposal facility that may be impacted by GTCC and transuranic wastes. For example, the requirements in 10 CFR part 73 would require licensees to develop safeguards systems to protect against acts of radiological sabotage and to prevent the theft or diversion of Special Nuclear Material (i.e., transuranic waste such as plutonium, uranium-233, or uranium enriched in the isotopes uranium-233 or uranium-235) if a sufficient amount of Special Nuclear Material were present above ground at the disposal facility.

Question 3: How might GTCC and transuranic wastes affect disposal facility design for post-closure safety including protection of an inadvertent intruder?

The NRC is considering disposal units (e.g., a single trench, borehole, and vault) that would contain a single category of waste (e.g., sealed sources) as well as disposal units that contain a mixture of all three waste types. However, the NRC believes the best approach for understanding the issues would be to assume that waste within a disposal unit would be separated by the waste category and not be co-mingled. Such an approach could provide a clear understanding of the issues associated with how a specific waste category might affect disposal facility design. Certain waste streams associated with GTCC and transuranic wastes have larger inventories and concentrations of radionuclides than was typically considered at LLRW disposal facilities. For example, certain GTCC and transuranic wastes in sufficient quantities have the potential for: (1) Significant thermal output that could affect degradation processes within a disposal unit, and (2) hydrogen gas generation through radiolysis that could also affect degradation processes of the waste package and waste form. Additionally, waste streams associated with GTCC and transuranic wastes may have fissile materials that require facilities to be designed to limit the potential for a criticality event or limit the amount of fissile material that can be disposed. There is a potential balance between security/safety and economic feasibility of design, construction, and operation. The NRC would like to hear from the stakeholders on these aspects as well. The information provided on economic feasibility would be in concert with the NRC's strategies on examining the cumulative effects of potential regulatory actions. The NRC is interested in identifying the various scenarios that should be considered in evaluating the post-closure safety for the disposal of GTCC and transuranic wastes especially scenarios associated with specific issues and concerns that may not have been previously considered for commercial disposal facilities (e.g., synergistic effects of the thermal output on geochemical processes affecting release of radionuclides).

To facilitate the understanding of the public and other stakeholders of these issues and the submission of comments, the NRC staff has scheduled a public meeting for February 22, 2018, from 1:00 p.m. to 3:00 p.m. (EST) in the NRC Auditorium at 11545 Rockville, Pike, Rockville, MD. In addition, those wishing to participate by Webinar will be able to view the presentation slides prepared by the NRC and electronically submit comments during the meeting. Participants must register to participate in the Webinar. Registration information may be found in the meeting notice (https://www.nrc.gov/pmns/mtg?do=details&Code=20180033). The meeting notice can also be accessed through the NRC's public website under the headings Public Meetings & Involvement > Public Meeting Schedule; see web page https://www.nrc.gov/public-involve/publicmeetings/index.cfm.

Additionally, the final agenda for the public meeting will be posted no fewer than 10 days prior to the Webinar at this website. Those who are unable to participate in person or via Webinar may also participate via teleconference. For details on how to participate via teleconference, please contact Sarah Achten; telephone: 301-415-6009; email: [email protected].

Comments Invited

We invite you to send any written relevant data, views, or arguments about this proposal. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2018-0078; Product Identifier 2017-NM-107-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this NPRM. We will consider all comments received by the closing date and may amend this NPRM because of those comments.

We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We will also post a report summarizing each substantive verbal contact we receive about this proposed AD.

We issued AD 2017-01-02, Amendment 39-18769 (82 FR 4775, January 17, 2017) (“AD 2017-01-02”), for certain The Boeing Company Model 787-8 and 787-9 airplanes. AD 2017-01-02 requires an inspection for discrepant inboard and outboard trailing edge flap rotary actuators. AD 2017-01-02 resulted from a report that indicated that some rotary actuators of the inboard and outboard trailing edge flap may have been assembled with an incorrect no-back brake rotor-stator stack sequence during manufacturing. We issued AD 2017-01-02 to detect and replace incorrectly assembled rotary actuators, which could cause accelerated unit wear that will eventually reduce braking performance. This degradation could lead to loss of no-back brake function and reduced controllability of the airplane.

Since we issued AD 2017-01-02, we have determined that it is necessary to revise the applicability to include additional airplanes, and to reduce the number of affected actuators.

We reviewed Boeing Alert Service Bulletin B787-81205-SB270032-00, Issue 003, dated July 28, 2017. The service information describes procedures for an inspection of the inboard and outboard trailing edge flap rotary actuator for any discrepant rotary actuator, and corrective actions if necessary. The related investigative action includes a functional test of the trailing edge flap no-back brake. The corrective actions include replacement of the discrepant rotary actuator with a non-discrepant rotary actuator. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

We are proposing this AD because we evaluated all the relevant information and determined the unsafe condition described previously is likely to exist or develop in other products of the same type design.

This proposed AD would retain all requirements of AD 2017-01-02 and add airplanes to the applicability. This proposed AD would require accomplishing the actions specified in the service information described previously. For information on the procedures and compliance times, see this service information at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-0078.

The phrase “related investigative actions” is used in this proposed AD. Related investigative actions are follow-on actions that (1) are related to the primary action, and (2) further investigate the nature of any condition found. Related investigative actions in an AD could include, for example, inspections.

The phrase “corrective actions” is used in this proposed AD. Corrective actions correct or address any condition found. Corrective actions in an AD could include, for example, repairs.

To support operations, many operators have put processes in place that, given certain conditions, allow them to rotate or transfer parts or equipment within their fleets to different aircraft than what is defined in the manufacturer's type design. We have determined that the parts or equipment subject to the unsafe condition may have been rotated or transferred in this manner, due to similarity with parts or equipment not subject to the unsafe condition. Therefore, the applicability of this proposed AD is for all The Boeing Company Model 787 series airplanes.

The effectivity specified in Boeing Alert Service Bulletin B787-81205-SB270032-00, Issue 001, dated November 3, 2015, consists of only certain Boeing Model 787-8 and 787-9 airplanes. In this proposed AD, the actions required by paragraphs (g) and (h) of this AD would be accomplished on any The Boeing Company Model 787 series airplane with an original Certificate of Airworthiness or an original Export Certificate of Airworthiness dated on or before the effective date of the final rule. Expanding the applicability of this proposed AD addresses the rotability issue of the trailing edge flap rotary actuators. We have confirmed with the manufacturer that the accomplishment instructions in the following service information are applicable to the expanded group of airplanes:

• Boeing Alert Service Bulletin B787-81205-SB270032-00, Issue 001, dated November 3, 2015.

• Boeing Alert Service Bulletin B787-81205-SB270032-00, Issue 002, dated November 3, 2016.

• Boeing Alert Service Bulletin B787-81205-SB270032-00, Issue 003, dated July 28, 2017.

The Boeing Company Model 787 series airplanes with an original Certificate of Airworthiness or an original Export Certificate of Airworthiness dated after the effective date of the final rule are not required to complete the actions specified in paragraphs (g) and (h) of this AD, but must comply with the parts installation prohibition in paragraph (i) of this AD.

We estimate that this proposed AD affects 89 airplanes of U.S. registry. We estimate the following costs to comply with this proposed AD:

We estimate the following costs to do any necessary on-condition actions that would be required based on the results of the proposed inspection. We have no way of determining the number of aircraft or the number of rotary actuators (up to 8 per shipset) that might need these on-condition actions:

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, Section 106, describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the Agency's authority.

We are issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701, “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

This proposed AD is issued in accordance with authority delegated by the Executive Director, Aircraft Certification Service, as authorized by FAA Order 8000.51C. In accordance with that order, issuance of ADs is normally a function of the Compliance and Airworthiness Division, but during this transition period, the Executive Director has delegated the authority to issue ADs applicable to transport category airplanes to the Director of the System Oversight Division.

We have determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect 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.

For the reasons discussed above, I certify that the proposed regulation:

(1) Is not a “significant regulatory action” under Executive Order 12866,

(2) Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979),

(3) Will not affect intrastate aviation in Alaska, and

(4) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

Table of Contents I. Executive Summary A. Purpose of the Proposed Rule B. Summary of the Major Provisions of the Proposed Rule C. Legal Authority D. Costs and Benefits II. Background A. Need for the Regulation B. Current Regulatory Framework III. Legal Authority IV. Description of the Proposed Rule A. Scope B. Proposed Provisions V. Proposed Effective and Compliance Dates VI. Economic Analysis of Impacts VII. Analysis of Environmental Impact VIII. Paperwork Reduction Act of 1995 IX. Federalism I. Executive Summary A. Purpose of the Proposed Rule

FDA is issuing this proposed rule to amend our regulations under § 514.80 (21 CFR 514.80) to require electronic submission of certain postmarketing safety reports for approved new animal drugs and to provide a procedure for requesting a temporary waiver of the requirement. This action is intended to improve our systems for collecting and analyzing postmarketing safety reports. The proposed change would help us to more rapidly review postmarketing safety reports, identify emerging safety problems, and disseminate safety information in support of our public health mission. In addition, the proposed amendments would facilitate international harmonization and exchange of safety information.

We require applicants to submit to us postmarketing safety reports of adverse drug experiences and product/manufacturing defects for approved new animal drugs (see § 514.80). An applicant is defined as “a person or entity who owns or holds on behalf of the owner the approval for an NADA [new animal drug application] or an ANADA [abbreviated new animal drug application], and is responsible for compliance with applicable provisions of the act and regulations.” (§ 514.3 (21 CFR 514.3)) In addition, nonapplicants, defined in § 514.3 as “any person other than the applicant whose name appears on the label and who is engaged in manufacturing, packing, distribution, or labeling of the product,” may elect to submit adverse drug experience reports directly to us (§ 514.80(b)(3)).

We propose to require electronic submission for the following reports for approved new animal drugs: 3-day alert reports that applicants elect to submit directly to FDA's Center for Veterinary Medicine (CVM) in addition to the requirement they have to submit these reports on paper Form FDA 1932 to the appropriate FDA District Office or local FDA resident post; 15-day alert reports and followup reports; product/manufacturing defect and adverse drug experience reports submitted by nonapplicants who elect to report adverse drug experiences directly to CVM in addition to providing these reports to the applicant; product/manufacturing defect and adverse drug experience reports (including reports of previously not reported adverse drug experiences that occur in postapproval studies) required to be submitted as part of the periodic drug experience report. We propose to replace the current paper submission process with the electronic submission requirement and a procedure for requesting a temporary waiver of the electronic submission requirement. Finally, we propose to clarify where to submit reports not required to be submitted electronically. Under the proposed rule, we would continue to require 3-day alert reports to be submitted to the appropriate FDA District Office or local FDA resident post. However, as noted, if in addition to the report an applicant submits on paper Form FDA 1932 to the appropriate FDA District Office or local FDA resident post, an applicant elects to submit a 3-day field alert report directly to CVM, the applicant would be required to submit the report to CVM electronically.

Our legal authority to require electronic submission of postmarketing safety reports for approved new animal drugs derives from sections 201, 301, 501, 502, 512, and 701 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 321, 331, 351, 352, 360b, and 371).

