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Proposed Rule

Introduction to the Unified Agenda of Federal Regulatory and Deregulatory Actions

Action

Introduction To The Unified Agenda Of Federal Regulatory And Deregulatory Actions.

Summary

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). Executive Order 12866 “Regulatory Planning and Review,” signed September 30, 1993 (58 FR 51735), and Office of Management and Budget memoranda implementing section 4 of that Order establish minimum standards for agencies' agendas, including specific types of information for each entry.

The Unified Agenda of Federal Regulatory and Deregulatory Actions (Unified Agenda) helps agencies fulfill these requirements. All Federal regulatory agencies have chosen to publish their regulatory agendas as part of the Unified Agenda.

Editions of the Unified Agenda prior to fall 2007 were printed in their entirety in the Federal Register. Beginning with the fall 2007 edition, the Internet is the basic means for conveying regulatory agenda information to the maximum extent legally permissible. The complete Unified Agenda for fall 2011, which contains the regulatory agendas for 59 Federal agencies, is available to the public at http://reginfo.gov.

The fall 2011 Unified Agenda publication appearing in the Federal Register consists of 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.

 

Table of Contents Back to Top

Tables Back to Top

ADDRESSES: Back to Top

Regulatory Information Service Center (MI), General Services Administration, One Constitution Square, 1275 First Street NE., 651A, Washington, DC 20417.

FOR FURTHER INFORMATION CONTACT: Back to Top

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: John C. Thomas, Executive Director, Regulatory Information Service Center (MI), General Services Administration, One Constitution Square, 1275 First Street NE., 642, Washington, DC 20417, 202 482-7340. You may also send comments to us by email at: RISC@gsa.gov.

SUPPLEMENTARY INFORMATION: Back to Top

Table of Contents Back to Top

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

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 2011 Regulatory Plan Back to Top

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

Architectural and Transportation Barriers Compliance Board

Environmental Protection Agency

Equal Employment Opportunity Commission

Financial Stability Oversight Council

General Services Administration

National Aeronautics and Space Administration

National Archives and Records Administration

Office of Personnel Management

Pension Benefit Guaranty Corporation

Small Business Administration

Social Security Administration

Independent Regulatory Agencies

Consumer Financial Protection Bureau

Consumer Product Safety Commission

Federal Trade Commission

National Indian Gaming Commission

Nuclear Regulatory Commission

AGENCY 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

Architectural and Transportation Barriers Compliance Board

Environmental Protection Agency

General Services Administration

National Aeronautics and Space Administration

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

Federal Communications Commission

Federal Deposit Insurance Corporation

Federal Reserve System

Nuclear Regulatory Commission

Securities and Exchange Commission

Introduction to the Unified Agenda of Federal Regulatory and Deregulatory Actions Back to Top

I. What Is the Unified Agenda? Back to Top

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. To further the objective of using modern technology to deliver better service to the American people for lower cost, beginning with the fall 2007 edition, the Internet is the basic means for conveying regulatory agenda information to the maximum extent legally permissible. The complete Unified Agenda is available to the public at http://reginfo.gov. The online Unified Agenda offers flexible search tools and will soon offer access to the entire historic Unified Agenda database.

The fall 2011 Unified Agenda publication appearing in the Federal Register consists of 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.

These publication formats meet the publication mandates of the Regulatory Flexibility Act and Executive Order 12866, as well as move the Agenda process toward the goal of e-Government, at a substantially reduced printing cost compared with prior editions. The current format does not reduce the amount of information available to the public, but it does limit most of the content of the Agenda to online access. The complete online edition of the Unified Agenda includes regulatory agendas from 59 Federal agencies. Agencies of the United States Congress are not included.

The following agencies have no entries identified for inclusion in the printed regulatory flexibility agenda. An asterisk (*) indicates agencies that appear in The Regulatory Plan. The regulatory agendas of these agencies are available to the public at http://reginfo.gov.

Department of Housing and Urban Development*

Department of State

Department of Veterans Affairs*

Agency for International Development

Commission on Civil Rights

Committee for Purchase From People Who Are Blind or Severely Disabled

Corporation for National and Community Service

Court Services and Offender Supervision Agency for the District of Columbia

Equal Employment Opportunity Commission*

Federal Mediation and Conciliation Service

Financial Stability Oversight Council*

Institute of Museum and Library Services

National Archives and Records Administration*

National Endowment for the Humanities

National Science Foundation

Office of Government Ethics

Office of Management and Budget

Office of Personnel Management*

Peace Corps

Pension Benefit Guaranty Corporation*

Railroad Retirement Board

Selective Service System

Social Security Administration*

Commodity Futures Trading Commission

Consumer Product Safety Commission*

Farm Credit Administration

Federal Energy Regulatory Commission

Federal Housing Finance Agency

Federal Maritime Commission

Federal Trade Commission*

National Credit Union Administration

National Indian Gaming Commission*

National Labor Relations Board

Postal Regulatory Commission

Surface Transportation Board

The Regulatory Information Service Center (the 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. The Center also provides information about Federal regulatory activity to the President and his Executive Office, the Congress, agency managers, 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 Unified Agenda does 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 Is the Unified Agenda Published? Back to Top

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 entitled “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 entitled “Regulatory Planning and Review,” signed 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 13132

Executive Order 13132 entitled “Federalism,” signed 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 nonstatutory 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.

Executive Order 13563

Executive Order 13563 entitled “Improving Regulation and Regulatory Review,” signed January 18, 2011, 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.

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 entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use,” signed 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 Is the Unified Agenda Organized? Back to Top

Agency regulatory flexibility agendas are printed in a single daily edition of the Federal Register. A regulatory flexibility agenda is printed 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 parts are organized alphabetically in four groups: Cabinet departments; other executive agencies; the Federal Acquisition Regulation, a joint authority; and independent regulatory agencies. Agencies may in turn be divided into subagencies. 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.

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 whose 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.

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 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? Back to Top

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 12/00/11 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 published in fall 2010.

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, http://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.

Some agencies that participated in the fall 2010 edition of The Regulatory Plan have chosen to include the following information for those entries that appeared in the Plan:

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 Back to Top

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.

EO—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;
  • 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.

PL (or 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, Pub. L. 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 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 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 Agenda? Back to Top

Copies of the Federal Register issue containing the printed edition of the Unified Agenda (agency regulatory flexibility agendas) are available from the Superintendent of Documents, U.S. Government Printing 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 Web site. 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 http://reginfo.gov, along with flexible search tools.

In accordance with regulations for the Federal Register, the Government Printing Office's GPO FDsys Web site contains copies of the Agendas and Regulatory Plans that have been printed in the Federal Register. These documents are available at http://www.fdsys.gov.

Dated: December 19, 2011.

John C. Thomas,

Director.

Introduction to the Fall 2011 Regulatory Plan Back to Top

Executive Order 12866, issued in 1993, requires the annual production of a Unified Regulatory Agenda and Regulatory Plan. It does so 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. Consistent with Executive Orders 13563 and 12866, we are now providing the Unified Regulatory Agenda and the Regulatory Plan for public scrutiny and review. Such scrutiny and review are closely connected with the general goal, central to Executive Order 13563, of promoting public participation in the rulemaking process.

It is important to understand that the Agenda and Plan are intended merely to serve as a preliminary statement, for public understanding and assessment, of regulatory and deregulatory policies and priorities that are now under contemplation. This preliminary statement often includes a number of rules that are not issued in the following year and that may well not be issued at all. This year, we have taken several new steps to clarify the purposes and uses of the Agenda and Plan and to improve its presentation. Among other things, we have narrowed the list of “active rulemakings” to rules that are not merely under some form of contemplation but that also have at least some possibility of issuance over the next year. We have also made it easier to understand which rules are active rulemakings rather than long-term actions or completed actions. But it remains true that rules on this list, designed among other things “to involve the public and its State, local, and tribal officials in regulatory planning,” must undergo serious internal and external scrutiny before they are issued—and that there are rules on the list that may never be issued.

In this light, it should be clear that this preliminary statement of policies and priorities has extremely important limitations. No regulatory action can be made effective until it has gone through legally required processes, including those that involve public scrutiny and review. For this reason, the inclusion of a regulatory action here does not necessarily mean that it will be finalized or even proposed. Any proposed or final action must satisfy the requirements of relevant statutes, Executive Orders, and Presidential Memoranda. Those requirements, public comments, and new information may or may not lead an agency to go forward with an action that is currently under contemplation and that is included here. For example, the directives of Executive Order 13563, emphasizing the importance of careful consideration of costs and benefits, may lead an agency to decline to proceed with a regulatory action that is presented here.

It is also important to note that under Executive Order 12866, whether a regulation counts as “economically significant” is not an adequate measure of whether it imposes high costs on the private sector. Economically significant actions may impose small costs or even no costs. For example, regulations may count as economically significant not because they impose significant costs, but because they confer large benefits. Moreover, many regulations count as economically significant not because they impose significant regulatory costs on the private sector, but because they involve transfer payments as required or authorized by law.

It should be observed that the number of economically significant actions listed as under active consideration here—138—is lower than the corresponding figure for Spring 2011 (149) and for Fall 2010 (140). It is notable that the number of such rules has not grown even taking account of rules implementing the Affordable Care Act and the Wall Street Reform and Consumer Protection Act. We also note that the net benefits of regulation were unusually high in Fiscal Year 2011 (well over $50 billion for the year alone). In addition, the aggregate costs for that year (under $8 billion) were lower than in Fiscal Year 2010 and were not out of line with those in recent years, including during the Bush Administration.

With these notes and qualifications, the Regulatory Plan provides a list of important regulatory actions that are now under contemplation for issuance in proposed or final form during the upcoming fiscal year. In contrast, the Unified Agenda is a more inclusive list, including numerous ministerial actions and routine rulemakings, as well as long-term initiatives that agencies do not plan to complete in the coming year.

We hope that public scrutiny of the Regulatory Plan and the Unified Agenda might help ensure, in the words of Executive Order 13563, a regulatory system that protects “public health, welfare, safety, and our environment while promoting economic growth, innovation, competitiveness, and job creation.”

As discussed below, a large number of significant recent steps have been taken, consistent with Executive Order 13563, to reduce regulatory costs and ensure that our regulatory system is consistent with promoting growth and job creation. At the same time, a number of steps have been taken to promote public health, welfare, safety, and our environment. It is important to emphasize that the net benefits of recent rules, including the monetized benefits, are high—over the first two fiscal years of this Administration, in excess of $35 billion. Rules have been issued and initiatives have been undertaken that are saving lives on the highways and in workplaces; reducing air and water pollution, preventing thousands of deaths in the process; increasing fuel economy, thus saving money while reducing pollution; making both trains and planes safer; increasing energy efficiency, saving billions of dollars while increasing energy security; combating childhood obesity; and creating a “race to the top” in education. Consider, as merely one example, the fact that in 2010, the rates of roadway fatalities and injuries fell to their lowest recorded levels and to their lowest numbers since 1949. The decrease is attributable, in part, to a range of regulatory actions and to private-public partnerships that have increased safety.

Since President Reagan's Executive Order 12291, issued in 1981, a principal focus of the Office of Information and Regulatory Affairs, and of regulatory policy in general, has been on maximizing net benefits. In this Administration, agencies and OMB have worked together to issue a number of rules for which the benefits exceed the costs, and by a large margin. Consider the following figure:

These figures reflect the numbers for 2009 and 2010. As noted, the net benefits for 2011 are expected to be unusually high (in excess of $50 billion); they will be discussed in detail in the 2012 Report to Congress on the Benefits and Costs of Federal Regulations.

The recent steps build on a great deal of new learning about regulation. As a result of conceptual and empirical advances, we know far more than during the New Deal and the Great Society. We have also learned much since the 1980s and 1990s. These lessons have informed the Administration's efforts to protect public health and safety while also promoting economic growth and job creation. Eight points are particularly important:

1. We are now equipped with state-of-the-art techniques for anticipating, cataloguing, and monetizing the consequences of regulation, including both benefits and costs.

2. We know that risks are part of systems, and that efforts to reduce a certain risk may increase other risks, perhaps even deadly ones, thus producing ancillary harms—and that efforts to reduce a certain risk may reduce other risks, perhaps even deadly ones, thus producing ancillary benefits.

3. We know that flexible, innovative approaches, maintaining freedom of choice and respecting heterogeneity and the fact that one size may not fit all, are often desirable, both because they preserve liberty and because they frequently cost less.

4. We know that large benefits can come from seemingly modest and small steps, including simplification of regulatory requirements, provision of information, and sensible default rules, such as automatic enrollment for retirement savings.

5. We know, more clearly than ever before, that it is important to allow public participation in the design of rules, because members of the public have valuable information about likely effects, existing problems, creative solutions, and possible unintended consequences.

6. We know that if carefully designed, disclosure policies can promote informed choices and save both money and lives.

7. We know that intuitions and anecdotes are unreliable, and that advance testing of the effects of rules, as through pilot programs or randomized controlled experiments, can be highly illuminating.

8. We know that it is important to explore the effects of regulation in the real world, to learn whether they are having beneficial consequences or producing unintended harm. We need to consult, and to learn from, those who are affected by rules.

Executive Order 13563 draws on these understandings and emphasizes the importance of protecting “public health, welfare, safety, and our environment while promoting economic growth, innovation, competitiveness, and job creation.” Executive Order 13563 explicitly points to the need for predictability and for certainty, and for use of the least burdensome tools for achieving regulatory ends. It indicates that agencies “must take into account benefits and costs, both quantitative and qualitative.” It explicitly draws attention to the need to measure and to improve “the actual results of regulatory requirements”—a clear reference to the importance of retrospective evaluation.

Executive Order 13563 reaffirms the principles, structures, and definitions in Executive Order 12866, which has long governed regulatory review. In addition, it endorses, and quotes, a number of provisions of that Executive Order that specifically emphasize the importance of considering costs—including the requirement that to the extent permitted by law, agencies should not proceed in the absence of a reasoned determination that the benefits justify the costs. Importantly, Executive Order 13563 directs agencies “to use the best available techniques to quantify anticipated present and future benefits and costs as accurately as possible.” This direction reflects a strong emphasis on quantitative analysis as a means of improving regulatory choices and increasing transparency.

Among other things, Executive Order 13563 sets out five sets of requirements to guide regulatory decision making:

  • Public participation. Agencies are directed to promote public participation, in part by making supporting documents available on Regulations.gov in order to promote transparency and public comment. Executive Order 13563 also directs agencies, where feasible and appropriate, to engage the public, including affected stakeholders, before rulemaking is initiated.
  • Integration and innovation. Agencies are directed to attempt to reduce “redundant, inconsistent, or overlapping” requirements, in part by working with one another to simplify and harmonize rules. This important provision is designed to reduce confusion, redundancy, and excessive cost. An important goal of simplification and harmonization is to promote rather than to hamper innovation, which is a foundation of both growth and job creation. Different offices within the same agency might work together to harmonize their rules; different agencies might work together to achieve the same objective. Such steps can also promote predictability and certainty.
  • Flexible approaches. Agencies are directed to identify and consider flexible approaches to regulatory problems, including warnings, appropriate default rules, and disclosure requirements. Such approaches may “reduce burdens and maintain flexibility and freedom of choice for the public.” In certain settings, they may be far preferable to mandates and bans, precisely because they maintain freedom of choice and reduce costs. The reference to “appropriate default rules” signals the possibility that important social goals can be obtained through simplification—as, for example, in the form of automatic enrollment, direct certification, or reduced paperwork burdens.
  • Science. Agencies are directed to promote scientific integrity, and in a way that ensures a clear separation between judgments of science and judgments of policy.
  • Retrospective analysis of existing rules. Agencies are directed to produce preliminary plans to engage in retrospective analysis of existing significant regulations to determine whether they should be modified, streamlined, expanded, or repealed.

Executive Order 13563 addresses both the “flow” of new regulations that are under development and the “stock” of existing regulations that are already in place. Executive Order 13563 emphasizes the importance of promoting predictability, of carefully considering costs, of choosing the least burdensome approach, and of selecting the most flexible, least costly tools. In addition, Executive Order 13563 calls for careful reassessment, based on empirical analysis. It is understood that the prospective analysis required by Executive Order 13563 may depend on a degree of speculation and that the actual costs and benefits of a regulation may be lower or higher than what was anticipated when the rule was originally developed. It is also understood that circumstances may change in a way that requires reconsideration of regulatory requirements. After retrospective analysis has been undertaken, agencies will be in a position to reevaluate existing rules and to streamline, modify, or eliminate those that do not make sense in their current form.

In August 2011, over two dozen agencies released final plans to remove what the President has called unjustified rules and “absurd and unnecessary paperwork requirements that waste time and money.” Over the next five years, billions of dollars in savings are anticipated from just a few initiatives from the Department of Transportation, the Department of Labor, the Department of Health and Human Services, and the Environmental Protection Agency. And all in all, the plans' initiatives will save tens of millions of hours in annual paperwork burdens on individuals, businesses, and state and local governments.

The plans span over 800 pages and offer more than 500 proposals. Some plans list well over 50 reforms. Many of the proposals focus on small business. Indeed, a number of the initiatives are specifically designed to reduce burdens on small business and to enable them to do what they do best, which is to create jobs. Some of the proposed initiatives represent a fundamental rethinking of how things have long been done—as, for example, with numerous efforts to move from paper to electronic reporting. For both private and public sectors, those efforts can save a great deal of money. Over the next five years, the Department of Treasury's paperless initiative will be saving $400 million and 12 million pounds of paper.

Many of the reforms will have a significant economic impact:

  • The Occupational Safety and Health Administration has announced a final rule that will remove over 1.9 million annual hours of redundant reporting burdens on employers and save more than $40 million in annual costs. Businesses will no longer be saddled with the obligation to fill out unnecessary government forms, meaning that their employees will have more time to be productive and do their real work.
  • To eliminate unjustified economic burdens on railroads, the Department of Transportation is reconsidering parts of a rule that requires railroads to install equipment on trains. DOT has proposed to refine the requirements so that the equipment is installed only where it is really needed on grounds of safety. DOT expects initial savings of up to $325 million, with total 20-year savings of up to $755 million.
  • EPA has proposed to eliminate the obligation for many states to require air pollution vapor recovery systems at local gas stations, on the ground that modern vehicles already have effective air pollution control technologies. The anticipated annual savings are $87 million.
  • The Departments of Commerce and State are undertaking a series of steps to eliminate unnecessary barriers to exports, including duplicative and unnecessary regulatory requirements, thus reducing the cumulative burden and uncertainty faced by American companies and their trading partners. These steps will make it a lot easier for American companies to reach new markets, increasing our exports while creating jobs here at home.
  • To promote flexibility, the Department of Health and Human Services has proposed two rules, and finalized another, to reduce burdensome regulatory requirements now placed on hospitals and doctors. These reforms are expected to save more than $1 billion annually.

The regulatory lookback is not merely a one-time exercise. Regular reporting, about recent progress and coming initiatives, is required. The goal is to change the regulatory culture to ensure that rules on the books are reevaluated and are effective, cost-justified, and based on the best available science. By creating regulatory review teams at agencies, we will continue to examine what is working and what is not and to eliminate unjustified and outdated regulations.

In addition to looking back at existing regulations, we are looking forward to ensure that future regulations are well-justified. Executive Order 13563 provides critical guidance with its emphasis on careful consideration of costs and benefits, public participation, integration and innovation, flexible approaches, and science. These requirements are meant to produce a regulatory system that draws on recent learning, that is driven by evidence, and that is suited to the distinctive circumstances of the twenty-first century.

Department of Agriculture Back to Top
Sequence No. Title Regulation Identifier No. Rulemaking Stage
1 Wholesale Pork Reporting Program 0581-AD07 Proposed Rule Stage.
2 National Organic Program: Sunset Review for Nutrient Vitamins and Minerals (NOP-10-0083) 0581-AD17 Proposed Rule Stage.
3 Animal Welfare; Regulations and Standards for Birds 0579-AC02 Proposed Rule Stage.
4 Plant Pest Regulations; Update of General Provisions 0579-AC98 Proposed Rule Stage.
5 Importation of Live Dogs 0579-AD23 Final Rule Stage.
6 Animal Disease Traceability 0579-AD24 Final Rule Stage.
7 Supplemental Nutrition Assistance Program: Farm Bill of 2008 Retailer Sanctions 0584-AD88 Proposed Rule Stage.
8 National School Lunch and School Breakfast Programs: Nutrition Standards for All Foods Sold in School, as Required by the Healthy, Hunger-Free Kids Act of 2010 0584-AE09 Proposed Rule Stage.
9 WIC: Electronic Benefit Transfer (EBT) Implementation 0584-AE21 Proposed Rule Stage.
10 Nutrition Standards in the National School Lunch and School Breakfast Programs 0584-AD59 Final Rule Stage.
11 Direct Certification of Children in Food Stamp Households and Certification of Homeless, Migrant, and Runaway Children for Free Meals 0584-AD60 Final Rule Stage.
12 Eligibility, Certification, and Employment and Training Provisions of the Food, Conservation, and Energy Act of 2008 0584-AD87 Final Rule Stage.
13 Supplemental Nutrition Assistance Program: Nutrition Education and Obesity Prevention Grant 0584-AE07 Final Rule Stage.
14 Prior Labeling Approval System: Generic Label Approval 0583-AC59 Proposed Rule Stage.
15 Product Labeling: Use of the Voluntary Claim “Natural” on the Labeling of Meat and Poultry Products 0583-AD30 Proposed Rule Stage.
16 New Poultry Slaughter Inspection 0583-AD32 Proposed Rule Stage.
17 Electronic Imported Product Inspection Application and Certification of Imported Product and Foreign Establishments; Amendments to Facilitate the Public Health Information System (PHIS) 0583-AD39 Proposed Rule Stage.
18 Electronic Export Application and Certification as a Reimbursable Service and Flexibility in the Requirements for Official Export Inspection Marks, Devices, and Certificates 0583-AD41 Proposed Rule Stage.
19 Performance Standards for the Production of Processed Meat and Poultry Products; Control of Listeria Monocytogenes in Ready-To-Eat Meat and Poultry Products 0583-AC46 Final Rule Stage.
20 Notification, Documentation, and Recordkeeping Requirements for Inspected Establishments 0583-AD34 Final Rule Stage.
Department of Commerce Back to Top
Sequence No. Title Regulation Identifier No. Rulemaking Stage
21 Revisions to the Export Administration Regulations (EAR): Control of Military Vehicles and Related Items That the President Determines do not Warrant Control on the United States Munitions List 0694-AF17 Final Rule Stage.
22 Fishery Management Plan for Regulating Offshore Marine Aquaculture in the Gulf of Mexico 0648-AS65 Proposed Rule Stage.
23 Reducing Disturbances to Hawaiian Spinner Dolphins From Human Interactions 0648-AU02 Proposed Rule Stage.
24 Designation of Critical Habitat for the North Atlantic Right Whale 0648-AY54 Proposed Rule Stage.
25 Regulatory Amendments To Implement the Shark Conservation Act and Revise the Definition of Illegal, Unreported, and Unregulated Fishing 0648-BA89 Proposed Rule Stage.
Department of Education Back to Top
Sequence No. Title Regulation Identifier No. Rulemaking Stage
26 Title IV of the Higher Education Act of 1965, as Amended 1840-AD05 Proposed Rule Stage.
Department of Energy Back to Top
Sequence No. Title Regulation Identifier No. Rulemaking Stage
27 Energy Efficiency Standards for Battery Chargers and External Power Supplies 1904-AB57 Proposed Rule Stage.
28 Energy Conservation Standards for Walk-In Coolers and Walk-In Freezers 1904-AB86 Proposed Rule Stage.
29 Energy Efficiency Standards for Manufactured Housing 1904-AC11 Proposed Rule Stage.
30 Energy Conservation Standards for ER, BR, and Small Diameter Incandescent Reflector Lamps 1904-AC15 Proposed Rule Stage.
31 Energy Efficiency Standards for Fluorescent Lamp Ballasts 1904-AB50 Final Rule Stage.
Department of Health and Human Services Back to Top
Sequence No. Title Regulation Identifier No. Rulemaking Stage
32 Health Information Technology: New and Revised Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology 0991-AB82 Proposed Rule Stage.
33 Electronic Submission of Data From Studies Evaluating Human Drugs and Biologics 0910-AC52 Proposed Rule Stage.
34 Current Good Manufacturing Practice and Hazard Analysis and Risk-Benefit Preventive Controls for Food for Animals 0910-AG10 Proposed Rule Stage.
35 Unique Device Identification 0910-AG31 Proposed Rule Stage.
36 Produce Safety Regulation 0910-AG35 Proposed Rule Stage.
37 Hazard Analysis and Risk-Based Preventive Controls 0910-AG36 Proposed Rule Stage.
38 Foreign Supplier Verification Program 0910-AG64 Proposed Rule Stage.
39 Accreditation of Third Parties to Conduct Food Safety Audits and for Other Related Purposes 0910-AG66 Proposed Rule Stage.
40 Infant Formula: Current Good Manufacturing Practices; Quality Control Procedures; Notification Requirements; Records and Reports; and Quality Factors 0910-AF27 Final Rule Stage.
41 Medical Device Reporting; Electronic Submission Requirements 0910-AF86 Final Rule Stage.
42 Electronic Registration and Listing for Devices 0910-AF88 Final Rule Stage.
43 Food Labeling: Nutrition Labeling for Food Sold in Vending Machines 0910-AG56 Final Rule Stage.
44 Food Labeling: Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments 0910-AG57 Final Rule Stage.
45 Medicare and Medicaid Programs: Reform of Hospital and Critical Access Hospital Conditions of Participation (CMS-3244-P) 0938-AQ89 Proposed Rule Stage.
46 Regulatory Provisions To Promote Program Efficiency, Transparency, and Burden Reduction (CMS-9070-P) 0938-AQ96 Proposed Rule Stage.
47 Proposed Changes to Hospital OPPS and CY 2013 Payment Rates; ASC Payment System and CY 2013 Payment Rates (CMS-1589-P) 0938-AR10 Proposed Rule Stage.
48 Revisions to Payment Policies Under the Physician Fee Schedule and Part B for CY 2013 (CMS-1590-P) 0938-AR11 Proposed Rule Stage.
49 Changes to the Hospital Inpatient an Long-Term Care Prospective Payment System for FY 2013 (CMS-1588-P) 0938-AR12 Proposed Rule Stage.
50 Medicaid Eligibility Expansion Under the Affordable Care Act of 2010 (CMS-2349-F) 0938-AQ62 Final Rule Stage.
51 Establishment of Exchanges and Qualified Health Plans Part I (CMS-9989-F) 0938-AQ67 Final Rule Stage.
52 State Requirements for Exchange—Reinsurance and Risk Adjustments (CMS-9975-F) 0938-AR07 Final Rule Stage.
Department of Homeland Security Back to Top
Sequence No. Title Regulation Identifier No. Rulemaking Stage
53 Secure Handling of Ammonium Nitrate Program 1601-AA52 Proposed Rule Stage.
54 Asylum and Withholding Definitions 1615-AA41 Proposed Rule Stage.
55 New Classification for Victims of Criminal Activity; Eligibility for the U Nonimmigrant Status 1615-AA67 Proposed Rule Stage.
56 Exception to the Persecution Bar for Asylum, Refugee, and Temporary Protected Status, and Withholding of Removal 1615-AB89 Proposed Rule Stage.
57 Electronic Filing of Requests for Immigration Benefits; Requiring an Application To Change or Extend Nonimmigrant Status To Be Filed Electronically 1615-AB94 Proposed Rule Stage.
58 Immigration Benefits Business Transformation: Nonimmigrants; Student and Exchange Visitor Program 1615-AB95 Proposed Rule Stage.
59 Application of the William Wilberforce Trafficking Victims Protection Reauthorization Act of 2008 to Unaccompanied Alien Children Seeking Asylum 1615-AB96 Proposed Rule Stage.
60 Administrative Appeals Office: Procedural Reforms To Improve Efficiency 1615-AB98 Proposed Rule Stage.
61 New Classification for Victims of Severe Forms of Trafficking in Persons; Eligibility for T Nonimmigrant Status 1615-AA59 Final Rule Stage.
62 Adjustment of Status to Lawful Permanent Resident for Aliens in T and U Nonimmigrant Status 1615-AA60 Final Rule Stage.
63 Application of Immigration Regulations to the Commonwealth of the Northern Mariana Islands 1615-AB77 Final Rule Stage.
64 Implementation of the 1995 Amendments to the International Convention on Standards of Training, Certification, and Watchkeeping (STCW) for Seafarers, 1978 1625-AA16 Final Rule Stage.
65 Vessel Requirements for Notices of Arrival and Departure, and Automatic Identification System 1625-AA99 Final Rule Stage.
66 Nontank Vessel Response Plans and Other Vessel Response Plan Requirements 1625-AB27 Final Rule Stage.
67 Offshore Supply Vessels of At Least 6000 GT ITC 1625-AB62 Final Rule Stage.
68 Revision to Transportation Worker Identification Credential (TWIC) Requirements for Mariners 1625-AB80 Final Rule Stage.
69 Importer Security Filing and Additional Carrier Requirements 1651-AA70 Final Rule Stage.
70 Changes to the Visa Waiver Program To Implement the Electronic System for Travel Authorization (ESTA) Program 1651-AA72 Final Rule Stage.
71 Establishment of Global Entry Program 1651-AA73 Final Rule Stage.
72 Implementation of the Guam-CNMI Visa Waiver Program 1651-AA77 Final Rule Stage.
73 General Aviation Security and Other Aircraft Operator Security 1652-AA53 Proposed Rule Stage.
74 Freight Railroads, Public Transportation and Passenger Railroads, and Over-the-Road Buses—Security Training of Employees 1652-AA55 Proposed Rule Stage.
75 Freight Railroads and Passenger Railroads—Vulnerability Assessment and Security Plan 1652-AA56 Proposed Rule Stage.
76 Standardized Vetting, Adjudication, and Redress Services 1652-AA61 Proposed Rule Stage.
77 Aircraft Repair Station Security 1652-AA38 Final Rule Stage.
78 Continued Detention of Aliens Subject to Final Orders of Removal 1653-AA60 Proposed Rule Stage.
79 Continued Detention of Aliens Subject to Final Orders of Removal 1653-AA13 Final Rule Stage.
80 Extending Period for Optional Practical Training by 17 Months for F-1 Nonimmigrant Students With STEM Degrees and Expanding the CAP-GAP Relief for All F-1 Students With Pending H-1B Petitions 1653-AA56 Final Rule Stage.
81 Update of FEMA's Public Assistance Regulations 1660-AA51 Proposed Rule Stage.
Department of Housing and Urban Development Back to Top
Sequence No. Title Regulation Identifier No. Rulemaking Stage
82 Federal Housing Administration (FHA): Strengthening the Home Equity Conversion Mortgages (HECM) Program to Promote Sustained Homeownership (FR-5353) 2502-AI79 Proposed Rule Stage.
83 Supportive Housing for Persons With Disabilities Implementing New Project Rental Assistance Authority (FR-5576) 2502-AJ10 Proposed Rule Stage.
84 Tenant-Based Rental Assistance; Improving Performance Through a Strengthened Section 8 Management Assessment Program (FR-5201) 2577-AC76 Proposed Rule Stage.
Department of Justice Back to Top
Sequence No. Title Regulation Identifier No. Rulemaking Stage
85 National Standards to Prevent, Detect, and Respond to Prison Rape 1105-AB34 Final Rule Stage.
Department of Labor Back to Top
Sequence No. Title Regulation Identifier No. Rulemaking Stage
86 Construction Contractors' Affirmative Action Requirements 1250-AA01 Proposed Rule Stage.
87 Persuader Agreements: Employer and Labor Relations Consultant Reporting Under the LMRDA 1245-AA03 Final Rule Stage.
88 Equal Employment Opportunity in Apprenticeship Amendment of Regulations 1205-AB59 Proposed Rule Stage.
89 Labor Certification Process and Enforcement for Temporary Employment in Occupations Other Than Agriculture or Registered Nursing in the United States (H-2B Workers) 1205-AB58 Final Rule Stage.
90 Definition of “Fiduciary” 1210-AB32 Proposed Rule Stage.
91 Respirable Crystalline Silica 1219-AB36 Proposed Rule Stage.
92 Criteria and Procedures for Proposed Assessment of Civil Penalties 1219-AB72 Proposed Rule Stage.
93 Proximity Detection Systems for Mobile Machines in Underground Mines 1219-AB78 Proposed Rule Stage.
94 Lowering Miners' Exposure to Coal Mine Dust, Including Continuous Personal Dust Monitors 1219-AB64 Final Rule Stage.
95 Proximity Detection Systems for Continuous Mining Machines in Underground Coal Mines 1219-AB65 Final Rule Stage.
96 Pattern of Violations 1219-AB73 Final Rule Stage.
97 Examination of Work Areas in Underground Coal Mines for Violations of Mandatory Health or Safety Standards 1219-AB75 Final Rule Stage.
98 Infectious Diseases 1218-AC46 Prerule Stage.
99 Injury and Illness Prevention Program 1218-AC48 Prerule Stage.
100 Occupational Exposure to Crystalline Silica 1218-AB70 Proposed Rule Stage.
101 Improve Tracking of Workplace Injuries and Illnesses 1218-AC49 Proposed Rule Stage.
102 Hazard Communication 1218-AC20 Final Rule Stage.
Department of Transportation Back to Top
Sequence No. Title Regulation Identifier No. Rulemaking Stage
103 Accessibility of Carrier Websites and Ticket Kiosks 2105-AD96 Proposed Rule Stage.
104 Enhancing Airline Passenger Protections III 2105-AE11 Proposed Rule Stage.
105 Carrier-Supplied Medical Oxygen, Accessible In-Flight Entertainment Systems, Service Animals, and Accessible Lavatories on Single-Aisle Aircraft 2105-AE12 Proposed Rule Stage.
106 Qualification, Service, and Use of Crewmembers and Aircraft Dispatchers 2120-AJ00 Proposed Rule Stage.
107 New York Congestion Management Rule for LaGuardia Airport, John F. Kennedy International Airport, and Newark Liberty International Airport 2120-AJ89 Proposed Rule Stage.
108 Air Ambulance and Commercial Helicopter Operations; Safety Initiatives and Miscellaneous Amendments 2120-AJ53 Final Rule Stage.
109 Safety Management Systems for Certificate Holders 2120-AJ86 Final Rule Stage.
110 Carrier Safety Fitness Determination 2126-AB11 Proposed Rule Stage.
111 National Registry of Certified Medical Examiners 2126-AA97 Final Rule Stage.
112 Passenger Car and Light Truck Corporate Average Fuel Economy Standards MYs 2017 and Beyond 2127-AK79 Proposed Rule Stage.
113 Sound for Hybrid and Electric Vehicles 2127-AK93 Proposed Rule Stage.
114 Motorcoach Rollover Structural Integrity 2127-AK96 Proposed Rule Stage.
115 Electronic Stability Control Systems for Heavy Vehicles 2127-AK97 Proposed Rule Stage.
116 Require Installation of Seat Belts on Motorcoaches, FMVSS No. 208 2127-AK56 Final Rule Stage.
117 Major Capital Investment Projects (RRR) 2132-AB02 Proposed Rule Stage.
118 Regulations To Be Followed by All Departments, Agencies, and Shippers Having Responsibility To Provide a Preference for U.S.-Flag Vessels in the Shipment of Cargoes on Ocean Vessels 2133-AB74 Proposed Rule Stage.
Department of Veterans Affairs Back to Top
Sequence No. Title Regulation Identifier No. Rulemaking Stage
119 VA Compensation and Pension Regulation Rewrite Project 2900-AO13 Proposed Rule Stage.
120 Caregivers Program 2900-AN94 Final Rule Stage.
Architectural and Transportation Barriers Compliance Board Back to Top
Sequence No. Title Regulation Identifier No. Rulemaking Stage
121 Accessibility Standards for Medical Diagnostic Equipment 3014-AA40 Proposed Rule Stage.
Environmental Protection Agency Back to Top
Sequence No. Title Regulation Identifier No. Rulemaking Stage
122 Risk and Technology Review for National Emission Standards for Hazardous Air Pollutants From the Pulp and Paper Industry 2060-AQ41 Proposed Rule Stage.
123 Joint Rulemaking To Establish 2017 and Later Model Year Light Duty Vehicle GHG Emissions and CAFE Standards 2060-AQ54 Proposed Rule Stage.
124 Petroleum Refinery Sector Risk and Technology Review and NSPS 2060-AQ75 Proposed Rule Stage.
125 Control of Air Pollution From Motor Vehicles: Tier 3 Motor Vehicle Emission and Fuel Standards 2060-AQ86 Proposed Rule Stage.
126 Greenhouse Gas New Source Performance Standard for Electric Generating Units for New Sources 2060-AQ91 Proposed Rule Stage.
127 National Emission Standards for Hazardous Air Pollutant Emissions: Group IV Polymers and Resins, Pesticide Active Ingredient Production, and Polyether Polyols Production Risk and Technology Review 2060-AR02 Proposed Rule Stage.
128 National Emission Standards for Hazardous Air Pollutants for Major Sources: Industrial, Commercial, and Institutional Boilers and Process Heaters; Proposed Reconsideration 2060-AR13 Proposed Rule Stage.
129 National Emission Standards for Hazardous Air Pollutants for Area Sources: Industrial, Commercial, and Institutional Boilers; Reconsideration and Proposed Rule Amendments 2060-AR14 Proposed Rule Stage.
130 Standards of Performance for New Stationary Sources and Emission Guidelines for Existing Sources: Commercial and Industrial Solid Waste Incineration Units; Reconsideration and Proposed Amendments 2060-AR15 Proposed Rule Stage.
131 NPDES Electronic Reporting Rule 2020-AA47 Proposed Rule Stage.
132 Pesticides; Certification of Pesticide Applicators 2070-AJ20 Proposed Rule Stage.
133 Pesticides; Agricultural Worker Protection Standard Revisions 2070-AJ22 Proposed Rule Stage.
134 Formaldehyde; Third-Party Certification Framework for the Formaldehyde Standards for Composite Wood Products 2070-AJ44 Proposed Rule Stage
135 Mercury; Regulation of Use in Certain Products 2070-AJ46 Proposed Rule Stage.
136 Lead; Renovation, Repair, and Painting Program for Public and Commercial Buildings 2070-AJ56 Proposed Rule Stage.
137 Revisions to the National Oil and Hazardous Substances Pollution Contingency Plan; Subpart J Product Schedule Listing Requirements 2050-AE87 Proposed Rule Stage.
138 Stormwater Regulations Revision To Address Discharges From Developed Sites 2040-AF13 Proposed Rule Stage.
139 Effluent Limitations Guidelines and Standards for the Steam Electric Power Generating Point Source Category 2040-AF14 Proposed Rule Stage.
140 National Pollutant Discharge Elimination System (NPDES) Concentrated Animal Feeding Operation (CAFO) Reporting Rule 2040-AF22 Proposed Rule Stage.
141 National Pollutant Discharge Elimination System (NPDES) Application and Program Updates Rule 2040-AF25 Proposed Rule Stage.
142 Review of the Secondary National Ambient Air Quality Standards for Oxides of Nitrogen and Oxides of Sulfur 2060-AO72 Final Rule Stage.
143 National Emission Standards for Hazardous Air Pollutants From Coal- and Oil-Fired Electric Utility Steam Generating Units and Standards of Performance for Electric Utility Steam Generating Units 2060-AP52 Final Rule Stage.
144 Oil and Natural Gas Sector—New Source Performance Standards and National Emission Standards for Hazardous Air Pollutants 2060-AP76 Final Rule Stage.
145 Criteria and Standards for Cooling Water Intake Structures 2040-AE95 Final Rule Stage.
Equal Employment Opportunity Commission Back to Top
Sequence No. Title Regulation Identifier No. Rulemaking Stage
146 Disparate Impact and Reasonable Factors Other Than Age Under the Age Discrimination in Employment Act 3046-AA76 Final Rule Stage.
National Archives and Records Administration Back to Top
Sequence No. Title Regulation Identifier No. Rulemaking Stage
147 Federal Records Management; Electronic Records Archives (ERA) 3095-AB74 Proposed Rule Stage.
Small Business Administration Back to Top
Sequence No. Title Regulation Identifier No. Rulemaking Stage
148 Small Business Technology Transfer (STTR) Policy Directive 3245-AF45 Proposed Rule Stage.
149 Small Business Innovation Research (SBIR) Program Policy Directive 3245-AF84 Proposed Rule Stage.
150 Acquisition Process: Task and Delivery Order Contracts, Bundling, Consolidation 3245-AG20 Proposed Rule Stage.
151 Small Business Jobs Act: Small Business Mentor-Protégé Programs 3245-AG24 Proposed Rule Stage.
Social Security Administration Back to Top
Sequence No. Title Regulation Identifier No. Rulemaking Stage
152 Revised Medical Criteria for Evaluating Respiratory System Disorders (859P) 0960-AF58 Proposed Rule Stage.
153 Revised Medical Criteria for Evaluating Hematological Disorders (974P) 0960-AF88 Proposed Rule Stage.
154 Revised Medical Criteria for Evaluating Mental Disorders (886F) 0960-AF69 Final Rule Stage.
155 How We Collect and Consider Evidence of Disability (3487P) 0960-AG89 Final Rule Stage.
156 Amendments to Regulations Regarding Withdrawals of Applications and Voluntary Suspension of Benefits (3573F) 0960-AH07 Final Rule Stage.
157 Expedited Vocational Assessment Under the Sequential Evaluation Process (3684P) 0960-AH26 Final Rule Stage.
Nuclear Regulatory Commission Back to Top
Sequence No. Title Regulation Identifier No. Rulemaking Stage
158 Medical Use of Byproduct Material—Amendments/Medical Event Definition [NRC-2008-0071] 3150-AI26 Proposed Rule Stage.
159 Fitness-For-Duty Programs [NRC-2009-0090] 3150-AI58 Proposed Rule Stage.
160 U.S. Evolutionary Power Reactor (EPR) Design Certification Amendment [NRC-2010-0132] 3150-AI82 Proposed Rule Stage.
161 Disposal of Unique Waste Streams [NRC-2011-0012] 3150-AI92 Proposed Rule Stage.
162 Revision of Fee Schedules: Fee Recovery for FY 2012 [NRC-2011-0207] 3150-AJ03 Proposed Rule Stage.
163 Risk-Informed Changes to Loss-of-Coolant Accident Technical Requirements [NRC-2004-0006] 3150-AH29 Final Rule Stage.
164 Physical Protection of Byproduct Material [NRC-2008-0120] 3150-AI12 Final Rule Stage.
165 Environmental Effect of Renewing the Operating License of a Nuclear Power Plant [NRC-2008-0608] 3150-AI42 Final Rule Stage.
166 AP1000 Design Certification Amendment [NRC-2010-0131] 3150-AI81 Final Rule Stage.
167 U.S. Advanced Boiling Water Reactor (ABWR) Aircraft Impact Design Certification Amendment [NRC-2010-0134] 3150-AI84 Final Rule Stage.
168 Economic Simplified Boiling-Water Reactor (ESBWR) Design Certification [NRC-2010-0135] 3150-AI85 Final Rule Stage.
169 List of Approved Spent Fuel Storage Casks—MAGNASTOR, Revision 2 [NRC-2011-0008] 3150-AI91 Final Rule Stage.

BILLING CODE 6820-27-P

DEPARTMENT OF AGRICULTURE (USDA) Back to Top

Statement of Regulatory Priorities

USDA's focus in 2012 will be on programs that create/save jobs, particularly in rural America, while identifying and taking action on those programs that could be modified, streamlined, and simplified, or reporting burdens reduced, particularly with the public's access to USDA programs. In addition, USDA's regulatory efforts in the coming year will be focused on achieving the Department's goals identified in the Department's Strategic Plan for 2010 to 2015.

  • Assist rural communities to create prosperity so they are self-sustaining, re-populating, and economically thriving. USDA is the leading advocate for rural America. The Department supports rural communities and enhances quality of life for rural residents by improving their economic opportunities, community infrastructure, environmental health, and the sustainability of agricultural production. The common goal is to help create thriving rural communities with good jobs where people want to live and raise families, and where children have economic opportunities and a bright future.
  • Ensure that all of America's children have access to safe, nutritious, and balanced meals. A plentiful supply of safe and nutritious food is essential to the well-being of every family and the healthy development of every child in America. USDA provides nutrition assistance to children and low-income people who need it and works to improve the healthy eating habits of all Americans, especially children. In addition, the Department safeguards the quality and wholesomeness of meat, poultry, and egg products and addresses and prevents loss and damage from pests and disease outbreaks.
  • Ensure our national forests and private working lands are conserved, restored, and made more resilient to climate change, while enhancing our water resources. America's prosperity is inextricably linked to the health of our lands and natural resources. Forests, farms, ranches, and grasslands offer enormous environmental benefits as a source of clean air, clean and abundant water, and wildlife habitat. These lands generate economic value by supporting the vital agriculture and forestry sectors, attracting tourism and recreation visitors, sustaining green jobs, and producing ecosystem services, food, fiber, timber and non-timber products, and energy. They are also of immense social importance, enhancing rural quality of life, sustaining scenic and culturally important landscapes, and providing opportunities to engage in outdoor activity and reconnect with the land.
  • Help America promote agricultural production and biotechnology exports as America works to increase food security. A productive agricultural sector is critical to increasing global food security. For many crops, a substantial portion of domestic production is bound for overseas markets. USDA helps American farmers and ranchers use efficient, sustainable production, biotechnology, and other emergent technologies to enhance food security around the world and find export markets for their products.

Important regulatory activities supporting the accomplishment of these goals in 2012 will include the following:

  • Rural Development and Renewable Energy. USDA priority regulatory actions for the Rural Development mission will be to revise regulations for the Business and Industry Guaranteed Loan Program, Rural Development's flagship job creation and capital expansion business program, and finalize regulations for the bioenergy programs.
  • USDA will continue to promote sustainable economic opportunities to create jobs in rural communities through the purchase and use of biobased products through the BioPreferred® program. USDA will continue to designate groups of biobased products to receive procurement preference from Federal agencies and contractors. BioPreferred has made serious efforts to minimize burdens on small business by providing a standard mechanism for product testing, an online application process, and individual assistance for small manufacturers when needed. Both the Federal preferred procurement and the certified label parts of the program are voluntary, and both are designed to assist biobased businesses in securing additional sales.
  • Nutrition Assistance. As changes are made to the nutrition assistance programs, USDA will work to foster actions that ensure access to program benefits, improve program integrity, improve diets and healthy eating through nutrition education, and promote physical activity consistent with the national effort to reduce obesity. In support of these activities in 2012, the Food and Nutrition Service (FNS) plans to publish the final rule regarding the nutrition standards in the school meals programs; finalize a rule updating the WIC food packages; and establish permanent rules for the Fresh Fruit and Vegetable Program. FNS will continue to work to implement rules that minimize participant and vendor fraud in its nutrition assistance programs.
  • Food Safety. In the area of food safety, USDA will continue to develop science-based regulations that improve the safety of meat, poultry, and processed egg products in the least burdensome and most cost-effective manner. Regulations will be revised to address emerging food safety challenges, streamlined to remove excessively prescriptive regulations, and updated to be made consistent with hazard analysis and critical control point principles. In 2012, the Food Safety and Inspection Service (FSIS) plans to propose regulations to establish new systems for poultry slaughter inspection, requirements for federally inspected egg product plants to develop and implement hazard analysis and critical control point systems and sanitation standard operating procedures, and finalize regulations on catfish inspection. To assist small entities to comply with food safety requirements, the FSIS will continue to collaborate with other USDA agencies and State partners in the enhanced small business outreach program.
  • Farm Loans, Disaster Designation, and Environmental Compliance. USDA will work to ensure a strong U.S. agricultural system through farm income support and farm loan programs. In addition, USDA will streamline the disaster designation process and update and consolidate the environmental compliance regulations.
  • Forestry and Conservation. In the conservation area, USDA plans to finalize regulations that would provide financial assistance grants to local governments, tribal governments, and nonprofit organizations to establish community forests by acquiring and protecting private forestlands.
  • Marketing and Regulatory Programs. USDA will work to support the organic sector and continue regulatory work to protect the health and value of U.S. agricultural and natural resources. USDA will also implement regulations to enhance enforcement of the Packers and Stockyards Act. In addition, USDA plans to finalize acceptable animal disease traceability standards. Regarding plant health, USDA anticipates revising the permitting of movement of plant pests and biological control organisms. For the Animal Welfare Act, USDA will propose specific standards for the humane care of birds and finalize specific standards for the humane care of dogs imported for resale.

Retrospective Review and Executive Order 13563

In January 2011, President Obama issued Executive Order (E.O.) 13563 on Improving Regulation and Regulatory Review. As part of this E.O., agencies were asked to review existing rules that may be outmoded, ineffective, insufficient, or excessively burdensome, and to modify, streamline, expand, or repeal them accordingly. Reducing the regulatory burden on the American people and our trading partners is a priority for USDA, and we will continually work to improve the effectiveness of our existing regulations. As a result of our regulatory review efforts in 2011, USDA will make regulatory changes in 2012, including the following:

Labeling—Generic Approval and Regulations Consolidation. FSIS is developing a rule that will expand the circumstances in which the labels of meat and poultry products will be deemed to be generically approved by FSIS. The rule will reduce duplication and streamline the regulations on this subject by combining them into a single part of the Code of Federal Regulations (CFR);

Electronic Export Application and Certification Fee. FSIS is planning a rule to provide for the electronic transmittal of foreign establishment certifications between FSIS and foreign governments. The rule will consolidate four inspection certificates (meat, meat by-products, poultry, and egg products) into one certificate. The rulemaking is intended, in part, to accommodate the Agency's electronic Public Health Information System.

Environmental Compliance. The Farm Service Agency (FSA) will consolidate and update the environmental compliance regulations to ensure regulations are consistent and current for all FSA programs and remove obsolete regulations;

National Environmental Policy Act (NEPA) Streamlining. The Natural Resources and Environment mission area and the Forest Service (FS), in cooperation with the Council on Environmental Quality (CEQ), is considering a series of initiatives to improve and streamline the NEPA process as it applies to FS projects;

Rural Energy for America Program. This new program will modify the existing grant and guaranteed loan program for renewable energy system (RES) and energy efficiency improvement (EEI) projects. In addition, it would add a grant program for RES feasibility studies and a grant program for energy audits and renewable energy development assistance. This rulemaking will streamline the process for smaller grants, lessening the burden to the customer. It will also make the guaranteed portion of the rule consistent with other programs Rural Development (RD) manages and allow applications to be accepted year around;

Business and Industry Loan Guaranteed Program. RD plans to rewrite the regulations, which will result in improved efficiency and effectiveness of the program, fewer errors because the guidelines and requirements will be clearer, and items will be more easily found in a better organized volume of regulations; and

Water and Waste Loans and Grants. RD will update the operations aspects of the loan and grant program to reduce the burden on the borrower.

Reducing the Paperwork Burden on Customers and Executive Order 13563

USDA has continued to make substantial progress in realizing the goal of the Paperwork Reduction Act. For example, the Farm and Foreign Agricultural Services (FFAS) mission area will reduce the paperwork burden on program participants by consolidating the information collections required to participate in farm programs administered by FSA and the Federal crop insurance program administered by the Risk Management Agency (RMA).

