Correction

In the Federal Register (FR) on March 3, 2022, in proposed rule FR Doc. 2022-03131, the following corrections are made:

1. On page 12301, under “O. Removal of License Conditions and Withdrawal of Orders,” in the center column, beginning with the first full sentence through the end of the paragraph, the text is corrected to read, “The Mitigation of Beyond-Design-Basis Events rule subsequently moved § 50.54(hh)(2) to § 50.155(b)(2). As a result, neither Order EA-06-137 nor the license condition is necessary. Accordingly, the NRC proposes finding that good cause is shown to rescind Order EA-06-137 for each licensee that received the order. In addition, because § 50.155(b)(2) provides the same requirements as the license condition associated with Order EA-06-0137, the NRC proposes deeming the license condition removed from each applicable nuclear power reactor license.”

2. On page 12301, under “O. Removal of License Conditions and Withdrawal of Orders,” in the center column, beginning with the last sentence through the third column, end of the first paragraph, the text is corrected to read, “Because licensees comply with both the regulations and Mitigation Strategy License Condition via the same guidance, such that the former § 50.54(hh)(2) requirements encompass the license condition requirements, the NRC proposes concluding that § 50.155(b)(2) fully replaces the requirements that exist in the Mitigation Strategy License Condition and deeming that the Mitigation Strategy License Conditions imposed in 2007 are removed from the licenses for those licensees that received that license condition.”

Table of Contents I. Introduction A. Authority and Background B. Rulemaking History II. Request for Information A. Scope and Definitions B. Test Procedure 1. Energy Use Measurements 2. Representative Average Use Cycle 3. Updates to Industry Test Procedures III. Submission of Comments I. Introduction

Compressors are among the consumer and industrial equipment for which DOE is authorized to establish and amend test procedures and energy conservation standards. (42 U.S.C. 6311(2)) DOE's test procedures for compressors are prescribed at title 10 of the Code of Federal Regulations (“CFR”) 431.344 and appendix A to subpart T of part 431. The following sections discuss DOE's authority to establish and amend test procedures for compressors, as well as relevant background information regarding DOE's consideration of test procedures for this equipment.

The Energy Policy and Conservation Act, as amended (“EPCA”), 1 authorizes DOE to regulate the energy efficiency of a number of consumer products and certain industrial equipment. (42 U.S.C. 6291-6317) Title III, Part C  2 of EPCA, added by Public Law 95-619, Title IV, § 441(a) (42 U.S.C. 6311-6317 as codified), established the Energy Conservation Program for Certain Industrial Equipment, which sets forth a variety of provisions designed to improve energy efficiency. Under EPCA, DOE may include a type of industrial equipment, including compressors, as covered equipment if it determines that to do so is necessary to carry out the purposes of Part A-1. (42 U.S.C. 6311(1)(L), 42 U.S.C. 6311(2)(B)(i), and 42 U.S.C. 6312(b)). The purpose of Part A-1 is to improve the efficiency of electric motors and pumps and certain other industrial equipment in order to conserve the energy resources of the Nation. (42 U.S.C. 6312(a)) On November 15, 2016, DOE published a final rule, which determined that coverage for compressors is necessary to carry out the purposes of Part A-1 of Title III of EPCA. 81 FR 79991. (42 U.S.C. 6311(1)(L); 42 U.S.C. 6311 (2)(A); 42 U.S.C. 6311 (2)(B)(i))

The energy conservation program under EPCA consists essentially of four parts: (1) Testing, (2) labeling, (3) Federal energy conservation standards, and (4) certification and enforcement procedures. Relevant provisions of EPCA include definitions (42 U.S.C. 6311), test procedures (42 U.S.C. 6314), labeling provisions (42 U.S.C. 6315), energy conservation standards (42 U.S.C. 6313), and the authority to require information and reports from manufacturers (42 U.S.C. 6316; 42 U.S.C. 6296).

Federal energy efficiency requirements for covered equipment established under EPCA generally supersede State laws and regulations concerning energy conservation testing, labeling, and standards. (42 U.S.C. 6316(a) and 42 U.S.C. 6316(b); 42 U.S.C. 6297).) DOE may, however, grant waivers of Federal preemption in limited instances for particular State laws or regulations, in accordance with the procedures and other provisions set forth under 42 U.S.C. 6316(b)(2)(D).

The Federal testing requirements consist of test procedures that manufacturers of covered equipment must use as the basis for: (1) Certifying to DOE that their equipment complies with the applicable energy conservation standards adopted pursuant to EPCA (42 U.S.C. 6316(a); 42 U.S.C. 6295(s)), and (2) making other representations about the efficiency of that equipment (42 U.S.C. 6314(d)). Similarly, DOE must use these test procedures to determine whether the equipment complies with relevant standards promulgated under EPCA. (42 U.S.C. 6316(a); 42 U.S.C. 6295(s))

EPCA also requires that, at least once every 7 years, DOE evaluate test procedures for each type of covered equipment, including compressors, to determine whether amended test procedures would more accurately or fully comply with the requirements for the test procedures to not be unduly burdensome to conduct and be reasonably designed to produce test results that reflect energy efficiency, energy use, and estimated operating costs during a representative average use cycle. (42 U.S.C. 6314(a)(1)) In addition, if the Secretary determines that a test procedure amendment is warranted, the Secretary must publish proposed test procedures in the Federal Register , and afford interested persons an opportunity (of not less than 45 days' duration) to present oral and written data, views, and arguments on the proposed test procedures. (42 U.S.C. 6314(b)) If DOE determines that test procedure revisions are not appropriate, DOE must publish its determination not to amend the test procedures. DOE is publishing this RFI to collect data and information to inform its decision in satisfaction of the 7-year review requirement specified in EPCA. (42 U.S.C. 6314(a)(1)).

As stated, DOE published a final rule on November 15, 2016, in which DOE determined that coverage of compressors is necessary to carry out the purposes of Part A-1 of Title III of EPCA. 81 FR 79991. DOE's test procedure for determining compressor energy efficiency of certain varieties of compressors was established in a final rule published on January 4, 2017. 82 FR 1052. The test procedure is codified in 10 CFR 431.344 and appendix A to subpart T of part 431.

The compressor test procedure currently adopts through reference certain sections of the ISO Standard 1217:2009(E) “Displacement compressors—Acceptance tests” and accompanying ISO standard 1217:2009/Amd.1:2016(E) “Displacement compressors—Acceptance tests (Fourth edition); Amendment 1: Calculation of isentropic efficiency and relationship with specific energy,” (“ISO 1217:2009(E)”) in conjunction with the additional clarifications and test methods and calculations established in the final rule. 82 FR 1052, 1054.

In the following sections, DOE has identified a variety of issues on which it seeks input to aid in its analysis of whether an amended test procedure for compressors would more accurately or fully comply with the requirement in EPCA that the test procedure produces results that measure energy use during a representative average use cycle for the product, and not be unduly burdensome to conduct. (42 U.S.C. 6314(a)(2)) Additionally, DOE welcomes comments on any aspect of the existing test procedures for compressors and on other relevant issues that may not specifically be identified in this document.

A compressor is a machine or apparatus that converts different types of energy into the potential energy of gas pressure for displacement and compression of gaseous media to any higher pressure values above atmospheric pressure and has a pressure ratio at full-load operating pressure greater than 1.3. 10 CFR 431.342.

DOE's test procedure applies to compressors that meet the following criteria:

(1) Is an air compressor;

(2) Is a rotary compressor;

(3) Is not a liquid ring compressor;

(4) Is driven by a brushless electric motor;

(5) Is a lubricated compressor;

(6) Has a full-load operating pressure greater than or equal to 75 pounds per square inch gauge (psig) and less than or equal to 200 psig;

(7) Is not designed and tested to the requirements of the American Petroleum Institute Standard 619, “Rotary-Type Positive-Displacement Compressors for Petroleum, Petrochemical, and Natural Gas Industries;”

(8) Has full-load actual volume flow rate greater than or equal to 35 cubic feet per minute (cfm), or is distributed in commerce with a compressor motor nominal horsepower greater than or equal to 10 horsepower (hp); and

(9) Has a full-load actual volume flow rate less than or equal to 1,250 cfm, or is distributed in commerce with a compressor motor nominal horsepower less than or equal to 200 hp. 10 CFR 431.344(a).

To support the scope of the compressor test method at appendix A to subpart T of part 431, DOE established the following definitions related to compressors:

Actual volume flow rate means the volume flow rate of air, compressed and delivered at the standard discharge point, referred to conditions of total temperature, total pressure and composition prevailing at the standard inlet point, and as determined in accordance with the test procedures prescribed in § 431.344.

Air compressor means a compressor designed to compress air that has an inlet open to the atmosphere or other source of air, and is made up of a compression element (bare compressor), driver(s), mechanical equipment to drive the compressor element, and any ancillary equipment.

Brushless electric motor means a machine that converts electrical power into rotational mechanical power without use of sliding electrical contacts.

Compressor motor nominal horsepower means the motor horsepower of the electric motor, as determined in accordance with the applicable procedures in subparts B and X of this part, with which the rated air compressor is distributed in commerce.

Full-load actual volume flow rate means the actual volume flow rate of the compressor at the full-load operating pressure.

Lubricated compressor means a compressor that introduces an auxiliary substance into the compression chamber during compression.

Positive displacement compressor means a compressor in which the admission and diminution of successive volumes of the gaseous medium are performed periodically by forced expansion and diminution of a closed space(s) in a working chamber(s) by means of displacement of a moving member(s) or by displacement and forced discharge of the gaseous medium into the high-pressure area.

Pressure ratio at full-load operating pressure means the ratio of discharge pressure to inlet pressure, determined at full-load operating pressure in accordance with the test procedures prescribed in § 431.344.

Rotary compressor means a positive displacement compressor in which gas admission and diminution of its successive volumes or its forced discharge are performed cyclically by rotation of one or several rotors in a compressor casing. 10 CFR 431.342.

Issue 1: DOE requests comment on the scope of the compressors test procedure, and on any developments in the industry that may warrant reexamination of the respective scope criteria.

Issue 2: DOE requests comment on the definitions related to the scope of the compressors test procedures, and whether any of the terms should be amended, and if so the reason for any such change and how the terms should be amended. In particular, DOE requests comment on whether the terms are sufficient to identify which equipment is subject to the test procedure and whether any test procedure amendments are required to ensure that all such equipment can be appropriately tested in accordance with the test procedure.

DOE specifies package isentropic efficiency as the test metric for compressors. 10 CFR 431.464(b). Package isentropic efficiency is determined at “full-load” and “part-load,” which respectively apply to fixed- and variable-speed compressors. 10 CFR 431.344(b).

As stated, the current DOE test procedure for compressors is codified in 10 CFR part 431, subpart T, appendix A. The test procedure provides for measuring the energy required by a compressor to compress a certain volume of air under specific conditions and divides that value by the energy that would be required by a thermodynamically idealized compressor performing an identical compression process with no increase in entropy. 3

Issue 3: DOE seeks comment on whether existing test procedure requirements ( e.g., instrumentation, testing configurations/specifications, calculation methodologies) accurately measure energy use. DOE requests comment on the costs associated with the test procedure and whether amendments would reduce test cost while maintaining the representativeness of the results.

Compressors supply pressurized gas at pressure levels greater than ambient at flow rates matched to application demand. Accordingly, energy use varies as a function of the quantity of pressurized gas called for. The current DOE test procedure for compressors measures energy use during a representative average use cycle.

Issue 4: DOE seeks comment on what constitutes a representative average use cycle/period of use for compressors with distinction made, as appropriate, between fixed- and variable-speed compressors.

DOE's established practice is to adopt industry standards as DOE test procedures unless such methodology would be unduly burdensome to conduct or would not produce test results that reflect the energy efficiency, energy use, water use (as specified in EPCA) or estimated operating costs of that product during a representative average use cycle. 10 CFR 431.4; 10 CFR part 430 subpart C appendix A section 8(c). In cases where the industry testing standard does not meet the EPCA statutory criteria for test procedures, DOE will make any necessary modifications to these testing standards through the rulemaking process when adopting them for inclusion into DOE's regulations.

DOE's compressor test procedures incorporate certain sections of industry standard ISO 1217:2009(E), in conjunction with the additional detail and test methods and calculations established in the DOE test procedure. 10 CFR 431.343(b). ISO 1217:2009(E) was reviewed and reaffirmed by ISO in 2021 and remains current. 4

Issue 5: DOE requests comment on ISO 1217:2009(E) and its associated amendment, ISO 1217:2009/Amd.1:2016(E), in the context of suitability for continued use as the basis of compressors test procedures and on any anticipated forthcoming updates.

DOE invites all interested parties to submit in writing by the date specified under the DATES heading, comments and information on matters addressed in this RFI and on other matters relevant to DOE's consideration of amended test procedures for compressors. These comments and information will aid in the development of a test procedure NOPR for compressors if DOE determines that amended test procedures may be appropriate for this equipment.

Submitting comments via www.regulations.gov. The www.regulations.gov web page will require you to provide your name and contact information. Your contact information will be viewable to DOE Building Technologies staff only. Your contact information will not be publicly viewable except for your first and last names, organization name (if any), and submitter representative name (if any). If your comment is not processed properly because of technical difficulties, DOE will use this information to contact you. If DOE cannot read your comment due to technical difficulties and cannot contact you for clarification, DOE may not be able to consider your comment.

However, your contact information will be publicly viewable if you include it in the comment or in any documents attached to your comment. Any information that you do not want to be publicly viewable should not be included in your comment, nor in any document attached to your comment. Following this instruction, persons viewing comments will see only first and last names, organization names, correspondence containing comments, and any documents submitted with the comments.

Do not submit to www.regulations.gov information for which disclosure is restricted by statute, such as trade secrets and commercial or financial information (hereinafter referred to as Confidential Business Information (“CBI”)). Comments submitted through www.regulations.gov cannot be claimed as CBI. Comments received through the website will waive any CBI claims for the information submitted. For information on submitting CBI, see the Confidential Business Information section.

DOE processes submissions made through www.regulations.gov before posting. Normally, comments will be posted within a few days of being submitted. However, if large volumes of comments are being processed simultaneously, your comment may not be viewable for up to several weeks. Please keep the comment tracking number that www.regulations.gov provides after you have successfully uploaded your comment.

Submitting comments via email. Comments and documents submitted via email also will be posted to www.regulations.gov. If you do not want your personal contact information to be publicly viewable, do not include it in your comment or any accompanying documents. Instead, provide your contact information on a cover letter. Include your first and last names, email address, telephone number, and optional mailing address. The cover letter will not be publicly viewable as long as it does not include any comments.

Include contact information each time you submit comments, data, documents, and other information to DOE. Faxes will not be accepted.

Comments, data, and other information submitted to DOE electronically should be provided in PDF (preferred), Microsoft Word or Excel, WordPerfect, or text (ASCII) file format. Provide documents that are not secured, written in English and free of any defects or viruses. Documents should not contain special characters or any form of encryption and, if possible, they should carry the electronic signature of the author.

Campaign form letters. Please submit campaign form letters by the originating organization in batches of between 50 to 500 form letters per PDF or as one form letter with a list of supporters' names compiled into one or more PDFs. This reduces comment processing and posting time.

Confidential Business Information. According to 10 CFR 1004.11, any person submitting information that he or she believes to be confidential and exempt by law from public disclosure should submit via email two well-marked copies: One copy of the document marked confidential including all the information believed to be confidential, and one copy of the document marked “non-confidential” with the information believed to be confidential deleted. DOE will make its own determination about the confidential status of the information and treat it according to its determination.

It is DOE's policy that all comments may be included in the public docket, without change and as received, including any personal information provided in the comments (except information deemed to be exempt from public disclosure).

DOE considers public participation to be a very important part of the process for developing test procedures and energy conservation standards. DOE actively encourages the participation and interaction of the public during the comment period in each stage of this process. Interactions with and between members of the public provide a balanced discussion of the issues and assist DOE in the process. Anyone who wishes to be added to the DOE mailing list to receive future notices and information about this process should contact Appliance and Equipment Standards Program staff at (202) 287-1445 or via email at ApplianceStandardsQuestions@ee.doe.gov.

This document of the Department of Energy was signed on May 2, 2022, by Kelly J. Speakes-Backman, Principal Deputy Assistant Secretary for Energy Efficiency and Renewable Energy, pursuant to delegated authority from the Secretary of Energy. That document with the original signature and date is maintained by DOE. For administrative purposes only, and in compliance with requirements of the Office of the Federal Register, the undersigned DOE Federal Register Liaison Officer has been authorized to sign and submit the document in electronic format for publication, as an official document of the Department of Energy. This administrative process in no way alters the legal effect of this document upon publication in the Federal Register .

The FAA invites you to send any written relevant data, views, or arguments about this proposal. Send your comments to an address listed under ADDRESSES . Include “Docket No. FAA-2022-0505; Project Identifier MCAI-2021-01289-T” at the beginning of your comments. The most helpful comments reference a specific portion of the proposal, explain the reason for any recommended change, and include supporting data. The FAA will consider all comments received by the closing date and may amend this proposal because of those comments.

Except for Confidential Business Information (CBI) as described in the following paragraph, and other information as described in 14 CFR 11.35, the FAA will post all comments received, without change, to https://www.regulations.gov, including any personal information you provide. The agency will also post a report summarizing each substantive verbal contact received about this NPRM.

CBI is commercial or financial information that is both customarily and actually treated as private by its owner. Under the Freedom of Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public disclosure. If your comments responsive to this NPRM contain commercial or financial information that is customarily treated as private, that you actually treat as private, and that is relevant or responsive to this NPRM, it is important that you clearly designate the submitted comments as CBI. Please mark each page of your submission containing CBI as “PROPIN.” The FAA will treat such marked submissions as confidential under the FOIA, and they will not be placed in the public docket of this NPRM. Submissions containing CBI should be sent to Dan Rodina, Aerospace Engineer, Large Aircraft Section, FAA, International Validation Branch, 2200 South 216th St., Des Moines, WA 98198; phone: 206-231-3225; email: dan.rodina@faa.gov. Any commentary that the FAA receives which is not specifically designated as CBI will be placed in the public docket for this rulemaking.

EASA, which is the Technical Agent for the Member States of the European Union, has issued EASA AD 2021-0258, dated November 17, 2021 (EASA AD 2021-0258) (also referred to as the MCAI), to correct an unsafe condition for all Airbus SAS Model A300-600 series airplanes.

This proposed AD was prompted by a determination that new or more restrictive airworthiness limitations are necessary. The FAA is proposing this AD to prevent reduced structural integrity of the airplane.

EASA previously issued EASA AD 2019-0090, dated April 26, 2019 (EASA AD 2019-0090), requiring the actions described in the Airbus A300-600 Airworthiness Limitations Section (ALS), Part 2, “Damage Tolerant Airworthiness Limitation Items (DT-ALI),” Revision 03, dated December 14, 2018, which also includes the limit of validity (LOV) for the Model A300-600 airplanes. EASA AD 2019-0090 corresponds to FAA AD 2019-21-01, Amendment 39-19767 (84 FR 56935, October 24, 2019) (AD 2019-21-01). Since that EASA AD was issued, Airbus published the Variation, as defined in EASA AD 2021-0258, which reduces the LOV for Model A300-600 airplanes, reflecting the engineering data that supports the structural maintenance program and that corresponds to the period of time during which it is demonstrated that Widespread Fatigue Damage will not occur. EASA AD 2021-0258 does not supersede EASA AD 2019-0090, but does specify that it invalidates the LOV as specified in the Airbus A300-600 ALS, Part 2. Therefore, this proposed AD would replace the LOVs specified in Airbus A300-600 Airworthiness Limitations Section (ALS), Part 2, “Damage Tolerant Airworthiness Limitation Items (DT-ALI),” Revision 03, dated December 14, 2018, as required by FAA AD 2019-21-01.

For the reason described above, this AD requires compliance with the reduced LOV as specified in the variation. See the MCAI for additional background information.

EASA AD 2021-0258 describes new or more restrictive airworthiness limitations for airplane LOVs. This material 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.

These products have been approved by the aviation authority of another country and are approved for operation in the United States. Pursuant to the FAA's bilateral agreement with the State of Design Authority, it has notified the FAA of the unsafe condition described in the MCAI referenced above. The FAA is issuing this NPRM after determining that the unsafe condition described previously is likely to exist or develop in other products of the same type design.

This proposed AD would require revising the existing maintenance or inspection program, as applicable, to incorporate new or more restrictive airworthiness limitations, which are specified in EASA AD 2021-0258 described previously, as incorporated by reference. Any differences with EASA AD 2021-0258 are identified as exceptions in the regulatory text of this AD.

This proposed AD would require revisions to certain operator maintenance documents to include new actions. Compliance with these actions is required by 14 CFR 91.403(c). For airplanes that have been previously modified, altered, or repaired in the areas addressed by this proposed AD, the operator may not be able to accomplish the actions described in the revisions. In this situation, to comply with 14 CFR 91.403(c), the operator must request approval for an alternative method of compliance according to paragraph (j)(1) of this proposed AD.

As described in FAA Advisory Circular 120-104 ( https://www.faa.gov/documentLibrary/media/Advisory_Circular/120-104.pdf ), several programs have been developed to support initiatives that will ensure the continued airworthiness of aging airplane structure. The last element of those initiatives is the requirement to establish a LOV of the engineering data that support the structural maintenance program under 14 CFR 26.21. This proposed AD is the result of an assessment of the previously established programs by the design approval holder (DAH) during the process of establishing the LOV for the affected airplanes. The actions specified in this proposed AD are necessary to complete certain programs to ensure the continued airworthiness of aging airplane structure and to support an airplane reaching its LOV.

