[The Regulatory Plan and Unified Agenda of Federal Regulatory and Deregulatory Actions]
[Introduction to The Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions]
[From the U.S. Government Printing Office, www.gpo.gov]
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Part II
Regulatory Information Service Center
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Introduction to The Regulatory Plan and the Unified Agenda of Federal
Regulatory and Deregulatory Actions
Federal Register / Vol. 73, No. 227 / Monday, November 24, 2008 / The
Regulatory Plan
Federal Register / Vol. 73, No. 227 / Monday, November 24, 2008 / The
Regulatory Plan
[[Page 71095]]
REGULATORY INFORMATION SERVICE CENTER
Introduction to The Regulatory Plan and the Unified Agenda of Federal
Regulatory and Deregulatory Actions
AGENCY: Regulatory Information Service Center.
ACTION: Introduction to The Regulatory Plan and 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), as amended, 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. Section 4 of Executive Order 12866 also
directs that each agency prepare, as part of its submission to the fall
edition of the Unified Agenda, a regulatory plan of the most important
significant regulatory actions that the agency reasonably expects to
issue in proposed or final form during the upcoming fiscal year. The
Regulatory Plan (Plan) and the Unified Agenda of Federal Regulatory and
Deregulatory Actions (Unified Agenda) help agencies fulfill these
requirements.
Editions of the Unified Agenda prior to fall 2007 were printed in
their entirety in the Federal Register. Beginning with the fall 2007
edition, the Internet is the basic means for conveying Regulatory
Agenda information to the maximum extent legally permissible. The
complete Unified Agenda for fall 2008, including The Regulatory Plan,
is available to the public at http://reginfo.gov.
The fall 2008 Unified Agenda publication appearing in the Federal
Register consists of The Regulatory Plan and agency regulatory
flexibility agendas, in accordance with the publication requirements of
the Regulatory Flexibility Act. Agency regulatory flexibility agendas
contain only those Agenda entries for rules which are likely to have a
significant economic impact on a substantial number of small entities
and entries that have been selected for periodic review under section
610 of the Regulatory Flexibility Act.
The complete fall 2008 Unified Agenda contains the plans of 28
Federal agencies and the regulatory agendas for these and 33 other
Federal agencies.
ADDRESSES: Regulatory Information Service Center (MI), General Services
Administration, 1800 F Street NW., Suite 3039, Washington, DC 20405.
FOR FURTHER INFORMATION CONTACT: For further information about specific
regulatory actions, please refer to the Agency Contact listed for each
entry.
To provide comment on or to obtain further information about this
publication, contact: John C. Thomas, Executive Director, Regulatory
Information Service Center (MI), General Services Administration, 1800
F Street NW., Suite 3039, Washington, DC 20405, (202) 482-7340. You may
also send comments to us by e-mail at:
[email protected]
SUPPLEMENTARY INFORMATION:
TABLE OF CONTENTS
Page
Introduction to The Regulatory Plan and the Unified Agenda of Federal
Regulatory and Deregulatory Actions
I. What Are The Regulatory Plan and the Unified Agenda?......... 71096
II. Why Are The Regulatory Plan and the Unified Agenda 71097
Published?.....................................................
III. How Are The Regulatory Plan and the Unified Agenda 71097
Organized?.....................................................
IV. What Information Appears for Each Entry?.................... 71098
V. Abbreviations................................................ 71100
VI. How Can Users Get Copies of the Plan and the Agenda?........ 71100
Introduction to the Fall 2008 Regulatory Plan................... 71101
AGENCY REGULATORY PLANS
Cabinet Departments
Department of Agriculture....................................... 71112
Department of Commerce.......................................... 71134
Department of Defense........................................... 71146
Department of Education......................................... 71152
Department of Energy............................................ 71154
Department of Health and Human Services......................... 71157
Department of Homeland Security................................. 71165
Department of Housing and Urban Development..................... 71199
Department of the Interior...................................... 71203
Department of Justice........................................... 71217
Department of Labor............................................. 71223
Department of Transportation.................................... 71230
Department of the Treasury...................................... 71242
Department of Veterans Affairs.................................. 71253
Other Executive Agencies
Environmental Protection Agency................................. 71254
Equal Employment Opportunity Commission......................... 71270
General Services Administration................................. 71272
National Aeronautics and Space Administration................... 71273
National Archives and Records Administration.................... 71274
Office of Personnel Management.................................. 71275
Pension Benefit Guaranty Corporation............................ 71276
Small Business Administration................................... 71278
Social Security Administration.................................. 71280
Independent Regulatory Agencies
Consumer Product Safety Commission.............................. 71289
Federal Maritime Commission..................................... 71291
Federal Trade Commission........................................ 71292
National Indian Gaming Commission............................... 71302
Postal Regulatory Commission.................................... 71303
AGENCY AGENDAS
Cabinet Departments
Department of Agriculture....................................... 71305
Department of Commerce.......................................... 71325
Department of Health and Human Services......................... 71355
Department of Homeland Security................................. 71377
Department of Housing and Urban Development..................... 71387
Department of Justice........................................... 71391
Department of Labor............................................. 71395
Department of Transportation.................................... 71401
Other Executive Agencies
Environmental Protection Agency................................. 71423
General Services Administration................................. 71435
National Foundation on the Arts and the Humanities
Institute of Museum and Library Services...................... 71439
National Endowment for the Arts............................... 71441
[[Page 71096]]
Office of Personnel Management.................................. 71443
Small Business Administration................................... 71447
Joint Authority
Department of Defense/General Services Administration/National 71453
Aeronautics and Space Administration (Federal Acquisition
Regulation)....................................................
Independent Regulatory Agencies
Federal Communications Commission............................... 71457
Federal Reserve System.......................................... 71503
National Credit Union Administration............................ 71507
Nuclear Regulatory Commission................................... 71509
Securities and Exchange Commission.............................. 71513
INTRODUCTION TO THE REGULATORY PLAN AND THE UNIFIED AGENDA OF
FEDERAL REGULATORY AND DEREGULATORY ACTIONS
I. What Are The Regulatory Plan and the Unified Agenda?
The Regulatory Plan serves as a defining statement of the
Administration's regulatory and deregulatory policies and priorities.
The Plan is part of the fall edition of the Unified Agenda. Each
participating agency's regulatory plan contains: (1) A narrative
statement of the agency's regulatory priorities and, for most agencies,
(2) a description of the most important significant regulatory and
deregulatory actions that the agency reasonably expects to issue in
proposed or final form during the upcoming fiscal year. This edition
includes the regulatory plans of 28 agencies.
The Unified Agenda provides information about regulations that the
Government is considering or reviewing. The Unified Agenda has appeared
in the Federal Register twice each year since 1983 and has been
available online since 1995. In order to further the Administration's
commitment to use modern technology to deliver better service to the
American people for lower cost, beginning with the fall 2007 edition,
the Internet is the basic means for conveying Regulatory Agenda
information to the maximum extent legally permissible. The complete
Unified Agenda, including The Regulatory Plan, is available to the
public at http://reginfo.gov. The online Unified Agenda offers flexible
search tools and will soon offer access to the entire historic Unified
Agenda database.
The fall 2008 Unified Agenda publication appearing in the Federal
Register consists of The Regulatory Plan and agency regulatory
flexibility agendas, in accordance with the publication requirements of
the Regulatory Flexibility Act. Agency regulatory flexibility agendas
contain only those Agenda entries for rules which 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 amended, as
well as move the Agenda process toward the Administration's goal of e-
Government, while providing a substantial reduction in printing costs
compared with prior editions. The current format does not reduce the
amount of information available to the public, but it does limit most
of the content of the Agenda to online access. The complete online
edition of the Unified Agenda includes regulatory agendas from 61
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 Defense *
Department of Education *
Department of Energy *
Department of the Interior *
Department of State
Department of the Treasury *
Department of Veterans Affairs *
Agency for International Development
Architectural and Transportation Barriers Compliance Board
Commission on Civil Rights
Commodity Futures Trading Commission
Committee for Purchase From People Who Are Blind or Severely
Disabled
Consumer Product Safety Commission *
Corporation for National and Community Service
Court Services and Offender Supervision Agency for the District of
Columbia
Equal Employment Opportunity Commission *
Farm Credit Administration
Farm Credit System Insurance Corporation
Federal Council on the Arts and the Humanities
Federal Deposit Insurance Corporation
Federal Energy Regulatory Commission
Federal Housing Finance Agency
Federal Housing Finance Board
Federal Maritime Commission *
Federal Mediation and Conciliation Service
Federal Trade Commission *
National Aeronautics and Space Administration *
National Archives and Records Administration *
National Endowment for the Humanities
National Indian Gaming Commission *
National Science Foundation
Office of Federal Housing Enterprise Oversight
Office of Government Ethics
Office of Management and Budget
Peace Corps
Pension Benefit Guaranty Corporation *
Postal Regulatory Commission *
Railroad Retirement Board
Selective Service System
Social Security Administration *
Surface Transportation Board
The Regulatory Information Service Center (the Center) compiles the
Plan and the Unified Agenda for the Office of Information and
Regulatory Affairs (OIRA), part of the Office
[[Page 71097]]
of Management and Budget. OIRA is responsible for overseeing the
Federal Government's regulatory, paperwork, and information resource
management activities, including implementation of Executive Order
12866. The Center also provides information about Federal regulatory
activity to the President and his Executive Office, the Congress,
agency managers, and the public.
The activities included in the Agenda are, in general, those that
will have a regulatory action within the next 12 months. Agencies may
choose to include activities that will have a longer timeframe than 12
months. Agency agendas also show actions or reviews completed or
withdrawn since the last Unified Agenda. Executive Order 12866 does not
require agencies to include regulations concerning military or foreign
affairs functions or regulations related to agency organization,
management, or personnel matters.
Agencies prepared entries for this publication to give the public
notice of their plans to review, propose, and issue regulations. They
have tried to predict their activities over the next 12 months as
accurately as possible, but dates and schedules are subject to change.
Agencies may withdraw some of the regulations now under development,
and they may issue or propose other regulations not included in their
agendas. Agency actions in the rulemaking process may occur before or
after the dates they have listed. The Regulatory Plan and the Unified
Agenda do not create a legal obligation on agencies to adhere to
schedules in this publication or to confine their regulatory activities
to those regulations that appear within it.
II. Why Are The Regulatory Plan and the Unified Agenda Published?
The Regulatory Plan and the Unified Agenda help 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. The requirements for
regulatory plans were amended by Executive Order 13422 entitled
``Further Amendment to Executive Order 12866 on Regulatory Planning and
Review,'' signed January 18, 2007 (72 FR 2763).
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 regulations 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 regulations, which consists of a description of the extent of
the agency's prior consultation with State and local officials, a
summary of their concerns and the agency's position supporting the need
to issue the regulation, and a statement of the extent to which those
concerns have been met. As part of this effort, agencies include in
their submissions for the Unified Agenda information on whether their
regulatory actions may have an effect on the various levels of
government and whether those actions have federalism implications.
Unfunded Mandates Reform Act of 1995
The Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4, title II)
requires agencies to prepare written assessments of the costs and
benefits of significant regulatory actions ``that may result in the
expenditure by State, local, and tribal governments, in the aggregate,
or by the private sector, of $100,000,000 or more . . . in any 1 year .
. . .'' The requirement does not apply to independent regulatory
agencies, nor does it apply to certain subject areas excluded by
section 4 of the Act. Affected agencies identify in the Unified Agenda
those regulatory actions they believe are subject to title II of the
Act.
Executive Order 13211
Executive Order 13211 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 Are The Regulatory Plan and the Unified Agenda
Organized?
The Regulatory Plan appears in part II of a daily edition of the
Federal Register. The Plan is a single document beginning with an
introduction, followed by a table of contents, followed by each
agency's section of the Plan.
[[Page 71098]]
Following the Plan in the Federal Register, as separate parts, are the
regulatory flexibility agendas for each agency whose agenda includes
entries for rules which are likely to have a significant economic
impact on a substantial number of small entities or rules that have
been selected for periodic review under section 610 of the Regulatory
Flexibility Act. Each printed agenda appears as a separate part. The
sections of the Plan and the parts of the Unified Agenda are organized
alphabetically in four groups: Cabinet departments; other executive
agencies; the Federal Acquisition Regulation, a joint authority (Agenda
only); and independent regulatory agencies. Agencies may in turn be
divided into subagencies. Each printed agency agenda has a table of
contents listing the agency's printed entries that follow.
Each agency's section of the Plan contains a narrative statement
of regulatory priorities and, for most agencies, a description of the
agency's most important significant regulatory and deregulatory
actions. Each agency's part of the Agenda contains a preamble providing
information specific to that agency plus descriptions of the agency's
regulatory and deregulatory actions.
The online, complete Unified Agenda contains the preambles of all
participating agencies. Unlike the printed edition, the online Agenda
has no fixed ordering. In the online Agenda, users can select the
particular agencies 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. In the Plan, only the first three stages are applicable. Some
agencies use subheadings to identify regulations that are grouped
according to particular topics. 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.
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. This sequence number is used as the reference in the
printed table of contents. Sequence numbers are not used in the online
Unified Agenda because the unique Regulation Identifier Number (RIN) is
able to provide this cross-reference capability.
Editions of the Unified Agenda prior to fall 2007 contained
several indexes, which identified entries with various characteristics.
These included regulatory actions for which agencies believe that the
Regulatory Flexibility Act may require a Regulatory Flexibility
Analysis, actions selected for periodic review under section 610(c) of
the Regulatory Flexibility Act, and actions that may have federalism
implications as defined in Executive Order 13132 or other effects on
levels of government. These indexes are no longer compiled, because
users of the online Unified Agenda have the flexibility to search for
entries with any combination of desired characteristics. The online
edition retains the Unified Agenda's subject index based on the Federal
Register Thesaurus of Indexing Terms. In addition, online users have
the option of searching Agenda text fields for words or phrases.
IV. What Information Appears for Each Entry?
All entries in the 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 as separate fields.
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
[[Page 71099]]
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 printed in the form 08/00/09 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 (new data
element, added in fall 2008).
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.
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, e-mail 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 RINs associated with
activity related to this action, such as merged RINs, split RINs, new
activity for previously completed RINs, or duplicate RINs.
Entries appearing in The Regulatory Plan include some or all of
the following additional data elements, but will, at a minimum, include
information in Statement of Need and in Anticipated Costs and Benefits:
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
[[Page 71100]]
the action to reduce this risk, and the relation of the risk and this
risk reduction effort to other risks and risk reduction efforts within
the agency's jurisdiction.
V. Abbreviations
The following abbreviations appear throughout this publication:
ANPRM -- An Advance Notice of Proposed Rulemaking is a preliminary
notice, published in the Federal Register, announcing that an agency is
considering a regulatory action. An agency may issue an ANPRM before it
develops a detailed proposed rule. An ANPRM describes the general area
that may be subject to regulation and usually asks for public comment
on the issues and options being discussed. An ANPRM is issued only when
an agency believes it needs to gather more information before
proceeding to a notice of proposed rulemaking.
CFR -- The Code of Federal Regulations is an annual codification
of the general and permanent regulations published in the Federal
Register by the agencies of the Federal Government. The Code is divided
into 50 titles, each title covering a broad area subject to Federal
regulation. The CFR is keyed to and kept up to date by the daily issues
of the Federal Register.
EO -- An Executive order is a directive from the President to
Executive agencies, issued under constitutional or statutory authority.
Executive orders are published in the Federal Register and in title 3
of the Code of Federal Regulations.
FR -- The Federal Register is a daily Federal Government
publication that provides a uniform system for publishing Presidential
documents, all proposed and final regulations, notices of meetings, and
other official documents issued by Federal agencies.
FY -- The Federal fiscal year runs from October 1 to September 30.
NPRM -- A Notice of Proposed Rulemaking is the document an agency
issues and publishes in the Federal Register that describes and
solicits public comments on a proposed regulatory action. Under the
Administrative Procedure Act (5 U.S.C. 553), an NPRM must include, at a
minimum:
a statement of the time, place, and nature of the public
rulemaking proceeding;
a reference to the legal authority under which the rule is
proposed; and
either the terms or substance of the proposed rule or a
description of the subjects and issues involved.
PL (or Pub. L.) -- A public law is a law passed by Congress and
signed by the President or enacted over his veto. It has general
applicability, unlike a private law that applies only to those persons
or entities specifically designated. Public laws are numbered in
sequence throughout the 2-year life of each Congress; for example, PL
110-4 is the fourth public law of the 110th Congress.
RFA -- A Regulatory Flexibility Analysis is a description and
analysis of the impact of a rule on small entities, including small
businesses, small governmental jurisdictions, and certain small not-
for-profit organizations. The Regulatory Flexibility Act (5 U.S.C. 601
et seq.) requires each agency to prepare an initial RFA for public
comment when it is required to publish an NPRM and to make available a
final RFA when the final rule is published, unless the agency head
certifies that the rule would not have a significant economic impact on
a substantial number of small entities.
RIN -- The Regulation Identifier Number is assigned by the
Regulatory Information Service Center to identify each regulatory
action listed in The Regulatory Plan and the Unified Agenda, as
directed by Executive Order 12866 (section 4(b)). Additionally, OMB has
asked agencies to include RINs in the headings of their Rule and
Proposed Rule documents when publishing them in the Federal Register,
to make it easier for the public and agency officials to track the
publication history of regulatory actions throughout their development.
Seq. No. -- The sequence number identifies the location of an
entry in the printed edition of the 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 Regulatory Plan and the Agenda.
Sequence numbers are not used in the online Unified Agenda.
USC -- The United States Code is a consolidation and codification
of all general and permanent laws of the United States. The USC is
divided into 50 titles, each title covering a broad area of Federal
law.
VI. How Can Users Get Copies of the Plan and the Agenda?
Copies of the Federal Register issue containing the printed
edition of The Regulatory Plan and the Unified Agenda (agency
regulatory flexibility agendas) are available from the Superintendent
of Documents, U.S. Government 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 website. Please contact
the particular agency for further information.
All editions of The Regulatory Plan and the Unified Agenda of
Federal Regulatory and Deregulatory Actions since fall 1995 are
available in electronic form at http://reginfo.gov. This site currently
offers flexible search tools for recent editions. By early 2009,
searchable access to the entire historic Unified Agenda database back
to 1983 will be added to the site.
In accordance with regulations for the Federal Register, the
Government Printing Office's GPO Access website contains copies of the
Agendas and Regulatory Plans that have been printed in the Federal
Register. These documents are available at:
http://www.gpoaccess.gov/ua/index.html
Dated: November 12, 2008.
John C. Thomas,
Executive Director.
[FR Doc. Filed 11-21-08; 8:45 am]
BILLING CODE 6820-27-S
The Regulatory Plan
____________________________________________________________________
[[Page 71101]]
INTRODUCTION TO THE FALL 2008 REGULATORY PLAN
Federal regulation is a fundamental instrument of
national policy. It is one of the three major tools --
in addition to spending and taxing -- used to implement
policy. It is used to advance numerous public
objectives, including homeland security, transportation
safety, environmental protection, educational quality,
food safety, health care quality, equal employment
opportunity, energy security, immigration control, and
consumer protection. The Office of Management and
Budget's (OMB) Office of Information and Regulatory
Affairs (OIRA) is responsible for overseeing and
coordinating the Federal Government's regulatory
policies.
