The Commission has requested comment on a release proposing amendments to its rules under the Securities Act and Exchange Act that would require registrants to provide certain climate-related information in their registration statements and annual reports. The proposed rules would require information about a registrant's climate-related risks that are reasonably likely to have a material impact on its business, results of operations, or financial condition. The required information about climate-related risks would also include disclosure of a registrant's greenhouse gas emissions, which have become a commonly used metric to assess a registrant's exposure to such risks. In addition, under the proposed rules, certain climate-related financial metrics would be required in a registrant's audited financial statements.

The comment period for the release was originally scheduled to close on May 20, 2022. The Commission believes that providing the public additional time to consider and comment on the matters addressed in the release would benefit the Commission in its consideration of final rules. Therefore, the Commission is extending the comment period for Release Nos. 33-11042; 34-94478, “The Enhancement and Standardization of Climate-Related Disclosures for Investors,” until June 17, 2022.

I. Private Fund Advisers; Documentation of Registered Investment Adviser Compliance Reviews

The Commission has requested comment on the Advisers Act Proposing Release, 1 which proposes new rules and amendments to existing rules under the Advisers Act. The proposed rules would require registered investment advisers to private funds to provide transparency to their investors regarding the full cost of investing in private funds and the performance of such private funds. The proposed rules also would require a registered private fund adviser to obtain an annual financial statement audit of each private fund it advises and, in connection with an adviser-led secondary transaction, a fairness opinion from an independent opinion provider. In addition, the proposed rules would prohibit all private fund advisers, including those that are not registered with the Commission, from engaging in certain sales practices, conflicts of interest, and compensation schemes that are contrary to the public interest and the protection of investors. All private fund advisers would also be prohibited from providing preferential treatment to certain investors in a private fund, unless the adviser discloses such treatment to other current and prospective investors. The proposed rules include corresponding amendments to the Advisers Act books and records rule to facilitate compliance with these proposed new rules and assist our examination staff. Finally, the proposed rules would amend the Advisers Act compliance rule, which would affect all registered investment advisers, to better enable our staff to conduct examinations. The original comment period for the Advisers Act Proposing Release ended on April 25, 2022.

The Commission has requested comment on the Exchange Act Proposing Release, 2 which proposes amendments to its rules under the Exchange Act that would amend 17 CFR 240.3b-16 under the Exchange Act, which defines certain terms used in the statutory definition of “exchange” under Section 3(a)(1) of the Exchange Act to include systems that offer the use of non-firm trading interest and communication protocols to bring together buyers and sellers of securities. In addition, the Exchange Act Proposing Release is re-proposing amendments to the Commission's regulations under the Exchange Act that were initially proposed in September 2020 for ATSs to take into consideration systems that may fall within the definition of exchange because of the proposed amendments in the Exchange Act Proposing Release and operate as an ATS. In the Exchange Act Proposing Release, the Commission is also re-proposing, with certain revisions, amendments to its regulations for Government Securities ATSs. In the Exchange Act Proposing Release, the Commission is proposing to amend Form ATS-N for NMS Stock ATSs, which would require existing NMS Stock ATSs to amend their existing disclosures. In addition, in the Exchange Act Proposing Release the Commission is proposing to amend the fair access rule for ATSs. The Commission is also proposing to require electronic filing of and to modernize Form ATS-R and Form ATS, which would require existing Form ATS filers to amend their existing disclosures. Further, in the Exchange Act Proposing Release the Commission is re-proposing amendments to its regulations regarding systems compliance and integrity to apply to ATSs that meet certain volume thresholds in U.S. Treasury Securities or in Agency Securities. The original comment period for the Exchange Act Proposing Release ended on April 18, 2022.

The Commission believes that providing the public additional time to consider and comment on the matters addressed in the Advisers Act Proposing Release and the Exchange Act Proposing Release would benefit the Commission in its consideration of final rules. Therefore, the Commission is reopening the comment periods for Release No. IA-5955 “Private Fund Advisers; Documentation of Registered Investment Adviser Compliance Reviews” and Release No. 34-94062 “Amendments Regarding the Definition of `Exchange' and Alternative Trading Systems (ATSs) That Trade U.S. Treasury and Agency Securities, National Market System (NMS) Stocks, and Other Securities” until June 13, 2022.

Under title VIII of the Alaska National Interest Lands Conservation Act (ANILCA; 16 U.S.C. 3111-3126), the Secretary of the Interior and the Secretary of Agriculture (Secretaries) jointly implement the Federal Subsistence Management Program. This program provides a preference for take of fish and wildlife resources for subsistence uses on Federal public lands and waters in Alaska. The Secretaries published temporary regulations to carry out this program in the Federal Register on June 29, 1990 (55 FR 27114), and published final regulations in the Federal Register on May 29, 1992 (57 FR 22940). The program regulations have subsequently been amended a number of times. Because this program is a joint effort between Interior and Agriculture, these regulations are located in two titles of the Code of Federal Regulations (CFR): Title 36, “Parks, Forests, and Public Property,” and Title 50, “Wildlife and Fisheries,” at 36 CFR 242.1-242.28 and 50 CFR 100.1-100.28, respectively. The regulations contain subparts as follows: Subpart A, General Provisions; Subpart B, Program Structure; Subpart C, Board Determinations; and Subpart D, Subsistence Taking of Fish and Wildlife.

Consistent with subpart B of these regulations, the Secretaries established a Federal Subsistence Board to administer the Federal Subsistence Management Program (Program). The Board comprises:

• A Chair appointed by the Secretary of the Interior with concurrence of the Secretary of Agriculture;

• The Alaska Regional Director, U.S. Fish and Wildlife Service;

• The Alaska Regional Director, National Park Service;

• The Alaska State Director, Bureau of Land Management;

• The Alaska Regional Director, Bureau of Indian Affairs;

• The Alaska Regional Forester, U.S. Forest Service; and

• Two public members appointed by the Secretary of the Interior with concurrence of the Secretary of Agriculture.

Through the Board, these agencies and public members participate in the development of regulations for subparts C and D, which, among other things, set forth program eligibility and specific harvest seasons and limits.

In administering the program, the Secretaries divided Alaska into 10 subsistence resource regions, each of which is represented by a Regional Advisory Council (Council). The Councils provide a forum for rural residents with personal knowledge of local conditions and resource requirements to have a meaningful role in the subsistence management of fish and wildlife on Federal public lands and waters in Alaska. The Council members represent varied geographical, cultural, and user interests within each region.

The Regional Advisory Councils and the public will be briefed on this proposed rule and the methods for submitting comments during their series of meetings for the winter 2022 cycle. For more information on these meetings visit the Councils' website at https://www.doi.gov/subsistence/regions.

The Board will discuss and evaluate submitted comments and public testimony on this proposed rule during a public meeting scheduled for April 12 through 15, 2022, in Anchorage, Alaska. Additional public testimony may be presented to the Board on this proposed rule at that time. At that public meeting, the Board will deliberate and make final recommendations to the Secretaries on this proposed rule. A teleconference will substitute for the in-person meeting if public health or safety restrictions are in effect. A public notice of specific dates, times, call-in number(s), and how to participate and provide public testimony will be published in local and statewide newspapers prior to the meeting.

You may submit written comments and materials concerning this proposed rule by one of the methods listed in ADDRESSES . If you submit a comment via https://www.regulations.gov, your entire comment, including any personal identifying information, will be posted on the website. If you submit a hardcopy comment that includes personal identifying information, you may request at the top of your document that we withhold this information from public review. However, we cannot guarantee that we will be able to do so. We will post all hardcopy comments on https://www.regulations.gov.

Comments and materials we receive, as well as supporting documentation we used in preparing this proposed rule, will be available for public inspection on https://www.regulations.gov, or by appointment, provided no public health or safety restrictions are in effect, between 8 a.m. and 3 p.m., Monday through Friday, except Federal holidays, at: USFWS, Office of Subsistence Management, 1011 East Tudor Road, Anchorage, AK 99503.

The Federal Subsistence Board is committed to providing access to these meetings for all participants. Please direct all requests for sign language interpreting services, closed captioning, or other accommodation needs to Robbin La Vine, 907-786-3888, subsistence@fws.gov, or 800-877-8339 (TTY), 7 business days prior to the meeting you would like to attend.

As expressed in Executive Order 13175, “Consultation and Coordination with Indian Tribal Governments,” the Federal officials that have been delegated authority by the Secretaries are committed to honoring the unique government-to-government political relationship that exists between the Federal Government and Federally Recognized Indian Tribes (Tribes) as listed in 82 FR 4915 (January 17, 2017). Consultation with Alaska Native corporations is based on Public Law 108-199, div. H, Sec. 161, Jan. 23, 2004, 118 Stat. 452, as amended by Public Law 108-447, div. H, title V, Sec. 518, Dec. 8, 2004, 118 Stat. 3267, which provides that: “The Director of the Office of Management and Budget and all Federal agencies shall hereafter consult with Alaska Native corporations on the same basis as Indian tribes under Executive Order No. 13175.”

ANILCA does not provide specific rights to Tribes for the subsistence taking of wildlife, fish, and shellfish. However, because Tribal members are affected by subsistence fishing, hunting, and trapping regulations, the Secretaries, through the Board, will provide Tribes and Alaska Native corporations an opportunity to consult on this proposed rule.

The Board will engage in outreach efforts for this proposed rule, including a notification letter, to ensure that Tribes and Alaska Native corporations are advised of the mechanisms by which they can participate. The Board provides a variety of opportunities for consultation: Proposing changes to the existing rule; commenting on proposed changes to the existing rule; engaging in dialogue at the Regional Advisory Council meetings; engaging in dialogue at the Board's meetings; and providing input in person, by mail, email, or phone at any time during the rulemaking process. The Board will commit to efficiently and adequately providing an opportunity to Tribes and Alaska Native corporations for consultation in regard to subsistence rulemaking.

The Board will consider Tribes' and Alaska Native corporations' information, input, and recommendations, and address their concerns as much as practicable.

The U.S. District Court for Alaska in its October 17, 2011, order in Peratrovich et al. v. United States and the State of Alaska, 3:92-cv-0734-HRH (D. Alaska), enjoined the United States “to promptly initiate regulatory proceedings for the purpose of implementing the subsistence provisions in Title VIII of the Alaska National Interest Lands Conservation Act (ANILCA) with respect to submerged public lands within Tongass National Forest” and directed entry of judgment. The Peratrovich case dates back to 1992 and has a long and involved procedural history. The plaintiffs in that litigation raised the question of which marine waters in the Tongass National Forest, if any, are subject to the jurisdiction of the Federal Subsistence Management Program. In its May 31, 2011, order, the U.S. District Court for Alaska (Court) stated that “it is the duty of the Secretaries [Agriculture & Interior] to identify any submerged lands (and the marine waters overlying them) within the Tongass National Forest to which the United States holds title.” It also stated that, if such title exists, it “creates an interest in [the overlying] waters sufficient to make those marine waters public lands for purposes of [the subsistence provisions] of ANILCA.”

Most of the marine waters within the Tongass National Forest were not initially identified in the regulations as public lands subject to the subsistence priority based upon a determination that the submerged lands were State lands, and later through reliance upon a disclaimer of interest filed by the United States in Alaska v. United States, No. 128 Orig., 546 U.S. 413 (2006). In that case, the State of Alaska had sought to quiet title to all lands underlying marine waters in southeast Alaska, which includes most of the Tongass National Forest. Ultimately, the United States disclaimed ownership to most of the submerged lands in the Tongass National Forest. The Supreme Court accepted the disclaimer by the United States to title to the marine waters within the Tongass National Forest, excepting from that disclaimer several classes of submerged public lands that generally involve small tracts. Alaska v. United States, 546 U.S. at 415.

When the United States took over the subsistence program in Alaska in 1990, the Departments of the Interior and Agriculture stated in response to comments on the scope of the program during promulgation of the interim regulations that “the United States generally does not hold title to navigable waters and thus navigable waters generally are not included within the definition of public lands” (55 FR 27115; June 29, 1990). That position was changed in 1999 when the subsistence priority was extended to inland waters subject to a Federal reserved water right following the Katie John litigation. While locating these inland waters, the Board also identified certain submerged marine lands that did not pass to the State and, therefore, where the subsistence priority applied. However, the Board did not attempt to identify each and every small parcel of submerged public lands and thereby marine water possibly subject to the Federal Subsistence Management Program because of the potentially overwhelming administrative burden. Instead the Board invited the public to petition to have submerged marine lands included. Over the years, several small areas of submerged marine lands in the Tongass National Forest have been identified as public lands subject to the subsistence priority.

In its May 31, 2011, order, the Court stated that the petition process was not sufficient and found that “concerns about costs and management problems simply cannot trump the congressional policy that the subsistence lifestyle of rural Alaskans be preserved as to public lands.” The Court acknowledged in its order that inventorying all these lands could be an expensive undertaking, but that it is a burden “necessitated by the `complicated regulatory scheme' which has resulted from the inability of the State of Alaska to implement Title VIII of ANILCA.” The Court then “enjoined” the United States “to promptly initiate regulatory proceedings for the purpose of implementing the subsistence provisions in Title VIII of ANILCA with respect to submerged public lands within Tongass National Forest” and directed entry of judgment.

