Introduction to the Unified Agenda of Federal Regulatory and Deregulatory Actions-Fall 2022

REGULATORY INFORMATION SERVICE CENTER

Introduction to the Unified Agenda of Federal Regulatory and Deregulatory Actions—Fall 2022

AGENCY:

Regulatory Information Service Center.

ACTION:

Introduction to the Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions.

SUMMARY:

Publication of the Fall 2022 Unified Agenda of Federal Regulatory and Deregulatory Actions represents a key component of the regulatory planning mechanism prescribed in Executive Order (“E.O.”) 12866, “Regulatory Planning and Review,” (58 FR 51735) and reaffirmed in E.O. 13563, “Improving Regulation and Regulatory Review,” (76 FR 3821). The Regulatory Flexibility Act requires that agencies publish semiannual regulatory agendas in the

Federal Register

describing regulatory actions they are developing that may have a significant economic impact on a substantial number of small entities (5 U.S.C. 602).

The Unified Agenda of Regulatory and Deregulatory Actions (Unified Agenda), published in the fall and spring, helps agencies fulfill all of these requirements. All federal regulatory agencies have chosen to publish their regulatory agendas as part of this publication. The complete Unified Agenda and Regulatory Plan can be found online at

www.reginfo.gov

and a reduced print version can be found in the

Federal Register

. Information regarding obtaining printed copies can also be found on the

Reginfo.gov

website (or below, VI. How Can Users Get Copies of the Plan and the Agenda?).

The Fall 2022 Unified Agenda publication appearing in the

Federal Register

includes the Regulatory Plan and agency regulatory flexibility agendas, in accordance with the publication requirements of the Regulatory Flexibility Act. Agency regulatory flexibility agendas contain only those Agenda entries for rules that are likely to have a significant economic impact on a substantial number of small entities and entries that have been selected for periodic review under section 610 of the Regulatory Flexibility Act.

The complete Fall 2022 Unified Agenda contains the Regulatory Plans of 29 Federal agencies and 67 Federal agency regulatory agendas.

ADDRESSES:

Regulatory Information Service Center (MV), General Services Administration, 1800 F Street NW, Washington, DC 20405.

FOR FURTHER INFORMATION CONTACT:

For further information about specific regulatory actions, please refer to the agency contact listed for each entry. To provide comment on or to obtain further information about this publication, contact: Boris Arratia, Director, Regulatory Information Service Center (MV), General Services Administration, 1800 F Street NW, Washington, DC 20405, 703-795-0816. You may also send comments to us by email at:

RISC@gsa.gov

.

SUPPLEMENTARY INFORMATION:

Table of Contents

Introduction to the Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions

I. What are the Regulatory Plan and the Unified Agenda?

II. Why are the Regulatory Plan and the Unified Agenda published?

III. How are the Regulatory Plan and the Unified Agenda organized?

IV. What information appears for each entry?

V. Abbreviations

VI. How can users get copies of the Plan and the Agenda?

Introduction to the Fall 2022 Regulatory Plan

Agency Regulatory Plans

Cabinet Departments

Department of Agriculture

Department of Commerce

Department of Defense

Department of Education

Department of Energy

Department of Health and Human Services

Department of Homeland Security

Department of Housing and Urban Development

Department of the Interior

Department of Justice

Department of Labor

Department of Transportation

Department of the Treasury

Department of Veterans Affairs

Other Executive Agencies

Corporation for National and Community Service

Environmental Protection Agency

General Services Administration

National Aeronautics and Space Administration

National Archives and Records Administration

National Science Foundation

Office of Personnel Management

Pension Benefit Guaranty Corporation

Small Business Administration

Social Security Administration

Department of Defense/General Services Administration/National Aeronautics and Space Administration (Federal Acquisition Regulation)

Independent Regulatory Agencies

Consumer Product Safety Commission

Federal Trade Commission

National Indian Gaming Commission

Nuclear Regulatory Commission

Regulatory Flexibility Agendas

Cabinet Departments

Department of Agriculture

Department of Commerce

Department of Defense

Department of Education

Department of Energy

Department of Health and Human Services

Department of Homeland Security

Department of the Interior

Department of Justice

Department of Labor

Department of Transportation

Department of the Treasury

Other Executive Agencies

Environmental Protection Agency

General Services Administration

Office of Personnel Management

Small Business Administration

Joint Authority

Department of Defense/General Services Administration/National Aeronautics and Space Administration (Federal Acquisition Regulation)

Independent Regulatory Agencies

Consumer Financial Protection Bureau

Consumer Product Safety Commission

Federal Communications Commission

Federal Reserve System

National Labor Relations Board

Nuclear Regulatory Commission

Securities and Exchange Commission

Surface Transportation Board

Introduction to the Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions

I. What are the Regulatory Plan and the Unified Agenda?

The Regulatory Plan serves as a defining statement of the Administration's regulatory and deregulatory policies and priorities. The Plan is part of the fall edition of the Unified Agenda. Each participating agency's regulatory plan contains: (1) A narrative statement of the agency's regulatory and deregulatory priorities, and, for the most part; and (2) a description of the most important significant regulatory and deregulatory actions that the agency reasonably

expects to issue in proposed or final form during the upcoming fiscal year. This edition includes the regulatory plans of 29 agencies.

The Unified Agenda provides information about regulations that the Government is considering or reviewing. The Unified Agenda has appeared in the

Federal Register

twice each year since 1983 and has been available online since 1995. The complete Unified Agenda is available to the public at

www.reginfo.gov

. The online Unified Agenda offers flexible search tools and access to the historic Unified Agenda database to1995. The complete online edition of the Unified Agenda includes regulatory agendas from 65 Federal agencies. Agencies of the United States Congress are not included.

The Fall 2022 Unified Agenda publication appearing in the

Federal Register

consists of the Regulatory Plan and agency regulatory flexibility agendas, in accordance with the publication requirements of the Regulatory Flexibility Act. Agency regulatory flexibility agendas contain only those Agenda entries for rules that are likely to have a significant economic impact on a substantial number of small entities and entries that have been selected for periodic review under section 610 of the Regulatory Flexibility Act. Printed entries display only the fields required by the Regulatory Flexibility Act. Complete agenda information for those entries appears, in a uniform format, in the online Unified Agenda at

http://reginfo.gov

.

The regulatory agendas for agencies not publishing Regulatory flexibility agendas are available to the public at

http://reginfo.gov

.

Cabinet Departments

Department of Housing and Urban Development*

Department of State

Department of Veterans Affairs*

Other Executive Agencies

Agency for International Development

Architectural and Transportation Barriers Compliance Board

Committee for Purchase From People Who Are Blind or Severely Disabled

Commission on Civil Rights

Corporation for National and Community Service*

Council on Environmental Quality

Court Services and Offender Supervision Agency for the District of Columbia

Federal Mediation Conciliation Service

Institute of Museum and Library Services

Inter-American Foundation

National Aeronautics and Space Administration*

National Archives and Records Administration*

National Endowment for the Arts

National Endowment for the Humanities

National Mediation Board

National Science Foundation*

Office of Government Ethics

Office of the Intellectual Property Enforcement Coordinator

Office of Management and Budget

Office of National Drug Control Policy

Peace Corps

Pension Benefit Guaranty Corporation*

Railroad Retirement Board*

Social Security Administration*

U.S. Agency for Global Media

U.S. Commission on Civil Rights

Independent Agencies

Commodity Futures Trading Commission

Farm Credit Administration

Federal Deposit Insurance Corporation

Federal Energy Regulatory Commission

Federal Housing Finance Agency

Federal Maritime Commission

Federal Mine Safety and Health Review Commission

Federal Permitting Improvement Steering Council

Federal Trade Commission*

National Credit Union Administration

National Indian Gaming Commission*

National Transportation Safety Board

Postal Regulatory Commission

The Regulatory Information Service Center compiles the Unified Agenda for the Office of Information and Regulatory Affairs (OIRA), part of the Office of Management and Budget. OIRA is responsible for overseeing the Federal Government's regulatory, paperwork, and information resource management activities, including implementation of Executive Order 12866 (incorporated in Executive Order 13563). The Center also provides information about Federal regulatory activity to the President and his Executive Office, the Congress, agency officials, and the public.

The activities included in the Agenda are, in general, those that will have a regulatory action within the next 12 months. Agencies may choose to include activities that will have a longer timeframe than 12 months. Agency agendas also show actions or reviews completed or withdrawn since the last Unified Agenda. Executive Order 12866 does not require agencies to include regulations concerning military or foreign affairs functions or regulations related to agency organization, management, or personnel matters.

Agencies prepared entries for this publication to give the public notice of their plans to review, propose, and issue regulations. They have tried to predict their activities over the next 12 months as accurately as possible, but dates and schedules are subject to change. Agencies may withdraw some of the regulations now under development, and they may issue or propose other regulations not included in their agendas. Agency actions in the rulemaking process may occur before or after the dates they have listed. The Regulatory Plan and Unified Agenda do not create a legal obligation on agencies to adhere to schedules in this publication or to confine their regulatory activities to those regulations that appear within it.

II. Why are the Regulatory Plan and the Unified Agenda published?

The Regulatory Plan and the Unified Agenda helps agencies comply with their obligations under the Regulatory Flexibility Act and various Executive orders and other statutes.

Regulatory Flexibility Act

The Regulatory Flexibility Act requires agencies to identify those rules that may have a significant economic impact on a substantial number of small entities (5 U.S.C. 602). Agencies meet that requirement by including the information in their submissions for the Unified Agenda. Agencies may also indicate those regulations that they are reviewing as part of their periodic review of existing rules under the Regulatory Flexibility Act (5 U.S.C. 610). Executive Order 13272, “Proper Consideration of Small Entities in Agency Rulemaking,” signed August 13, 2002 (67 FR 53461), provides additional guidance on compliance with the Act.

Executive Order 12866

Executive Order 12866, “Regulatory Planning and Review,” September 30, 1993 (58 FR 51735), requires covered agencies to prepare an agenda of all regulations under development or review. The Order also requires that certain agencies prepare annually a regulatory plan of their “most important significant regulatory actions,” which appears as part of the fall Unified Agenda. Executive Order 13497, signed January 30, 2009 (74 FR 6113), revoked the amendments to Executive Order 12866 that were contained in Executive Order 13258 and Executive Order 13422.

Executive Order 13563

Executive Order 13563, “Improving Regulation and Regulatory Review,” January 18, 2011 (76 FR 3821) supplements and reaffirms the principles, structures, and definitions

governing contemporary regulatory review that were established in Executive Order 12866, which includes the general principles of regulation and public participation, and orders integration and innovation in coordination across agencies; flexible approaches where relevant, feasible, and consistent with regulatory approaches; scientific integrity in any scientific or technological information and processes used to support the agencies' regulatory actions; and retrospective analysis of existing regulations.

Executive Order 13132

Executive Order 13132, “Federalism,” August 4, 1999 (64 FR 43255), directs agencies to have an accountable process to ensure meaningful and timely input by State and local officials in the development of regulatory policies that have “federalism implications” as defined in the Order. Under the Order, an agency that is proposing a regulation with federalism implications, which either preempt State law or impose non-statutory unfunded substantial direct compliance costs on State and local governments, must consult with State and local officials early in the process of developing the regulation. In addition, the agency must provide to the Director of the Office of Management and Budget a federalism summary impact statement for such a regulation, which consists of a description of the extent of the agency's prior consultation with State and local officials, a summary of their concerns and the agency's position supporting the need to issue the regulation, and a statement of the extent to which those concerns have been met. As part of this effort, agencies include in their submissions for the Unified Agenda information on whether their regulatory actions may have an effect on the various levels of government and whether those actions have federalism implications.

Unfunded Mandates Reform Act of 1995

The Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4, title II) requires agencies to prepare written assessments of the costs and benefits of significant regulatory actions “that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more in any 1 year.” The requirement does not apply to independent regulatory agencies, nor does it apply to certain subject areas excluded by section 4 of the Act. Affected agencies identify in the Unified Agenda those regulatory actions they believe are subject to title II of the Act.

Executive Order 13211

Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use,” May 18, 2001 (66 FR 28355), directs agencies to provide, to the extent possible, information regarding the adverse effects that agency actions may have on the supply, distribution, and use of energy. Under the Order, the agency must prepare and submit a Statement of Energy Effects to the Administrator of the Office of Information and Regulatory Affairs, Office of Management and Budget, for “those matters identified as significant energy actions.” As part of this effort, agencies may optionally include in their submissions for the Unified Agenda information on whether they have prepared or plan to prepare a Statement of Energy Effects for their regulatory actions.

Small Business Regulatory Enforcement Fairness Act

The Small Business Regulatory Enforcement Fairness Act (Pub. L. 104-121, title II) established a procedure for congressional review of rules (5 U.S.C. 801

et seq.

), which defers, unless exempted, the effective date of a “major” rule for at least 60 days from the publication of the final rule in the

Federal Register

. The Act specifies that a rule is “major” if it has resulted, or is likely to result, in an annual effect on the economy of $100 million or more or meets other criteria specified in that Act. The Act provides that the Administrator of OIRA will make the final determination as to whether a rule is major.

III. How are the Regulatory Plan and the Unified Agenda organized?

The Regulatory Plan appears in part II in a daily edition of the

Federal Register

. The Plan is a single document beginning with an introduction, followed by a table of contents, followed by each agency's section of the Plan. Following the Plan in the

Federal Register

, as separate parts, are the regulatory flexibility agendas for each agency whose agenda includes entries for rules which are likely to have a significant economic impact on a substantial number of small entities or rules that have been selected for periodic review under section 610 of the Regulatory Flexibility Act. Each printed agenda appears as a separate part. The sections of the Plan and the parts of the Unified Agenda are organized alphabetically in four groups: Cabinet departments; other executive agencies; the Federal Acquisition Regulation, a joint authority (Agenda only); and independent regulatory agencies. Agencies may in turn be divided into subagencies. Each printed agency agenda has a table of contents listing the agency's printed entries that follow. Each agency's part of the Agenda contains a preamble providing information specific to that agency. Each printed agency agenda has a table of contents listing the agency's printed entries that follow.

Each agency's section of the Plan contains a narrative statement of regulatory priorities and, for most agencies, a description of the agency's most important significant regulatory and deregulatory actions. Each agency's part of the Agenda contains a preamble providing information specific to that agency plus descriptions of the agency's regulatory and deregulatory actions.

The online, complete Unified Agenda contains the preambles of all participating agencies. Unlike the printed edition, the online Agenda has no fixed ordering. In the online Agenda, users can select the particular agencies' agendas they want to see. Users have broad flexibility to specify the characteristics of the entries of interest to them by choosing the desired responses to individual data fields. To see a listing of all of an agency's entries, a user can select the agency without specifying any particular characteristics of entries.

Each entry in the Agenda is associated with one of five rulemaking stages. The rulemaking stages are:

1. Prerule Stage

—actions agencies will undertake to determine whether or how to initiate rulemaking. Such actions occur prior to a Notice of Proposed Rulemaking (NPRM) and may include Advance Notices of Proposed Rulemaking (ANPRMs) and reviews of existing regulations.

2. Proposed Rule Stage

—actions for which agencies plan to publish a Notice of Proposed Rulemaking as the next step in their rulemaking process or for which the closing date of the NPRM Comment Period is the next step.

3. Final Rule Stage

—actions for which agencies plan to publish a final rule or an interim final rule or to take other final action as the next step.

4. Long-Term Actions

—items under development but for which the agency does not expect to have a regulatory action within the 12 months after publication of this edition of the Unified Agenda. Some of the entries in this section may contain abbreviated information.

5. Completed Actions

—actions or reviews the agency has completed or withdrawn since publishing its last

agenda. This section also includes items the agency began and completed between issues of the Agenda.

6. Long-Term Actions

—are rulemakings reported during the publication cycle that are outside of the required 12-month reporting period for which the Agenda was intended. Completed Actions in the publication cycle are rulemakings that are ending their lifecycle either by Withdrawal or completion of the rulemaking process. Therefore, the Long-Term and Completed RINs do not represent the ongoing, forward-looking nature intended for reporting developing rulemakings in the Agenda pursuant to Executive Order 12866, section 4(b) and 4(c). To further differentiate these two stages of rulemaking in the Unified Agenda from active rulemakings, Long-Term and Completed Actions are reported separately from active rulemakings, which can be any of the first three stages of rulemaking listed above. A separate search function is provided on

www.reginfo.gov

to search for Completed and Long-Term Actions apart from each other and active RINs.

A bullet (•) preceding the title of an entry indicates that the entry is appearing in the Unified Agenda for the first time.

In the printed edition, all entries are numbered sequentially from the beginning to the end of the publication. The sequence number preceding the title of each entry identifies the location of the entry in this edition. The sequence number is used as the reference in the printed table of contents. Sequence numbers are not used in the online Unified Agenda because the unique Regulation Identifier Number (RIN) is able to provide this cross-reference capability.