In the FAA's ongoing efforts to improve the efficiency of the AD process, the FAA developed a process to use some civil aviation authority (CAA) ADs as the primary source of information for compliance with requirements for corresponding FAA ADs. The FAA has been coordinating this process with manufacturers and CAAs. As a result, the FAA proposes to incorporate EASA AD 2021-0258 by reference in the FAA final rule. Service information required by EASA AD 2021-0258 for compliance will be available at https://www.regulations.gov by searching for and locating Docket No. FAA-2022-0505 after the FAA final rule is published.

The FAA's process of incorporating by reference MCAI ADs as the primary source of information for compliance with corresponding FAA ADs has been limited to certain MCAI ADs (primarily those with service bulletins as the primary source of information for accomplishing the actions required by the FAA AD). However, the FAA is now expanding the process to include MCAI ADs that require a change to airworthiness limitation documents, such as airworthiness limitation sections.

For these ADs that incorporate by reference an MCAI AD that changes airworthiness limitations, the FAA requirements are unchanged. Operators must revise the existing maintenance or inspection program, as applicable, to incorporate the information specified in the new airworthiness limitation document. The airworthiness limitations must be followed according to 14 CFR 91.403(c) and 91.409(e).

The previous format of the airworthiness limitation ADs included a paragraph that specified that no alternative actions ( e.g., inspections) or intervals may be used unless the actions and intervals are approved as an alternative method of compliance (AMOC) in accordance with the procedures specified in the AMOCs paragraph under “Additional FAA Provisions.” This new format includes a “New Provisions for Alternative Actions and Intervals” paragraph that does not specifically refer to AMOCs, but operators may still request an AMOC to use an alternative action or interval.

The FAA estimates that this proposed AD would affect 110 airplanes of U.S. registry. The FAA estimates the following costs to comply with this proposed AD:

The FAA has determined that revising the existing maintenance or inspection program takes an average of 90 work-hours per operator, although the agency recognizes that this number may vary from operator to operator. Since operators incorporate maintenance or inspection program changes for their affected fleet(s), the FAA has determined that a per-operator estimate is more accurate than a per-airplane estimate. Therefore, the agency estimates the average total cost per operator to be $7,650 (90 work-hours × $85 per work-hour).

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.

The FAA is 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.

The FAA has 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 this proposed regulation:

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

(2) Would not affect intrastate aviation in Alaska, and

(3) Would 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:

The FAA invites you to send any written relevant data, views, or arguments about this proposal. Send your comments to an address listed under ADDRESSES . Include “Docket No. FAA-2022-0503; Project Identifier MCAI-2021-01244-T” at the beginning of your comments. The most helpful comments reference a specific portion of the proposal, explain the reason for any recommended change, and include supporting data. The FAA will consider all comments received by the closing date and may amend the proposal because of those comments.

Except for Confidential Business Information (CBI) as described in the following paragraph, and other information as described in 14 CFR 11.35, the FAA will post all comments received, without change, to https://www.regulations.gov, including any personal information you provide. The agency will also post a report summarizing each substantive verbal contact received about this proposed AD.

CBI is commercial or financial information that is both customarily and actually treated as private by its owner. Under the Freedom of Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public disclosure. If your comments responsive to this NPRM contain commercial or financial information that is customarily treated as private, that you actually treat as private, and that is relevant or responsive to this NPRM, it is important that you clearly designate the submitted comments as CBI. Please mark each page of your submission containing CBI as “PROPIN.” The FAA will treat such marked submissions as confidential under the FOIA, and they will not be placed in the public docket of this NPRM. Submissions containing CBI should be sent to Vladimir Ulyanov, Aerospace Engineer, Large Aircraft Section, International Validation Branch, FAA, 2200 South 216th St., Des Moines, WA 98198; telephone 206-231-3229; email vladimir.ulyanov@faa.gov. Any commentary that the FAA receives which is not specifically designated as CBI will be placed in the public docket for this rulemaking.

The FAA issued AD 2018-03-12, Amendment 39-19185 (83 FR 5906, February 12, 2018) (AD 2018-03-12), which applies to certain Airbus SAS Model A318 series airplanes; Model A319-111, -112, -113, -114, -115, -131, -132, and -133 airplanes; Model A320-211, -212, -214, -231, -232, and -233 airplanes; and Model A321-111, -112, -131, -211, -212, -213, -231, and -232 airplanes. AD 2018-03-12 requires repetitive rototest inspections for cracking of the fastener holes in certain door stop fittings, and repair if necessary. The FAA issued AD 2018-03-12 to address cracking at the door stop fitting holes of fuselage frame (FR) 66 and FR68. Such cracking could result in reduced structural integrity of the airplane due to the failure of structural components.

Since the FAA issued AD 2018-03-12, Airbus has revised the compliance times to accomplish the rototest inspections based on reports from operators and new analysis.

EASA, which is the Technical Agent for the Member States of the European Union, has issued EASA AD 2021-0242, dated November 8, 2021 (EASA AD 2021-0242) (also referred to as the Mandatory Continuing Airworthiness Information, or the MCAI), to correct an unsafe condition for certain Airbus SAS Model A318 series airplanes; Model A319-111, -112, -113, -114, -115, -131, -132, and -133 airplanes; Model A320-211, -212, -214, -215, -216, -231, -232, and -233 airplanes; and Model A321-111, -112, -131, -211, -212, -213, -231, and -232 airplanes. EASA AD 2021-0242 supersedes EASA AD 2016-0238 (which corresponds to FAA AD 2018-03-12). Model A320-215 airplanes are not certificated by the FAA and are not included on the U.S. type certificate data sheet; this AD therefore does not include those airplanes in the applicability.

This proposed AD was prompted by reports of fatigue damage in the structure for the door stop fittings on certain fuselage frames. The FAA is proposing this AD to address cracking at the door stop fitting holes of fuselage FR66 and FR68 which could result in reduced structural integrity of the airplane. See the MCAI for additional background information.

The Airbus SAS Model A320-216 was U.S. type certificated on December 19, 2016. Before that date, any EASA ADs that affected Model A320-216 airplanes were included in the U.S. type certificate as part of the Required Airworthiness Actions List (RAAL). One or more Model A320-216 airplanes have subsequently been placed on the U.S. Register, and will now be included in FAA AD actions. For Model A320-216 airplanes, the requirements that correspond to AD 2018-03-12 were mandated by the MCAI via the RAAL. Although that RAAL requirement is still in effect, for continuity and clarity the FAA has identified Model A320-216 airplanes in paragraph (c) of this proposed AD; the MCAI that is specified in paragraph (g) in this proposed AD includes retained requirements, which would therefore apply to those airplanes.

Although this proposed AD does not explicitly restate the requirements of AD 2018-03-12, this proposed AD would retain all of the requirements of AD 2018-03-12. Those requirements are referenced in EASA AD 2021-0242, which, in turn, is referenced in paragraph (g) of this proposed AD.

EASA AD 2021-0242 describes procedures for rototest inspections for cracking of the fastener holes in the airframe structure for the door stop fittings installation in FR66 and FR68, and corrective actions. Corrective actions include repair or modification of fastener holes at door stop locations.

This material 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.

This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to the FAA's bilateral agreement with the State of Design Authority, the FAA has been notified of the unsafe condition described in the MCAI referenced above. The FAA is proposing this AD because the FAA evaluated all pertinent information and determined an unsafe condition exists and is likely to exist or develop on other products of the same type design.

This proposed AD would require accomplishing the actions specified in EASA AD 2021-0242 described previously, as incorporated by reference, except for any differences identified as exceptions in the regulatory text of this proposed AD.

In the FAA's ongoing efforts to improve the efficiency of the AD process, the FAA developed a process to use some civil aviation authority (CAA) ADs as the primary source of information for compliance with requirements for corresponding FAA ADs. The FAA has been coordinating this process with manufacturers and CAAs. As a result, the FAA proposes to incorporate EASA AD 2021-0242 by reference in the FAA final rule. This proposed AD would, therefore, require compliance with EASA AD 2021-0242 in its entirety through that incorporation, except for any differences identified as exceptions in the regulatory text of this proposed AD. Using common terms that are the same as the heading of a particular section in EASA AD 2021-0242 does not mean that operators need comply only with that section. For example, where the AD requirement refers to “all required actions and compliance times,” compliance with this AD requirement is not limited to the section titled “Required Action(s) and Compliance Time(s)” in EASA AD 2021-0242. Service information required by EASA AD 2021-0242 for compliance will be available at https://www.regulations.gov by searching for and locating Docket No. FAA-2022-0503 after the FAA final rule is published.

The FAA estimates that this proposed AD affects 1,084 airplanes of U.S. registry. The FAA estimates the following costs to comply with this proposed AD:

The FAA estimates the following costs to do any necessary on-condition modifications that would be required based on the results of any required actions. The FAA has no way of determining the number of aircraft that might need these on-condition modifications:

The FAA has received no definitive data on which to base the cost estimates for the on-condition repairs specified in this proposed AD.

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.

The FAA is 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.

The FAA 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 this proposed regulation:

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

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

(3) 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:

The FAA invites you to send any written relevant data, views, or arguments about this proposal. Send your comments to an address listed under ADDRESSES . Include “Docket No. FAA-2022-0507; Project Identifier MCAI-2021-01372-T” at the beginning of your comments. The most helpful comments reference a specific portion of the proposal, explain the reason for any recommended change, and include supporting data. The FAA will consider all comments received by the closing date and may amend this proposal because of those comments.

Except for Confidential Business Information (CBI) as described in the following paragraph, and other information as described in 14 CFR 11.35, the FAA will post all comments received, without change, to https://www.regulations.gov, including any personal information you provide. The agency will also post a report summarizing each substantive verbal contact received about this NPRM.

CBI is commercial or financial information that is both customarily and actually treated as private by its owner. Under the Freedom of Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public disclosure. If your comments responsive to this NPRM contain commercial or financial information that is customarily treated as private, that you actually treat as private, and that is relevant or responsive to this NPRM, it is important that you clearly designate the submitted comments as CBI. Please mark each page of your submission containing CBI as “PROPIN.” The FAA will treat such marked submissions as confidential under the FOIA, and they will not be placed in the public docket of this NPRM. Submissions containing CBI should be sent to Shahram Daneshmandi, Aerospace Engineer, Large Aircraft Section, FAA, International Validation Branch, 2200 South 216th St., Des Moines, WA 98198; telephone 206-231-3220; email shahram.daneshmandi@faa.gov. Any commentary that the FAA receives which is not specifically designated as CBI will be placed in the public docket for this rulemaking.

EASA, which is the Technical Agent for the Member States of the European Union, has issued EASA AD 2021-0273, dated December 8, 2021 (EASA AD 2021-0273) (also referred to as the MCAI), to correct an unsafe condition for certain Saab AB, Support and Services Model 340A (SAAB/SF340A) and SAAB 340B airplanes.

This proposed AD was prompted by a report that there is no evidence that post-machining stress relief or de-embrittlement post-cadmium plating was performed on affected torque arm center pins. Affected torque arm center pins are pins with part number (P/N) AIR134762 and batch number 17138, 21098, or 22863. Absence of the treatments could degrade the mechanical characteristics of the pins. The FAA is proposing this AD to address untreated torque arm center pins installed on any MLG, which, if not corrected, could lead to failure of the torque arm center pin and free swinging of the MLG, possibly resulting in loss of control of the airplane on ground, or loss of the MLG hydraulic braking function. See the MCAI for additional background information.

EASA AD 2021-0273 specifies procedures for replacing each affected torque arm center pin on the MLG. EASA AD 2021-0273 also prohibits the installation of affected parts. This material 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.

This product has been approved by the aviation authority of another country and is approved for operation in the United States. Pursuant to the FAA's bilateral agreement with the State of Design Authority, it has notified the FAA of the unsafe condition described in the MCAI referenced above. The FAA is issuing this NPRM after determining that the unsafe condition described previously is likely to exist or develop in other products of the same type design.

This proposed AD would require accomplishing the actions specified in EASA AD 2021-0273 described previously. This proposed AD would also prohibit the installation of affected parts.

In the FAA's ongoing efforts to improve the efficiency of the AD process, the FAA developed a process to use some civil aviation authority (CAA) ADs as the primary source of information for compliance with requirements for corresponding FAA ADs. The FAA has been coordinating this process with manufacturers and CAAs. As a result, the FAA proposes to incorporate EASA AD 2021-0273 by reference in the FAA final rule. This proposed AD would, therefore, require compliance with EASA AD 2021-0273 in its entirety through that incorporation, except for any differences identified as exceptions in the regulatory text of this proposed AD. Using common terms that are the same as the heading of a particular section in EASA AD 2021-0273 does not mean that operators need comply only with that section. For example, where the AD requirement refers to “all required actions and compliance times,” compliance with this AD requirement is not limited to the section titled “Required Action(s) and Compliance Time(s)” in EASA AD 2021-0273. Service information required by EASA AD 2021-0273 for compliance will be available at https://www.regulations.gov by searching for and locating Docket No. FAA-2022-0507 after the FAA final rule is published.

The FAA estimates that this proposed AD would affect 43 airplanes of U.S. registry. The FAA estimates the following costs to comply with this proposed AD:

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.

The FAA is 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.

The FAA 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 this proposed regulation:

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

(2) Would not affect intrastate aviation in Alaska, and

(3) Would 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:

The FAA invites you to send any written relevant data, views, or arguments about this proposal. Send your comments to an address listed under ADDRESSES . Include “Docket No. FAA-2022-0508; Project Identifier MCAI-2021-01120-T” at the beginning of your comments. The most helpful comments reference a specific portion of the proposal, explain the reason for any recommended change, and include supporting data. The FAA will consider all comments received by the closing date and may amend the proposal because of those comments.

Except for Confidential Business Information (CBI) as described in the following paragraph, and other information as described in 14 CFR 11.35, the FAA will post all comments received, without change, to https://www.regulations.gov, including any personal information you provide. The agency will also post a report summarizing each substantive verbal contact received about this proposed AD.

CBI is commercial or financial information that is both customarily and actually treated as private by its owner. Under the Freedom of Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public disclosure. If your comments responsive to this NPRM contain commercial or financial information that is customarily treated as private, that you actually treat as private, and that is relevant or responsive to this NPRM, it is important that you clearly designate the submitted comments as CBI. Please mark each page of your submission containing CBI as “PROPIN.” The FAA will treat such marked submissions as confidential under the FOIA, and they will not be placed in the public docket of this NPRM. Submissions containing CBI should be sent to Todd Thompson, Aerospace Engineer, Large Aircraft Section, International Validation Branch, FAA, 2200 South 216th St., Des Moines, WA 98198; telephone 206-231-3228; email Todd.Thompson@faa.gov. Any commentary that the FAA receives which is not specifically designated as CBI will be placed in the public docket for this rulemaking.

The FAA issued AD 2015-07-05, Amendment 39-18133 (80 FR 19871, April 14, 2015) (AD 2015-07-05), for all BAE Systems (Operations) Limited Model BAe 146 series airplanes and Model Avro 146-RJ series airplanes. AD 2015-07-05 requires repetitive external eddy current inspections on the aft skin lap joints of the rear fuselage for cracking, corrosion, and other defects, and repair if necessary. AD 2015-07-05 resulted from a report of a pressurization problem on an airplane during climb-out; a subsequent investigation showed a crack in the fuselage skin. The FAA issued AD 2015-07-05 to address cracking, corrosion, and other defects, which could affect the structural integrity of the airplane.

Since the FAA issued AD 2015-07-05, it has been determined that adding repetitive LFEC inspections for any cracking, corrosion, and other defects in the aft skin lap joints of the rear fuselage and in the fuselage skin panels are necessary. The compliance times for inspection of certain stringers must also be revised.

The Civil Aviation Authority (CAA), which is the aviation authority for the United Kingdom, has issued CAA AD G-2021-0008, dated September 8, 2021 (also referred to after this as the Mandatory Continuing Airworthiness Information, or the MCAI), to correct an unsafe condition for all BAE Systems (Operations) Limited Model BAe 146 series airplanes and Model Avro 146-RJ series airplanes. You may examine the MCAI in the AD docket on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-2022-0508.

This proposed AD was prompted by a report of a pressurization problem on an airplane during climb-out; a subsequent investigation showed a crack in the fuselage skin; and that repetitive LFEC inspections in the rear fuselage aft skin lap joints and in the fuselage skin panels are necessary. Certain compliance times also must be revised. The FAA is proposing this AD to address cracking, corrosion, and other defects on the rear fuselage aft skin joints and frames and in the fuselage panels, which could affect the structural integrity of the airplane. See the MCAI for additional background information.

BAE Systems (Operations) Limited has issued Inspection Service Bulletin 53-239, including Appendix 2, Revision 5, and including Appendix 3, Revision 1, dated March 2, 2017. This service information describes procedures for repetitive external eddy current and LFEC inspections on the aft skin lap joints of the rear fuselage and in the fuselage skin panels, for any cracking, corrosion, and other defects ( e.g., surface damage and spot displacement); and repair if necessary.

This proposed AD would also require BAE Systems (Operations) Limited Inspection Service Bulletin 53-239, including Appendix 2, Revision 3, dated May 7, 2014, which the Director of the Federal Register approved for incorporation by reference as of May 19, 2015 (80 FR 19871, April 14, 2015).

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.

This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to the FAA's bilateral agreement with the State of Design Authority, the FAA has been notified of the unsafe condition described in the MCAI and service information referenced above. The FAA is proposing this AD because the FAA evaluated all the relevant information and determined the unsafe condition described previously is likely to exist or develop on other products of the same type design.

This proposed AD would retain all of the requirements of AD 2015-07-05, with certain revised compliance times. This proposed AD would also require accomplishing the actions specified in the service information described previously.

The FAA estimates that this proposed AD affects 20 airplanes of U.S. registry.

The FAA estimates the following costs to comply with this proposed AD:

The FAA has received no definitive data on which to base the cost estimates for the repairs specified in this proposed AD.

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.

The FAA is 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.

The FAA has 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 this proposed regulation:

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

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

(3) 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:

In the proposed rule, the Department stated that, if no significant adverse comments were received by March 16, 2022 (the end of the public comment period), the Department would publish a timely withdrawal in the Federal Register informing the public that the proposed rule was being withdrawn and the DFR would become effective. As the Department received no significant adverse comments within the scope of the rulemaking prior to the close of the comment period, the Department is withdrawing the proposed rule and implementing the DFR, which took effect April 15, 2022, a notice of which has been published in the Federal Register concurrent with this withdrawal.

The Department received seven comments on this rulemaking. Several of these comments were supportive of the provisions this rulemaking proposed to implement. While other comments could be characterized as negative or adverse, none of those comments were significant or within the scope of this rulemaking. One commenter was opposed to the time limit; however, that time limit is set forth in the Supporting Older Americans Act of 2020, and is, therefore, a statutory requirement beyond the purview of the rulemaking. The remaining comments were outside the scope of the rulemaking. The comments are publicly available as part of the rulemaking docket at https://www.regulations.gov/docket/ETA-2022-0002/comments.

The Department has determined that none of the negative or adverse comments are significant and within the scope of the rulemaking. Therefore, the proposed rule published at 87 FR 8186 on February 14, 2022, is withdrawn.

I. Table of Abbreviations CFR Code of Federal Regulations DHS Department of Homeland Security FR Federal Register NPRM Notice of proposed rulemaking § Section U.S.C. United States Code II. Background, Purpose, and Legal Basis

On April 21, 2022, Team Magic Inc. notified the Coast Guard that it will be conducting a triathlon from 6 a.m. though 10 a.m. on July 24, 2022. The swim will be held between Mile Markers 602 and 603 on the Ohio River near Louisville, KY. The swim will consist of roughly 700 participants.

The purpose of this rulemaking would be to ensure the safety of vessels and the navigable waters during, the scheduled event. The Coast Guard is proposing this rulemaking under authority in 46 U.S.C. 70034 (previously 33 U.S.C. 1231).

The COTP is proposing to establish a special local regulation from 6 a.m. to 10 a.m. on July 24, 2022. The special local regulation would cover all navigable waters of the Ohio River from mile markers 602 to 603. The duration of the special local regulation is intended to ensure the safety of vessels and these navigable waters before, during, and after the scheduled triathalon. No vessel or person would be permitted to enter the special local regulation without obtaining permission from the COTP or a designated representative. The regulatory text we are proposing appears at the end of this document.

We developed this proposed rule after considering numerous statutes and Executive orders related to rulemaking. Below we summarize our analyses based on a number of these statutes and Executive orders, and we discuss First Amendment rights of protestors.

Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. This NPRM has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, the NPRM has not been reviewed by the Office of Management and Budget (OMB).

This regulatory action determination is based on the size, location, and duration of the special local regulation. This special local regulation would restrict transit on a one-mile stretch of the Ohio River for 4 hours on one day. Moreover, the Coast Guard would issue Broadcast Notice to Mariners (BNMs), Local Notices to Mariners (LNMs), and Marine Safety Information Bulletins (MSIBs) about this special local regulation so that waterway users may plan according for this restriction on transit, and the rule would allow vessels to request permission to enter the zone.

The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this proposed rule would not have a significant economic impact on a substantial number of small entities.

While some owners or operators of vessels intending to transit the special local regulation may be small entities, for the reasons stated in section IV.A above, this proposed rule would not have a significant economic impact on any vessel owner or operator.

If you think that your business, organization, or governmental jurisdiction qualifies as a small entity and that this proposed rule would have a significant economic impact on it, please submit a comment (see ADDRESSES ) explaining why you think it qualifies and how and to what degree this rule would economically affect it.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this proposed rule. If the proposed rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please call or email the person listed in the FOR FURTHER INFORMATION CONTACT section. The Coast Guard will not retaliate against small entities that question or complain about this proposed rule or any policy or action of the Coast Guard.

This proposed rule would not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

A rule has implications for federalism under Executive Order 13132 (Federalism), if it has 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. We have analyzed this proposed rule under that order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.