Following the Court's decision, the Departments published a notice in the Federal Register (77 FR 33391; June 6, 2012) announcing the initiation of reviews of pre-statehood withdrawals and reservation in the Tongass National Forest. The Bureau of Land Management (BLM) and the USDA-Forest Service (USDA-FS) started a review of hundreds of potential pre-statehood (January 3, 1959) withdrawals in the marine waters of the Tongass National Forest. These reviews included dock sites, log transfer sites, and other areas that may not have passed to the State at statehood. On June 8, 2016, the Departments published a proposed rule in the Federal Register (81 FR 36836) that listed the initial findings identifying pre-statehood withdrawals, and on May 23, 2018, the Departments published a final rule (83 FR 23813) to revise the subsistence management regulations to add those submerged parcels. The purpose of this proposed rule is to complete regulatory proceedings addressing submerged public lands within the Tongass National Forest as directed by the Court.

This proposed rule will add submerged public lands to the list in the subsistence regulations to ensure compliance with the Court's order. In addition, this proposed rule would make nonsubstantive changes to 36 CFR 242.3 and 50 CFR 100.3 by transferring the listings into a table to effect a user friendly format.

Because this proposed rule concerns public lands managed by an agency or agencies in both the Departments of Agriculture and the Interior, identical text will be incorporated into 36 CFR part 242 and 50 CFR part 100.

This action is taken by the Department of the Interior pursuant to delegated authority.

A Draft Environmental Impact Statement that described four alternatives for developing a Federal Subsistence Management Program was distributed for public comment on October 7, 1991. The Final Environmental Impact Statement (FEIS) was published on February 28, 1992. The Record of Decision (ROD) on Subsistence Management for Federal Public Lands in Alaska was signed April 6, 1992. The selected alternative in the FEIS (Alternative IV) defined the administrative framework of an annual regulatory cycle for subsistence regulations.

A 1997 environmental assessment dealt with the expansion of Federal jurisdiction over fisheries and is available at the office listed under FOR FURTHER INFORMATION CONTACT . The Secretary of the Interior, with concurrence of the Secretary of Agriculture, determined that expansion of Federal jurisdiction does not constitute a major Federal action significantly affecting the human environment and, therefore, signed a Finding of No Significant Impact.

An ANILCA section 810 analysis was completed as part of the FEIS process on the Federal Subsistence Management Program. The intent of all Federal subsistence regulations is to accord subsistence uses of fish and wildlife on public lands a priority over the taking of fish and wildlife on such lands for other purposes, unless restriction is necessary to conserve healthy fish and wildlife populations. The final section 810 analysis determination appeared in the April 6, 1992, ROD and concluded that the Federal Subsistence Management Program, under Alternative IV with an annual process for setting subsistence regulations, may have some local impacts on subsistence uses, but will not likely restrict subsistence uses significantly.

During the subsequent environmental assessment process for extending fisheries jurisdiction, an evaluation of the effects of the subsistence program regulations was conducted in accordance with section 810. This evaluation also supported the Secretaries' determination that the regulations will not reach the “may significantly restrict” threshold that would require notice and hearings under ANILCA section 810(a).

This proposed rule does not contain any new collections of information that require Office of Management and Budget (OMB) approval under the PRA (44 U.S.C. 3501 et seq. ). OMB has reviewed and approved the collections of information associated with the subsistence regulations at 36 CFR part 242 and 50 CFR part 100, and assigned OMB Control Number 1018-0075, with an expiration date of January 31. 2024. We may not conduct or sponsor and you are not required to respond to a collection of information unless it displays a currently valid OMB control number.

Executive Order 12866 provides that the Office of Information and Regulatory Affairs (OIRA) in the Office of Management and Budget will review all significant rules. OIRA has determined that this proposed rule is not significant.

Executive Order 13563 reaffirms the principles of E.O. 12866 while calling for improvements in the nation's regulatory system to promote predictability, to reduce uncertainty, and to use the best, most innovative, and least burdensome tools for achieving regulatory ends. The executive order directs agencies to consider regulatory approaches that reduce burdens and maintain flexibility and freedom of choice for the public where these approaches are relevant, feasible, and consistent with regulatory objectives. E.O. 13563 emphasizes further that regulations must be based on the best available science and that the rulemaking process must allow for public participation and an open exchange of ideas. We have developed this proposed rule in a manner consistent with these requirements.

The Regulatory Flexibility Act of 1980 (5 U.S.C. 601 et seq. ) requires preparation of flexibility analyses for rules that will have a significant effect on a substantial number of small entities, which include small businesses, organizations, or governmental jurisdictions. In general, the resources to be harvested under this proposed rule are already being harvested and consumed by the local harvester and do not result in an additional dollar benefit to the economy. However, we estimate that two million pounds of meat are harvested by subsistence users annually and, if given an estimated dollar value of $3.00 per pound, this amount would equate to about $6 million in food value statewide. Based upon the amounts and values cited above, the Departments certify that this rulemaking will not have a significant economic effect on a substantial number of small entities within the meaning of the Regulatory Flexibility Act.

Under the Small Business Regulatory Enforcement Fairness Act (5 U.S.C. 801 et seq. ), this proposed rule is not a major rule. It will not have an effect on the economy of $100 million or more, will not cause a major increase in costs or prices for consumers, and will not have significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of U.S.-based enterprises to compete with foreign-based enterprises.

Title VIII of ANILCA requires the Secretaries to administer a subsistence priority on Federal public lands and waters. The scope of this program is limited by definition to certain public lands. Likewise, these proposed regulations have no potential takings of private property implications as defined by Executive Order 12630.

The Secretaries have determined and certify pursuant to the Unfunded Mandates Reform Act, 2 U.S.C. 1502 et seq., that this proposed rulemaking will not impose a cost of $100 million or more in any given year on local or State governments or private entities. The implementation of this rule is by Federal agencies and there is no cost imposed on any State or local entities or tribal governments.

The Secretaries have determined that these regulations meet the applicable standards provided in sections 3(a) and 3(b)(2) of Executive Order 12988, regarding civil justice reform.

In accordance with Executive Order 13132, the proposed rule does not have sufficient federalism implications to warrant the preparation of a federalism assessment. Title VIII of ANILCA precludes the State from exercising subsistence management authority over fish and wildlife resources on Federal lands unless it meets certain requirements.

Title VIII of ANILCA does not provide specific rights to Tribes for the subsistence taking of wildlife, fish, and shellfish. However, as described above under Tribal Consultation and Comment, the Secretaries, through the Board, will provide federally recognized Tribes and Alaska Native corporations a variety of opportunities for consultation: Commenting on proposed changes to the existing rule; engaging in dialogue at the Regional Council meetings; engaging in dialogue at the Board's meetings; and providing input in person, by mail, email, or phone at any time during the rulemaking process.

This Executive Order requires agencies to prepare statements of energy effects when undertaking certain actions. However, this proposed rule is not a significant regulatory action under E.O. 13211, affecting energy supply, distribution, or use, and no statement of energy effects is required.

Theo Matuskowitz drafted this proposed rule under the guidance of Sue Detwiler of the Office of Subsistence Management, Alaska Regional Office, U.S. Fish and Wildlife Service, Anchorage, Alaska. Additional assistance was provided by:

• Chris McKee, Alaska State Office, Bureau of Land Management;

• Dr. Joshua Ream, Alaska Regional Office, National Park Service;

• Dr. Glenn Chen, Alaska Regional Office, Bureau of Indian Affairs;

• Jill Klein, Alaska Regional Office, U.S. Fish and Wildlife Service; and

• Gregory Risdahl, Alaska Regional Office, USDA-Forest Service.

For the reasons set out in the preamble, the Secretaries propose to amend 36 CFR 242.3 and 50 CFR 100.3 as set forth below.

I. Executive Summary A. Does this action apply to me?

You may be affected by this action if you have submitted or expect to submit information to EPA under TSCA and have made or expect to make any confidentiality claims concerning that information. Persons who seek information on such submissions may also be affected by this action. The following list of North American Industrial Classification System (NAICS) codes 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:

• Manufacturers, importers, or processors of chemical substances (NAICS codes 325 and 324110), e.g., chemical manufacturing and petroleum refineries.

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 .

TSCA section 14, 15 U.S.C. 2613, includes requirements for asserting confidentiality claims and for EPA review of such claims to determine whether the information is entitled to the requested protections. Implementing rules are explicitly contemplated for some provisions of TSCA section 14 ( e.g., TSCA section 14(c)(1)(a) requires persons seeking to protect information from disclosure to assert such a claim concurrent with submission of the information, in accordance with existing or future rules; TSCA section 14(c)(3) generally requires that confidentiality claims be substantiated “in accordance with such rules as the Administrator has promulgated or may promulgate pursuant to this section”). In addition, other TSCA section 14 requirements imply authority to promulgate rules addressing the form and manner in which those requirements should be fulfilled ( e.g., manner of submitting confidentiality claims, manner in which EPA will make required notices under TSCA sections 14(g) or 14(e)).

Discussion of authority to require electronic reporting under TSCA may be found in the preamble to the final rule entitled “Electronic Reporting under the Toxic Substances Control Act; Final Rule” (Ref. 1). In addition, the Government Paperwork Elimination Act (GPEA), 44 U.S.C. 3504, provides that, when practicable, Federal organizations use electronic forms, electronic filings, and electronic signatures to conduct official business with the public.

EPA is proposing new and amended requirements concerning the assertion and treatment of CBI claims under TSCA, 15 U.S.C. 2601, et seq. The Frank R. Lautenberg Chemical Safety for the 21st Century Act of 2016, Public Law 114-182 (referred to in this Notice as “the Lautenberg amendments”), made significant amendments to TSCA, including new provisions governing the assertion and review of CBI claims that EPA is proposing to implement in this action.

In this document, EPA is proposing to specify procedures for submitting and supporting CBI claims under TSCA, including among other things: (1) Substantiation requirements applicable at the time of submission; (2) Electronic reporting requirements; (3) Requirements to provide certification statements and generic names when making confidentiality claims; (4) Treatment of information used for TSCA purposes that EPA could obtain under TSCA but was originally submitted via other means; and (5) Maintenance or withdrawal of confidentiality claims.

EPA is also proposing to specify procedures for reviewing and communicating with TSCA submitters about confidentiality claims, including requirements for submitters to maintain contact information, and procedures for EPA to provide notices to submitters concerning their claims.

EPA is proposing new provisions, as well as to amend and reorganize existing provisions concerning assertion of confidentiality claims under TSCA. Regulatory provisions concerning TSCA CBI claims are currently spread over a large number of parts in the Code of Federal Regulations (CFR). EPA has general provisions regarding confidentiality claims at 40 CFR part 2, subpart B. Those general provisions are accompanied by sections pertaining to confidentiality for many of the statutes administered by the Agency. The TSCA-specific provisions of the Agency's general business confidentiality regulations are at 40 CFR 2.306. In addition, many of the specific TSCA regulations in title 40 of the CFR contain their own provisions regarding CBI, such as in parts 711 (Chemical Data Reporting) and 720 (Premanufacture Notification).

In this proposed rule, most procedural requirements for asserting and maintaining confidentiality claims would be organized into a proposed new part of title 40 of the CFR, i.e., in part 703. The provisions in proposed part 703 would apply to any TSCA submission, except as modified elsewhere in part 2 or other TSCA-specific regulations, as spelled out in this proposed rule. Further discussion of the interactions between the various provisions regarding confidentiality can be found in Unit II.B. of this document.

EPA has evaluated the potential incremental impacts of this proposed rulemaking, including alternative options. The details are presented in the economic analysis prepared for the proposed rule (Ref. 2), which is available in the docket and is briefly summarized here.

The benefits of the proposed rule include improvements to EPA's management of CBI, specifically in cases of deficient claims, and improved communication and increased public transparency for chemical information. The proposed rule is expected to decrease the frequency of submitter error and increase efficiency in the processes for asserting and maintaining CBI claims. Lastly, the proposed rule would bring TSCA confidentiality regulations in line with the changes to TSCA section 14 brought about by the Lautenberg amendments.

EPA estimates that the public will incur a one-time burden and cost of approximately 2,945 hours with an associated cost of approximately $271,000 in the first year after the rule is finalized and an annual, ongoing burden of approximately 525 hours with an associated cost of approximately $45,000 in each following year.

The proposed rule does not involve environmental health or safety risks that the EPA has reason to believe may disproportionately affect children. However, the Agency believes that the information collected under this proposed rule, if finalized, will assist EPA and others in evaluating potential hazards and risks associated with chemicals. Although not directly impacting environmental health or safety risks, this information will enable the Agency to better protect human health and the environment, including the health of children.

This proposed action does not address human health or environmental risks or otherwise have disproportionately high and adverse human health or environmental effects on minority populations, low-income populations and/or indigenous peoples. Although not directly impacting environmental justice-related concerns, the information collected under this proposed rule will enable the Agency to better protect human health and the environment, including in low-income and minority communities.

The Lautenberg amendments included several significant changes to TSCA section 14. These include requirements that persons submitting information under TSCA substantiate most confidentiality claims at the time of submission, as well as additional statement, certification, and generic name requirements. Under TSCA section 14(e), in order to maintain most claims beyond a 10-year period, submitters are required to reassert and resubstantiate those claims. Several new requirements also apply to EPA, including requirements at TSCA section 14(g) to review and approve or deny all chemical identity claims asserted since the Lautenberg amendments were enacted concerning substances that are offered for commercial distribution, as well as a subset of all other confidentiality claims, within 90 days of assertion of the claim. Further requirements that EPA review all confidentiality claims for the chemical identity of substances listed as active on the TSCA Inventory, a requirement to assign and apply unique identifiers (UIDs) to substances with approved confidentiality claims for chemical identity, as well as new provisions providing expanded access to TSCA CBI, have been discussed in previous documents that published in the Federal Register , see e.g., Refs. 3 (about the CBI review plan), 4 (about UIDs) and 5 (about expanded access to CBI). Additionally, some TSCA regulations promulgated or amended since the Lautenberg amendments have included confidentiality provisions conforming to the amendments ( e.g., Chemical Data Reporting at 40 CFR 711.30 and Active/Inactive Inventory Reporting at 40 CFR 710.37).