Editions of the Unified Agenda prior to fall 2007 contained several indexes, which identified entries with various characteristics. These included regulatory actions for which agencies believe that the Regulatory Flexibility Act may require a Regulatory Flexibility Analysis, actions selected for periodic review under section 610(c) of the Regulatory Flexibility Act, and actions that may have federalism implications as defined in Executive Order 13132 or other effects on levels of government. These indexes are no longer compiled, because users of the online Unified Agenda have the flexibility to search for entries with any combination of desired characteristics. The online edition retains the Unified Agenda's subject index based on the

Federal Register

Thesaurus of Indexing Terms. In addition, online users have the option of searching Agenda text fields for words or phrases.

IV. What information appears for each entry?

All entries in the online Unified Agenda contain uniform data elements including, at a minimum, the following information:

Title of the Regulation

—a brief description of the subject of the regulation. In the printed edition, the notation “Section 610 Review” following the title indicates that the agency has selected the rule for its periodic review of existing rules under the Regulatory Flexibility Act (5 U.S.C. 610(c)). Some agencies have indicated completions of section 610 reviews or rulemaking actions resulting from completed section 610 reviews. In the online edition, these notations appear in a separate field.

Priority

—an indication of the significance of the regulation. Agencies assign each entry to one of the following five categories of significance.

(1) Economically Significant

As defined in Executive Order 12866, a rulemaking action that will have an annual effect on the economy of $100 million or more or will adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities. The definition of an “economically significant” rule is similar but not identical to the definition of a “major” rule under 5 U.S.C. 801 (Pub. L. 104-121). (See below.)

(2) Other Significant

A rulemaking that is not Economically Significant but is considered Significant by the agency. This category includes rules that the agency anticipates will be reviewed under Executive Order 12866 or rules that are a priority of the agency head. These rules may or may not be included in the agency's regulatory plan.

(3) Substantive, Nonsignificant

A rulemaking that has substantive impacts, but is neither Significant, nor Routine and Frequent, nor Informational/Administrative/Other.

(4) Routine and Frequent

A rulemaking that is a specific case of a multiple recurring application of a regulatory program in the Code of Federal Regulations and that does not alter the body of the regulation.

(5) Informational/Administrative/Other

A rulemaking that is primarily informational or pertains to agency matters not central to accomplishing the agency's regulatory mandate but that the agency places in the Unified Agenda to inform the public of the activity.

Major

—whether the rule is “major” under 5 U.S.C. 801 (Pub. L. 104-121) because it has resulted or is likely to result in an annual effect on the economy of $100 million or more or meets other criteria specified in that Act. The Act provides that the Administrator of the Office of Information and Regulatory Affairs will make the final determination as to whether a rule is major.

Unfunded Mandates

—whether the rule is covered by section 202 of the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). The Act requires that, before issuing an NPRM likely to result in a mandate that may result in expenditures by State, local, and tribal governments, in the aggregate, or by the private sector of more than $100 million in 1 year, agencies, other than independent regulatory agencies, shall prepare a written statement containing an assessment of the anticipated costs and benefits of the Federal mandate.

Legal Authority

—the section(s) of the United States Code (U.S.C.) or Public Law (Pub. L.) or the Executive order (E.O.) that authorize(s) the regulatory action. Agencies may provide popular name references to laws in addition to these citations.

CFR Citation

—the section(s) of the Code of Federal Regulations that will be affected by the action.

Legal Deadline

—whether the action is subject to a statutory or judicial deadline, the date of that deadline, and whether the deadline pertains to an NPRM, a Final Action, or some other action.

Abstract

—a brief description of the problem the regulation will address; the need for a Federal solution; to the extent available, alternatives that the agency is considering to address the problem; and potential costs and benefits of the action.

Timetable

—the dates and citations (if available) for all past steps and a projected date for at least the next step for the regulatory action. A date displayed in the form 12/00/19 means the agency is predicting the month and year the action will take place but not the day it will occur. In some instances, agencies may indicate what the next action will be, but the date of that action is “To Be Determined.” “Next Action Undetermined” indicates the agency does not know what action it will take next.

Regulatory Flexibility Analysis Required

—whether an analysis is required by the Regulatory Flexibility Act (5 U.S.C. 601

et seq.

) because the rulemaking action is likely to have a significant economic impact on a substantial number of small entities as defined by the Act.

Small Entities Affected

—the types of small entities (businesses, governmental jurisdictions, or organizations) on which the rulemaking action is likely to have an impact as defined by the Regulatory Flexibility Act. Some agencies have chosen to indicate likely effects on small entities even though they believe that a Regulatory Flexibility Analysis will not be required.

Government Levels Affected

—whether the action is expected to affect levels of government and, if so, whether the governments are State, local, tribal, or Federal.

International Impacts

—whether the regulation is expected to have international trade and investment effects, or otherwise may be of interest to the Nation's international trading partners.

Federalism

—whether the action has “federalism implications” as defined in Executive Order 13132. This term refers to actions “that 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.” Independent regulatory agencies are not required to supply this information.

Included in the Regulatory Plan

—whether the rulemaking was included in the agency's current regulatory plan.

Agency Contact

—the name and phone number of at least one person in the agency who is knowledgeable about the rulemaking action. The agency may also provide the title, address, fax number, email address, and TDD for each agency contact.

Some agencies have provided the following optional information:

RIN Information URL

—the internet address of a site that provides more information about the entry.

Public Comment URL

—the internet address of a site that will accept public comments on the entry.

Alternatively, timely public comments may be submitted at the Governmentwide e-rulemaking site,

www.regulations.gov

.

Additional Information

—any information an agency wishes to include that does not have a specific corresponding data element.

Compliance Cost to the Public

—the estimated gross compliance cost of the action.

Affected Sectors

—the industrial sectors that the action may most affect, either directly or indirectly. Affected sectors are identified by North American Industry Classification System (NAICS) codes.

Energy Effects

—an indication of whether the agency has prepared or plans to prepare a Statement of Energy Effects for the action, as required by Executive Order 13211 “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use,” signed May 18, 2001 (66 FR 28355).

Related RINs

—one or more past or current RIN(s) associated with activity related to this action, such as merged RINs, split RINs, new activity for previously completed RINs, or duplicate RINs.

Statement of Need

—a description of the need for the regulatory action.

Summary of the Legal Basis

—a description of the legal basis for the action, including whether any aspect of the action is required by statute or court order.

Alternatives

—a description of the alternatives the agency has considered or will consider as required by section 4(c)(1)(B) of Executive Order 12866.

Anticipated Costs and Benefits

—a description of preliminary estimates of the anticipated costs and benefits of the action.

Risks

—a description of the magnitude of the risk the action addresses, the amount by which the agency expects the action to reduce this risk, and the relation of the risk and this risk reduction effort to other risks and risk reduction efforts within the agency's jurisdiction.

V. Abbreviations

The following abbreviations appear throughout this publication:

ANPRM

—An Advance Notice of Proposed Rulemaking is a preliminary notice, published in the

Federal Register

, announcing that an agency is considering a regulatory action. An agency may issue an ANPRM before it develops a detailed proposed rule. An ANPRM describes the general area that may be subject to regulation and usually asks for public comment on the issues and options being discussed. An ANPRM is issued only when an agency believes it needs to gather more information before proceeding to a notice of proposed rulemaking.

CFR

—The Code of Federal Regulations is an annual codification of the general and permanent regulations published in the

Federal Register

by the agencies of the Federal Government. The Code is divided into 50 titles, each title covering a broad area subject to Federal regulation. The CFR is keyed to and kept up to date by the daily issues of the

Federal Register

.

E.O.

—An Executive order is a directive from the President to Executive agencies, issued under constitutional or statutory authority. Executive orders are published in the

Federal Register

and in title 3 of the Code of Federal Regulations.

FR

—The

Federal Register

is a daily Federal Government publication that provides a uniform system for publishing Presidential documents, all proposed and final regulations, notices of meetings, and other official documents issued by Federal agencies.

FY

—The Federal fiscal year runs from October 1 to September 30.

NPRM

—A Notice of Proposed Rulemaking is the document an agency issues and publishes in the

Federal Register

that describes and solicits public comments on a proposed regulatory action. Under the Administrative Procedure Act (5 U.S.C. 553), an NPRM must include, at a minimum: A statement of the time, place, and nature of the public rulemaking proceeding.

Legal Authority

—A reference to the legal authority under which the rule is proposed; and either the terms or substance of the proposed rule or a description of the subjects and issues involved.

Pub. L.

—A public law is a law passed by Congress and signed by the President or enacted over his veto. It has general applicability, unlike a private law that applies only to those persons or entities specifically designated. Public laws are numbered in sequence throughout the 2-year life of each Congress; for example, Public Law 112-4 is the fourth public law of the 112th Congress.

RFA

—A Regulatory Flexibility Analysis is a description and analysis of the impact of a rule on small entities, including small businesses, small governmental jurisdictions, and certain small not-for-profit organizations. The Regulatory Flexibility Act (5 U.S.C. 601

et seq.

) requires each agency to prepare an initial RFA for public comment when it is required to publish an NPRM and to make available a final RFA when the final rule is published, unless the agency head certifies that the rule would not have a significant economic impact on a substantial number of small entities.

RIN

—The Regulation Identifier Number is assigned by the Regulatory Information Service Center to identify each regulatory action listed in the Regulatory Plan and the Unified Agenda, as directed by Executive Order

12866 (section 4(b)). Additionally, OMB has asked agencies to include RINs in the headings of their Rule and Proposed Rule documents when publishing them in the

Federal Register

, to make it easier for the public and agency officials to track the publication history of regulatory actions throughout their development.

Seq. No.

—The sequence number identifies the location of an entry in the printed edition of the Regulatory Plan and the Unified Agenda. Note that a specific regulatory action will have the same RIN throughout its development but will generally have different sequence numbers if it appears in different printed editions of the Unified Agenda. Sequence numbers are not used in the online Unified Agenda.

U.S.C.

—The United States Code is a consolidation and codification of all general and permanent laws of the United States. The U.S.C. is divided into 50 titles, each title covering a broad area of Federal law.

VI. How can users get copies of the Plan and the Agenda?

Copies of the

Federal Register

issue containing the printed edition of The Regulatory Plan and the Unified Agenda (agency regulatory flexibility agendas) are available from the Superintendent of Documents, U.S. Government Publishing Office, P.O. Box 371954, Pittsburgh, PA 15250-7954. Telephone: (202) 512-1800 or 1-866-512-1800 (toll-free).

Copies of individual agency materials may be available directly from the agency or may be found on the agency's website. Please contact the particular agency for further information.

All editions of The Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions since fall 1995 are available in electronic form at

www.reginfo.gov

, along with flexible search tools.

The Government Publishing Office's GPO GovInfo website contains copies of the Agendas and Regulatory Plans that have been printed in the

Federal Register

. These documents are available at

www.govinfo.gov

.

Dated: December 20, 2022.

Boris Arratia,

Director.

Introduction to the Fall 2022 Regulatory Plan

Executive Order 12866, issued in 1993, requires the annual production of a Unified Regulatory Agenda and Regulatory Plan. It does so in order to promote transparency—or in the words of the Executive Order itself, “to have an effective regulatory program, to provide for coordination of regulations, to maximize consultation and the resolution of potential conflicts at an early stage, to involve the public and its State, local, and tribal officials in regulatory planning, and to ensure that new or revised regulations promote the President's priorities and the principles set forth in this Executive order.” The requirements of Executive Order 12866 were reaffirmed in Executive Order 13563, issued in 2011.

We are now providing the Fall 2022 Regulatory Plan. The regulatory plans and agendas submitted by agencies and included here offer a window into how the Administration plans to continue delivering on the President's agenda to advance economic prosperity and equity, tackle the climate crisis, advance public health, and much more to improve the lives of the American people. Agencies will also be continuing their work to implement landmark new legislation passed in 2022, including the implementation of the PACT Act, (Pub. L. 117-168); the Inflation Reduction Act, (Pub. L. 117-169); and the CHIPS and Science Act, (Pub. L. 117-167); as well as ongoing efforts to implement the Infrastructure Investment and Jobs Act (Bipartisan Infrastructure Law), Pub. L. 117-58.

Department of Agriculture

Sequence No.

Title

Regulation

Identifier No.

Rulemaking stage

1

Unfair Practices, Undue Preferences, and Harm to Competition Under the Packers and Stockyards Act (AMS-FTPP-21-0046)

0581-AE04

Proposed Rule.

2

Inclusive Competition and Market Integrity Under the Packers and Stockyards Act (AMS-FTPP-21-0045)

0581-AE05

Proposed Rule.

3

Poultry Growing Tournament Systems: Fairness and Related Concerns—Harm to Competition (AMS-FTPP-22-0046)

0581-AE18

Proposed Rule.

4

Transparency in Poultry Grower Contracting and Tournaments (AMS-FTPP-21-0044)

0581-AE03

Final Rule.

5

Organic Livestock and Poultry Standards (AMS-NOP-21-0073)

0581-AE06

Final Rule.

6

Special Supplemental Nutrition Program for Women, Infants and Children (WIC): Revisions in the WIC Food Packages

0584-AE82

Proposed Rule.

7

Child Nutrition Programs: Revisions to Meal Patterns Consistent With the 2020 Dietary Guidelines for Americans

0584-AE88

Proposed Rule.

8

Community Eligibility Provision: Increasing Options for Schools

0584-AE93

Proposed Rule.

9

Special Supplemental Nutrition Program for Women, Infants, and Children (WIC): Implementation of the Access to Baby Formula Act of 2022 and Related Provisions

0584-AE94

Final Rule.

10

Voluntary Labeling of Products With “Product of USA” and Similar Statements

0583-AD87

Proposed Rule.

11

Labeling of Meat and Poultry Products Made Using Animal Cell Culture Technology

0583-AD89

Proposed Rule.

12

Revision of the Nutrition Facts Panels for Meat and Poultry Products and Updating Certain Reference Amounts Customarily Consumed

0583-AD56

Final Rule.

13

Prior Label Approval System: Expansion of Generic Label Approval

0583-AD78

Final Rule.

Department of Commerce

Sequence No.

Title

Regulation

Identifier No.

Rulemaking stage

14

Section 1758 Technologies: Proposed Controls; Request for Comments

0694-AH80

Proposed Rule.

15

The Imposition of Emerging Technology Export Controls on Instruments for the Automated Chemical Synthesis of Peptides

0694-AI84

Proposed Rule.

16

Updates to Bayh-Dole Implementing Regulations

0693-AB66

Final Rule.

17

Illegal, Unreported, and Unregulated Fishing; Fisheries Enforcement; High Seas Driftnet Fishing Moratorium Protection Act

(Reg Plan Seq No. 17)

0648-BG11

Final Rule.

18

Amendments to the North Atlantic Right Whale Vessel Strike Reduction Rule

0648-BI88

Final Rule.

19

Setting and Adjusting Trademark Fees

0651-AD65

Proposed Rule.

Department of Defense

Sequence No.

Title

Regulation

Identifier No.

Rulemaking stage

20

Department of Defense (DoD)-Defense Industrial Base (DIB) Cybersecurity (CS) Activities

0790-AK86

Proposed Rule.

21

Cybersecurity Maturity Model Certification (CMMC) Program

0790-AL49

Proposed Rule.

22

Nondiscrimination on the Basis of Disability in Programs or Activities Assisted or Conducted by the DoD and in Equal Access to Information and Communication Technology Used by DoD

0790-AJ04

Final Rule.

23

Definitions of Gold Star Family and Gold Star Survivor

0790-AL56

Final Rule.

24

Assessing Contractor Implementation of Cybersecurity Requirements (DFARS Case 2019-D041)

0750-AK81

Proposed Rule.

25

Small Business Innovation Research Program Data Rights (DFARS Case 2019-D043)

0750-AK84

Proposed Rule.

26

Defense Commercial Solutions Opening (DFARS Case 2022-D006)

0750-AL57

Proposed Rule.

27

Modification of Prize Authority For Advanced Technology Achievements (DFARS Case 2022-D014)

0750-AL65

Proposed Rule.

28

DFARS Buy American Act Requirements (DFARS Case 2022-D019)

0750-AL74

Proposed Rule.

29

Past Performance of Subcontractors and Joint Venture Partners (DFARS Case 2018-D055)

0750-AK16

Final Rule.

30

Restriction on Acquisition of Personal Protective Equipment and Certain Items From Non-Allied Foreign Nations (DFARS Case 2022-D009)

0750-AL60

Final Rule.

31

Natural Disaster Procedures: Preparedness, Response, and Recovery Activities of the Corps of Engineers

0710-AA78

Proposed Rule.

32

Policy and Procedures for Processing Requests to Alter U.S. Army Corps of Engineers Civil Works Projects Pursuant to 33 U.S.C. 408

0710-AB22

Proposed Rule.