Also, this proposed rule does not have tribal implications under Executive Order 13175 (Consultation and Coordination with Indian Tribal Governments) because it would not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. If you believe this proposed rule has implications for federalism or Indian tribes, please call or email the person listed in the FOR FURTHER INFORMATION CONTACT section.

The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this proposed rule would not result in such an expenditure, we do discuss the potential effects of this proposed rule elsewhere in this preamble.

We have analyzed this proposed rule under Department of Homeland Security Directive 023-01, Rev. 1, associated implementing instructions, and Environmental Planning COMDTINST 5090.1 (series), which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have made a preliminary determination that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This proposed rule involves a special local regulation lasting 4 hours that would prohibit entry between mile marker 602 to 603 on the Ohio River. Normally such actions are categorically excluded from further review under paragraph L61 of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 1. A preliminary Memorandum for the Record supporting this determination is available in the docket. For instructions on locating the docket, see the ADDRESSES section of this preamble. We seek any comments or information that may lead to the discovery of a significant environmental impact from this proposed rule.

The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to call or email the person listed in the FOR FURTHER INFORMATION CONTACT section to coordinate protest activities so that your message can be received without jeopardizing the safety or security of people, places, or vessels.

We view public participation as essential to effective rulemaking, and will consider all comments and material received during the comment period. Your comment can help shape the outcome of this rulemaking. If you submit a comment, please include the docket number for this rulemaking, indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation.

Submitting comments. We encourage you to submit comments through the Federal Decision Making Portal at https://www.regulations.gov. To do so, go to https://www.regulations.gov, type USCG-2022-0340 in the search box and click “Search.” Next, look for this document in the Search Results column, and click on it. Then click on the Comment option. If you cannot submit your material by using https://www.regulations.gov, call or email the person in the FOR FURTHER INFORMATION CONTACT section of this proposed rule for alternate instructions.

Viewing material in docket. To view documents mentioned in this proposed rule as being available in the docket, find the docket as described in the previous paragraph, and then select “Supporting & Related Material” in the Document Type column. Public comments will also be placed in our online docket and can be viewed by following instructions on the https://www.regulations.gov. Frequently Asked Questions web page. We review all comments received, but we will only post comments that address the topic of the proposed rule. We may choose not to post off-topic, inappropriate, or duplicate comments that we receive.

Personal information. We accept anonymous comments. Comments we post to https://www.regulations.gov will include any personal information you have provided. For more about privacy and submissions to the docket in response to this document, see DHS's eRulemaking System of Records notice (85 FR 14226, March 11, 2020).

For the reasons discussed in the preamble, the Coast Guard is proposing to amend 33 CFR part 100 as follows:

PTE under 35 U.S.C. 156 enables the owners of patents that claim certain human drug products, medical device products, animal drug products, veterinary biological products, and food or color additive products to restore to the terms of those patents some of the time lost while awaiting premarket Government approval for the products from a regulatory agency. See, e.g., section 2750 of the Manual of Patent Examining Procedure (MPEP, Ninth Edition, R-10.2019). The USPTO administers 35 U.S.C. 156 in partnership with the relevant regulatory agencies ( i.e., the Food and Drug Administration (FDA) and the United States Department of Agriculture (USDA)). As part of its administration, the USPTO sends to the relevant agency a copy of any initial submission for PTE that the USPTO receives ( i.e., a copy of any PTE application under 35 U.S.C. 156(d)(1) and 37 CFR 1.740 or any interim PTE application under 35 U.S.C. 156(d)(5) and 37 CFR 1.790).

Prior to the COVID-19 pandemic, the USPTO prohibited the electronic filing of initial submissions for PTE. See section B2 of the Legal Framework for Patent Electronic System, available at www.uspto.gov/patents/apply/filing-online/legal-framework-efs-web, and section 502.05(I)(B)(2) of the MPEP. Requiring initial PTE submissions, which often comprise hundreds of pages, to be physically filed in triplicate under 37 CFR 1.740(b) was viewed as the most effective way to minimize processing errors.

Due to the workplace changes caused by the COVID-19 pandemic, the USPTO waived its prohibition on the electronic filing of initial submissions for PTE and the triplicate copy requirements in 37 CFR 1.740(b) and 1.790(b). See Relief Available to Patentees in View of the COVID-19 Outbreak for Submission of Initial Patent Term Extension Applications Filed Pursuant to 35 U.S.C. 156, 1475 Off. Gaz. Pat. Office 234 (June 23, 2020). The waiver did not impact related follow-on submissions to the USPTO, which were already permitted to be filed electronically prior to the pandemic.

Through informal feedback received during the processing of PTE applications, stakeholders have thus far communicated unanimous support for electronic filing of initial PTE submissions. Additionally, the USPTO and its partner agencies have successfully implemented a system by which the USPTO electronically transmits a copy of any initial submission for PTE to the relevant agency. The new system has not caused any processing errors.

Accordingly, the USPTO is proposing to change its rules of practice to require that PTE applications, interim PTE applications, and any related submissions to the USPTO be submitted electronically via the USPTO patent electronic filing system. The proposed rule changes are designed to streamline the filing of PTE applications and related documents and minimize paper handling. As has been the case since the June 2020 implementation of the electronic filing waiver, the proposed rule changes will result in PTE applications being viewable in USPTO patent electronic viewing systems (the Patent Application Information Retrieval (PAIR) system or Patent Center) immediately upon filing. Additionally, the changes would permit the USPTO to more efficiently allocate the personnel and physical space it currently deploys for the handling of physical copies of PTE submissions.

If the proposed rule changes are adopted, PTE applicants must use the correct document description to ensure that USPTO personnel are timely apprised of electronic submissions. “Patent Term Extension Application Under 35 U.S.C. 156” (Doc Code TERM.REQ) is the correct document description for a PTE application under 35 U.S.C. 156(d)(1) and 37 CFR 1.740, and “Interim Patent Term Extension Application Under 35 U.S.C. 156(d)(5)” (Doc Code TERM.REQ.ITM) is the correct document description for an interim PTE application under 35 U.S.C. 156(d)(5) and 37 CFR 1.790. The USPTO has also created the new document descriptions “Interim Patent Term Extension Request Under 35 U.S.C. 156(e)(2)” (Doc Code TERM.REQ.E2) for requests for interim extension of the patent term under 35 U.S.C. 156(e)(2) and 37 CFR 1.760, and “Disclosure Under 37 CFR 1.765 in a Patent Term Extension Application” (Doc Code TERM.DISCL) for disclosures to the USPTO under 37 CFR 1.765. PTE applicants are reminded that, when multiple PTE applications are filed for different patents based on the same regulatory review period, it is incumbent upon the PTE applicants to inform the USPTO of the various PTE applications, pursuant to 37 CFR 1.740(a)(13) and 37 CFR 1.765. See also section 2761 of the MPEP.

In addition, the USPTO has created the new document description “Limited POA and/or Change of Address for a Patent Term Extension Application” (Doc Code PTE.POA) for limited powers of attorney and/or changes of correspondence address that are filed specifically for PTE applications. Although a power of attorney or limited power of attorney is not required for a practitioner to prosecute a PTE application (practitioners may prosecute PTE applications by acting in a representative capacity pursuant to 37 CFR 1.34), the USPTO routinely receives limited powers of attorney specifying that the power is limited to prosecution of the PTE application. A limited power of attorney filed using the document description “Limited POA and/or Change of Address for a Patent Term Extension Application” (Doc Code PTE.POA) will not be processed by the Office of Patent Application Processing (OPAP) and will not serve to change an existing power for the underlying patent or establish power for the underlying patent.

As for a change of the correspondence address that is filed specifically for a PTE application, the USPTO uses the 37 CFR 1.740(a)(15) address provided in an initial PTE or interim PTE application strictly for communications regarding the PTE application. If a PTE applicant subsequently wishes to change the 37 CFR 1.740(a)(15) address, the document description “Limited POA and/or Change of Address for a Patent Term Extension Application” (Doc Code PTE.POA) should be used for the submission. A change of address filed using the document description “Limited POA and/or Change of Address for a Patent Term Extension Application” (Doc Code PTE.POA) will not be processed by the OPAP and will not serve to change the correspondence address for the underlying patent. PTE applicants are reminded to separately file a change of address with any other relevant regulatory agency to timely receive copies of correspondence from that agency.

PTE applicants are strongly encouraged to confirm that they have used the correct document description for any PTE submission, especially time-sensitive PTE submissions, such as interim PTE applications under 35 U.S.C. 156(d)(5) and 37 CFR 1.790. Use of the correct document description may be verified by reviewing the EFS Acknowledgement Receipt (Doc Code N417) issued for the submission. In addition, both the document description and code for a submission may be verified in the electronic application file. If a mistake is identified, PTE applicants should contact the Patent Electronic Business Center at 866-217-9197 or EBC@uspto.gov.

When electronically filing a PTE or interim PTE application, the PTE or interim PTE application, including all exhibits, attachments, or appendices, should be submitted as a single file. If the single file comprising the application and its exhibits, attachments, or appendices exceeds the upload limit of the USPTO patent electronic filing system, the file may be split into smaller files to permit uploading, but the number of separate files to be uploaded should be minimized. Additionally, when splitting a file into smaller files, the order of the exhibits, attachments, or appendices as mentioned in the application should be maintained, and a single exhibit, attachment, or appendix should not be split, if possible. The USPTO has created a new document description, “Continuation of Patent Term Extension Application” (Doc Code PTE.APPENDIX), to be used for any exhibit, attachment, or appendix to a PTE or interim PTE application that is filed separately from the application.

The following is a discussion of the proposed amendments to 37 CFR part 1.

Section 1.740: Section 1.740(a)(15) is proposed to be amended to require the provision of an email address of the person to whom inquiries and correspondence related to the PTE application are to be directed. The USPTO has found that the availability of an email address facilitates contact with the PTE applicant's representative.

Section 1.740(b) is proposed to be amended to require that PTE applications under § 1.740, and any related submissions to the USPTO, be submitted using the USPTO patent electronic filing system in accordance with the USPTO patent electronic filing system requirements. Submissions to the USPTO related to PTE applications under § 1.740 include any related follow-on documents that must be submitted to the USPTO, such as corrections of informalities under § 1.740(c), petitions requesting review of incomplete filings or review of an accorded filing date under § 1.741(b), requests for reconsideration of notices of final determination and responses to requirements for information under § 1.750, requests for 35 U.S.C. 156(e)(2) interim extensions under § 1.760, disclosures to the USPTO under § 1.765, express withdrawals under § 1.770, and replies to requests to identify the holder of an approval under § 1.785(d). PTE-related submissions to the FDA or the USDA, such as disclosures to the Secretary of Health and Human Services or the Secretary of Agriculture under § 1.765, should continue to be filed directly with the relevant agency. The proposed amendment of § 1.740(b) would remove the requirement in the current § 1.740(b) to file each PTE application in triplicate.

Section 1.741: Section 1.741(a) is proposed to be amended to provide that the filing date of a PTE application is the date on which a complete PTE application is either received in the USPTO via the USPTO patent electronic filing system or filed pursuant to the procedure set forth in § 1.8(a)(1)(i)(C) and (a)(1)(ii). The provision in the current § 1.741(a), which provides that the filing date of a PTE application may be the date on which a complete application is filed pursuant to the physical mailing or facsimile transmission procedures set forth in §§ 1.8(a)(1)(i)(A) or (B) or 1.10, is proposed to be removed in view of the proposed requirement to file PTE applications via the USPTO patent electronic filing system.

Section 1.770: Section 1.770 is proposed to be amended to remove the requirement to file duplicates of express declarations of withdrawal of PTE applications. The requirement would no longer be needed in view of the proposed requirement to file submissions related to PTE applications via the USPTO patent electronic filing system.

Section 1.790: Section 1.790(a) is proposed to be amended to clarify that the referenced paragraphs are paragraphs of 35 U.S.C. 156(g). Additionally, the time periods in the current § 1.790(a) for filing initial and subsequent applications for interim extension are proposed to be moved to newly proposed paragraphs (c)(1) and (d)(1), respectively, of this section.

Section 1.790(b) is proposed to be amended to require any application for interim extension under this section ( i.e., both initial and subsequent interim extension applications) to be filed using the USPTO patent electronic filing system in accordance with the USPTO patent electronic filing system requirements. The provisions in the current § 1.790(b) regarding a complete application for interim extension are proposed to be moved to newly proposed paragraph (c)(2) of this section.

Section 1.790(c) is proposed to be amended to provide the requirements for complete initial applications for interim extension. Newly proposed § 1.790(c)(1) contains the time period in the current § 1.790(a) for filing an initial interim extension application. Newly proposed § 1.790(c)(2) contains the provisions in the current § 1.790(b) regarding a complete interim extension application. Note that the reference in the current § 1.790(b) to § 1.740(a)(16) and (17) is proposed to not be included in newly proposed § 1.790(c)(2) to correct an oversight. Paragraphs (a)(16) and (17) were removed from § 1.740 on September 8, 2000. Newly proposed § 1.790(c)(3) requires a statement that the applicable regulatory review period, described in 35 U.S.C. 156(g)(1)(B)(ii), (2)(B)(ii), (3)(B)(ii), (4)(B)(ii), or (5)(B)(ii), has begun for the product. It also requires an identification of the application, petition, or notice that caused the applicable regulatory review period, described in 35 U.S.C. 156(g)(1)(B)(ii), (2)(B)(ii), (3)(B)(ii), (4)(B)(ii), or (5)(B)(ii), to begin. For a human drug, antibiotic, or human biological product, it would be the number associated with the new drug application or Product License Application submitted for the product. For a new animal drug, it would be the number associated with the new animal drug application submitted for the drug. For a veterinary biological product, it would be the number associated with the application for license submitted under the Virus-Serum-Toxin Act for the product. For a food or color additive, it would be the number associated with the petition for product approval submitted under the Federal Food, Drug, and Cosmetic Act for the additive. For a medical device, it would be the number associated with the premarket approval application or notice of completion of a product development protocol submitted for the device. The USPTO has occasionally received applications for interim extension under 35 U.S.C. 156(d)(5) and § 1.790 that fail to meet the statutory requirement regarding the applicable regulatory review period.

Newly proposed § 1.790(d) contains the requirements for subsequent interim extension applications. Newly proposed § 1.790(d)(1) contains the time period in the current § 1.790(a) for filing each subsequent interim extension application. Newly proposed § 1.790(d)(2) contains provisions in the current § 1.790(c) regarding the content of each subsequent interim extension application. Newly proposed § 1.790(d)(3) contains the requirement in the current § 1.790(c) that an application contain a statement that the applicable regulatory review period, described in 35 U.S.C. 156(g)(1)(B)(ii), (2)(B)(ii), (3)(B)(ii), (4)(B)(ii), or (5)(B)(ii), has not been completed.

A. Administrative Procedure Act: The changes proposed in this rulemaking involve rules of agency practice and procedure, and/or interpretive rules. See Perez v. Mortg. Bankers Ass'n, 135 S. Ct. 1199, 1204 (2015) (Interpretive rules “advise the public of the agency's construction of the statutes and rules which it administers.” (citation and internal quotation marks omitted)); Nat'l Org. of Veterans' Advocates v. Sec'y of Veterans Affairs, 260 F.3d 1365, 1375 (Fed. Cir. 2001) (rule that clarifies the interpretation of a statute is interpretive); Bachow Commc'ns Inc. v. FCC, 237 F.3d 683, 690 (D.C. Cir. 2001) (Rules governing an application process are procedural under the Administrative Procedure Act.); Inova Alexandria Hosp. v. Shalala, 244 F.3d 342, 350 (4th Cir. 2001) (Rules for handling appeals were procedural where they did not change the substantive standard for reviewing claims.).

Accordingly, prior notice and opportunity for public comment for the changes proposed in this rulemaking are not required pursuant to 5 U.S.C. 553(b) or (c), or any other law. See Perez, 135 S. Ct. at 1206 (Notice-and-comment procedures are required neither when an agency “issue[s] an initial interpretive rule” nor “when it amends or repeals that interpretive rule.”); Cooper Techs. Co. v. Dudas, 536 F.3d 1330, 1336-37 (Fed. Cir. 2008) (stating that 5 U.S.C. 553, and thus 35 U.S.C. 2(b)(2)(B), do not require notice-and-comment rulemaking for “interpretative rules, general statements of policy, or rules of agency organization, procedure, or practice” (quoting 5 U.S.C. 553(b)(A))). However, the USPTO has chosen to seek public comment before implementing this rule to benefit from the public's input.

B. Regulatory Flexibility Act: Under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ), whenever an agency is required by 5 U.S.C. 553 (or any other law) to publish a notice of proposed rulemaking, the agency must prepare and make available for public comment an Initial Regulatory Flexibility Analysis, unless the agency certifies under 5 U.S.C. 605(b) that the proposed rule, if implemented, will not have a significant economic impact on a substantial number of small entities. 5 U.S.C. 603, 605. For the reasons set forth in this document, the Senior Counsel for Regulatory and Legislative Affairs, Office of General Law, of the USPTO has certified to the Chief Counsel for Advocacy of the Small Business Administration that the proposed rule, if implemented, will not have a significant economic impact on a substantial number of small entities. See 5 U.S.C. 605(b).

As a threshold matter, PTE under 35 U.S.C. 156 is only available for patents that claim drug products, medical devices, food or color additives, or methods of using or manufacturing such products, devices, or additives. Approximately 100 PTE applications are filed annually, and they are typically filed by non-small entity pharmaceutical and medical device companies because of the expense required to develop and obtain marketing approval for such inventions.

The changes proposed in this rule are procedural in nature and are not expected to result in significant costs to applicants. The current rules of practice permit follow-on documents related to PTE applications to be filed electronically. The USPTO estimates that approximately 99% of follow-on documents related to PTE applications are filed electronically. Accordingly, the proposed rule change requiring follow-on documents related to PTE applications to be filed electronically should not cause a substantial change in practice or result in additional costs to applicants. As for the proposed rule change requiring PTE applications to be filed electronically, although this would be a change in practice, stakeholders have unanimously communicated support for the USPTO's current waiver of the prohibition against electronic filing of PTE applications as a result of the COVID-19 outbreak, and the proposed rule change would not result in any additional cost to applicants. Thus, this proposed rule change requiring PTE applications to be filed electronically is not expected to negatively impact stakeholders' PTE practice.

Finally, the USPTO patent electronic filing system will allow PTE applicants to file PTE documents through their standard web browser without downloading special software, changing their documentation preparation tools, or altering their workflow processes. PTE applicants may create their documents using the tools and processes that they already use and then convert those documents into standard PDF files for submission through the USPTO patent electronic filing system.

For these reasons, the proposed changes will not have a significant economic impact on a substantial number of small entities.

C. Executive Order 12866 (Regulatory Planning and Review): This proposed rule has been determined to be not significant for purposes of Executive Order 12866 (Sept. 30, 1993).

D. Executive Order 13563 (Improving Regulation and Regulatory Review): The USPTO has complied with Executive Order 13563 (Jan. 18, 2011). Specifically, the USPTO has, to the extent feasible and applicable: (1) Made a reasoned determination that the benefits justify the costs of the proposed rule; (2) tailored the proposed rule to impose the least burden on society consistent with obtaining the regulatory objectives; (3) selected a regulatory approach that maximizes net benefits; (4) specified performance objectives; (5) identified and assessed available alternatives; (6) involved the public in an open exchange of information and perspectives among experts in relevant disciplines, affected stakeholders in the private sector, and the public as a whole, and provided online access to the rulemaking docket; (7) attempted to promote coordination, simplification, and harmonization across Government agencies and identified goals designed to promote innovation; (8) considered approaches that reduce burdens and maintain flexibility and freedom of choice for the public; and (9) ensured the objectivity of scientific and technological information and processes.

E. Executive Order 13132 (Federalism): This proposed rule does not contain policies with federalism implications sufficient to warrant preparation of a Federalism Assessment under Executive Order 13132 (Aug. 4, 1999).

F. Executive Order 13175 (Tribal Consultation): This proposed rule will not: (1) Have substantial direct effects on one or more Indian tribes; (2) impose substantial direct compliance costs on Indian tribal governments; or (3) preempt tribal law. Therefore, a tribal summary impact statement is not required under Executive Order 13175 (Nov. 6, 2000).

G. Executive Order 13211 (Energy Effects): This proposed rule is not a significant energy action under Executive Order 13211 because the proposed rule is not likely to have a significant adverse effect on the supply, distribution, or use of energy. Therefore, a Statement of Energy Effects is not required under Executive Order 13211 (May 18, 2001).

H. Executive Order 12988 (Civil Justice Reform): This proposed rule meets applicable standards to minimize litigation, eliminate ambiguity, and reduce burden as set forth in sections 3(a) and 3(b)(2) of Executive Order 12988 (Feb. 5, 1996).

I. Executive Order 13045 (Protection of Children): This proposed rule does not concern an environmental risk to health or safety that may disproportionately affect children under Executive Order 13045 (Apr. 21, 1997).

J. Executive Order 12630 (Taking of Private Property): This proposed rule will not effect a taking of private property or otherwise have taking implications under Executive Order 12630 (Mar. 15, 1988).

K. Congressional Review Act: Under the Congressional Review Act provisions of the Small Business Regulatory Enforcement Fairness Act of 1996 (5 U.S.C. 801-808), prior to issuing any final rule, the USPTO will submit a report containing any final rule resulting from this proposed rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the Government Accountability Office. The changes in this proposed rule are not expected to result in an annual effect on the economy of $100 million or more, a major increase in costs or prices, or significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of United States-based enterprises to compete with foreign-based enterprises in domestic and export markets. Therefore, this proposed rule is not a “major rule” as defined in 5 U.S.C. 804(2).