As proposed, this rulemaking would implement additional requirements of the Lautenberg amendments concerning confidentiality claims and would apply to all TSCA submissions. The proposal is intended to clarify the TSCA section 14 requirements for submitters of TSCA confidentiality claims. This would reduce the likelihood of claims being denied because of procedural insufficiencies and facilitate the public availability of information for which confidentiality is either not requested or not allowed under TSCA. The proposed procedural rules would aid efficient and timely EPA review of confidentiality claims and reduce the likelihood of inadvertent disclosure of CBI.

Currently, CBI claims are asserted according to TSCA section 14 and existing TSCA rule requirements that are specific to certain reporting requirements (see Unit II.E. of this document). In some cases, further claim assertion procedures are included in EPA's general CBI regulations at 40 CFR part 2.

The procedures currently used by EPA to review TSCA CBI claims are found in 40 CFR part 2, subpart B. These regulations were developed to, among other things, apply Exemption 4 of the Freedom of Information Act (FOIA), 5 U.S.C. 552, relating to business confidentiality, to review CBI claims in response to a FOIA request. Some TSCA-specific provisions in 40 CFR 2.306 add to or modify the general CBI regulations found in 40 CFR 2.201 through 2.215. 40 CFR 2.306 was last modified in 1993. In the absence of revisions to accommodate the changes introduced by the Lautenberg amendments, EPA has continued to use the 40 CFR part 2 regulations to complete the mandatory confidentiality determinations required by the Lautenberg amendments.

The proposed rule would tailor all TSCA CBI claim assertion and review procedures to the requirements of TSCA rules and consolidate them in the TSCA rules—primarily in the proposed new part 703. 40 CFR 2.306 would be reduced in scope. It would clarify that most of the general claim assertion and review rules found in the 40 CFR part 2 CBI rules no longer apply to TSCA CBI claims and to elaborate on special circumstances where CBI may be disclosed based on the provisions of TSCA section 14(d) (disclosure to states, local governments and tribes under TSCA section 14(d)(4); health or environmental professionals under TSCA section 14(d)(5); or to certain emergency responders under TSCA section 14(d)(6) or as relevant to a proceeding under TSCA section 14(d)(7)). EPA is proposing to retain certain notice requirements in 40 CFR part 2 that are not required by TSCA Section 14. Specifically, under TSCA section 14(g)(2)(C)(iii), EPA is not required to provide notice prior to disclosure of information pursuant to TSCA sections 14(d)(1), (2), (7), or (8), i.e., to Federal employees or officers, to contractors, if relevant to a proceeding, or required to be made public under other Federal law. EPA is proposing to retain certain existing notice requirements in 40 CFR part 2 for disclosure to Federal employees at 40 CFR 2.306(d), if relevant to a proceeding at 40 CFR 2.306(e), and for contractors and subcontractors at 40 CFR 2.306(f).

Additionally, the consolidation of TSCA CBI claim review procedures into the proposed new part 703 includes the review procedures relating to FOIA requests ( i.e., CBI claim review required by TSCA section 14(f)(2)(A)). CBI claim review procedures in 40 CFR 2.306(d), (e), and (g), and the procedures in 40 CFR 2.204 and 2.205 that are currently cross-referenced in 40 CFR 2.306 are replaced with corresponding provisions in the proposed new part 703.

EPA intends for the proposed requirements to apply broadly to any information that is reported to, or otherwise obtained by, the Agency under TSCA. 15 U.S.C. 2613(a)(1). This includes, for example, information that is submitted pursuant to a requirement of TSCA or its implementing regulations ( e.g., a TSCA section 5 Premanufacture Notification (PMN) or a TSCA section 8(e) notice of substantial risk), information that is collected in the course of a TSCA inspection or other TSCA enforcement-related activity, and materials that are subpoenaed pursuant to TSCA. The proposed rule would also cover information which is first obtained by EPA under an authority other than TSCA but which meets the following criteria: (1) EPA has authority to collect the information under TSCA; and (2) the information is either used to satisfy the obligation of a person under TSCA or used by EPA in the course of carrying out its responsibilities under TSCA. EPA is proposing to interpret the phrase “that is reported to, or otherwise obtained by, the Administrator under TSCA” to include information that meets the two criteria identified above. The term “under” is not defined in TSCA section 14; therefore, EPA is proposing to interpret this term as it is commonly used as well as from its statutory context. See Kucana v. Holder, 558 U.S. 233, 245 (2010) (quoting Ardestani v. INS, 502 U.S. 129, 135 (1991)) (“The word `under' `has many dictionary definitions and must draw its meaning from its context.' ”). Dictionary definitions can provide some insight into how a reasonable or ordinary person would interpret the term. “Under” is defined as “subject to the authority, control, guidance, or instruction of,” under, Merriam-Webster Online (2021), and “subject to” is defined as “affected by or possibly affected by (something).” Subject to, Merriam-Webster Online (2021). In addition, the broad inclusive language used—“reported to, or otherwise obtained by”—suggests that Congress intended the provision to apply broadly. It applies not only to information reported under TSCA but also to information obtained under TSCA in manners other than reporting.

Language added to TSCA by the Lautenberg amendments also supports the proposed interpretation that any information EPA has the authority to collect under TSCA and is used for TSCA purposes should be considered obtained “under” TSCA. First, TSCA section 4(h)(3)(A) refers to the submission “under this subchapter” of voluntary information, suggesting information need not be required by a rule or order to be submitted “under” TSCA. Section 26(j) further provides that subject to TSCA section 14, the Administrator shall make available to the public “a list of the studies considered by the Administrator in carrying out each such risk evaluation, along with the results of those studies.” 15 U.S.C. 2625(j)(4). Moreover, TSCA section 26(k) requires the Administrator to consider “reasonably available” information when conducting a risk evaluation. This language appears to suggest that TSCA section 14 would govern confidentiality determinations for all studies considered by the Agency under TSCA section 6(b), regardless of where the studies originated or how they were obtained.

However, there may be instances where information covered under proposed new part 703 was originally submitted to EPA pursuant to a statute with provisions regarding confidentiality, disclosure and treatment of information that materially differ from those in TSCA. EPA has addressed conflicts between regulatory provisions in 40 CFR 2.202(d), which states that the “rule which provides greater or wider availability to the public of the information shall govern,” and more specifically in the existing 40 CFR 2.306(b), which provides that under the appropriate circumstances TSCA provisions would apply to certain information originally submitted to EPA for some non-TSCA purpose. But under the Lautenberg amendments to TSCA, EPA will be making use of significant amounts of data originating from a variety of sources, including existing studies submitted under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).

An example of a scenario in which such a situation may occur is where a health and safety study is originally submitted to EPA under FIFRA, but is subsequently used for TSCA purposes ( e.g., in support of a TSCA section 6 risk evaluation) and where the health and safety study could have been collected under a TSCA authority ( e.g., pursuant to TSCA section 8(d)). Under FIFRA section 10(g), the disclosure of such a study is limited to protect against disclosure to foreign or multinational pesticide producers, but if the study were submitted under TSCA, much of the information in the study would not be protected from disclosure under TSCA section 14(b)(2).

The potential for conflict between statutory data protection regimes, and the potential for disclosure of information originally submitted under the expectation of specified information protection requirements, has greatly increased from when the earlier regulations were promulgated. EPA recognizes that there are several options for dealing with these potential conflicts. As noted above, EPA is proposing that in certain circumstances some information obtained under authorities other than TSCA are information obtained under TSCA. EPA also seeks to ensure that when information is submitted to EPA under a statutory provision that provides an assurance of privacy, those privacy protections continue to apply even when the information is used for a different purpose. Cf Food Marketing Institute v. Argus Leader Media, 139 S.Ct. 2356, 2366 (2019) (acknowledging the importance of assurances of privacy to determinations regarding the confidentiality of information). Thus, EPA is proposing that when there is a conflict between statutory data protection regimes, the rules regarding the treatment of information in that statute under which the information was originally collected should continue to apply to the information, regardless of how it is used by the Agency under TSCA. The proposed regulations establishing this approach to potential conflicts appear in proposed section 703.1. In addition, there are procedures in TSCA section 14 that would be appropriate to apply to such data, such as the limited disclosure authority, often under confidentiality agreements, that is provided by TSCA section 14(d).

Other alternatives on which EPA requests comment include the approach embodied in 40 CFR 2.202(d) that the statute which provides for the greatest disclosure of the information governs, or the opposite, that the most disclosure-restrictive statute governs. Either approach could be implemented by applying the most (or least) restrictive statute as a whole or by comparing specific statutory provisions with TSCA section 14 and applying the least (or most) restrictive provision on a provision-by provision basis. EPA believes that the approach presented in proposed section 703.1 strikes an appropriate balance and provides greater clarity, as well as being consistent with the disclosure requirements applicable when the submitter originally provided the information to EPA.

EPA requests comment broadly on these and any other options for addressing, minimizing, or eliminating conflict between provisions under different statutes regarding confidentiality, disclosure, and treatment of information, including but not limited to alternative statutory interpretations, principles that should govern the resolution of conflicts, and options for resolving specific conflicts. EPA specifically requests comment on whether the proposed approach appropriately balances transparency under TSCA while also ensuring appropriate protections for information obtained initially under another statute consistent with the assurance of privacy implicitly or explicitly provided by the government when such information is obtained. See Food Marketing Institute v. Argus Leader Media, 139 S.Ct. 2356, 2366 (2019).

EPA also specifically seeks public comment on the proposed scope of the rulemaking, particularly that information originally obtained without the use of a TSCA authority is nevertheless obtained under TSCA if the Agency has the authority to collect the information and it was used for a TSCA purpose. EPA is also seeking comment on whether EPA needs to exercise its TSCA authority or invoke its TSCA authority in the original information collection in order for information to be covered by TSCA section 14. EPA also seeks public comment on the proposed treatment of information that was originally submitted under another statute, as well as the alternatives identified. EPA is particularly interested in comments on how studies that were originally submitted under FIFRA should be treated under the TSCA regulations.

Finally, EPA is interested in comments on whether and, if so, how the term “TSCA submission” should be defined in proposed section 703.3.

TSCA section 14(c) governs assertion of confidentiality claims for TSCA submissions. This provision requires that persons submitting information under TSCA substantiate most confidentiality claims at the time of submission. It also includes additional certification and generic name requirements. These and related requirements are elaborated upon in Unit III.C.

TSCA section 14(c)(1)(a) requires an affected business to assert a claim for protection from disclosure concurrent with submission of the information. Consistent with this provision, proposed section 703.5 would require that confidentiality claims be asserted at the time of submission. If no such claim is made, the information may be made available to the public without prior notice to the person who submitted the information. While similar language appears in some of the existing regulations that implement TSCA ( e.g., 40 CFR 711.30(e)), this proposal would clarify that the up-front assertion requirement is applicable to all non-exempt TSCA CBI claims, in accordance with TSCA section 14(c)(1)(A).

Proposed section 703.5 would further clarify and reiterate that where a TSCA submission identifies a chemical substance listed on the confidential portion of the TSCA Inventory but does not assert a confidentiality claim for the chemical identity as required by TSCA section 14 or in the manner required by the applicable rule (see, e.g., 40 CFR 711.30), the specific chemical identity would no longer be eligible for confidential treatment on the TSCA Inventory. This would not apply where the submission does not pertain to manufacture or processing for commercial purposes, e.g., research and development.

The TSCA Inventory is a list of chemical substances manufactured or processed for a commercial purpose. A substance may be afforded confidential Inventory treatment ( e.g., listing by generic name and accession number) so long as the fact that anyone manufactures or processes that substance for commercial purposes in the United States has not been disclosed to the public. By making a non-confidential report of having manufactured or processed a particular substance, the reporter in effect discloses their activities concerning the substance to the public and renders the substance ineligible for continued confidential Inventory treatment. EPA would update the TSCA Inventory to publicly list the specific chemical name and Chemical Abstracts Service Registry Number (CASRN), if available, without further notice (to any person who may have made a CBI claim for this substance). (Updates to individual submissions that contain a prior claim for what appears to be the same information would occur only after that claim is withdrawn or as result of a review and final determination in accordance with TSCA section 14 denying the claim in that submission.) Under some existing rules, once the chemical identity is listed on the public portion of the TSCA Inventory, claims can no longer be asserted for such information (see, e.g., 40 CFR 711.30(a)(2)(i)). This is also intended to clarify that the Agency will not provide notice to submitters with previously approved or pending claims for the same chemical identity prior to such disclosure on the TSCA Inventory. 40 CFR 711.30(a)(2)(i)). In addition, other chemical identity CBI claims for the substance would likely be denied upon review. However, claims for information related to the chemical identity, e.g., the identity of the submitter, would not be precluded.

EPA previously published an interpretation concerning the requirement to substantiate CBI claims in TSCA section 14(c)(3), see (Ref. 6). In that document, EPA stated that the statute requires persons asserting CBI claims to substantiate those claims at the time the affected business submits the claimed information to EPA. This proposed rule, in proposed section 703.5(b)(1), would make EPA's TSCA confidentiality regulations consistent with TSCA section 14(c)(3).

