OMB Releases Fall 2022 Unified Agenda of Regulatory and Deregulatory Actions
On January 4, the Biden Administration released its third Unified Agenda of Regulatory and Deregulatory Actions. The semiannual document provides a list of regulatory actions the administration plans to work on, but not necessarily complete, over the next year. Overall, the Agenda reflects the administration’s priorities to implement key legislation, namely the Inflation Reduction Act (IRA), CHIPS and Science Act, Honoring Our PACT Act, and the Infrastructure Investment and Jobs Act (IIJA).
Arriving several months late, this most recent update also continues several priorities set out in the spring version, including those addressing trade issues primarily related to USMCA, numerous proposed revisions to the Privacy Act, and a variety of healthcare and energy-focused actions including rulemakings related to TRICARE, organ donor eligibility, coal combustion, spent fuel, hazardous waste, and polychlorinated biphenyls (PCBs) cleanup.
Fall 2022 Unified Agenda By-the-Numbers
The newest edition includes 2,651 “active” actions, or those that agencies expect to work on over the next 12 months. This is relatively similar to the spring's 2,673 active actions. The number of actions in the pre-rule and proposed rule stages are slightly less than Fall 2021’s report, coming in at a net decrease of 18 for pre-rules and 34 for proposed rules.
As is typical, the major cabinet departments lead the way in the total number of actions among agencies. The Department of the Interior (DOI), followed by the Treasury (USDT) and Transportation (DOT) Departments, remain in the top three spots. Like the Agenda from the spring, the Department of Homeland Security (DHS) remains in the number ten spot, having outweighed the Department of Justice (DOJ). The Department of Defense (DoD) has once again moved ahead of the Department of Commerce (DOC).
The agenda includes many final rulemakings as well as nearly 1,700 newly proposed or pre-rules, which could be some of the most influential rulemakings for the remainder of President Joe Biden’s term. However, there is no guarantee they will be finalized by the 2025 deadline.
Notable Rulemakings
Environmental Protection Agency
Designating PFOA and PFOS as CERCLA Hazardous Substances: The proposal to designate PFOA and PFOS as hazardous substances was one of several key actions mentioned in the 2021 PFAS Strategic Roadmap. A designation would require facilities across the country to report on PFOA and PFOS releases that meet or exceed the reportable quantity. The Final Rule is expected to be released in August 2023.
Phasedown of Hydrofluorocarbons: Allowance Allocation Methodology for 2024 and Later Years: This rule will continue to implement the hydrofluorocarbon (HFC) phasedown under the American Innovation and Manufacturing (AIM) Act, allocating annual allowances in 2024 and later years and making adjustments based on the lessons learned from implementation of the framework rule. The Final Rule is expected to be released in August 2023.
Volume Requirements for 2023 and Beyond Under the Renewable Fuel Standard Program: The statutory provisions governing the Renewable Fuel Standard (RFS) program provide target volumes through 2022. For years 2023 onward, the Environmental Protection Agency (EPA) must set those volumes itself. The Final Rule is expected to be released in June 2023.
Greenhouse Gas Emissions Standards for Heavy-Duty Engines and Vehicles-Phase 3: The EPA will propose a set of emissions standards for greenhouse gases for heavy-duty vehicles, beginning with model year 2027 and running through model year 2030 and beyond. The Notice of Proposed Rulemaking (NPRM) is expected to be released in March 2023.
Department of Agriculture
Smart Utility Authority for Broadband: The Agriculture Department (USDA) requested comments in September 2020 to establish the authority authorized in the Agriculture Improvement Act of 2018 which assists rural families and small businesses in gaining access to broadband service by permitting recipients of a loan, grant, or loan guarantee to use up to 10 percent of the amount provided to construct broadband infrastructure in areas not served by minimum acceptable level of broadband service. The Final Rule was effective September 15, 2020, however public comments were received and are currently being considered. The Final Rule is expected to be confirmed in March 2023.