The purpose of this proposed rule is to require electronic submission of certain postmarketing safety reports for approved new animal drugs. The rule, if finalized, would also provide a procedure for requesting a temporary waiver of the electronic reporting requirement for “good cause” shown, such as a natural disaster. As currently proposed, this rule would not change the content of the postmarketing safety reports or the frequency of the reporting requirements. Currently, most submitters have chosen, voluntarily, to use electronic submission for the reports that would be affected by this proposed rule. As of 2016, approximately 99.7 percent of postmarketing safety reports eligible for electronic submission were electronically submitted. Thus, this proposed rule would affect a small proportion of these reports.

The major benefits of this proposed rule, if finalized, would be to animal health and the Agency in the form of quicker access to postmarketing safety information. The annual cost savings to the Agency is estimated at $7,535. The present value of these benefits over 10 years is $64,272 at a 3 percent discount rate, and $52,920 at a 7 percent discount rate.

Total one-time costs to industry would be $61,311 for changing standard operating procedures (SOPs) and training employees to electronically submit postmarketing safety reports in accordance with the new SOPs. Recurring costs to the Agency would be $153 per year, for processing the waivers to the electronic reporting requirement. Annualizing these costs over a 10-year period, we estimate total annualized costs to be $7,131 at a 3 percent discount rate, and $8,310 at a 7 percent discount rate. The present value of these costs over 10 years is $60,823 at a 3 percent discount rate, and $58,368 at a 7 percent discount rate.

When a new animal drug is approved and enters the market, the product is introduced to a larger population in settings different from the controlled studies required by the approval process. New information generated during the postmarketing period offers further insight into the benefits and/or risks of the product, and evaluation of this information is important to ensure the safe and effective use of these products.

CVM receives information regarding adverse drug experiences for approved new animal drugs from postmarketing safety reports. For over 25 years, we have received these safety reports on paper. However, the majority of submitters have chosen, voluntarily, to utilize electronic submission as electronic means became available. As of 2016, approximately 99.7 percent of postmarketing safety reports eligible for electronic submission were electronically submitted. The proposed rule would require electronic submission of the remaining 0.3 percent of postmarketing safety reports eligible for electronic submission.

Electronic submission improves our ability to process and archive postmarketing safety reports in a timely manner, and to make postmarketing reports more readily available for analysis. Information from electronic and paper reports is entered into our computerized database, which is designed to support our postmarketing safety surveillance program for animal drug products. Scientists at CVM use the database to make decisions about product safety, which may include regulatory action. Electronically submitted reports are available for analysis as soon as they have been processed, generally within 2 days of receipt. Safety reports submitted to us on paper must be physically received, reviewed, and then manually entered into our computerized database, a process that can take several weeks. Paper reports increase the time it takes us to review safety information, impede our ability to analyze the data comprehensively, and hinder our ability to quickly identify problems. Voluntary electronic submission of safety reports has been an important step in improving our postmarketing surveillance capabilities.

The proposed rule, which would require electronic submission of certain postmarketing safety reports, would further improve our systems for collecting and analyzing these reports and would save FDA an expected $7,459 annually, primarily in the cost of processing paper submissions. The proposal would:

• Expedite our access to safety information and provide us data in a format that would support more efficient and comprehensive reviews;

• Enhance our ability to rapidly communicate information about suspected problems to animal owners, veterinarians, consumers, and industry within the United States and internationally in support of our public health mission; and

• Eliminate or reduce the time and costs to industry associated with submitting paper reports, and the time, costs, errors, and physical storage needs of the Agency associated with manually entering data from paper reports into the electronic system for review and analysis.

The proposed rule would allow us to be more responsive to rapidly occurring changes in the technological environment. Consistent with our current practice for voluntarily provided electronic submissions, the proposed rule would require that data in electronic submissions conform to the data elements in Form FDA 1932 and our technical documents on how to provide electronic submissions (e.g., method of transmission and processing, media, file formats, preparation and organization of files). The proposed rule would allow us to issue updated technical documents, as necessary. The most current information on submitting postmarketing safety reports to us in electronic format can be found on our web page at http://www.fda.gov/AnimalVeterinary/SafetyHealth/ReportaProblem/ucm212682.htm (see, e.g., “Instructions for Electronic Submission of Mandatory Adverse Event Reports to FDA CVM”). As necessary, we will revise the technical specifications referenced in our technical documents to address changing technical specifications or any additional specifications needed for electronic submission. Using guidance documents and technical documents to communicate these technical specifications will permit us to be more responsive to rapidly occurring changes in the technological environment.

The proposed rule is also an important step in our continuing efforts to harmonize our postmarketing safety reporting regulations with international standards for submitting safety information. Currently, the technical specifications referenced in our guidance documents supporting the voluntary electronic submission processes rely upon and adopt certain safety reporting and transmission standards recommended by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). VICH was formed to facilitate the harmonization of technical requirements for the marketing authorization or “registration” of veterinary medicinal products among three regions: The European Union, Japan, and the United States. Our electronic submission specifications allow applicants or nonapplicants to submit postmarketing safety reports using the Health Level 7 (HL7) Individual Case Safety Report (ICSR) standard that has been adopted worldwide by VICH. In this proposed rule, we reaffirm our intention to continue to rely on these VICH-recommended standards. We believe the continued use of VICH standards will promote harmonization of safety reporting among regulatory agencies and facilitate the international exchange of postmarketing safety information. Accordingly, this proposed rule is consistent with our ongoing initiatives to encourage the widest possible use of electronic submission and to promote international harmonization of safety reporting for animal drug products through reliance on VICH standards. We anticipate that the proposed rule would enhance industry's global pharmacovigilance practices by allowing it to use common data elements and transmission standards when submitting ICSRs to multiple regulators.

The current postmarketing safety reports required under § 514.80 for approved NADAs and approved ANADAs are summarized below. The proposed electronic submission requirement would leave the substantive aspects of these reports largely unchanged.

Under section 512(l) of the FD&C Act, we may require holders of approved NADAs to submit reports regarding postapproval experiences with their animal drugs. Our implementing regulation at § 514.80 requires applicants to submit to us postmarketing safety reports of adverse drug experiences and product/manufacturing defects. As stated previously, an applicant is defined as “a person or entity who owns or holds on behalf of the owner the approval for an NADA or an ANADA, and is responsible for compliance with applicable provisions of the act and regulations.” (See § 514.3.) In addition, nonapplicants, defined in § 514.3 as “any person other than the applicant whose name appears on the label and who is engaged in manufacturing, packing, distribution, or labeling of the product,” may elect to submit adverse drug experience reports directly to us (§ 514.80(b)(3)).

Specifically, § 514.80(b) requires the following adverse drug experience reports, among other reports:

• Three-day field alert reports (§ 514.80(b)(1)). Applicants must submit a report to the appropriate FDA District Office or local resident post with information pertaining to product and manufacturing defects that may result in serious adverse drug events within 3 working days of first becoming aware that a defect may exist.

• Fifteen-day alert reports (§ 514.80(b)(2)(i)) and followup reports (§ 514.80(b)(2)(ii)). Applicants must submit a report to us for each postmarketing adverse drug event that is both serious and unexpected within 15 working days of first receiving the information about the adverse drug event. A followup report must be submitted within 15 working days of receipt of significant new information or as requested by us.

• Nonapplicant reports (§ 514.80(b)(3)). Nonapplicants are required to forward reports of adverse drug experiences to the applicant within 3 working days of first receiving the information. A nonapplicant may choose to also submit an additional report directly to us within 15 working days of first receiving the information, but must still provide the report to the applicant. (As noted above, a “nonapplicant” is any person other than the applicant whose name appears on the label of the approved new animal drug product and who is engaged in the manufacturing, packing, distribution, or labeling of that drug product. 21 CFR 514.3.)

• Reports of product/manufacturing defects and adverse drug experiences submitted as part of the periodic drug experience report (§ 514.80(b)(4)(iv)(A) and (C)). Applicants are required to submit a periodic report every 6 months for the first 2 years following approval (6-month periodic drug experience reports) and yearly thereafter (yearly periodic drug experience report). The periodic drug experience report must contain, among other things, reports for each product/manufacturing defect and adverse drug experience not previously reported as 3-day field alert reports under § 514.80(b)(1) or 15-day alert or followup reports under § 514.80 (b)(2) (i.e., the periodic drug experience report must contain reports of all expected or nonserious adverse drug events and product/manufacturing defects that did not result in an adverse drug event report). This also includes previously not reported adverse drug experiences that occur in postapproval studies.

As noted, for over 25 years we have received postmarketing safety reports on paper. Currently, § 514.80 requires that applicants and nonapplicants submit to us reports of adverse drug experiences and product/manufacturing defects on paper Form FDA 1932. It further requires that 3-day field alert reports must be submitted to the appropriate FDA District Field Office or local FDA resident post while 15-day alert reports and followup reports, periodic drug experience reports, and nonapplicant reports must be submitted to CVM (§ 514.80(b)(1) to (3), (b)(4)(iv)(A) and (C), and (g)).

As noted earlier in this preamble, since May 2010 we have provided industry with the option of submitting certain postmarketing safety reports electronically. Since that time, the majority of submitters have chosen, voluntarily, to utilize electronic submission. As of 2016, approximately 99.7 percent of postmarketing safety reports eligible for electronic submission were electronically submitted.

Reports that may be submitted electronically include 15-day alert reports and followup reports (§ 514.80(b)(2)(i) and (ii)); nonapplicant reports of adverse drug experiences submitted directly to FDA (§ 514.80(b)(3)); and reports of product/manufacturing defects and adverse drug experiences submitted as part of the periodic drug experience report (§ 514.80(b)(4)(iv)(A) and (C)). At this time, 3-day field alert reports (§ 514.80(b)(1)) must be submitted on paper Form FDA 1932 to the appropriate FDA District Office or local resident post. CVM collaborates with the FDA District Office or local resident post to follow up as appropriate in response to 3-day field alert reports. If an applicant elects to submit a 3-day field alert report directly to CVM, the applicant would be required to submit the report electronically. However, this would not alleviate the applicant's responsibility to submit this report to the FDA District Field Office or local FDA resident post on paper Form FDA 1932.

Electronic reports may be submitted through FDA's Electronic Submission Gateway or through the FDA-National Institutes of Health Safety Reporting Portal (Safety Reporting Portal). The Electronic Submission Gateway allows applicants or nonapplicants to submit postmarketing safety reports using the HL7 ICSR standard, which, as discussed earlier in this preamble, has been adopted worldwide by VICH. The Electronic Submission Gateway provides industry with gateway-to-gateway access to transmit an HL7 ICSR message using the FDA electronic submission standard. The Safety Reporting Portal provides applicants or nonapplicants a means to submit individual postmarketing safety reports without having to make financial investments in the technical infrastructure needed to access the Electronic Submission Gateway. Any person who has internet access can use the Safety Reporting Portal to submit reports through a user-friendly, interactive questionnaire available at https://www.safetyreporting.hhs.gov/.