Subsequent to the interpretation that published in the Federal Register of January 19, 2017 (Ref. 6), some TSCA rules were updated to include a set of required substantiation questions and apply the substantiation exemptions in TSCA section 14(c)(2). See, e.g., Chemical Data Reporting at 40 CFR 711.30. This proposed rule includes a standard set of substantiation questions in proposed sections 703.5(b)(3) and (4) that would be applicable to any confidentiality claim in any TSCA submission for which substantiation is required and includes additional substantiation questions specific to chemical identity claims. However, proposed section 703.4(b)(3) would provide that individual TSCA rules may modify the questions (by, for example, not requiring answers to substantiation questions that are not applicable in a particular TSCA submission type).

The substantiation questions in proposed sections 703.5(b)(3) and (4) have been designed to elicit information to allow EPA to determine whether the submitter's claim for confidentiality meets the substantive review criteria set forth in proposed section 703.7(f). EPA is interested in public comment concerning the proposed question set, including whether some questions might be consolidated or revised to minimize burden while also assuring responses are adequate to support a confidentiality determination ( i.e., according to the criteria in proposed section 703.7(f)). The questions proposed here are similar to those included in the 2020 amendments to the Chemical Data Reporting (CDR) rule (see 40 CFR part 711) which the Agency believes are adequate to support its review of confidentiality claims in those submissions.

EPA is proposing a question on patents in proposed section 703.5(b)(3)(iii)(C) and is seeking comment on alternatives to the proposed question language, or whether a standalone patent question is necessary at all. The Agency requests comment on whether a standalone patent question is necessary or if it can be reasonably added to the publications question found in proposed section 703.5(b)(3)(iii)(B). In the Agency's experience, patents related to information claimed as CBI under TSCA rarely if ever disclose information in the same context or with the same level of detail as in the related TSCA submission. The Agency notes that asking whether information appears in a patent is not the same thing as asking whether the information is covered by a patent. For the purposes of TSCA confidentiality claims, the Agency is interested in both whether the same information claimed to be confidential in the TSCA submission appears in a patent and whether it is covered by a patent. More specifically, if the exact same information appears in both a published patent and in the TSCA submission, then the information should not be entitled to confidential treatment. Also, if the information is covered ( i.e., legally protected) by a patent in such a way that no substantial harm to the competitive position of the business would result from the release of the information, then the information is not subject to confidential treatment on that ground as well. If the question of whether TSCA information claimed as CBI can both appear in and be covered by a patent without destroying the CBI claim can always be answered with a yes or no response with no additional explanation, then a standalone patent question may not be necessary. The Agency seeks comment from submitters explaining why they believe existence of a patent that contains and covers the information claimed CBI should not affect the ability of the submitter to the claim the same information as CBI under TSCA.

Alternatively, the Agency requests comment on whether the standalone patent question used in the 2020 CDR rule (40 CFR 711.30) and proposed section 703.5(b)(3)(iii)(C) is adequate, or whether can be improved to elicit more pertinent responses from submitters regarding the potential public disclosure in a patent of the information claimed confidential in the TSCA submission. The existing question is as follows: Does any of the information claimed as confidential appear in one or more patents or patent applications? If yes, provide the associated patent number or patent application number (or numbers) and explain why the information should be treated as confidential.

Particularly, the Agency would like to know how a company would be reasonably likely to suffer substantial competitive harm if the information is released under TSCA if the company already enjoys legal protections against competitors for patent infringement. Further, should the patent question elicit substantiation to explain why the information claimed to be confidential in the TSCA submission is not actually revealed in the particular patent? The Agency proposes the following as an alternative substantiation question: Has a patent been published for the chemical identity you claim confidential? What chemical identity information is not revealed by the patent? How is release of that specific information likely to cause substantial competitive harm? Failure to explain this harm may lead to denial of your confidentiality claim.

The Agency requests comment on whether the proposed alternative question is more likely to elicit pertinent responses on the relevance of a patent and invites suggestions that may help improve how the Agency considers patents in its CBI reviews.

EPA has observed that the question concerning trade secrets found in several existing TSCA rules, e.g., at 40 CFR 711.30(b)(4), tends to elicit answers that are either redundant with the answers to other substantiation questions, or otherwise do not tend to include information that is useful for the agency to consider whether the information meets the specific legal standard for trade secrets. This is rooted in confusion about trade secrets and CBI, which are distinct but related concepts.

TSCA section 14(a) invokes FOIA Exemption 4 as a ceiling for protecting business information. Exemption 4 protects “trade secrets and commercial or financial information obtained from a person and privileged or confidential.” 5 U.S.C. 552(b)(4). Trade secrecy has long been held as grounds for Exemption 4 protection distinct from that for “commercial or financial information obtained from a person and privileged or confidential.” See, e.g., Public Citizen Health Research Group v. FDA, 704 F.2d 1280, 1286 (D.C. Cir. 1983).

A trade secret has been defined by the D.C. Circuit as “a secret, commercially valuable plan, formula, process, or device that is used for the making, preparing, compounding, or processing of trade commodities and that can be said to be the end product of either innovation or substantial effort.” Public Citizen at 1288. This definition also incorporates a requirement that there be a “direct relationship” between the trade secret and the productive process.

CBI is defined by 5 U.S.C. 552(b)(4) as information that is (a) commercial or financial, (b) obtained from a person, and (c) privileged or confidential. The U.S. Supreme Court has addressed the meaning of the word “confidential” in 5 U.S.C. 552(b)(4) stating that “confidential” must be given its “ordinary” meaning, which is information that is “private” or “secret.” Food Marketing Institute v. Argus Leader Media, 139 S. Ct. 2356, 2363 (2019). The Court held that at least where commercial or financial information is both customarily and actually treated as private by its owner and provided to the government under an assurance of privacy, the information is “confidential” within the meaning of FOIA Exemption 4. Food Marketing at 2366. In addition, TSCA section 14 requires the submitter to demonstrate that it has a reasonable basis to conclude that disclosure of the information is likely to cause substantial harm to the competitive position of the business.

While the trade secret standard and CBI standard could theoretically provide two avenues to protect information from disclosure, EPA is not aware of any situation where information submitted under TSCA was determined to be entitled to trade secret protection but not CBI protection. EPA does not believe that asking a specific trade secret question for TSCA confidentiality substantiations will generate useful information because of the considerable overlap between the two standards. EPA seeks comment on whether the trade secret question still has value in the context of TSCA confidentiality claims.

In order to properly evaluate the various CBI claims in a single submission, EPA needs a separate explanation from the submitter for each type of information claimed as confidential to explain why disclosure of that information would be likely to cause substantial competitive harm. To that end, EPA proposes two versions of the substantiation question concerning substantial competitive harm in this rulemaking. The first version of the question comes directly from the CDR rule, which states: “will disclosure of the information claimed as confidential likely cause substantial harm to your business's competitive position? If you answered yes, describe the substantial harmful effects that would likely result to your competitive position if the information is disclosed, including but not limited to how a competitor could use such information, and the causal relationship between the disclosure and the harmful effects.” 40 CFR 711.30(b).

The second version for consideration is in proposed section 703.5(b)(3)(i): Please specifically explain what harm to the competitive position of your business would be likely to result from the release of the information claimed as confidential. How would that harm be substantial? Why is the substantial harm to your competitive position likely ( i.e., probable) to be caused by release of the information rather than just possible? If you claimed multiple types of information to be confidential ( e.g., site information, exposure information, environmental release information, etc.), explain how disclosure of each type of information would be likely to cause substantial harm to the competitive position of your business.

The version of the question in proposed section 703.5(b)(3)(i) may enable EPA to better determine whether disclosure of the information is likely to cause substantial harm to the competitive position of the submitter. For purposes of this question, the term “substantial” means “of considerable importance.” Oxford English Dictionary (2021). “Likely” means “probable.” Oxford English Dictionary (2021). The last portion of the question is intended to help submitters explain how each type of information claimed confidential could harm the business if released. For instance, the harm to the business that could result from release of a confidential chemical identity may be different from the harm that could result from release of information concerning the number of workers exposed to the chemical during processing.

EPA requests comment from submitters and the public on which of the two proposed versions of the question would be most likely to elicit information from submitters that will best allow EPA to determine that the submitter has demonstrated a reasonable basis to conclude that disclosure of the information is likely to cause substantial harm to the competitive position of its business. EPA is also seeking comment on how “substantial” and “likelihood” should be defined.

The proposed section 703.5(b)(5) addresses the TSCA section 14(c)(2) exemptions from the substantiation requirement. This proposed provision includes criteria for the exemption in TSCA section 14(c)(2)(G) pertaining to substances that have not been offered for commercial distribution. The other proposed exemptions include:

• Specific information describing the processes used to manufacture or process a chemical ( e.g., information reported under 40 CFR 720.45(g)(2));

• Marketing and sales information (note that submitting company identifiers are not generally themselves considered marketing and sales information);

• Information identifying a supplier or customer (such as the identities of some joint submitters reporting information under 40 CFR720.40(e) or 711.15);

• Details on mixture composition and percentage (such as might be included in a TSCA section 8(e) notice of substantial risk that concerns a mixture);

• Specific chemical substance use information (such as is required to be reported under 40 CFR 720.45(f) and 725.155(g)); and

• Specific production or import volumes (such as are required to be reported under 40 CFR 711.15 and 720.45(e).

EPA expects to update the reporting forms and applications for most TSCA submissions to prompt the submitter for substantiation where required, but not to prompt the submitter for types of data the Agency has concluded are always covered by a substantiation exemption.

In proposed section 703.5(c), EPA proposes to require public copies of submissions that include confidentiality claims. The proposed rule would not require preparation of a separate public copy where the reporting form or electronic reporting application contains a specific CBI designation identifying specifically what is claimed as CBI. However, where the submission is made without the use of such a TSCA reporting form ( e.g., subpoena responses), or includes attachments or other “non-fielded” data, the submitter would be required to produce and submit a public (sanitized) copy of the submission and/or attachments. Some existing TSCA rules already include such a requirement. See, e.g., 40 CFR 720.40(d)(2) and 716.55(b). This proposed rule would consolidate existing requirements in proposed new part 703 and extend them generally.

The proposed provision would also provide that the sanitized version would have to redact only that information that is claimed as confidential. Any information not included in the sanitized version, or redacted from the sanitized version, must be subject to a confidentiality claim and as such must be substantiated as described in this unit. It further states that a public copy that redacts all or substantially all of the original submission would most likely not meet the requirements of the rule because it is unlikely that all of the information in a form or attachment can be appropriately claimed CBI. Additionally, any information not included in or redacted from a public copy is subject to the supporting statement in TSCA section 14(c)(1)(B) and the certification requirement in TSCA section 14(c)(5). False statements may give rise to criminal liability under 18 U.S.C. 1001.

TSCA section 14(c)(1)(B) requires that each claim of confidentiality be accompanied by a standard supporting statement regarding the eligibility of the information for confidential treatment. TSCA section 14(c)(5) also requires a certification that the TSCA section 14(c)(1)(B) statement and information required to substantiate the claim under TSCA section 14(c)(3) are true and correct. (See explanation in Unit III.A.2. of the preamble to the CDR rule (Ref. 7)). This supporting statement and certification language has already been incorporated in most TSCA reporting forms (example available at https://www.epa.gov/tsca-cbi/making-cbi-claims-tsca-submissions#howto ). To the extent that the submission is not being made on such a reporting form ( e.g., a subpoena response), proposed section 703.5(a) provides language that may be included in a cover letter or other attachment to a submission.

TSCA section 14(c)(1)(C) requires the submission of a generic name any time a specific chemical identity is claimed as confidential. This provision further requires that the generic name be “structurally descriptive” and that it “describe the chemical structure [. . .] as specifically as practicable” while also protecting the features of the chemical substance that are claimed confidential or where disclosure would likely cause substantial harm. 15 U.S.C. 2613(c)(1)(C)(ii). The generic name must also be consistent with the generic name guidance developed in accordance with TSCA section 14(c)(4)(A), 15 U.S.C. 2613(c)(1)(C)(i). See Refs. 8, 9 and 10. The generic name guidance document provides information to assist companies in creating structurally descriptive generic names for chemical substances whose specific chemical identities are claimed confidential, for the purposes of protecting the specific chemical identities from disclosure while describing the chemical substance as specifically as practicable, and for listing substances on the TSCA Chemical Substance Inventory. The proposed rule acknowledges that the TSCA Inventory already includes generic names for confidential substances, and that in most cases, such generic names are expected to be acceptable for the purposes of compliance with TSCA section 14(c)(1)(C) (possible exceptions may include generic names for some substances added to the TSCA Inventory prior to June 22, 2016, which would be addressed under proposed section 703.5(d)(2)).

For substances that are not on the TSCA Inventory ( e.g., new chemical submissions under TSCA sections 5 or 8(e) submissions concerning pre-market chemical substances), the proposed rule includes a few basic criteria, drawn mainly from the TSCA section 14(c)(4)(A) guidance ( e.g., the generic name should mask only the confidential portions of the specific chemical name, generally only one structural element of a specific chemical name may be masked to protect a confidential chemical identity), and would require that where the submitter believes those criteria are in some way inappropriate or inapplicable to a particular substance or generic name, the submission must also include an explanation for why more extensive masking of the specific chemical identity is necessary in the particular case.