FFAS will evaluate methods to simplify and standardize, to the extent practical, acreage reporting processes, program dates, and data definitions across the various USDA programs and agencies. FFAS expects to allow producers to use information from their farm-management and precision agriculture systems for reporting production, planted and harvested acreage, and other key information needed to participate in USDA programs. FFAS will also streamline the collection of producer information by FSA and RMA with the agricultural production information collected by National Agricultural Statistics Service.

These process changes will allow for program data that is common across agencies to be collected once and utilized or redistributed to Agency programs in which the producer chooses to participate. FFAS plans to implement the Acreage and Crop Reporting Streamlining Initiative (ACRSI) in an incremental approach starting in late 2012 with a pilot in Kansas for growers of winter wheat when OMB approves the information collection. Full implementation is planned for 2013. When specific changes are identified, FSA and RMA will make any required conforming changes in their respective regulations.

Increasingly, USDA is providing electronic alternatives to its traditionally paper-based customer transactions. As a result, customers increasingly have the option to electronically file forms and other documentation online, allowing them to choose when and where to conduct business with USDA.

For example, Rural Development continues to review its regulations to determine which application procedures for Business Programs, Community Facilities Programs, Energy Programs, and Water and Environmental Programs can be streamlined and its requirements synchronized. RD is approaching the exercise from the perspective of the people it serves, by communicating with stakeholders on two common areas of regulation that can provide the basis of reform.

The first area provides support for entrepreneurship and business innovation. This initiative would provide for the streamlining and reformulating of the Business & Industry Loan Guarantee Program and the Intermediary Relending Program—the first such overhauls in over 20 years. The second area would provide for streamlining programs being made available to municipalities, tribes, and non-profit organizations; specifically Water and Waste Disposal, Community Facilities, and Rural Business Enterprise Grants, plus programs such as Electric and Telecommunications loans that provide basic community needs. This regulatory reform initiative has the potential to significantly reduce the burden to respondents (lenders and borrowers).

To the extent practicable, each reform initiative will consist of a common application and uniform documentation requirements making it easier for constituency groups to apply for multiple programs. In addition, there will be associated regulations for each program that will contain program specific information.

Natural Resources Conservation Service will also improve the delivery of technical and financial assistance by simplifying customer access to NRCS' technical and financial assistance programs, streamlining the delivery and timeliness of conservation assistance to clients, and enhancing the technical quality of its conservation planning and services. The streamlining initiatives will allow NRCS field staff to spend more time on conservation planning in the field with customers, reduce the time needed to implement cost-share contracts, and provide more flexibility for customers to work with NRCS in different ways. NRCS estimates that this initiative has the potential to reduce the amount of time required for producers to participate in USDA's conservation programs by almost 800,000 hours annually. This includes efficiencies from reduced paperwork, data entry by the client, and reduced travel time to and from the local office to complete forms and other administrative tasks. Improvements being considered include the following:

  • Providing an online portal that will allow customers to apply for programs or services, review their plans and contracts, view and assess natural resource information specifically about their farm, evaluate the costs and benefits for various conservation treatment alternatives, notify NRCS of installed practices, and check on contract payments at their convenience;
  • Creating an e-customer profile that will improve customer service by allowing the client to view, finalize, and electronically sign documents using remote electronic signature, on-site rather than at a local office;
  • Providing clients with more timely and specific information on alternative conservation treatments, including the environmental benefits of their planned and applied practices;
  • Accelerating payments to clients; and
  • Simplifying conservation plan documents to more specifically address client needs and goals.

Major Regulatory Priorities

This document represents summary information on prospective significant regulations as called for in E.O.s 12866 and 13563. The following USDA agencies are represented in this regulatory plan, along with a summary of their mission and key regulatory priorities in 2012:

Food and Nutrition Service

Mission: FNS increases food security and reduces hunger in partnership with cooperating organizations by providing children and low-income people access to food, a healthful diet, and nutrition education in a manner that supports American agriculture and inspires public confidence.

Priorities: In addition to responding to provisions of legislation authorizing and modifying Federal nutrition assistance programs, FNS' 2012 regulatory plan supports USDA's Strategic Goal “Ensure that all of America's children have access to safe, nutritious, and balanced meals,” and its two related objectives:

Access to Nutritious Food. This objective represents FNS's efforts to improve nutrition by providing access to program benefits (food consumed at home, school meals, commodities) and distributing State administrative funds to support program operations. To advance this objective, FNS plans to publish a final rule of the 2008 Farm Bill that ensures access to SNAP benefits and addresses other eligibility, certification, employment, and training issues. An interim rule, implementing provisions of the Child Nutrition and WIC Reauthorization Act of 2004 to establish automatic eligibility for homeless children for school meals, further supports this objective.

Promote Healthy Diet and Physical Activity Behaviors. This objective represents FNS' efforts to improve the diets of its clients through nutrition education, support the national effort to reduce obesity by promoting healthy eating and physical activity, and to ensure that program benefits meet appropriate standards to effectively improve nutrition for program participants. In support of this objective, FNS plans to publish the final rule regarding the nutrition standards in the school meals programs, finalize a rule updating the WIC food packages, and establish permanent rules for the Fresh Fruit and Vegetable Program, which currently operates in a select number of schools in each State, the District of Columbia, Guam, Puerto Rico, and the Virgin Islands.

Food Safety and Inspection Service

Mission: FSIS is responsible for ensuring that meat, poultry, egg, and catfish products in interstate and foreign commerce are wholesome, not adulterated, and properly marked, labeled, and packaged.

Priorities: FSIS is committed to developing and issuing science-based regulations intended to ensure that meat, poultry, egg, and catfish products are wholesome and not adulterated or misbranded. FSIS regulatory actions support the objective to protect public health by ensuring that food is safe under USDA's goal to ensure access to safe food. To reduce the number of foodborne illnesses and increase program efficiencies, FSIS will continue to review its existing authorities and regulations to ensure that it can address emerging food safety challenges, to streamline excessively prescriptive regulations, and to revise or remove regulations that are inconsistent with the FSIS' hazard analysis and critical control point (HACCP) regulations. FSIS is also working with the Food and Drug Administration (FDA) to improve coordination and increase the effectiveness of inspection activities. FSIS' priority initiatives are as follows:

➢ Rulemakings that support initiatives of the President's Food Safety Working Group:

  • Poultry Slaughter Inspection. Based on the Administration's top-to-bottom review of food safety activities, the Food Safety and Inspection Service will issue regulations that will prevent thousands of food-borne illnesses by more clearly focusing FSIS inspection activities on improving food safety, streamline poultry inspections, and reduce Government spending.
  • Revision of Egg Products Inspection Regulations. FSIS is planning to propose requirements for federally inspected egg product plants to develop and implement HACCP systems and sanitation standard operating procedures. FSIS will be proposing pathogen reduction performance standards for egg products and will remove prescriptive requirements for egg product plants.

➢ Initiatives that provide for disclosure or that enable economic growth. FSIS plans to issue two rules to promote disclosure of information to the public or that provide flexibility for the adoption of new technologies:

  • Product Labeling; Use of the Voluntary Claim “Natural” in the Labeling of Meat and Poultry Products. FSIS will propose to amend the meat and poultry products regulations to define the conditions under which the voluntary claim “natural” may be used on meat and poultry product labeling.
  • Food Ingredients and Sources of Radiation Listed and Approved for Use in the Production of Meat and Poultry Products. FSIS will propose to amend its food ingredient regulations to provide for the use under certain conditions of benzoic acid, sodium propionate, or sodium benzoate.

Notification, Documentation, and Recordkeeping Requirements for Inspected Establishments. As authorized by the 2008 Farm Bill, FSIS will issue final regulations that will require establishments that are subject to inspection to promptly notify FSIS when an adulterated or misbranded product received by or originating from the establishment has entered into commerce. The regulations also will require the establishments to prepare and maintain current procedures for the recall of all products produced and shipped by the establishments and to document each reassessment of the establishments' process control plans.

Catfish Inspection. FSIS is developing final regulations to implement provisions of the 2008 Farm Bill provisions that make catfish an amenable species under the Federal Meat Inspection Act (FMIA).

Public Health Information System. To support its food safety inspection activities, FSIS is implementing the Public Health Information System (PHIS). PHIS, which is user-friendly and Web-based, will replace many of FSIS' current systems and automate many business processes. PHIS also will improve FSIS' ability to systematically verify the effectiveness of foreign food safety systems and enable greater exchange of information between FSIS and other Federal agencies (such as U.S. Customs and Border Protection) involved in tracking cross-border movement of import and export shipments of meat, poultry, and processed egg products. To facilitate the implementation of some PHIS components, FSIS is proposing to provide for electronic export and import application and certification processes as alternatives to the current paper-based systems for these certifications.

Other Planned Initiatives. FSIS plans to finalize a February 2001 proposed rule to establish food safety performance standards for all processed ready-to-eat (RTE) meat and poultry products and for partially heat-treated meat and poultry products that are not ready-to-eat. Some provisions of the proposal addressed post-lethality contamination of RTE products with Listeria monocytogenes. In June 2003, FSIS published an interim final rule requiring establishments to prevent L. monocytogenes contamination of RTE products. FSIS has carefully reviewed its economic analysis of the interim final rule and is planning to affirm the interim rule as a final rule with changes.

FSIS Small Business Implications. The great majority of businesses regulated by FSIS are small businesses. Some of the regulations listed above substantially affect small businesses. FSIS conducts a small business outreach program that provides critical training, access to food safety experts, and information resources (such as compliance guidance and questions and answers on various topics) in forms that are uniform, easily comprehended, and consistent. FSIS collaborates in this effort with other USDA agencies and cooperating State partners. For example, FSIS makes plant owners and operators aware of loan programs, available through USDA's Rural Business and Cooperative programs, to help them in upgrading their facilities. FSIS employees meet with small and very small plant operators to learn more about their specific needs and provide joint training sessions for small and very small plants and FSIS employees.

Animal and Plant Health Inspection Service

Mission: A major part of the mission of the Animal and Plant Health Inspection Service (APHIS) is to protect the health and value of American agricultural and natural resources. APHIS conducts programs to prevent the introduction of exotic pests and diseases into the U.S. and conducts surveillance, monitoring, control, and eradication programs for pests and diseases in this country. These activities enhance agricultural productivity and competitiveness and contribute to the national economy and the public health. APHIS also conducts programs to ensure the humane handling, care, treatment, and transportation of animals under the Animal Welfare Act.

Priorities: With respect to animal health, APHIS is continuing work to revise its regulations concerning bovine spongiform encephalopathy (BSE) to provide a more comprehensive and universally applicable framework for the importation of certain animals and products. In the area of plant health, APHIS is in the midst of a revision to its regulations for the importation and interstate movement of plant pests and biological control organisms to clarify the factors that would be considered when assessing the risks associated with the movement of certain organisms, facilitate the movement of regulated organisms and articles in a manner that also protects U.S. agriculture, and address gaps in the current regulations. APHIS also plans to propose standards for the humane handling, care, treatment, and transportation of birds covered under the Animal Welfare Act.

Additional information about APHIS and its programs is available on the Internet at http://www.aphis.usda.gov.

Agricultural Marketing Service

Mission: The Agricultural Marketing Service (AMS) provides marketing services to producers, manufacturers, distributors, importers, exporters, and consumers of food products. The AMS also manages the Government's food purchases, supervises food quality grading, maintains food quality standards, and supervises the Federal research and promotion programs.

Priorities: AMS' priority items for the next year include rulemaking that impact the organic industry, as well as the wholesale pork industry. Rulemakings the Agency intends to initiate within the next 12 months include:

Sunset Review (2012)—Nutrient Vitamins and Minerals. On March 26, 2010, the National Organic Program (NOP) issued an Advanced Notice of Proposed Rulemaking (ANPRM) announcing the National Organic Standards Board's (NOSB) sunset review of exempted and prohibited substances codified at the National List of Allowed and Prohibited Substances of the NOP regulations. This review included a listing for “Nutrient vitamins and minerals” scheduled to sunset on October 21, 2012. AMS intends to publish a proposed rule to address a recommendation submitted by the NOSB for this listing. This proposed rule would continue the exemption (use) for nutrient vitamins and minerals for 5 years after the October 21, 2012, sunset date. This proposed rule would amend the annotation for nutrient vitamins and minerals to correct an inaccurate cross reference to U.S. Food and Drug Administration (FDA) regulations as AMS determined that the current exemption for the use of nutrient vitamins and minerals in organic products in the NOP regulations is inaccurate. In effect, the proposed amendment would clarify what synthetic substances are allowed as nutrient vitamins and minerals in organic products. Further, the NOP regulations do not correctly provide for the fortification of infant formula that would meet FDA requirements. This proposed rule would incorporate the correct FDA citation with respect to the addition of required vitamins and minerals to organic infant formula.

Livestock Mandatory Reporting; Establishing Regulations for Wholesale Pork. As directed by the 2008 Farm Bill, the Secretary conducted a study to determine advantages, drawbacks, and potential implementation issues associated with adopting mandatory wholesale pork reporting. The report from this study concluded that negotiated wholesale pork price reporting is thin and becoming thinner and found some degree of support for moving to mandatory price reporting exists at every segment of the industry interviewed. That study also concluded that the benefits likely would exceed the cost of moving from a voluntary to a mandatory reporting program for wholesale pork.

Subsequently, the Mandatory Price Reporting Act of 2010 (2010 Reauthorization Act) (Pub. L. 111-239), was signed into law on September 28, 2010, and reauthorized Livestock Mandatory Reporting for 5 years and added a provision for mandatory reporting of wholesale pork cuts. The 2010 Reauthorization Act directed the Secretary to engage in negotiated rulemaking to make required regulatory changes for mandatory wholesale pork reporting.

Further, the 2010 Reauthorization Act directed the Secretary to establish a Committee that represented the spectrum of interests within the pork industry, as well as related stakeholders, to ensure all parties had input into the regulatory framework. Specifically, the statute required that the Committee include representatives from (i) organizations representing swine producers; (ii) organizations representing packers of pork, processors of pork, retailers of pork, and buyers of wholesale pork; (iii) Department of Agriculture; and (iv) interested parties that participate in swine or pork production.

The Agricultural Marketing Service (AMS) convened the Wholesale Pork Reporting Negotiated Rulemaking Committee (Committee) through notice in the Federal Register on January 26, 2011. The Committee met three times over the period February through May of 2011 to develop the regulatory framework necessary to implement a mandatory program of wholesale pork reporting.

The regulatory text developed by the Committee will serve as the primary basis for the proposed rule, consistent with both the intent of Congress and the Negotiated Rulemaking Act. It is important to note that the Committee reached consensus on all items included in the proposed rule—where consensus was defined by the Committee bylaws as being unanimous agreement. Therefore, AMS is confident the proposed rule to implement wholesale pork reporting will be met with little or no resistance from the industry members who will be required to report under the mandatory system.

Grain Inspection, Packers, and Stockyards Administration

Mission: The Grain Inspection, Packers, and Stockyards Administration (GIPSA) facilitates the marketing of livestock, poultry, meat, cereals, oilseeds, and related agricultural products and promotes fair and competitive trading practices for the overall benefit of consumers and American agriculture. GIPSA's activities contribute significantly to USDA's goal to increase prosperity in rural areas by supporting a competitive agricultural system.

Priorities: GIPSA intends to issue a final rule that will define practices or conduct that are unfair, unjustly discriminatory, or deceptive, and/or that represent the making or giving of an undue or unreasonable preference or advantage, and ensure that producers and growers can fully participate in any arbitration process that may arise relating to livestock or poultry contracts. This regulation is being finalized in accordance with the authority granted to the Secretary by the Packers and Stockyards Act of 1921 and with the requirements of sections 11005 and 11006 of the 2008 Farm Bill.

Farm Service Agency

Mission: FSA's mission is to equitably serve all farmers, ranchers, and agricultural partners through the delivery of effective, efficient agricultural programs, which contributes to two USDA goals: Assist rural communities in creating prosperity so they are self-sustaining, re- populating, and economically thriving; and enhance the Nation's natural resource base by assisting owners and operators of farms and ranches to conserve and enhance soil, water, and related natural resources. FSA supports the first goal by stabilizing farm income, providing credit to new or existing farmers and ranchers who are temporarily unable to obtain credit from commercial sources, and helping farm operations recover from the effects of disaster. FSA supports the second goal by administering several conservation programs directed toward agricultural producers. The largest program is the Conservation Reserve Program (CRP), which protects nearly 32 million acres of environmentally sensitive land.

Priorities: Farm Loan Programs. FSA will develop and issue regulations to amend programs for farm operating loans, down payment loans, and emergency loans to include socially disadvantaged farmers, increase loan limits, loan size, funding targets, interest rates, and graduating borrowers to commercial credit. In addition, FSA will further streamline normal loan servicing activities and reduce burden on borrowers while still protecting the loan security.

Disaster Designation. FSA will revise the disaster designation process to streamline it and reduce the burden on States and tribes requesting disaster designations. One result may be fewer delays in delivering disaster assistance to help farm operations recover from the effects of disaster.

Forest Service

Mission: The mission of the Forest Service is to sustain the health, productivity, and diversity of the Nation's forests and rangelands to meet the needs of present and future generations. This includes protecting and managing National Forest System lands, providing technical and financial assistance to States, communities, and private forest landowners, and developing and providing scientific and technical assistance and scientific exchanges in support of international forest and range conservation. FS' regulatory priorities support the accomplishment of USDA's goal to ensure our national forests are conserved, restored, and made more resilient to climate change, while enhancing our water resources.

Priorities: Special Areas; State-Specific Inventoried Roadless Area Management: Colorado. FS planned final rulemaking would establish a State-specific rule to provide management direction for conserving and managing inventoried roadless areas on National Forest System lands in the State of Colorado.

Land Management Planning Rule. FS is required to issue rulemaking for National Forest System land management planning under 16 U.S.C. 1604. The first planning rule was adopted in 1979, and amended in 1982. FS published a new planning rule on April 21, 2008 (73 FR 21468). On June 30, 2009, the United States District Court for the Northern District of California invalidated FS' 2008 Planning Rule published at 36 CFR 219 based on violations of NEPA and the Endangered Species Act in the rulemaking process. The District Court vacated the 2008 rule, enjoined USDA from further implementing it, and remanded it to USDA for further proceedings. USDA has determined that the 2000 planning rule is now in effect, including its transition provisions as amended in 2002 and 2003, and as clarified by interpretative rules issued in 2001 and 2004, which allows the use of the provisions of the 1982 planning rule to amend or revise plans. FS is now in the 2000 planning rule transition period. FS published a proposed planning rule on February 14, 2011 (76 FR 8480). The final rule is expected to be published December 2011. In so doing, FS plans to correct deficiencies that have been identified over two decades of forest planning and update planning procedures to reflect contemporary collaborative planning practices.

Community Forest and Open Space Conservation Program. The purpose of the Community Forest Program is to achieve community benefits through financial assistance grants to local governments, tribal governments, and nonprofit organizations to establish community forests by acquiring and protecting private forestlands. Community forest benefits are specified in the authorizing statute and include economic benefits from sustainable forest management, natural resource conservation, forest-based educational programs, model forest stewardship activities, and recreational opportunities.

Rural Business-Cooperative Service

Mission: Promoting a dynamic business environment in rural America is the goal of the Rural Business-Cooperative Service (RBS). Business Programs works in partnership with the private sector and the community-based organizations to provide financial assistance and business planning, and helps fund projects that create or preserve quality jobs and/or promote a clean rural environment. The financial resources are often leveraged with those of other public and private credit source lenders to meet business and credit needs in under-served areas. Recipients of these programs may include individuals, corporations, partnerships, cooperatives, public bodies, nonprofit corporations, Indian tribes, and private companies. The mission of Cooperative Programs of RBS is to promote understanding and use of the cooperative form of business as a viable organizational option for marketing and distributing agricultural products.

Priorities: In support USDA's goal to increase the prosperity of rural communities, RBS regulatory priorities will facilitate sustainable renewable energy development and enhance the opportunities necessary for rural families to thrive economically. RBS' priority will be to publish regulations to fully implement the 2008 Farm Bill. This includes promulgating regulations for the Biorefinery Assistance Program (sec. 9003), the Repowering Assistance Program (sec. 9004), the Bioenergy Program for Advanced Biofuels (sec. 9005), and the Rural Microentrepreneur Assistance Program (RMAP). RBS has been administering sections 9003, 9004, and 9005 through the use of Notices of Funds Availability and Notices of Contract Proposals. Revisions to the Rural Energy for America Program (sec. 9007) will be made to incorporate Energy Audits and Renewable Energy Development Assistance and Feasibility Studies for Rural Energy Systems as eligible grant purposes, as well as other Farm Bill initiatives and various technical changes throughout the rule. In addition, revisions to the Business and Industry Guaranteed Loan Program will be made to implement 2008 Farm Bill provisions and other program initiatives. These rules will minimize program complexity and burden on the public while enhancing program delivery and RBS oversight.

Rural Utilities Service

Mission: The mission of the Rural Utilities Service (RUS) is to improve the quality of life in rural America by providing investment capital for the deployment of critical rural utilities telecommunications, electric, and water and waste disposal infrastructure. Financial assistance is provided to rural utilities, municipalities, commercial corporations, limited liability companies, public utility districts, Indian tribes, and cooperative, non-profit, limited-dividend, or mutual associations. The public-private partnership, which is forged between RUS and these industries, results in billions of dollars in rural infrastructure development and creates thousands of jobs for the American economy.

Priorities: RUS' regulatory priorities will be to achieve the President's goal to bring affordable broadband to all rural Americans. To accomplish this, RUS will continue to improve the Broadband Program established by the 2002 Farm Bill. The 2002 Farm Bill authorized RUS to approve loans and loan guarantees for the costs of construction, improvement, and acquisition of facilities and equipment for broadband service in eligible rural communities. The 2008 Farm Bill significantly changed the statutory requirements of the Broadband Loan Program. As such, RUS issued an interim rule to implement the statutory changes and requested comments on the section of the rule that was not part of the proposed rule published in May 2007. Comments were received and the agency will analyze the comments and finalize the rule.

Departmental Management

Mission: Departmental Management's mission is to provide management leadership to ensure that USDA administrative programs, policies, advice, and counsel meet the needs of USDA program organizations, consistent with laws and mandates, and provide safe and efficient facilities and services to customers.

Priorities: In support of the Department's goal to increase rural prosperity, USDA's departmental management will finalize regulations to revise the BioPreferred program guidelines to continue adding designated product categories to the preferred procurement program, including intermediates and feedstocks and finished products made of intermediates and feedstocks.

Aggregate Costs and Benefits

USDA will ensure that its regulations provide benefits that exceed costs but is unable to provide an estimate of the aggregated impacts of its regulations. Problems with aggregation arise due to differing baselines, data gaps, and inconsistencies in methodology and the type of regulatory costs and benefits considered. Some benefits and costs associated with rules listed in the regulatory plan cannot currently be quantified as the rules are still being formulated. For 2012, USDA's focus will be to implement the changes to programs in such a way as to provide benefits while minimizing program complexity and regulatory burden for program participants.

USDA—Agricultural Marketing Service (AMS) Back to Top

Proposed Rule Stage

1. Wholesale Pork Reporting Program Back to Top

Priority: Other Significant.

Legal Authority: 7 U.S.C. 1635 to 1636

CFR Citation: 7 CFR 59.

Legal Deadline: Final, Statutory, March 28, 2012.

With the passage of S. 3656, the Mandatory Price Reporting Act of 2010, the Secretary of Agriculture is required to amend chapter 3 of subtitle B of the Agricultural Marketing Act of 1946 by adding a new section for mandatory reporting of wholesale pork cuts. To make these amendments, the Secretary was directed to promulgate a final rule no later than 11/2years after the date of the enactment of the Act. Accordingly, a final rule will be promulgated by March 28, 2012.

Abstract: On September 15, 2010, Congress passed the Mandatory Price Reporting Act of 2010 reauthorizing Livestock Mandatory Reporting for 5 years and adding a provision for mandatory reporting of wholesale pork cuts. The Act was signed by the President on September 28, 2010. Congress directed the Secretary to engage in negotiated rulemaking to make required regulatory changes for mandatory wholesale pork reporting. Further, Congress required that the negotiated rulemaking committee include representatives from (i) organizations representing swine producers; (ii) organizations representing packers of pork, processors of pork, retailers of pork, and buyers of wholesale pork; (iii) the Department of Agriculture; and (iv) interested parties that participate in swine or pork production.

Statement of Need: Implementation of mandatory pork reporting is required by Congress. Congress delegated responsibility to the Secretary for determining what information is necessary and appropriate. The Food, Conservation, and Energy Act of 2008 (Pub. L. 110-234) directed the Secretary to conduct a study to determine advantages, drawbacks, and potential implementation issues associated with adopting mandatory wholesale pork reporting. The report from this study generally concluded that voluntary wholesale pork price reporting is thin and becoming thinner, and some degree of support for moving to mandatory price reporting exists at every segment of the industry interviewed. The report was delivered to Congress on March 25, 2010.

Summary of Legal Basis: Livestock Mandatory Reporting is authorized under the Agricultural Marketing Act (7 U.S.C. 1635 to 1636). The Livestock and Seed Program of USDA's Agricultural Marketing Service has day-to-day responsibility for collecting and disseminating LMR data.

Alternatives: There are no alternatives, as this rulemaking is a matter of law based on the Mandatory Price Reporting Act of 2010.

Anticipated Cost and Benefits: Estimation of costs will follow the previous methodology used in earlier Livestock Mandatory Reporting rulemaking. The focus of the cost estimation is the burden placed on reporting companies in providing pork marketing data to the Livestock and Seed Program. Previous rulemaking cost estimates of boxed beef reporting of similar data found the burden to be an annual total of 65 hours in additional reporting requirements per firm. Because no official USDA grade standards are used in the marketing of pork, and there are fewer cutting styles, the burden for pork reporting firms in comparison with beef reporting firms could be lower. However, the impact is not truly known at this stage.

Risks: Implementing wholesale pork reporting presents few risks to the Agency and the impacted industry. Members of the industry who served on the negotiated rulemaking committee expressed some concern with reporting prices under a different reporting basis than what is used for voluntary pork reporting. However, ultimately the committee reached consensus on having prices reporting on both an FOB Omaha and FOB Plant basis in order to reduce market volatility.

Timetable:

Action Date FR Cite
Changes to Livestock Mandatory Reporting 11/24/10 75 FR 71568
Wholesale Pork Reporting; Notice of Meeting 01/26/11 76 FR 4554
NPRM 02/00/12  
Final Action 10/00/12  

Regulatory Flexibility Analysis Required: Yes.

Small Entities Affected: Businesses.

Government Levels Affected: None.

Agency Contact: Michael P. Lynch, Department of Agriculture, Agricultural Marketing Service, 14th and Independence Avenue SW., Washington, DC 20250, Phone: 202 720-6231.

RIN: 0581-AD07

USDA—AMS Back to Top

2. • National Organic Program: Sunset Review for Nutrient Vitamins and Minerals (NOP-10-0083) Back to Top

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

Legal Authority: 7 U.S.C. 6501

CFR Citation: 7 CFR 205.

Legal Deadline: None.

Abstract: This proposed rule would address a recommendation submitted to the Secretary of Agriculture (Secretary) by the National Organic Standards Board (NOSB) on April 29, 2011. The recommendation pertains to the 2012 Sunset Review of the listing for nutrient vitamins and minerals on the U.S. Department of Agriculture's (USDA) National List of Allowed and Prohibited Substances (National List). As recommended by the NOSB, the proposed rule would continue the exemption (use) for nutrient vitamins and minerals for 5 years after the October 21, 2012, sunset date. In addition, the proposed rule would amend the annotation to correct an inaccurate cross reference to U.S. Food and Drug Administration regulations. The proposed amendment to the annotation would clarify what synthetic substances are allowed as nutrient vitamins and minerals in organic products labeled as “organic” or “made with organic (specified ingredients or food group(s)).”

Statement of Need: The Agricultural Marketing Service (AMS) has determined that the current exemption for the use of nutrient vitamins and minerals in organic products in the National Organic Program (NOP) regulations (7 CFR part 205) is inaccurate. The proposed rule would amend the annotation for nutrient vitamins and minerals to correct an inaccurate cross reference to U.S. Food and Drug Administration (FDA) regulations. In effect, the proposed amendment would clarify what synthetic substances are allowed as nutrient vitamins and minerals in organic products. Further, the NOP regulations do not correctly provide for the fortification of infant formula that would meet FDA requirements. This proposed rule would incorporate the correct FDA citation with respect to the addition of required vitamins and minerals to organic infant formula.

Summary of Legal Basis: This proposed rule would address a recommendation submitted to the Secretary of Agriculture by the National Organic Standards Board (NOSB) on April 29, 2011, to continue the exemption for nutrient vitamins and minerals in organic products as provided by the NOP National List of Allowed and Prohibited Substances (National List). The Organic Foods Production Act of 1990 (OFPA) authorizes the Secretary to amend the National List based on proposed amendments developed by the NOSB. The Sunset Provision, in section 6517(e) of the OFPA, provides that no exemption or prohibition on the National List will remain valid after 5 years unless the exemption or prohibition has been reviewed and the Secretary renews the listing. The exemption for nutrient vitamins and minerals is scheduled to sunset on October 21, 2012.

Alternatives: AMS considered two alternatives to this proposed rulemaking: (1) Renew the existing listing for nutrient vitamins and minerals or (2), in lieu of a rule, issue guidance stating NOP's intent to interpret the current listing for nutrient vitamins and minerals as proposed in this action. AMS determined that neither alternative is viable as both would retain a regulatory provision that is inaccurate and remains vulnerable to misinterpretations of what substances are permitted in organic products.

Anticipated Cost and Benefits: This proposed rule would establish a finite list of essential and required vitamins and minerals for use in organic food and infant formula. The action addresses the requests of a broad spectrum of public commenters for clarification on the parameters for adding nutrient vitamins and minerals to organic products and is expected to reduce the submission of consumer complaints alleging the unlawful addition of substances to organic products. This proposed rule would also provide more certainty to certifying agents and organic operations in determining whether substances are acceptable for use in organic products. Further, this proposed action also would foster greater transparency by ensuring that exemptions for the use of vitamins, minerals, and other nutrients are subject to National Organic Standards Board (NOSB) evaluation in accordance with the criteria established in OFPA.

This action could directly impact a subset of certified organic operations, which add substances to organic products that are not essential vitamins and minerals for human nutrition (21 CFR 101.9) or required vitamins and minerals for infant formula (21 CFR 107.100 or 107.10), as enumerated by FDA regulation. AMS believes the impacts will be concentrated within five categories of organic products in which nutrient supplementation has been more prevalent: Infant formula, baby food, milk, breakfast cereal, and pet food. The proposed rule could indirectly impact producers who supply organic agricultural commodities to affected product categories. However, AMS expects that there will be opportunities for producers to divert organic agricultural products to other purchasers to buffer the impact of any disruption to the manufacture of certain processed organic products as a result of this proposed action.

There are several impact mitigation factors which are expected to reduce the costs of complying with this proposed action. AMS is proposing a 2-year implementation phase, which is intended to provide time for NOSB to consider petitions for substances that are affected by this action and for AMS to conclude any rulemaking to add substances to the National List. The implementation phase would also provide entities the time to explore reformulation of affected products. Further, if some products are discontinued as a result of this proposed rule, AMS anticipates that some consumers will purchase, as an alternative, an organic product within the same category rather than a nonorganic product.

Risks: For the 2-year implementation phase to function as a mitigation measure, the timeframe may be tight to complete the review of petitions received by publication of this proposed rule and for any rulemaking action recommended by NOSB. Therefore, AMS has requested comments on the length of the implementation phase as part of this proposed rule.

Timetable:

Action Date FR Cite
NPRM 01/12/12 77 FR 1980
NPRM Comment Period End 03/12/12
Final Action 10/00/12

Regulatory Flexibility Analysis Required: Undetermined.

Government Levels Affected: Local, State.

Agency Contact: Melissa R. Bailey, Director, Standards Division, Department of Agriculture, Agricultural Marketing Service, Washington, DC 20250, Phone: 202 720-3252, Fax: 202 205-7808, Email: melissa.bailey@usda.gov.

Related RIN: Split from 0581-AC96.

RIN: 0581-AD17

USDA—ANIMAL AND PLANT HEALTH INSPECTION SERVICE (APHIS) Back to Top

Proposed Rule Stage

3. Animal Welfare; Regulations and Standards for Birds Back to Top

Priority: Other Significant.

Legal Authority: 7 U.S.C. 2131 to 2159

CFR Citation: 9 CFR 1 to 3.

Legal Deadline: None.

Abstract: APHIS intends to establish standards for the humane handling, care, treatment, and transportation of birds other than birds bred for use in research.

Statement of Need: The Farm Security and Rural Investment Act of 2002 amended the definition of animal in the Animal Welfare Act (AWA) by specifically excluding birds, rats of the genus Rattus, and mice of the genus Mus, bred for use in research. While the definition of animal in the regulations contained in 9 CFR part 1 has excluded rats of the genus Rattus and mice of the genus Mus bred for use in research, that definition has also excluded all birds (i.e., not just those birds bred for use in research). In line with this change to the definition of animal in the AWA, APHIS intends to establish standards in 9 CFR part 3 for the humane handling, care, treatment, and transportation of birds other than those birds bred for use in research and to revise the regulations in 9 CFR parts 1 and 2 to make them applicable to birds.

Summary of Legal Basis: The Animal Welfare Act (AWA) authorizes the Secretary of Agriculture to promulgate standards and other requirements governing the humane handling, care, treatment, and transportation of certain animals by dealers, research facilities, exhibitors, operators of auction sales, and carriers and immediate handlers. Animals covered by the AWA include birds that are not bred for use in research.

Alternatives: To be identified.

Anticipated Cost and Benefits: Benefits of the rule would stem from improvements in the humane handling and care of birds by affected dealers, exhibitors, carriers, and intermediate handlers. At a minimum, these entities would be required to satisfy certain reporting provisions and undergo periodic compliance inspections by APHIS—measures that they are not subject to now with respect to birds. Regulated entities, therefore, may incur certain costs because of the proposed rule. Most facilities that use birds in research, such as pharmaceutical companies, universities, and research institutes, would not be affected. Retail pet stores could be affected to the extent that regulatory costs are passed on to them by breeders and other suppliers.

Most entities affected by the proposal are likely to be small in size, based on Small Business Administration standards. We have not been able to conduct a comprehensive analysis of the rule's potential economic impact because of the paucity of available data on the affected industries. APHIS welcomes public comment that would permit a more complete assessment of the proposed rule's impact.

Risks: Not applicable.

Timetable:

Action Date FR Cite
NPRM 05/00/12
NPRM Comment Period End 08/00/12

Regulatory Flexibility Analysis Required: Yes.

Small Entities Affected: Businesses.

Government Levels Affected: Undetermined.

Additional Information: Additional information about APHIS and its programs is available on the Internet at http://www.aphis.usda.gov.

Agency Contact: Johanna Briscoe, Veterinary Medical Officer and Avian Specialist, Animal Care, Department of Agriculture, Animal and Plant Health Inspection Service, 4700 River Road, Unit 84, Riverdale, MD 20737-1234, Phone: 301 734-0658.

RIN: 0579-AC02

USDA—APHIS Back to Top

4. Plant Pest Regulations; Update of General Provisions Back to Top

Priority: Other Significant.

Legal Authority: 7 U.S.C. 450; 7 U.S.C. 2260; 7 U.S.C. 7701 to 7772; 7 U.S.C. 7781 to 7786; 7 U.S.C. 8301 to 8817; 19 U.S.C. 136; 21 U.S.C. 111; 21 U.S.C. 114a; 21 U.S.C. 136 and 136a; 31 U.S.C. 9701; 42 U.S.C. 4331 and 4332

CFR Citation: 7 CFR 318 and 319; 7 CFR 330; 7 CFR 352.

Legal Deadline: None.

Abstract: We are proposing to revise our regulations regarding the movement of plant pests. We are proposing to regulate the movement of, not only plant pests, but also biological control organisms and associated articles. We are proposing risk-based criteria regarding the movement of biological control organisms and are proposing to exempt certain types of plant pests from permitting requirements for their interstate movement and movement for environmental release. We are also proposing to revise our regulations regarding the movement of soil and to establish regulations governing the biocontainment facilities in which plant pests, biological control organisms, and associated articles are held. This proposed rule replaces a previously published proposed rule, which we are withdrawing as part of this document. This proposal would clarify the factors that would be considered when assessing the risks associated with the movement of certain organisms, facilitate the movement of regulated organisms and articles in a manner that also protects U.S. agriculture, and address gaps in the current regulations.

Statement of Need: APHIS is preparing a proposed rule to revise its regulations regarding the movement of plant pests. The revised regulations would address the importation and interstate movement of plant pests, biological control organisms, and associated articles, and the release into the environment of biological control organisms. The revision would also address the movement of soil and establish regulations governing the biocontainment facilities in which plant pests, biological control organisms, and associated articles are held. This proposal would clarify the factors that would be considered when assessing the risks associated with the movement of certain organisms, facilitate the movement of regulated organisms and articles in a manner that also protects U.S. agriculture, and address gaps in the current regulations.

Summary of Legal Basis: Under section 411(a) of the Plant Protection Act (PPA), no person shall import, enter, export, or move in interstate commerce any plant pest, unless the importation, entry, exportation, or movement is authorized under a general or specific permit and in accordance with such regulations as the Secretary of Agriculture may issue to prevent the introduction of plant pests into the United States or the dissemination of plant pests within the United States.

Under section 412 of the PPA, the Secretary may restrict the importation or movement in interstate commerce of biological control organisms by requiring the organisms to be accompanied by a permit authorizing such movement and by subjecting the organisms to quarantine conditions or other remedial measures deemed necessary to prevent the spread of plant pests or noxious weeds. That same section of the PPA also gives the Secretary explicit authority to regulate the movement of associated articles.

Alternatives: The alternatives we considered were taking no action at this time or implementing a comprehensive risk reduction plan. This latter alternative would be characterized as a broad risk mitigation strategy that could involve various options such as increased inspection, regulations specific to a certain organism or group of related organisms, or extensive biocontainment requirements.

We decided against the first alternative because leaving the regulations unchanged would not address the needs identified immediately above. We decided against the latter alternative, because available scientific information, personnel, and resources suggest that it would be impracticable at this time.

Anticipated Cost and Benefits: To be determined.

Risks: Unless we issue such a proposal, the regulations will not provide a clear protocol for obtaining permits that authorize the movement and environmental release of biological control organisms. This, in turn, could impede research to explore biological control options for various plant pests and noxious weeds known to exist within the United States, and could indirectly lead to the further dissemination of such pests and weeds.

Moreover, unless we revise the soil regulations, certain provisions in the regulations will not adequately address the risk to plants, plant parts, and plant products within the United States that such soil might present.

Timetable:

Action Date FR Cite
Notice of Intent To Prepare an Environmental Impact Statement 10/20/09 74 FR 53673
Notice Comment Period End 11/19/09
NPRM 05/00/12
NPRM Comment Period End 07/00/12

Regulatory Flexibility Analysis Required: Yes.

Small Entities Affected: Businesses, Organizations.

Government Levels Affected: Local, State, Tribal.

International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest.

Additional Information: Additional information about APHIS and its programs is available on the Internet at http://www.aphis.usda.gov.

Agency Contact: Shirley Wager—Page Chief, Pest Permitting Branch, Plant Health Programs, PPQ, Department of Agriculture, Animal and Plant Health Inspection Service, 4700 River Road, Unit 131, Riverdale, MD 20737-1236, Phone: 301 734-8453.

RIN: 0579-AC98

USDA—APHIS Back to Top

Final Rule Stage

5. Importation of Live Dogs Back to Top

Priority: Other Significant.

Legal Authority: 7 U.S.C. 2148

CFR Citation: 9 CFR 1 and 2.

Legal Deadline: None.

Abstract: This rulemaking would amend the Animal Welfare Act (AWA) regulations to regulate dogs imported for resale as required by a recent amendment to the AWA. Importation of dogs for resale would be prohibited unless the dogs are in good health, have all necessary vaccinations, and are 6 months of age or older. This proposal would also reflect the exemptions provided in the amendment to the AWA for dogs imported for research purposes or veterinary treatment and for dogs legally imported into the State of Hawaii from the British Isles, Australia, Guam, or New Zealand.

Statement of Need: The Food, Conservation, and Energy Act of 2008 mandates that the Secretary of Agriculture promulgate regulations to implement and enforce new provisions of the Animal Welfare Act (AWA) regarding the importation of dogs for resale. In line with the changes to the AWA, APHIS intends to amend the regulations in 9 CFR parts 1 and 2 to regulate the importation of dogs for resale.

Summary of Legal Basis: The Food, Conservation, and Energy Act of 2008 (Pub. L. 110-246, signed into law on Jun. 18, 2008) added a new section to the Animal Welfare Act (7 U.S.C. 2147) to restrict the importation of live dogs for resale. As amended, the AWA now prohibits the importation of dogs into the United States for resale unless the Secretary of Agriculture determines that the dogs are in good health, have received all necessary vaccinations, and are at least 6 months of age. Exceptions are provided for dogs imported for research purposes or veterinary treatment. An exception to the 6-month age requirement is also provided for dogs that are lawfully imported into Hawaii for resale purposes from the British Isles, Australia, Guam, or New Zealand in compliance with the applicable regulations of Hawaii, provided the dogs are vaccinated, are in good health, and are not transported out of Hawaii for resale purposes at less than 6 months of age.

Alternatives: To be identified.

Anticipated Cost and Benefits: To be determined.

Risks: Not applicable.

Timetable:

Action Date FR Cite
NPRM 09/01/11 76 FR 54392
NPRM Comment Period End 10/31/11
Final Rule 08/00/12

Regulatory Flexibility Analysis Required: Undetermined.

Government Levels Affected: None.

Additional Information: Additional information about APHIS and its programs is available on the Internet at http://www.aphis.usda.gov.

Agency Contact: Gerald Rushin, Veterinary Medical Officer, Animal Care, Department of Agriculture, Animal and Plant Health Inspection Service, 4700 River Road, Unit 84, Riverdale, MD 20737-1234, Phone: 301 734-0954.

RIN: 0579-AD23

USDA—APHIS Back to Top

6. Animal Disease Traceability Back to Top

Priority: Other Significant.

Legal Authority: 7 U.S.C. 8305

CFR Citation: 9 CFR 90.

Legal Deadline: None.

Abstract: This rulemaking would establish a new part in the Code of Federal Regulations containing minimum national identification and documentation requirements for livestock moving interstate. The proposed regulations specify approved forms of official identification for each species covered under this rulemaking but would allow such livestock to be moved interstate with another form of identification, as agreed upon by animal health officials in the shipping and receiving States or tribes. The purpose of the new regulations is to improve our ability to trace livestock in the event that disease is found.

Statement of Need: Preventing and controlling animal disease is the cornerstone of protecting American animal agriculture. While ranchers and farmers work hard to protect their animals and their livelihoods, there is never a guarantee that their animals will be spared from disease. To support their efforts, USDA has enacted regulations to prevent, control, and eradicate disease, and to increase foreign and domestic confidence in the safety of animals and animal products. Traceability helps give that reassurance. Traceability does not prevent disease, but knowing where diseased and at-risk animals are, where they have been, and when, is indispensable in emergency response and in ongoing disease programs. The primary objective of these proposed regulations is to improve our ability to trace livestock in the event that disease is found in a manner that continues to ensure the smooth flow of livestock in interstate commerce.

Summary of Legal Basis: Under the Animal Health Protection Act (7 U.S.C. 8301 et seq.), the Secretary of Agriculture may prohibit or restrict the interstate movement of any animal to prevent the introduction or dissemination of any pest or disease of livestock, and may carry out operations and measures to detect, control, or eradicate any pest or disease of livestock. The Secretary may promulgate such regulations as may be necessary to carry out the Act.

Alternatives: As part of its ongoing efforts to safeguard animal health, APHIS initiated implementation of the National Animal Identification System (NAIS) in 2004. More recently, the Agency launched an effort to assess the level of acceptance of NAIS through meetings with the Secretary, listening sessions in 14 cities, and public comments. Although there was some support for NAIS, the vast majority of participants were highly critical of the program and of USDA's implementation efforts. The feedback revealed that NAIS has become a barrier to achieving meaningful animal disease traceability in the United States in partnership with America's producers.

The option we are proposing pertains strictly to interstate movement and gives States and tribes the flexibility to identify and implement the traceability approaches that work best for them.

Anticipated Cost and Benefits: A workable and effective animal traceability system would enhance animal health programs, leading to more secure market access and other societal gains. Traceability can reduce the cost of disease outbreaks, minimizing losses to producers and industries by enabling current and previous locations of potentially exposed animals to be readily identified. Trade benefits can include increased competitiveness in global markets generally, and when outbreaks do occur, the mitigation of export market losses through regionalization. Markets benefit through more efficient and timely epidemiological investigation of animal health issues.

Other societal benefits include improved animal welfare during natural disasters.

The main economic effect of the rule is expected to be on the beef and cattle industry. For other species such as horses and other equine species, poultry, sheep and goats, swine, and captive cervids, APHIS would largely maintain and build on the identification requirements of existing disease program regulations.

Costs of an animal traceability system would include those for tags and interstate certificates of veterinary inspection (ICVIs) or other movement documentation, for animals moved interstate. Incremental costs incurred are expected to vary depending upon a number of factors, including whether an enterprise does or does not already use eartags to identify individual cattle. For many operators, costs of official animal identification and ICVIs would be similar, respectively, to costs associated with current animal identification practices and the in-shipment documentation currently required by individual States. To the extent that official animal identification and ICVIs would simply replace current requirements, the incremental costs of the rule for private enterprises would be minimal.

Risks: This rulemaking is being undertaken to address the animal health risks posed by gaps in the existing regulations concerning identification of livestock being moved interstate. The current lack of a comprehensive animal traceability program is impairing our ability to trace animals that may be infected with disease.

Timetable:

Action Date FR Cite
NPRM 08/11/11 76 FR 50082
NPRM Comment Period End 11/09/11
Final Rule 08/00/12

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: Businesses.

Government Levels Affected: State, Tribal.

Additional Information: Additional information about APHIS and its programs is available on the Internet at http://www.aphis.usda.gov.

Agency Contact: Neil Hammerschmidt, Program Manager, Animal Disease Traceability, VS, Department of Agriculture, Animal and Plant Health Inspection Service, 4700 River Road, Unit 46, Riverdale, MD 20737-1231, Phone: 301 734-5571.

RIN: 0579-AD24

USDA—FOOD AND NUTRITION SERVICE (FNS) Back to Top

Proposed Rule Stage

7. Supplemental Nutrition Assistance Program: Farm Bill of 2008 Retailer Sanctions Back to Top

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

Legal Authority: Pub. L. 110-246

CFR Citation: 7 CFR 276.

Legal Deadline: None.

Abstract: This proposed rule would implement provisions under section 4132 of the Food, Conservation, and Energy Act of 2008, also referred to as the Farm Bill of 2008. Under section 4132, the Department of Agriculture's Food and Nutrition Service (FNS) is provided with greater authority and flexibility when sanctioning retail or wholesale food stores that violate Supplemental Nutrition Assistance Program (SNAP) rules. Specifically, the Department is authorized to assess a civil penalty and to disqualify a retail or wholesale food store authorized to participate in SNAP. Previously, the Department could assess a civil penalty or disqualification but not both. Section 4132 also eliminates the minimum disqualification period, which was previously set at 6 months.

Statement of Need: This proposed rule would implement provisions under section 4132 of the Food, Conservation, and Energy Act of 2008, also referred to as the Farm Bill of 2008. Under section 4132, the Department of Agriculture's Food and Nutrition Service (FNS) is provided with greater authority and flexibility when sanctioning retail or wholesale food stores that violate Supplemental Nutrition Assistance Program (SNAP) rules. Specifically, the Department is authorized to assess a civil penalty and to disqualify a retail or wholesale food store authorized to participate in SNAP. Previously, the Department could assess a civil penalty or disqualification, but not both. Section 4132 also eliminates the minimum disqualification period, which was previously set at 6 months. In addition to implementing statutory provisions, this rule proposes to provide a clear administrative penalty when an authorized retailer or wholesale food store redeems a SNAP participant's program benefits without the knowledge of the participant. All program benefits are issued through the Electronic Benefits Transfer (EBT) system. The EBT system establishes data that may be used to identify fraud committed by retail food stores. While stealing program benefits could be prosecuted under current statute, program regulations do not provide a clear penalty for these thefts. The proposed rule would establish an administrative penalty for such thefts equivalent to the penalty for trafficking in program benefits, which is the permanent disqualification of a retailer or wholesale food store from SNAP participation. Finally, the Department proposes to identify additional administrative retail violations and the associated sanction that would be imposed against the retail food store for committing the violation. For instance, to maintain integrity, FNS requires retail and wholesale food stores to key enter EBT card data in the presence of the actual EBT card. The proposed rule would codify this requirement and identify the specific sanction that would be imposed if retail food stores are found to be in violation.

Summary of Legal Basis: Section 4132, Food, Conservation, and Energy Act of 2008 (Pub. L. 110-246).

Alternatives: Because this proposed rule is under development, alternatives are not yet articulated.

Anticipated Cost and Benefits: Because this proposed rule is under development, anticipated costs and benefits have not yet been articulated.

Risks: The risk that retail or wholesale food stores will violate SNAP rules, or continue to violate SNAP rules, is expected to be reduced by refining program sanctions for participating retailers and wholesalers.

Timetable:

Action Date FR Cite
NPRM 02/00/12

Regulatory Flexibility Analysis Required: Undetermined.

Government Levels Affected: Undetermined.

Federalism: Undetermined.

Additional Information: Note: This RIN replaces the previously issued RIN 0584-AD78.

Agency Contact: James F. Herbert, Regulatory Review Specialist, Department of Agriculture, Food and Nutrition Service, 10th Floor, 3101 Park Center Drive, Alexandria, VA 22302, Phone: 703 305-2572, Email: james.herbert@fns.usda.gov.

RIN: 0584-AD88

USDA—FNS Back to Top

8. • National School Lunch and School Breakfast Programs: Nutrition Standards for All Foods Sold in School, as Required by the Healthy, Hunger-Free Kids Act of 2010 Back to Top

Priority: Other Significant.

Unfunded Mandates: Undetermined.

Legal Authority: Pub. L. 111-296

CFR Citation: 7 CFR 210; 7 CFR 220.

Legal Deadline: None.

Abstract: This proposed rule would codify the following provisions of the Healthy, Hunger-Free Kids Act (Pub. L. 111-296; the Act) as appropriate, under 7 CFR parts 210 and 220.

Section 203 requires schools participating in the National School Lunch Program to make available to children free of charge, as nutritionally appropriate, potable water for consumption in the place where meals are served during meal service.

Section 208 requires the Secretary to promulgate proposed regulations to establish science-based nutrition standards for all foods sold in schools not later than December 13, 2011. The nutrition standards would apply to all food sold outside the school meal programs, on the school campus, and at any time during the school day. (11-004)

Statement of Need: This proposed rule would codify the following provisions of the Healthy, Hunger-Free Kids Act (Pub. L. 111-296; the Act) as appropriate, under 7 CFR parts 210 and 220.