33

Flood Control Cost-Sharing Requirements Under the Ability to Pay Provision

0710-AB34

Proposed Rule.

34

USACE Implementing Procedures for Principles, Requirements, and Guidelines Applicable to Actions Involving Investment in Water Resources

0710-AB41

Proposed Rule.

35

Appendix C Procedures for the Protection of Historic Properties

0710-AB46

Proposed Rule.

36

Revised Definition of “Waters of the United States”—Rule 2

0710-AB47

Proposed Rule.

37

Credit Assistance for Water Resources Infrastructure Projects

0710-AB31

Final Rule.

38

Revised Definition of “Waters of the United States”—Rule 1

0710-AB40

Final Rule.

39

TRICARE Reimbursement of Ambulatory Surgery Centers and Outpatient Services Provided in Cancer and Children's Hospitals

0720-AB73

Final Rule.

40

TRICARE Coverage of National Institute of Allergy and Infectious Disease Coronavirus Disease 2019 Clinical Trials

0720-AB83

Final Rule.

41

Expanding TRICARE Access to Care in Response to the COVID-19 Pandemic

0720-AB85

Final Rule.

42

Collection From Third Party Payers of Reasonable Charges for Healthcare Services; Amendment

0720-AB87

Final Rule.

Department of Education

Sequence No.

Title

Regulation

Identifier No.

Rulemaking stage

43

Nondiscrimination on the Basis of Sex in Athletics Education Programs or Activities Receiving Federal Financial Assistance

1870-AA19

Proposed Rule.

44

Nondiscrimination on the Basis of Sex in Education Programs or Activities Receiving Federal Financial Assistance

1870-AA16

Final Rule.

45

Gainful Employment

1840-AD57

Proposed Rule.

46

Improving Income Driven Repayment

1840-AD81

Proposed Rule.

Department of Energy

Sequence No.

Title

Regulation

Identifier No.

Rulemaking stage

47

Clean Energy Rule for New Federal Buildings and Major Renovations

1904-AB96

Proposed Rule.

48

Energy Conservation Standards for Residential Non-Weatherized Gas Furnaces and Mobile Home Gas Furnaces

1904-AD20

Final Rule.

49

Loan Guarantees for Clean Energy Projects

1901-AB59

Final Rule.

Department of Health and Human Services

Sequence No.

Title

Regulation

Identifier No.

Rulemaking stage

50

Amendments to Civil Monetary Penalty Law Regarding Grants, Contracts, and Information Blocking

0936-AA09

Final Rule.

51

Rulemaking on Discrimination on the Basis of Disability in Health and Human Services Programs or Activities

0945-AA15

Proposed Rule.

52

Nondiscrimination in Health Programs and Activities

0945-AA17

Final Rule.

53

ONC Health IT Certification Program Updates, Health Information Network Attestation Process for the Trusted Exchange Framework and Common Agreement, and Enhancements to Support Information Sharing

0955-AA03

Proposed Rule.

54

Establishment of Disincentives for Health Care Providers who Have Committed Information Blocking

0955-AA05

Proposed Rule.

55

Patient Engagement, Information Sharing, and Public Health Interoperability

0955-AA06

Proposed Rule.

56

Medications for the Treatment of Opioid Use Disorder

0930-AA39

Proposed Rule.

57

Control of Communicable Diseases; Foreign Quarantine

0920-AA75

Final Rule.

58

World Trade Center Health Program; Addition of Uterine Cancer to the List of WTC-Related Health Conditions

0920-AA81

Final Rule.

59

Biologics Regulation Modernization

0910-AI14

Proposed Rule.

60

Certifications Concerning Imported Foods

0910-AI66

Proposed Rule.

61

Use of Salt Substitutes to Reduce the Sodium Content in Standardized Foods

0910-AI72

Proposed Rule.

62

Tobacco Product Standard for Nicotine Level of Certain Tobacco Products

0910-AI76

Proposed Rule.

63

Mammography Quality Standards Act

0910-AH04

Final Rule.

64

Nonprescription Drug Product With an Additional Condition for Nonprescription Use

0910-AH62

Final Rule.

65

Tobacco Product Standard for Characterizing Flavors in Cigars

0910-AI28

Final Rule.

66

Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Relating to Agricultural Water

0910-AI49

Final Rule.

67

Tobacco Product Standard for Menthol in Cigarettes

0910-AI60

Final Rule.

68

Provider Nondiscrimination Requirements for Group Health Plans and Health Insurance Issuers in the Group and Individual Markets (CMS-9910)

0938-AU64

Proposed Rule.

69

Short-Term Limited Duration Insurance; Update (CMS-9904)

0938-AU67

Proposed Rule.

70

Assuring Access to Medicaid Services (CMS-2442)

0938-AU68

Proposed Rule.

71

Transitional Coverage for Emerging Technologies (CMS-3421)

0938-AU86

Proposed Rule.

72

Interoperability and Prior Authorization for MA Organizations, Medicaid and CHIP Managed Care and State Agencies, FFE QHP Issuers, MIPS Eligible Clinicians, Eligible Hospitals and CAHs (CMS-0057)

0938-AU87

Proposed Rule.

73

Medicare and Medicaid Program Integrity (CMS-6084)

0938-AU90

Proposed Rule.

74

Culturally Competent and Person-Centered Requirements to Increase Access to Care and Improve Quality for All (CMS-3418)

0938-AU91

Proposed Rule.

75

Mental Health Parity and Addiction Equity Act and the Consolidated Appropriations Act, 2021 (CMS-9902)

0938-AU93

Proposed Rule.

76

Coverage of Certain Preventive Services Under the Affordable Care Act (CMS-9903)

0938-AU94

Proposed Rule.

77

Contract Year 2024 Changes to the Medicare Advantage, Medicare Prescription Drug Benefit, Medicare Cost Plan Programs, Medicare Overpayment Provisions of the Affordable Care Act, and PACE (CMS-4201)

0938-AU96

Proposed Rule.

78

FY 2024 Skilled Nursing Facility (SNFs) Prospective Payment System and Consolidated Billing and Updates to the Value-Based Purchasing and Quality Reporting Programs (CMS-1779)

0938-AV02

Proposed Rule.

79

Streamlining the Medicaid and CHIP Application, Eligibility Determination, Enrollment, and Renewal Processes (CMS-2421)

0938-AU00

Final Rule.

80

Foster Care Legal Representation

0970-AC89

Proposed Rule.

81

Separate Licensing Standards for Relative or Kinship Foster Family Homes

0970-AC91

Proposed Rule.

82

Unaccompanied Children Program Foundational Rule

0970-AC93

Proposed Rule.

83

Federal Licensing of Office of Refugee Resettlement Facilities

0970-AC94

Proposed Rule.

84

Strengthening TANF as a Safety Net and Work Program

0970-AC97

Proposed Rule.

85

Adoption and Foster Care Analysis and Reporting System (AFCARS)

0970-AC98

Proposed Rule.

86

Modification of the Tribal Non-Federal Share Requirement

0970-AC99

Proposed Rule.

87

ANA Non-Federal Share Emergency Waivers

0970-AC88

Final Rule.

88

Older Americans Act, Titles III, VI, and VII

0985-AA17

Proposed Rule.

89

Adult Protective Services Functions and Grant Programs

0985-AA18

Proposed Rule.

Department of Homeland Security

Sequence No.

Title

Regulation

Identifier No.

Rulemaking stage

90

Victims of Qualifying Criminal Activities; Eligibility Requirements for U Nonimmigrant Status and Adjustment of Status

1615-AA67

Proposed Rule.

91

Improving the Regulations Governing the Adjustment of Status to Lawful Permanent Residence and Related Immigration Benefits

1615-AC22

Proposed Rule.

92

Particular Social Group and Related Definitions and Interpretations for Asylum and Withholding of Removal

1615-AC65

Proposed Rule.

93

U.S. Citizenship and Immigration Services Fee Schedule and Changes to Certain Other Immigration Benefit Request Requirements

1615-AC68

Proposed Rule.

94

Bars to Asylum Eligibility and Related Procedures

1615-AC69

Proposed Rule.

95

Modernization and Reform of the H-2 Programs

1615-AC76

Proposed Rule.

96

Citizenship and Naturalization and Other Related Flexibilities

1615-AC80

Proposed Rule.

97

Relief Under the Violence Against Women Act of 1994 and Subsequent Legislation

1615-AC81

Proposed Rule.

98

Security Bars and Processing

1615-AC57

Final Rule.

99

Cybersecurity in the Marine Transportation System

1625-AC77

Proposed Rule.

100

MARPOL Annex VI; Prevention of Air Pollution From Ships

1625-AC78

Proposed Rule.

101

Advance Passenger Information System: Electronic Validation of Travel Documents

1651-AB43

Proposed Rule.

102

Enhancing Surface Cyber Risk Management

1652-AA74

Prerule.

103

Vetting of Certain Surface Transportation Employees

1652-AA69

Proposed Rule.

104

Amending Vetting Requirements for Employees With Access to a Security Identification Display Area (SIDA)

1652-AA70

Proposed Rule.

105

Flight Training Security Program

1652-AA35

Final Rule.

106

Immigration Bond Notifications and Electronic Service

1653-AA85

Final Rule.

107

Optional Alternative to the Physical Examination Associated With Employment Eligibility Verification (Form I-9)

1653-AA86

Final Rule.

108

National Flood Insurance Program: Standard Flood Insurance Policy, Homeowner Flood Form

1660-AB06

Proposed Rule.

109

Individual Assistance Program Equity

1660-AB07

Proposed Rule.

110

Update of FEMA's Public Assistance Regulations

1660-AB09

Proposed Rule.

111

Updates to Floodplain Management and Protection of Wetlands Regulations

1660-AB12

Proposed Rule.

112

National Flood Insurance Program's Floodplain Management Standards for Land Management & Use, & an Assessment of the Program's Impact on Threatened and Endangered Species & Their Habitats

1660-AB11

Long-Term Action.

113

Ammonium Nitrate Security Program

1670-AA00

Proposed Rule.

114

Chemical Facility Anti-Terrorism Standards (CFATS)

1670-AA01

Proposed Rule.

Department of Housing and Urban Development

Sequence No.

Title

Regulation

Identifier No.

Rulemaking stage

115

24 CFR 5, 92, 93, 200, 247, 574, 576 578 Violence Against Women Act Reauthorization Act of 2022: Compliance in HUD Housing Programs (FR-6319)

2501-AE05

Proposed Rule.

116

24 CFR 50 Floodplain Management and Protection of Wetlands (FR-6272)

2506-AC54

Proposed Rule.

Department of Interior

Sequence No.

Title

Regulation

Identifier No.

Rulemaking stage

117

Onshore Oil and Gas Operations—Annual Civil Penalties Inflation Adjustments

1004-AE91

Final Rule.

Department of Justice

Sequence No.

Title

Regulation

Identifier No.

Rulemaking stage

118

Home Confinement Under the Coronavirus Aid, Relief, and Economic Security (CARES) Act

1120-AB79

Final Rule.

119

Implementation of the ADA Amendments Act of 2008: Federally Conducted (Section 504 of the Rehabilitation Act of 1973)

1190-AA73

Proposed Rule.

120

Nondiscrimination on the Basis of Disability by State and Local Governments: Medical Diagnostic Equipment

1190-AA78

Proposed Rule.

121

Nondiscrimination on the Basis of Disability: Accessibility of Web Information and Services of State and Local Governments

1190-AA79

Proposed Rule.

122

Nondiscrimination on the Basis of Disability by State and Local Governments; Public Right-of-Way

1190-AA77

Long-Term Action.

123

Medications to Prevent Narcotic Opioid Withdrawal Symptoms

1117-AB73

Proposed Rule.

124

Expansion of Induction of Buprenorphine via Telemedicine Encounter

1117-AB78

Proposed Rule.

125

Bars to Asylum Eligibility and Related Procedures

1125-AB12

Proposed Rule.

126

Particular Social Group and Related Definitions and Interpretations for Asylum and Withholding of Removal

1125-AB13

Proposed Rule.

127

Procedures for Asylum and Withholding of Removal

1125-AB15

Proposed Rule.

128

Appellate Procedures and Decisional Finality in Immigration Proceedings; Administrative Closure

1125-AB18

Proposed Rule.

129

Procedures for Credible Fear Screening and Consideration of Asylum, Withholding of Removal and CAT Protection Claims by Asylum Officers

1125-AB20

Final Rule.

Sequence No.

Title

Regulation

Identifier No.

Rulemaking stage

130

Final Action on Proposal to Rescind Implementing Legal Requirements Regarding the Equal Opportunity Clause's Religious Exemption

1250-AA09

Final Rule.

131

Pre-enforcement Notice and Conciliation Procedures

1250-AA14

Final Rule.

132

Form LM-10 Employer Report

1245-AA13

Final Rule.

133

Defining and Delimiting the Exemptions for Executive, Administrative, Professional, Outside Sales and Computer Employees

1235-AA39

Proposed Rule.

134

Nondisplacement of Qualified Workers Under Service Contracts

1235-AA42

Proposed Rule.

135

Updating the Davis-Bacon and Related Acts Regulations

1235-AA40

Final Rule.

136

Wagner-Peyser Act Staffing

1205-AC02

Final Rule.

137

Definition of the Term “Fiduciary”

1210-AC02

Proposed Rule.

138

Mental Health Parity and Addiction Equity Act and the Consolidated Appropriations Act, 2021

1210-AC11

Proposed Rule.

139

Respirable Crystalline Silica

1219-AB36

Proposed Rule.

140

Safety Program for Surface Mobile Equipment

1219-AB91

Final Rule.

141

Prevention of Workplace Violence in Health Care and Social Assistance

1218-AD08

Prerule.

142

Heat Illness Prevention in Outdoor and Indoor Work Settings

1218-AD39

Prerule.

143

Infectious Diseases

1218-AC46

Proposed Rule.

144

Occupational Exposure to COVID-19 in Healthcare Settings

1218-AD36

Final Rule.

Department of Transportation

Sequence No.

Title

Regulation

Identifier No.

Rulemaking stage

145

+Enhancing Transparency of Airline Ancillary Service Fees

2105-AF10

Proposed Rule.

146

+Accessible Lavatories on Single-Aisle Aircraft: Part II

2105-AE89

Final Rule.

147

+Safety Management System for Parts 21, 91, 135 and 145

2120-AL60

Proposed Rule.

148

+National Electric Vehicle Infrastructure Formula Program

2125-AG10

Final Rule.

149

+Heavy Vehicle Automatic Emergency Braking

2127-AM36

Proposed Rule.

150

+Light Vehicle Automatic Emergency Braking (AEB) with Pedestrian AEB

2127-AM37

Proposed Rule.

151

+Fuel Efficiency and Greenhouse Gas Standards for Medium- and Heavy-Duty Engines and Vehicles

2127-AM39

Proposed Rule.

152

+Light Vehicle CAFE Standards Beyond MY 2026

2127-AM55

Proposed Rule.

153

+Train Crew Staffing

2130-AC88

Proposed Rule.

154

+Pipeline Safety: Class Location Requirements

2137-AF29

Final Rule.

Department of Veterans Affairs

Sequence No.

Title

Regulation

Identifier No.

Rulemaking stage

155

Updating VA Adjudication Regulations for Disability or Death Benefit Claims Related to Herbicide Exposure

2900-AR10

Proposed Rule.

156

Pilot Veterans Services Organization Complementary and Integrative Health Self-Care Well-Being Center Grant Program

2900-AR60

Proposed Rule.

157

Expanded Burial Benefits

2900-AR69

Proposed Rule.

158

Updating VA Adjudication Regulations for Disability or Death Benefits Based on Toxic Exposure

2900-AR75

Proposed Rule.

159

Reevaluation of Claims for Dependency and Indemnity Compensation Based on Public Law 117-168

2900-AR76

Proposed Rule.

160

Authorization of Electronic Notice in Claims Under Laws Administered by the Secretary of Veterans Affairs

2900-AR77

Proposed Rule.

161

Modifying Copayments for Veterans at High Risk for Suicide

2900-AQ30

Final Rule.

162

Home Visits in Program of Comprehensive Assistance for Family Caregivers During COVID-19 National Emergency

2900-AQ96

Final Rule.

163

Staff Sergeant Parker Gordon Fox Suicide Prevention Grant Program

2900-AR16

Final Rule.

164

Copayment Exemption for Indian Veterans

2900-AR48

Final Rule.

165

Technical Revisions to Expand Health Care for Certain Toxic Exposure and Overseas Contingency Service

2900-AR73

Final Rule.

166

Procedural Updates for the PACT Act

2900-AR74

Final Rule.

Environmental Protection Agency

Sequence No.

Title

Regulation

Identifier No.