In proposed section 703.5(d)(3), EPA is also proposing that where a generic name submitted for a substance that is not on the TSCA Inventory is acceptable for the purposes of meeting the requirements of TSCA section 14(c)(1)(C), the generic name might nonetheless be later subject to additional review and potential change when commercial manufacture of the substance is commenced ( e.g., when a Notice of Commencement (NOC) is submitted). Further procedures and requirements for review and acceptance of generic names submitted with an NOC are elaborated in proposed revisions to 40 CFR 720.102 and 725.190, As discussed in Unit II.E.5.

Finally, in proposed section 703.5(d)(4), EPA is proposing to provide an opportunity to revise proposed generic names that EPA concludes are not in compliance with 15 U.S.C. 2613(c)(1)(C). EPA would provide an electronic notice of the deficiency to the submitting company, who would then be afforded ten days to propose a revised generic name. If the submitter does not submit a compliant generic name, EPA would reject the underlying submission and may ultimately deny the CBI claim. (See discussion in Unit III.C.4. and proposed section 703.5(e) on deficient submissions.)

In proposed section 703.5(e), EPA is proposing to specify that confidentiality claims, identified for review pursuant to proposed section 703.7(a), that are missing the certification, substantiation, or generic name (where applicable) required by TSCA section 14(c) will be considered deficient. Submissions that are missing a public copy or where the public copy does not meet the requirements of proposed section 703.5(b)(6) would also be considered deficient-EPA has observed many instances where the attachments to TSCA submissions appear over-redacted ( e.g., public copies of health and safety studies or the Safety Data Sheets (SDSs) that are often provided with TSCA section 5 PMN submissions might be entirely or largely blank). This level of redaction is rarely if ever consistent with the limitations that TSCA section 14(b) places on CBI protections for health and safety information. Submissions that include a generic name that does not meet the requirements of proposed section 703.5(d) or rely on inappropriate substantiation exemption assertions would also be considered deficient.

EPA anticipates that electronic reporting requirements, coupled with modifications to new and existing reporting forms to incorporate the certification statements and prompt for substantiation and generic names, will eliminate most such deficiencies. However, to the extent TSCA submissions are occasionally still made on paper or are not made using a TSCA form for which entries can be automatically validated ( e.g., unformatted information in attachments to TSCA forms, such as health and safety study reports or SDSs), such deficiencies may still occur. EPA is proposing that when such deficiencies are identified, EPA would initially place a hold on the submission.

In such an instance, EPA would provide notice of the deficiency to the submitter and provide them with a ten (10) business day opportunity to fix the deficiency. Meanwhile, any applicable review periods for the underlying submission and for the confidentiality claim would be suspended while the hold is in place. For example, if EPA held a PMN for an inadequate public copy, both the CBI review period and the 90-day review period for the PMN would be suspended until either (1) the deficiency in the CBI claim is remedied, or (2) ten (10) business days pass without the deficiency being remedied.

If the deficiency is not remedied within ten (10) business days of EPA providing the notice of deficiency, EPA will resume the review of the submission and will likely deny the CBI claim(s).

EPA is interested in public comment on this approach to claim deficiencies, and on alternative approaches, such as strictly interpreting the requirements of TSCA section 14(c) as necessary to making a valid confidentiality claim ( i.e., claims that don't meet the requirements of TSCA section 14(c) would not be recognized, and could thereby be released to the public without prior notice to the submitter). Additionally, EPA is not proposing a time window in which the Agency may identify deficiencies, which potentially leaves open the possibility that a deficiency is identified, for example, on day 45 of the review period for the underlying submission. EPA is particularly interested in public comment on whether a time period for identifying deficiencies, e.g., between 10 to 15 business days from the date of submission, would be appropriate.

Most TSCA submissions must now be made electronically, using various reporting tools built into CISS (Chemical Information Submission System, EPA's web-based reporting tool for preparing and submitting TSCA submissions) and submitted via EPA's CDX system (Central Data Exchange, EPA's centralized electronic document reporting portal). The proposed section 703.5(f) would fill most of the current gaps in electronic reporting requirements by requiring that nearly all TSCA confidentiality claims be asserted electronically. For example, while current TSCA section 8(e) notices of substantial risk may be made either on paper or via an optional electronic reporting form, EPA is proposing that all TSCA section 8(e) notices that include a confidentiality claim would be required to be submitted electronically, using an EPA-provided reporting tool. Similarly, electronic reporting applications would be developed or updated for TSCA section 12(b) notices of export and TSCA section 5 polymer exemption notifications. Means of providing information via CDX relating to TSCA section 6 prioritization, risk evaluation, and risk management have already been made available. These new and updated reporting applications would be available by the time the new electronic reporting provisions become effective. This proposal would expand the electronic reporting requirement to all TSCA section 12(b) notices of export and TSCA section 5 polymer exemption notifications (whether or not they include confidentiality claims), thereby closing most remaining gaps in electronic reporting requirements under TSCA. A discussion on the benefits of electronic reporting under TSCA relevant to the expansion described in this proposed rule was provided in a previous document (Ref. 1). Some exceptions to the general requirement to report CBI-containing materials electronically will remain, such as for materials that EPA has subpoenaed or requested or collected in the course of a TSCA inspection, which may be collected in person, and/or in a format or volume that makes electronic submission impractical.

Closing these gaps in electronic reporting is intended to reduce the likelihood of submitter error when asserting a confidentiality claim, facilitate EPA's ability to review confidentiality claims in a timely manner, reduce resources required to process, handle, and store TSCA submissions, reduce the opportunity for errors related to the handling of CBI, facilitate public access to information not claimed as CBI, and enable or enhance EPA and TSCA submitters' ability to promptly communicate about the status of confidentiality claims in the submission in the future. EPA will enhance its current practice of assigning a document or “case” number to each TSCA submission ( e.g., P-20-0XXX or 8EHQ-2020-0XXXX) by assigning and making that submission identifier available to the submitter within the submitter's CDX account.

As stated above, EPA is proposing to require any information or materials not obtained under TSCA section 11 to be submitted through CDX if they contain a TSCA CBI claim. The Agency is requesting public comment broadly on this approach, and on whether there are scenarios the Agency should consider where a person providing TSCA CBI to EPA via an irregular means ( e.g., a letter) would not be able to or would face substantial difficulties in using CDX to submit information claimed CBI.

In proposed section 703.5(g), EPA is proposing a requirement to provide health and safety studies and information from health and safety studies in a templated format, using Organisation for Economic Co-operation and Development (OECD) Harmonized Templates, where an applicable template is available. See https://www.oecd.org/ehs/templates/harmonised-templates.htm. EPA is interested in comment on this proposed requirement. Many TSCA submitters may be familiar with and already have created templated versions of health and safety study reports they may be required to submit under TSCA, owing to reporting requirements in other countries. For these submitters, the burden associated with this requirement to submit templated data is expected to be minimal. EPA anticipates that data that has been put into one of these standardized templates will be more readily used and shared within the Agency, and (where permitted by confidentiality restrictions and other agreements) across jurisdictions. In addition, CBI clams may be more clearly indicated if asserted via a templated format ( e.g., CBI claims could be indicated by checking a box for each discrete data element, rather than by redacting sections of text piecemeal from a study report line by line). It should be noted, however, that the proposed requirement to provide data in a templated format does not supersede existing regulatory requirements to also submit a full study report, such as the present requirement for TSCA section 4 test reports.

EPA is soliciting public comment on the proposed requirement that information obtained from a study, in addition to whole study submissions, be provided in templated form to the Agency. EPA is also interested in public comments on the requirement that submitters identify the “appropriate” OECD template for a particular submission.

From time to time, EPA needs to contact a company about CBI claims made in a TSCA submission. These contacts may be made relatively soon after submission, in order to clarify something about a claim or provide an opportunity to correct a deficiency with the claim (see proposed section 703.5(e)), or they may be required notifications made months or years later, such as a notice concerning a denied confidentiality claim, or a notice concerning a pending confidentiality review under TSCA section 14(f). In the future, EPA will also need to contact or notify companies about expiring confidentiality claims, pursuant to TSCA section 14(e). For all of these reasons, it is important for EPA to have current contact information for the submitter of each TSCA submission and an efficient means for satisfying the notice requirements under the statute. EPA is proposing to require companies to maintain current contact information for all individuals associated with a submission (which reinforces and complements existing CDX terms and conditions concerning maintenance of CDX accounts, particularly the requirement to notify EPA when individual account access is no longer needed so that the account can be deactivated; see https://cdx.epa.gov/Terms ), enhance the means by which companies update contact information, and require the submission of notices of transfer of ownership via CDX.

In light of the significant resources and document tracking concerns related to continuing to largely rely on paper correspondence for such communication and notifications, the rulemaking proposes that most such correspondence would be electronic, via CDX. See proposed section 703.5(h). “Two-way” communication via CDX provides a secure means for EPA and companies to correspond about a TSCA submission or confidentiality claims. EPA can more readily assure that a communication is available to a company or specific submitter by using CDX to communicate, rather than certified mail or a courier. In CDX, EPA is able to verify that a particular communication is available to the submitter of a particular submission and is able to track the date the communication was sent. EPA believes that these facts satisfy the requirement in TSCA section 14(g)(2)(A) that notification, including for the denial of a confidentiality claim, be sent by means that “allows verification of the fact and date of receipt.” This would be the case even if EPA does not receive a “read receipt” or cannot otherwise verify that the submitter opened the electronic notice, much as EPA cannot verify whether or when a recipient of certified mail opens the envelope and reads the contents.

The proposed rule describes how EPA expects to furnish the required notices concerning expiration of confidentiality claims under TSCA section 14(e). The first expirations will occur in 2026, for claims that were asserted in 2016 and that were not exempt from substantiation and review according to TSCA sections 14(c)(2) and 14(g). As proposed, EPA would periodically publish a list of TSCA case numbers that are approaching claim expiration on the EPA website, or other appropriate platform. In addition, EPA intends to send individual notices of upcoming claim expiration and other individual notices concerning CBI claims to the company via CDX.

The proposed rule includes similar notice and communication provisions for when review of claims is initiated under TSCA section 14(f) ( e.g., in response to a FOIA request for information that has been claimed as confidential). EPA would provide any necessary notice of review and/or opportunity to substantiate or resubstantiate to the Authorized Official or Technical Contact listed on the most recent version of the submission (or as listed in a more recent notice of transfer of ownership relating to that submission), along with instructions for response. Alternatively, if the submission with the relevant CBI claim is not associated with a CDX account, EPA would send the notice via CDX to the company contact provided in the most recent TSCA submission made by that company.

For TSCA submissions that were not originally made via CDX, EPA is proposing to send the notice by certified mail or courier to the address provided in the most recent TSCA submission from that company, or via other means that allows verification of the fact and date of receipt. For example, EPA is also considering further development of two-way CDX communication to permit EPA to also send these notices, likely using the contact information in the most recent CDX submission from the same company.

TSCA confidentiality claims may be voluntarily withdrawn by the submitter at any time. See 15 U.S.C. 2613(e)(1)(A)(i) and (B)(ii)(I). Proposed section 703.5(i) includes instructions for voluntarily withdrawing confidentiality claims prior to automatic expiration or denial. The preferred approach is for the company to amend the submission electronically, via CDX, to withdraw the claims ( i.e., “uncheck” the CBI boxes or unredact the submission and resubmit it). When this is not possible (for example, when the submission was not originally submitted via CDX, or because the company does not have access to the electronic submission), claims may be withdrawn by CDX submission as well, using a new correspondence tool that enables efficient linking of the withdrawal letter with the related submission, and permits EPA to communicate with the company about the withdrawal ( e.g., if clarification is needed).

Following the denial or expiration of a confidentiality claim, the public copy of the submission must be revised to provide public access to the newly non-CBI information. For some electronic submissions this may be a more or less straightforward process of un-checking some boxes and generating a new public copy of the submission, but for other TSCA submissions, the denied or expired claims may be intermingled with still-valid or approved claims, or the claims may have been indicated by numerous redactions throughout a voluminous text. The proposed rule (see proposed section 703.5(j)) would encourage companies to prepare this updated public copy themselves. EPA believes that submitters are in the best position to assert and indicate their remaining claims accurately. However, in the case that the submitter is unavailable or otherwise unable to update the public copy, the proposed rule makes clear that EPA will undertake this function, as needed.

EPA invites comment on the option of requiring TSCA submitters to update their original submission to reflect CBI claims that have been withdrawn or denied.

TSCA section 14(g)(1)(A) requires that EPA approve or deny confidentiality claims, except for claims exempt from review under TSCA section 14(c)(2). TSCA section 14(g)(1)(C) further specifies that EPA review all confidentiality claims for chemical identity (except those exempt under TSCA section 14(c)(2)(G)) and a “representative subset” comprising at least 25% of all other claims, with the exception (as provided in TSCA section 14(g)(1)(A)) of information exempted from substantiation under TSCA section 14(c)(2).

Proposed section 703.7 would codify EPA's current practice of reviewing all claims (except those exempt from substantiation requirements under TSCA section 14(c)(2)) in every fourth submission received via CDX that contains CBI claims besides those pertaining to chemical identity.

Consistent with current practice, submissions with CBI claims not submitted through CDX would be excluded from the representative subset. As explained above, all submissions other than those submitted pursuant to TSCA section 11 will be required to be submitted through CDX (see proposed section 703.5(f)), so the Agency believes that only a small number of infrequent TSCA submissions would not be included in the total number of claims received for purposes of determining the representative subset. Moreover, these materials are not representative of TSCA submissions because they are collected irregularly, from widely spread geographic locations, may be voluminous, provided in multiple batches, be of assorted media type (photos, large maps, etc.) or exist only on paper or other physical media at the time of collection. EPA is also proposing that amendments to submissions would not be counted as new submissions for purposes of selecting the representative subset—rather, the confidentiality claim review will include amendments available at the time of review. EPA is interested in public comment concerning its selection of the representative subset, including possible alternative representative selection methods.