Rural eConnectivity Program- Amendments to Conform Audit Requirements and Other Updates: The ReConnect Program was established by the Rural Utility Service (RUS) through a Final Rule in February 2021. The rule seeks to update the regulation with several edits including clarifying that applications must include a Tribal Government Resolution of Consent from the Tribal council of the Tribal Governments with jurisdiction over the Tribal Lands where services are being proposed. Additionally, it clarifies Buy America requirements and aligns the language with the IIJA. The Final Rule was expected to be released in December 2022.
Department of Commerce
Securing the Information and Communications Technology and Services Supply Chain: Licensing Procedures: The Commerce Department is seeking public input regarding establishing a licensing process for entities to seek pre-approval before engaging in or continuing to engage in potentially regulated Information and Communications Technology Services (ICTS) transitions. The NPRM is expected to be released in May 2023.
Securing the Information and Communications Technology and Services Supply Chain: The Commerce Department is implementing the process and procedures for the Secretary of Commerce to use in identifying, assessing, and addressing transactions that pose a risk to the security, integrity, and reliability of information and communications technology services provided and used in the U.S. The Final Rule is expected in April 2023.
Taking Additional Steps to Address the National Emergency With Respect to Significant Malicious Cyber-Enabled Activities: Pursuant to Executive Order (EO) 13984, the rule directs the Secretary of Commerce to implement regulations that would govern the process and procedures that will be used to deter foreign malicious cyber actors use of the U.S. Infrastructure as a Service (IaaS) products and assist in investigation transactions involving foreign malicious cyber actors. The NPRM is expected to be released in June 2023.
Securing the Information and Communications Technology and Services Supply Chain; Connected Software Applications: This proposed rule would update the Supply Chain Interim Final Rule to clarify that ICTS includes connected software applications. This update also would add the term connected software applications to the definition section of the Supply Chain IFR, as well as to the definition of ICTS and ICTS Transaction. Additionally, this proposed rule would make other conforming changes to the Supply Chain IFR to explicitly state that ICTS transactions include transactions that involve connected software applications. The Final Rule was expected to be released in December 2022.
Implementation of Additional Export Controls: Certain Advanced Computing and Semiconductor Manufacturing Items; Supercomputer and Semiconductor End Use; Entity List Modification: This rule finalizes the Export Administration Regulations’ (EAR) ability to implement necessary controls on advanced computing integrated circuits (ICs), computer commodities that contain such ICs, and certain semiconductor manufacturing items. In addition, the Bureau of Industry and Security (BIS) is expanding controls on transactions involving items for supercomputer and semiconductor manufacturing end uses. BIS is also informing the public that specific activities of U.S. persons that support the development or production of certain ICs in China require a license. Lastly, to minimize short term impact on the semiconductor supply chain from this rule, BIS is establishing a Temporary General License to permit specific, limited manufacturing activities in China related to items destined for use outside China and is identifying a model certificate that may be used in compliance programs to assist, along with other measures, in conducting due diligence. The Final Rule is expected to be released in March 2023.
Export Administration Regulations: Implementation of Wassenaar Arrangement 2022 Plenary Agreements: This rule harmonizes the Commerce Control List (CCL) with the agreements reached at the 2022 Plenary meeting by revising Export Control Classification Numbers (ECCNs) controlled for national security reasons in each category of the CCL. The Final Rule is expected to be released in June 2023.
Department of Defense
DoD-Defense Industrial Base (DIB) Cybersecurity (CS) Activities: The proposed rule would allow revisions so that all defense contractors who process, store, develop, or transit DoD controlled unclassified information are eligible for the program and to receive cyber threat information. The NPRM is expected to be released in April 2023.