Rulemaking stage

167

Phasedown of Hydrofluorocarbons: Management of Certain Hydrofluorocarbons and Substitutes Under Subsection (h) of the American Innovation and Manufacturing Act of 2020

2060-AV84

Prerule.

168

PFAS-Related Designations as CERCLA Hazardous Substances

2050-AH25

Prerule.

169

National Emission Standards for Hazardous Air Pollutants: Ethylene Oxide Commercial Sterilization and Fumigation Operations

2060-AU37

Proposed Rule.

170

Amendments to the NSPS for GHG Emissions From New, Modified, & Reconstructed Stationary Sources: EGUs

2060-AV09

Proposed Rule.

171

Emission Guidelines for Greenhouse Gas Emissions From Fossil Fuel-Fired Existing Electric Generating Units

2060-AV10

Proposed Rule.

172

Volume Requirements for 2023 and Beyond Under the Renewable Fuel Standard Program

2060-AV14

Proposed Rule.

173

New Source Performance Standards and Emission Guidelines for Crude Oil and Natural Gas Facilities: Climate Review

2060-AV16

Proposed Rule.

174

Review of Final Rule Reclassification of Major Sources as Area Sources Under Section 112 of the Clean Air Act

2060-AV20

Proposed Rule.

175

Revisions to the Air Emission Reporting Requirements (AERR)

2060-AV41

Proposed Rule.

176

Phasedown of Hydrofluorocarbons: Allowance Allocation Methodology for 2024 and Later Years

2060-AV45

Proposed Rule.

177

Restrictions on Certain Uses of Hydrofluorocarbons Under Subsection (i) of the American Innovation and Manufacturing Act

2060-AV46

Proposed Rule.

178

Implementing Regulations Under 40 CFR Part 60 Subpart Ba Adoption and Submittal of State Plans for Designated Facilities

2060-AV48

Proposed Rule.

179

Multi-Pollutant Emissions Standards for Model Years 2027 and Later Light-Duty and Medium-Duty Vehicles

2060-AV49

Proposed Rule.

180

Reconsideration of the National Ambient Air Quality Standards for Particulate Matter

2060-AV52

Proposed Rule.

181

NESHAP: Coal-and Oil-Fired Electric Utility Steam Generating Units-Review of the Residual Risk and Technology Review

2060-AV53

Proposed Rule.

182

Methane Emissions and Waste Reduction Incentive Program and Revisions to the Mandatory Greenhouse Gas Reporting Rule for Petroleum and Natural Gas Systems

2060-AV83

Proposed Rule.

183

Fees for the Administration of the Toxic Substances Control Act (TSCA)

2070-AK64

Proposed Rule.

184

Methylene Chloride; Rulemaking Under Section 6(a) of the Toxic Substances Control Act (TSCA)

2070-AK70

Proposed Rule.

185

1-Bromopropane; Rulemaking Under Section 6(a) of the Toxic Substances Control Act (TSCA)

2070-AK73

Proposed Rule.

186

Carbon Tetrachloride; Rulemaking Under Section 6(a) of the Toxic Substances Control Act (TSCA)

2070-AK82

Proposed Rule.

187

Trichloroethylene; Rulemaking Under Section 6(a) of the Toxic Substances Control Act (TSCA)

2070-AK83

Proposed Rule.

188

Perchloroethylene; Rulemaking Under Section 6(a) of the Toxic Substances Control Act (TSCA)

2070-AK84

Proposed Rule.

189

N-Methylpyrrolidone; Rulemaking Under Section 6(a) of the Toxic Substances Control Act (TSCA)

2070-AK85

Proposed Rule.

190

Procedures for Chemical Risk Evaluation Under the Toxic Substances Control Act (TSCA)

2070-AK90

Proposed Rule.

191

Reconsideration of the Dust-Lead Hazard Standards and Dust-Lead Post Abatement Clearance Levels

2070-AK91

Proposed Rule.

192

Hazardous and Solid Waste Management System: Disposal of Coal Combustion Residuals From Electric Utilities; Legacy Surface Impoundments

2050-AH14

Proposed Rule.

193

Revisions to Standards for the Open Burning/Open Detonation of Waste Explosives

2050-AH24

Proposed Rule.

194

Listing of PFOA, PFOS, PFBS, and GenX as Resource Conservation and Recovery Act (RCRA) Hazardous Constituents

2050-AH26

Proposed Rule.

195

Definition of Hazardous Waste Applicable to Corrective Action for Solid Waste Management Units

2050-AH27

Proposed Rule.

196

Reporting Requirements for Emissions From Animal Waste Under the Emergency Planning and Community Right-to-Know Act

2050-AH28

Proposed Rule.

197

Federal Baseline Water Quality Standards for Indian Reservations

2040-AF62

Proposed Rule.

198

Revised Definition of “Waters of the United States”

2040-AG13

Proposed Rule.

199

National Primary Drinking Water Regulations for Lead and Copper: Improvements (LCRI) (

2040-AG16

Proposed Rule.

200

Water Quality Standards Regulatory Revisions to Protect Tribal Reserved Rights

2040-AG17

Proposed Rule.

201

Per- and Polyfluoroalkyl Substances (PFAS) National Primary Drinking Water Regulation Rulemaking

2040-AG18

Proposed Rule.

202

Effluent Limitations Guidelines and Standards for the Steam Electric Power Generating Point Source Category

2040-AG23

Proposed Rule.

203

Control of Air Pollution From New Motor Vehicles: Heavy-Duty Engine and Vehicle Standards

2060-AU41

Final Rule.

204

NESHAP: Coal- and Oil-Fired Electric Utility Steam Generating Units-Revocation of the 2020 Reconsideration, and Affirmation of the Appropriate and Necessary Supplemental Finding

2060-AV12

Final Rule.

205

Pesticides; Exemptions of Certain Plant-Incorporated Protectants (PIPs) Derived From Newer Technologies

2070-AK54

Final Rule.

206

Asbestos Part 1: Chrysotile Asbestos; Regulation of Certain Conditions of Use Under Section 6(a) of the Toxic Substances Control Act (TSCA)

2070-AK86

Final Rule.

207

Hazardous and Solid Waste Management System: Disposal of Coal Combustion Residuals From Electric Utilities; Federal CCR Permit Program

2050-AH07

Final Rule.

208

Hazardous and Solid Waste Management System: Disposal of CCR; A Holistic Approach to Closure Part B: Implementation of Closure

2050-AH18

Final Rule.

209

Accidental Release Prevention Requirements: Risk Management Program Under the Clean Air Act; Safer Communities by Chemical Accident Prevention

2050-AH22

Final Rule.

210

Clean Water Act Section 401: Water Quality Certification

2040-AG12

Final Rule.

211

Revised Definition of “Waters of the United States”

2040-AG19

Final Rule.

Office of Personnel Management

Sequence No.

Title

Regulation

Identifier No.

Rulemaking stage

212

Postal Service Health Benefits Program

3206-AO43

Final Rule.

Pension Benefit Guaranty Corporation

Sequence No.

Title

Regulation

Identifier No.

Rulemaking stage

213

Actuarial Assumptions for Determining an Employer's Withdrawal Liability

1212-AB54

Proposed Rule.

214

Special Financial Assistance by PBGC

1212-AB53

Final Rule.

Social Security Administration

Sequence No.

Title

Regulation

Identifier No.

Rulemaking stage

215

Use of Electronic Payroll Data To Improve Program Administration

0960-AH88

Proposed Rule.

216

Omitting Food From In-Kind Support and Maintenance Calculations

0960-AI60

Proposed Rule.

217

Social Security Number Use in Government Records

0960-AI80

Proposed Rule.

218

Revised Medical Criteria for Evaluating Digestive Disorders and Skin Disorders

0960-AG65

Proposed Rule.

Consumer Product Safety Commission

Sequence No.

Title

Regulation

Identifier No.

Rulemaking stage

219

Regulatory Options for Table Saws

3041-AC31

Final Rule.

220

Petition for Rulemaking to Eliminate Accessible Cords on Window Covering Products

3041-AD31

Final Rule.

221

Furniture Tip Overs: Clothing Storage Units

3041-AD65

Final Rule.

Nuclear Regulatory Commission

Sequence No.

Title

Regulation

Identifier No.

Rulemaking stage

222

Enhanced Weapons for Spent Fuel Storage Installations and Transportation—Section 161A Authority [NRC-2015-0018]

3150-AJ55

Prerule.

223

American Society of Mechanical Engineers Code Cases and Update Frequency [NRC-2018-0291]

3150-AK23

Proposed Rule.

224

Risk-Informed, Technology Inclusive Regulatory Framework [NRC-2019-0062]

3150-AK31

Proposed Rule.

225

Renewing Nuclear Power Plant Operating Licenses—Environmental Review [NRC-2018-0296]

3150-AK32

Proposed Rule.

226

Revision of Fee Schedules: Fee Recovery for FY 2023 [NRC-2021-0024]

3150-AK58

Proposed Rule.

DEPARTMENT OF AGRICULTURE

Statement of Regulatory Priorities

The U.S. Department of Agriculture's (USDA) fall 2022 Regulatory Agenda and Plan prioritizes initiatives fostering 21st century innovation like delivering broadband to farmers, ranchers, small businesses, and rural communities, addressing the effects of climate change such as drought and wildfire risks via climate-smart agriculture, expanding economic and market opportunity at home and abroad, job creation, improving access and delivery of our programs, particularly among historically underserved people and communities, and tackling food and nutrition insecurity while maintaining a safe food supply. Meanwhile, as we've responded to immediate needs during the past two years, USDA will continue to leverage our existing programs in response to those unforeseen domestic and international events and national emergencies that impact the American farm economy, schools, individual households, and our National Forests. Finally, we note that all USDA programs, including the priorities contained in this Regulatory Plan, will be structured to advance the cause of equity by removing barriers and opening new opportunities.

In 2022, the USDA:

Risk Management Agency implemented the

Pandemic Cover Crop Program

that reduced crop insurance premiums for agricultural producers to help them maintain cover crop systems, an important conservation practice, while keeping producers eligible for a premium benefit under the program.

Food and Nutrition Service (FNS) implemented a final rule that establishes

Standards for Milk, Whole Grains, and Sodium

in its Child Nutrition Programs for school years 2022-2023 and 2023-2024 to give schools time to transition in the short term as FNS works to develop long-term nutrition standards—based on the newest Dietary Guidelines for America and extensive input from a wide range of partners—that will work for schools, families, and industry alike. In 2022, FNS also implemented streamlining requirements in its Child Nutrition Programs to simplify the application process, enhance monitoring requirements, offer more clarity on existing requirements, and provide more discretion at the State agency level to manage program operations.

In late 2022, USDA plans to announce Phase 2 of the

Emergency Relief Program

that provides assistance to producers who suffered crop losses due to qualifying disaster events, and the

Pandemic Assistance Revenue Program,

a new program that provides support for agricultural producers impacted by the COVID-19 pandemic. In addition, this action makes changes to the Coronavirus Food Assistance Program; the Emergency Conservation Program; the Emergency Assistance for Livestock, Honeybees, and Farm-Raised Fish Program; the Livestock Forage Disaster Program; the Livestock Indemnity Program; the Noninsured Crop Disaster Assistance Program; and general payment eligibility provisions. For more information about this rule, see RIN 0503-AA75.

Outlined below are some of USDA's most important upcoming regulatory actions for 2023. These include efforts to restore and expand economic opportunity; address the climate crisis; and support agricultural markets that are free, open and promote competition. This Regulatory Plan also reflects USDA's continued commitments to ensuring a safe and nutritious food supply and animal welfare protections. As always, our Semiannual Regulatory Agenda contains information on a broad-spectrum of USDA's initiatives and upcoming regulatory actions.

Combat Climate Change To Support America's Working Lands, Natural Resources and Communities

Special Areas; Roadless Area Conservation; National Forest System Lands in Alaska:

In November 2021, USDA proposed to repeal a final rule promulgated in 2020 that exempted the Tongass National Forest from the 2001 Roadless Area Conservation Rule (2001 Roadless Rule). The 2001 Roadless Rule prohibited timber harvest and road construction or reconstruction within designated Inventoried Roadless Areas, with limited exceptions. USDA is planning to finalize this proposed rule in a manner consistent with President Biden's Executive Order 13990,

Protecting Public Health and the Environment and Restoring Science to Tackle the Climate Crisis,

directing review of Federal regulations issued during the previous four years that may conflict with protecting the environment, and in support of efforts to confront the climate crisis. For more information about this rule, see RIN 0596-AD51.

Foster an Equitable and Competitive Marketplace for All Agricultural Producers

Inclusive Competition and Market Integrity Rules Under the Packers and Stockyards Act:

In October 2022, USDA proposed to revise regulations under the Packers and Stockyards (P&S) Act, prohibiting certain prejudices and disadvantages and unjustly discriminatory conduct against covered producers in the livestock, meat, and poultry markets. The proposal identified retaliatory practices that interfere with lawful communications, assertion of rights, and participation in associations, among other protected activities. The proposal also identified unlawfully deceptive practices that violate the P&S Act with respect to contract formation, contract performance, contract termination and contract refusal. The purpose of the final rule is to promote inclusive competition and market integrity in the livestock, meats, and poultry markets. For more information about this rule, see RIN 0581-AE05.

Transparency in Poultry Grower Contracting and Tournaments Systems:

The final rule would address the use of poultry grower ranking systems as a method of payment and settlement grouping for poultry growers under

contract in poultry growing arrangements with live poultry dealers. The final rule would establish certain requirements with which a live poultry dealer must comply if a poultry grower ranking system is utilized to determine grower payment. A live poultry dealer's failure to comply would be deemed an unfair, unjustly discriminatory, and deceptive practice according to factors outlined in the final rule. A proposed rule was published in the

Federal Register

on June 8, 2022, 87 FR 48091. For more information about this rule, see RIN 0581-AE03.

Unfair Practices, Undue Preferences, and Harm to Competition under the Packers and Stockyards Act:

The proposal would revise regulations under the Packers and Stockyards Act (Act), providing clarity regarding conduct that may violate the Act, including addressing harm to competition. For more information about this rule, see RIN 0581-AE04.

Poultry Growing Tournament Systems: Fairness and Related Concerns—Harm to Competition:

The proposal seeks to address the use of poultry grower ranking systems, commonly known as “tournaments” in contract poultry production. Based on inputs from poultry growers, the proposal will seek to improve the market for poultry grower services. An advance notice of proposed rulemaking was published in the

Federal Register

on June 8, 2022, 87 FR 34814. For more information about this rule, see RIN 0581-AE18.

Provide All Americans Safe, Nutritious Food

USDA's Food Safety and Inspection Service (FSIS) continues to ensure that meat, poultry, and egg products are safe, wholesome, and properly marked, labeled, and packaged, and prohibits the distribution in-commerce of meat, poultry, and egg products that are adulterated or misbranded. One of FSIS' top priorities is to develop a more comprehensive and effective strategy to reduce Salmonella illnesses associated with poultry products. The agency is gathering the data and information necessary to support future action and move closer to the national target of a 25 percent reduction in Salmonella illnesses.

In addition, to enhance the safety of raw beef products, FSIS is strengthening its sampling and testing programs for shiga-toxin producing Escherichia coli in these products.

Moreover, consistent with the President's priorities of advancing the country's economic recovery and promoting economic resilience, FSIS is proposing several rules to improve regulatory certainty, which assure consumers that meat, poultry, and egg products are safe and truthfully labeled and fosters fair competition among the regulated industry. In a similar vein, AMS has prepared proposed standards for organic livestock and poultry production.

Voluntary Labeling of Meat Products With “Product of USA” and Similar Statements:

In accordance with Executive Order 14036, Promoting Competition in the American Economy, FSIS will propose to address concerns that the voluntary “Product of USA” label claim may confuse consumers about the origin of FSIS regulated products and undermine fair competition. FSIS intends to define the voluntary claim so that it is more meaningful to consumers and ensures a fair and competitive marketplace for American farmers and ranchers. For more information about this rule, see RIN 0583-AD87.

Labeling of Meat or Poultry Products Comprised of or Containing Cultured Animal Cells; Revision of the Nutrition Facts Panels for Meat and Poultry Products and Updating Certain Reference Amounts Customarily Consumed; and Prior Label Approval System: Expansion of Generic Label Approval:

FSIS will propose to establish new requirements for the labeling of meat or poultry products made using animal cell culture technology. FSIS also plans to finalize two other labeling rules, one to update nutrition labeling for meat and poultry products and another to expand the categories of meat and poultry product labels deemed generically approved that may be used in commerce without prior FSIS review and approval. The rule expanding the categories of generically approved labels will reduce labeling costs for meat and poultry establishments, including small and very small establishments. The three rules will provide additional certainty about what is required for meat and poultry labeling while ensuring that consumers have accurate information about the food they buy. For more information about these rules, see RINs 0583-AD56, 0583-AD78, and 0583-AD89.