The Regulatory Plan is published as part of the fall
edition of the Unified Agenda of Federal Regulatory and
Deregulatory Actions, and serves as a statement of the
Administration's regulatory and deregulatory policies
and priorities. The purpose of the Plan is to make the
regulatory process more accessible to the public and to
ensure that the planning and coordination necessary for
a well-functioning regulatory process occurs. The Plan
identifies regulatory priorities and contains
information about the most significant regulatory
actions agencies expect to undertake in the coming
year. An accessible regulatory process enables citizen
centered service.
Federal Regulatory Policy
Federal regulations should be sensible and based on
sound science, economics, and the law. Accordingly, the
Bush Administration strove for a regulatory process
that adopted new rules when markets failed to serve the
public interest, simplified and modified existing rules
to make them more effective, less costly or less
intrusive, and rescinded outmoded rules whose benefits
did not justify their costs. In pursuing this agenda,
OMB has adopted an approach based on the principles of
regulatory analysis and policy espoused in Executive
Order 12866, signed by President Clinton in 1993.
Effective regulatory policy is not uniformly pro-
regulation or anti-regulation. It originates with the
authority granted under the law. Within the discretion
available to the regulating agency through its
statutory authority, agencies apply a number of
principles articulated in Executive Order 12866, as
well as other applicable Executive Orders, in order to
design regulations that achieve their desired ends in
the most efficient way. This involves bringing to bear
on the policy problem sound economic principles, the
highest quality information, and the best possible
science. This is not always an easy task, and designing
regulations does not involve the rote application of
quantified data to reach policy decisions. In making
regulatory decisions, we expect agencies to consider
not only benefits and costs that can be quantified and
expressed in monetary units, but also other attributes
and factors that cannot be integrated readily in a
benefit-cost framework, such as privacy and fairness.
Effective regulation is the result of the careful use
of all available high-quality data, and the application
of broad principles established by the President.
The Administration's e-rulemaking program is designed
to increase transparency and improve the public's
ability to become involved in the rulemaking process.
Visitors to the website, www.regulations.gov, can view
and
[[Page 71102]]
comment electronically on regulations proposed by
Federal departments and agencies. Current and prior
editions of the Regulatory Plan and Unified Agenda are
available electronically in searchable database format
on both www.regulations.gov and www.reginfo.gov.
For new rulemakings and programs, OIRA has enhanced the
transparency of OMB's regulatory review process. OIRA's
website allows the public to identify which rules are
formally under review at OMB and which rules have
recently completed review or have been returned to
agencies for reconsideration. OIRA has increased the
amount of information available on its website. In
addition to information on meetings and correspondence,
OIRA makes available communications from the OIRA
Administrator to agencies, including ``prompt
letters,'' ``return letters,'' and ``post review
letters.''
For existing rulemakings, OMB initiated a series of
calls for reform nominations in 2001, 2002, and 2004.
In the 2004 draft Report to Congress on the Costs and
Benefits of Federal Regulation, OMB requested public
nominations of promising regulatory reforms relevant to
the manufacturing sector. Commenters were asked to
suggest specific reforms to rules, guidance documents,
or paperwork requirements that would improve
manufacturing regulation by reducing unnecessary costs,
increasing effectiveness, enhancing competitiveness,
reducing uncertainty, and increasing flexibility. In
response to the solicitation, OMB received 189 distinct
reform nominations from 41 commenters. Of these,
Federal agencies and OMB have determined that 76
nominations have potential merit and justify further
action. According to the 2008 draft OMB Report to
Congress on the Costs and Benefits of Federal
Regulation, agencies have completed 60 of the 76
priority reforms. For further information, all of these
Reports are available on OIRA's website at http://
www.whitehouse.gov/omb/inforeg/regpol.html.
The Administration's 2008 Regulatory Priorities
With regard to Federal regulation, the Administration's
objective is quality, not quantity. Those rules that
are finalized promise to be more effective, less
intrusive, and more cost-effective in achieving
national objectives while demonstrating greater
resilience. OMB seeks to ensure that the public is
provided with the information needed to understand and
comment on the Federal regulatory agenda. Accordingly,
the 2008 Regulatory Plan highlights the following
themes:
Regulations that are particularly good
examples of the Administration's ``smart''
regulation agenda to streamline regulations
and reporting requirements, which is a key
part of the President's economic plan.
Regulations of particular concern to
small businesses.
Regulations addressing the 2004
nominations for promising regulatory
reforms in the manufacturing sector.
In addition, the 2008 Regulatory Plan includes for the
first time an identification of regulations that may
have international trade and investment effects. The
Plan now includes an ``international flag'' for such
regulations, which the public can use to search for a
list of entries with international impacts or interest.
This enhanced capability grew out of a recommendation
developed through OMB's ongoing work with the
Secretariat General of the European Commission through
the U.S.-EU High Level Regulatory Forum. Specifically,
the Forum recognized the value of timely announcement
of planned regulations that may have international
trade and investment effects, and recommended that both
the U.S. and the EU develop a mechanism to provide the
public with such information.
[[Page 71103]]
Conclusion
Smarter regulatory policies, created through public
participation, transparency, and cooperation across
Federal agencies, are key Executive Branch objectives.
The following department and agency plans provide
further information on regulatory priorities. All
agencies' plans are a reflection of the
Administration's Federal Regulatory Policy objectives,
which aim at implementing an effective and results-
oriented regulatory system. As the eighth and final
Regulatory Plan of the Administration, this plan
reflects our efforts to have a regulatory system that
protects and improves Americans' health, safety and
environment, secures their rights, and ensures a fair
and competitive economic system, while respecting their
prerogative to make their own decisions and not
imposing unnecessary costs. One of the opportunities
for the new Administration, in addition to maintaining
and furthering these efforts, will be to continue
enhancing the transparency and accountability of the
regulatory process to the public. The following
department and agency plans provide additional
information on their individual regulatory priorities.
[[Page 71105]]
DEPARTMENT OF AGRICULTURE
--------------------------------------------------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier Rulemaking Stage
Number Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
1 Animal Welfare; Regulations and Standards for Birds 0579-AC02 Proposed Rule
Stage
2 Importation of Plants for Planting; Establishing a New Category of Plants for Planting Not 0579-AC03 Proposed Rule
Authorized for Importation Pending Risk Assessment Stage
3 Bovine Spongiform Encephalopathy; Importation of Bovines and Bovine Products 0579-AC68 Proposed Rule
Stage
4 Introduction of Organisms and Products Altered or Produced Through Genetic Engineering 0579-AC31 Final Rule Stage
5 Child and Adult Care Food Program: Improving Management and Program Integrity 0584-AC24 Final Rule Stage
6 FSP: Eligibility and Certification Provisions of the Farm Security and Rural Investment Act of 2002 0584-AD30 Final Rule Stage
7 Quality Control Provisions 0584-AD31 Final Rule Stage
8 Direct Certification of Children in Food Stamp Households and Certification of Homeless, Migrant, 0584-AD60 Final Rule Stage
and Runaway Children for Free Meals in the NSLP, SBP, and SMP
9 Special Supplemental Nutrition Program for Women, Infants, and Children (WIC): WIC Vendor Cost 0584-AD71 Final Rule Stage
Containment
10 Changes to Regulatory Jurisdiction Over Certain Food Products Containing Meat and Poultry 0583-AD28 Proposed Rule
Stage
11 New Poultry Slaughter Inspection 0583-AD32 Proposed Rule
Stage
12 Notification, Documentation and Recordkeeping Requirements for Inspected Establishments 0583-AD34 Proposed Rule
Stage
13 Mandatory Inspection of Catfish and Catfish Products 0583-AD36 Proposed Rule
Stage
14 Federal-State Interstate Shipment Cooperative Inspection Program 0583-AD37 Proposed Rule
Stage
15 Performance Standards for the Production of Processed Meat and Poultry Products; Control of 0583-AC46 Final Rule Stage
Listeria Monocytogenes in Ready-To-Eat Meat and Poultry Products
16 Requirements for the Disposition of Cattle that Become Non-Ambulatory Disabled Following Ante- 0583-AD35 Final Rule Stage
Mortem Inspection
17 Mandatory Country Of Origin Labeling Of Covered Commodities Including Muscle Cuts Of Beef 0583-AD38 Final Rule Stage
(Including Veal), Lamb, Chicken, Goat, and Pork; Ground Beef, Gr. Lamb, Gr. Chicken, Gr. Goat, and
Gr. Pork
18 Resource Agency Procedures for Conditions and Prescriptions in Hydropower Licenses 0596-AC42 Final Rule Stage
19 Special Areas; State-Specific Inventoried Roadless Area Management: Colorado 0596-AC74 Final Rule Stage
--------------------------------------------------------------------------------------------------------------------------------------------------------
DEPARTMENT OF COMMERCE
--------------------------------------------------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier Rulemaking Stage
Number Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
20 Amendment to Coastal Migratory Pelagics FMP, Red Drum FMP, Reef Fish FMP, Spiny Lobster FMP, and 0648-AS65 Proposed Rule
Stone Crab FMP To Provide for Regulation of Marine Aquaculture Stage
21 Certification of Nations Whose Fishing Vessels Are Engaged in IUU Fishing or Bycatch of Protected 0648-AV51 Proposed Rule
Living Marine Resources Stage
22 Magnuson-Stevens Fishery Conservation and Management Act Provisions and Interjurisdictional 0648-AW38 Proposed Rule
Fisheries Act Disaster Assistance Programs Stage
23 Provide Guidance for the Limited Access Privilege Program Provisions of the Magnuson-Stevens 0648-AX13 Proposed Rule
Fishery Conservation and Management Reauthorization Act of 2006 Stage
24 Magnuson-Stevens Fishery Conservation and Management Reauthorization Act (MSRA) Environmental 0648-AV53 Final Rule Stage
Review Procedure
25 Guidance for Annual Catch Limits and Accountability Measures to End Overfishing 0648-AV60 Final Rule Stage
26 Taking and Importing Marine Mammals; U.S. Navy Training in the Hawaii Range Complex 0648-AW86 Final Rule Stage
[[Page 71106]]
27 Taking and Importing Marine Mammals; U.S. Navy's Atlantic Fleet Active Sonar Training (AFAST) 0648-AW90 Final Rule Stage
28 Taking and Importing Marine Mammals; U.S. Navy Training in the Southern California Range Complex 0648-AW91 Final Rule Stage
(SOCAL)
--------------------------------------------------------------------------------------------------------------------------------------------------------
DEPARTMENT OF DEFENSE
--------------------------------------------------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier Rulemaking Stage
Number Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
29 Civilian Health and Medical Program of the Uniformed Services (CHAMPUS); TRICARE Pharmacy Benefits 0720-AB27 Proposed Rule
Program Stage
30 TRICARE: Relationship Between the TRICARE Program and Employer-Sponsored Group Health Coverage 0720-AB17 Final Rule Stage
31 TRICARE: Outpatient Hospital Prospective Payment System (OPPS) 0720-AB19 Final Rule Stage
32 CHAMPUS/TRICARE: Inclusion of TRICARE Retail Pharmacy Program in Federal Procurement of 0720-AB22 Final Rule Stage
Pharmaceuticals
--------------------------------------------------------------------------------------------------------------------------------------------------------
DEPARTMENT OF EDUCATION
--------------------------------------------------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier Rulemaking Stage
Number Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
33 Title IV and Title II of the Higher Education Act of 1965, as Amended 1840-AC95 Proposed Rule
Stage
--------------------------------------------------------------------------------------------------------------------------------------------------------
DEPARTMENT OF ENERGY
--------------------------------------------------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier Rulemaking Stage
Number Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
34 Energy Efficiency Standards for Fluorescent and Incandescent Reflector Lamps 1904-AA92 Proposed Rule
Stage
35 Energy Conservation Standards for Residential Electric and Gas Ranges and Ovens and Microwave 1904-AB49 Final Rule Stage
Ovens, and Commercial Clothes Washers
36 Energy Efficiency Standards for Commercial Refrigeration Equipment 1904-AB59 Final Rule Stage
--------------------------------------------------------------------------------------------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
--------------------------------------------------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier Rulemaking Stage
Number Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
37 Control of Communicable Diseases Foreign Quarantine 0920-AA12 Final Rule Stage
38 Medical Device Reporting; Electronic Submission Requirements 0910-AF86 Proposed Rule
Stage
39 Electronic Registration and Listing for Devices 0910-AF88 Proposed Rule
Stage
40 Prevention of Salmonella Enteritidis in Shell Eggs 0910-AC14 Final Rule Stage
41 Expanded Access to Investigational Drugs for Treatment Use 0910-AF14 Final Rule Stage
42 Changes to the Hospital Inpatient Prospective Payment System for FY 2010 (CMS-1406-P) 0938-AP39 Proposed Rule
Stage
43 Revisions to Payment Policies under the Physician Fee Schedule for CY 2010 (CMS-1413-P) 0938-AP40 Proposed Rule
Stage
[[Page 71107]]
44 Changes to the Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center 0938-AP41 Proposed Rule
Payment System for CY 2010 (CMS-1414-P) Stage
--------------------------------------------------------------------------------------------------------------------------------------------------------
DEPARTMENT OF HOMELAND SECURITY
--------------------------------------------------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier Rulemaking Stage
Number Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
45 Collection of Alien Biometric Data Upon Exit from the United States at Air and Sea Ports of 1601-AA34 Final Rule Stage
Departure; United States Visitor and Immigrant Status Indicator Technology Program (US-VISIT)
46 United States Visitor and Immigrant Status Indicator Technology Program (US-VISIT), Enrollment of 1601-AA35 Final Rule Stage
Additional Aliens in US-VISIT
47 Documents and Receipts Acceptable for Employment Eligibility Verification 1615-AB72 Proposed Rule
Stage
48 Commonwealth of the Northern Mariana Islands Transitional Nonimmigrant Investor Classification 1615-AB75 Proposed Rule
Stage
49 Commonwealth of the Northern Mariana Islands Transitional Workers Classification 1615-AB76 Proposed Rule
Stage
50 Changes to Requirements Affecting H-2A Nonimmigrants 1615-AB65 Final Rule Stage
51 Changes to Requirements Affecting H-2B Nonimmigrants and Their Employers 1615-AB67 Final Rule Stage
52 Transportation Worker Identification Credential (TWIC); Card Reader Requirements (USCG-2007-28915) 1625-AB21 Prerule Stage
53 Implementation of the 1995 Amendments to the International Convention on Standards of Training, 1625-AA16 Proposed Rule
Certification, and Watchkeeping (STCW) for Seafarers, 1978 (USCG-2004-17914) Stage
54 Standards for Living Organisms in Ships' Ballast Water Discharged in U.S. Waters (USCG-2001-10486) 1625-AA32 Proposed Rule
Stage
55 Vessel Requirements for Notices of Arrival and Departure, and Automatic Identification System (USCG- 1625-AA99 Proposed Rule
2005-21869) Stage
56 Passenger and Inspected Vessel Stability Requirements (USCG-2007-0030) 1625-AB20 Proposed Rule
Stage
57 Advance Information on Private Aircraft Arriving and Departing the United States 1651-AA41 Final Rule Stage
58 Importer Security Filing and Additional Carrier Requirements 1651-AA70 Final Rule Stage
59 Changes to the Visa Waiver Program To Implement the Electronic System for Travel Authorization 1651-AA72 Final Rule Stage
(ESTA) Program
60 Implementation of the Guam-CNMI Visa Waiver Program 1651-AA77 Final Rule Stage
61 Aircraft Repair Station Security 1652-AA38 Proposed Rule
Stage
62 Large Aircraft Security Program, Other Aircraft Operator Security Programs, and Airport Operator 1652-AA53 Proposed Rule
Security Program Stage
63 Public Transportation--Security Training of Employees 1652-AA55 Proposed Rule
Stage
64 Public Transportation--Security Plan 1652-AA56 Proposed Rule
Stage
65 Railroads--Security Training of Employees 1652-AA57 Proposed Rule
Stage
66 Railroads--Vulnerability Assessment and Security Plan 1652-AA58 Proposed Rule
Stage
67 Over-the-Road Buses--Security Training of Employees 1652-AA59 Proposed Rule
Stage
68 Over-the-Road Buses--Vulnerability Assessment and Security Plan 1652-AA60 Proposed Rule
Stage
69 Secure Flight Program 1652-AA45 Final Rule Stage
70 Rail Transportation Security 1652-AA51 Final Rule Stage
[[Page 71108]]
71 Air Cargo Screening 1652-AA64 Final Rule Stage
72 Amendment of Flight Training Regulations for F and M Nonimmigrants and to Transition J Flight 1653-AA43 Proposed Rule
Training Programs of the Department of State to M Flight Programs with the Department of Homeland Stage
Security
73 Clarification of Criteria for Certification, Oversight, and Recertification of Schools by the 1653-AA44 Proposed Rule
Student and Exchange Visitor Program (SEVP) To Enroll F or M Nonimmigrant Students Stage
74 Special Community Disaster Loans Program 1660-AA44 Proposed Rule
Stage
75 Update of FEMA's Public Assistance Regulations 1660-AA51 Proposed Rule
Stage
76 Disaster Assistance; Federal Assistance to Individuals and Households 1660-AA18 Final Rule Stage
--------------------------------------------------------------------------------------------------------------------------------------------------------
DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT
--------------------------------------------------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier Rulemaking Stage
Number Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
77 Refinement of Income and Rent Determinations in Public and Assisted Housing Programs (FR-4998) 2501-AD16 Final Rule Stage
78 Real Estate Settlement Procedures Act (RESPA): Simplification and Improvement of the Process of 2502-AI61 Final Rule Stage
Obtaining Home Mortgages and Reducing Consumer Costs (FR-5180)
--------------------------------------------------------------------------------------------------------------------------------------------------------
DEPARTMENT OF THE INTERIOR
--------------------------------------------------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier Rulemaking Stage
Number Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
79 Placement of Excess Spoil 1029-AC04 Final Rule Stage
80 Oil Shale Leasing and Operations 1004-AD90 Final Rule Stage
--------------------------------------------------------------------------------------------------------------------------------------------------------
DEPARTMENT OF JUSTICE
--------------------------------------------------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier Rulemaking Stage
Number Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
81 Nondiscrimination on the Basis of Disability in Public Accommodations and Commercial Facilities 1190-AA44 Final Rule Stage
82 Nondiscrimination on the Basis of Disability in State and Local Government Services 1190-AA46 Final Rule Stage
--------------------------------------------------------------------------------------------------------------------------------------------------------
DEPARTMENT OF LABOR
--------------------------------------------------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier Rulemaking Stage
Number Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
83 Senior Community Service Employment Program 1205-AB48 Proposed Rule
Stage
84 Senior Community Service Employment Program; Performance Accountability 1205-AB47 Final Rule Stage
85 Fiduciary Requirements for Disclosure in Participant-Directed Individual Account Plans 1210-AB07 Final Rule Stage
86 Prohibited Transaction Exemption for Provision of Investment Advice to Participants in Individual 1210-AB13 Final Rule Stage
Account Plans
87 Occupational Exposure to Crystalline Silica 1218-AB70 Prerule Stage
88 Cranes and Derricks 1218-AC01 Proposed Rule
Stage
89 Hazard Communication 1218-AC20 Proposed Rule
Stage
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 71109]]
DEPARTMENT OF TRANSPORTATION
--------------------------------------------------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier Rulemaking Stage
Number Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
90 Enhancing Airline Passenger Protections 2105-AD72 Proposed Rule
Stage
91 Automatic Dependent Surveillance--Broadcast (ADS-B) Equipage Mandate To Support Air Traffic Control 2120-AI92 Proposed Rule
Service Stage
92 National Registry of Certified Medical Examiners 2126-AA97 Proposed Rule