L. Unfunded Mandates Reform Act of 1995: The proposed changes set forth in this rulemaking do not involve a Federal intergovernmental mandate that will result in the expenditure by State, local, and tribal governments, in the aggregate, of $100 million (as adjusted) or more in any one year, or a Federal private sector mandate that will result in the expenditure by the private sector of $100 million (as adjusted) or more in any one year, and will not significantly or uniquely affect small governments. Therefore, no actions are necessary under the provisions of the Unfunded Mandates Reform Act of 1995. See 2 U.S.C. 1501 et seq.

M. National Environmental Policy Act of 1969: This proposed rule will not have any effect on the quality of the environment and is thus categorically excluded from review under the National Environmental Policy Act of 1969. See 42 U.S.C. 4321 et seq.

N. National Technology Transfer and Advancement Act of 1995: The requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) are not applicable because this proposed rule does not contain provisions that involve the use of technical standards.

O. Paperwork Reduction Act of 1995: The Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ) requires that the USPTO consider the impact of paperwork and other information collection burdens imposed on the public. In accordance with section 3507(d) of the Paperwork Reduction Act of 1995, the paperwork and other information collection burdens involved with this proposed rule have already been approved under the Office of Management and Budget (OMB) Control Number 0651-0020 (Patent Term Extension). However, 0651-0020 will be updated to reflect a reduction in burden (time) due to the removal of the requirement to file PTE applications in paper in triplicate. The USPTO estimates that this information collection's annual burden will decrease by a total of approximately 51 burden hours. This estimate is based on the current OMB-approved burdens (response volumes) associated with this information collection, which may fluctuate over time and may be different from any forecasts mentioned in other parts of this proposed rule.

Notwithstanding any other provision of law, no person is required to respond to, nor shall any person be subject to a penalty for failure to comply with, a collection of information subject to the requirements of the Paperwork Reduction Act unless that collection of information has a currently valid OMB control number.

P. E-Government Act Compliance: The USPTO is committed to compliance with the E-Government Act to promote the use of the internet and other information technologies, to provide increased opportunities for citizen access to Government information and services, and for other purposes.

For the reasons set forth in the preamble, the USPTO proposes to amend 37 CFR part 1 as follows:

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

Submit your comments, identified by Docket ID No. EPA-R07-OAR-2022-0382, at https://www.regulations.gov. Once submitted, comments cannot be edited or removed from Regulations.gov . The EPA may publish any comment received to its public docket. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Multimedia submissions (audio, video, etc.) must be accompanied by a written comment. The written comment is considered the official comment and should include discussion of all points you wish to make. The EPA will generally not consider comments or comment contents located outside of the primary submission ( i.e. on the web, cloud, or other file sharing system). For additional submission methods, the full EPA public comment policy, information about CBI or multimedia submissions, and general guidance on making effective comments, please visit https://www.epa.gov/dockets/commenting-epa-dockets.

The EPA is proposing to approve the removal of 10 Code of State Regulation (CSR) 10-5.440, Control of Emissions From Bakery Ovens, from the Missouri SIP.

Section 110(l) of the CAA prohibits the EPA from approving a SIP revision that interferes with any applicable requirement concerning attainment and reasonable further progress (RFP), or any other applicable requirement of the CAA. The State supplemented its SIP revision with a July 11, 2019 letter in order to address the requirements of section 110(l) of the CAA.

According to the January 15, 2019, letter from the Missouri Department of Natural Resources (MoDNR), available in the docket for this proposed action, Missouri rescinded 10 CSR 10-5.440, Control of Emissions from Bakery Ovens because the only source subject to the rule ceased operations in 2012. The state asserts in their submission to the Agency that this rule is no longer necessary for controlling emissions of volatile organic compounds (VOC's) because there are no existing sources subject to the rule and new sources would be controlled by other rules.

In its supplemental submission dated July 11, 2019, MoDNR notes that the purpose of 10 CSR 10-5.440, Control of Emissions From Bakery Ovens, was to reduce VOC emissions from bakery ovens located in the St. Louis nonattainment area, which at the time of promulgation (state effective Date: December 30, 1996), included the City of St. Louis and the counties of Franklin, Jefferson, St. Charles, and St. Louis (hereinafter referred to in this document as the “St. Louis Area”). 1 The rule applied to new or existing commercial bakeries with potential VOC emissions greater than 100 tons per year (tpy).

MoDNR stated that following rescission of this rule, any new source is required to meet New Source Review (NSR) in attainment or attainment/unclassifiable areas, and for nonattainment areas, Nonattainment New Source Review (NANSR) in the St. Louis Area.

EPA agrees that in the St. Louis nonattainment area for the 2015 ozone standard, which includes St. Louis City and the counties of Franklin (partial; Boles Township), Jefferson, St. Charles, and St. Louis, any new sources or major modifications of existing sources are subject to NANSR permitting. 2 Under NANSR, a new major source or major modification of an existing source with a PTE of 100 tpy or more of any NAAQS pollutant is required to obtain a NANSR permit when the area is in nonattainment, which requires an analysis of Lowest Achievable Emission Rate (LAER) in addition to an air quality analysis, an additional impacts analysis and emission offsets. LAER is defined in § 51.165(a)(1)(xiii), in pertinent part, “. . . for any source, the more stringent rate of emissions based on the following: (A) The most stringent emissions limitation which is contained in the implementation plan of any State for such class or category of stationary source, unless the owner or operator of the proposed stationary source demonstrates that such limitations are not achievable; or (B) The most stringent emissions limitation which is achieved in practice by such class or category of stationary sources. This limitation, when applied to a modification, means the lowest achievable emissions rate for the new or modified emissions units within or stationary source. In no event shall the application of the term permit a proposed new or modified stationary source to emit any pollutant in excess of the amount allowable under an applicable new source standard of performance.”  3

Therefore, any new bakery oven that would have been subject to 10 CSR 10-5.440, in the St. Louis ozone Nonattainment Area, will be subject to NANSR permitting which would result in a LAER limit at least as stringent as the limit in this rule in addition to the requirement to offset the emissions.

In the rest of Franklin County (the portions that do not include Boles Township), any new sources or major modifications of existing sources are subject to NSR permitting. Under NSR, for attainment or attainment/unclassifiable areas, a new major source or major modification of an existing source with a potential to emit (PTE) of 250 tpy or more of any NAAQS pollutant is required to obtain a Prevention of Significant Deterioration (PSD) permit. Sources with a PTE greater than 100 tpy of VOC's, but less than 250 tpy, are required to obtain a minor permit in accordance with Missouri's NSR permitting program, which is approved into the SIP. 4 In the Final Area Designations for the 2015 Ozone National Ambient Air Quality Standards (NAAQS) Technical Support Document (TSD) EPA observes that emissions from sources outside Boles Township are relatively low, with levels less than the more densely populated City of St. Louis and five other counties in the area of analysis. 5 As noted in the TSD, there are no other large sources of VOC or NOx in Franklin County, outside of Boles Township, which remains a nonattainment area and therefore subject to NANSR permitting. Therefore, EPA believes that any newly permitted NSR or minor NSR bakery ovens in Franklin County would have little to no impact on the St. Louis Area ozone levels.

Therefore, EPA agrees with the State that approving this SIP revision will not have an adverse impact on air quality because the only source subject to the rule has permanently shutdown and new sources would be subject to NANSR, NSR and minor NSR in the St. Louis Area. As stated above, new bakery ovens with a PTE of 100 tpy or more of VOC's would be very well controlled in all areas where 10 CSR 10-5.440 previously applied.

Further, the rescission of this rule from the SIP will have no impact on any approved maintenance plan. On September 20, 2018, the EPA redesignated the St. Louis, Missouri area to attainment of the 2008 ozone NAAQS. In the state's maintenance plan submittal for this standard, this rule was not relied upon. The EPA agrees with this analysis.

For these reasons, EPA proposes to determine that the SIP revision submission meets the substantive requirements of the CAA, including section 110 and implementing regulations.

EPA is proposing to approve this SIP revision.

The State submission has met the public notice requirements for SIP submissions in accordance with 40 CFR 51.102. The submission also satisfied the completeness criteria of 40 CFR part 51, appendix V. The State provided public notice on this SIP revision from May 15, 2018 to August 2, 2018 and received 11 comments from the EPA. Missouri received 11 comments from the EPA that related to Missouri's lack of an adequate demonstration that the rule could be removed from the SIP in accordance with section 110(l) of the CAA. Missouri's July 11, 2019 letter addressed the EPA's comments. In addition, as explained above, the revision meets the substantive SIP requirements of the CAA, including section 110 and implementing regulations.

The EPA is proposing to approve Missouri's request to rescind 10 CSR 10-5.440 from the SIP because the rule applied to a single source that has permanently ceased operations and it therefore no longer serves to reduce emissions in the St. Louis Area. Furthermore, any new sources or major modifications of existing sources in the St. Louis Area are subject to NSR permitting. 6 We are processing this as a proposed action because we are soliciting comments on this proposed action. Final rulemaking will occur after consideration of any comments.

In this document, the EPA is proposing to amend regulatory text that includes incorporation by reference. As described in Sections II, III, and V of this preamble and set forth below in the proposed amendments to 40 CFR part 52, the EPA is proposing to remove provisions of the EPA-Approved Missouri Regulations from the Missouri State Implementation Plan, which is incorporated by reference in accordance with the requirements of 1 CFR part 51.

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 approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:

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

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

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

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

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

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

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

• Is not subject to requirements of the National Technology Transfer and Advancement Act (NTTA) because this rulemaking does not involve technical standards; 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).

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).

For the reasons stated in the preamble, the EPA proposes to amend 40 CFR part 52 as set forth below:

Public participation: Submit your comments, identified by Docket No. EPA-R08-OAR-2019-0140, at https://www.regulations.gov. Once submitted, comments cannot be edited or removed from the docket. EPA may publish any comment received to its public docket. Do not submit to EPA's docket at https://www.regulations.gov any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Multimedia submissions (audio, video, etc.) must be accompanied by a written comment. The written comment is considered the official comment and should include discussion of all points you wish to make. EPA will generally not consider comments or comment contents located outside of the primary submission ( i.e., on the web, cloud, or other file sharing system).

There are two dockets supporting this proposed action, EPA-R08-OAR-2019-0140 and EPA-HQ-OAR-2021-0663. Docket No. EPA-R08-OAR-2019-0140 contains information specific to Colorado, including the notice of proposed rulemaking. Docket No. EPA-HQ-OAR-2021-0663 contains additional modeling files, emissions inventory files, technical support documents, and other relevant supporting documentation regarding interstate transport of emissions for the 2015 8-hour ozone NAAQS which are being used to support this proposed action. All comments regarding information in either of these dockets must be made in Docket No. EPA-R08-OAR-2019-0140. For additional submission methods, please email or call a person listed in the FOR FURTHER INFORMATION CONTACT . For the full EPA public comment policy, information about CBI or multimedia submissions, and general guidance on making effective comments, please visit https://www.epa.gov/dockets/commenting-epa-dockets.

The index to Docket No. EPA-HQ-OAR-2021-0663 is available electronically at https://www.regulations.gov. While all documents in that docket are listed in the index, some information may not be publicly available due to docket file size restrictions or content ( e.g., CBI).

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

On October 1, 2015, EPA promulgated a revision to the ozone NAAQS (2015 8-hour ozone NAAQS), lowering the level of both the primary and secondary standards to 0.070 parts per million (ppm). 1 Section 110(a)(1) of the CAA requires states to submit, within three years after promulgation of a new or revised standard, SIP submissions meeting the applicable requirements of CAA section 110(a)(2). 2

One of the applicable requirements of section 110(a)(2) is found in CAA section 110(a)(2)(D)(i)(I), otherwise known as the “interstate transport” or “good neighbor” provision, which generally requires SIPs to contain adequate provisions to prohibit in-state emissions activities from having certain adverse air quality effects on other states due to interstate transport of pollution. There are two so-called “prongs” within CAA section 110(a)(2)(D)(i)(I). A SIP submission for a new or revised NAAQS must contain adequate provisions prohibiting any source or other type of emissions activity within the state from emitting air pollutants in amounts that will significantly contribute to nonattainment of the NAAQS in another state (prong 1) or interfere with maintenance of the NAAQS in another state (prong 2). EPA and states must give independent significance to prong 1 and prong 2 when evaluating downwind air quality problems under CAA section 110(a)(2)(D)(i)(I). 3

EPA is using the 4-step interstate transport framework (or 4-step framework) to evaluate state SIP submissions addressing the interstate transport provision for the 2015 8-hour ozone NAAQS. EPA has addressed the interstate transport requirements of CAA section 110(a)(2)(D)(i)(I) with respect to prior ozone NAAQS in several regional regulatory actions, including the Cross-State Air Pollution Rule (CSAPR), which addressed interstate transport with respect to the 1997 ozone NAAQS as well as the 1997 and 2006 fine particulate matter standards, 4 and the CSAPR Update, 5 and the Revised CSAPR Update, both of which addressed the 2008 ozone NAAQS. 6

Through the development and implementation of the CSAPR rulemakings and prior regional rulemakings pursuant to the interstate transport provision, 7 EPA, working in partnership with states, developed the following 4-step interstate transport framework to evaluate a state's obligations to eliminate interstate transport emissions under the interstate transport provision for the ozone NAAQS: (1) Identify monitoring sites that are projected to have problems attaining and/or maintaining the NAAQS ( i.e., nonattainment and/or maintenance receptors); (2) identify states that impact those air quality problems in other ( i.e., downwind) states sufficiently such that the states are considered “linked” and therefore warrant further review and analysis; (3) identify the emissions reductions necessary (if any), applying a multifactor analysis, to eliminate each linked upwind state's significant contribution to nonattainment or interference with maintenance of the NAAQS at the locations identified in step 1; and (4) adopt permanent and enforceable measures needed to achieve those emissions reductions.

In general, EPA has performed nationwide air quality modeling to project ozone design values which are used in combination with measured data to identify nonattainment and maintenance receptors. To quantify the contribution of emissions from specific upwind states on 2023 ozone design values for the identified downwind nonattainment and maintenance receptors, EPA performed nationwide, state-level ozone source apportionment modeling for 2023. The source apportionment modeling provided contributions to ozone at receptors from precursor emissions of anthropogenic nitrogen oxides (NO X ) and volatile organic compounds (VOC) in individual upwind states.

EPA has released several documents containing projected ozone design values, contributions, and information relevant to evaluating interstate transport with respect to the 2015 8-hour ozone NAAQS. First, on January 6, 2017, EPA published a notice of data availability (NODA) in which we requested comment on preliminary interstate ozone transport data including projected ozone design values and interstate contributions for 2023 using a 2011 base year platform. 8 In the NODA, EPA used the year 2023 as the analytic year for this preliminary modeling because that year aligns with the expected attainment year for moderate ozone nonattainment areas for the 2015 8-hour ozone NAAQS. 9 On October 27, 2017, we released a memorandum (October 2017 memorandum) containing updated modeling data for 2023, which incorporated changes made in response to comments on the NODA, and noted that the modeling may be useful for states developing SIPs to address interstate transport obligations for the 2008 ozone NAAQS. 10 On March 27, 2018, we issued a memorandum (March 2018 memorandum) noting that the same 2023 modeling data released in the October 2017 memorandum could also be useful for identifying potential downwind air quality problems with respect to the 2015 8-hour ozone NAAQS at Step 1 of the 4-step interstate transport framework. 11 The March 2018 memorandum also included the then newly available contribution modeling data to assist states in evaluating their impact on potential downwind air quality problems for the 2015 8-hour ozone NAAQS under Step 2 of the 4-step interstate transport framework. 12 EPA subsequently issued two more memoranda in August and October 2018, providing additional information to states developing interstate transport SIP submissions for the 2015 ozone NAAQS concerning, respectively, potential contribution thresholds that may be appropriate to apply in Step 2 of the 4-step framework, and considerations for identifying downwind areas that may have problems maintaining the standard at Step 1 of the 4-step framework. 13

Since the release of the modeling data shared in the March 2018 memorandum, EPA performed updated modeling using a 2016-based emissions modeling platform ( i.e., 2016v1). This emissions platform was developed under the EPA/Multi-Jurisdictional Organization (MJO)/state collaborative project. 14 This collaborative project was a multi-year joint effort by EPA, the MJOs, and states to develop a new, more recent emissions platform for use by EPA and states in regulatory modeling as an improvement over the dated 2011-based platform that EPA had used to project ozone design values and contribution data provided in the 2017 and 2018 memoranda. EPA used the 2016v1 emissions to project ozone design values and contributions for 2023. On October 30, 2020, in the Notice of Proposed Rulemaking for the Revised CSAPR Update, EPA released and accepted public comment on 2023 modeling that used the 2016v1 emissions platform. 15 Although the Revised CSAPR Update addressed transport for the 2008 ozone NAAQS, the projected design values and contributions from the 2016v1 platform are also useful for identifying downwind ozone problems and linkages with respect to the 2015 ozone NAAQS. 16

Following the final Revised CSAPR Update, EPA made further updates to the 2016 emissions platform to include mobile emissions from EPA's Motor Vehicle Emission Simulator MOVES3 model  17 and updated emissions projections for electric generating units (EGUs) that reflect the emissions reductions from the Revised CSAPR Update, recent information on plant closures, and other sector trends. The construct of the updated emissions platform, 2016v2, is described in an emissions modeling technical support document (TSD). 18 EPA performed air quality modeling of the 2016v2 emissions using the most recent public release version of the Comprehensive Air-quality Model with extensions (CAMx) photochemical modeling, version 7.10. 19

EPA now proposes to primarily rely on modeling based on the updated and newly available 2016v2 emissions platform in evaluating these submissions with respect to Steps 1 and 2 of the 4-step framework and generally references it within this action as 2016v2 modeling for 2023. By using the updated modeling results, EPA is using the most current and technically appropriate information for this proposed rulemaking. Section III of this document and the Air Quality Modeling TSD for 2015 Ozone NAAQS Transport SIP Proposed Actions, included in Docket No. EPA-HQ-OAR-2021-0663 for this proposal, contain additional detail on EPA's 2016v2 modeling. EPA is accepting public comment on this updated 2023 modeling, which uses a 2016v2 emissions platform as the modeling pertains to this proposed action. Comments on EPA's air quality modeling as used in this proposed action should be submitted in the Regional docket for this action, Docket No. EPA-R08-OAR-2019-0140. EPA is not accepting comments in Docket No. EPA-HQ-OAR-2021-0663.

CAA section 110(a)(2)(E)(i) requires that a state provide “necessary assurances” that it will have, among other things, adequate authority under state law to carry out its SIP to meet CAA requirements with respect to the relevant NAAQS. 20 Specifically, a state's infrastructure SIP submission should show that the state has the legal authority to carry out the provisions identified in the state's infrastructure SIP submission and is not prohibited by federal or state law from carrying out the SIP submission.

On September 17, 2018, the State of Colorado submitted to EPA its infrastructure SIP submission for the 2015 ozone NAAQS. On July 29, 2019, EPA proposed to approve Colorado's submission with respect to all relevant CAA elements. 21 EPA proposed approval of the portion of Colorado's infrastructure SIP related to prongs 1 and 2 of CAA section 110(a)(2)(D)(i)(I), primarily relying on the 2023 modeling (2011 base year platform) presented in the March 2018 memorandum. 22 EPA's analysis of the 2023 modeling indicated that Colorado's largest impacts at any identified downwind receptor would be less than 1 percent (0.70 ppb) of the 2015 ozone NAAQS. 23 Thus, EPA proposed to find that Colorado's emissions would not significantly contribute to nonattainment or interfere with maintenance of the 2015 ozone NAAQS in any other state. 24

On September 13, 2019, the United States Court of Appeals for the D.C. Circuit issued a decision in Wisconsin v. EPA, remanding the CSAPR Update to the extent that it failed to require upwind states to eliminate their significant contribution by the next applicable attainment date by which downwind states must come into compliance with the NAAQS, as established under CAA section 181(a). 25 In our 2020 final rule (published on April 10, 2020), EPA defended the use of the 2023 analytical year on the basis of what was then, in the Agency's view, a position consistent with Wisconsin —specifically that the Wisconsin holding did not apply with respect to the attainment date for marginal areas. 26 However, EPA also offered an alternative rationale. EPA used linear interpolation to estimate Colorado's maximum contribution to a potential receptor in 2021 and concluded that even if it were appropriate to use the 2021 marginal area date rather than the 2023 moderate area date, Colorado's impacts would be similar to those projected for 2023 and thus it would not significantly contribute to nonattainment or interfere with maintenance in other states. 27

On May 19, 2020, the D.C. Circuit issued a ruling in Maryland v. EPA that cited the Wisconsin decision in holding that EPA must assess the impact of interstate transport on air quality at the next downwind attainment date, including marginal area attainment dates, in evaluating the basis for EPA's denial of a petition under CAA section 126(b). 28 The court noted that “section 126(b) incorporates the Good Neighbor Provision,” and, therefore, “EPA must find a violation [of section 126] if an upwind source will significantly contribute to downwind nonattainment at the next downwind attainment deadline. Therefore, the Agency must evaluate downwind air quality at that deadline, not at some later date.” Id. at 1204 (emphasis added).