EPA is proposing that two additional types of submissions not be included in the representative subset as they are not representative of TSCA submissions as a whole. These include: (1) Bona fide inquiries under 40 CFR 720.25, and 721.11 and (2) TSCA section 5 prenotice communications (correspondence submitted prior to a prospective TSCA section 5 submission asking questions or requesting a meeting to discuss whether and how a prospective TSCA submission should be made). These document types are not representative of TSCA submissions as a whole. These submission types help submitters ascertain whether a TSCA submission is required in a particular situation and/or what type or format should be used to make a particular submission. Moreover, in each case in which EPA confirms that a specific TSCA submission is required, these pre-notice or bona fide submissions would be followed by the corresponding TSCA submission, which itself would be subject to selection as part of the representative subset ( e.g., a PMN or Significant New Use Notice). Conversely, where no TSCA submission is deemed necessary, the information in these documents does not relate to EPA's regulation of chemical substances under TSCA.

EPA is interested in public comment concerning the universe of claims that contribute to the representative subset and its identification of, and exclusions from, the representative subset, including possible alternatives.

EPA is proposing to revise EPA's procedures for reviewing confidentiality claims. As noted in previous EPA statements ( e.g., Ref. 6), EPA reviews confidentiality claims in accordance with the requirements in TSCA section 14 and has relied to date on the review procedures set out in 40 CFR part 2 for all TSCA CBI reviews. However, the review procedures described in 40 CFR part 2 (including TSCA-specific provisions at section 2.306), which were promulgated prior to the Lautenberg amendments, do not fully accommodate or account for the requirements in TSCA section 14, particularly the demands of the TSCA section 14(g)(1) mandatory review program. Rather than extensively update the EPA review procedures for TSCA CBI in 40 CFR part 2 to reflect the amendments to TSCA section 14, this rulemaking proposes to consolidate most of them in the proposed new part 703, consistent with the broader effort to centralize regulations on TSCA CBI.

In many respects, the procedures and substantive review criteria in proposed new part 703 mirror those in 40 CFR part 2 but include adaptations to reflect the requirements of TSCA section 14, and to facilitate the high volume, time-limited review process required to meet the requirements of TSCA sections 14(e) and 14(g). For example, the substantive criteria in 40 CFR 2.208, as referenced and modified by 40 CFR 2.306(g), would be retained, but would be somewhat modified to align with the substantial competitive harm language in TSCA section 14. (The other criteria include that the CBI claim has not expired, been waived, or withdrawn; that the business protects the confidentiality of the information; and that no statute prohibits confidential protection.)

The criteria would also be revised to clarify that whether a substance may be readily reverse engineered is among the factors EPA considers as part of the criterion on whether the CBI-claimed information is legitimately and reasonably obtainable without the business's consent. Alternatively, the Agency could consider whether a substance may be readily reverse engineered as a stand-alone criterion. The Agency requests comment on how this reverse engineering component should be incorporated into the Agency's substantive review criteria in proposed section 703.7(f), either as a stand-alone review criterion or as part of the existing criterion. The substantive review criteria in proposed section 703.7(f) will establish the Agency's standard of review for all TSCA CBI claims. For each claim to be approved, submitters' substantiations would be required to adequately address all of the criteria set forth in proposed section 703.7(f). Accordingly, the Agency would then be able to deny TSCA CBI claims for failure to address any one of the proposed criteria in the substantiation.

The requirement in 40 CFR 2.306(e)(1) that EPA's Office of General Counsel (OGC) make most final confidentiality determinations would no longer be required by regulation under the proposed new part 703; rather, final determinations may be made by OGC or other EPA offices ( e.g., the EPA Office of Pollution Prevention and Toxics), as designated by the General Counsel. Regardless of which office within EPA issues a given final determination, EPA expects to continue to publish final CBI determinations on its website.

EPA also proposes, in proposed section 703.7(g), to add a means to request reconsideration by OGC of determinations denying confidential treatment. Reconsideration would be available during the 30-day notice and appeal period prior to disclosure of the information. This mechanism is intended to permit parties to identify any EPA errors in the determination prior to the point that the information is disclosed, and without immediately proceeding to judicial review of the decision. If a request for reconsideration is timely received, EPA will suspend the 30-day notice period described in proposed section 703.7(e) while OGC reconsiders the Agency's determination. OGC will review the submission de novo and will only consider the submission record as it existed for the final determination. EPA requests comment on this reconsideration approach and the suspension of the 30-day notice period.

The proposed rule sets forth review procedures to apply to CBI reviews initiated under TSCA section 14(g)(1) (including reviewing requests for extension under TSCA section 14(e)) as well as some additional procedures to implement CBI reviews initiated under TSCA section 14(f). In proposed section 703.7(b)(2), EPA proposes to permit submitters requesting extension of confidentiality protections under TSCA section 14(e) to either submit new substantiation or rely on substantiation that was provided with the initial submission, certifying that the substantiation remains true and correct.

In proposed section 703.8, EPA proposes similar procedures for reviews initiated under TSCA section 14(f) as for those under TSCA section 14(g), though the notice and resubstantiation provisions necessarily vary to reflect the fact that the review of different claims may be triggered by TSCA section 14(f) versus TSCA section 14(g). The proposed rule also clarifies that EPA is not required to review claims as designated in TSCA section 14(f)(1) (claims concerning active or TSCA section 6(b) high-priority substances or where disclosure would assist EPA in conducting a risk evaluation under TSCA section 6); rather, reviews of such claims are discretionary.

The proposed rule also elaborates on the timing and scope of review in proposed section 703.7(c). For the purposes of TSCA section 14(g), the proposed rule specifies that the 90-day review period begins on the day EPA accepts a new TSCA submission that includes confidentiality claims (TSCA submissions under TSCA section 5 must clear a brief “pre-screen” review for basic completeness to ensure consistency with requirements in 40 CFR part 720, which is usually complete within a few days of submission; following that review, the submission is considered “accepted”), and that amendments to non-chemical identity information in the submission will be considered in the confidentiality review for that submission up to 60 days after the original submission date. (New confidentiality claims concerning chemical identity would be reviewed within 90 days of EPA accepting the submission or amendment including the new chemical identity claim.) The date that the submission is considered “accepted” will be used to calculate the 10-year sunset period for purposes of TSCA section 14(e). “Accepted” is defined in the proposed section 703.3.

EPA notes that some submission types are often amended one or more times after submission ( e.g., new chemical-related submissions under TSCA section 5) as new information is developed, or as requested by EPA. In order to meet the 90-day statutory review deadline, EPA believes it is important that submissions be complete, at least procedurally, prior to starting review, and notes that there is a point in the 90-day period past which significant amendments to the submission and related claims would be difficult or impossible to consider while still meeting the statutory review deadline.

EPA has considered some alternatives in developing this proposed rule, including either resetting the 90-day clock every time an amendment is received, or not commencing confidentiality claim review at all until some period of time after initial submission, to allow for a majority of amendments to be made prior to beginning the confidentiality review. In the first case, EPA identified that resetting the 90-day clock with each amendment would likely require a lot of duplicative effort. EPA also anticipates that either of these options would often delay confidentiality determinations considerably, especially for new chemical submissions, in which public interest has been heightened in recent years. EPA invites public comment on the proposed approach described in proposed section 703.7(c), as well as these and other alternatives.

In the preamble of the 2020 final rule on CDR (Ref. 7), EPA noted that the Agency did not view the Supreme Court's decision in Food Marketing Institute v. Argus Leader Media, 139 S. Ct. 2356, 2363 (2019) as necessitating the Agency to remove the “substantial competitive harm” substantiation question for TSCA CBI claims. See also Ref. 11. Congress amended TSCA section 14 in 2016 to, among other things, specifically require any person asserting a CBI claim under TSCA to include a certified statement that the person has “a reasonable basis to conclude that disclosure of the information is likely to cause substantial harm to the competitive position of the person.” TSCA section 14(c)(1)(B)(iii) and (c)(5); see also TSCA section 14(c)(1)(C)(ii)(II) (referencing substantial competitive harm). For each claim, the Agency's review will determine whether the business has made a satisfactory showing that it has a reasonable basis to conclude that disclosure of the information is likely to cause substantial harm to the competitive position of the business.

The proposed rule clarifies that the Agency requires the certification statement on substantial competitive harm and considers substantial competitive harm as part of its substantive review criteria for TSCA CBI claims.

The proposed rule also elaborates on the limitations on confidentiality protections for health and safety information described in TSCA section 14(b). TSCA section 14(b)(2), which denies confidentiality protection to health and safety studies and information from health and safety studies, excludes from its coverage certain categories of information in health and safety studies, such as formulas. In addition, existing regulations allow withholding of specified information beyond that provided in TSCA section 14(b)(2). See, e.g., 40 CFR 720.90(3) (allowing withholding of “[i]nformation which is not in any way related to the effects of a substance on human health or the environment, such as the name of the submitting company, cost or other financial data, product development or marketing plans, and advertising plans”). However, the applicable regulations are not uniform in this respect; nor has the statutory basis for these provisions (which itself has changed under the Lautenberg amendments) been previously enunciated by EPA. The Agency is proposing here to systematize these provisions, generally allowing CBI claims for very limited categories of information contained within a health and safety study.

While such ancillary information may be contained in a study document submitted under TSCA, EPA does not consider such information to be part of a “health and safety study” as defined in TSCA section 3(8). That definition states that the term `health and safety study' means any study of any effect of a chemical substance or mixture on health or the environment or on both, including underlying information and epidemiological studies, studies of occupational exposure to a chemical substance or mixture, toxicological, clinical, and ecological studies of a chemical substance or mixture, and any test performed pursuant to this chapter. This definition does not seek to provide an exclusive list of what is or is not “included” in the health and safety study but instead clarifies that all “underlying” information must be considered part of the study. The term “underlying” is an adjective “used to describe something on which something else is based.” Cambridge Dictionary (Online). A study report may contain information beyond that which is the basis for the study. Information such as the names of lab technicians neither form the basis for the study nor are relevant to the study results.

Additionally, TSCA section 14(b)(1) provides that information that is protected from disclosure under this section, and which is mixed with information that is not protected from disclosure under this section, does not lose its protection from disclosure notwithstanding that it is mixed with information that is not protected from disclosure. TSCA section 14(b)(1) is consistent with the interpretation that a study report can contain information not included within the definition of a “health and safety study” under TSCA section 3(8) and adopting such an interpretation gives effect to TSCA section 14(b)(1).

EPA is therefore proposing a definition of “health and safety study” (for purposes of this proposed rule) in proposed section 703.3 that specifies types of information that are not within the scope of TSCA section 3(8):

• Name of the submitting company;

• Name of the laboratory;

• Internal product codes;

• Names of laboratory personnel;

• Names and other private information included in study data or reports;

• Cost or other financial data; and

• Product development, advertising, or marketing plans.

The Agency is requesting comment on the underlying interpretation and this list.

This proposed rule would clarify these existing provisions and make them uniform for all TSCA submissions. EPA invites comment on the proposed examples of information that might be in a study, but nonetheless permissible to withhold as confidential, should the information otherwise meet the confidentiality criteria in TSCA section 14.

In addition to proposing a new confidentiality claim section of the TSCA rules, the proposed rule would revise confidentiality provisions in existing rules. In some cases, the proposed revisions would replace existing provisions with a cross reference to the proposed new part 703. In others, more specific and extensive revision is proposed.

EPA is proposing to revise the following provisions to reference the general CBI provisions in the proposed new part 703:

• 40 CFR 702.37(d), the confidentiality provisions for manufacturer requests for risk evaluations;

• 40 CFR 704.7, the confidentiality provision for TSCA section 8(a) rules;

• 40 CFR 707.75(d), the confidentiality provision of rules concerning TSCA section 12(b) notices of export;

• 40 CFR 716.55, the confidentiality provisions for TSCA section 8(d) reporting rules;

• 40 CFR 717.19, the confidentiality provision for TSCA section 8(c) recordkeeping and reporting rules;

• 40 CFR 723.50(l) and 723.250 (f), the confidentiality provision for certain exemption requests under TSCA section 5 (low volume exemption and low releases and low exposures exemption); and

• 40 CFR part 790, the confidentiality provision of rules concerning TSCA section 4 test rules, orders, and agreements.

EPA is proposing to revise the provision concerning the contents of TSCA section 12(b) notices of export, 40 CFR 707.67(a), by adding a sentence to provide that in most cases, a confidential specific chemical identity need not be included in the notice (the primary exception would be in the case where the substance to be reported under TSCA section 12(b) is claimed as confidential but does not have a TSCA accession number). Instead, the TSCA section 12(b) notice of export may identify the substance by the generic name and accession number that appeared in the TSCA section 4, 5, 6, or 7 action that triggered the TSCA section 12(b) reporting requirement. EPA anticipates that with this change, TSCA section 12(b) submitters would submit fewer confidentiality claims for specific chemical identity, which in almost all cases is unnecessary to report under the existing TSCA section 12(b) rules.

EPA proposes to modify 40 CFR 717.17 and 723.250(f) to reflect the proposed new electronic reporting requirement discussed in Unit II.C.5.