Stage
93 Carrier Safety Fitness Determination 2126-AB11 Proposed Rule
Stage
94 Commercial Driver's License Testing and Commercial Learner's Permit Standards 2126-AB02 Final Rule Stage
95 Ejection Mitigation 2127-AK23 Proposed Rule
Stage
96 Pipeline Safety: Distribution Integrity Management 2137-AE15 Final Rule Stage
--------------------------------------------------------------------------------------------------------------------------------------------------------
DEPARTMENT OF THE TREASURY
--------------------------------------------------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier Rulemaking Stage
Number Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
97 Basel II Standardized Approach 1557-AD07 Final Rule Stage
--------------------------------------------------------------------------------------------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
--------------------------------------------------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier Rulemaking Stage
Number Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
98 Review of the Primary National Ambient Air Quality Standard for Nitrogen Dioxide 2060-AO19 Prerule Stage
99 Review of the Secondary National Ambient Air Quality Standards for Oxides of Nitrogen and Oxides of 2060-AO72 Prerule Stage
Sulfur
100 Formaldehyde Emissions from Pressed Wood Products 2070-AJ44 Prerule Stage
101 Definition of Solid Waste for Non-Hazardous Materials 2050-AG44 Prerule Stage
102 Greenhouse Gas Mandatory Reporting Rule 2060-AO79 Proposed Rule
Stage
103 Renewable Fuels Standard Program 2060-AO81 Proposed Rule
Stage
104 Risk and Technology Review Phase II Group 2A 2060-AO91 Proposed Rule
Stage
105 Effluent Limitations Guidelines and Standards for the Construction and Development Point Source 2040-AE91 Proposed Rule
Category Stage
106 Prevention of Significant Deterioration and Nonattainment New Source Review: Emission Increases for 2060-AN28 Final Rule Stage
Electric Generating Units
107 Hazardous Waste Manifest Revisions -- Standards and Procedures for Electronic Manifests 2050-AG20 Final Rule Stage
108 CERCLA--Administrative Reporting Exemption for Air Releases of Hazardous Substances From Animal 2050-AG37 Final Rule Stage
Waste at Farms
--------------------------------------------------------------------------------------------------------------------------------------------------------
EQUAL EMPLOYMENT OPPORTUNITY COMMISSION
--------------------------------------------------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier Rulemaking Stage
Number Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
109 Genetic Information Nondiscrimination Act 3046-AA84 Proposed Rule
Stage
110 Disparate Impact Under the Age Discrimination in Employment Act 3046-AA76 Final Rule Stage
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 71110]]
NATIONAL ARCHIVES AND RECORDS ADMINISTRATION
--------------------------------------------------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier Rulemaking Stage
Number Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
111 Federal Records Management 3095-AB16 Final Rule Stage
--------------------------------------------------------------------------------------------------------------------------------------------------------
SMALL BUSINESS ADMINISTRATION
--------------------------------------------------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier Rulemaking Stage
Number Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
112 Lender Oversight Program 3245-AE14 Final Rule Stage
--------------------------------------------------------------------------------------------------------------------------------------------------------
SOCIAL SECURITY ADMINISTRATION
--------------------------------------------------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier Rulemaking Stage
Number Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
113 Revised Medical Criteria for Evaluating Respiratory System Disorders (859P) 0960-AF58 Proposed Rule
Stage
114 Revised Medical Criteria for Evaluating Mental Disorders (886P) 0960-AF69 Proposed Rule
Stage
115 Revised Medical Criteria for Evaluating Hematological Disorders (974P) 0960-AF88 Proposed Rule
Stage
116 Additional Insured Status Requirements for Certain Alien Workers (2882P) 0960-AG22 Proposed Rule
Stage
117 Revisions to Rules on Representation of Parties (3396F) 0960-AG56 Proposed Rule
Stage
118 Setting the Time and Place for a Hearing before an Administrative Law Judge (3481P) 0960-AG61 Proposed Rule
Stage
119 Revised Medical Criteria for Evaluating Immune (HIV) System Disorders (3466P) 0960-AG71 Proposed Rule
Stage
120 Amendments to Application Filing Date Requirements for Certain Military Members of the Uniformed 0960-AG73 Proposed Rule
Service (3474P) Stage
121 Reestablishing Appeals Council Level Provisions in the Boston Region (3502P) 0960-AG80 Proposed Rule
Stage
122 Disability Determinations by State Agency Disability Examiners (3510P) 0960-AG87 Proposed Rule
Stage
123 Amendments to Rules on Fee Payments and Sanctions (3513P) 0960-AG90 Proposed Rule
Stage
124 Revised Medical Criteria for Evaluating Hearing Loss (2862F) 0960-AG20 Final Rule Stage
125 Revised Medical Criteria for Malignant Neoplastic Diseases (3429F) 0960-AG57 Final Rule Stage
126 Authorization of Representative Fees (3508F) 0960-AG82 Final Rule Stage
--------------------------------------------------------------------------------------------------------------------------------------------------------
CONSUMER PRODUCT SAFETY COMMISSION
--------------------------------------------------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier Rulemaking Stage
Number Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
127 Flammability Standard for Upholstered Furniture 3041-AB35 Final Rule Stage
--------------------------------------------------------------------------------------------------------------------------------------------------------
NATIONAL INDIAN GAMING COMMISSION
--------------------------------------------------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier Rulemaking Stage
Number Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
128 Technical Standards for Gaming Machines and Gaming Systems 3141-AA29 Final Rule Stage
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 71111]]
POSTAL REGULATORY COMMISSION
--------------------------------------------------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier Rulemaking Stage
Number Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
129 Accounting Practices and Principles 3211-AA04 Final Rule Stage
--------------------------------------------------------------------------------------------------------------------------------------------------------
[FR Doc. Filed 11-21-08;8:45 am]
BILLING CODE 6820-27-S
[[Page 71112]]
DEPARTMENT OF AGRICULTURE (USDA)
Statement of Regulatory Priorities
USDA's regulatory efforts in 2009 will focus on implementing the Food,
Conservation, and Energy Act of 2008 (``2008 Farm Bill'') covering
major farm, trade, conservation, rural development, nutrition
assistance and other programs. In addition to work implementing the
2008 Farm Bill, USDA's regulatory activities in 2009 will cover a broad
range of issues. Within the rulemaking process is the department-wide
effort to reduce burden on participants and program administrators
alike by focusing on improving program outcomes, and particularly on
achieving the performance measures specified in the USDA and agency
Strategic Plans. Important areas of activity include the following:
USDA will continue regulatory work to protect the health and
value of U.S. agricultural and natural resources while
facilitating trade flows. This includes amending
regulations related to the importation of fruits and
vegetables, nursery products, animals and animal products,
and continuing work related to regulation of plant and
animal biotechnologies. In addition, USDA will propose
specific standards for the humane handling, care,
treatment, and transportation of birds under the Animal
Welfare Act.
In the area of food safety, USDA will continue to develop
science-based regulations that improve the safety of meat,
poultry, and 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. As required by the 2008 Farm
Bill, USDA will also develop science-based regulations that
improve the safety of catfish in the least burdensome and
most cost-effective manner. To assist small entities to
comply with food safety requirements, the Food Safety and
Inspection Service will continue to collaborate with other
USDA agencies and State partners in the enhanced small
business outreach program.
As changes are made for the nutrition assistance programs,
USDA will work to foster actions that will help improve
diets, and particularly to prevent and reduce overweight
and obesity. In 2009, FNS will continue to promote
nutritional knowledge and education while minimizing
participant and vendor fraud. USDA has priority projects in
the Rural Development mission area to strengthen the
regulations for its broadband access program to better
focus on areas without such access, to consolidate and
streamline its regulations relating to the delivery of its
guaranteed loan programs, and to promulgate new regulations
that promote the development and production of advanced
biofuels.
USDA has priority projects in the Rural Development mission
area to strengthen the regulations for its broadband access
program to better focus on areas without access. Rural
Development will publish new regulations that will
consolidate and streamline the delivery of its guaranteed
loan programs. Rural Development is anticipating the
publication of both interim final rules by the end of the
year. Finally, pursuant to the 2008 Farm Bill, Rural
Development will promulgate new regulations that promote
the development and production of advanced biofuels.
USDA will continue to promote economic opportunities for
agriculture and rural communities through its BioPreferred
Program (formerly the Federal Biobased Product Preferred
Procurement Program). USDA will continue to designate
groups of biobased products to receive procurement
preference from Federal agencies and contractors. In
addition, USDA will publish rules establishing the
Voluntary Labeling Program for biobased products.
Reducing Paperwork Burden on Customers
USDA has made substantial progress in implementing the goal of the
Paperwork Reduction Act of 1995 to reduce the burden of information
collection on the public. To meet the requirements of the Government
Paperwork Elimination Act (GPEA) and the E-Government Act, agencies
across USDA are providing electronic alternatives to their
traditionally paper-based customer transactions. As a result, producers
increasingly have the option to electronically file forms and all other
documentation online. To facilitate the expansion of electronic
government, USDA implemented an electronic authentication capability
that allows customers to ``sign-on'' once and conduct business with all
USDA agencies. Supporting these efforts are ongoing analyses to
identify and eliminate redundant data collections and streamline
collection instructions. The end result of implementing these
initiatives is better service to our customers enabling them to choose
when and where to conduct business with USDA.
The Role of Regulations
The programs of USDA are diverse and far reaching, as are the
regulations that attend their delivery. Regulations codify how USDA
will conduct its business, including the specifics of access to, and
eligibility for, USDA programs. Regulations also specify the
responsibilities of State and local governments, private industry,
businesses, and individuals that are necessary to comply with their
provisions.
The diversity in purpose and outreach of USDA programs contributes
significantly to USDA being near the top of the list of departments
that produce the largest number of regulations annually. These
regulations range from nutrition standards for the school lunch
program, to natural resource and environmental measures governing
national forest usage and soil conservation, to emergency producer
assistance as a result of natural disasters, to regulations protecting
American agribusiness (a major dollar value contributor to exports)
from the ravages of domestic or foreign plant or animal pestilence, and
they extend from farm to supermarket to ensure the safety, quality, and
availability of the Nation's food supply.
Many regulations function in a dynamic environment, which requires
their periodic modification. The factors determining various
entitlement, eligibility, and administrative criteria often change from
year to year. Therefore, many significant regulations must be revised
annually to reflect changes in economic and market benchmarks.
Almost all legislation that affects USDA programs has accompanying
regulatory needs, often with a significant impact resulting in the
modification, addition, or deletion of many programs. In 2009, USDA
will implement the 2008 Farm Bill through regulations on major programs
covering domestic commodity support, crop insurance, conservation,
export and foreign food assistance, bioenergy, rural development,
agricultural research, and food and nutrition programs.
[[Page 71113]]
Major Regulatory Priorities
This document represents summary information on prospective significant
regulations as called for in Executive Order 12866. The following
agencies are represented in this regulatory plan, along with a summary
of their mission and key regulatory priorities for 2009:
Farm Service Agency
Mission: The Farm Service Agency's (FSA) mission is to stabilize farm
income; to assist owners and operators of farms and ranches to conserve
and enhance soil, water, and related natural resources; to provide
credit to new or existing farmers and ranchers who are temporarily
unable to obtain credit from commercial sources; and to help farm
operations recover from the effects of disaster, as prescribed by
various statutes.
Priorities: FSA's priority for 2009 will be to fully implement the 2008
Farm Bill, the Food, Conservation, and Energy Act of 2008. The 2008
Farm Bill, which was enacted on June 18, 2008, governs Federal farm
programs through 2012. Among its major provisions are to provide income
support for wheat, feed grains, upland cotton, rice, oilseeds, and
other commodities through three programs: Direct payments, counter-
cyclical payments, and marketing loans. It also provides a new
alternative income support program, the average crop revenue election
program. In addition, the 2008 Farm Bill provides a set of standing
disaster assistance programs, including a new revenue based program for
supplemental agricultural disaster assistance. These entirely new
programs require completely new regulations and revision of the
existing program regulations. In addition, significant revisions in
existing regulations will be required to address new reforms in
criteria for program eligibility and limitations on payments to
participants. It also requires changes to farm operating loans, down
payment loans, and emergency loans, including expanding to include
socially disadvantaged farmers, increasing loan limits, loan size,
funding targets, interest rates, and graduating borrowers to commercial
credit. In addition, it establishes a new direct and guaranteed loan
program to assist farmers in implementing conservation practices. FSA
will develop and issue the regulations and make program funds available
to eligible clientele in as timely a manner as possible. As these and
future changes required by Administration initiatives and new
legislation are made, the Agency's focus will be to implement the
changes in such a way as to provide benefits while minimizing program
complexity and regulatory burden for program participants.
Opportunities will be taken to clarify, simplify, and reduce confusion
whenever possible. The Agency's ability to promote new policy
initiatives when implementing these regulations is limited due to the
need to adhere to legislative intent. Therefore, due to their combined
economic magnitude, they are noted here to acknowledge their
significance in the overall USDA regulatory plan, but are not further
listed in the body of the plan that appears below (the regulations are
all included in the Unified Agenda).
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
2008 regulatory plan supports USDA's Strategic Goal 5, ``Improve the
Nation's Nutrition and Health,'' and its three related objectives:
Improve Access to Nutritious Food. This objective represents
FNS's efforts to improve nutrition by providing access to
program benefits (Food Stamps, WIC food vouchers and
nutrition services, school meals, commodities) and
distributing State administrative funds to support program
operations. To advance this objective, FNS plans to
finalize rules implementing provisions of the Farm Security
and Rural Investment Act of 2002 (P.L. 107-171) to simplify
program administration, support work, and improve access to
benefits in the Food Stamp Program (FSP). The Agency will
also issue rules implementing provisions of the Child
Nutrition and WIC Reauthorization Act of 2004 (P.L. 108-
265) to establish automatic eligibility for homeless
children for school meals.
Promote Healthier Eating Habits and Lifestyles. This objective
represents FNS's efforts to improve nutrition knowledge and
behavior through nutrition education and breastfeeding
promotion, and to ensure that program benefits meet the
appropriate nutrition standards to effectively improve
nutrition for program participants. In support of this
objective, FNS plans to finalize a rule revising
requirements that allow schools to substitute
nutritionally-equivalent non-dairy beverages for fluid milk
at the request of a recipient's parent in addition to
medical care providers.
Improve Nutrition Assistance Program Management and Customer
Service. This objective represents FNS's ongoing commitment
to maximize the accuracy of benefits issued, maximize the
efficiency and effectiveness of program operations, and
minimize participant and vendor fraud. In support of this
objective, FNS plans to finalize rules in the Child and
Adult Care Food Program (CACFP) and the Special
Supplemental Nutrition Program for Women, Infants and
Children Program (WIC) to improve program management and
prevent vendor fraud, as well as finalize rules in the FSP
to improve the Quality Control process.
Food Safety and Inspection Service
Mission: The Food Safety and Inspection Service (FSIS) is responsible
for ensuring that meat, poultry, egg, and catfish products in
interstate and foreign commerce are wholesome, not adulterated, and
properly marked, labeled, and packaged.
Priorities: FSIS' 2008 Regulatory Plan helps implement USDA's Strategic
Goal 4, ``Enhance Protection and Safety of the Nation's Agriculture and
Food Supply,'' particularly the objective to reduce the incidence of
foodborne illnesses related to meat, poultry, egg products, and, once a
program is implemented, catfish in the U.S. FSIS is working toward a
more scientific inspection system with a more risk-based approach to
ensuring that meat, poultry, egg products, and catfish are wholesome
and not adulterated or misbranded.
FSIS is committed to developing and issuing science-based regulations
intended to ensure that meat, poultry, egg, and catfish products are
wholesome and not adulterated or misbranded. FSIS continues to review
its existing authorities and regulations to streamline excessively
prescriptive regulations, to revise or remove regulations that are
inconsistent with the Agency's hazard analysis and critical control
point regulations, and to ensure that it can address emerging food
safety challenges. FSIS is also working with the Food and Drug
Administration (FDA) to better delineate the two agencies'
jurisdictions over various food products.
[[Page 71114]]
Following are some of the Agency's recent and planned initiatives:
In July 2008, FSIS published a final rule on the Availability of Retail
Consignee During Meat and Poultry Product recalls. This final rule
should enhance the public health by helping consumers to determine
whether they have recalled product in their refrigerator freezer or
pantry.
FSIS is proposing to require that all cattle that become non-ambulatory
disabled at any time before slaughter, including those that become non-
ambulatory disabled after passing ante-mortem inspection, must be
condemned and properly disposed of. Under the current regulations, FSIS
inspection personnel determine, on case by-case basis, the disposition
of cattle that become nonambulatory disabled after they have passed
ante-mortem inspection. FSIS is proposing to remove the provision for
case-by-case determination by FSIS inspection personnel.
2008 Farm Bill-related Rulemakings:
The Food, Conservation, and Energy Act of 2008 (Pub. L. 110-246), known
as the 2008 Farm Bill, made several amendments to statutes administered
by FSIS and gave the Agency other instructions. As a result, FSIS is
developing new regulations to implement: mandatory inspection for
catfish; a program for interstate shipment of State-inspected meat and
poultry products; and recall procedure and process control reassessment
requirements for inspected establishments. FSIS is also developing
regulations on country-of-origin labeling (COOL) for certain meat and
poultry commodities to conform to final regulations promulgated by
USDA's Agricultural Marketing Service.
Catfish Inspection:
FSIS is developing regulations to implement Farm Bill amendments of the
FMIA (in Pub. L. 110-246, Sec. 11016) to make catfish amenable to the
FMIA. The regulations will define ``catfish'' and the scope of coverage
of the regulations to apply to establishments that process catfish and
catfish products. The regulations, to be implemented no later than 18
months from the date of enactment of the 2008 Farm Bill, will take into
account the conditions under which the catfish are raised and
transported to a processing establishment.