For applicants or nonapplicants that submit large numbers of reports, sending an HL7 ICSR electronic file is more cost effective because the information from the reports is transmitted directly from the submitter's database to FDA, eliminating the need for additional resources for collating, copying, storing, retrieving, and mailing paper copies. For applicants or nonapplicants that submit a small number of reports, the use of the web-based Safety Reporting Portal may be more cost effective than implementing a system to send an HL7 ICSR message through the FDA Electronic Submission Gateway.

Section 512(l) of the FD&C Act requires that, following approval of a NADA or ANADA, applicants must establish and maintain records and make reports to the Agency of data related to experience, as prescribed by regulation or order. FDA has general rulemaking authority under section 701(a) of the FD&C Act, which permits the Secretary of Health and Human Services to promulgate regulations for the efficient enforcement of the FD&C Act. In order to implement section 512(l) of the FD&C Act, FDA promulgated regulations for records and updates concerning experience with new animal drugs (see § 514.80). The proposed amendments to this regulation will further efficient enforcement of section 512(l) by permitting records and reports to be reported electronically.

We are proposing to amend our regulations in part 514 (21 CFR part 514). The proposed rule would require electronic submission of certain postmarketing safety reports for approved new animal drugs and provide a procedure for requesting a temporary waiver of the requirement. This action is intended to improve our systems for collecting and analyzing postmarketing safety reports.

The proposed rule would amend § 514.80 to require electronic submission of the following postmarketing safety reports for approved new animal drugs:

• Three-day alert reports that applicants elect to submit directly to CVM in addition to the requirement they have to submit these reports on paper Form FDA 1932 to the appropriate FDA District Office or local FDA resident post (§ 514.80(b)(1);

• Fifteen-day alert reports (§ 514.80(b)(2)(i)) and followup reports (§ 514.80(b)(2)(ii));

• Product/manufacturing defects and adverse drug experience reports submitted by nonapplicants who elect to report adverse drug experiences directly to FDA under § 514.80(b)(3) in addition to providing these reports to the applicant; and

• Product/manufacturing defects and adverse drug experience reports (including reports of previously not reported adverse drug experiences that occur in postapproval studies) required to be submitted as part of the periodic drug experience report (§ 514.80(b)(4)(iv)(A) and (C)).

At this time, we are not proposing to require electronic submission of 3-day field alert reports (§ 514.80(b)(1)) to the appropriate FDA District Office or local resident post because, as noted previously, we currently do not have the information technology systems in place to share with FDA District Offices or local resident posts reports submitted electronically through the Electronic Submission Gateway or Safety Reporting Portal. Under this proposed rule, these reports would continue to be submitted on paper Form FDA 1932 directly to the appropriate FDA District Office or local resident post. CVM will continue to collaborate with the FDA District Office or local resident post to follow up as appropriate in response to 3-day field alert reports submitted directly to the FDA District Office or local resident post. However, as noted, if an applicant elects to submit a 3-day field alert report directly to CVM, the applicant would be required to submit the report electronically. This would not alleviate the applicant's responsibility to submit this report to the FDA District Field Office or local FDA resident post on paper Form FDA 1932.

We are proposing that applicants would continue to have the obligation to submit 3-day field alert reports directly to the appropriate FDA District Office or local resident post within 3 working days of first becoming aware that a defect may exist. However, if applicants choose to also report directly to CVM in addition to reporting to the appropriate FDA District Office or local resident post, they would be required to submit the report to CVM electronically, unless we grant a waiver permitting an alternate submission method or we otherwise request an alternate submission method. (See proposed § 514.80(b)(1).)

We are proposing that 15-day alert reports and followup reports would be required to be submitted to us electronically, unless we grant a waiver permitting an alternate submission method (see section IV.B.2 of this document) or we otherwise request an alternate submission method (see section IV.B.3 of this document). (See proposed § 514.80(b)(2)(i) and (ii).)

We are proposing that nonapplicants would continue to have the obligation of forwarding reports of adverse drug experiences to the applicant within 3 working days of first receiving the information. Nonapplicants would also continue to have the option of choosing to report directly to us in addition to reporting to the applicant. However, if nonapplicants opt to report directly to us, they would be required to submit the report electronically, unless we grant a waiver permitting an alternate submission method or we otherwise request an alternate submission method. (See proposed § 514.80(b)(3).)

We are proposing that reports of product/manufacturing defects and adverse drug experiences required to be submitted as part of the periodic drug experience report would be required to be submitted to us electronically, unless we grant a waiver permitting an alternate submission method or we otherwise request an alternate submission method. (See proposed § 514.80(b)(4)(iv)(A) and (C).) This includes reports of defects and experiences not previously reported under § 514.80(b)(1) and (2) and previously not reported adverse drug experiences that occur in postapproval studies. These reports could be submitted individually at any time within the timeframe for submitting the periodic drug experience report under current § 514.80(b)(4).

We are proposing that reports submitted to us under § 514.80(b)(1), (b)(2)(i) and (ii), (b)(3), and (b)(4)(iv)(A) and (C) be submitted in an electronic format that FDA can process, review, and archive, and that data submitted in electronic submissions conform to the data elements in Form FDA 1932 and our technical documents on how to provide electronic submissions (e.g., method of transmission and processing, media, file formats, preparation and organization of files). The proposed rule would allow us to issue updated technical documents, as necessary. (See proposed § 514.80(d)(1).)

We are proposing to allow applicants or nonapplicants to request a temporary waiver from the electronic submission requirement for “good cause” shown. Examples of circumstances that could constitute “good cause” for granting waivers of the electronic submission requirement include crisis situations that impact an applicant's or nonapplicant's ability to report electronically, such as natural disasters, pandemics, and terrorism. The proposed rule would require applicants and nonapplicants to submit a waiver request to us in writing. The initial request, however, could be made by telephone or email to CVM's Division of Veterinary Product Safety, with prompt written followup submitted as a letter to the application. If we grant the request for a temporary waiver, the applicant or nonapplicant would be required to follow the conditions for reporting that we specify upon granting the waiver. (See proposed § 514.80(d)(2).)

We anticipate that temporary waivers of the electronic submission requirement will only be needed in rare circumstances such as natural disasters, pandemics, and terrorism, as noted. An applicant or nonapplicant experiencing technical difficulties that temporarily prevent use of the Electronic Submission Gateway could, as a backup, electronically submit reports using the Safety Reporting Portal. An applicant or nonapplicant that relies on the Safety Reporting Portal but experiences a short-term, temporary interruption of internet services could, as a backup, electronically submit reports from any other computer with access to a working internet connection.

We may require an applicant or nonapplicant to submit reports that would otherwise be required to be submitted electronically to be submitted in an alternate format, such as on paper using Form FDA 1932. We anticipate that we would request the submission of reports through an alternate method only in the event that we experience a prolonged system outage or other major technical problem. During such an event, we would provide advice on the desired method for submission (most likely on paper using Form FDA 1932) and the types of reports that should be submitted using the alternate method. Applicants and nonapplicants should be prepared to comply with such a request by maintaining the capability to submit paper reports using Form FDA 1932 if needed. (See proposed § 514.80(b)(1) to (3), and (b)(4)(iv)(A) and (C).)

Finally, we propose to clarify where to submit reports not required to be submitted electronically. Under the proposed rule, we would continue to require 3-day alert reports to be submitted to the appropriate FDA District Office or local FDA resident post. (See proposed § 514.80(g).)

We propose that any final rule based on this proposal become effective 30 days after the date on which it is published in the Federal Register. Although we are proposing that the final rule become effective 30 days after the date of publication in the Federal Register, we are proposing to provide additional time before applicants and nonapplicants would be required to comply with the electronic submission requirement. We propose that the compliance date would be 12 months after the publication date of the final regulation. The Safety Reporting Portal currently is capable of receiving all of the affected reports and is available to any applicant or nonapplicant with access to the internet. We tentatively conclude that applicants and nonapplicants not currently submitting the affected reports electronically would, in 12 months, be able to make changes to their business practices that would be needed to come into compliance with the proposed requirements.

We have examined the impacts of the proposed rule under Executive Order 12866, Executive Order 13563, Executive Order 13771, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and 13563 direct us to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). Executive Order 13771 requires that the costs associated with significant new regulations “shall, to the extent permitted by law, be offset by the elimination of existing costs associated with at least two prior regulations.” We believe that this proposed rule is not a significant regulatory action as defined by Executive Order 12866.

The Regulatory Flexibility Act requires us to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because the costs of the rule are minimal in both absolute value and in comparison to average yearly sales of small firms in this industry, we propose to certify that the proposed rule will not have a significant economic impact on a substantial number of small entities.

The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires us to prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $148 million, using the most current (2016) Implicit Price Deflator for the Gross Domestic Product. This proposed rule would not result in an expenditure in any year that meets or exceeds this amount.

The purpose of this proposed rule is to require electronic submission of certain postmarketing safety reports for approved new animal drugs. The rule, if finalized, would also provide a procedure for requesting a temporary waiver of the electronic reporting requirement for “good cause” shown, such as a natural disaster. As currently proposed, this rule would not change the content of the postmarketing safety reports or the frequency of the reporting requirements.

The major benefits of this proposed rule, if finalized, would be to animal health and the Agency in the form of quicker access to postmarketing safety information; the annual cost savings to the Agency is estimated at $7,535. The present value of these benefits over 10 years is $64,272 at a 3 percent discount rate, and $52,920 at a 7 percent discount rate.

Total one-time costs to industry would be $61,311 for changing SOPs and training employees to electronically submit postmarketing safety reports in accordance with the new SOPs. Recurring costs to the Agency would be $153 per year, for processing the waivers to the electronic reporting requirement. Annualizing these costs over a 10-year period, we estimate total annualized costs to be $7,131 at a 3 percent discount rate, and $8,310 at a 7 percent discount rate. The present value of these costs over 10 years is $60,823 at a 3 percent discount rate, and $58,368 at a 7 percent discount rate.

The public hearing will provide interested parties the opportunity to present data, views, or arguments concerning the EPA's proposed response to the June 1, 2016, petition. The EPA may ask clarifying questions during the oral presentations, but will not respond to the presentations at that time. Written statements and supporting information that are submitted during the comment period will be considered with the same weight as any oral comments and supporting information presented at the public hearing. Written comments must be postmarked by the last day of the comment period.

The public hearing will convene at 9:00 a.m. and end at 6:00 p.m. Eastern Time (ET) or at least two hours after the last registered speaker has spoken. The EPA will make every effort to accommodate all individuals interested in providing oral testimony. A lunch break is scheduled from 12:00 p.m. until 1:00 p.m. Please note that this hearing will be held at a U.S. government facility. Individuals planning to attend the hearing should be prepared to show valid picture identification to the security staff in order to gain access to the meeting room. The REAL ID Act, passed by Congress in 2005, established new requirements for entering federal facilities. These requirements took effect July 21, 2014. If your driver's license is issued by the states of Michigan, Minnesota, New York, Vermont or Washington, you must present an additional form of identification to enter the federal building where the public hearing will be held. Acceptable alternative forms of identification include: Federal employee badges, passports, enhanced driver's licenses and military identification cards. For additional information for the status of your state regarding REAL ID, go to http://www.dhs.gov/real-id-enforcement-brief. In addition, you will need to obtain a property pass for any personal belongings you bring with you. Upon leaving the building, you will be required to return this property pass to the security desk. No large signs will be allowed in the building, and demonstrations will not be allowed on federal property for security reasons.