On June 9, 2020, the Center for Biological Diversity (Center) filed a petition for review of the 2020 final rule in the United States Court of Appeals for the Tenth Circuit (Tenth Circuit). 29 The Center challenged two sub-elements of the SIP approval: (1) EPA's conclusion that Colorado's infrastructure SIP submission satisfies the good neighbor provision, CAA section 110(a)(2)(D)(i)(I); and (2) EPA's conclusion that the State's infrastructure SIP submission satisfies Colorado's obligation to provide necessary assurances that the State has authority to regulate all agricultural sources of air pollution as may be required by the CAA section 110(a)(2)(E)(i). 30

In challenging EPA's approval of the portion of Colorado's infrastructure SIP submission addressing CAA section 110(a)(2)(D)(i)(I), the Center argued that EPA's analysis focused on the wrong analytical year, failed to adequately analyze all of the relevant potential out-of-state receptor locations, and should have accounted for air quality impacts from various proposed and final federal rules. 31

With respect to the state authority issue, the Center argued that a provision of state law, Colo. Rev. Stat. § 25-7-109(8)(a), bars Colorado from regulating agricultural sources other than those that are major sources. The Center argued that this means that Colorado's infrastructure SIP submission failed to provide “necessary assurances” of the State's authority to regulate all agricultural sources, as may be needed to comply with CAA requirements for SIPs, pursuant to CAA section 110(a)(2)(E)(i). 32

On December 31, 2020, EPA filed a motion for a voluntary remand without vacatur of the two challenged parts of the 2020 final rule. EPA stated that it intended to consider additional information, including the Maryland decision and new information developed after EPA issued the 2020 final rule that was not available in the administrative record for the 2020 final rule. 33 The Tenth Circuit granted EPA's motion on January 5, 2021. 34

In this document, EPA proposes to address the two remanded portions of EPA's 2020 final rule by proposing to approve Colorado's infrastructure SIP submission for the 2015 ozone standards with respect to CAA section 110(a)(2)(D)(i)(I) and (E)(i). EPA seeks comment on its conclusions under CAA section 110(a)(2)(D)(i)(I) and (E)(i) in this proposed approval. We are not otherwise addressing or reopening for comment any of the other portions of our 2020 final rule. We will deem any comments on such portions beyond the scope of this action.

EPA proposes to apply a consistent set of policy judgments across all states for purposes of evaluating interstate transport obligations and the approvability of interstate transport SIP submissions for the 2015 8-hour ozone NAAQS. These policy judgments reflect consistency with relevant case law and past agency practice as reflected in the CSAPR and related rulemakings. Nationwide consistency in approach is particularly important in the context of interstate ozone transport, which is a regional-scale pollution problem involving many smaller contributors. Effective policy solutions to the problem of interstate ozone transport going back to the NO X SIP Call have necessitated the application of a uniform framework of policy judgments in order to ensure an “efficient and equitable” approach. 35

The remainder of this section describes EPA's proposed framework with respect to analytic year, definition of nonattainment and maintenance receptors, selection of contribution threshold, and multifactor control strategy assessment.

In general, the states and EPA must implement the interstate transport provision in a manner “consistent with the provisions of [title I of the CAA].”  36 This requires, among other things, that these obligations are addressed consistently with the timeframes for downwind areas to meet their CAA obligations. With respect to ozone NAAQS, under CAA section 181(a), this means obligations must be addressed “as expeditiously as practicable” and no later than the schedule of attainment dates provided in CAA section 181(a)(1). 37 As discussed in Section I of this proposed rulemaking, recent case law makes clear that the states and the Agency are obligated, under the good neighbor provision, to assess downwind air quality as expeditiously as practicable and no later than the next applicable attainment date. This is now the moderate area attainment date under CAA section 181 for ozone nonattainment. The moderate area attainment date for the 2015 8-hour ozone NAAQS is August 3, 2024. 38 EPA believes that 2023 is now the appropriate year for analysis of interstate transport obligations for the 2015 8-hour ozone NAAQS, because the 2023 ozone season is the last relevant ozone season during which achieved emissions reductions in linked upwind states could assist downwind states with meeting the August 3, 2024, moderate area attainment date for the 2015 8-hour ozone NAAQS.

EPA recognizes that the attainment date for nonattainment areas classified as marginal for the 2015 8-hour ozone NAAQS was August 3, 2021. Under the Maryland holding, any necessary emissions reductions to satisfy interstate transport obligations should have been implemented by no later than this date. At the time of the statutory deadline to submit interstate transport SIPs (October 1, 2018), many states, including Colorado, relied upon EPA modeling of the year 2023, and no state provided an alternative analysis using a 2021 analytic year (or the prior 2020 ozone season). EPA appreciates that among the arguments raised by the Center in challenging the 2020 final rule was the failure to analyze a year earlier than 2023. However, EPA must act on SIP submissions—even in this action on remand—using the information available at the time it takes such action. In this circumstance, EPA does not believe it would be appropriate to evaluate Colorado's obligations under CAA section 110(a)(2)(D)(i)(I) as of an attainment date that is wholly in the past, because the Agency interprets the interstate transport provision as forward looking. 39 It would not make sense to analyze air quality, contribution levels, or emissions control strategies for the 2021 attainment date, for purposes of interstate transport obligations, when no emissions reductions, if shown to be needed, could be implemented by that date anyway. 40 Consequently, in this proposal EPA will use the analytical year of 2023 to evaluate Colorado's CAA section 110(a)(2)(D)(i)(I) SIP submission with respect to the 2015 8-hour ozone NAAQS.

In Step 1, EPA identifies monitoring sites that are projected to have problems attaining and/or maintaining the NAAQS in the 2023 analytic year. Where EPA's analysis shows that a site does not fall under the definition of a nonattainment or maintenance receptor, that site is excluded from further analysis under EPA's 4-step interstate transport framework. For sites that are identified as a nonattainment or maintenance receptor in 2023, we proceed to the next step of our 4-step interstate transport framework by identifying the upwind state's contribution to those receptors.

EPA's approach to identifying ozone nonattainment and maintenance receptors in this action is consistent with the approach used in previous transport rulemakings. EPA's approach gives independent consideration to both the “contribute significantly to nonattainment” and the “interfere with maintenance” prongs of CAA section 110(a)(2)(D)(i)(I), consistent with the D.C. Circuit's direction in North Carolina v. EPA. 41

For this proposal, EPA identifies nonattainment receptors as those monitoring sites that are projected to have average design values that exceed the NAAQS and that are also measuring nonattainment based on the most recent monitored design values. This approach is consistent with prior transport rulemakings, such as the CSAPR Update, where EPA defined nonattainment receptors as those areas that both currently measure nonattainment and that EPA projects will be in nonattainment in the future analytic year ( i.e., 2023). 42

In addition, in this proposal, EPA identifies a receptor to be a “maintenance” receptor for purposes of defining interference with maintenance, consistent with the method used in the CSAPR and upheld by the D.C. Circuit in EME Homer City Generation, L.P. v. EPA. 43 Specifically, EPA identified maintenance receptors as those receptors that would have difficulty maintaining the relevant NAAQS in a scenario that takes into account historical variability in air quality at that receptor. The variability in air quality was determined by evaluating the “maximum” future design value at each receptor based on a projection of the maximum measured design value over the relevant period. EPA interprets the projected maximum future design value to be a potential future air quality outcome consistent with the meteorology that yielded maximum measured concentrations in the ambient data set analyzed for that receptor ( i.e., ozone conducive meteorology). EPA also recognizes that previously experienced meteorological conditions ( e.g., dominant wind direction, temperatures, air mass patterns) promoting ozone formation that led to maximum concentrations in the measured data may reoccur in the future. The maximum design value gives a reasonable projection of future air quality at the receptor under a scenario in which such conditions do, in fact, reoccur. The projected maximum design value is used to identify upwind emissions that, under those circumstances, could interfere with the downwind area's ability to maintain the NAAQS.

Recognizing that nonattainment receptors are also, by definition, maintenance receptors, EPA often uses the term “maintenance-only” to refer to those receptors that are not nonattainment receptors. Consistent with the concepts for maintenance receptors, as described above, EPA identifies “maintenance-only” receptors as those monitoring sites that have projected average design values above the level of the applicable NAAQS, but that are not currently measuring nonattainment based on the most recent official design values. In addition, those monitoring sites with projected average design values below the NAAQS, but with projected maximum design values above the NAAQS are also identified as “maintenance-only” receptors, even if they are currently measuring nonattainment based on the most recent official design values.

In Step 2, EPA quantifies the contribution of each upwind state to each receptor in the 2023 analytic year. The contribution metric used in Step 2 is defined as the average impact from each state to each receptor on the days with the highest ozone concentrations at the receptor based on the 2023 modeling. If a state's contribution value does not equal or exceed the threshold of 1 percent of the NAAQS ( i.e., 0.70 ppb for the 2015 8-hour ozone NAAQS), the upwind state is not “linked” to a downwind air quality problem, and EPA, therefore, concludes that the state does not significantly contribute to nonattainment or interfere with maintenance of the NAAQS in the downwind states. However, if a state's contribution equals or exceeds the 1 percent threshold, the state's emissions are further evaluated in Step 3, considering both air quality and cost as part of a multi-factor analysis, to determine what, if any, emissions might be deemed “significant” and, thus, must be eliminated under CAA section 110(a)(2)(D)(i)(I). EPA is proposing to rely in the first instance on the 1 percent threshold for the purpose of evaluating a state's contribution to nonattainment or maintenance of the 2015 8-hour ozone NAAQS ( i.e., 0.70 ppb) at downwind receptors. This is consistent with the Step 2 approach that EPA applied in CSAPR for the 1997 ozone NAAQS, which has subsequently been applied in the CSAPR Update when evaluating interstate transport obligations for the 2008 ozone NAAQS. EPA continues to find 1 percent to be an appropriate threshold.

For ozone, as EPA found in the Clean Air Interstate Rule (CAIR), CSAPR, and CSAPR Update, a portion of the nonattainment problems from anthropogenic sources in the United States results from the combined impact of relatively small contributions from many upwind states, along with contributions from in-state sources and, in some cases, substantially larger contributions from a subset of particular upwind states. EPA's analysis shows that much of the ozone transport problem being analyzed in this proposed rule is still the result of the collective impacts of contributions from many upwind states. Therefore, application of a consistent contribution threshold is necessary to identify those upwind states that should have responsibility for addressing their contribution to the downwind nonattainment and maintenance problems to which they collectively contribute. Continuing to use 1 percent of the NAAQS as the screening metric to evaluate collective contribution from many upwind states also allows EPA (and states) to apply a consistent framework to evaluate interstate emissions transport under the interstate transport provision from one NAAQS to the next. 44

Consistent with EPA's longstanding approach to eliminating significant contribution or interference with maintenance, at Step 3, states linked at Steps 1 and 2 are generally expected to prepare a multifactor assessment of potential emissions controls. EPA's analysis at Step 3 in prior federal actions addressing interstate transport requirements has focused primarily on an evaluation of cost-effectiveness of potential emissions controls (on a marginal cost-per-ton basis), the total emissions reductions that may be achieved by requiring such controls (if applied across all linked upwind states), and an evaluation of the air quality impacts such emissions reductions would have on the downwind receptors to which a state is linked; other factors may potentially be relevant if adequately supported. In general, where EPA's or alternative air quality and contribution modeling establishes that a state is linked at Steps 1 and 2, it will be insufficient at Step 3 for a state merely to point to its existing rules requiring control measures as a basis for approval. In general, the emissions-reducing effects of all existing emissions control requirements are already reflected in the air quality results of the modeling for Steps 1 and 2. If the state is shown to still be linked to one or more downwind receptor(s), states must provide a well-documented evaluation determining whether their emissions constitute significant contribution or interference with maintenance by evaluating additional available control opportunities by preparing a multifactor assessment. While EPA has not prescribed a particular method for this assessment, EPA expects states at a minimum to present a sufficient technical evaluation. This would typically include information on emissions sources, applicable control technologies, emissions reductions, costs, cost effectiveness, and downwind air quality impacts of the estimated reductions, before concluding that no additional emissions controls should be required. 45

At Step 4, states (or EPA) develop permanent and federally enforceable control strategies to achieve the emissions reductions determined to be necessary at Step 3 to eliminate significant contribution to nonattainment or interference with maintenance of the NAAQS. For a state linked at Steps 1 and 2 to rely on an emissions control measure at Step 3 to address its interstate transport obligations, that measure must be included in the state's SIP so that it is permanent and federally enforceable. 46

As mentioned above, the State of Colorado submitted a SIP submission to EPA on September 17, 2018, to meet the good neighbor requirements for the 2015 ozone NAAQS. In its prong 1 and prong 2 analysis, Colorado's SIP submission relies on analysis of the year 2023 (using a 2011 base year platform), among other things, to conclude that the State does not significantly contribute to nonattainment or interfere with maintenance of the 2015 ozone NAAQS in any other state. 47 As explained in Section I of this proposed rulemaking, EPA has conducted an updated analysis for the 2023 analytical year (using a 2016 base year platform) and proposes to rely primarily on this updated modeling to evaluate Colorado's transport SIP submission.

As described in Section I, EPA performed air quality modeling to project design values and contributions for 2023 using the 2016v2 emissions platform. EPA examined these data to determine if emissions in Colorado contribute at or above the threshold of 1 percent of the 2015 8-hour ozone NAAQS (0.70 ppb) to any downwind nonattainment or maintenance receptor in this most recent round of modeling. The data  48 indicate that the highest contribution in 2023 from Colorado to a downwind nonattainment or maintenance receptor is 0.06 ppb and 0.20 ppb, respectively. 49 Specifically, EPA's analysis indicates that Colorado will have a 0.06 ppb impact at the projected nonattainment receptor in Kenosha County, Wisconsin (Site ID 550590019), which has a 2023 projected average design value of 72.8 ppb and a 2023 projected maximum design value of 73.7 ppb. EPA's analysis further indicates that Colorado will have a 0.20 ppb impact at a projected maintenance receptor in Denton County, Texas (Site ID 481210034), which has a projected 2023 average design value of 70.4 ppb and a 2023 projected maximum design value of 72.2 ppb. The data also indicate that the only contribution in 2023 from Colorado to any downwind monitor above the 1 percent threshold is to a monitor in San Juan, New Mexico (0.99 ppb). This monitor's 2023 average and maximum design values are projected to be below the 2015 ozone NAAQS and the monitor is therefore not projected to be a nonattainment and/or maintenance receptor for the 2015 ozone NAAQS. Accordingly, EPA proposes to conclude that the most recent data support EPA's conclusion that Colorado does not contribute to nonattainment or interfere with maintenance of the 2015 ozone NAAQS in any other state.

In its comments on the 2020 rule and in its brief in the Tenth Circuit litigation, the Center identified several downwind areas that it argued may have been in nonattainment in 2020 but that EPA had screened out by using the incorrect analytic year of 2023. These included: Tarrant and Denton County, Texas; the Northern and Southern Wasatch Fronts in Utah; and monitors in New Mexico. 50 In response to this argument, EPA is providing in Table 1 the projected 2023 design values (DV) and associated contributions from Colorado for all monitors located in these areas for which EPA's modeling provides valid contribution data. 51

The EPA is making two aquatic toxicity reports, submitted by Tidal Vision Products, LLC, available for public comment. The EPA seeks input from stakeholders on how these reports may be used to inform the Agency's assessment of the aquatic toxicity of chitosan and its salts.

On November 2, 2020, the EPA published “Pesticides; Proposal to Add Chitosan to the List of Active Ingredients Permitted in Exempted Minimum Risk Pesticide Product,” 85 FR 69307 (FRL-10009-24). The proposed rule addressed the subject matter of a 2018 petition by Tidal Vision Products LLC that requested that the substance commonly known as chitosan (also known by its chemical name poly-D-glucosamine) (CAS Reg. No. 9012-76-4) be added to the list of active ingredients allowed in exempted minimum risk pesticide products under 40 CFR 152.25(f)(1).

Public comments on the proposed rule discussed these salts. The EPA notes that chitosan may form as a salt ( e.g., acetate, lactate, hydrochloride, and salicylate) when it is solubilized in acids for end use product formulation and subsequently applied in the environment. The new information submitted by Tidal Vision pertains to these salts.

As authorized by the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) section 25(b), the EPA has exempted from the requirement of registration certain pesticide products if they are composed of specified ingredients (recognized active and inert substances which are listed in the regulations) and labeled according to the EPA's regulations in 40 CFR 152.25(f). The EPA created the exemption for minimum risk pesticides to eliminate the need for the Agency to expend significant resources to regulate products that were deemed to be of minimum risk to human health and the environment. Prior to submission of these aquatic toxicity reports, the EPA received a petition from Tidal Vision Products, LLC, requesting that the substance commonly known as chitosan (also known by its chemical name poly-D-glucosamine) (CAS Reg. No. 9012-76-4) be added to the list of active ingredients allowed in exempted minimum risk pesticide products under 40 CFR 152.25(f)(1). This matter was the subject of a proposed regulation (85 FR 69307) (FRL-10009-24).

The EPA is considering the information submitted by Tidal Vision in its decision regarding whether to finalize the proposal to add chitosan to the list of permitted active ingredients, and if so, whether and how to address chitosan salts in the exemption.

The following is a listing of the documents that are specifically referenced in this document. For assistance in locating these other documents, please consult the person listed under FOR FURTHER INFORMATION CONTACT .

You may be potentially affected by this action if you manufacture (defined by statute to include import) or process asbestos. Any use of the term “manufacture” in this document will encompass “import,” and the term “manufacturer” will encompass “importer.” Any use of the term “asbestos” will apply to asbestos in bulk form, in an article, or as an impurity, or as a component of a mixture. For a more thorough discussion of the subject asbestos forms, please see Unit III.A. of this document. You may also be potentially affected by this action if you manufacture (including import) or process other chemical substances or mixtures not on the TSCA inventory if they include asbestos.

The following list of North American Industry Classification System (NAICS) codes are provided to assist in determining whether this action might apply to you. This list is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include entities identified in:

• NAICS code 211—Oil and Gas Extraction;

• NAICS code 212—Mining (except Oil and Gas);

• NAICS code 325—Chemical Manufacturing;

• NAICS code 327—Nonmetallic Mineral Product Manufacturing;

• NAICS code 332—Fabricated Metal Product Manufacturing;

• NAICS code 336—Transportation Equipment Manufacturing;

• NAICS code 339—Miscellaneous Manufacturing;

• NAICS code 447—Gasoline Stations; and

• NAICS code 811—Repair and Maintenance.

Additionally, you should carefully examine the proposed regulatory text in this document to determine if your business would be impacted by this rule. If you have any questions regarding the applicability of this action to a particular entity, consult the technical contact person listed under FOR FURTHER INFORMATION CONTACT .

EPA is proposing this action under the authority of section 8(a) of the Toxic Substances Control Act (TSCA), 15 U.S.C. 2607(a), which generally authorizes EPA to promulgate rules that require each person, other than small manufacturers (including importers) or processors, who manufactures (including import) or processes, or proposes to manufacture (including import) or process, the chemical substance identified in the rule, to maintain such records and submit such reports as the EPA Administrator may reasonably require.

Although TSCA section 8(a)(1) provides an express exemption for small manufacturers (including importers) and processors, TSCA section 8(a)(3) enables EPA to require small manufacturers (including importers) and processors to report under TSCA section 8(a) with respect to a chemical substance that is the subject of a rule proposed or promulgated under TSCA sections 4, 5(b)(4), or 6, or is the subject of an order in effect under TSCA sections 4 or 5(e), a consent agreement under TSCA section 4, or relief that has been granted under a civil action under TSCA sections 5 or 7. Asbestos is subject to TSCA section 6 rulemaking under the Asbestos Ban and Phaseout rule of 1989 (Ref. 1). A portion of this rule was overturned in Corrosion Proof Fittings v. EPA, 947 F.2d 1201 (5th Cir. 1991), however, a portion remains. The remaining portion of EPA's 1989 asbestos ban and phaseout rule prohibits the manufacture, importation, processing, and distribution in commerce of: Commercial Paper, Corrugated Paper, Rollboard, Specialty Paper, Flooring Felt, and New Uses (the manufacture, importation or processing of which would be initiated for the first time after August 25, 1989). See 40 CFR 763.160 et seq. Thus EPA proposes to exercise its authority provided under TSCA section 8(a)(3)(A)(ii) to require small manufacturers (including importers) and processors of asbestos or asbestos-containing mixtures (other than Libby Amphibole asbestos) to maintain records and submit reports. Libby Amphibole asbestos is not subject to an applicable proposed or promulgated rule under TSCA sections 4, 5(b)(4) or 6, an order in effect under TSCA section 4 or 5(e), or a consent agreement under TSCA section 4, nor is it the subject of relief that has been granted under a civil action under TSCA section 5 or 7. Therefore, small manufacturers (including importers) and processors of Libby Amphibole asbestos are expected to be exempt from this proposed reporting and recordkeeping rule. For a more thorough discussion of the proposed reporting for small manufacturers (including importers) and processors, see Unit III.B.

TSCA section 8(a)(1)(A) also excludes from the scope of EPA's regulatory authority under that paragraph any manufacturer (including importer) or processor of “a chemical substance described in subparagraph (B)(ii).” TSCA section 8(a)(1)(B)(ii), in turn, provides EPA authority to require recordkeeping and reporting by each person (other than a small manufacturer [including importer] or processor) who manufactures (including imports) or processes, or proposes to manufacture (including import) or process, a chemical substance “in small quantities . . . solely for purposes of scientific experimentation or analysis or chemical research on, or analysis of, such substance or another substance, including any such research or analysis for the development of a product,” but only to the extent EPA determines the recordkeeping and/or reporting is necessary for the effective enforcement of TSCA. EPA is not proposing to require recordkeeping or reporting by persons who manufacture (including import) or process, or propose to manufacture (including import) or process, asbestos in small quantities solely for research or analysis for the development of a product as described in TSCA section 8(a)(1)(B)(ii). “ Small quantities solely for research and development” is defined in 40 CFR 704.3 to mean quantities of a chemical substance manufactured, imported, or processed or proposed to be manufactured, imported, or processed solely for research and development that are not greater than reasonably necessary for such purposes.

TSCA section 14 imposes requirements for the assertion, substantiation, and review of information that is claimed as confidential under TSCA (also known as confidential business information or CBI. Some information submitted at the time of the proposed reporting under this rule may be claimed as confidential.