Interstate shipment of State-inspected meat and poultry products:
FSIS is proposing regulations to implement a new voluntary Federal-
State cooperative inspection program under which State-inspected
establishments with 25 or fewer employees would be eligible to ship
meat and poultry products in interstate commerce. State-inspected
establishments selected to participate in this program would be
required to comply with all Federal standards under the FMIA and the
PPIA. These establishments would receive inspection services from State
inspection personnel that have been trained and certified to assist
with enforcement of the FMIA and PPIA. Meat and poultry products
produced under the program that have been inspected and passed by
selected State inspection personnel would bear a Federal mark of
inspection. Section 11015 of the 2008 Farm Bill provides for the
interstate shipment of State-inspected meat and poultry product from
selected establishments and requires that FSIS promulgate implementing
regulations no later than 18 months from the date of its enactment.
Food safety improvement:
FSIS is proposing regulations that will implement Sec. 11017 of the
2008 Farm Bill on notification, documentation, and recordkeeping
requirements for inspected establishments. This section amends the FMIA
and PPIA to require establishments that are subject to inspection under
these Acts to promptly notify the Agency that an adulterated or
misbranded product received by or originating from the establishment
has entered into commerce, if the establishment has reason to believe
that this has happened. Section 11017 also requires establishments
subject to inspection under the FMIA and PPIA to: (1) prepare and
maintain current procedures for the recall of all products produced and
shipped by the establishment; (2) document each reassessment of the
process control plans of the establishment; and (3) upon request, make
the procedures and reassessed control plans available to FSIS
inspection personnel for review and copying.
In June 2003, FSIS published an interim final rule requiring
establishments to prevent L. monocytogenes contamination of RTE
products. The Agency is evaluating the effectiveness of this interim
final rule, which in 2004 was the subject of a regulatory reform
nomination to OMB. FSIS has carefully reviewed its economic analysis of
the interim final rule in response to this recommendation and is
planning to adjust provisions of the rule to reduce the information
collection burden on small businesses. FSIS is also planning further
action with respect to other elements of the 2001 proposal, based on
quantitative risk assessments of target pathogens in processed
products.
FSIS plans to propose to amend the poultry products inspection
regulations to put in place a system in which the establishment sorts
the carcasses for defects, and the Agency verifies that the system is
under control and producing safe and wholesome product. The Agency
would propose to adopt performance standards, designed to ensure that
the establishments are carrying out slaughter, dressing, and chilling
operations in a manner that ensures no significant growth of pathogens,
as demonstrated by control of the pathogens or indicator organisms. The
Agency would also verify that vulnerable points in the process are
under control.
Small business implications:
The great majority of businesses regulated by FSIS are small
businesses. With the exception of the non-ambulatory disabled cattle
rulemaking, the regulations listed above substantially affect small
businesses. Some rulemakings can benefit small businesses. For example,
the rule on interstate shipment of State-inspected products will open
interstate markets to some small State-inspected establishments that
previously could only sell their products within State boundaries.
FSIS recognizes the difficulties faced by many small and very small
establishments in complying with necessary, science-based food-safety
or other consumer protection requirements and in assuming the
associated technical and financial burdens. FSIS attempts to reduce the
burdens of its regulations on small business by providing alternative
dates of compliance, furnishing detailed compliance guidance material,
and conducting outreach programs to small and very small
establishments.
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.
The Agency collaborates in this effort with other USDA agencies and
cooperating State partners. For
[[Page 71115]]
example, FSIS makes plant owners and operators aware of loan programs,
available through USDA's Rural Business and Cooperative programs, to
help them in upgrading their facilities. FSIS employees meet
proactively with small and very small plant operators to learn more
about their specific needs and provide joint training sessions for
small and very small plants and FSIS employees.
International trade or investment effects:
To be eligible for the importation of meat, poultry, or egg products
into the United States, foreign inspection systems and establishments
must meet regulatory standards that are equivalent to those that FSIS
administers. For most of the regulatory initiatives described above,
foreign inspection systems will have to ensure that they are
maintaining equivalent standards. For example, in order to be able to
continue to ship catfish-type products to the United States, foreign
countries will have to have inspection systems for catfish and catfish
products that impose requirements that are equivalent to those that
FSIS will establish in the rulemaking described above.
Animal and Plant Health Inspection Service
Mission: A major part of the mission of the Animal and Plant Health
Inspection Service (APHIS) is to protect the health and value of
American agricultural and natural resources. APHIS conducts programs to
prevent the introduction of exotic pests and diseases into the 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 Animal Welfare Act.
Priorities: APHIS is continuing work to revise its biotechnology
regulations to reflect new consolidated authorities under the Plant
Protection Act and to address advances in technology. APHIS also plans
to revise its regulations for importing nursery stock to better address
plant health risks associated with propagative material. With respect
to animal health, the Agency intends to revise its regulations
concerning bovine spongiform encephalopathy (BSE) to provide a more
comprehensive framework for the importation of certain animals and
products. The revision of the regulations regarding BSE will likely be
of most interest to those countries that currently export large volumes
of live bovines or bovine-derived products to the United States, as
well as to those countries from which such commodities are currently
prohibited, but that may wish to export live bovines or bovine products
to the United States in the future. APHIS also plans to propose
standards for the humane handling, care, treatment, and transportation
of birds covered under the Animal Welfare Act.
Additional information about APHIS and its programs is available on the
Internet at http://www.aphis.usda.gov.
Agricultural Marketing Service
Mission: The Agricultural Marketing Service (AMS) provides marketing
services to producers, manufacturers, distributors, importers,
exporters, and consumers of food products. The AMS also manages the
government's food purchases, supervises food quality grading, maintains
food quality standards, and supervises the Federal research and
promotion programs.
Priorities: AMS priority items for the next year include several
rulemakings as a result of passage of the Food, Conservation, and
Energy Act of 2008 (2008 Farm Bill). These include the following:
Country of Origin Labeling:
On August 1, 2008, AMS published an interim final rule implementing the
Mandatory Country of Origin and Labeling (COOL) of Beef, Pork, Lamb,
Chicken, Goat, Perishable Agricultural Commodities, Peanuts, Pecans,
Ginseng, and Macadamia Nuts as directed by the 2002 Farm Bill. The rule
requires retailers to notify their customers of the country of origin
of covered commodities. Covered commodities include muscle cuts of beef
(including veal), lamb, chicken, goat, and pork; ground beef, ground
lamb, ground chicken, ground goat, and ground pork; perishable
agricultural commodities; macadamia nuts; pecans; ginseng; and peanuts.
Because the 2008 Farm Bill contained a number of provisions that amends
the regulations, AMS published an interim final rule with request for
comments to allow newly affected industries the opportunity to comment
prior to issuance of a final rule. The COOL interim final rule for wild
and farm-raised fish and shellfish was published On October 5, 2004.
Dairy Promotion and Research Program:
The Dairy Production Stabilization Act of 1983 (Dairy Act) authorized
USDA to create a national producer program for dairy product promotion,
research, and nutrition education as part of a comprehensive strategy
to increase human consumption of milk and dairy products. Dairy farmers
fund this self-help program through a mandatory assessment on all milk
produced in the contiguous 48 States and marketed commercially. Dairy
farmers administer the national program through the National Dairy
Promotion and Research Board (Dairy Board).
The 2008 Farm Bill extended the program to include producers in Alaska,
Hawaii, and Puerto Rico who will pay an assessment of $0.15 per
hundredweight of milk production. Imported dairy products will be
assessed at $0.075 per hundredweight of fluid milk equivalent. An
interim final rule will implement these new provisions.
Dairy Forward Pricing:
The 2008 Farm Bill re-established the Dairy Forward Pricing Program,
which allows dairy farmers to voluntarily enter into forward contracts
with milk handlers. The original Dairy Forward Pricing Program operated
on a pilot basis from 1999 through 2004. A forward contract is an
agreement to sell a stated quantity of milk, for a stated period, at a
stated priced. This voluntary risk management tool will allow producers
and handlers to ``lock in'' prices, reducing risks associated with
changes in price and income and enhancing the ability to obtain
financing. AMS intends to issue an interim final rule to implement the
program as provided for in the 2008 Farm Bill.
Establish Procedures for Farmers' Market Promotion Program:
The Agricultural Marketing Service (AMS) will establish regulations for
the operation of the Farmers' Market Promotion Program (FMPP)
incorporating new amendments enacted in the 2008 Farm Bill. The purpose
of the FMPP is to make grants available to eligible entities for
projects to ``establish, expand, and promote farmers' markets and to
promote direct producer-to-consumer marketing''; increase domestic
consumption of agricultural commodities by improving and expanding, or
assisting in the improvement and expansion of domestic farm ers'
markets, roadside stands, community-supported agriculture programs,
agri-tourism activities, and other direct producer-to-
[[Page 71116]]
consumer market opportunities; and develop, or aid in the development
of, new farmers' markets, roadside stands, community-supported
agriculture programs, agri-tourism activities, and other direct
producer-to-consumer marketing opportunities.
Other important rulemakings the Agency will undertake include two
proposed rules amending the National Organic Program regulations. The
1990 Organic Foods Production Act, established the National Organic
Program (NOP) within the Agricultural Marketing Service (AMS). It also
established the National Organic Standards Board (NOSB), as an advisory
body to the NOP. The program was established to create organic
standards and to require and oversee mandatory certification or organic
production. The NOP regulations were implemented in 2002.
Access to Pasture:
Since implementation of the NOP, some members of the public have
advocated for a more explicit regulatory standard on the relationship
between livestock, particularly dairy animals, and grazing land. They
have asserted the current regulatory language on access to pasture for
ruminants and temporary confinement based on an animal's stage of
production, when applied together, do not provide a uniform requirement
for the pasturing of ruminant animals that meet the principles
underlying an organic management system for livestock and livestock
products that consumers expect.
Dairy Replacement:
The Agricultural Marketing Service (AMS) is proposing to amend the
National Organic Program (NOP) regulations to clarify the regulations
with respect to the sourcing of dairy replacement animals. AMS expects
to publish a proposed rule with request for comment in spring 2009
requesting input on existing origin of livestock provisions.
AMS Program Rulemaking Pages: All of AMS' rules published in the
Federal Register are available on the Internet at http://
www.regulations.gov. This site also includes commenting instructions
and addresses, links to news releases and background material, and
comments received on various rules.
Forest Service
Mission: The mission of the Forest Service is to sustain the health,
productivity, and diversity of the Nation's forests and rangelands to
meet the needs of present and future generations. This includes
protecting and managing National Forest System lands; providing
technical and financial assistance to States, communities, and private
forest landowners; and developing and providing scientific and
technical assistance and scientific exchanges in support of
international forest and range conservation.
Priorities: Roadless Rules - On January 12, 2001, the Department of
Agriculture promulgated the Roadless Area Conservation Rule (RACR) to
provide for the conservation and management of approximately 58.5
million acres of inventoried roadless areas within the National Forest
System under the principles of the Multiple-Use Sustained-Yield Act of
1960. On July 14, 2003, the U.S. District Court for the District of
Wyoming found the 2001 roadless rule to be unlawful and ordered that
the rule be permanently enjoined. The final rule for Inventoried
Roadless Area Management for the State of Idaho was published October
16, 2008. The State of Colorado has petitioned the Secretary pursuant
to 5 U.S.C. Sec. 553(e) and 7 C.F.R. Sec. 1.28 for state specific rules
to replace this national rule.
The 2008 Farm Bill identifies 3 rule-making actions specific to the
Forest Service. These proposals are priority for the agency for fall
2008.
Community Forest And Open Space Conservation Program - This
program will provide federal matching grants to help local
government, tribes, or non-profit organizations acquire
private forests that are threatened by conversion to non-
forest uses.
Pest And Disease Revolving Loan Fund - The Pest and Disease
Revolving Loan Fund authorizes low interest loans to local
governments for equipment & contracts to aid in combating
invasive species outbreaks in community trees and forests.
Forest Products For Traditional And Cultural Purposes - The
Forest Products for Traditional and Cultural Purposes
provision authorizes Indian Tribes free use of forest
products from National Forest System lands for traditional
and cultural purposes.
Rural Development
Mission: Rural Development's mission is to support increased economic
opportunities and improved quality of life in rural America. This
support is provided through loan guarantees, grants and technical
assistance for rural housing, community facilities, business and
industry, and electric, telecommunication and water and waste disposal
facilities.
Priorities: USDA has priority projects in Rural Development to
strengthen the regulations for its broadband access program to better
focus on areas without such access. Rural Development will publish new
regulations that will consolidate and streamline the delivery of its
guaranteed loan programs. Rural Development is anticipating the
publication of both interim final rules by the end of the year.
Finally, pursuant to the 2008 Farm Bill, Rural Development will
promulgate new regulations that promote the development and production
of advanced biofuels.
Departmental Administration
Mission: Departmental Administration's mission is to provide management
leadership to ensure that USDA administrative programs, policies,
advice and counsel meet the needs of USDA program organizations,
consistent with laws and mandates; and provide safe and efficient
facilities and services to customers.
Priorities: The regulatory priority for Departmental Administration is
to continue implementing the BioPreferred Program (formerly the Federal
Biobased Product Preferred Procurement Program) authorized by the 2008
Farm Bill (Public Law 110-246). Included in this priority are proposed
and final regulations designating items for preferred Federal
procurement. These regulations will assist in the expansion of market
opportunities for manufacturers of biobased products, resulting in
economic opportunities for American agricultural producers and rural
communities. These efforts support USDA's strategic goal ``To enhance
the competitiveness and sustainability of rural and farm economies.''
In addition, Departmental Administration will look to begin
implementation of the BioPreferred labeling program. Once implemented,
this program will allow biobased manufacturers to receive a label to be
used in the commercial market to distinguish their products as
biobased.
Aggregate Costs and Benefits
Per E.O. 13422, USDA is required to provide its best estimate of the
combined aggregate costs and benefits of final regulations included in
the Regulatory Plan. For calendar year 2009, USDA's priority will be to
fully implement the 2008 Farm Bill, the Food, Conservation, and Energy
Act of 2008. The 2008 Farm Bill governs
[[Page 71117]]
Federal farm programs through 2012. Provisions will require completely
new regulations and revision of existing program regulations. The
Department's focus on Farm Bill and other regulations will be to
implement the changes in such a way as to provide benefits while
minimizing program complexity and regulatory burden for program
participants.
_______________________________________________________________________
USDA--Animal and Plant Health Inspection Service (APHIS)
-----------
PROPOSED RULE STAGE
-----------
1. ANIMAL WELFARE; REGULATIONS AND STANDARDS FOR BIRDS
Priority:
Other Significant
Legal Authority:
7 USC 2131 to 2159
CFR Citation:
9 CFR 1 to 3
Legal Deadline:
None
Abstract:
APHIS intends to establish standards for the humane handling, care,
treatment, and transportation of birds other than birds bred for use in
research.
Statement of Need:
The Farm Security and Rural Investment Act of 2002 amended the
definition of animal in the Animal Welfare Act (AWA) by specifically
excluding birds, rats of the genus Rattus, and mice of the genus Mus,
bred for use in research. While the definition of animal in the
regulations contained in 9 CFR part 1 has excluded rats of the genus
Rattus and mice of the genus Mus bred for use in research, that
definition has also excluded all birds (i.e., not just those birds bred
for use in research). In line with this change to the definition of
animal in the AWA, APHIS intends to establish standards in 9 CFR part 3
for the humane handling, care, treatment, and transportation of birds
other than those birds bred for use in research.
Summary of Legal Basis:
The Animal Welfare Act (AWA) authorizes the Secretary of Agriculture to
promulgate standards and other requirements governing the humane
handling, care, treatment, and transportation of certain animals by
dealers, research facilities, exhibitors, operators of auction sales,
and carriers and immediate handlers. Animals covered by the AWA include
birds that are not bred for use in research.
Alternatives:
To be identified.
Anticipated Cost and Benefits:
To be determined.
Risks:
Not applicable.
Timetable:
_______________________________________________________________________
Action Date FR Cite
_______________________________________________________________________
NPRM 02/00/09
NPRM Comment Period End 04/00/09
Regulatory Flexibility Analysis Required:
Yes
Small Entities Affected:
Businesses
Government Levels Affected:
Undetermined
Additional Information:
Additional information about APHIS and its programs is available on the
Internet at http://www.aphis.usda.gov.
Agency Contact:
Darrel Styles
Veterinary Medical Officer, Animal Care
Department of Agriculture
Animal and Plant Health Inspection Service
4700 River Road, Unit 84
Riverdale, MD 20737-1234
Phone: 301 734-0658
RIN: 0579-AC02
_______________________________________________________________________
USDA--APHIS
2. IMPORTATION OF PLANTS FOR PLANTING; ESTABLISHING A NEW CATEGORY OF
PLANTS FOR PLANTING NOT AUTHORIZED FOR IMPORTATION PENDING RISK
ASSESSMENT (RULEMAKING RESULTING FROM A SECTION 610 REVIEW)
Priority:
Other Significant
Legal Authority:
7 USC 450; 7 USC 7701 to 7772; 7 USC 7781 to 7786; 21 USC 136 and 136a
CFR Citation:
7 CFR 319
Legal Deadline:
None
Abstract:
This action would establish a new category in the regulations governing
the importation of nursery stock, also known as plants for planting.
This category would list taxa of plants for planting whose importation
is not authorized pending risk assessment. We would allow foreign
governments to request that a pest risk assessment be conducted for a
taxon whose importation is not authorized pending risk evaluation.
After the pest risk assessment was completed, we would conduct
rulemaking to remove the taxon from the proposed category if determined
appropriate by the risk assessment. We are also proposing to expand the
scope of the plants regulated in the plants for planting regulations to
include non-vascular plants. These changes would allow us to react more
quickly to evidence that a taxon of plants for planting may pose a pest
risk while ensuring that our actions are based on scientific evidence.
Statement of Need:
APHIS typically relies on inspection at a Federal plant inspection
station or port of entry to mitigate the risks of pest introduction
associated with the importation of plants for planting. Importation of
plants for planting is further restricted or prohibited only if there
is specific evidence that such importation could introduce a quarantine
pest into the United States. Most of the taxa of plants for planting
currently being imported have not been thoroughly studied to determine
whether their importation presents a risk of introducing a quarantine
pest into the United States. The volume and the number of types of
plants for planting have increased dramatically in recent years, and
there are several problems associated with gathering data on what
plants for planting are being imported and on the risks such
importation presents. In addition, quarantine pests that enter the
United States via the importation of plants for planting pose a
particularly high risk of becoming established within the United
States. The current regulations need to be amended to better address
these risks.
Summary of Legal Basis:
The Secretary of Agriculture may prohibit or restrict the importation
or entry of any plant if the Secretary determines that the prohibition
or
[[Page 71118]]
restriction is necessary to prevent the introduction into the United
States of a plant pest or noxious weed (7 U.S.C. 7712).
Alternatives:
APHIS has identified one alternative to the approach we are
considering. We could prohibit the importation of all nursery stock
pending risk evaluation, approval, and notice-and-comment rulemaking,
similar to APHIS's approach to regulating imported fruits and
vegetables. This approach would lead to a major interruption in
international trade and would have significant economic effects on both
U.S. importers and U.S. consumers of plants for planting.
Anticipated Cost and Benefits:
Undetermined.