Section 203 requires schools participating in the National School Lunch Program to make available to children free of charge, as nutritionally appropriate, potable water for consumption in the place where meals are served during meal service.

Section 208 requires the Secretary to promulgate proposed regulations to establish science-based nutrition standards for all foods sold in schools not later than December 13, 2011. The nutrition standards would apply to all food sold outside the school meal programs, on the school campus, and at any time during the school day.

Summary of Legal Basis: There is no existing regulatory requirement to make water available where meals are served. Regulations at 7 CFR parts 210.11 direct State agencies and school food authorities to establish such rules or regulations necessary to control the sale of foods in competition with lunches served under the NSLP. Such rules or regulations shall prohibit the sale of foods of minimal nutritional value in the food service areas during the lunch periods. The sale of other competitive foods may, at the discretion of the State agency and school food authority, be allowed in the food service area during the lunch period only if all income from the sale of such foods accrues to the benefit of the nonprofit school food service or the school or student organizations approved by the school. State agencies and school food authorities may impose additional restrictions on the sale of and income from all foods sold at any time throughout schools participating in the Program.

Alternatives: None.

Anticipated Cost and Benefits: Expected Costs Analysis and Budgetary Effects Statement: The Congressional Budget Office determined these provisions would incur no Federal costs.

Expected Benefits of the Proposed Action: The provisions in this proposed rulemaking would result in better nutrition for all school children.

Risks: None known.

Timetable:

Action Date FR Cite
NPRM 04/00/12

Regulatory Flexibility Analysis Required: Yes.

Small Entities Affected: Governmental Jurisdictions.

Government Levels Affected: Local, State.

Agency Contact: James F. Herbert, Regulatory Review Specialist, Department of Agriculture, Food and Nutrition Service, 10th Floor, 3101 Park Center Drive, Alexandria, VA 22302, Phone: 703 305-2572, Email: james.herbert@fns.usda.gov.

RIN: 0584-AE09

USDA—FNS Back to Top

9. • WIC: Electronic Benefit Transfer (EBT) Implementation Back to Top

Priority: Other Significant.

Unfunded Mandates: Undetermined.

Legal Authority: Pub. L. 111-296

CFR Citation: 7 CFR 246.

Legal Deadline: NPRM, Statutory, October 1, 2020, Require all WIC State agencies to implement EBT Statewide.

Abstract: This proposed rule would revise and expand regulations regarding WIC EBT at 7 CFR 246 and implement statutory provisions related to EBT as defined in the Healthy, Hunger-Free Kids Act of 2010, 11. The EBT requirements addressed in the proposed rule would promote improved access to Program benefits, standardize EBT operations, and establish implementation guidelines and timeframes.

Statement of Need: This proposed rule would revise and expand regulations regarding WIC EBT at 7 CFR 246 and implement statutory provisions related to EBT as defined in the Healthy, Hunger-Free Kids Act of 2010, 11. The EBT requirements addressed in the proposed rule would promote improved access to program benefits, standardize EBT operations, and establish implementation guidelines and timeframes.

WIC EBT has been an ongoing effort within the WIC community for several years. The proposed rule would address the following:

  • Set forth the definition of EBT.
  • Require all WIC State agencies to implement EBT statewide by October 1, 2020.
  • Require State agencies to submit status reports demonstrating their progress toward Statewide EBT implementation.
  • Revise the current provision regarding the imposition of EBT costs to vendors to include: (1) The formation of cost-sharing criteria associated with any equipment or system not solely dedicated to EBT; (2) the allowance of the payment of fees imposed by a third-party processor for EBT transactions; (3) the disallowance of the payment of interchange fees; (4) clarification of EBT cost impositions after Statewide implementation; (5) elimination of the requirement for State agencies to fund ongoing maintenance costs for vendors using multi-function EBT equipment; and (6) require vendors to demonstrate the capability to accept program benefits electronically prior to authorization after Statewide implementation of EBT.
  • Establish minimum lane coverage guidelines for vendor equipment, as set forth in the operating rules, and require State agencies to provide the necessary EBT-only equipment if vendors do not wish to acquire multi-function equipment.
  • Require that EBT technical standards and operating rules be established and adhered to by State agencies.
  • Require all State agencies to use the universal product code database.

Summary of Legal Basis: Healthy, Hunger-Free Kids Act of 2010 (Pub. L. 111-296).

Alternatives: None.

Anticipated Cost and Benefits: Expected Costs Analysis and Budgetary Effects Statement:

FNS estimates costs of approximately $30 to $60 million per fiscal year (as reflected in the program's budget) for State agencies to comply with the mandate. The costs will vary depending on implementation activity and are expected to decline as more State agencies adopt WIC EBT.

Expected Benefits of the Proposed Action: The EBT requirements addressed in the proposed rule would promote improved access to program benefits, standardize EBT operations, and establish implementation guidelines and timeframes.

Risks: None known.

Timetable:

Action Date FR Cite
NPRM 06/00/12

Regulatory Flexibility Analysis Required: Undetermined.

Government Levels Affected: Undetermined.

Federalism: Undetermined.

Agency Contact: James F. Herbert, Regulatory Review Specialist, Department of Agriculture, Food and Nutrition Service, 10th Floor, 3101 Park Center Drive, Alexandria, VA 22302, Phone: 703 305-2572, Email: james.herbert@fns.usda.gov.

RIN: 0584-AE21

USDA—FNS Back to Top

Final Rule Stage

10. Nutrition Standards in the National School Lunch and School Breakfast Programs Back to Top

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

Legal Authority: Pub. L. 108-265, sec 103

CFR Citation: 7 CFR 210; 7 CFR 220.

Legal Deadline: None.

Abstract: Public Law 108-265 requires the Secretary to issue regulations that reflect specific recommendations for increased consumption of foods and food ingredients in school nutrition programs based on the most recent Dietary Guidelines for Americans.

The current regulations require that reimbursable meals offered by schools meet the applicable recommendations of the Dietary Guidelines for Americans. This rule would revise the regulations on meal patterns and nutrition standards to ensure that school meals reflect the 2005 Dietary Guidelines for Americans (04-017).

Statement of Need: This final rule will implement the requirement in section 201 of the Healthy, Hunger-Free Kids Act of 2010 (Pub. L. 111-296) (the Act) that USDA promulgate regulations to update the meal patterns and nutrition standards for school lunches and breakfasts based on recommendations made by the Institute of Medicine (IOM). USDA issued a proposed rule on January 13, 2011. The Act requires USDA to issue interim or final regulations not later than 18 months after promulgation of the proposed regulation.

This final rule will implement meal patterns and nutrition standards recommended by IOM in its report “School Meals: Building Blocks for Healthy Children.” In addition, the final rule will address the comments submitted by the public in response to USDA's proposed rule.

Summary of Legal Basis: The meal patterns and nutrition standards for school lunches and breakfast are established in 7 CFR 210.10 and 7 CFR 220.8, respectively. State agencies monitor compliance with the meal patterns and nutrition standards through program reviews authorized in 7 CFR 210.19.

Alternatives: None.

Anticipated Cost and Benefits: Expected Costs Analysis and Budgetary Effects Statement:

While there are no increased Federal costs associated with implementation of this final rule, the Act provides schools that comply with the new meal requirements with an increased Federal reimbursement. The Act also provides Federal funding for training, technical assistance, certification, and oversight activities related to compliance with this rule. It is expected that the total costs of compliance with the final rule will exceed $100 million per year.

Expected Benefits of the Proposed Action: The final rule is projected to make substantial improvements to the meals served daily in over 101,000 schools nationwide to more than 31 million children. It will align school meals with national nutrition guidelines and help safeguard the health of school children.

Risks: None known.

Timetable:

Action Date FR Cite
NPRM 01/13/11 76 FR 2494
NPRM Comment Period End 04/13/11
Final Action 02/00/12

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: No.

Government Levels Affected: Local, State.

Federalism: This action may have federalism implications as defined in EO 13132.

Agency Contact: James F. Herbert, Regulatory Review Specialist, Department of Agriculture, Food and Nutrition Service, 10th Floor, 3101 Park Center Drive, Alexandria, VA 22302, Phone: 703 305-2572, Email: james.herbert@fns.usda.gov.

RIN: 0584-AD59

USDA—FNS Back to Top

11. Direct Certification of Children in Food Stamp Households and Certification of Homeless, Migrant, and Runaway Children for Free Meals Back to Top

Priority: Other Significant. Major under 5 U.S.C. 801.

Legal Authority: Pub. L. 108-265, sec 104

CFR Citation: 7 CFR 210; 7 CFR 215; 7 CFR 220; 7 CFR 225; 7 CFR 226; 7 CFR 245.

Legal Deadline: None.

Abstract: In response to Public Law 108-265, which amended the Richard B. Russell National School Lunch Act, 7 CFR 245, Determining Eligibility for Free and Reduced Price Meals and Free Milk in Schools, is amended to establish categorical (automatic) eligibility for free meals and free milk upon documentation that a child is (1) homeless as defined by the McKinney-Vento Homeless Assistance Act; (2) a runaway served by grant programs under the Runaway and Homeless Youth Act; or (3) migratory as defined in section 1309(2) of the Elementary and Secondary Education Act. The rule also requires phase-in of mandatory direct certification for children who are members of households receiving benefits from the Supplemental Nutrition Assistance Program and continues discretionary direct certification for other categorically eligible children (04-018).

Statement of Need: The changes made to the Richard B. Russell National School Lunch Act concerning direct certification are intended to improve program access, reduce paperwork, and improve the accuracy of the delivery of free meal benefits. This regulation will implement the statutory changes and provide State agencies and local educational agencies with the policies and procedures to conduct mandatory and discretionary direct certification.

Summary of Legal Basis: These changes are being made in response to provisions in Public Law 108-265.

Alternatives: None; statutory requirements.

Anticipated Cost and Benefits: This regulation will reduce paperwork, target benefits more precisely, and will improve program access of eligible school children.

Risks: This regulation may require adjustments to existing computer systems to more readily share information between schools and assistance agencies.

Timetable:

Action Date FR Cite
Interim Final Rule 04/25/11 76 FR 22785
Interim Final Rule Effective 06/24/11
Interim Final Rule Comment Period End 10/24/11
Final Rule 05/00/12

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: No.

Government Levels Affected: Local, State.

Agency Contact: James F. Herbert, Regulatory Review Specialist, Department of Agriculture, Food and Nutrition Service, 10th Floor,3101 Park Center Drive, Alexandria, VA 22302, Phone: 703 305-2572, Email: james.herbert@fns.usda.gov.

Related RIN: Merged with 0584-AD62.

RIN: 0584-AD60

USDA—FNS Back to Top

12. Eligibility, Certification, and Employment and Training Provisions of the Food, Conservation, and Energy Act of 2008 Back to Top

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

Legal Authority: Pub. L. 110-246; Pub. L. 104-121

CFR Citation: 7 CFR 273.

Legal Deadline: None.

Abstract: This proposed rule would amend the regulations governing the Supplemental Nutrition Assistance Program (SNAP) to implement provisions from the Food, Conservation, and Energy Act of 2008 (Pub. L. 110-246) (FCEA) concerning the eligibility and certification of SNAP applicants and participants and SNAP employment and training. In addition, this proposed rule would revise the SNAP regulations throughout 7 CFR part 273 to change the program name from the Food Stamp Program to SNAP and to make other nomenclature changes as mandated by the FCEA. The statutory effective date of these provisions was October 1, 2008. Food and Nutrition Service (FNS) is also proposing two discretionary revisions to SNAP regulations to provide State agencies options that are currently available only through waivers. These provisions would allow State agencies to average student work hours and to provide telephone interviews in lieu of face-to-face interviews. FNS anticipates that this rule would impact the associated paperwork burdens (08-006).

Statement of Need: This proposed rule would amend the regulations governing SNAP to implement provisions from the FCEA concerning the eligibility and certification of SNAP applicants and participants and SNAP employment and training. In addition, this proposed rule would revise the SNAP regulations throughout 7 CFR part 273 to change the program name from the Food Stamp Program to SNAP and to make other nomenclature changes as mandated by the FCEA. The statutory effective date of these provisions was October 1, 2008. FNS is also proposing two discretionary revisions to SNAP regulations to provide State agencies options that are currently available only through waivers. These provisions would allow State agencies to average student work hours and to provide telephone interviews in lieu of face-to-face interviews. FNS anticipates that this rule would impact the associated paperwork burdens.

Summary of Legal Basis: Food, Conservation, and Energy Act of 2008 (Pub. L. 110-246).

Alternatives: Most aspects of the rule are non-discretionary and tie to explicit, specific requirements for SNAP in the FCEA. However, FNS did consider alternatives in implementing section 4103 of the FCEA, Elimination of Dependent Care Deduction Caps. FNS considered whether to limit deductible expenses to costs paid directly to the care provider or whether to permit households to deduct other expenses associated with dependent care in addition to the direct costs. FNS chose to allow households to deduct the cost of transportation to and from the dependent care provider and the cost of separately identified activity fees that are associated with dependent care. Section 4103 signaled an important shift in congressional recognition that dependent care costs constitute major expenses for working households. In addition, it was noted during the floor discussion in both houses of Congress prior to passage of the FCEA that some States already counted transportation costs as part of dependent care expenditures.

Anticipated Cost and Benefits: The estimated total SNAP costs to the Government of the FCEA provisions implemented in the rule are estimated to be $831 million in FY 2010 and $5.619 billion over the 5 years FY 2010 through FY 2014. These impacts are already incorporated into the President's budget baseline.

There are many potential societal benefits of this rule. Some provisions may make some households newly eligible for SNAP benefits. Other provisions may increase SNAP benefits for certain households. Certain provisions in the rule will reduce the administrative burden for households and State agencies.

Risks: The statutory changes and discretionary ones under consideration would streamline program operations. The changes are expected to reduce the risk of inefficient operations.

Timetable:

Action Date FR Cite
NPRM 05/04/11 76 FR 25414
NPRM Comment Period End 07/05/11
Final Action 10/00/12

Regulatory Flexibility Analysis Required: No.

Government Levels Affected: Local, State.

Agency Contact: Kevin Kwon, Chief, Planning and Regulatory Affairs Branch, Department of Agriculture, Food and Nutrition Service, 10th Floor, 3101 Park Center Drive, Alexandria, VA 22302, Phone: 703 605-0800, Email: kevin.kwon@fns.usda.gov.

RIN: 0584-AD87

USDA—FNS Back to Top

13.• Supplemental Nutrition Assistance Program: Nutrition Education and Obesity Prevention Grant Back to Top

Priority: Other Significant.

Legal Authority: Pub. L. 111-296

CFR Citation: 7 CFR 272.

Legal Deadline: Final, Statutory, January 1, 2012, Pub. L. 111-296

Abstract:[Pub. L. 111-296, The Healthy, Hunger-Free Kids Act of 2001, title II; Reducing Childhood Obesity and Improving the Diets of Children, subtitle D; Miscellaneous, sec. 241.] The Nutrition Education and Obesity Prevention Grant Program amends the Food and Nutrition Act of 2008 to replace the current nutrition education program under the Act with a program providing grants to States for the implementation of a nutrition education and obesity prevention program that promotes healthy food choices consistent with the most recent Dietary Guidelines for Americans.

Statement of Need: The Nutrition Education and Obesity Prevention Grant Program rule amends the Food and Nutrition Act of 2008 to replace the current nutrition education program under the Act with a program providing grants to States for the implementation of a nutrition education and obesity prevention program that promotes healthy food choices consistent with the most recent Dietary Guidelines for Americans. This rule will implement all requirements of the law. It makes eligible for program participation: (1) Supplemental Nutrition Assistance Program (SNAP) participants, (2) participants in the school lunch or breakfast programs, and (3) individuals who reside in low-income communities or are low-income individuals. The rule continues commitment to serving low-income populations while focusing on the issue of obesity, a priority of this Administration. It ensures that interventions implemented as part of State nutrition education plans recognize the constrained resources of the eligible population.

The rule requires activities be science-based and outcome-driven and provides for accountability and transparency through State plans. It will require coordination and collaboration among Federal agencies and stakeholders, including the Centers for Disease Control and Prevention, the public health community, the academic and research communities, nutrition education practitioners, representatives of State and local governments, and community organizations that serve the low-income populations. The rule allows for 100 percent Federal funding, and States will not have to provide matching funds. The grant funding will be based on 2009 expenditures. For 3 years after enactment, States will receive grant funds based on their level of funds expended for the 2009 base year with funds indexed for inflation thereafter. The new funding structure is phased in over a 7-year period. From fiscal year 2014 forward, funds will be allocated based on a formula that considers participation.

Summary of Legal Basis: Section 241, Healthy, Hunger-Free Kids Act of 2010 (Pub. L. 111-296).

Alternatives: None.

Anticipated Cost and Benefits: Expected Costs Analysis and Budgetary Effects Statement:

The action allows for 100 percent Federal funding which gives States more flexibility to target services where they can be most effective without the constraints of a State match. For 3 years after enactment, States will receive grant funds based on their level of funds expended for the 2009 base year with funds indexed for inflation thereafter. The new funding structure is phased in over a 7-year period. From fiscal year 2014 forward, funds will be allocated based on a formula that considers participation.

Expected Benefits of the Proposed Action: This regulatory action seeks to improve the effectiveness of the program and make it easier for the States to administer, while still allowing funding to grow. It allows for 100 percent Federal funding, which gives States more flexibility to target services where they can be most effective without the constraints of a State match. It allows grantees to adopt individual and group-based nutrition education, as well as community and public health approaches. It allows coordinated services to be provided to participants in all the Federal food assistance programs and to other low-income persons.

Risks: None known.

Timetable:

Action Date FR Cite
Interim Final Rule 01/00/12

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: No.

Government Levels Affected: State.

Agency Contact: James F. Herbert, Regulatory Review Specialist, Department of Agriculture, Food and Nutrition Service, 10th Floor,3101 Park Center Drive, Alexandria, VA 22302, Phone: 703 305-2572, Email: james.herbert@fns.usda.gov.

RIN: 0584-AE07

USDA—FOOD SAFETY AND INSPECTION SERVICE (FSIS) Back to Top

Proposed Rule Stage

14. Prior Labeling Approval System: Generic Label Approval Back to Top

Priority: Other Significant.

Legal Authority: 21 U.S.C. 451 to 470; 21 U.S.C. 601 to 695

CFR Citation: 9 CFR 317; 9 CFR 327; 9 CFR 381; 9 CFR 412.

Legal Deadline: None.

Abstract: This rulemaking will continue an effort initiated several years ago by amending FSIS' regulations to expand the types of labeling that are generically approved. FSIS plans to propose that the submission of labeling for approval prior to use be limited to certain types of labeling, as specified in the regulations. In addition, FSIS plans to reorganize and amend the regulations by consolidating the nutrition labeling rules that currently are stated separately for meat and poultry products (in part 317, subpart B, and part 381, subpart Y, respectively) and by amending their provisions to set out clearly various circumstances under which these products are misbranded.

Statement of Need: Expanding the types of labeling that are generically approved would permit Agency personnel to focus their resources on evaluating only those claims or special statements that have health and safety or economic implications. This would essentially eliminate the time needed for FSIS personnel to evaluate labeling features and allocate more time for staff to work on other duties and responsibilities. A major advantage of this proposal is that it is consistent with FSIS' current regulatory approach, which separates industry and Agency responsibilities.

Summary of Legal Basis: 21 U.S.C. 457 and 607.

Alternatives: FSIS considered several options. The first was to expand the types of labeling that would be generically approved and consolidate into one part all of the labeling regulations applicable to products regulated under the FMIA and PPIA and the policies currently contained in FSIS Directive 7220.1, Revision 3. The second option FSIS considered was to consolidate only the meat and poultry regulations that are similar and to expand the types of generically approved labeling that can be applied by Federal and certified foreign establishments. The third option, and the one favored by FSIS, was to amend the prior labeling approval system in an incremental three-phase approach.

Anticipated Cost and Benefits: The proposed rule would permit the Agency to realize an estimated discounted cost savings of $2.9 million over 10 years. The proposed rule would be beneficial because it would streamline the generic labeling process, while imposing no additional cost burden on establishments. Consumers would benefit because industry would have the ability to introduce products into the marketplace more quickly.

Risks: None

Timetable:

Action Date FR Cite
NPRM 12/05/11 76 FR 75809
NPRM Comment Period End 02/03/12

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: Businesses.

Government Levels Affected: None.

Agency Contact: Jeff Canavan, Labeling and Program Delivery Division, Department of Agriculture, Food Safety and Inspection Service, Patriots Plaza 3, 8th Floor, 8-146, Stop 5273, 1400 Independence Avenue SW., Washington, DC 20250-5273, Phone: 301 504-0878, Fax: 301 504-0872, Email: jeff.canavan@fsis.usda.gov.

RIN: 0583-AC59

USDA—FSIS Back to Top

15. Product Labeling: Use of the Voluntary Claim “Natural” on the Labeling of Meat and Poultry Products Back to Top

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.

Legal Deadline: None.

Abstract: The Food Safety and Inspection Service (FSIS) is proposing to amend the Federal meat and poultry products inspection regulations to define the conditions under which it will permit the voluntary claim “natural” to be used in the labeling of meat and poultry products. FSIS is also proposing that label approval requests for labels that contain “natural” claims include documentation to demonstrate that the products meet the criteria to bear a “natural” claim. FSIS is proposing to require that meat or poultry products meet these conditions to qualify for a “natural” claim to make the claim more meaningful to consumers.

Statement of Need: A codified “natural” claim definition will reduce uncertainty about which products qualify to be labeled as “natural” and will increase consumer confidence in the claim. A codified “natural” definition that clearly articulates the criteria that meat and poultry products must meet to qualify to be labeled as “natural” will make the Agency's approval of “natural” claims more transparent and will allow the Agency to review labels that contain “natural” claims in a more efficient and consistent manner. A codified “natural” definition will also make the claim more meaningful to consumers.

Summary of Legal Basis: 21 U.S.C. 601 et seq.; 21 U.S.C. 451 et seq.

Alternatives: The Agency has considered not proceeding with rulemaking and maintaining the existing policy guidance on “natural” claims and using that policy guidance to evaluate “natural” claims on a case-by-case basis. The Agency has also considered alternative definitions of “natural” and establishing separate codified definitions of “natural,” “natural * * * minimally processed,” and “natural * * * minimally processed/all natural ingredients.”

Anticipated Cost and Benefits: FSIS anticipates that a clear and simple definition of “natural” will minimize cognitive costs to consumers. FSIS also anticipates benefits from a consistent USDA policy on “natural” claims. FSIS anticipates costs to establishments to change their labels or change their production practices.

Risks: None.

Timetable:

Action Date FR Cite
ANPRM 09/14/09 74 FR 46951
ANPRM Comment Period End 11/13/09  
NPRM 09/00/12  

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: Businesses.

Government Levels Affected: None.

Agency Contact: Rosalyn Murphy-Jenkins, Director, Labeling and Program Delivery Division, Department of Agriculture, Food Safety and Inspection Service, Patriots Plaza 3, 8th Floor, Room 8-148, Stop 5273, 1400 Independence Avenue SW, Washington, DC 20250-5273, Phone: 301 504-0878, Fax: 301 504-0872, Email: rosalyn.murphy-jenkins@fsis.usda.gov.

RIN: 0583-AD30

USDA—FSIS Back to Top

16. New Poultry Slaughter Inspection Back to Top

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

Legal Authority: 21 U.S.C. 451 et seq.

CFR Citation: 9 CFR 381.66; 9 CFR 381.67; 9 CFR 381.76; 9 CFR 381.83; 9 CFR 381.91; 9 CFR 381.94.

Legal Deadline: None.

Abstract: FSIS is proposing a new inspection system for young poultry slaughter establishments that would facilitate public health-based inspection. This new system would be available initially only to young chicken and turkey slaughter establishments. Establishments that slaughter broilers, fryers, roasters, and Cornish game hens (as defined in 9 CFR 381.170) would be considered as “young chicken establishments.” FSIS is also proposing to revoke the provisions that allow young chicken slaughter establishments to operate under the current Streamlined Inspection System (SIS) or the New Line Speed (NELS) Inspection System, and to revoke the New Turkey Inspection System (NTIS). FSIS anticipates that this proposed rule would provide the framework for action to provide public health-based inspection in all establishments that slaughter amenable poultry species.

Under the proposed new system, young chicken slaughter establishments would be required to sort chicken carcasses and to conduct other activities to ensure that carcasses are not adulterated before they enter the chilling tank.

Statement of Need: Because of the risk to the public health associated with pathogens on young chicken carcasses, FSIS is proposing a new inspection system that would allow for more effective inspection of young chicken carcasses, would allow the Agency to more effectively allocate its resources, would encourage industry to more readily use new technology, and would include new performance standards to reduce pathogens.

This proposed rule is an example of regulatory reform because it would facilitate technological innovation in young chicken slaughter establishments. It would likely result in more cost-effective dressing of young chickens that are ready to cook or ready for further processing. Similarly, it would likely result in more efficient and effective use of Agency resources.

Summary of Legal Basis: 21 U.S.C. 451 to 470.

Alternatives: FSIS considered the following options in developing this proposal:

(1) No action.

(2) Propose to implement HACCP-based Inspection Models Pilot in regulations.

(3) Propose to establish a mandatory, rather than a voluntary, new inspection system for young chicken slaughter establishments.

Anticipated Cost and Benefits: Not publicly available at this time.

Risks: Salmonella and other pathogens are present on a substantial portion of poultry carcasses inspected by FSIS. Foodborne salmonella cause a large number of human illnesses that at times lead to hospitalization and even death. There is an apparent relationship between human illness and prevalence levels for salmonella in young chicken carcasses. FSIS believes that through better allocation of inspection resources and the use of performance standards, it would be able to better address the prevalence of salmonella and other pathogens in young chickens.

Timetable:

Action Date FR Cite
NPRM 01/00/12  

Regulatory Flexibility Analysis Required: Undetermined.

Small Entities Affected: Businesses.

Government Levels Affected: None.

Agency Contact: Dr. Daniel L. Engeljohn, Assistant Administrator, Office of Policy and Program Development, Department of Agriculture, Food Safety and Inspection Service, 1400 Independence Avenue SW., Washington, DC 20250, Phone: 202 205-0495, Fax: 202 401-1760, Email: daniel.engeljohn@fsis.usda.gov.

RIN: 0583-AD32

USDA—FSIS Back to Top

17. Electronic Imported Product Inspection Application and Certification of Imported Product and Foreign Establishments; Amendments To Facilitate the Public Health Information System (PHIS) Back to Top

Priority: Other Significant.

Legal Authority: Federal Meat Inspection Act (FMIA) (21 U.S.C. 601 to 695), the Poultry Products Inspection Act (PPIA) (21 U.S.C. 451 to 470); Egg Products Inspection Act (EPIA) (21 U.S.C. 1031 to 1056)

CFR Citation: 9 CFR 304.3; 9 CFR 327.2 and 327.4; 9 CFR 381.196 to 381.198; 9 CFR 590.915 and 590.920.

Legal Deadline: None.

Abstract: FSIS is proposing to amend the meat, poultry, and egg products import inspection regulations to provide for an electronic import inspection application, and electronic imported product foreign inspection and foreign establishment certification system. FSIS is also proposing to delete the “streamlined” import inspection procedures for Canadian product. In addition, the Agency is proposing that official import inspection establishment must develop, implement, and maintain written Sanitation SOPs, as provided in 9 CFR 416.11 through 416.17. FSIS is also announcing that it is discontinuing its practice of conducting imported product reinspection based on a foreign government's guarantee.

Statement of Need: FSIS is proposing these regulations to provide for the electronic import system, which will be available through the Agency's Public Health Information System (PHIS), a computerized, Web-based inspection information system. The import system will enable applicants to electronically submit and track import inspection applications that are required for all commercial entries of FSIS-regulated products imported into the U.S. FSIS inspection program personnel will be able to access the PHIS system to assign appropriate imported product inspection activities. The electronic import system will also facilitate the imported product foreign inspection and annual foreign establishment certifications by providing immediate and direct electronic government-to-government exchange of information. The Agency is proposing to delete the Canadian streamlined import inspection procedures because they have not been in use since 1990 and are obsolete. Sanitation SOPs are written procedures establishments develop, implement, and maintain to prevent direct contamination or adulteration of meat or poultry products. To ensure that imported meat and poultry products do not become contaminated while undergoing reinspection prior to entering the U.S., FSIS is proposing to clarify that official import inspection establishments must develop written Sanitation SOPs.

Summary of Legal Basis: 21 U.S.C. 601 to 695; 21 U.S.C. 451 to 470; 21 U.S.C. 1031 to 1056.

Alternatives: The use of the electronic import system is voluntary. The Agency will continue to accept and process paper import inspection applications, and foreign establishment and imported product foreign inspection certificates. The Canadian streamlined import inspection procedures are not currently in use. Proposing Sanitation SOPs in official import inspection establishments will prevent direct contamination or adulteration of product. Therefore, no alternatives were considered.

Anticipated Cost and Benefits: Under this proposed rule, the industry will have the option of filing inspection applications electronically and submitting electronic imported foreign inspection product and establishment certificates through the PHIS. Since the electronic option is voluntary, applicants and the foreign countries that choose to file electronically will do so only if the benefits outweigh the cost. Sanitation SOPs are a condition of approval for official import inspection establishments and as a requirement for official import inspection establishments to continue to operate under Federal inspection. The proposed rule will clarify that official import inspection establishments must have developed written Sanitation SOPs before being granted approval and that existing official import inspection establishments must meet Sanitation SOP requirements. Since, in practice, FSIS has always expected official import inspection establishments to maintain Sanitation SOPs during the reinspection of imported products, the proposed amendment for these sanitation requirements will have little, if any, cost impact on the industry.

Risks: None.

Timetable:

Action Date FR Cite
NPRM 03/00/12  

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: Businesses.

Government Levels Affected: None.

International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest.

Agency Contact: Mary Stanley, Director, International Policy Division Office of Policy and Program, Department of Agriculture, Food Safety and Inspection Service, Room 2125, 1400 Independence Avenue SW., Washington, DC 20250, Phone: 202 720-0287.

RIN: 0583-AD39

USDA—FSIS Back to Top

18. Electronic Export Application and Certification as a Reimbursable Service and Flexibility in the Requirements for Official Export Inspection Marks, Devices, and Certificates Back to Top

Priority: Other Significant.

Legal Authority: Federal Meat Inspection Act (FMIA) (21 U.S.C. 601 to 695); Poultry Products Inspection Act (PPIA) (21 U.S.C. 451 to 470); Egg Products Inspection Act (EPIA) (21 U.S.C. 1031 to 1056)

CFR Citation: 9 CFR 312.8; 9 CFR 322.1 and 322.2; 9 CFR 350.7; 9 CFR 362.5; 9 CFR 381.104 to 381.106; 9 CFR 590.407; 9 CFR 592.20 and 592.500.

Legal Deadline: None.

Abstract: The Food Safety and Inspection Service (FSIS) is proposing to amend the meat, poultry, and egg product inspection regulations to provide an electronic export application and certification system. The electronic export application and certification system will be a component of the Agency's Public Health Information System (PHIS). The export component of PHIS will be available as an alternative to the paper-based application and certification process. FSIS is proposing to charge users for the use of the proposed system. FSIS is proposing to establish a formula for calculating the fee. FSIS is also proposing to provide establishments that export meat, poultry, and egg products with flexibility in the official export inspection marks, devices, and certificates. In addition, FSIS is proposing egg product export regulations that parallel the meat and poultry export regulations.

Statement of Need: FSIS is proposing these regulations to facilitate the electronic processing of export applications and certificates through the Public Health Information System (PHIS), a computerized, Web-based inspection information system. The current export application and certification regulations provide only for a paper-based process. This proposed rule will provide this electronic export system as a reimbursable certification service charged to the exporter.

Summary of Legal Basis: 21 U.S.C. 601 to 695; 21 U.S.C. 451 to 470; 21 U.S.C. 1031 to 1056; 7 U.S.C. 1622(h).

Alternatives: The electronic export applications and certification system is being proposed as a voluntary service; therefore, exporters have the option of continuing to use the current paper-based system. Therefore, no alternatives were considered.

Anticipated Cost and Benefits: FSIS is proposing to charge exporters an application fee for the electronic system. Automating the export application and certification process will facilitate the exportation of U.S. meat, poultry, and egg products by streamlining and automating the processes that are in use while ensuring that foreign regulatory requirements are met. The cost to an exporter would depend on the number of electronic applications submitted. An exporter that submits only a few applications per year would not be likely to experience a significant economic impact. Under this proposal, inspection personnel workload is reduced through the elimination of the physical handling and processing of applications and certificates. When an electronic government-to-government system interface or data exchange is used, fraudulent transactions, such as false alterations and reproductions, will be significantly reduced, if not eliminated. The electronic export system is designed to ensure authenticity, integrity, and confidentiality. Exporters will be provided a more efficient and effective application and certification process. The proposed egg product export regulations provide the same export requirements across all products regulated by FSIS and consistency in the export application and certification process. The total annual paperwork burden to egg processing industry to fill out the paper-based export application is approximately $32,340 per year for a total of 924 hours a year. The average establishment burden would be 11 hours, and $385.00 per establishment.

Risks: None.

Timetable:

Action Date FR Cite
NPRM 01/00/12  

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: Businesses.

Government Levels Affected: None.

International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest.

Agency Contact: Dr. Ron Jones, Assistant Administrator, Office of International Affairs, Department of Agriculture, Food Safety and Inspection Service, 1400 Independence Avenue SW., Washington, DC 20250, Phone: 202 720-3473.

RIN: 0583-AD41

USDA—FSIS Back to Top

Final Rule Stage

19. Performance Standards for the Production of Processed Meat and Poultry Products; Control of Listeria Monocytogenes in Ready-to-Eat Meat and Poultry Products Back to Top

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

Legal Authority: 21 U.S.C. 451 et seq.; 21 U.S.C. 601 et seq.

CFR Citation: 9 CFR 301; 9 CFR 303; 9 CFR 317; 9 CFR 318; 9 CFR 319; 9 CFR 320; 9 CFR 325; 9 CFR 331; 9 CFR 381; 9 CFR 417; 9 CFR 430; 9 CFR 431.

Legal Deadline: None.

Abstract: FSIS has proposed to establish pathogen reduction performance standards for all ready-to-eat (RTE) and partially heat-treated meat and poultry products, and measures, including testing, to control Listeria monocytogenes in RTE products. The performance standards spell out the objective level of pathogen reduction that establishments must meet during their operations in order to produce safe products, but allow the use of customized, plant-specific processing procedures other than those prescribed in the earlier regulations. With HACCP, food safety performance standards give establishments the incentive and flexibility to adopt innovative, science-based food safety processing procedures and controls, while providing objective, measurable standards that can be verified by Agency inspectional oversight. This set of performance standards will include and be consistent with standards already in place for certain ready-to-eat meat and poultry products.

Statement of Need: Although FSIS routinely samples and tests some ready-to-eat products for the presence of pathogens prior to distribution, there are no specific regulatory pathogen reduction requirements for most of these products. The proposed performance standards are necessary to help ensure the safety of these products; give establishments the incentive and flexibility to adopt innovative, science-based food safety processing procedures and controls; and provide objective, measurable standards that can be verified by Agency oversight.

Summary of Legal Basis: 21 U.S.C. 601 to 695; 21 U.S.C. 451 to 470.

Alternatives: As an alternative to all of the proposed requirements, FSIS considered taking no action. As alternatives to the proposed performance standard requirements, FSIS considered end-product testing and requiring “use-by” date labeling on ready-to-eat products.

Anticipated Cost and Benefits: Benefits are expected to result from fewer contaminated products entering commercial food distribution channels as a result of improved sanitation and process controls and in-plant verification. FSIS believes that the benefits of the rule would exceed the total costs of implementing its provisions. FSIS currently estimates net benefits from the 2003 interim final rule at $470 to $575 million, with annual recurring costs at $150.4 million, if FSIS discounts the capital cost at 7 percent. FSIS is continuing to analyze the potential impact of the other provisions of the proposal.

The other main provisions of the proposed rule are: Lethality performance standards for Salmonella and E. coli O157:H7 and stabilization performance standards for C. perfringens that firms must meet when producing RTE meat and poultry products. Most of the costs of these requirements would be associated with one-time process performance validation in the first year of implementation of the rule and with revision of HACCP plans. Benefits are expected to result from the entry into commercial food distribution channels of product with lower levels of contamination resulting from improved in-plant process verification and sanitation. Consequently, there will be fewer cases of foodborne illness.

Risks: Before FSIS published the proposed rule, FDA and FSIS had estimated that each year L. monocytogenes caused 2,540 cases of foodborne illness, including 500 fatalities. The Agencies estimated that about 65.3 percent of these cases, or 1660 cases and 322 deaths per year, were attributable to RTE meat and poultry products. The analysis of the interim final rule on control of L. monocytogenes conservatively estimated that implementation of the rule would lead to an annual reduction of 27.3 deaths and 136.7 illnesses at the median. FSIS is continuing to analyze data on production volume and Listeria controls in the RTE meat and poultry products industry and is using the FSIS risk assessment model for L. monocytogenes to determine the likely risk reduction effects of the rule. Preliminary results indicate that the risk reductions being achieved are substantially greater than those estimated in the analysis of the interim rule.

FSIS is also analyzing the potential risk reductions that might be achieved by implementing the lethality and stabilization performance standards for products that would be subject to the proposed rule. The risk reductions to be achieved by the proposed rule and that are being achieved by the interim rule are intended to contribute to the Agency's public health protection effort.

Timetable:

Action Date FR Cite
NPRM 02/27/01 66 FR 12590
NPRM Comment Period End 05/29/01
NPRM Comment Period Extended 07/03/01 66 FR 35112
NPRM Comment Period Extended End 09/10/01
Interim Final Rule 06/06/03 68 FR 34208
Interim Final Rule Effective 10/06/03
Interim Final Rule Comment Period End 01/31/05
NPRM Comment Period Reopened 03/24/05 70 FR 15017
NPRM Comment Period Reopened End 05/09/05
Affirmation of Interim Final Rule 01/00/12
Final Action 09/00/12

Regulatory Flexibility Analysis Required: Yes.

Small Entities Affected: Businesses.

Government Levels Affected: None.

Agency Contact: Dr. Daniel L. Engeljohn, Assistant Administrator, Office of Policy and Program Development,Department of Agriculture, Food Safety and Inspection Service, 1400 Independence Avenue SW., Washington, DC 20250, Phone: 202 205-0495, Fax: 202 401-1760, Email: daniel.engeljohn@fsis.usda.gov.

RIN: 0583-AC46

USDA—FSIS Back to Top

20. Notification, Documentation, and Recordkeeping Requirements for Inspected Establishments Back to Top

Priority: Other Significant.

Legal Authority: 21 U.S.C. 612 to 613; 21 U.S.C. 459

CFR Citation: 9 CFR 417.4; 9 CFR 418.

Legal Deadline: None.

Abstract: The Food Safety and Inspection Service (FSIS) has proposed to require establishments subject to inspection under the Federal Meat Inspection Act and the Poultry Products Inspection Act to promptly notify the Secretary of Agriculture that an adulterated or misbranded product received by or originating from the establishment has entered into commerce, if the establishment believes or has reason to believe that this has happened. FSIS has also proposed to require these establishments to: (1) Prepare and maintain current procedures for the recall of all products produced and shipped by the establishment and (2) document each reassessment of the process control plans of the establishment.

Statement of Need: The Food, Conservation, and Energy Act of 2008 (Pub. L. 110-246, sec. 11017), known as the 2008 Farm Bill, amended the Federal Meat Inspection Act (FMIA) and the Poultry Products Inspection Act (PPIA) to require establishments subject to inspection under these Acts to promptly notify the Secretary that an adulterated or misbranded product received by or originating from the establishment has entered into commerce, if the establishment believes or has reason to believe that this has happened. Section 11017 also requires establishments subject to inspection under the FMIA and PPIA to: (1) Prepare and maintain current procedures for the recall of all products produced and shipped by the establishment and (2) document each reassessment of the process control plans of the establishment.

Summary of Legal Basis: 21 U.S.C. 612 and 613; 21 U.S.C. 459, and Public Law 110-246, section 11017.

Alternatives: The option of no rulemaking is unavailable.

Anticipated Cost and Benefits: Approximate costs: $5.0 million for labor and costs; $5.2 million for first-year costs; $0.7 million average costs adjusted with a 3.0 percent inflation rate for following years. Total approximate costs: $10.2 million. The average cost of this final rule to small entities is expected to be less than 1/10 of 1 cent of meat and poultry food products per annum. Therefore, FSIS has determined that this rule will not have a significant economic impact on a substantial number of small entities. Approximate benefits: Benefits have not been monetized because quantified data on benefits attributable to this final rule are not available. Non-monetary benefits include improved protection of the public health, improved HACCP plans, and improved recall effectiveness.

Risks: In preparing regulations on the shipment of adulterated meat and poultry products by meat and poultry establishments, the preparation and maintenance of procedures for recalled products produced and shipped by establishments, and the documentation of each reassessment of the process control plans by the establishment, the Agency considered any risks to public health or other pertinent risks associated with these actions.

Timetable:

Action Date FR Cite
NPRM 03/25/10 75 FR 14361
NPRM Comment Period End 05/24/10
Final Action 04/00/12

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: Businesses.

Government Levels Affected: None.

Agency Contact: Victoria Levine, Program Analyst, Policy Issuances Division, Department of Agriculture, Food Safety and Inspection Service, 1400 Independence Avenue SW., Washington, DC 20250, Phone: 202 720-5627, Fax: 202 690-0486, Email: victoria.levine@fsis.usda.gov.

RIN: 0583-AD34

BILLING CODE 3410-90-P

DEPARTMENT OF COMMERCE (DOC) Back to Top

Statement of Regulatory and Deregulatory Priorities

Established in 1903, the Department of Commerce is one of the oldest Cabinet-level agencies in the Federal Government. The Department's mission is to create the conditions for economic growth and opportunity by promoting innovation, entrepreneurship, competitiveness, and environmental stewardship. Commerce has 12 operating units, which are responsible for managing a diverse portfolio of programs and services, ranging from trade promotion and economic development assistance to broadband and the National Weather Service.

The Department touches Americans daily, in many ways—making possible the daily weather reports and survey research; facilitating technology that all of us use in the workplace and in the home each day; supporting the development, gathering, and transmission of information essential to competitive business; enabling the diversity of companies and goods found in America's and the world's marketplace; and supporting environmental and economic health for the communities in which Americans live.

Commerce has a clear and compelling vision for itself, for its role in the Federal Government, and for its roles supporting the American people, now and in the future. To achieve this vision, the Department works in partnership with businesses, universities, communities, and workers 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, 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 by providing accurate economic and demographic data.

The Department is a vital resource base, a tireless advocate, and Cabinet-level voice for job creation.

The Regulatory Plan tracks the most important regulations that implement these policy and program priorities, several of which involve regulation of the private sector by the Department.

Responding to the Administration's Regulatory Philosophy and Principles

The vast majority of the Department's programs and activities do not involve regulation. Of the Department's 12 primary operating units, only the National Oceanic and Atmospheric Administration (NOAA) will be planning actions that are considered the “most important” significant preregulatory or regulatory actions for FY 2012. During the next year, NOAA plans to publish four rulemaking actions that are designated as regulatory plan actions. The Bureau of Industry and Security (BIS) will also publish rulemaking actions designated as regulatory plan actions. Further information on these actions is provided below.

The Department has a long-standing policy to prohibit the issuance of any regulation that discriminates on the basis of race, religion, gender, or any other suspect category and requires that all regulations be written so as to be understandable to those affected by them. The Secretary also requires that the Department afford the public the maximum possible opportunity to participate in departmental rulemakings, even where public participation is not required by law.

National Oceanic and Atmospheric Administration

NOAA establishes and administers Federal policy for the conservation and management of the Nation's oceanic, coastal, and atmospheric resources. It provides a variety of essential environmental and climate services vital to public safety and to the Nation's economy, such as weather forecasts, drought forecasts, and storm warnings. It is a source of objective information on the state of the environment. NOAA plays the lead role in achieving the Departmental goal of promoting stewardship by providing assessments of the global environment.

Recognizing that economic growth must go hand-in-hand with environmental stewardship, the Department, through NOAA, conducts programs designed to provide a better understanding of the connections between environmental health, economics, and national security. Commerce's emphasis on “sustainable fisheries” is designed to boost long-term economic growth in a vital sector of the U.S. economy while conserving the resources in the public trust and minimizing any economic dislocation necessary to ensure long-term economic growth. The Department is where business and environmental interests intersect, and the classic debate on the use of natural resources is transformed into a “win-win” situation for the environment and the economy.

Three of NOAA's major components, the National Marine Fisheries Service (NMFS), the National Ocean Service (NOS), and the National Environmental Satellite, Data, and Information Service (NESDIS), exercise regulatory authority.

NMFS oversees the management and conservation of the Nation's marine fisheries, protects threatened and endangered marine and anadromous species and marine mammals, 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 the national marine sanctuaries; monitors marine pollution; and directs the national program for deep-seabed minerals and ocean thermal energy. NESDIS administers the civilian weather satellite program and licenses private organizations to operate commercial land-remote sensing satellite systems.

The Department, through NOAA, has a unique role in promoting stewardship of the global environment through effective management of the Nation's marine and coastal resources and in monitoring and predicting changes in the Earth's environment, thus linking trade, development, and technology with environmental issues. NOAA has the primary Federal responsibility for providing sound scientific observations, assessments, and forecasts of environmental phenomena on which resource management, adaptation, and other societal decisions can be made.

In the environmental stewardship area, NOAA's goals include: Rebuilding and maintaining strong U.S. fisheries by using market-based tools and ecosystem approaches to management; increasing the populations of depleted, threatened, or endangered species and marine mammals by implementing recovery plans that provide for their recovery while still allowing for economic and recreational opportunities; promoting healthy coastal ecosystems by ensuring that economic development is managed in ways that maintain biodiversity and long-term productivity for sustained use; and modernizing navigation and positioning services. In the environmental assessment and prediction area, goals include: Understanding climate change science and impacts, and communicating that understanding to government and private sector stakeholders enabling them to adapt; continually improving the National Weather Service; implementing reliable seasonal and interannual climate forecasts to guide economic planning; providing science-based policy advice on options to deal with very long-term (decadal to centennial) changes in the environment; and advancing and improving short-term warning and forecast services for the entire environment.

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). Among the several hundred rulemakings that NOAA plans to issue in FY 2012, a number of the preregulatory and regulatory actions will be significant. The exact number of such rulemakings is unknown, since they are usually initiated by the actions of eight regional Fishery Management Councils (FMCs) that are responsible for preparing fishery management plans (FMPs) and FMP amendments, and for drafting implementing regulations for each managed fishery. NOAA issues regulations to implement FMPs and FMP amendments. Once a rulemaking is triggered by an FMC, the Magnuson-Stevens Act places stringent deadlines upon NOAA by which it must exercise its rulemaking responsibilities. FMPs and FMP amendments for Atlantic highly migratory species, such as bluefin tuna, swordfish, and sharks, are developed directly by NOAA, not by FMCs.

FMPs address a variety of issues including maximizing fishing opportunities on healthy stocks, rebuilding overfished stocks, and addressing gear conflicts. One of the problems that FMPs may address is preventing overcapitalization (preventing excess fishing capacity) of fisheries. This may be resolved by market-based systems such as catch shares, which permit shareholders to harvest a quantity of fish and which can be traded on the open market. Harvest limits based on the best available scientific information, whether as a total fishing limit for a species in a fishery or as a share assigned to each vessel participant, enable stressed stocks to rebuild. Other measures include staggering fishing seasons or limiting gear types to avoid gear conflicts on the fishing grounds and establishing seasonal and area closures to protect fishery stocks.

The FMCs provide a forum for public debate and, using the best scientific information available, make the judgments needed to determine optimum yield on a fishery-by-fishery basis. Optional management measures are examined and selected in accordance with the national standards set forth in the Magnuson-Stevens Act. This process, including the selection of the preferred management measures, constitutes the development, in simplified form, of an FMP. The FMP, together with draft implementing regulations and supporting documentation, is submitted to NMFS for review against the national standards set forth in the Magnuson-Stevens Act, in other provisions of the Act, and other applicable laws. The same process applies to amending an existing approved FMP.

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 take of marine mammals. Exceptions allow for permitting the collection of wild animals for scientific research or public display or to enhance the survival of a species or stock. NMFS initiates rulemakings under the MMPA to establish a management regime to reduce marine mammal mortalities and injuries as a result of interactions with fisheries. The MMPA also established the Marine Mammal Commission, which makes recommendations to the Secretaries of the Departments of Commerce and the Interior and other Federal officials on protecting and conserving marine mammals. The Act underwent significant changes in 1994 to allow for takings incidental to commercial fishing operations, to provide certain exemptions for subsistence and scientific uses, and to require the preparation of stock assessments for all marine mammal stocks in waters under U.S. jurisdiction.

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. The ESA authorizes both NMFS and the Fish and Wildlife Service (FWS) to jointly administer the provisions of the MMPA. NMFS manages marine and “anadromous” species, and FWS manages land and freshwater species. Together, NMFS and FWS work to protect critically imperiled species from extinction. Of the 1,310 listed species found in part or entirely in the United States and its waters, NMFS has jurisdiction over approximately 60 species. NMFS' rulemaking actions 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, under the ESA's procedural framework, Federal agencies consult with NMFS on any proposed action authorized, funded, or carried out by that agency that may affect one of the listed species or designated critical habitat, or is likely to jeopardize proposed species or adversely modify proposed critical habitat that is under NMFS' jurisdiction.

NOAA's Regulatory Plan Actions

While most of the rulemakings undertaken by NOAA do not rise to the level necessary to be included in the Department's regulatory plan, NMFS is undertaking four actions that rise to the level of “most important” of the Department's significant regulatory actions and thus are included in this year's regulatory plan. The four actions implement provisions of the Magnuson-Stevens Fishery Conservation and Management Act, as reauthorized in 2006. The third action may be of particular interest to international trading partners as it concerns the Certification of Nations Whose Fishing Vessels are Engaged in Illegal, Unreported, and Unregulated Fishing or Bycatch of Protected Living Marine Resources. A description of the four regulatory plan actions is provided below.

1. Fishery Management Plan for Regulating Offshore Marine Aquaculture in the Gulf of Mexico (0648-AS65): In January 2009, the Gulf of Mexico Fishery Management Council approved the Aquaculture Fishery Management Plan, which authorizes NMFS to issue permits to culture species managed by the Council (except shrimp and corals). This was the first time a regional Fishery Management Council approved a comprehensive regulatory program for offshore aquaculture in U.S. Federal waters. On September 3, 2009, the Aquaculture Fishery Management Plan entered into effect by operation of law and Dr. Lubchenco announced that NOAA would develop a new National Aquaculture Policy, which would provide context for the Aquaculture Fishery Management Plan. On June 9, 2011, NOAA released the final National Aquaculture Policy and announced that the Agency will move forward with the rulemaking to implement the Aquaculture Fishery Management Plan. The Aquaculture Plan has received regional and national media attention and was challenged in two lawsuits. Although the lawsuits were dismissed, additional legal challenges are anticipated when the final rule is issued. A vocal coalition of environmental, non-governmental organizations and fishermen's groups opposed to marine aquaculture has been actively following the process. Others, including some fishing and seafood groups, support the Aquaculture Fishery Management Plan.