National Organic Program; Organic Livestock and Poultry Standards:

The final rule would establish standards that support additional practice standards for organic livestock and poultry production. This final action would add provisions to the USDA organic regulations to address and clarify livestock and poultry living conditions (for example, outdoor access, housing environment and stocking densities), health care practices (for example physical alterations, administering medical treatment, euthanasia), and animal handling and transport to and during slaughter. For more information about this rule, see RIN 0581-AE06.

FNS' Child Nutrition Programs: Revisions to Meal Patterns Consistent with the 2020 Guidelines for Americans:

The proposed revisions would revise meal patterns in the National School Lunch Program and School Breakfast Program to make school meals healthier and more consistent with the most recent Dietary Guidelines for Americans while reflecting the nutrient needs of children at risk for food insecurity. For more information about this rule, see RIN 0584-AE88.

FNS' Special Supplemental Nutrition Program for Women, Infants and Children (WIC): Revisions in the WIC Food Packages:

Consistent with recommendations from the National Academies of Sciences, Engineering, and Medicine and the latest Dietary Guidelines for Americans, the proposal seeks to provide participants with greater choices in variety and food package sizes. For more information about this rule, see RIN 0584-AE82.

FNS' Community Eligibility Provision: Increasing Options for Schools:

The Community Eligibility Provision (CEP) is an option for schools to offer no-cost meals to all students without the burden of collecting household applications. This provision saves local educational agencies time and money by streamlining paperwork and administrative requirements and facilitates low-income children's access to nutritious school meals. This rule would lower the minimum participation threshold, which would expand access to CEP and provide greater flexibility to States and schools that want to use additional State and local funds to provide no-cost meals to students. For more information about this rule, see RIN 0584-AE93.

USDA—AGRICULTURAL MARKETING SERVICE (AMS)

Proposed Rule Stage

1. Unfair Practices, Undue Preferences, and Harm to Competition Under the Packers and Stockyards Act (AMS-FTPP-21-0046) [0581-AE04]

Priority:

Other Significant.

Legal Authority:

7 U.S.C. 181 to 229c

CFR Citation:

9 CFR 201.

Legal Deadline:

None.

Abstract:

This action proposes to revise regulations issued under the Packers and Stockyards Act (Act) (7

U.S.C.181 229c), providing clarity regarding conduct that may violate the Act. Revisions are intended to support market growth, assure fair trade practices and competition, and protect livestock and poultry growers and producers. The action addresses long-standing issues related to competitiveness and showings of harm or likely harm to competition.

Statement of Need:

Revisions to regulations pertaining to the Packers and Stockyards Act (Act) clarify the types of conduct by packers, swine contractors, or live poultry dealers that the Agricultural Marketing Service (AMS) considers unfair practices or undue preferences and a violation of sections 202(a) or 202(b) of the Act.

Sections 202(a) and 202(b) of the P&S Act are broadly written to prohibit unjustly practices and undue preferences. Industry members have complained that the regulations effectuating the Act are too vague and do not provide adequate clarity about the types of conduct or action that are likely to violate the Act. This rule is needed to provide essential clarity about what would be considered violations of the Act.

Revisions to regulations pertaining to the Packers and Stockyards Act (Act) that would also clarify the scope of the Act are needed to establish what conduct or action, depending on their nature and the circumstances, violate the Act without a finding of harm or likely harm to competition or as they may relate to harm or likely harm to competition as such terms were contemplated under the Act. Such revisions reflect the Department of Agriculture's (USDA) longstanding position in this regard.

Summary of Legal Basis:

The Packers and Stockyards Act (Act) authorizes AMS to determine if conduct within the poultry and livestock industries are unfair practices or undue preferences and, therefore a violation of the Act.

The Act provides USDA with the authority to assure fair competition and trade practices and to safeguard farmers against receiving less than the true market value of their livestock. Sections 202(c), (d), and (e) of the Act limit the application of those sections to acts or practices that have an adverse effect on competition, such as acts restraining commerce, creating a monopoly, or producing another type of antitrust injury. However, provisions in sections 202(a) and (b) restrict practices that are deceptive, unfair, unjust, undue, and unreasonable; terms that are understood to encompass more than anticompetitive conduct. USDA's position is that Congress did not intend application of sections 202(a) and (b) to be limited to instances in which there is harm to competition.

Alternatives:

USDA considered doing nothing. However, courts are not unanimous in their findings. Further, several courts disagree with USDA's position. Lack of clarity hinders the agency's ability to consistently administer and enforce the Act.

Anticipated Cost and Benefits:

USDA estimate annual costs related to this rule of $9 million for the first five years, decreasing in subsequent years, for total ten-year costs of $66 million. We believe the primary benefit of the proposed regulation is the increased ability to protect producers and growers through enforcement of the Act for violations of section 202(a) and/or (b) that do not result in harm, or a likelihood of harm, to competition.

Risks:

Courts have recognized that the proper analysis of alleged violations of these two sections depends on the facts of each case. However, four courts of appeals have disagreed with USDA's interpretation of the Act and have concluded that plaintiffs could not prove their claims under those sections without proving harm to competition or likely harm to competition. There is a risk if future legal challenge of USDA interpretation of sections 202(c), (d), and (e) of the Act.

Timetable:

Action

Date

FR Cite

NPRM

12/00/22

Regulatory Flexibility Analysis Required:

No.

Government Levels Affected:

None.

Agency Contact:

Michael V. Durando, Deputy Administrator, Fair Trade Practices Program, Department of Agriculture, Agricultural Marketing Service, 1400 Independence Avenue SW, Washington, DC 20250-0237,

Phone:

202 720-219.

RIN:

0581-AE04

USDA—AMS

2. Inclusive Competition and Market Integrity Under the Packers and Stockyards Act (AMS-FTPP-21-0045) [0581-AE05]

Priority:

Other Significant.

Legal Authority:

7 U.S.C. 181 to 229c

CFR Citation:

9 CFR 201.

Legal Deadline:

None.

Abstract:

This final rule would supplement a recent revision to regulations issued under the Packers and Stockyards Act (Act) (7 U.S.C.181 229c) that provided criteria for the Secretary to consider when determining whether certain conduct or action by packers, swine contractors, or live poultry dealers is unduly or unreasonably or advantageous. Supplemental amendments clarify the conduct the Department considers unfair, preferential unjustly discriminatory, or deceptive and a violation of sections 202(a) and (b) of the Act. The rule also clarifies the criteria and types of conduct that would be considered unduly or unreasonably preferential, advantageous, prejudicial, or disadvantageous and violations of the Act.

Statement of Need:

Revisions to regulations pertaining to the Packers and Stockyards Act (Act) clarify the types of conduct by packers, swine contractors, or live poultry dealers that the Agricultural Marketing Service (AMS) considers unfair, unjustly discriminatory, or deceptive and a violation of section 202(a) of the Act, regardless of whether such action harms or is likely to harm competition. The rule also clarifies the criteria and/or types of conduct that would be considered unduly or unreasonably preferential, advantageous, prejudicial, or disadvantageous and a violation of section 202(b) of the Act.

Sections 202(a) and 202(b) of the P&S Act are broadly written to prohibit unjustly practices and undue preferences and prejudices. Industry members have complained that the regulations effectuating the Act are too vague and do not provide adequate clarity about the types of conduct or action that are likely to violate the Act. This rule is needed to provide essential clarity about what would be considered violations of the Act, regardless of whether such violations harm or are likely to harm competition.

Summary of Legal Basis:

The Packers and Stockyards Act (Act) authorizes AMS to determine if conduct within the poultry and livestock industries are unfair, unjustly discriminatory, or deceptive and, therefore a violation of the Act.

Alternatives:

AMS considered taking no further action, allowing 100 years of case law to determine precedent in making determinations about whether certain behaviors violate the Act. AMS also considered revisiting the withdrawn 2016 rulemaking approach that would have identified criteria with which to determine whether certain behaviors violate the Act.

Anticipated Cost and Benefits:

USDA estimates first-year costs associated with this rule to be $517 thousand, with decreased costs each year thereafter, resulting in a ten-year total cost of $2.88

million. AMS expects this rule to benefit all segments of the industry, providing greater clarity about what would be considered violations of the Act. AMS expects this rule, coupled with a concurrent rule on the scope of the Act, to strengthen enforcement of the Act, resulting in fairer and more competitive markets for producers and poultry growers.

Risks:

Industry is divided about adding lists or examples of specific prohibited conduct to the regulations. Some argue such lists would inhibit freedom to forge contracts that fit individual situations, while others contend greater specificity is required so that affected parties can more readily identify violative behavior. Industry is also split on the question of whether identified prohibited behaviors must be found to harm or likely harm competition to be considered violations of the Act. AMS expects to resolve some of the controversy by being proactive and transparent with the industry to allow for critical discussions and decisions on the rule.

Timetable:

Action

Date

FR Cite

NPRM

10/03/22

87 FR 60010

NPRM Comment Period Extended

11/30/22

87 FR 73507

NPRM Comment Period End

12/02/22

NPRM Comment Period Extended End

01/17/23

Final Rule

04/00/23

Regulatory Flexibility Analysis Required:

Yes.

Small Entities Affected:

Businesses.

Government Levels Affected:

None.

Agency Contact:

Michael V. Durando, Deputy Administrator, Fair Trade Practices Program, Department of Agriculture, Agricultural Marketing Service, 1400 Independence Avenue SW, Washington, DC 20250-0237,

Phone:

202 720-0219.

RIN:

0581-AE05

USDA—AMS

3. Poultry Growing Tournament Systems: Fairness and Related Concerns—Harm to Competition (AMS-FTPP-22-0046) [0581-AE18]

Priority:

Other Significant.

Legal Authority:

7 U.S.C. 181

et seq.,

192

CFR Citation:

9 CFR 201.

Legal Deadline:

None.

Abstract:

This action seeks comments on proposed amendments to regulations that promote transparency in the poultry grower ranking systems, more commonly known as tournaments, in contract poultry production. Proposed amendments serve to remove obstacles to fair contracting.

Statement of Need:

Executive Order 14036 Promoting Competition in the American Economy, directs the Secretary of Agriculture to address unfair treatment of farmers and improve conditions of competition in their markets by considering rulemaking to address, among other things, certain practices related to poultry grower ranking systems. AMS is responding to numerous complaints from poultry growers about the use of tournament systems and recognizes that measures beyond disclosure and transparency may be necessary to address those practices, given the economic power imbalances and competition concerns that exist in today's markets. Responses to requests for comment have helped AMS tailor further policy development and rulemaking under the Packers and Stockyards Act, as amended, to address, through specific prohibitions, limits, and/or conventionalities, potential unfairness that may arise from the use of the tournament contracts in the poultry sector.

Summary of Legal Basis:

Sections 202(a) and 202(b) of the Packers and Stockyards Act prohibits unfair practices and undue preferences.

Alternatives:

The alternative considered is to continue with other efforts already underway to enhance fair and competitive markets in poultry. These include: (1) a separate rulemaking, under RIN 0581-AE03, in which USDA proposed a series of new transparency measures designed to address many grower concerns relating to deception and lack of access to critical information in connection with poultry contracting and tournament systems; (2) under the American Rescue Plan Act's provision to enhance supply chain resiliency, investing directly into the creation of new, and expansion of existing, local and regional meat and poultry processing enterprises; and (3) in partnership with DOJ, through such means as a newly established joint complaints and tips portal,

www.farmerfairness.gov

, enhancing enforcement activities including responding in a more coordinated manner to a range of competition and fair markets concerns.

Anticipated Cost and Benefits:

AMS is at an early stage of evaluating the costs and benefits of the contemplated regulatory interventions. However, expected benefits include greater certainty, investment, and supply of poultry products, greater returns to poultry growers and enhanced rural economic welfare, and expanded competitive choices in the poultry sector. Expected costs may include compliance costs, such as certain contract change costs.

Risks:

Agricultural production is an inherently risky endeavor, and returns have some level of risk no matter the marketing channel or structural arrangement. Tournament systems do not insulate growers from the financial risk, liquidity risk, the risk from incomplete contracts, and the lack of control over inputs and production variables. Tournaments also introduce new categories of risks to growers: Group composition risk and added risks of settlement-related deception or fraud. The risks of deception or fraud as discussed above include the inability of growers to verify the accuracy of payments, and to detect discrimination or retaliation.

Timetable:

Action

Date

FR Cite

ANPRM: Request for Comments

06/08/22

87 FR 34814

ANPRM Comment Period End

09/06/22

NPRM

07/00/23

Regulatory Flexibility Analysis Required:

No.

Government Levels Affected:

None.

Agency Contact:

Stephen Slinsky, Department of Agriculture, Agricultural Marketing Service, 1400 Independence Avenue SW, Washington, DC 20250,

Phone:

901 287-9719,

Email: stephen.slinsky@usda.gov.

RIN:

0581-AE18

USDA—AMS

Final Rule Stage

4. Transparency in Poultry Grower Contracting and Tournaments (AMS-FTPP-21-0044) [0581-AE03]

Priority:

Other Significant.

Legal Authority:

7 U.S.C. 181 to 229c

CFR Citation:

9 CFR 201.

Legal Deadline:

None.

Abstract:

This action amends regulations issued under the Packers and Stockyards Act (P&S Act), revising the list of disclosures and information live poultry dealers must furnish to poultry growers and sellers with whom dealers make poultry growing arrangements. The rule establishes parameters for the use of poultry grower ranking systems by dealers to determine settlement payments for poultry growers. Amendments are intended to

promote transparency in poultry production contracting and to give poultry growers relevant information with which to make business decisions.

Statement of Need:

Differences in size and imbalances of power between parties in contractual poultry growing arrangements can have detrimental effects on one of the contracting parties and may result in marketplace inefficiencies. An often-cited concern is the live poultry dealer's full control over inputs,

e.g.,

chick, feed, medication, etc., to the poultry growing process. Industry members have asked the Agricultural Marketing Service (AMS) to address such imbalances by specifying the conduct that would be considered violative of the Packers and Stockyards Act (Act).

Summary of Legal Basis:

The Agricultural Marketing Service (AMS) is delegated authority by the Secretary of Agriculture to enforce the P&S Act. AMS has received numerous complaints regarding the imbalance of power in poultry growing agreements, wherein one side controls all of the inputs, then arbitrarily ranks grower performance against other growers to determine pay.

Alternatives:

AMS considered finalizing a 2016 proposed rule that would have identified criteria for determining whether a live poultry dealer's use of a grower ranking system for payment purposes might be unlawful under the Packers and Stockyards Act.

Anticipated Cost and Benefits:

USDA estimates the first-year costs associated with this proposed rule to be $17.37 million. Subsequent year costs are expected to be significantly less than first-year costs, resulting in a ten-year total cost of $34.64 million. USDA expects the primary benefit of the regulation will be the increased ability to protect poultry growers from unfair practices associated with the use of poultry grower ranking systems. At the same time, the rule is expected to improve efficiencies through the use of new technologies and to reduce market failures among poultry growers.

Risks:

Extended litigation over legal challenges from the industry could result in the rule being struck down by the courts, hindering the agency's ability to enforce the Act for years.

Timetable:

Action

Date

FR Cite

NPRM

06/08/22

87 FR 34980

NPRM Comment Period End

08/08/22

Notice of Reopening of Comment Period

08/08/22

87 FR 48091

NPRM Comment Period End

08/23/22

Final Rule

05/00/23

Regulatory Flexibility Analysis Required:

Yes.

Small Entities Affected:

Businesses.

Government Levels Affected:

None.

Agency Contact:

Michael V. Durando, Deputy Administrator, Fair Trade Practices Program, Department of Agriculture, Agricultural Marketing Service, 1400 Independence Avenue SW, Washington, DC 20250-0237,

Phone:

202 720-0219.

RIN:

0581-AE03

USDA—AMS

5. Organic Livestock and Poultry Standards (AMS-NOP-21-0073) [0581-AE06]

Priority:

Economically Significant. Major under 5 U.S.C. 801.

Legal Authority:

7 U.S.C. 6501 to 7 U.S.C. 6524

CFR Citation:

7 CFR 205.

Legal Deadline:

None.

Abstract:

This action establishes additional practice standards for organic livestock and poultry production. The rule amends the USDA organic regulations related to: livestock and poultry living conditions (for example, outdoor access, housing environment, and stocking densities); animal health care (for example, physical alterations, administering medical treatment, and euthanasia); animal transport; and slaughter.

Statement of Need:

The Organic Livestock and Poultry Standards (OLPS) rule is needed to clarify the USDA organic standards for livestock and poultry living conditions and health practices. The current regulations for livestock production provide general requirements but some of these provisions are ambiguous and have led to inconsistent divergent practices, particularly in the organic poultry sector. This rule responds to nine recommendations from the National Organic Standards Board and findings from a USDA Office of Inspector General (OIG) report. (See USDA, Office of the Inspector General. March 2010. Audit Report 01601-03-Hy, Oversight of the National Organic Program. Available at:

http://www.usda.gov/oig/rptsauditsams.htm

.) This rule includes provisions to support the expression of natural behaviors and the welfare of organic livestock and poultry.