EPA is proposing to simplify and replace many of the confidentiality provisions in 40 CFR part 720, subpart E with a cross reference to the general confidentiality provisions in proposed new part 703. The general provisions on confidentiality in PMNs, 40 CFR 720.80, is proposed to be replaced with this cross reference. Requirements in 40 CFR 720.85 and 720.90 are proposed to be deleted, with portions moved to 40 CFR part 720, subpart F, the provisions concerning NOCs.

The existing provisions concerning chemical identity claims in PMNs and in health and safety studies would be covered in the proposed new part 703. In addition, TSCA section 14(c)(2)(G) created an exemption from the substantiation requirement for confidentiality claims for chemical identity when identity information is submitted before substance is offered for commercial distribution. The CBI claim review provisions of TSCA section 14(g) exclude these exempt claims from routine EPA review requirements, diminishing the need to elaborate on requirements for asserting and maintaining such claims in the PMN rules.

Relatedly, a confidentiality claim review process in existing 40 CFR 720.90, whereby claims that were made in health and safety studies in the PMN are revisited at the NOC stage, is a poor fit with new TSCA section 14(g) requirements that confidentiality claims be reviewed within 90 days of receipt, or in accordance with the discretionary or mandatory provisions of TSCA section 14(f). In practice, PMNs and NOCs (the latter of which may be submitted many months or years after the corresponding PMN, if at all) are treated by EPA as separate submissions for the purposes of routine CBI review. At the PMN stage, chemical identity claims, including claims made in health and safety studies, are generally exempt from review, per the exemptions from substantiation and review set out in TSCA sections 14(c) and (g). NOCs, on the other hand, do not include health and safety information. With the proposed deletion of 40 CFR 720.90, the review of confidentiality claims in NOC submissions would be limited to the information included in the NOC submission—principally chemical identity and submitting company information. Claims that were made in the PMN submission may be revisited at a later time, in accordance with either mandatory or discretionary review provisions in TSCA section 14(f).

The proposed rule leaves much of 40 CFR part 720, subpart F, intact, but reorganizes some provisions that concern specific chemical identity claims in or following submission of an NOC. These provisions are presently in subpart E and would move to subpart F. Additionally, the proposed revisions would update and clarify NOC reporting instructions in 40 CFR 720.102(c)(2), concerning the assertion and substantiation of confidentiality claims throughout the NOC reporting form. The existing rule only reflects the substantiation requirements that pre-dated the Lautenberg amendments, which were limited to specific chemical identity confidentiality claims, and do not reflect the newer generic name and certification requirements in TSCA section 14(c).

Revisions include adding a new paragraph (e) in 40 CFR 720.102, the substance of which is currently in 40 CFR 720.85(b)(3), concerning requirements that apply when asserting a confidentiality claim for chemical identity in the period after commencing commercial manufacture. Additionally, there is a cross-reference to the requirements of proposed new part 703, which, among other things, would replace the list of substantiation questions currently in 40 CFR 720.85 (which under existing rules, only apply to chemical identity claims in NOCs).

Finally, the proposed revisions to 40 CFR 720.102 would include a new paragraph (f), concerning generic names. These provisions are intended to be consistent with generic name provisions in proposed new part 703, but include some additional provisions specific to the submission and review of generic names for the purposes of listing on the TSCA Inventory, including additional procedures intended to aid the prompt negotiation by the submitter and EPA of more difficult generic names (which are themselves based in part on procedures presently in 40 CFR 720.85), and a provision that NOCs will be temporarily held in situations where the submitter has not provided an acceptable generic name despite the negotiation. If the submission is not corrected, EPA would proceed with review of the CBI claim for chemical identity and would likely deny the claim. EPA invites comments on these and other possible approaches to efficiently developing an acceptable generic name for purposes of listing on the TSCA Inventory.

EPA is proposing to replace much of the confidentiality provisions currently in 40 CFR part 725, subpart C, with a new, simplified subpart C, which largely relies on a cross-reference to the proposed new general confidentiality provisions to be placed in proposed new part 703. The proposed amendments would remove current provisions that are inconsistent with the Lautenberg amendments, such as existing requirements to provide upfront substantiation of organism identity confidentiality claims prior to the commencement of commercial manufacture. The proposed rule also proposes some adjustments to the general confidentiality provisions in proposed new part 703 when they are applied to genetically modified microorganisms and other products of biotechnology covered by 40 CFR part 725. These include some adjustments to the substantiation questions to reflect some practical differences between these products and other types of TSCA chemical substances.

The proposed rule also includes proposed revisions to 40 CFR 725.190, concerning NOCs, that are similar to the proposed revisions to the parallel conventional chemical NOC provisions in 40 CFR 720.102, including some elaboration on what must be included in a generic name. As in the case with NOCs relating to PMNs, EPA proposes to update 40 CFR 725.190 to be generally consistent with generic name provisions in proposed new part 703, but with some additional provisions specific to the review of generic names for the purposes of listing on the TSCA Inventory, including additional procedures intended to aid the prompt negotiation of more difficult generic names, and a provision that NOCs will be held in situations where the submitter has not provided an acceptable generic name despite the negotiation (and that such deficiencies, if not promptly corrected, may result in denial of the claim). EPA invites comments on these and other possible approaches to efficiently developing an acceptable generic name for purposes of listing on the TSCA Inventory.

This action proposes a significant number of new and revised CBI provisions to be included in proposed new part 703 and proposes to revise confidentiality provisions in other existing regulatory provisions to cross reference the proposed new part 703. EPA recognizes that during the pendency of this rulemaking process, EPA is developing other rulemakings that may address confidentiality provisions. For example, EPA is developing a proposed rule regarding asbestos reporting under TSCA section 8(a). Until this CBI rule is finalized, however, additional regulations proposed or finalized need to refer to the existing CBI regulations, rather than to the new and revised CBI provisions addressed in this rulemaking. EPA requests comment on options for harmonizing such provisions. Specifically, EPA requests comment on using this action to make any needed conforming amendments, e.g., adding cross references to the new and revised CBI provisions proposed here to any CBI provisions finalized during the pendency of this action including any CBI provisions finalized in the asbestos TSCA section 8(a) rule.

EPA is seeking public comment on all aspects of this proposed rule and the Economic Analysis prepared in support of this proposed rule (Ref. 2). In addition to specific requests for comment included throughout this document, EPA is interested in comments pertaining to specific issues discussed in this unit. EPA encourages all interested persons to submit comments on the issues identified in this proposed rule 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 rulemaking. EPA requests that commenters making specific recommendations include supporting documentation where appropriate. EPA invites specific comment on:

• EPA's interpretation of the coverage of TSCA section 14(a) (proposed section 703.1), and how this may impact submitters of information to the Agency under other statutes, such as FIFRA. EPA is particularly interested in comments on the treatment of FIFRA studies on inert ingredients under TSCA section 14(b)(2).

• The applicability of the proposed new or revised requirements to submissions received before the effective date of the subsequent final rule. Specifically, EPA requests comment on whether each proposed new or revised requirement should apply only to submissions received on or after the effective date of the final rule; to all submissions received on or after the effective date of the Lautenberg amendments; or to all submissions regardless of submission date.

• The proposed substantiation questions (proposed section 703.5(b)), especially the proposal to omit a trade secrets-specific question; on how the patents question might be modified to elicit more pertinent information; and comment on the alternative substantial competitive harm question.

• The proposed list of information that might be included with health and safety information, but that might be permissible to withhold as confidential (proposed section 703.5(b)(6)). EPA is also interested in comment on alternatives to the proposal that might better assure that health and safety information is not inappropriately treated as confidential.

• The proposed approach to CBI claim deficiencies (proposed section 703.5(e)) and on alternative approaches.

• Whether submitting templated data should be required (proposed section 703.5(g)).

• The option of requiring TSCA submitters to update their original submission to reflect CBI claims that have been withdrawn or denied (proposed section 703.5(j)).

• Selection of the representative subset, including possible alternative representative selection methods (proposed section 703.7).

• Whether bona fide or pre-notice inquiries or correspondence should be considered part of a representative subset of TSCA submissions (proposed section 703.7).

• On the proposed approach to determining when a TSCA section 14(g) CBI review period begins and how amendments to the submission are included in the review (proposed section 703.7).

• The proposed and alternative possible approaches to efficiently developing an acceptable generic name for purposes of listing on the TSCA Inventory, as described in proposed sections 720.102 and 725.190.

• On how to incorporate whether a substance may be readily reverse engineered into the Agency's substantive review criteria in proposed section 703.7(f).

The following is a list 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 http://www2.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 Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011). EPA prepared an analysis of the estimated costs and benefits associated with this action (Ref. 2), which is available in the docket and is summarized in Unit I.D. Any changes made in response to OMB recommendations have been documented in the docket for this action as required by section 6(a)(3)(E) of Executive Order 12866.

The information collection activities in this proposed rule have been submitted for approval to OMB under the PRA, 44 U.S.C. 3501 et seq. The Information Collection Request (ICR) document that EPA prepared has been assigned EPA ICR No. 2706.01 (Ref. 12). You can find a copy of the ICR in the docket for this action, and it is briefly summarized here.

The reporting requirements identified in this proposed rule implement statutory requirements in TSCA section 14, including new requirements that persons submitting information under TSCA must substantiate most confidentiality claims at the time of submission, as well as additional certification and generic name requirements. In order to maintain most claims beyond a 10-year period, submitters will also be required to reassert and substantiate those claims. Several new requirements also apply to EPA, including requirements to review and approve or deny all chemical identity claims asserted concerning substances that are offered for commercial distribution, as well a subset of all other confidentiality claims, within 90 days of the claim being asserted. Further requirements that EPA review all confidentiality claims concerning substances listed as active on the TSCA Inventory, a requirement to assign and apply unique identifiers (UIDs) to substances with approved confidentiality claims for chemical identity, as well as new provisions providing expanded access to TSCA Confidential Business Information (CBI), have been discussed in previous Federal Register documents. Additionally, TSCA rules promulgated since the Lautenberg amendments have included confidentiality provisions conforming to the amendments ( e.g., 40 CFR parts 710 and 711).

Respondents/affected entities: Firms asserting claims for confidentiality in submissions to EPA under TSCA.

Respondent's obligation to respond: Required to obtain or retain a benefit. TSCA section 14; 15 U.S.C. 2613.

Estimated number of respondents: 1,100 firms with an estimated additional 55 new firms each year.

Frequency of response: On occasion.

Total estimated burden: 2,945 hours paperwork burden in the first year and 523 hours in each following year. Burden is defined at 5 CFR 1320.3(b).

Total estimated cost: $ 270,783 in the first year and $ 44,605 in each following year (2020$), and an estimated cost of $ 0 for non-burden hour paperwork costs, e.g., capital investment or maintenance and operational 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 for EPA's regulations in title 40 of the CFR, after appearing in the Federal Register , are listed in 40 CFR part 9, and displayed on the information collection instruments ( e.g., forms, instructions).

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 https://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 13, 2022. The EPA will respond to 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 chemical manufacturers (including importers). EPA estimates that 1,096 small firms would be affected by the proposed requirements. Of those small firms, 100% would have cost impacts of less than 1% of annual revenues, which EPA has determined does not qualify as a significant impact. Details of this analysis are presented in the Economic Analysis of the proposed rule (Ref. 2), which is available in the docket.

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 4, 1999). It will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government.

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.

The EPA interprets Executive Order 13045 (62 FR 19885, April 23, 1997) as applying only to those regulatory actions that concern environmental health or safety risks that the EPA has reason to believe may disproportionately affect children, per the definition of “covered regulatory action” in section 2-202 of the Executive Order. This action is not subject to Executive Order 13045 because it 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.” The action is predicted to reduce energy use and is not expected to reduce energy supply or increase energy prices.

This proposed action does not involve any technical standards as specified in NTTAA section 12(d), 15 U.S.C. 272 note.

The EPA believes that this action does not have disproportionately high and adverse human health or environmental effects on minority populations, low-income populations and/or indigenous peoples, as specified in Executive Order 12898 (59 FR 7629, February 16, 1994).

Therefore, for the reasons stated in the preamble, it is proposed that 40 CFR chapter I be amended as follows:

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

Table 1 lists the rule addressed by this proposal with the dates that it was adopted and submitted by the California Air Resources Board (CARB).

The submission also contains a staff report evaluating the Oil and Gas Methane Rule against the Federal RACT standard, and concluding that the Oil and Gas Methane Rule, in combination with applicable SIP-approved local air district rules, meets the RACT requirement for 2008 and 2015 ozone National Ambient Air Quality Standards (NAAQS) for sources covered by the EPA's 2016 Control Techniques Guidelines for the Oil and Natural Gas Industry for SMAQMD, SJVAPCD, SCAQMD, 1 VCAPCD, and YSAQMD. On June 11, 2019, the submittal for the Oil and Gas Methane Rule was deemed by operation of law to meet the completeness criteria in 40 CFR part 51 Appendix V, which must be met before formal EPA review.

There are no previous versions of the Oil and Gas Methane Rule in the California SIP.

Emissions of VOCs contribute to the production of ground-level ozone, smog and particulate matter (PM), which harm human health and the environment. Section 110(a) of the CAA requires states to submit regulations that control VOC emissions. The Oil and Gas Methane Rule establishes methane emission standards for crude oil and natural gas facilities in furtherance of the California Global Warming Solutions Act (AB 32, as codified in sections 38500-38599 of the Health and Safety Code). Because many of the methane controls in the Oil and Gas Methane Rule also reduce VOC emissions, the Oil and Gas Methane Rule was submitted into the California SIP as a rule that controls VOC emissions. The EPA's technical support document (TSD) has more information about this rule.