2. Amend the Definition of Illegal, Unreported, and Unregulated Fishing Under the High Seas Driftnet Fishing Moratorium Protection Act to Include International Provisions of the Shark Conservation Act (0648-BA89): As required under the international provisions of the Shark Conservation Act, the rule would amend the identification and certification procedures under the High Seas Driftnet Fishing Moratorium Protection to include the identification of a foreign nation whose fishing vessels engaged during the preceding calendar year in fishing activities in areas beyond any national jurisdiction that target or incidentally catch sharks if that nation has not adopted a regulatory program to provide for the conservation of sharks that is comparable to that of the United States, taking into account different conditions. NMFS also intends to amend the regulatory definition of “illegal, unreported, and unregulated (IUU) fishing” for purposes of the identification and certification procedures under the Moratorium Protection Act.

3. Critical Habitat for North Atlantic Right Whale (0648-AY54): In 1994, NMFS designated critical habitat for the northern right whale in the North Atlantic Ocean. This critical habitat designation includes portions of Cape Cod Bay and Stellwagen Bank, the Great South Channel, and waters adjacent to the coasts of Georgia and Florida. In 2008, NMFS published final determinations listing right whales in the North Atlantic and North Pacific as separate endangered species under the ESA and initiated work on new critical habitat designations triggered by these 2008 listings. On October 1, 2009, NMFS received a petition from the Center for Biological Diversity, Defenders of Wildlife, Humane Society of the United States, Ocean Conservancy, and the Whale and Dolphin Conservation Society to revise the designated critical habitat of the North Atlantic right whale. The petition seeks an expansion of the areas designated as critical feeding and calving habitats and also seeks to include a migratory corridor as part of the critical habitat designation. On October 6, 2010, NMFS published a 90-day finding and 12-month determination stating the intent to proceed with publishing a proposed rule to revise critical habitat.

4. Reduce Disturbance to Hawaiian Spinner Dolphins from Human Interactions (0648-AU02): Spinner dolphins are being disturbed in their natural resting habitats by human activities, which may be altering the dolphins' normal behavioral patterns. NMFS is proposing time-area closures to protect the essential resting habitat of spinner dolphins and to reduce the human activities that cause unauthorized taking of these dolphins under the Marine Mammal Protection Act and its implementing regulations. The proposed rule lists time-area closures including four bays on the island of Hawaii, and one on the island of Maui. Adaptive management strategies will be used to monitor the effectiveness of the proposed rule and allow for necessary improvements. This proposed action will set a precedent for NMFS' management of wildlife viewing activities. This proposed action represents the first proposal by NMFS to use regulated area closures to reduce harassment of non-ESA listed marine mammals resulting from activities aimed at viewing and interacting with these animals.

At this time, NOAA is unable to determine the aggregate cost of the identified Regulatory Plan actions as several of these actions are currently under development.

Bureau of Industry and Security

The 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.

In August 2009, the President directed a broad-based interagency review of the U.S. export control system with the goal of strengthening national security and the competitiveness of key U.S. manufacturing and technology sectors by focusing on the current threats and adapting to the changing economic and technological landscape. In August 2010, the President outlined an approach under which agencies that administer export controls will apply new criteria for determining what items need to be controlled and a common set of policies for determining when an export license is required. The control list criteria are to be based on transparent rules, which will reduce the uncertainty faced by our Allies, U.S. industry and its foreign customers, and will allow the Government to erect higher walls around the most sensitive export items in order to enhance national security.

Under the President's approach, agencies will apply the criteria and revise the lists of munitions and dual use items that are controlled for export so that they:

Are “tiered” to distinguish the types of items that should be subject to stricter or more permissive levels of control for different destinations, end-uses, and end-users;

Create a “bright line” between the two current control lists to clarify jurisdictional determinations and reduce government and industry uncertainty about whether particular items are subject to the control of the State Department or the Commerce Department; and

Are structurally aligned so that they potentially can be combined into a single list of controlled items.

BIS' current regulatory plan action is designed to implement the initial phase of the President's directive.

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 also regulates participation of U.S. persons in certain boycotts administered by foreign governments. The National Defense 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, 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 with respect to an agreement between the United States and the International Atomic Energy Agency.

BIS also has an enforcement component with eight field offices in the United States. BIS export control officers are also 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 to promote effective export controls through cooperation with other governments.

BIS' Regulatory Plan Actions

As the agency responsible for leading the administration and enforcement of the U.S. dual-use export control system, BIS plays a central role in the Administration's efforts to fundamentally reform the export control system. Changing what we control, how we control it, and how we enforce and manage our controls will help strengthen our national security by focusing our efforts on controlling the most critical products and technologies, and by enhancing the competitiveness of key U.S. manufacturing and technology sectors.

In FY 2011, BIS took several steps to implement the President's Export Control Reform Initiative. BIS published a final rule (76 FR 35276, June 16, 2011) implementing a license exception that authorizes exports, reexports, and transfers to destinations that do not pose a national security concern, provided certain safeguards against diversion to other destinations are taken. BIS also proposed a rule that provides a framework for controlling militarily less significant defense articles, largely generic parts and components, on the Commerce Control List (CCL) rather than the United States Munitions List. In the immediate future, BIS will work with other agencies to implement transfers of such items to the CCL and to make the CCL a more positive list. Looking further ahead BIS will work with other agencies to place items on the CCL into one of three tiers, corresponding to different levels of sensitivity.

Tier 1 will include the most sensitive items. These are items that provide a critical military or intelligence advantage to the United States and are available almost exclusively from the United States, or are items that are a weapon of mass destruction.

Tier 2 will include items that are sensitive but not as sensitive, as those in Tier 1. These are items that provide a substantial military or intelligence advantage to the United States and are available almost exclusively from either the United States or our partners and allies.

Tier 3 will include items that are less sensitive than those in Tier 2. These items will be those that provide a significant military or intelligence advantage but are available more broadly. BIS will also be developing other rules to implement additional aspects of the export control reform as those aspects are identified and decided.

Retrospective Review of Existing Regulations

Pursuant to section 6 of Executive Order 13563 “Improving Regulation and Regulatory Review” (Jan. 18, 2011), the following Regulatory Identifier Numbers (RINs) have been identified as associated with retrospective review and analysis in the Department's final retrospective review of regulations plan. Accordingly, the Agency is reviewing these rules to determine whether action under E.O. 13563 is appropriate. Some of these entries on this list may be completed actions, which do not appear in The Regulatory Plan. However, more information can be found about these completed rulemakings in past publications of the Unified Agenda on Reginfo.gov in the Completed Actions section for the Agency. These rulemakings can also be found on Regulations.gov. The final Agency retrospective analysis plan can be found at: http://open.commerce.gov/sites/default/files/Commerce%20Plan%20for%20Retrospective%20Analysis%20of%20Existing%20Rules%20-%202011-08-22%20Final.pdf.

RIN Title Expected To Significantly Reduce Burdens on Small Businesses?
0610-AA66 Revisions to EDA's Regulations Yes.
0625-AA81 Foreign Trade Zones Yes.
0648-AN55 Amendments 61/61/13/8 to Implement Major Provisions of the American Fisheries Act  
0648-AL92 Western Alaska Community Development Quota Program  
0648-AP12 Atlantic Mackerel, Squid and Butterfish Fisheries; Framework Adjustment 2 Yes.
0648-AO62 Reef Fish Fishery of the Gulf of Mexico: Charter Vessel and Headboat Permit Moratorium Yes.
0648-AL41 Nearshore Area Closures Around American Samoa by Vessels More Than 50 Feet in Length  
0648-AP78 Fisheries of the Northeastern United States: Northeast Multispecies Fishery  
0648-AN75 Pelagic Longline Gear Restrictions, Seasonal Area Closure, and Other Sea Turtle Mitigation Measures  
0648-AP37 Atlantic Herring Fishery; 2002 Specifications  
0648-AO35 Measures To Reduce the Incidental Catch of Seabirds in the Hawaii Pelagic Longline Fishery  
0648-AP76 Atlantic Deep-Sea Red Crab Fishery Management Plan  
0648-AP39 Pacific Coast Groundfish Fishery: Experimental Setnet Sablefish Landings To Qualify Limited Entry Sablefish-Endorsed permits for Tier Assignment  
0648-AO20 Fisheries of the Exclusive Economic Zone off Alaska: Revisions to Recordkeeping and Reporting Requirements Yes.
0648-AQ05 Extend the Interim Groundfish Observer Program Through December 31, 2007, and Amend Regulations for the North Pacific Groundfish Observer Program  
0648-AN88 Taking of Marine Mammals Incidental to Commercial Fishing Operations: Atlantic Large Whale Take Reduction Plan Regulations  
0648-AK23 Fisheries Off West Coast States and in the Western Pacific: Precious Corals Fisheries; Harvest Quotas, Definitions, Size Limits, Gear Restrictions, and Bed Classification  
0648-AP21 Implementation of the Shark Finning Prohibition Act  
0648-AP49 Atlantic Highly Migratory Species; Pelagic Longline Fishery; Shark Gillnet Fishery: Sea Turtle and Whale Protection Measures  
0648-AM40 License Limitation Program for Groundfish of the Bering Sea and Aleutian Islands Area  
0648-AP79 Prohibition of Non-pelagic Trawl Gear in Cook Inlet in the Gulf of Alaska  
0648-AO69 Fisheries Off the West Coast States and in the Western Pacific; Pacific Coast Groundfish Fishery: Annual Specifications and Management Measures  
0648-AK70 Fisheries of the Exclusive Economic Zone Off Alaska: Individual Fishing Quota Program  
0648-AP81 Sea Turtle Conservation Measures of the Pound Net Fishery in Virginia Waters  
0648-AP17 Take of Four Threatened Evolutionarily Significant Units of West Coast Salmon  
0648-AP68 Atlantic Large Whale Seasonal Area Management Program  
0648-AN29 Regulations Governing the Approach to Humpback Whales in Alaska  
0648-AK50 Fisheries of the Exclusive Economic Zone Off Alaska: Improved Individual Fishing Quota Program  
0648-AM72 Western Alaska Community Development Quota Program  
0648-AN23 Fisheries of the Exclusive Economic Zone Off Alaska: Revisions to Definition of Length Overall of a Vessel  
0648-AL95 Fisheries of the Exclusive Economic Zone Off Alaska: License Limitation Program  
0648-AO02 Atlantic Coastal Fisheries Cooperative Management Act Provisions: Horseshoe Crab Fishery—Closed Area  
0648-AF87 Fisheries of the Northeastern United States: Fishery Management Plan for Tilefish  
0648-AN27 Pacific Coast Groundfish Fishery: Groundfish Observer Program  
0648-AL51 West Coast Salmon Fisheries: Amendment 14.  
0648-AO41 Pacific Coast Groundfish Fishery: Amendment 13.  
0648-AO97 Pacific Coast Groundfish Fishery: Amendment 14.  
0648-AO42 International Fisheries Regulations: Pacific Tuna Fisheries  
0648-BA42 Fisheries of the Northeastern United States; Tilefish Cost Recovery Regulatory Amendment  
0648-BA06 Fisheries of the Caribbean, Gulf of Mexico, and South Atlantic; Reef Fish Fishery of the Gulf of Mexico; Emergency Rule To Authorize Re-Opening the Recreational Red Snapper Season Yes.
0694-AF03 Export Control Reform Initiative: Strategic Trade Authorization License Exception  
0694-AF17 Revisions to the Export Administration Regulations (EAR): Control of Items the President Determines No Longer Warrant Control Under the United States Munitions List (USML) Yes.

DOC—BUREAU OF INDUSTRY AND SECURITY (BIS) Back to Top

Final Rule Stage

21. Revisions to the Export Administration Regulations (EAR): Control of Military Vehicles and Related Items That the President Determines Do Not Warrant Control on the United States Munitions List Back to Top

Priority: Other Significant.

Legal Authority: 10 U.S.C. 7420; 10 U.S.C. 7430(e); 15 U.S.C. 1824a; 22 U.S.C. 287c; 22 U.S.C. 6004; 22 U.S.C. 7201 et seq.; 22 U.S.C. 7210; 30 U.S.C. 185(s); 42 U.S.C. 2139a; 42 U.S.C. 2139a; 42 U.S.C. 6212; 43 U.S.C. 1354; 50 U.S.C. 1701 et seq.; 50 U.S.C. 2401 et seq.; 50 U.S.C. 5; EO 12058; EO 12851; EO 12938; EO 12947; EO 13026; EO 13099; EO 13222; EO 13224; 22 U.S.C. 2151 note; 22 U.S.C. 3201 et seq.; EO 11912; EO 12002; EO 12214; EO 12854; EO 12918; EO 12918; EO 12981; EO 13020; EO 13338; 30 U.S.C. 185(u)

CFR Citation: 15 CFR 740; 15 CFR 743; 15 CFR 744; 15 CFR 748; 15 CFR 774; 15 CFR 730; 15 CFR 732; 15 CFR 738; 15 CFR 742; 15 CFR 746; 15 CFR 756; 15 CFR 762; 15 CFR 770; 15 CFR 772.

Legal Deadline: None.

Abstract: In August 2009, President Obama directed a fundamental review of the U.S. Export control system be conducted. This review included a fundamental review of the two primary control lists of the U.S. Export control system; i.e., the Commerce Control List (CCL) and the United States Munitions List (USML). In December 2010, the Departments of Commerce and State each published an Advanced Notice of Proposed Rulemaking (ANPRM) requesting public comments on creating more “positive” and clear control lists and recommendations for how items listed on the two control lists could be tiered based on criteria developed during the Export Control Reform (ECR) initiative.

An integral part of creating a “positive” USML requires a proper control structure be put into place under the EAR to appropriately control the less significant items moved from the USML to the CCL, which is the subject of this proposed rule. This rule outlines the control structure developed under the ECR initiative to ensure appropriate controls are in place for these less significant items moved from the USML to the CCL.

Statement of Need: This rule is needed to describe how items that no longer warrant ITAR control—but, because they are specially designed for military applications, warrant some degree of control—will be made subject to the EAR and listed on the CCL. In particular, this rule establishes the framework within which items that are transferred from the ITAR to the EAR will be identified in and controlled by the EAR. Such ready identification is needed to allow for public understanding of the changes and to facilitate executive branch compliance with the requirements to notify Congress when items are removed from the ITAR. Such controls are needed to accomplish the national security and foreign policy objectives of controlling transfers of military items, which includes complying with statutory and international obligations to prevent the transfer of such items to certain countries, end uses, and end users.

Summary of Legal Basis: The Export Administration Act of 1979, as amended, authorizes the President to prohibit or curtail exports for national security or foreign policy reasons. Section 3(1) of that Act provides that “It is the policy of the United States to minimize uncertainties in export control policy and to encourage trade with all countries with which the United States has diplomatic or trading relations, except those countries with which such trade has been determined by the President to be against the national interest.” Although the Export Administration Act of 1979 (EAA), as amended, expired on August 20, 2001, Executive Order 13222 of August 17, 2001 (3 CFR, 2001 Comp., p. 783 (2002)) as extended by Notice of August 12, 2010, 75 FR 50681 (Aug. 16, 2010) continues the EAR in effect under the International Emergency Economic Powers Act (IEEPA). The EAA and the IEEPA provide the President with the discretion to tailor controls, such as through the use of license exceptions and the creation of country groups in the implementing regulations, over different types of items based on their significance or other factors relevant to the national interest.

The Arms Export Control Act (22 U.S.C. 2778) gives the President the authority to identify any item as a “defense article.” The list of “defense articles” is identified on the U.S. Munitions List (USML) of the International Traffic in Arms Regulations (ITAR) (22 CFR chapter I, subchapter M). Section 38(f) of the AECA requires the President to periodically review the list of defense articles and determine which, if any, should be removed from the list. Section 38(f) authorizes the President to remove defense articles from the USML and control them under other statutory and regulatory authorities, such as the export control regulations administered by the Commerce Department, after completing a 30-day congressional notification.

Alternatives: BIS considered several alternative regulatory structures for the items that would be moved from the ITAR to the EAR, including creating a separate Commerce Munitions List in the EAR and attempting to insert all items transferred into the existing ECCN structure. BIS selected the “600 series” structure because it provided the best balance between ease of use and the need to readily identify items moved or to be moved from the ITAR to the EAR for congressional notification purposes. A separate Commerce Munitions List would have readily identified items moved from the ITAR, but would have required the public to consult two lists to assess whether license requirements applied to a particular item. Attempting to place all transferred items within the existing ECCN structure would have minimized the number of ECCNs to be consulted but would have unduly obscured the ITAR origin of the transferred items.

Anticipated Cost and Benefits: The underlying policy motivation for the reform effort is not a traditional economic cost/benefit analysis. Rather, it is a national security effort. When the Administration first began to consider how the export control system should be reformed to enhance national security, it did not take into account whether there would be particular economic benefits or costs. After conducting the review, the Administration ultimately determined that our national security will be strengthened if (i) our export control system allows for more interoperability with our NATO and other close allies; (ii) our industrial base is enhanced by, for example, reducing the current incentives created by the export control rules for foreign companies to design out or avoid U.S.-origin content; and (iii) our resources are more focused on controlling or prohibiting, as needed, the items that provide at least a significant military or intelligence advantage to the United States. Items made subject to the EAR as a result of this rule generally would require a license to all destinations except Canada and exporters, reexporters and transferors would incur the costs associated with applying for such licenses. BIS would need additional resources to review the additional licenses and to handle the related compliance activities that will accompany the planned change in jurisdictional status of items. The net burden on the government and that the government imposes on industry, however, would be substantially reduced because this rule would apply to items that currently are subject to strict, generally inflexible ITAR license requirements that impose many collateral compliance burdens and costs on exporters and the U.S. Government. BIS believes that replacing such ITAR license requirements with the more flexible EAR license requirements is not likely to result in any net increase in costs. However, the benefits of the move would be substantial, although not readily quantifiable.

Risks: Not all items currently subject to the ITAR are appropriate for movement to the EAR. Care must be taken to ensure that large sophisticated weapons and other inherently military items (as opposed to items unique to defense articles merely because of a change in form or fit) are not moved to the EAR. BIS believes that the ongoing interagency review process is adequate to guard against any transfers contrary to national security and foreign policy interests. At the same time, one must consider the risks of not transferring to the EAR defense articles that no longer warrant ITAR controls. These risks include continued excessive costs to exporters in complying with unnecessarily restrictive rules, continued disincentives for defense manufacturers to use U.S. origin parts and components, and continued excessive costs associated with supplying allied armed forces with U.S. origin parts and components. BIS believes that this rule sets up a structure for controls that will allow for the appropriate balance between the risks of continuing the status quo and the risks of unwarranted relaxation of controls.

Timetable:

Action Date FR Cite
NPRM 07/15/11 76 FR 41958
NPRM Comment Period End 09/13/11
Final Rule 12/00/11

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: No.

Government Levels Affected: None.

Agency Contact: Timothy Mooney, Export Policy Analyst, Department of Commerce, Bureau of Industry and Security, 14th Street and Pennsylvania Avenue NW., Washington, DC 20230, Phone: 202 482-3371, Fax: 202 482-3355, Email: timothy.mooney@bis.doc.gov.

Related RIN: Merged with 0694-AF09.

RIN: 0694-AF17

DOC—NATIONAL OCEANIC AND ATMOSPHERIC ADMINISTRATION (NOAA) Back to Top

Proposed Rule Stage

22. Fishery Management Plan for Regulating Offshore Marine Aquaculture in the Gulf of Mexico Back to Top

Priority: Other Significant.

Legal Authority: 16 U.S.C. 1801 et seq.

CFR Citation: 50 CFR 622.

Legal Deadline: None.

Abstract: The purpose of this fishery management plan (FMP) is to develop a regional permitting process for regulating and promoting environmentally sound and economically sustainable aquaculture in the Gulf of Mexico (Gulf) exclusive economic zone. This FMP consists of ten actions, each with an associated range of management alternatives, which would facilitate the permitting of an estimated 5 to 20 offshore aquaculture operations in the Gulf over the next 10 years, with an estimated annual production of up to 64 million pounds. By establishing a regional permitting process for aquaculture, the Gulf of Mexico Fishery Management Council will be positioned to achieve their primary goal of increasing maximum sustainable yield and optimum yield of federal fisheries in the Gulf by supplementing harvest of wild caught species with cultured product.

Statement of Need: Demand for protein is increasing in the United States and commercial wild-capture fisheries will not likely be adequate to meet this growing demand. Aquaculture is one method to meet current and future demands for seafood. Supplementing the harvest of domestic fisheries with cultured product will help the U.S. meet consumers' growing demand for seafood and may reduce the Nation's dependence on seafood imports.

Currently, the U.S. imports over 80 percent of the seafood consumed in the country, and the annual U.S. seafood trade deficit is at an all time high of over $9 billion.

Summary of Legal Basis: Magnuson-Stevens Fishery Conservation and Management Act, 16 U.S.C. 1801 et seq.

Alternatives: The Council's Aquaculture FMP includes 10 actions, each with an associated range of alternatives. These actions and alternatives are collectively intended to establish a regional permitting process for offshore aquaculture. Management actions in the FMP include: (1) Aquaculture permit requirements, eligibility, and transferability; (2) duration aquaculture permits are effective; (3) aquaculture application requirements, operational requirements, and restrictions; (4) species allowed for aquaculture; (5) allowable aquaculture systems; (6) marine aquaculture siting requirements and conditions; (7) restricted access zones for aquaculture facilities; (8) recordkeeping and reporting requirements; (9) biological reference points and status determination criteria; and (10) framework procedures for modifying biological reference points and regulatory measures.

Anticipated Cost and Benefits: Environmental and social/economic costs and benefits are described in detail in the Council's Aquaculture FMP. Potential benefits include: establishing a rigorous review process for reviewing and approving/denying aquaculture permits; increasing optimum yield by supplementing the harvest of wild domestic fisheries with cultured products; and reducing the nation's dependence on imported seafood. Anticipated costs include increased administration and oversight of an aquaculture permitting process, and potential negative environmental impacts to wild marine resources. Approval of an aquaculture permitting system may also benefit fishing communities by creating new jobs or impact fishing communities if cultured products economically displace domestic seafood.

Risks: National offshore aquaculture legislation has also been previously proposed by the Administration. This action may reduce the need for uniform national legislation and allow aquaculture regulations to vary by region.

Timetable:

Action Date FR Cite
Notice of Availability (NOA) 06/04/09 74 FR 26829
NOA Comment Period End 08/03/09
NPRM 12/00/11
Final Action 03/00/12

Regulatory Flexibility Analysis Required: Yes.

Small Entities Affected: Businesses.

Government Levels Affected: None.

Agency Contact: Roy E. Crabtree, Southeast Regional Administrator, Department of Commerce, National Oceanic and Atmospheric Administration, 263 13th Avenue South, St. Petersburg, FL 33701, Phone: 727 824-5305, Fax: 727 824-5308, Email: roy.crabtree@noaa.gov.

RIN: 0648-AS65

DOC—NOAA Back to Top

23. Reducing Disturbances to Hawaiian Spinner Dolphins From Human Interactions Back to Top

Priority: Other Significant.

Legal Authority: 16 U.S.C. 1361 et seq.

CFR Citation: 50 CFR 216.

Legal Deadline: None.

Abstract: The National Marine Fisheries Service proposes regulations to protect the essential resting habitat of wild spinner dolphins (Stenella longirostris) in the main Hawaiian Islands, and to reduce the human activities that may cause “take,” as defined in the Marine Mammal Protection Act (MMPA) and its implementing regulations, or from other actions that otherwise adversely affect the dolphins, by proposing time-area closures in four bays on the island of Hawaii, and one on the island of Maui.

Statement of Need: NMFS is concerned about the cumulative impacts on Hawaiian spinner dolphin populations from human interactions. Human interactions with dolphins in their resting habitats has increased over the past decade, with spinner dolphins now being the target of viewing or swim-with-wild-dolphins tours on a daily basis. Because spinner dolphins routinely use the same habitats, and stay in the bays for most of the day to rest, these same animals may be disturbed multiple times per day from the multiple tours that seek these animals daily. The unauthorized taking of spinner dolphins is occurring at these bays, with many adverse impacts as a result including: behavioral changes, shorter resting periods, and displacement from primary resting habitats. By protecting the essential resting habitat of the spinner dolphins, NMFS proposes to prevent the taking of these animals.

Summary of Legal Basis: All marine mammals are protected under the Marine Mammal Protection Act (MMPA). NMFS is proposing these regulations pursuant to its rulemaking authority under MMPA 16 U.S.C. 1361 et seq.; 16 U.S.C. 1372 et seq., which generally prohibits the take of any marine mammals; and 16 U.S.C. 1382 et seq.

Alternatives:

1. No Action.

2. Regulate human behaviors and activities.

3. Implement time-area closures in specified spinner dolphin resting habitats.

4. Combine limits on specified human behaviors with time-area closures.

5. Full closure of all identified spinner dolphin resting habitats.

6. Codify the West Hawaii Voluntary Standards for Marine Tourism.

Anticipated Cost and Benefits: The primary benefit of this action would be to reduce the unauthorized taking of spinner dolphins in their primary resting habitat. These animals are being disturbed in an area that is significant to their health, reproduction and survival. Managing the amount of interactions humans can have with spinner dolphins will help protect the animals in their natural environment. Costs with this proposed rule would affect humans as their use of these particular bays would be limited. Commercial tour operators, kayak companies, and spiritual retreat operators may be negatively economically impacted. The public at large would not be allowed to engage in activities in the closure areas, and they may therefore associate a cost with this proposed action.

Risks: No risks to public health, safety or the environment were identified with implementation of this rule.

Timetable:

Action Date FR Cite
ANPRM 12/12/05 70 FR 73426
ANPRM Comment Period End 01/11/06
NPRM 12/00/11

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: No.

Government Levels Affected: None.

Agency Contact: Melissa Andersen. Fishery Biologist, Management, Department of Commerce, National Oceanic and Atmospheric Administration, 1315 East-West Highway, Silver Spring, MD 20910, Phone: 301 713-2322, Fax: 301 713-2521, Email: melissa.andersen@noaa.gov.

RIN: 0648-AU02

DOC—NOAA Back to Top

24. Designation of Critical Habitat for the North Atlantic Right Whale Back to Top

Priority: Other Significant.

Legal Authority: 16 U.S.C. 1361 et seq.; 16 U.S.C. 1531 to 1543

CFR Citation: 50 CFR 226; 50 CFR 229.

Legal Deadline: None.

Abstract: In June 1970, the northern right whale was listed as endangered under the Endangered Species Conservation Act, the precursor to the Endangered Species Act (ESA) (35 FR 8495; codified at 50 CFR 17.11). Subsequently, right whales were listed as endangered under the ESA in 1973, and as depleted under the Marine Mammal Protection Act (MMPA) the same year. In 1994, NMFS designated critical habitat for the northern right whale, a single species thought at the time to include right whales in both the north Atlantic and the North Pacific.

In 2006, NMFS published a comprehensive right whale status review that concluded that recent genetic data provided unequivocal support to distinguish three right whale lineages (including the southern right whale) as separate phylogenetic species (Rosenbaum et al. 2000). Rosenbaum et al. (2000), concluded that the right whale should be regarded as the following three separate species: (1) The North Atlantic right whale (Eubalaena glacialis) ranging in the North Atlantic Ocean; (2) the North Pacific right whale (Eubalaena japonica), ranging in the North Pacific Ocean; and (3) the southern right whale (Eubalaena australis), historically ranging throughout the southern hemisphere's oceans.

Based on these findings, NMFS published a proposed and final determination listing right whales in the North Atlantic and North Pacific as separate endangered species under the ESA (71 FR 77704, Dec. 27, 2006; 73 FR 12024, Mar. 6, 2008). Based on the new listing determination, NMFS is required by the ESA to designate critical habitat separately for both the North Atlantic right whale and the North Pacific right whale.

In April 2008, a final critical habitat determination was published for the North Pacific right whale (73 FR 19000; Apr. 8, 2008). At this time, NMFS is preparing a proposal to designate critical habitat for the North Atlantic right whale.

Statement of Need: Under section 4 of the Endangered Species Act, NOAA Fisheries is required to designate critical habitat for newly listed species.

Summary of Legal Basis: Endangered Species Act.

Alternatives: Because this rule is presently in the beginning stages of development, no alternatives have been formulated or analyzed at this time.

Anticipated Cost and Benefits: Because this rule is presently in the beginning stages of development, no analysis has been completed at this time to assess costs and benefits.

Risks: Loss of critical habitat for a species listed as protected under the ESA and MMPA, as well as potential loss of right whales due to habitat loss.

Timetable:

Action Date FR Cite
NPRM 12/00/11

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: No.

Government Levels Affected: None.

Agency Contact: Marta Nammack, Office of Protected Resources, Department of Commerce, National Oceanic and Atmospheric Administration, 1315 East-West Highway, Silver Spring, MD 20910, Phone: 301 713-1401, Fax: 301 427-2523, Email: marta.nammack@noaa.gov.

RIN: 0648-AY54

DOC—NOAA Back to Top

25. Regulatory Amendments To Implement the Shark Conservation Act and Revise the Definition of Illegal, Unreported, and Unregulated Fishing Back to Top

Priority: Other Significant.

Legal Authority: 16 U.S.C. 1826d to 1826k

CFR Citation: 50 CFR 300.

Legal Deadline: Final, Statutory, January 4, 2012, The rule needs to be published by December 4, 2011, due to the 30-day delay in effectiveness.

Abstract: NMFS is amending identification and certification procedures under the High Seas Driftnet Fishing Moratorium Protection Act to help achieve shark conservation in international fisheries. NMFS must identify nations whose fishing vessels have engaged in high seas fisheries targeting or incidentally catching sharks not subject to a regulatory program for the conservation of sharks comparable to that of the United States, taking into account different conditions, as required under the Shark Conservation Act (Pub. L. 111-348). NMFS would subsequently certify whether identified nations have adopted regulatory programs governing the conservation of sharks that are comparable to U.S. programs, taking into account different conditions, and established management plans for sharks. The absence of sufficient steps may lead to prohibitions on the importation of certain fisheries products into the United States and other measures.

NMFS is also amending the regulatory definition of “illegal, unreported, and unregulated fishing” under the High Seas Driftnet Fishing Moratorium Protection Act.

The procedures for identification and certification would entail a multilateral approach of consultations and negotiations with other nations to achieve shark conservation.

This action is not expected to have adverse economic impacts, and any such impacts would be well below the economic threshold of impact pursuant to E.O. 12866. In addition, there are no novel legal or policy issues associated with this action since identification and certification procedures have already been established in regulations (50 CFR part 300). However, this action is significant under the meaning of E.O. 12866 because it could lead to trade restrictive measures applied against foreign nations.

Statement of Need: These regulatory amendments are required to implement the international provisions of the Shark Conservation Act to identify and certify nations whose vessels are engaged in shark finning and/or fishing for sharks in a manner that is not consistent with international management efforts. Additionally, this rule would revise the definition of Illegal, Unreported, and Unregulated (IUU) Fishing in response to comments on a prior rulemaking (0648-AV51) that set out the regulatory definition of IUU fishing.

Summary of Legal Basis: Shark Conservation Act (Pub. L. 111-348) and 16 U.S.C. 1826d to 1826k.

Alternatives: This action is categorically excluded from analysis under the National Environmental Policy Act because the proposed action is the promulgation of regulations of an administrative, financial, legal, technical, or procedural nature and the environmental effects of which are too broad, speculative, or conjectural to lend themselves to meaningful analysis and for which any potential cumulative effects are negligible. Consequently, no alternatives were analyzed.

Anticipated Cost and Benefits: This action is not expected to have adverse economic impacts, and any such impacts would be well below the economic threshold of impact pursuant to E.O. 12866. Potential benefits, if any, would be indirect and accrue to internationally managed fisheries by strengthening Regional Fishery Management Organizations and by restricting U.S. market access through prohibiting illegally harvested fishery products.

Risks: There are no novel legal or policy issues associated with this action since identification and certification procedures have already been established in regulations (50 CFR part 300). However, this action is significant under the meaning of E.O. 12866 because it could lead to trade restrictive measures applied against foreign nations.

Timetable:

Action Date FR Cite
NPRM 12/00/11
Final Action 06/00/12

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: No.

Government Levels Affected: None.

International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest.

Agency Contact: Christopher Rogers, Division Chief, Department of Commerce, National Oceanic and Atmospheric Administration, 1315 East-West Highway, Silver Spring, MD 20910, Phone: 301 713-9090, Fax: 301 713-9106, Email: christopher.rogers@noaa.gov.

RIN: 0648-BA89

BILLING CODE 3510-12-P

DEPARTMENT OF DEFENSE Back to Top

Statement of Regulatory Priorities

Background

The Department of Defense (DoD) is the largest Federal department, consisting of 3 Military departments (Army, Navy, and Air Force), 10 Unified Combatant Commands, 14 Defense Agencies, and 10 DoD Field Activities. It has 1,434,450 military personnel and 782,386 civilians assigned as of March 31, 2011, and over 200 large and medium installations in the continental United States, U. S. territories, and foreign countries. The overall size, composition, and dispersion of DoD, coupled with an innovative regulatory program, presents a challenge to the management of the Defense regulatory efforts under Executive Order (E.O.) 12866 “Regulatory Planning and Review” of September 30, 1993.

Because of its diversified nature, DoD is affected by the regulations issued by regulatory agencies such as the Departments of Energy, Health and Human Services, Housing and Urban Development, Labor, Transportation, and the Environmental Protection Agency. In order to develop the best possible regulations that embody the principles and objectives embedded in E.O. 12866, there must be coordination of proposed regulations among the regulatory agencies and the affected DoD components. Coordinating the proposed regulations in advance throughout an organization as large as DoD is straightforward, yet a formidable undertaking.

DoD is not a regulatory agency, but occasionally it issues regulations that have an effect on the public. These regulations, while small in number compared to the regulating agencies, can be significant as defined in E.O. 12866. In addition, some of DoD's regulations may affect the regulatory agencies. DoD, as an integral part of its program, not only receives coordinating actions from the regulating agencies, but coordinates with the agencies that are affected by its regulations as well.

Overall Priorities

The Department needs to function at a reasonable cost, while ensuring that it does not impose ineffective and unnecessarily burdensome regulations on the public. The rulemaking process should be responsive, efficient, cost-effective, and both fair and perceived as fair. This is being done in DoD while reacting to the contradictory pressures of providing more services with fewer resources. The Department of Defense, as a matter of overall priority for its regulatory program, fully incorporates the provisions of the President's priorities and objectives under Executive Order (E.O.) 12866.

Retrospective Review of Existing Regulations

Pursuant to section 6 of Executive Order 13563 “Improving Regulation and Regulatory Review (January 18, 2011), the following Regulatory Identifier Numbers (RINs) have been identified as associated with retrospective review and analysis in the Department's final retrospective review of regulations plan. All are of particular interest to small businesses. Some of these entries on this list may be completed actions, which do not appear in The Regulatory Plan. However, more information can be found about these completed rulemakings in past publications of the Unified Agenda on Reginfo.gov in the Completed Actions section for that agency. These rulemakings can also be found on Regulations.gov. The final agency plans can be found at: http://www.regulations.gov/exchange/topic/eo-13563

  • 0750-AH19—Accelerated Payments to Small Business (DFARS Case 2011-D008)
  • 0750-AH44—Extension of DoD Mentor-Protégé Pilot Program (DFARS Case 2011-D050)
  • 0750-AH45—Deletion of Text Implementing 10 U.S.C. 2323 (DFARS Case 2011-D038)

Administration Priorities

1. Rulemakings That Are Expected To Have High Net Benefits Well in Excess of Costs

The Department plans to—

  • Finalize the DFARS rule to permit offerors to propose an alternative line item structure to reflect the offeror's business practices for selling and billing commercial items, and initial provisioning of spares for weapon systems. This rule should prevent misalignment of line item structure in receipt documents and invoices, which causes manual intervention and can delay payment;
  • Finalize the DFARS rule to conduct discussions prior to contract award for source selections of $100 million or more. A DoD study showed a significant positive correlation between high-dollar source selections that were conducted without discussions and protests sustained. This rule should reduce the number of protests filed and their resultant costs to contractors and the Government; and
  • Finalize the DFARS rule to implement section 866 of the National Defense Authorization Act (NDAA) for Fiscal Year (FY) 2011 establishing a pilot program to acquire military purpose nondevelopmental items. This pilot program is designed to test whether the streamlined procedures, similar to those available for commercial items, can serve as an effective incentive for nontraditional defense contractors to (1) channel investment and innovation into areas that are useful to DoD and (2) provide items developed exclusively at private expense to meet validated military requirements. (2011-D034)

2. Rulemakings That Promote Open Government and Use Disclosure as a Regulatory Tool

The Department plans to—

  • Finalize the Federal Acquisition Regulation (FAR) to inform contractors of the statutory requirement of section 3010 of Public Law 111-212, to make Federal Awardee Performance and Integrity Information System information, excluding past performance reviews, available to the public;
  • Finalize the FAR rule that implements section 743 of Division C of the Fiscal Year 2010 Consolidated Appropriations Act, which requires agencies to develop inventories of their service contacts, including number and work location of contractor employees;
  • Finalize the FAR rule to establish standard evaluation factors and rating scales for documenting contractor performance;
  • Finalize the FAR rule that implements the Federal Funding Accountability and Transparency Act of 2006, which requires the Office of Management and Budget (OMB) to establish a free, public, Web site containing full disclosure of all Federal contract award information. This rule requires contractors to report executive compensation and first-tier subcontractor awards on unclassified contracts expected to be $25,000 or more, except contracts with individuals;
  • Finalize the FAR rule that implements section 811 of the NDAA for FY 2010, which requires a written justification and approval prior to awarding a sole-source contract in an amount over $20 million under the 8(a) program; and
  • Finalize the DFARS rule to implement section 814 of the NDAA for FY 2010, which imposed additional reporting requirements for awards of single task and delivery-order contracts.

3. Rulemakings That Streamline Regulations and Reduce Unjustified Burdens

The Department plans to—

  • Finalize the DFARS rule to remove the requirement to use DD Forms 2626 and 2631 to report past performance information for construction and architect-engineer services and to instead provide the performance reports electronically;
  • Finalize the DFARS rule to amend the definition of “qualifying country end product” to make it comparable to the change in the definition of “domestic end product” by waiving the component test for qualifying country end products;
  • Finalize the DFARS rule to update appendix F, Material Inspection and Receiving Report, to incorporate procedures for using the electronic Wide Area WorkFlow (WAWF) Receiving Report, which is required for use in most contracts in lieu of the DD Form 250. WAWF is the electronic tool for documenting receipt and acceptance of supplies and services and for electronic invoicing; and
  • Finalize the rule for DFARS coverage of patents, data, and copyrights, which significantly reduces the amount of regulatory text and the number of required clauses.

4. Efforts To Minimize Burdens on Small Businesses

Of interest to Small Businesses are regulations to—

  • Finalize the DFARS rule to accelerate payments to all DoD small business contractors.

5. Rules To Be Modified, Streamlined, Expanded, or Repealed To Make the Agency's Regulatory Program More Effective or Less Burdensome in Achieving the Regulatory Objectives

  • DFARS Case 2011-D028—Removes component test for COTS items that are qualifying country end products. Require only determination of country of origin of the COTS item, not the components of the COTS item.
  • DFARS Case 2011-D013—Only One Offer. Motivate effective competition by driving behavior to allow sufficient time for submission of offers.
  • DFARS Case 2011-D008—Accelerate Small Business Payments. Accelerate payments to all small businesses, not just small disadvantaged businesses.
  • DFARS Case 2010-D018—Responsibility and Liability for Government Property. Includes fixed-price contracts that are awarded on the basis of adequate competition on the list of contract types whereby contractors are not held liable for loss of Government property.
  • DFARS Case 2010-D001—Patents, Data, and Copyrights. Rewrite of DFARS part 227, Patents, Data, and Copyrights.
  • DFARS Case 2009-D026—Multiyear Contracting. Comprehensive review of DFARS subpart 217.1 to simplify and clarify the coverage of multiyear acquisition.

Specific DoD Priorities

For this regulatory plan, there are six specific DoD priorities, all of which reflect the established regulatory principles. In those areas where rulemaking or participation in the regulatory process is required, DoD has studied and developed policy and regulations that incorporate the provisions of the President's priorities and objectives under the Executive order.

DoD has focused its regulatory resources on the most serious environmental, health, and safety risks. Perhaps most significant is that each of the priorities described below promulgates regulations to offset the resource impacts of Federal decisions on the public or to improve the quality of public life, such as those regulations concerning acquisition, security, energy projects, education, and health affairs.

1. Defense Procurement and Acquisition Policy

The Department of Defense continuously reviews the DFARS and continues to lead Government efforts to—

  • Revise the DFARS to specify circumstances under which the U.S. Government needs to obtain data other than certified cost or pricing data from Canadian contractors via the Canadian Commercial Corporation.
  • Revise the DFARS to provide detailed guidance and instruction to DoD contracting officers for the use of DoD's performance-based payments analysis tool when contemplating the use of performance-based payments on new fixed-price type contracts.
  • Revise the DFARS to implement a DoD Better Buying Power initiative by providing a proposal-adequacy checklist in a provision to ensure offerors take responsibility for providing thorough, accurate, and complete proposals.
  • Revise the DFARS to address standards and structures for the safeguarding of unclassified DoD information.
  • Revise the DFARS to implement the DoD Better Buying Power initiative to address acquisitions using competitive procedures in which only one offer is received. With some exceptions, the contracting officer must resolicit for an additional period of at least 30 days, if the solicitation allowed fewer than 30 days for receipt of proposals and only one offer is received. If a period of at least 30 days was allowed for receipt of proposals, the contracting officer must determine prices to be fair and reasonable through price or cost analysis or enter negotiations with the offeror.
  • Revise the DFARS to implement a DoD Better Buying Power initiative by requiring contractors to submit annual technical descriptions for their independent research and development projects.
  • Revise the DFARS to establish means for cleared contractors, who have unclassified U.S. Government information resident on or transiting through contractor information systems, to share cyber threat information.
  • Revise the FAR to implement section 841 of the National Defense Authorization Act for FY 2009, which required a review of the FAR coverage on organizational conflicts of interest (OCIs).
  • Finalize the DFARS rule to clarify DoD policy regarding the definition and administration of contractor business systems to improve the effectiveness of DCMA/DCAA oversight of contractor business systems;
  • Finalize the DFARS rule to implement a DoD Better Buying Power initiative to increase the use of fixed-price incentive (firm target) contracts;

2. Logistics and Materiel Readiness, Department of Defense

The Department of Defense published or plans to publish rules on contractors supporting the military in contingency operations:

  • Final Rule: Private Security Contractors (PSCs) Operating in Contingency Operations, Combat Operations or Other Significant Military Operations. In order to meet the mandate of section 862 of the 2008 National Defense Authorization Act (NDAA) (as amended by section 813 (b) of the 2010 NDAA and section 832 of the 2011 NDAA), this rule establishes policy, assigns responsibilities, and provides procedures for the regulation of the selection, accountability, training, equipping, and conduct of personnel performing private security functions under a covered contract during contingency operations, combat operations, or other significant military operations. It also assigns responsibilities and establishes procedures for incident reporting, use of and accountability for equipment, rules for the use of force, and a process for administrative action or the removal, as appropriate, of PSCs and PSC personnel. DoD published an interim final rule on July 17, 2009 (74 FR 34690 to 34694), with an effective date of July 17, 2009. The comment period ended August 31, 2009. DoD, in coordination with the Department of State and the United States Agency for International Development, prepared a final rule, which included the responses to the public comments, and incorporated changes to the interim final rule, where appropriate. The final rule also incorporated the legislative changes required by section 813 (b) of the 2010 NDAA and section 832 of the 2011 NDAA. The final rule was published August 11, 2011 (76 FR 49650), with an effective date of September 12, 2011.
  • Interim Final Rule: Operational Contract Support. This rule will incorporate the latest changes and lessons learned into policy and procedures for operational contract support (OCS), including OCS program management, contract support integration, and the integration of DoD contractor personnel into contingency operations outside the United States. DoD anticipates publishing the interim final rule in the first or second quarter of FY 2012.

3. Installations and Environment, Department of Defense

The Department of Defense will publish a rule regarding the process for evaluating the impact of certain types of structures on military operations and readiness:

  • Interim Final Rule: This rule implements policy, assigns responsibilities, and prescribes procedures for the establishment and operation of a process for evaluation of proposed projects submitted to the Secretary of Transportation under section 44718 of title 49, United States Code. The evaluation process is established for the purpose of identifying any adverse impact of proposed projects on military operations and readiness, minimizing or mitigating such adverse impacts, and determining if any such projects pose an unacceptable risk to the national security of the United States. The rule also includes procedures for the operation of a central DoD siting clearinghouse to facilitate both informal and formal reviews of proposed projects. This rule was required by section 358 of Public Law 111-383. DoD anticipates publishing an interim final rule in fourth quarter of FY 2011.

4. Military Community and Family Policy, Department of Defense

The Department of Defense plans to publish a final rule to implement policy, assign responsibilities, and prescribe procedures for the operation of voluntary education programs within DoD:

  • Final Rule: Voluntary Education Programs. In this rule, the Department of Defense (DoD) implements policy, assigns responsibilities, and prescribes procedures for the operation of voluntary education programs within DoD. Several of the subject areas in this rule include: Procedures for Service members participating in education programs; guidelines for establishing, maintaining, and operating voluntary education programs including, but not limited to, instructor-led courses offered on-installation and off-installation, as well as via distance learning; procedures for obtaining on-base voluntary education programs and services; minimum criteria for selecting institutions to deliver higher education programs and services on military installations; the establishment of a DoD Voluntary Education Partnership Memorandum of Understanding (MOU) between DoD and educational institutions receiving tuition assistance payments; and procedures for other education programs for Service members and their adult family members. The new requirement for a signed MOU with DoD from participating educational institutions will be effective January 1, 2012. The Department published a proposed rule on August 6, 2010 (75 FR 47504 to 47514). The comment period ended October 10, 2010, which contained a total of 110 comments. Several comments from the general public were accepted, including suggestions to clarify terms such as “one single tuition rate” and a “needs assessment.” DoD anticipates publishing the final rule during the first quarter of FY 2012.

5. Health Affairs, Department of Defense

The Department of Defense is able to meet its dual mission of wartime readiness and peacetime health care by operating an extensive network of medical treatment facilities. This network includes DoD's own military treatment facilities supplemented by civilian health care providers, facilities, and services under contract to DoD through the TRICARE program. TRICARE is a major health care program designed to improve the management and integration of DoD's health care delivery system. The program's goal is to increase access to health care services, improve health care quality, and control health care costs.

The TRICARE Management Activity has published or plans to publish the following rules:

  • Final rule on TRICARE: Reimbursement of Sole Community Hospitals and Adjustment to Reimbursement of Critical Access Hospitals. The rule implements the statutory provision in 10 United States Code 1079(j)(2) that TRICARE payment methods for institutional care shall be determined to the extent practicable in accordance with the same reimbursement rules as those that apply to payments to providers of services of the same type under Medicare. This rule implements a reimbursement methodology similar to that furnished to Medicare beneficiaries for services provided by sole community hospitals. It is projected that implementation of this rule will result in a health care savings of $31 million per year with proposed phase-in period and an estimated initial start-up cost of $200,000. Any on-going administrative costs would be minimal and there are no applicable risks to the public. The proposed rule was published July 5, 2011 (76 FR 39043). The comment period ended on September 6, 2011. DoD anticipates publishing a final rule in the second quarter of FY 2012.
  • Final rule on TRICARE: TRICARE Young Adult. The purpose of this interim final rule is to establish the TRICARE Young Adult program implementing section 702 of the Ike Skelton NDAA for FY 2011 (Pub. L. 111-383) to provide medical coverage to unmarried children under the age of 26 who no longer meet the age requirements for TRICARE eligibility (age 21, or 23 if enrolled in a full-time course of study at an institution of higher learning approved by the Secretary of Defense) and who are not eligible for medical coverage from an eligible employer-sponsored plan (as defined in section 5000A(f)(2) of the Internal Revenue Code of 1986). If qualified, they can purchase TRICARE Standard/Extra or TRICARE Prime benefits coverage. The particular TRICARE plan available depends on the military sponsor's eligibility and the availability of the TRICARE plan in the dependent's geographic location. It is projected that implementation of this rule will result in an estimated initial start-up cost of $3,000,000. Premiums are designed to cover the anticipated health care costs, as well as ongoing administrative costs. The interim final rule was published April 27, 2011 (76 FR 23479), with an immediate effective date. The comment period ended June 27, 2011. DoD anticipates publishing a final rule in the first quarter of FY 2012.

6. Personnel and Readiness, Department of Defense

The Department of Defense will publish a rule regarding Service Academies:

  • Final Rule: Service Academies. This rule establishes policy, assigns responsibilities, and prescribes procedures for Department of Defense oversight of the Service Academies. Administrative costs are negligible and benefits are clear, concise rules that enable the Secretary of Defense to insure that the Service Academies are efficiently operated and meet the needs of the armed forces. The proposed rule was published October 18, 2007 (72 FR 59053), and included policy that has since changed. The final rule, particularly the explanation of separation policy, will reflect recent changes in the Don't Ask, Don't Tell policy. DoD anticipates publishing the final rule in the second quarter of FY 2012.

BILLING CODE 5001-06-P

DEPARTMENT OF EDUCATION (DOE) Back to Top

Statement of Regulatory Priorities

I. Introduction

The U.S. Department of Education (Department) supports States, local communities, institutions of higher education, and others in improving education nationwide and in helping to ensure that all Americans receive a quality education. We provide leadership and financial assistance pertaining to education at all levels to a wide range of stakeholders and individuals, including State educational agencies, local school districts, providers of early learning programs, elementary and secondary schools, institutions of higher education, career and technical schools, nonprofit organizations, postsecondary students, members of the public, families, and many others. These efforts are helping to ensure that all children and students from pre-kindergarten through grade 12 will be ready for, and succeed in, postsecondary education and that students attending postsecondary institutions are prepared for a profession or career.

We also vigorously monitor and enforce the implementation of Federal civil rights laws in educational programs and activities that receive Federal financial assistance, and support innovative programs, research and evaluation activities, technical assistance, and the dissemination of research and evaluation findings to improve the quality of education.

Overall, the laws, regulations, and programs we administer will affect nearly every American during his or her life. Indeed, in the 2011 to 2012 school year, about 55 million students will attend an estimated 99,000 elementary and secondary schools in approximately 13,800 public school districts, and about 21 million students will enroll in degree-granting postsecondary schools. All of these students may benefit from some degree of financial assistance or support from the Department.

In developing and implementing regulations, guidance, technical assistance, and monitoring related to our programs, we are committed to working closely with affected persons and groups. Specifically, we work with a broad range of interested parties and the general public including families, students, and educators; State, local, and tribal governments; and neighborhood groups, community-based early learning programs, elementary and secondary schools, colleges, rehabilitation service providers, adult education providers, professional associations, advocacy organizations, businesses, and labor organizations.

We also continue to seek greater and more useful public participation in our rulemaking activities through the use of transparent and interactive rulemaking procedures and new technologies. If we determine that it is necessary to develop regulations, we seek public participation at the key stages in the rulemaking process. We invite the public to submit comments on all proposed regulations through the Internet or by regular mail.

To facilitate the public's involvement, we participate in the Federal Docketing Management System (FDMS), an electronic single Governmentwide access point (www.regulations.gov) that enables the public to submit comments on different types of Federal regulatory documents and read and respond to comments submitted by other members of the public during the public comment period. This system provides the public with the opportunity to submit comments electronically on any notice of proposed rulemaking or interim final regulations open for comment, as well as read and print any supporting regulatory documents.

We are continuing to streamline information collections, reduce the burden on information providers involved in our programs, and make information easily accessible to the public.

II. Regulatory Priorities

A. American Recovery and Reinvestment Act of 2009

On February 17, 2009, President Obama signed into law the American Recovery and Reinvestment Act of 2009 (ARRA), historic legislation designed, in part, to invest in critical sectors, including education. ARRA laid the foundation for education reform by supporting investments in innovative strategies that are most likely to lead to improved results for students, long-term gains in school and school system capacity, and increased productivity and effectiveness. ARRA provided funding for several key discretionary grant programs, including the Race to the Top Fund and the Investing in Innovation Fund (i3) programs.

The Race to the Top Fund program, the largest competitive education grant program in U.S. history, is designed to provide incentives to States to implement system-changing reforms that result in improved student achievement, narrowed achievement gaps, and increased high school graduation and college enrollment rates. Congress authorized and provided $4.35 billion for ARRA in 2010, and the Department awarded approximately $4 billion in Race to the Top State grant funds in two phases. The Department awarded $600 million to Delaware and Tennessee under the Race to the Top Phase 1 competition and approximately $3.4 billion to the winners of the Phase 2 competition: The District of Columbia, Florida, Georgia, Hawaii, Maryland, Massachusetts, New York, North Carolina, Ohio, and Rhode Island.

In announcing the winners of the Race to the Top Phase 2 competition, the Secretary noted that “[we] had many more competitive applications than money to fund them in this round” and expressed the hope that any Race to the Top funding included in the Department's FY 2011 appropriations would be available for Race to the Top Phase 3 awards. In particular, there were nine finalists in the Phase 2 competition that did not receive funding despite submitting bold and ambitious plans for comprehensive reforms and innovations in their systems of elementary and secondary education. These nine finalists were: Arizona, California, Colorado, Illinois, Kentucky, Louisiana, New Jersey, Pennsylvania, and South Carolina.

On April 15, 2011, President Obama signed into law Public Law 112-10, the Department of Defense and Full-Year Continuing Appropriations Act, 2011 (FY 2011 Appropriations Act), which made $698.6 million available for the Race to the Top Fund, authorized the Secretary to make awards on “the basis of previously submitted applications,” and amended ARRA to permit the Secretary to make grants for improving early childhood care and learning under the program.

Race to the Top—Early Learning Challenge (RTT-ELC). On May 25, 2011, Secretary Duncan and the Secretary of Health and Human Services, Kathleen Sebelius, announced the RTT-ELC, a new $500 million State-level grant competition to be held in 2011 and authorized under ARRA and the FY 2011 Appropriations Act. The Departments of Education and Health and Human Services are administering this competition jointly. At its core is a strong commitment by the Administration to stimulate a national effort to make sure all children enter kindergarten ready to succeed. Through the RTT-ELC, the Administration seeks to help close the achievement gap between children with high needs and their peers by supporting State efforts to build strong systems of early learning and development that provide increased access to high-quality programs for the children who need it most. This competition represents an unprecedented opportunity for States to focus deeply on their early learning and development systems for children from birth through age five. It is an opportunity to build a more unified approach to supporting young children and their families—an approach that increases access to high-quality early learning and development programs and services, and helps ensure that children enter kindergarten with the skills, knowledge, and dispositions toward learning that they need to be successful.

The Departments of Education and Health and Human Services have published requirements for the FY 2011 competition and will complete the competition and make awards by the end of 2011.

Race to the Top Phase 3. On May 25, 2011, the Department also announced that approximately $200 million of the FY 2011 Race to the Top funds would be made available to some or all of the nine unfunded finalists from the 2010 Race to the Top Phase 2 competition. The Department recognizes that $200 million is not sufficient to support full implementation of the plans submitted during the Phase 2 competition, and therefore believes that making these funds available to the remaining nine finalists is the best way to create incentives for these States to carry out the bold reforms proposed in their applications. We have issued final eligibility requirements for the nine unfunded finalists to apply for Race to the Top Phase 3 funds.

B. Elementary and Secondary Education Act of 1965, as Amended

In 2010, the Administration released the Blueprint for Reform: The Reauthorization of the Elementary and Secondary Education Act, the President's plan for revising the Elementary and Secondary Education Act of 1965 (ESEA) and replacing the No Child Left Behind Act of 2001 (NCLB). The blueprint can be found at the following Web site: http://www2.ed. gov/policy/elsec/leg/blueprint/index.html.

We look forward to congressional reauthorization of the ESEA that will build on many of the reforms States and LEAs will be implementing under the ARRA grant programs. In the interim, we may propose amendments to our current regulations implementing the ESEA.

Additionally, as we continue to work with Congress on reauthorization of the ESEA, we are currently implementing a plan to provide flexibility on certain provisions of current law for States and school districts that are willing to embrace reform. The mechanisms we are implementing will ensure continued accountability and commitment to quality education for all students while at the same time providing States and school districts with increased flexibility to implement State and local reforms to improve student achievement.

C. Higher Education Act of 1965, as Amended

Changes to the FFEL and Direct Loan Programs. On March 30, 2010, the President signed into law the Health Care and Education Reconciliation Act of 2010, Public Law 111-152, title II of which is the SAFRA Act. SAFRA made a number of changes to the Federal student financial aid programs under title IV of the Higher Education Act of 1965, as amended (HEA). One of the most significant changes made by SAFRA is that it ended new loans under the Federal Family Education Loan (FFEL) Program authorized by title IV, part B, of the HEA as of July 1, 2010.

On May 5, 2011, ED announced through a notice in the Federal Register that it was beginning a negotiated rulemaking process to streamline the loan program regulations by repealing unnecessary FFEL Program regulations and incorporating and modifying necessary requirements within the Direct Loan Program regulations, as appropriate. ED held four public hearings in May 2011 to obtain public feedback on proposed amendments, as well as on possible amendments to other ED regulations, including those governing income-based and income-contingent loan repayment plans and loan discharges based on the total and permanent disability of the borrower. Based on the feedback received from these hearings, ED will soon form a negotiated rulemaking committee to consider proposed amendments and intends to conduct these negotiations in 2012.

Approval of New Gainful Employment Programs. Over the last 2 years, the Department has conducted two significant rulemakings to enhance its program integrity regulations related to the title IV, student aid programs. As part of this effort, on October 29, 2010, the Department issued regulations that included requirements for an institution to notify the Department before offering a new educational program that provides training leading to gainful employment in a recognized occupation (Gainful Employment—New Programs). The Department established the notification requirement out of concern that some institutions might attempt to circumvent proposed regulations regarding gainful employment standards by adding new programs before those standards could take effect. The Department explained that the notification process requirements were intended to remain in effect until the final regulations that established eligibility measures for gainful employment programs would take effect.

We published the final regulations establishing the gainful employment eligibility measures on June 13, 2011 (Gainful Employment—Debt Measures). In those regulations, the Department established measures for gainful employment programs that are intended to identify the worst performing programs. We believe that when these new regulations go into effect on July 1, 2013, the notification process for all new gainful employment programs established in the Gainful Employment—New Programs final regulations will no longer be needed. Accordingly, the Department has issued a new NPRM, which among other changes, proposes to reduce burden for institutions by amending the Gainful Employment—New Programs final regulations to establish a smaller group of gainful employment programs for which an institution must obtain approval from the Department.

Title II of the HEA. The Secretary intends to develop regulations under title II of the HEA to streamline the program, institutional, and State report cards; prescribe data quality standards to ensure reliability, validity, and accuracy of the data submitted; and establish standards for identifying low-performing teacher preparation programs.

D. Individuals With Disabilities Education Act

We have issued final regulations that revise the regulations implementing the Early Intervention Program for Infants and Toddlers with Disabilities authorized under part C of the Individuals with Disabilities Education Act (IDEA) to make changes needed for the appropriate implementation of the early intervention program. The final part C regulations incorporate provisions from the 2004 amendments to part C of the IDEA. Additionally, the final regulations provide States with flexibility in some areas, while ensuring State accountability to improve results, and needed services for infants and toddlers with disabilities and their families.

The Department has also issued a notice of proposed rulemaking to revise the regulations implementing the Assistance to States for the Education of Children with Disabilities program authorized under part B of the IDEA and intends to issue final regulations in the coming year.

Specifically, over the last 6 months, we engaged in a review of one particular provision of the part B regulations, relating to the use of public benefits or insurance to pay for services provided to children under part B. IDEA and the part B regulations allow public agencies to use public benefits or insurance (e.g., Medicaid) to provide or pay for services required under part B with the consent of the parent of a child who is enrolled in a public benefits or insurance program. Public insurance is an important source of financial support for services required under part B. With respect to the use of public insurance, our current regulations specifically provide that a public agency must obtain parental consent each time access to public benefits or insurance is sought.

We are now proposing to amend the regulations to provide that, instead of having to obtain parental consent each time access to public benefits or insurance is sought, the public agency responsible for providing special education and related services to a child would be required, before accessing a child's or parent's public benefits or insurance, to provide written notification to the child's parents. The notification would inform parents of their rights under the part B regulations regarding the use of public benefits or insurance to pay for part B services, including information about the limitations on a public agency's billing of public benefits or insurance programs, as well as parents' rights under the Family Educational Rights and Privacy Act and IDEA to consent prior to the disclosure of personally identifiable information.

We are proposing these amendments to reduce unnecessary burden on a public agency's ability to access public benefits or insurance in appropriate circumstances but still maintain critical parent protections, and we do this for several reasons. Specifically, we are mindful of the importance of ensuring that parents have sufficient information to make decisions about a public agency's use of their public benefits or insurance and the disclosure of their child's educational records for that purpose. At the same time, these proposed amendments are designed to address the concern expressed to the Department by many State personnel and other interested parties that, since the publication of the part B regulations in 2006, the inability to obtain parental consent has contributed to public agencies' failure to claim all of the Federal financial assistance available for part B services covered under Medicaid. In addition, public agencies have expressed concern over using limited resources and the significant administrative burden of obtaining parental consent for the use of Medicaid and other public benefits or insurance each time that access to public benefits or insurance is sought. Consequently, many of these parties have requested that the Department remove the parental consent requirement.

E. Family Educational Rights and Privacy Act

Given the President's emphasis on improving the collection and use of data as a key element of educational reform, we intend to issue final regulations in the coming year to amend our current regulations for the Family Educational Rights and Privacy Act of 1974 (FERPA) to ensure that States are able to effectively establish and expand robust statewide longitudinal data systems while protecting student privacy.

F. Other Potential Regulatory Activities

Congress may reauthorize the Adult Education and Family Literacy Act (AEFLA) (title II of the Workforce Investment Act of 1998) and the Rehabilitation Act of 1973 (title IV of the Workforce Investment Act of 1998). The Administration is working with Congress to ensure that any changes to these laws (1) improve the State grant and other programs providing assistance for adult education under the AEFLA and for vocational rehabilitation and independent living services for persons with disabilities under the Rehabilitation Act of 1973; and (2) provide greater accountability in the administration of programs under both statutes. Changes to our regulations may be necessary as a result of the reauthorization of these two statutes.

III. Retrospective Review of Existing Regulations

Pursuant to section 6 of Executive Order 13563 “Improving Regulation and Regulatory Review” (Jan. 18, 2011), the following Regulatory Identifier Numbers (RINs) have been identified as associated with retrospective review and analysis in the Department's final retrospective review of regulations plan. Some of the entries on this list may be completed actions, which do not appear in The Regulatory Plan. However, more information can be found about these completed rulemakings in past publications of the Unified Agenda on Reginfo.gov in the Completed Actions section for that agency. These rulemakings can also be found on Regulations.gov. The final agency plans can be found at: http://www2.ed.gov/about/open.html.

RIN Title of Rulemaking Do we expect this rulemaking to significantly reduce burden on small businesses?
1820-AB64 Assistance to States for the Education of Children With Disabilities No.
1840-AD01 High School Equivalency Program and College Assistance Migrant Program, the Federal TRIO Programs, and Gaining Early Awareness, and Readiness for Undergraduate Program No.
1848-AD02 Program Integrity Issues No.
1840-AD05 Title IV of the Higher Education Act of 1965, as Amended No.
1840-AD06 Program Integrity: Gainful Employment—Measures No.
1840-AD08 Titles III and V of the Higher Education Act of 1965, as Amended No.
1840-AD10 Application and Approval Process for New Programs Yes.
1880-AA86 Family Educational Rights and Privacy No.
1880-AA84 The Freedom of Information Act No.
1890-AA14 Direct Grant Programs and Definitions That Apply to Department Regulations No.
1890-AA16 Department of Education Acquisition Regulations No.

IV. Principles for Regulating

Over the next year, other regulations may be needed because of new legislation or programmatic changes. In developing and promulgating regulations we follow our Principles for Regulating, which determine when and how we will regulate. Through consistent application of the following principles, we have eliminated unnecessary regulations and identified situations in which major programs could be implemented without regulations or with limited regulatory action.

In deciding when to regulate, we consider the following:

  • Whether regulations are essential to promote quality and equality of opportunity in education.
  • Whether a demonstrated problem cannot be resolved without regulation.
  • Whether regulations are necessary to provide a legally binding interpretation to resolve ambiguity.
  • Whether entities or situations subject to regulation are similar enough that a uniform approach through regulation would be meaningful and do more good than harm.
  • Whether regulations are needed to protect the Federal interest; that is, to ensure that Federal funds are used for their intended purpose and to eliminate fraud, waste, and abuse.

In deciding how to regulate, we are mindful of the following principles:

  • Regulate no more than necessary.
  • Minimize burden, to the extent possible, and promote multiple approaches to meeting statutory requirements if possible.
  • Encourage coordination of federally funded activities with State and local reform activities.
  • Ensure that the benefits justify the costs of regulating.
  • To the extent possible, establish performance objectives rather than specify compliance behavior.
  • Encourage flexibility, to the extent possible, and as needed to enable institutional forces to achieve desired results.

ED—OFFICE OF POSTSECONDARY EDUCATION (OPE) Back to Top

Proposed Rule Stage

26. Title IV of the Higher Education Act of 1965, as Amended Back to Top

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

Legal Authority: 20 U.S.C. 1070a; 20 U.S.C. 1071 to 1087-4; 20 U.S.C. 1087a to 1087j; 20 U.S.C. 1098e; Pub. L. 111-152

CFR Citation: 34 CFR chapter VI.

Legal Deadline: None.

Abstract: The Secretary proposes to amend the title IV, HEA student assistance regulations to (1) reflect that, as of July 1, 2010, under title II of the Health Care and Education Reconciliation Act of 2010 (the SAFRA Act), no new Federal Family Education Loan Program loans will be made and (2) to reflect other changes to improve the effectiveness and efficiency of the student loan programs, particularly with regard to the discharge of loans for persons with total and permanent disabilities.

Statement of Need: These regulations are needed to reflect the provisions of the SAFRA Act (title II of the Health Care and Education Reconciliation Act of 2010) and to reflect other amendments to the HEA resulting from the SAFRA Act.

Summary of Legal Basis: Health Care and Education Reconciliation Act of 2010, Public Law 111-152.

Alternatives: The Department is still developing these proposed regulations; our discussion of alternatives will be included in the notice of proposed rulemaking.

Anticipated Cost and Benefits: Estimates of the costs and benefits are currently under development and will be included in the notice of proposed rulemaking.

Risks: None.

Timetable:

Action Date FR Cite
NPRM 03/00/12

Regulatory Flexibility Analysis Required: Undetermined.

Government Levels Affected: None.

URL for Public Comments: www.regulations.gov.

Agency Contact: David Bergeron, Department of Education, Office of Postsecondary Education, Room 8022, 1990 K Street NW., Washington, DC 20006, Phone: 202 502-7815, Email: david.bergeron@ed.gov.

RIN: 1840-AD05

BILLING CODE 4000-01-P

DEPARTMENT OF ENERGY (DOE) Back to Top

Fall 2011 Statement of Regulatory and Deregulatory Priorities

The Department of Energy (Department or DOE) makes vital contributions to the Nation's welfare through its activities focused on improving national security, energy supply, energy efficiency, environmental remediation, and energy research. The Department's mission is to:

  • Promote dependable, affordable, and environmentally sound production and distribution of energy;
  • Advance energy efficiency and conservation;
  • Provide responsible stewardship of the Nation's nuclear weapons;
  • Provide a responsible resolution to the environmental legacy of nuclear weapons production;
  • Strengthen U.S. scientific discovery, economic competitiveness, and improving quality of life through innovations in science and technology.

The Department's regulatory activities are essential to achieving its critical mission and to implementing major initiatives of the President's National Energy Policy. Among other things, the Regulatory Plan and the Unified Agenda contain the rulemakings the Department will be engaged in during the coming year to fulfill the Department's commitment to meeting deadlines for issuance of energy conservation standards and related test procedures. The Regulatory Plan and Unified Agenda also reflect the Department's continuing commitment to cut costs, reduce regulatory burden, and increase responsiveness to the public.

Energy Efficiency Program for Consumer Products and Commercial Equipment

The Energy Policy and Conservation Act (EPCA) requires DOE to set appliance efficiency standards at levels that achieve the maximum improvement in energy efficiency that is technologically feasible and economically justified. The standards already published in 2011 have an estimated net benefit to the Nation of up to $16.6 billion over 30 years. By 2045, these standards are expected to save enough energy to operate all U.S. homes for more than 7 months.

The Department continues to follow its schedule for setting new appliance efficiency standards. These rulemakings are expected to save American consumers billions of dollars in energy costs. The schedule outlines how DOE will address the various appliance standards rulemakings necessary to meet statutory requirements established in EPCA, the Energy Policy Act of 2005 (EPACT 2005), and the Energy Independence and Security Act of 2007 (EISA 2007).

The overall plan for implementing the schedule is contained in the Report to Congress under section 141 of EPACT 2005 that was released on January 31, 2006. This plan was last updated in the August 2011 report to Congress and now includes the requirements of the Energy Independence and Security Act of 2007 (EISA 2007). The reports to Congress are posted at: http://www.eere.energy.gov/buildings/appliance_standards/schedule_setting.html. The August 2011 report identifies all products for which DOE has missed the deadlines established in EPCA (42 U.S.C. section 6291 et seq.). It also describes the reasons for such delays and the Department's plan for expeditiously prescribing new or amended standards. Information and timetables concerning these actions can also be found in the Department's regulatory agenda, which is posted online at: www.reginfo.gov.

Estimate of Combined Aggregate Costs and Benefits

The regulatory actions included in this regulatory plan are expected to provide significant benefits to the Nation for product categories including: Fluorescent lamp ballasts, manufactured housing, battery chargers and external power supplies, walk-in coolers and freezers, and incandescent reflector lamps. DOE believes that the benefits to the Nation of the proposed energy standards for fluorescent lamp ballasts (energy savings, consumer average lifecycle cost savings, national net present value increase, and emission reductions) outweigh the costs (loss of industry net present value and life-cycle cost increases for some consumers). DOE estimates that these regulations will produce an energy savings between 3.7 and 6.3 quads over 30 years. The benefit to the Nation will be between $8.1 billion (7% discount rate) and $24.7 billion (3% discount rate). DOE believes that the proposed energy standards for manufactured housing, battery chargers and external power supplies, walk-in coolers and freezers, and incandescent reflector lamps will also be beneficial to the Nation. However, because DOE has not yet proposed candidate standard levels for this equipment, DOE cannot provide an estimate of combined aggregate costs and benefits for these actions. DOE will, however, in compliance with all applicable law, issue standards that provide the maximum energy savings that are technologically feasible and economically justified. Estimates of energy savings will be provided when DOE issues the notices of proposed rulemaking for this equipment.

DOE—ENERGY EFFICIENCY AND RENEWABLE ENERGY (EE) Back to Top

Proposed Rule Stage

27. Energy Efficiency Standards for Battery Chargers and External Power Supplies Back to Top

Priority: Economically Significant. Major status under 5 U.S.C. 801 is undetermined.

Unfunded Mandates: Undetermined.

Legal Authority: 42 U.S.C. 6295(u)

CFR Citation: 10 CFR 430.

Legal Deadline: Final, Statutory, July 1, 2011.

Abstract: In addition to the existing general definition of “external power supply,” the Energy Independence and Security Act of 2007 (EISA) defines a “Class A external power supply” and sets efficiency standards for those products. EISA directs DOE to publish a final rule to determine whether the standards set for Class A external power supplies should be amended. EISA also requires DOE to issue a final rule prescribing energy conservation standards for battery chargers, if technologically feasible and economically justified.

Statement of Need: The Energy Policy and Conservation Act (EPCA) requires minimum energy standards for appliances, which has the effect of eliminating inefficient appliances and equipment from the market.

Summary of Legal Basis: Title III of EPCA sets forth a variety of provisions designed to improve energy efficiency. Part A of title III (42 U.S.C. 6291 to 6309) provides for the Energy Conservation Program for Consumer Products other than Automobiles. EPCA directs DOE to conduct a rulemaking to establish energy conservation standards for battery chargers or determine that no energy conservation standard is technically feasible and economically justified (42 U.S.C. 6295 (u)(1)(E)(i) and (ii)).

In addition to the existing general definition of “external power supply,” EPCA defines a “Class A external power supply” (42 U.S.C. 6291(36)(C)) and sets efficiency standards for those products (42 U.S.C. 6295(u)(3)). EPCA directs DOE to publish a final rule to determine whether amended standards should be set for Class A external power supplies, or new standards set for other classes of external power supplies. If such determination is positive, DOE must include any amended or new standards as part of that final rule.

DOE is bundling the two requirements to establish energy conservation standards for battery chargers and to consider amended or new standards for external power supplies into a single rulemaking.

Alternatives: The statute requires the Department to conduct rulemakings to review standards and to revise standards to achieve the maximum improvement in energy efficiency that the Secretary determines is technologically feasible and economically justified. In making this determination, the Department conducts a thorough analysis of the alternative standard levels, including the existing standard, based on the criteria specified by the statute.

Anticipated Cost and Benefits: Because DOE has not yet proposed candidate standard levels for this equipment, DOE cannot provide an estimate of combined aggregate costs and benefits for these actions. DOE will, however, in compliance with all applicable law, issue standards that provide the maximum energy savings that are technologically feasible and economically justified. Estimates of energy savings will be provided when DOE issues the notices of proposed rulemaking for this equipment.

Timetable:

Action Date FR Cite
Notice: Public Meeting, Framework Document Availability 06/04/09 74 FR 26816
Comment Period End 07/20/09
Notice: Public Meeting, Data Availability 09/15/10 75 FR 56021
Comment Period End 10/15/10
Final Rule (Technical Amendment) 09/19/11 76 FR 57897
NPRM 12/00/11
Final Action 07/00/12

Regulatory Flexibility Analysis Required: Yes.

Small Entities Affected: Businesses.

Government Levels Affected: Local, State.

Federalism: Undetermined.

URL for More Information: www1.eere.energy.gov/buildings/appliance_standards/residential/battery_external.html.

Agency Contact: Victor Petrolati, Office of Building Technologies Program, EE-2J, Department of Energy, Energy Efficiency and Renewable Energy, 1000 Independence Avenue SW., Washington, DC 20585, Phone: 202 586-4549, Email: victor.petrolati@ee.doe.gov.

Related RIN: Related to 1904-AB75.

RIN: 1904-AB57

DOE—EE Back to Top

28. Energy Conservation Standards for Walk-In Coolers and Walk-In Freezers Back to Top

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

Unfunded Mandates: Undetermined.

Legal Authority: 42 U.S.C. 6313(f)(4)

CFR Citation: 10 CFR 431.

Legal Deadline: Final, Statutory, January 1, 2012.

Abstract: The Energy Independence and Security Act of 2007 amendments to the Energy Policy and Conservation Act require that DOE establish maximum energy consumption levels for walk-in coolers and walk-in freezers.

Statement of Need: The Energy Policy and Conservation Act requires minimum energy efficiency standards for appliances, which has the effect of eliminating inefficient appliances and equipment from the market.

Summary of Legal Basis: Section 312 of the Energy Independence and Security Act of 2007 (EISA) establishes definitions and standards for walk-in coolers and walk-in freezers. EISA directs DOE to establish performance-based standards not later than January 1, 2012 (42 U.S.C. 6313 (f)(4)).

Alternatives: The statute requires the Department to conduct rulemakings to review standards and to revise standards to achieve the maximum improvement in energy efficiency that the Secretary determines is technologically feasible and economically justified. In making this determination, the Department conducts a thorough analysis of the alternative standard levels, including the existing standard, based on the criteria specified by the statute.

Anticipated Cost and Benefits: Because DOE has not yet proposed candidate standard levels for this equipment, DOE cannot provide an estimate of combined aggregate costs and benefits for these actions. DOE will, however, in compliance with all applicable law, issue standards that provide the maximum energy savings that are technologically feasible and economically justified. Estimates of energy savings will be provided when DOE issues the notice of proposed rulemaking for this equipment.

Timetable:

Action Date FR Cite
Notice: Public Meeting, Framework Document Availability 01/06/09 74 FR 411
Notice: Public Meeting, Data Availability 04/05/10 75 FR 17080
Comment Period End 05/20/10
NPRM 12/00/11
Final Action 02/00/12

Regulatory Flexibility Analysis Required: Yes.

Small Entities Affected: Businesses.

Government Levels Affected: Local, State.

Federalism: Undetermined.

Additional Information: Comments pertaining to this rule may be submitted electronically to WICF-2008-STD-0015@ee.doe.gov.

URL for More Information: www.eere.energy.gov/buildings/appliance_standards/commercial/wicf.html.

URL for Public Comments: www.regulations.gov.

Agency Contact: Charles Llenza, Office of Building Technologies Program, EE-2J, Department of Energy, Energy Efficiency and Renewable Energy, 1000 Independence Avenue SW., Washington, DC 20585, Phone: 202 586-2192, Email: charles.llenza@ee.doe.gov.

Related RIN: Related to 1904-AB85.

RIN: 1904-AB86

DOE—EE Back to Top

29. Energy Efficiency Standards for Manufactured Housing Back to Top

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

Unfunded Mandates: Undetermined.

Legal Authority: 42 U.S.C. 17071

CFR Citation: 10 CFR 460.

Legal Deadline: Final, Statutory, December 19, 2011.

Abstract: The rule would establish energy efficiency standards for manufactured housing and a system to ensure compliance with, and enforcement of, the standards.

Statement of Need: The Energy Independence and Security Act requires increased energy efficiency standards for manufactured housing.

Summary of Legal Basis: Section 413 of the Energy Independence and Security Act of 2007 (EISA), 42 U.S.C. 17071, directs DOE to develop and publish energy standards for manufactured housing.

Alternatives: The statute requires DOE to conduct a rulemaking to establish standards to achieve the maximum improvement in energy efficiency that the Secretary determines is technologically feasible and economically justified. In making this determination, DOE conducts a thorough analysis of the alternative standard levels, including the existing standard, based on the criteria specified by the statute.

Anticipated Cost and Benefits: Because DOE has not yet proposed candidate standard levels, DOE cannot provide an estimate of combined aggregate costs and benefits for these actions. DOE will, however, in compliance with all applicable law, issue standards that provide the increased energy savings that are technologically feasible and economically justified. Estimates of energy savings will be provided when DOE issues the notice of proposed rulemaking.

Timetable:

Action Date FR Cite
ANPRM 02/22/10 75 FR 7556
ANPRM Comment Period End 03/24/10
NPRM 02/00/12
Final Action 12/00/12

Regulatory Flexibility Analysis Required: Undetermined.

Government Levels Affected: None.

URL for More Information: www.energycodes.gov/status/mfg_housing.stm.

URL for Public Comments: www.regulations.gov.

Agency Contact: Ronald B. Majette, Program Manager, Office of Building Technologies Program, EE-2J, Department of Energy, Energy Efficiency and Renewable Energy, 1000 Independence Avenue SW., Washington, DC 20585, Phone: 202 586-7935, Email: ajett.majette@hq.doe.gov.

RIN: 1904-AC11

DOE—EE Back to Top

30. Energy Conservation Standards for ER, BR, and Small Diameter Incandescent Reflector Lamps Back to Top

Priority: Other Significant. Major under 5 U.S.C. 801.

Unfunded Mandates: Undetermined.

Legal Authority: 42 U.S.C. 6291(30)(C)(ii) and (F); 42 U.S.C. 6295(i)

CFR Citation: 10 CFR 430.

Legal Deadline: None.

Abstract: Amendments to Energy Policy and Conservation Act (EPCA) in the Energy Independence and Security Act of 2007 (EISA) amended the energy conservation standards to extend coverage to certain classes of IRL that had previously been outside the statutory definition of “incandescent reflector lamp” although these lamps were excluded from the statutory standard levels. However, EISA 2007 authorized DOE to amend these standards if such amendments were warranted. Specifically, as amended, EPCA exempted certain small diameter, ellipsoidal reflector (ER) and bulged reflector (BR) lamps from standards. In June 2009, DOE published a final rule amending existing standards for IRL. In earlier stages of the June 2009 rulemaking, DOE had interpreted its authority with regard to IRL as limited to amending congressionally established standard levels only, and not to the exemptions set by Congress for certain explicitly identified small diameter ER and BR lamps, commonly used in track lighting and recessed cans. On further review, DOE has concluded that DOE has authority to establish efficiency standards for these currently exempt small diameter ER and BR lamps. However, as a practical matter, DOE could not consider these lamps as part of the previous rulemaking because it had not conducted the requisite analyses to set appropriate standard levels. Pursuant to EPCA, DOE is now conducting a rulemaking as to energy conservation standards for certain incandescent reflector lamps (IRL) that have ER or BR bulb shapes, and for certain IRL with diameters less than 2.25 inches.

Statement of Need: The Energy Policy and Conservation Act requires minimum energy efficiency standards for appliances, which has the effect of eliminating inefficient appliances and equipment from the market.

Summary of Legal Basis: Section 322 of the Energy Independence and Security Act of 2007 (EISA) establishes definitions and standards for ER, BR, and BPAR incandescent reflector lamps. (42 U.S.C. 6291(54) to 6291(56), 42 U.S.C. 6295 (i)) Furthermore, section 305 of EISA directs DOE to, not later than 6 years after issuance of any final rule establishing or amending a standard, publish either a notice of determination that standards do not need to be amended or a notice of proposed rulemaking including new proposed standards. (42 U.S.C. 6295 (m))

Alternatives: The statute requires the Department to conduct rulemakings to review standards and to revise standards to achieve the maximum improvement in energy efficiency that the Secretary determines is technologically feasible and economically justified. In making this determination, the Department conducts a thorough analysis of the alternative standard levels, including the existing standard, based on the criteria specified by the statute.

Anticipated Cost and Benefits: Because DOE has not yet proposed candidate standard levels for this equipment, DOE cannot provide an estimate of combined aggregate costs and benefits for these actions. DOE will, however, in compliance with all applicable law, issue standards that provide the maximum energy savings that are technologically feasible and economically justified. Estimates of energy savings will be provided when DOE issues the notice of proposed rulemaking for this equipment.

Timetable:

Action Date FR Cite
Notice: Public Meeting, Framework Document Availability 05/03/10 75 FR 23191
Comment Period End 06/17/10
NPRM 12/00/11
Final Action 01/00/12

Regulatory Flexibility Analysis Required: Yes.

Small Entities Affected: Businesses.

Government Levels Affected: Undetermined.

Federalism: Undetermined.

URL for More Information: www1.eere.energy.gov/buildings/appliance_standards/residential/incandescent_lamps.html.

URL for Public Comments: www.regulations.gov.

Agency Contact: Lucy Debutts, Office of Building Technologies Program, EE-2J, Department of Energy, Energy Efficiency and Renewable Energy, 1000 Independence Avenue SW., Washington, DC 20585, Phone: 202 287-1604, Email: lucy.debutts@ee.doe.gov.

Related RIN: Related to 1904-AA92.

RIN: 1904-AC15

DOE—EE Back to Top

Final Rule Stage

31. Energy Efficiency Standards for Fluorescent Lamp Ballasts Back to Top

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

Unfunded Mandates: This action may affect the private sector under Public Law 104-4.

Legal Authority: 42 U.S.C. 6295(g)

CFR Citation: 10 CFR 430.

Legal Deadline: Final, Judicial, October 28, 2011.

Abstract: DOE is reviewing and updating energy efficiency standards, as required by the Energy Policy and Conservation Act, to reflect technological advances. All amended energy efficiency standards must be technologically feasible and economically justified. This is the second review of the statutory standards for fluorescent lamp ballasts.

Statement of Need: The Energy Policy and Conservation Act requires minimum energy efficiency standards for appliances, which has the effect of eliminating inefficient appliances and equipment from the market.

Summary of Legal Basis: The Energy Policy and Conservation Act (EPCA) of 1975 (42 U.S.C. 6291 to 6309) established an energy conservation program for major household appliances. Amendments to EPCA in the National Appliance Energy Conservation Amendments of 1988 (NAECA 1988) established energy conservation standards for fluorescent lamp ballasts. These amendments also required that DOE (1) conduct two rulemaking cycles to determine whether these standards should be amended, and (2) for each rulemaking cycle, determine whether the standards in effect for fluorescent lamp ballasts should be amended to apply to additional fluorescent lamp ballasts. (42 U.S.C. 6295(g)(7)(A) and (B)). On September 19, 2000, DOE published a final rule in the Federal Register, which completed the first rulemaking cycle to amend energy conservation standards for fluorescent lamp ballasts. 65 FR 56740. This rulemaking encompasses DOE's second cycle of review to determine whether the standards in effect for fluorescent lamp ballasts should be amended and whether the standards should be applicable to additional fluorescent lamp ballasts.

Alternatives: The statute requires DOE to conduct rulemakings to review standards and to revise standards to achieve the maximum improvement in energy efficiency that the Secretary determines is technologically feasible and economically justified. In making this determination, DOE conducts a thorough analysis of the alternative standard levels, including the existing standard, based on the criteria specified by the statute.

Anticipated Cost and Benefits: DOE believes that the benefits to the Nation from energy standards for fluorescent lamp ballasts (energy savings, consumer average lifecycle cost (LCC) savings, national net present value (NPV) increase, and emission reductions) outweigh the burdens (loss of NPV and LCC increases of some small electric motor users). DOE estimates that energy savings from electricity will be between 3.7 and 6.3 quads over 30 years and the benefits to the Nation will be between $8.1 and $24.7 billion.

Timetable:

Action Date FR Cite
Notice: Public Meeting, Framework Document Availability 01/22/08 73 FR 3653
Notice: Public Meetings, Data Availability 03/24/10 75 FR 14319
NPRM 04/11/11 76 FR 20090
NPRM Comment Period End 06/11/11
Notice of Data Availability (NODA); Request for Comments 08/24/11 76 FR 52892
NODA Comment Period End 09/14/11
Final Action 12/00/11

Regulatory Flexibility Analysis Required: Yes.

Small Entities Affected: Businesses.

Government Levels Affected: Local, State.

Federalism: This action may have federalism implications as defined in EO 13132.

URL for More Information: www1.eere.energy.gov/buildings/appliance_standards/residential/fluorescent_lamp_ballasts.html

URL for Public Comments: www.regulations.gov.

Agency Contact: Tina Kaarsberg, Office of Building Technologies Program, EE-2J, Department of Energy, Energy Efficiency and Renewable Energy, 1000 Independence Avenue SW., Washington, DC 20585, Phone: 202 287-1393, Email: tina.kaarsberg@ee.doe.gov.

Related RIN: Related to 1904-AB77, Related to 1904-AA99.

RIN: 1904-AB50

BILLING CODE 6450-01-P

DEPARTMENT OF HEALTH AND HUMAN SERVICES Back to Top

Statement of Regulatory Priorities for FY 2012

The Department of Health and Human Services is the Federal Government's principal agency charged with protecting the health of all Americans and providing essential human services, especially for those least able to help themselves. The Department operates more than 300 programs covering a wide spectrum of activities, manages almost a quarter of all Federal outlays, and administers more grant dollars than all other Federal agencies combined. The Department's major program responsibilities include: Medicare and Medicaid; control and prevention of communicable and chronic disease; support for public health preparedness and emergency response; biomedical research; substance abuse and mental health treatment and prevention; assuring safe and effective drugs, devices, and other medical products; protecting the food supply; assistance to low-income families; the Head Start program; and improving access to health care services to the uninsured, isolated, or medically vulnerable. Currently, the Department is the principal agency charged with implementing one of the President's signature achievements—transformative health care reform through the Affordable Care Act of 2010.

To implement this vast program portfolio, the Department develops an active regulatory agenda each year, driven largely by statutory mandates and interactions with stakeholders. The President also called upon Federal agencies to reform the regulatory process in his January 18, 2011, Executive Order 13563 “Improving Regulation and Regulatory Review.” A key directive in that Executive order was to require agencies to conduct an inventory of existing regulations to determine whether such regulations should be modified, streamlined, expanded, or repealed to make an agency's regulatory scheme more effective or less burdensome in achieving its programmatic objectives.

With these regulatory drivers in mind, Secretary Kathleen Sebelius has worked with HHS agencies to craft a regulatory agenda that reflects her commitments to implementing meaningful health care reform, access to health care coverage, and high value health care services that are safe and effective for all Americans. The agenda also reflects her other strategic initiatives, which include securing and maintaining health care coverage for all Americans; improving quality and patient safety; more rapidly responding to adverse events; implementing a 21st century food safety system; helping Americans achieve and maintain healthy living habits; advancing scientific research; and streamlining regulations to reduce the regulatory burden on industry and States. Within this agenda, the Secretary has also been mindful of the need to reform the ongoing regulatory process through retrospective review of existing regulations, and this agenda reflects her commitment to that review by incorporating some of the most significant burden reduction reforms across all Federal agencies. In fact, of the $10 billion in savings from retrospective regulatory review across all Federal agencies announced by the Administrator of the Office of Information and Regulatory Affairs, $5 billion was attributable to regulations contained within this Department's current regulatory agenda.

What follows is an overview of the Department's regulatory priorities for FY 2012 and some of the regulations on the agenda that best exemplify these priorities.

Making Health Insurance Coverage More Secure for Those Who Have Insurance and Extending Coverage to the Uninsured

As a result of the Affordable Care Act, the Department is making affordable health care coverage more stable and secure through insurance market reforms designed to protect consumers against unreasonable insurance premium increases, provide them with more comprehensive and understandable information with which to make decisions, and enable eligible consumers to receive financial support for health insurance easily and seamlessly. In 2014, all people who suffer from chronic conditions will no longer be excluded from insurance coverage or charged higher premiums because of a pre-existing condition or medical history.

Already, insurers are prohibited from putting lifetime dollar limits and restrictive annual caps on what they will pay for health care services needed by the people they insure, ensuring that those people have access to medical care throughout their lives, especially when it is most needed. HHS is working with States to help identify and put a stop to unreasonable health insurance premium rate increases and will require new health plans to implement a comprehensive appeals process for those beneficiaries who have been denied coverage or payment by the insurance plan. New health insurers will also be required to spend the majority of health insurance premiums on medical care and health care quality improvement, not on administration and overhead. As well, the Affordable Care Act is providing reimbursement to employers that offer health benefits to early retirees, providing insurance coverage through the Pre-existing Condition Insurance Plan to people who would otherwise be locked out of the insurance market because of their pre-existing health conditions, and requiring plans that offer dependent coverage to make that coverage available to young adults up to age 26.

Moving forward this year, the Department will continue to implement the Affordable Care Act to promote consumer protections, improve quality and safety, provide incentives for more efficient care delivery, and slow the growth of health care costs. The Centers for Medicare & Medicaid Services (CMS) will finalize three rules that will expand access to health insurance and provide consumers with better options and information about insurance:

  • CMS will issue standards for the establishment of the Affordable Insurance Exchanges (Exchanges) to provide competitive marketplaces for individuals and small employers to directly compare available private health insurance options on the basis of price and quality. These Exchanges will help enhance competition in the health insurance market, improve choice of affordable health insurance, and give small businesses the same purchasing clout as large businesses.
  • Another rule helps to make coverage more secure by offsetting market uncertainty and risk selection to maintain the viability of Exchanges. Under risk adjustment, HHS, in consultation with the States, will establish criteria and methods to be used by States in determining the actuarial risk of plans within a State to minimize the negative effects of adverse selection. Under reinsurance, all health insurance issuers, and third-party administrators on behalf of self-insured group health plans, will contribute to a nonprofit reinsurance entity to support reinsurance payments to individual market issuers that cover high risk individuals.
  • To extend health insurance to greater numbers of low-income people, Medicaid eligibility in 2014 will expand to cover adults under the age of 65 earning up to 133 percent of the Federal poverty level, and those who earn above that level may be eligible for tax credits through the Exchanges to help pay their premiums. New, simplified procedures for determining Medicaid, CHIP, and tax credit eligibility will be forthcoming in 2012. CMS will simplify eligibility rules to make it easier for eligible individuals and families to obtain premium tax credits and Medicaid coverage, including ensuring that Medicaid uses the same eligibility standards as other insurance affordability programs available through the Exchange, as directed by law. The rule further outlines how Medicaid and CHIP will coordinate closely with the Exchange, including sharing data to ensure that individuals are determined eligible for the appropriate insurance affordability program regardless of where an applicant submits the application.

Improving Health Care Quality and Patient Safety

Across America and for all Americans, the Department is working to improve patient outcomes, ensure patient safety, promote efficiency and accountability, encourage shared responsibility, and reduce health care costs. Through improved administrative processes, reforms, innovations, and additional information to support consumer decisionmaking, HHS is supporting high-value, safe, and effective care across health care settings and in the community.

In 2011, the Department published a key regulation to advance this priority—the final rule for Accountable Care Organizations. This rule establishes a system of shared savings for qualified organizations that deliver primary care services to a given patient population. The objective is to promote accountability and shared responsibility for the delivery of care, especially to those with co-morbidities of chronic health problems in order to prevent unnecessary and costly in-patient hospital care, reduce health care acquired conditions, and improve the quality of life for those individuals. This rule serves as a companion to additional demonstration programs designed to explore alternative services delivery and payment systems that are being sponsored by the new Center for Medicare and Medicaid Innovation. Several more key regulations are on the agenda to move forward in meeting these quality and patient safety goals:

  • CMS is implementing value-based purchasing programs throughout its payment structure in order to reward hospitals and other health care providers for delivering high-quality care, rather than just a high volume of services. The payment rules scheduled for publication this year will reflect a mix of standards, processes, outcomes, and patient experience of care measures, including measures of care transition and changes in patient functional status.
  • The Department continues to encourage health care providers to become meaningful users of health information technology (IT) by accelerating health IT adoption and promoting electronic health records to help improve the quality of health care, reduce costs, and ultimately, improve health outcomes. Electronic health records and health information exchange can help clinicians provide higher quality and safer care for their patients. By adopting electronic health records in a meaningful way, clinicians will know more about their patients to better coordinate and improve the quality of patient care, and they can make better decisions about treatments and conditions.

Improving Response to Adverse Events

In a related activity, the FDA will be proposing a new rule to establish a unique identification system for medical devices in order to track a device from pre-market application through distribution and use. This system will allow FDA and other public health entities to track individual devices so that when an adverse event occurs, epidemiologists can quickly track down and identify other users of the device to provide guidance and recommendations on what steps to take to prevent additional adverse actions.

Implementing a 21st Century Food Safety System

The Food Safety Modernization Act of 2010, signed into law by the President in January 2011, directs the Food and Drug Administration (FDA), working with a wide range of public and private partners, to build a new system of food safety oversight—one focused on applying the best available science and good common sense to prevent the problems that can make people sick. In implementing that Act, the Department's goal is to shift emphasis from removing unsafe products from the market place to keeping unsafe food from entering commerce in the first place.

FDA will propose several new rules to establish a robust, enhanced food safety program.

  • FDA will propose regulations establishing preventive controls in the manufacture and distribution of human foods and of animal feeds. These regulations will constitute the heart of the food safety program by instituting, for the first time, good manufacturing practices for the manufacture and distribution of food products to ensure that those products are safe for consumption and will not cause or spread disease.
  • Perhaps most anticipated in light of food borne illnesses occurring in 2011, FDA will introduce a rule addressing produce safety to ensure that produce sold in the marketplace meets rigorous safety standards. The regulation will set enforceable, science-based standards for the safe production and harvesting of fresh produce at the farm and the packing house to minimize the risk of serious adverse health consequences.
  • In another proposed rule, FDA will require food importers to have a foreign supplier verification program that will be adequate to provide assurances that each foreign supplier produces food in a manner that provides the same level of protection as required for domestic production under the Food Drug and Cosmetic Act.
  • FDA will establish a program to accredit third-party auditors to conduct food safety audits of foreign entities. Such a program will relieve importers of having to establish such programs themselves and, instead, allow them to contract with an accredited auditor to meet the audit requirements.

Empowering Americans To Make Healthy Choices in the Marketplace

Roughly two-thirds of adults and one-third of children in the United States are overweight or obese, increasing their risk for chronic diseases, including heart disease, type 2 diabetes, certain cancers, stroke, and arthritis. Almost 10 percent of all medical spending is used to treat obesity-related conditions. In order to reverse the obesity epidemic, HHS is employing a comprehensive approach that includes both clinical and public health strategies and touches people where they live, work, learn, and play.

To help advance this agenda, FDA will finalize two rules aimed at empowering consumers to make healthy eating choices. The rules require nutrition labeling on standard menu items in restaurants and similar retail food establishments, as well as on food sold in vending machines. One rule will require restaurants and similar retail food establishments with 20 or more locations to list calorie content information for standard menu items on restaurant menus and menu boards, including drive-through menu boards. Other nutrient information—total calories, fat, saturated fat, cholesterol, sodium, total carbohydrates, sugars, fiber and total protein—would have to be made available in writing upon request. The other rule will require vending machine operators who own or operate 20 or more vending machines to disclose calorie content for some items. The Department anticipates that such information will ensure that patrons of chain restaurants and vending machines have nutritional information about the food they are consuming.

Two additional rules will also improve dietary information available to consumers. One is a revision to the nutrition and supplement facts labels. Much of the information found on the Nutrition Facts label has not been updated since 1993 when mandatory nutrition labeling of food was first required. The aim of the proposed revision is to provide updated and easier to read nutrition information on the label to help consumers maintain healthy dietary practices. The other proposed rule will focus on the serving sizes of foods that can reasonably consumed in one serving. This rule would amend the labeling regulations to provide updated reference amounts for certain food categories with new consumption data derived from the current National Health and Nutrition Survey.

Advancing Scientific Research

To effectively address the challenges the Department faces in crafting the best, evidence-based approaches to advance health services delivery, protect the public health, ensure essential human services, promote biomedical research, and ensure the availability of safe medical and food products, the Department must rely on research. The lynchpin of this research is found in the ethical rules governing research on human subjects.

In a major undertaking, the Department is in the process of reviewing and revising those ethical rules, commonly referred to as the Common Rule. The Common Rule serves to guide researchers and investigators in the Department, but also throughout the Federal Government, in the conduct and protocols for doing research on human subjects. The proposed revisions will be designed to better protect human subjects who are involved in research, while facilitating research and reducing burden, delay, and ambiguity for investigators.

Streamlining Regulations To Reduce Regulatory Burdens

Consistent with the President's Executive Order 13563, the Department continues its commitment to reducing the regulatory burden on the health care industry through the use of modern technology. As part of this effort, FDA will advance several rules designed to reduce the reporting and data submission requirements from manufacturers of drugs and medical devices.

In one such rule, FDA will permit manufacturers, importers, and users of medical devices to submit reports of adverse events to the FDA electronically. This proposed change will not only reduce the paper reporting burden on industry, but also allow FDA to more quickly review safety reports and identify emerging public health issues. Under another proposed rule, FDA would revise existing regulations to allow clinical study data and bioequivalence data for new drug applications and biological license applications to be provided electronically. Again, this rule will reduce the reporting burden on industry and also permit FDA to more readily process and review applications.

CMS is also engaged in regulatory reduction and streamlining activities. Of particular note are several rules on conditions of participation for hospitals and other providers. The most comprehensive of these rules is the one reducing regulatory burdens on hospitals, which is expected to save as much as $940 million annually over the next 5 years. This rule will implement changes to hospital conditions of participation to reflect substantial advances in health care delivery and patient safety knowledge and practices.

HHS—OFFICE OF THE SECRETARY (OS) Back to Top

Proposed Rule Stage

32. • Health Information Technology: New and Revised Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology Back to Top

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

Legal Authority: 42 U.S.C. 300jj-14

CFR Citation: 45 CFR 170.

Legal Deadline: None.

Abstract: The final rule that established the initial set of standards, implementation specifications, and certification criteria was published in the Federal Register on July 28, 2010. The initial set represented the first round of an incremental approach to adopting future sets of standards, implementation specifications, and certification criteria to enhance electronic health record (EHR) interoperability, functionality, and utility. Under the authority provided by section 3004 of the Public Health Service Act (PHSA), this notice of proposed rulemaking would propose that the Secretary adopt revisions to the initial set as well as new standards, implementation specifications and certification criteria. The proposed new and revised standards, implementation specifications, and certification criteria would establish the technical capabilities that certified EHR technology would need to include to support meaningful use under the CMS Medicare and Medicaid EHR Incentive Programs.

Statement of Need: The final rule that established the initial set of standards, implementation specifications, and certification criteria was published in the Federal Register on July 28, 2010. The initial set represented the first round of an incremental approach to adopting future sets of standards, implementation specifications, and certification criteria for electronic health record (EHR) technology. In a notice of proposed rulemaking, the Secretary would propose new and revised standards, implementation specifications, and certification criteria that would establish the technical capabilities that certified EHR technology would need to include in order to support meaningful use under the CMS Medicare and Medicaid EHR Incentive Programs.

Summary of Legal Basis: Under the authority provided by section 3004 of the Public Health Service Act (PHSA), the Secretary would propose to adopt revisions to the initial set of standards, implementation specifications, and certification criteria and propose new standards, implementation specifications and certification criteria.

Alternatives: No alternatives are available because eligible professionals, eligible hospitals, and critical access hospitals under the CMS Medicare and Medicaid EHR Incentive Programs are required to demonstrate meaningful use of certified EHR technology. This rule ensures that the certification requirements necessary to support the achievement of meaningful use Stage 2 keep pace with the changes to the requirements in the CMS Medicare and Medicaid EHR Incentive Programs.

Anticipated Cost and Benefits: EHR technology developers seeking certification are expected to incur costs related to EHR technology redesign, reprogramming, and new capability development. Benefits include greater standardization and increased EHR technology interoperability and functionality.

Risks: Absent a rulemaking, it is unlikely that currently certified EHR technology would include the requisite capacities to support an eligible professional's, eligible hospital's, or critical access hospital's achievement of meaningful use under the CMS Medicare and Medicaid EHR Incentive Programs.

Timetable:

Action Date FR Cite
NPRM 01/00/12

Regulatory Flexibility Analysis Required: Undetermined.

Government Levels Affected: None.

Agency Contact: Steven Posnack, Policy Analyst, Department of Health and Human Services, Office of the Secretary, Office of the National Coordinator for Health Information Technology, 200 Independence Avenue SW., Washington, DC 20201, Phone: 202 690-7151.

RIN: 0991-AB82

HHS—FOOD AND DRUG ADMINISTRATION (FDA) Back to Top

Proposed Rule Stage

33. Electronic Submission of Data From Studies Evaluating Human Drugs and Biologics Back to Top

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

Unfunded Mandates: This action may affect the private sector under Public Law 104-4.

Legal Authority: 21 U.S.C. 355; 21 U.S.C. 371; 42 U.S.C. 262

CFR Citation: 21 CFR 314.50; 21 CFR 601.12; 21 CFR 314.94; 21 CFR 314.96.

Legal Deadline: None.

Abstract: The Food and Drug Administration is proposing to amend the regulations governing the format in which clinical study data and bioequivalence data are required to be submitted for new drug applications (NDAs), biological license applications (BLAs), and abbreviated new drug applications (ANDAs). The proposal would revise our regulations to require that data submitted for NDAs, BLAs, and ANDAs, and their supplements and amendments, be provided in an electronic format that FDA can process, review, and archive.

Statement of Need: Before a drug is approved for marketing, FDA must determine that the drug is safe and effective for its intended use. This determination is based in part on clinical study data and bioequivalence data that are submitted as part of the marketing application. Study data submitted to FDA in electronic format have generally been more efficient to process and review.

FDA's proposed rule would address the submission of study data in a standardized electronic format. Electronic submission of study data would improve patient safety and enhance health care delivery by enabling FDA to process, review, and archive data more efficiently. Standardization would also enhance the ability to share study data and communicate results. Investigators and industry would benefit from the use of standards throughout the lifecycle of a study—in data collection, reporting, and analysis. The proposal would work in concert with ongoing Agency and national initiatives to support increased use of electronic technology as a means to improve patient safety and enhance health care delivery.

Summary of Legal Basis: Our legal authority to amend our regulations governing the submission and format of clinical study data and bioequivalence data for human drugs and biologics derives from sections 505 and 701 of the Act (21 U.S.C. 355 and 371) and section 351 of the Public Health Service Act (42 U.S.C. 262).

Alternatives: FDA considered issuing a guidance document outlining the electronic submission and the standardization of study data, but not requiring electronic submission of the data in the standardized format. This alternative was rejected because the Agency would not fully benefit from standardization until it became the industry standard, which could take up to 20 years.

We also considered a number of different implementation scenarios, from shorter to longer time-periods. The 2-year time-period was selected because the Agency believes it would provide ample time for applicants to comply without too long a delay in the effective date. A longer time-period would delay the benefit from the increased efficiencies, such as standardization of review tools across applications, and the incremental cost savings to industry would be small.

Anticipated Cost and Benefits: Standardization of clinical data structure, terminology, and code sets will increase the efficiency of the Agency review process. FDA estimates that the costs resulting from the proposal would include substantial one-time costs, additional waves of one-time costs as standards mature, and possibly some annual recurring costs. One-time costs would include, among other things, the cost of converting data to standard structures, terminology, and cost sets (i.e., purchase of software to convert data); the cost of submitting electronic data (i.e., purchase of file transfer programs); and the cost of installing and validating the software and training personnel. Additional annual recurring costs may result from software purchases and licensing agreements for use of proprietary terminologies. The proposal could result in many long-term benefits associated with reduced time for preparing applications, including reduced preparation costs and faster time to market for beneficial products. In addition, the proposed rule would improve patient safety through faster, more efficient, comprehensive and accurate data review, as well as enhanced communication among sponsors and clinicians.

Risks: None.

Timetable:

Action Date FR Cite
NPRM 03/00/12

Regulatory Flexibility Analysis Required: Yes.

Small Entities Affected: Businesses.

Government Levels Affected: None.

Agency Contact: Martha Nguyen, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO 51, Room 6352, 10903 New Hampshire Avenue, Silver Spring, MD 20993-0002, Phone: 301 796-3471, Fax: 301 847-8440, Email: martha.nguyen@fda.hhs.gov.

RIN: 0910-AC52

HHS—FDA Back to Top

34. Current Good Manufacturing Practice and Hazard Analysis and Risk-Benefit Preventive Controls for Food for Animals Back to Top

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

Legal Authority: 21 U.S.C. 342; 21 U.S.C. 350e; 21 U.S.C. 371; 21 U.S.C. 374; 42 U.S.C. 264; Pub. L. 110-85, sec 1002(a)(2); Pub. L. 111-353

CFR Citation: 21 CFR 228.

Legal Deadline: Final, Statutory, September 27, 2009, FDA is directed to issue proposed and final regulations under FDA Amendments Act by the statutory deadline.

The legal deadline for FDA under the Food Safety and Modernization Act to promulgate regulations is July 2012.

Abstract: The Food and Drug Administration (FDA) is proposing regulations for preventive controls for animal feed ingredients and mixed animal feed to provide greater assurance that marketed animal feed ingredients and mixed feeds intended for all animals, including pets, are safe. This action is being taken as part of the FDA's Animal Feed Safety System initiative. This action is also being taken to carry out the requirements of the Food and Drug Administration Amendments Act of 2007, under section 1002(a), and the Food Safety Modernization Act of 2010 (FSMA), under section 103.

Statement of Need: Regulatory oversight of the animal food industry has traditionally been limited and focused on a few known safety issues, so there could be potential human and animal health problems that remain unaddressed. The massive pet food recall due to adulteration of pet food with melamine and cyanuric acid in 2007 is a prime example. The actions taken by two protein suppliers in China affected a large number of pet food suppliers in the United States and created a nationwide problem. By the time the cause of the problem was identified, melamine and cyanuric acid contaminated ingredients resulted in the adulteration of millions of individual servings of pet food. Congress passed FSMA which the President signed into law on January 4, 2011 (Pub. L. 111-353). Section 103 of FSMA amended the Federal Food, Drug, and Cosmetic Act (FD Act) by adding section 418 (21 U.S.C. 350g) Hazard Analysis and Risk Based Preventive Controls. In enacting FSMA, Congress sought to improve the safety of food in the United States by taking a risk-based approach to food safety, emphasizing prevention. Section 418 of the FD Act requires owners, operators, or agents in charge of food facilities to develop and implement a written plan that describes and documents how their facility will implement the hazard analysis and preventive controls required by this section.

Summary of Legal Basis: FDA's authority for issuing this rule is provided in FSMA (Pub. L. 111-353), which amended the FD Act by establishing section 418, which directed FDA to publish implementing regulations. FSMA also amended section 301 of the FD Act to add 301(uu) that states the operation of a facility that manufactures, processes, packs, or holds food for sale in the United States if the owner, operator, or agent in charge of such facility is not in compliance with section 418 of the FD Act is a prohibited act. Further authority comes from section 1002(a) of title X of the FDAAA of 2007 (21 U.S.C. 2102) requiring the Secretary to update standards for the processing of pet food.

FDA is also issuing this rule under the general requirements of section 402 of the FD Act (21 U.S.C. 342) for adulterated food.

In addition, section 701(a) of the FD Act (21 U.S.C. 371(a)) authorizes the Agency to issue regulations for the efficient enforcement of the Act.

Alternatives: The 2011 FSMA limited the Agency's flexibility to exclude many requirements. It described in detail its requirements for subpart C, concerning the hazard analysis and risk-based preventive controls part of the proposed rule. Alternatives include certain requirements listed in subpart B concerning operations and practices.

Anticipated Cost and Benefits: The benefits of the proposed rule would result from fewer cases of contaminated animal food ingredients or finished animal food products. Discovering contaminated food ingredients before they are used in a finished product would reduce the number of recalls of contaminated animal food products. Benefits would include reduced medical treatment costs for animals and humans, reduced loss of market value of live animals, reduced loss of animal companionship, and reduced loss in value of animal food products. More stringent requirements for animal food manufacturing would maintain public confidence in the safety of animal foods and protect animal and human health. FDA lacks sufficient data to quantify the benefits of the proposed rule.

The compliance costs of the proposed rule would result from the additional labor and capital required to perform the hazard analyses, write and implement the preventive controls, monitor and verify the preventive controls, take corrective actions if preventive controls fail to prevent feeds from becoming contaminated, and implement requirements from the operations and practices section.

Risks: FDA is proposing this rule to provide greater assurance that food intended for animals is safe and will not cause illness or injury to animals or humans. This rule would implement a risk-based, preventive controls food safety system intended to prevent animal food containing hazards, which may cause illness or injury to animals or humans, from entering into the food supply. The rule would apply to domestic and imported animal food (including raw materials and ingredients). Fewer cases of animal food contamination would (1) reduce the risk of serious illness and death to animals, (2) reduce the risk of adverse health effects to humans handling animal food, and (3) reduce the risk of consuming human food from animals that consumed contaminated food.

Timetable:

Action Date FR Cite
NPRM 01/00/12

Regulatory Flexibility Analysis Required: Yes.

Small Entities Affected: Businesses.

Government Levels Affected: None.

International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest.

Agency Contact: Kim Young, Deputy Director, Division of Compliance, Department of Health and Human Services, Food and Drug Administration, Center for Veterinary Medicine, Room 106 (MPN-4, HFV-230), 7519 Standish Place, Rockville, MD 20855, Phone: 240 276-9207, Email: kim.young@fda.hhs.gov.

RIN: 0910-AG10

HHS—FDA Back to Top

35. Unique Device Identification Back to Top

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

Legal Authority: Not Yet Determined

CFR Citation: 21 CFR 16; 21 CFR 801; 21 CFR 803; 21 CFR 806; 21 CFR 810; 21 CFR 814; 21 CFR 820; 21 CFR 821; 21 CFR 822.

Legal Deadline: None.

Abstract: The Food and Drug Administration Amendments Act of 2007 (FDAAA), amended the Federal Food, Drug, and Cosmetic Act by adding section 519(f) (21 U.S.C. 360i(f)). This section requires FDA to promulgate regulations establishing a unique identification system for medical devices requiring the label of medical devices to bear a unique identifier, unless FDA specifies an alternative placement or provides for exceptions. The unique identifier must adequately identify the device through distribution and use, and may include information on the lot or serial number.

Statement of Need: A unique device identification system will help reduce medical errors; will allow FDA, the healthcare community, and industry to more rapidly review and organize adverse event reports; identify problems relating to a particular device (even down to a particular lot or batch, range of serial numbers, or range of manufacturing or expiration dates); and thereby allow for more rapid, effective, corrective actions that focus sharply on the specific devices that are of concern.

Summary of Legal Basis: Section 519(f) of the FD&C Act (added by sec. 226 of the Food and Drug Administration Amendments Act of 2007) directs the Secretary to promulgate regulations establishing a unique device identification (UDI) system for medical devices, requiring the label of devices to bear a unique identifier that will adequately identify the device through its distribution and use.

Alternatives: FDA considered several alternatives that would allow certain requirements of the proposed rule to vary, such as the required elements of a UDI and the scope of affected devices.

Anticipated Cost and Benefits: FDA estimates that the affected industry would incur one-time and recurring costs, including administrative costs, to change and print labels that include the required elements of a UDI, costs to purchase equipment to print and verify the UDI, and costs to purchase software and integrate and validate the UDI into existing IT systems. FDA anticipates that implementation of a UDI system would help improve the efficiency and accuracy of medical device recalls and medical device adverse event reporting. The proposed rule would also standardize how medical devices are identified and contribute to future potential public health benefits of initiatives aimed at optimizing the use of automated systems in healthcare. Most of these benefits, however, require complementary developments and innovations in the private and public sectors.

Risks: This rule is intended to substantially eliminate existing obstacles to the consistent identification of medical devices used in the United States. By providing the means to rapidly and accurately identify a device and key attributes that affect its safe and effective use, the rule would reduce medical errors that result from misidentification of a device or confusion concerning its appropriate use. The rule will fulfill a statutory directive to establish a unique device identification system.

Timetable:

Action Date FR Cite
NPRM 01/00/12

Regulatory Flexibility Analysis Required: Yes.

Small Entities Affected: Businesses.

Government Levels Affected: None.

Federalism: Undetermined.

Agency Contact: John J. Crowley, Senior Advisor for Patient Safety, Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, WO 66, Room 2315, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 980-1936, Email: jay.crowley@fda.hhs.gov.

RIN: 0910-AG31

HHS—FDA Back to Top

36. Produce Safety Regulation Back to Top

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

Unfunded Mandates: This action may affect the private sector under Public Law 104-4.

Legal Authority: 21 U.S.C. 342; 21 U.S.C. 350h; 21 U.S.C. 371; 42 U.S.C. 264; Pub. L. 111-353 (signed on Jan. 4, 2011)

CFR Citation: Not Yet Determined.

Legal Deadline: NPRM, Statutory, January 4, 2012, Proposed rule not later than 12 months after the date of enactment of the Food Safety Modernization Act.

Abstract: The Food Safety Modernization Act requires the Secretary to establish and publish science-based minimum standards for the safe production and harvesting of those types of fruits and vegetables, including specific mixes or categories of fruits and vegetables, that are raw agricultural commodities for which the Secretary has determined that such standards minimize the risk of serious adverse health consequences or death. FDA is proposing to promulgate regulations setting enforceable standards for fresh produce safety at the farm and packing house. The purpose of the proposed rule is to reduce the risk of illness associated with contaminated fresh produce. The proposed rule will be based on prevention-oriented public health principles and incorporate what we have learned in the past decade since the Agency issued general good agricultural practice guidelines entitled “Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables” (GAPs Guide). The proposed rule also will reflect comments received on the Agency's 1998 update of its GAPs guide and its July 2009 draft commodity specific guidances for tomatoes, leafy greens, and melons. Although the proposed rule will be based on recommendations that are included in the GAPs guide, FDA does not intend to make the entire guidance mandatory. FDA's proposed rule would, however, set out clear standards for implementation of modern preventive controls. The proposed rule also would emphasize the importance of environmental assessments to identify hazards and possible pathways of contamination and provide examples of risk reduction practices recognizing that operators must tailor their preventive controls to particular hazards and conditions affecting their operations. The requirements of the proposed rule would be scale appropriate and commensurate with the relative risks and complexity of individual operations. FDA intends to issue guidance to assist industry in complying with the requirements of the new regulation.

Statement of Need: FDA is taking this action to meet the requirements of the FSMA and to address the food safety challenges associated with fresh produce and thereby protect the public health. Data indicate that between 1973 and 1997, outbreaks of foodborne illness in the U.S. associated with fresh produce increased in absolute numbers and as a proportion of all reported foodborne illness outbreaks. The Agency issued general good agricultural practice guidelines for fresh fruits and vegetables over a decade ago. Incorporating prevention-oriented public heath principles and incorporating what we have learned in the past decade into a regulation is a critical step in establishing standards for the growing, harvesting, packing, and storing of produce and reducing the foodborne illness attributed to fresh produce.

Summary of Legal Basis: FDA is relying on the amendments to the Federal Food, Drug, and Cosmetic Act (the FD Act), provided by section 105 of the Food Safety Modernization Act (codified primarily in sec. 419 of the FD Act (21 U.S.C. 350h)). FDA's legal basis also derives in part from sections 402(a)(4) and 701(a) of the FD Act (21 U.S.C. 342(a)(4) and 371(a)). FDA also intends to rely on section 361 of the Public Health Service Act (PHS Act) (42 U.S.C. 264), which gives FDA authority to promulgate regulations to control the spread of communicable disease.

Alternatives: Section 105 of the Food Safety Modernization Act requires FDA to conduct this rulemaking.

Anticipated Cost and Benefits: FDA estimates that the costs to more than 300,000 domestic and foreign producers and packers of fresh produce from the proposal would include one-time costs (e.g., new tools and equipment) and recurring costs (e.g., monitoring, training, recordkeeping). FDA anticipates that the benefits would be a reduction in foodborne illness and deaths associated with fresh produce. Monetized estimates of costs and benefits are not available at this time.

Risks: This regulation would directly and materially advance the Federal Government's substantial interest in reducing the risks for illness and death associated with foodborne infections associated with the consumption of fresh produce. Less restrictive and less comprehensive approaches have not been sufficiently effective in reducing the problems addressed by this regulation. FDA anticipates that the regulation would lead to a significant decrease in foodborne illness associated with fresh produce consumed in the U.S.

Timetable:

Action Date FR Cite
NPRM 01/00/12

Regulatory Flexibility Analysis Required: Yes.

Small Entities Affected: Businesses.

Government Levels Affected: None.

Federalism: Undetermined.

International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest.

Agency Contact: Samir Assar, Supervisory Consumer Safety Officer, Department of Health and Human Services, Food and Drug Administration, Center for Food Safety and Applied Nutrition, Office of Food Safety, 5100 Paint Branch Parkway, College Park, MD 20740, Phone: 240 402-1636, Email: samir.assar@fda.hhs.gov.

RIN: 0910-AG35

HHS—FDA Back to Top

37. Hazard Analysis and Risk-Based Preventive Controls Back to Top

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

Legal Authority: 21 U.S.C. 342; 21 U.S.C. 371; 42 U.S.C. 264; Pub. L. 111-353 (signed on Jan. 4, 2011)

CFR Citation: 21 CFR 110.

Legal Deadline: Final, Statutory, July 4, 2012, Final rule must be published no later than 18 months after the date of enactment of the FDA Food Safety Modernizaton Act.

Not later than 9 months after the date of enactment of the FDA Food Safety Modernization Act.

Abstract: The Food and Drug Administration (FDA) Food Safety Modernization Act (the FSMA) requires the Secretary of Health and Human Services to promulgate regulations to establish science-based minimum standards for conducting a hazard analysis, documenting hazards, implementing preventive controls, and documenting the implementation of the preventive controls; and to define the terms “small business” and “very small business.” The FSMA also requires the Secretary to promulgate regulations with respect to activities that constitute on-farm packing or holding of food that is not grown, raised, or consumed on a farm or another farm under the same ownership and activities that constitute on farm manufacturing or processing of food that is not grown, raised, or consumed on a farm or another farm under the same ownership.

FDA is proposing to amend its current good manufacturing practice (CGMP) regulations (21 CFR part 110) for manufacturing, packing, or holding human food to require food facilities to develop and implement a written food safety plan. This proposed rule would require a food facility to have and implement preventive controls to significantly minimize or prevent the occurrence of hazards that could affect food manufactured, processed, packed, or held by the facility and to provide assurances that such food will not be adulterated under section 402 or misbranded under section 403(w).

Statement of Need: FDA is taking this action to meet the requirements of the FSMA and to better address changes that have occurred in the food industry and thereby protect public health.

FDA last updated its food CGMP regulations for the manufacturing, packing, or holding of human food in 1986. Modernizing these food CGMP regulations to address risk-based preventive controls and more explicitly address issues such as environmental pathogens, food allergens, mandatory employee training, and sanitation of food contact surfaces, would be a critical step in raising the standards for food production and distribution. By amending 21 CFR 110 to modernize good manufacturing practices, the agency could focus the attention of food processors on measures that have been proven to significantly reduce the risk of food-borne illness. An amended regulation also would allow the agency to better focus its regulatory efforts on ensuring industry compliance with controls that have a significant food safety impact.

Summary of Legal Basis: FDA is relying on section 103 of the FSMA. FDA is also relying on sections 402(a)(3), (a)(4) and 701(a) of the Federal Food, Drug, and Cosmetic Act (the FD Act) (21 U.S.C. 342(a)(3), (a)(4), and 371(a)). Under section 402(a)(3) of the FD Act, a food is adulterated if it consists in whole or in part of any filthy, putrid, or decomposed substance, or if it is otherwise unfit for food. Under section 402(a)(4), a food is adulterated if it has been prepared, packed, or held under unsanitary conditions whereby it may have become contaminated with filth or may have been rendered injurious to health. Under section 701(a) of the FD Act, FDA is authorized to issue regulations for the efficient enforcement of the FD Act. FDA's legal basis also derives from section 361 of the Public Health Service Act (PHS Act) (42 U.S.C. 264), which gives FDA authority to promulgate regulations to control the spread of communicable disease.

Alternatives: An alternative to this rulemaking is not to update the CGMP regulations, and instead issue separate regulations to implement the FDA Food Safety Modernization Act.

Anticipated Cost and Benefits: FDA estimates that the costs from the proposal to domestic and foreign producers and packers of processed foods would include new one-time costs (e.g., adoption of written food safety plans, setting up training programs, implementing allergen controls, and purchasing new tools and equipment) and recurring costs (e.g., auditing and monitoring suppliers of sensitive raw materials and ingredients, training employees, and completing and maintaining records used throughout the facility). FDA anticipates that the benefits would be a reduced risk of food-borne illness and death from processed foods and a reduction in the number of safety related recalls.

Risks: This regulation will directly and materially advance the Federal Government's substantial interest in reducing the risks for illness and death associated with food-borne infections. Less restrictive and less comprehensive approaches have not been effective in reducing the problems addressed by this regulation. The regulation will lead to a significant decrease in foodborne illness in the U.S.

Timetable:

Action Date FR Cite
NPRM 01/00/12

Regulatory Flexibility Analysis Required: Yes.

Small Entities Affected: Businesses.

Government Levels Affected: None.

Federalism: Undetermined.

International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest.

Agency Contact: John F. Sheehan, Director, Office of Food Safety, Division of Plant and Dairy Food Safety, Department of Health and Human Services, Food and Drug Administration, Center for Food Safety and Applied Nutrition (HFS-315), 5100 Paint Branch Parkway, College Park, MD 20740, Phone: 240 402-1488, Fax: 301 436-2632, Email: john.sheehan@fda.hhs.gov.

RIN: 0910-AG36

HHS—FDA Back to Top

38. Foreign Supplier Verification Program Back to Top

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

Unfunded Mandates: Undetermined.

Legal Authority: Title III, sec 301 of FDA Food Safety Modernization Act, Pub. L. 111-353, establishing sec 805 of the Federal Food, Drug, and Cosmetic Act (FD Act)

CFR Citation: Not Yet Determined.

Legal Deadline: Final, Statutory, January 4, 2012.

Abstract: The proposed rule would establish regulations concerning the content of foreign supplier verification programs. The regulations will require that each importer have a foreign supplier verification program that is adequate to provide assurances that each foreign supplier produces food in compliance with: (1) Processes and procedures that provide the same level of public health protection as those required under section 418 (concerning hazard analysis and risk-based preventative controls) or section 419 (concerning produce safety standards) of the FD&C Act; and (2) sections 402 (concerning adulteration) and 403(w) (concerning major food allergens) of the FD&C Act. In promulgating the foreign supplier verification regulations, we will, as appropriate, take into account differences among importers and types of imported foods, including differences related to the level of risk posed by an imported food. Methods of foreign supplier verification may include monitoring records for shipments, lot-by-lot certifications of compliance, annual on-site inspections, checking the hazard analysis and risk-based preventive control plans of foreign suppliers, and periodically testing and sampling shipments.

Statement of Need: The proposed rule is needed to help improve the safety of food that is imported into the United States. Imported food products have increased dramatically over the last several decades. Data indicate that about 15% of the U.S. food supply is imported. FSMA provides the Agency with additional tools and authorities to help ensure that imported foods are safe for U.S. consumers. Included among these tools and authorities is a requirement that importers perform risk-based foreign supplier verification activities to verify that the food they import is produced in compliance with U.S. requirements and is not adulterated or misbranded. This proposed rule on the content of foreign supplier verification program (FSVPs) sets forth the proposed steps that food importers would be required to take to fulfill their responsibility to ensure the safety of the food they bring into this country.

Summary of Legal Basis: Section 805(c) of the FD Act (21 U.S.C. 384a(c)) directs FDA, not later than 1 year after the date of enactment of FSMA, to issue regulations on the content of FSVPs. Section 805(c)(4) states that verification activities under such programs may include monitoring records for shipments, lot-by-lot certification of compliance, annual onsite inspections, checking the hazard analysis and risk-based preventive control plans of foreign suppliers, and periodically testing and sampling shipments of imported products. Section 301(b) of FSMA amends section 301 of the FD Act (21 U.S.C. 331) by adding section 301(zz), which designates as a prohibited act the importation or offering for importation of a food if the importer (as defined in section 805) does not have in place an FSVP in compliance with section 805. In addition, section 301(c) of FSMA amends section 801(a) of the FD Act (21 U.S.C. 381(a)) by stating that an article of food being imported or offered for import into the United States shall be refused admission if it appears from an examination of a sample of such an article or otherwise that the importer is in violation of section 805.

Alternatives: We are considering a range of alternative approaches to the requirements for foreign supplier verification activities. These might include: (1) Establishing a general requirement that importers determine and conduct whatever verification activity that would adequately address the risks associated with the foods they import; (2) allowing importers to choose from a list of possible verification mechanisms, such as the activities listed in section 805(c)(4) of the FD&C Act; (3) requiring importers to conduct particular verification activities for certain types of foods or risks (e.g., for high-risk foods) but allowing flexibility in verification activities for other types of foods or risks; and (4) specifying use of a particular verification activity for each particular kind of food or risk. To the extent possible while still ensuring that verification activities are adequate to ensure that foreign suppliers are producing food in accordance with U.S. requirements, we will seek to give importers the flexibility to choose verification procedures that are appropriate to adequately address the risks associated with the importation of a particular food.

Anticipated Cost and Benefits: We have not yet quantified the cost and benefits for this proposed rule. However, the available information suggests that the costs will be significant. Our preliminary analysis of FY10 OASIS data suggests that this rule will cover about 60,000 importers, 240,000 unique combinations of importers and foreign suppliers, and 540,000 unique combinations of importers, products, and foreign suppliers. These numbers imply that provisions that require activity for each importer, each unique combination of importer and foreign supplier, or each unique combination of importer, product, and foreign supplier will generate significant costs. An example of a provision linked to combinations of importers and foreign suppliers would be a requirement to conduct a verification activity, such as an onsite audit, under certain conditions. The cost of onsite audits will depend in part on whether foreign suppliers can provide the same onsite audit results to different importers or whether every importer will need to take some action with respect to each of their foreign suppliers. The benefits of this proposed rule will consist of the reduction of adverse health events linked to imported food that could result from compliance with the FSVP requirements. We have not yet estimated the benefits of the rule.

Risks: As stated above, about 15 percent of the U.S. food supply is imported, and many of these imported foods are high-risk commodities. According to recent data from the Centers for Disease Control and Prevention, each year, about 48 million Americans get sick, 128,000 are hospitalized, and 3,000 die from foodborne diseases. From July 1, 2007, through June 30, 2008, FDA oversaw 40 recalls of imported foods that were so contaminated that the Agency deemed them to be an imminent threat. We expect that the adoption of FSVPs by food importers will lead to a significant reduction to the threat to public health posed by unsafe imported food, though we are still in the process of trying to quantify the reduction in risk that will occur through importer compliance with the FSVP regulations.

Timetable:

Action Date FR Cite
NPRM 01/00/12

Regulatory Flexibility Analysis Required: Undetermined.

Small Entities Affected: Businesses.

Government Levels Affected: None.

International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest.

Agency Contact: Brian L. Pendleton, Senior Policy Advisor, Department of Health and Human Services, Food and Drug Administration, Office of Policy, WO32, Room 4245, 10903 New Hampshire Avenue, Silver Spring, MD 20993-0002, Phone: 301 796-4614, Fax: 301 847-8616, Email: brian.pendleton@fda.hhs.gov.

RIN: 0910-AG64.

HHS—FDA Back to Top

39. Accreditation of Third Parties To Conduct Food Safety Audits and for Other Related Purposes Back to Top

Priority: Other Significant.

Legal Authority: Pub. L. 111-353, sec 307, FDA Food Safety Modernization Act; Other sections of FDA Food Safety Modernization Act, as appropriate.

CFR Citation: Not Yet Determined.

Legal Deadline: Final, Statutory, July 2012, Promulgate implementing regulations. Per Public Law 111-353, section 307(c)(5)(C), promulgate, within 18 months of enactment, implementing regulations for accreditation of third-party auditors to conduct food safety audits.

Abstract: The Food and Drug Administration (FDA) is proposing regulations relating to the accreditation of third-party auditors to conduct food safety audits of foreign entities, including foreign facilities in the food import supply chain. The proposed regulations will include provisions to protect against conflicts of interest between accredited auditors and audited entities, as described in section 307 of the FDA Food Safety Modernization Act (FSMA), Public Law 111-353. As part of this rulemaking, FDA may propose regulations relating to the accreditation of third parties to perform related activities, such as conducting laboratory analyses of food, authorized by other sections of FSMA.

Statement of Need: The use of accredited third-party auditors to certify high-risk food imports to assist in ensuring the safety of food from foreign origin entering U.S. commerce. Accredited third-party auditors auditing foreign process facilities may be viewed as increasing FDA's “coverage” of foreign facilities that FDA may not have adequate resources to inspect in a particular year while using identified standards creating overall uniformity to complete the task. Audits that result in issuance of facility certificates will provide FDA information about the compliance status of the facility. Additionally, auditors will be required to submit audit reports that may be reviewed by FDA for purposes of compliance assessment and work planning.

Summary of Legal Basis: Not later than 2 years after the date of enactment, establish a system for the recognition of accreditation bodies that accredit third-party auditors, certifying that their eligible entities meet the requirements, directly accredit third-party auditors should none be identified and recognized by the 2-year date of enactment, obtain a list of all accredited third-party auditors and their agents from recognized accreditation bodies, and determine requirements for regulatory audit reports while avoiding unnecessary duplication of efforts and costs.

Alternatives: FSMA described in detail the framework for, and requirements of, the accredited third-party auditor program. Alternatives include certain oversight activities required of recognized accreditation bodies that accredit third-party auditors, as distinguished from third-party auditors directly accredited by FDA. Another alternative relates to the nature of the required standards and the degree to which those standards are prescriptive or flexible.

Anticipated Cost and Benefits: The benefits of the proposed rule would result from fewer cases of unsafe or misbranded food entering U.S. commerce. Additional benefits include the increased flow of credible information to FDA regarding the compliance status of foreign firms and their foods that are ultimately offered for import Into the United States, which information in turn would inform FDA's work planning for inspection of foreign food facilities and might result in a signal of possible problems with a particular firm or its products, and with sufficient signals, might raise questions about the rigor of the food safety regulatory system of the country of origin.

The compliance costs of the proposed rule would result from the additional labor and capital required of accreditation bodies seeking FDA recognition and of third-party auditors seeking accreditation to the extent that will involve the assembling of information for an application unique to the FDA third-party program. The compliance costs associated with certification will be accounted for separately under the costs associated with participation In the foreign supplier verification program and the costs associated with mandatory certification for high-risk food imports. The third-party program is funded through revenue neutral user fees, which will be developed by FDA through rulemaklng. User fee costs will be accounted for in that rulemaklng.

Risks: FDA is proposing this rule to provide greater assurance the food offered for import into the United States is safe and will not cause injury or illness to animals or humans. The rule would implement a program for accrediting third-party auditors to conduct food safety audits of foreign food entities, including registered foreign food facilities, and based on the findings of the regulatory audit, to issue certifications to foreign food entities found to be in compliance with FDA requirements. The certifications would be used by importers seeking to participate in the Voluntary Qualified Importer Program for expedited review and entry of product and would be a means to provide assurance of compliance as required by FDA based on risk-related considerations. The rule would apply to any foreign or domestic accreditation body seeking FDA recognition, any foreign or domestic third-party auditor seeking accreditation, any registered foreign food facility or other foreign food entity subject to a food safety audit (including a regulatory audit conducted for purposes of certification), and any importer seeking to participate in the Voluntary Qualified Importer Program. Fewer cases of unsafe or misbranded food entering U.S. commerce would reduce the risk of serious illness and death to humans and animals.

Timetable:

Action Date FR Cite
NPRM 02/00/12

Regulatory Flexibility Analysis Required: No.

Government Levels Affected: Undetermined.

International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest.

Agency Contact: Charlotte A. Christin, Senior Policy Advisor, Department of Health and Human Services, Food and Drug Administration, Office of Policy WO32, Room 4234, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 796-4718, Fax: 301 847-3541, Email: charlotte.christin@fda.hhs.gov.

RIN: 0910-AG66

HHS—FDA Back to Top

Final Rule Stage

40. Infant Formula: Current Good Manufacturing Practices; Quality Control Procedures; Notification Requirements; Records and Reports; and Quality Factors Back to Top

Priority: Other Significant.

Legal Authority: 21 U.S.C. 321; 21 U.S.C. 350a; 21 U.S.C. 371

CFR Citation: 21 CFR 106 and 107.

Legal Deadline: None.

Abstract: The Food and Drug Administration (FDA) is revising its infant formula regulations in 21 CFR parts 106 and 107 to establish requirements for current good manufacturing practices (CGMP), including audits; to establish requirements for quality factors; and to amend FDA's quality control procedures, notification, and record and reporting requirements for infant formula. FDA is taking this action to improve the protection of infants who consume infant formula products.

Statement of Need: The Agency published a proposed rule on July 9, 1996, that would establish current good manufacturing practice regulations, quality control procedures, quality factors, notification requirements, records, and reports for the production of infant formula. This proposal was issued in response to the 1986 Amendments to the Infant Formula Act of 1980. On April 28, 2003, FDA reopened the comment period to update comments on the proposal. The comment was extended on June 27, 2003, and ended on August 26, 2003. The comment period was reopened on August 1, 2006, and ended on September 15, 2006.

Summary of Legal Basis: The Infant Formula Act of 1980 (the 1980 Act) (96) amended the Federal Food, Drug, and Cosmetic Act (the Act) to include section 412 (21 U.S.C. 350a). This law is intended to improve protection of infants consuming infant formula products by establishing greater regulatory control over the formulation and production of infant formula. In 1982, FDA adopted infant formula recall procedures in subpart D of 21 CFR part 107 of its regulations (47 FR 18832, Apr. 30, 1982), and infant formula quality control procedures in subpart B of 21 CFR part 106 (47 FR 17016, Apr. 20, 1982). In 1985, FDA further implemented the 1980 Act by establishing subparts B, C, and D in 21 CFR part 107 regarding the labeling of infant formula, exempt infant formulas, and nutrient requirements for infant formula, respectively (50 FR 1833, Jan. 14, 1985; 50 FR 48183, Nov. 22, 1985; and 50 FR 45106, Oct. 30, 1985).

In 1986, Congress, as part of the Anti-Drug Abuse Act of 1986 (99) (the 1986 amendments), amended section 412 of the act to address concerns that had been expressed by Congress and consumers about the 1980 Act and its implementation related to the sufficiency of quality control testing, CGMP, recordkeeping, and recall requirements. The 1986 amendments: (1) State that an infant formula is deemed to be adulterated if it fails to provide certain required nutrients, fails to meet quality factor requirements established by the Secretary (and, by delegation, FDA), or if it is not processed in compliance with the CGMP and quality control procedures established by the Secretary; (2) require that the Secretary issue regulations establishing requirements for quality factors and CGMP, including quality control procedures; (3) require that infant formula manufacturers regularly audit their operations to ensure that those operations comply with CGMP and quality control procedure regulations; (4) expand the circumstances in which firms must make a submission to the Agency to include when there is a major change in an infant formula or a change that may affect whether the formula is adulterated; (5) specify the nutrient quality control testing that must be done on each batch of infant formula; (6) modify the infant formula recall requirements; and (7) give the Secretary authority to establish requirements for retention of records, including records necessary to demonstrate compliance with CGMP and quality control procedures. In 1989, the Agency implemented the provisions on recalls (secs. 412(f) and (g) of the Act) by establishing subpart E in 21 CFR part 107 (54 FR 4006, Jan. 27, 1989). In 1991, the Agency implemented the provisions on record and record retention requirements by revising 21 CFR 106.100 (56 FR 66566, Dec. 24, 1991).

The Agency has already promulgated regulations that respond to a number of the provisions of the 1986 amendments. The final rule would address additional provisions of these amendments.

Alternatives: The 1986 amendments require the Secretary (and, by delegation, FDA) to establish, by regulation, requirements for quality factors and CGMPs, including quality control procedures. Therefore, there are no alternatives to rulemaking.

Anticipated Cost and Benefits: FDA estimates that the costs from the final rule to producers of infant formula would include first year and recurring costs (e.g., administrative costs, implementation of quality controls, records, audit plans, and assurances of quality factors in new infant formulas). FDA anticipates that the primary benefits would be a reduced risk of illness due to Cronobacter sakazakii and Salmonella spp in infant formula. Additional benefits stem from the quality factors requirements that would assure the healthy growth of infants consuming infant formula. Monetized estimates of costs and benefits for this final rule are not available at this time. The analysis for the proposed rule estimated costs of less than $1 million per year. FDA was not able to quantify benefits in the analysis for the proposed rule.

Risks: Special controls for infant formula manufacturing are especially important because infant formula, particularly powdered infant formula, is an ideal medium for bacterial growth and because infants are at high risk of foodborne illness because of their immature immune systems. In addition, quality factors are of critical need to assure that the infant formula supports healthy growth in the first months of life when infant formula may be an infant's sole source of nutrition. The provisions of this rule will address weaknesses in production that may allow contamination of infant formula, including, contamination with C. sakazakii and Salmonella spp which can lead to serious illness with devastating sequelae and/or death. The provisions would also assure that new infant formulas support healthy growth in infants.

Timetable:

Action Date FR Cite
NPRM 07/09/96 61 FR 36154
NPRM Comment Period End 12/06/96  
NPRM Comment Period Reopened 04/28/03 68 FR 22341
NPRM Comment Period Extended 06/27/03 68 FR 38247
NPRM Comment Period End 08/26/03  
NPRM Comment Period Reopened 08/01/06 71 FR 43392
NPRM Comment Period End 09/15/06  
Final Action 03/00/12  

Regulatory Flexibility Analysis Required: Yes.

Small Entities Affected: Businesses.

Government Levels Affected: None.

International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest.

Agency Contact: Benson Silverman, Department of Health and Human Services, Food and Drug Administration, Center for Food Safety and Applied Nutrition (HFS-850), 5100 Paint Branch Parkway, College Park, MD 20740, Phone: 240 402-1459, Email: benson.silverman@fda.hhs.gov.

Related RIN: Split from 0910-AA04.

RIN: 0910-AF27

HHS—FDA Back to Top

41. Medical Device Reporting; Electronic Submission Requirements Back to Top

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

Legal Authority: 21 U.S.C. 352, 360, 360i, 360j, 371, 374

CFR Citation: 21 CFR 803.

Legal Deadline: None.

Abstract: The Food and Drug Administration (FDA) is amending its postmarket medical device reporting (MDR) regulations to require that manufacturers, importers, and user facilities submit mandatory reports of medical device adverse events to the Agency in an electronic format that FDA can process, review, and archive. FDA is taking this action to improve the Agency's systems for collecting and analyzing postmarketing safety reports. The proposed change would help the Agency to more quickly review safety reports and identify emerging public health issues.

Statement of Need: The final rule would require user facilities and medical device manufacturers and importers to submit medical device adverse event reports in electronic format instead of using a paper form. FDA is taking this action to improve its adverse event reporting program by enabling it to more quickly receive and process these reports.

Summary of Legal Basis: The Agency has legal authority under section 519 of the Federal Food, Drug, and Cosmetic Act to require adverse event reports. The final rule would require manufacturers, importers, and user facilities to change their procedures to send reports of medical device adverse events to FDA in electronic format instead of using a hard copy form.

Alternatives: There are two alternatives. The first alternative is to allow the voluntary submission of electronic MDRs. If a substantial number of reporters fail to voluntarily submit electronic MDRs, FDA will not obtain the benefits of standardized formats and quicker access to medical device adverse event data. The second alternative is to allow small entities more time to comply. This would significantly postpone the benefits of the rule; moreover, it would only delay, rather than reduce or eliminate, the costs of compliance.

Anticipated Cost and Benefits: The principal benefit would be to public health, due to the increased speed in the processing and analysis of medical device reports currently submitted annually on paper. In addition, requiring electronic submission would reduce FDA annual operating costs and generate industry savings.

The one-time costs are for modifying standard operating procedures and establishing electronic submission capabilities. Annually recurring costs include maintenance of electronic submission capabilities, including renewing the electronic certificate, and for some firms, the incremental cost to maintain high-speed Internet access.

Risks: None.

Timetable:

Action Date FR Cite
NPRM 08/21/09 74 FR 42203
NPRM Comment Period End 11/19/09  
Final Action 03/00/12  

Regulatory Flexibility Analysis Required: No.

Government Levels Affected: None.

Agency Contact: Nancy Pirt, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, WO 66, Room 4438, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 796-6248, Fax: 301 847-8145, Email: nancy.pirt@fda.hhs.gov.

RIN: 0910-AF86

HHS—FDA Back to Top

42. Electronic Registration and Listing for Devices Back to Top

Priority: Other Significant.

Legal Authority: Pub. L. 110-85; Pub. L. 107-188, sec 321; Pub. L. 107-250, sec 207; 21 U.S.C. 360(a) through 360(j); 21 U.S.C. 360(p)

CFR Citation: 21 CFR 807.

Legal Deadline: None.

Abstract: This rule would codify the requirements for electronic registration and listing. However, for those companies that do not have access to the Web, FDA will offer an avenue by which they can register, list, and update information with a paper submission. The rule also will amend part 807 to reflect the timeframes for device establishment registration and listing established by sections 222 and 223 of Food and Drug Administration Amendment Act (FDAAA) and to reflect the requirement in section 510(i) of the Act, as amended by section 321 of the Public Health Security and Bioterrorism Preparedness and Response Act (BT Act), that foreign establishments provide FDA with additional pieces of information as part of their registration.

Statement of Need: FDA is amending the medical device establishment registration and listing requirements under 21 CFR part 807 to reflect the electronic submission requirements in section 510(p) of the Act, which was added by section 207 of MDUFMA and later amended by section 224 of FDAAA. FDA also is amending 21 CFR part 807 to reflect the requirements in section 321 of the BT Act for foreign establishments to furnish additional information as part of their registration. This rule will improve FDA's device establishment registration and listing system and utilize the latest technology in the collection of this information.

Summary of Legal Basis: The statutory basis for our authority includes sections 510(a) through (j), 510(p), 701, 801, and 1003 of the Act.

Alternatives: The alternatives to this rulemaking include not updating the registration and listing regulations. Because of the new FDAAA statutory requirements and the advances in data collection and transmission technology, FDA believes this rulemaking is the preferable alternative.

Anticipated Cost and Benefits: The Agency believes that there may be some one-time costs associated with the rulemaking, which involve resource costs of familiarizing users with the electronic system. Recurring costs related to submission of the information by domestic firms would probably remain the same or decrease because a paper submission and postage is not required. There might be some increase in the financial burden on foreign firms since they will have to supply additional registration information as required by section 321 of the BT Act.

Risks: None.

Timetable:.

Action Date FR Cite
NPRM 03/26/10 75 FR 14510
NPRM Comment Period End 06/24/10
Final Rule 05/00/12

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: Businesses.

Government Levels Affected: None.

Agency Contact: Nancy Pirt, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, WO 66, Room 4438, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 796-6248, Fax: 301 847-8145, Email: nancy.pirt@fda.hhs.gov.

RIN: 0910-AF88

HHS—FDA Back to Top

43. Food Labeling: Nutrition Labeling for Food Sold in Vending Machines Back to Top

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

Legal Authority: 21 U.S.C. 321; 21 U.S.C. 343; 21 U.S.C. 371

CFR Citation: Not Yet Determined.

Legal Deadline: None.

Abstract: The Food and Drug Administration (FDA) published a proposed rule in the Federal Register of April 6, 2011 (72 FR 19238) to establish requirements for nutrition labeling of certain food items sold in certain vending machines. FDA also proposed the terms and conditions for vending machine operators registering to voluntarily be subject to the requirements. FDA took this action to carry out section 4205 of the Patient Protection and Affordable Care Act (“Affordable Care Act” or “ACA”), which was signed into law on March 23, 2010.

Statement of Need: This rulemaking was mandated by section 4205 of the Patient Protection and Affordable Care Act (Affordable Care Act).

Summary of Legal Basis: On March 23, 2010, the Affordable Care Act (Pub. L. 111-148) was signed into law. Section 4205 amended 403(q)(5) of the Federal Food, Drug, and Cosmetic Act (FD Act) by, among other things, creating new clause (H) to require that vending machine operators, who own or operate 20 or more machines, disclose calories for certain food items. FDA has the authority to issue this rule under sections 403(q)(5)(H) and 701(a) of the FD Act (21 U.S.C. 343(q)(5)(H), and 371(a)). Section 701(a) of the FD Act vests the Secretary of Health and Human Services, and, by delegation, the Food and Drug Administration (FDA) with the authority to issue regulations for the efficient enforcement of the FD Act.

Alternatives: Section 4205 of the Affordable Care Act requires the Secretary (and by delegation, the FDA) to establish by regulation requirements for calorie labeling of articles of food sold from covered vending machines. Therefore, there are no alternatives to rulemaking. FDA has analyzed alternatives that may reduce the burden of the rulemaking, including analyzing the benefits and costs of: Restricting the flexibility of the format for calorie disclosure, lengthening the compliance time, and extending the coverage of the rule to bulk vending machines without selection buttons.

Anticipated Cost and Benefits: Any vending machine operator operating fewer than 20 machines may voluntarily choose to be covered by the national standard. It is anticipated that vending machine operators that own or operate 20 or more vending machines will bear costs associated with adding calorie information to vending machines. FDA estimates that the total cost of complying with section 4205 of the Affordable Care Act and this rulemaking will be approximately $25.8 million initially, with a recurring cost of approximately $24 million.

Because comprehensive national data for the effects of vending machine labeling do not exist, FDA has not quantified the benefits associated with section 4205 of the Affordable Care Act and this rulemaking. Some studies have shown that some consumers consume fewer calories when calorie content information is displayed at the point of purchase. Consumers will benefit from having this important nutrition information to assist them in making healthier choices when consuming food away from home. Given the very high costs associated with obesity and its associated health risks, FDA estimates that if 0.02 percent of the adult obese population reduces energy intake by at least 100 calories per week, then the benefits of Section 4205 of the Affordable Care Act and this rulemaking will be at least as large as the costs.

Risks: Americans now consume an estimated one-third of their total calories from foods prepared outside the home and spend almost half of their food dollars on such foods. This rule will provide consumers with information about the nutritional content of food to enable them to make healthier food choices, and may help mitigate the trend of increasing obesity in America.

Timetable:

Action Date FR Cite
NPRM 04/06/11 76 FR 19238
NPRM Comment Period End 07/05/11
Final Action 11/00/12

Regulatory Flexibility Analysis Required: Yes.

Small Entities Affected: Businesses, Governmental Jurisdictions.

Government Levels Affected: Federal, Local, State.

Federalism: This action may have federalism implications as defined in EO 13132.

Agency Contact: Daniel Reese, Department of Health and Human Services, Food and Drug Administration, Center for Food Safety and Applied Nutrition (HFS-820), 5100 Paint Branch Parkway, College Park, MD 20740, Phone: 240 402-2126, Email: daniel.reese@fda.hhs.gov.

RIN: 0910-AG56

HHS—FDA Back to Top

44. Food Labeling: Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments Back to Top

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

Unfunded Mandates: This action may affect the private sector under Public Law 104-4.

Legal Authority: 21 U.S.C. 321; 21 U.S.C. 343; 21 U.S.C. 371

CFR Citation: Not Yet Determined.

Legal Deadline: None.

Abstract: The Food and Drug Administration (FDA) published a proposed rule in the Federal Register of April 6, 2011 (72 FR 19192), to establish requirements for nutrition labeling of standard menu items in chain restaurants and similar retail food establishments. FDA also proposed the terms and conditions for restaurants and similar retail food establishments registering to voluntarily be subject to the Federal requirements. FDA took this action to carry out section 4205 of the Patient Protection and Affordable Care Act (“Affordable Care Act” or “ACA”), which was signed into law on March 23, 2010.

Statement of Need: This rulemaking was mandated by section 4205 of the Patient Protection and Affordable Care Act (Affordable Care Act).

Summary of Legal Basis: On March 23, 2010, the Affordable Care Act (Pub. L. 111-148) was signed into law. Section 4205 of the Affordable Care Act amended 403(q)(5) of the Federal Food, Drug, and Cosmetic Act (FD Act) by, among other things, creating new clause (H) to require that certain chain restaurants and similar retail food establishments with 20 or more locations disclose certain nutrient information for standard menu items. FDA has the authority to issue this rule under sections 403(a)(1), 403(q)(5)(H), and 701(a) of the FD Act (21 U.S.C. 343(a)(1), 343(q)(5)(H), and 371(a)). Section 701(a) of the FD Act vests the Secretary of Health and Human Services, and, by delegation, the Food and Drug Administration (FDA) with the authority to issue regulations for the efficient enforcement of the FD Act.

Alternatives: Section 4205 of the Affordable Care Act requires the Secretary, and by delegation the FDA, to establish by regulation requirements for nutrition labeling of standard menu items for covered restaurants and similar retail food establishments. Therefore, there are no alternatives to rulemaking. FDA has analyzed alternatives that may reduce the burden of this rulemaking, including analyzing the benefits and costs of expanding and contracting the set of establishments automatically covered by this rule and shortening or lengthening the compliance time relative to the rulemaking.

Anticipated Cost and Benefits: Chain restaurants and similar retail food establishments operating in local jurisdictions that impose different nutrition labeling requirements will benefit from having a uniform national standard. Any restaurant or similar retail food establishment with fewer than 20 locations may voluntarily choose to be covered by the national standard. It is anticipated that chain restaurants with 20 or more locations will bear costs for adding nutrition information to menus and menu boards. FDA estimates that the total cost of section 4205 and this rulemaking will be approximately $80 million, annualized over 10 years, with a low annualized estimate of approximately $33 million and a high annualized estimate of approximately $125 million over 10 years. These costs include an initial cost of approximately $320 million with an annually recurring cost of $45 million.

Because comprehensive national data for the effects of menu labeling do not exist, FDA has not quantified the benefits associated with section 4205 of the Affordable Care Act and this rulemaking. Some studies have shown that some consumers consume fewer calories when menus have information about calorie content displayed. Consumers will benefit from having important nutrition information for the approximately 30 percent of calories consumed away from home. Given the very high costs associated with obesity and its associated health risks, FDA estimates that if 0.6 percent of the adult obese population reduces energy intake by at least 100 calories per week, then the benefits of section 4205 of the Affordable Care Act and this rule will be at least as large as the costs.

Risks: Americans now consume an estimated one-third of their total calories on foods prepared outside the home and spend almost half of their food dollars on such foods. Unlike packaged foods that are labeled with nutrition information, foods in restaurants, for the most part, do not have nutrition information that is readily available when ordered. Dietary intake data have shown that obese Americans consume over 100 calories per meal more when eating food away from home rather than food at home. This rule will provide consumers information about the nutritional content of food to enable them to make healthier food choices and may help mitigate the trend of increasing obesity in America.

Timetable:

Action Date FR Cite
NPRM 04/06/11 76 FR 19192
NPRM Comment Period End 07/05/11
Final Action 11/00/12

Regulatory Flexibility Analysis Required: Yes.

Small Entities Affected: Businesses, Governmental Jurisdictions.

Government Levels Affected: Federal, Local, State.

Federalism: This action may have federalism implications as defined in EO 13132.

Agency Contact: Geraldine A. June, Supervisor, Product Evaluation and Labeling Team, Department of Health and Human Services, Food and Drug Administration, Center for Food Safety and Applied Nutrition, (HFS-820), 5100 Paint Branch Parkway, College Park, MD 20740, Phone: 240 402-1802, Fax: 301 436-2636, Email: geraldine.june@fda.hhs.gov.

RIN: 0910-AG57

HHS—CENTERS FOR MEDICARE&MEDICAID SERVICES (CMS) Back to Top

Proposed Rule Stage

45. Medicare and Medicaid Programs: Reform of Hospital and Critical Access Hospital Conditions of Participation (CMS-3244-P) Back to Top

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

Legal Authority: 42 U.S.C. 1302; 42 U.S.C. 1395hh and 1395rr

CFR Citation: 42 CFR 482; 42 CFR 485.

Legal Deadline: None.

Abstract: This proposed rule would revise the requirements that hospitals and critical access hospitals (CAHs) must meet to participate in the Medicare and Medicaid programs. These changes are necessary to reflect substantial advances in health care delivery and in patient safety knowledge and practices. They are also an integral part of our efforts to achieve broad-based improvements in the quality of health care furnished through Federal programs and in patient safety, while at the same time reducing procedural burdens on providers.

Statement of Need: CMS is revising many of the hospital CoPs to ensure that they meet the needs of hospital and CAH patients in an effective and efficient manner. CMS is proposing changes to reduce unnecessary, obsolete, or burdensome regulations on U.S. hospitals. This retrospective review of existing regulations meets the President's Executive Order that all Federal agencies identify such rules and make proposals to “modify, streamline, expand, or repeal them.” CMS is also proposing additional quality and safety requirements to protect patients.

Summary of Legal Basis: The provisions that are included in this proposed rule are necessary to implement the requirements of Executive Order 13563 “Improving Regulations and Regulatory Review.”

Alternatives: To date, nearly 90 specific reforms have been identified and scheduled for action. These reforms impact hospitals, physicians, home health agencies, ambulance providers, clinical labs, skilled nursing facilities, intermediate care facilities, managed care plans, Medicare Advantage organizations, and States. Many of these reforms will be included in proposed rules that relate to particular categories of regulations or types of providers. Other reforms are being implemented without the need for regulations.

This proposed rule includes reforms that do not fit directly in other rules scheduled for publication.

Anticipated Cost and Benefits: This proposed rule would reduce costs to tens of thousands of physicians, ambulatory surgical centers, End Stage Renal Disease facilities, and other small entities. Achieving the full scope of potential savings will depend on future decisions by hospitals, by State regulators, and others. Many other factors will influence long-term results. We believe, however, that likely savings and benefits will reach many billions of dollars. Our primary estimate of the net savings to hospitals from reductions in regulatory requirements that we can quantify at this time, offset by increases in other regulatory costs, are approximately $940 million a year.

Risks: None.

Timetable:

Action Date FR Cite
NPRM 10/24/11 76 FR 65891
NPRM Comment Period End 12/23/11

Regulatory Flexibility Analysis Required: Yes.

Small Entities Affected: Businesses.

Government Levels Affected: None.

Agency Contact: CDR Scott Cooper, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Clinical Standards Group, Mail Stop S3-05-15, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-9465, Email: scott.cooper@cms.hhs.gov.

RIN: 0938-AQ89

HHS—CMS Back to Top

46. Regulatory Provisions To Promote Program Efficiency, Transparency, and Burden Reduction (CMS-9070-P) Back to Top

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

Legal Authority: 42 U.S.C. 1302 and 1395hh and 44 U.S.C. 35

CFR Citation: 42 CFR 400, 405, 416, 418, 423; 42 CFR 424, 440, 442, 486, 494.

Legal Deadline: None.

Abstract: This proposed rule identifies and proposes reforms in Medicare and Medicaid regulations that CMS has identified as unnecessary, obsolete, or excessively burdensome on health care providers and beneficiaries. This proposed rule would increase the ability of health care professionals to devote resources to improving patient care, by eliminating or reducing requirements that impede quality patient care or that divert providing high quality patient care.

Statement of Need: In January 2011, the President issued an Executive order that requires agencies to identify rules that may be “outmoded, ineffective, insufficient, or excessively burdensome, and to modify, streamline, expand, or repeal them in accordance with what has been learned.” In accordance with the Executive order, we identified obsolete and unnecessarily burdensome rules that could be eliminated or reformed to achieve similar objectives, with a particular focus on freeing up resources that health care providers, health plans, and States could use to improve or enhance patient health and safety. We examined policies and practices not codified in rules that could be changed or streamlined to achieve better outcomes for patients while reducing burden on providers of care. We also sought to increase transparency and become a better business partner.

Summary of Legal Basis: The provisions that are included in this proposed rule are necessary to implement the requirements of Executive Order 13563 “Improving Regulations and Regulatory Review.”

Alternatives: To date, nearly 90 specific reforms have been identified and scheduled for action. These reforms impact hospitals, physicians, home health agencies, ambulance providers, clinical labs, skilled nursing facilities, intermediate care facilities, managed care plans, Medicare Advantage organizations, and States. Many of these reforms will be included in proposed rules that relate to particular categories of regulations or types of providers. Other reforms are being implemented without the need for regulations. This proposed rule includes reforms that do not fit directly in other rules scheduled for publication.

Anticipated Cost and Benefits: We anticipate that the provider industry and health professionals would welcome the proposed changes and reductions in burden. We also expect that health professionals would experience increased efficiencies and resources to appropriately devote to improving patient care, increasing accessibility to care, and reducing associated health care costs.

Risks: None.

Timetable:

Action Date FR Cite
NPRM 10/24/11 76 FR 65909
NPRM Comment Period End 12/23/11

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: Businesses, Governmental Jurisdictions, Organizations.

Government Levels Affected: Federal, State.

Agency Contact: Michelle Shortt, Director, Regulations Development Group, OSORA, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mailstop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-4675, Email: michelle.shortt@cms.hhs.gov.

RIN: 0938-AQ96

HHS—CMS Back to Top

47. • Proposed Changes to Hospital OPPS and CY 2013 Payment Rates; ASC Payment System and CY 2013 Payment Rates (CMS-1589-P) (Section 610 Review) Back to Top

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

Unfunded Mandates: Undetermined.

Legal Authority: Sec 1833 of the Social Security Act

CFR Citation: 42 CFR 410; 42 CFR 416; 42 CFR 419.

Legal Deadline: Final, Statutory, November 1, 2012.

Abstract: This final rule would revise the Medicare hospital outpatient prospective payment system to implement applicable statutory requirements and changes arising from our continuing experience with this system. The proposed rule also describes changes to the amounts and factors used to determine payment rates for services. In addition, the rule proposes changes to the Ambulatory Surgical Center Payment System list of services and rates.

Statement of Need: Medicare pays over 4,000 hospitals for outpatient department services under the hospital outpatient prospective payment system (OPPS). The OPPS is based on groups of clinically similar services called ambulatory payment classification groups (APCs). CMS annually revises the APC payment amounts based on the most recent claims data, proposes new payment policies, and updates the payments for inflation using the hospital operating market basket. The proposed rule solicits comments on the proposed OPPS payment rates and new policies. Medicare pays roughly 5,000 Ambulatory Surgical Centers (ASCs) under the ASC payment system. CMS annually revises the payment under the ASC payment system, proposes new policies, and updates payments for inflation using the Consumer Price Index for All Urban Consumers (CPI-U). CMS will issue a final rule containing the payment rates for the 2013 OPPS and ASC payment system at least 60 days before January 1, 2013.

Summary of Legal Basis: Section 1833 of the Social Security Act establishes Medicare payment for hospital outpatient services and ASC services. The final rule revises the Medicare hospital OPPS and ASC payment system to implement applicable statutory requirements. In addition, the proposed and final rules describe changes to the outpatient APC system, relative payment weights, outlier adjustments, and other amounts and factors used to determine the payment rates for Medicare hospital outpatient services paid under the prospective payment system, as well as changes to the rates and services paid under the ASC payment system. These changes would be applicable to services furnished on or after January 1, 2013.

Alternatives: None. This is a statutory requirement.

Anticipated Cost and Benefits: Total expenditures will be adjusted for CY 2013.

Risks: If this regulation is not published timely, outpatient hospital and ASC services will not be paid appropriately beginning January 1, 2013.

Timetable:

Action Date FR Cite
NPRM 06/00/12

Regulatory Flexibility Analysis Required: Yes.

Small Entities Affected: Businesses.

Government Levels Affected: Federal.

Federalism: Undetermined.

Agency Contact: Paula Smith, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mail Stop C4-05-13, 7500 Security Blvd., Baltimore, MD 21244, Phone: 410 786-4709, Email: paula.smith@cms.hhs.gov.

RIN: 0938-AR10

HHS—CMS Back to Top

48. • Revisions to Payment Policies Under the Physician Fee Schedule and Part B for CY 2013 (CMS-1590-P) (Section 610 Review) Back to Top

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

Unfunded Mandates: Undetermined.

Legal Authority: Social Security Act, secs 1102, 1871, 1848

CFR Citation: Not Yet Determined.

Legal Deadline: Final, Statutory, November 1, 2012.

Abstract: This annual proposed rule would revise payment polices under the physician fee schedule, as well as other policy changes to payment under Part B. These changes would be applicable to services furnished on or after January 1.

Statement of Need: The statute requires that we establish each year, by regulation, payment amounts for all physicians' services furnished in all fee schedule areas. This major proposed rule would implement changes affecting Medicare Part B payment to physicians and other Part B suppliers. The final rule has a statutory publication date of November 1, 2012, and an implementation date of January 1, 2013.

Summary of Legal Basis: Section 1848 of the Social Security Act (the Act) establishes the payment for physician services provided under Medicare. Section 1848 of the Act imposes a deadline of no later than November 1 for publication of the final rule or final physician fee schedule.

Alternatives: None. This implements a statutory requirement.

Anticipated Cost and Benefits: Total expenditures will be adjusted for CY 2013.

Risks: If this regulation is not published timely, physician services will not be paid appropriately, beginning January 1, 2013.

Timetable:

Action Date FR Cite
NPRM 06/00/12

Regulatory Flexibility Analysis Required: Yes.

Small Entities Affected: Businesses.

Government Levels Affected: Undetermined.

Federalism: Undetermined.

Agency Contact: Christina Ritter, Director, Division of Practitioner Services, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mail Stop C4-03-06, 7500 Security Blvd., Baltimore, MD 21244, Phone: 410 786-4636, Email: christina.ritter@cms.hhs.gov.

RIN: 0938-AR11

HHS—CMS Back to Top

49. • Changes to the Hospital Inpatient an Long-Term Care Prospective Payment System for FY 2013 (CMS-1588-P) (Section 610 Review) Back to Top

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

Unfunded Mandates: Undetermined.

Legal Authority: Sec 1886(d) of the Social Security Act

CFR Citation: 42 CFR 412.

Legal Deadline: NPRM, Statutory, April 1, 2012. Final, Statutory, August 1, 2012.

Abstract: This annual major proposed rule would revise the Medicare hospital inpatient and long-term care hospital prospective payment systems for operating and capital-related costs. This proposed rule would implement changes arising from our continuing experience with these systems.

Statement of Need: CMS annually revises the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital-related costs to implement changes arising from our continuing experience with these systems. In addition, we describe the proposed changes to the amounts and factors used to determine the rates for Medicare hospital inpatient services for operating costs and capital-related costs. Also, CMS annually updates the payment rates for the Medicare prospective payment system (PPS) for inpatient hospital services provided by long-term care hospitals (LTCHs). The proposed rule solicits comments on the proposed IPPS and LTCH payment rates and new policies. CMS will issue a final rule containing the payment rates for the FY 2013 IPPS and LTCHs at least 60 days before October 1, 2012.

Summary of Legal Basis: The Social Security Act (the Act) sets forth a system of payment for the operating costs of acute care hospital inpatient stays under Medicare Part A (Hospital Insurance) based on prospectively set rates. The Act requires the Secretary to pay for the capital-related costs of hospital inpatient and Long Term Care stays under a PPS. Under these systems, Medicare payment for hospital inpatient and Long Term Care operating and capital-related costs is made at predetermined, specific rates for each hospital discharge. These changes would be applicable to services furnished on or after October 1, 2012.

Alternatives: None. This implements a statutory requirement.

Anticipated Cost and Benefits: Total expenditures will be adjusted for FY 2013.

Risks: If this regulation is not published timely, inpatient hospital and LTCH services will not be paid appropriately beginning October 1, 2012.

Timetable:

Action Date FR Cite
NPRM 04/00/12  

Regulatory Flexibility Analysis Required: Yes.

Small Entities Affected: Businesses.

Government Levels Affected: Federal.

Agency Contact: Ankit Patel, Health Insurance Specialist, Division of Acute Care, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Hospital and Ambulatory Policy Group, Mail Stop, C4-25-11, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-4537, Email: ankit.patel@cms.hhs.gov.

RIN: 0938-AR12

HHS—CMS Back to Top

Final Rule Stage

50. Medicaid Eligibility Expansion Under the Affordable Care Act of 2010 (CMS-2349-F) Back to Top

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

Legal Authority: Pub. L. 111-148, secs 1413, 1414, 2001, 2002, 2101, 2201

CFR Citation: 42 CFR 431, 435, 457.

Legal Deadline: Final, Statutory, January 1, 2014.

Abstract: This rule implements provisions of the Affordable Care Act expanding access to health insurance through improvements in Medicaid, the establishment of American Health Benefit Exchanges (“Exchanges”), and coordination between Medicaid, the Children's Health Insurance Program (CHIP), and Exchanges. This rule also implements sections of the Affordable Care Act related to Medicaid eligibility, enrollment simplification, and coordination.

Statement of Need: This rule expands Medicaid eligibility, simplifies Medicaid eligibility procedures, and streamlines Medicaid enrollment processes. It also coordinates eligibility processes and policies with the processes for premium tax credits for Exchange coverage. Millions of uninsured low-income persons who do not have access to, or could not afford, health insurance will obtain coverage.

Summary of Legal Basis: The provisions that are included in this rule are necessary to implement the requirements of sections 1413, 1414, 2001, 2002, 2101, and 2201 of the Affordable Care Act.

Alternatives: None. This is a statutory requirement.

Anticipated Cost and Benefits: We anticipate that this rule provides significant benefits to low-income individuals by expanding the availability of affordable health coverage. We expect that States may incur short term increases in administrative costs (depending on their current systems and practices) but that these costs will be wholly offset by administrative savings over the longer term.

Risks: None.

Timetable:

Action Date FR Cite
NPRM 08/17/11 76 FR 51148
NPRM Comment Period End 10/31/11  
Final Action 02/00/12  

Regulatory Flexibility Analysis Required: Undetermined.

Small Entities Affected: Governmental Jurisdictions.

Government Levels Affected: Federal, Local, State, Tribal.

Agency Contact: Sarah DeLone, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mail Stop S2-01-16, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-0615, Email: sarah.delone@cms.hhs.gov.

RIN: 0938-AQ62.

HHS—CMS Back to Top

51. Establishment of Exchanges and Qualified Health Plans Part I (CMS-9989-F) Back to Top

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

Legal Authority: Affordable Care Act, secs 1301 to 1343, secs 1401 to 1413

CFR Citation: 45 CFR 155 to 157.

Legal Deadline: Final, Statutory, January 1, 2014.

Abstract: This rule implements the new Affordable Insurance Exchanges (“Exchanges”), consistent with title I of the Affordable Care Act of 2010, referred to collectively as the Affordable Care Act. The Exchanges will provide competitive marketplaces for individuals and small employers to directly compare available private health insurance options on the basis of price, quality, and other factors. The Exchanges, which will become operational by January 1, 2014, will help enhance competition in the health insurance market, improve choice of affordable health insurance, and give small businesses the same purchasing clout as large businesses.

Statement of Need: A central aim of Title I of the Affordable Care Act is to expand access to health insurance coverage through the establishment of Exchanges. The number of uninsured Americans is rising due to the lack of affordable insurance, barriers to insurance for people with pre-existing conditions, and high prices due to limited competition and market failures. Millions of people without health insurance use health care services for which they do not pay, shifting the uncompensated cost of their care to health care providers. Providers pass much of this cost to insurance companies, resulting in higher premiums that make insurance unaffordable to even more people. The Affordable Care Act includes a number of policies to address these problems, including the creating of Affordable Insurance Exchanges.

Summary of Legal Basis: This rule implements the new Affordable Insurance Exchanges consistent with title I of the Affordable Care Act of 2010.

Alternatives: None. This is a statutory requirement.

Anticipated Cost and Benefits: This rule will help enhance competition in the health insurance market, promote the choice of affordable health insurance, and give small businesses the same purchasing clout as large businesses. States seeking to operate an Exchange will incur administrative expenses as a result of implementing and subsequently maintaining Exchanges. There is no Federal requirement that each State establish an Exchange.

Risks: If this regulation is not published, the Exchanges will not become operational by January 1, 2014, thereby violating the statute.

Timetable:

Action Date FR Cite
NPRM 07/15/11 76 FR 41866
NPRM Comment Period End 09/28/11  
Final Action 02/00/12  

Regulatory Flexibility Analysis Required: Undetermined.

Small Entities Affected: Businesses, Governmental Jurisdictions.

Government Levels Affected: Federal, State, Tribal.

Federalism: This action may have federalism implications as defined in EO 13132.

Agency Contact: Alissa DeBoy, Department of Health and Human Services, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 301 492-4428, Email: alissa.deboy@cms.hhs.gov.

RIN: 0938-AQ67

HHS—CMS Back to Top

52. • State Requirements for Exchange—Reinsurance and Risk Adjustments (CMS-9975-F) Back to Top

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

Legal Authority: Pub. L. 111-148, secs 1341 and 1342

CFR Citation: 45 CFR 155, 156.

Legal Deadline: Final, Statutory, January 1, 2014.

Abstract: This rule implements requirements for States related to reinsurance, risk corridors, and a permanent risk adjustment. The goals of these programs are to minimize negative impacts of adverse selection inside the Exchanges.

Statement of Need: This rule finalizes guidelines for the transitional risk-sharing programs, reinsurance and risk corridors, as well as for the risk adjustment program that will continue beyond the first 3 years of Exchange operation. The purpose of these programs is to protect health insurance issuers from the negative effects of adverse selection and to protect consumers from increases in premiums due to uncertainty for issuers.

Summary of Legal Basis: This rule implements the new Affordable Insurance Exchanges consistent with title I of the Affordable Care Act of 2010.

Alternatives: None. This is a statutory requirement.

Anticipated Cost and Benefits: Payments through reinsurance, risk adjustment, and risk corridors reduce the increased risk of financial loss that health insurance issuers might otherwise expect to incur in 2014 due to market reforms such as guaranteed issue and the elimination of medical underwriting. These payments reduce the risk to the issuer and the issuer can pass on a reduced risk premium to enrollees. Administrative costs will vary across States and health insurance issuers depending on the sophistication of technical infrastructure and prior experience with data collection and risk adjustment. States and issuers that already have systems in place for data collection and reporting will have reduced administrative costs.

Risks: If this regulation is not published, the Exchanges will not become operational by January 1, 2014, thereby violating the statute.

Timetable:

Action Date FR Cite
NPRM 07/15/11 76 FR 41866
NPRM Comment Period End 09/28/11  
Final Action 01/00/12  

Regulatory Flexibility Analysis Required: Undetermined.

Small Entities Affected: Governmental Jurisdictions.

Government Levels Affected: State.

Federalism: This action may have federalism implications as defined in EO 13132.

Agency Contact: Alissa DeBoy, Health Insurance Specialist, Center for Consumer Information & Insurance Oversight, Department of Health and Human Services, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 301 492-4428, Email: alissa.deboy@cms.hhs.gov.

RIN: 0938-AR07

BILLING CODE 4150-24-P

DEPARTMENT OF HOMELAND SECURITY (DHS) Back to Top

Fall 2011 Statement of Regulatory Priorities

The Department of Homeland Security (DHS or Department) was created in 2003 pursuant to the Homeland Security Act of 2002, Public Law 107-296. DHS has a vital mission: To secure the Nation from the many threats we face. This requires the dedication of more than 225,000 employees in jobs that range from aviation and border security to emergency response, from cybersecurity analyst to chemical facility inspector. Our duties are wide-ranging, but our goal is clear—keeping America safe.

Our mission gives us six main areas of responsibility:

1. Prevent Terrorism and Enhance Security,

2. Secure and Manage Our Borders,

3. Enforce and Administer our Immigration Laws,

4. Safeguard and Secure Cyberspace,

5. Ensure Resilience to Disasters, and

6. Mature and Strengthen DHS.

In achieving these goals, we are continually strengthening our partnerships with communities, first responders, law enforcement, and government agencies—at the State, local, tribal, Federal, and international levels. We are accelerating the deployment of science, technology, and innovation in order to make America more secure, and we are becoming leaner, smarter, and more efficient, ensuring that every security resource is used as effectively as possible. For a further discussion of our main areas of responsibility, see the DHS Web site at http://www.dhs.gov/xabout/responsibilities.shtm.

The regulations we have summarized below in the Department's fall 2011 regulatory plan and in the agenda support the Department's responsibility areas listed above. These regulations will improve the Department's ability to accomplish its mission.

The regulations we have identified in this year's fall regulatory plan continue to address legislative initiatives including, but not limited to, the following acts: The Implementing Recommendations of the 9/11 Commission Act of 2008 (9/11 Act), Public Law 110-53 (Aug. 3, 2007); the Post-Katrina Emergency Management Reform Act of 2006 (PKEMRA), Public Law 109-295 (Oct. 4, 2006); the Consolidated Natural Resources Act of 2008 (CNRA), Public Law 110-220 (May 7, 2008); the Security and Accountability for Every Port Act of 2006 (SAFE Port Act), Public Law 109-347 (Oct. 13, 2006); and the Consolidated Security, Disaster Assistance, and Continuing Appropriations Act, 2009, Public Law 110-329 (Sep. 30, 2008).

DHS strives for organizational excellence and uses a centralized and unified approach in managing its regulatory resources. The Office of the General Counsel manages the Department's regulatory program, including the agenda and regulatory plan. In addition, DHS senior leadership reviews each significant regulatory project to ensure that the project fosters and supports the Department's mission.

The Department is committed to ensuring that all of its regulatory initiatives are aligned with its guiding principles to protect civil rights and civil liberties, integrate our actions, build coalitions and partnerships, develop human resources, innovate, and be accountable to the American public.

DHS is also committed to the principles described in Executive Orders 13563 and 12866 (as amended). Both Executive orders direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. Many of the regulations in DHS' regulatory plan support the Department's efforts pursuant to the DHS Final Plan for the Retrospective Review of Existing Regulations. DHS issued its final plan on August 22, 2011.

Finally, the Department values public involvement in the development of its regulatory plan, agenda, and regulations, and takes particular concern with the impact its rules have on small businesses. DHS and each of its components continue to emphasize the use of plain language in our notices and rulemaking documents to promote a better understanding of regulations and increased public participation in the Department's rulemakings.

Retrospective Review of Existing Regulations

Pursuant to section 6 of Executive Order 13563 “Improving Regulation and Regulatory Review” (Jan. 18, 2011), DHS identified the following regulatory actions in the Department's Final Plan for the Retrospective Review of Existing Regulations (“DHS Final Plan”). DHS has identified these regulatory actions as associated with retrospective review and analysis. You can view the DHS Final Plan on www.regulations.gov by searching for docket number DHS-2011-0015. Some of the regulatory actions on the below list may be completed actions, which do not appear in The Regulatory Plan. You can find more information about these completed rulemakings in past publications of the Unified Agenda (search the Completed Actions sections) on www.reginfo.gov. Some of the entries on this list, however, are active rulemakings. You can find entries for these rulemakings on www.regulations.gov.

RIN Rule Significantly Reduces Burdens on Small Businesses
1615-AB71 Registration Requirement for Petitioners Seeking to File H-1B Petitions on Behalf of Aliens Subject to Numerical Limitations No.
1615-AB76 Commonwealth of the Northern Mariana Islands Transitional Worker Classification No.
1615-AB83 Immigration Benefits Business Transformation, Increment I No.
1615-AB95 Immigration Benefits Business Transformation: Nonimmigrants; Student and Exchange Visitor Program No.
1625-AA16 Implementation of the 1995 Amendments to the International Convention on Standards of Training, Certification, and Watchkeeping (STCW) for Seafarers, 1978 No.
1625-AB38 Updates to Maritime Security No.
TBD Elimination of TWIC for Certain Mariner Populations (Implementation of Section 809 of the 2010 Coast Guard Authorization Act) No.
1651-AA73 Establishment of Global Entry Program No.
1651-AA93 Closing of the Port of Whitetail, Montana No.
1651-AA94 Internet Publication of Administrative Seizure/Forfeiture Notices No.
1652-AA01 Aviation Security Infrastructure Fee (ASIF) No.
1652-AA35 Flight Training for Aliens and Other Designated Individuals; Security Awareness Training for Flight School Employees No.
1653-AA44 Clarification of Eligibility Criteria for F and M Students and for Schools Certified by the Student and Exchange Visitor Program To Enroll F and/or M Students No.

The fall 2011 regulatory plan for DHS includes regulations from DHS components—including U.S. Citizenship and Immigration Services (USCIS), the U.S. Coast Guard (Coast Guard), U.S. Customs and Border Protection (CBP), the Federal Emergency Management Agency (FEMA), the U.S. Immigration and Customs Enforcement (ICE), and the Transportation Security Administration (TSA), which have active regulatory programs. In addition, it includes regulations from the Department's major offices and directorates such as the National Protection and Programs Directorate (NPPD). Below is a discussion of the fall 2011 regulatory plan for DHS regulatory components, as well as for DHS offices and directorates.

United States Citizenship and Immigration Services

U.S. Citizenship and Immigration Services (USCIS) administers immigration benefits and services while protecting and securing our homeland. USCIS has a strong commitment to welcoming individuals who seek entry through the U.S. immigration system, providing clear and useful information regarding the immigration process, promoting the values of citizenship, and assisting those in need of humanitarian protection. Based on a comprehensive review of the planned USCIS regulatory agenda, USCIS will promulgate several rulemakings to directly support these commitments and goals.

Improvements to the Immigration System. USCIS is currently engaged in a multi-year transformation effort to create a more efficient, effective, and customer-focused organization by improving our business processes and technology. In the coming years, USCIS will publish rules to facilitate that effort, including rules that will remove references to form numbers, form titles, expired regulatory provisions, and descriptions of internal procedure; will mandate electronic filing in certain circumstances; and will comprehensively reorganize 8 CFR part 214. In addition, to streamline processes and improve efficiency, USCIS plans to revise its regulations governing appeals and motions before the Administrative Appeals Office. USCIS will also finalize a final rule related to the extension of immigration law to the Commonwealth of the Northern Mariana Islands.

Requirements for Filing Motions and Administrative Appeals. USCIS will propose to revise the procedural regulations governing appeals and motions to reopen or reconsider before its Administrative Appeals Office, and to require that applicants and petitioners exhaust administrative remedies before seeking judicial review of an unfavorable decision. The changes proposed by the rule will streamline the procedures before the Administrative Appeals Office and improve the efficiency of the adjudication process.

Regulations Related to the Commonwealth of Northern Mariana Islands. During 2009, USCIS issued three regulations to implement the extension of U.S. immigration law to the Commonwealth of Northern Mariana Islands (CNMI), as required under title VII of the Consolidated Natural Resources Act of 2008. During fiscal year 2011, USCIS issued two final rules related to the extension of the U.S. immigration law to the CNMI. In fiscal year 2012, USCIS will issue the following CNMI final rule: The joint USCIS/Department of Justice (DOJ) regulation “Application of Immigration Regulations to the CNMI.”

Regulatory Changes Involving Humanitarian Benefits. USCIS offers protection to individuals who face persecution by adjudicating applications for refugees and asylees. Other humanitarian benefits are available to individuals who have been victims of severe forms of trafficking or criminal activity.

Asylum and Withholding Definitions. USCIS plans a regulatory proposal to amend the regulations that govern asylum eligibility and refugee status determinations. The amendments are expected to focus on portions of the regulations that deal with determinations of whether suffered or feared persecution is on account of a protected ground, the requirements for establishing that the government is unable or unwilling to protect the applicant, and the definition of membership in a particular social group. This effort should provide greater clarity and consistency in this important area of the law.

Exception to the Persecutor Bar for Asylum, Refugee, or Temporary Protected Status, and Withholding of Removal. In a joint rulemaking, DHS and DOJ will propose amendments to existing DHS and DOJ regulations to resolve ambiguity in the statutory language precluding eligibility for asylum, refugee resettlement, temporary protected status, and withholding or removal of an applicant who ordered, incited, assisted, or otherwise participated in the persecution of others. The proposed rule would provide a limited exception for persecutory actions taken by the applicant under duress and would clarify the required level of the applicant's knowledge of the persecution.

“T” and “U” Nonimmigrants. USCIS plans additional regulatory initiatives related to T nonimmigrants (victims of trafficking), U nonimmigrants (victims of criminal activity), and Adjustment of Status for T and U status holders. By promulgating additional regulations related to these victims of specified crimes or severe forms of human trafficking, USCIS hopes to provide greater consistency for these vulnerable groups, their advocates, and the community. These rulemakings will contain provisions to adjust documentary requirements for this vulnerable population and provide greater clarity to the law enforcement community.

Application of the William Wilberforce Trafficking Victims Protection Act of 2008. In a joint rulemaking, DHS and DOJ will propose amendments to implement the William Wilberforce Trafficking Victims Protection Act of 2008 (TVPRA). Among other things, this statute specified that USCIS has initial jurisdiction over an asylum application filed by an unaccompanied alien child in removal proceedings before an immigration judge in DOJ. The agencies implemented this legislation with interim procedures that the TVPRA mandated within 90 days after enactment. The proposed rule would amend both agencies' regulations to finalize the procedures to determine when an alien child is unaccompanied and how jurisdiction is transferred to USCIS for initial adjudication of the child's asylum application. In addition, this rule would address adjustment of status for special immigrant juveniles and voluntary departure for unaccompanied alien children in removal proceedings.

United States Coast Guard

The U.S. Coast Guard (Coast Guard) is a military, multi-mission, maritime service of the United States and the only military organization within DHS. It is the principal Federal agency responsible for maritime safety, security, and stewardship, and delivers daily value to the Nation through multi-mission resources, authorities, and capabilities.

Effective governance in the maritime domain hinges upon an integrated approach to safety, security, and stewardship. The Coast Guard's policies and capabilities are integrated and interdependent, delivering results through a network of enduring partnerships. The Coast Guard's ability to field versatile capabilities and highly-trained personnel is one of the U.S. Government's most significant and important strengths in the maritime environment.

America is a maritime nation, and our security, resilience, and economic prosperity are intrinsically linked to the oceans. Safety, efficient waterways, and freedom of transit on the high seas are essential to our well-being. The Coast Guard is leaning forward, poised to meet the demands of the modern maritime environment. The Coast Guard creates value for the public through solid prevention and response efforts. Activities involving oversight and regulation, enforcement, maritime presence, and public and private partnership foster increased maritime safety, security, and stewardship.

The statutory responsibilities of the Coast Guard include ensuring marine safety and security, preserving maritime mobility, protecting the marine environment, enforcing U.S. laws and international treaties, and performing search and rescue. The Coast Guard supports the Department's overarching goals of mobilizing and organizing our Nation to secure the homeland from terrorist attacks, natural disasters, and other emergencies. The rulemaking projects identified for the Coast Guard in the Unified Agenda, and the rules appearing in the fall 2011 regulatory plan below, contribute to the fulfillment of those responsibilities and reflect our regulatory policies.

Implementation of the 1995 Amendments to the International Convention on Standards of Training, Certification, and Watchkeeping (STCW) for Seafarers, 1978. The Coast Guard proposed to amend its regulations to implement changes to an interim rule published on June 26, 1997. These proposed amendments go beyond changes found in the interim rule and seek to more fully incorporate the requirements of the STCW in the requirements for the credentialing of U.S. merchant mariners. The proposed changes are primarily substantive and: (1) Are necessary to continue to give full and complete effect to the STCW Convention; (2) incorporate lessons learned from implementation of the STCW through the interim rule and through policy letters and Navigation and Vessel Inspection Circulars (NVICs); and (3) attempt to clarify regulations that have generated confusion. The Coast Guard published this proposal as a Supplemental Notice of Proposed Rulemaking (SNPRM) on August 1, 2011. The Coast Guard intends to review and analyze comments received on that SNPRM, and publish a subsequent rule complying with the requirements of the newly amended STCW Convention. DHS included this rulemaking in the DHS Final Plan for the Retrospective Review of Existing Regulations, which DHS released on August 22, 2011.

Vessel Requirements for Notices of Arrival and Departure, and Automatic Identification System. The Coast Guard intends to expand the applicability of notice of arrival and departure (NOAD) and automatic identification system (AIS) requirements to include more commercial vessels. This rule, once final, would expand the applicability of notice of arrival (NOA) requirements to include additional vessels, establish a separate requirement for vessels to submit notices of departure (NOD) when departing for a foreign port or place, set forth a mandatory method for electronic submission of NOA and NOD, and modify related reporting content, timeframes, and procedures. This rule would also extend the applicability of AIS requirements beyond Vessel Traffic Service (VTS) areas to all U.S. navigable waters and require additional commercial vessels install and use AIS. These changes are intended to improve navigation safety, enhance Coast Guard's ability to identify and track vessels, and heighten the Coast Guard's overall maritime domain awareness, thus helping the Coast Guard address threats to maritime transportation safety and security and mitigate the possible harm from such threats.

Nontank Vessel Response Plans and Other Vessel Response Plan Requirements. The Coast Guard intends to promulgate a rule to further protect the Nation from the threat of oil spills in U.S. waters, which supports the strategic goals of protection of natural resources and maritime mobility. The rule, once final, would require owners and operators of nontank vessels to prepare and submit oil spill response plans. The Federal Water Pollution Control Act defines nontank vessels as self-propelled vessels of 400 gross tons or greater that operate on the navigable waters of the United States, carry oil of any kind as fuel for main propulsion, and are not tank vessels. The rule would specify the content of a response plan and would address, among other issues, the requirement that a plan for responding to a worst case discharge and a substantial threat of such a discharge. Additionally, the rule would require vessel owners and operators to submit their vessel response plan control number as part of already required notice of arrival information.

Revision to Transportation Worker Identification Credential (TWIC) Requirements for Mariners. The Coast Guard is developing revisions to its merchant mariner credentialing regulations, to implement changes made by section 809 of the Coast Guard Authorization Act of 2010. Section 809 eliminated the requirement for certain mariner populations to obtain TWIC. The Coast Guard is also considering revising its regulations to provide an exemption for certain fees associated with merchant mariner credentialing for those mariners not required to hold a TWIC who may still be required to visit a TWIC enrollment center to provide the information necessary to obtain a Merchant Mariner Credential. DHS highlighted this rulemaking in the DHS Final Plan for the Retrospective Review of Existing Regulations, which DHS released on August 22, 2011.

Offshore Supply Vessels of 6,000 or more GT ITC. The Coast Guard Authorization Act of 2010 (the Act) removed the size limit on offshore supply vessels (OSVs) and directed the Coast Guard to issue, as soon as practicable, regulations to implement section 617 of the Act. As required by the Act, this regulation would provide for the safe carriage of oil, hazardous substances, and individuals in addition to crew on OSVs of at least 6,000 gross tonnage as measured under the International Convention on Tonnage Measurement of Ships (6,000 GT ITC). In developing the regulations, the Coast Guard is taking into account the characteristics of offshore supply vessels, their methods of operation, and their service in support of exploration, exploitation, or production of offshore mineral or energy resources.

United States Customs and Border Protection

U.S. Customs and Border Protection (CBP) is the Federal agency principally responsible for the security of our Nation's borders at and between the ports of entry and at official crossings into the United States. CBP must accomplish its border security and enforcement mission while facilitating the flow of legitimate trade and travel. The primary mission of CBP is its homeland security mission; that is, to prevent terrorists and terrorist weapons from entering the United States. An important aspect of this priority mission involves improving security at our borders and ports of entry, but it also means extending our zone of security beyond our physical borders.

CBP is also responsible for administering laws concerning the import and export of goods into and out of the United States, and enforcing the laws concerning the entry of persons into and out of the United States. This includes regulating and facilitating international trade; collecting import duties; enforcing U.S. trade, immigration, and other laws of the United States at our borders; inspecting imports and exports; overseeing the activities of persons and businesses engaged in importing; enforcing the laws concerning smuggling and trafficking in contraband; apprehending individuals attempting to enter the United States illegally; protecting our agriculture and economic interests from harmful pests and diseases; conducting inspections of all people, vehicles, and cargo entering the United States; enforcing export controls; and protecting U.S. businesses from theft of their intellectual property.

In carrying out its priority mission, CBP's goal is to facilitate the processing of legitimate trade and people efficiently without compromising security. Consistent with its primary mission of homeland security, CBP intends to finalize several rules during the next fiscal year that are intended to improve security at our borders and ports of entry. We have highlighted some of these rules below.

Electronic System for Travel Authorization (ESTA). On June 9, 2008, CBP published an interim final rule amending DHS regulations to implement the Electronic System for Travel Authorization (ESTA) for aliens who wish to enter the United States under the Visa Waiver Program (VWP) at air or sea ports of entry. This rule is intended to fulfill the requirements of section 711 of the Implementing Recommendations of the 9/11 Commission Act of 2007 (9/11 Act). The rule establishes ESTA and delineates the data field DHS has determined will be collected by the system. The rule requires that each alien traveling to the United States under the VWP must obtain electronic travel authorization via the ESTA in advance of such travel. VWP travelers may obtain the required ESTA authorization by electronically submitting to CBP biographic and other information as currently required by the I-94W Nonimmigrant Alien Arrival/Departure Form (I-94W). By Federal Register notice dated November 13, 2008, the Secretary of Homeland Security informed the public that ESTA would become mandatory beginning January 12, 2009. This means that all VWP travelers must either obtain travel authorization in advance of travel under ESTA or obtain a visa prior to traveling to the United States.

By shifting from a paper to an electronic form and requiring the data in advance of travel, CBP will be able to determine before the alien departs for the U.S. the eligibility of nationals from VWP countries to travel to the United States and to determine whether such travel poses a law enforcement or security risk. By modernizing the VWP, the ESTA is intended to increase national security and provide for greater efficiencies in the screening of international travelers by allowing for vetting of subjects of potential interest well before boarding, thereby reducing traveler delays based on lengthy processes at ports of entry. On August 9, 2010, CBP published an interim final rule amending the ESTA regulations to require ESTA applicants to pay a congressionally mandated fee, which is the sum of two amounts, a $10 travel promotion fee for an approved ESTA and a $4.00 operational fee for the use of ESTA set by the Secretary of Homeland Security to at least ensure the recovery of the full costs of providing and administering the ESTA system. During the next fiscal year, CBP intends to issue a final rule on ESTA and the ESTA fee.

Importer Security Filing and Additional Carrier Requirements. The Security and Accountability for Every Port Act of 2006 (SAFE Port Act) calls for CBP to promulgate regulations to require the electronic transmission of additional data elements for improved high-risk targeting. See Public Law 109- 347, section 203 (October 13, 2006). This includes appropriate security elements of entry data for cargo destined for the United States by vessel prior to loading of such cargo on vessels at foreign seaports. The SAFE Port Act requires that the information collected reasonably improve CBP's ability to identify high-risk shipments to prevent smuggling and ensure cargo safety and security.

On November 25, 2008, CBP published an interim final rule “Importer Security Filing and Additional Carrier Requirements,” amending CBP Regulations to require carriers and importers to provide to CBP via a CBP-approved electronic data interchange system, information necessary to enable CBP to identify high-risk shipments to prevent smuggling, and ensure cargo safety and security. This rule, which became effective on January 26, 2009, improves CBP risk assessment and targeting capabilities, facilitates the prompt release of legitimate cargo following its arrival in the United States, and assists CBP in increasing the security of the global trading system. The comment period for the interim final rule concluded on June 1, 2009. CBP is analyzing comments and conducting a structured review of certain flexibility provided in the interim final rule. CBP intends to publish a final rule during the next fiscal year.

Implementation of the Guam-CNMI Visa Waiver Program. CBP published an interim final rule in November 2008 amending the DHS regulations to replace the current Guam Visa Waiver Program with a new Guam-CNMI Visa Waiver program. This rule implements portions of the Consolidated National Resources Act of 2008 (CNRA), which extends the immigration laws of the United States to the Commonwealth of the Northern Mariana Islands (CNMI) and, among others things, provides for a visa waiver program for travel to Guam and the CNMI. The amended regulations set forth the requirements for nonimmigrant visitors who seek admission for business or pleasure and solely for entry into and stay on Guam or the CNMI without a visa. The rule also establishes six ports of entry in the CNMI for purposes of administering and enforcing the Guam-CNMI Visa Waiver program. CBP intends to issue a final rule during the next fiscal year.

Global Entry Program. In the fall of 2009, pursuant to section 7208(k) of the Intelligence Reform and Terrorism Prevention Act of 2004, as amended, CBP issued a Notice of Proposed Rulemaking (NPRM), proposing to establish an international trusted traveler program, called Global Entry. This voluntary program would allow CBP to expedite clearance of pre-approved, low-risk air travelers into the United States. CBP has been operating the Global Entry program as a pilot at several airports since June 6, 2008. Based on the successful operation of the pilot, CBP proposed to establish Global Entry as a permanent voluntary regulatory program. CBP has evaluated the public comments received in response to the NPRM and intends to issue a final rule during the next fiscal year.

In the above paragraphs, DHS discusses the CBP regulations that foster DHS's mission. CBP also issues regulations related to the mission of the Department of the Treasury. Under section 403(1) of the Homeland Security Act of 2002, the former U.S. Customs Service, including functions of the Secretary of the Treasury relating thereto, transferred to the Secretary of Homeland Security. As part of the initial organization of DHS, the Customs Service inspection and trade functions were combined with the immigration and agricultural inspection functions and the Border Patrol and transferred into CBP. It is noted that certain regulatory authority of the United States Customs Service relating to customs revenue function was retained by the Department of the Treasury (see the Department of the Treasury regulatory plan). In addition to its plans to continue issuing regulations to enhance border security, CBP, during fiscal year 2012, expects to continue to issue regulatory documents that will facilitate legitimate trade and implement the trade benefit program. CBP regulations regarding the customs revenue function are discussed in the regulatory plan of the Department of the Treasury.

Federal Emergency Management Agency

The mission of the Federal Emergency Management Agency (FEMA) is to support our citizens and first responders to ensure that, as a Nation, we work together to build, sustain, and improve our capability to prepare for, protect against, respond to, recover from, and mitigate all hazards. In fiscal year 2012, FEMA will continue to serve that mission and promote the Department of Homeland Security's goals. In furtherance of the Department and Agency's goals, in the upcoming fiscal year, FEMA will work on regulations to implement provisions of the Post-Katrina Emergency Management Reform Act of 2006 (PKEMRA) (Pub. L. 109-295, Oct. 4, 2006) and to implement lessons learned from past events.

Public Assistance Program Regulations. FEMA will work to revise the Public Assistance Program regulations in 44 CFR part 206 to reflect changes made to the Robert T. Stafford Disaster Relief and Emergency Assistance Act by PKEMRA, the Pets Evacuation and Transportation Standards Act of 2006 (PETS Act) (Pub. L. 109-308, Oct. 6, 2006), the Local Community Recovery Act of 2006 (Pub. L. 109-218, Apr. 20, 2006), and the Security and Accountability for Every Port Act of 2006 (SAFE Port Act) (Pub. L. 109-347, Oct. 13, 2006), and to make other substantive and nonsubstantive clarifications and corrections to the Public Assistance regulations. The proposed changes would expand eligibility to include performing arts facilities and community arts centers pursuant to section 688 of PKEMRA; include education in the list of critical services pursuant to section 689(h) of PKEMRA, thus allowing private nonprofit educational facilities to be eligible for restoration funding; add accelerated Federal assistance to available assistance pursuant to section 681 of PKEMRA; include household pets and service animals in essential assistance pursuant to section 689 of PKEMRA and section 4 of the PETS Act; provide for expedited payments of grant assistance for the removal of debris pursuant to section 610 of the SAFE Port Act; and allow for a contract to be set aside for award based on a specific geographic area pursuant to section 2 of the Local Community Recovery Act of 2006. Other changes would include adding or changing requirements to improve and streamline the Public Assistance grant application process.

Federal Law Enforcement Training Center

The Federal Law Enforcement Training Center (FLETC) does not have any significant regulatory actions planned for fiscal year 2012.

United States Immigration and Customs Enforcement

ICE is the principal criminal investigative arm of the Department of Homeland Security and one of the three Department components charged with the civil enforcement of the Nation's immigration laws. Its primary mission is to protect national security, public safety, and the integrity of our borders through the criminal and civil enforcement of Federal law governing border control, customs, trade, and immigration.

During fiscal year 2012, ICE will pursue rulemaking actions that improve two critical subject areas: The detention of aliens who are subject to final orders of removal and the processes for the Student and Exchange Visitor Program (SEVP).

Continued Detention of Aliens Subject to Final Orders of Removal. ICE will improve the post order custody review process in a Final Rule related to the continued detention of aliens subject to final orders of removal in light of the U.S. Supreme Court's decisions in Zadvydas v. Davis, 533 U.S. 678 (2001) and Clark v. Martinez, 543 U.S. 371 (2005), as well as changes pursuant to the enactment of the Homeland Security Act of 2002. During fiscal year 2012, ICE will also issue a companion Notice of Proposed Rulemaking (NPRM) that will allow the public an opportunity to comment on new sections of the custody determination process not previously published for comment.

Processes for the Student and Exchange Visitor Program. ICE will improve SEVP processes by publishing a final Optional Practical Training (OPT) rule, which will respond to comments on the OPT Interim Final Rule (IFR). The IFR increased the maximum period of OPT from 12 months to 29 months for nonimmigrant students who have completed a science, technology, engineering, or mathematics degree and who accept employment with employers who participate in USCIS's E-Verify employment verification program.

National Protection and Programs Directorate

The goal of the National Protection and Programs Directorate (NPPD) is to advance the Department's risk-reduction mission. Reducing risk requires an integrated approach that encompasses both physical and virtual threats and their associated human elements.

Ammonium Nitrate Security Program. The Secure Handling of Ammonium Nitrate Act, section 563 of the Fiscal Year 2008 Department of Homeland Security Appropriations Act, Public Law 110-161, amended the Homeland Security Act of 2002 to provide DHS with the authority to “regulate the sale and transfer of ammonium nitrate by an ammonium nitrate facility * * * to prevent the misappropriation or use of ammonium nitrate in an act of terrorism.”

The Secure Handling of Ammonium Nitrate Act directs DHS to promulgate regulations requiring potential buyers and sellers of ammonium nitrate to register with DHS. As part of the registration process, the statute directs DHS to screen registration applicants against the Federal Government's Terrorist Screening Database. The statute also requires sellers of ammonium nitrate to verify the identities of those seeking to purchase it; to record certain information about each sale or transfer of ammonium nitrate; and to report thefts and losses of ammonium nitrate to DHS.

The Ammonium Nitrate Security Program Notice of Proposed Rulemaking proposes requirements that would implement the Secure Handling of Ammonium Nitrate Act. The rule would aid the Federal Government in its efforts to prevent the misappropriation of ammonium nitrate for use in acts of terrorism. By preventing such misappropriation, this rule aims to limit terrorists' abilities to threaten the public and to threaten the Nation's critical infrastructure and key resources. By securing the Nation's supply of ammonium nitrate, it will be more difficult for terrorists to obtain ammonium nitrate materials for use in terrorist acts.

On October 29, 2008, DHS published an Advance Notice of Proposed Rulemaking (ANPRM) for the Secure Handling of Ammonium Nitrate Program, and received a number of public comments on that ANPRM. DHS reviewed those comments and published a Notice of Proposed Rulemaking (NPRM) on August 3, 2011. NPPD will accept public comment on until December 1, 2011, after which NPPD will review the public comments and develop a Final Rule related to the Security Handling of Ammonium Nitrate Program.

Transportation Security Administration

The Transportation Security Administration (TSA) protects the Nation's transportation systems to ensure freedom of movement for people and commerce. TSA is committed to continuously setting the standard for excellence in transportation security through its people, processes, and technology as we work to meet the immediate and long-term needs of the transportation sector.

In fiscal year 2012, TSA will promote the DHS mission by emphasizing regulatory efforts that allow TSA to better identify, detect, and protect against threats against various modes of the transportation system, while facilitating the efficient movement of the traveling public, transportation workers, and cargo.

General Aviation Security and Other Aircraft Operator Security. TSA plans to issue a Supplemental Notice of Proposed Rulemaking (SNPRM) to propose amendments to current aviation transportation security regulations to enhance the security of general aviation (GA) by expanding the scope of current requirements and by adding new requirements for certain GA aircraft operators. To date, the Government's focus with regard to aviation security generally has been on air carriers and commercial operators. As vulnerabilities and risks associated with air carriers and commercial operators have been reduced or mitigated, terrorists may perceive that GA aircraft are more vulnerable and may view them as attractive targets. This rule would enhance aviation security by requiring operators of certain GA aircraft to adopt a security program and to undertake other security measures. TSA published a Notice of Proposed Rulemaking on October 30, 2008, and received over 7,000 public comments, generally urging significant changes to the proposal. The SNPRM will respond to the comments and contain proposals on addressing security in the GA sector.

Security Training for Surface Mode Employees. TSA will propose regulations to enhance the security of several non-aviation modes of transportation. In particular, TSA will propose regulations requiring freight railroad carriers, public transportation agencies (including rail mass transit and bus systems), passenger railroad carriers, and over-the-road bus operators to conduct security training for front line employees. This regulation would implement sections 1408 (Public Transportation), 1517 (Freight Railroads), and 1534(a) (Over the Road Buses) of the Implementing Recommendations of the 9/11 Commission Act of 2008 (9/11 Act), Public Law 110-53 (Aug. 3, 2007). In compliance with the definitions of frontline employees in the pertinent provisions of the 9/11 Act, the Notice of Proposed Rulemaking (NPRM) would define which employees are required to undergo training. The NPRM would also propose definitions for transportation security-sensitive materials, as required by section 1501 of the 9/11 Act.

Railroad Carrier Vulnerability Assessment and Security Plans. TSA will also propose regulations requiring high-risk freight and passenger railroads to conduct vulnerability self-assessments, as well as develop and implement comprehensive security plans. TSA would need to approve both the vulnerability assessment and security plan. This regulation, implementing section 1512 of the 9/11 Act, would include proposed provisions to identify which railroads would be considered high-risk and include proposed provisions about the associated vulnerability assessment and security planning requirements.

Aircraft Repair Station Security. TSA will finalize a rule requiring repair stations that are certificated by the Federal Aviation Administration under 14 CFR part 145 to adopt and implement standard security programs and to comply with security directives issued by TSA. TSA issued an Notice of Proposed Rulemaking (NPRM) on November 18, 2009. The final rule will also codify the scope of TSA's existing inspection program and could require regulated parties to allow DHS officials to enter, inspect, and test property, facilities, and records relevant to repair stations. This rulemaking action will implement section 1616 of the 9/11 Act.

Standardized Vetting, Adjudication, and Redress Process and Fees. TSA is developing a proposed rule to revise and standardize the procedures, adjudication criteria, and fees for most of the security threat assessments (STA) of individuals that TSA conducts. DHS is considering a proposal that would include procedures for conducting STAs for transportation workers from almost all modes of transportation, including those covered under the 9/11 Act. In addition, TSA will propose equitable fees to cover the cost of the STAs and credentials for some personnel. TSA plans to identify new efficiencies in processing STAs and ways to streamline existing regulations by simplifying language and removing redundancies.

As part of this proposed rule, TSA will propose revisions to the Alien Flight Student Program (AFSP) regulations. TSA published an interim final rule for ASFP on September 20, 2004. TSA regulations require aliens seeking to train at Federal Aviation Administration-regulated flight schools to complete an application and undergo an STA prior to beginning flight training. There are four categories under which students currently fall; the nature of the STA depends on the student's category. TSA is considering changes to the AFSP that would improve equity among fee payers and enable the implementation of new technologies to support vetting.

United States Secret Service

The United States Secret Service does not have any significant regulatory actions planned for fiscal year 2012.

DHS Regulatory Plan for Fiscal Year 2012

A more detailed description of the priority regulations that comprise DHS's fall 2011 regulatory plan follows.

DHS—OFFICE OF THE SECRETARY (OS) Back to Top

Proposed Rule Stage

53. Secure Handling of Ammonium Nitrate Program Back to Top

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

Unfunded Mandates: This action may affect the private sector under Public Law 104-4.

Legal Authority: 2008 Consolidated Appropriations Act, sec 563, subtitle J—Secure Handling of Ammonium Nitrate, Pub. L. 110-161

CFR Citation: 6 CFR 31.

Legal Deadline: NPRM, Statutory, May 26, 2008, Publication of Notice of Proposed Rulemaking.

Abstract: This rulemaking will implement the December 2007 amendment to the Homeland Security Act entitled “Secure Handling of Ammonium Nitrate.” The amendment requires the Department of Homeland Security to “regulate the sale and transfer of ammonium nitrate by an ammonium nitrate facility * * * to prevent the misappropriation or use of ammonium nitrate in an act of terrorism.”

Statement of Need: Pursuant to section 563 of the 2008 Consolidated Appropriations Act, subtitle J—Secure Handling of Ammonium Nitrate, Public Law 110-161, the Department of Homeland Security is required to promulgate a rulemaking to create a registration regime for certain buyers and sellers of ammonium nitrate. The rule, as proposed by this NPRM, would create that regime, and would aid the Federal Government in its efforts to prevent the misappropriation of ammonium nitrate for use in acts of terrorism. By preventing such misappropriation, this rule could limit terrorists' abilities to threaten the public and to threaten the Nation's critical infrastructure and key resources. By securing the Nation's supply of ammonium nitrate, it should be much more difficult for terrorists to obtain ammonium nitrate materials for use in improvised explosive devices. As a result, there is a direct value in the deterrence of a catastrophic terrorist attack using ammonium nitrate, such as the Oklahoma City attack that killed over 160 and injured 853 people.

Summary of Legal Basis: Section 563 of the 2008 Consolidated Appropriations Act, subtitle J—Secure Handling of Ammonium Nitrate, Public Law 110-161, authorizes and requires this rulemaking.

Alternatives: The Department considered several alternatives when developing the Ammonium Nitrate Security Program proposed rule. The alternatives considered were: (a) Register individuals applying for an AN Registered User Number using a paper application (via facsimile or the U.S. mail) rather than through in person application at a local Cooperative Extension office or only through a web-based portal; (b) verify AN Purchasers through both an Internet based verification portal and call center rather than only a verification portal or call center; (c) communicate with applicants for an AN Registered User Number through U.S. Mail rather than only through email or a secure web-based portal; (d) establish a specific capability within the Department to receive, process, and respond to reports of theft or loss rather than leverage a similar capability which already exists with the ATF; (e) require AN Facilities to maintain records electronically in a central database provided by the Department rather than providing flexibility to the AN Facility to maintain their own records either in paper or electronically; (f) require agents to register with the Department prior to the sale or transfer of ammonium nitrate involving an agent rather than allow oral confirmation of the agent with the AN Purchaser on whose behalf the agent is working; and (g) exempt explosives from this regulation rather than not exempting them. As part of its notice of proposed rulemaking, the Department seeks public comment on the numerous alternative ways in which the final Secure Handling of Ammonium Nitrate Program could carry out the requirements of the Secure Handling of Ammonium Nitrate Act.

Anticipated Cost and Benefits: The Department estimates the number of entities that purchase ammonium nitrate to range from 64,950 to 106,200. These purchasers include farms, fertilizer mixers, farm supply wholesalers and cooperatives (co-ops), golf courses, landscaping services, explosives distributors, mines, retail garden centers, and lab supply wholesalers. The Department estimates the number of entities that sell ammonium nitrate to be between 2,486 and 6,236, many of which are also purchasers. These sellers include ammonium nitrate fertilizer and explosive manufacturers, fertilizer mixers, farm supply wholesalers and co-ops, retail garden centers, explosives distributors, fertilizer applicator services, and lab supply wholesalers. Individuals or firms that provide transportation services within the distribution chain may be categorized as sellers, agents, or facilities depending upon their business relationship with the other parties to the transaction. The total number of potentially regulated farms and other businesses ranges from 64,986 to 106,236 (including overlap between the categories).

The cost of this proposed rule ranges from $300 million to $1,041 million over 10 years at a 7 percent discount rate. The primary estimate is the mean which is $670.6 million. For comparison, at a 3 percent discount rate, the cost of the program ranges from $364 million to $1.3 billion with a primary (mean) estimate of $814 million. The average annualized cost for the program ranges from $43 million to $148 million (with a mean of $96 million), also employing a 7 percent discount rate.

Because the value of the benefits of reducing risk of a terrorist attack is a function of both the probability of an attack and the value of the consequence, it is difficult to identify the particular risk reduction associated with the implementation of this rule. These elements and related qualitative benefits include point of sale identification requirements and requiring individuals to be screened against the Terrorist Screening Database (TSDB) resulting in known bad actors being denied the ability to purchase ammonium nitrate.

The Department of Homeland Security aims to prevent terrorist attacks within the United States and to reduce the vulnerability of the United States to terrorism. By preventing the misappropriation or use of ammonium nitrate in acts of terrorism, this rulemaking will support the Department's efforts to prevent terrorist attacks and to reduce the Nation's vulnerability to terrorist attacks. This rulemaking is complementary to other Department programs seeking to reduce the risks posed by terrorism, including the Chemical Facility Anti-Terrorism Standards program (which seeks in part to prevent terrorists from gaining access to dangerous chemicals) and the Transportation Worker Identification Credential program (which seeks in part to prevent terrorists from gaining access to certain critical infrastructure), among other programs.

Risks: Explosives containing ammonium nitrate are commonly used in terrorist attacks. Such attacks have been carried out both domestically and internationally. The 1995 Murrah Federal Building attack in Oklahoma City claimed the lives of 167 individuals and demonstrated firsthand to America how ammonium nitrate could be misused by terrorists. In addition to the Murrah Building attack, the Provisional Irish Republican Army used ammonium nitrate as part of its London, England bombing campaign in the early 1980s. More recently, ammonium nitrate was used in the 1998 East African Embassy bombings and in November 2003 bombings in Istanbul, Turkey. Additionally, since the events of 9/11, stores of ammonium nitrate have been confiscated during raids on terrorist sites around the world, including sites in Canada, England, India, and the Philippines.

Timetable:

Action Date FR Cite
ANPRM 10/29/08 73 FR 64280
Correction 11/05/08 73 FR 65783
ANPRM Comment Period End 12/29/08
NPRM 08/03/11 76 FR 46908
Notice of Public Meetings 10/07/11 76 FR 62311
Notice of Public Meetings 11/14/11 76 FR 70366
NPRM Comment Period End 12/01/11

Regulatory Flexibility Analysis Required: Yes.

Small Entities Affected: Businesses.

Government Levels Affected: Federal.

Federalism: This action may have federalism implications as defined in EO 13132.

URL For More Information: www.regulations.gov.

URL for Public Comments: www.regulations.gov.

Agency Contact: Jon MacLaren, Ammonium Nitrate Program Manager, Department of Homeland Security, Office of the Secretary, Infrastructure Security Compliance Division (NPPD/ISCD), Mail Stop 0610, 245 Murray Lane SW.,Arlington, VA 20598-0610, Phone: 703 235-5263, Email: jon.m.maclaren@hq.dhs.gov.

RIN: 1601-AA52

DHS—U.S. CITIZENSHIP AND IMMIGRATION SERVICES (USCIS) Back to Top

Proposed Rule Stage

54. Asylum and Withholding Definitions Back to Top

Priority: Other Significant.

Legal Authority: 8 U.S.C. 1103; 8 U.S.C. 1158; 8 U.S.C. 1226; 8 U.S.C. 1252; 8 U.S.C. 1282

CFR Citation: 8 CFR 2; 8 CFR 208.

Legal Deadline: None.

Abstract: This rule proposes to amend Department of Homeland Security regulations that govern asylum eligibility. The amendments focus on portions of the regulations that deal with the definitions of membership in a particular social group, the requirements for failure of State protection, and determinations about whether persecution is inflicted on account of a protected ground. This rule codifies long-standing concepts of the definitions. It clarifies that gender can be a basis for membership in a particular social group. It also clarifies that a person who has suffered or fears domestic violence may under certain circumstances be eligible for asylum on that basis. After the Board of Immigration Appeals published a decision on this issue in 1999, Matter of R-A-, Int. Dec. 3403 (BIA 1999), it became clear that the governing regulatory standards required clarification. The Department of Justice began this regulatory initiative by publishing a proposed rule addressing these issues in 2000.

Statement of Need: This rule provides guidance on a number of key interpretive issues of the refugee definition used by adjudicators deciding asylum and withholding of removal (withholding) claims. The interpretive issues include whether persecution is inflicted on account of a protected ground, the requirements for establishing the failure of State protection, and the parameters for defining membership in a particular social group. This rule will aid in the adjudication of claims made by applicants whose claims fall outside of the rubric of the protected grounds of race, religion, nationality, or political opinion. One example of such claims which often fall within the particular social group ground concerns people who have suffered or fear domestic violence. This rule is expected to consolidate issues raised in a proposed rule in 2000 and to address issues that have developed since the publication of the proposed rule. This rule should provide greater stability and clarity in this important area of the law.

Summary of Legal Basis: The purpose of this rule is to provide guidance on certain issues that have arisen in the context of asylum and withholding adjudications. The 1951 Geneva Convention relating to the Status of Refugees contains the internationally accepted definition of a refugee. United States immigration law incorporates an almost identical definition of a refugee as a person outside his or her country of origin “who is unable or unwilling to return to, and is unable or unwilling to avail himself or herself of the protection of, that country because of persecution or a well-founded fear of persecution on account of race, religion, nationality, membership in a particular social group, or political opinion.” Section 101(a)(42) of the Immigration and Nationality Act.

Alternatives: A sizable body of interpretive case law has developed around the meaning of the refugee definition. Historically, much of this case law has addressed more traditional asylum and withholding claims based on the protected grounds of race, religion, nationality, or political opinion. In recent years, however, the United States increasingly has encountered asylum and withholding applications with more varied bases, related, for example, to an applicant's gender or sexual orientation. Many of these new types of claims are based on the ground of “membership in a particular social group,” which is the least well-defined of the five protected grounds within the refugee definition.

On December 7, 2000, DOJ published a proposed rule in the Federal Register providing guidance on the definitions of “persecution” and “membership in a particular social group.” Prior to publishing a new proposed rule, the Department will be considering how the nexus between persecution and a protected ground might be further conceptualized; how membership in a particular social group might be defined and evaluated; and what constitutes a State's inability or unwillingness to protect the applicant where the persecution arises from a non-State actor. This rule will provide guidance to the following adjudicators: USCIS asylum officers, Department of Justice Executive Office for Immigration Review (EOIR) immigration judges, and members of the EOIR Board of Immigration Appeals. The alternative to publishing this rule would be to allow the standards governing this area of law to continue to develop piecemeal through administrative and judicial precedent. This approach has resulted in inconsistent and confusing standards, and the Department has therefore determined that promulgation of the new proposed rule is necessary.

Anticipated Cost and Benefits: By providing a clear framework for key asylum and withholding issues, we anticipate that adjudicators will have clear guidance, increasing administrative efficiency and consistency in adjudicating these cases. The rule will also promote a more consistent and predictable body of administrative and judicial precedent governing these types of cases. We anticipate that this will enable applicants to better assess their potential eligibility for asylum, and to present their claims more efficiently when they believe that they may qualify, thus reducing the resources spent on adjudicating claims that do not qualify. In addition, a more consistent and predictable body of law on these issues will likely result in fewer appeals, both administrative and judicial, and reduce associated litigation costs. The Department has no way of accurately predicting how this rule will impact the number of asylum applications filed in the United States. Based on anecdotal evidence and on the reported experience of other nations that have adopted standards under which the results are similar to those we anticipate for this rule, we do not believe this rule will cause a change in the number of asylum applications filed.

Risks: The failure to promulgate a final rule in this area presents significant risks of further inconsistency and confusion in the law. The Government's interests in fair, efficient, and consistent adjudications would be compromised.

Timetable:

Action Date FR Cite
NPRM 12/07/00 65 FR 76588
NPRM Comment Period End 01/22/01
NPRM 05/00/12

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: No.

Government Levels Affected: None.

Additional Information: CIS No. 2092-00, Transferred from RIN 1115-AF92.

Agency Contact: Ted Kim, Deputy Chief, Asylum Division, Department of Homeland Security, U.S. Citizenship and Immigration Services, Office of Refugee, Asylum, and International Operations, Suite 3200, 20 Massachusetts Avenue NW., Washington, DC 20259, Phone: 202 272-1614, Fax: 202 272-1994, Email: ted.kim@dhs.gov.

RIN: 1615-AA41

DHS—USCIS Back to Top

55. New Classification for Victims of Criminal Activity; Eligibility for the U Nonimmigrant Status Back to Top

Priority: Other Significant.

Legal Authority: 5 U.S.C. 552; 5 U.S.C. 552a; 8 U.S.C. 1101; 8 U.S.C. 1101 note; 8 U.S.C. 1102

CFR Citation: 8 CFR 103; 8 CFR 204; 8 CFR 212; 8 CFR 214; 8 CFR 299.

Legal Deadline: None.

Abstract: This rule sets forth application requirements for a new nonimmigrant status. The U classification is for non-U.S. Citizen/Lawful Permanent Resident victims of certain crimes who cooperate with an investigation or prosecution of those crimes. There is a limit of 10,000 principals per year.

This rule establishes the procedures to be followed in order to petition for the U nonimmigrant classifications. Specifically, the rule addresses the essential elements that must be demonstrated to receive the nonimmigrant classification, procedures that must be followed to make an application, and evidentiary guidance to assist in the petitioning process. Eligible victims will be allowed to remain in the United States. The Trafficking Victims Protection Reauthorization Act of 2008, Public Law 110-457, made amendments to the T nonimmigrant status provisions of the Immigration and Nationality Act. The Department will issue a proposed rule to make the changes required by recent legislation and to provide the opportunity for notice and comment.

Statement of Need: This rule provides requirements and procedures for aliens seeking U nonimmigrant status. U nonimmigrant classification is available to alien victims of certain criminal activity who assist government officials in the investigation or prosecution of that criminal activity. The purpose of the U nonimmigrant classification is to strengthen the ability of law enforcement agencies to investigate and prosecute such crimes as domestic violence, sexual assault, and trafficking in persons, while offering protection to alien crime victims in keeping with the humanitarian interests of the United States.

Summary of Legal Basis: Congress created the U nonimmigrant classification in the Battered Immigrant Women Protection Act of 2000 (BIWPA). Congress intended to strengthen the ability of law enforcement agencies to investigate and prosecute cases of domestic violence, sexual assault, trafficking of aliens, and other crimes, while offering protection to victims of such crimes. Congress also sought to encourage law enforcement officials to better serve immigrant crime victims.

Alternatives: USCIS has identified four alternatives, the first being chosen for the rule:

1. USCIS would adjudicate petitions on a first in, first out basis. Petitions received after the limit has been reached would be reviewed to determine whether or not they are approvable, but for the numerical cap. Approvable petitions that are reviewed after the numerical cap has been reached would be placed on a waiting list and written notice sent to the petitioner. Priority on the waiting list would be based upon the date on which the petition is filed. USCIS would provide petitioners on the waiting list with interim relief until the start of the next fiscal year in the form of deferred action, parole, or a stay of removal.

2. USCIS would adjudicate petitions on a first in, first out basis, establishing a waiting list for petitions that are pending or received after the numerical cap has been reached. Priority on the waiting list would be based upon the date on which the petition was filed. USCIS would not provide interim relief to petitioners whose petitions are placed on the waiting list.

3. USCIS would adjudicate petitions on a first in, first out basis. However, new filings would be reviewed to identify particularly compelling cases for adjudication. New filings would be rejected once the numerical cap is reached. No official waiting list would be established; however, interim relief until the start of the next fiscal year would be provided for some compelling cases. If a case was not particularly compelling, the filing would be denied or rejected.

4. USCIS would adjudicate petitions on a first in, first out basis. However, new filings would be rejected once the numerical cap is reached. No waiting list would be established nor would interim relief be granted.

Anticipated Cost and Benefits: USCIS estimates the total annual cost of this interim rule to applicants to be $6.2 million. This cost includes the biometric services fee that petitioners must pay to USCIS, the opportunity cost of time needed to submit the required forms, the opportunity cost of time required for a visit to an Application Support Center, and the cost of traveling to an Application Support Center.

This rule will strengthen the ability of law enforcement agencies to investigate and prosecute such crimes as domestic violence, sexual assault, and trafficking in persons, while offering protection to alien crime victims in keeping with the humanitarian interests of the United States.

Risks: In the case of witness tampering, obstruction of justice, or perjury, the interpretive challenge for USCIS was to determine whom the BIWPA was meant to protect, given that these criminal activities are not targeted against a person. Accordingly it was determined that a victim of witness tampering, obstruction of justice, or perjury is an alien who has been directly and proximately harmed by the perpetrator of one of these three crimes, where there are reasonable grounds to conclude that the perpetrator principally committed the offense as a means: (1) To avoid or frustrate efforts to investigate, arrest, prosecute, or otherwise bring him or her to justice for other criminal activity; or (2) to further his or her abuse or exploitation of, or undue control over, the alien through manipulation of the legal system.

Timetable:

Action Date FR Cite
Interim Final Rule 09/17/07 72 FR 53013
Interim Final Rule Effective 10/17/07
Interim Final Rule Comment Period End 11/17/07
NPRM 06/00/12

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: No.

Government Levels Affected: Federal, Local, State.

Additional Information: Transferred from RIN 1115-AG39.

Agency Contact: Laura M. Dawkins, Chief, Family Immigration and Victim Protection Division, Department of Homeland Security, U.S. Citizenship and Immigration Services, Suite 1200, 20 Massachusetts Avenue NW., Washington, DC 20529, Phone: 202 272-1470, Fax: 202 272-1480, Email: laura.dawkins@dhs.gov.

RIN: 1615-AA67

DHS—USCIS Back to Top

56. Exception to the Persecution Bar for Asylum, Refugee, and Temporary Protected Status, and Withholding of Removal Back to Top

Priority: Other Significant.

Legal Authority: 8 U.S.C. 1101; 8 U.S.C. 1103; 8 U.S.C. 1158; 8 U.S.C. 1226; Pub. L. 107-26; Pub. L. 110-229

CFR Citation: 8 CFR 1; 8 CFR 208; 8 CFR 244; 8 CFR 1244.

Legal Deadline: None.

Abstract: This joint rule proposes amendments to Department of Homeland Security (DHS) and Department of Justice (DOJ) regulations to describe the circumstances under which an applicant will continue to be eligible for asylum, refugee, or temporary protected status, special rule cancellation of removal under the Nicaraguan Adjustment and Central American Relief Act, and withholding of removal, even if DHS or DOJ has determined that the applicant's actions contributed, in some way, to the persecution of others. The purpose of this rule is to resolve ambiguity in the statutory language precluding eligibility for asylum, refugee, and temporary protected status of an applicant who ordered, incited, assisted, or otherwise participated in the persecution of others. The proposed amendment would provide a limited exception for actions taken by the applicant under duress and clarify the required levels of the applicant's knowledge of the persecution.

Statement of Need: This rule resolves ambiguity in the statutory language precluding eligibility for asylum, refugee, and temporary protected status of an applicant who ordered, incited, assisted, or otherwise participated in the persecution of others. The proposed amendment would provide a limited exception for actions taken by the applicant under duress and clarify the required levels of the applicant's knowledge of the persecution.

Summary of Legal Basis: In Negusie v. Holder, 129 S. Ct. 1159 (2009), the Supreme Court addressed whether the persecutor bar should apply where an alien's actions were taken under duress. DHS believes that this is an appropriate subject for rulemaking and proposes to amend the applicable regulations to set out its interpretation of the statute. In developing this regulatory initiative, DHS has carefully considered the purpose and history behind enactment of the persecutor bar, including its international law origins and the criminal law concepts upon which they are based.

Alternatives: DHS did consider the alternative of not publishing a rulemaking on these issues. To leave this important area of the law without an administrative interpretation would confuse adjudicators and the public.

Anticipated Cost and Benefits: The programs affected by this rule exist so that the United States may respond effectively to global humanitarian situations and assist people who are in need. USCIS provides a number of humanitarian programs and protection to assist individuals in need of shelter or aid from disasters, oppression, emergency medical issues, and other urgent circumstances. This rule will advance the humanitarian goals of the asylum/refugee program, and other specialized programs. The main benefits of such goals tend to be intangible and difficult to quantify in economic and monetary terms. These forms of relief have not been available to certain persecutors. This rule will allow an exception to this bar from protection for applicants who can meet the appropriate evidentiary standard. Consequently, this rule may result in a small increase in the number of applicants for humanitarian programs. To the extent a small increase in applicants occurs, there could be additional fee costs incurred by these applicants.

Risks: If DHS were not to publish a regulation, the public would face a lengthy period of confusion on these issues. There could also be inconsistent interpretations of the statutory language, leading to significant litigation and delay for the affected public.

Timetable:

Action Date FR Cite
NPRM 05/00/12

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: No.

Government Levels Affected: None.

Agency Contact: Molly Groom, Office of the Chief Counsel Department of Homeland Security, U.S. Citizenship and Immigration Services, 20 Massachusetts Avenue NW., Washington, DC 20259, Phone: 202 272-1400, Fax: 202 272-1408, Email: molly.groom@dhs.gov.

RIN: 1615-AB89

DHS—USCIS Back to Top

57. • Electronic Filing of Requests for Immigration Benefits; Requiring an Application To Change or Extend Nonimmigrant Status To Be Filed Electronically Back to Top

Priority: Other Significant.

Legal Authority: 8 U.S.C. 1101; 8 U.S.C. 1103; 8 U.S.C. 1151; 8 U.S.C. 1153

CFR Citation: 8 CFR 103; 8 CFR 204.

Legal Deadline: None.

Abstract: The Department of Homeland Security (DHS) is proposing regulations to govern the electronic filing of requests for immigration benefit requests with the U.S. Citizenship and Immigration Services (USCIS). DHS also proposes to mandate electronic applications in the new Integrated Operating Environment that is under development, with limited exceptions, for an Application to Extend/Change Nonimmigrant Status from any individual in the M, J, B-1, and B-2 classifications; change of status requests to the F, M, J, B-1, or B-2 classifications; and reinstatement of status requests in the F or M classification.

Statement of Need: USCIS is in the process of transforming its operations to improve service, operational efficiency, and national security. This rule will allow USCIS to modernize its processes, which will provide applicants and petitioners with better and faster services and enhance the ability of USCIS to process cases with greater accuracy, security, and timeliness.

Summary of Legal Basis: Authority for this rule falls within the broad authority of the Secretary of Homeland Security to administer DHS, the administration of immigration and nationality laws, and other delegated authority. See Homeland Security Act of 2002, Public Law 107-296 section 102 (Nov. 25, 2002), 6 U.S.C. 112, and the Immigration and Nationality Act of 1952, as amended, section 103, 8 U.S.C. 1103.

The Government Paperwork Elimination Act provides that, when possible, Federal agencies are directed to make available electronic forms and provide for electronic filing and submissions when conducting agency business with the public. See Public Law 105-277, section 1703 (Oct. 21, 1998), 44 U.S.C. 3504. GPEA also establishes the means for the use and acceptance of electronic signatures.

The INA provides a detailed list of classes of nonimmigrant aliens. See, e.g., INA sections 101(a)(15)(B), (C), (F), and (M); 8 U.S.C. 1101(a)(15) (B), (C), (F), and (M). The Secretary of Homeland Security may authorize a change to any other nonimmigrant classification in the case of any alien who is lawfully admitted to the United States as a nonimmigrant, maintains his or her lawful status, does not fall under certain nonimmigrant visa categories that are listed in the statute, and is not inadmissible or whose inadmissibility has been waived under the pertinent sections of the immigration and nationality laws of the United States. See INA section 248(a); 8 U.S.C. 1258(a).

This rule is also proposed in compliance with Executive Order 13571 “Streamlining Service Delivery and Improving Customer Service.” See Executive Order No. 13571, 76 FR 24339 (Apr. 27, 2011). Executive Order 13571 tasks each Federal department and agency with establishing an initiative that uses technology to improve the experience of individuals and entities receiving services from that Federal department or agency. See Executive Order No. 13571, section 2(a).

Alternatives: DHS has examined the alternative of maintaining paper processing for applications to extend/change status (Form I-539) and has determined that the continuation of legacy data systems and current processes do not meet the need for USCIS to modernize operations.

Anticipated Cost and Benefits: DHS is proposing to mandate the electronic filing of stand-alone Applications to Extend/Change Nonimmigrant Status. Only a limited number of nonimmigrants would be impacted by this change. Specifically, those individuals in the following nonimmigrant classifications would be required to file this application electronically: B-1, B-2, F, M, or J. In transforming its immigration benefit processes into a paperless system, DHS anticipates the following benefits:

  • Streamlined operations
  • More timely submission and adjudication of the benefit requested
  • Reduced requests for additional or missing information
  • Enhanced security for the applicant
  • Enhanced customer service

For those applicants that do not currently possess or have access to the tools needed to submit immigration benefit requests electronically—namely, computer, Internet service, and a scanner—this rule would result in additional costs to these petitioners or applicants. DHS is in the process of examining the potential monetary costs and benefits of the proposed rule.

Risks: Populations with no or limited Internet access and individuals with no or limited English proficiency may be affected by this rule. This risk can be mitigated by including a waiver process.

Timetable:

Action Date FR Cite
NPRM 08/00/12

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: No.

Government Levels Affected: None.

Agency Contact: Dan Konnerth, Policy and Coordination Chief, Office of Transformation Coordination, Department of Homeland Security, U.S. Citizenship and Immigration Services, 6th Floor, 633 Third Street NW., Washington, DC 20529, Phone: 202 233-2381, Email: dan.konnerth@dhs.gov.

RIN: 1615-AB94

DHS—USCIS Back to Top

58. • Immigration Benefits Business Transformation: Nonimmigrants; Student and Exchange Visitor Program Back to Top

Priority: Other Significant.

Legal Authority: 5 U.S.C. 301; 5 U.S.C. 552; 5 U.S.C. 552a; 8 U.S.C. 1101; 8 U.S.C. 1103

CFR Citation: 8 CFR 103; 8 CFR 212; 8 CFR 214; 8 CFR 245; 8 CFR 248; 8 CFR 274a.

Legal Deadline: None.

Abstract: The Department of Homeland Security (DHS) is amending its nonimmigrant regulations to enable U.S. Citizenship and Immigration Services (USCIS) to migrate from a paper file-based, non-integrated systems environment to an electronic, customer-focused, centralized case management environment for benefit processing. This rulemaking, the second in a series of business transformation rules, primarily focuses on 8 CFR part 214, reorganizes and streamlines general information relating to nonimmigrant classifications, and relocates other information relating to specific, individual nonimmigrant classifications to a separate subpart for each major nonimmigrant classification. DHS is making these amendments because part 214 contains more than 20 nonimmigrant classifications, and it has become very large and complex to navigate. This regulation will provide the public with simpler, better organized regulatory requirements for each nonimmigrant classification and facilitate future revisions.

Statement of Need: USCIS is in the process of transforming its operations to improve service, operational efficiency, and national security. This rule will provide the public with clearly written, better organized regulatory requirements for each nonimmigrant classification.

Summary of Legal Basis: The Homeland Security Act of 2002, Public Law 107-296, section 102, 116 Stat. 2135 (Nov. 25, 2002), 6 U.S.C. 112, and the Immigration and Nationality Act of 1952 (INA), charge the Secretary of Homeland Security (Secretary) with administration and enforcement of the immigration and nationality laws. See INA section 103, 8 U.S.C. 1103.

This rule will significantly enhance the ability of USCIS to fully implement the Government Paperwork Elimination Act (GPEA). See Public Law 105-277, tit. XVII, section 1701 to 1710, 112 Stat. 2681 at 2681-749, (Oct. 21, 1998) (codified at 44 U.S.C. 3504 note). GPEA provides that, when possible, Federal agencies use electronic forms, electronic filing, and electronic submissions to conduct agency business with the public. Id. The USCIS modernization and transformation effort will move its operations away from a paper-based system to an electronic environment wherever possible in an effort to implement the requirements of GPEA.

Alternatives: The regulations for the more than 20 nonimmigrant classifications are included in 8 CFR 214. As more nonimmigrant classifications have been added to the Act and as the statutory requirements for existing classifications have become more complex, sections within 8 CFR 214 have become increasingly difficult to read, comprehend and cite. DHS will reorganize 8 CFR 214 to address this lack of clarity.

Anticipated Cost and Benefits: DHS will amend its regulations at 8 CFR part 214 to streamline and reorganize the content into a more reader-friendly and logical format. DHS is not making substantive changes to the content or requirements of existing regulations. There are no additional costs anticipated as a result of this rulemaking.

Risks: This rule may initially lead to confusion of those who are familiar with the previous organization of 8 CFR 214. USCIS can mitigate this risk by informing the public of these changes.

Timetable:

Action Date FR Cite
NPRM 06/00/12

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: No.

Government Levels Affected: None.

Additional Information: CIS# 2505-11. This rule (RIN 1615-AB95) is adopting the following three rules as final rules: 1615-AA35, 1615-AA56, and 1615-AA53.

Agency Contact: Dan Konnerth, Policy and Coordination Chief, Office of Transformation Coordination, Department of Homeland Security, U.S. Citizenship and Immigration Services, 6th Floor, 633 Third Street NW., Washington, DC 20529, Phone: 202 233-2381, Email: dan.konnerth@dhs.gov.

RIN: 1615-AB95

DHS—USCIS Back to Top

59. • Application of the William Wilberforce Trafficking Victims Protection Reauthorization Act of 2008 to Unaccompanied Alien Children Seeking Asylum Back to Top

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

Unfunded Mandates: Undetermined.

Legal Authority: Pub. L. 110-457

CFR Citation: Not Yet Determined.

Legal Deadline: None.

Abstract: This rule implements the provisions of the William Wilberforce Trafficking Victims Protection Reauthorization Act of 2008 (TVPRA), Public Law 110-457, 122 Stat. 5074 (Dec. 23, 2008) relating to unaccompanied alien children seeking asylum. Specifically, the rule proposes to amend Department of Homeland Security and Department of Justice regulations relating to asylum applications filed by unaccompanied alien children. The rule will amend both Departments' regulations to reflect that U.S. Citizenship and Immigration Services (USCIS) has initial jurisdiction over any asylum application filed by an unaccompanied alien child. The rule will also add new special procedures for all children in interviews before USCIS officers and for unaccompanied alien children in proceedings before immigration judges in the Executive Office for Immigration Review.

Statement of Need: The TVPRA mandated promulgation of regulations taking into account the specialized needs of unaccompanied alien children and addressing both procedural and substantive aspects of handling unaccompanied alien children's cases. This rule will codify existing agency guidance on the specialized needs of unaccompanied alien children. The rule will also codify agency guidance implementing the TVPRA. Such guidance has been in effect since March 2009 and, based on experience gained in following the guidance, will be revised in the rule.

Summary of Legal Basis: The purpose of this rule is to comply with the TVPRA mandate to promulgate regulations taking into account the specialized needs of unaccompanied alien children and addressing both procedural and substantive aspects of handling unaccompanied alien children's cases.

Alternatives: N/A.

Anticipated Cost and Benefits: Congress has given USCIS initial jurisdiction over the asylum claims of unaccompanied alien children. New costs can accrue when EOIR immigration judges transfer cases involving unaccompanied alien minors to USCIS for asylum interviews and adjudication if USCIS does not grant the asylum application and the case is returned to EOIR for further adjudication. This additional cost is offset, however, when USCIS grants such an application because the costs of USCIS asylum adjudications are generally much lower than the processing of immigration court applications for that benefit. In addition, USCIS provides a non-adversarial setting for asylum seeker interviews and has recently developed extensive and ongoing training in children's issues. These factors can assist unaccompanied children in expressing their fear of return to their native countries. Unaccompanied alien children also compose a uniquely vulnerable population with often compelling protection issues; therefore, affording unaccompanied alien children every consideration in the asylum process greatly benefits them. Finally, benefits will also accrue because the regulation will improve upon the process initially implemented upon passage of the TVPRA, incorporating lessons learned and optimizing the procedures for USCIS and EOIR.

Risks: N/A.

Timetable:

Action Date FR Cite
NPRM 06/00/12

Regulatory Flexibility Analysis Required: Undetermined.

Government Levels Affected: Federal.

Agency Contact: Ted Kim, Deputy Chief, Asylum Division, Department of Homeland Security, U.S. Citizenship and Immigration Services, Office of Refugee, Asylum, and International Operations, Suite 3200, 20 Massachusetts Avenue NW., Washington, DC 20259, Phone: 202 272-1614, Fax: 202 272-1994, Email: ted.kim@dhs.gov.

RIN: 1615-AB96

DHS—USCIS Back to Top

60. • Administrative Appeals Office: Procedural Reforms To Improve Efficiency Back to Top

Priority: Other Significant.

Legal Authority: 5 U.S.C. 552; 5 U.S.C. 552a; 8 U.S.C. 1101; 8 U.S.C. 1103; 8 U.S.C. 1304; 6 U.S.C. 112

CFR Citation: 8 CFR 103; 8 CFR 204; 8 CFR 205; 8 CFR 210; 8 CFR 214; 8 CFR 245a; 8 CFR 320; 8 CFR 105 (new); * * *.

Legal Deadline: None.

Abstract: This proposed rule revises the requirements and procedures for the filing of motions and appeals before the Department's U.S. Citizenship and Immigration Services and its Administrative Appeals Office. The proposed changes are intended to streamline the existing processes for filing motions and appeals and will reduce delays in the review and appellate process. This rule also makes additional changes necessitated by the establishment of the Department of Homeland Security and its components.

Statement of Need: This rule proposes to make numerous changes to streamline the current appeal and motion processes which: (1) Will result in cost savings to the Government, applicants, and petitioners; and (2) will provide for a more efficient use of USCIS officer and clerical staff time, as well as more uniformity with Board of Immigration Appeals appeal and motion processes.

Summary of Legal Basis: 5 U.S.C. 301; 5 U.S.C. 552; 5 U.S.C. 552a; 8 U.S.C. 1101 and note 1102, 1103, 1151, 1153, 1154, 1182, 1184, 1185 note (sec. 7209 of Pub. L. 108-458; title VII of Pub. L. 110-229), 1186a, 1187, 1221,1223, 1225 to 1227, 1255a, and 1255a note, 1281, 1282, 1301 to 1305, 1324a, 1356, 1372, 1379, 1409(c), 1443 to 1444, 1448, 1452, 1455, 1641, 1731 to 1732; 31 U.S.C. 9701; 48 U.S.C. 1901, 1931 note; section 643, Public Law 104-208, 110 Stat. 3009-708; section 141 of the Compacts of Free Association with the Federated States of Micronesia and the Republic of the Marshall Islands, and with the Government of Palau,; title VII of Public Law 110-229; Public Law 107-296, 116 Stat. 2135 (6 U.S.C. 1 et seq.); 82, 66 Stat. 173, 238, 254, 264; title VII of Public Law 110-229; E.O. 12356.

Alternatives: The alternative to this rule would be to continue under the current process without change.

Anticipated Cost and Benefits: As a result of streamlining the appeal and motion process, USCIS anticipates quantitative and qualitative benefits to DHS and the public. We also anticipate cost savings to DHS and applicants as a result of the proposed changes.

Timetable:

Action Date FR Cite
NPRM 03/00/12

Regulatory Flexibility Analysis Required: Undetermined.

Government Levels Affected: None.

Additional Information: Previously 1615-AB29 (CIS 2311-04), which was withdrawn in 2007. DHS has included this rule in its Final Plan for the Retrospective Review of Existing Regulations, which DHS issued on August 22, 2011.

Agency Contact: William K Renwick, Supervisory Citizenship and Immigration Appeals Officer, Department of Homeland Security, U.S. Citizenship and Immigration Services, Administrative Appeals Office, Washington, DC 20529-2090, Phone: 703 224-4501, Email: william.k.renwick@dhs.gov.

Related RIN: Duplicate of 1615-AB29.

RIN: 1615-AB98

DHS—USCIS Back to Top

Final Rule Stage

61. New Classification for Victims of Severe Forms of Trafficking in Persons; Eligibility for T Nonimmigrant Status Back to Top

Priority: Other Significant.

Legal Authority: 5 U.S.C. 552; 5 U.S.C. 552a; 8 U.S.C. 1101 to 1104; 8 U.S.C. 1182; 8 U.S.C. 1184; 8 U.S.C. 1187; 8 U.S.C. 1201; 8 U.S.C. 1224 to 1227; 8 U.S.C. 1252 to 1252a; 22 U.S.C. 7101; 22 U.S.C. 7105

CFR Citation: 8 CFR 103; 8 CFR 212; 8 CFR 214; 8 CFR 274a; 8 CFR 299.

Legal Deadline: None.

Abstract: T classification was created by 107(e) of the Victims of Trafficking and Violence Protection Act of 2000 (VTVPA), Public Law 106-386. The T nonimmigrant classification was designed for eligible victims of severe forms of trafficking in persons who aid law enforcement with their investigation or prosecution of the traffickers, and who can establish that they would suffer extreme hardship involving unusual and severe harm if they were removed from the United States. The rule establishes application procedures and responsibilities for the Department of Homeland Security and provides guidance to the public on how to meet certain requirements to obtain T nonimmigrant status. The Trafficking Victims Protection Reauthorization Act of 2008, Public Law 110-457, made amendments to the T nonimmigrant status provisions of the Immigration and Naturalization Act. The Department will issue another interim final rule to make the changes required by recent legislation and to provide the opportunity for notice and comment.

Statement of Need: T nonimmigrant status is available to eligible victims of severe forms of trafficking in persons who have complied with any reasonable request for assistance in the investigation or prosecution of acts of trafficking in persons, and who can demonstrate that they would suffer extreme hardship involving unusual and severe harm if removed from the United States. This rule addresses the essential elements that must be demonstrated for classification as a T nonimmigrant alien; the procedures to be followed by applicants to apply for T nonimmigrant status; and evidentiary guidance to assist in the application process.

Summary of Legal Basis: Section 107(e) of the Trafficking Victims Protection Act (TVPA), Public Law 106-386, as amended, established the T classification to create a safe haven for certain eligible victims of severe forms of trafficking in persons, who assist law enforcement authorities in investigating and prosecuting the perpetrators of these crimes.

Alternatives: To develop a comprehensive Federal approach to identifying victims of severe forms of trafficking in persons, to provide them with benefits and services, and to enhance the Department of Justice's ability to prosecute traffickers and prevent trafficking in persons in the first place, a series of meetings with stakeholders were conducted with representatives from key Federal agencies; national, State, and local law enforcement associations; non-profit, community-based victim rights organizations; and other groups. Suggestions from these stakeholders were used in the drafting of this regulation.

Anticipated Cost and Benefits: There is no cost to applicants associated with this regulation. Applicants for T nonimmigrant status do not pay application or biometric fees.

The anticipated benefits of these expenditures include: Assistance to trafficked victims and their families, prosecution of traffickers in persons, and the elimination of abuses caused by trafficking activities.

Benefits which may be attributed to the implementation of this rule are expected to be:

1. An increase in the number of cases brought forward for investigation and/or prosecution;

2. Heightened awareness by the law enforcement community of trafficking in persons;

3. Enhanced ability to develop and work cases in trafficking in persons cross-organizationally and multi-jurisdictionally, which may begin to influence changes in trafficking patterns.

Risks: There is a 5,000-person limit to the number of individuals who can be granted T-1 status per fiscal year. Eligible applicants who are not granted T-1 status due solely to the numerical limit will be placed on a waiting list to be maintained by U.S. Citizenship and Immigration Services (USCIS).

To protect T-1 applicants and their families, USCIS will use various means to prevent the removal of T-1 applicants on the waiting list, and their family members who are eligible for derivative T status, including its existing authority to grant deferred action, parole, and stays of removal.

Timetable:

Action Date FR Cite
Interim Final Rule 01/31/02 67 FR 4784
Interim Final Rule Effective 03/04/02
Interim Final Rule Comment Period End 04/01/02
Interim Final Rule 06/00/12

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: No.

Government Levels Affected: Federal, Local, State.

Additional Information: CIS No. 2132-01; AG Order No. 2554-2002. There is a related rulemaking, CIS No. 2170-01, the new U nonimmigrant status (RIN 1615-AA67). Transferred from RIN 1115-AG19.

Agency Contact: Laura M. Dawkins, Chief, Family Immigration and Victim Protection Division, Department of Homeland Security, U.S. Citizenship and Immigration Services, Suite 1200, 20 Massachusetts Avenue NW., Washington, DC 20529, Phone: 202 272-1470, Fax: 202 272-1480, Email: laura.dawkins@dhs.gov.

Related RIN: Related to 1615-AA67.

RIN: 1615-AA59

DHS—USCIS Back to Top

62. Adjustment of Status to Lawful Permanent Resident for Aliens in T and U Nonimmigrant Status Back to Top

Priority: Other Significant.

Legal Authority: 5 U.S.C. 552; 5 U.S.C. 552a; 8 U.S.C. 1101 to 1104; 8 U.S.C. 1182; 8 U.S.C. 1184; 8 U.S.C. 1187; 8 U.S.C. 1201; 8 U.S.C. 1224 to 1227; 8 U.S.C. 1252 to 1252a; 8 U.S.C. 1255; 22 U.S.C. 7101; 22 U.S.C. 7105

CFR Citation: 8 CFR 204; 8 CFR 214; 8 CFR 245.

Legal Deadline: None.

Abstract: This rule sets forth measures by which certain victims of severe forms of trafficking who have been granted T nonimmigrant status and victims of certain criminal activity who have been granted U nonimmigrant status may apply for adjustment to permanent resident status in accordance with Public Law 106-386, Victims of Trafficking and Violence Protection Act of 2000; and Public Law 109-162, Violence Against Women and Department of Justice Reauthorization Act of 2005. The Trafficking Victims Protection Reauthorization Act of 2008, Public Law 110-457, made amendments to the T nonimmigrant status provisions of the Immigration and Naturalization Act. The Department will issue another interim final rule to make the changes required by recent legislation and to provide the opportunity for notice and comment.

Statement of Need: This regulation is necessary to permit aliens in lawful T or U nonimmigrant status to apply for adjustment of status to that of lawful permanent residents. T nonimmigrant status is available to aliens who are victims of a severe form of trafficking in persons and who are assisting law enforcement in the investigation or prosecution of the acts of trafficking. U nonimmigrant status is available to aliens who are victims of certain crimes and are being helpful to the investigation or prosecution of those crimes.

Summary of Legal Basis: This rule implements the Victims of Trafficking and Violence Protection Act of 2000 (VTVPA), Public Law 106-386, 114 Stat. 1464 (Oct. 28, 2000), as amended, to permit aliens in lawful T or U nonimmigrant status to apply for adjustment of status to that of lawful permanent residents.

Alternatives: USCIS did not consider alternatives to managing T and U applications for adjustment of status. Ease of administration dictates that adjustment of status applications from T and U nonimmigrants would be best handled on a first in, first out basis, because that is the way applications for T and U status are currently handled.

Anticipated Cost and Benefits: USCIS uses fees to fund the cost of processing applications and associated support benefits. The fees to be collected resulting from this rule will be approximately $3 million in the first year, $1.9 million in the second year, and an average of about $32 million in the third and subsequent years. To estimate the new fee collections to be generated by this rule, USCIS estimated the fees to be collected for new applications for adjustment of status from T and U nonimmigrants and their eligible family members. After that, USCIS estimated fees from associated applications that are required such as biometrics, and others that are likely to occur in direct connection with applications for adjustment, such as employment authorization or travel authorization.

The anticipated benefits of these expenditures include: Continued assistance to trafficked victims and their families, increased investigation and prosecution of traffickers in persons, and the elimination of abuses caused by trafficking activities.

Benefits that may be attributed to the implementation of this rule are expected to be:

1. An increase in the number of cases brought forward for investigation and/or prosecution;

2. Heightened awareness of trafficking-in-persons issues by the law enforcement community; and

3. Enhanced ability to develop and work cases in trafficking in persons cross-organizationally and multi-jurisdictionally, which may begin to influence changes in trafficking patterns.

Risks: Congress created the U nonimmigrant status (“U visa”) to provide immigration protection to crime victims who assist in the investigation and prosecution of those crimes. Although there are no specific data on alien crime victims, statistics maintained by the Department of Justice have shown that aliens, especially those aliens without legal status, are often reluctant to help in the investigation or prosecution of crimes. U visas are intended to help overcome this reluctance and aid law enforcement accordingly.

Timetable:

Action Date FR Cite
Interim Final Rule 12/12/08 73 FR 75540
Interim Final Rule Effective 01/12/09
Interim Final Rule Comment Period End 02/10/09
Interim Final Rule 06/00/12

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: No.

Government Levels Affected: Federal, Local, State.

Additional Information: CIS No. 2134-01. Transferred from RIN 1115-AG21.

Agency Contact: Laura M. Dawkins, Chief, Family Immigration and Victim Protection Division, Department of Homeland Security, U.S. Citizenship and Immigration Services, Suite 1200, 20 Massachusetts Avenue NW., Washington, DC 20529, Phone: 202 272-1470, Fax: 202 272-1480, Email: laura.dawkins@dhs.gov.

RIN: 1615-AA60

DHS—USCIS Back to Top

63. Application of Immigration Regulations to the Commonwealth of the Northern Mariana Islands Back to Top

Priority: Other Significant.

Legal Authority: Pub. L. 110-229

CFR Citation: 8 CFR 208 and 209; 8 CFR 214 and 215; 8 CFR 217; 8 CFR 235; 8 CFR 248; 8 CFR 264; 8 CFR 274a.

Legal Deadline: Final, Statutory, November 28, 2009, Consolidated Natural Resources Act (CNRA) of 2008.

Abstract: This final rule amends the Department of Homeland Security (DHS) and the Department of Justice (DOJ) regulations to comply with the Consolidated Natural Resources Act of 2008 (CNRA). The CNRA extends the immigration laws of the United States to the Commonwealth of the Northern Mariana Islands (CNMI). This rule finalizes the interim rule and implements conforming amendments to their respective regulations.

Statement of Need: This rule finalizes the interim rule to conform existing regulations with the CNRA. Some of the changes implemented under the CNRA affect existing regulations governing both DHS immigration policy and procedures and proceedings before the immigration judges and the Board. Accordingly, it is necessary to make amendments both to the DHS regulations and to the DOJ regulations. The Secretary and the Attorney General are making conforming amendments to their respective regulations in this single rulemaking document.

Summary of Legal Basis: Congress extended the immigration laws of the United States to the CNMI. The stated purpose of the CNRA is to ensure effective border control procedures, to properly address national security and homeland security concerns by extending U.S. immigration law to the CNMI (phasing-out the CNMI's nonresident contract worker program while minimizing to the greatest extent practicable the potential adverse economic and fiscal effects of that phase-out), to maximize the CNMI's potential for future economic and business growth, and to assure worker protections from the potential for abuse and exploitation.

Anticipated Cost and Benefits: Costs: The interim rule established basic provisions necessary for the application of the INA to the CNMI and updated definitions and existing DHS and DOJ regulations in areas that were confusing or in conflict with how they are to be applied to implement the INA in the CNMI. As such, that rule made no changes that had identifiable direct or indirect economic impacts that could be quantified.

Benefits: This final rule makes additional regulatory changes in order to lessen the adverse impacts of the CNRA on employers and employees in the CNMI and assist the CNMI in its transition to the INA.

Timetable:

Action Date FR Cite
Interim Final Rule 10/28/09 74 FR 55725
Interim Final Rule Comment Period End 11/27/09  
Correction 12/22/09 74 FR 67969
Final Action 03/00/12  

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: No.

Government Levels Affected: None.

Additional Information: CIS 2460-08.

Agency Contact: Kevin Cummings, Branch Chief, Business and Trade Services, Department of Homeland Security, U.S. Citizenship and Immigration Services, Second Floor, Office of Program and Regulations Development, 20 Massachusetts Avenue NW., Washington, DC 20529, Phone: 202 272-1470, Fax: 202 272-1480, Email: kevin.cummings@dhs.gov.

Related RIN: Related to 1615-AB76, Related to 1615-AB75.

RIN: 1615-AB77

DHS—U.S. COAST GUARD (USCG) Back to Top

Final Rule Stage

64. Implementation of the 1995 Amendments to the International Convention on Standards of Training, Certification, and Watchkeeping (STCW) for Seafarers, 1978 Back to Top

Priority: Other Significant.

Legal Authority: 46 U.S.C. 2103; 46 U.S.C. chapters 71 and 73; DHS Delegation No. 0170.1

CFR Citation: 46 CFR 10; 46 CFR 11; 46 CFR 12; 46 CFR 15.

Legal Deadline: None.

Abstract: The International Maritime Organization (IMO) comprehensively amended the International Convention on Standards of Training, Certification, and Watchkeeping (STCW) for Seafarers, 1978, in 1995 and 2010. The 1995 amendments came into force on February 1, 1997. This project implements those amendments by r