Risks:
In the absence of some action to revise the nursery stock regulations
to allow us to better address pest risks, increased introductions of
plant pests via imported nursery stock are likely, causing extensive
damage to both agricultural and natural plant resources.
Timetable:
_______________________________________________________________________
Action Date FR Cite
_______________________________________________________________________
NPRM 02/00/09
NPRM Comment Period End 04/00/09
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:
Additional information about APHIS and its programs is available on the
Internet at http://www.aphis.usda.gov.
Agency Contact:
Arnold T. Tschanz
Senior Import Specialist, Commodity Import Analysis and Operations, PPQ
Department of Agriculture
Animal and Plant Health Inspection Service
4700 River Road, Unit 133
Riverdale, MD 20737-1236
Phone: 301 734-5306
RIN: 0579-AC03
_______________________________________________________________________
USDA--APHIS
3. BOVINE SPONGIFORM ENCEPHALOPATHY; IMPORTATION OF BOVINES AND BOVINE
PRODUCTS
Priority:
Other Significant
Legal Authority:
7 USC 450; 7 USC 1622; 7 USC 7701 to 7772; 7 USC 8301 to 8317; 21 USC
136 and 136a; 31 USC 9701
CFR Citation:
9 CFR 92 to 96; 9 CFR 98
Legal Deadline:
None
Abstract:
This rulemaking would amend the regulations regarding the importation
of bovines and bovine products. Under this rulemaking, countries would
be classified as either negligible risk, controlled risk, or
undetermined risk for bovine spongiform encephalopathy (BSE). Some
commodities would be allowed importation into the United States
regardless of the BSE classification of the country of export. Other
commodities would be subject to importation restrictions or
prohibitions based on the type of commodity and the BSE classification
of the country. The criteria for country classification and commodity
import would be closely aligned with those of the World Organization
for Animal Health.
Statement of Need:
We are proposing to amend the regulations after conducting a thorough
review of relevant scientific literature and a comprehensive evaluation
of the issues and concluding that the proposed changes would continue
to guard against the introduction of BSE into the United States, while
allowing the importation of additional animals and animal products into
this country.
Summary of Legal Basis:
Under the Animal Health Protection Act of 2002 (7 U.S.C. 8301 et seq.),
the Secretary of Agriculture is authorized to promulgate regulations to
prevent the introduction into the United States or dissemination of any
pest or disease of livestock.
Alternatives:
We could leave the bovine regulations unchanged. The current
regulations are not consistent with the latest scientific information,
however, and, as a result, are more restrictive than necessary. Another
alternative--modifying the BSE regulations related to the importation
of bovines and bovine-derived products to precisely match the OIE
guidelines without allowing for modification deemed necessary by
APHIS--would not allow APHIS to independently interpret the scientific
literature or reflect current USDA regulations and policies. Making no
changes to the current regulations that govern the importation of
cervids and camelids would perpetuate an unnecessary constraint on
trade in those commodities, because cervids and camelids pose an
extremely low BSE risk.
Anticipated Cost and Benefits:
Undetermined.
Risks:
APHIS has concluded that the proposed changes would continue to guard
against the introduction of BSE into the United States.
Timetable:
_______________________________________________________________________
Action Date FR Cite
_______________________________________________________________________
NPRM 02/00/09
NPRM Comment Period End 04/00/09
Regulatory Flexibility Analysis Required:
Yes
Small Entities Affected:
Businesses
Government Levels Affected:
Federal
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.
[[Page 71119]]
Agency Contact:
Christopher Robinson
Senior Staff Veterinarian, Technical Trade Services, National Center
for Import and Export, VS
Department of Agriculture
Animal and Plant Health Inspection Service
4700 River Road, Unit 40
Riverdale, MD 20737-1231
Phone: 301 734-7837
RIN: 0579-AC68
_______________________________________________________________________
USDA--APHIS
-----------
FINAL RULE STAGE
-----------
4. INTRODUCTION OF ORGANISMS AND PRODUCTS ALTERED OR PRODUCED THROUGH
GENETIC ENGINEERING
Priority:
Other Significant
Legal Authority:
7 USC 7701 to 7772; 7 USC 7781 to 7786; 31 USC 9701
CFR Citation:
7 CFR 340
Legal Deadline:
None
Abstract:
This rulemaking would revise the regulations regarding the importation,
interstate movement, and environmental release of certain genetically
engineered organisms in order to bring the regulations into alignment
with provisions of the Plant Protection Act. The revisions would also
update the regulations in response to advances in genetic science and
technology and our accumulated experience in implementing the current
regulations. This is the first comprehensive review and revision of the
regulations since they were established in 1987. This rule would affect
persons involved in the importation, interstate movement, or release
into the environment of genetically engineered plants and certain other
genetically engineered organisms.
Statement of Need:
APHIS currently regulates the introduction (movement into the United
States or interstate, or release into the environment) of genetically
engineered organisms that may present a plant pest risk under 7 CFR
part 340, ``Introduction of Organisms and Products Altered or Produced
Through Genetic Engineering Which Are Plant Pests or Which There Is
Reason to Believe Are Plant Pests.'' APHIS is evaluating its regulatory
program to determine if there is a need to revise its regulations in
light of our current knowledge and experience and advances in science
and technology.
Summary of Legal Basis:
The primary authority is provided by the Plant Protection Act, which
authorizes the Secretary of Agriculture to prohibit or restrict the
importation, entry, and movement in interstate commerce any plant,
plant product, biological control organism, noxious weed, or other
article if necessary to prevent the introduction into or dissemination
within the United States of any plant pest or noxious weed. Such
articles may include genetically engineered products.
Alternatives:
A draft environmental impact statement (DEIS) prepared for this action
evaluates all of the regulatory alternatives under consideration by the
Agency. Some key alternatives considered include whether APHIS should
broaden the scope of the regulations to reflect its authority over
noxious weeds and biological control organisms; whether and how to
revise the regulations to make the Agency's use of risk-based
categories--where genetically engineered organisms are classified
according to risk and familiarity so that oversight and confinement
vary by category--more refined, more explicit and more transparent to
the industry and the public and what criteria should be used to
establish risk-based categories; how to manage genetically engineered
organisms that present only minor unresolved risks that can be
mitigated effectively, and what factors should be considered in
establishing appropriate mitigations; whether new or additional
regulatory mechanisms are needed to ensure that genetically engineered
organisms producing pharmaceutical or industrial compounds are subject
to requirements and oversight commensurate with the potential risks;
for organisms that might be commercialized but that do not meet the
criteria for deregulation, whether a new type of permitting system
would be more appropriate in terms of efficiency and effectiveness than
the current system; whether APHIS should establish a new regulatory
approach to address incidents of low-level presence of genetically
engineered plant material; whether APHIS should establish a new
regulatory mechanism to allow for imports of commodities for
nonpropagative use, that is, for food, feed, or processing, in cases
where these commodities might not have been deregulated in the United
States; and whether to expand its current exemption from interstate
movement restrictions additional well-studied, low-risk, genetically
engineered research organisms.
Anticipated Cost and Benefits:
To be determined.
Risks:
While APHIS has always used a risk-based approach in regulating
genetically engineered organisms, there is a trend toward more highly
varied organisms. For example, genetic engineering technology has
advanced to the point where organisms can be developed that produce
novel proteins and other substances with biological activity or
industrial utility. We have initiated this rulemaking because APHIS
recognizes that the regulatory process may need greater flexibility and
rigor to more appropriately regulate the increasing variety of
organisms.
Timetable:
_______________________________________________________________________
Action Date FR Cite
_______________________________________________________________________
Notice of Intent to
Prepare an
Environmental Impact
Statement 01/23/04 69 FR 3271
Comment Period End 03/23/04
Notice of Availability of
Draft Environmental
Impact Statement 07/17/07 72 FR 39021
Comment Period End 09/11/07
NPRM 10/09/08 73 FR 60007
NPRM Comment Period End 11/24/08
Final Action 01/00/09
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.
[[Page 71120]]
Additional Information:
Additional information about APHIS and its programs is available on the
Internet at http://www.aphis.usda.gov.
Agency Contact:
John Turner
Director, Policy Coordination Division, BRS
Department of Agriculture
Animal and Plant Health Inspection Service
4700 River Road, Unit 146
Riverdale, MD 20737-1236
Phone: 301 734-5720
RIN: 0579-AC31
_______________________________________________________________________
USDA--Food and Nutrition Service (FNS)
-----------
FINAL RULE STAGE
-----------
5. CHILD AND ADULT CARE FOOD PROGRAM: IMPROVING MANAGEMENT AND PROGRAM
INTEGRITY
Priority:
Other Significant
Legal Authority:
42 USC 1766; PL 103-448; PL 104-193; PL 105-336
CFR Citation:
7 CFR 226
Legal Deadline:
None
Abstract:
This rule amends the Child and Adult Care Food Program (CACFP)
regulations. The changes in this rule result from the findings of State
and Federal program reviews and from audits and investigations
conducted by the Office of Inspector General. This rule revises: State
agency criteria for approving and renewing institution applications;
program training and other operating requirements for child care
institutions and facilities; and State and institution-level monitoring
requirements. This rule also includes changes that are required by the
Healthy Meals for Healthy Americans Act of 1994 (Pub. L. 103-448), the
Personal Responsibility and Work Opportunities Reconciliation Act of
1996 (Pub. L. 104-193), and the William F. Goodling Child Nutrition
Reauthorization Act of 1998 (Pub. L. 105-336).
The changes are designed to improve program operations and monitoring
at the State and institution levels and, where possible, to streamline
and simplify program requirements for State agencies and institutions.
(95-024)
Statement of Need:
In recent years, State and Federal program reviews have found numerous
cases of mismanagement, abuse, and in some instances, fraud, by child
care institutions and facilities in the CACFP. These reviews revealed
weaknesses in management controls over program operations and examples
of regulatory noncompliance by institutions, including failure to pay
facilities or failure to pay them in a timely manner; improper use of
program funds for non-program expenditures; and improper meal
reimbursements due to incorrect meal counts or to miscategorized or
incomplete income eligibility statements. In addition, audits and
investigations conducted by the Office of Inspector General (OIG) have
raised serious concerns regarding the adequacy of financial and
administrative controls in CACFP. Based on its findings, OIG
recommended changes to CACFP review requirements and management
controls.
Summary of Legal Basis:
Some of the changes proposed in the rule are discretionary changes
being made in response to deficiencies found in program reviews and OIG
audits. Other changes codify statutory changes made by the Healthy
Meals for Healthy Americans Act of 1994 (Pub. L. 103-448), the Personal
Responsibility and Work Opportunities Reconciliation Act of 1996 (Pub.
L. 104-193), and the William F. Goodling Child Nutrition
Reauthorization Act of 1998 (Pub. L. 105-336).
Alternatives:
In developing the proposal, the Agency considered various alternatives
to minimize burden on State agencies and institutions while ensuring
effective program operation. Key areas in which alternatives were
considered include State agency reviews of institutions and sponsoring
organization oversight of day care homes.
Anticipated Cost and Benefits:
This rule contains changes designed to improve management and financial
integrity in the CACFP. When implemented, these changes would affect
all entities in CACFP, from USDA to participating children and
children's households. These changes will primarily affect the
procedures used by State agencies in reviewing applications submitted
by, and monitoring the performance of, institutions which are
participating or wish to participate in the CACFP. Those changes which
would affect institutions and facilities will not, in the aggregate,
have a significant economic impact.
Data on CACFP integrity is limited, despite numerous OIG reports on
individual institutions and facilities that have been deficient in
CACFP management. While program reviews and OIG reports clearly
illustrate that there are weaknesses in parts of the program
regulations and that there have been weaknesses in oversight, neither
program reviews, OIG reports, nor any other data sources illustrate the
prevalence and magnitude of CACFP fraud and abuse. This lack of
information precludes USDA from estimating the amount of money lost due
to fraud and abuse or the reduction in fraud and abuse the changes in
this rule will realize.
Risks:
Operating under interim rules puts State agencies and institutions at
risk of implementing Program provisions subject to change in a final
rule.
Timetable:
_______________________________________________________________________
Action Date FR Cite
_______________________________________________________________________
NPRM 09/12/00 65 FR 55103
NPRM Comment Period End 12/11/00
Interim Final Rule 06/27/02 67 FR 43448
Interim Final Rule
Effective 07/29/02
Interim Final Rule
Comment Period End 12/24/02
Interim Final Rule 09/01/04 69 FR 53502
Interim Final Rule
Effective 10/01/04
Interim Final Rule
Comment Period End 09/01/05
Final Action 09/00/09
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
No
Government Levels Affected:
Local, State
Federalism:
This action may have federalism implications as defined in EO 13132.
[[Page 71121]]
Agency Contact:
James F. Herbert
Regulatory Review Specialist
Department of Agriculture
Food and Nutrition Service
9th Floor
3101 Park Center Drive
Alexandria, VA 22302
Phone: 703 305-1625
Email: [email protected]
Related RIN: Merged with 0584-AC94
RIN: 0584-AC24
_______________________________________________________________________
USDA--FNS
6. FSP: ELIGIBILITY AND CERTIFICATION PROVISIONS OF THE FARM SECURITY
AND RURAL INVESTMENT ACT OF 2002
Priority:
Economically Significant. Major under 5 USC 801.
Legal Authority:
PL 107-171, secs 4101 to 4109, 4114, 4115, and 4401
CFR Citation:
7 CFR 273
Legal Deadline:
None
Abstract:
This rulemaking will amend Food Stamp Program regulations to implement
11 provisions of the Farm Security and Rural Investment Act of 2002
that establish new eligibility and certification requirements for the
receipt of food stamps. (02-007)
Statement of Need:
The rule is needed to implement the food stamp certification and
eligibility provisions of Public Law 107-171, the Farm Security and
Rural Investment Act of 2002.
Summary of Legal Basis:
The legal basis for this rule is Public Law 107-171, the Farm Security
and Rural Investment Act of 2002.
Alternatives:
This final rule deals with changes required by Public Law 107-171, the
Farm Security and Rural Investment Act of 2002. The Department has
limited discretion in implementing provisions of that law. Most of the
provisions in this rule were effective October 1, 2002, and must be
implemented by State agencies prior to publication of this rule.
Anticipated Cost and Benefits:
The provisions of this rule simplify State administration of the Food
Stamp Program, increase eligibility for the program among certain
groups, increase access to the program among low-income families and
individuals, and increase benefit levels. The provisions of Public Law
107-171 implemented by this rule have a 5-year cost of approximately
$1.9 billion.
Risks:
The FSP provides nutrition assistance to millions of Americans
nationwide--working families, eligible non-citizens, and elderly and
disabled individuals. Many low-income families don't earn enough money
and many elderly and disabled individuals don't receive enough in
retirement or disability benefits to meet all of their expenses and
purchase healthy and nutritious meals. The FSP serves a vital role in
helping these families and individuals achieve and maintain self-
sufficiency and purchase a nutritious diet. This rule implements the
certification and eligibility provisions of Public Law 107-171, the
Farm Security and Rural Investment Act of 2002. It simplifies State
administration of the Food Stamp Program, increases eligibility for the
program among certain groups, increases access to the program among
low-income families and individuals, and increases benefit levels. The
provisions of this rule increase benefits by approximately $1.95
billion over 5 years. When fully effective in FY 2006, the provisions
of this rule will add approximately 415,000 new participants.
Timetable:
_______________________________________________________________________
Action Date FR Cite
_______________________________________________________________________
NPRM 04/16/04 69 FR 20724
NPRM Comment Period End 06/15/04
Final Action 01/00/09
Final Action Effective 03/00/09
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
No
Government Levels Affected:
Federal, Local, State, Tribal
Agency Contact:
James F. Herbert
Regulatory Review Specialist
Department of Agriculture
Food and Nutrition Service
9th Floor
3101 Park Center Drive
Alexandria, VA 22302
Phone: 703 305-1625
Email: [email protected]
RIN: 0584-AD30
_______________________________________________________________________
USDA--FNS
7. QUALITY CONTROL PROVISIONS
Priority:
Other Significant
Legal Authority:
7 USC 2011 to 2032; PL 107-171
CFR Citation:
7 CFR 273; 7 CFR 275
Legal Deadline:
None
Abstract:
This rule finalizes the interim rule ``Non-Discretionary Quality
Control Provisions of Title IV of Public Law 107-171'' (published
October 16, 2003 at 68 FR 59519) and the proposed rule ``Discretionary
Quality Control Provisions of Title IV of Public Law 107-171''
(published September 23, 2005 at 70 FR 55776).
The following quality control (QC) provisions required by sections 4118
and 4119 of the Farm Security and Rural Investment Act of 2002 (title
IV of Pub. L. 107-171) and contained in the interim rule are
implemented by this final rule:
1) Timeframes for completing quality control reviews;
2) Timeframes for completing the arbitration process;
3) Timeframes for determining final error rates;
4) The threshold for potential sanctions and time period for sanctions;
5) The calculation of State error rates;
6) The formula for determining States' liability amounts;
7) Sanction notification and method of payment; and
8) Corrective action plans.
The following provisions required by sections 4118 and 4119 and
additional policy and technical changes, and contained in the proposed
rule, are implemented by this final rule:
[[Page 71122]]
Legislative changes based on or required by sections 4118 and 4119:
1) Eliminate enhanced funding;
2) Establish timeframes for completing individual quality control
reviews; and
3) Establish procedures for adjusting liability determinations
following appeal decisions.
Policy and technical changes:
1) Require State agency QC reviewers to attempt to complete review when
a household refuses to cooperate;
2) Mandate FNS validation of negative sample for purposes of high
performance bonuses;
3) Revise procedures for conducting negative case reviews;
4) Revise time frames for household penalties for refusal to cooperate
with State and Federal QC reviews;
5) Revise procedures for QC reviews of demonstration and SSA processed
cases;
6) Eliminate requirement to report variances resulting from Federal
information exchange systems (FIX) errors;
7) Eliminate references to integrated QC; and
8) Update definitions section to remove out-dated definitions. (02-014)
Statement of Need:
The rule is needed to implement the food stamp quality control
provisions of Public Law 107-171, the Farm Security and Rural
Investment Act of 2002.
Summary of Legal Basis:
The legal basis for this rule is Public Law 107-171, the Farm Security
and Rural Investment Act of 2002.
Alternatives:
This rule deals with changes required by Public Law 107-171, the Farm
Security and Rural Investment Act of 2002. The Department has no
discretion in implementing the time frames for completing quality
control reviews, the arbitration process, and determining the final
error rates; the threshold for potential sanctions and the time period
for the sanctions; the calculation for State error rates; the formula
for determining liability amounts; the sanction notification; method of
payment for liabilities; corrective action planning, and the
elimination of enhanced funding. These provisions were effective for
the fiscal year 2003 quality control review period and must have been
implemented by FNS and State agencies during fiscal year 2003. This
rule also deals in part with discretionary changes to the quality
control system resulting from Public Law 107-171. The provision
addressing results of appeals is required to be regulated by Public Law
107-171. The remaining changes amend existing regulations and are
required to make technical changes resulting from these changes or to
update policy consistent with current requirements.