EPA is proposing to require asbestos manufacturers (including importers) and processors to report to EPA certain information known to or reasonably ascertainable by those entities. For this action, the term “asbestos” includes various forms of asbestos, including Libby Amphibole asbestos, as described in more detail in Unit III.A. of this document. The following is a brief list of the primary data requirements being proposed. These proposed requirements are described in detail in Unit III.

1. Asbestos domestic manufacturers (Asbestos Mine and Mill): The provisions in this proposed rule would require asbestos domestic manufacturers to provide the quantity manufactured per asbestos type, use, and employee exposure information to EPA. This would include situations in which asbestos is being mined or milled as an intentional or non-intentional impurity, such as in vermiculite and talc.

2. Asbestos importers: The provisions in this proposed rule would require importers of asbestos to provide the quantity imported per asbestos type, use, and employee exposure information. This includes importers of mixtures containing asbestos, articles containing asbestos components, and impurities (in articles, bulk materials, or mixtures, such as in talc and vermiculite).

3. Asbestos processors: The provisions of the proposed rule would require processors of asbestos (including processors of mixtures or articles) to provide the quantity processed per asbestos type, use, and employee exposure information. This includes both primary processors and secondary processors of asbestos, as described in Units III.F.3. and 4. This would include situations in which asbestos is appearing as an intentional or non-intentional impurity, such as in vermiculite and talc.

The Agency is proposing this action to obtain certain information known to or reasonably ascertainable by manufacturers (including importers) and processors of asbestos that EPA believes would help the Agency better understand the exposures and uses associated with asbestos, including asbestos in articles and as an impurity (in articles, bulk materials, or mixtures, such as in talc and vermiculite), that fall under the scope of this proposal. Reported information would be used by EPA and other Federal agencies in considering potential actions involving asbestos, including EPA's TSCA risk evaluation and risk management activities. This action is also subject to a settlement agreement, as discussed in Unit II.C.4. of this document. For a more thorough discussion of the TSCA risk evaluation and risk management process, please see Unit II.C.5. of this document.

EPA has prepared an economic analysis (Ref. 2) of the potential impacts associated with this proposed rule. The primary purpose of this proposed rule is the collection of detailed data on asbestos uses and exposures. Reported information would be used by EPA and other Federal agencies in considering potential actions involving asbestos, including EPA's TSCA risk evaluation and risk management activities. EPA estimates that at least 18 firms may submit reports for 27 sites based on the intentional manufacturing (including importing) or processing of asbestos, including mixtures and articles containing asbestos. EPA does not currently have information on the extent to which asbestos occurs as an impurity in products that are currently manufactured (including imported) or processed in the U.S., so the number of firms that may report for impurities is not estimated.

The industry is expected to incur one-time burdens and costs associated with rule familiarization, form completion, CBI claim substantiation, recordkeeping, and electronic reporting activities. Where asbestos is intentionally manufactured (including imported) or processed, the estimated average burden and cost per site ranges from approximately 12 hours and $1,146 to 26 hours and $2,265, depending on the type of activities the respondent is engaged in and the information known to or reasonably ascertainable by them. For products where asbestos occurs as an impurity, the estimated average burden and cost per site ranges from approximately 17 hours and $1,573 to 40 hours and $3,334, again depending on the type of activities and the information that is known to or reasonably ascertainable. EPA estimates a total industry quantified burden of approximately 1,157 hours, with a quantified total cost of approximately $99,496.

EPA estimates that at least 14 small firms, which included article importers, will be affected by the proposed rule. Of those small firms, 12 are expected to have cost impacts of less than 1% of annual revenues, one is expected to have impacts between 1-3%, and one is expected to have impacts of more than 3% of annual revenues. Again, these estimates do not include firms that are impacted by the requirement to report for impurities. The Agency is expected to incur a cost of $560,343. The total social burden and cost are therefore estimated to be approximately 1,157 hours and $659,839, respectively (Refs. 2 and 3).

1. Submitting CBI. Do not submit this information to EPA through regulations.gov or email. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as CBI and then identify electronically within the disk or CD-ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.

2. Tips for preparing your comments. When preparing and submitting your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.

TSCA section 8(a)(1) generally authorizes EPA to promulgate rules that require entities, other than small manufacturers (including importers) or processors, who manufacture (including import) or process, or propose to manufacture (including import) or process, a chemical substance to maintain such records and submit such reports as the EPA Administrator may reasonably require.

Under TSCA section 8(a)(2), EPA may require reporting and recordkeeping of the following information:

• The common or trade name, chemical identity and molecular structure of each chemical substance or mixture;

• Categories or proposed categories of use for each substance or mixture;

• Total amount of each substance or mixture manufactured (including imported) or processed, the amounts manufactured (including imported) or processed for each category of use, and reasonable estimates of the respective amounts to be manufactured (including imported) or processed for each of its categories of use or proposed categories of use;

• Descriptions of byproducts resulting from the manufacture (including import), processing, use, or disposal of each substance or mixture;

• All existing information concerning the environmental and health effects of each substance or mixture;

• The number of individuals exposed, and reasonable estimates of the number of individuals who will be exposed, to each substance or mixture in their places of employment and the duration of their exposure; and

• The manner or method of disposal of each substance or mixture, and any change in such manner or method.

Asbestos is one or more of a group of highly fibrous silicate minerals that readily separate into long, thin, strong fibers that have sufficient flexibility to be woven, are heat resistant and chemically inert, are electrical insulators, and are therefore suitable for uses where incombustible, nonconducting, or chemically resistant materials are required.

Asbestos is a mineral fiber that occurs in rock and soil. Because of its fiber strength and heat resistance, asbestos has been used in a variety of building construction materials for insulation and as a fire retardant. Asbestos has also been used in a wide range of manufactured goods, mostly in building materials (roofing shingles, ceiling and floor tiles, paper products, and asbestos cement products), friction products (automobile clutch, brake, and transmission parts), heat-resistant fabrics, packaging, gaskets, and coatings (Ref. 3).

For purposes of this proposed rule, EPA considers “asbestos” to include the asbestiform varieties included in the definition of asbestos in TSCA Title II (added to TSCA in 1986), section 202 and Libby Amphibole asbestos. “Asbestos” is defined in TSCA Title II, section 202 as the asbestiform varieties of six fiber types—chrysotile (serpentine), crocidolite (riebeckite), amosite (cummingtonite-grunerite), anthophyllite, tremolite or actinolite. The general CAS Registry Number (CASRN) of asbestos is 1332-21-4; this is the only asbestos on the TSCA Inventory. However, CASRNs are also available for specific fiber types. See Unit III.A.1. for additional discussion.

In addition, EPA is proposing to include reporting for Libby Amphibole asbestos (mainly consisting of tremolite ([CASRN 77536-68-6], winchite [CASRN 12425-92-2], and richterite [CASRN 17068-76-7]) to identify if this particular type of asbestos continues to be manufactured (including imported) or processed in the United States. The term “Libby Amphibole asbestos” is used in this document to identify the naturally occurring mixture of amphibole mineral fibers of varying elemental composition (winchite, richterite, tremolite, etc.) that have been identified in the Rainy Creek complex near Libby, Montana (Ref. 4). EPA does not anticipate that there is ongoing manufacture (including import) or processing of the Libby Amphibole asbestos, but to help confirm this understanding has included this substance in the scope of this proposed rule.

EPA requests comment on whether reporting on Libby Amphibole asbestos' component parts, winchite and richterite, which are not asbestos types but are indicative of the presence of Libby Amphibole asbestos in a substance, should be included in the scope of this TSCA section 8(a) data collection and be reported on individually in addition to reporting on Libby Amphibole asbestos (Ref. 5). Any reporting on Libby Amphibole asbestos would improve EPA's understanding of this substance and would inform risk evaluation activities involving asbestos.

Asbestos is a hazard to human health (Ref. 6). Some of the health effects caused by exposure to asbestos are:

• Lung cancer;

• Ovarian cancer;

• Laryngeal cancer; and

• Mesothelioma, a cancer of the thin lining of the lung, chest and the abdomen and heart.

As part of the TSCA Risk Evaluation of chrysotile asbestos published in December 2020 (Ref. 6). EPA evaluated the database of health effects associated with asbestos exposure cited in U.S. and international data sources and reviewed and evaluated scientific information on toxicity, exposure, and hazard. Many authorities have established that there are causal associations between asbestos exposures and cancer (Ref. 7).

For a more thorough discussion on the asbestos types addressed by this proposed rule, see Unit III.A. of this document.

In 1982, EPA finalized a rule entitled: “Asbestos Reporting Requirements” (47 FR 33198, August 30, 1982) (TSH-FRL-2124-4), under the authority of TSCA section 8(a) that required one-time reporting to EPA by asbestos manufacturers, importers, and processors. The information sought included data on the quantities of asbestos used in making products, employee exposure data, and waste disposal and pollution control equipment data. Reported information was used by EPA and other Federal agencies in considering the regulation of asbestos.

The information gathered as a result of the 1982 data collection rule was used in the drafting of the 1989 rule entitled “Asbestos: Manufacture, Importation, Processing, and Distribution in Commerce Prohibitions” (54 FR 29460, July 12, 1989) (FRL-3476-2). In that action, EPA used TSCA section 6 authority to ban most asbestos-containing products. However, most of the ban was overturned in 1991 by the Fifth Circuit Court of Appeals. Corrosion Proof Fittings v. EPA, 947 F.2d 1201 (5th Cir. 1991). As a result, the 1989 asbestos regulation only bans new uses of asbestos in products that would be initiated “for the first time” after 1989 and five other specific product types (40 CFR part 763, subpart I).

It has been nearly 40 years since the 1982 rule was implemented, and EPA needs an updated data collection to better understand the universe of asbestos types in commerce and the specific entities presently manufacturing (including importing) and processing asbestos, including asbestos-containing products. This proposal is modeled after the 1982 data collection but requires more detailed information from manufacturers (including importers) and processors in addition to information about asbestos appearing as an impurity.

In limited circumstances, asbestos has been reported under the Chemical Data Reporting (CDR) rule (40 CFR part 711). The CDR rule requires manufacturers (including importers) to provide EPA with information on the production and use of chemicals in commerce. (Ref. 8). Under CDR, naturally occurring substances (including asbestos), impurities, and chemical substances when imported as part of articles are exempted from reporting (Ref. 9). This proposed rule differs from the existing CDR universe of data collected as it would: (a) Be a one-time data collection as opposed to a reoccurring data collection; (b) require reporting for naturally-occurring asbestos; (c) require processors of asbestos to report ( i.e., sites manufacturing (including importing) and/or processing asbestos would be subject to this rule); and (d) require reporting by entities who are manufacturing (including importing), and/or processing asbestos and to whom the asbestos content is known or reasonably ascertainable (see TSCA section 8(b)(2)). “Known to or reasonably ascertainable by” would be defined to include “all information in a person's possession or control, plus all information that a reasonable person similarly situated might be expected to possess, control, or know.” EPA acknowledges that it is possible that an importer, particularly an importer of articles containing asbestos, may not have knowledge that they have imported asbestos and thus not report under this rule, even after they have conducted their due diligence under this reporting standard as described in this paragraph. Such an importer should document its activities to support any claims it might need to make related to due diligence. EPA is asking for public comment on importers' anticipated ability to know or reasonably ascertain whether those entities import asbestos. This proposed rule would also differ from CDR data collection as it would apply to impurities and articles, both of which are exempted from CDR data collection (40 CFR 711.10(b) & (c)) (Ref. 9, Ref. 10).

In 2019, EPA promulgated a SNUR (84 FR 17345, April 25, 2019) (FRL-9991-33) for the manufacturing (including import) or processing of asbestos for use in adhesives, sealants, and roof and nonroof coatings; arc chutes; beater-add gaskets; cement products; extruded sealant tape and other tape; filler for acetylene cylinders; friction materials (with certain exceptions); high-grade electrical paper; millboard; missile liner; packings; pipeline wrap; reinforced plastics; roofing felt; separators in fuel cells and batteries; vinyl-asbestos floor tile; woven products; any other building material; and any other use of asbestos that was not already prohibited under TSCA or under evaluation in the TSCA Risk Evaluation for Asbestos Part 1: Chrysotile Asbestos.

Activities that were under evaluation in the TSCA Risk Evaluation for Asbestos Part 1: Chrysotile Asbestos were not subject to the SNUR since there was ongoing manufacturing (including importing) or processing for those uses. Those activities not subject to the SNUR were manufacturing (including importing) or processing for the use of chrysotile in asbestos diaphragms; sheet gaskets; oilfield brake blocks; aftermarket automotive brakes/linings; other vehicle friction products; and other gaskets. Because all the ongoing uses of asbestos identified in the SNUR were of chrysotile, any use of crocidolite, amosite, anthophyllite, tremolite, or actinolite would be considered a significant new use.

A person wishing to begin manufacturing, importing, or processing asbestos (including as part of an article) for a significant new use must first submit a Significant New Use Notice (SNUN) to EPA. Before any significant new use of asbestos begins, EPA must evaluate it for potential risks to health and the environment and take any necessary regulatory action, which may include a prohibition.

On September 27, 2018, and January 31, 2019, respectively, petitioners Asbestos Disease Awareness Organization et al. (ADAO) (Ref. 11), and Attorneys General from ten states and the District of Columbia (the States) (Ref. 12) submitted petitions under TSCA section 21 (15 U.S.C. 2620) requesting EPA to amend the CDR Rule in ways that petitioners asserted would increase reporting of asbestos. Both petitions sought to close alleged asbestos CDR reporting gaps (including immediate submission of asbestos reports), remove the naturally occurring and byproduct exemptions, lower the reporting threshold, require reporting by processors, and eliminate the ability to claim information as confidential, in order to maximize the information reported to aid the Agency in conducting the ongoing TSCA section 6 risk evaluation of asbestos and subsequent TCSA Section 6(a) risk management rule (see Unit II.C.3. for more information). EPA denied the petitions on December 21, 2018, and April 30, 2019, respectively, and issued associated explanations for the denials in the Federal Register on February 12, 2019 (84 FR 3396) (FRL-9988-56) and May 8, 2019 (84 FR 20062) (FRL-9992-67), respectively, asserting that the petitioners failed to demonstrate that it is necessary to amend the CDR rule. EPA's denial was also in part due to a timing issue with the asbestos risk evaluation. Petitioners filed lawsuits on February 18, 2019, and June 28, 2019, respectively, in the U.S. District Court in the Northern District of California, reiterating concerns about the need to amend the CDR rule to increase asbestos reporting. Asbestos Disease Awareness Organization v. EPA, No. 19-CV-00871; State of California et al. v. EPA, No. 19-CV-03807. The cases were consolidated. On December 22, 2020, after full briefing and oral argument, the Court issued an opinion granting summary judgment to Plaintiffs and denying summary judgment to EPA.

Following the litigation, EPA reached an agreement with the Plaintiffs on June 7, 2021. The parties agreed that no later than nine months from the effective date of the agreement (Ref. 13), EPA will sign for publication in the Federal Register , a notice of proposed action to promulgate a rule pursuant to TSCA section 8(a), 15 U.S.C. 2607(a), for the maintenance of records and submission to EPA of reports by manufacturers (including importers) and processors of asbestos (including asbestos that is a component of a mixture), and articles containing asbestos (including as an impurity) that address the information-gathering deficiencies identified in the Court's Summary Judgment Order. Additionally, the parties agreed that no later than eighteen months from the effective date of the agreement (Ref. 13), EPA will sign for publication in the Federal Register a notice of final action regarding the proposed TSCA section 8(a) rule.

Pursuant to TSCA section 6(b)(4)(A), EPA conducts risk evaluations to determine whether a chemical substance presents unreasonable risk of injury to health or the environment, without consideration of costs or non-risk factors, including an unreasonable risk to potentially exposed or susceptible subpopulations identified as relevant by the Agency, under the conditions of use. (15 U.S.C. 2605(b)(4)(A)).

EPA is developing the TSCA Risk Evaluation on asbestos in two parts. In December 2020, EPA released the TSCA Risk Evaluation for Asbestos Part 1: Chrysotile Asbestos (Ref. 6), which determined that chrysotile asbestos presents an unreasonable risk of injury to health based upon the following conditions of use: Processing and industrial use of chrysotile asbestos diaphragms in the chlor-alkali industry; processing and industrial use of chrysotile asbestos-containing sheet gaskets in chemical production; industrial use and disposal of chrysotile asbestos-containing brake blocks in the oil industry; commercial use and disposal of aftermarket automotive chrysotile asbestos-containing brakes/linings; commercial use and disposal of other chrysotile asbestos-containing vehicle friction products; commercial use and disposal of other asbestos-containing gaskets; consumer use and disposal of aftermarket automotive chrysotile asbestos-containing brakes/linings; and consumer use and disposal of other asbestos-containing gaskets.

EPA initially focused the risk evaluation for asbestos on chrysotile asbestos as this is the only asbestos type that EPA believes is currently imported, processed, or distributed in the U.S. EPA informed the public of this decision to focus on ongoing uses of asbestos and exclude legacy uses and associated disposals in the Scope of the Risk Evaluation for Asbestos document, published in June 2017 (Ref. 14). However, in late 2019, the court in Safer Chemicals, Healthy Families v. EPA, 943 F.3d 397, 426-27 (9th Cir. 2019) held that EPA's Risk Evaluation Rule (82 FR 33726, July 20, 2017) (FRL-9964-38) should not have excluded “legacy uses” ( i.e., uses without ongoing or prospective manufacturing (including importing), processing, or distribution) or “associated disposals” ( i.e., future disposal of legacy uses) from the definition of conditions of use, although the court did uphold EPA's exclusion of “legacy disposals” ( i.e., past disposal). Following this court ruling, EPA continued development of the risk evaluation for chrysotile asbestos and determined that the complete TSCA Risk Evaluation for Asbestos would be issued in two parts. The TSCA Risk Evaluation for Asbestos Part 1: Chrysotile Asbestos was released in December 2020, allowing the Agency to expeditiously move into risk management for the unreasonable risk identified in Part 1.

EPA is currently conducting the TSCA Risk Evaluation for Asbestos Part 2: Supplemental Evaluation Including Legacy Uses and Associated Disposals of Asbestos. EPA intends to include in Part 2 of the risk evaluation the legacy uses and associated disposal of asbestos. For the purposes of scoping and risk evaluation, EPA has adopted the definition of asbestos as defined by TSCA Title II (added to TSCA in 1986), section 202 definition as the “asbestiform varieties of six fiber types—chrysotile (serpentine), crocidolite (riebeckite), amosite (cummingtonite-grunerite), anthophyllite, tremolite or actinolite,” The TSCA Title II definition identified five amphibole types of asbestos (crocidolite, amosite, anthophyllite, tremolite, and actinolite) plus a serpentine type (chrysotile). Part 2 will also consider Libby Amphibole Asbestos as well as asbestos present as an impurity in talc and other substances. EPA expects that the data collected from this proposed rule will be used in Part 2 of the TSCA Risk Evaluation for asbestos and will also inform risk management actions for asbestos under TSCA section 6(a).

Reported information would be used by EPA and other Federal agencies in considering potential actions on asbestos, including EPA's TSCA risk evaluation and risk management activities. Reporting requirements may provide EPA with baseline information needed to assess whether certain “conditions of use” of asbestos pose an unreasonable risk to health or the environment under TSCA section 6(b). EPA must consider reasonably available information as part of the risk evaluation process under TSCA section 6(b), and as part of any subsequent risk management rulemaking efforts under TSCA section 6(a). Reported information would be useful in the risk management stage because EPA would consider potential risk management actions taking into account relevant information obtained through this rulemaking. Understanding the health risks of asbestos and protecting the public, including potentially exposed or susceptible subpopulations, from these risks is a priority for EPA.

As part of the risk evaluation process under TSCA section 6(b), EPA must determine whether asbestos presents an unreasonable risk of injury to health or the environment, without consideration of costs or other non-risk factors, including unreasonable risk to relevant potentially exposed or susceptible subpopulations, under the conditions of use. EPA must also use scientific information and approaches in a manner that is consistent with the requirements in TSCA for the best available science, and ensure decisions are based on the weight of scientific evidence. See TSCA section 26(h) and (i), 15 U.S.C. 2625(h) and (i). In order to follow this framework, EPA shall take into consideration reasonably available information to inform the Part 2 risk evaluation. Data collected by this rule could help to fill potential data gaps that EPA may have for asbestos that could better inform Part 2 of the asbestos risk evaluation. Following risk evaluation, TSCA mandates that EPA take action if the Agency determines that asbestos presents unreasonable risk of injury to health or the environment. EPA needs to ensure that sufficient information is reasonably available on the uses and trends of asbestos activities to develop a risk management rule that eliminates the unreasonable risk. The information collected in this rulemaking may be available to support the Part II risk evaluation and the final risk evaluation document expected by December 1, 2024. Additionally, the information collected in this rulemaking will help inform risk management following the risk evaluation process.

For these reasons, EPA believes that the reporting and recordkeeping requirements proposed in this document are reasonable. See TSCA section 8(a)(1)(A).

EPA is proposing to require the reporting of information on specific asbestos forms, or if specific information is not known or reasonably ascertainable, reporting on “asbestos” as it is more generally listed on the TSCA Inventory. EPA is also proposing to require the reporting of information related to asbestos as it is manufactured (including imported) or processed in bulk, as a component of a mixture, in an article, or as an impurity in bulk materials or products.

See Units III.A.2 and 3 for more details.