Assessing Contractor Implementation of Cybersecurity Requirements (DFARS Case 2019-D041): This rule amends an interim rule to implement the Cybersecurity Maturity Model Certification (CMMC) Framework 2.0, a DoD certification process that measures DIB contractors’ institutionalization of the processes and implementation of cybersecurity practices. The NPRM is expected to be released in May 2023.
Cybersecurity Maturity Model Certification (CMMC) Program: This rule proposes implementing the CMMC Framework, to help assess a DIB contractor’s compliance with and implementation of cybersecurity requirements to safeguard Federal Contract Information (FCI) and Controlled Unclassified Information (CUI) transiting non-federal systems and mitigate the threats posed by adversaries with sophisticated levels of expertise and significant resources. The NPRM is expected to be released in May 2023.
Department of Energy
Loan Guarantees for Clean Energy Projects: The IRA added new categories of eligible projects to the Department of Energy (DOE) Loan Programs Office program. The Interim Final Rule is expected in February 2023.
Department of Health and Human Services
World Trade Center Health Program: Addition of Uterine Cancer to the List of WTC-Related Health Conditions: This rule proposes adding uterine cancer to the List of WTC (World Trade Center)-Related Health Conditions. The Final Rule is expected this month.
Tobacco Product Standard for Nicotine Level of Certain Tobacco Products: This rule proposes a tobacco product standard that would establish a maximum nicotine level in cigarettes and certain other finished tobacco products. The NPRM is expected in October 2023.
Prohibition of Sale of Tobacco Products to Persons Younger Than 21 Years of Age: This rule requires the Food and Drug Administration (FDA) to make conforming changes to its regulations including increasing the minimum age of sale for tobacco products from 18 to 21 years of age and increasing the minimum age for verification from under the age of 27 to under the age of 30. The Final Rule is expected in October 2023.
Remedy for 340B-Acquired Drugs Purchased in Cost Years 2018-2022: In 2022, the Supreme Court ruled the Department of Health and Human Services’ (HHS) Medicare reimbursement rates for Outpatient Prospective Payment Services (OPPS) hospitals, or 340B hospitals, were unlawful for 2018-2019, as the department did not collect a survey of acquisition costs. As a result, HHS is expected to release a proposed rulemaking for remedying the matter. The NPRM is expected in April 2023.
Department of the Interior
Rights-of-Way for Communications Including Broadband: This proposed rule would amend the existing rights-of-way (ROW) regulations to streamline and improve efficiencies in the communications uses program including broadband, update the cost recovery fee schedules for ROW work activities, and include provisions governing the development and approval of operating plans and agreements for ROWs for electric transmission and distribution facilities. The NPRM was expected to be released in December 2022.
Department of Justice
Amending and Clarifying Foreign Agents Registration Act Regulations: DOJ plans to issue an NPRM relating to the Foreign Agents Registration Act (FARA). It is expected to be released in March 2023.
Special Registration to Engage in the Practice of Telemedicine: The Drug Enforcement Administration (DEA) proposes to amend registration requirements to permit special registration. The NPRM is expected to be released this month.
Disaster Registration Emergency Authorities: This proposal would create a temporary registration option to be utilized during a disaster or declared emergency for hospitals/clinics and pharmacies and a temporary registration exemption to allow for emergency practitioner mobility. The NRPM is expected to be released in February.
Operation of Automated Dispensing Systems at Long Term Care Facilities by Hospital/Clinic Pharmacies: This rule proposes to revise its existing regulations to allow registered hospitals/clinics to install and operate automatic dispensing systems in long term Care facilities, where permitted under state law to do so.
Department of Labor
Communication Tower Safety: The Occupational Safety and Health Administration (OSHA) will use information collected from a Small Business Regulatory Enforcement Fairness Act (SBREFA) panel to identify work practices and advances in engineering technology that best address industry concerns. They will also continue to consider covering structures that have telecommunications equipment on or attached to them (e.g., buildings, rooftops, water towers, billboards). The NPRM is expected to be released in March 2023.