Rules in the SIP must be enforceable (see CAA section 110(a)(2)), must not interfere with applicable requirements concerning attainment and reasonable further progress or other CAA requirements (see CAA section 110(l)), and must not modify certain SIP control requirements in nonattainment areas without ensuring equivalent or greater emissions reductions (see CAA section 193).

Generally, SIP rules must require reasonably available control technology (RACT) for each category of sources covered by a Control Techniques Guidelines (CTG) document as well as each major source of VOCs in ozone nonattainment areas classified as Moderate or above (see CAA section 182(b)(2)). Five California air districts contain nonattainment areas classified as Moderate or above for the 2008 or 2015 ozone NAAQS, and contain operations covered by the Oil and Gas CTG: SMAQMD, SJVAPCD, SCAQMD, VCAPCD, and YSAQMD. 2 We refer to these districts collectively as “applicable local air districts.” The Oil and Gas Methane Rule applies statewide, including within the applicable local air districts. Therefore, this rule must implement RACT.

Guidance and policy documents that we used to evaluate enforceability, revision/relaxation, and rule stringency requirements for the applicable criteria pollutants include the following:

The Oil and Gas Methane Rule improves the SIP by establishing emission limits and by clarifying monitoring, recording and recordkeeping provisions. The rule is largely consistent with CAA requirements and relevant guidance regarding enforceability, RACT and SIP revisions. However, the Oil and Gas Methane Rule contains a number of deficiencies that preclude full approval. The rule provisions that do not meet the evaluation criteria are summarized below and discussed further in the TSD.

The Oil and Gas Methane Rule contains several provisions that do not meet the enforceability or stringency criteria. These provisions do not satisfy the requirements of section 110 and part D of title I of the Act and prevent full approval of the SIP revision. Key issues include insufficiently bounded director's discretion, lack of clearly specified test methods for some categories of emission sources, undefined terms, references to undefined district rules, insufficient reporting and recordkeeping, and a lack of initial and continuous compliance requirements for some categories of emission sources. Additionally, the rule may not capture all storage tanks in the oil and gas sector in the applicable local air districts that are required to meet RACT; the rule allows delay of leak repairs in several sections; and there are several exemptions in the rule that may reduce the rule's stringency. The TSD includes in-depth descriptions of the rule deficiencies.

In addition, the RACT demonstration for the applicable local air districts relies on both the Oil and Gas Methane Rule, and the SIP-approved local rules regulating sources covered by the Oil and Gas CTG. Some of these rules contain deficiencies that would preclude approval of the RACT demonstration for these districts, even if the deficiencies in the Oil and Gas Methane Rule were rectified. These deficiencies are identified and discussed in the TSD.

The TSD includes recommendations for the next time CARB modifies the rule.

As authorized in section 110(k)(3) of the Act, the EPA is proposing a limited approval and limited disapproval of the submitted rule. Even though the rule has deficiencies, the EPA concludes that the Oil and Gas Methane Rule would substantially strengthen the SIP. The limited disapproval for the Oil and Gas Methane Rule is based on the enforceability and stringency issues identified in section II.C. of this notice and described in detail in the TSD.

In addition, as authorized in section 110(k)(3) of the Act, the EPA is proposing a disapproval of the RACT demonstrations for the 2008 and 2015 ozone National Ambient Air Quality Standards (NAAQS) for sources covered by the Oil and Gas CTG for SMAQMD, SJVAPCD, SCAQMD, VCAPCD, and YSAQMD.

We will accept comments from the public on this proposal until June 13, 2022. If finalized, this action would incorporate the submitted rule into the SIP, including those provisions identified as deficient. If we finalize this disapproval, CAA section 110(c) would require the EPA to promulgate a Federal implementation plan within 24 months unless we approve subsequent SIP revisions that correct the deficiencies identified in the final disapproval.

In addition, final disapproval would trigger the offset sanction in CAA section 179(b)(2) 18 months after the effective date of a final disapproval, and the highway funding sanction in CAA section 179(b)(1) six months after the offset sanction is imposed. A sanction will not be imposed if the EPA determines that a subsequent SIP submission corrects the deficiencies identified in our final action before the applicable deadline. The EPA intends to work with the CARB and the applicable local air districts to correct the deficiencies in a timely manner.

Note that the submitted rule has been adopted by CARB, and the EPA's final limited disapproval would not prevent the State from enforcing it. The limited disapproval also would not prevent any portion of the rule from being incorporated by reference into the federally enforceable SIP as discussed in a July 9, 1992 EPA memo found at: https://www.epa.gov/sites/production/files/2015-07/documents/procsip.pdf.

In this rulemaking, the EPA is proposing to include in a final EPA rule regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, the EPA is proposing to incorporate by reference the CARB rule listed in Table 1 and discussed in Section I of this preamble. The EPA has made, and will continue to make, these materials available through https://www.regulations.gov and at the EPA Region IX Office (please contact the person identified in the FOR FURTHER INFORMATION CONTACT section of this preamble for more information).

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

This action does not impose an information collection burden under the PRA because this action does not impose additional requirements beyond those imposed by state law.

I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA. This action will not impose any requirements on small entities beyond those imposed by state law.

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

This action does not have federalism implications. It will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government.

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

The EPA interprets Executive Order 13045 as applying only to those regulatory actions that concern environmental health or safety risks that the EPA has reason to believe may disproportionately affect children, per the definition of “covered regulatory action” in section 2-202 of the Executive order. This action is not subject to Executive Order 13045 because it does not impose additional requirements beyond those imposed by state law.

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

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

The EPA lacks the discretionary authority to address environmental justice in this rulemaking.

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

Table 1 lists the rules addressed by this proposal with the dates when they were amended by the District and submitted by the California Air Resources Board (CARB). These rules constitute part of the District's current program for preconstruction review and permitting of new or modified stationary sources under its jurisdiction. The rule revisions that are the subject of this action represent an update to the SDAPCD's preconstruction review and permitting program and are intended to satisfy the requirements under part D of title I of the Act (“Nonattainment NSR” or “NNSR”) as well as the general preconstruction review requirements under section 110(a)(2)(C) of the Act (“Minor NSR”).

On March 21, 2021, the submittal of Rule 11 became complete by operation of law. On March 28, 2022, the EPA determined that the February 2, 2022 submittal of revised Rules 20.1, 20.3, and 20.4 met the completeness criteria in 40 CFR part 51, appendix V, which must be met before formal EPA review.

The SIP-approved versions of the submitted rules are identified below in Table 2.

If the EPA finalizes the action proposed herein, these rules will be replaced in the SIP by the submitted set of rules listed in Table 1. Additionally, as described below, the EPA's final approval of Rule 20.1 will address our previous limited disapproval.

As described in further detail below, the submitted rules are intended to resolve the NSR program deficiency we identified in our September 16, 2020 final action (“2020 NSR Action”), 1 which included a limited disapproval of a prior version of Rule 20.1. In addition, the submitted rules are intended to demonstrate that the District's NNSR program meets the requirements applicable to San Diego County following the EPA's June 2, 2021 reclassification of San Diego County as a Severe nonattainment area for the 2008 and 2015 ozone national ambient air quality standards (NAAQS). 2 Other minor revisions in the rules revise some permit exemptions, provide minor edits, and address recent changes to regulatory requirements related to interpollutant trading (IPT) of offsets.

The EPA has evaluated the submitted rules to determine whether they address the deficiency identified in our 2020 NSR Action. We have also evaluated the rules for compliance with applicable regulations at 40 CFR 51.160 through 51.165, consistent with the District's current classification as a Severe nonattainment area for both the 2008 and 2015 ozone standards, and including the recent removal of provisions related to IPT of offsets made in response to the D.C. Circuit Court of Appeals decision in Sierra Club v. EPA, 21 F.4th 815 (2021). 3 We have also reviewed the rules for consistency with other CAA general requirements for SIP submittals, including requirements at section 110(a)(2)(A) regarding rule enforceability, and requirements at sections 110(l) and 193 for SIP revisions.

The implementing regulations at 40 CFR 51.165 contain the NNSR program requirements for major stationary sources and major modifications at facilities that are located in a nonattainment area and that are major sources for the pollutants for which the area has been designated nonattainment. Section 110(a)(2)(A) of the Act requires that regulations submitted to the EPA for SIP approval must be clear and legally enforceable. Section 110(l) of the Act prohibits the EPA from approving SIP revisions that would interfere with any applicable requirement concerning attainment and reasonable further progress (RFP) or any other applicable requirement of the CAA. Section 193 of the Act prohibits the modification of a SIP-approved control requirement in effect before November 15, 1990, in a nonattainment area, unless the modification ensures equivalent or greater emission reductions of the relevant pollutant(s). With respect to procedures, CAA sections 110(a) and 110(l) require that a state conduct reasonable notice and hearing before adopting a SIP revision.

The EPA finds that the submitted rules satisfy the applicable CAA and regulatory requirements. Below, we discuss generally our evaluation of the submitted rules. The technical support document (TSD) for this proposed rulemaking contains a more detailed analysis and is included in the docket for this action.

We find that the revision to Rule 20.1 Section (a) to remove the sentence that was the basis for the deficiency identified in our 2020 NSR Action corrects this deficiency. We find that the submitted rules satisfy the applicable NNSR requirements for both the 2008 and 2015 ozone NAAQS, in that the rules contain the proper major source and major modification thresholds and offset ratio for a Severe ozone nonattainment area. We find that the revisions to Rule 11, “Exemptions,” are approvable as the emissions from new and revised permit exemptions are inconsequential to attainment or maintenance of the NAAQS, considering local air quality concerns, and as the changes to the rule are otherwise acceptable. We find that the removal of IPT provisions from Rules 20.3 and 20.4 is consistent with the EPA's recent changes to 40 CFR 51.165(a)(11) addressing the Sierra Club decision and are therefore approvable. Finally, we find that the other minor non-substantive edits to the rules are approvable.

The submitted rules comply with the substantive and procedural requirements of CAA section 110(l). With respect to the procedural requirements, based on our review of the public process documentation included with the submitted rules, we find that the SDAPCD has provided sufficient evidence of public notice and opportunity for comment and public hearings prior to submittal of this SIP revision and has satisfied these procedural requirements under CAA section 110(l).

With respect to the substantive requirements of CAA section 110(l), we have determined that our approval of the submitted rules would not interfere with the area's ability to attain or maintain the NAAQS or with any other applicable requirements of the CAA. Similarly, we find that the submitted rules are approvable under section 193 of the Act because they do not modify any control requirement in effect before November 15, 1990, without ensuring equivalent or greater emission reductions. The submitted rules are otherwise consistent with criteria for the EPA's approval of regulations submitted for inclusion in the SIP, including the requirement at CAA section 110(c)(2)(A) that submitted regulations be clear and legally enforceable.

For the reasons stated above and explained further in our TSD, we find that the submitted NSR rules satisfy the applicable CAA and regulatory requirements for NNSR permit programs under CAA section 110(a)(2)(A) and part D of title I of the Act and other applicable requirements. This submittal also corrects the deficiency described in our 2020 NSR Action. If we finalize this action as proposed, our action will resolve the limited disapproval of Rule 20.1 and will be codified through revisions to 40 CFR 52.220 (Identification of plan—in part). Elsewhere in this issue of the Federal Register , we are making an interim final determination that will defer the imposition of sanctions triggered by that limited disapproval.

As authorized in section 110(k)(3) of the Act, the EPA is proposing approval of Rules 11, 20.1, 20.3, and 20.4. We are proposing this action based on our determination that the submitted rules satisfy the applicable statutory and regulatory provisions governing regulation of stationary sources under part D of title I of the Act and accompanying regulations at 40 CFR 51.160 through 51.165. In support of our proposed action, we have concluded that our approval would comply with sections 110(l) and 193 of the Act because the amended rules will not interfere with continued attainment of the NAAQS in San Diego County and do not relax control technology and offset requirements.

This action would also revise the regulatory provisions at 40 CFR 52.281(d) concerning the applicability of the visibility Federal implementation plan (FIP) at 40 CFR 52.28 as it pertains to California, to provide that this FIP does not apply to sources subject to review under the District's SIP-approved NNSR program. As described in more detail in the TSD for this action, the EPA has previously found Subsection (e)(3) of District Rule 20.3 acceptable to meet the visibility provisions for sources subject to the NNSR program at 40 CFR 51.307. 4

We will accept comments from the public on this proposal until June 13, 2022. If finalized, this action would incorporate the submitted rules into the SIP and our action would be codified through revisions to 40 CFR 52.220, “Identification of plan—in part.”

In this rule, the EPA is proposing to include in a final EPA rule regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, the EPA is proposing to incorporate by reference the SDAPCD rules described in Table 1 of this preamble. The EPA has made, and will continue to make, these materials available through https://www.regulations.gov and at the EPA Region IX Office (please contact the person identified in the FOR FURTHER INFORMATION CONTACT section of this preamble for more information).

Under the Clean Air Act, 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 Clean Air Act. Accordingly, this proposed action merely proposes to approve state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this proposed action:

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

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

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

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

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

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

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

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

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

In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where the EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rules do 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).

After considering the requests to extend the public comment period received from various parties, the EPA has decided to extend the public comment period until June 21, 2022. This extension will ensure that the public has additional time to review the proposed rule.