EPA is proposing to obtain manufacturing (including importing) and processing information associated with the following different asbestos forms, and therefore is proposing to require that reporting be completed for each of the forms, to the extent that the information is known or reasonably ascertainable. If the specific asbestos type is unknown, a submitter would provide information under the general asbestos form (CASRN 1332-21-4). See Unit II.B. for more information about what is considered asbestos:

• Asbestos—CASRN 1332-21-4;

• Chrysotile—CASRN 132207-32-0;

• Crocidolite—CASRN 12001-28-4;

• Amosite—CASRN 2172-73-5;

• Anthophyllite—CASRN 77536-67-5;

• Tremolite—CASRN 77536-68-6;

• Actinolite—CASRN 77536-66-4;

• Libby Amphibole Asbestos—CASRN not applicable (mainly consisting of tremolite [CASRN 77536-68-6], winchite [CASRN 12425-92-2], and richterite [CASRN 17068-76-7]).

Impurity means a chemical substance which is unintentionally present with another chemical substance (40 CFR 704.3). Asbestos may occur naturally as an impurity in other products such as talc, vermiculite, and potentially other substances. These products are distributed and used in commerce in the United States. For example, talc, a hydrous magnesium silicate mineral, is used in a wide variety of applications. Talc deposits can contain asbestos as an impurity that poses a risk to human health (Ref. 15). If all other reporting conditions are met, these products would be subject to reporting under this rule. EPA proposes to collect data on asbestos as an impurity because EPA may lack data on the extent to which asbestos as an impurity occurs in products under TSCA jurisdiction that are currently being manufactured (including imported) or processed. In particular, data on asbestos as an impurity could better inform the Part 2 asbestos risk evaluation where EPA will determine and then evaluate the relevant conditions of use of asbestos in talc.

This rule would require reporting on articles containing asbestos (including as an impurity). An “article” is defined in 40 CFR 704.3 as “a manufactured item (1) which is formed to a specific shape or design during manufacture, (2) which has end-use function(s) dependent in whole or in part upon its shape or design during end use, and (3) which has either no change of chemical composition during its end use or only those changes of composition which have no commercial purpose separate from that of the article, and that result from a chemical reaction that occurs upon end use of other chemical substances, mixtures, or articles; except that fluids and particles are not considered articles regardless of shape or design.” EPA proposes to collect more data on imported articles containing asbestos; this data could inform Part 2 of the TSCA Risk Evaluation for Asbestos where EPA will determine and then evaluate the relevant conditions of use of such articles containing asbestos. Articles included in Part 1 of the TSCA Risk Evaluation for Asbestos included brake blocks for use in the oil industry, rubber sheets for gaskets used to create a chemical-containment seal in the production of titanium dioxide, certain other types of preformed gaskets, and some vehicle friction products (Ref. 18); EPA is interested in identifying if there are other articles or if there is information about specific forms of asbestos in these articles.

Under TSCA section 3(10) (15 U.S.C. 2602(10)), the term “mixture” means any combination of two or more chemical substances if the combination does not occur in nature and is not, in whole or in part, the result of a chemical reaction; except that such term does include any combination which occurs, in whole or in part, as a result of a chemical reaction if none of the chemical substances comprising the combination is a new chemical substance and if the combination could have been manufactured (including imported) for commercial purposes without a chemical reaction at the time the chemical substances comprising the combination were combined. EPA proposes to collect data on asbestos in circumstances where it is a component of a mixture to inform Part 2 of the TSCA Risk Evaluation for Asbestos. In the Part 2 Evaluation, EPA will determine the relevant conditions of use of asbestos in talc; EPA will use the results to evaluate asbestos exposures and associated risks.

Legislative history affirms that EPA can conduct risk evaluations on a chemical substance when the substance is present as a component of a mixture (See Senate Congressional Record, S3511, June 7, 2016): “In section 6(b) of TSCA, as amended by the Frank R Lautenberg Chemical Safety for the 21st Century Act, EPA is directed to undertake risk evaluations on chemical substances in order to determine whether they pose an unreasonable risk to health or the environment. Some have questioned whether the failure to explicitly authorize risk evaluations on mixtures calls into question EPA's authority to evaluate the risks from chemical substances in mixtures. The definition of ‘conditions of use' . . . plainly covers all uses of a chemical substance, including its incorporation in a mixture, and thus would clearly enable and require, where relevant, EPA to evaluate the risks of the chemical substance as a component of a mixture.”

Although TSCA section 8(a)(1) provides an exemption for small manufacturers (including importer) and processors, TSCA section 8(a)(3) enables EPA to require small manufacturers (including importers) and processors to report pursuant to TSCA section 8(a) with respect to a chemical substance that is the subject of a rule proposed or promulgated under TSCA sections 4, 5(b)(4), or 6, an order in effect under TSCA sections 4 or 5(e), a consent agreement under TSCA section 4, or relief that has been granted under a civil action under TSCA sections 5 or 7. Six of the asbestos types subject to this proposal (chrysotile, crocidolite, amosite, anthophyllite, tremolite, and actinolite) are subject to a TSCA section 6 rule under the Asbestos Ban and Phaseout rule of 1989 (Ref. 1) (40 CFR 763.160 et seq. ) and therefore EPA is proposing that these forms of asbestos are not eligible for a small manufacturer (including importer) or processor exemption. Although most of the original ban was overturned in 1991 by the Fifth Circuit Court of Appeals, a portion of the section 6 rulemaking remains in effect ( See 40 CFR 763.160 et seq. ) Libby Amphibole asbestos, however, is not subject to an applicable proposed or promulgated rule under TSCA sections 4, 5(b)(4), or 6; an order under TSCA sections 4 or 5(e); or a consent agreement under TSCA section 4; and is not the subject of relief that has been granted under a civil action under TSCA section 5 or 7. Therefore, EPA is proposing that Libby Amphibole asbestos continue to be eligible for such an exemption.

EPA's experience with TSCA Risk Evaluation for Asbestos Part 1: Chrysotile Asbestos, indicates that small businesses are associated with certain identified conditions of use associated with asbestos. For some conditions of use, EPA identified a single business engaged in each of the activities and, in two cases, the companies were small businesses. In addition, EPA identified multiple conditions of use for which it was unable to identify a single company engaged in the condition of use. Because of the low number of companies found to be involved in specific conditions of use, it is possible that companies associated with other conditions of use that need to be considered in the Part 2 TSCA Risk Evaluation, are small businesses.

Because EPA has much less information on the activities of small businesses, the Agency is concerned that certain conditions of use for which the Agency lacks detailed information may be conducted largely or entirely by small businesses. Given EPA's experience and the petitioners' concerns (Refs. 11 and 12), the Agency believes that exempting all small businesses from reporting may exclude most or all of the reporting for some conditions of use which could severely hinder EPA's risk evaluation or risk management activities. As a result, EPA is proposing that small businesses—small manufacturers (including importers) and processors of asbestos, and asbestos mixtures (other than Libby Amphibole asbestos)—will need to maintain records and report under this action.

As discussed previously, at the time of this proposal, Libby Amphibole asbestos is not the subject of any of the activities described in TSCA section 8(a)(3) (Unit III.B.) and therefore manufacturers (including importers) and processors of that substance may be eligible for a small business exemption.

EPA proposes to use the small manufacturer (including importer) definition already established at 40 CFR 704.3. Thus, any entity manufacturing (including importing) Libby Amphibole asbestos would be considered a small manufacturer and exempt from reporting if it meets either of these two standards (as adjusted by an inflation index):

• Total sales during the most recent year of the reporting period, combined with those of the parent company, domestic or foreign (if any), are less than $120 million and the annual production and importation volume of that chemical substance ( i.e., asbestos) does not exceed 100,000 pounds at any individual plant site. If the annual production and importation volume of the chemical substance ( i.e., asbestos) at any individual site owned or controlled by the submitter is greater than 100,000 pounds, the submitter is required to report for that particular site unless it qualifies as small under the following standard.

• Total sales during the most recent year of the reporting period, combined with those of the parent company, domestic or foreign (if any), are less than $12 million regardless of the quantity of asbestos produced or imported.

The small manufacturer (including importer) exemption as written in Small manufacturer and Small government definitions (40 CFR 704.3) applies to domestic manufacturers and importers, but does not cover processors. Therefore, EPA proposes a definition for small processors, functionally identical to that established in 40 CFR 704.20—Chemical substances manufactured or processed at the nanoscale (Ref. 16). EPA proposes this definition because it is most similar to the small manufacturing (including importing) definition already promulgated. This definition would state: “Small processor means any processor whose total annual sales, when combined with those of its parent company (if any), are less than $12 million.” Note that in the nanoscale rule, the total annual sales threshold is $11 million. EPA increased the threshold to $12 million to align with the non-volume portion of the TSCA small manufacturer definition, which was updated in 2020. The small manufacturer definition has a second standard that exempts companies on a chemical-by-chemical volume basis ( i.e., 100,000-pound threshold when company sales are less than $120 million), thus exempting small manufacturers for some chemicals but not for others. The second standard would not be appropriate to include in the small processor definition because the amount of asbestos in products may vary drastically. It is also not appropriate because EPA is not basing reporting requirements on volumes for this rule. Thus, the volume of asbestos is less applicable as a measure than sales.

EPA requests additional comment on how to best provide guidance for small processors of Libby Amphibole asbestos.

EPA is proposing that this rule would use the reporting standard used for certain other TSCA section 8(a) reporting requirements, including CDR. This standard requires that manufacturers (including importers) and processors report information to the extent that the information is known to or reasonably ascertainable by the manufacturer (including importer) or processor (see TSCA section 8(a)(2)). “Known to or reasonably ascertainable by” includes “all information in a person's possession or control, plus all information that a reasonable person similarly situated might be expected to possess, control, or know” (40 CFR 704.3). This reporting standard requires reporting entities to evaluate their current level of knowledge of their manufactured products (including imports) or processed products, as well as evaluate whether there is additional information that a reasonable person, similarly situated, would be expected to know, possess, or control. This standard carries with it an exercise of due diligence, and the information-gathering activities that may be necessary for manufacturers (including importers) and processors to achieve this reporting standard may vary from case-to-case.

This standard requires that submitters conduct a reasonable inquiry within the full scope of their organization (not just the information known to managerial or supervisory employees). This standard may also entail inquiries outside the organization to fill gaps in the submitter's knowledge. Such activities may, though not necessarily, include phone calls or email inquiries to upstream suppliers or downstream users or employees or other agents of the manufacturer (including importer) or processor, including persons involved in the research and development, import or production, or marketing of asbestos.

Examples of types of information that are considered to be in a manufacturer's (including importer's) or processor's possession or control, or that a reasonable person similarly situated might be expected to possess, control, or know include: Files maintained by the manufacturer (including importer) or processor such as marketing studies, sales reports, or customer surveys; information contained in standard references showing use information or concentrations of chemical substances in mixtures, such as a Safety Data Sheet (SDS) or a supplier notification; and information from the Chemical Abstracts Service (CAS) or from Dun & Bradstreet (D-U-N-S). This information may also include knowledge gained through discussions, conferences, and technical publications.

EPA has provided CDR reporting guidance materials on this reporting standard, including hypothetical examples of applying the “known to or reasonably ascertainable by” reporting standard in the context of collecting processing and use data for CDR, which would be instructive for reporting under this rule as well (Ref. 9). Therefore, EPA anticipates some submitters under this proposed rule will be familiar with this reporting standard, and resources are available to support those submitters who may not be familiar with the standard.

EPA acknowledges that it is possible that a manufacturer (including importer) or processor, particularly an importer of articles containing asbestos (including as an impurity), may not have knowledge that they have imported asbestos and thus not report under this rule, even after they have conducted their due diligence under this reporting standard as described previously. Such an importer should document its activities to support any claims it might need to make related to due diligence.

In the event that a manufacturer (including importer) or processor does not have actual data ( e.g., measurements or monitoring data) to report to EPA, the manufacturer (including importer) or processor would be required to make “reasonable estimates” of such information. “Reasonable estimates” may rely, for example, on approaches such as mass balance calculations, emissions factors, or best engineering judgment.

This proposed rule would result in a one-time reporting obligation. EPA proposes reporting for persons who have manufactured (including imported) or processed asbestos at any time during the four complete calendar years prior to the effective date of the final rule. EPA anticipates that the four calendar years would be 2019 to 2022. These entities would report to EPA during a three-month submission period, which EPA proposes would begin six months following the effective date of the final rule. Therefore, manufacturers (including importers) and processors would have up to nine months following the effective date of the final rule to collect and submit all required information to EPA.

EPA believes that providing six months between the effective date of the rule and the start of the submission period would allow sufficient time for both the Agency to finalize the reporting tool and for submitters to familiarize themselves with the rule and compile the required information. Since this TSCA section 8(a) reporting rule would result in the collection of similar information to that collected under CDR, EPA anticipates some submitters would be familiar with the types of information requested and how to report. EPA believes that three months would be adequate time for submissions, in addition to the six-month period between the effective date and the start of the submission period.

EPA is asking for public comment on the submission period start date and duration (see Unit IV.), as well as alternative compliance timelines for small businesses.

EPA is proposing different reporting requirements based on a two-part knowledge-based reporting approach in order to obtain as complete a picture as possible of the manufacturing (including importing), processing, and use of asbestos. Because asbestos can be included in small quantities in some products, having a threshold concentration for reporting would be expected to eliminate much of the information that may be useful to support EPA's TSCA risk evaluation and risk management efforts. Therefore, EPA is proposing that reporting would be required whenever the presence of asbestos is known or reasonably ascertainable.

However, EPA is also aware that there may be circumstances under which a manufacturer (including importer), or processor is unable to provide a reliable quantity of the asbestos in their products because the percentage of asbestos in their products is not known or reasonably ascertainable by them. For those situations, EPA is proposing a short form (Form A) for attestation purposes. For other situations, submitters that can determine or estimate the quantity would provide more detailed information in the full form (Form B). EPA anticipates that most submitters would know or be able to estimate the quantity of the asbestos and would complete the full form.

For entities that are aware of asbestos in their product, but unable to determine or estimate the quantity manufactured (including imported) or processed, submitters would provide a subset of the information required on Form B. This subset would consist of information related to manufacturing (including importing) or processing asbestos, including as an impurity, in an article, or as a component of a mixture, and information about the employees involved with such activities.

One of the goals of this rule is to ensure EPA has a complete picture of the status of asbestos in the U.S. Therefore, EPA is proposing a reporting approach that would ensure that even circumstances where asbestos appears in smaller or unknown quantities are captured. Some entities manufacturing (including importing) or processing asbestos as a component of a mixture or articles containing asbestos ( e.g., the importers of articles), may be aware of asbestos in their products but unable to determine or estimate the quantity of the asbestos for reporting purposes. Therefore, EPA is proposing to include a short form (Form A) for such entities that are aware of a quantity of asbestos in their products, but unable to determine (or estimate) the quantity manufactured (including imported) or processed of asbestos to report.

For a more detailed discussion of the data elements, please see Unit III.F. EPA anticipates that Form A will be the less common option of the two reporting forms.

EPA proposes that if a quantity of asbestos in a product is known to or reasonably ascertainable by the submitter then the submitter must provide the more detailed reporting information required by Form B. For example, if submitters are able to determine that their quantity is close to 25 pounds (or another quantity value), they would be required to report using Form B.

Form B would require specific quantity information per asbestos type, more detailed processing information, and employee information (including employee exposure information). EPA is requesting public comments on whether other information, such as waste and disposal information, should be reported. For a more detailed discussion on specifics included in Form B, see Unit III.C.2.

EPA is requesting comment on whether there should be a threshold for the amount of asbestos when determining whether to report using Form B and, if so, whether the threshold should be concentration-based ( e.g., a certain percentage of asbestos in the product) or annual volume-based ( e.g., the total volume of asbestos manufactured [including imported] or processed). In addition, EPA is requesting comment on whether any submitter under the threshold should alternatively report using Form A. Having a threshold for Form B but reporting using Form A for entities under the reporting threshold may decrease burden on certain submitters while still allowing EPA to obtain information on all instances where asbestos is a component of a mixture and all articles with known asbestos content. Asbestos can occur naturally as impurities in other products that may be handled in very large volumes, such as talc, vermiculite, and potentially other substances. A de minimis concentration could reduce the compliance determination and reporting burdens. Comments suggesting threshold levels should include the justification for that particular level.

EPA is proposing certain information to be reported in either Form A or Form B. Unit III.E. describes how to choose which form to use for reporting. This unit provides a more in-depth overview of the information to be reported. Each form has sections about respondent identification, mined or milled bulk asbestos, imported bulk asbestos, primary processor production, secondary processor production, importation of mixtures, and importation of articles. Form A is a subset of Form B. If a data element is included in Form B only, it is indicated by “(Form B only)” following the name of the data element.

EPA is proposing that both Form A and B will include information associated with identifying the respondent company and site and information about contacts at the company or site who can respond to any clarifying or other follow up questions. Specifically, EPA is proposing that submitters report the following information (proposed 40 CFR 704.180(e)(3)):

• U.S. Parent Company Information;

• Authorized Official Contact Information;

• Technical Contact Information; and

• Site Information (including NAICs codes and total number of employees at site).

In addition, submitters would identify the activity for which they are reporting, selecting from the list provided in proposed 40 CFR 704.180(e)(4)(i). If more than one activity applies, the submitter would indicate all that apply. Each activity and the associated data elements are described in the remainder of this Unit.

An asbestos mine or mill is an entity that either mines or mills asbestos. Mined or extracted asbestos-containing ore is further milled to produce bulk asbestos. Milling involves the separation of the fibers from the ore, grading and sorting the fibers, or fiberizing crude asbestos ore. An importer of Bulk Asbestos imports bulk asbestos into the customs territory of the U.S. EPA anticipates that companies that are mining, milling, or importing bulk asbestos will report using Form B, because the volume of asbestos is likely to be known or reasonably ascertainable by them.

For companies that are mining, milling, or importing talc, vermiculite, or another bulk material where asbestos can be found as an impurity, EPA anticipates that they would report using either Form A or Form B, based upon their knowledge of the amount of asbestos in their bulk material.

Specifically, EPA is proposing that sites involved in mining, milling, or importing asbestos or bulk materials containing asbestos report certain information associated with those activities, as listed in proposed 40 CFR 704.180(e)(4)(ii) and (iii), and (e)(5). All submitters would report the applicable asbestos form associated with the mining, milling, or importing activity.

a. Bulk asbestos. In addition, EPA is proposing that sites involved in mining, milling, or importing bulk asbestos, for each asbestos type and for each year, report the quantity of asbestos and the disposition of asbestos. Table 3 in proposed 40 CFR 704.180(e)(4)(ii)(B) provides a list of dispositions from which to select, including: Used on site, sent to another U.S. site, exported, or disposed of. EPA is proposing that a site selecting “Disposed of within the U.S.” would provide additional explanation to indicate the quantity and type of disposal ( e.g., disposed in a landfill).

b. Bulk materials containing asbestos. EPA is proposing that sites involved in mining, milling, or importing bulk materials containing asbestos also report the type of bulk material that is manufactured (including imported) or processed, and for each type of bulk material and year, report:

• The quantity of bulk material quantity by weight (Form B only);

• The percentage of asbestos in the bulk material (Form B only);

• The most specific identity of asbestos (Form B only);

• Information describing how you know the amount of asbestos in the bulk material (Form B only); and

• The disposition of the bulk material as described in Unit III.F.2.a.

A primary processor starts with bulk asbestos or bulk materials containing asbestos and makes a mixture that contains asbestos. A primary processor may simply mix or repackage different types or sizes of fibers and then sell that product. Mixtures that contain asbestos are products to which asbestos has been intentionally added and which can be used or processed further and incorporated into other products. For example, asbestos cement, asbestos paper, and asbestos-reinforced plastics are instances where asbestos is contained in a mixture. Primary processors are defined in the proposed 40 CFR 704.180(a), a definition adapted from the definition of primary processor in the 1982 Asbestos Reporting Requirements Rule (see Unit II.C.1.).

EPA anticipates that primary processors starting with bulk asbestos are more likely to report using Form B while those starting with bulk materials containing asbestos may report using either Form A or Form B.

EPA is proposing that primary processors report, for each year, the total quantity of asbestos processed (Form B only) and the end product type (selected from Table 4 in proposed 40 CFR 704.180(e)(4)(iv)(B)). For each product type, report by year:

• The most specific identity of asbestos (Form B only);

• The total annual production quantity of end product, using the unit of measure as listed in Table 4 in proposed 40 CFR 704.180(e)(4)(iv)(B);

• The percentage of asbestos in the end product (Form B only);

• If the asbestos content is an impurity, how you know about the presence, amount, and type of asbestos ( i.e., do you have test results (provide the results), how often is testing conducted, other methods for identifying the asbestos content); and

• The disposition of the end product (Form B only) as described in Unit III.F.2.a.

Secondary processors are those who start with asbestos when it is a component of a mixture and incorporate the mixture into their own products. For example, persons who fabricate asbestos cement sheet by cutting the sheet to make an electrical switch board, or persons who make garments by cutting an asbestos-containing textile, are secondary processors. Secondary processors are defined in the proposed 40 CFR 704.180(a), a definition adapted from the definition of primary processor in the 1982 Asbestos Reporting Requirements Rule (see Unit II.C.1.).

EPA anticipates that secondary processors may report using either Form A or Form B. EPA is proposing that secondary processors report, for each year, the total quantity of asbestos processed (Form B only) and the end product type (selected from Table 4 in proposed 40 CFR 704.180(e)(4)(iv)(B)). For each product type, report by year:

• The most specific identity of asbestos and the quantity of asbestos (Form B only);

• The total annual production quantity of end product, using the unit of measure as listed in Table 4 in proposed 40 CFR 704.180(e)(4)(iv)(B);

• The percentage of asbestos in the end product (Form B only);

• If the asbestos content is an impurity, how you know about the presence, amount, and type of asbestos ( i.e., do you have test results [provide the results], how often is testing conducted, other methods for identifying the asbestos content); and

• The disposition of the end product (Form B only) as described in Unit III.F.2.a.