If you would like to present oral testimony at the hearing, please notify Ms. Pamela Long, U.S. Environmental Protection Agency, OAQPS, Air Quality Planning Division, (C504-01), Research Triangle Park, NC 27711, telephone (919) 541-0641, fax number (919) 541-5509, email address [email protected], no later than 4:00 p.m. ET on February 21, 2018. Ms. Long will arrange a general time slot for you to speak. The EPA will make every effort to follow the schedule as closely as possible on the day of the hearing.

Oral testimony will be limited to 5 minutes for each commenter. The EPA encourages commenters to provide the EPA with a copy of their oral testimony electronically (via email) or in hard copy form. The EPA will not provide audiovisual equipment for presentations unless we receive special requests in advance. Commenters should notify Ms. Long if they will need specific equipment. Commenters should also notify Ms. Long if they need specific translation services for non-English speaking commenters.

The hearing schedule, including the list of speakers, will be posted on the EPA's Web at site https://www.epa.gov/ozone-pollution/connecticut-126-petition prior to the hearing. Verbatim transcripts of the hearing and written statements will be included in the docket for the action.

The EPA has established a docket for this action under Docket ID No. EPA-HQ-OAR-2016-0347 (available at http://www.regulations.gov). The EPA has made available information related to the proposed action at this website: https://www.epa.gov/ozone-pollution/connecticut-126-petition.

Throughout this document “we,” “us,” and “our” means the EPA.

The Act at Section 110(a)(2)(C) requires states to develop and submit to EPA for approval into the SIP, preconstruction review and permitting programs applicable to certain new and modified stationary sources of air pollutants for attainment and nonattainment areas that cover both major and minor new sources and modifications, collectively referred to as the NSR SIP. The CAA NSR SIP program is composed of three separate programs: Prevention of Significant Deterioration (PSD), Nonattainment New Source Review (NNSR), and Minor NSR. The EPA codified minimum requirements for these State permitting programs including public participation and notification requirements at 40 CFR 51.160-51.164. Requirements specific to construction of new stationary sources and major modifications in nonattainment areas are codified at 40 CFR 51.165 for the NNSR program. Requirements for permitting of new stationary sources and major modifications in attainment areas subject to PSD, including additional public participation requirements, are found at 40 CFR 51.166. This proposed approval action will address four separate revisions to the Texas NSR SIP submitted on December 12, 2016 and February 21, 2017. On December 12, 2016, the Texas Commission on Environmental Quality (TCEQ) submitted a revision to the major NSR program to remove from the Texas SIP the Compliance History provisions at 30 TAC Sections 116.120-116.123, 116.125 and 116.126. On February 21, 2017, the TCEQ submitted three separate revisions to the Texas SIP revising the public notice provisions applicable to air quality permit applications.

The accompanying Technical Support Documents for this action include a detailed analysis of the submitted revisions to the Texas SIP. In many instances the revisions are minor or non-substantive in nature and do not change the intent of the originally approved SIP requirements. Following is a summary of our analysis for the submitted revisions.

The Chapter 116 Compliance History provisions were initially adopted by the State on June 17, 1998, at 30 TAC Sections 116.120-116.126. These revisions were submitted to the EPA as a SIP revision on July 22, 1998. The EPA approved these requirements into the SIP on September 18, 2002 at 67 FR 58697.

The TCEQ repealed the requirements of 30 TAC Section 116.124 on September 2, 1999. The EPA approved this repeal on January 6, 2014 at 79 FR 551. The TCEQ repealed the remaining provisions at 30 TAC Sections 116.120-116.123, 116.125 and 116.126 on August 7, 2002 and replaced the requirements with media neutral compliance history requirements under 30 TAC Chapter 60 pursuant to the requirements of Texas House Bill 2912. The TCEQ did not submit the repeal of 30 TAC Sections 116.120-116.123, 116.125 and 116.126 at the time of the state rulemaking. The repeal of these requirements was submitted on December 12, 2016 as Rule Project Number 2016-028-SIP-NR.

The repeal of the remaining compliance history provisions at 30 TAC Sections 116.120-116.123, 116.125 and 116.126 is approvable. This repeal was developed in accordance with the CAA and the State provided reasonable notice and public hearing. The repeal of these provisions will remove obsolete requirements from the Texas SIP. The EPA has determined it is appropriate to approve the repeal and removal of these provisions from the SIP since there are no federal requirements to include comparable provisions in a SIP. This repeal will have no negative impact on the Texas New Source Review program because the SIP-approved permit programs do not rely on the repealed Compliance History provisions. Therefore, we conclude that this repeal maintains consistency with federal requirements for SIP development and New Source Review permitting, and therefore, will not interfere with attainment or reasonable further progress.

On February 21, 2017, the TCEQ submitted three separate revisions to the Texas SIP revising the public notice provisions applicable to air quality permit applications. The revisions to 30 TAC Chapters 39 and 55 submitted under Rule Project No 2015-018-080-LS make non-substantive revisions to the existing SIP requirements. The revisions to repeal the Chapter 116 public notice provisions submitted under Rule Project No. 2016-026-116-AI remove obsolete requirements that have been replaced with the existing SIP public notice provisions in Chapter 39. The revisions to 30 TAC Chapter 39 and 55 submitted under Rule Project No. 2016-030-039-LS substantively revise the existing public notice SIP requirements for concrete batch plant standard permits such that the notice requirements are consolidated into one 30-day notice period that satisfies the requirements of minor NSR public participation. The EPA has determined it is appropriate to approve these three revisions to the Texas SIP because these revisions continue to be consistent with federal requirements for public notice and therefore, will not interfere with attainment or reasonable further progress.

We are proposing to approve revisions to the Texas SIP that revise the NSR permitting and public notice requirements. We have determined that the revisions submitted on December 12, 2016 were developed in accordance with the CAA and EPA's regulations, policy and guidance for NSR permitting. Therefore, under section 110 of the Act, the EPA proposes approval of the following revisions to the Texas SIP:

• Repeal of 30 TAC Section 116.120—Applicability—adopted on November 2, 2016, and submitted on December 12, 2016;

• Repeal of 30 TAC Section 116.121—Exemptions—adopted on November 2, 2016, and submitted on December 12, 2016;

• Repeal of 30 TAC Section 116.122—Contents of Compliance History—adopted on November 2, 2016, and submitted on December 12, 2016;

• Repeal of 30 TAC Section 116.123—Effective Dates—adopted on November 2, 2016, and submitted on December 12, 2016;

• Repeal of 30 TAC Section 116.125—Preservation of Existing Rights and Procedures—adopted on November 2, 2016, and submitted on December 12, 2016; and

• Repeal of 30 TAC Section 116.126—Voidance of Permit Applications—adopted on November 2, 2016, and submitted on December 12, 2016.

Additionally, we have determined that the revisions submitted on February 21, 2017, were developed in accordance with the CAA and EPA's regulations, policy and guidance for public notice for air permitting. Under section 110 of the Act, the EPA proposes to approve the following revisions into the Texas SIP:

• Revisions to 30 TAC Section 39.405 adopted on December 9, 2015, and submitted on February 21, 2017;

• Revisions to 30 TAC Section 39.411 adopted on December 7, 2016, and submitted on February 21, 2017;

• Revisions to 30 TAC Section 39.419 adopted on December 9, 2015, and submitted on February 21, 2017;

• Revisions to 30 TAC Section 39.603 adopted on December 7, 2016, and submitted on February 21, 2017;

• Revisions to 30 TAC Section 55.152 adopted on December 7, 2016, and submitted on February 21, 2017;

• Withdrawal of 30 TAC Section 55.156(e) from the Texas SIP as adopted on December 9, 2015, and submitted on February 21, 2017; and the

• Repeal of 30 TAC Sections 116.130-116.134, 116.136, and 116.137 from the Texas SIP as adopted on November 2, 2016 and submitted on February 21, 2017.

We also propose to revise the amendatory language at 40 CFR 52.2270(c) to identify specific provisions adopted by the State were not submitted for inclusion in the Texas SIP. We propose to revise the language at 40 CFR 52.2270(c) to clearly indicate that the Texas SIP does not include the revisions to 30 TAC Sections 39.405(h(1)(A) and 39.602(c) as adopted on December 9, 2015, or 30 TAC Section 39.411(e)(10) as adopted on December 7, 2016.

In this rule, the EPA is proposing to include in a final rule regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, the EPA is proposing to incorporate by reference the revisions to the Texas regulations as described in the Final Action section above. The EPA has made, and will continue to make, these materials generally available through www.regulations.gov or at the EPA Region 6 Office (please contact Adina Wiley for more information).

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 approve state choices, provided that they meet the criteria of the CAA. Accordingly, this action merely proposes to approve state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:

• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);

• Is not an Executive Order 13771 (82 FR 9339, February 2, 2017) regulatory action because SIP approvals are exempted under Executive Order 12866;

• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);

• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.);

• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);

• Does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);

• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);

• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);

• Is not subject to requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA; and

• Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).

In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).

Throughout this document wherever “we,” “us,” or “our” is used, we mean the EPA.

Under section 109 of the CAA, we establish NAAQS to protect human health and public welfare. In 1997, we established a new annual NAAQS for PM2.5 of 15 micrograms per cubic meter (μg/m3), and a new 24-hour NAAQS for PM2.5 of 65 μg/m3 (62 FR 38652, July 18, 1997). In 2006, we revised the 24-hour PM2.5 NAAQS to 35 μg/m3 (71 FR 61144, October 17, 2006).1 The CAA requires states to submit, within three years after promulgation of a new or revised standard, SIPs meeting the applicable “infrastructure” elements of sections 110(a)(1) and (2). One of these applicable infrastructure elements, CAA section 110(a)(2)(D)(i), requires SIPs to contain “good neighbor” provisions to prohibit certain adverse air quality effects on neighboring states due to interstate transport of pollution. There are four sub-elements within CAA section 110(a)(2)(D)(i). This action reviews how the first two sub-elements of the good neighbor provisions at CAA section 110(a)(2)(D)(i)(I) were addressed in an infrastructure SIP submission from Texas for the 1997 and 2006 PM2.5 NAAQS. These sub-elements require that each SIP for a new or revised NAAQS contain adequate provisions to prohibit any emissions activity within the state from emitting air pollutants that will “contribute significantly to nonattainment” or “interfere with maintenance” of the applicable air quality standard in any other state.