Anticipated Cost and Benefits:
The provisions of this rule are not anticipated to have any impact on
benefit levels or administrative costs.
Risks:
The FSP provides nutrition assistance to millions of Americans
nationwide. The quality control system measures the accuracy of States
providing food stamp benefits to the program recipients. This rule is
intended to implement the quality control provisions of Public Law 107-
701, the Farm Security and Rural Investment Act of 2002. It will
significantly revise the system for determining State agency
liabilities and sanctions for high payment error rates.
Timetable:
_______________________________________________________________________
Action Date FR Cite
_______________________________________________________________________
Interim Final Rule 10/16/03 68 FR 59519
Interim Final Rule
Effective 12/15/03
Interim Final Rule
Comment Period End 01/14/04
NPRM 02/23/05 70 FR 55776
NPRM Comment Period End 12/22/05
Final Action 06/00/09
Regulatory Flexibility Analysis Required:
No
Government Levels Affected:
Federal, Local, State
Agency Contact:
James F. Herbert
Regulatory Review Specialist
Department of Agriculture
Food and Nutrition Service
9th Floor
3101 Park Center Drive
Alexandria, VA 22302
Phone: 703 305-1625
Email: [email protected]
Related RIN: Merged with 0584-AD37
RIN: 0584-AD31
_______________________________________________________________________
USDA--FNS
8. DIRECT CERTIFICATION OF CHILDREN IN FOOD STAMP HOUSEHOLDS AND
CERTIFICATION OF HOMELESS, MIGRANT, AND RUNAWAY CHILDREN FOR FREE MEALS
IN THE NSLP, SBP, AND SMP
Priority:
Other Significant
Legal Authority:
PL 108-265, sec 104
CFR Citation:
7 CFR 210; 7 CFR 215; 7 CFR 220; 7 CFR 245
Legal Deadline:
None
Abstract:
In response to Public Law 108-265, which amended the Richard B. Russell
National School Lunch Act, 7 CFR 245, Determining Eligibility for Free
and Reduced Price Meals and Free Milk in Schools, will be amended to
establish categorical (automatic) eligibility for free meals and free
milk upon documentation that a child is (1) homeless as defined by the
McKinney-Vento Homeless Assistance Act; (2) a runaway served by grant
programs under the Runaway and Homeless Youth Act; or (3) migratory as
defined in section 1309(2) of the Elementary and Secondary Education
Act. The rule also requires phase-in of mandatory direct certification
for children who are members of households receiving food stamps and
continues discretionary direct certification for other categorically
eligible children. (04-018)
Statement of Need:
The changes made to the Richard B. Russell National School Lunch Act
concerning direct certification are intended to improve program access,
reduce paperwork, and improve the accuracy of the delivery of free meal
benefits. This regulation will implement the statutory changes and
provide State agencies and local educational agencies with the policies
and procedures to conduct mandatory and discretionary direct
certification.
Summary of Legal Basis:
These changes are being made in response to provisions in Public Law
108-265.
Alternatives:
FNS will be working closely with State agencies to implement the
changes made by this regulation and will be
[[Page 71123]]
developing extensive guidance materials in conjunction with our
cooperators.
Anticipated Cost and Benefits:
This regulation will reduce paperwork, target benefits more precisely,
and will improve program access of eligible school children.
Risks:
This regulation may require adjustments to existing computer systems to
more readily share information between schools, food stamp offices, and
other agencies.
Timetable:
_______________________________________________________________________
Action Date FR Cite
_______________________________________________________________________
Interim Final Rule 08/00/09
Interim Final Rule
Comment Period End 11/00/09
Final Action 12/00/10
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
9th Floor
3101 Park Center Drive
Alexandria, VA 22302
Phone: 703 305-1625
Email: [email protected]
Related RIN: Merged with 0584-AD62
RIN: 0584-AD60
_______________________________________________________________________
USDA--FNS
9. SPECIAL SUPPLEMENTAL NUTRITION PROGRAM FOR WOMEN, INFANTS, AND
CHILDREN (WIC): WIC VENDOR COST CONTAINMENT
Priority:
Other Significant
Legal Authority:
42 USC 1786
CFR Citation:
7 CFR 246
Legal Deadline:
Final, Statutory, June 30, 2006.
Abstract:
This final rule amends the WIC regulations to strengthen vendor cost
containment. The rule incorporates into program regulations new
legislative requirements that affect the selection, authorization, and
reimbursement of retail vendors. These requirements are contained in
the Child Nutrition and WIC Reauthorization Act of 2004 (Pub. L. 108-
265), which was enacted on June 30, 2004. The rule reflects the
statutory provisions that require WIC State agencies to implement a
vendor peer group system, competitive price selection criteria, and
allowable reimbursement levels in a manner that ensures that the WIC
Program pays authorized vendors competitive prices for supplemental
foods. It also requires State agencies to ensure that vendors that
derive more than 50 percent of their annual food sales revenue from WIC
food instruments do not result in higher food costs to the program than
do other vendors. The intent of these provisions is to maximize the
number of women, infants, and children served with available Federal
funding. (04-029)
Statement of Need:
This action is needed to implement the vendor cost containment
provisions of the Child Nutrition and WIC Reauthorization Act of 2004,
Public Law 108-265. The rule requires WIC State agencies to operate
vendor management systems that effectively contain food costs by
ensuring that prices paid for supplemental foods are competitive. The
rule also responds to data which indicate that WIC food expenditures
increasingly include payments to a type of vendor whose prices are not
governed by the market forces that affect most retail grocers. As a
result, the prices charged by these vendors tend to be higher than
those of other retail grocery stores participating in the program. To
ensure that the program pays competitive prices, this rule codifies the
new statutory requirements for State agencies to use in evaluating
vendor applicants' prices during the vendor selection process and when
paying vendors for supplemental foods following authorization.
Summary of Legal Basis:
Section 203(e)(10) of Public Law 108-265, Child Nutrition and WIC
Reauthorization Act of 2004.
Alternatives:
This rule implements the vendor peer group provisions of the Child
Nutrition and WIC Reauthorization Act of 2004, which FNS believes is an
effective means of controlling WIC food costs. While this Act mandates
that States establish peer groups, competitive price criteria, and
allowable reimbursement levels, and states that these requirements must
result in the outcome of paying above-50-percent vendors no more than
regular vendors, the rule does not specify particular criteria for peer
groups or acceptable methods of setting competitive price criteria and
allowable reimbursement levels. FNS considered mandating specific means
of developing peer groups, competitive price criteria, and allowable
reimbursement levels in order to ensure that the outcome of this
legislation was achieved.
However, given States' responsibility to manage WIC as a discretionary
grant program and the varying market conditions in each State, FNS
believes that States need flexibility to develop their own peer groups,
competitive price criteria, and allowable reimbursement levels. At the
October 2004 meeting the FNS convened to gain input for this rule,
States indicated that they needed the ability to design cost
containment practices that would be effective in their own markets and
would ensure participant access. In addition, there is little
information about the effectiveness of particular cost containment
practices in the variety of markets represented by the 89 WIC State
agencies. Mandating more specific means of developing peer groups,
competitive price criteria, and allowable reimbursement levels could
have unintended negative consequences for participant access, food
costs and administrative burden.
As States gain experience and the results of their vendor cost
containment practices become apparent, FNS may develop further
regulations and guidance to improve vendor cost containment. In the
interim, FNS believes that the current rule will substantially
accomplish the goal of the Act of containing food costs and ensuring
that above-50-percent vendors do not result in higher costs to the WIC
Program than regular vendors.
Anticipated Cost and Benefits:
Costs: This rule places new requirements on State agencies; therefore,
the cost implications of this rule relate primarily to administrative
burden for WIC State agencies. These cost implications are partially
dependent on the current practices of State agencies relative to the
requirements of the rule. Detailed
[[Page 71124]]
information regarding the cost implications of this rule is contained
in the Regulatory Impact Analysis developed by FNS to accompany this
rulemaking.
Benefits: The WIC Program will benefit from the provisions of this rule
by reducing unnecessary food expenditures, thus increasing the
potential to serve more eligible women, infants, and children for the
same cost. This rule should have the effect of ensuring that payments
to vendors, particularly vendors that derive more than 50 percent of
their annual food sales revenue from WIC food instruments, reflect
competitive prices for WIC foods. The Regulatory Impact Analysis
prepared by FNS to accompany this rulemaking projects an estimated
monthly cost savings of over $6.25 million. (Details of this projection
can be found in the complete Regulatory Impact Analysis.)
Risks:
Because the vendor peer group provisions in the Child Nutrition and WIC
Reauthorization Act of 2004 and this rule provide for some flexibility
in implementation, and because there is a wide degree of variation in
food prices and current vendor cost containment practices across State
agencies, the impact of many of the provisions of this rule is
uncertain. Uncertainties include the administrative burden State
agencies will incur and the savings that can be realized nationally or
in any State agency. The major uncertainties for both administrative
burden and program savings are discussed in greater detail in the
Regulatory Impact Analysis.
Timetable:
_______________________________________________________________________
Action Date FR Cite
_______________________________________________________________________
Interim Final Rule 11/29/05 70 FR 71708
Interim Final Rule
Comment Period End 11/29/06
Interim Final Rule
Effective 12/29/05
Final Action 04/00/09
Final Action Effective 05/00/09
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
Governmental Jurisdictions
Government Levels Affected:
Federal, Local, State, Tribal
URL For More Information:
www.fns.usda.gov/wic
Agency Contact:
James F. Herbert
Regulatory Review Specialist
Department of Agriculture
Food and Nutrition Service
9th Floor
3101 Park Center Drive
Alexandria, VA 22302
Phone: 703 305-1625
Email: [email protected]
RIN: 0584-AD71
_______________________________________________________________________
USDA--Food Safety and Inspection Service (FSIS)
-----------
PROPOSED RULE STAGE
-----------
10. CHANGES TO REGULATORY JURISDICTION OVER CERTAIN FOOD PRODUCTS
CONTAINING MEAT AND POULTRY
Priority:
Other Significant. Major status under 5 USC 801 is undetermined.
Legal Authority:
21 USC 601(j); 21 USC 454(f)
CFR Citation:
9 CFR 303.1; 9 CFR 381.15
Legal Deadline:
None
Abstract:
The Food Safety and Inspection Service (FSIS) and the Food and Drug
Administration (FDA) have concluded that a clearer approach to
determining jurisdiction over meat and poultry products is possible.
This approach involves considering the contribution of the meat or
poultry ingredients to the identity of the food. FSIS is proposing to
amend the Federal meat and poultry products inspection regulations to
provide consistency and predictability in the regulatory jurisdiction
over nine products or product categories. Historically there has been
confusion about whether these products fall within the jurisdiction of
FSIS or FDA. These proposed changes would exempt cheese and cheese
products prepared with less than 50 percent meat or poultry; breads,
rolls and buns prepared with less than 50 percent meat or poultry;
dried poultry soup mixes; flavor bases and flavors; pizza with meat or
poultry; and salad dressings prepared with less than 50 percent meat or
poultry from the requirements of the Federal Meat Inspection Act and
the Poultry Product Inspection Act and would clarify that bagel dogs,
natural casings, and close faced-sandwiches are subject to the
requirements of the Federal Meat Inspection Act and the Poultry
Products Inspection Act.
Statement of Need:
Over the years, FSIS has made decisions about the jurisdiction under
which food products containing meat or poultry ingredients are produced
based on the amount of meat or poultry in the product; whether the
product is represented as a meat or poultry product (that is, whether a
term that refers to meat or poultry is used on labeling); whether the
product is perceived by consumers as a product of the meat or poultry
industries; and whether the product contains poultry or meat from an
accepted source. With regard to the consumer perception factor, FSIS
made decisions on a case-by-case basis, mostly in response to
situations involving determinations for compliance and enforcement.
Although this case-by-case approach resulted in decisions that made
sense at the time that they were made, a review in 2004 to 2005 by a
working group of FSIS and FDA representatives showed that some of the
decisions do not appear to be fully consistent with other product
decisions and that the reasoning behind various determinations was not
fully articulated or supported.
Summary of Legal Basis:
Under the Federal Meat Inspection Act (FMIA) (21 U.S.C. 601 to 695),
the Poultry Products Inspection Act (PPIA) (21 U.S.C. 451 to 470), and
the Egg Products Inspection Act (EPIA) (21 U.S.C. 1032), and the
regulations that implement these Acts, FSIS has authority over all meat
food and poultry products and processed egg products. Under the Federal
Food, Drug, and Cosmetic Act (FFDCA) and the regulations that implement
it, FDA has authority over all foods not under FSIS' jurisdiction,
including dairy, bread and other grain products, vegetables and other
produce, and other products, such as seafood.
According to the provisions of the FMIA and PPIA, the Secretary has the
authority to exempt certain human food products from the definition of
a meat food product (21 U.S.C. 601(j)) or a poultry product (20 U.S.C.
454(f)) based on either of two factors: (1) The product contains only a
relatively small
[[Page 71125]]
proportion of livestock ingredients or poultry ingredients, or (2) the
product historically has not been considered by consumers as a product
of the meat food or poultry industry, and under such conditions as he
or she may prescribe to ensure that the livestock or poultry
ingredients are not adulterated and that the products are not
represented as meat food or poultry products.
Alternatives:
FSIS has considered over the years a number of variations to clarify
the confusion regarding jurisdiction for these various products.
Alternative 1: Maintain the status quo. Although FSIS has considered
taking no action at this time, the Agency does not recommend this
option because of the continued confusion that exists among industry
and consumers as to jurisdictional coverage for nine categories of
products.
Alternative 2: Reassess the statutory factors for making jurisdiction
decision and recommend an amendment. The amendment of the statute would
be from the historical perception factor because that is the factor, of
the two statutory factors, that the working group identified as leading
to the state of confusion about the jurisdiction of certain products
containing meat or poultry.
Alternative 3: Adopt some of the FDA/FSIS working group's suggested
approach to making clear and transparent jurisdiction decisions by
proposing changes to regulations to codify the current policies on
exempted products.
Anticipated Cost and Benefits:
FSIS estimates that the initial and recurring costs of the rule to
industry would be approximately $5 million and $7 million,
respectively. These costs would be attributable to new Sanitation SOP
and HACCP plan development, as well as to labeling changes and
training. FSIS would incur $7 million in annual recurring costs
(salaries and benefits). Establishments coming under FSIS jurisdiction
also would incur costs for recordkeeping, monitoring, testing, and
annual HACCP plan reassessment.
Benefits to industry would accrue from reduced confusion over Agency
jurisdiction, which may affect labeling and recordkeeping costs. There
may be spill-over benefits accruing from changes in consumer behavior.
Also, there would be improvement in efficiency in use of FDA and FSIS
resources.
Risks:
None
Timetable:
_______________________________________________________________________
Action Date FR Cite
_______________________________________________________________________
NPRM 09/00/09
Regulatory Flexibility Analysis Required:
Undetermined
Small Entities Affected:
Businesses
Government Levels Affected:
None
Agency Contact:
Charles Gioglio
Labeling and Program Delivery Division
Department of Agriculture
Food Safety and Inspection Service
1400 Independence Avenue SW
Washington, DC 20250
Phone: 202 205-0279
Fax: 202 205-3625
Email: [email protected]
RIN: 0583-AD28
_______________________________________________________________________
USDA--FSIS
11. NEW POULTRY SLAUGHTER INSPECTION
Priority:
Economically Significant. Major under 5 USC 801.
Legal Authority:
21 USC 451 et seq
CFR Citation:
9 CFR 381.66; 9 CFR 381.67; 9 CFR 381.76; 9 CFR 381.83; 9 CFR 381.91; 9
CFR 381.94
Legal Deadline:
None
Abstract:
FSIS is proposing a new inspection system for young poultry slaughter
establishments that would facilitate public health-based inspection.
This new system would be available initially only to young chicken
slaughter establishments. Establishments that slaughter broilers,
fryers, roasters, and Cornish game hens (as defined in 9 CFR 381.170)
would be considered as ``young chicken establishments.'' FSIS is also
proposing to revoke the provisions that allow young chicken slaughter
establishments to operate under the current Streamlined Inspection
System (SIS) or the New Line Speed (NELS) Inspection System. The
proposed rule would establish new performance standards to reduce
pathogens. FSIS anticipates that this proposed rule would provide the
framework for action to provide public health-based inspection in all
establishments that slaughter amenable poultry species.
Under the proposed new system, young chicken slaughter establishments
would be required to sort chicken carcasses and to conduct other
activities to ensure that carcasses are not adulterated before they
enter the chilling tank.
Statement of Need:
Because of the risk to the public health associated with pathogens on
young chicken carcasses, FSIS is proposing a new inspection system that
would allow for more effective inspection of young chicken carcasses,
would allow the Agency to more effectively allocate its resources,
would encourage industry to more readily use new technology, and would
include new performance standards to reduce pathogens.
This proposed rule is an example of regulatory reform because it would
facilitate technological innovation in young chicken slaughter
establishments. It would likely result in more cost-effective dressing
of young chickens that are ready to cook or ready for further
processing. Similarly, it would likely result in more efficient and
effective use of Agency resources.
Summary of Legal Basis:
The Secretary of Agriculture is charged by the Poultry Products
Inspection Act (PPIA--21 U.S.C. 451 et seq.) with carrying out a
mandatory poultry products inspection program. The Act requires post-
mortem inspection of all carcasses of slaughtered poultry subject to
the Act and such reinspection as deemed necessary (21 U.S.C. 455(b)).
The Secretary is authorized to promulgate such rules and regulations as
are necessary to carry out the provisions of the Act (21 U.S.C.
463(b)). The Agency has tentatively determined that this rule would
facilitate FSIS post-mortem inspection of young chicken carcasses. The
proposed new system would likely result in more efficient and effective
use of Agency resources and in industry innovations.
Alternatives:
FSIS considered the following options in developing this proposal:
1) No action.
2) Propose to implement HACCP-Based Inspection Models Pilot in
regulations.
[[Page 71126]]
3) Propose to establish a mandatory, rather than a voluntary, new
inspection system for young chicken slaughter establishments.
4) Propose standards of identity regulations for young chickens that
include trim and processing defect criteria and that take into account
the intended use of the product.
5) Propose a voluntary new inspection system for young chicken
slaughter establishments and propose standards of identity for whole
chickens, regardless of the products' intended use.
Anticipated Cost and Benefits:
The proposed performance standards and the implementation of public
health-based inspection would likely improve the public health. FSIS is
conducting a risk assessment for this proposed rule to assess the
likely public health benefits that the implementation of this rule may
achieve.
Establishments that volunteer for this proposed new inspection system
alternative would likely need to make capital investments in facilities
and equipment. They may also need to add labor (trained employees).
However, one of the beneficial effects of these investments would
likely be the lowering of the average cost per pound to dress poultry
properly. Cost savings would likely result because of increased line
speeds, increased productivity, and increased flexibility to industry.
The expected lower average unit cost for dressing poultry would likely
give a marketing advantage to establishments under the new system.