An importer of asbestos contained in a mixture or articles that contain asbestos, including as an impurity, imports these substances into the customs territory of the U.S.

EPA anticipates that an importer of products may report using either Form A or Form B. EPA is proposing that importers report, for each year, the total quantity of asbestos processed (Form B only) and the imported product type (selected from Table 4 in proposed 40 CFR 704.180(e)(4)(iv)(B)). For each product type, report by year:

• Whether the imported product including asbestos is contained in a mixture or a part of an article;

• The most specific identity of asbestos and the quantity of asbestos (Form B only);

• The total annual import quantity of the imported product, using the unit of measure as listed in Table 4 of proposed 40 CFR 704.180(e)(4)(iv)(B);

• The percentage of asbestos in the imported product (Form B only);

• Information about how you know about the presence, amount, and type of asbestos ( i.e., do you have test results (provide the results), how often is testing conducted, other methods for identifying the asbestos content); and

• The disposition of the imported product (Form B only) as described in Unit III.F.2.a.

For each activity reported, EPA is proposing that submitters also report certain information about the number of employees involved with the activity. Specifically, EPA is proposing that submitters report the number of employees associated with the activity, whether personal protective equipment was used and, if yes, the type of equipment used, and any workplace exposure measurement assessments such as monitoring data. When supplying the measurement assessment data, also include information about how the assessment was conducted and other explanations to help EPA better understand and use the data.

When evaluating which data elements to include in this proposal, EPA also considered potentially requiring reporting on additional information related to current employee exposures, wastewater treatment, disposal information, and customer sites. EPA presently believes the additional information might be useful for a more in-depth analysis of the potential exposures associated with asbestos. However, EPA also presently believes that the proposed data elements described in Unit III.F. would provide sufficient information for use by EPA and other Federal agencies in potential actions involving asbestos, including EPA's TSCA risk evaluation and risk management activities. EPA chose not to include these additional data elements in this proposed rule in the interest of maintaining a manageable level of burden for reporting entities, while also considering the need for creating a manageable reporting tool.

EPA is seeking public comment on whether any additional data (particularly, information related to current employee exposures, wastewater treatment information, additional disposal information, and customer sites) should be added as required data elements on Form B.

EPA considered collecting a more detailed breakdown of the number and types of employees by work category. This information would enable the agency to consider exposures to employees conducting different types of work at a site, including those conducting production, shipping or receiving, maintenance, waste management, or other activities.

EPA also considered collecting employee exposure information, including 8-hr time-weighted average exposures, 15- or 30-minute peak or maximum exposures, related statistical data (medians, arithmetic means, standard deviations, etc.), levels of detection and non-detectable measurements, and descriptions of sampling and analysis, such as sampling and analytical chemistry methods. Due to the anticipated burden for reporters in contrast to the usefulness of the data that the agency could collect, EPA is not including reporting on these additional employee data elements in this proposed rule.

EPA considered collecting information related to asbestos or asbestos-containing discharges, including releases, wastes, and disposal data. These data included a description of any discharges, such as to water or to off-site public treatment facilities, and descriptions of solids disposal, such as to land-based facilities. Wastewater related information included volumes of wastewater, amount of asbestos in the wastewater, on-site treatment methods (if any), National Pollutant Discharge Elimination System (NPDES) permit numbers and copies of reports, transport to off-site treatment, and removed solids management. General waste and disposal information included the identity of the end product being disposed, the form of the waste, the quantity of asbestos in the waste, the type of land disposal facility ( e.g., impoundment, waste pile, landfill, injection well), and whether the disposal is on- or off-site. Note, however, that EPA is proposing that a site reporting “Disposed of within the U.S.” in response to Table 3 would provide additional explanation to indicate the quantity, address of the disposal facility, and type of disposal ( e.g., disposed in a landfill). EPA believes this level of reporting on waste disposal data is sufficient for purposes of this data collection. Due to the anticipated burden for reporters in contrast to the usefulness of the data that the agency could collect, EPA is not including reporting on additional data elements related to wastewater discharge and waste disposal in this proposed rule beyond the disposal explanation that would be included in response to reporting “Disposed of within the U.S.” in response to Table 3.

EPA considered collecting information related to air emissions at facilities that manufacture (including import) or process asbestos or asbestos-containing mixtures and products. The information included sources of emissions, methods of air pollution control, descriptions of control devices, and pollution control equipment operation and testing frequency and methods. Due to the anticipated burden for reporters in contrast to the usefulness of the data that the agency could collect, EPA is not including reporting on these additional data elements in this proposed rule.

EPA also considered requiring additional information about the number of customers respondents have. As proposed, this action would only collect information about asbestos manufacturers (including importers) and processors. Additional customer information from companies selling a product could be useful in understanding the universe of asbestos users. For the reasons described previously, EPA is not including reporting on these additional employee data elements in this proposed rule, however, EPA is requesting comment on requiring manufactures (including importers) and processors of asbestos that are selling a product that contains asbestos to report the number of customer sites they have.

EPA is proposing to require electronic reporting similar to the requirements established in 2013 for submitting other information under TSCA (see 40 CFR 704.20(e)). EPA is proposing to require submitters to use EPA's CDX (Central Data Exchange), the Agency's electronic reporting portal, for all reporting under this rule. In 2013, EPA finalized a rule to require electronic reporting of certain information submitted to the Agency under TSCA sections 4, 5, 8(a), and 8(d) (78 FR 72818) (FRL-2013-28510). The final rule followed two previous rules requiring similar electronic reporting of information submitted to EPA for TSCA CDR and for premanufacture notices (PMNs). In proposing to require similar electronic reporting under this rule, EPA expects that electronic reporting would save time, improve data quality, and increase efficiencies for both the submitters and the Agency.

EPA developed the Chemical Information Submission System (CISS) for use in submitting data electronically to the Agency for TSCA sections 4, 5, 6, 8(a), 8(b), 8(d), 8(e), and Title VI. CISS, a web-based reporting tool housed within the CDX environment, provides submitters with user-friendly applications to build and submit data packages to EPA within a secure, encrypted environment. CISS applications provide for the capture of both fielded data as well as the attachment of additional information using a wide variety of file types. Submitted information is rendered into PDF and XML formats, which are provided to submitters in the form of a Copy of Record.

EPA is proposing to require submitters to follow the same submission procedures used for other TSCA submissions, i.e., to register with EPA's CDX and use CISS to prepare a data file for submission. Registration enables CDX to authenticate user identity. To submit electronically to EPA via CDX, individuals must first register with CDX at http://cdx.epa.gov/. To register in CDX, the CDX registrant (also referred to as “Electronic Signature Holder” or “Public/Private Key Holder”) agrees to the Terms and Conditions, provides information about the submitter and organization, selects a username and password, and follows the procedures outlined in the guidance document for CDX available at https://cdx.epa.gov/FAQ#CSPP.

Within CDX, CISS is available under the “Submission for Chemical Safety and Pesticide Program (CSPP)” CDX flow. Users who have previously submitted under TSCA through CDX, including submitting information under TSCA sections 4 and 5, CDR, or reporting under the TSCA Inventory Notification (Active-Inactive) Requirements rule (82 FR 37520, Aug. 11, 2017) (FRL-9964-22), will already have the CSPP flow linked to their account. Users reporting to EPA using other CDX housed applications, including the Toxics Release Inventory TRI-MEweb, would be able to add the CSPP flow to their existing CDX accounts.

All submitters would be required to use CISS to prepare their submissions. CISS guides users through a “hands-on” process of creating an electronic submission. Once a user completes the relevant data fields and attaches appropriate PDF files, or other file types, such as XML files, the web-based tool validates the submission by performing a basic error check and makes sure all the required fields and attachments are provided and complete. Further instructions for uploading PDF attachments or other file types, such as XML, and completing metadata information would be available through CISS reporting guidance.

CISS also allows the user to choose to “Preview,” “Save,” or “Submit” the data package. Once the submission process is initiated, the user is asked to certify the information and provide requested information to complete the submission process. The data package is then sent, in an encrypted state, to the Agency. The user can login to the application and check the submission status of their data package. Upon successful receipt of the submission by EPA, the submission status of the submissions will be flagged as “Completed” and a confirmation email will be sent to the submitter's CDX inbox. The CDX inbox is used to notify the users when submissions are received by EPA or to notify users when a submission-specific communication has been received and how to locate and access the communication. Information on accessing the CDX user inbox is provided in the guidance document for CDX at https://cdx.epa.gov/FAQ#CSPP. To access CISS log into CDX using the link: https://cdx.epa.gov/ and click on the appropriate user role associated with the CSPP data flow. For further instructions, visit https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/electronic-reporting-requirements-certain-information. Procedures for reporting under this proposed rule would be similar.

EPA believes that electronic reporting reduces the reporting burden for submitters by reducing the cost and time required to review, edit, and transmit data to the Agency. It also allows submitters to share a draft submission within their organization, and more easily save a copy for their records or future use. Additionally, EPA believes that some of the anticipated submitters under this proposed rule have experience with reporting electronically to EPA through CDX. The resource and time requirements to review and process data by the Agency will also be reduced and document storage and retrieval will require fewer resources. EPA expects to benefit from receiving electronic submissions and communicating electronically with submitters.

In a separate rulemaking under development, EPA plans to propose new provisions concerning the assertion and treatment of CBI claims for information reported to or otherwise obtained by EPA under TSCA. Unless otherwise stated in specific TSCA regulations (such as those proposed here), EPA intends the proposed provisions to govern how CBI claims made for information submitted under TSCA, including information submitted under this part, will be asserted, reviewed, and maintained.

In this rulemaking, EPA is proposing in proposed 40 CFR 704.180(h) that a person submitting a reporting form under this action may claim some information in the form as confidential at the time of submission, consistent with TSCA section 14. EPA is also proposing that certain data elements cannot be claimed as confidential:

• Site NAICS code in proposed 40 CFR 704.180(e)(3)(v), because it represents a general description associated with the manufacture (including import) or processing of a chemical substance.

• Chemical and bulk material identities (as identified in proposed 40 CFR 704.180(h)(1)(ii)(B)), because the chemical identities are listed in the asbestos definition in proposed 40 CFR 704.180(a) or are general identities of bulk materials that are already publicly known.

• Responses that are blank or “not known or reasonably ascertainable” (as identified in proposed 40 CFR 704.180(h)(1)(ii)(C)) because there is no data to claim as confidential.

• Health and safety study data (as identified in proposed 40 CFR 704.180(h)(1)(ii)(D)), because, under TSCA section 14(b)(2), such information is not protected from disclosure. Note, however, that CBI claims may be asserted to the extent that disclosure of data from studies would reveal certain information as provided in proposed 40 CFR 704.180(h)(1)(ii)(D)(1)-(3). The electronic reporting tool described in proposed 40 CFR 704.180(i) enables the submitter of a health and safety study containing CBI claims to attach a public copy of the study, as described in proposed 40 CFR 704.180(h)(2)(vi).

TSCA section 14 also requires that the submitter attest to a statement concerning the confidential status of the information, that they have a reasonable basis to conclude that release of the information would likely result in substantial harm to the competitive position of their business and that the information is not readily discoverable through reverse engineering. The submitter must certify that this statement and any substantiation provided are true and correct. This certification statement will be incorporated into the electronic reporting tool identified in proposed 40 CFR 704.180(i).

TSCA section 14(c)(3) further requires that substantiation be provided at the time a confidentiality claim is asserted. However, TSCA section 14(c)(2) exempts certain information from that substantiation requirement ( e.g., specific production volume). Under the proposed rule, CBI claims for specific production or import volumes of the manufacturer need not be substantiated, as identified in proposed 40 CFR 704.180(h)(2)(iv). For all other information submitted under this proposed rule, submitters are required to substantiate their confidentiality claims at the time of submission. Substantiation questions are listed in proposed 40 CFR 704.180(h)(2)(iii) and will be incorporated into the electronic reporting tool identified in proposed section 704.180(i). Responses to the substantiation questions that are not specific to the data element for which a claim of confidentiality is being substantiated may be inadequate to justify confidential protection.

Any information which is claimed as confidential will be disclosed by EPA only in accordance with the procedures and requirements of TSCA section 14 and 40 CFR part 2, or any TSCA-specific CBI provisions that may in the future replace or supplement portions of 40 CFR part 2. TSCA section 14(b)(2) limits confidentiality protections for health and safety studies and information from health and safety studies regarding chemical substances that have been offered for commercial distribution, except to the extent such studies or information reveals “information that discloses processes used in the manufacturing (including importing) or processing of a chemical substance or mixture or, in the case of a mixture, the portion of the mixture comprised by any of the chemical substances in the mixture”. Additionally, in some cases EPA may consider information contained in a study as not part of a health and safety study as defined in TSCA section 3(8). The workplace exposure measurement data listed in proposed 40 CFR 704.180(e)(5)(iii) are from studies pertaining to human exposure in the workplace and therefore are considered health and safety study data. Submitters asserting a confidentiality claim for such information in health and safety studies (as well as for other information claimed as confidential) will be required to submit a sanitized copy of the study, removing only that information which is claimed as confidential. See proposed 40 CFR 704.180(h)(1)(ii)(D) for additional information regarding health and safety studies and proposed 40 CFR 704.180(h)(2)(vi)) regarding public copies.

EPA is proposing that each person who reports under this part must maintain records that document information reported under this part and, in accordance with TSCA, permit access to and the copying of such records by EPA officials. Consistent with the CDR rule, EPA is proposing a five-year recordkeeping period, beginning on the last date of the submission period. The five-year retention requirement generally corresponds with the statute of limitations for TSCA violations. Information in this one-time data collection will be used by EPA for risk evaluation and risk management activities, and the companies must maintain the records for five years in the event that EPA has follow-up questions as the agency activities are completed. Further, EPA believes the burden of retaining these records, which are likely electronic, is minimal.

EPA requests comment on the content of this proposed rule and the Economic Analysis prepared in support of this proposed rule (Ref. 2). In addition, EPA is providing a list of issues on which the Agency is specifically requesting public comment. EPA encourages all interested persons to submit comments on these issues, and to identify any other relevant issues as well. This input will assist the Agency in developing a final rule that successfully addresses information needs while minimizing potential reporting burdens associated with the rule. EPA requests that commenters making specific recommendations include supporting documentation where appropriate.

1. EPA is soliciting comment on the total number of manufactures (including importers) and processors that will be impacted by the promulgation of this rule, and on the related burden and costs for reporting. In addition, due to the lack of information on the extent to which asbestos occurs as an impurity, EPA was unable to determine the number of potential manufacturers (including importers) or processors of asbestos as an impurity that would report under this rule. EPA is soliciting public comment on the number of manufacturers (including importers) and processors that may be subject to the proposed rule due to the presence of impurities in their products, and on the related burden and cost for reporting.

2. As described further in Unit III.B., because there is no existing small processers definition that would be applicable under TSCA section 8(a), EPA is requesting comment on how to best provide guidance for small processors of Libby Amphibole asbestos.

3. As described further in Unit III.C.2, EPA is seeking comment on what additional guidance, if any, might be useful for helping entities, including small businesses, understand the reporting standard, as well as to how the reporting standard would apply to impurities.

As described further in Unit III.D., EPA is requesting public comment on the submission start date and duration, including for small businesses.

4. As described further in Unit III.E.2., EPA is requesting comment on whether there should be a threshold for reporting using Form B and, if so, whether the threshold should be concentration-based ( e.g., a certain percentage) or annual volume-based. In addition, EPA is requesting comment on whether any submitter under the threshold should alternatively report using Form A. Having a threshold for Form B may decrease burden on certain submitters while still allowing EPA to obtain information on all bulk materials, mixtures, and articles with known asbestos content. The substances subject to the rule can occur naturally as impurities in other products that may be handled in very large volumes, such as talc, vermiculite, and potentially other substances. A de minimis concentration could reduce the compliance determination and reporting burdens. Comments suggesting threshold levels should include the justification for that particular level.

5. As described further in Unit III.F. and first mentioned in Unit III.F.3., EPA is requesting comment on whether there should be other end product types listed in Table 4 in proposed 40 CFR 704.180(e)(4)(iv)(B). In addition, EPA is interested in whether the units of measure listed with the product types are appropriate.

6. As described further in Unit III.G., EPA identifies additional data elements related to employee data, wastewater discharge and waste disposal, air emissions data and customer sites data, considered for this proposed rule and is soliciting public comment on whether any of the additional data elements should be included in the action. While EPA believes the proposed data elements in Unit III.F provide sufficient information for use by EPA and other Federal agencies in potential actions involving asbestos, EPA is seeking comment on whether any additional data elements should be included in this action.

7. As described further in Unit III.AC.2, EPA is seeking comment on what additional guidance, if any, might be useful.

The following is a listing of the documents that are specifically referenced in this document. The docket includes these documents and other information considered by EPA, including documents that are referenced within the documents that are included in the docket, even if the referenced document is not physically located in the docket. For assistance in locating these other documents, please consult the technical person listed under FOR FURTHER INFORMATION CONTACT .

Additional information about these statutes and Executive Orders can be found at https://www.epa.gov/laws-regulations/laws-and-executive-orders .

This action is a significant regulatory action that was submitted to the Office of Management and Budget (OMB) for review under Executive Order 12866 (58 FR 51735, October 4, 1993) and Executive Order 13563 (76 FR 3821, January 21, 2011). Any changes made in response to OMB recommendations have been documented in the docket. EPA prepared an economic analysis of the potential costs and benefits associated with this action (Ref. 2), which is available in the docket and summarized in Unit I.E. (Ref. 2).

The information collection requirements in this proposed rule have been submitted to OMB for review and comment under the PRA, 44 U.S.C. 3501 et seq. The Information Collection Request (ICR) document prepared by EPA has been assigned the EPA ICR No. 2711.01 (Ref. 17). You can find a copy of the ICR in the docket for this action, and it is briefly summarized here.

The information collection activities in the proposed rule include a one-time reporting requirement and recordkeeping requirements. Companies that manufacture (including import) or process asbestos must report certain information to EPA and maintain corresponding records.

Respondents/affected entities: Chrysotile asbestos manufacturers (including importers) and processors. See Unit I.A. for a list of potentially affected entities.

Respondent's obligation to respond: Mandatory. TSCA section 8(a) and proposed 40 CFR 704.180.

Estimated number of respondents: 27.

Frequency of response: One time.

Total estimated burden: 1,157 hours (per report). Burden is defined at 5 CFR 1320.3(b).

Total estimated cost: $99,496 (per report), which includes no annualized capital or operation and maintenance costs.

An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers are displayed either by publication in the Federal Register or by other appropriate means, such as on the related collection instrument or form, if applicable. The display of OMB control numbers for certain EPA regulations is consolidated in 40 CFR part 9.

Submit your comments on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden to EPA using the docket identified at the beginning of this proposed rule. You may also send your ICR-related comments to OMB's Office of Information and Regulatory Affairs using the interface at www.reginfo.gov/public/do/PRAMain . Find this particular ICR by selecting “Currently under Review—Open for Public Comments” or by using the search function. Since OMB is required to make a decision concerning the ICR between 30 and 60 days after receipt, OMB must receive comments no later than June 6, 2022. The EPA will respond to any ICR-related comments in the final rule.

I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA, 5 U.S.C. 601 et seq. The small entities subject to the requirements of this action are persons who have manufactured (including imported), or processed asbestos, including asbestos as a component of a mixture, asbestos in articles, and asbestos as an impurity in the four full calendar years prior to the effective date of this rule. EPA estimates that at least 14 small firms will be affected by the proposed rule. Of those small firms, which include importers of articles and processors, 12 are expected to have cost impacts of less than 1% of annual revenues, one is expected to have impacts between 1-3%, and one is expected to have impacts of more than 3% of annual revenues. These estimates do not include firms that are impacted by the requirement to report for impurities, which EPA was unable to identify. Based on information available to EPA, the Agency does not believe there are a substantial number of such firms. Further, EPA believes that impacts to any such firms would not significantly alter the Agency's analysis under the RFA. Details of this analysis are presented in the Economic Analysis (Ref. 2).

This action does not contain an unfunded mandate of $100 million or more as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. The action imposes no enforceable duty on any state, local or tribal governments or the private sector.

This action does not have federalism implications, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999). In EPA's experience, states do not engage in the activities that would make them subject to the requirements in the proposed rule. As such this action will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government.

This action does not have tribal implications, as specified in Executive Order 13175 (65 FR 67249, November 9, 2000). It does not have substantial direct effects on tribal government because asbestos is not manufactured (including imported) or processed by tribes and would not impose substantial direct compliance costs on tribal governments.

EPA interprets Executive Order 13045 (62 FR 19885, April 23, 1997) as applying to those regulatory actions that concern environmental health or safety risks that the EPA has reason to believe may disproportionately affect children, per the definition of “covered regulatory action” in section 2-202 of the Executive Order. This action is not subject to Executive Order 13045, because it is a data gathering rulemaking and does not concern an environmental health risk or safety risk.

This action is not a “significant energy action” under Executive Order 13211 (66 FR 28355, May 22, 2001), because it is not likely to have a significant adverse effect on the supply, distribution or use of energy and has not otherwise been designated by the Administrator of OMB's Office of Information and Regulatory Affairs as a “significant energy action.” This action is not expected to affect energy use, energy supply or energy prices.

This proposed rulemaking does not involve technical standards. As such, NTTAA section 12(d), 15 U.S.C. 272 note, does not apply to this action.

The EPA believes that this action is not subject to Executive Order 12898 (59 FR 7629, February 16, 1994) because this action does not establish an environmental health or safety standard. The collected information, however, will be used by EPA and other Federal agencies to inform considerations of potential future actions involving asbestos, potentially including risk evaluation and risk management activities that could benefit underserved communities and indigenous peoples.

For the reasons set forth in the preamble, it is proposed that 40 CFR chapter I be amended as follows: