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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 became the basic means for conveying regulatory agenda information to the maximum extent legally permissible. The complete 2012 Unified Agenda, which contains the regulatory agendas for 60 Federal agencies, is available to the public at http://reginfo.gov.

The 2012 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 (MVC), General Services Administration, One Constitution Square, 1275 First Street NE., 630, 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 (MVC), General Services Administration, One Constitution Square, 1275 First Street NE., 630, Washington, DC 20417, (202) 482-7340. You may also send comments to us by email at: RISC@gsa.gov.

SUPPLEMENTARY INFORMATION: Back to Top

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 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 became 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 access to the historic Unified Agenda database to 1995.

The 2012 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 online availability, at a substantially reduced printing cost. The current online format does not reduce the amount of information available to the public. The complete online edition of the Unified Agenda includes regulatory agendas from 60 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 Justice *

Department of State

Department of Veterans Affairs *

Agency for International Development

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 *

Export-Import Bank of the United States

Federal Mediation and Conciliation Service

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

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

Recovery Accountability and Transparency Board

Special Inspector General for Afghanistan Reconstruction

Surface Transportation Board

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

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

Agencies prepared entries for this publication to give the public notice of their plans to review, propose, and issue regulations. They have tried to predict their activities over the next 12 months as accurately as possible, but dates and schedules are subject to change. Agencies may withdraw some of the regulations now under development, and they may issue or propose other regulations not included in their agendas. Agency actions in the rulemaking process may occur before or after the dates they have listed. The 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 sub-agencies. 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 http://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 12/00/12 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 2011.

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 2012 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.

Pulic Law (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 21, 2012.

John C. Thomas,

Executive Director.

Introduction to the 2012 Regulatory Plan Back to Top

Executive Order 12866, issued in 1993, requires the production of a Unified Regulatory Agenda and Regulatory Plan. Executive Order 13563, issued in 2011, reaffirmed the requirements of Executive Order 12866.

Consistent with Executive Orders 12866 and 13563, we are providing the Unified Regulatory Agenda and the Regulatory Plan for public review. The Agenda and Plan are a preliminary statement of regulatory and deregulatory policies and priorities under consideration. The Agenda and Plan may include rules that are not issued in the following year and some that might never be issued. Indeed, at this point, executive agencies have finalized only 43 out of the 132 economically significant active rulemakings listed in the Fall 2011 agenda. Continuing last year's practice, OMB took several steps to clarify the purposes and uses of the Agenda and Plan, including focusing the list of “active rulemakings” on rules that have at least some possibility of issuance over the next year. OMB also worked with agencies to make it easier to understand which rules are truly active rulemakings rather than long-term actions or completed actions.

We emphasize that rules listed on the agenda, designed among other things “to involve the public and its State, local, and tribal officials in regulatory planning,” must still undergo significant internal and external scrutiny before they are issued. No regulatory action can be made effective until it has gone through legally required processes, which generally include public review and comment. Any proposed or final action must also 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 previously contemplated regulatory action.

Whether a regulation is listed on the Agenda as “economically significant” within the meaning of Executive Order 12866 (generally, having an annual effect on the economy of $100 million or more) 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 or remove significant burdens. 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. As an example, the Department of Health and Human Services issues regulations on an annual basis, pursuant to statute, to govern how Medicare payments are increased each year. These regulations effectively authorize transfers of billions of dollars to hospitals and other health care providers each year.

The number of economically significant actions from Executive agencies listed as ”active rulemakings”—128—is lower than the corresponding figure for the last two editions of the Agenda, which contained 132 and 145 such rules, respectively. It is notable that the number of such rules has not grown even taking account of rules implementing the Affordable Care Act (Public Laws 111-148 and 111-152) and the Wall Street Reform and Consumer Protection Act (Public Law 111-203). Moreover, it is worth noting that a number of the rulemakings stay on the agenda from year to year; compared to the last Agenda, for example, this agenda adds only 12 new active economically significant non-recurring rules from Executive Agencies. [1] Also, the estimated net benefits of regulation have been remarkably high in this Administration; in total, net benefits over the first three fiscal years of this Administration were $91 billion.

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.

OMB hopes that the public examination of the Regulatory Plan and the Unified Agenda will 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.”

Executive Order 13563 explicitly points to the need for predictability and for certainty, as well as 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 Executive Order 12866 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 13610, Identifying and Reducing Regulatory Burdens, issued in 2012, institutionalizes the “look back” mechanism set out in Executive Order 13563, by requiring agencies to report to OMB and the public twice each year (January and July) on the status of their retrospective review efforts, to “describe progress, anticipated accomplishments, and proposed timelines for relevant actions.” (See below for additional details on Executive Order 13610.)

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. With respect to agencies' review of existing regulations, the Executive Order 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 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 offer more than 500 proposals. Many of the proposals focus on small business. 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 money.

Many of the reforms will have a significant impact. Recent plan updates include the following examples:

  • The Treasury Department, along with the Department of Homeland Security's Customs and Border Protection, issued a final rule in August 2012 eliminating the mailing of paper “courtesy” notices of liquidation, which provide informal, advanced notice of the liquidation date to the importers of record whose entry summaries are electronically filed. This effort to proceed only electronically streamlines the notification process and reduces printing and mailing costs.
  • The Department of Transportation would allow combined drug and alcohol testing for operators conducting commercial air tours. This rulemaking would allow certificate holders to implement one drug and alcohol testing program for what had been considered to this point two separate employing entities. The intent is to decrease operating costs by eliminating duplicate programs while ensuring no loss in safety.
  • The Federal Acquisition Regulation (FAR) will be amended to implement policy guidance provided by Office of Management and Budget (OMB) in Memorandum M-12-16, dated July 11, 2012, Providing Prompt Payment to Small Business Subcontractors, to address the acceleration of payments to small business subcontractors.

The regulatory look back is not 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 also focused on reducing unjustified reporting and paperwork burdens. In a June 22, 2012 Memorandum, “Reducing Reporting and Paperwork Burdens,” OIRA asked executive departments and agencies to implement Executive Order 13610, Identifying and Reducing Regulatory Burdens, by taking continuing steps to reassess regulatory requirements and, where appropriate, to streamline, improve, or eliminate those requirements. Agencies were asked to prioritize “initiatives that will produce significant quantifiable monetary savings or significant quantifiable reductions in paperwork burdens” (emphasis added). Agencies were also asked to “give special consideration to initiatives that would reduce unjustified regulatory burdens or simplify or harmonize regulatory requirements imposed on small businesses.” In addition, Executive Order 13610 requires agencies to focus on “cumulative burdens” and to “give priority to reforms that would make significant progress in reducing those burdens.” Fundamentally, looking retrospectively to reduce existing burdens, while looking forward to ensure that future regulations are well-justified, will promote the nation's economic growth while continuing to protect the health and safety of the American people.

Agencies prioritized these reviews, including opportunities for measurable reductions in paperwork burdens, and are pursuing plans that include the following:

  • The Department of Veterans Affairs (VA) is working to consolidate the application and renewal process for health benefits by eliminating the collection of financial information that is already collected by the Internal Revenue Service (IRS) and Social Security Administration (SSA). In addition to the re-use of data, the VA expects to improve the application by making it more adaptive to data provided by respondents and the information needed to make a determination for benefits. VA expects veterans to save thousands of hours and the Federal government to save millions of dollars from this improved process.
  • The Federal Emergency Management Agency (FEMA) is progressing toward the implementation of an integrated agency-wide e-Grants online application that will be available to the public online. The system will simplify submission of grant program applications across FEMA by creating online forms. Fully integrating and automating these systems will improve efficiency and the effectiveness of FEMA operations to better serve the needs of internal and external stakeholders. Grantees are expected to save over 500,000 hours in paperwork burden per year.

OMB would also like to highlight Executive Order 13609, “Promoting International Regulatory Cooperation,” which was issued by President Obama in May 2012. The Executive Order emphasizes the importance of international regulatory cooperation as a key tool for eliminating unnecessary differences in regulation between the United States and its major trading partners which, in turn, supports economic growth, job creation, innovation, trade and investment, while also protecting public health, safety, and welfare. Among other things, the Executive Order provides that agencies that are required to submit a Regulatory Plan must “include in that plan a summary of its international regulatory cooperation activities that are reasonably anticipated to lead to significant regulations, with an explanation of how these activities advance the purposes of Executive Order 13563” and Executive Order 13609. Further, the Executive Order requires agencies to “ensure that significant regulations that the agency identifies as having significant international impacts are designated as such” in the Agenda. Additionally, as part of the regulatory lookback initiative, Executive Order 13609 requires agencies to “consider reforms to existing significant regulations that address unnecessary differences in regulatory requirements between the United States and its major trading partners * * * when stakeholders provide adequate information to the agency establishing that the differences are unnecessary.”

OMB believes the implementation of Executive Order 13609 and 13610 will further strengthen the emphasis that Executive Order 13563 has placed 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 National Organic Program, Origin of Livestock, NOP-11-0009 0581-AD08 Proposed Rule Stage.
2 National Organic Program, Streamlining Enforcement Related Actions 0581-AD09 Proposed Rule Stage.
3 Plant Pest Regulations; Update of General Provisions 0579-AC98 Proposed Rule Stage.
4 Importation of Live Dogs 0579-AD23 Final Rule Stage.
5 Animal Disease Traceability 0579-AD24 Final Rule Stage.
6 Animal Welfare; Retail Pet Stores 0579-AD57 Final Rule Stage.
7 Child Nutrition Program Integrity 0584-AE08 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 Child Nutrition Programs: Professional Standards for School Food Service and State Child Nutrition Program Directors as Required by the Healthy, Hunger-Free Kids Act of 2010 0584-AE19 Proposed Rule Stage.
10 SNAP: Immediate Payment Suspension for Fraudulent Retailer Activity 0584-AE22 Proposed Rule Stage.
11 Special Supplemental Nutrition Program for Women, Infants, and Children (WIC): Revisions in the WIC Food Packages 0584-AD77 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 Egg Products Inspection Regulations 0583-AC58 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 Descriptive Designation for Needle or Blade Tenderized (Mechanically Tenderized) Beef Products 0583-AD45 Proposed Rule Stage.
17 Proposed Rule: Records to be Kept by Official Establishments and Retail Stores That Grind or Chop Raw Beef Products 0583-AD46 Proposed Rule Stage.
18 Prior Labeling Approval System: Generic Label Approval 0583-AC59 Final Rule Stage.
19 Modernization of Poultry Slaughter Inspection 0583-AD32 Final Rule Stage.
20 Electronic Export Application and Certification as a Reimbursable Service and Flexibility in the Requirements for Official Export Inspection Marks, Devices, and Certificates 0583-AD41 Final Rule Stage.
Department of Defense Back to Top
Sequence No. Title Regulation Identifier No. Rulemaking Stage
21 Service Academies 0790-AI19 Final Rule Stage.
22 Sexual Assault Prevention and Response Program Procedures 0790-AI36 Final Rule Stage.
23 Operational Contract Support 0790-AI48 Final Rule Stage.
24 Voluntary Education Programs 0790-AI50 Final Rule Stage.
25 Defense Industrial Base (DIB) Cyber Security/Information Assurance (CS/IA) Activities 0790-AI60 Final Rule Stage.
26 Mission Compatibility Evaluation Process 0790-AI69 Final Rule Stage.
27 TRICARE; Reimbursement of Sole Community Hospitals 0720-AB41 Final Rule Stage.
28 Civilian Health and Medical Program of the Uniformed Services (CHAMPUS); TRICARE Young Adult 0720-AB48 Final Rule Stage.
Department of Education Back to Top
Sequence No. Title Regulation Identifier No. Rulemaking Stage
29 Transitioning from the FFEL Program to the Direct Loan Program and Loan Rehabilitation under the FFEL, Direct Loan, and Perkins Loan Programs 1840-AD12 Proposed Rule Stage.
Department of Energy Back to Top
Sequence No. Title Regulation Identifier No. Rulemaking Stage
30 Energy Conservation Standards for Walk-In Coolers and Walk-In Freezers 1904-AB86 Proposed Rule Stage.
31 Energy Efficiency Standards for Battery Chargers and External Power Supplies 1904-AB57 Final Rule Stage.
32 Energy Efficiency Standards for Distribution Transformers 1904-AC04 Final Rule Stage.
Department of Health and Human Services Back to Top
Sequence No. Title Regulation Identifier No. Rulemaking Stage
33 Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals 0910-AG10 Proposed Rule Stage.
34 Produce Safety Regulation 0910-AG35 Proposed Rule Stage.
35 Hazard Analysis and Risk-Based Preventive Controls 0910-AG36 Proposed Rule Stage.
36 Foreign Supplier Verification Program 0910-AG64 Proposed Rule Stage.
37 Accreditation of Third Parties To Conduct Food Safety Audits and for Other Related Purposes 0910-AG66 Proposed Rule Stage.
38 Revision of Postmarketing Reporting Requirements Discontinuance or Interruption in Supply of Certain Products (Drug Shortages) 0910-AG88 Proposed Rule Stage.
39 Unique Device Identification 0910-AG31 Final Rule Stage.
40 Food Labeling: Nutrition Labeling for Food Sold in Vending Machines 0910-AG56 Final Rule Stage.
41 Food Labeling: Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments 0910-AG57 Final Rule Stage.
42 Patient Protection and Affordable Care Act; Standards Related to Essential Health Benefits, Actuarial Value, and Accreditation (CMS-9980-F) 0938-AR03 Proposed Rule Stage.
43 Part II—Regulatory Provisions To Promote Program Efficiency, Transparency, and Burden Reduction (CMS-3267-P) 0938-AR49 Proposed Rule Stage.
44 Notice of Benefit and Payment Parameters (CMS-9964-P) 0938-AR51 Proposed Rule Stage.
45 Changes to the Hospital Inpatient and Long-Term Care Prospective Payment System for FY 2014 (CMS-1599-P) 0938-AR53 Proposed Rule Stage.
46 Changes to the Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System for CY 2014 (CMS-1601-P) 0938-AR54 Proposed Rule Stage.
47 Revisions to Payment Policies Under the Physician Fee Schedule and Medicare Part B for CY 2014 (CMS-1600-P) 0938-AR56 Proposed Rule Stage.
48 Prospective Payment System for Federally Qualified Health Centers (FQHCs) (CMS-1443-P) 0938-AR62 Proposed Rule Stage.
49 Child Care and Development Fund Reforms to Support Child Development and Working Families 0970-AC53 Proposed Rule Stage.
Department of Homeland Security Back to Top
Sequence No. Title Regulation Identifier No. Rulemaking Stage
50 Asylum and Withholding Definitions 1615-AA41 Proposed Rule Stage.
51 Exception to the Persecution Bar for Asylum, Refugee, and Temporary Protected Status, and Withholding of Removal 1615-AB89 Proposed Rule Stage.
52 Employment Authorization for Certain H-4 Dependent Spouses 1615-AB92 Proposed Rule Stage.
53 Enhancing Opportunities for High-Skilled H-1B1 and E-3 Nonimmigrants and EB-1 Immigrants 1615-AC00 Proposed Rule Stage.
54 New Classification for Victims of Severe Forms of Trafficking in Persons; Eligibility for T Nonimmigrant Status 1615-AA59 Final Rule Stage.
55 Adjustment of Status to Lawful Permanent Resident for Aliens in T and U Nonimmigrant Status 1615-AA60 Final Rule Stage.
56 New Classification for Victims of Criminal Activity; Eligibility for the U Nonimmigrant Status 1615-AA67 Final Rule Stage.
57 Provisional Unlawful Presence Waivers of Inadmissibility for Certain Immediate Relatives 1615-AB99 Final Rule Stage.
58 Transportation Worker Identification Credential (TWIC); Card Reader Requirements 1625-AB21 Proposed Rule Stage.
59 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.
60 Vessel Requirements for Notices of Arrival and Departure, and Automatic Identification System 1625-AA99 Final Rule Stage.
61 Offshore Supply Vessels of at Least 6000 GT ITC 1625-AB62 Final Rule Stage.
62 Changes to the Visa Waiver Program To Implement the Electronic System for Travel Authorization (ESTA) Program 1651-AA72 Final Rule Stage.
63 Security Training for Surface Mode Employees 1652-AA55 Proposed Rule Stage.
64 Standardized Vetting, Adjudication, and Redress Services 1652-AA61 Proposed Rule Stage.
65 Passenger Screening Using Advanced Imaging Technology 1652-AA67 Proposed Rule Stage.
66 Aircraft Repair Station Security 1652-AA38 Final Rule Stage.
67 Adjustments to Limitations on Designated School Official Assignment and Study by F-2 and M-2 Nonimmigrants 1653-AA63 Proposed Rule Stage.
68 Standards To Prevent, Detect and Respond to Sexual Abuse and Assault in Confinement Facilities 1653-AA65 Proposed Rule Stage.
Department of Justice Back to Top
Sequence No. Title Regulation Identifier No. Rulemaking Stage
69 Implementation of the ADA Amendments Act of 2008 (Title II and Title III of the ADA) 1190-AA59 Proposed Rule Stage.
70 Implementation of the ADA Amendments Act of 2008 (Section 504 of the Rehabilitation Act of 1973) 1190-AA60 Proposed Rule Stage.
71 Nondiscrimination on the Basis of Disability; Movie Captioning and Video Description 1190-AA63 Proposed Rule Stage.
72 Nondiscrimination on the Basis of Disability: Accessibility of Web Information and Services of State and Local Governments 1190-AA65 Proposed Rule Stage.
73 Nondiscrimination on the Basis of Disability; Accessibility of Web Information and Services of Public Accommodations 1190-AA61 Long-Term Actions.
Architectural and Transportation Barriers Compliance Board Back to Top
Sequence No. Title Regulation Identifier No. Rulemaking Stage
74 Americans With Disabilities Act (ADA) Accessibility Guidelines for Passenger Vessels 3014-AA11 Proposed Rule Stage.
75 Telecommunications Act Accessibility Guidelines; Electronic and Information Technology Accessibility Standards 3014-AA37 Proposed Rule Stage.
76 Accessibility Standards for Medical Diagnostic Equipment 3014-AA40 Final Rule Stage.
Environmental Protection Agency Back to Top
Sequence No. Title Regulation Identifier No. Rulemaking Stage
77 Hydraulic Fracturing Chemicals; Chemical Information Reporting Under TSCA Section 8(a) and Health and Safety Data Reporting Under TSCA Section 8(d) 2070-AJ93 Prerule Stage.
78 Review of the National Ambient Air Quality Standards for Ozone 2060-AP38 Proposed Rule Stage.
79 Petroleum Refinery Sector Risk and Technology Review and NSPS 2060-AQ75 Proposed Rule Stage.
80 Control of Air Pollution From Motor Vehicles: Tier 3 Motor Vehicle Emission and Fuel Standards 2060-AQ86 Proposed Rule Stage.
81 Implementation of the 2008 National Ambient Air Quality Standards for Ozone: State Implementation Plan Requirements 2060-AR34 Proposed Rule Stage.
82 Petroleum Refinery Sector Amendment for Flares 2060-AR69 Proposed Rule Stage.
83 NPDES Electronic Reporting Rule 2020-AA47 Proposed Rule Stage.
84 Formaldehyde; Third-Party Certification Framework for the Formaldehyde Standards for Composite Wood Products 2070-AJ44 Proposed Rule Stage.
85 Formaldehyde Emissions Standards for Composite Wood Products 2070-AJ92 Proposed Rule Stage.
86 Revisions to the National Oil and Hazardous Substances Pollution Contingency Plan; Subpart J Product Schedule Listing Requirements 2050-AE87 Proposed Rule Stage.
87 Effluent Limitations Guidelines and Standards for the Steam Electric Power Generating Point Source Category 2040-AF14 Proposed Rule Stage.
88 National Primary Drinking Water Regulations for Lead and Copper: Regulatory Revisions 2040-AF15 Proposed Rule Stage.
89 Clean Water Protection Rule 2040-AF30 Proposed Rule Stage.
90 Greenhouse Gas New Source Performance Standard for Electric Generating Units for New Sources 2060-AQ91 Final Rule Stage.
91 Hazardous Waste Management Systems: Identification and Listing of Hazardous Waste: Carbon Dioxide (CO2) Streams in Geological Sequestration Activities 2050-AG60 Final Rule Stage.
92 Rulemaking on the Definition of Solid Waste 2050-AG62 Final Rule Stage.
93 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
94 Revisions to Procedures for Complaints or Charges of Employment Discrimination Based on Disability Subject to the Americans With Disabilities Act and Section 504 of the Rehabilitation Act of 1973 3046-AA91 Proposed Rule Stage.
95 Revisions to Procedures for Complaints/Charges of Employment Discrimination Based on Disability Filed Against Employers Holding Government Contracts or Subcontracts 3046-AA92 Proposed Rule Stage.
96 Revisions to Procedures for Complaints of Employment Discrimination Filed Against Recipients of Federal Financial Assistance 3046-AA93 Proposed Rule Stage.
97 Revisions to the Federal Sector's Affirmative Employment Obligations of Individuals with Disabilities Under Section 501 of the Rehabilitation Act of 1973, as Amended 3046-AA94 Proposed Rule Stage.
Small Business Administration Back to Top
Sequence No. Title Regulation Identifier No. Rulemaking Stage
98 504 and 7(a) Regulatory Enhancements 3245-AG04 Proposed Rule Stage.
99 Small Business Jobs Act: Small Business Mentor-Protégé Programs 3245-AG24 Proposed Rule Stage.
100 Small Business Technology Transfer (STTR) Policy Directive 3245-AF45 Final Rule Stage.
101 Small Business Innovation Research (SBIR) Program Policy Directive 3245-AF84 Final Rule Stage.
102 Acquisition Process: Task and Delivery Order Contracts, Bundling, Consolidation 3245-AG20 Final Rule Stage.
Social Security Administration Back to Top
Sequence No. Title Regulation Identifier No. Rulemaking Stage
103 Revised Medical Criteria for Evaluating Neurological Impairments (806P) 0960-AF35 Proposed Rule Stage.
104 Revised Medical Criteria for Evaluating Respiratory System Disorders (859P) 0960-AF58 Proposed Rule Stage.
105 Revised Medical Criteria for Evaluating Hematological Disorders (974P) 0960-AF88 Proposed Rule Stage.
106 Revised Medical Criteria for Evaluating Genitourinary Disorders (3565P) 0960-AH03 Proposed Rule Stage.
107 Hearings by Video Teleconferencing (VTC) (3728P) 0960-AH37 Proposed Rule Stage.
108 Revised Medical Criteria for Evaluating Mental Disorders (886F) 0960-AF69 Final Rule Stage.
109 Revised Medical Criteria for Evaluating Congenital Disorders That Affect Multiple Body Systems (3566F) 0960-AH04 Final Rule Stage.
110 Amendments to Regulations Regarding Withdrawals of Applications and Voluntary Suspension of Benefits (3573F) 0960-AH07 Final Rule Stage.
111 Revised Medical Criteria for Evaluating Visual Disorders (3696F) 0960-AH28 Final Rule Stage.
112 Amendments to the Rules on Determining Hearing Appearances and to the Rules on Objecting to the Time and Place of the Hearing (3401F) 0960-AH40 Final Rule Stage.
Nuclear Regulatory Commission Back to Top
Sequence No. Title Regulation Identifier No. Rulemaking Stage
113 Medical Use of Byproduct Material—Amendments/Medical Event Definition [NRC-2008-0071] 3150-AI26 Proposed Rule Stage.
114 Fitness-for-Duty (HHS Requirements) [NRC-2009-0225] 3150-AI67 Proposed Rule Stage.
115 Disposal of Unique Waste Streams [NRC-2011-0012] 3150-AI92 Proposed Rule Stage.
116 Station Blackout Mitigation [NRC-2011-0299] 3150-AJ08 Proposed Rule Stage.
117 Revision of Fee Schedules: Fee Recovery for FY 2013 [NRC-2012-0211] 3150-AJ19 Proposed Rule Stage.
118 Physical Protection of Byproduct Material [NRC-2008-0120] 3150-AI12 Final Rule Stage.
119 Environmental Effect of Renewing the Operating License of a Nuclear Power Plant [NRC-2008-0608] 3150-AI42 Final Rule Stage.
120 Domestic Licensing of Source Material—Amendments/Integrated Safety Analysis [NRC-2009-0079] 3150-AI50 Final Rule Stage.
121 List of Approved Spent Fuel Storage Casks—Transnuclear, Inc., Standardized NUHOMS□ System, Revision 11 [NRC-2012-0020] 3150-AJ10 Final Rule Stage.
122 List of Approved Spent Fuel Storage Casks—Holtec International, HI-STORM 100, Revision 9 [NRC-2012-0052] 3150-AJ12 Final Rule Stage.

BILLING CODE 6820-27-P

DEPARTMENT OF AGRICULTURE (USDA) Back to Top

Statement of Regulatory Priorities

In FY 2013, USDA's focus will continue to 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. The 2008 Farm Bill covering major farm, trade, conservation, rural development, nutrition assistance and other programs expired at the end of fiscal year 2012 and is expected to be reauthorized in 2013. It is anticipated that a number of high priority regulations will be developed during 2013 to implement this legislation should it be enacted. USDA's regulatory efforts in the coming year will achieve the Department's goals identified in the Department's Strategic Plan for 2010-2015.

  • 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 or 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 recreational visitors, sustaining green jobs, and producing ecosystem services, food, fiber, timber and non-timber products. 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 2013 will include the following:

  • Improving Access to Nutrition Assistance and Dietary Behaviors. As changes are made to the nutrition assistance programs, USDA will work to ensure access to program benefits, improve program integrity, improve diets and healthy eating, and promote physical activity consistent with the national effort to reduce obesity. In support of these activities in 2013, the Food and Nutrition Service (FNS) plans to publish the proposed rule regarding the nutrition standards for foods sold in schools outside of the reimbursable meal 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.
  • Strengthening Food Safety Inspection. 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 2013, the Food Safety and Inspection Service (FSIS) plans to finalize regulations to establish new systems for poultry slaughter inspection, which would save money for establishments and taxpayers while improving food safety. Among other actions, USDA will provide export certificates through the use of technology, and define conditions under which the “natural” claim may be used on meat and poultry labeling. To assist small entities to comply with food safety requirements, FSIS will continue to collaborate with other USDA agencies and State partners in its small business outreach program.
  • Forestry and Conservation. USDA plans to finalize regulations that would streamline the Natural Resources Conservation Service's (NRCS) financial assistance programs, which would make program participation easier for producers. USDA will update its EQIP participation requirements to allow limited resource producers with incomplete irrigation histories to participate in the program. Additionally, USDA will allow NRCS' State Conservationists to remove undue burdens on producers that have acted in good faith on incorrect program information provided by NRCS. USDA will also publish proposed Agency guidance for implementation of the Forest Service's 2012 Planning Rule. This guidance will provide the detailed monitoring, assessing, and documenting requirements that National Forests require to begin revising their land management plans under the 2012 Planning Rule (currently 70 of the 120 Forest Service's Land Management Plans are expired and in need of revision).
  • Making Marketing and Regulatory Programs More Effective. USDA will continue to protect the health and value of U.S. agricultural and natural resources. USDA plans to continue work on implementing a national animal disease traceability system and anticipates revising the permitting of plant pests and biological control organisms. A national, effective animal disease traceability system will enhance our ability to respond to animal disease detections. Revising the plant pests and biological control organisms' regulations on permitting would facilitate the movement of regulated organisms and articles in a manner that also protects U.S. agriculture, and address gaps in the current regulations. For the Animal Welfare Act (AWA), USDA plans to finalize specific standards for the humane care of dogs imported for resale and the definition of a retail pet store. USDA will support the organic sector by updating the National List of Allowed and Prohibited Substances as advised by the National Organic Standards Board, streamlining organic regulatory enforcement actions, developing organic pet food standards, and proposing that all existing and replacement dairy animals from which milk or milk products are intended to be sold as organic must be managed organically from the last third of gestation.
  • Promoting Biobased Products. 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. The Federal preferred procurement and the certified label parts of the program are voluntary; both are designed to assist biobased businesses in securing additional sales.

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 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 plan can be found at http://www.usda.gov/wps/portal/usda/usdahome?navid=USDA_OPEN.

RIN Title Significantly Reduce Burdens on Small Businesses
0583-AC59 Prior Labeling Approval System: Generic Label Approval Yes.
0583-AD41 Electronic Export Application and Certification Fee Yes.
0583-AD39 Electronic Import Inspection and Certification of Imported Products and Foreign Establishments Yes.
0583-AD32 Modernization of Poultry Slaughter Inspection Yes.
0570-AA76 Rural Energy America Program Yes.
0575-AC91 Community Facilities Loan and Grants Yes.
0596-AD01 National Environmental Policy Act Efficiencies Yes.
0570-AA85 Business and Industry Loan Guaranteed Program Yes.

Subsequent to EO 13563, and consistent with its goals as well as the importance of public participation, President Obama issued EO 13610 on Identifying and Reducing Regulatory Burdens in May 2012. EO 13610 directs agencies, in part, to give priority consideration to those initiatives that will produce costs savings or significant reductions in paperwork burdens. 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 ongoing regulatory review and burden reduction efforts, USDA will make regulatory changes in 2013, including the following:

  • Increase Use of Generic Approval and Regulations Consolidation. FSIS is finalizing 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 regulatory burden and generate taxpayer savings of $2.9 million over 10 years.
  • Implement Electronic Export Application for Meat and Poultry Products. FSIS is finalizing a rule to provide exporters a fee-based option for transmitting U.S. certifications to foreign importers and governments electronically. Automating the export application and certification process will facilitate the export of U.S. meat, poultry, and egg products by streamlining the processes that are used while ensuring that foreign regulatory requirements are met.
  • Simplify FSA NEPA Compliance. FSA will revise its regulations that implement the National Environmental Policy Act (NEPA) to update, improve, and clarify requirements. It will also remove obsolete provisions. Annual cost savings to FSA as a result of this rule could be $345,000 from conducting 314 fewer environmental assessments per year, while retaining strong environmental protection.
  • Streamline Forest Service NEPA Compliance. The Forest Service (FS), in cooperation with the Council on Environmental Quality (CEQ), is promulgating rulemaking to establish three new Categorical Exclusions for simple restoration activities. These Categorical Exclusions will improve and streamline the NEPA process, and reduce the paperwork burden, as it applies to FS projects without reducing environmental protection.
  • Rural Energy for America Program (REAP). Under REAP, Rural Development provides guaranteed loans and grants to support the purchase, construction, or retrofitting of a renewable energy system. This rulemaking will streamline the process for grants, lessening the burden to the customer. It will also make the guaranteed loan portion of the rule consistent with other programs RD manages. The rulemaking is expected to reduce the information collection burden.
  • Reduced Duplication in Farm Programs. 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). As a result, producers will be able to spend less time reporting information to USDA. Additionally, FSA and RMA will be better able to share information, thus improving operational efficiency. 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 the 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. Full implementation of the Acreage and Crop Reporting Streamlining Initiative (ACRSI) is planned for 2013. When specific changes are identified, FSA and RMA will make any required conforming changes in their respective regulations.
  • Increased Use of Electronic Forms. 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, Indian 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 constituent groups to apply for multiple programs. In addition, there will be associated regulations for each program that will contain program specific information.

Promoting International Regulatory Cooperation Under EO 13609

President Obama issued EO 13609 on promoting international regulatory cooperation in May 2012. The EO charges the Regulatory Working Group, an interagency working group chaired by the Administrator of Office of Information and Regulatory Affairs (OIRA), with examining appropriate strategies and best practices for international regulatory cooperation. The EO also directs agencies to identify factors that should be taken into account when evaluating the effectiveness of regulatory approaches used by trading partners with whom the U.S. is engaged in regulatory cooperation. At this time, USDA is identifying international regulatory cooperation activities that are reasonably anticipated to lead to significant regulations, while working closely with the Administration to refine the guidelines implementing the EO. Apart from international regulatory cooperation, the Department has continued to identify regulations with international impacts, as it has done in the past. Such regulations are those that are expected to have international trade and investment effects, or otherwise may be of interest to our international trading partners. For example, FSIS is working with Canada's Treasury Board and Canadian Food Inspection Agency to facilitate the movement of meat, poultry, and egg products between the U.S. and Canada while still ensuring food safety. The effort may lead to a future proposed rule to revise FSIS's regulations regarding the importation of these products.

Major Regulatory Priorities

This following represents summary information on prospective priority regulations as called for in EO's 12866 and 13563:

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's 2013 regulatory plan supports USDA's Strategic Goal to “ensure that all of America's children have access to safe, nutritious and balanced meals,” and its two related objectives:

  • Increase 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 from the 2008 Farm Bill addressing SNAP eligibility, certification, and employment and training issues. This rule also responds to the principles outlined in EO 13563 and responds to EO 13610 by eliminating the requirement for face-to-face interviews in the SNAP certification process, eliminating substantial burdens for SNAP clients and providing additional flexibility to State agencies that administer the program.
  • Improve Program Integrity. FNS also plans to publish a number of rules to increase the efficiency and reduce the burden of program operations. Program integrity provisions will continue to be strengthened in the SNAP and Child Nutrition programs to ensure Federal taxpayer dollars are spent effectively.
  • Promote Healthy Diet and Physical Activity Behaviors. This objective represents FNS's efforts to ensure that program benefits meet appropriate standards to effectively improve nutrition for program participants, to improve the diets of its clients through nutrition education, and to support the national effort to reduce obesity by promoting healthy eating and physical activity. In support of this objective, FNS plans to publish a proposed rule implementing Healthy, Hunger-Free Kids Act provisions setting nutrition standards for all foods sold in school, establishing professional standards for school food service and State child nutrition program directors, and establishing requirements for the SNAP Nutrition Education and Obesity Prevention Grant Program; and finalizing a rule updating food packages in WIC. FNS' goal is by 2015 to reduce child obesity from 16.9 percent to 15.5 percent, to double the proportion of adults consuming five or more servings of fruits and vegetables daily, and to increase breastfeeding rates.

Food Safety and Inspection Service

Mission: FSIS is responsible for ensuring that meat, poultry, and egg 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, and egg 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's priority initiatives are as follows:

  • Poultry Slaughter Modernization. FSIS plans to issue a final rule to implement a new inspection system for young poultry slaughter establishments that would facilitate public health-based inspection. The rule would allow for more effective inspection of carcasses and allocation of agency resources, as well as encourage industry to more readily use new technology. It would save money for businesses and taxpayers while improving food safety.
  • “Natural” Claim. 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. Requests for a “natural” label approval would need to include documentation to demonstrate that the products meet the criteria to bear the claim. A codified “natural” claim definition will reduce uncertainty about which products qualify for the label and will increase consumer confidence in the claim.
  • Public Health Information System. To support its food safety inspection activities, FSIS is continuing to implement the Public Health Information System (PHIS), a user-friendly and Web-based system that automates many of the Agency's business processes. PHIS also enables 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 has proposed to provide for electronic export application and certification processes and will propose similar import processes as alternatives to current paper-based systems.

Retrospective Review of Regulations. FSIS will continue to review its regulations to determine how to improve information collection procedures and the quality and sufficiency of data available to support regulatory decision making, and how to decrease the recordkeeping burden on the industry.

In addition to the planned amendments to provide for electronic import and export application and certification, mentioned above, and in response to comments received on the request for information preparatory to the Department's regulatory review plan, FSIS is developing a final rule that will reduce regulatory burden by expanding the circumstances in which the labels of meat and poultry products will be deemed to be generically approved by FSIS.

  • FSIS Small Business Implications. The great majority of businesses regulated by FSIS are 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 will meet with small and very small plant operators to learn more about their specific needs and explore how FSIS can tailor regulations to better meet the needs of small and very small establishments, while maintaining the highest level of food safety.

Animal and Plant Health Inspection Service

Mission: The Animal and Plant Health Inspection Service (APHIS) is a multi-faceted Agency with a broad mission area that includes protecting and promoting U.S. agricultural health, regulating genetically engineered organisms, administering the AWA and carrying out wildlife damage management activities.

Priorities: With regard to plant and animal health, APHIS is committed to developing and issuing science-based regulations intended 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 United States 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 AWA. APHIS priority issues are as follows:

  • Animal Disease Traceability. APHIS is continuing work to implement a robust national animal disease traceability system. This rulemaking would amend the regulations to establish minimum national official identification and documentation requirements for the traceability of livestock moving interstate. Continuing this work is expected to improve our ability to trace livestock in the event that disease is found.
  • Bovine Spongiform Encephalopathy (BSE). APHIS is continuing work to revise its regulations concerning BSE to provide a more comprehensive and universally applicable framework for the importation of certain animals and products. APHIS believes that this work will continue to guard against the introduction of BSE into the United States.
  • Update of Plant Pest Regulations. APHIS proposes to regulate the movement of not only plant pests, but also biological control organisms and associated articles. APHIS proposes risk-based criteria regarding the movement of biological control organisms, and proposes to establish regulations to allow the movement in interstate commerce of certain types of plant pests when appropriate. APHIS also proposes to revise 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 proposal would also clarify the factors that would be considered when assessing the risks associated with the movement of certain organisms. Finally, this proposal is expected to facilitate the movement of regulated organisms and articles in a manner that protects U.S. agriculture and address gaps in the current regulations.
  • Retail Pet Stores. APHIS is continuing work to revise the definition of retail pet store and related regulations to bring more pet animals sold at retail under the protection of the AWA.

Agricultural Marketing Service

Mission: The Agricultural Marketing Service (AMS) provides marketing services to producers, manufacturers, distributors, importers, exporters, and consumers of food products. AMS also manages the government's food purchases, supervises food quality grading, maintains food quality standards, supervises the Federal research and promotion programs, and oversees the country of origin labeling program as well as the National Organic Program (NOP).

Priorities: AMS priority items for next year include rulemaking that affects the organic industry. These are:

  • National List of Allowed and Prohibited Substances (National List). The agency will continue to follow the requirements of the Organic Food Production Act of 1990 by publishing rules to amend the National List based upon recommendations of the National Organic Standards Board (NOSB) and publish a rule to address substances due to sunset from the National List in 2013.
  • Streamline Enforcement Actions for NOP. AMS would propose a regulation streamlining enforcement actions, by shortening the process by which AMS may initiate formal administrative proceedings for proposed suspensions or revocations of accreditation or certification.
  • Organic Pet Food Standards. AMS would propose standards for organic pet food following recommendations of the NOSB.
  • Organic Dairy Animals. AMS would propose a rule on the replacement of dairy animals which is intended to level the playing field by instituting the same requirements across all organic dairy producers, regardless of how they transitioned to organic production.

Farm Service Agency

Mission: FSA's mission is to deliver timely, effective programs and services to America's farmers and ranchers to support them in sustaining our Nation's vibrant agricultural economy, as well as to provide first-rate support for domestic and international food aid efforts. FSA supports USDA's strategic goals 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 administers several conservation programs directed toward agricultural producers. The largest program is the Conservation Reserve Program, which protects up to 32 million acres of environmentally sensitive land.

Priorities: FSA is focused on providing the best possible service to producers while protecting the environment by updating and streamlining environmental compliance and further strengthening Farm Loan Programs. Changes in the loan programs will better assist small farmers and socially disadvantaged farmers and will make loan servicing more efficient. FSA is also strengthening its ability to help the Nation respond to national defense emergencies. FSA's priority initiatives are as follows:

  • Microloan Programs. FSA will implement a Microloan Program, which will help small and family operations progress through their start-up years with needed resources, while building capacity, increasing equity, and eventually graduating to commercial credit. The Microloan Program will improve the FSA Operating Loan Program to better meet the needs of small farmers. In addition, 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.
  • Environmental Compliance (National Environmental Policy Act). FSA will revise its regulations that implement the National Environmental Policy Act. The changes improve the efficiency, transparency, and consistency of NEPA implementation. Changes include aligning the regulations to NEPA regulations and guidance from the President's Council on Environmental Quality; providing a single set of regulations that reflect the agency's current structure; clarifying the types of actions that require an Environmental Assessment (EA); and adding to the list of actions that are categorically excluded from further environmental review because they have no significant effect on the human environment.
  • Agriculture Priorities and Allocations Systems (APAS). USDA was directed to develop APAS as part of a suite of rules that are being modeled after the Defense Priorities and Allocations System (DPAS). Under APAS, USDA would secure food and agriculture-related resources as part of preparing for, and responding to, national defense emergencies by placing priorities on orders or by using resource allocation authority. APAS is authorized by the Defense Production Act Reauthorization Act of 2009 (DPA). The authorities under DPA have already been implemented by the Department of Commerce (DOC) via memoranda of understanding with other Departments. The suite of DPA rules relieves DOC from implementation responsibility for items outside their jurisdiction and places these responsibilities with the relevant Departments.

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, plus developing and providing scientific and technical assistance, and the exchange of scientific information to support international forest and range conservation. Forest Service regulatory priorities support the accomplishment of the Department's goal to ensure our National forests are conserved, restored, and made more resilient to climate change, while enhancing our water resources.

Priorities: FS is committed to developing and issuing science-based regulations intended to ensure public participation in the management of our Nation's National Forest, while also moving forward the FS' ability to plan and conduct restoration projects on National Forest System lands. FS will continue to review its existing authorities and regulations to ensure that it can address emerging challenges, to streamline excessively burdensome business practices, and to revise or remove regulations that are inconsistent with the USDA's vision for restoring the health and function of the lands it is charged with managing. FS' priority initiatives are as follows:

  • Land Management Planning Rule Policy. The Forest Service promulgated a new Land Management Planning rule in April 2012. This rule streamlined the Forest Service's paperwork requirements but expanded the public participation requirements for revising National Forest's Land Management Plans. Having promulgated the 2012 Planning Rule, the Agency is planning to publish for comment the follow-up internal guidance on how to implement the new planning rule. These directives, once finalized, will enable National Forests to begin revising their management plans under the new rule.
  • Ecological Restoration Policy. This policy would recognize the adaptive capacity of ecosystems, and includes the role of natural disturbances and uncertainty related to climate and other environmental change. The need for ecological restoration of National Forest System (NFS) lands is widely recognized, and the Forest Service has conducted restoration-related activities across many programs for decades. “Restoration” is a common way of describing much of the agency's work and the concept is threaded throughout existing authorities, program directives, and collaborative efforts such as the National Fire Plan 10-Year Comprehensive Strategy and Implementation Plan and the Healthy Forests Restoration Act. However, the agency did not have a definition of restoration established in policy. That was identified as a barrier to collaborating with the public and partners to plan and accomplish restoration work.

Rural Development

Mission: Rural Development (RD) promotes a dynamic business environment in rural America that creates jobs, community infrastructure, and housing opportunities in partnership with the private sector and community-based organizations by providing financial assistance and business planning services, and supporting projects that create or preserve quality jobs and/or promote a clean rural environment, while focusing on the development of single and multi-family housing and community infrastructure. RD 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.

Priorities: RD regulatory priorities will facilitate sustainable renewable energy development and enhance the opportunities necessary for rural families to thrive economically. RD's rules will minimize program complexity and the related burden on the public while enhancing program delivery and RBS oversight.

  • Business and Industry (B&I) Guaranteed Loan Program. RD will enhance current operations of the B&I program, streamline existing practices, and minimize program complexity and the related burden on the public.
  • Rural Energy for America Program (REAP). REAP will be revised to ensure a larger number of applicants will be made available by issuing smaller grants. By doing so, funding will be distributed evenly across the applicant pool and encourage greater development of renewable energy.
  • Broadband Loans. RD will finalize the interim rule that implemented provisions of the 2008 Farm Bill that made credit more accessible for broadband providers serving rural areas. The key provisions of the regulation include modifications to rural areas, financial coverage ratios, defining broadband speed and the publication of an annual notice.

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 programs, consistent with laws and mandates, and provide safe and efficient facilities and services to customers.

Priorities

  • USDA Procurement Reform: Department Management would incorporate in all moderate to large USDA contracts a new clause requiring the contractor to certify compliance with three specific labor laws, and to notify the contracting officer if it becomes aware of a violation of one of these laws. This would mitigate the risk of potentially awarding contracts to non-responsible entities and ensure that compliance with labor laws is factored into contracting decisions.
  • BioPreferred® Program: In support of the Department's goal to increase prosperity in rural areas, 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 are 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 2013, 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

1. National Organic Program, Origin of Livestock, NOP-11-0009

Proposed Rule Stage

Priority: Other Significant.

Legal Authority: 7 U.S.C. 6501

CFR Citation: 7 CFR part 205.

Legal Deadline: None.

Abstract: The current regulations provide two tracks for replacing dairy animals which are tied to how dairy farmers transition to organic production. Farmers who transition an entire distinct herd must thereafter replace dairy animals with livestock that has been under organic management from the last third of gestation. Farmers who do not transition an entire distinct herd may perpetually obtain replacement animals that have been managed organically for 12 months prior to marketing milk or milk products as organic. The proposed action would eliminate the two track system and require that upon transition, all existing and replacement dairy animals from which milk or milk products are intended to be sold, labeled or represented as organic, must be managed organically from the last third of gestation.

Statement of Need: This action is being taken because of concerns raised by various parties, including the National Organic Standards Board (NOSB), about the dual tracks for dairy replacement animals. The organic community argues that the “two track system” encourages producers to sell their organic young stock and replace them with animals converted from conventional production. The organic community points out that with this continual state of transitioning, animals treated with and fed prohibited substances, prior to conversion, are constantly entering organic agriculture. Some producers have taken this route because it is cheaper and easier to convert or purchase converted animals than to raise organic young stock. As a result, this continual state of transition has discouraged development of a viable organic market for young dairy stock. The organic community has expressed that this is contrary to the intent of organic and the expectations of organic dairy product consumers. These concerns are ultimately rooted in a discrepancy between the regulatory intent and interpretation whereby some organic dairy producers are required to manage/obtain animals that have been raised organically since the last third of gestation, while other producers may continually obtain replacement animals from conventional production, which have been managed organically for 12 months. The proposed action would level the playing field by instituting the same requirements across all producers, regardless of their transition approach.

Summary of Legal Basis: The National Organic Program regulations stipulate the requirements for dairy replacement animals in section 205.236(a)(2) Origin of Livestock. In addition, in response to the final ruling in the 2005 case, Harvey v. Johanns, the USDA committed to rulemaking to address the concerns about dairy replacement animals.

Alternatives: The program considered initiating the rulemaking with an ANPR. It was determined that there is sufficient awareness of the expectations of the organic community to proceed with a proposed rule. As alternatives, we considered the status quo, however, this would continue the disparity between producers who can continually transition conventional dairy animals into organic production and producers who must source dairy animals that are organic from the last third of gestation. Based on the information available, this disparity appears to create a barrier to the development of an organic heifer market. We also considered an action that would restrict the source of breeder stock and movement of breeder stock after they are brought onto an organic operation, however, this would minimize the flexibility of producers to purchase breeder stock from any source as specified under the Organic Foods Production Act.

Anticipated Cost and Benefits: Organic producers who routinely convert conventional dairy livestock to organic will either need to find a source to procure organic replacement animals, or begin to raise replacement animals within their operation. The costs associated with compliance have not been quantified, however, the comments to the proposed rule will provide a basis for those estimates. Organic operations that converted a whole-herd to organic status and do not convert conventional animals for replacements will be able to readily comply with the rule and may find new market opportunities for organic replacement dairy livestock.

Risks: Continuation of the two-track system jeopardizes the viability of the market for organic heifers. A potential risk associated with the rulemaking would be a temporary supply shortage of dairy replacement animals due to the increased demand.

Timetable:

Action Date FR Cite
NPRM 06/00/13

Regulatory Flexibility Analysis Required: No.

Government Levels Affected: None.

Agency Contact: Melissa R Bailey, Director, Standards Division, Department of Agriculture, Agricultural Marketing Service, 14th & Independence Avenue SW., Rm. 2646-South Building, Washington, DC 20250, Phone: 202 720-3252, Fax: 202 205-7808, Email: melissa.bailey@usda.gov.

RIN: 0581-AD08

USDA—AMS Back to Top

2. National Organic Program, Streamlining Enforcement Related Actions Back to Top

Priority: Other Significant.

Legal Authority: 7 U.S.C. 6501

CFR Citation: 7 CFR part 205.

Legal Deadline: None.

Abstract: This rulemaking would amend sections of the NOP regulations which pertain to the adverse action appeals process. It would require the Agency to initiate formal administrative proceedings for proposed suspensions or revocations of accreditation or certification issued by the NOP. Under the current NOP regulations, a formal administrative proceeding is initiated following the decision of the Administrator to deny an appeal. This rulemaking would omit the step of appealing to the Administrator when NOP has initiated the adverse action. This action also would amend the NOP regulations to require appellants who want to further contest a decision of the Administrator to deny an appeal to request a hearing. Under the current regulations, the formal administrative proceeding is initiated by default upon issuance of the Administrator's denial.

Also, this rulemaking would add clarifying language concerning mediation and stipulations entered into by the NOP, as well as correct the address to which appeals are submitted.

Statement of Need: The March 2010 Office of Inspector General (OIG) audit of the NOP, raised issues related to the program's progress for imposing enforcement actions. One concern was that organic producers and handlers facing revocation or suspension of their certification are able to market their products as organic during what can be a lengthy appeals process. As a result, AMS expects to publish a proposed rule in FY2013 to revise language in section 205.681 of the NOP regulations, which pertains to adverse action appeals. It is expected that this rule will streamline the NOP appeals process such that appeals are reviewed and responded to in a more timely manner.

Summary of Legal Basis: The Organic Foods Production Act of 1990 (OFPA), 7 U.S.C. section 6501 et seq., requires that the Secretary establish an expedited administrative appeals procedure for appealing an action of the Secretary or certifying agent (section 6520). The NOP regulations describe how appeals of proposed adverse action concerning certification and accreditation are initiated and further contested (sections 205.680, 205.681).

Alternatives: The program considered maintaining the status quo and hiring additional support for the NOP Appeals Team. This rulemaking was determined to be preferable because it will reduce redundancy in the appeals process, where an appellant can more quickly appeal the Administrator's decision to an Administrative Law Judge.

Anticipated Cost and Benefits: This action will affect certified operations and accredited certifying agents. The primary impact is expected to be expedited enforcement action, which may benefit the organic community through deterrence and increase consumer confidence in the organic label. It is not expected to have a significant cost burden upon affected entities beyond any monetary penalty or suspension or revocation of certification or accreditation, to which these entities are already subject to under current regulations.

RISKS: None have been identified.

Risks: None.

Timetable:

Action Date FR Cite
NPRM 06/00/13  

Regulatory Flexibility Analysis Required: No.

Government Levels Affected: None.

Agency Contact: Melissa R Bailey, Director, Standards Division, Department of Agriculture, Agricultural Marketing Service, 14th & Independence Avenue SW., Rm. 2646-South Building, Washington, DC 20250, Phone: 202 720-3252, Fax: 202 205-7808, Email: melissa.bailey@usda.gov.

RIN: 0581-AD09

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

Proposed Rule Stage

3. 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 parts 318 and 319; 7 CFR part 330; 7 CFR part 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 establish regulations to allow the movement in interstate commerce of certain types of plant pests without restriction by granting exceptions from permitting requirements for those pests. 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 04/00/13  
NPRM Comment Period End 06/00/13  

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: 301 851-2323.

RIN: 0579-AC98

USDA—APHIS Back to Top

Final Rule Stage

4. Importation of Live Dogs Back to Top

Priority: Other Significant.

Legal Authority: 7 U.S.C. 2148.

CFR Citation: 9 CFR parts 1 and 2.

Legal Deadline: None.

Abstract: We are amending the regulations to implement an amendment to the Animal Welfare Act (AWA). The Food, Conservation, and Energy Act of 2008 added a new section to the AWA to restrict the importation of certain live dogs. Consistent with this amendment, this rule prohibits the importation of dogs, with limited exceptions, from any part of the world into the continental United States or Hawaii for purposes of resale, research, or veterinary treatment, unless the dogs are in good health, have received all necessary vaccinations, and are at least 6 months of age. This action is necessary to implement the amendment to the AWA and will help to ensure the welfare of imported dogs.

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 June 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 04/00/13  

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 20737-1231, Phone: 301 851-3735.

RIN: 0579-AD23

USDA—APHIS Back to Top

5. Animal Disease Traceability Back to Top

Priority: Other Significant.

Legal Authority: 7 U.S.C. 8305

CFR Citation: 9 CFR part 86.

Legal Deadline: None.

Abstract: This rulemaking will amend the regulations to establish minimum national official identification and documentation requirements for the traceability of livestock moving interstate. The purpose of this rulemaking 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 12/00/12  

Regulatory Flexibility Analysis Required: Yes.

Small Entities Affected: Businesses.

Government Levels Affected: State, Tribal.

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

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: 301 851-3539.

RIN: 0579-AD24

USDA—APHIS Back to Top

6. Animal Welfare; Retail Pet Stores Back to Top

Priority: Other Significant.

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

CFR Citation: 9 CFR parts 1 and 2.

Legal Deadline: None.

Abstract: This rulemaking will revise the definition of retail pet store and related regulations to bring more pet animals sold at retail under the protection of the Animal Welfare Act (AWA). Retail pet stores are not required to be licensed and inspected under the AWA. This rulemaking is necessary to ensure that animals sold at retail are monitored for their health and humane treatment.

Statement of Need:“Retail pet stores” are not required to obtain a license under the Animal Welfare Act (AWA) or comply with the AWA regulations and standards. Currently, anyone selling, at retail, the following animals for use as pets are considered retail pet stores: Dogs, cats, rabbits, guinea pigs, hamsters, gerbils, rats, mice, gophers, chinchilla, domestic ferrets, domestic farm animals, birds, and cold-blooded species. This rulemaking would rescind the “retail pet store” status of anyone selling, at retail for use as pets, those types of animals to buyers who do not physically enter his or her place of business or residence in order to personally observe the animals available for sale prior to purchase and/or to take custody of the animals after purchase. Unless otherwise exempt under the regulations, these entities would be required to obtain a license from APHIS and would become subject to the AWA regulations and standards.

Summary of Legal Basis: Under the Animal Welfare Act (AWA or the Act, 7 U.S.C. 2131 et seq.), the Secretary of Agriculture is authorized 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 intermediate handlers. The Secretary has delegated responsibility for administering the AWA to the Administrator of APHIS.

Alternatives: We recognize that retailers who sell some animals to walk-in customers and some animals remotely may be subject to a certain degree of oversight by the customers who enter their place of business or residence. As a result, we considered establishing a regulatory threshold based on the percentage of such a retailer's remote sales. A second alternative we considered in preparing the proposed rule was to add an exception from licensing for retailers that are subject to oversight by State or local agencies or by breed and registry organizations that enforce standards of welfare comparable to those standards established under the AWA. A third alternative we considered during the development of the proposed rule was to amend the definition of retail pet store so that only high-volume breeders would be subject to the AWA regulations and standards. We determined, however, that the proposed action would be preferable to these alternatives.

Anticipated Cost and Benefits: Although we have attempted to estimate the impact of the proposed rule, we did not initially have enough information to fully assess it, particularly information on the number of entities that may be affected or breadth of operational changes that may result. In the proposed rule, we encouraged public comment on the number of entities that may be affected and the degree to which operations would be altered to comply with the rule. We believe that the benefits of the rule—primarily enhanced animal welfare—would justify the costs. The rule would help ensure that animals sold at retail, but lacking public oversight receive humane handling, care and treatment in keeping with the requirements of the AWA. It would also address the competitive disadvantage of retail breeders who adhere to the AWA regulations, when compared to those retailers who do not operate their facilities according to AWA standards and may therefore bear lower costs. These benefits are not quantified.

Risks: Not applicable.

Timetable:

Action Date FR Cite
NPRM 05/16/12 77 FR 28799
NPRM Comment Period End 07/16/12  
NPRM Comment Period Extended 07/16/12 77 FR 41716
NPRM Comment Period End 08/15/12  
Final Rule 02/00/13  

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 20737-1231, Phone: 301 851-3735.

RIN: 0579-AD57

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

Proposed Rule Stage

7. Child Nutrition Program Integrity Back to Top

Priority: Other Significant.

Unfunded Mandates: Undetermined.

Legal Authority: Pub. L. 111-296

CFR Citation: Not Yet Determined.

Legal Deadline: None.

Abstract: This rule proposes to codify three provisions of the Healthy, Hunger-Free Kids Act of 2010 (the Act). Section 303 of the Act requires the Secretary to establish criteria for imposing fines against schools, school food authorities, or State agencies that fail to correct severe mismanagement of the program, fail to correct repeat violations of program requirements, or disregard a program requirement of which they had been informed. Section 322 of the Act requires the Secretary to establish procedures for the termination and disqualification of organizations participating in the Summer Food Service Program (SFSP). Section 362 of the Act requires that any school, institution, service institution, facility, or individual that has been terminated from any program authorized under the Richard B. Russell National School Lunch Act or the Child Nutrition Act of 1966, and appears on either the SFSP or the Child and Adult Care Food Program's (CACFP's) disqualified list, may not be approved to participate in or administer any other programs authorized under those two Acts.

Statement of Need: There are currently no regulations imposing fines on schools, school food authorities or State agencies for program violations and mismanagement. This rule will (1) establish criteria for imposing fines against schools, school food authorities or State agencies that fail to correct severe mismanagement of the program or repeated violations of program requirements; (2) establish procedures for the termination and disqualification of organizations participating in the Summer Food Service Program (SFSP); and (3) require that any school, institutions, or individual that has been terminated from any Federal Child Nutrition Program and appears on either the SFSP or the Child and Adult Care Food Program's (CACFP's) disqualified list may not be approved to participate in or administer any other Child Nutrition Program.

Summary of Legal Basis: This rule codifies Sections 303, 322, and 362 of the Healthy, Hunger-Free Kids Act of 2010 (Pub. L. 111-296).

Alternatives: None identified; this rule implements statutory requirements.

Anticipated Cost and Benefits: This rule is expected to help promote program integrity in all of the child nutrition programs. FNS anticipates that these provisions will have no significant costs and no major increase in regulatory burden to States.

Risks: None identified.

Timetable:

Action Date FR Cite
NPRM 04/00/13  
NPRM Comment Period End 06/00/13  

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-AE08

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: Economically Significant.

Unfunded Mandates: Undetermined.

Legal Authority: Pub. L. 111-296

CFR Citation: 7 CFR part 210; 7 CFR part 220.

Legal Deadline: None.

Abstract: This proposed rule would codify the two provisions of the Healthy, Hunger-Free Kids Act (Pub. L. 111-296; the Act) 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.

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 regulations necessary to control the sale of foods in competition with lunches served under the NSLP, and 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 04/00/13
NPRM Comment Period End 06/00/13

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. Child Nutrition Programs: Professional Standards for School Food Service and State Child Nutrition Program Directors 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 part 210; 7 CFR part 220.

Legal Deadline: None.

Abstract: This proposed rule would codify section 306 of the Healthy, Hunger-Free Kids Act (Pub. L. 111-296; the Act) under 7 CFR parts 210 and 220 which requires the Secretary to establish a program of required education, training, and certification for all school food service directors responsible for the management of a school food authority; and criteria and standards for States to use in the selection of State agency directors with responsibility for the school lunch program and the school breakfast program.

Statement of Need: The Healthy, Hunger-Free Kids Act of 2010 requires USDA to establish a program of required education, training, and certification for all school food service directors responsible for the management of a school food authority, as well as criteria and standards for States to use in the selection of State agency directors with responsibility for the school lunch program and the school breakfast program. The Act also requires each State to provide at least annual training in administrative practices to local education agency and school food service personnel.

Summary of Legal Basis: This proposed rule would codify section 306 of the Healthy, Hunger-Free Kids Act of 2010 (Pub. L. 111-296).

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

Anticipated Cost and Benefits: This rule is expected to establish consistent required education and professional standards for school food service and state agency directors; and education, training and certification of food service personnel. Consistent standards should help strengthen program integrity and quality. The Act provides a small amount ($5 million in the first year, $1 million annually thereafter) to establish and manage the training and certification programs. USDA anticipates that the rule will have no significant cost and no major increase in regulatory burden to States.

Risks: None identified.

Timetable:

Action Date FR Cite
NPRM 03/00/13
NPRM Comment Period End 05/00/13

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.

RIN: 0584-AE19

USDA—FNS Back to Top

10. SNAP: Immediate Payment Suspension for Fraudulent Retailer Activity Back to Top

Priority: Other Significant.

Unfunded Mandates: Undetermined.

Legal Authority: Pub. L. 111-246

CFR Citation: Not Yet Determined.

Legal Deadline: None.

Abstract: This rule proposes to implement part of section 4132 of the Food, Conservation and Energy Act of 2008 (Pub. L. 110-246) by authorizing the Food and Nutrition Service (FNS) to suspend the payment of redeemed program benefits to a suspected retail food store or wholesale food concern pending administrative action to disqualify the firm.

Statement of Need: Under current rules, some firms authorized to redeem SNAP benefits conduct substantial trafficking or other fraudulent SNAP activity in a short period of time, flee with the fraudulently-obtained funds, and ultimately appreciate large profits from this before USDA is able to complete a formal investigation. The ability to withhold some revenues from such violators would depreciate their profits and may discourage this illegal activity.

Summary of Legal Basis: This rule codifies part of section 4132 of the 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: This rule will improve SNAP integrity by allowing USDA to take appropriate action against retailers who commit fraud. The Department does not anticipate that this provision will have a significant cost impact.

Risks: Suspension of funds for firms suspected of flagrant program violations runs a small risk that firms that are ultimately found not to have trafficked will temporarily lose the use of these funds. USDA anticipates that this provision will only affect a small subset of firms charged with trafficking, and that the small risk of inappropriate suspensions far outweighs the much larger risk of permitting a firm to profit from trafficking in SNAP benefits while a decision is made on its case.

Timetable:

Action Date FR Cite
NPRM 12/00/12
NPRM Comment Period End 02/00/13
Final Action 07/00/13

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-AE22

USDA—FNS Back to Top

Final Rule Stage

11. Special Supplemental Nutrition Program for Women, Infants, and Children (WIC): Revisions in the WIC Food Packages Back to Top

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

Legal Authority: 42 U.S.C. 1786

CFR Citation: 7 CFR part 246.

Legal Deadline: None.

Abstract: This final rule will affirm and address comments from stakeholders on an interim final rule that went into effect October 1, 2009, governing WIC food packages to align them more closely with updated nutrition science.

Statement of Need: As the population served by WIC has grown and become more diverse over the past 20 years, the nutritional risks faced by participants have changed, and though nutrition science has advanced, the WIC supplemental food packages remained largely unchanged until FY 2010. This rule is needed to respond to comments and experience, and to implement recommended changes to the WIC food packages based on the current nutritional needs of WIC participants and advances in nutrition science.

Summary of Legal Basis: The Child Nutrition and WIC Reauthorization Act of 2004, enacted on June 30, 2004, requires the Department to issue a final rule within 18 months of receiving the Institute of Medicine's report on revisions to the WIC food packages. This report was published and released to the public on April 27, 2005.

Alternatives: FNS developed a regulatory impact analysis that addressed a variety of alternatives that were considered in the interim final rulemaking. The regulatory impact analysis was published as an appendix to the interim rule.

Anticipated Cost and Benefits: The regulatory impact analysis for this rule provided a reasonable estimate of the anticipated effects of the rule. This analysis estimated that the provisions of the rule would have a minimal impact on the costs of overall operations of the WIC Program over 5 years. The regulatory impact analysis was published as an appendix to the interim rule.

Risks: This rule applies to WIC State agencies with respect to their selection of foods to be included on their food lists. As a result, vendors will be indirectly affected and the food industry will realize increased sales of some foods and decreases in other foods, with an overall neutral effect on sales nationally. The rule may have an indirect economic affect on certain small businesses because they may have to carry a larger variety of certain foods to be eligible for authorization as a WIC vendor. With the high degree of State flexibility allowable under this final rule, small vendors will be impacted differently in each State depending upon how that State chooses to meet the new requirements. It is, therefore, not feasible to accurately estimate the rule's impact on small vendors. Since neither FNS nor the State agencies regulate food producers under the WIC Program, it is not known how many small entities within that industry may be indirectly affected by the rule. FNS has, however, modified the new food provision in an effort to mitigate the impact on small entities. This rule adds new food items, such as fruits and vegetables and whole grain breads, which may require some WIC vendors, particularly smaller stores, to expand the types and quantities of food items stocked in order to maintain their WIC authorization. In addition, vendors also have to make available more than one food type from each WIC food category, except for the categories of peanut butter and eggs, which may be a change for some vendors. To mitigate the impact of the fruit and vegetable requirement, the rule allows canned, frozen, and dried fruits and vegetables to be substituted for fresh produce. Opportunities for training on and discussion of the revised WIC food packages will be offered to State agencies and other entities as necessary.

Timetable:

Action Date FR Cite
NPRM 08/07/06 71 FR 44784
NPRM Comment Period End 11/06/06
Interim Final Rule 12/06/07 72 FR 68966
Interim Final Rule Effective 02/04/08
Interim Final Rule Comment Period End 02/01/10
Final Action 04/00/13

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: Businesses, Governmental Jurisdictions.

Government Levels Affected: Federal, Local, State, Tribal.

URL For More Information: www.fns.usda.gov/wic.

URL For Public Comments: www.fns.usda.gov/wic.

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-AD77

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 part 273.

Legal Deadline: None.

Abstract: This final rule amends 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.

Statement of Need: This rule amends 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 rule revises 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 implementing two discretionary revisions to SNAP regulations to provide State agencies options that are currently available only through waivers. These provisions 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 will 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 tied 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 Rule 06/00/13

Regulatory Flexibility Analysis Required: 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.

RIN: 0584-AD87

USDA—FNS Back to Top

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

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

Legal Authority: Pub. L. 111-296

CFR Citation: 7 CFR part 272.

Legal Deadline: Final, Statutory, January 1, 2012, Public Law 111-296.

A legal deadline of 01/01/2012 was placed on this action by Public Law 111-296.

Abstract: Section 241 of the Healthy, Hunger-Free Kids Act of 2010 amends the Food and Nutrition Act of 2008 to authorize grants to States for 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 01/00/13  
Interim Final Rule Comment Period End 03/00/13  

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. Egg Products Inspection Regulations Back to Top

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

Unfunded Mandates: Undetermined.

Legal Authority: 21 U.S.C. 1031 to 1056

CFR Citation: 9 CFR 590.570; 9 CFR 590.575; 9 CFR 590.146; 9 CFR 590.10; 9 CFR 590.411; 9 CFR 590.502; 9 CFR 590.504; 9 CFR 590.580; 9 CFR part 591; * * *

Legal Deadline: None.

Abstract: The Food Safety and Inspection Service (FSIS) is proposing to require egg products plants and establishments that pasteurize shell eggs to develop and implement Hazard Analysis and Critical Control Points (HACCP) systems and sanitation SOPs. FSIS is also proposing pathogen reduction performance standards that would be applicable to egg products and pasteurized shell eggs. FSIS is proposing to amend the Federal egg products inspection regulations by removing current requirements for prior approval by FSIS of egg products plant drawings, specifications, and equipment prior to their use in official plants.

Statement of Need: The actions being proposed are part of FSIS' regulatory reform effort to improve FSIS' shell egg products food safety regulations, better define the roles of Government and the regulated industry, encourage innovations that will improve food safety, remove unnecessary regulatory burdens on inspected egg products plants, and make the egg products regulations as consistent as possible with the Agency's meat and poultry products regulations. FSIS also is taking these actions in light of changing inspection priorities and recent findings of Salmonella in pasteurized egg products.

This proposal is directly related to FSIS' PR/HACCP initiative.

Summary of Legal Basis: 21 U.S.C. 1031 to 1056.

Alternatives: A team of FSIS economists and food technologists is conducting a cost-benefit analysis to evaluate the potential economic impacts of several alternatives on the public, egg products industry, and FSIS. These alternatives include: (1) Taking no regulatory action; (2) Requiring all inspected egg products plants to develop, adopt, and implement written sanitation SOPs and HACCP plans; and (3) Converting to a lethality-based pathogen reduction performance standard many of the current highly prescriptive egg products processing requirements. The team will consider the effects of the uniform; across-the-board standard for all egg products; a performance standard based on the relative risk of different classes of egg products; and a performance standard based on the relative risks to public health of different production processes.

Anticipated Cost and Benefits: FSIS is analyzing the potential costs of this proposed rulemaking to industry, FSIS, and other Federal agencies, State and local governments, small entities, and foreign countries. The expected costs to industry will depend on a number of factors. These costs include the required lethality, or level of pathogen reduction, and the cost of HACCP plan and sanitation SOP development, implementation, and associated employee training. The pathogen reduction costs will depend on the amount of reduction sought and on the classes of product, product formulations, or processes.

Relative enforcement costs to FSIS and Food and Drug Administration may change because the two Agencies share responsibility for inspection and oversight of the egg industry and a farm-to-table approach for shell egg and egg products food safety. Other Federal agencies and local governments are not likely to be affected.

Egg product inspection systems of foreign countries wishing to export egg products to the U.S. must be equivalent to the U.S. system. FSIS will consult with these countries, as needed, if and when this proposal becomes effective.

This proposal is not likely to have a significant impact on small entities. The entities that would be directly affected by this proposal would be the approximately 80 federally inspected egg products plants, most of which are small businesses, according to the Small Business Administration criteria. If necessary, FSIS will develop compliance guides to assist these small firms in implementing the proposed requirements.

Potential benefits associated with this rulemaking include: Improvements in human health due to pathogen reduction; improved utilization of FSIS inspection program resources; and cost savings resulting from the flexibility of egg products plants in achieving a lethality-based pathogen reduction performance standard. Once specific alternatives are identified, economic analysis will identify the quantitative and qualitative benefits associated with each alternative.

Human health benefits from this rulemaking are likely to be small because of the low level of (chiefly post-processing) contamination of pasteurized egg products.

The preliminary anticipated annualized costs of the proposed action are approximately $7 million. The preliminary anticipated benefits of the proposed action are approximately $90 million per year.

Risks: FSIS believes that this regulatory action may result in a further reduction in the risks associated with egg products. The development of a lethality-based pathogen reduction performance standard for egg products, replacing command-and-control regulations, will remove unnecessary regulatory obstacles to, and provide incentives for, innovation to improve the safety of egg products.

To assess the potential risk-reduction impacts of this rulemaking on the public, an intra-Agency group of scientific and technical experts is conducting a risk management analysis. The group has been charged with identifying the lethality requirement sufficient to ensure the safety of egg products and the alternative methods for implementing the requirement. FSIS has developed new risk assessments for Salmonella Enteritidis in eggs and for Salmonella app. In liquid egg products to evaluate the risk associated with the regulatory alternatives.

Timetable:

Action Date FR Cite
NPRM 09/00/13  

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-AC58

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 part 317; 9 CFR part 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 09/00/13  

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. Descriptive Designation for Needle or Blade Tenderized (Mechanically Tenderized) Beef Products Back to Top

Priority: Other Significant.

Legal Authority: 21 U.S.C. 453 and 21 U.S.C. 601

CFR Citation: 9 CFR 317.8; 9 CFR 381.129.

Legal Deadline: None.

Abstract: FSIS is proposing to require the use of the descriptive designation “mechanically tenderized” on the labels of raw or partially cooked needle or blade tenderized beef products, including beef products injected with marinade or solution, unless such products are destined to be fully cooked at an official establishment. Beef products that have been needle or blade tenderized are referred to as “mechanically tenderized” products. FSIS is proposing that the product name for such beef products include the descriptive designation “mechanically tenderized” and accurate description of the beef component. FSIS is also proposing that the print for all words in the descriptive designation as the product name appear in the same style, color, and size and on a single-color contrasting background. In addition, FSIS is proposing to require that labels of raw and partially cooked needle or blade tenderized beef products destined for household consumers, hotels, restaurants, or similar institutions include validated cooking instructions that inform consumers that these products need to be cooked to a specified minimum internal temperature, and whether they need to be held at that minimum internal temperature for a specified time before consumption, i.e., dwell time or rest time, to ensure that they are thoroughly cooked.

Statement of Need: FSIS has concluded that without proper labeling, raw or partially cooked mechanically tenderized beef products could be mistakenly perceived by consumers to be whole, intact muscle cuts. The fact that a cut of beef has been needle or blade tenderized is a characterizing feature of the product and, as such, a material fact that is likely to affect consumers' purchase decisions and that should affect their preparation of the product. FSIS has also concluded that the addition of validated cooking instruction is required to ensure that potential pathogens throughout the product are destroyed. Without thorough cooking, pathogens that may have been introduced to the interior of the product during the tenderization process may remain in the product.

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

Alternatives: As an alternative to the proposed requirements, FSIS considered not proposing new requirements for needle or blade tenderized beef products. A second alternative was for the Agency to propose to amend the labeling regulations to include a new requirement for labeling all mechanically tenderized meat and poultry products.

Anticipated Cost and Benefits: Benefits:

Benefits are both qualitative and quantifiable. The proposed new labeling requirements will improve public awareness of product identities, meaning that it will provide truthful and accurate labeling of beef products to clearly differentiate the non-intact, mechanically tenderized beef products from intact products. Since needle or blade tenderized beef products are not readily distinguishable from non-tenderized beef products, the descriptive designation of “mechanically tenderized” on the labels of these products will inform the consumers of the true nature of the product when deciding whether to purchase the products. Additionally, the knowledge of knowing that these products are mechanically tenderized will help consumers, official establishments, and retail establishments become aware that they need to cook these products differently from intact products before they can be safely consumed.

Costs: FSIS estimated that 32,130 labels are for beef product. Assuming 10.5 percent of the 32,130 labels are for products that are mechanically tenderized, then 3,374 labels will be required to add “mechanically tenderized” to their labels in accordance with this proposed rule. If we include the labels that are for beef product that are mechanically tenderized and contain added solutions, then we would assume that an additional, 5,077 labels will be required to add “mechanically tenderized” to their labels. From the 2011 Model to Estimate Costs of Using Labeling as a Risk Reduction Strategy for Consumer Products Regulated by the Food and Drug Administration, a minor labeling change was defined as one in which only one color is affected and the label does not need to be redesigned. FSIS concluded that the change that is required by this propose rule is minor. The mid-point label design modification costs for a minor coordinated label change are an estimated $310 per label. In the case of a coordinated label change, only administrative and recordkeeping costs are attributed to the regulation, and all other costs are not. FSIS estimates the cost to be $1.05 million (3,374 labels × $310) for mechanically tenderized only. For all products that are mechanically tenderized and contain added solutions, the cost is estimated to be $2.6 million. Establishments would also incur minimal costs to validate the required cooking instructions for raw and partially cooked needle or blade tenderized beef products. These costs would be incurred to ensure that the cooking instructions are adequate to destroy any potential pathogens that may remain in the beef product after being tenderized.

Risks: In 2011, FSIS conducted a Comparative Risk Assessment for Intact and Non-intact Beef. The comparative risk assessment was conducted to determine the difference in risk between different types of steak products and to examine the effect of different cooking practices on reducing human illness. This comparative risk assessment informed this rule. The risk assessment looked at the comparative effects of cooking at 140, 150, 160, and 165 degrees Fahrenheit. In its risk assessment, FSIS estimated the annual E. coli O157:H7 illnesses prevented from achieving various internal temperatures. From the risk assessment it was estimated that between 191 and 239 illnesses would be prevented annually, if mechanically tenderized meat were cooked to 160 degrees. Using the FSIS average cost per case for E. coli O157:H7 of $3,281, the propose rule would save approximately $627,000 to $784,000.

Timetable:

Action Date FR Cite
NPRM 12/00/12  

Regulatory Flexibility Analysis Required: Yes.

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-AD45

USDA—FSIS Back to Top

17. Proposed Rule: Records To Be Kept by Official Establishments and Retail Stores That Grind or Chop Raw Beef Products Back to Top

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

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

CFR Citation: 9 CFR part 320.

Legal Deadline: None.

Abstract: The Food Safety and Inspection Service (FSIS) is proposing to amend its recordkeeping regulations to specify that all official establishments and retail stores that grind or chop raw beef products for sale in commerce must keep records that disclose the identity of the supplier of all source materials that they use in the preparation of each lot of raw ground or chopped product and identify the names of those source materials.

FSIS is aware of the other activities that occur at retail that may, ultimately, prove also to be of concern due to inadequate recordkeeping (e.g., fabrication of steaks and roasts from non-intact beef in which the non-intact beef is later associated with an outbreak; grinding and chopping pork or even poultry; or slicing ready-to-eat meat and poultry). While these issues have been considered during the development of this proposal, the Agency has decided to ask for comment on whether and how such additional issues should be addressed, but will not include them in the current rulemaking.

Statement of Need: Under the authority of the Federal Meat Inspection Act (FMIA) (21 U.S.C. 601 et seq.) and its implementing regulations, FSIS investigates complaints and reports of consumer foodborne illness possibly associated with FSIS-regulated meat products. Many such investigations into consumer foodborne illnesses involve those caused by the consumption of raw beef ground by official establishments or retail stores.

FSIS investigators and public health officials frequently use records kept by all levels of the food distribution chain, including the retail level, to identify and trace back product that is the source of the illness the suppliers that produced the source material for the product. The Agency, however, has often been thwarted in its effort to trace back ground beef products, some associated with consumer illness, to the suppliers that provided source materials for the products. In some situations, official establishments and retail stores have not kept records necessary to allow trace back and trace forward activities to occur. Without such necessary records, FSIS's ability to conduct timely and effective consumer foodborne illness investigations and other public health activities throughout the stream of commerce is also affected, thereby placing the consuming public at risk. Therefore, for FSIS to be able to conduce trace back and trace forward investigations, foodborne illnesses investigations, or to monitor product recalls, the records kept by official establishments and retail stores that grind raw beef products must disclose the identity of the supplier and the names of the sources of all materials that they use in the preparation of each lot of raw ground beef product.

Summary of Legal Basis: Under 21 U.S.C. 642, official establishments and retail stores that grind raw beef products for sale in commerce are persons, firms, or corporations that must keep such records as willfully and correctly disclose all transactions involved in their businesses subject to the Act. This is because they engage in the business of preparing products of an amenable species for use as human food and they engage in the business of buying of selling (as meat brokers, wholesalers or otherwise) in commerce products of carcasses of an amenable species. These businesses must also provide access to, and inspection of, these records by FSIS personnel.

Further, under 9 CFR 320.1(a), every person, firm, or corporation required by section 642 of the FMIA to keep records must keep those records that willfully and correctly disclose all transactions involved in his or its business subject to the Act. Records specifically required to be kept under section 320.1(b) include, but are not limited to, bills of sale; invoices; bills of lading; and receiving and shipping papers. With respect to each transaction, the records must provide the name or description of the livestock or article; the net weight of the livestock or article; the number of outside containers; the name and address of the buyer or seller of the livestock or animal; and the date and method of shipment, among other things.

Alternatives: FSIS considered two alternatives to the proposed requirements: the status quo and a voluntary recordkeeping program.

Anticipated Cost and Benefits: Costs occur because about 76,390 retail stores and official establishments will need to develop and maintain records, and make those records available for the Agency's review. Using the best available data, FSIS believes that industry labor costs of developing, recording, and maintaining records, and storage costs, would be approximately $20.5 million. Agency costs of approximately $15,000 would result from record reviews at official establishments and retail stores, as well as travel time to and from retail stores.

Annual benefits from this rule come from:

(1) Savings from more efficient recalls of $3.6 million.

(2) Estimated averted E. coli O157:H7 illnesses of $23.4 million.

Total benefits from this rule are estimated to be $27.0 million.

Non-monetized benefits under this rule include, for the raw ground beef processing industry: (1) An increase in consumers' confidence and greater acceptance of products because mandatory grinding logs will result in a more efficient traceability system, recalls of reduced volume, and reduced negative press; (2) smaller volume recalls will result in higher confidence and acceptability of products including the disposition of product once recovered; (3) improved productivity, which improves profit opportunities.

Avoiding loss of business reputation is an indirect benefit. By identifying and defining the responsible party, FSIS will be able to get to the suspect a lot quicker and execute a better targeted recall, meaning that a recall will involve a smaller amount of product. This lower volume per recall will decrease costs for the recalls and the disposition of product. In addition, the Agency expects consumers to benefit from improved traceability and, thus, a reduced incidence of E. coli O157:H7 in ground raw beef products due to the rapid removal of those products from commerce. The Agency believes that by having official meat establishments and retail stores that engage in the business of grinding raw beef products keep records, traceability of ground raw beef in the U.S. food supply will be greatly enhanced.

Risks: FSIS believes that a projected 30% of foodborne E. coli O157:H7 illnesses could possibly be averted if this rule was in place, dropping from a high of 23,732 to 16,612 (a decline of 7,120).

Timetable:

Action Date FR Cite
NPRM 02/00/13  

Regulatory Flexibility Analysis Required: No.

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-AD46

USDA—FSIS Back to Top

Final Rule Stage

18. 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 part 317; 9 CFR part 327; 9 CFR part 381; 9 CFR part 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 final rule would permit the Agency to realize an estimated discounted cost savings of $2.9 million over 10 years. The final 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 03/05/12  
Final Action 03/00/13  

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

19. Modernization of 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 intends to provide 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 also intends 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). Young chicken and turkey slaughter establishments would be required to operate under the new inspection system or under Traditional Inspection. 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 new system, young chicken and turkey 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 intends to provide 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 and would encourage industry to more readily use new technology.

This final rule is the result of the Agency's 2011 regulatory review efforts conducted under Executive Order 13563 on Improving Regulation and Regulatory Review. 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: The proposed rule estimated that the expected annual costs to establishments would total $24.5 million. Expected annual total benefits were $285.5 million (with a range of $259.5 to $314.8 million). Expected annual net benefits were $261.0 million (with a range of $235.0 million to $290.3 million). These estimates will be updated in the final rule.

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 01/27/12 77 FR 4408
NPRM Comment Period End 05/29/12 77 FR 24873
Final Rule 04/00/13  

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: Businesses.

Government Levels Affected: None.

Agency Contact: Rachel Edelstein, Acting Assistant Administrator, Office of Policy and Program Development, Department of Agriculture, Food Safety and Inspection Service, 1400 Independence Avenue SW., 351-E JWB, Washington, DC 20250, Phone: 202 205-0495, Fax: 202 720-2025, Email: rachel.edelstein@fsis.usda.gov.

RIN: 0583-AD32

USDA—FSIS Back to Top

20. 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 amending the meat, poultry, and egg product inspection regulations to provide for 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 will charge users for the use of the system. FSIS is establishing a formula for calculating the fee. FSIS is also providing establishments that export meat, poultry, and egg products with flexibility in the official export inspection marks, devices, and certificates. In addition, FSIS is amending the egg product export regulations to parallel the meat and poultry export regulations.

Statement of Need: These regulations will facilitate the electronic processing of export applications and certificates through the Public Health Information System (PHIS), a computerized, Web-based inspection information system. This rule will provide the 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 charging exporters an application fee for the electronic export 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 rate, inspection personnel workload will be 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 the authenticity, integrity, and confidentiality. Exporters will be provided with a more efficient and effective application and certification process. The 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 the 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 01/23/12 77 FR 3159
NPRM Comment Period End 03/23/12  
Final Action 04/00/13  

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

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 (Commerce) is one of the oldest Cabinet-level agencies in the Federal Government. Commerce's mission is to create the conditions for economic growth and opportunity 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.

Commerce 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, Commerce 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.

Commerce 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 Commerce.

Responding to the Administration's Regulatory Philosophy and Principles

The vast majority of the Commerce's programs and activities do not involve regulation. Of Commerce'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.

Commerce 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 Commerce 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 Commerce's goal of promoting stewardship by providing assessments of the global environment.

Recognizing that economic growth must go hand-in-hand with environmental stewardship, Commerce, 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. Commerce 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.

Commerce, 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. The MMPA allows NMFS to permit 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 Commerce's regulatory plan, NMFS is undertaking three actions that rise to the level of “most important” of Commerce's significant regulatory actions and thus are included in this year's regulatory plan. The three actions implement provisions of the Magnuson-Stevens Fishery Conservation and Management Act, as reauthorized in 2006. The first 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. 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.

2. 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. 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.

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, we listed North Atlantic and North Pacific right whales as separate species under the ESA. This action will fulfill the ESA requirement of designating critical habitat following final listing determinations.

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 U.S. export controls on dual-use and other items warranting controls but not under the provisions of export control regulations administered by other departments, 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 (ECRI). BIS published a final rule (76 FR 35275, 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 several rules to control under the EAR items that the President has determined do not warrant control under the International Traffic in Arms Regulations (ITAR), administered by the Department of State rule (76 FR 41957), and its United States Munitions List (USML).

In FY 2012, BIS followed up on its FY 2011 successes with the ECRI and proposed rules that would move items currently controlled in nine categories of the USML to control under the Commerce Control List (CCL), administered by BIS. In addition, BIS proposed a rule to ease the implementation process for transitioning items and re-proposed a revised key definition from the July 15 Rule, “specially designed,” that had received extensive public comment. In FY 2013, after State Department notification to Congress of the transfer of items from the USML, BIS expects to be able to publish a final rule incorporating many of the proposed changes, and revisions based on public responses to the proposals.

Promoting International Regulatory Cooperation

As the President noted in Executive Order 13609, “international regulatory cooperation, consistent with domestic law and prerogatives and U.S. trade policy, can be an important means of promoting” public health, welfare, safety, and our environment as well as economic growth, innovation, competitiveness, and job creation. Accordingly, in EO 13609, the President requires each executive agency to include in its Regulatory Plan a summary of its international regulatory cooperation activities that are reasonably anticipated to lead to significant regulations.

The Department of Commerce engages with numerous international bodies in various forums to promote the Department's priorities and foster regulations that do not “impair the ability of American business to export and compete internationally.” EO 13609(a). For example, the United States Patent and Trademark Office is working with the European Patent Office to develop a new classification system for both offices' use. The Bureau of Industry and Security, along with the Department of State and Department of Defense, engages with other countries in the Wassenaar Arrangement, through which the international community develops a common list of items that should be subject to export controls because they are conventional arms or items that have both military and civil uses. Other multilateral export control regimes include the Missile Technology Control Regime, the Nuclear Suppliers Group, and the Australia Group, which lists items controlled for chemical and biological weapon nonproliferation purposes. In addition, the National Oceanic and Atmospheric Administration works with other countries' regulatory bodies through regional fishery management organizations to develop fair and internationally-agreed-to fishery standards for the High Seas.

BIS is also engaged, in partnership with the Departments of State and Defense, in revising the regulatory framework for export control, through the President's Export Control Reform Initiative (ECRI). Through this effort, the United States government is moving certain items currently controlled by the United States Military List (USML) to the Commerce Control List (CCL) in BIS' Export Administration Regulations. The objective of ECRI is to improve interoperability of U.S. military forces with those of allied countries, strengthen the U.S. industrial base by, among other things, reducing incentives for foreign manufacturers to design out and avoid U.S.-origin content and services, and allow export control officials to focus government resources on transactions that pose greater concern. This effort may be accomplished by as early as 2013, when the final rules are published. Once fully implemented, the new export control framework also will benefit companies in the United States seeking to export items through more flexible and less burdensome export controls.

Some specific domestic regulatory actions that have resulted from the Department's international regulatory cooperation efforts include the rule on Identification and Certification of Fishing Vessels Engaged in Illegal, Unreported, or Unregulated Fishing or Bycatch of Protected Living Marine Resources (0648-AV51, 76 FR 2011); the Amendments to Implement the Shark Conservation Act and Revise the Definition of Illegal, Unreported, and Unregulated Fishing (0648-BA89); and the proposed rule to comply with the 2010 Shark Conservation Provisions and Other Regulations in the Atlantic Smoothhound Shark Fishery (0648-BB02).

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?
0648-BC03 Regulatory Amendment 12 to the Fishery Management Plan for the Snapper-Grouper Fishery of the South Atlantic Region Yes.
0648-BB44 Regulatory Amendment 11 to the Fishery Management Plan for the Snapper-Grouper Fishery of the South Atlantic Region  
0648-BB56 Amendment 18A to the Fishery Management Plan for the Snapper-Grouper Fishery of the South Atlantic Region Yes.
0648-XC088 Temporarily Extending the Recreational Red Snapper Fishing Season in Federal Waters of the Gulf of Mexico  
0648-BB72 Amendment 34 to the Fishery Management Plan for the Reef Fish Resources of the Gulf of Mexico  
0648-BB45 Western Pacific Pelagic Fisheries; Modification of American Samoa Large Vessel Prohibited Area  
0648-BB49 Amend the Regulations that Implement the National Saltwater Angler Registry and State Exemption Program  
0694-AF03 Export Control Reform Initiative: Strategic Trade Authorization License Exception  
0694-AF17 Revision to the Export Administration Regulations: Control of Items the President Determines No Longer Warrant Control Under the United States Munitions List  
0694-AF36 Revision to the Export Administration Regulations: Control of Aircraft and Related Items the President Determines No Longer Warrant Control Under the United States Munitions List  
0694-AF41 Revisions to the Export Administration Regulations: Control of Gas Turbine Engines and Related Items the President Determines No Longer Warrant Control Under the United States Munitions List  
0694-AF17 Revisions to the Export Administration Regulations: Control of Military Vehicles and Related Items the President Determines No Longer Warrant Control Under the United States Munitions List  
0694-AF42 Revisions to the Export Administration Regulations: Control of Vessels of War and Related Articles the President Determines No Longer Warrant Control Under the United States Munitions List  
0694-AF39 Revisions to the Export Administration Regulations: Control of Submersible Vessels, Oceanographic Equipment and Related Articles the President Determines No Longer Warrant Control Under the United States Munitions List  
0694-AF17 Revisions to the Export Administration Regulations: Export Control Classification Number 0Y521 Series, Items Not Elsewhere Listed on the Commerce Control List (CCL)  
0694-AF53 Revisions to the Export Administration Regulations: Control of Energetic Materials and Related Articles the President Determines No Longer Warrant Control Under the United States Munitions List  
0694-AF51 Revisions to the Export Administration Regulations: Auxiliary and Miscellaneous Items that No Longer Warrant Control Under the United States Munitions List and Items on the Wassenaar Arrangement Munitions List  
0694-AF58 Revisions to the Export Administration Regulations: Control of Personal Protective Equipment, Shelters, and Related Items the President Determines No Longer Warrant Control Under the United States Munitions List  
0694-AF54 Revisions to the Export Administration Regulations: Control of Military Training Equipment and Related Articles the President Determines No Longer Warrant Control Under the United States Munitions List  
0694-AF66 “Specially Designed” Definition  
0694-AF68 Feasibility of Enumerating “Specially Designed” Components  
0694-AF65 Proposed Revisions to the Export Administration Regulations: Implementation of Export Control Reform; Revisions to License Exceptions After Retrospective Regulatory Review  
0694-AF47 Revisions to the Export Administration Regulations: Control of Firearms and Related Articles the President Determines No Longer Warrant Control Under the United States Munitions List  
0694-AF48 Revisions to the Export Administration Regulations: Control of Guns and Armament and Related Articles the President Determines No Longer Warrant Control Under the United States Munitions List  
0694-AF49 Revisions to the Export Administration Regulations: Control of Ammunition and Ordnance the President Determines No Longer Warrant Control Under the United States Munitions List  
0694-AF64 Revisions to the Export Administration Regulations: Control of Military Electronic Equipment and Related Items the President Determines No Longer Warrant Control Under the United States Munitions List  
0694-AF37 Revisions to the Export Administration Regulations (EAR) to Make the Commerce Control List (CCL) Clearer  
0694-AF56 EAR Revision: Items Related to Launch Vehicles, Missiles, Rockets, and Military Explosive Devices That the President Determines No Longer Warrant Control Under the United States Munitions List  
0694-AF60 Amendment to Licensing Requirements for Exports to Canada of Shotguns, Shotgun Shells and Optical Sighting Devices under the Export Administration Regulations Yes.
0651-AC54 Setting and Adjusting Patent Fees  

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), 9 Unified Combatant Commands, 13 Defense Agencies, and 10 DoD Field Activities. It has 1,409,877 military personnel and 766,425 civilians assigned as of March 31, 2012, 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 a straightforward, yet formidable undertaking.

DoD occasionally issues regulations that have an effect on the public and can be significant as defined in E.O. 12866. In addition, some of DoD's regulations may affect other agencies. DoD, as an integral part of its program, not only receives coordinating actions from other 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.

International Regulatory Cooperation

As the President noted in Executive Order 13609, “international regulatory cooperation, consistent with domestic law and prerogatives and U.S. trade policy, can be an important means of promoting” public health, welfare, safety, and our environment as well as economic growth, innovation, competitiveness, and job creation. Accordingly, in EO 13609, the President requires each executive agency to include in its Regulatory Plan a summary of its international regulatory cooperation activities that are reasonably anticipated to lead to significant regulations.

The Department of Defense, along with the Department of State and Department of Commerce, engages with other countries in the Wassenaar Arrangement, through which the international community develops a common list of items that should be subject to export controls.

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

RIN Rule Title (*expected to significantly reduce burdens on small businesses)
0790-AI73 Withholding of Unclassified Technical Data From Public Disclosure.
0790-AI75 Presentation of DoD-Related Scientific and Technical Papers at Meetings.
0790-AI77 Provision of Early Intervention and Special Education Services to Eligible DoD Dependents.
0790-AI84 National Defense Science and Engineering Graduate (NDSEG) Fellowships.
0790-AI54 Defense Support of Civilian Law Enforcement Agencies.
0790-AI88 Shelter for the Homeless.
0710-AA66 Civil Monetary Penalty Inflation Adjustment Rule.
0710-AA60 Nationwide Permit Program Regulations*.
0703-AA91 Unofficial Use of the Seal, Emblem, Names, or Initials of the Marine Corps.
0703-AA92 Professional Conduct of Attorneys Practicing Under the Cognizance and Supervision of the Judge Advocate General.
0703-AA88 Professional Conduct of Attorneys Practicing Under the Cognizance and Supervision of the Judge Advocate General.

Pursuant to Executive Order 13563, DoD also plans to finalize the DFARS rule to delete text in DFARS part 219 that implemented 10 U.S.C. 2323 because 10 U.S.C. 2323 has expired.

Administration Priorities

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

The Department plans to—

  • Revise the DFARS to implement section 806 of the National Defense Authorization Act (NDAA) for Fiscal Year (FY) 2011, which requires the evaluation of offeror's supply chain risks for information technology purchases relating to national security systems. This rule enables agencies to exclude sources that are identified as having a supply chain risk.
  • Revise the DFARS to use Commercial and Government Entity (CAGE) codes and NCAGE (if foreign) for awards greater than the micropurchase threshold to identify the immediate corporate parent. This rule will provide standardization across the Federal government to facilitate data collection and support anti-counterfeiting efforts by uniquely identifying vendors.
  • Revise the DFARS to use Activity Address Codes as the unique identifier for contracting offices and other offices, as well as the use of standard procurement instrument identification numbers. This will provide for standardization across the Federal government to facilitate data tracking and collection.

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

The Department plans to—

  • Finalize the DFARS rule, which revises reporting requirements for Government-furnished property to include items uniquely and non-uniquely identified, which will permit enterprise-wide visibility thereby enhancing DoD's ability to reutilize items. The data will be available to users in the logistics, financial, and property accountability arenas.

3. Rulemakings That Streamline Regulations, Reduce Unjustified Burdens, and Minimize Burdens on Small Businesses

The Department plans to—

  • 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. 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 2012-D022—Provides guidance relating to rights in technical data under contracts for production and sustainment of systems or subsystems.
  • DFARS Case 2012-D008—Proposes a new convention for prescribing clauses with alternates to provide alternate clauses in full text. This will facilitate selection of alternate clauses using automated contract writing systems.
  • DFARS Case 2011-D056—Provides a new approach to identifying required provisions and clauses for the acquisition of commercial items, by replacing the omnibus contract clause at DFARS 252.212-7001 with an amplified list in part 212 of required provisions and clauses. This supports simplified clause prescriptions and facilitates commercial item clause selections using automated contract writing systems.
  • DFARS Case 2010-D001—Finalizes the rule for DFARS coverage of patents, data, and copyrights, which significantly reduces the amount of regulatory text and the number of required clauses.

Specific DoD Priorities

For this regulatory plan, there are six specific DoD priorities, all of which reflect the established regulatory principles. 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 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 implement a DoD Better Buying Power initiative by providing a forward-pricing-rate-agreement 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 include contractor reporting and documentation requirements regarding contractor compliance with the DFARS business systems' criteria.

2. Logistics and Material Readiness, Department of Defense

The Department of Defense plans to finalize a rule on contractors supporting the military in contingency operations:

  • Final Rule: Operational Contract Support. This rule incorporates 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. It was required to procedurally close gaps and ensure the correct planning, oversight and management of DoD contractors supporting contingency operations, by updating outdated policy. DoD published an interim final rule on December 29, 2011 (32 CFR part 158, 76 FR 81807-81825) with an effective date of December 29, 2011. The comment period ended February 27, 2012. DoD is preparing a final rule, which includes the responses to the public comments. The final rule is expected to be published the second quarter of FY 2013.

3. Installations and Environment, Department of Defense

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

  • 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 is required by section 358 of Public Law 111-383. An interim final rule was published on October 20, 2011 (76 FR 65112). DoD anticipates publishing a final rule in the second quarter of FY 2013.

4. Military Community and Family Policy, Department of Defense

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

  • Final Rule: In this final rule, the Department of Defense (DoD) plans to implement policy, assigns responsibilities, and prescribes procedures for the operation of voluntary education programs within DoD. Several of the subject areas in this final 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 DoD MOU policy was scheduled to commence in early 2012; however, due to concerns received by DoD from several institutions of higher learning (IHLs) involving the language in the DoD Voluntary Education Partnership Memorandum of Understanding (MOU), commencement was put on-hold. DoD extended the deadline to work with the stakeholders (American Council on Education, IHLs, and key veteran and military service organizations) to address these concerns by clarifying the terminology contained in the DoD MOU. One change was informally coordinated with all key stakeholders (Congress, the White House, American Council on Education and select IHL) and now captures the agreed upon MOU policy. The new deadline to implement the policy requiring participating IHLs to sign the MOU is sixty days following the publication of the final rule in the Federal Register. A proposed rule was published on August 6, 2010 (75 FR 47504). DoD anticipates publishing a final rule in the second quarter of FY2013.

Earlier this year, the White House worked with an interagency group, including the Departments of Education, Veterans Affairs, Justice, and Defense, on the development of an Executive Order establishing the Principles of Excellence for educational institutions servicing Service members, Veterans, spouses, and other family members. The President signed Executive Order 13607 on April 27, 2012. Implementation of the protections stated in E.O. 13607 will require developing and coordinating an amendment to the rule, Voluntary Education Programs. The White House guidance states DoD will implement these new student protections by the start of academic year 2013-2014. DoD anticipates publishing a final rule the third quarter of FY 2013.

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 health care savings of $36.5 million per year with proposed phase-in period and an estimated initial startup cost of $200,000. Any ongoing administrative costs would be minimal and there do not appear to be any 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 2013.
  • 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 second quarter of FY 2013.

6. Sexual Assault Prevention and Response Office, Department of Defense

The Department of Defense plans to publish an interim final rule regarding Sexual Assault Prevention and Response (SAPR) Program Procedures:

  • Interim Final Rule: Sexual Assault Prevention and Response (SAPR) Program Procedures. This part implements Department of Defense (DoD) policy and assigns responsibilities for the SAPR Program on prevention, response, and oversight to sexual assault. It is DoD policy to establish a culture free of sexual assault by providing an environment of prevention, education and training, response capability, victim support, reporting procedures, and accountability that enhances the safety and well being of all persons covered by the regulation. DoD anticipates publishing the interim final rule in the first or second quarter of FY 2013.

7. Personnel and Readiness, Department of Defense

The Department of Defense plans to 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. It will also incorporate changes resulting from interagency coordination. DoD anticipates publishing the final rule in the first or second quarter of FY 2013.

8. Chief Information Officer, Department of Defense

The Department of Defense plans to publish a final rule to establish the voluntary cyber security information sharing program between DoD and eligible cleared defense contractors:

  • Final Rule: Defense Industrial Base (DIB) Voluntary Cyber Security/Information Assurance (CS/IA) Activities. The DIB CS/IA program enhances and supplements DIB participant's capabilities to safeguard DoD information that resides on, or transits, DIB unclassified information systems. At the core of this voluntary program is a bilateral cyber security information sharing activity, in which DoD provides cyber threat information and information assurance best practices to DIB companies, and in return, DIB companies report certain types of cyber intrusion incidents to the DoD-DIB Collaborative Information Sharing Environment (DCISE), located at the DoD Cyber Crime Center. The information sharing arrangements between DoD and each participating DIB company are memoralized in a standardized bilateral Framework Agreement. The interim final rule was published on May 11, 2012 (77 FR 27615). The comment period on the interim final rule ended on July 11, 2012. Once adjudication of the comments is complete, DoD anticipates publishing a final rule in the second quarter of FY 2013.

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

Final Rule Stage

21. Service Academies Back to Top

Priority: Other Significant.

Legal Authority: 10 U.S.C. 301

CFR Citation: 32 CFR part 217.

Legal Deadline: None.

Abstract: The Department is revising and updating policy guidance and oversight of the Military Service Academies. This rule implements 10 U.S.C. 403, 603, and 903 for the establishment and operation of the United States Military Academy, the United States Naval Academy, and the United States Air Force Academy. 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.

Statement of Need: The Department of Defense revises and updates the current rule providing the policy guidance and oversight of the Military Service Academies. This rule implements 10 U.S.C. 403, 603, and 903 for the establishment and operation of the United States Military Academy, the United States Naval Academy, and the United States Air Force Academy.

Summary of Legal Basis: 10 U.S.C. Chapters 403, 603, 903.

Alternatives: None. The Federal statute directs the Department of Defense to develop policy, assign responsibilities, and prescribe procedures for operations and oversight of the Service academies.

Anticipated Cost and Benefits: Administrative costs are negligible and benefits would be clear, concise rules that enable the Secretary of Defense to ensure that the Service Academies are efficiently operated and meet the needs of the armed forces.

Risks: None.

Timetable:

Action Date FR Cite
NPRM 10/18/07 72 FR 59053
NPRM Comment Period End 12/17/07  
Final Action 03/00/13  

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: No.

Government Levels Affected: None.

Additional Information: DoD Instruction 1322.22.

Agency Contact: Paul Nosek, Department of Defense, Office of the Secretary, 4000 Defense Pentagon, Washington, DC 20301-4000, Phone: 703 695-5529.

RIN: 0790-AI19

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22. Sexual Assault Prevention and Response Program Procedures Back to Top

Priority: Other Significant.

Legal Authority: 10 U.S.C. ch 47 sec 113

CFR Citation: 32 CFR part 105.

Legal Deadline: None.

Abstract: This rule implements policy, assigns responsibilities, provides guidance and procedures, and establishes the Sexual Assault Advisory Council for the DoD Sexual Assault Prevention and Response program consistent with the Task Force Report on Care for Victims of Sexual Assault, and pursuant to 10 U.S.C. 113 and 32 CFR part 103. The intent of the program is to prevent and eliminate sexual assault within the Department by providing comprehensive procedures to better establish a culture of prevention, response, and accountability that enhances the safety and well-being of all DoD members.

Statement of Need: This rule implements policy, assigns responsibilities, and provides guidance and procedures for the SAPR Program. It establishes the processes and procedures for the Sexual Assault Forensic Examination (SAFE) Kit; the multidisciplinary Case Management Group to include guidance for the group on how to handle sexual assault; SAPR minimum program standards; SAPR training requirements; and SAPR requirements for the DoD Annual Report on Sexual Assault in the Military.

Summary of Legal Basis: Section 113 of Title 10, United States Code (U.S.C.); and Public Laws 109-364, 109-163, 108-375, 106-65, 110-417, and 111-84.

Alternatives: The Sexual Assault Prevention and Response Office (SAPRO) will lack updated and revised rules for implementing DoD policy on prevention and response to sexual assaults involving members of the U.S. Armed Forces if this rule is not implemented.

Anticipated Cost and Benefits: The preliminary estimate of the anticipated cost associated with this rule for the current fiscal year (2011) is approximately $14.819 million. Additionally, each of the Military Services establishes its own SAPR budget for the programmatic costs arising from the implementation of the training, prevention, reporting, response, and oversight requirements established by this rule.

The anticipated benefits associated with this rule include:

(1) Guidance with which the Department may establish a culture free of sexual assault by providing an environment of prevention, education and training, response capability, victim support, reporting procedures, and appropriate accountability that enhances the safety and well being of all persons covered by this rule;

(2) Treatment of sexual assault patients as emergency cases, which prevents loss of life or suffering resulting from physical injuries (internal or external), sexually transmitted infections, pregnancy, and psychological distress;

(3) The availability of two reporting options for Service members and their dependents who are 18 years of age or older covered by this rule who are victims of sexual assault. The two reporting options are as follows:

(a) Unrestricted Reporting allows an eligible person who is sexually assaulted to access medical treatment and counseling and request an official investigation of the allegation using existing reporting channels (e.g., chain of command, law enforcement, healthcare personnel, the Sexual Assault Response Coordinator [SARC]). When a sexual assault is reported through Unrestricted Reporting, a SARC shall be notified as soon as possible, respond, assign a SAPR Victim Advocate (VA), and offer the victim medical care and a sexual assault forensic examination (SAFE); and

(b) Restricted Reporting allows sexual assault victims to confidentially disclose the assault to specified individuals (i.e., SARC, SAPR VA, or healthcare personnel), in accordance with DoD Directive (DoDD) 5400.11, and receive medical treatment, including emergency care, counseling, and assignment of a SARC and SAPR VA, without triggering an official investigation. The victim's report to healthcare personnel (including the information acquired from a SAFE Kit), SARCs, or SAPR VAs will not be reported to law enforcement, or to the victim's command to initiate the official investigative process, unless the victim consents or an established exception applies in accordance with DoD Instruction (DoDI) 6495.02.

The Department's preference is for complete Unrestricted Reporting of sexual assaults to allow for the provision of victims' services and to pursue accountability. However, Unrestricted Reporting may represent a barrier for victims to access services, when the victim desires no command or law enforcement involvement. Consequently, the Department recognizes a fundamental need to provide a confidential disclosure vehicle via the Restricted Reporting option.

(4) Service members who are on active duty but were victims of sexual assault prior to enlistment or commissioning are eligible to receive SAPR services and utilize either reporting option. The focus of this rule and DoDI 6495.02 is on the victim of sexual assault. The DoD shall provide support to an active duty Service member regardless of when or where the sexual assault took place; and

(5) Guidance for the development of response capabilities that will enable sexual assault victims to recover, and, if Service members, to be fully mission capable and engaged.

Risks: The rule intends to enable military readiness by establishing a culture free of sexual assault. Sexual assault poses a serious threat to military readiness because the potential costs and consequences are extremely high: chronic psychological consequences may include depression, post-traumatic stress disorder, and substance abuse. In the U.S. Armed Forces, sexual assault not only degrades individual resilience but also may erode unit integrity. An effective fighting force cannot tolerate sexual assault within its ranks. Sexual assault is incompatible with military culture and mission readiness, and risks to mission accomplishment. This rule aims to mitigate this risk to mission readiness.

Timetable:

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

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: No.

Government Levels Affected: None.

Additional Information: DoD Instruction 6495.02.

Agency Contact: Teresa Scalzo, Department of Defense, Office of the Secretary, 4000 Defense Pentagon, Washington, DC 20301-1155, Phone: 703 696-8977.

RIN: 0790-AI36

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23. Operational Contract Support Back to Top

Priority: Other Significant.

Legal Authority: Pub. L. 110-181

CFR Citation: 32 CFR part 158.

Legal Deadline: None.

Abstract: In accordance with Public Law 110-181 and Public Law 110-417, DoD is revising policy and assigning responsibilities for program management of operational contract support (OCS) in contingency operations and integration of DoD contractor personnel into military contingency operations outside the United States. An interim final rule is required to procedurally close gaps and ensure the correct planning, oversight and management of DoD contractors supporting contingency operations, by updating the existing outdated policy. The existing policies are causing significant confusion, as they do not reflect current practices and legislative mandates. The apparent mismatch between local Geographic Command guidance and the DoD-wide policies and the Defense Federal Acquisition Regulations Supplement is confusing for those in the field—in particular policy with regard to accountability and visibility requirements. Since the Presidential decision to expand the number of troops in Afghanistan and the subsequent increase of troops and contractors in theater, this issue has become so significant that DoD needs to revise the DoD-wide policies as a matter of urgency.

Statement of Need: This rule revises policy and assigns responsibilities for program management of operational contract support (OCS) in contingency operations and integration of DoD contractor personnel into military contingency operations outside the United States. GAO, the Commission on Wartime Contracting, and the Special Inspector General for Iraq Reconstruction/Afghanistan Reconstruction are among those who have highlighted the urgent requirement to update the policy.

Summary of Legal Basis: Parts of the rule are required by section 861 of the 2008 NDAA, Public Law 110-181 and Public Law 110-417.

Alternatives: Given the legal requirement to revise this regulation and separately publish a corresponding revision to the Federal Acquisition Regulation, we did not consider any alternatives.

Anticipated Cost and Benefits: This regulation establishes policies and procedures for the oversight and management of contractors supporting contingency operations outside the United States; therefore, there is no cost to public. Updated and refined policy regarding contractors supporting contingency operations will result in improved management, oversight and efficiency.

Risks: This rule represents an update to the existing DoD Instruction and incorporates the latest changes in policy and procedures. This revision is required to integrate lessons learned and improvements in practices gleaned from five years of operational experience. The risk of not publishing this rule is that there would be outdated policy which doesn't reflect practices in the field. This will lead to inefficient and ineffective management of the contractor workforce supporting contingency operations.

Timetable:

Action Date FR Cite
Interim Final Rule 12/29/11 76 FR 81807
Interim Final Rule Effective 12/29/11
Interim Final Rule Comment Period End 02/27/12
Final Action 01/00/13

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: No.

Government Levels Affected: Federal.

Additional Information: DoD Instruction 3020.41.

Agency Contact: Kerry Powell, Department of Defense, Office of the Secretary, 3500 Defense Pentagon, Washington, DC 20201-3500, Phone: 703 614-1944, Fax: 703 697-4942, Email: kerry.powell@osd.mil.

RIN: 0790-AI48

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24. Voluntary Education Programs Back to Top

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

Legal Authority: 10 U.S.C. 2005; 10 U.S.C. 2007

CFR Citation: 32 CFR part 68.

Legal Deadline: None.

Abstract: This rule will implement policy, assign responsibilities, and prescribe procedures for the operation of voluntary education programs within DoD. Included are: 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 between DoD and educational institutions receiving tuition assistance payments; and procedures for other education programs for Service members and their adult family members.

Statement of Need: A March 2011 Government Accountability Office report on the DoD TA program recommended the Department take steps to enhance its oversight of schools receiving TA funds. As a result, a DoD Memorandum of Understanding (MOU) requirement was included in this rule, which is designated not only to improve Departmental oversight but also to account for our Service members' unique lifestyle requirements. The purpose of the DoD MOU is to establish a partnership between the Department and institutions to improve educational opportunities while protecting the integrity of each institution's core educational values. This partnership serves to ensure a quality, viable program exists that provides for our Service members to realize their educational goals, while allowing for judicious oversight of taxpayer dollars.

Summary of Legal Basis: Sections 2005 and 2007 of title 10, United States Code.

Alternatives: None.

Anticipated Cost and Benefits: Voluntary Education Programs include: High School Completion/Diploma; Military Tuition Assistance (TA); Postsecondary Degree Programs; Independent Study and Distance Learning Programs; College Credit Examination Program; Academic Skills Program; and Certification/Licensure Programs. Funding for Voluntary Education Programs during 2009 was $800 million, which included tuition assistance and operational costs. This funding provided more than 650,000 individuals (Service members and their adult family members) with the opportunity to participate in Voluntary Education Programs around the world.

Risks: None.

Timetable:

Action Date FR Cite
NPRM 08/06/10 75 FR 47504
NPRM Comment Period End 10/05/10
Final Action 12/00/12

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: No.

Government Levels Affected: None.

Additional Information: DoD Instruction 1322.25.

Agency Contact: Kerrie Tucker Department of Defense, Office of the Secretary, Defense Pentagon, Washington, DC 20301, Phone: 703 602-4949.

RIN: 0790-AI50

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25. Defense Industrial Base (DIB) Cyber Security/Information Assurance (CS/IA) Activities Back to Top

Priority: Other Significant.

Legal Authority: EO 12829

CFR Citation: Not Yet Determined.

Legal Deadline: None.

Abstract: In accordance with Executive Order 12829, this rule will establish policy, assign responsibilities, and delegate authority for directing the conduct of Defense Industrial Base (DIB) Cyber Security/Information Assurance (CS/IA) activities to protect unclassified DoD information that transits or resides on unclassified DIB information systems and networks.

Statement of Need: Adversaries target Defense Industrial Base (DIB) unclassified networks daily. Unauthorized access and compromise of DoD unclassified information poses an unacceptable risk and imminent threat to U.S. national and economic security. DoD's voluntary DIB Cyber Security and Information Assurance (CS/IA) program enhances and supplements DIB participants' capabilities to safeguard DoD information on DIB unclassified information systems.

Summary of Legal Basis: Government and private sector information assurance, which includes cyber threat information sharing, is an urgent U.S. national and economic security priority. The following authorities and policy guidance identify government-industry partnerships as necessary to contend with advanced cyber threats and support the collection of cyber incident information from the DIB.

DoD Information Assurance (IA): DoD is required by statute to establish programs and activities to protect DoD information and DoD information systems, including information and information systems operated and maintained by contractors or others in support of DoD activities. Section 2224 of title 10, U.S. Code (U.S.C.), requires DoD to establish a Defense IA Program to protect and defend DoD information, information systems, and information networks that are critical to the Department during day to day operations and operations in times of crisis. (10 U.S.C. section 2224(a)). The program must provide continuously for the availability, integrity, authentication, confidentiality, non-repudiation, and rapid restitution of information and information systems that are essential elements of the Defense information infrastructure. (10 U.S.C. section 2224(b)). The program strategy also must include vulnerability and threat assessments for defense and supporting non-defense information infrastructures, joint activities with elements of the national information infrastructure, and coordination with representatives of those national critical infrastructure systems that are essential to DoD operations. (10 U.S.C. section 2224(c)). The program must provide for coordination, as appropriate, with the heads of any relevant federal agency and with representatives of those national critical information infrastructure systems that are essential to the operations of the Department regarding information assurance measures necessary to the protection of these systems. (10 U.S.C. section 2224(d)).

Federal Information Security: The Defense IA Program also must ensure compliance with Federal information security requirements of the Federal Information Security Management Act (FISMA), 44 U.S.C. section 3541 et seq. FISMA requires all federal agencies to provide information security protections for information collected or maintained by, or on behalf of, the agency. Information systems used or operated by an agency or by a contractor of an agency or other organization on behalf of an agency must be in accordance with 44 U.S.C. section 3544(a)(1)(A). Agencies are expressly required to develop, document, and implement programs to provide information security for information and information systems that support the operations and assets of the agency, including those provided by another agency, contractor, or other source in accordance with 44 U.S.C. section 3544(b).

Critical Infrastructure Protection (CIP): Under Homeland Security Presidential Directive 7 (HSPD-7), “Critical Infrastructure Identification, Prioritization, and Protection,” the Department of Defense is the Sector Specific Agency (SSA) for the Defense Industrial Base (DIB) sector (HSPD-7), (18)(g)), and thus engages with the DIB on a wide range of CIP matters, including but not limited to cyber security. HSPD-7 charges the SSAs to: collaborate with all relevant Federal departments and agencies, State and local governments, and the private sector, including with key persons and entities in their infrastructure sector; conduct or facilitate vulnerability assessments of the sector; and encourage risk management strategies to protect against and mitigate the effects of attacks against critical infrastructure and key resources. (HSPD-7), (19)). The Department of Homeland Security (DHS) leads the national effort to protect public and private critical infrastructure. (HSPD-7), (7)). This includes coordinating implementation activities between federal agencies, state and local authorities, and the private sector. Regarding cyber security, these efforts are to include analysis, warning, information sharing, vulnerability reduction, mitigation, and aiding national recovery efforts for critical infrastructure information systems. (HSPD-7), (12)) More specifically, regarding coordination with the private sector, HSPD-7 provides that DHS and the SSAs “will collaborate with appropriate private sector entities and continue to encourage the development of information sharing and analysis mechanisms [to] identify, prioritize, and coordinate the protection of critical infrastructure and key resources; and to facilitate sharing of information about physical and cyber threats, vulnerabilities, incidents, potential protective measures, and best practices.” (HSPD-7), (25)).

Alternatives: Private sector DIB company participation in the DIB CS/IA program is completely voluntary, allowing DIB companies to elect whether to participate in the program, or to choose from any other available alternatives, based on their individual approaches to cyber security and information security. The DIB CS/IA bilateral information sharing activities are a core element of the DoD's multi-pronged approach to fulfill its information assurance responsibilities and cyber security. The program enhances and supplements DIB participants' capabilities to safeguard DoD information that resides on, or transits, DIB unclassified information systems.

Anticipated Cost and Benefits: Participation in the DIB CS/IA program is voluntary and does not obligate the DIB participant to use government furnished information (GFI) in, or otherwise to implement any changes to, its information systems. Any action taken by the DIB participant based on GFI or other participation in this program is taken on the DIB participant's own volition and at the participant's own risk and expense. As a voluntary program in which the DIB participants and the Government each bear independent responsibility for their own activities, the costs to both the private sector and to the government are minimized. This voluntary participation will not create an inconsistency or otherwise interfere with any action taken or planned by another Agency. We do not believe that it raises novel legal policy issues arising out of legal mandates, the President's priorities, or principles set forth in Executive Orders.

All DIB participants must have or obtain DoD-approved, medium assurance certificates to enable encrypted unclassified information sharing between DoD and DIB participants. Cost of the DoD approved medium assurance certificates is approximately $175 for each individual identified by the DIB participant. See http://iase.disa.mil/pki/eca/ for more information about DoD-approved certificates.

For classified information sharing, each DIB participant will have start up costs of approximately $3,000 per DIBNet-Secret terminal installed in their cleared facility(ies). An estimate of $1,000 per year is projected as sustainment costs for each classified DIBNet-Secret terminal, including associated personnel costs for maintaining software updates for each stand-alone terminal.

There is an estimated annual burden for DIB participants projected at $1,367 for incident reporting. This is based on a DIB participant reporting average of 5 cyber incidents a year affecting DoD information, with 7 hours of labor per incident, at a cost of $39.06 per man hour. These man hour costs are according to the Bureau of Labor Statistics, Occupational Employment and Wages, May 2010, and depending upon the number of cyber incidents experienced and their severity, the annual burden could increase.

These costs provide beneficial capabilities to enhance and supplement DIB participants' capabilities to safeguard DoD information that resides on, or transits, DIB unclassified information systems.

Risks: Cyber threats to DIB unclassified information systems represent an unacceptable risk of compromise of DoD information and pose an imminent threat to U.S. national security and economic security interests. DoD's voluntary DIB CS/IA program enhances and supplements DIB participant's capabilities to safeguard DIB information that resides on, or transits, DIB unclassified information systems.

Timetable:

Action Date FR Cite
Interim Final Rule 05/11/12 77 FR 27615
Interim Final Rule Comment Period End 06/10/12
Final Action 02/00/13

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: No.

Government Levels Affected: None.

Additional Information: DoD Instruction 5205.ff.

Agency Contact: Brian Fredericks, Department of Defense, Office of the Secretary, 1155 Defense Pentagon, Washington, DC 20301, Phone: 703 604-5522, Email: brian.fredericks2@osd.mil.

RIN: 0790-AI60

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26. Mission Compatibility Evaluation Process Back to Top

Priority: Other Significant.

Legal Authority: Pub. L. 111-383, sec 358

CFR Citation: 32 CFR part 211.

Legal Deadline: None.

Abstract: The Department of Defense (DoD) is issuing this interim final rule to implement section 358 of the Ike Skelton National Defense Authorization Act for Fiscal Year 2011, Public Law 111-383. That section requires that the DoD issue procedures addressing the impacts upon military operations of certain types of structures if they pose an unacceptable risk to the national security of the United States. The structures addressed are those for which an application is required to be filed with the Secretary of Transportation under section 44718 of title 49, United States Code. Section 358 also requires the designation of a lead organization to coordinate DoD review of applications for projects filed with the Secretary of Transportation pursuant to section 44718, and received by the Department of Defense from the Secretary of Transportation. Section 358 also requires the designation of certain officials by the Secretary of Defense to perform functions pursuant to the section and this implementing rule. Section 358 also requires the establishment of a comprehensive strategy for addressing military impacts of renewable energy projects and other energy projects, with the objective of ensuring that the robust development of renewable energy sources and the expansion of the commercial electrical grid may move forward in the United States, while minimizing or mitigating any adverse impacts on military operations and readiness. Implementing that requirement, however, is not required at this time and is not part of this rule. Other aspects of section 358 not required at this time, such as annual reports to Congress, are also not addressed in this rule. Nor does this rule deal with other clearance processes not included in section 358, such as those applied by the Bureau of Land Management, Department of the Interior.

Statement of Need: 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.

Summary of Legal Basis: Public Law 111-383, Section 358.

Alternatives: The requirement to have a rule and the policies, responsibilities, and procedures contained in the rule were prescribed by section 358 of Public Law 111-383. In the areas where DoD has discretion, e.g., the internal procedures used within DoD to comply with the law, alternative arrangements would have no impact on the net economic effects of the rule.

Anticipated Cost and Benefits: The Department of Defense has long participated in the Department of Transportation review process, interacting with the Federal Aviation Administration (FAA). Prior to Section 358 of Public Law 111-383, DoD's engagement was decentralized—each Military Service participated separately working with FAA representatives at the regional level. In addition, each Service set its own standards for challenging a project application. Section 358 directed that DoD develop a single DoD point of contact for responses, established the threshold level of harm that must be reached before DoD could object to a project application on the basis of national security, and directed that DoD negotiate mitigation with project developers if potential harm is identified. The directed threshold level of harm, identified as “unacceptable risk to national security,” is higher than the standard previously used. This will result in DoD objecting to fewer project applications than before, reducing the impact of DoD reviews on non-DoD economic activity. The requirement to engage in mitigation negotiations may delay some projects (which has a negative impact on non-DoD economic activity), but it may result in still fewer DoD objections (which has a positive impact on non-DoD economic activity). DoD estimates that the net effect of these factors on non-DoD economic activity will be a benefit of approximately $70 million.

The higher standard for objection imposed by section 358 of Public Law 111-383 may allow projects that conflict with military activity, but do not achieve the high level of conflict required by law to object, to proceed. This may impose costs on DoD, e.g., systems testing may have to be moved to alternative test ranges, training and readiness activities may be curtailed or moved, and changes to operations may have to be implemented to overcome interference with coastal, border, and interior homeland surveillance. The early outreach and negotiation over mitigation required by section 358 may allow modification of some projects to reduce or eliminate their conflict with military activities in cases where the absence of early outreach and negotiation would result in the project proceeding without mitigation. This would provide a benefit to DoD. The net effect of these costs and benefits on DoD has not been quantitatively estimated.

Risks: The higher standard for a DoD objection to a project and the requirement to allow early consultation by developers with DoD will reduce the risk to both developers and to industry of planning a project that is unacceptable to DoD. Per the discussion above, there is a risk to DoD that projects in conflict with military activity, but that do not achieve the high level of conflict required by law to object, will proceed and impair DoD's test and evaluation; training and readiness; and coastal, border, and interior homeland surveillance capabilities.

Timetable:

Action Date FR Cite
Interim Final Rule 10/20/11 76 FR 65112
Interim Final Rule Effective 10/20/11
Interim Final Rule Comment Period End 12/19/11
Final Action 02/00/13

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: Businesses.

Government Levels Affected: Federal, Local, State, Tribal.

Agency Contact: David Belote, Department of Defense, Office of the Secretary, 3400 Defense Pentagon, Washington, DC 20301-3400, Phone: 703 697-7301, Email: david.belote@osd.smil.mil.

RIN: 0790-AI69

DOD—OFFICE OF ASSISTANT SECRETARY FOR HEALTH AFFAIRS (DODOASHA) Back to Top

Final Rule Stage

27. TRICARE; Reimbursement of Sole Community Hospitals Back to Top

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

Legal Authority: 5 U.S.C. 301; 10 U.S.C. ch 55

CFR Citation: 32 CFR part 199.

Legal Deadline: None.

Abstract: This proposed rule would implement the statutory provision at 10 U.S.C. 1079(j)(2) that TRICARE payment methods for institutional care 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 proposed rule implements a reimbursement methodology similar to that furnished to Medicare beneficiaries for inpatient services provided by Sole Community Hospitals (SCHs). It will be phased in over a several-year period.

Statement of Need: This rule is being published to implement the statutory provision in 10 U.S.C. 1079(j)(2), that TRICARE payment methods for institutional care be determined, to the extent practicable, in accordance with the same reimbursement rules as apply to payments to providers of services of the same type under Medicare. This proposed rule implements a reimbursement methodology similar to that furnished to Medicare beneficiaries for inpatient services provided by Sole Community Hospitals.

Summary of Legal Basis: There is a statutory basis for this proposed rule: 10 U.S.C. 1079(j)(2).

Alternatives: Alternatives were considered for phasing in the needed reform and an alternative was selected for a gradual, smooth transition.

Anticipated Cost and Benefits: We estimate the total reduction (from the proposed changes in this rule) in hospital revenues under the SCH reform for its first year of implementation (assumed for purposes of this RIA to be FY 2011), compared to expenditures in that same period without the proposed SCH changes, to be approximately $190 million. The estimated impact for FYs 2012 through 2015 (in $ millions) is $208, $229, $252, and $278 respectively.

Risks: Failure to publish this proposed rule would result in noncompliance with a statutory provision.

Timetable:

Action Date FR Cite
NPRM 07/05/11 76 FR 39043
NPRM Comment Period End 09/06/11
Final Action 12/00/12

Regulatory Flexibility Analysis Required: Yes.

Small Entities Affected: Businesses, Organizations.

Government Levels Affected: None.

Agency Contact: Marty Maxey, Department of Defense, Office of Assistant Secretary for Health Affairs, 1200 Defense Pentagon, Washington, DC 20301, Phone: 303 676-3627.

RIN: 0720-AB41

DOD—DODOASHA Back to Top

28. Civilian Health and Medical Program of the Uniformed Services (CHAMPUS); TRICARE Young Adult Back to Top

Priority: Other Significant.

Legal Authority: 10 U.S.C. ch 55; 5 U.S.C. 301

CFR Citation: 32 CFR part 199.

Legal Deadline: Final, Statutory, January 1, 2011, Public Law 111-383, section 702.

The amendments by this section took effect on January 1, 2011. The statute provided that the Secretary of Defense would prescribe an interim final rule with respect to such amendments, effective not later than January 1, 2011.

Abstract: This interim final rule implements section 702 of the Ike Skelton National Defense Authorization Act for Fiscal Year 2011 (NDAA for FY11). It establishes the TRICARE Young Adult (TYA) program to provide an extended medical coverage opportunity to most unmarried children under the age of 26 of uniformed services sponsors. The TRICARE Young Adult program is a premium-based program.

Statement of Need: This rule executes section 1110b of title 10, United States Code, “TRICARE Young Adult,” as mandated by section 702 of the Ike Skelton National Defense Act for Fiscal Year 2011. Section 702 authorizes the Department of Defense to provide an unmarried child under the age of 26 who is not otherwise eligible for TRICARE medical coverage at age 21 (23 if enrolled in a full-time course of study at an institution of higher learning approved by the Secretary of Defense) unless the dependent is enrolled in or eligible for medical coverage with an employer-sponsored plan as defined by section 5000A(f)(2) of the Internal Revenue Code of 1986. If qualified, the dependent can purchase TRICARE Standard/Extra or TRICARE Prime benefits depending on the military sponsor's eligibility and the availability of the TRICARE plan in the dependent's geographic location.

Summary of Legal Basis: Title 10, U.S.C., section 1110b and section 702 of the Ike Skelton National Defense Authorization Act for Fiscal Year 2011.

Alternatives: None.

Anticipated Cost and Benefits: There are no anticipated budgetary health care or administrative cost increases.

Risks: Failure to publish this rule would result in certain former Military Health System beneficiaries being denied the opportunity to purchase extended dependent medical coverage (similar to one of the significant benefit provisions of the Patient Protection and Affordable Care Act) when they are not longer eligible for care at age 21 (age 23 if enrolled in a full-time course of study at an institution of higher learning approved by the Secretary of Defense) and are under the age of 26.

Timetable:

Action Date FR Cite
Interim Final Rule 04/27/11 76 FR 23479
Interim Final Rule Effective 04/27/11
Interim Final Rule Comment Period End 06/27/11
Final Action 02/00/13

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: No.

Government Levels Affected: None.

Agency Contact: Mark Ellis, Department of Defense, Office of Assistant Secretary for Health Affairs, 5111 Leesburg Pike, Suite 810A, Falls Church, VA 22041, Phone: 703 681-0039.

RIN: 0720-AB48

BILLING CODE 5001-06-P

DEPARTMENT OF EDUCATION Back to Top

Statement of Regulatory Priorities

I. Introduction Back to Top

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 2012-2013 school year about 55 million students will attend an estimated 132,000 elementary and secondary schools in approximately 13,800 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 Back to Top

A. Race to the Top Fund

The Race to the Top Fund program 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. On May 22, 2012, the Secretary announced the Race to the Top—District competition, which is designed to build on the momentum of other Race to the Top competitions by encouraging bold, innovative reform at the local level. This district-level FY 2012 competition is authorized under sections 14005 and 14006 of the ARRA, as amended by section 1832(b) of the Department of Defense and Full-Year Continuing Appropriations Act, 2011 and the Department of Education Appropriations Act, 2012 (Title III of Division F of Pub. L. 112-74, the Consolidated Appropriations Act, 2012). The Department expects to fund about 15-25 grants in the range of $5 to $40 million. The amount of an award for which an applicant is eligible to apply depends on the number of students who would be served under the grant.

The Race to the Top—District competition is aimed squarely at classrooms and the all-important relationship between educators and students and invites applicants to demonstrate how they can personalize education for all students in their schools. In that regard, the Race to the Top—District competition will encourage and reward those local educational agencies (LEAs) or consortia of LEAs that have the leadership and vision to implement the strategies, structures, and systems needed for personalized, student-focused approaches to learning and teaching that will produce excellence and ensure equity for all students.

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 are implementing under the ARRA grant programs.

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

C. Carl D. Perkins Career and Technical Education Act of 2006

In 2012, we released Investing in America's Future: A Blueprint for Transforming Career and Technical Education, our plan for a reauthorized Carl D. Perkins Career and Technical Education Act of 2006 (2006 Perkins Act). The Blueprint can be found at the following Web site: http://www2.ed.gov/about/offices/list/ovae/pi/cte/transforming-career-technical-education.pdf.

The 2006 Perkins Act made important changes in Federal support for career and technical education (CTE), such as the introduction of a requirement that all States offer “programs of study.” These changes in the 2006 Perkins Act helped to improve the learning experiences of CTE students but did not go far enough to systemically create better outcomes for students and employers competing in a 21st-century global economy. The Administration's Blueprint would usher in a new era of rigorous, relevant, and results-driven CTE shaped by four core principles: (1) Alignment. Effective alignment between high-quality CTE programs and labor market needs to equip students with 21st-century skills and prepare them for in-demand occupations in high-growth industry sectors; (2) Collaboration. Strong collaboration among secondary and postsecondary institutions, employers, and industry partners to improve the quality of CTE programs; (3) Accountability. Meaningful accountability for improving academic outcomes and building technical and employability skills in CTE programs for all students, based upon common definitions and clear metrics for performance; and (4) Innovation. Increased emphasis on innovation supported by systemic reform of State policies and practices to support CTE implementation of effective practices at the local level. The Administration's Blueprint proposal reflects a commitment to promoting equity and quality across these alignment, collaboration, accountability, and innovation efforts in order to ensure that more students have access to high-quality CTE programs.

D. 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. The SAFRA Act 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 the SAFRA Act is that it ended new loans under the Federal Family Education Loan (FFEL) pprogram 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. Based on the feedback received from these hearings, ED formed a negotiated rulemaking committee to consider proposed amendments and conducted these negotiations in January, February, and March of 2012.

At the final meeting in March 2012, the Loans Committee reached consensus on the full agenda of loans issues, resulting in two notices of proposed rulemaking (NPRMs). We published the first of the two NPRMs on July 17, 2012, and published one of the two final regulations on November 1, 2012. These final regulations implement the new Income-Contingent Repayment (ICR) plan in the Direct Loan program based on the President's “Pay As You Earn” repayment initiative, incorporate recent statutory changes to the Income-Based Repayment (IBR) plan in the Direct Loan and FFEL programs, and streamline and add clarity to the total and permanent disability (TPD) discharge process for borrowers in loan programs under title IV of the HEA.

We intend to publish the second of the two NPRMs in 2013 to amend the Student Assistance General Provisions, Federal Perkins Loan (Perkins Loan) Program, Federal Family Education Loan (FFEL) Program, and William D. Ford Federal Direct Loan (Direct Loan) Program regulations. The NPRM would reflect that, as of July 1, 2010, under the SAFRA Act, no new FFEL Program loans will be made and allow a borrower to get out of default on his or her loans if the borrower makes 9 reasonable and affordable payments over a 10-month period. The NPRM would also make other improvements to the Direct Loan, FFEL, and Perkins Loan programs. The NPRM would provide for greater consistency in the regulations governing the title IV, HEA student loan programs and ensure that these programs operate as efficiently as possible.

E. Individuals With Disabilities Education Act

In September of 2011, the Department issued an NPRM 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 this year.

Specifically, last year we reviewed one particular provision of the Part B regulations related 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 have proposed 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 proposed 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 did 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.

The Secretary also intends to issue a notice of proposed rulemaking to amend regulations under Part B of IDEA regarding local maintenance of effort (MOE) to ensure that all parties involved in implementing, monitoring, and auditing LEA compliance with MOE requirements understand the rules. Specifically, we will be seeking public comment on proposed amendments to the regulation regarding local MOE to clarify existing policy and make other related changes regarding: (1) The compliance standard; (2) the eligibility standard; (3) the level of effort required of a local educational agency (LEA) in the year after it fails to maintain effort under section 613(a)(2)(A)(iii) of the IDEA; and (4) the consequence for a failure to maintain local effort.

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 Back to Top

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 that 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. These rulemakings can also be found on Regulations.gov. The final agency plan can be found at: www.ed.gov.

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—Public Benefits or Insurance No.
1840-AD05 Title IV of the Higher Education Act of 1965, as Amended—Income-Based Repayment, Income-Contingent Repayment, and Total and Permanent Disability No.
1840-AD08 Titles III and V of the Higher Education Act, as Amended No.
1840-AD12 Transitioning from the FFEL Program to the Direct Loan Program and Loan Rehabilitation under the FFEL, Direct Loan, and Perkins Loan Programs Undetermined.
1890-AA14 Direct Grant Programs and Definitions that Apply to Department Regulations No.

IV. Principles for Regulating Back to Top

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

29. Transitioning From the FFEL Program to the Direct Loan Program and Loan Rehabilitation Under the FFEL, Direct Loan, and Perkins Loan Programs 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 ch VI.

Legal Deadline: None.

Abstract: The Secretary proposes amendments to the title IV, HEA student assistance regulations to (a) reflect that, as of July 1, 2010, under the SAFRA Act, no new FFEL Program loans will be made, (b) allow a borrower to get out of default on his or her loans if the borrower makes 9 reasonable and affordable payments over a 10-month period, and (c) make other improvements to the DL, FFEL, and Perkins Loan programs.

Statement of Need: The proposed regulations are needed amend the FFEL and Direct Loan program regulations to reflect changes made to the Higher Education Act of 1965, as amended (HEA), by the SAFRA Act included in the Health Care and Education Reconciliation Act of 2010; incorporate other recent statutory changes in the Direct Loan Program regulations; update, strengthen, and clarify various areas of the Student Assistance General Provisions, Perkins Loan, FFEL, and Direct Loan program regulations; and provide for greater consistency in the regulations governing the title IV, HEA student loan programs.

Anticipated Cost and Benefits: We will provide a comprehensive discussion of the anticipated costs and benefits in the NPRM.

Timetable:

Action Date FR Cite
NPRM 03/00/13  

Regulatory Flexibility Analysis Required: Undetermined.

Government Levels Affected: None.

Additional Information: Includes Retrospective Review under E.O. 13563.

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-AD12

BILLING CODE 4001-01-P

Fall 2012 Back to Top

DEPARTMENT OF ENERGY (DOE) Back to Top

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; and
  • 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.

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 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 plan can be found at http://www.whitehouse.gov/sites/default/files/other/2011-regulatory-action-plans/departmentofenergyregulatoryreformplanaugust2011.pdf.

Rulemakings Subject to Retrospective Analysis

RIN Title Small Business Burden Reduction
1904-AB57 Standards for Battery Chargers and External Power Supplies.
1904-AB90 Standards for Residential Clothes Washers.
1904-AC04 Standards for Distribution Transformers.
1904-AC46 Alternative Efficiency Determination Methods and Alternate Rating Methods. This rule is expected to reduce burden on small manufacturers of covered products and equipment.
1904-AC60 Federal Building Standards Rule-Update-90.1-2010.
1904-AC64 Standards for Residential Dishwashers.
1904-AC70 Waiver and Interim Waiver for Consumer Products and Commercial and Industrial Equipment. This rule is expected to reduce burden on small manufacturers of covered products and equipment.

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 Residential Clothes Washer, Fluorescent Lamp Ballast, and Residential Dishwasher standards, which were already published in 2012, have an estimated net benefit to the nation of up to $13.1 billion over 30 years. By 2045, these standards are estimated to save enough energy to operate the current inventory of all U.S. homes for almost two 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 overall plan for implementing the schedule is contained in the Report to Congress under section 141 of EPACT 2005, which was released on January 31, 2006. This plan was last updated in the August 2012 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 2012 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 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 for distribution transformers, battery chargers and external power supplies, and walk-in coolers and freezers may provide significant benefits to the Nation. DOE believes that the benefits to the Nation of the proposed energy standards for distribution transformers and battery chargers and external power supplies (energy savings, consumer average lifecycle cost savings, increase in national net present value, and emission reductions) outweigh the costs (loss of industry net present value and life-cycle cost increases for some consumers). In the proposed rulemakings, DOE estimated that these regulations would produce energy savings of 3.74 quads over thirty years. The net benefit to the Nation was estimated to be between $9.59 billion (seven-percent discount rate) and $24.58 billion (three-percent discount rate). DOE believes that the proposed energy standards for walk-in coolers and freezers 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 this action. 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 walk-in coolers and freezers.

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

Proposed Rule Stage

30. 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 part 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 and directs the Department of Energy to develop energy conservation standards that are technologically feasible and economically justified.

Statement of Need: EPCA requires minimum energy efficiency standards for certain appliances and commercial equipment, which has the effect of eliminating inefficient appliances and equipment from the market.

Summary of Legal Basis: Section 312 of EISA 2007 establishes definitions and standards for walk-in coolers and walk-in freezers. EISA 2007 directs DOE to establish performance-based standards for this equipment (42 U.S.C. 6313 (f)(4)).

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: 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 04/00/13  
Final Action 12/00/13  

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

Final Rule Stage

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

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

Unfunded Mandates: This action may affect the private sector under Pub. L. 104-4.

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

CFR Citation: 10 CFR part 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 or to determine that no energy conservation standard is technically feasible and economically justified.

Statement of Need: 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)-(ii)and (w)(3)(D)).

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 external power supplies or 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 completed this determination in 2012. 75 FR 7170 (May 14, 2010)

DOE is bundling these separate rulemaking requirements into a single rulemaking action.

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 of the proposed energy standards for battery chargers and external power supplies (such as energy savings, consumer average lifecycle cost savings, an increase in national net present value, and emission reductions) outweigh the burdens (such as loss of industry net present value). DOE estimates that energy savings from electricity will be 2.16 quads over 30 years and the benefit to the Nation will be between $6.68 billion and $12.44 billion

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 03/27/12 77 FR 18478
Final Rule: Technical Amendment 04/16/12 77 FR 22472
NPRM Comment Period End 05/29/12
NPRM Comment Period Reopened 06/29/12 77 FR 38743
Reopened NPRM Comment Period End 07/16/12
Final Action 02/00/13

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.

Additional Information: Includes Retrospective Review under E.O. 13563.

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

Agency Contact: Jeremy Dommu, Office of Building Technologies Program, EE-2J, Department of Energy, Energy Efficiency and Renewable Energy, 1000 Independence Avenue SW., Washington, DC 20585, Phone: 202 586-9870, Email: jeremy.dommu@ee.doe.gov.

Related RIN: Related to 1904-AB75.

RIN: 1904-AB57

DOE—EE Back to Top

32. Energy Efficiency Standards for Distribution Transformers Back to Top

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

Legal Authority: 42 U.S.C. 6317(a); 42 U.S.C. 6313(a)(6)(C)

CFR Citation: 10 CFR part 431.

Legal Deadline: Other, Judicial, October 1, 2011, Determination or NOPR. Final, Judicial, October 1, 2012.

Abstract: The current distribution transformer efficiency standards for medium-voltage-transformers apply to transformers manufactured or imported on or after January 1, 2010, and to low-voltage, dry type transformers manufactured or imported on or after January 1, 2007. As a result of a settlement agreement, DOE agreed to conduct a review of the standards for liquid-immersed and medium-voltage dry-type distribution transformers to determine if, pursuant to EPCA. The standards for these products need to be amended. As a result of the review, DOE published in the Federal Register a notice of proposed rulemaking which included new proposed standards for these products as well as low-voltage, dry-type transformers. Under the settlement agreement, DOE is obligated to publish in the Federal Register, no later than October 1, 2012, a final rule including any amendments to the standards for liquid-immersed and medium-voltage dry-type distribution transformers.

Statement of Need: EPAC requires minimum energy efficiency standards for appliances, which has the effect of eliminating inefficient appliances and equipment from the market.

Summary of Legal Basis: EPCA of 1975 established an energy conservation program for major household appliances. The National Energy Conservation Policy Act of 1978 amended EPCA to add part C of title III, which established an energy conservation program for certain industrial equipment. The Energy Policy Act of 1992 amended EPCA to add certain commercial equipment, including distribution transformers.

DOE published a final rule in October 2007 that established energy conservation standards for liquid-immersed and medium-voltage dry-type distribution transformers. 72 FR 58190 (October 12, 2007); see 10 CFR 431.196(b)-(c). During the course of that rulemaking, EPACT 2005, Public Law 109-58, amended EPCA to set standards for low-voltage dry-type distribution transformers. (EPACT 2005, section 135(c); codified at 42 U.S.C. 6295(y)) Consequently, DOE removed these transformers from the scope of that rulemaking. 72 FR 58191. Prior to publishing the energy conservation standard, DOE published a final rule test procedure for distribution transformers on April 27, 2006. 71 FR 24972; see appendix A to subpart K of 10 CFR 431.

DOE is currently conducting a rulemaking to review and amend the energy conservation standards in effect for distribution transformers. This new rulemaking includes liquid-immersed, medium-voltage dry-type, and low-voltage dry-type distribution transformers.

On July 29, 2011, DOE gave notice that it intends to establish a negotiated rulemaking subcommittee under the Energy Efficiency and Renewables Advisory Committee (ERAC) in accordance with the Federal Advisory Committee Act (FACA) and the Negotiated Rulemaking Act (NRA) to negotiate proposed Federal standards for the energy efficiency of liquid-immersed and medium-voltage dry-type distribution transformers. 77 FR 4547. On August 12, 2011, DOE gave notice that it intends to establish a negotiated rulemaking subcommittee under the ERAC in accordance with the FACA and the NRA to negotiate proposed Federal standards for the energy efficiency of low-voltage dry-type distribution transformers. 76 FR 50148.

ERAC subcommittees met several times from September to December 2011. Subcommittee members included manufacturers, utilities, and energy efficiency advocates. The medium-voltage subcommittee reached consensus on standards for medium-voltage, dry-type distribution transformers, but consensus was not reached for the two other transformer types.

DOE's February publication of the proposed rule for energy conservation standards for liquid-immersed, medium-voltage dry-type, and low-voltage dry-type distribution transformers fulfills DOE's obligation under a court order. 77 FR 7282 (February 10, 2011).

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 of the proposed energy standards for distribution transformers (such as energy savings, consumer average lifecycle cost savings, an increase in national net present value, and emission reductions) outweigh the burdens (such as loss of industry net present value). DOE estimates that energy savings from electricity will be 1.58 quads over 30 years and the benefit to the Nation will be between $2.9 billion and $12.1 billion.

Timetable:

Action Date FR Cite
Notice: Public Meeting; Preliminary Technical Support Document Availability 03/02/11 76 FR 11396
Comment Period End 04/18/11  
Notice of Intent to Negotiate NPRM for MVDT 07/29/11 76 FR 45471
MVDT NOI Comment Period End 08/15/11  
Notice of Intent to Negotiate NOPR for LVDT 08/12/11 76 FR 50148
LVDT NOI Comment Period End 08/20/11  
Notice of Public Meeting of Working Group 09/09/11 76 FR 55834
NPRM 02/10/12 77 FR 7282
NPRM Correction 02/24/12 77 FR 10997
NPRM Comment Period End 04/10/12  
Comment Period End 06/29/12  
Final Action 12/00/12  

Regulatory Flexibility Analysis Required: Yes.

Small Entities Affected: Businesses.

Government Levels Affected: Undetermined.

Additional Information: RIN 1904-AC62 was merged into this rulemaking.

URL for More Information: www1.eere.energy.gov/buildings/appliance_standards/commercial/distribution_transformers.html.

URL for Public Comments: www.regulations.gov.

Agency Contact: James Raba, Office of Building Technologies Program, EE-2J, Department of Energy, Energy Efficiency and Renewable Energy, 1000 Independence Avenue SW., Washington, DC 20585, Phone: 202 586-8654, Email: jim.raba@ee.doe.gov.

Related RIN: Merged with 1904-AC62.

RIN: 1904-AC04

BILLING CODE 6450-01-P

DEPARTMENT OF HEALTH AND HUMAN SERVICES Back to Top

Statement of Regulatory Priorities for Fiscal Year 2013

The Department of Health and Human Services (HHS) 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 expenditures, and administers more grant dollars than all other Federal agencies combined. In fiscal year 2013, HHS agencies will continue to implement programs that strengthen the health care system; advance scientific knowledge and innovation; advance the health, safety, and well-being of the American people; increase efficiency, transparency, and accountability of HHS programs; and strengthen the nation's health and human services infrastructure and workforce.

To carry out its mission, the Department develops an ambitious regulatory agenda each year. HHS actively encourages public participation in the regulatory process and is currently engaging in a Department-wide effort to identify ways to make the rulemaking process more accessible to the general public. Incorporating this feedback, Secretary Kathleen Sebelius has worked with HHS agencies to identify opportunities to streamline regulations and reduce the regulatory burden on industry and states; secure and maintain health care coverage for all Americans; take advantage of technology to promote health care innovation and rapidly respond to adverse events; implement a 21st century food safety system; promote children's health and well-being; and arm consumers with information to help them make healthy choices.

This overview outlines the Department's regulatory priorities for FY 2013 and some of the regulations on the agenda that best exemplify these priorities.

Streamlining Regulations To Reduce Regulatory Burdens

Consistent with the President's Executive Order 13563, “Improving Regulation and Regulatory Review,” the Department remains committed to reducing regulatory burden on states, health care providers and suppliers, and other regulated industries by eliminating outdated procedures, streamlining rules, and providing flexibility to use technology.

The Centers for Medicare Medicaid Services (CMS) has an ambitious effort underway to reduce burdens on hospitals and other health care providers and save providers money and time so that they can focus their resources on caring for patients. In May 2012, CMS finalized two rules—addressing the Medicare conditions of participation for hospitals and critical access hospitals (CAH) (0938-AQ89) and regulatory requirements for a broader range of health care providers and suppliers regulated under Medicare and Medicaid (0938-AQ96)—that will save approximately $1.1 billion across the health care system in just the first year while reducing unnecessary burdens on hospitals and other health care providers. For the second phase of this effort, CMS will issue regulations that will eliminate or streamline Medicare rules and requirements that are unnecessary, obsolete, or excessively burdensome to health care professionals and patients. [1] This effort will allow health care professionals to devote more time and effort to improving patient care.

The Food and Drug Administration (FDA) will finalize amendments to its medical device reporting regulations to require manufacturers and importers to submit electronic reports of individual medical device adverse events to the agency. [2] This will help move the medical device industry from paper to electronic reporting, which will reduce paperwork burden on industry and increase the speed at which FDA processes critical information.

In a major undertaking, the Department and White House Office of Science and Technology Policy are reviewing and considering making revisions to the ethical rules governing research on human subjects, often referred to as the Common Rule. [3] The Common Rule governs institutions and researchers supported by HHS, and researchers throughout much of the Federal Government, in the conduct of research on humans. The proposed revisions will aim to better protect human subjects who are involved in research while facilitating research and reducing burden, delay, and ambiguity for investigators.

The Administration for Children and Families (ACF) will propose reforms to its child support regulations that will simplify program operations, clarify technical provisions in the existing rules, and allow States and tribes to take advantage of advances in technology and move toward electronic communication with ACF and with other States and tribes. [4] These reforms will create more efficient child support systems that better serve families in need of this crucial financial support.

Strengthening Medicare and Expanding Coverage in the Private Health Care Market

The Department continues to implement Affordable Care Act provisions that expand health insurance coverage and ensure that the American people can rely on their existing coverage when they need it most. Millions of Americans—including women, families, seniors, and small business owner—are already benefitting from the Affordable Care Act. In June, HHS announced that 12.8 million Americans will benefit from $1.1 billion in rebates from insurance companies, as a result of HHS regulations that require insurers to spend the majority of health insurance premiums on medical care and health care quality improvement, instead of administration and overhead. [5] As well, the Affordable Care Act has provided $4.8 billion in reinsurance payments to employers and other sponsors of early retiree health coverage to help them continue to provide health benefits to retired workers who are not yet eligible for Medicare and to the families of these retired workers. At least 19 million retirees and their family members have already benefitted or will benefit from this program. Because of another Affordable Care Act provision, approximately 54 million Americans with private health insurance and 32.5 million seniors with Medicare received at least one free preventive service from their health care provider in 2011. [6] And as of August 1, 2012, about 47 million women will be able to receive preventive care such as mammograms, cervical cancer screenings, and annual preventive care visits without paying co-pays or deductibles. [7]

Building on those efforts, HHS will provide guidance this year to States, providers, and insurers that are preparing for the reforms to the health care marketplace that become effective in 2014.

The Department will finalize a rule that outlines standards for the state-run and federally-facilitated Affordable Insurance Exchanges, which will provide competitive marketplaces for individuals and small employers to directly compare available private health insurance options on the basis of price and quality. These standards will ensure, for example, that individual and small group plans provide certain levels of coverage. This means that consumers can rest assured that plans inside and outside of the Exchanges will cover certain essential health benefits. [8]

The Department will also implement provisions of the Affordable Care Act that set the rules for risk adjustment, reinsurance, risk corridors, advanced premium tax credits, and cost-sharing reductions. [9]

Another final rule would outline many of the consumer protections at the heart of the Affordable Care Act. [10] These new health insurance market standards will promote access to, and the affordability of, health insurance coverage by extending new guaranteed availability rights to individuals and employers, continuing current guaranteed renewability protections, specifying a limited, transparent set of factors that can be used to set premiums, and requiring broader pooling of insurance risk. This rule, in tandem with rules implementing Affordable Care Act provisions that establish Exchanges; provide tax credits to certain individuals and employers for purchasing health insurance coverage; and create the risk adjustment, reinsurance, and risk corridor programs; lays the foundation for a more affordable, better-functioning insurance market.

Another rule would implement provisions of the Affordable Care Act that expand access to health insurance through Medicaid, the establishment of the Affordable Insurance Exchanges, and coordination between Medicaid, the Children's Health Insurance Program (CHIP), and the Exchanges. This proposed rule would continue CMS's efforts to assist States in implementing changes to the eligibility, appeals, and enrollment under Medicaid and other State health subsidy programs. [11]

In addition, CMS will update several Medicare provider payment rules in ways that strengthen Medicare, better reflect the state of practice, and are responsive to feedback from providers. [12] These rules, which are published annually, provide predictability for health care providers so they can manage their finances appropriately.

Finally, CMS will implement the Affordable Care Act provision that establishes a new prospective payment system for Federally Qualified Health Centers (FQHCs), which are facilities that provide primary care services to underserved urban and rural communities. [13] This rule will bring the FQHC payment system in line with the payment procedure for the majority of Medicare providers and will allow FQHCs to anticipate future reimbursements for providing services to Medicare beneficiaries.

Advancing Innovation To Improve Consumer Health and Safety

Through administrative reforms, innovations, and providing additional information to support consumer decision-making, HHS is supporting high-value, safe, and effective care across health care settings and in the community. For example, FDA will issue a Unique Device Identifier final rule to establish a unique identification system for medical devices to track a device from pre-market application through distribution and use. This system will allow FDA and other public health professionals 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 medical errors. [14]

As discussed previously, FDA is also amending its post-marketing medical device reporting regulations to require manufacturers and importers to submit electronic reports of individual medical device adverse events to the Agency. These electronic submissions will help FDA receive information about malfunctioning devices quickly and will enhance the Agency's ability to collect and analyze data from these adverse events. In addition to providing the Agency with this information soon after an adverse event occurs, this final rule is expected to result in significant burden reductions in reporting and recordkeeping for device manufacturers and suppliers. [15]

Implementing a 21st Century Food Safety System

FDA will continue its work to implement the Food Safety Modernization Act, working with public and private partners to build a new system of food safety oversight. In implementing that Act, the Department is focusing on applying the best available science and lessons from previous outbreaks to shift the Agency's emphasis from recalling unsafe products from the market place to preventing 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 [16] and of animal feeds. [17] These regulations constitute the heart of the food safety program by instituting uniform 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.

FDA will continue its work on a rule to ensure that produce sold in the United States meets rigorous safety standards. [18] 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 establish a verification program to improve the safety of food that is imported into the United States. [19] Specifically, the FDA will outline proposed standards that foreign food suppliers must meet to ensure that imported food is produced in a manner that is as safe as food produced in the United States.

FDA will also establish a program to accredit third-party auditors to conduct audits of foreign food suppliers. [20] This program will allow importers to contract with an accredited auditor to meet the audit requirements instead of having to establish such programs themselves.

Promoting Children's Health and Well-Being

ACF's regulatory portfolio includes several rules that promote children's health and well-being. For example, one proposed rule would provide the first comprehensive update of Child Care and Development Fund (CCDF) regulations since 1998. [21] The CCDF is a Federal program that provides formula grants to States, territories, and tribes. The program provides financial assistance to low-income families to access child care so that they can work or attend a job training or educational program. It also provides funding to improve the quality of child care and increase the supply and availability of care for all families, including those who receive no direct assistance through CCDF. The proposed rule would make improvements in four key areas: (1) Health and safety; (2) child care quality; (3) family-friendly policies that promote continuity of care and support working families; and (4) program integrity. These proposed changes reflect current research and knowledge about the early care and education sector, State innovations in policies and practices over the past decade, and increased recognition that high quality child care both supports work for low-income parents and promotes children's learning and healthy development. The rule is responsive to the need for State flexibility in administering the CCDF program.

Empowering Americans To Make Healthy Choices in the Marketplace

As of 2010, more than one-third of U.S. adults [22] and 17% of all children and adolescents [23] in the United States are obese, representing a dramatic increase in the rise of this health status. Since 1980, the prevalence of obesity among children and adolescents has almost tripled. [24] Obesity has both immediate and long-term effects on the health and quality of life of those affected, increasing their risk for chronic diseases, including heart disease, type 2 diabetes, certain cancers, stroke, and arthritis—as well as increasing medical costs for the individual and the health system.

Building on the momentum of the First Lady Obama's “Let's Move” initiative and the Secretary's leadership, HHS has marshaled the skills and expertise from across the Department to address this epidemic with research, public education, and public health strategies. Adding to this effort, FDA will issue several rules designed to provide more useful, easy to understand dietary information—tools that will help millions of American families identify healthy choices in the marketplace. [25]

One final 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. [26] 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.

■ A second final rule will require vending machine operators who own or operate 20 or more vending machines to disclose calorie content for some items. [27] 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.

■ A third proposed rule would revise the nutrition and supplement facts labels on packaged food, which 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. [28]

Another proposed rule will focus on the serving sizes of foods that can reasonably consumed in one serving. This rule would provide consumers with nutrition information based on the amount of food that is typically eaten as a serving, which would assist consumers in maintaining health dietary practices. [29]

Promoting International Regulatory Cooperation With Our Global Partners

The Department is working to implement Executive Order 13609, “Promoting International Regulatory Cooperation,” which charges the Federal Government to identify efforts to align U.S. regulations with those of our global partners to address shared regulatory challenges. FDA has already established such relationships through its participation in key international regulatory cooperation fora, including Codex Alimentarius, the U.S.-Mexico High Level Regulatory Cooperation Council, the U.S.-Canada Regulatory Cooperation Councils. In addition, FDA is developing several rulemakings that have a specific international focus.

■ In one proposed rule, FDA will use international standards and promotes harmonization by allowing medical devices companies to use certain kinds of international symbols in device labeling. [30]

■ As a result of collaboration under the U.S.-Canada Regulatory Cooperation Council (RCC), FDA will propose a rule to add the common cold indication to certain over-the-counter (OTC) antihistamine active ingredients. [31] The objectives of the RCC monograph alignment working group are to conduct a pilot program to develop aligned monograph elements for a selected over-the-counter (OTC) drug category (e.g. aligned directions, warnings, indications and conditions of use) and subsequently, develop recommendations to determine the feasibility of an ongoing mechanism for alignment in review and adoption of these OTC drug monograph elements.

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 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 plan can be found at reginfo.gov.

RIN Title Reduce Small Business Burden?
0970-AC43 Performance Standards for Runaway and Homeless Youth Grantees No.
0970-AC50 Flexibility, Efficiency, and Modernization of Child Support Enforcement Programs No.
0920-AA23 Control of Communicable Disease: Foreign; Requirements for Importers of Nonhuman Primates No.
0938-AO53 Home and Community-Based State Plan Services Program and Provider Payment Reassignments (CMS-2249-F) Yes.
0938-AP61 Home and Community Based Services Waivers (CMS-2296-F) Yes.
0938-AQ38 CLIA Program and HIPAA Privacy Rule; Patients' Access to Test Reports (CMS-2319-F) No.
0938-AR49 Part II—Regulatory Provisions to Promote Program Efficiency, Transparency, and Burden Reduction (CMS-3267-P) Yes.
0910-AF22 Food Labeling; Revision of the Nutrition and Supplement Facts Labels No.
0910-AF81 Current Good Manufacturing Practice for Combination Products No.
0910-AF82 Postmarket Safety Reporting for Combination Products Yes.
0910-AF86 Medical Device Reporting; Electronic Submission Requirements No.
0910-AF87 Laser Products; Amendment to Performance Standard No.
0910-AG14 Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992; Policies, Requirements, and Administrative Procedures Yes.
0910-AG18 Electronic Distribution of Prescribing Information for Human Drugs Including Biological Products No.
0910-AG36 Hazard Analysis and Risk-Based Preventive Controls No.
0910-AG54 General Hospital and Personal Use Devices: Issuance of Draft Special Controls Guidance for Infusion Pumps No.
0910-AG70 Amendments to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals—Components No.
0910-AG74 Use of Symbols in Labeling Yes.
0906-AA87 Elimination of Duplication Between the Healthcare Integrity and Protection Data Bank (HIPDB) into the National Practitioner Data Bank (NPDB) No.
0925-AA43 National Institutes of Health Loan Repayment Program No.
0937-AA02 Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators No.
0945-AA03 Modifications to the HIPAA Privacy, Security, Enforcement, and Breach Notification Rules Yes.
0945-AA00 HIPAA Privacy Rule Accounting of Disclosures under the Health Information Technology for Economic and Clinical Health Act No.
0930-AA14 Opioid Drugs in Maintenance or Detoxification Treatment of Opiate Addiction No.

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

Proposed Rule Stage

33. Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals Back to Top

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

Unfunded Mandates: This action may affect the private sector under Pub. L. 104-4.

Legal Authority: 21 U.S.C. 321; 21 U.S.C. 331; 21 U.S.C. 342; 21 U.S.C. 350d note; 21 U.S.C. 350g; 21 U.S.C. 350g note; 21 U.S.C. 371; 21 U.S.C. 374; 42 U.S.C. 264; 42 U.S.C. 243; 42 U.S.C. 271

CFR Citation: 21 CFR part 507.

Legal Deadline: The legal deadline for FDA under the Food Safety Modernization Act to promulgate proposed regulations is October 2011 for certain requirements, with a final rule to publish 9 months after the close of the comment period. The Food Safety Modernization Act mandates that FDA promulgate final regulations for certain other provisions by July 2012. Finally, the FDA Amendments Act of 2007 directs FDA to publish final regulations for a subset of the proposed requirements by September 2009.

Abstract: FDA is proposing regulations for preventive controls for animal food, including ingredients and mixed animal feed. This action is intended to provide greater assurance that food marketed for all animals, including pets, is safe.

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.

FDA is also issuing this rule under the certain provisions of section 402 of the FD Act (21 U.S.C. 342) regarding 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 Food Safety Modernization Act requires this rulemaking.

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, 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. 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 reduce the risk of serious illness and death to animals.

Timetable:

Action Date FR Cite
NPRM 01/00/13

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

34. 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 Pub. L. 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: FDA is proposing to establish science-based minimum standards for the safe production and harvesting of those types 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. The purpose of the proposed rule is to reduce the risk of illness associated with fresh produce.

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 health principles and incorporating what we have learned in the past decade into a regulation is a critical step in establishing standards for the production and harvesting 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 section 419 of the FD Act (21 U.S.C. 350h)). FDA's legal basis also derives in part from sections 402(a)(3), 402(a)(4), and 701(a) of the FD Act (21 U.S.C. 342(a)(3), 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 01/00/13

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

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

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

Unfunded Mandates: This action may affect the private sector under Pub. L. 104-4.

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 part 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 Modernization Act.

Abstract: 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. This action is intended to prevent or, at a minimum, quickly identify foodborne pathogens before they get into the food supply.

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 foodborne 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 foodborne 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 foodborne 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 01/00/13  

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.

Additional Information: Includes Retrospective Review under E.O. 13563.

Agency Contact: Jenny Scott, Senior Advisor, Department of Health and Human Services, Food and Drug Administration, 5100 Paint Branch Parkway, Office of Food Safety, College Park, MD 20740, Phone: 240 402-1488, Email: jenny.scott@fda.hhs.gov.

RIN: 0910-AG36

HHS—FDA Back to Top

36. 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: 21 U.S.C. 384a; 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: FDA is proposing regulations that describe what a food importer must do to verify that its foreign suppliers produce food that is as safe as food produced in the United States. FDA is taking this action to improve the safety of food that is imported into the United States.

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, as applicable, and is not adulterated or misbranded. This proposed rule on the content of foreign supplier verification programs (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 are still estimating 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 increased compliance with applicable requirements.

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.

Timetable:

Action Date FR Cite
NPRM 01/00/13  

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, WO 32, 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

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

Priority: Other Significant.

Legal Authority: 21 U.S.C. 384d; 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 Pub. L. 111-353, section 307, promulgate, within 18 months of enactment, certain implementing regulations for accreditation of third-party auditors to conduct food safety audits.

Abstract: FDA is proposing regulations for accreditation of third-party auditors to conduct food safety audits. FDA is taking this action to improve the safety of food that is imported into the United States.

Statement of Need: The use of accredited third-party auditors to certify food imports will assist in ensuring the safety of food from foreign origin entering U.S. commerce. Accredited third-party auditors auditing foreign facilities can increase FDA's information about foreign facilities that FDA may not have adequate resources to inspect in a particular year. FDA will establish 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: Section 808 of the FD&C Act directs FDA to establish, not later than 2 years after the date of enactment, a system for the recognition of accreditation bodies that accredit third-party auditors, who in turn certify that their eligible entities meet the requirements. To directly accredit third-party auditors should none be identified and recognized by the 2-year date of enactment, FDA is to 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 voluntary qualified importer 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 rulemaking. User fee costs will be accounted for in that rulemaking.

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 could 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 01/00/13  

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, WO 32, 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

38. • Revision of Postmarketing Reporting Requirements Discontinuance or Interruption in Supply of Certain Products (Drug Shortages) Back to Top

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

Legal Authority: secs 506C, 506C-1, 506D, and 506F of the FDA Act, as amended by title X (Drug Shortages) of FDASIA, Pub. L. 112-144, July 9, 2012

CFR Citation: 21 CFR 314.81; 21 CFR 314.91.

Legal Deadline: NPRM, Statutory, January 9, 2014. Not later than 18 months after the date of enactment of FDASIA, FDA must adopt the final regulation implementing section 506C as amended. Section 1001 of FDASIA states that not later than 18 months after the date of enactment of FDASIA, the Secretary shall adopt a final regulation implementing section 506C as amended.

Abstract: FDASIA amends the FD&C Act to require manufacturers of certain drug products to report to FDA discontinuances or interruptions in the production of these products 6 months prior to the discontinuance or interruption, or if that is not possible, as soon as practicable. Manufacturers must notify FDA of a discontinuance or interruption in the manufacture of drugs that are life-supporting, life-sustaining or intended for use in the prevention or treatment of a debilitating disease or condition. FDASIA requires FDA to define in regulation the terms “life-supporting,” “life-sustaining,” and “intended for use in the prevention or treatment of a debilitating disease or condition,” and to distribute, to the maximum extent practical, information on the discontinuation or interruption in the manufacture of these products to appropriate organizations. FDASIA also amends the FD&C Act to include other provisions related to drug shortages, and to require FDA to adopt a final regulation implementing amended section 506C not later than 18 months after the date of enactment of FDASIA. When finalized, this rule will implement the drug shortages provisions of FDASIA.

Statement of Need: The Food and Drug Administration Safety and Innovation Act (FDASIA), Public Law No. 112-144 (July 9, 2012), amends the FD&C Act to require manufacturers of certain drug products to report to FDA discontinuances or interruptions in the production of these products that are likely to meaningfully disrupt supply 6 months prior to the discontinuance or interruption, or if that is not possible, as soon as practicable. FDASIA also amends the FD&C Act to include other provisions related to drug shortages. Drug shortages have a significant impact on patient access to critical medications and the number of drug shortages has risen steadily since 2005 to a high of 251 shortages in 2011. Notification to FDA of a shortage or an issue that may lead to a shortage is critical—FDA was able to prevent more than 100 shortages in the first three quarters of 2012 due to early notification. This rule will implement the FDASIA drug shortages provisions, allowing FDA to more quickly and efficiently respond to shortages, thereby improving patient access to critical medications and promoting public health.

Summary of Legal Basis: Sections 506C, 506C-1, 506D, 506E, and 506F of the FD&C Act, as amended by title X (Drug Shortages) of FDASIA.

Alternatives: The principal alternatives assessed were to provide guidance on voluntary notification to FDA or to continue to rely on the requirements under the current interim final rule on notification. These alternatives would not meet the statutory requirement to issue the final regulation required by title X, section 1001 of FDASIA.

Anticipated Cost and Benefits: The rule would increase the modest reporting costs associated with notifying FDA of discontinuances or interruptions in the production of certain drug products. The rule would generate benefits in the form of the value of public health gains through more rapid and effective FDA responses to potential or actual drug shortages that otherwise would limit patient access to critical medications.

Risks: Drug shortages can significantly impede patient access to critical, sometimes life-saving, medications. Drug shortages, therefore, can pose a serious risk to public health and patient safety. This rule will require early notification of potential shortages, enabling FDA to more quickly and effectively respond to potential or actual drug shortages that otherwise would limit patient access to critical medications.

Timetable:

Action Date FR Cite
NPRM 03/00/13  

Regulatory Flexibility Analysis Required: Undetermined.

Government Levels Affected: None.

Agency Contact: Valerie Jensen, Department of Health and Human Services, Food and Drug Administration, White Oak, Building 22, Room 6202, New Hampshire Avenue, Silver Spring, MD 20903, Phone: 301 796-0737.

RIN: 0910-AG88

HHS—FDA Back to Top

Final Rule Stage

39. Unique Device Identification Back to Top

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

Unfunded Mandates: This action may affect the private sector under Pub. L. 104-4.

Legal Authority: 21 U.S.C. 351; 21 U.S.C. 352; 21 U.S.C. 360; 21 U.S.C. 360h; 21 U.S.C. 360i; 21 U.S.C. 360j; 21 U.S.C. 360l; 21 U.S.C. 371

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

Legal Deadline: Final, Statutory, May 7, 2013, Must be finalized no later than 6 months after end of comment period (November 7, 2012).

Deadlines added by section 614 of FDASIA, Pub. L. 112-144.

Abstract: FDA is issuing a final rule establishing a unique device identification system for medical devices. A unique device identification system would allow health care professionals and others to rapidly and precisely identify a device and obtain important information concerning the device and would reduce medical errors.

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. UDI will allow FDA to more rapidly and effectively identify and aggregate adverse event reports and is central to improvement in FDA's medical device postmarket surveillance plan. 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.

Timetable:

Action Date FR Cite
NPRM 07/10/12 77 FR 40735
NPRM Comment Period End 11/07/12  
Final Action 05/00/13  

Regulatory Flexibility Analysis Required: Yes.

Small Entities Affected: Businesses.

Government Levels Affected: None.

URL for More Information: www.fda.gov/medicaldevices/deviceregulationandguidance/uniquedeviceidentification/default.htm.

URL for Public Comments: www.regulations.gov.

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

40. 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 04/00/13  

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 E.O. 13132.

Agency Contact: Daniel Reese, Food Technologist, 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

41. 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 Pub. L. 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 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 covered by the Federal law 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 04/00/13  

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 E.O. 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

42. Patient Protection and Affordable Care Act; Standards Related to Essential Health Benefits, Actuarial Value, and Accreditation (CMS-9980-F) Back to Top

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

Legal Authority: Pub. L. 111-148, title I

CFR Citation: 45 CFR part 156; 45 CFR part 155; 45 CFR part 147.

Legal Deadline: Final, Statutory, January 1, 2014.

Abstract: This final rule details standards for health insurance consistent with title I of the Affordable Care Act. Specifically, this rule outlines Exchange and issuer standards related to coverage of essential health benefits (EHB) and actuarial value (AV). This rule also proposes a timeline for qualified health plans to be accredited in Federally-facilitated Exchanges and an amendment that provides an application process for the recognition of additional accrediting entities for purposes of certification of qualified health plans.

Statement of Need: This rule sets forth standards related to EHB and AV consistent with the Affordable Care Act. HHS believes that the provisions that are included in this rule are necessary to fulfill the Secretary's obligations under sections 1302 and 1311 of the Affordable Care Act. Establishing specific approaches for defining EHB and calculating AV will bring needed clarity for States, issuers, and other stakeholders. Absent the provisions outlined in this rule, States, issuers, and consumers would face significant uncertainty about how coverage of EHB should be defined and evaluated. Similarly, failing to specify a method for calculating AV could result in significant inconsistency across States and issuers. Finally, establishing a clear timeline for potential qualified health plans to become accredited is essential to successful issuer participation in Federally-facilitated Exchanges.

Summary of Legal Basis: The provisions that are included in this rule are necessary to implement the requirements of title I of the Affordable Care Act.

Alternatives: None. This is a statutory requirement.

Anticipated Cost and Benefits: HHS anticipates that the provisions of this rule will assure consumers that they will have health insurance coverage for essential health benefits, and significantly increase consumers' ability to compare health plans, make an informed selection by promoting consistency across covered benefits and levels of coverage, and more efficiently purchase coverage. This rule ensures that consumers can shop on the basis of issues that are important to them such as price, network physicians, and quality, and be confident that the plan they choose does not include unexpected coverage gaps, like hidden benefit exclusions. It also allows for some flexibility for plans to promote innovation in benefit design. HHS anticipates that the provisions of this proposed regulation will likely result in increased costs related to increased utilization of health care services by people receiving coverage for previously uncovered benefits.

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
Notice 09/14/11 76 FR 56767
Comment Period End 10/31/11  
NPRM 11/26/12 77 FR 70644
NPRM Comment Period End 12/26/12  

Regulatory Flexibility Analysis Required: Undetermined.

Small Entities Affected: Businesses, Governmental Jurisdictions, Organizations.

Government Levels Affected: Federal, Local, State, Tribal.

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

Agency Contact: Leigha Basini, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 301 492-4307, Email: leigha.basini@cms.hhs.gov.

RIN: 0938-AR03

HHS—CMS Back to Top

43. PART II—Regulatory Provisions To Promote Program Efficiency, Transparency, and Burden Reduction (CMS-3267-P) Back to Top

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

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

CFR Citation: 42 CFR part 482; 42 CFR part 485; 42 CFR part 491; 42 CFR part 483; 42 CFR part 416; 42 CFR part 486; 42 CFR part 488; 42 CFR part 493.

Legal Deadline: None.

Abstract: This proposed rule identifies and proposes reforms in Medicare 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 resources away from providing high quality patient care. This is one of several rules that CMS is proposing to achieve regulatory reforms under Executive Order 13563 on Improving Regulation and Regulatory Review and the Department's Plan for Retrospective Review of Existing Rules.

Statement of Need: In Executive Order 13563, the President recognized the importance of a streamlined, effective, efficient regulatory framework designed to promote economic growth, innovation, job creation, and competitiveness. To achieve a more robust and effective regulatory framework, the President has directed each executive agency to establish a plan for ongoing retrospective review of existing significant regulations to identify those rules that can be eliminated as obsolete, unnecessary, burdensome, or counterproductive or that can be modified to be more effective, efficient, flexible, and streamlined. This rule continues our direct response to the President's instructions in Executive Order 13563 by reducing outmoded or unnecessarily burdensome rules, and thereby increasing the ability of health care entities to devote resources to providing high quality patient care.

Summary of Legal Basis: The provisions that are included in this 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 rules that relate to particular categories of regulations or types of providers. Other reforms are being implemented without the need for regulations. This rule includes reforms that do not fit directly in other rules scheduled for publication.

Anticipated Cost and Benefits: This rule makes several changes that create measurable monetary savings for providers and suppliers, while others create less tangible savings of time and administrative burden. We anticipate that the provider industry and health professionals will welcome the changes and reductions in burden. We also expect that health professionals will experience increased efficiencies and resources to appropriately devote to improving patient care, increasing accessibility to care, and reducing associated health care costs.

Risks: If this regulation is not published, outdated and obsolete regulations would remain in place, thereby violating the Executive Order. Proposals to remove excessively burdensome requirements and increased efficiencies in patient care would not be achieved.

Timetable:

Action Date FR Cite
NPRM 12/00/12  

Regulatory Flexibility Analysis Required: Undetermined.

Small Entities Affected: Businesses.

Government Levels Affected: None.

Additional Information: Includes Retrospective Review under E.O. 13563 with small business burden reduction.

Agency Contact: Lauren Oviatt, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Office of Clinical Standards and Quality, Mailstop S3-23-27, 7500 Security Boulevard, Baltimore, MD 21244-1850, Phone: 410 786-4683, Email: lauren.oviatt@cms.hhs.gov.

RIN: 0938-AR49

HHS—CMS Back to Top

44. • Notice of Benefit and Payment Parameters (CMS-9964-P) Back to Top

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

Legal Authority: Pub. L. 111-148, secs 1341 to 1343

CFR Citation: 45 CFR part 153; 45 CFR part 155.

Legal Deadline: Final, Statutory, January 1, 2014.

Abstract: Under the Affordable Care Act, this proposed rule would establish parameters of the risk adjustment, reinsurance, risk corridors, advanced premium tax credit, and cost-sharing reduction programs.

Statement of Need: This rule would provide additional guidance for several programs including risk adjustment, reinsurance, and risk corridors. 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. The rule would also provide new information on the cost-sharing reductions (CSRs) and advanced premium tax credits (APTCs) programs. These programs provide financial support for purchasing insurance and increase access to care for individuals through the Affordable Insurance Exchanges. They also provide assistance on user fees and administrative fees used to implement the Federally-facilitated Exchange and the risk adjustment and reinsurance programs.

Summary of Legal Basis: The provisions that are included in this rule are necessary to implement the requirements of sections 1341, 1342, 1343, 1401, 1402, 1411, and 1412 of the Affordable Care Act.

Alternatives: None. This is a statutory requirement.

Anticipated Cost and Benefits: Payments through reinsurance, risk adjustment, and risk corridors would 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 would reduce the risk to the issuer and the issuer could pass on a reduced risk premium to enrollees. Administrative costs would 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 would have reduced administrative costs.

Federal financial assistance for enrollees through the CSR and APTC programs would enable many low- and moderate-income individuals to purchase health insurance. The user fees and administrative fees would be charged on a per capita basis to issuers of certain plans. Those fees would be used to administer the Federally-facilitated Exchange and the HHS-operated risk adjustment and reinsurance programs.

Risks: If this regulation is not published, the Exchanges may be at risk for not becoming fully operational by January 1, 2014, thereby delaying the benefits of health insurance coverage to millions of Americans.

Timetable:

Action Date FR Cite
NPRM 12/07/12 77 FR 73118
NPRM Comment Period End 12/31/12  

Regulatory Flexibility Analysis Required: No.

Government Levels Affected: Federal, State.

Agency Contact: Sharon Arnold, Acting Director, Payment Policy and Financial Management Group, Department of Health and Human Services, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 301 492-4415, Email: sharon.arnold@cms.hhs.gov.

RIN: 0938-AR51

HHS—CMS Back to Top

45. • Changes to the Hospital Inpatient and Long-Term Care Prospective Payment System for FY 2014 (CMS-1599-P) 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: Not Yet Determined.

Legal Deadline: NPRM, Statutory, April 1, 2013. Final, Statutory, August 1, 2013.

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 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 2014 IPPS and LTCHs at least 60 days before October 1, 2013.

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, 2013.

Alternatives: None. This implements a statutory requirement.

Anticipated Cost and Benefits: Total expenditures will be adjusted for FY 2014.

Risks: If this regulation is not published timely, inpatient hospital and LTCH services will not be paid appropriately beginning October 1, 2013.

Timetable:

Action Date FR Cite
NPRM 04/00/13  

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.

Agency Contact: Brian Slater, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mail Stop C4-07-07, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-5229, Email: brian.slater@cms.hhs.gov.

RIN: 0938-AR53

HHS—CMS Back to Top

46. • Changes to the Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System for CY 2014 (CMS-1601-P) 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: Not Yet Determined.

Legal Deadline: Final, Statutory, November 1, 2013.

Abstract: This proposed 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 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. CMS will issue a final rule containing the payment rates for the 2014 OPPS and ASC payment system at least 60 days before January 1, 2014.

Summary of Legal Basis: Section 1833 of the Social Security Act establishes Medicare payment for hospital outpatient services and ASC services. The rule revises the Medicare hospital OPPS and ASC payment system to implement applicable statutory requirements. In addition, the rule describes 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, 2014.

Alternatives: None. This is a statutory requirement.

Anticipated Cost and Benefits: Total expenditures will be adjusted for CY 2014.

Risks: If this regulation is not published timely, outpatient hospital and ASC services will not be paid appropriately beginning January 1, 2014.

Timetable:

Action Date FR Cite
NPRM 06/00/13  

Regulatory Flexibility Analysis Required: Yes.

Small Entities Affected: Businesses.

Government Levels Affected: Federal.

Federalism: Undetermined.

Agency Contact: Marjorie Baldo, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Medicare Management, 7500 Security Boulevard, C4-03-06, Baltimore, MD 21244, Phone: 410 786- 4617, Email: marjorie.baldo@cms.hhs.gov.

RIN: 0938-AR54

HHS—CMS Back to Top

47. • Revisions to Payment Policies Under the Physician Fee Schedule and Medicare Part B for CY 2014 (CMS-1600-P) 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, 2013.

Abstract: This proposed rule would revise payment polices under the Medicare physician fee schedule, and make other policy changes to payment under Medicare Part B. These changes would be applicable to services furnished on or after January 1 annually.

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 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, 2013, and an implementation date of January 1, 2014.

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 2014.

Risks: If this regulation is not published timely, physician services will not be paid appropriately, beginning January 1, 2014.

Timetable:

Action Date FR Cite
NPRM 06/00/13  

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 Boulevard, Baltimore, MD 21244, Phone: 410 786-4636, Email: christina.ritter@cms.hhs.gov.

RIN: 0938-AR56

HHS—CMS Back to Top

48. • Prospective Payment System for Federally Qualified Health Centers (FQHCS) (CMS-1443-P) (Section 610 Review) Back to Top

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

Unfunded Mandates: Undetermined.

Legal Authority: Pub. L. 111-148, sec 10501

CFR Citation: Not Yet Determined.

Legal Deadline: Final, Statutory, October 1, 2014.

Abstract: The Affordable Care Act amends the current Medicare FQHC payment policy by requiring the establishment of a new payment system, effective with cost reporting periods beginning on or after October 1, 2014. This rule proposes the establishment of the new prospective payment system.

Statement of Need: FQHCs include providers such as community health centers, public housing centers, outpatient health programs funded by the Indian Health Service, and programs serving migrants and the homeless. The main purpose of the FQHC program is to enhance the provision of primary care services in underserved urban and rural communities. CMS is required by statute to develop a prospective payment system for FQHCs effective October 1, 2014.

Summary of Legal Basis: Sections 5502 and 10501 of the Affordable Care Act.

Alternatives: None. This implements a statutory requirement.

Anticipated Cost and Benefits: Total expenditures will be adjusted for fiscal year 2015.

Risks: If this regulation is not published timely, FQHC services will not be paid appropriately beginning October 1, 2014.

Timetable:

Action Date FR Cite
NPRM 06/00/13  

Regulatory Flexibility Analysis Required: Yes.

Small Entities Affected: Governmental Jurisdictions, Organizations.

Government Levels Affected: Federal, Local, State.

Federalism: Undetermined.

Agency Contact: Sarah Harding, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Mail Stop C4-01-26, Windsor Mill, MD 21244, Phone: 410 786-4001, Email: sarah.harding@cms.hhs.gov.

RIN: 0938-AR62

HHS—ADMINISTRATION FOR CHILDREN AND FAMILIES (ACF) Back to Top

Proposed Rule Stage

49. Child Care and Development Fund Reforms To Support Child Development and Working Families Back to Top

Priority: Other Significant.

Legal Authority: sec 658E and other provisions of the Child Care and Development Block Grant Act of 1990, as amended

CFR Citation: 45 CFR part 98.

Legal Deadline: None.

Abstract: This proposed rule would provide the first comprehensive update of Child Care and Development Fund (CCDF) regulations since 1998. It would make changes in four key areas: (1) Improving health and safety; (2) improving the quality of child care; (3) establishing family-friendly policies; and (4) strengthening program integrity. The rule seeks to retain much of the flexibility afforded to States, Territories, and Tribes consistent with the nature of a block grant. The changes would update the regulation to reflect: Current research and knowledge about the early care and education sector; state innovations in policies and practices over the past decade; and increased recognition that high quality child care both supports work for low-income parents and promotes children's learning and healthy development.

Statement of Need: The CCDF program has far-reaching implications for America's poorest children. It provides child care assistance to 1.7 million children from nearly 1 million low-income working families and families who are attending school or job training. Half of the children served are living at or below poverty level. In addition, children who receive CCDF are cared for alongside children who do not receive CCDF, by approximately 570,000 participating child care providers, some of whom lack basic assurances needed to ensure children are safe, healthy, and learning.

Since 1996, a body of research has demonstrated the importance of the early years on brain development and has shown that high quality, consistent child care can positively impact later success in school and life. This is especially true for low-income children who face a school readiness and achievement gap and can benefit the most from high quality early learning environments. In light of this research, many States, Territories, and tribes, working collaboratively with the Federal Government, have taken important steps over the last 15 years to make the CCDF program more child-focused and family-friendly; however, implementation of these evidence-informed practices is uneven across the country and critical gaps remain.

This regulatory action is needed in order to increase accountability in the CCDF program by ensuring that all children receiving federally-funded child care assistance are in safe, quality programs that both support their parent's labor market participation, and help children develop the tools and skills they need to reach their full potential.

A major focus of this proposed rule is to raise the bar on quality by establishing a floor of health and safety standards for child care paid for with Federal funds. National surveys have demonstrated that most parents logically assume that their child care providers have had a background check, have had training in child health and safety, and are regularly monitored. However, State policies surrounding the training and oversight of child care providers vary widely. In some States, many children receiving CCDF subsidies are cared for by providers that have little to no oversight with respect to compliance with basic standards designed to safeguard children's well-being, such as first-aid and safe sleep practices. This can leave children in unsafe conditions, even as their care is being funded with public dollars.

In addition, the proposed rule empowers all parents who choose child care, regardless of whether they receive a Federal subsidy, with better information to make the best choices for their children. This includes providing parents with information about the quality of child care providers and making information about providers' compliance with health and safety regulations more transparent so that parents can be aware of the safety track record of providers when it's time to choose child care.

Summary of Legal Basis: This proposed regulation is being issued under the authority granted to the Secretary of Health and Human Services by the CCDBG Act (42 U.S.C. 9858, et seq.) and Section 418 of the Social Security Act (42 U.S.C. 618).

Alternatives: The Administration for Children and Families considered a range of approaches to improve early childhood care and education, including administrative and regulatory action. ACF has taken administrative actions to recommend that States adopt stronger health and safety requirements and provided technical assistance to States. Despite these efforts to assist States in making voluntary reforms, unacceptable health and safety lapses remain. An alternative to this rule would be to take no regulatory action or to limit the nature of the required standards and the degree to which those standards are prescriptive. ACF believes this rulemaking is the preferable alternative to ensure children's health and safety and promote their learning and development.

Anticipated Cost and Benefits: Changes in this proposed rule directly benefit children and parents who use CCDF assistance to pay for child care. The 1.7 million children who are in child care funded by CCDF would have stronger protections for their health and safety, which addresses every parent's paramount concern. All children in the care of a participating CCDF provider will be safer because that provider is more knowledgeable about health and safety issues. In addition, the families of the 12 million children who are served in child care will benefit from having clear, accessible information about the safety compliance records and quality indicators of providers available to them as they make critical choices about where their children will be cared for while they work. Provisions also will benefit child care providers by encouraging States to invest in high quality child care providers and professional development and to take into account quality when they determine child care payment rates.

A primary reason for revising the CCDF regulations is to better reflect current State and local practices to improve the quality of child care. Therefore, there are a significant number of States, Territories, and Tribes that have already implemented many of these policies. The cost of implementing the changes in this proposed rule will vary depending on a State's specific situation. ACF does not believe the costs of this proposed regulatory action would be economically significant and that the tremendous benefits to low-income children justify costs associated with this proposed rule.

Timetable:

Action Date FR Cite
NPRM 12/00/12  
NPRM Comment Period End 02/00/13  

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: No.

Government Levels Affected: State, Tribal.

Agency Contact: Andrew Williams, Policy Division Director, Department of Health and Human Services, Administration for Children and Families, Office of Child Care, 370 L'Enfant Promenade SW., Washington, DC 20447, Phone: 202 401-4795, Fax: 202 690-5600, Email: andrew.williams@acf.hhs.gov.

RIN: 0970-AC53

BILLING CODE 4150-24-P

DEPARTMENT OF HOMELAND SECURITY (DHS) Back to Top

Fall 2012 Statement of Regulatory Priorities Back to Top

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/our-mission.

The regulations we have summarized below in the Department's fall 2012 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.

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 Back to Top

Pursuant to Executive Order 13563 “Improving Regulation and Regulatory Review” (Jan. 18, 2011), DHS identified the following regulatory actions as associated with retrospective review and analysis. 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
1615-AB71 Electronic Communications; Registration Requirement for Petitioners Seeking to File H-1B Petitions.
1615-AB99 Provisional Unlawful Presence Waivers of Inadmissibility for Certain Immediate Relatives.
1615-AB92 Employment Authorization for Certain H-4 Spouses.
1615-AB95 Immigration Benefits Business Transformation: Nonimmigrants; Student and Exchange Visitor Program.
1625-AA16 Implementation of the Amendments to the International Convention on Standards of Training, Certification, and Watchkeeping for Seafarers (STCW) and Changes to Domestic Endorsements.
1625-AB38 Update to Maritime Security Regulations.
1625-AB80 Elimination of Transportation Worker Identification Credential (TWIC) for Certain Mariner Populations. (Implementation of Section 809 of the 2010 Coast Guard Authorization Act).
1651-AA96 Definition of Form I-94 to Include Electronic Format.
1651-AA93 Closing of the Port of Whitetail, Montana.
1651-AA94 Internet Publication of Administrative Seizure/Forfeiture Notices.
1652-AA43 Modification of the Aviation Security Infrastructure Fee (ASIF).
1652-AA61 Revisions to the Alien Flight Student Program (AFSP) Regulations.
1653-AA44 Amendment to Accommodate Process Changes with the Student and Exchange Visitor Information System (SEVIS) II.
1660-AA75 Increased Federal Cost Share and Reimbursement for Force Account Labor for Public for Public Assistance Debris Removal.
1660-XXXX State Standard and Enhanced Mitigation Plan.

Promoting International Regulatory Cooperation Back to Top

Pursuant to Sections 3 and 4(b) of Executive Order 13609 “Promoting International Regulatory Cooperation” (May 1, 2012), DHS has identified the following regulatory actions that have significant international impacts. Some of the regulatory actions on the below list may be completed actions. 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
1625-AB38 Updates to Maritime Security.
1651-AA70 Importer Security Filing and Additional Carrier Requirements.
1651-AA72 Changes to the Visa Waiver Program To Implement the Electronic System for Travel Authorization (ESTA) Program.
1651-AA98 Amendments to Importer Security Filing and Additional Carrier Requirements.
1651-AA96 Definition of Form I-94 to Include Electronic Format.

DHS participates in some international regulatory cooperation activities that are reasonably anticipated to lead to significant regulations. For example, the Coast Guard is the primary U.S. representative to the International Maritime Organization (IMO) and plays a major leadership role in establishing international standards in the global maritime community. IMO's work to establish international standards for maritime safety, security, and environmental protection closely aligns with Coast Guard regulations. As an IMO member nation, the U.S. is obliged to incorporate IMO treaty provisions not already part of U.S. domestic policy into regulations for those vessels affected by the international standards. Consequently, the Coast Guard initiates rulemakings to harmonize with IMO international standards such as treaty provisions and the codes, conventions, resolutions, and circulars that supplement them.

Also, President Obama and Prime Minister Harper created the Canada-US Regulatory Cooperation Council (RCC) in February 2011. The RCC is an initiative between both federal governments aimed at pursuing greater alignment in regulation, increasing mutual recognition of regulatory practices and establishing smarter, more effective and less burdensome regulations in specific sectors. The Canada-US RCC initiative arose out of the recognition that high level, focused, and sustained effort would be required to reach a more substantive level of regulatory cooperation. Since its creation in early 2011, USCG has participated in stakeholder consultations with their Transport Canada counterparts and the public, drafted items for inclusion in the RCC Action Plan, and detailed work plans for each included Action Plan item.

The fall 2012 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 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 2012 regulatory plan for DHS regulatory components, as well as for DHS offices and directorates.

United States Citizenship and Immigration Services Back to Top

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.

Regulations To Facilitate Retention of High-Skilled Workers

Employment Authorization for Certain H-4 Dependent Spouses. USCIS will propose to amend its regulations to extend eligibility for employment authorization to H-4 dependent spouses of principal H-1B nonimmigrants who have begun the process of seeking lawful permanent resident status through employment and have extended their authorized period of admission or “stay” in the United States under section 104(c) or 106(a) of Public Law 106-313, also known as the American Competitiveness in the Twenty-First Century Act of 2000 (AC21). Allowing the eligible class of H-4 dependent spouses to work encourages professionals with high-demand skills to remain in the country and help spur innovation and growth of U.S. businesses.

Enhancing Opportunities for High-Skilled Workers. USCIS will propose to amend its regulations affecting high-skilled workers within the nonimmigrant classifications for specialty occupation professionals from Chile and Singapore (H-1B1) and from Australia (E-3), to include these classifications in the list of classes of aliens authorized for employment incident to status with a specific employer, to extend automatic employment authorization extensions with pending extension of stay requests, and to update filing procedures. USCIS will also propose amendments related to the immigration classification for employment-based first preference (EB-1) outstanding professors or researchers to allow the submission of comparable evidence. These changes will encourage and facilitate the employment and retention of these high-skilled workers.

Improvements to the Immigration System

Provisional Unlawful Presence Waivers of Inadmissibility for Certain Immediate Relatives. USCIS will amend its regulations to allow certain immediate relatives of U.S. citizens, who are physically present in the United States and must seek immigrant visas through consular processing abroad, to apply for provisional unlawful presence waivers under section 212(a)(9)(B)(v) of the Immigration and Nationality Act of 1952; 8 U.S.C. 1182(a)(9)(B)(v) while in the United States. This regulatory change would significantly reduce the length of time U.S. citizens are separated from their immediate relatives who must use the consular process abroad. It also creates greater efficiencies for both the U.S. Government and applicants.

Regulations Related to Transformation. 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 regulations to facilitate that effort, including regulations that would accomplish the following changes: Remove references to form numbers, form titles, expired regulatory provisions, and descriptions of internal procedure; mandate electronic filing in certain circumstances; and comprehensively reorganize 8 CFR part 214.

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. In 2009, USCIS issued three regulations (two interim final rules and one notice of proposed rulemaking) 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 (CNRA). During fiscal year 2011, USCIS issued two final rules finalizing the interim final rules from 2009 related to the extension of the U.S. immigration law to the CNMI. In fiscal year 2013, USCIS plans to issue with the Department of Justice (DOJ) a joint final rule titled “Application of Immigration Regulations to the CNMI.” This regulation would implement the applicable CNRA provisions to extend U.S. immigration law to the CNMI.

Regulatory Changes Involving Humanitarian Benefits

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 revise the portions of the existing 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 proposal would provide greater clarity and consistency in this important area of the law.

Exception to the Persecution 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 nonimmigrants to lawful permanent resident status. USCIS hopes to provide greater consistency in eligibility, application and procedural requirements for these vulnerable groups, their advocates, and the community through these regulatory initiatives. 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). 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. 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 would be 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 Back to Top

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 2012 Regulatory Plan below, contribute to the fulfillment of those responsibilities and reflect our regulatory policies.

Transportation Worker Identification Credential (TWIC); Card Reader Requirements. The Coast Guard is proposing to establish electronic card reader requirements for maritime facilities and vessels to be used in combination with the Transportation Security Administration's (TSA) TWIC. Congress enacted several statutory requirements within the Security and Accountability For Every (SAFE) Port Act of 2006 pertaining to TWIC readers, including a requirement to evaluate TSA's final pilot program report as part of the TWIC reader rulemaking. During the rulemaking process, the Coast Guard is taking into account the final pilot data and the various conditions in which TWIC readers may be employed. For example, the Coast Guard is considering the types of vessels and facilities that will use TWIC readers, locations of secure and restricted areas, operational constraints, and need for accessibility. This rulemaking will also address recordkeeping requirements, amendments to security plans, and the requirement for data exchanges (i.e., Canceled Card List) between TSA and vessel or facility owners/operators.

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; and (3) attempt to clarify regulations that have generated confusion. This proposal published as a Supplemental Notice of Proposed Rulemaking (SNPRM) on August 1, 2011. The Coast Guard has reviewed and analyzed comments received on that SNPRM, and intends to publish a final 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 our 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.

Offshore Supply Vessels of 6000 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, an interim rule to implement section 617 of the Act. As required by the Act, this interim rule is intended to provide for the safe carriage of oil, hazardous substances, and individuals in addition to crew on OSVs of at least 6000 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 Back to Top

U.S. Customs and Border Protection (CBP) is the federal agency principally responsible for the security of our Nation's borders, both at and between the ports of entry and at official crossings into the United States. CBP must accomplish its border security and enforcement mission without stifling 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 importation into the United States of goods, and enforcing the laws concerning the entry of persons into 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, 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; servicing all people, vehicles and cargo entering the United States; maintaining 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. These rules foster the DHS' Strategic Goals of awareness and prevention. 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 System in advance of such travel. VWP travelers may obtain the required ESTA authorization by electronically submitting to CBP biographic and other information that was previously submitted to CBP via the I-94W Nonimmigrant Alien Arrival/Departure Form (I-94W). ESTA became mandatory on January 12, 2009. Therefore, VWP travelers must either obtain travel authorization in advance of travel under ESTA or obtain a visa prior to traveling to the United States.

The shift from a paper to an electronic form and requiring the data in advance of travel enables CBP 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 increases national security and provides 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 also 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. CBP intends to issue a final rule on ESTA and the ESTA fee during the next fiscal year.

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 Pub. L. No. 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. Id. 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. Id.

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 identity 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 Guan-CNMI Visa Waiver program. This rule implements portions of the 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 Guan 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.

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 2013, expects to continue to issue regulatory documents that will facilitate legitimate trade and implement 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 Back to Top

The Federal Emergency Management Agency does not have any significant regulatory actions planned for fiscal year 2013.

Federal Law Enforcement Training Center Back to Top

The Federal Law Enforcement Training Center (FLETC) does not have any significant regulatory actions planned for fiscal year 2013.

United States Immigration and Customs Enforcement Back to Top

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 2013, ICE will pursue rulemaking actions to make improvements in three critical subject areas: Setting national standards to prevent, detect, and respond to sexual abuse and assault in DHS confinement facilities; improving the detention of aliens who are subject to final orders of removal; and updating and enhancing policies and procedures governing the Student and Exchange Visitor Program (SEVP).

Setting National Standards to Prevent, Detect, and Respond to Sexual Abuse and Assault in DHS Confinement Facilities. In cooperation with Department and CBP, ICE will set national detention standards to prevent, detect, and respond to sexual abuse and assault in DHS confinement facilities. For purposes of this rulemaking, DHS confinement facilities are broken down into two distinct types: 1) immigration detention facilities and 2) holding facilities. The proposed standards will reflect existing ICE and other DHS detention policies and are in response to the President's Memorandum “Implementing the Prison Rape Elimination Act,” issued on May 17, 2012, the same day the Department of Justice issued its final rule in response to the Prison Rape Elimination Act of 2003 (PREA), 42 U.S.C. 15601 et seq. President Obama's Memorandum affirmed the goals of PREA and directed Federal agencies with confinement facilities to propose rules or procedures necessary to satisfy the requirements of PREA within 120 days of the Memorandum. The DHS notice of proposed rulemaking (NPRM) will be issued during fiscal year 2012, with a final rule to follow addressing comments received through the notice-and-comment process.

Improving 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 2013, ICE will also issue a companion NPRM that will allow the public an opportunity to comment on new sections of the custody determination process not previously published for comment.

Updating and enhancing limitations on designated school official assignment and study by F-2 and M-2 nonimmigrants. ICE will revise the current regulation that limits the number of designated school officials (DSOs) that may be nominated for the oversight of each school's campus(es) where international students are enrolled, as well as modify the restrictions placed on the dependents of an F-1 or M-1 nonimmigrant student, in order to permit F-2 and M-2 nonimmigrants to enroll in less than a full course of study at an SEVP-certified school. Currently, schools are limited to ten DSOs per school or per campus in a multi-campus school. ICE has found that the current DSO limit of ten per campus is too constraining, especially in schools that have large numbers of F and M nonimmigrant students. ICE believes that, in many circumstances, elimination of a DSO limit may improve the capability of DSOs to meet their liaison, reporting and oversight responsibilities. In addition, ICE recognizes that there is increasing global competition to attract the best and brightest international students to study in our schools. Allowing a more flexible approach by permitting F-2 and M-2 nonimmigrant spouses and children to engage in study in the United States at SEVP-certified schools, so long as that study does not amount to a full course of study, will provide greater incentive for international students to travel to the United States for their education.

National Protection and Programs Directorate Back to Top

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. 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.” This authority is contained in a new Secure Handling of Ammonium Nitrate subtitle of the Homeland Security Act (Subtitle J, 6 U.S.C. 488-488i).

The Secure Handling of Ammonium Nitrate provisions of the Homeland Security Act direct 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 with DHS.

The Ammonium Nitrate Security Program Notice of Proposed Rulemaking proposes requirements that would implement the Secure Handling of Ammonium Nitrate provisions of the Homeland Security 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) for the Ammonium Nitrate Security Program on August 3, 2011. NPPD accepted public comments until December 1, 2011, and is now reviewing the public comments and developing a Final Rule related to the Ammonium Nitrate Security Program.

Transportation Security Administration Back to Top

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 2013, 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.

Passenger Screening Using Advanced Imaging Technology (AIT). TSA will propose to amend its civil aviation regulations to clarify that screening and inspection of an individual, conducted to control access to the sterile area of an airport or to an aircraft, may include the use of advanced imaging technology (AIT). This NPRM will be issued to comply with the decision rendered by the U.S. Court of Appeals for the District Columbia Circuit in Electronic Privacy Information Center (EPIC) v. U.S. Department of Homeland Security on July 15, 2011. 653 F.3d 1 (D.C. Cir. 2011). The Court directed TSA to conduct notice and comment rulemaking on the use of AIT in the primary screening of passengers.

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.

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 a 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 Back to Top

The United States Secret Service does not have any significant regulatory actions planned for fiscal year 2013.

DHS Regulatory Plan for Fiscal Year 2013 Back to Top

A more detailed description of the priority regulations that comprise DHS's fall 2012 regulatory plan follows.

DHS—U.S. CITIZENSHIP AND IMMIGRATION SERVICES (USCIS) Back to Top

Proposed Rule Stage

50. 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 part 2; 8 CFR part 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. This rule will also 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 (BIA).

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. 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 risk 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 05/00/13

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, Office of Refugee, Asylum, and International Operations, Department of Homeland Security, U.S. Citizenship and Immigration Services, 20 Massachusetts Avenue NW., Suite 3200, Washington, DC 20259, Phone: 202 272-1614, Fax: 202 272-1994, Email: ted.h.kim@uscis.dhs.gov.

RIN: 1615-AA41

DHS—USCIS Back to Top

51. 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 part 1; 8 CFR part 208; 8 CFR part 244; 8 CFR part 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 03/00/13  

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: No.

Government Levels Affected: None.

Agency Contact: Molly Groom,Chief, Refugee and Asylum Law Division, 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.m.groom@uscis.dhs.gov.

RIN: 1615-AB89

DHS—USCIS Back to Top

52. Employment Authorization for Certain H-4 Dependent Spouses Back to Top

Priority: Other Significant.

Legal Authority: INA sec 214(a)(1) 8 U.S.C. 1184(a)(1); INA 274A(h)(3) 8 U.S.C. 1324a(h)(3); 8 CFR 274a.12(c); sec 104(c) of Pub. L. 106-313; sec 106(a) of Pub. L. 106-313; * * *

CFR Citation: 8 CFR 274a.12(c).

Legal Deadline: None.

Abstract: The Department of Homeland Security (DHS) proposes to amend its regulations by extending the availability of employment authorization to H-4 dependent spouses of principal H-1B nonimmigrants who have begun the process of seeking lawful permanent resident status through employment and have extended their authorized period of admission or “stay” in the U.S. under section 104(c) or 106(a) of Public Law 106-313, also known as the American Competitiveness in the Twenty-First Century Act of 2000 (AC21). Allowing the eligible class of H-4 dependent spouses to work encourages professionals with high demand skills to remain in the country and help spur the innovation and growth of U.S. companies.

Statement of Need: Congress intended that the AC21 provisions allowing for extension of H-1B status past the 6th year for workers who are the beneficiaries of certain pending or approved employment-based immigrant petitions or labor certification applications would minimize the disruption to U.S. businesses employing H-1B workers that would result if such workers were required to leave the United States. DHS recognizes that the limitation on the period of stay is not the only event that could cause an H-1B worker to leave his or her employment and cause disruption to the employer's business, inclusive of the loss of significant time and money invested in the immigration process. The rule, as proposed by this NPRM, is intended to mitigate some of the negative economic effects of limiting H-1B households to one income during lengthy waiting periods in the adjustment of status process. Also, this rule will encourage H-1B skilled workers to not abandon their adjustment application because their H-4 spouse is unable to work.

Summary of Legal Basis: Sections 103(a), and 274A(h)(3) of the Immigration and Nationality Act (INA) generally authorize the Secretary to provide for employment authorization for aliens in the United States. In addition, section 214(a)(1) of the INA authorizes the Secretary to prescribe regulations setting terms and conditions of admission of nonimmigrants.

Alternatives: An alternative considered by DHS was to permit employer authorization for all H-4 dependent spouses. In enacting AC21, Congress was especially concerned with avoiding the disruption to U.S. businesses caused by the required departure of H-1B workers (for whom the businesses intended to file employment-based immigrant visa petitions) upon the expiration of workers' maximum six-year period of authorized stay. Although the inability of an H-4 spouse to work may cause an H-1B worker to consider departing from the United States prior to his or her eligibility for an H-1B extension. This alternative was rejected in favor of the proposed process to limit employment authorization to the smaller sub-class of H-4 nonimmigrants who intend to remain in the United States permanently and who have been granted an extension of H status under the provisions of AC21.

Anticipated Cost and Benefits: The proposed changes would only impact spouses of H-1B workers who have been admitted or have extended their stay under the provisions of AC21. The costs of the rule would stem from filing fees and the opportunity costs of time associated with filing an Application for Employment Authorization for those eligible H-4 spouses who decide to seek employment while residing in the United States. Allowing certain H-4 spouses the opportunity to work would result in a negligible increase to the overall domestic labor force.

The benefits of this rule are retaining highly-skilled persons who intend to adjust to lawful permanent resident status. This is important when considering the contributions of these individuals to the U.S. economy, including advances in entrepreneurial and research and development endeavors, which are highly correlated with overall economic growth and job creation. In addition, the proposed amendments would bring U.S. immigration laws more in line with other countries that seek to attract skilled foreign workers.

Timetable:

Action Date FR Cite
NPRM 03/00/13  

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: No.

Government Levels Affected: None.

Additional Information: Includes Retrospective Review under E.O. 13563.

URL for More Information: www.regulations.gov.

URL for Public Comments: www.regulations.gov.

Agency Contact: Kevin J. Cummings,Chief, Business and Foreign Workers Division,Department of Homeland Security,U.S. Citizenship and Immigration Services,Office of Policy and Strategy,20 Massachusetts Avenue NW.,Washington, DC 20529-2140, Phone: 202 272-1470, Fax: 202 272-1480, Email: kevin.j.cummings@uscis.dhs.gov.

RIN: 1615-AB92

DHS—USCIS Back to Top

53. Enhancing Opportunities for High-Skilled H-1B1 and E-3 Nonimmigrants and EB-1 Immigrants 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; 8 U.S.C. 1154; 8 U.S.C. 1182; 8 U.S.C. 1184; 8 U.S.C. 1186a; 8 U.S.C. 1255; 8 U.S.C. 1641; * * *

CFR Citation: 8 CFR part 204; 8 CFR part 214; 8 CFR part 248; 8 CFR part 274a.

Legal Deadline: None.

Abstract: The Department of Homeland Security (DHS) proposes to amend its regulations affecting high-skilled workers within the nonimmigrant classifications for specialty occupation professionals from Chile and Singapore (H-1B1) and from Australia (E-3), and the immigration classification for employment-based first preference (EB-1) outstanding professors or researchers. DHS proposes changes that would harmonize the regulations for E-3 and H-1B1 nonimmigrant classifications with existing regulations for other, similarly situated nonimmigrant classifications. DHS is proposing these changes to the regulations to encourage and facilitate the employment and retention of these high-skilled workers.

Statement of Need: DHS proposes to amend its regulations to improve the programs serving the E-3 and H-1B1 nonimmigrant classifications and the EB-1 immigrant classification for outstanding professors and researchers. The regulatory changes to these categories would significantly improve procedures to more effectively encourage and facilitate the retention of these high-skilled workers in the United States.

Anticipated Cost and Benefits: The portion of the proposed rule addressing E-3 and H-1B1 visas would extend the period of employment authorized while requests for an extension of these employment-based nonimmigrant visa classifications are being reviewed. We do not anticipate that this rule would impose any additional costs. The benefits of this portion of the proposed rule include easing the regulatory burden on employers of E-3 and H-1B1 nonimmigrants and avoiding potential gaps in employment for these nonimmigrant workers.

The portion of the proposed rule addressing the evidentiary requirements for the EB-1 outstanding professor and researcher employment-based immigrant classification would allow for the submission of comparable evidence (achievements not listed in the criteria such as important patents or prestigious, peer-reviewed funding grants) for that listed in 8 CFR 204.5(i)(3)(i)(A)-(F) to establish that the EB-1 professor or researcher is recognized internationally as outstanding in his or her academic field. We do not anticipate that this part of the proposed rule would impose additional costs.

The non-quantified benefits would include the harmonization of the evidentiary requirements for EB-1 outstanding professors and researchers with other comparable employment-based immigrant classifications and easing petitioners' recruitment of these highly skilled individuals by expanding the range of evidence that may be adduced to support their petitions.

Timetable:

Action Date FR Cite
NPRM 03/00/13

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: Businesses, Organizations.

Government Levels Affected: None.

Agency Contact: Kevin J. Cummings,Chief, Business and Foreign Workers Division,Department of Homeland Security,U.S. Citizenship and Immigration Services,Office of Policy and Strategy,20 Massachusetts Avenue NW.,Washington, DC 20529-2140, Phone: 202 272-1470, Fax: 202 272-1480, Email: kevin.j.cummings@uscis.dhs.gov.

RIN: 1615-AC00

DHS—USCIS Back to Top

Final Rule Stage

54. 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 part 103; 8 CFR part 212; 8 CFR part 214; 8 CFR part 274a; 8 CFR part 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 (DHS) 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.

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. DHS is considering and using suggestions from these stakeholders in developing this regulation.

Anticipated Cost and Benefits: 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 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 09/00/13  

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, Regulatory Coordination 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@uscis.dhs.gov.

Related RIN: Related to 1615-AA67.

RIN: 1615-AA59

DHS—USCIS Back to Top

55. 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 part 204; 8 CFR part 214; 8 CFR part 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 of Homeland Security (DHS) will issue another interim final rule to make the changes required by recent legislation.

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: DHS 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: DHS uses fees to fund the cost of processing applications and associated support benefits. In the 2008 interim final rule, DHS estimated the fee collection resulting from this rule at approximately $3 million in the first year, $1.9 million in the second year, and an average about $32 million in the third and subsequent years. To estimate the new fee collections to be generated by this rule, DHS 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, DHS 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. DHS is in the process of updating these cost estimates.

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 09/00/13  

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, Regulatory Coordination 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@uscis.dhs.gov.

RIN: 1615-AA60

DHS—USCIS Back to Top

56. 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 part 103; 8 CFR part 204; 8 CFR part 212; 8 CFR part 214; 8 CFR part 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 U nonimmigrant status provisions of the Immigration and Nationality Act. The Department of Homeland Security will issue another interim final rule to make the changes required by the legislation.

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: DHS 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: DHS estimated the total annual cost of this interim rule to petitioners to be $6.2 million in the IFR published in 2007. This cost included the biometric services fee, the opportunity cost of time needed to submit the required forms, the opportunity cost of time required for a visit to a USCIS Application Support Center, and the cost of traveling to an Application Support Center. DHS is currently in the process of updating our cost estimates since U nonimmigrant visa applicants are no longer required to pay the biometric service fee.

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
Interim Final Rule 09/00/13

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, Regulatory Coordination 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@uscis.dhs.gov.

RIN: 1615-AA67

DHS—USCIS Back to Top

57. Provisional Unlawful Presence Waivers of Inadmissibility for Certain Immediate Relatives Back to Top

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

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; 8 U.S.C. 1304; 8 U.S.C. 1182 and note; 8 U.S.C. 1184; 8 U.S.C. 1187; 8 U.S.C. 1223; 8 U.S.C. 1225; 8 U.S.C. 1226; 8 U.S.C. 1227; 8 U.S.C. 1255; 8 U.S.C. 1304; 8 U.S.C. 1356; 8 U.S.C. 1185 and note (section 7209 of Pub. L. 108-458); 31 U.S.C. 9701; Pub. L. 107-296, 116 Stat 2135 (6 U.S.C. 1 et seq.); EO 12356, 47 FR 14874, 47 FR 15557; 3 CFR 1982 Comp p 166; 8 CFR 2; sec 212.1(q) also issued under sec 702, Pub. L. 110-229, 122 Stat 754, 854

CFR Citation: 8 CFR part 103; 8 CFR part 212.

Legal Deadline: None.

Abstract: On April 2, 2012, the Department of Homeland Security (DHS) published a proposed rule at 77 FR 19902 to amend its regulations to allow certain immediate relatives of U.S. citizens who are physically present in the United States to request provisional unlawful presence waivers under section 212(a)(9)(B)(v) of the Immigration and Nationality Act of 1952 (INA); 8 U.S.C. 1182(a)(9)(B)(v) in anticipation of immigrant visa processing abroad. The final rule implements the provisional unlawful presence waiver process, and finalizes clarifying amendments to other provisions in part 212 of title 8 of the Code of Federal Regulations. Based on the final rule, individuals who are immediate relatives of U.S. citizens who are physically present in the United States and are seeking immigrant visas through consular processing abroad will be able to apply for provisional unlawful presence waivers while in the United States. These changes will significantly reduce the length of time U.S. citizens are separated from their immediate relatives who are consular processing abroad and reduce the degree of interchange between DOS and USCIS, creating greater efficiencies for both the U.S. Government and most applicants.

Statement of Need: Currently, certain spouses, children, and parents of U.S. citizens (immediate relatives) who are in the United States are not eligible to apply for lawful permanent resident (LPR) status while in the United States. These immediate relatives must travel abroad to obtain an immigrant visa from the Department of State (DOS) and, in many cases, also must request from DHS a waiver of the inadmissibility as a result of their unlawful presence in the United States. These immediate relatives cannot apply for the waiver until after their immigrant visa interviews and must remain outside of the United States, separated from their U.S. citizen spouses, parents, or children while their waiver applications are adjudicated by USCIS. In some cases, waiver application processing can take well over 1 year, prolonging the separation of these immediate relatives from their U.S. citizen spouses, parents, and children. In addition, the action required for these immediate relatives to obtain LPR status in the United States—departure from the United States to apply for an immigrant visa at a DOS consulate abroad—is the very action that triggers the unlawful presence inadmissibility grounds under section 212(a)(9)(B)(i) of the INA; 8 U.S.C. 1182(a)(9)(B)(i). As a result, many immediate relatives who may qualify for an immigrant visa are reluctant to proceed abroad to seek an immigrant visa.

In addition, the action required for these immediate relatives to obtain LPR status in the United States (i.e., departure from the United States to apply for an immigrant visa at a DOS consulate abroad) is the very action that triggers the unlawful presence inadmissibility grounds under section 212(a)(9)(B)(i) of the INA; 8 U.S.C. 1182(a)(9)(B)(i).

Summary of Legal Basis: The Secretary of Homeland Security (Secretary)'s authority to promulgate this final rule is found in the Homeland Security Act of 2002, Public Law 107-296, section 102, 116 Stat. 2135, 6 U.S.C. 112, and section 103 of the INA, 8 U.S.C. 1103, which give the Secretary the authority to administer and enforce the immigration and nationality laws. The Secretary's discretionary authority to waive the ground of inadmissibility for unlawful presence can be found in INA section 212(a)(9)(B)(v), 8 U.S.C. 1182(a)(9)(B)(v). The regulation governing certain inadmissibility waivers is 8 CFR 212.7. The fee schedule for provisional unlawful presence waiver applications is found at 8 CFR 103.7(b)(1)(i)(AA).

Anticipated Cost and Benefits: This final rule is expected to result in a reduction in the time that U.S. citizens are separated from their alien immediate relatives, thus reducing the financial and emotional hardship for these families. In addition, the Federal Government should achieve increased efficiencies in processing immigrant visas for individuals subject to the unlawful presence inadmissibility bars under section 212(a)(9)(B) of the INA; 8 U.S.C. 1182(a)(9)(B).

Estimates of the preliminary costs of the rule were developed assuming that current demand is constrained because of concerns that families may endure lengthy separations under the current system. Due to uncertainties as to the degree of the current constraint of demand, DHS used a range of constraint levels with corresponding increases in demand to estimate the costs. In the proposed rule, 77 FR 19913, DHS estimated that the discounted total ten-year cost of this rule would range from approximately $100.6 million to approximately $303.8 million at a seven percent discount rate. Compared with the current waiver process, this rule requires that provisional waiver applicants submit biometric information. Included in the total cost estimate is the cost of collecting biometrics, which we estimated in the proposed rule to range from approximately $28 million to approximately $42.5 million discounted at seven percent over ten years. In addition, as this rule significantly streamlines the current process, DHS expects that additional applicants will apply for the provisional waiver as compared to the current waiver process. To the extent that this rule induces new demand for immediate relative visas, additional immigration benefit forms, such as the Petition for Alien Relative, Form I-130, will be filed compared to the pre-rule baseline. These additional forms will involve fees being paid by applicants to the Federal Government for form processing and additional opportunity costs of time being incurred by applicants to provide the information required by the forms. The cost estimate in the proposed rule also includes the impact of this induced demand, which we estimate will range from approximately $72.6 million to approximately $261.3 million discounted at seven percent over ten years. DHS is currently drafting the final rule in response to comments, and preparing final cost estimates.

Timetable:

Action Date FR Cite
NPRM 04/02/12 77 FR 19902
NPRM Comment Period End 06/01/12
Final Action 12/00/12

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: No.

Government Levels Affected: None.

Additional Information: Includes Retrospective Review under EO 13563.

URL for More Information: www.regulations.gov.

URL for Public Comments: www.regulations.gov.

Agency Contact: Mark Phillips, Chief, Residence and Naturalization Division, Department of Homeland Security, U.S. Citizenship and Immigration Services, Office of Policy and Strategy, 20 Massachusetts Avenue NW., Suite 1100, Washington, DC 20529, Phone: 202 272-1470, Fax: 202 272-1480, Email: mark.phillips@uscis.dhs.gov.

Related RIN: Related to 1615-ZB10.

RIN: 1615-AB99

DHS—U.S. COAST GUARD (USCG) Back to Top

Proposed Rule Stage

58. Transportation Worker Identification Credential (TWIC); Card Reader Requirements Back to Top

Priority: Other Significant.

Legal Authority: 33 U.S.C. 1226; 33 U.S.C. 1231; 46 U.S.C. ch 701; 50 U.S.C. 191 and 192; EO 12656

CFR Citation: 33 CFR, subchapter H.

Legal Deadline: Final, Statutory, August 20, 2010, SAFE Port Act, codified at 46 U.S.C. 70105(k).

The final rule is required 2 years after the commencement of the pilot program.

Abstract: The Coast Guard is establishing electronic card reader requirements for maritime facilities and vessels to be used in combination with TSA's Transportation Worker Identification Credential. Congress enacted several statutory requirements within the Security and Accountability For Every (SAFE) Port Act of 2006 to guide regulations pertaining to TWIC readers, including the need to evaluate TSA's final pilot program report as part of the TWIC reader rulemaking. During the rulemaking process, we will take into account the final pilot data and the various conditions in which TWIC readers may be employed. For example, we will consider the types of vessels and facilities that will use TWIC readers, locations of secure and restricted areas, operational constraints, and need for accessibility. Recordkeeping requirements, amendments to security plans, and the requirement for data exchanges (i.e., Canceled Card List) between TSA and vessel or facility owners/operators will also be addressed in this rulemaking.