Summary of Legal Basis:

OLPS is authorized by the Organic Foods Production Act of 1990 (OFPA), 7 U.S.C. 65016524. OFPA authorizes the USDA to establish national standards governing the marketing of certain agricultural products as organically produced products to assure consumers that organically produced products meet a consistent standard and to facilitate interstate commerce in fresh and processed food that is organically produced.

Alternatives:

AMS considered several alternatives and presents these in the rule. AMS presents two compliance date alternatives in the rule that would affect the costs and benefits of the rule. Additionally, AMS discusses alternatives to specific policies included in the rule, including alternative indoor and outdoor space requirements, and non-regulatory alternatives, including consumer education or no rule.

Anticipated Cost and Benefits:

AMS assumes no costs or benefits are accumulated for clarifying and codifying existing practices. However, AMS does expect costs and benefits to occur for organic broiler production through increased indoor space and for organic broilers and in egg production through increased outdoor access for layers.

AMS estimates that the discounted costs for layer operations would range between $3.6 million and $8.4 million annually. To monetize the benefits of this rule, AMS used research that measured consumers' willingness-to-pay for outdoor access at a premium of between $0.16 and $0.25 per dozen eggs, controlling for other factors, including the organic label. Based on this, AMS estimates the annually discounted benefits falling between $11.6 million to $27.1 million.

AMS estimates that the total annual discounted costs for broiler compliance would be between $5.7 million and $6.3 million. The benefits for broilers are calculated using a willingness-to-pay at a premium of $0.34/lb. With this willingness-to-pay, the annual discounted benefits range between $97 million and $107 million.

Qualitatively, AMS also anticipates the rule will establish a clear standard protecting the value of the USDA organic seal to consumers, provide a consistent, level playing field for organic livestock producers, and facilitate enforcement of organic livestock and poultry standards.

Risks:

This rule is similar to the rule published on January 19, 2017 (82 FR 7042). That rule was subsequently withdrawn and never became effective. The USDA continues to face two legal challenges related to the withdrawal of that rule. USDA argued in its

withdrawal of the rule that USDA had no authority under the Organic Foods Production Act to promulgate the rule, so there is legal risk in reversing direction and publishing a similar rule.

Publishing a new proposed rule indicated that the USDA is taking new steps to advance the regulations. This has been viewed favorably by some, although others would prefer reinstating the January 2017 rule without the associated steps required to finalize a new rule.

Timetable:

Action

Date

FR Cite

NPRM

08/09/22

87 FR 48562

NPRM Comment Period End

10/11/22

Comment Period Extended

10/11/22

87 FR 61268

Comment Period Extended End

11/10/22

Final Rule

04/00/23

Regulatory Flexibility Analysis Required:

Yes.

Small Entities Affected:

Businesses.

Government Levels Affected:

None.

Agency Contact:

Erin Healy, Director, Standards Division, National Organic Program, Department of Agriculture, Agricultural Marketing Service, Washington, DC 20024,

Phone:

202 617-4942,

Email: erin.healy@usda.gov.

Related RIN:

Related to 0581-AD44, Related to 0581-AD74, Related to 0581-AD75

RIN:

0581-AE06

USDA—FOOD AND NUTRITION SERVICE (FNS)

Proposed Rule Stage

6. Special Supplemental Nutrition Program for Women, Infants and Children (WIC): Revisions in the WIC Food Packages [0584-AE82]

Priority:

Economically Significant. Major under 5 U.S.C. 801.

Legal Authority:

42 U.S.C. 1786, sec. 17(f)(11)(C)

CFR Citation:

7 CFR 246.10.

Legal Deadline:

None.

Abstract:

This proposed rulemaking would amend regulations governing the WIC food packages to: (1) incorporate recommendations of the National Academies of Science, Engineering, and Medicine 2017 scientific report, Review of WIC Food Packages: Improving Balance and Choice; (2) align with 2020 Dietary Guidelines for Americans; and (3) make other administrative revisions or clarifications to food package requirements.

Statement of Need:

The National Academies of Sciences, Engineering, and Medicine (NASEM) issued a 2017 report with recommendations to align the WIC food packages with the available nutrition science and to reflect the supplemental nature of the Program. In December 2020, the USDA and the Department of Health and Human Services released the 2020-2025 Dietary Guidelines for Americans (DGAs). USDA FNS will propose rulemaking to incorporate NASEM recommendations and align the food package with the latest DGAs.

Summary of Legal Basis:

42 U.S.C. 1786, sec. 17(f)(11)(C).

Alternatives:

N/A.

Anticipated Cost and Benefits:

This is discussed in the Regulatory Impact Analysis which was published on November 21, 2022 as an appendix to the rule, available at 87 FR 71090.

Risks:

N/A.

Timetable:

Action

Date

FR Cite

NPRM

11/21/22

87 FR 71090

NPRM Comment Period End

02/21/23

Regulatory Flexibility Analysis Required:

Undetermined.

Government Levels Affected:

Federal, Local, State.

Federalism:

This action may have federalism implications as defined in E.O. 13132.

Agency Contact:

Michael DePiro, Department of Agriculture, Food and Nutrition Service, 1320 Braddock Place, Alexandria, VA 22314,

Phone:

703 305-2876,

Email: michael.depiro@usda.gov.

Maureen Lydon, Department of Agriculture, Food and Nutrition Service, 1320 Braddock Place, Alexandria, VA 22314,

Phone:

703 457-7713,

Email: maureen.lydon@usda.gov.

RIN:

0584-AE82

USDA—FNS

7. Child Nutrition Programs: Revisions to Meal Patterns Consistent With the 2020 Dietary Guidelines for Americans [0584-AE88]

Priority:

Economically Significant. Major under 5 U.S.C. 801.

Legal Authority:

42 U.S.C. 1758, sec. 9(f)(1)

CFR Citation:

7 CFR 210.10; 7 CFR 210.11; 7 CFR 215.7a; 7 CFR 220.8; 7 CFR 226.20; . . .

Legal Deadline:

None.

Abstract:

This rule will propose long-term school nutrition standards based on the Dietary Guidelines for Americans, 2020-2025, and feedback from child nutrition program stakeholders. The proposed revisions are expected to make school meals more nutritious and more consistent with the goals of the most recent Dietary Guidelines, as required by statute. In addition, FNS is merging “Buy American Provision in the National School Lunch and School Breakfast Programs” (0584-AE91),which was listed as a long-term rule on the Fall 2021 Regulatory Agenda, with this rule (0584-AE88). When developing this proposed rule, FNS will consider comments submitted in response to the February 2022 final rule, “Child Nutrition Programs: Transitional Standards for Milk, Whole Grains, and Sodium” (0584-AE81). FNS will also consider comments submitted in response to the August 2021 “Request for Information: Buy American in the National School Lunch Program and School Breakfast Program,” including feedback on how FNS can better support local schools as they strive to purchase domestic foods and food products.

Statement of Need:

The proposed revisions are needed to make school meals more nutritious and more consistent with the goals of the most recent Dietary Guidelines, as required by statute.

Summary of Legal Basis:

42 U.S.C. 1758, sec. 9(f)(1).

Alternatives:

Alternatives not identified to date.

Anticipated Cost and Benefits:

These would be addressed in the Regulatory Impact Analysis for the rule.

Risks:

None known at this time.

Timetable:

Action

Date

FR Cite

NPRM

01/00/23

Regulatory Flexibility Analysis Required:

No.

Small Entities Affected:

No.

Government Levels Affected:

Local, State.

Federalism:

Undetermined.

Agency Contact:

Michael DePiro, Department of Agriculture, Food and Nutrition Service, 1320 Braddock Place, Alexandria, VA 22314,

Phone:

703 305-2876,

Email: michael.depiro@usda.gov.

Maureen Lydon, Department of Agriculture, Food and Nutrition Service, 1320 Braddock Place, Alexandria, VA 22314,

Phone:

703 457-7713,

Email: maureen.lydon@usda.gov.

Related RIN:

Merged with 0584-AE913

RIN:

0584-AE88

USDA—FNS

8. • Community Eligibility Provision: Increasing Options for Schools [0584-AE93]

Priority:

Other Significant. Major status under 5 U.S.C. 801 is undetermined.

Legal Authority:

42 U.S.C. 1759a(a)(1)(F)

CFR Citation:

7 CFR 245.9.

Legal Deadline:

None.

Abstract:

This proposed rule would lower the minimum participation threshold for Community Eligibility Provision (CEP) elections. Currently, to elect CEP, a local educational agency (LEA), group of schools, or individual school must meet a minimum identified student percentage threshold of 40 percent. This rule would lower the minimum participation threshold, which would provide an additional option for LEAs and schools to receive special assistance payments as Federal reimbursement for meals served to students, in lieu of taking applications.

Statement of Need:

The Community Eligibility Provision (CEP) is an option for schools to offer no-cost meals to all students without the burden of collecting household applications. This provision saves local educational agencies time and money by streamlining paperwork and administrative requirements and facilitates low-income children's access to nutritious school meals. Lowering the participation threshold expands access to CEP and provides greater flexibility to States and schools that want to use additional State and local funds to provide no-cost meals to students.

Summary of Legal Basis:

Per the Richard B. Russell National School Lunch Act (42 U.S.C. 1759a(a)(1)(F)(viii)(II)): “For each school year beginning on or after July 1, 2014, the Secretary may use a threshold that is less than 40 percent.”

Alternatives:

None.

Anticipated Cost and Benefits:

Expanding access to CEP to additional schools is not expected to measurably increase costs to the Federal government due to the cost sharing aspect. FNS anticipates that this provision could impact State and/or local costs. FNS expects that local educational agencies that choose to elect CEP at lower eligibility levels will have increased State and/or local obligations. A cost/benefit analysis will be addressed in the economic analysis section to be included within the rule.

Risks:

No risks have been identified at this time.

Timetable:

Action

Date

FR Cite

NPRM

07/00/23

Regulatory Flexibility Analysis Required:

No.

Small Entities Affected:

Governmental Jurisdictions.

Government Levels Affected:

Federal, Local, State, Tribal.

Agency Contact:

Michael DePiro, Department of Agriculture, Food and Nutrition Service, 1320 Braddock Place, Alexandria, VA 22314,

Phone:

703 305-2876,

Email: michael.depiro@usda.gov.

Maureen Lydon, Department of Agriculture, Food and Nutrition Service, 1320 Braddock Place, Alexandria, VA 22314,

Phone:

703 457-7713,

Email: maureen.lydon@usda.gov.

RIN:

0584-AE93

USDA—FNS

Final Rule Stage

9. • Special Supplemental Nutrition Program for Women, Infants, and Children (WIC): Implementation of the Access to Baby Formula Act of 2022 and Related Provisions [0584-AE94]

Priority:

Other Significant. Major status under 5 U.S.C. 801 is undetermined.

Legal Authority:

Pub. L. 117-129

CFR Citation:

7 CFR 246.

Legal Deadline:

None.

Abstract:

This rule would amend 7 CFR 246 to codify the provisions of the Access to Baby Formula Act of 2022 (ABFA). ABFA amends Section 17 of the Child Nutrition Act of 1966 to (1) add requirements to State agency infant formula cost containment contracts; and (2) establish waiver authority to the Secretary of Agriculture to address certain emergencies, disasters, and supply chain disruptions impacting WIC. FNS would make other related technical corrections and updates as necessary to modernize applicable WIC Program regulations.

Statement of Need:

This rule would codify requirements for State agencies to include language in their WIC infant formula rebate contracts that describes remedies in the event of an infant formula recall, including how an infant formula manufacturer would protect against disruption to program participants in the State (

i.e.,

ensure that WIC participants can purchase formula using WIC benefits). The rule would also codify permanent expanded waiver authority to aid participants in obtaining and redeeming WIC benefits during certain emergencies, disasters, and supply chain disruptions impacting WIC. Finally, the rule would make other miscellaneous technical corrections and updates as necessary to update WIC regulations.

Summary of Legal Basis:

The Access to Baby Formula Act of 2022 (ABFA, Pub. L. 117-129) amends section 17 of the Child Nutrition Act of 1966 (Pub. L. 89-642).

Alternatives:

No alternatives have been identified at this time.

Anticipated Cost and Benefits:

The costs associated with implementing the rule's regulatory requirements are not expected to significantly add to current program costs at the State and local levels.

Risks:

No risks have been identified at this time.

Timetable:

Action

Date

FR Cite

Final Rule With Comment

05/00/23

Regulatory Flexibility Analysis Required:

No.

Small Entities Affected:

No.

Government Levels Affected:

Local, State.

Agency Contact:

Michael DePiro, Department of Agriculture, Food and Nutrition Service, 1320 Braddock Place, Alexandria, VA 22314,

Phone:

703 305-2876,

Email: michael.depiro@usda.gov.

Maureen Lydon, Department of Agriculture, Food and Nutrition Service, 1320 Braddock Place, Alexandria, VA 22314,

Phone:

703 457-7713,

Email: maureen.lydon@usda.gov.

RIN:

0584-AE94

USDA—FOOD SAFETY AND INSPECTION SERVICE (FSIS)

Proposed Rule Stage

10. Voluntary Labeling of Products With “Product of USA” and Similar Statements [0583-AD87]

Priority:

Other Significant.

Legal Authority:

21 U.S.C. 601

et seq.;

21 U.S.C. 451

et seq.;

21 U.S.C. 1031

et seq.

CFR Citation:

9 CFR 317.8.

Legal Deadline:

None.

Abstract:

The Food Safety and Inspection Service (FSIS) is proposing to amend its regulations to define the conditions under which the labeling of products can bear voluntary statements indicating that the product is of United States (U.S.) origin, such as Product of USA or Made in the USA.

Statement of Need:

In 2018 and 2019, FSIS received two petitions requesting that it change its policy regarding the labeling of meat products to indicate U.S. origin. After considering the petitions and the public comments submitted in response to them, FSIS concluded that adherence to the current labeling policy guidance may be causing confusion in the marketplace with respect to certain imported products and that the current labeling policy may no longer meet consumer expectations of what the Product of USA claim signifies. In 2021, FSIS received another petition related to its Product of USA policy. The Agency wants to ensure that any changes to its current policy are accomplished by an open and transparent process. Therefore, FSIS commissioned a consumer survey and decided that, instead of changing the Policy Book entry, it would initiate rulemaking to define the conditions under which the labeling of FSIS-regulated products would be permitted to bear voluntary statements indicating that the product is of U.S. origin.

Summary of Legal Basis:

Under the Federal Meat Inspection Act (FMIA) (21 U.S.C. 601-695, at 607), the Poultry Products Inspection Act (PPIA) (21 U.S.C. 451-470, at 457), and the Egg Products Inspection Act (21 U.S.C. 1031-1056, at 1036) (the Acts), the labels of meat, poultry, and egg products must be approved by the Secretary of Agriculture, who has delegated this authority to FSIS, before these products can enter commerce. The Acts prohibit the sale or offer for sale by any person, firm, or corporation of any article in commerce under any name or other marking or labeling that is false or misleading or in any container of a misleading form or size (21 U.S.C. 607(d); 21 U.S.C. 457(c)). The Acts also prohibit the distribution in commerce of meat or poultry products that are adulterated or misbranded. The FMIA and PPIA give FSIS broad authority to promulgate such rules and regulations as are necessary to carry out the provisions of the Acts (21 U.S.C. 621 and 463(b)).

Alternatives:

FSIS has considered the current labeling guidance and the alternatives proposed in the two petitions: (1) to amend the FSIS Policy Book to state that FSIS-regulated products may be labeled as Product of USA only if significant ingredients are of domestic origin and; (2) to amend the FSIS Policy Book to provide that any FSIS regulated product labeled as Made in the USA, Product of the USA, USA Beef or in any other manner that suggests that the origin is the United States, be derived from animals that have been born, raised, and slaughtered in the United States. FSIS is conducting a comprehensive review of origin labeling claims and conducting a consumer perception survey pursuant to developing the proposed regulations.

Anticipated Cost and Benefits:

Establishments may incur costs associated with voluntarily changing their labels as a result of any revised Product of USA labeling claim definition. This proposed rule is expected to benefit consumers as well as producers by providing them more specific information on what Product of USA means for FSIS-regulated products.

Risks:

N/A.

Timetable:

Action

Date

FR Cite

NPRM

12/00/22

Regulatory Flexibility Analysis Required:

No.

Small Entities Affected:

Businesses.

Government Levels Affected:

None.

Agency Contact:

Melissa Hammar, Acting Director, Regulations Development Staff, Department of Agriculture, Food Safety and Inspection Service, 1400 Independence Avenue SW, Washington, DC 20250-3700,

Phone:

202 720-2096,

Email: melissa.hammar@usda.gov.

RIN:

0583-AD87

USDA—FSIS

11. Labeling of Meat and Poultry Products Made Using Animal Cell Culture Technology [0583-AD89]

Priority:

Other Significant.

Legal Authority:

21 U.S.C. 451

et seq.

CFR Citation:

9 CFR ch. III.

Legal Deadline:

None.

Abstract:

This notice of proposed rulemaking seeks public comments to inform future Food Safety and Inspection Service (FSIS) regulations for the labeling of meat and poultry products made using animal cell culture technology.

Statement of Need:

Many companies, both domestic and foreign, are currently developing cultured products derived from the cells of food animals amenable to the Federal Meat Inspection Act (FMIA; 21 U.S.C. 601

et seq.

) (cattle, sheep, swine, goats, and fish of the order Siluriformes,

e.g.,

catfish) or the Poultry Products Inspection Act (PPIA; 21 U.S.C. 451

et seq.

) (chickens, turkeys, ducks, geese, guineas, ratites, and squabs). Human food products derived from these species fall under FSIS jurisdiction.

Summary of Legal Basis:

The Federal Meat Inspection Act (FMIA; 21 U.S.C. 601

et seq.

) and the Poultry Products Inspection Act (PPIA; 21 U.S.C. 451

et seq.

) require that meat and poultry products be truthfully and accurately labeled and that their labels be pre-approved by FSIS (21 U.S.C. 607(d) and 457(c), respectively), prior to movement in commerce. FSIS issues labeling regulations and reviews and approves meat and poultry product labels pursuant to these statutory labeling requirements. Food products made using animal cell culture technology and derived from the cells of livestock subject to the FMIA or the PPIA are subject to the labeling (and other applicable) requirements of these Acts and the regulations issued thereunder.

Alternatives:

FSIS will consider at least three alternatives for the rule: (1) Adopting a naming convention that is preferred by cellular agriculture industry; (2) Adopting a naming convention that is preferred by traditional agriculture industry; (3) Adopting a naming convention that is preferred by consumers groups.

Anticipated Cost and Benefits:

This proposed rule would benefit the public by providing truthful and accurate labeling of meat and poultry products produced using animal cell culture technology.

FSIS expects its costs to be minimal and that current FSIS staffing would meet sketch approval needs.

Risks:

None.

Timetable:

Action

Date

FR Cite

ANPRM

09/03/21

86 FR 49491

ANPRM Comment Period End

12/02/21

NPRM

08/00/23

Regulatory Flexibility Analysis Required:

No.

Small Entities Affected:

No.

Government Levels Affected:

None.

Agency Contact:

Melissa Hammar, Acting Director, Regulations Development Staff, Department of Agriculture, Food Safety and Inspection Service, 1400 Independence Avenue SW, Washington, DC 20250-3700,

Phone:

202 720-2096,

Email: melissa.hammar@usda.gov.

RIN:

0583-AD89

USDA—FSIS

Final Rule Stage

12. Revision of the Nutrition Facts Panels for Meat and Poultry Products and Updating Certain Reference Amounts Customarily Consumed [0583-AD56]

Priority:

Other Significant.

Legal Authority:

21 U.S.C. 601

et seq.;

21 U.S.C. 451

et seq.

CFR Citation:

9 CFR 317; 9 CFR 381; 9 CFR 413.

Legal Deadline:

None.

Abstract:

Consistent with the changes that the Food and Drug Administration (FDA) finalized, the Food Safety and Inspection Service (FSIS) is amending the Federal meat and poultry products inspection regulations to update and revise the nutrition labeling requirements for meat and poultry products to reflect recent scientific research and dietary recommendations and to improve the presentation of nutrition information to assist consumers in maintaining healthy dietary practices.

Statement of Need:

On May 27, 2016, the Food and Drug Administration (FDA) published two final rules: (1) “Food Labeling: Revision of the Nutrition and Supplement Facts Labels” (81 FR 33742); and (2) “Food Labeling: Serving Sizes of Foods that Can Reasonably be Consumed at One Eating Occasion; Dual-Column Labeling; Updating, Modifying, and Establishing Certain Reference Amounts Customarily Consumed; Serving Size for Breath Mints; and Technical Amendments” (81 FR 34000). FDA finalized these rules to update the Nutrition Facts label to reflect new nutrition and public health research, to reflect recent dietary recommendations from expert groups, and to improve the presentation of nutrition information to help consumers make more informed choices and maintain healthy dietary practices. FSIS has reviewed FDA's analysis and, to ensure that nutrition information is presented consistently across the food supply, FSIS is amending the nutrition labeling regulations for meat and poultry products to parallel, to the extent possible, FDA's regulations. This approach will help increase clarity of information for consumers and will improve efficiency in the marketplace.

Summary of Legal Basis:

Under the Federal Meat Inspection Act (FMIA) (21 U.S.C. 601-695, at 607), the Poultry Products Inspection Act (PPIA) (21 U.S.C. 451-470, at 457), and the Egg Products Inspection Act (21 U.S.C. 1031-1056, at 1036) (the Acts), the labels of meat, poultry, and egg products must be approved by the Secretary of Agriculture, who has delegated this authority to FSIS, before these products can enter commerce. The Acts prohibit the sale or offer for sale by any person, firm, or corporation of any article in commerce under any name or other marking or labeling that is false or misleading or in any container of a misleading form or size (21 U.S.C. 607(d); 21 U.S.C. 457(c)). The Acts also prohibit the distribution in commerce of meat or poultry products that are adulterated or misbranded. The FMIA and PPIA give FSIS broad authority to promulgate such rules and regulations as are necessary to carry out the provisions of the Acts (21 U.S.C. 621 and 463(b)).

To prevent meat and poultry products from being misbranded, the meat and poultry product inspection regulations require that the labels of meat and poultry products include specific information, such as nutrition labels, and that such information be displayed as prescribed in the regulations (9 CFR part 317 and part 381). The nutrition labeling requirements for meat and meat food products are in 9 CFR 317.300-317.400, and the nutrition labeling requirements for poultry products are in 9 CFR 381.400-381.500.

Alternatives:

FSIS considered three alternatives for the final rule: (1.) No action; (2.) A 24-month compliance period for large businesses and a 36-month compliance period for small businesses (as proposed); or (3.) A 12-month compliance period for large businesses and a 24-month compliance period for small businesses for faster label harmonization.

Anticipated Cost and Benefits:

These regulations are expected to benefit consumers by increasing and improving dietary information available in the market. Firms will incur a one-time cost for relabeling, recordkeeping costs, and costs associated with voluntary reformulation. Many firms have voluntarily begun using the FDA format, which will reduce costs.

Risks:

None.

Timetable:

Action

Date

FR Cite

NPRM

01/19/17

82 FR 6732

NPRM Comment Period End

04/19/17

Final Action

06/00/23

Regulatory Flexibility Analysis Required:

No.

Small Entities Affected:

Businesses.

Government Levels Affected:

None.

Agency Contact:

Melissa Hammar, Acting Director, Regulations Development Staff, Department of Agriculture, Food Safety and Inspection Service, 1400 Independence Avenue SW, Washington, DC 20250-3700,

Phone:

202 720-2096,

Email: melissa.hammar@usda.gov.

RIN:

0583-AD56

USDA—FSIS

13. Prior Label Approval System: Expansion of Generic Label Approval [0583-AD78]

Priority:

Other Significant.

Legal Authority:

21 U.S.C. 601

et seq.;

21 U.S.C. 451

et seq.;

21 U.S.C. 1031

et seq.

CFR Citation:

9 CFR 412.2(a)(1); 9 CFR 317.7; 9 CFR 381.128; 9 CFR 412.2(b).

Legal Deadline:

None.

Abstract:

The Food Safety and Inspection Service (FSIS) is amending its labeling regulations to expand the categories of meat, poultry, and egg product labels that it will deem generically approved and thus not required to be submitted to FSIS. These reforms will reduce the regulatory burden on producers seeking to bring products to market, as well as the Agency costs expended to evaluate the labels.

Statement of Need:

This action is needed to reduce the regulatory burden on producers seeking to bring products to market, as well as the Agency costs expended to evaluate the labels. Based on FSIS experience evaluating the labels in question and the ability of inspection personnel to verify labeling in the field, FSIS anticipates this action will have no impact on food safety or the accuracy of meat, poultry, and egg product labeling.

Summary of Legal Basis:

The Acts direct the Secretary of Agriculture to maintain meat, poultry, and egg inspection programs designed to assure consumers that these products are safe, wholesome, not adulterated, and properly marked, labeled, and packaged. Section 7(d) of the Federal Meat Inspection Act (21 U.S.C. 607(d)) states:

No article subject to this title shall be sold or offered for sale by any person, firm, or corporation, in commerce, under any name or other marking or labeling which is false or misleading, or in any container of a misleading form or size, but established trade names and other marking and labeling and containers which are not false or misleading and which are approved by the Secretary are permitted. The Poultry Products Inspection Act and the Egg Products Inspection Act contain similar language in section 21 U.S.C. 457(c) and 1036(b), respectively.

Alternatives:

FSIS considered three alternatives for the rule: taking no action, adopting the current proposal except with continued evaluation of labels that would otherwise be generically approved, and allowing all labels to be generically approved.

Anticipated Cost and Benefits:

There are no additional costs to industry, or the Agency associated with this rule. FSIS will continue to verify that product labels, including those that are generically approved, are truthful and not misleading and otherwise comply with FSIS' requirements.

This rule is expected to reduce the number of labels industry is required to submit to FSIS for evaluation by approximately 35 percent. Establishments will realize a cost savings because they will no longer need to incur costs for submitting certain types of labels to FSIS for evaluation (

e.g.,

preparing a printer's proof). In addition, streamlining the evaluation process for specific types of labels will allow a faster introduction of products into the marketplace by reducing wait times for label approvals.

FSIS will also benefit from a reduction in the number of labels submitted to it for review. FSIS will be able to reallocate staff hours from evaluating labels towards the development of labeling policy.

Risks:

None.

Timetable:

Action

Date

FR Cite

NPRM

09/14/20

85 FR 56538

NPRM Comment Period End

11/13/20

Final Rule

01/00/23

Regulatory Flexibility Analysis Required:

No.

Small Entities Affected:

Businesses.

Government Levels Affected:

None.

Agency Contact:

Melissa Hammar, Acting Director, Regulations Development Staff, Department of Agriculture, Food Safety and Inspection Service, 1400 Independence Avenue SW, Washington, DC 20250-3700,

Phone:

202 720-2096,

Email: melissa.hammar@usda.gov.

RIN:

0583-AD78

BILLING CODE 3410-90-P

DEPARTMENT OF COMMERCE

Statement of Regulatory and Deregulatory Priorities

Established in 1903, the Department of Commerce (Commerce or Department) is one of the oldest Cabinet-level agencies in the Federal Government. Commerce's mission is to create the conditions for economic growth and opportunity across all American communities by promoting innovation, entrepreneurship, competitiveness, and environmental stewardship. Commerce has 12 operating units, which manage a diverse portfolio of programs and services ranging from trade promotion and economic development assistance to improved broadband access and the National Weather Service, and from standards development and statistical data production, including the decennial census, to patents and fisheries management. Across these varied activities, the Department seeks to provide a foundation for a more equitable, resilient, and globally competitive economy.

To fulfill its mission, Commerce works in partnership with businesses, educational institutions, community organizations, government agencies, and individuals to:

• Innovate by creating new ideas through cutting-edge science and technology, from advances in nanotechnology to ocean exploration to broadband deployment, and by protecting American innovations through the patent and trademark system;

• Support entrepreneurship and commercialization by enabling community development and strengthening minority businesses and small manufacturers;

• Maintain U.S. economic competitiveness in the global marketplace by promoting exports and foreign direct investment, ensuring a level playing field for U.S. businesses, and ensuring that technology transfer is consistent with our nation's economic and security interests;

• Provide effective management and stewardship of our nation's resources and assets to ensure sustainable economic opportunities; and

• Make informed policy decisions and enable better understanding of the economy and our communities by providing timely, accessible, and accurate economic and demographic data.

Responding to the Administration's Regulatory Philosophy and Principles

Commerce's Regulatory Plan tracks the most important regulations that the Department anticipates issuing to implement these policy and program priorities and foster sustainable and equitable growth. Of Commerce's 12 primary operating units, three bureaus—the National Oceanic and Atmospheric Administration (NOAA), the United States Patent and Trademark Office (USPTO), and the Bureau of Industry and Security (BIS)—issue the vast majority of the Department's regulations, and these three bureaus account for all the planned actions that are considered the Department's most important significant pre-regulatory or regulatory actions for FY 2022.

National Oceanic and Atmospheric Administration

NOAA's mission is built on three pillars: science, service, and stewardship—to understand and predict changes in climate, weather, oceans, and coasts; to share that knowledge and information with others; and to conserve and manage coastal and marine ecosystems and resources.

At its core, NOAA is a scientific agency. It observes, measures, monitors, and collects data from the depths of the ocean to the surface of the sun, and it does so following principles of scientific integrity. These data are turned into weather and climate models and forecasts that are then used for everything from local weather forecasts to predicting the movement of wildfire smoke to identifying the impacts of climate change on fisheries and living marine resources.

With respect to service, NOAA not only collects data but is mandated to make it operational, and NOAA seeks to be the authoritative provider of climate products and services. By providing Federal, State, and local government partners, the private sector, and the public with actionable environmental information, NOAA can facilitate decisions in the face of climate change. Such decisions can range from businesses planning the location of offices; insurance companies trying to incorporate climate risk into their insurance policies; and municipalities looking to ensure that plans for construction of new housing developments will be resilient to increasing sea level risk, flooding, and heavy precipitation.

The final pillar of NOAA's mission is stewardship. NOAA seeks to conserve our lands, waters, and natural resources, protecting people and the environment now and for future generations. As part of Commerce, moreover, NOAA recognizes that economic growth must go hand-in-hand with environmental stewardship. For example, with respect to the nation's fisheries, NOAA looks simultaneously to optimize productivity and ensure sustainability in order to boost long-term economic growth and competitiveness in this vital sector of the U.S. economy. Similarly, national marine sanctuaries both protect important natural resources and also are significant drivers of eco-tourism and local recreation.

Within NOAA, the National Marine Fisheries Services (NMFS) and the National Ocean Service (NOS) are the components that most often exercise regulatory authority to implement NOAA's mission. NMFS oversees the management and conservation of the nation's marine fisheries; protects marine mammals and Endangered Species Act (ESA)-listed marine and anadromous species; and promotes economic development of the U.S. fishing industry. NOS assists the coastal states in their management of land and ocean resources in their coastal zones, including estuarine research reserves; manages national marine sanctuaries; monitors marine pollution; and directs the national program for deep-seabed minerals and ocean thermal energy.

Much of NOAA's rulemaking is conducted pursuant to the following key statutes:

Magnuson-Stevens Fishery Conservation and Management Act

Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act) rulemakings concern the conservation and management of fishery resources in the U.S. Exclusive Economic Zone (generally 3-200 nautical miles from shore). As itemized in the Unified Agenda, NOAA plans to take several hundred actions in FY 2022 under Magnuson-Stevens Act authority, of which roughly 20 are expected to be significant rulemakings, as defined in Executive Order 12866. With certain exceptions, rulemakings under Magnuson-Stevens are usually initiated by the actions of eight regional Fishery Management Councils (FMCs or Councils). These Councils are comprised of representatives from the commercial and recreational fishing sectors, environmental groups, academia, and Federal and State government, and they are responsible for preparing fishery management plans (FMPs) and FMP amendments, and for recommending implementing regulations for each managed fishery. FMPs address a variety of issues, including maximizing fishing opportunities on healthy stocks, rebuilding overfished stocks, and addressing gear conflicts. After considering the FMCs' recommendations in light of the standards and requirements set forth in the Magnuson-Stevens Act and in other applicable laws, NOAA may issue regulations to implement the proposed FMPs and FMP amendments.

Marine Mammal Protection Act

The Marine Mammal Protection Act of 1972 (MMPA) provides the authority for the conservation and management of marine mammals under U.S. jurisdiction. It expressly prohibits, with certain exceptions, the intentional take of marine mammals. The MMPA allows, upon request and subsequent authorization, the incidental take of marine mammals by U.S. citizens who engage in a specified activity (

e.g.,

oil and gas development, pile driving) within a specified geographic region. NMFS authorizes incidental take under the MMPA if it finds that the taking would be of small numbers, have no more than a “negligible impact” on those marine mammal species or stock, and would not have an “unmitigable adverse impact” on the availability of the species or stock for “subsistence” uses. NMFS also initiates rulemakings under the MMPA to establish a management regime to reduce marine mammal mortalities and injuries as a result of interactions with fisheries. In addition, the MMPA allows NMFS to permit the take or import of wild animals for scientific research or public display or to enhance the survival of a species or stock.