The EPA has addressed the interstate transport requirements of CAA section 110(a)(2)(D)(i)(I) with respect to PM2.5 in several past regulatory actions. Most recently, in 2011 we promulgated the Cross-State Air Pollution Rule (CSAPR) in order to address the obligations of states—and of the EPA when states have not met their obligations—under CAA section 110(a)(2)(D)(i)(I) to prohibit air pollution contributing significantly to nonattainment in, or interfering with maintenance by, any other state with regard to several NAAQS, including the 1997 annual and 2006 24-hour PM2.5 NAAQS.2

CSAPR replaced the Clean Air Interstate Rule (CAIR) which was promulgated in 2005 for the 1997 PM2.5 and 1997 ozone NAAQS (May 12, 2005, 70 FR 25172). CAIR was remanded to the EPA by the D.C. Circuit in North Carolina v. EPA, 531 F.3d 896 (D.C. Cir. 2008), modified on reh'g, 550 F.3d 1176. For more discussion on CSAPR and CAIR, please see EPA's August 8, 2011 CSAPR final rulemaking action (76 FR 48208).

To address Texas' transport obligation under CAA section 110(a)(2)(D)(i)(I) with regard to the 1997 annual PM2.5 NAAQS, CSAPR established Federal Implementation Plan (FIP) requirements for affected electric generating units (EGUs) in Texas, including emissions budgets that apply to the EGUs' collective annual emissions of sulfur dioxide (SO2) and nitrogen oxides (NOX).3 In July 2015, the D.C. Circuit issued a decision on a range of challenges to CSAPR in EME Homer City Generation, L.P. v. EPA (EME Homer City II) denying most claims but remanding several CSAPR emissions budgets to the EPA for reconsideration, including the Phase 2 SO2 budget for Texas.4 To address the Phase 2 SO2 budget remand we issued a final rule withdrawing the FIP provisions that required affected EGUs in Texas to participate in Phase 2 of the CSAPR trading programs for annual emissions of SO2 and NOX (82 FR 45481, September 29, 2017). In that final rule we also determined that emissions 5 from sources in Texas will not contribute significantly to nonattainment in, or interfere with maintenance by, any other state with regard to the 1997 PM2.5 NAAQS and that we therefore have no obligation to issue new FIP requirements for Texas sources to address transported PM2.5 pollution under CAA section 110(a)(2)(D)(i)(I) with regard to that NAAQS.

Relevant to this proposed action, Texas made the following SIP submittals to address CAA requirements to prohibit emissions which will significantly contribute to nonattainment or interfere with maintenance of the 1997 and 2006 PM2.5 NAAQS in other states: (1) An April 4, 2008 submittal stating that the State had addressed any potential CAA section 110(a)(2) infrastructure issues associated with the 1997 PM2.5 NAAQS, including the four sub-elements for interstate transport (CAA section 110(a)(2)(D)(i)), (2) a separate but similar May 1, 2008 submittal which discussed how the four sub-elements of the good neighbor provision were addressed with respect to the 1997 PM2.5 NAAQS, and (3) a November 23, 2009 submittal which addressed all the CAA section 110(a)(2) infrastructure elements, including the four sub-elements of the good neighbor provision, for the 2006 PM2.5 NAAQS. The SIP submittals may be accessed through the www.regulations.gov website (Docket EPA-R06-OAR-2016-0716). In these SIP revisions, Texas relied on its participation in the CAIR program to conclude that the State had addressed its obligation to prohibit emissions which will significantly contribute to nonattainment or interfere with maintenance of the 1997 and 2006 PM2.5 NAAQS in other states.

For the reasons described below, this action proposes to approve the state's three SIP submittals with respect to the state's conclusions regarding the first two sub-elements of the good neighbor provisions at CAA section 110(a)(2)(D)(i)(I) for the 1997 and 2006 PM2.5 NAAQS. In 2011, we originally proposed to disapprove the portion of the November 23, 2009 submittal that intended to demonstrate that the SIP met the requirements of CAA section 110(a)(2)(D)(i)(I) for the 2006 PM2.5 NAAQS (71 FR 20602, April 13, 2011). However, in a separate Federal Register action published in conjunction with this current proposal we are withdrawing that original proposal and in this notice we now are proposing to approve the same portion of the submittal. See Docket No. EPA-R06-OAR-2011-0335 in www.regulations.gov.

Each of the above-referenced Texas SIP submittals relied on the State's participation in the CAIR allowance trading programs to support a conclusion that the Texas SIP had adequate provisions to prohibit emissions which will significantly contribute to nonattainment or interfere with maintenance of the 1997 and 2006 PM2.5 NAAQS in any other state. While CAIR was still in place at the time the State submitted its SIPs, the CAIR rule had been remanded by the D.C. Circuit in 2008 based on the Court's conclusion that the rule was “fundamentally flawed” and must be replaced “from the ground up.” North Carolina, 531 F.3d 929-30, modified, 550 F.3d 1176 (2008). Moreover, we began implementation of CSAPR in 2015, and therefore neither the states nor EPA are currently implementing the annual SO2 and NOX trading program promulgated in CAIR. Accordingly, we cannot approve the State's SIP submissions based on the implementation of CAIR that sought to address the provisions of the good neighbor provision for any NAAQS. However, more recent information discussed in detail below, provides support for our proposed approval of the conclusions in the SIP submittals that the State will not significantly contribute to nonattainment or interfere with maintenance of these NAAQS in any other state.

Air quality modeling conducted for the 2011 CSAPR rulemaking projected the effect of emissions on ambient air quality monitors (receptors). The modeling projected that a receptor located in Madison County, Illinois (monitor ID 171191007) would have difficulty attaining and maintaining both the 1997 and 2006 PM2.5 NAAQS in 2012 (76 FR 48208, 48233 and 48235). The modeling also showed that Texas emissions were projected to contribute more than the threshold amount of PM2.5 pollution necessary in order to be considered “linked” to the Madison County receptor for the 1997 and 2006 PM2.5 NAAQS (76 FR 48208, 48239-43). This was the only PM2.5 receptor with projected air quality problems to which Texas was found to be linked.

In CSAPR we used air quality projections for the year 2012, which was also the intended start year for implementation of the CSAPR Phase 1 EGU emission budgets, to identify receptors projected to have air quality problems. The CSAPR final rule record also contained air quality projections for 2014, which was the intended start year for implementation of the CSAPR Phase 2 EGU emission budgets. The 2014 modeling results projected that the Madison County receptor would have maximum “design values” of 15.02 μg/m3 for annual PM2.5 of and 35.3 μg/m3 for 24-hour PM2.5 before considering the emissions reductions anticipated from implementation of CSAPR.6 These values are below the values of 15.05 and 35.5 μg/m3 that we used to determine whether a particular PM2.5 receptor should be identified as having air quality problems that may trigger transport obligations in upwind states with regard to the 1997 annual or 2006 24-hour PM2.5 NAAQS, respectively (82 FR 45481, 45485-86, September 29, 2017).

As noted above, in our September 29, 2017 final rule addressing the remand for the annual SO2 and NOX emissions budgets we determined that emissions from Texas sources will not contribute significantly to nonattainment in, or interfere with maintenance by, any other state with regard to the 1997 PM2.5 NAAQS (82 FR 45481, September 29, 2017). As explained in the separate September 29, 2017 action, our 2014 base case modeling in the CSAPR final rule also showed that (1) the Madison County receptor was projected to no longer have air quality problems sufficient to trigger transport obligations with regard to the 2006 24-hour PM2.5 NAAQS and (2) no other 24-hour PM2.5 receptors with projected air quality problems were linked to Texas. Due to those findings, we now propose to determine that emissions from Texas sources will not contribute significantly to nonattainment in, or interfere with maintenance by, any other state with regard to the 2006 24-hour PM2.5 NAAQS. Given the determination for the 1997 annual PM2.5 NAAQS made in the September 29, 2017 final rule and our proposed determination for the 2006 24 PM2.5 NAAQS, we are now proposing to approve the portions of three Texas SIP submittals to the extent they conclude that the state has addressed interstate transport of air pollution which will significantly contribute to nonattainment or interfere with maintenance of the 1997 and 2006 PM2.5 NAAQS in other states.

Based on our analysis of the modeling data from the 2011 CSAPR rulemaking provided above, we are proposing to approve the relevant portions of the Texas SIP submittals that Texas emissions will not significantly contribute to nonattainment or interfere with maintenance of the 1997 and 2006 PM2.5 NAAQS in other states. It should be noted, as discussed above, that we are not proposing to approve the State's analyses to the extent they rely on the State's prior participation in the CAIR allowance trading program, nor are we are proposing to approve any Texas SIP revisions that pertain to implementation of CAIR.

We are proposing to approve portions of three Texas SIP submittals pertaining to the CAA section 110(a)(2)(D)(i)(I) requirements based on our conclusion, which is consistent with the state's ultimate conclusion, that emissions from Texas will not significantly contribute to nonattainment or interfere with maintenance of the 1997 and 2006 PM2.5 NAAQS in other states. Specifically, we propose to approve (1) the portions of the April 4, 2008 and May 1, 2008 SIP submittals for the 1997 PM2.5 NAAQS and (2) the portion of the November 23, 2009 submittal for the 2006 PM2.5 NAAQS, as they pertain to CAA section 110(a)(2)(D)(i)(I).

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 approve state choices, provided that they meet the criteria of the CAA. Accordingly, this action merely proposes to approve state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:

• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);

• Is not an Executive Order 13771 (82 FR 9339, February 2, 2017) regulatory action because SIP approvals are exempted under Executive Order 12866;

• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);

• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.);

• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);

• Does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);

• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);

• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);

• Is not subject to requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA; and

• Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).

In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the proposed rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).

I. What action is being proposed?

This rulemaking proposes to approve Kentucky's September 13, 2017, SIP revision in support of Kentucky's petition to opt-out of the federal RFG requirements in Boone, Campbell, and Kenton Counties.1 Specifically, EPA is proposing to approve Kentucky's changes to the maintenance plan mobile emissions inventory and the associated MVEBs related to its redesignation request for the Kentucky portion of the Cincinnati-Hamilton 2008 8-hour ozone maintenance area to reflect removal of reliance on federal RFG requirements. As part of this proposed approval, EPA is also proposing to find that the Commonwealth has demonstrated that removing the federal RFG requirements in Boone, Campbell, and Kenton Counties will not interfere with attainment or maintenance of any national ambient air quality standards (NAAQS or standard) or with any other applicable requirement of the CAA.

On August 26, 2016, Kentucky submitted a 2008 8-hour ozone redesignation request and maintenance plan for the Cincinnati-Hamilton Area, which EPA approved on July 5, 2017 (82 FR 30976).2 With its redesignation request, Kentucky included a maintenance demonstration plan that estimates emissions through 2030 that modeled RFG because Kentucky previously opted into the RFG program. However, through this SIP revision, KDAQ is updating the mobile (on-road and non-road) emissions inventory for that maintenance plan (including the MVEBs) to reflect Kentucky's petition to opt-out of the RFG requirements for Boone, Campbell, and Kenton counties in the Northern Kentucky Area. The updates are summarized in Kentucky's submittal.

In support of the September 13, 2017, SIP revision, Kentucky has evaluated whether removing reliance on the federal RFG requirements would interfere with air quality in the Area. To make this demonstration of noninterference, Kentucky completed a technical analysis, including modeling, to estimate the change in emissions that would result from removing RFG from Boone, Campbell, and Kenton Counties in the Northern Kentucky Area.

In the noninterference demonstration, Kentucky used EPA's Motor Vehicle Emissions Simulator (MOVES) to develop its projected emissions inventory according to EPA's guidance for on-road mobile sources using MOVES version 2014a.3 Future-year on-road mobile source emissions estimates for volatile organic compounds (VOC) and nitrogen oxides (NOX) for years 2020 and 2030 were generated with MOVES2014a without RFG. Emissions estimates were interpolated for the year 2025. The noninterference demonstration showed compliance with and maintenance of the 2008 8-hour ozone NAAQS by showing that current and future emissions of NOX and VOC remain at or below the 2014 base year emissions inventory without the use of RFG. For more detailed information on the current approved maintenance plan, see EPA's May 1, 2017 (82 FR 20297), proposed approval of Kentucky's maintenance plan for the 2008 8-hour ozone NAAQS.

In this action, EPA is proposing to approve the revision to the Commonwealth's maintenance plan emissions inventory and associated MVEBs to remove reliance on emissions reductions from the federal RFG program requirements, and to find that Kentucky's noninterference demonstration supports the conclusion that removal of reliance on federal RFG requirements in Boone, Campbell, and Kenton Counties in the Northern Kentucky Area will not interfere with attainment or maintenance of any NAAQS or with any other applicable requirement of the CAA.

Northern Kentucky was included in the Cincinnati-Hamilton Area which was originally designated as a moderate nonattainment area for the 1-hour ozone standard on November 6, 1991 (56 FR 56694). In 1995, Kentucky voluntarily opted into the RFG program under Phase I of a two-phase nationwide program to reduce the volatility of commercial gasoline during the summer ozone season. Kentucky elected to stay in the program under Phase II which was more stringent than Phase I.

On July 18, 1997, EPA promulgated a revised 8-hr ozone standard of 0.08 parts per million (ppm). This standard was more stringent than the 1-hour ozone standard. On June 19, 2000 (65 FR 37879), the Cincinnati-Hamilton 1-hour nonattainment Area was redesignated as attainment for the 1-hour ozone NAAQS, and was considered to be a maintenance area subject to a CAA section 175A maintenance plan for the 1-hour ozone NAAQS. On April 30, 2004, EPA designated the Cincinnati-Hamilton OH-KY-IN Area under subpart 1 as a “basic” 1997 8-hour ozone NAAQS nonattainment area (69 FR 23857).4 On August 5, 2010 (75 FR 47218), the Kentucky portion of the Cincinnati-Hamilton 1997 8-hour ozone area was redesignated to attainment. On March 12, 2008, EPA revised both the primary and secondary NAAQS for ozone to a level of 0.075 ppm to provide increased protection of public health and the environment. See 73 FR 16436 (March 27, 2008). The 2008 ozone NAAQS retains the same general form and averaging time as the 0.08 ppm NAAQS set in 1997, but is set at a more protective level. Under EPA's regulations at 40 CFR part 50, the 2008 8-hour ozone NAAQS is attained when the 3-year average of the annual fourth highest daily maximum 8-hour average ambient air quality ozone concentrations is less than or equal to 0.075 ppm. See 40 CFR 50.15.

Effective July 20, 2012, EPA designated any area that was violating the 2008 8-hour ozone NAAQS based on the three most recent years (2008-2010) of air monitoring data as a nonattainment area. See 77 FR 30088 (May 21, 2012). The Cincinnati-Hamilton, OH-KY-IN Area was designated as a marginal ozone nonattainment area.5 See 40 CFR 81.318. Areas that were designated as marginal nonattainment areas were required to attain the 2008 8-hour ozone NAAQS as expeditiously as possible but no later than July 20, 2015, based on 2012-2014 monitoring data. On May 4, 2016 (81 FR 26697), EPA published its determination that the Cincinnati-Hamilton, OH-KY-IN Area had attained the 2008 8-hour ozone NAAQS by the attainment deadline.

The 1990 amendments to the CAA designed the RFG program to reduce ozone levels in the largest metropolitan areas in the country with the worst ground-level ozone or smog problems by reducing vehicle emissions of compounds that form ozone, specifically VOC. The 1990 CAA amendments, specifically section 211(k)(5), directed EPA to issue regulations that specify how gasoline can be “reformulated” so as to result in significant reductions in vehicle emissions of ozone-forming and toxic air pollutants relative to the 1990 baseline fuel, and to require the use of such reformulated gasoline in certain “covered areas.” The Act defined certain nonattainment areas as “covered areas” which are required to use RFG and provided other areas with an ability to “opt-in” to the federal RFG program.6 Of relevance here is CAA section 211(k)(6), which provides that upon application of the Governor of a State, the Administrator shall apply the prohibition contained in section 211(k)(5) for areas to “opt-in” to the federal RFG program. In 1993,7 the Governor of the Commonwealth of Kentucky petitioned the Administrator to “opt-in” to the RFG program for the Northern Kentucky Area which consisted of Boone, Campbell, and Kenton Counties.

EPA first published regulations for the federal RFG program on February 16, 1994 (59 FR 7716). These regulations constituted Phase I of a two-phase nationwide program. A current listing of the RFG requirements for states can be found on EPA's website at: https://www.epa.gov/gasoline-standards. The federal RFG regulations also contain provisions, at 40 CFR 80.72, establishing criteria and procedures for opting out of the program for those states that had previously voluntarily opted into the program (“opt-out provisions”). For example, the opt-out provisions require that a governor, or his or her authorized representative, submit an opt-out petition to the Administrator of the Agency. The opt-out petition must include certain information, including a description of how, if at all, reformulated gasoline has been relied upon as a control measure in any state or local implementation plan or in any proposed plan that is pending before EPA. This would include, for example, attainment as well as maintenance plans. The petition must also include an explanation of whether the state is intending to submit a revision to an approved or pending plan that does not use RFG as a control measure, and a description of alternative air quality measures, if any, that will replace the use of RFG; a description of the current status of any proposed revision to an approved or pending plan that uses RFG; and a projected schedule for the plan revision submission. See 40 CFR 80.72(b)(3) and (b)(4).

On April 18, 2017, Kentucky submitted a petition to the EPA Administrator requesting to opt-out of the federal RFG program in the Northern Kentucky Area and as stated above, this SIP revision is submitted in support of that petition (particularly the requirements of 40 CFR 80.72(b)(3) and (b)(4)).8 Kentucky's opt-out petition will be acted on by the Administrator in a separate action, and if approved in that separate action, will establish the effective date of the opt-out, which cannot be less than 90 days from the effective date of the approval of the SIP revision that is the subject of today's proposal. EPA will also publish a notice in the Federal Register to notify the public of the effective date of any opt-out approval.

The modeling associated with KDAQ's maintenance plan for the 2008 8-hour ozone NAAQS is premised upon the future-year emissions estimates for 2017, 2020, and 2030, which are based on the RFG requirement. To support Kentucky's requested SIP revision to remove the maintenance plan's reliance on the federal RFG requirements in Boone, Campbell, and Kenton Counties, the Commonwealth must demonstrate that the requested change will satisfy section 110(l) of the CAA. Section 110(l) requires that a revision to the SIP not interfere with any applicable requirement concerning attainment and reasonable further progress (as defined in section 171), or any other applicable requirement of the Act. Kentucky submitted a non-interference demonstration with this SIP revision and EPA is proposing to find that the analysis demonstrates noninterference based on an evaluation of current air quality monitoring data and the information provided in the noninterference demonstration.

EPA evaluates each section 110(l) noninterference demonstration on a case-by-case basis considering the circumstances of each SIP revision. EPA interprets section 110(l) as applying to all NAAQS that are in effect, including those that have been promulgated but for which EPA has not yet made designations. The degree of analysis focused on any particular NAAQS in a noninterference demonstration varies depending on the nature of the emissions associated with the proposed SIP revision. EPA's section 110(l) analysis of the noninterference demonstration included as part of Kentucky's September 13, 2017, SIP revision is provided below.

The RFG program is designed to reduce ozone levels and air toxics in areas that are required to or volunteered to adopt the program. RFG gasoline reduces motor vehicle emissions of the ozone precursors, NOX and VOC (mainly VOC), through fuel reformulation. On September 13, 2017, KDAQ submitted a SIP revision along with a corresponding noninterference demonstration to support Kentucky's separate petition to opt-out of the RFG requirements for Boone, Campbell, and Kenton Counties. This noninterference demonstration includes an evaluation of the impact that removing RFG from these counties would have on the Area's ability to attain or maintain the 2008 ozone NAAQS and any other NAAQS in the Kentucky Area.9 Kentucky's noninterference analysis also evaluated the impact of the removal of RFG on the Area's ability to attain or maintain the ozone, particulate matter (PM),10 nitrogen dioxide (NO2), sulfur dioxide (SO2), and carbon monoxide (CO) NAAQS.

KDAQ's noninterference analysis utilized EPA's MOVES2014a emission modeling system to estimate emissions for years 2017, 2020, and 2030 for on-road and non-road mobile sources. See Appendix E-1 and E-2 of the September 13, 2017, submittal for detailed modeling protocol.11 The NONROAD2008 model within MOVES2014a was used to model the non-road sources. These mobile source emissions are used as part of the evaluation of the potential impacts to the NAAQS that might result exclusively from removing the RFG requirements. NOX and VOC emissions were calculated for a typical summer July day.

As summarized in Tables 1 and 2, below, the MOVES model projects small increases in on-road mobile source VOC and NOX emissions in the Northern Kentucky portion of the Cincinnati-Hamilton OH-IN-KY 2008 8-hour Ozone Area from removing the federal RFG requirements. On-road mobile sources include vehicles used on roads for transportation of passengers or freight. Daily on-road mobile VOC emissions are projected to increase by 0.25 ton in 2017 down to 0.05 ton in 2030 during the high ozone season.12 Daily on-road NOX emissions are projected to increase by 0.29 ton in 2017 down to 0.06 ton in 2030. The modeling shows an overall downward trend in on-road emissions from removing RFG from the area. Daily VOC emissions decrease by 64.5 percent and daily NOX emissions decrease by 74.6 percent.

Tables 3 and 4, below, show the total projected emissions of VOC and NOX from all sectors in the Northern Kentucky portion of the Cincinnati-Hamilton OH-KY-IN 2008 8-hour Ozone Area. Kentucky's emissions inventory for its portion of the Area provides 2011 anthropogenic emissions data for NOX and VOC for the following general source categories: Point (Electric Generating Units and Non-Electric Generating Units and aircraft emissions),14 area, non-road mobile, and on-road mobile. All emissions information provided is based on the partial county boundaries, through the applicable census tracts, that comprise the Kentucky portion of the Area. Tables 3 and 4, below, provides a summary of the emissions inventory.

Emissions reported for 2014 assume the use of RFG for Boone, Campbell, and Kenton Counties whereas emissions from 2017 through 2030 assume no RFG.