Statement of Need: The Maritime Transportation Security Act (MTSA) of 2002 explicitly required the issuance of a biometric transportation security card to all U.S. merchant mariners and to workers requiring unescorted access to secure areas of MTSA-regulated facilities and vessels. On May 22, 2006, the Transportation Security Administration (TSA) and the Coast Guard published a notice of proposed rulemaking (NPRM) to carry out this statute, proposing a Transportation Worker Identification Credential (TWIC) Program where TSA conducts security threat assessments and issues identification credentials, while the Coast Guard requires integration of the TWIC into the access control systems of vessels, facilities, and Outer Continental Shelf facilities. Based on comments received during the public comment period, TSA and the Coast Guard split the TWIC rule. The final TWIC rule, published in January of 2007, addressed the issuance of the TWIC and use of the TWIC as a visual identification credential at access control points. The ANPRM, published in March of 2009, proposed a risk-based approach to TWIC reader requirements and included proposals to classify MTSA-regulated vessels and facilities into one of three risk groups, based on specific factors related to TSI consequence, and apply TWIC reader requirements for vessels and facilities in conjunction with their relative risk-group placement.

This rulemaking is necessary to comply with the SAFE Port Act and to complete the implementation of the TWIC Program in our ports. By requiring electronic card readers at vessels and facilities, the Coast Guard will further enhance port security and improve access control measures.

Summary of Legal Basis: The statutory authorities for the Coast Guard to prescribe, change, revise, or amend these regulations are provided under 33 U.S.C. 1226, 1231; 46 U.S.C. chapter 701; 50 U.S.C. 191, 192; Executive Order 12656, 3 CFR 1988 Comp., p. 585; 33 CFR 1.05-1, 6.04-11, 6.14, 6.16, and 6.19; Department of Homeland Security Delegation No. 0170.1.

Alternatives: The implementation of TWIC reader requirements is mandated by the SAFE Port Act. The Coast Guard is currently considering several regulatory alternatives regarding how to implement the TWIC reader requirements. These alternatives will be further explored in the NPRM.

Anticipated Cost and Benefits: The main cost drivers of this proposal are the acquisition and installation of TWIC readers and the maintenance of the affected entity's TWIC reader system. Costs, which we would distribute over a phased-in implementation period, consist predominantly of the costs to purchase, install, and integrate approved TWIC readers to their current physical access control system. Recurring annual costs will be driven by costs associated with canceled card list updates, opportunity cost associated with delays and replacement of TWICs that cannot be read, and maintenance of the affected entity's TWIC reader system. At this time, we are still developing our estimates for the impacts of this proposed rule.

The benefits of the rulemaking include the enhancement of the security of vessel ports and other facilities by ensuring that only individuals who hold valid TWICs are granted unescorted access to secure areas at those locations. It will also implement the 2002 MTSA transportation security card requirements, thereby ensuring compliance with those statutes.

Risks: USCG used risk-based decision-making to develop this proposed rule.

Timetable:

Action Date FR Cite
ANPRM 03/27/09 74 FR 13360
Notice of Public Meeting 04/15/09 74 FR 17444
ANPRM Comment Period End 05/26/09
Notice of Public Meeting Comment Period End 05/26/09
NPRM 02/00/13

Regulatory Flexibility Analysis Required: Undetermined.

Government Levels Affected: None.

Additional Information: The docket number for this rulemaking is USCG-2007-28915. The docket can be found at www.regulations.gov.

URL for More Information: www.regulations.gov.

URL for Public Comments: www.regulations.gov.

Agency Contact: LCDR Loan O'Brien, Project Manager, Department of Homeland Security, U.S. Coast Guard, Commandant, (CG-FAC-2), 2100 Second Street SW., STOP 7581, Washington, DC 20593-7581, Phone: 202 372-1133, Email: loan.t.o'brien@uscg.mil.

Related RIN: Related to 1625-AB02.

RIN: 1625-AB21

DHS—USCG Back to Top

Final Rule Stage

59. 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. chs. 71 and 73; DHS Delegation No. 0170.1

CFR Citation: 46 CFR part 10; 46 CFR part 11; 46 CFR part 12; 46 CFR part 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 revising current rules to ensure that the United States complies with their requirements on: The training of merchant mariners, the documenting of their qualifications, and watch-standing and other arrangements aboard seagoing merchant ships of the United States. In addition, the Coast Guard has identified the need for additional changes to the interim rule issued in 1997. This project supports the Coast Guard's broad role and responsibility of maritime safety. It also supports the roles and responsibilities of the Coast Guard of reducing deaths and injuries of crew members on domestic merchant vessels and eliminating substandard vessels from the navigable waters of the United States.

The Coast Guard published an NPRM on November 17, 2009, and Supplemental NPRM (SNPRM) on March 23, 2010.

At a June 2010 diplomatic conference, the IMO adopted additional amendments to the STCW convention which change the minimum training requirements for seafarers. In response to feedback and to the adoption of those amendments, the Coast Guard developed a second Supplemental NPRM to incorporate the 2010 Amendments into the 1990 interim rule.

Statement of Need: The Coast Guard proposed to amend its regulations to implement changes to its 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 International Convention on Standards of Training, Certification, and Watchkeeping for Seafarers, 1978, as amended (STCW), in the requirements for the credentialing of United States merchant mariners. The new 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 NVICs; and (3) Attempt to clarify regulations that have generated confusion.

Summary of Legal Basis: The authority for the Coast Guard to prescribe, change, revise, or amend these regulations is provided under 46 U.S.C. 2103 and 46 U.S.C. chapters 71 and 73; and Department of Homeland Security Delegation No. 0170.1.

Alternatives: For each proposed change, the Coast Guard has considered various alternatives. We considered using policy statements, but they are not enforceable. We also considered taking no action, but this does not support the Coast Guard's fundamental safety and security mission. Additionally, we considered comments made during our 1997 rulemaking to formulate our alternatives. When we analyzed issues, such as license progression and tonnage equivalency, the alternatives chosen were those that most closely met the requirements of STCW.

Anticipated Cost and Benefits: In the SNPRM, we estimated the annualized cost of this rule over a 10-year period to be $32.8 million per year at a 7 percent discount rate. We estimate the total 10-year cost of this rulemaking to be $230.7 million at a 7 percent discount rate.

The changes in anticipated costs since the publication of 2009 NPRM are due to the 2010 amendments to the STCW Convention: Medical examinations and endorsements, leadership and management skills, engine room management training, tankerman endorsements, safety refresher training, and able seafarer deck and engine certification requirements. However, there would be potential savings from the costs of training requirements as the Coast Guard would accept various methods for demonstrating competence, including the on-the-job training and preservation of the “hawsepipe” programs.

We anticipate the primary benefit of this rulemaking is to ensure that the U.S. meets its obligations under the STCW Convention. Another benefit is an increase in vessel safety and a resulting decrease in the risk of shipping casualties.

Risks: No risks.

Timetable:

Action Date FR Cite
Notice of Meeting 08/02/95 60 FR 39306
Supplemental NPRM Comment Period End 09/29/95
Notice of Inquiry 11/13/95 60 FR 56970
Comment Period End 01/12/96
NPRM 03/26/96 61 FR 13284
Notice of Public Meetings 04/08/96 61 FR 15438
NPRM Comment Period End 07/24/96
Notice of Intent 02/04/97 62 FR 5197
Interim Final Rule 06/26/97 62 FR 34505
Interim Final Rule Effective 07/28/97
NPRM 11/17/09 74 FR 59353
NPRM Comment Period End 02/16/10
Supplemental NPRM 03/23/10 75 FR 13715
Supplemental NPRM 08/01/11 76 FR 45908
Public Meeting Notice 08/02/11 76 FR 46217
Supplemental NPRM Comment Period End 09/30/11
Final Rule 04/00/13

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.

Additional Information: The docket number for this rulemaking is USCG-2004-17914. The docket is located at www.regulations.gov. The old docket number is CGD 95-062. Includes Retrospective Review under E.O. 13563.

URL for More Information: www.regulations.gov.

URL for Public Comments: www.regulations.gov.

Agency Contact: Mark Gould, Project Manager, CG-5221, Department of Homeland Security, U.S. Coast Guard, 2100 Second Street SW., STOP 7126, Washington, DC 20593-7126, Phone: 202 372-1409.

RIN: 1625-AA16

DHS—USCG Back to Top

60. Vessel Requirements for Notices of Arrival and Departure, and Automatic Identification System Back to Top

Priority: Other Significant.

Legal Authority: 33 U.S.C. 1223; 33 U.S.C. 1225; 33 U.S.C. 1231; 46 U.S.C. 3716; 46 U.S.C. 8502 and ch 701; sec 102 of Pub. L. 107-295; EO 12234

CFR Citation: 33 CFR part 62; 33 CFR part 66; 33 CFR part 160; 33 CFR part 161; 33 CFR part 164; 33 CFR part 165.

Legal Deadline: None.

Abstract: This rulemaking would expand the applicability for Notice of Arrival and Departure (NOAD) and Automatic Identification System (AIS) requirements. These expanded requirements would better enable the Coast Guard to correlate vessel AIS data with NOAD data, enhance our ability to identify and track vessels, detect anomalies, improve navigation safety, and heighten our overall maritime domain awareness.

The NOAD portion of this rulemaking could expand the applicability of the NOAD regulations by changing the minimum size of vessels covered below the current 300 gross tons, require a notice of departure when a vessel is departing for a foreign port or place, and mandate electronic submission of NOAD notices to the National Vessel Movement Center. The AIS portion of this rulemaking would expand current AIS carriage requirements for the population identified in the Safety of Life at Sea (SOLAS) Convention and the Marine Transportation Marine Transportation Security Act (MTSA) of 2002.

Statement of Need: There is no central mechanism in place to capture vessel, crew, passenger, or specific cargo information on vessels less than or equal to 300 gross tons (GT) intending to arrive at or depart from U.S. ports unless they are arriving with certain dangerous cargo (CDC) or at a port in the 7th Coast Guard District; nor is there a requirement for vessels to submit notification of departure information. The lack of NOAD information of this large and diverse population of vessels represents a substantial gap in our maritime domain awareness (MDA). We can minimize this gap and enhance MDA by expanding NOAD applicability to vessels greater than 300 GT, all foreign commercial vessels and all U.S. commercial vessels coming from a foreign port, and further enhance (and corroborate) MDA by tracking those vessels (and others) with AIS. This information is necessary in order to expand our MDA and provide Nation maritime safety and security.

Summary of Legal Basis: This rulemaking is based on congressional authority provided in the Ports and Waterways Safety Act (see 33 U.S.C. 1223(a)(5), 1225, 1226, and 1231) and section 102 of the Maritime Transportation Security Act of 2002 (codified at 46 U.S.C. 70114).

Alternatives: Our goal is to extend our MDA and to identify anomalies by correlating vessel NOAD data with AIS data. NOAD and AIS information from a greater number of vessels, as proposed in this rulemaking, would expand our MDA. We considered expanding NOAD and AIS to even more vessels, but we determined that we needed additional legislative authority to expand AIS beyond what we propose in this rulemaking, and that it was best to combine additional NOAD expansion with future AIS expansion. Although not in conjunction with a proposed rule, the Coast Guard sought comment regarding expansion of AIS carriage to other waters and other vessels not subject to the current requirements (68 FR 39369, Jul. 1, 2003; USCG 2003-14878; see also 68 FR 39355). Those comments were reviewed and considered in drafting this rule and are available in this docket. To fulfill our statutory obligations, the Coast Guard needs to receive AIS reports and NOADs from vessels identified in this rulemaking that currently are not required to provide this information. Policy or other nonbinding statements by the Coast Guard addressed to the owners of these vessels would not produce the information required to sufficiently enhance our MDA to produce the information required to fulfill our Agency obligations.

Anticipated Cost and Benefits: This rulemaking will enhance the Coast Guard's regulatory program by making it more effective in achieving the regulatory objectives, which, in this case, is improved MDA. We provide flexibility in the type of AIS system that can be used, allowing for reduced cost burden. This rule is also streamlined to correspond with Customs and Border Protection's APIS requirements, thereby reducing unjustified burdens. We are further developing estimates of cost and benefit that were published in 2008. In the 2008 NPRM, we estimated that both segments of the proposed rule would affect approximately 42,607 vessels. The total number of domestic vessels affected is approximately 17,323 and the total number of foreign vessels affected is approximately 25,284. We estimated that the 10-year total present discounted value or cost of the proposed rule to U.S. vessel owners is between $132.2 and $163.7 million (7 and 3 percent discount rates, respectively, 2006 dollars) over the period of analysis.

The Coast Guard believes that this rule, through a combination of NOAD and AIS, would strengthen and enhance maritime security. The combination of NOAD and AIS would create a synergistic effect between the two requirements. Ancillary or secondary benefits exist in the form of avoided injuries, fatalities, and barrels of oil not spilled into the marine environment. In the 2008 NPRM, we estimated that the total discounted benefit (injuries and fatalities) derived from 68 marine casualty cases analyzed over an 8-year data period from 1996 to 2003 for the AIS portion of the proposed rule is between $24.7 and $30.6 million using $6.3 million for the value of statistical life (VSL) at 7 percent and 3 percent discount rates, respectively. Just based on barrels of oil not spilled, we expect the AIS portion of the proposed rule to prevent 22 barrels of oil from being spilled annually.

The Coast Guard may revise costs and benefits for the final rule to reflect changes resulting from public comments.

Risks: Considering the economic utility of U.S. ports, waterways, and coastal approaches, it is clear that a terrorist incident against our U.S. Maritime Transportation System (MTS) would have a direct impact on U.S. users and consumers and could potentially have a disastrous impact on global shipping, international trade, and the world economy. By improving the ability of the Coast Guard both to identify potential terrorists coming to the United States while the terrorists are far from our shores and to coordinate appropriate responses and intercepts before the vessel reaches a U.S. port, this rulemaking would contribute significantly to the expansion of MDA, and consequently is instrumental in addressing the threat posed by terrorist actions against the MTS.

Timetable:

Action Date FR Cite
NPRM 12/16/08 73 FR 76295
Notice of Public Meeting 01/21/09 74 FR 3534
Notice of Second Public Meeting 03/02/09 74 FR 9071
NPRM Comment Period End 04/15/09  
Notice of Second Public Meeting Comment Period End 04/15/09  
Final Rule 04/00/13  

Regulatory Flexibility Analysis Required: Undetermined.

Small Entities Affected: Businesses.

Government Levels Affected: None.

Additional Information: We have indicated in past notices and rulemaking documents, and it remains the case, that we have worked to coordinate implementation of AIS MTSA requirements with the development of our ability to take advantage of AIS data (68 FR 39355 and 39370, Jul. 1, 2003).

The docket number for this rulemaking is USCG-2005-21869. The docket can be found at www.regulations.gov.

URL for More Information: www.regulations.gov.

URL for Public Comments: www.regulations.gov.

Agency Contact: LCDR Michael D. Lendvay, Program Manager, Office of Commercial Vessel, Foreign and Offshore Vessel Activities Div. (CG-CVC-2), Department of Homeland Security, U.S. Coast Guard, 2100 Second Street SW., STOP 7581, Washington, DC 20593-7581, Phone: 202 372-1234, Email: michael.d.lendvay@uscg.mil.

Jorge Arroyo, Project Manager, Office of Navigation Systems (CG-5531), Department of Homeland Security, U.S. Coast Guard, 2100 Second Street SW., STOP 7683, Washington, DC 20593-7683, Phone: 202 372-1563, Email: jorge.arroyo@uscg.mil.

Related RIN: Related to 1625-AA93, Related to 1625-AB28.

RIN: 1625-AA99

DHS—USCG Back to Top

61. Offshore Supply Vessels of at Least 6000 GT ITC Back to Top

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

Legal Authority: Pub. L. 111-281, sec 617

CFR Citation: Not Yet Determined.

Legal Deadline: Other, Statutory, January 1, 2012, Coast Guard Authorization Act of 2010.

Abstract: The Coast Guard Authorization Act of 2010 removed the size limit on offshore supply vessels (OSVs). The Act also directed the Coast Guard to issue, as soon as is practicable, a regulation to implement section 617 of the Act and to ensure the safe carriage of oil, hazardous substances, and individuals in addition to the crew on vessels of at least 6,000 gross tonnage as measured under the International Convention on Tonnage Measurement of Ships (6,000 GT ITC). Accordingly, the Coast Guard's rule will address design, manning, carriage of personnel, and related topics for OSVs of at least 6,000 GT ITC. This rulemaking will meet the requirements of the Act and will support the Coast Guard's mission of marine safety, security, and stewardship.

Statement of Need: In section 617 of Public Law 111-281, Congress removed OSV tonnage limits and instructed the Coast Guard to promulgate regulations to implement the amendments and authorities of section 617. Additionally, Congress directed the Coast Guard to ensure the safe carriage of oil, hazardous substances, and individuals in addition to the crew on OSVs of at least 6,000 GT ITC.

Summary of Legal Basis: The statutory authority to promulgate these regulations is found in section 617(f) of Public Law 111-281.

Alternatives: The Coast Guard Authorization Act removed OSV tonnage limits and the Coast Guard will examine alternatives during the development of the regulatory analysis.

Anticipated Cost and Benefits: The Coast Guard is currently developing a regulatory impact analysis of regulations that ensure the safe carriage of oil, hazardous substances, and individuals in addition to the crew on OSVs of at least 6,000 GT ITC. A potential benefit of this rulemaking is the ability of industry to expand and take advantage of new commercial opportunities in the building of larger OSVs.

Risks: No risks.

Timetable:

Action Date FR Cite
Interim Final Rule 04/00/13  

Regulatory Flexibility Analysis Required: No.

Government Levels Affected: None.

URL for More Information: www.regulations.gov.

URL for Public Comments: www.regulations.gov.

Agency Contact: Thomas L. Neyhart, Program Manager (CG-ENG-1), Department of Homeland Security, U.S. Coast Guard, 2100 Second Street SW., STOP 7126, Washington, DC 20593-7126, Phone: 202 372-1360, Email: thomas.l.neyhart@uscg.mil.

RIN: 1625-AB62

DHS—U.S. CUSTOMS AND BORDER PROTECTION (USCBP) Back to Top

Final Rule Stage

62. Changes to the Visa Waiver Program To Implement the Electronic System for Travel Authorization (ESTA) Program Back to Top

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

Legal Authority: 8 U.S.C. 1103; 8 U.S.C. 1187

CFR Citation: 8 CFR 217.5.

Legal Deadline: None.

Abstract: CBP issued an interim final rule, which implemented the Electronic System for Travel Authorization (ESTA) for aliens who travel to the United States under the Visa Waiver Program (VWP) at air or sea ports of entry. Under the rule, VWP travelers must provide certain biographical information to CBP electronically before departing for the United States. This advance information allows CBP to determine before their departure whether these travelers are eligible to travel to the United States under the VWP and whether such travel poses a security risk. The interim final rule also fulfilled the requirements of section 711 of the Implementing recommendations of the 9/11 Commission Act of 2007 (9/11 Act). In addition to fulfilling a statutory mandate, the rule serves the twin goals of promoting border security and legitimate travel to the United States. By modernizing the VWP, the ESTA increases national security and to 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 at the ports of entry. CBP requested comments on all aspects of the interim final rule and plans to issue a final rule after completion of the comment analysis.

Statement of Need: Section 711 of the 9/11 Act requires the Secretary of Homeland Security, in consultation with the Secretary of State, to develop and implement a fully automated electronic travel authorization system to collect biographical and other information in advance of travel to determine the eligibility of the alien to travel to the United States, and to determine whether such travel poses a law enforcement or security risk. CBP issued the ESTA interim final rule to fulfill these statutory requirements.

Under the interim final rule, VWP travelers are now required to provide certain information to CBP electronically before departing for the United States. VWP travelers who receive travel authorization under ESTA are not required to complete the paper Form I-94W when arriving on a carrier that is capable of receiving and validating messages pertaining to the traveler's ESTA status as part of the traveler's boarding status. By automating the I-94W process and establishing a system to provide VWP traveler data in advance of travel, CBP is able to determine the eligibility of citizens and eligible nationals from VWP countries to travel to the United States and to determine whether such travel poses a law enforcement or security risk, before such individuals begin travel to the United States. ESTA provides for greater efficiencies in the screening of international travelers by allowing CBP to identify subjects of potential interest before they depart for the United States, thereby increasing security and reducing traveler delays upon arrival at U.S. ports of entry.

Summary of Legal Basis: The ESTA program is based on congressional authority provided under section 711 of the Implementing Recommendations of the 9/11 Commission Act of 2007 and section 217 of the Immigration and Nationality Act (INA).

Alternatives: When developing the interim final rule, CBP considered three alternatives to this rule:

1. The ESTA requirements in the rule, but with a $1.50 fee per each travel authorization (more costly).

2. The ESTA requirements in the rule, but with only the name of the passenger and the admissibility questions on the I-94W form (less burdensome).

3. The ESTA requirements in the rule, but only for the countries entering the VWP after 2009 (no new requirements for VWP, reduced burden for newly entering countries).

CBP determined that the rule provides the greatest level of enhanced security and efficiency at an acceptable cost to traveling public and potentially affected air carriers.

Anticipated Cost and Benefits: The purpose of ESTA is to allow DHS and CBP to establish the eligibility of certain foreign travelers to travel to the United States under the VWP, and whether the alien's proposed travel to the United States poses a law enforcement or security risk. Upon review of such information, DHS will determine whether the alien is eligible to travel to the United States under the VWP.

Costs to Air & Sea Carriers

CBP estimated that eight U.S.-based air carriers and eleven sea carriers will be affected by the rule. An additional 35 foreign-based air carriers and five sea carriers will be affected. CBP concluded that costs to air and sea carriers to support the requirements of the ESTA program could cost $137 million to $1.1 billion over the next 10 years depending on the level of effort required to integrate their systems with ESTA, how many passengers they need to assist in applying for travel authorizations, and the discount rate applied to annual costs.

Costs to Travelers

ESTA will present new costs and burdens to travelers in VWP countries who were not previously required to submit any information to the U.S. Government in advance of travel to the United States. Travelers from Roadmap countries who become VWP countries will also incur costs and burdens, though these are much less than obtaining a nonimmigrant visa (category B1/B2), which is currently required for short-term pleasure or business to travel to the United States. CBP estimated that the total quantified costs to travelers will range from $1.1 billion to $3.5 billion depending on the number of travelers, the value of time, and the discount rate. Annualized costs are estimated to range from $133 million to $366 million.

Benefits

As set forth in section 711 of the 9/11 Act, it was the intent of Congress to modernize and strengthen the security of the Visa Waiver Program under section 217 of the Immigration and Nationality Act (INA, 8 U.S.C. 1187) by simultaneously enhancing program security requirements and extending visa-free travel privileges to citizens and eligible nationals of eligible foreign countries that are partners in the war on terrorism.

By requiring passenger data in advance of travel, CBP may be able to determine, before the alien departs for the United States, the eligibility of citizens and eligible nationals from VWP countries to travel to the United States under the VWP, and whether such travel poses a law enforcement or security risk. In addition to fulfilling a statutory mandate, the rule serves the twin goals of promoting border security and legitimate travel to the United States. By modernizing the VWP, ESTA is intended to both increase national security and provide for greater efficiencies in the screening of international travelers by allowing for the screening of subjects of potential interest well before boarding, thereby reducing traveler delays based on potentially lengthy processes at U.S. ports of entry.

CBP concluded that the total benefits to travelers could total $1.1 billion to $3.3 billion over the period of analysis. Annualized benefits could range from $134 million to $345 million.

In addition to these benefits to travelers, CBP and the carriers should also experience the benefit of not having to administer the I-94W except in limited situations. While CBP has not conducted an analysis of the potential savings, it should accrue benefits from not having to produce, ship, and store blank forms. CBP should also be able to accrue savings related to data entry and archiving. Carriers should realize some savings as well, though carriers will still have to administer the I-94 for those passengers not traveling under the VWP and the Customs Declaration forms for all passengers aboard the aircraft and vessel.

Timetable:

Action Date FR Cite
Interim Final Action 06/09/08 73 FR 32440
Interim Final Rule Effective 08/08/08  
Interim Final Rule Comment Period End 08/08/08  
Notice—Announcing Date Rule Becomes Mandatory 11/13/08 73 FR 67354
Final Action 08/00/13  

Regulatory Flexibility Analysis Required: 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.

Additional Information: http://www.cbp.gov/xp/cgov/travel/id_visa/esta/.

URL for More Information: www.regulations.gov.

URL for Public Comments: www.regulations.gov.

Agency Contact: Suzanne Shepherd, Director, Electronic System for Travel Authorization, Department of Homeland Security, U.S. Customs and Border Protection, 1300 Pennsylvania Avenue NW., Washington, DC 20229, Phone: 202 344-2073, Email: suzanne.m.shepherd@cbp.dhs.gov.

Related RIN: Related to 1651-AA83.

RIN: 1651-AA72

DHS—TRANSPORTATION SECURITY ADMINISTRATION (TSA) Back to Top

Proposed Rule Stage

63. Security Training for Surface Mode Employees Back to Top

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

Legal Authority: 49 U.S.C. 114; Pub. L. 110-53, secs 1408, 1517, and 1534

CFR Citation: 49 CFR part 1520; 49 CFR part 1570; 49 CFR part 1580; 49 CFR part 1582 (New); 49 CFR part 1584 (New).

Legal Deadline: Final, Statutory, November 1, 2007, Interim Rule for public transportation agencies is due 90 days after date of enactment.

Final, Statutory, February 3, 2008, Rule for railroads and over-the-road buses are due 6 months after date of enactment.

Final, Statutory, August 3, 2008, Rule for public transportation agencies is due 1 year after date of enactment.

According to sec. 1408 of Public Law 110-53, Implementing Recommendations of the 9/11 Commission Act of 2007 (Aug. 3, 2007; 121 Stat. 266), interim final regulations for public transportation agencies are due 90 days after the date of enactment (Nov. 1, 2007), and final regulations are due 1 year after the date of enactment of this Act. According to sec. 1517 of the same Act, final regulations for railroads and over-the-road buses are due no later than 6 months after the date of enactment.

Abstract: The Transportation Security Administration (TSA) intends to propose a new regulation to improve the security of freight railroads, public transportation, passenger railroads, and over-the-road buses in accordance with the Implementing Recommendations of the 9/11 Commission Act of 2007. This rulemaking will propose general requirements for the owner/operators of a freight railroad, public transportation system, passenger railroad, and an over-the-road bus operation determined by TSA to be high-risk to develop and implement a security training program to prepare security-sensitive employees, including frontline employees identified in sections 1402 and 1501 of the Act, for potential security threats and conditions. The rulemaking will also propose extending the security coordinator and reporting security incident requirements applicable to rail operators under current 49 CFR part 1580 to the non-rail transportation components of covered public transportation agencies. In addition, the rulemaking will also propose requiring the affected over-the-road bus owner/operators to identify security coordinators and report security incidents, similar to the requirements for rail in current 49 CFR 1580. The regulation will take into consideration any current security training requirements or best practices.

Statement of Need: A security training program for freight railroads, public transportation agencies and passenger railroads, and over-the-road bus operations is proposed to prepare freight railroad security-sensitive employees, public transportation, passenger railroad security-sensitive employees, and over-the-road bus security-sensitive employees for potential security threats and conditions.

Summary of Legal Basis: 49 U.S.C. 114; sections 1408, 1517, and 1534 of Public Law 110-53, Implementing Recommendations of the 9/11 Commission Act of 2007 (Aug. 3, 2007; 121 Stat. 266).

Alternatives: TSA is required by statute to publish regulations requiring security training programs for these owner/operators. As part of its notice of proposed rulemaking, TSA will seek public comment on the alternative ways in which the final rule could carry out the requirements of the statute.

Anticipated Cost and Benefits: TSA will estimate the costs that the freight railroad systems, public transportation agencies, passenger railroads, and over-the-road bus (OTRB) entities covered by this proposed rule would incur following its implementation. These costs will include estimates for the following elements: (1) Creating or modifying a security training program and submitting it to TSA; (2) Training (initial and recurrent) all security-sensitive employees; (3) Maintaining records of employee training; (4) Being available for inspections; (5) As applicable, providing information on security coordinators and alternates; and (6) As applicable, reporting security concerns. TSA will also estimate the costs TSA itself would expect to incur with the implementation of this rule.

TSA has not quantified benefits. TSA, however, expects that the primary benefit of the Security Training NPRM will be the enhancement of the United States surface transportation security by reducing the vulnerability of freight railroad systems, public transportation agencies, passenger railroads, and over-the-road bus entities to terrorist activity through the training of security-sensitive employees. TSA uses a break-even analysis to assess the trade-off between the beneficial effects of the Security Training NPRM and the costs of implementing the rulemaking. This break-even analysis uses scenarios extracted from the TSA Transportation Sector Security Risk Assessment (TSSRA) to determine the degree to which the Security Training NPRM must reduce the overall risk of a terrorist attack in order for the expected benefits of the NPRM to justify the estimated costs. For its analyses, TSA uses scenarios with varying levels of risk, but only details the consequence estimates. To maintain consistency, TSA developed the analyses with a method similar to that used for the break-even analyses conducted in earlier DHS rules.

After estimating the total consequence of each scenario by monetizing lives lost, injuries incurred, and capital replacement and clean-up, TSA will use this figure and the annualized cost of the NPRM for freight rail, public transportation, passenger rail, and OTRB owner/operators to calculate a breakeven annual likelihood of attack.

Risks: 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 providing for security training for personnel, TSA intends in this rulemaking to reduce the risk of a terrorist attack on this transportation sector.

Timetable:

Action Date FR Cite
NPRM 07/00/13  

Regulatory Flexibility Analysis Required: Undetermined.

Government Levels Affected: Local.

URL for More Information: www.regulations.gov.

URL for Public Comments: www.regulations.gov.

Agency Contact: Scott Gorton,Manager, Freight Rail Security Branch,Department of Homeland Security,Transportation Security Administration,Office of Security Policy and Industry Engagement,TSA-28, HQ, E10-423N,601 South 12th Street,Arlington, VA 20598-6028, Phone: 571 227-1251, Fax: 571 227-2930, Email: scott.gorton@tsa.dhs.gov.

Steve Sprague,Highway Passenger, Infrastructure and Licensing Branch Chief; Highway and Motor Carrier Programs,Department of Homeland Security,Transportation Security Administration,Office of Security Policy and Industry Engagement,TSA-28, HQ, E,601 South 12th Street,Arlington, VA 20598-6028, Phone: 571 227-1468, Email: steve.sprague@tsa.dhs.gov.

Dominick S. CaridiDirector, Regulatory and Economic Analysis,Department of Homeland Security,Transportation Security Administration,Office of Security Policy and Industry Engagement,TSA-28, HQ, E10-419N,601 South 12th Street,Arlington, VA 20598-6028, Phone: 571 227-2952, Fax: 703 603-0404, Email: dominick.caridi@tsa.dhs.gov.

David Kasminoff,Senior Counsel, Regulations and Security Standards Division,Department of Homeland Security,Transportation Security Administration,Office of the Chief Counsel,TSA-2, HQ, E12-310N,601 South 12th Street,Arlington, VA 20598-6002, Phone: 571 227-3583, Fax: 571 227-1378, Email: david.kasminoff@tsa.dhs.gov.

Traci Klemm,Senior Counsel, Regulations and Security Standards Division,Department of Homeland Security,Transportation Security Administration,Office of the Chief Counsel,TSA-2, E12-335N,601 South 12th Street,Arlington, VA 20598-6002, Phone: 571 227-3596, Email: traci.klemm@tsa.dhs.gov.

Related RIN: Related to 1652-AA56, Merged with 1652-AA57, Merged with 1652-AA59.

RIN: 1652-AA55

DHS—TSA Back to Top

64. Standardized Vetting, Adjudication, and Redress Services Back to Top