Occupational Exposure to COVID-19 in Healthcare Settings: OSHA has continued to work to issue a final standard that will protect workers from COVID-19. The the Final Rule was expected in December 2022.
Procedures for the Handling of Retaliation Complaints under the Criminal Antitrust Anti-Retaliation Act: OSHA is promulgating procedures for handling complaints under the statute, which prohibits employers from retaliating against certain whistleblowers who report criminal antitrust violations to the federal government or their supervisors, or who otherwise assist in an investigation. The Interim Final Rule was issued in December.
Department of State
International Traffic in Arms Regulations: USML Technology Frontier 2022: The Department of State seeks public comment regarding the technology frontier, identifying specific technology capabilities that have sufficiently evolved to consider amending the International Traffic in Arms Regulations (ITAR), to revise and exclude entries on the U.S. Munitions List (USML) that no longer warrant inclusion and to add entries for critical and emerging technologies that do. The Notice of Inquiry (NOI) was published in December 2022.
International Traffic in Arms Regulations: Consolidation of Licensing and Exemptions and Restructuring of Part 123, 124, and 125: This proposal aims to reorganize part 125 of the International Traffic in Arms Regulations to consolidate all ITAR exemptions and organize the exemptions to enhance their clarity and ease of use. The Department of State also intends to reorganize parts 123 and 124 of the ITAR to consolidate regulatory provisions relevant to licenses for the export of defense articles and defense services, respectively, and to organize the content in a manner that enhances its clarity and ease of use. The NRPM is expected this month.
International Traffic in Arms Regulations: USML Categories IV and XV: The Department of State proposes to amend the ITAR with respect to controls on launch vehicles, ballistic missiles and other items in Category IV of the USML and spacecraft and related items in Category XV of the USML, to describe more precisely the articles warranting control on the USML. The NPRM is expected in March 2023.
International Traffic in Arms Regulations: Expansion of Definition of Activities That Are Not Exports, Reexports, Retransfers, or Temporary Imports: The Department of State proposes to amend the ITAR to expand the definition of activities that are not exports, reexports, retransfers, or temporary imports by specifying two additional activities. The NPRM comment period will end in February 2023. The Final Rule will be issued in December 2023.
International Traffic in Arms Regulations: USML Circuit Boards and Semiconductors: This proposal would amend the ITAR to revise paragraphs (c)(1) through (4) of Category XI of the USML to describe more precisely the articles warranting control on the USML. The NRPM is expected to be released in September 2023.
International Traffic in Arms Regulations: USML Targeted Revisions 2022: The State Department will work on revising and excluding entries in the USML that do not warrant inclusion, and to add entries for critical and emerging technologies that warrant inclusion. These changes revise specific paragraphs within the USML, as well as corresponding parts of the ITAR. The Interim Final Rule is expected in February 2023.
Department of Transportation
Processing Buy America and Buy American Waivers Based on Nonavailability: This rule proposes to establish the applicable regulatory standard for waivers from the Buy America requirement on the basis that a product is not manufactured in the U.S. meeting the applicable Buy America requirement. This standard will require the use of items and products with the maximum known amount of domestic content. The rule will also establish the required information, which is expected to be consistent across the department, applicants must provide in applying for such waivers. The NRPM is expected to be released in June 2023.
Categorical Exclusions and Environmental Procedure: This rulemaking proposes changes to 23 CFR part 771 to ensure consistency with related regulations. Part 771 – Environmental Impact and Procedures contains the joint National Environmental Policy Act (NEPA) implementing regulations of the Federal Highway Administration (FHWA), the Federal Railroad Administration (FRA), and the Federal Transit Administration (FTA). The NRPM is expected to be released in June 2023.
Statewide and Nonmetropolitan and Metropolitan Transportation Planning: This rule proposes to implement relevant requirements of IIJA; consider allowing additional flexibility in the development of the Transportation Improvement Program/Statewide Transportation Improvement Program (TIP/STIP); and other revisions, including updates to the planning factors and changes to improve the transportation planning process. The NRPM is expected to be released in June 2023.