Consumers would likely benefit from lower retail prices for high
quality poultry products. The rule would also likely provide
opportunities for the industry to innovate because of the increased
flexibility it would allow poultry slaughter establishments. In
addition, in the public sector, benefits would accrue to FSIS from the
more effective deployment of FSIS inspection program personnel to
verify process control based on risk factors at each establishment.
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 reduce the prevalence
of salmonella and other pathogens in young chickens.
Timetable:
_______________________________________________________________________
Action Date FR Cite
_______________________________________________________________________
NPRM 09/00/09
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
No
Government Levels Affected:
State
Agency Contact:
Dr. Daniel L. Engeljohn
Deputy Assistant Administrator, Office of Policy and Program
Development
Department of Agriculture
Food Safety and Inspection Service
1400 Independence Avenue SW
Washington, DC 20250
Phone: 202 205-0495
Fax: 202 401-1760
Email: [email protected]
RIN: 0583-AD32
_______________________________________________________________________
USDA--FSIS
12. NOTIFICATION, DOCUMENTATION AND RECORDKEEPING REQUIREMENTS
FOR INSPECTED ESTABLISHMENTS
Priority:
Other Significant. Major status under 5 USC 801 is undetermined.
Legal Authority:
21 U.S.C. 612 and 613; 21 U.S.C. 459
CFR Citation:
Not Yet Determined
Legal Deadline:
None
Abstract:
The Food Safety and Inspection Service (FSIS) is proposing to require
establishments subject to inspection under the Federal Meat Inspection
Act and the Poultry Products Inspection Act to promptly notify the
Secretary of Agriculture that an adulterated or misbranded product
received by or originating from the establishment has entered into
commerce, if the establishment believes or has reason to believe that
this has happened. FSIS is also proposing to require these
establishments to: (1) prepare and maintain current procedures for the
recall of all products produced and shipped by the establishment; (2)
document each reassessment of the process control plans of the
establishment; and (3) upon request, make the procedures and reassessed
control plans available to inspectors appointed by the Secretary for
review and copying.
Statement of Need:
The Food, Conservation, and Energy Act of 2008 (Public Law 110-246,
Sec. 11017), known as the 2008 Farm Bill, amended the Federal Meat
Inspection Act (FMIA) and the Poultry Products Inspection Act (PPIA) to
require establishments subject to inspection under these Acts to
promptly notify the Secretary that an adulterated or misbranded product
received by or originating from the establishment has entered into
commerce, if the establishment believes or has reason to believe that
this has happened. Section 11017 also requires establishments subject
to inspection under the FMIA and PPIA to: (1) prepare and maintain
current procedures for the recall of all products produced and shipped
by the establishment; and (2) document each reassessment of the process
control plans of the establishment.
Summary of Legal Basis:
21 U.S.C. 612 and 613; 21 U.S.C. 459, and Public Law 110-246, Sec.
11017.
Alternatives:
The option of no rulemaking is unavailable. The Agency will consider
alternative methods of implementation, and the effects on foreign and
domestic commerce and on small business associated with the
alternatives.
Anticipated Cost and Benefits:
FSIS will conduct an analysis to determine the costs and benefits
associated with this rulemaking. FSIS has made an initial determination
that this rule will not have a significant economic impact on a
substantial number of small entities.
Risks:
In preparing regulations on the shipment of adulterated meat and
poultry products by meat and poultry establishments, the preparation
and maintenance of procedures for recalled products produced and
shipped by establishments, and the documentation of each reassessment
of the process control plans by the establishment, the
[[Page 71127]]
Agency will consider any risks to public health or other pertinent
risks associated with these actions.
Timetable:
_______________________________________________________________________
Action Date FR Cite
_______________________________________________________________________
Proposed Rule 03/00/09
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: [email protected]
RIN: 0583-AD34
_______________________________________________________________________
USDA--FSIS
13. MANDATORY INSPECTION OF CATFISH AND CATFISH PRODUCTS
Priority:
Other Significant
Legal Authority:
21 U.S.C. 601 et seq. Pub L. 110-249, Sec. 11016
CFR Citation:
9 CFR Chapter III, Subchapter F (new)
Legal Deadline:
Final, Statutory, December 2009, Final regulations NLT 18 months after
enactment of Pub. L. 110-246.
Abstract:
The Food, Conservation, and Energy Act of 2008 (Public Law 110-246,
Sec. 11016), known as the 2008 Farm Bill, amended the Federal Meat
Inspection Act (FMIA) to make catfish an amenable species under the
FMIA. The regulations will define ``catfish'' and the scope of coverage
of the regulations to apply to establishments that process farm-raised
species of catfish and to catfish and catfish products. The regulations
will take into account the conditions under which the catfish are
raised and transported to a processing establishment.
Statement of Need:
The Food, Conservation, and Energy Act of 2008 (Public Law 110-246,
Sec. 11016), known as the 2008 Farm Bill, amended the Federal Meat
Inspection Act (FMIA) to make catfish an amenable species under the
FMIA. The Farm Bill directs the Department to issue final regulations
implementing the FMIA amendments not later than 18 months after the
enactment date (June 18, 2008) of the legislation.
Summary of Legal Basis:
21 U.S.C. 601-695 and Public Law 110-246, Sec. 11016
Alternatives:
The option of no rulemaking is unavailable. The Agency will consider
alternative methods of implementation and levels of stringency, and the
effects on foreign and domestic commerce and on small business
associated with the alternatives.
Anticipated Cost and Benefits:
FSIS anticipates benefits from uniform standards and the more extensive
and intensive inspection service that FSIS provides (compared with
current voluntary inspection programs). FSIS would apply requirements
for imported catfish that would be equivalent to those applying to
catfish raised and processed in the United States.
Risks:
In preparing regulations on catfish and catfish products, the Agency
will consider any risks to public health or other pertinent risks
associated with the production, processing, and distribution of the
products. FSIS will determine, through scientific risk assessment
procedures, the magnitude of the risks associated with catfish and how
they compare with those associated with other foods in FSIS's
jurisdiction.
Timetable:
_______________________________________________________________________
Action Date FR Cite
_______________________________________________________________________
NPRM 03/00/09
Final Action 12/00/09
Regulatory Flexibility Analysis Required:
Undetermined
Small Entities Affected:
Businesses
Government Levels Affected:
Federal, State
Agency Contact:
Dr. John Hicks
Risk Management Division, Department of Agriculture, Food Safety and
Inspection Service
Department of Agriculture
Food Safety and Inspection Service
1400 Independence Avenue SW
Washington, DC 20250
Phone: 202 205-0032
Fax: 202 720-7027
Email: [email protected]
RIN: 0583-AD36
_______________________________________________________________________
USDA--FSIS
14. FEDERAL-STATE INTERSTATE SHIPMENT COOPERATIVE INSPECTION
PROGRAM
Priority:
Other Significant. Major status under 5 USC 801 is undetermined.
Unfunded Mandates:
Undetermined
Legal Authority:
PL 110-246 (section 11015)
CFR Citation:
Not Yet Determined
Legal Deadline:
Final, Statutory, December 18, 2009.
Abstract:
FSIS is proposing regulations to implement a new voluntary Federal-
State cooperative inspection program under which State-inspected
establishments with 25 or fewer employees would be eligible to ship
meat and poultry products in interstate commerce. State-inspected
establishments selected to participate in this program would be
required to comply with all Federal standards under the Federal Meat
Inspection Act (FMIA) and the Poultry Products Inspection Act (PPIA).
These establishments would receive inspection services from State
inspection personnel that have been trained and certified to assist
with enforcement of the FMIA and PPIA. Meat and poultry products
produced under the program that have been inspected and passed by
selected State-inspection personnel would bear a Federal mark of
inspection. FSIS is proposing these regulations in response to the
Food, Conservation, and Energy Act, enacted on June 18, 2008 (the 2008
Farm Bill). Section 11015 of 2008 Farm Bill provides for the interstate
shipment of State-inspected meat and poultry
[[Page 71128]]
product from selected establishments and requires that FSIS promulgate
implementing regulations no later than 18 months from the date of its
enactment
Statement of Need:
This action is needed to implement a new Federal-State cooperative
program that will permit certain State-inspected establishments to ship
meat and poultry products in interstate commerce. Inspection services
for establishments selected to participate in the program will be
provided by state inspection personnel that have been trained and
certified in the administration and enforcement of the Federal Meat
Inspection Act (FMIA) (21 U.S.C. 601, et seq.) and the Poultry Products
Inspection Act (PPIA) (21 U.S.C. 451, et seq.) Meat and poultry
products produced by establishments selected to participate in the
program will bear a Federal mark of inspection.
Summary of Legal Basis:
This action is authorized under section 11015 of the Food,
Conservation, and Energy Act of 2008 (the 2008 Farm Bill) (PL-110-246).
Section 11015 amends the Federal Meat Inspection Act (FMIA) (21 U.S.C.
601, et seq.) and the Poultry Products Inspection Act (PPIA) (21 U.S.C.
451, et seq.) to establish an optional Federal-State cooperative
program under which State-inspected establishments would be permitted
to ship meat and poultry products in interstate commerce. The law
requires that FSIS promulgate implementing regulations no later than 18
months after the date of enactment.
Alternatives:
1. No action: FSIS did not consider the alternative of no action
because section 11015 of the 2008 Farm Bill requires that it promulgate
regulations to implement the new Federal-State cooperative program. The
Agency did consider alternatives on how to implement the new program.
2. Limit participation in the program to state-inspected establishments
with 25 or fewer employees on average: Under the law, state-inspected
establishments that have 25 or fewer employees on average are permitted
to participate in the program. The law also provides that FSIS may
select establishments that employ more than 25 but fewer than 35
employees on average as of June 18, 2008 (the date of enactment) to
participate in the program. Under the law, if these establishments
employ more than 25 employees on average 3 years after FSIS promulgates
implementing regulations, they are required to transition to a Federal
establishment. FSIS rejected the option of limiting the program to
establishment that employ 25 or fewer employees on average to give
additional small establishments the opportunity to participate in the
program and ship their meat of poultry products in interstate commerce.
3. Permit establishments with 25 to 35 employees on average as of June
18, 2008, to participate in the program. FSIS chose the option of
permitting these establishments to be selected to participate in the
program to give additional small establishments the opportunity to ship
their meat and poultry products in interstate commerce. Under this
option, FSIS will develop a procedure to transition any establishment
that employs more than 25 people on average to a Federal establishment.
Establishments that employee 24 to 35 employees on average as of June
18, 2008, would be subject to the transition procedure beginning on the
date three years after the Agency promulgates implementing regulations.
Anticipated Cost and Benefits:
FSIS is analyzing the costs of this proposed rule to industry, FSIS,
State and local governments, small entities, and foreign countries.
Participation in the new Federal-State cooperative program will be
optional. Thus, the costs and benefits associated with the proposed
rule will depend on the number of States and establishments that chose
to participate. Very small and certain small establishments State-
inspected establishments that are selected to participate in the
program are likely to benefit from the program because they will be
permitted sell their products to consumers in other States and foreign
countries.
Risks:
None.
Timetable:
_______________________________________________________________________
Action Date FR Cite
_______________________________________________________________________
NPRM 01/00/09
Final Action 01/00/10
Regulatory Flexibility Analysis Required:
Yes
Small Entities Affected:
Businesses
Government Levels Affected:
Federal, State
Federalism:
Undetermined
Agency Contact:
Rachel Edelstein
Director, 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: [email protected]
RIN: 0583-AD37
_______________________________________________________________________
USDA--FSIS
-----------
FINAL RULE STAGE
-----------
15. PERFORMANCE STANDARDS FOR THE PRODUCTION OF PROCESSED MEAT AND
POULTRY PRODUCTS; CONTROL OF LISTERIA MONOCYTOGENES IN READY-TO-EAT
MEAT AND POULTRY PRODUCTS
Priority:
Economically Significant. Major under 5 USC 801.
Legal Authority:
21 USC 451 et seq; 21 USC 601 et seq
CFR Citation:
9 CFR 301; 9 CFR 303; 9 CFR 317; 9 CFR 318; 9 CFR 319; 9 CFR 320; 9 CFR
325; 9 CFR 331; 9 CFR 381; 9 CFR 417; 9 CFR 430; 9 CFR 431
Legal Deadline:
None
Abstract:
FSIS has proposed to establish pathogen reduction performance standards
for all ready-to-eat (RTE) and partially heat-treated meat and poultry
products, and measures, including testing, to control Listeria
monocytogenes in RTE products. The performance standards spell out the
objective level of pathogen reduction that establishments must meet
during their operations in order to produce safe products but allow the
use of customized, plant-specific processing procedures other than
those prescribed in the earlier regulations. With HACCP, food safety
performance standards give establishments the incentive and flexibility
to adopt innovative, science-based food safety processing procedures
and controls, while providing objective, measurable standards that can
be
[[Page 71129]]
verified by Agency inspectional oversight. This set of performance
standards will include and be consistent with standards already in
place for certain ready-to-eat meat and poultry products.
Statement of Need:
Although FSIS routinely samples and tests some ready-to-eat products
for the presence of pathogens prior to distribution, there are no
specific regulatory pathogen reduction requirements for most of these
products. The proposed performance standards are necessary to help
ensure the safety of these products; give establishments the incentive
and flexibility to adopt innovative, science-based food safety
processing procedures and controls; and provide objective, measurable
standards that can be verified by Agency oversight.
Summary of Legal Basis:
Under the Federal Meat Inspection Act (21 U.S.C. 601 to 695) and the
Poultry Product Inspection Act (21 U.S.C. 451 to 470), FSIS issues
regulations governing the production of meat and poultry products
prepared for distribution in commerce. The regulations, along with FSIS
inspection programs, are designed to ensure that meat and poultry
products are safe, not adulterated, and properly marked, labeled, and
packaged.
Alternatives:
As an alternative to all of the proposed requirements, FSIS considered
taking no action. As alternatives to the proposed performance standard
requirements, FSIS considered end-product testing and requiring ``use-
by'' date labeling on ready-to-eat products.
Anticipated Cost and Benefits:
Benefits are expected to result from fewer contaminated products
entering commercial food distribution channels as a result of improved
sanitation and process controls and in-plant verification. FSIS
believes that the benefits of the rule would exceed the total costs of
implementing its provisions. FSIS currently estimates net benefits from
the 2003 interim final rule at $470 to $575 million, with annual
recurring costs at $150.4 million, if FSIS discounts the capital cost
at 7%. FSIS is continuing to analyze the potential impact of the other
provisions of the proposal.
The other main provisions of the proposed rule are: Lethality
performance standards for Salmonella and E. coli O157:H7 and
stabilization performance standards for C. perfringens that firms must
meet when producing RTE meat and poultry products. Most of the costs of
these requirements would be associated with one-time process
performance validation in the first year of implementation of the rule
and with revision of HACCP plans. Benefits are expected to result from
the entry into commercial food distribution channels of product with
lower levels of contamination resulting from improved in-plant process
verification and sanitation. Consequently, there will be fewer cases of
foodborne illness.
Risks:
Before FSIS published the proposed rule, FDA and FSIS had estimated
that each year L. monocytogenes caused 2,540 cases of foodborne
illness, including 500 fatalities. The Agencies estimated that about
65.3 percent of these cases, or 1660 cases and 322 deaths per year,
were attributable to RTE meat and poultry products. The analysis of the
interim final rule on control of L. monocytogenes conservatively
estimated that implementation of the rule would lead to an annual
reduction of 27.3 deaths and 136.7 illnesses at the median. FSIS is
continuing to analyze data on production volume and Listeria controls
in the RTE meat and poultry products industry and is using the FSIS
risk assessment model for L. monocytogenes to determine the likely risk
reduction effects of the rule. Preliminary results indicate that the
risk reductions being achieved are substantially greater than those
estimated in the analysis of the interim rule.
FSIS is also analyzing the potential risk reductions that might be
achieved by implementing the lethality and stabilization performance
standards for products that would be subject to the proposed rule. The
risk reductions to be achieved by the proposed rule and that are being
achieved by the interim rule are intended to contribute to the Agency's
public health protection effort.
Timetable:
_______________________________________________________________________
Action Date FR Cite
_______________________________________________________________________
NPRM 02/27/01 66 FR 12590
NPRM Comment Period End 05/29/01
NPRM Comment Period
Extended 07/03/01 66 FR 35112
NPRM Comment Period End 09/10/01
Interim Final Rule 06/06/03 68 FR 34208
Interim Final Rule
Effective 10/06/03
Interim Final Rule
Comment Period End 01/31/05
NPRM Comment Period
Reopened 03/24/05 70 FR 15017
NPRM Comment Period End 05/09/05
Affirmation of Interim
Final Rule 09/00/09
Final Action 09/00/09
Regulatory Flexibility Analysis Required:
Yes
Small Entities Affected:
Businesses
Government Levels Affected:
Undetermined
Agency Contact:
Dr. Daniel L. Engeljohn
Deputy Assistant Administrator, Office of Policy and Program
Development
Department of Agriculture
Food Safety and Inspection Service
1400 Independence Avenue SW
Washington, DC 20250
Phone: 202 205-0495
Fax: 202 401-1760
Email: [email protected]
RIN: 0583-AC46
_______________________________________________________________________
USDA--FSIS
16. REQUIREMENTS FOR THE DISPOSITION OF CATTLE THAT BECOME
NON-AMBULATORY DISABLED FOLLOWING ANTE-MORTEM INSPECTION
Priority:
Other Significant
Legal Authority:
21 U.S.C. 621; 21 U.S.C. 603(a); 21 U.S.C. 603(b)
CFR Citation:
9 CFR 309.3
Legal Deadline:
None
Abstract:
FSIS is proposing to remove the provision in 309.3(e) that allows FSIS
inspection personnel to determine the disposition of cattle that become
non-ambulatory disabled after they have passed ante-mortem inspection
on a case-by-case basis. If FSIS finalizes this proposed rule, cattle
that become non-ambulatory disabled from an acute
[[Page 71130]]
injury after ante-mortem inspection will no longer be eligible to
proceed to slaughter as ``U.S. Suspects.'' Instead, FSIS inspectors
will tag these cattle as ``U.S. condemned'' and prohibit these animals
from proceeding to slaughter.
Statement of Need:
This rule is necessary to better ensure effective implementation of
ante-mortem inspection pursuant to 21 USC 603(a) and of humane handling
requirements pursuant to 21 USC 603(b).
This rule is also necessary to make clear that establishments have an
affirmative obligation to make FSIS personnel aware when an animal goes
down. This regulatory requirement will preclude establishments from
attempting to force such animals to rise.
Summary of Legal Basis:
FSIS is proposing this rule under 21 U.S.C 621, which gives FSIS the
authority to adopt regulations for the efficient administration of the
FMIA. The amendment in this proposal would better ensure effective
implementation of ante-mortem inspection pursuant to 21 U.S.C. 603(a)
and of humane handling requirements established pursuant to 21 U.S.C
603(b).