Endangered Species Act

The Endangered Species Act of 1973 (ESA) provides for the conservation of species that are determined to be “endangered” or “threatened,” and the conservation of the ecosystems on which these species depend. NMFS and the Department of Interior's Fish and Wildlife Service (FWS) jointly administer the provisions of the ESA: NMFS manages marine and several anadromous species, and FWS manages land and freshwater species. Together, NMFS and FWS work to protect critically imperiled species from extinction. NMFS rulemaking actions under the ESA are focused on determining whether any species under its responsibility is an endangered or threatened species and whether those species must be added to the list of protected species. NMFS is also responsible for designating, reviewing and revising critical habitat for any listed species. In addition, as indicated in the list of highlighted actions below, NMFS and FWS may also issue rules clarifying how particular provisions of the ESA will be implemented.

The National Marine Sanctuaries Act

The National Marine Sanctuaries Act (NMSA) authorizes the Secretary of Commerce to designate and protect as national marine sanctuaries areas of the marine environment with special national significance due to their conservation, recreational, ecological, historical, scientific, cultural, archeological, educational, or aesthetic qualities. The primary objective of the NMSA is to protect marine resources, such as coral reefs, sunken historical vessels, or unique habitats.

NOAA's Office of National Marine Sanctuaries (ONMS), within NOS, has the responsibility for management of national marine sanctuaries. ONMS regulations, issued pursuant to NMSA, prohibit specific kinds of activities, describe and define the boundaries of the designated national marine sanctuaries, and set up a system of permits to allow the conduct of certain types of activities that would otherwise not be allowed.

These regulations can, among other things, regulate and restrict activities that may injure natural resources, including all extractive and destructive activities, consistent with community-specific needs and NMSA's purpose to “facilitate to the extent compatible with the primary objective of resource protection, all public and private uses of the resources of these marine areas.” In FY 2022, NOAA is expected to have at least three regulatory actions under NMSA.

Coastal Zone Management Act

The Coastal Zone Management Act (CZMA) was passed in 1972 to preserve, protect, and develop and, where possible, to restore and enhance the resources of the nation's coastal zone. The CZMA creates a voluntary state-federal partnership, where coastal states (States in, or bordering on, the Atlantic, Pacific or Arctic Ocean, the Gulf of Mexico, Long Island Sound, or one or more of the Great Lakes), may elect to develop comprehensive programs that meet federal approval standards. Currently, 34 of the 35 eligible entities are implementing a federally approved coastal management plan approved by the Secretary of Commerce.

NOAA's Regulatory Plan Actions

Of the numerous regulatory actions that NOAA is planning for this year and that are included in the Unified Agenda, there are five, described below, that the Department considers to be of particular importance.

1.

Illegal, Unreported, and Unregulated Fishing; Fisheries Enforcement; High Seas Driftnet Fishing Moratorium Protection Act (0648-BG11):

The United States is a signatory to the Port State Measures Agreement (PSMA). The agreement is aimed at combating illegal, unreported, and unregulated (IUU) fishing activities through increased port inspection of foreign fishing vessels and by preventing the products of illegal fishing from landing and entering into commerce. The High Seas Driftnet Fishing Moratorium Act (Fishing Moratorium Act) implemented provisions of the PSMA, and NOAA issued regulations under the Fishing Moratorium Act in 2011 and 2013. Since then, the provisions of the Fishing Moratorium Act have been amended by the Illegal, Unreported and Unregulated Fishing Enforcement Act of 2015 (Pub. L. 114-81) and the Ensuring Access to Pacific Fisheries Act (Pub. L. 114-327). This proposed rule would implement amendments made by these later two laws. NMFS will also propose changes to the definition of IUU fishing for the purposes of identifying and certifying nations.

2.

Amendments to the North Atlantic Right Whale Vessel Strike Reduction Rule (0648-BI88):

Regulatory modifications are needed to further reduce the likelihood of mortalities and serious injuries to endangered North Atlantic right whales from vessel collisions, which are a primary cause of the species' decline and greatly contributing to the ongoing Unusual Mortality Event (2017-present). Following two decades of growth, the species has been in decline over the past decade with a population estimate of only 368 individuals as of 2019. Vessel strikes are one of the two primary causes of North Atlantic right whale mortality and serious injury across their range, and human-caused mortality to adult females in particular is limiting recovery of the species. Entanglement in fishing gear is the other primary cause of mortality and serious injury, which is being addressed by separate regulatory actions.

3.

Endangered and Threatened Wildlife and Plants; Revision of the Regulations for Listing Endangered and Threatened Species and Designation of Critical Habitat (0648-BJ44):

This action responds to section 2 of the Executive Order on Protecting Public Health and the Environment and Restoring Science to Tackle the Climate Crisis (E.O. 13990) and the associated Fact Sheet (List of Agency Actions for Review). This is a joint rulemaking by NMFS and the FWS (the Services) to rescind the regulatory definition of the term “habitat.” This previously undefined term was defined by regulation for the first time in 2020 for the purpose of designating critical habitat under the ESA. Pursuant to Executive Order 13990, the Services also considered the alternatives of retaining the existing habitat definition or revising the habitat definition and will be considering any alternatives provided during the public comment period on the proposed rule.

4.

Endangered and Threatened Wildlife and Plants; Regulations for Listing Species and Designating Critical Habitat (0648-BK47):

This action responds to section 2 of the Executive Order on Protecting Public Health and the Environment and Restoring Science to Tackle the Climate Crisis (E.O. 13990) and the associated Fact Sheet (List of Agency Actions for Review). This is a joint rulemaking by the Services to revise joint regulations issued in 2019 implementing section 4 of the ESA. Specifically addressed in this action are joint regulations that address the classification of species as threatened or endangered and the criteria and process for designating critical habitat for listed species. Pursuant to Executive Order 13990, the Services reviewed the specific regulatory provisions that had been revised in the 2019 final rule. Following a review of the 2019 rule, the Services are proposing to revise a portion of these regulations but are also soliciting public comments on all aspects of the 2019 rule before issuing a final rule.

5.

Endangered and Threatened Wildlife and Plants; Revision of Regulations for Interagency Cooperation (0648-BK48):

This action responds to section 2 of the Executive Order on Protecting Public Health and the Environment and Restoring Science to Tackle the Climate Crisis (E.O. 13990) and the associated Fact Sheet (List of Agency Actions for Review). This is a joint rulemaking by the Services to revise joint regulations implementing section 7 of the ESA, which requires Federal agencies to consult with the Services whenever any action the agency undertakes, funds, or authorizes may affect endangered or threatened species or their critical habitat, to ensure that the action does not jeopardize listed species or adversely modify critical habitat. In 2019, the Services revised various aspects of the regulations governing the consultation process under ESA Section 7 including, significantly, how the Services define the “effects of the action,” which has importance for determining the scope of consultation. Pursuant to Executive Order 13990, the Services reviewed the specific regulatory provisions that had been revised in the 2019 final rule. Following this review of the 2019 rule, the Services are proposing to revise a portion of these regulations, including “effects of the action,” but are also soliciting public comments on all aspects of the 2019 rule before issuing a final rule. In addition to revising provisions from the 2019 rule, the Services are proposing to clarify the responsibilities of a Federal agency and the Services regarding the requirement to reinitiate consultation.

The United States Patent and Trademark Office

The USPTO's mission is to foster innovation, competitiveness, and economic growth, domestically and abroad, by delivering high quality and timely examination of patent and trademark applications, guiding domestic and international intellectual property policy, and delivering intellectual property information and education worldwide.

Major Programs and Activities

The USPTO is responsible for granting U.S. patents and registering trademarks. This system of secured property rights, which has its foundation in Article I, Section 8, Clause 8, of the Constitution (providing that Congress shall have the power to “promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries”) has enabled American industry to flourish. New products have been invented, new uses for old ones discovered, and employment opportunities created for millions of Americans. The continued demand for patents and trademarks underscores the importance to the U.S. economy of effective mechanisms to protect new ideas and investments in innovation, as well as the ingenuity of American inventors and entrepreneurs.

In addition to granting patents and trademarks, the USPTO advises the President of the United States, the Secretary of Commerce, and U.S. government agencies on intellectual property (IP) policy, protection, and enforcement; and promotes strong and effective IP protection around the world. The USPTO furthers effective IP

protection for U.S. innovators and entrepreneurs worldwide by working with ther agencies to secure strong IP provisions in free trade and other international agreements. It also provides training, education, and capacity building programs designed to foster respect for IP and encourage the development of strong IP enforcement regimes by U.S. trading partners. As part of its work, the USPTO administers regulations located at title 37 of the Code of Federal Regulations concerning its patent and trademark services and the other functions it performs.

The USPTO's Regulatory Plan Actions

1.

Final Rule: Changes to Implement Provisions of the Trademark Modernization Act of 2020 (0651-AD55):

The USPTO amends the rules of practice in trademark cases to implement provisions of the Trademark Modernization Act of 2020. This rule establishes ex parte expungement and reexamination proceedings for cancellation of a registration when the required use in commerce of the registered mark has not been made; provides for a new nonuse ground for cancellation before the Trademark Trial and Appeal Board; establishes flexible USPTO action response periods; and amends the existing letter-of-protest rule to indicate that letter-of-protest determinations are final and non-reviewable. The rule also sets fees for petitions requesting institution of ex parte expungement and reexamination proceedings, and for requests to extend USPTO action response deadlines.

The two new ex parte proceedings created by this rulemaking—one for expungement and one for reexamination—are intended to help ensure the accuracy of the trademark register by providing a new mechanism for removing a registered mark from the trademark register or cancelling the registration as to certain goods and/or services, when the registrant has not used the mark in commerce. The proposed changes will give U.S. businesses new tools to clear away unused registered trademarks from the federal trademark register and will give the USPTO the ability to move applications through the system more efficiently.

Bureau of Industry and Security

BIS advances U.S. national security, foreign policy, and economic objectives by maintaining and strengthening adaptable, efficient, and effective export control and treaty compliance systems as well as by administering programs to prioritize certain contracts to promote the national defense and to protect and enhance the defense industrial base.

Major Programs and Activities

BIS administers four sets of regulations. The Export Administration Regulations (EAR) regulate exports and reexports to protect national security, foreign policy, and short supply interests. The EAR includes the Commerce Control List (CCL), which describes commodities, software, and technology that are subject to licensing requirements for specific reasons for control. The EAR also regulates U.S. persons' participation in certain boycotts administered by foreign governments. The National Security Industrial Base Regulations provide for prioritization of certain contracts and allocations of resources to promote the national defense, require reporting of foreign government-imposed offsets in defense sales, provide for surveys to assess the capabilities of the industrial base to support the national defense, and address the effect of imports on the defense industrial base. The Chemical Weapons Convention Regulations implement declaration, reporting, and on-site inspection requirements in the private sector necessary to meet United States treaty obligations under the Chemical Weapons Convention treaty. The Additional Protocol Regulations implement similar requirements for certain civil nuclear and nuclear-related items with respect to an agreement between the United States and the International Atomic Energy Agency.

BIS also has an enforcement component with nine offices covering the United States, as well as BIS export control officers stationed at several U.S. embassies and consulates abroad. BIS works with other U.S. Government agencies to promote coordinated U.S. Government efforts in export controls and other programs. BIS participates in U.S. Government efforts to strengthen multilateral export control regimes and promote effective export controls through cooperation with other governments.

In FY 2022, BIS plans to publish a number of proposed and final rules amending the EAR. These rules will cover a range of issues, including emerging and foundational technology, country specific policies, CCL revisions based on decisions by the four multilateral export control regimes (Australia Group, Missile Technology Control Regime, Nuclear Suppliers Group, and Wassenaar Arrangement), and implementation of any interagency agreed transfers from the United States Munitions List to the CCL.

BIS's Regulatory Plan Actions

1.

Authorization of Certain “Items” to Entities on the Entity List in the Context of Specific Standards Activities (0694-AI06):

BIS is amending the EAR to clarify its applicability to releases of technology for standards setting or development to support U.S. participation in standards efforts.

2.

Commerce Control List: Implementation of Controls on “Software” Designed for Certain Automated Nucleic Acid Assemblers and Synthesizers (0694-AI08):

BIS is publishing this final rule to amend the CCL by adding a new Export Control Classification Number (ECCN) 2D352 to control software that is designed for automated nucleic acid assemblers and synthesizers controlled under ECCN 2B352.j and capable of designing and building functional genetic elements from digital sequence data. These amendments to the CCL are based upon a finding, consistent with the emerging and foundational technologies interagency process set forth in section 1758 of the Export Control Reform Act of 2018 (ECRA) (50 U.S.C. 4817), that such software is capable of being utilized in the production of pathogens and toxins and, consequently, the absence of export controls on such software could be exploited for biological weapons purposes.

3.

Information Security Controls: Cybersecurity Items (0694-AH56):

In 2013, the Wassenaar Arrangement (WA), a multilateral export control regime in which the United States participates, added cybersecurity items to the WA List, including a definition for “intrusion software.” In 2015, public comments on a BIS proposed implementation rule revealed serious issues concerning scope and implementation regarding these controls. Based on these comments, as well as substantial commentary from Congress, the private sector, academia, civil society, and others on the potential unintended consequences of the 2013 controls, the U.S. government returned to the WA to renegotiate the controls. This interim final rule outlines the progress the United States has made in this area, revises implementation, and requests from the public information about the impact of these revised controls on U.S. industry and the cybersecurity community. These items warrant controls because these tools could be used for surveillance, espionage, or other actions that disrupt, deny or degrade the network or devices on it.

4.

Imposition of Export Controls on Certain Brain-Computer Interface (BCI)

Emerging Technology (0694-AI41):

Section 1758 of ECRA, as codified under 50 U.S.C. 4817, authorizes BIS to establish appropriate controls on the export, reexport or transfer (in-country) of emerging and foundational technologies. Pursuant to ECRA, BIS has identified Brain Computer Interface technology as part of a representative list of technology categories for which BIS will seek public comment to determine whether this is an emerging technology that is important to U.S. national security and for which effective controls can be implemented. In this Advance Notice of Proposed Rulemaking, BIS is seeking comments specifically concerning whether this technology could provide the United States, or any of its adversaries, with a qualitative military or intelligence advantage. In addition, BIS is seeking public comments on how to ensure that the scope of any controls that may be imposed on this technology in the future would be effective and appropriate with respect to their potential impact on legitimate commercial or scientific applications.

5.

Foundational Technologies: Proposed Controls (0694-AH80):

BIS is considering expanding controls on certain foundational technologies. Foundational technologies may be items that are currently subject to control for military end use or military end user reasons. Additionally, foundational technologies may be additional items, for which an export license is generally not required (except for certain countries), that also warrant review to determine if they are foundational technologies essential to the national security. For example, such controls may be reviewed if the items are being utilized or are required for innovation in developing conventional weapons or enabling foreign intelligence collection activities or weapons of mass destruction applications. In an effort to address this concern, this proposed rule would amend the CCL by adding controls on certain aircraft reciprocating or rotary engines and powdered metals and alloys. This rule requests public comments to ensure that the scope of these proposed controls will be effective and appropriate, including with respect to their potential impact on legitimate commercial or scientific applications.

6.

Removal of Certain General Approved Exclusions (GAEs) Under the Section 232 Steel and Aluminum Tariff Exclusions Process (0694-AH55):

On December 14, 2020, BIS published an interim final rule (the December 14 rule) that revised aspects of the process for requesting exclusions from the duties and quantitative limitations on imports of aluminum and steel discussed in three previous Commerce interim final rules implementing the exclusion process authorized by the President under section 232 of the Trade Expansion Act of 1962, as amended (232), as well as a May 26, 2020, notice of inquiry. The December 14 rule added 123 General Approved Exclusions (GAEs) to the regulations. The addition of GAEs was an important step in improving the efficiency and effectiveness of the 232 exclusions process for certain Harmonized Tariff Schedule of the United States (HTSUS) codes for steel and aluminum that had not received objections. Commerce determined it could authorize imports under GAEs for these specified HTSUS codes for all importers instead of requiring each importer to submit an exclusion request. Subsequently, based on Commerce's review of the public comments received in response to the December 14 rule and additional analysis conducted by Commerce of 232 exclusion request submissions, Commerce determined that a subset of the GAEs added in the December 14 rule did not meet the criteria for inclusion as a GAE and should therefore be removed. Commerce is removing these GAEs in this interim final rule to ensure that only those GAEs that meet the stated criteria from the December 14 rule will continue to be included as eligible GAEs. Lastly, this interim final rule makes two conforming changes to the GAE list for a recent change to one HTSUS classification and adds a footnote to both GAE supplements to address future

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