Framework for Automated Driving Systems Safety: The extended comment period on the development of a framework for Automated Driving System (ADS) safety to define, assess, and manage the safety of ADS performance closed in 2021. Comments are expected to be analyzed in April 2023.
Department of the Treasury
Consideration of Updates to Trade Practice Regulations: The Alcohol and Tobacco Tax and Trade Bureau (TTB) is seeking public comment on TTB’s trade practice regulations in response to Executive Order 14036 on Promoting Competition in the American Economy and a related report issued by the Department of the Treasury on Competition in the Markets for Beer, Wine, and Spirits. The Advance Notice of Proposed Rulemaking (ANPRM) comment period is open now and will end in March 2023.
Enforce and Protect Act Regulations: This document amends U.S. Customs and Border Protection (CBP) regulations and implements the terms of the Enforce and Protect Act of 2015 (EAPA), which establishes a formal process for CBP to investigate allegations of the evasion of antidumping and countervailing duty orders (AD/CVD). Section 421 of the EAPA requires that regulations be prescribed as necessary and within 180 days of the Trade Facilitation and Trade Enforcement Act’s (TFTEA) enactment to implement the provisions of the EAPA that establish procedures for investigating claims of evasion of AD/CVD orders. The Final Rule will be issued in March 2023.
Inter Partes Proceedings Concerning Administration of Exclusion Orders Resulting From Final Determinations of the United States International Trade Commission Under Section 337: This rule amends CBP regulations with respect to administrative rulings concerning the importation of articles that may be subject to exclusion orders issued by the U.S. International Trade Commission (ITC) under section 337 of the Tariff Act. The amendments seek to promote the speed, accuracy, and transparency of such rulings through the creation of an inter partes proceeding, which is between the affected parties, in order to replace the current ex parte process, which is initiated by a single party. The NPRM is expected to be released in September 2023.
Definition of Qualifying Energy Property, Section 48 Investment Tax Credit: Proposed regulations will provide other rules applicable to energy property, such as rules for dual use property, application of the 80/20 Rule to retrofitted energy property, and eligibility of off-site components of energy property. Proposed regulations will also address issues raised due to IRA amendments. The NPRM is expected to be released in May 2023.
Securities and Exchange Commission
Climate Change Disclosure: The Office of Information and Regulatory Affairs (OIRA) is considering recommending that the commission adopt rule amendments to enhance registrant disclosures regarding climate-related risks and opportunities. Final action is expected in April 2023.
Veterans’ Affairs
Removal of Exclusion of Gender Alterations From the Medical Benefits Package: The Department of Veterans Affairs (VA) proposes revising its medical regulations by removing the exclusion on gender alterations from the medical benefits package so that transgender and gender diverse veterans may receive medically necessary health care, including surgical interventions for gender transition. The NPRM was expected to be released in December 2022.
Federal Trade Commission
Children's Online Privacy Protection Rule: Still in the pre-rule stage, this rule would require operators of commercial websites and online services to obtain verifiable parental consent before collecting, using, or disclosing personal information from or about children under the age of 13.
Consumer Financial Protection Bureau
Small Business Lending Data Collection: Following modifications to the Equal Credit Opportunity Act done by Section 1071 of the Dodd-Frank Wall Street Reform and Consumer Protection Act of 2010, the Consumer Financial Protection Bureau (CFPB) is engaged in a rulemaking on data collection on small business lending. Section 1071 requires reporting around lending to women-owned, minority owned, and small businesses. The NPRM comment period concluded one year ago, and in July 2022, the CFPB agreed to a March 31, 2023 deadline to release the final rule as part of a lawsuit in U.S. District Court compelling implementation of the rule. The Final Rule is expected to be released by March 31, 2023.