There were little to no changes in NOX and VOC emissions from the point source categories that would impact the RFG removal in the Northern Kentucky Area. The original point source categories inventory contains actual point source emissions data for facilities located within the nonattainment boundary for the Kentucky portion of the Area based on the Kentucky Emissions Inventory database.15

Area sources are small emission stationary sources which, due to their large number, collectively have significant emissions (e.g., dry cleaners, service stations). The modeling results show a reduction in VOC emissions and little to no change in NOX emissions by removing RFG from these sources

Non-road mobile sources include vehicles, engines, and equipment used for construction, agriculture, recreation, and other purposes that do not use roadways (e.g., lawn mowers, construction equipment, and railroad locomotives). Modeling results indicate there are slight VOC emissions increases from removing RFG. From 2017 to 2030, the VOC emissions increases fall within a range of 0.22 tsd to 0.24 tsd in the Northern Kentucky Area. The NOX emissions remain the same from 2017 to 2030 when RFG is removed. See Appendix E-2 of the submittal.16

Overall, the modeling shows VOC emissions decrease from the 2014 attainment year to the 2030 “out year” by 3.66 tsd which is a 20.5 percent reduction. NOX emissions also decrease from the 2014 attainment year to the 2030 “out year” by 10.88 tsd which is a 39.7 percent NOX reduction without RFG in the Northern Kentucky portion of the Cincinnati-Hamilton OH-KY-IN Area 2008 8-hour Ozone Area.

As a previous 1-hour ozone nonattainment area, Kentucky opted Boone, Campbell, and Kenton Counties into the federal RFG requirements for high ozone season gasoline to help bring the area into attainment for the 1-hour ozone NAAQS. This control measure continues to apply in the Northern Kentucky Area because the Commonwealth did not, until now, petition for the removal of the federal RFG requirements. The RFG program has contributed toward lowering VOC and NOX emissions in the Northern Kentucky Area. Implementation of federal control measures such as Tier 3 Motor Vehicle Emissions and Fuel Standards,17 Heavy-Duty Engine and Vehicle Standards and Highway Diesel Fuel Sulfur Control Requirements,18 Greenhouse Gas Emissions and Fuel Efficiency Standards for Medium and Heavy-Duty Engines and Vehicles-Phase 2,19 and Model Year 2017 and Later Light-Duty Vehicle Greenhouse Gas Emissions and Corporate Average Fuel Economy Standards,20 along with fleet turnover, further reduced NOX and VOC emissions in the area. As a result, the Northern Kentucky Area was redesignated to attainment for the 1-hour ozone NAAQS, the 1997 8-hour ozone NAAQS, and the 2008 8-hour ozone NAAQS. The Northern Kentucky Area is continuing to meet the 1-hour ozone NAAQS and the 1997 8-hour ozone NAAQS, even though these NAAQS have been revoked,21 as well as the 2008 8-hour ozone NAAQS, based on recent air quality monitoring data.22 The 2008 ozone NAAQS is met when the annual fourth-highest daily maximum 8-hour average concentration, averaged over 3 years is 0.075 ppm or less. The 2015 ozone NAAQS, as published in a final rule on October 26, 2015 (80 FR 65292), is met when the annual fourth-highest daily maximum 8-hour average concentration, averaged over 3 years is 0.070 ppm or less. The trend in monitoring levels for ozone for the Northern Kentucky portion of the Cincinnati-Hamilton OH-KY-IN Area is shown in Table 5, with the current monitoring levels for the Boone and Kenton County monitors for the period of 2014-2016 being 0.062 ppm and 0.070 ppm, respectively.

EPA also evaluated the potential increase in the VOC and NOX precursor emissions and whether it is reasonable to conclude that the requested removal of the RFG requirements in Northern Kentucky during the high ozone season would cause the Area to violate any ozone NAAQS. Table 5 shows that there is an overall downward trend in ozone concentrations in the Northern Kentucky Area. This decline can be attributed to federal and state programs in addition to those mentioned above that have led to significant emissions reductions in ozone precursors, such as the federal interstate transport rule known as the Cross State Air Pollution Rule (CSAPR), federal standards in on-road and non-road mobile source sectors such as the Corporate Average Fuel Economy (CAFÉ) standards (See 75 FR 25324), and Tier Motor Vehicle Emissions and Fuel Standards (79 FR 23414). Given the results of Kentucky's emissions analysis, the downward trend in precursor emissions, and the current ozone concentrations in the Northern Kentucky Area, EPA is proposing to find that removing reliance on RFG requirements in Boone, Campbell, and Kenton Counties will not interfere with Kentucky's ability to maintain the 2008 8-hour ozone NAAQS.

EPA initially established NAAQS for CO on April 30, 1971 (36 FR 8186). The standards were set at 9 ppm as an 8-hour average and 35 ppm as a 1-hour average, neither to be exceeded more than once per year. On November 6, 1971 (56 FR 56694), EPA designated areas for the 8-hour CO NAAQS. The Northern Kentucky counties of Boone, Campbell, and Kenton have never been designated nonattainment for any CO NAAQS. EPA retained the 1-hour and 8-hour CO NAAQS on August 31, 2011, and Kentucky has continued to maintain compliance with the NAAQS due to non-RFG federal control measures put in place. RFG requirements will have little to no impacts on CO emissions because, as mentioned earlier, the RFG program was developed to address emissions of the ozone precursors, NOX and VOC. As a result, EPA is proposing to find that removing reliance on RFG requirements in Boone, Campbell, and Kenton Counties will not interfere with Kentucky's ability to continue attaining the CO NAAQS.

The main precursor pollutants for PM2.5 are NOX, SO2, VOC, and ammonia. As mentioned above, the federal RFG requirements result in emissions benefits for VOC, NOX and air toxics. Over the course of several years, EPA has reviewed and revised the PM2.5 NAAQS a number of times. On July 16, 1997, EPA established an annual PM2.5 NAAQS of 15.0 micrograms per cubic meter (μg/m3), based on a 3-year average of annual mean PM2.5 concentrations, and a 24-hour PM2.5 NAAQS of 65 μg/m3, based on a 3-year average of the 98th percentile of 24-hour concentrations. See 62 FR 36852 (July 18, 1997). On September 21, 2006, EPA retained the 1997 Annual PM2.5 NAAQS of 15.0 μg/m3 but revised the 24-hour PM2.5 NAAQS to 35 μg/m3, based again on a 3-year average of the 98th percentile of 24-hour concentrations. See 71 FR 61144 (October 17, 2006). The 1997 Annual PM2.5 NAAQS has been revoked for all purposes effective October 24, 2016 (81 FR 58010). On December 14, 2012, EPA retained the 2006 24-hour PM2.5 NAAQS of 35 μg/m3 but revised the annual primary PM2.5 NAAQS to 12.0 μg/m3, based again on a 3-year average of annual mean PM2.5 concentrations. See 78 FR 3086 (January 15, 2013). The Northern Kentucky area was designated as unclassifiable/attainment on April 15, 2015 (80 FR 18535).

PM2.5 levels across Kentucky declined from 1999 to 2016. In 2016, there were 19 PM2.5 monitors in Kentucky including one in Campbell County. The Campbell County PM2.5 monitor calculated a 3-weighted average design value of 8.9 μg/m3. The largest sources of PM2.5 in Kentucky are from fires, agriculture, dust, fuel combustion, and industrial processes.23 Moreover, there have been a number of studies which have indicated that SO2 is the primary driver of PM2.5 formation in the Southeast.24 Opting out of the RFG requirements in the Area will have little to no impact on the precursor emissions as indicated by the decline in VOC and NOX emissions in Tables 3 and 4 above.

Based on this information and the current attainment status of the Cincinnati-Hamilton OH-KY-IN 2012 p.m.2.5 Area, EPA is proposing to find that removing reliance on RFG requirements in Boone, Campbell, and Kenton Counties will not interfere with Northern Kentucky's ability to maintain the 2012 PM2.5 NAAQS.

On February 9, 2010 (75 FR 6474), EPA strengthen the NO2 standards. All of the counties in Kentucky were designated unclassifiable/attainment for the 2010 NO2 NAAQS on February 17, 2012 (77 FR 9532). There are both primary and secondary standards for NO2. The primary NAAQS is an annual arithmetic mean that must not exceed 53 parts per billion (ppb). A 3-year average of the 98th percentile of daily maximum 1-hr averages must not exceed 100 ppb. The secondary standard is an annual arithmetic mean that must not exceed 53 ppb. In 2016, Kentucky operated seven NO2 monitors, including one in Campbell County. The 2014-2016 1-hr average design value for the Campbell County NO2 monitor is 30 ppb, with an annual mean of 2.31 ppb. Both of these values are significantly below the respective standards of 100 ppb and 53 ppb. Based on the technical analysis in Kentucky's September 13, 2017, noninterference demonstration, as shown in Table 4, there is a reduction in NOX emissions from the 2014 attainment year to the 2030 “out year” from 27.44 tsd to 16.56 tsd which is a 39.7 percent reduction overall.

Based on the amount of NOX reductions, the use of pollution control devices on power plants, industrial boilers, fleet turnover, and other federal control measures for motor vehicles, EPA is proposing to find that removing reliance on RFG requirements in Boone, Campbell and Kenton Counties will not interfere with Kentucky's ability to continue attaining the 2010 NO2 NAAQS in the Northern Kentucky Area.

On June 22, 2010 (75 FR 35520), EPA revised the SO2 standard. There are both primary and secondary standards for SO2. The primary SO2 NAAQS is a 3-year average of the 99th percentile of the daily maximum 1-hour concentration not to exceed 75 ppb. The secondary standard is a 3-hour concentration not to exceed 0.5 ppm more than once per year. In 2016, Kentucky operated 12 SO2 monitors, including one in Campbell County. The Campbell County SO2 monitor has a 2014-2016 design value of 30 ppb for the 1-hour SO2 NAAQS.

Based on the monitoring/modeling data, EPA is proposing to find that removing reliance on RFG requirements in Boone, Campbell, and Kenton Counties will not interfere with Kentucky's ability to maintain the SO2 NAAQS.

EPA is proposing to approve Kentucky's revision to its maintenance plan and corresponding noninterference demonstration, submitted on September 13, 2017, in support of Kentucky's separate petition to opt-out of the federal RFG requirements for Boone, Campbell, and Kenton Counties. Specifically, EPA is proposing to find that this change in removing reliance on the federal RFG requirements for Boone, Campbell, and Kenton Counties will not interfere with attainment or maintenance of the NAAQS or with any other applicable requirement of the CAA. Kentucky's September 13, 2017, SIP revision updates its maintenance plan and the associated MVEBs related to Kentucky's redesignation request for the Kentucky portion of the 2008 Cincinnati-Hamilton OH-IN-KY 8-hour Ozone Area to reflect emissions changes for opting out of the federal RFG requirements. EPA is proposing to approve the changes to update the 2008 maintenance plan and associated 2020 and 2030 MVEBs. The same criteria used to develop the MVEBs in the original SIP are used for this SIP revision. See Table 6 below.

EPA has preliminarily determined that Kentucky's September 13, 2017, SIP revision is consistent with the applicable provisions of the CAA, including section 110(l). In this action, EPA is not proposing to act on the Commonwealth's opt-out petition to the EPA Administrator to remove the federal RFG requirement for Boone, Campbell, and Kenton Counties. Any decision by the Administrator on the opt-out petition would occur in a separate action.

Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations. See 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the CAA. This action merely proposes to approve changes to the Commonwealth's maintenance plan emissions inventory and associated MVEBs to remove reliance on emissions reductions from the federal RFG program requirements. For that reason, this proposed action:

• Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);

• Is not an Executive Order 13771 (82 FR 9339, February 2, 2017) regulatory action because SIP approvals are exempted under Executive Order 12866.

• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);

• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.);

• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);

• Does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);

• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);

• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);

• Is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA; and

• Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).

In an April 13, 2011 action EPA proposed to disapprove the portion of a November 23, 2009 Texas SIP submittal that intended to demonstrate that the SIP met the requirements of CAA section 110(a)(2)(D)(i)(I) to prohibit emissions which will significantly contribute to nonattainment or interfere with maintenance of the 2006 24-hour PM2.5 NAAQS in other states (76 FR 20602). EPA is now withdrawing the proposal. In a separate Federal Register action published in conjunction with this withdrawal EPA is proposing to approve this portion of the SIP submittal. The rationale for the proposed approval is detailed in that proposal.

Consistent with the December 8, 2017, publication (82 FR 57905), OHS invites public comment on several specific changes being considered for the CLASS condition of the DRS as outlined in the Head Start Program Performance Standards. We also invite public comment on other improvements to the DRS based on feedback from stakeholders, grantees, and the results of the DRS implementation evaluation. In particular, we are considering changes to the CLASS condition with a goal of improving implementation and transparency of the DRS. Changes being considered include removal of the “lowest 10 percent” provision of the CLASS condition, an increase of the minimum thresholds for the Emotional Support and Classroom Organization domains to a score of 5, removal of the minimum threshold for the Instructional Support domain, and establishment of authority for the Secretary to set an absolute minimum threshold for the Instructional Support domain prior to the start of each fiscal year to be applied for DRS CLASS reviews in the same fiscal year. OHS requests feedback on these possible changes and alternative changes to the CLASS condition. Particularly in ways the Instructional Support and other thresholds could be set and/or adjusted that would incentivize continuous program improvement while acknowledging the current state of the field. OHS also invites feedback on other conditions of the DRS and the way it is implemented.

The Head Start program provides grants to local public and private non-profit and for-profit agencies to provide comprehensive education and child development services to economically disadvantaged children, from birth to age five, and families and to help young children develop the skills they need to be successful in school. Our agencies provide these families comprehensive services to support children's cognitive, social, and emotional development. In addition to education services, agencies provide children and their families with health, nutrition, social, and other services.

To drive program quality improvement, the Improving Head Start for School Readiness Act of 2007, Public Law 110-134, (the Act) required HHS to develop a system to facilitate designation of Head Start grantees delivering a high-quality and comprehensive program for a period of 5 years and required grantees not delivering high-quality and comprehensive services to enter open competition for continued funding. Prior to the Act, when HHS designated a Head Start agency, it remained a Head Start grantee indefinitely unless the grantee either relinquished funding or HHS terminated its grant.

To meet the requirement in the Act, HHS established the DRS, which is described in 45 CFR 1304.10 through 16. The DRS includes seven conditions. If an agency meets any of the seven conditions, it must compete with other providers in the community for renewed grant funding. The seven conditions are: (1) A deficiency under section 641A(c)(1)(A), (C), or (D) of the Act; (2) failure to establish, utilize, and analyze children's progress on agency-established School Readiness goals; (3) scores below minimum thresholds in the Classroom Assessment Scoring System: Pre-K (CLASS) domains or in the lowest 10 percent in any of the three domains of the agencies monitored in a given year unless the average score is equal to or above the standard of excellence; (4) revocation of a license to operate a center or program; (5) suspension from the program; (6) debarment from receiving federal or state funds or disqualified from the Child and Adult Care Food Program; or (7) an audit finding of at risk for failing to continue as “a going concern.” The Act also requires HHS to periodically evaluate whether or not the DRS criteria are applied in a manner that is transparent, reliable, and valid.

Section 641(c)(1)(D) of the Act requires the DRS to be based in part on classroom quality as measured under section 641A(c)(2)(F), which refers to a valid and reliable research-based observational instrument, implemented by qualified individuals with demonstrated reliability that assesses classroom quality. To include assessing multiple dimensions of teacher-child interactions that is linked to positive child development and later achievement. The third condition of the DRS is based on use of the CLASS, which is an observational measurement tool for assessing the quality of teacher-child interactions and classroom processes in three broad domains that support children's learning and development: Emotional Support, Classroom Organization, and Instructional Support.

Since HHS established the DRS, all grantees that had indefinite project periods have completed the DRS process. Based on CLASS data, observations collected throughout these cohorts, results of a recent evaluation, and feedback from the community, we are considering changes to the DRS in order to better improve implementation of the system, including changes to the CLASS condition.

There are concerns about some aspects of the CLASS condition of the DRS that have been raised by Head Start grantees as well as in the recent evaluation. First, the requirement for grantees with the lowest 10 percent of scores on any of the three CLASS domains to compete may not be optimally targeting the grantees for competition with the lowest measures of classroom quality. For example, grantees have been required to compete due to an Emotional Support score of 5.69, which is very close to the Standard of Excellence (a 6—which developers of the CLASS deem the highest quality). In addition, grantees scoring slightly higher than the minimum threshold in Instructional Support (e.g., score of 2.3) do not have to compete unless they fall into the lowest 10 percent of all grantees' scores for Instructional Support, which has been very close to the minimum threshold. We are considering an approach to establish higher specific thresholds that demonstrate an established acceptable level of quality in Emotional Support and Classroom Organization and an adjustable threshold for the Instructional Support domain where there is the greatest potential and need for program improvement.

Second, we understand that the delay between completion of the CLASS review and grantees knowing their DRS designation status, due to the need to collect and analyze a full monitoring year's CLASS scores to determine the lowest 10 percent. This creates uncertainty, stress, and concern among grantees, grantee staff, and families. Because classroom quality in Head Start programs is improving as demonstrated by recent analysis of data from the 2006, 2009, and 2014, cohorts of the Head Start Family and Child Experiences Survey (FACES),1 we are exploring options for the CLASS condition that would better balance an ability to drive quality improvement over time with an approach that would be more transparent, timely, and less burdensome for programs.

To inform our development of a notice of proposed rulemaking to change the DRS CLASS condition to meet the objectives described above, we are requesting public comments on several specific changes being considered. The changes under consideration are as follows:

1. Remove the “lowest 10 percent” provision of the CLASS condition described in 45 CFR 1304.11(c)(2).

2. Increase the minimum threshold described in 45 CFR 1304.11(c)(1)(i) for the Emotional Support domain from 4 to 5.

3. Increase the minimum threshold described in 45 CFR 1304.11(c)(1)(ii) for Classroom Organization from 3 to 5.

4. Remove the minimum threshold for the Instructional Support domain described in 45 CFR 1304.11(c)(1)(iii) and instead provide authority for the Secretary to set an absolute minimum threshold for the Instructional Support domain, considering the most recent CLASS data, by August 1 of each year to be used for CLASS Reviews conducted in the following fiscal year (October 1 through September 30).

Together, these changes would allow grantees to know by August 1, before CLASS Reviews are conducted for the coming fiscal year, the exact threshold of classroom quality in each of the three domains that will be used to determine which grantees will be subject to an open competition for funding and which grantees will receive renewed funding non-competitively. Grantees would no longer have to wait until several months following the conclusion of the CLASS reviews for the fiscal year (September 30) to learn the lowest 10 percent cutoff in each of the 3 domains. Setting minimum thresholds of 5 in the Emotional Support and Classroom Organization domains would set a clear and consistent expectation of quality for all Head Start programs. Allowing the Secretary to set the minimum threshold in the Instructional Support domain prior to the start of each program year and monitoring year would allow for consideration of the most recent CLASS data for Head Start grantees while still supporting continuous quality improvement across the program as a whole.

In addition to the CLASS condition, we are interested in receiving feedback about other conditions and improvements that could be made to DRS. This includes actions we can take without regulatory changes to ensure the DRS process is transparent, timely, and results in higher quality programs.

To inform our development of a notice of proposed rulemaking and continue improving the DRS, we are specifically requesting comments on:

• Changes OHS can make to incentivize robust competition, including ways OHS can ensure there are new and quality applicants at the local level;

• Changes OHS can make to facilitate an orderly transition between grantees without disrupting services for children (when recompetition is required and the incumbent does not regain its grant); and,

• Any other administrative changes OHS can make to the system that do not require regulatory changes, including changes to monitoring processes and timing of notifications and awards.

We invite comments about the specific changes being considered for the DRS CLASS condition as well as alternatives to these changes that would continue to improve program quality, while balancing the need to continue to provide transparency to grantees about what they will be measured on and being mindful of burden on grantees. We also invite comments about any unintended consequences of removing the lowest 10 percent condition and whether an absolute threshold could influence scores. We are particularly interested in recommendations related to how the Secretary would consider establishing the minimum threshold for Instructional Support, including in what increments to raise the threshold, what data to base the absolute thresholds on, and how often to revise the threshold. For example, the regulation could establish an initial Instructional Support threshold (e.g., 2.3 or 2.5) that could be raised in increments of 0.1 based on certain criteria related to the available CLASS data from all prior years of Head Start monitoring, or the threshold could be set one standard deviation below the mean Instructional Support score over the 3 or 5 previous fiscal years. We are interested in other ideas of ways the Instructional Support threshold could be set and/or adjusted that would incentivize program improvement while acknowledging the current state of the field. We are also interested in feedback on another potential change to establish or maintain a minimum absolute threshold (such as a 2) that would require competition and a higher threshold (such as 2.5 or 3) and require grantees to focus on quality improvement before they were reevaluated to see if their Instructional Support score has improved. Only grantees without improvement or still below the threshold would then have to compete. We are also interested in whether we should align the approach for Instructional Support with the other CLASS domains. We are interested in feedback on each of these possible approaches as well as others suggested by the field.

If commenters do not support the changes being considered, comments offering alternative proposals to the CLASS condition, whether changes to the absolute thresholds or the relative 10 percent threshold, or to other conditions of the DRS would be particularly helpful.

We are also particularly interested in soliciting feedback on other changes to DRS implementation that would spur local competition and improve the DRS process for grantees.

OHS published the “CLASS Condition of the Head Start Designation Renewal System” request for comments on December 8, 2017, to solicit comments from the public on changes we are considering to the Designation Renewal System (DRS). We unintentionally omitted language from the document that specifically asks the public to consider what changes OHS can make to incentivize robust competition and to facilitate orderly transitions between grantees when an incumbent does not regain its grant after competition, as well as any other administrative changes that do not require regulatory action.

We believe public feedback on the omitted language is important and can help us make better informed decisions about the DRS. For that reason, we withdraw the “CLASS Condition of the Head Start Designation Renewal System” request for comments, and we are publishing a new request for comments, titled “Head Start Designation Renewal System Improvements,” elsewhere in this issue of the Federal Register.