Alternatives:
This proposed rule is likely to have only minimum economic effects on
the beef industry and consumers. Based on the Agency's 2007 survey
data, out of the approximately 33.7 million cattle slaughtered in 2007,
FSIS estimates that about 1,300 cattle -- about 600 cull cattle (i.e.,
mostly cows and bulls) and 700 steers and heifers -- were in this
category. Data from the Agricultural Marketing Service (AMS) indicate
that the market value for a cull cattle carcass and parts is between
$500 and $1,000, and the market value for a steer or heifer carcass and
parts is between $900 and $1,100. Therefore, the estimated total market
value of the carcasses and parts from cattle that would be condemned
under this proposed rule would be in the range of $930,000 to
$1,370,000 per year.
If adopted as a final rule, the proposed amendment would benefit both
consumers and the beef industry by enhancing public confidence in the
U.S. beef supply. This proposed rule would enhance public confidence by
eliminating any controversy surrounding the condemnation of cattle that
become non-ambulatory disabled after ante-mortem inspection and by
preventing the slaughter of cattle that may be unfit for human food. It
would also reduce the potential for inhumane handling of non-ambulatory
disabled cattle at slaughter operations.
This proposed rule would also assist the United States in international
trade relations and negotiations by providing greater confidence to
those countries that continue to raise questions about American beef.
The proposed amendment would increase consumer confidence and U.S.
access to overseas markets. Thus, the proposed rule will generally
benefit the industry because it would likely lead to higher sales and
revenue.
Anticipated Cost and Benefits:
Not applicable.
Risks:
Not Applicable.
Timetable:
_______________________________________________________________________
Action Date FR Cite
_______________________________________________________________________
NPRM 08/29/08 73 FR 50889
Final Action 01/00/09
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
Businesses
Government Levels Affected:
State
Agency Contact:
Dr. Daniel L. Engeljohn
Deputy Assistant Administrator, Office of Policy and Program
Development
Department of Agriculture
Food Safety and Inspection Service
1400 Independence Avenue SW
Washington, DC 20250
Phone: 202 205-0495
Fax: 202 401-1760
Email: [email protected]
RIN: 0583-AD35
_______________________________________________________________________
USDA--FSIS
17. MANDATORY COUNTRY OF ORIGIN LABELING OF COVERED
COMMODITIES INCLUDING MUSCLE CUTS OF BEEF (INCLUDING VEAL), LAMB,
CHICKEN, GOAT, AND PORK; GROUND BEEF, GR. LAMB, GR. CHICKEN, GR. GOAT,
AND GR. PORK
Priority:
Other Significant
Legal Authority:
Public Law 110-234 (2008 Farm Bill)
CFR Citation:
9 CFR 317; 9 CFR 381
Legal Deadline:
Final, Statutory, September 30, 2008, Statutory implementation deadline
per the 2008 Bill.
Abstract:
FSIS is amending its regulations through an interim final rule to make
clear that country of origin labeling of covered commodities that
complies with the Food, Conservation and Energy Act of 2008 and the
Agricultural Marketing Service (AMS) interim regulations will be
generically approved under 9 CFR 317.5 and 9 CFR 381.133
Statement of Need:
Mandatory Country of Origin Labeling of Covered Commodities including
Muscle Cuts of Beef (including Veal), Lamb, Chicken, Goat, and Pork;
Ground Beef, Ground Lamb, Ground Chicken, Ground Goat, and Ground Pork
-- Interim final rule. (This rule makes minor changes to FSIS
regulations based on mandatory country of origin labeling
requirements.)
Summary of Legal Basis:
FSIS is amending its regulations based on mandatory country of origin
labeling for meat and poultry covered commodities based on the Food,
Conservation and Energy Act of 2008. Meat covered commodities include
muscle cuts of beef (including veal), lamb, chicken, goat, and pork;
ground beef, ground lamb, ground chicken, ground goat, and ground pork.
This rule will provide consumers with additional information on which
to base their purchasing decisions.
Alternatives:
Not applicable.
Anticipated Cost and Benefits:
None. All costs for this interim final rule are covered under the USDA/
AMS COOL rule published on August 1, 2008 (73 FR 45106).
Risks:
There are no risks associated with this rule.
Timetable:
_______________________________________________________________________
Action Date FR Cite
_______________________________________________________________________
Interim Final Rule 08/28/08 73 FR 50701
Final Action 12/00/08
Regulatory Flexibility Analysis Required:
No
[[Page 71131]]
Small Entities Affected:
No
Government Levels Affected:
None
Agency Contact:
Charles Gioglio
Labeling and Program Delivery Division
Department of Agriculture
Food Safety and Inspection Service
1400 Independence Avenue SW
Washington, DC 20250
Phone: 202 205-0279
Fax: 202 205-3625
Email: [email protected]
RIN: 0583-AD38
_______________________________________________________________________
USDA--Forest Service (FS)
-----------
FINAL RULE STAGE
-----------
18. RESOURCE AGENCY PROCEDURES FOR CONDITIONS AND PRESCRIPTIONS IN
HYDROPOWER LICENSES
Priority:
Other Significant
Legal Authority:
PL 109-58
CFR Citation:
7 CFR 1
Legal Deadline:
Final, Statutory, November 7, 2005.
Public Law 109-58 charges agencies requiring mandatory conditions and
prescriptions with the promulgation of new regulations by November 7,
2005, to provide the regulatory framework to implement a trial-type
hearing process.
Abstract:
The Energy Policy Act of 2005 (Pub. L. 109-58) contains provisions
requiring a trial-type hearing to resolve disputed issues of material
fact related to mandatory conditions and prescriptions required under
the issuance of a Federal hydropower license. The law also mandates
that the Agency consider alternatives to proposed mandatory conditions
and prescriptions. This law charges agencies requiring mandatory
conditions and prescriptions with the promulgation of new regulations
by November 7, 2005, to provide the regulatory framework to implement
the trial-type hearing process. The U.S. Department of Agriculture,
acting through the Forest Service, is one of the agencies required
under the Act to provide a trial-type hearing and issue an implementing
regulation. To meet the statutory deadline, the U.S. Department of
Agriculture, along with the U.S. Departments of the Interior and
Commerce, issued a joint interim final rule. The Department of the
Interior is the lead agency in this effort.
The Forest Service adopted an interim final rule at 7 CFR part 1
establishing a trial-type hearing procedure to resolve disputed issues
of material fact related to mandatory conditions and prescriptions
required under the issuance of a Federal hydropower license. The
interim final rule also provides a process for the filing of proposed
alternative conditions and prescriptions.
Statement of Need:
The Departments of Agriculture, the Interior, and Commerce are jointly
revising the procedures they established for expedited trial-type
hearings. The three Departments are also revising the procedures they
established for the consideration of alternative conditions and
prescriptions submitted by any party to a Federal Energy Regulatory
(FERC) hydroelectric licensing proceeding. Three substantially similar
rules are being promulgated - one for each agency - with a joint
preamble. The rules and preamble reflect changes to each Department's
interim final rules, in response to public comments and the
Departments' experience in implementing their interim final rules.
Summary of Legal Basis:
On November 17, 2005, the Departments of Agriculture, the Interior, and
Commerce jointly published interim final rules implementing section 241
of the Energy Policy Act of 2005 (EPAct), Pub. L. 109-58. 70 FR 69804-
51. In their joint preamble, the Departments stated that, based upon
comments received and experience gained with their interim final rules,
they would consider revising the rules.
Alternatives:
There was some discussion among the Departmental/Agency representatives
over the interpretation of the scope of work and trigger for conducting
an alternative condition analysis. DOI proposed that the group conduct
an alternative condition analysis on ALL mandatory conditions. The DOI
position was agreed to with some clarification that this approach was
selected as it is not explicit in the language of Section 241 of the
Energy Policy Act of 2005.
Anticipated Cost and Benefits:
The Final rule addresses the uncertainty by commenters about the
``Interim Final'' rule from 2005 and it incorporates some of the
lessons learned of some of the Trial Type and Alternative Condition
processes conducted since promulgation of the Interim Final Rule.
The most notable costs are staff time to conduct an Alternative
Condition Analysis for all mandatory terms and conditions submitted to
FERC and potential litigation challenging the Alternative Condition
Analysis due to limited expertise in some of the legislated
considerations when conducting an Alternative Condition Analysis.
Risks:
No risks have been identified at this time.
Timetable:
_______________________________________________________________________
Action Date FR Cite
_______________________________________________________________________
Interim Final Rule 11/17/05 70 FR 69804
Interim Final Rule
Comment Period End 01/17/06
Final Action 12/00/08
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
No
Government Levels Affected:
None
Agency Contact:
Lorrie Parker
Regulatory Analyst
Department of Agriculture
Forest Service
ATTN: ORMS, D&R Branch
1400 Independence Avenue SW
Washington, DC 20250-0003
Phone: 202 205-6560
Fax: 202 260-6539
Email: [email protected]
RIN: 0596-AC42
_______________________________________________________________________
USDA--FS
19. SPECIAL AREAS; STATE-SPECIFIC INVENTORIED ROADLESS AREA MANAGEMENT:
COLORADO
Priority:
Economically Significant. Major under 5 USC 801.
[[Page 71132]]
Legal Authority:
Not Yet Determined
CFR Citation:
36 CFR 294
Legal Deadline:
None
Abstract:
On April 11, 2007, Governor of Colorado Ritter submitted a petition
under the provisions of the Administrative Procedure Act (5 U.S.C.
553(e)) and Agriculture Department regulation (7 CFR 1.28) to
promulgate regulations, in cooperation with the State, for the
management of inventoried roadless areas within the State of Colorado.
After review and recommendation by the Roadless Area Conservation
National Advisory Committee, the Secretary accepted the Governor's
petition and initiated a proposed rulemaking for inventoried roadless
areas in Colorado. The proposed rulemaking would manage Colorado's
inventoried roadless areas by prohibiting road building and tree
cutting, with some exceptions, on 4.1 million acres of inventoried
roadless areas in Colorado. The 4.1 million acres reflect the most
updated IRA boundaries for Colorado, which incorporate planning rule
revisions since 2001 on several Colorado national forests. Inventoried
roadless areas that are allocated to ski area special uses
(approximately 10,000 acres) would also be removed from roadless
designation. Road construction and reconstruction plus timber
harvesting would be prohibited in inventoried roadless areas, with some
exceptions, on the Arapaho-Roosevelt, Grand Mesa-Uncompahgre, Gunnison,
Manti-La Sal, Pike-San Isabel, Rio Grande, Routt, San Juan, and White
River National Forests in Colorado. Exceptions to the prohibitions
would be allowed for certain health, safety, valid existing rights,
resource protection, and ecological management needs.
Web site: http://roadless.fs.fed.us
Statement of Need:
The Department of Agriculture is committed to conserving and managing
roadless values and considers inventoried roadless areas an important
component of the National Forest System. The roadless rule has been the
subject of 10 lawsuits in Federal district courts in Idaho, Utah, North
Dakota, Wyoming, Alaska, and the District of Columbia. On July 14,
2003, the U.S. District Court for the District of Wyoming found the
2001 roadless rule to be unlawful and ordered that the rule be
permanently enjoined. On May 13, 2005, the Forest Service promulgated
the State Petitions Rule. The State Petitions Rule allowed Governors to
voluntarily seek establishment of or adjustment of management
requirements for National Forest System inventoried roadless areas
within their States. If a petition was not received within 18 months,
inventoried roadless areas would be guided by individual land
management plans. It also established the Roadless Area Conservation
National Advisory Committee (RACNAC) to make recommendations on State-
petitions to the Secretary. With the promulgation of the State
Petitions Rule, the Tenth Circuit, which was reviewing an appeal by
intervenors of the Wyoming court's decision, dismissed the case as
moot. Under the guidance of the State Petitions Rule the States of
California, Idaho, New Mexico, North Carolina, South Carolina, and
Virginia filed a petition with the Secretary. The Secretary instructed
the Forest Service to enter into rulemaking for North Carolina, South
Carolina, and Virginia. Two lawsuits were filed against the State
Petitions Rule in the Federal district court for the Northern District
of California.
One suit was filed by the States of California, New Mexico, Oregon, and
Washington with the State of Montana being amicus curiae in support of
plaintiffs; and the States of Alaska and Idaho are amici curiae to
USDA. The other lawsuit was filed by a coalition of environmental
groups. On September 20, 2006, the Federal district court enjoined the
State Petitions Rule and reinstated the roadless rule. In an effort to
again re-enjoin the roadless rule, the State of Wyoming filed a second
lawsuit in the Federal district court for Wyoming on January 12, 2007.
Oral hearing for this lawsuit was held October 19 and decision is
pending. With the reinstatement of roadless rule, the Under Secretary
announced that interested States could still petition the Secretary
pursuant to 5 U.S.C. section 553(e) and 7 CFR section 1.28. On November
13, 2006, Colorado Governor Bill Owens submitted his petition under
these authorities. On April 11, 2007, Colorado Governor Bill Ritter
resubmitted the petition with amendments. The RACNAC reviewed the
petition and made recommendations to the Secretary on August 2, 2007.
Collaboratively working on the establishment of a State-specific
roadless rule for the petitioning State will allow the State the level
of management of inventoried roadless areas it seeks to best meet its
needs in balance with the Department's and Forest Service's goals for
the conserving and managing roadless values nationally. In addition, it
will allow for the management of these lands in that State without
being affected by other legal actions concerning the roadless rule or
State Petitions Rule.
Summary of Legal Basis:
On January 12, 2001, the Department of Agriculture promulgated the
Roadless Area Conservation Rule to provide for the conservation and
management of approximately 58.5 million acres of inventoried roadless
areas within the National Forest System under the principles of the
Multiple-Use Sustained-Yield Act of 1960. The State of Colorado has
petitioned the Secretary pursuant to 5 U.S.C. section 553(e) and 7 CFR
section 1.28 for state-specific rules to replace this national rule.
Alternatives:
The Forest Service is preparing environmental impact statements in
support of the rulemaking effort. Besides the proposed rule, two
alternatives are being considered: (1) Continuation of the RACR for
management of these inventoried roadless areas, and (2) using existing
forest plans and future forest plan revisions to determine the
management of these areas.
Anticipated Cost and Benefits:
The proposed rule is an economically significant rule, and will have an
annual effect of more than $100 million or more on the economy nor
adversely affect productivity, competition, jobs, the environment,
public health or safety, nor State or local governments. This proposed
rule is not expected to interfere with an action taken or planned by
another Agency nor raise new legal or policy issues. This proposed rule
will not alter the budgetary impact of entitlements, grants, user fees,
or loan programs or the rights and obligations of recipients of such
programs. Furthermore, the proposed rule is programmatic in nature,
consisting of direction for road construction, road reconstruction,
timber harvesting, special uses including ski resorts, and
discretionary mineral activities, which would be applied to future
management activities
[[Page 71133]]
on inventoried roadless areas in Colorado.
Risks:
The rule is programmatic in nature and would constrain certain
activities that would reduce roadless area characteristics. Reducing or
controlling the development of these lands will reduce the risk of
environmental effects associated with development activities like road
construction, timber harvesting, and mineral extraction. Therefore
soil, water, and air quality; sources of drinking water; diversity of
plant and animal communities; habitat for threatened, endangered,
proposed, candidate, and sensitive species dependent on large,
undisturbed areas of land; scenic quality; traditional cultural
properties and sacred sites; and other locally unique characteristics
would be maintained.
Timetable:
_______________________________________________________________________
Action Date FR Cite
_______________________________________________________________________
NPRM 07/25/08 73 FR 43544
NPRM Comment Period End 10/23/08
Final Action 01/00/09
Regulatory Flexibility Analysis Required:
Yes
Small Entities Affected:
Businesses
Government Levels Affected:
Federal, State, Tribal
URL For More Information:
www.roadless.fs.fed.us.
Agency Contact:
Lorrie Parker
Regulatory Analyst
Department of Agriculture
Forest Service
ATTN: ORMS, D&R Branch,
1400 Independence Avenue SW
Washington, DC 20250-0003
Phone: 202 205-6560
Fax: 202 205-6539
Email: [email protected]
RIN: 0596-AC74
BILLING CODE 3410-90-S
[[Page 71134]]
DEPARTMENT OF COMMERCE (DOC)
Statement of Regulatory and Deregulatory Priorities
Enhancing long-term economic growth is a central focus of the
President's policies and priorities. The mission of the Department of
Commerce is to promote job creation, economic growth, technological
competitiveness, sustainable development, and improve living standards
for all Americans by working in partnership with businesses,
universities, communities, and workers to:
Build for the future and promote U.S. economic competitiveness
in the global marketplace by strengthening and safeguarding
the Nation's economic infrastructure;
Keep America competitive with cutting-edge science and
technology and an unrivaled information base; and
Provide effective management and stewardship of our nation's
resources and assets to ensure sustainable economic
opportunities.
The DOC mission statement, containing our three strategic themes,
provides the vehicle for understanding the Department's aims, how they
interlock, and how they are to be implemented through our programs.
This statement was developed with the intent that it serve as both a
statement of departmental philosophy and as the guiding force behind
the Department's programs.
The importance that this mission statement and these strategic themes
have for the Nation is amplified by the vision they pursue for
America's communities, businesses, and families. Commerce is the
smallest Cabinet agency, yet our presence is felt, and our
contributions are found, in every State.
The DOC touches Americans, daily, in many ways--we make possible the
weather reports that all of us hear every morning; we facilitate the
technology that all of us use in the workplace and in the home each
day; we support the development, gathering, and transmitting of
information essential to competitive business; we make possible the
diversity of companies and goods found in America's (and the world's)
marketplace; and we support environmental and economic health for the
communities in which Americans live.
The DOC has a clear and powerful vision for itself, for its role in the
Federal Government, and for its roles supporting the American people,
now and in the future. We confront the intersection of trade promotion,
civilian technology, economic development, sustainable development, and
economic analysis, and we want to provide leadership in these areas for
the Nation.
We work to provide programs and services that serve our country's
businesses, communities, and families, as initiated and supported by
the President and the Congress. We are dedicated to making these
programs and services as effective as possible, while ensuring that
they are being delivered in the most cost-effective ways. We seek to
function in close concert with other agencies having complementary
responsibilities so that our collective impact can be most powerful. We
seek to meet the needs of our customers quickly and efficiently, with
programs, information, and services they require and deserve.
As a permanent part of the Federal Government, but serving an
Administration and Congress that can vary with election results, we
seek to serve the unchanging needs of the Nation, according to the
priorities of the President and the Congress. The President's
priorities for the Department range from issues concerning the economy
to the environment. For example, the President directs the Department
to promote electronic commerce activities; encourage open and free
trade; represent American business interests abroad; and assist small
businesses to expand and create jobs. We are able to address these
priorities effectively by functioning in accordance with the
legislation that supports our programs and by working closely with the
President and the committees in Congress that have programmatic and
financial oversight for our programs.
The DOC also promotes and expedites American exports, helps nurture
business contacts abroad, protects U.S. firms from unfair foreign
competition, and makes how-to-export information accessible to small
and mid-sized companies throughout the Nation, thereby ensuring that
U.S. market opportunities span the globe.
The DOC encourages development in every community, clearing the way for
private-sector growth by building and rebuilding economically deprived
and distressed communities. We promote minority entrepreneurship to
establish businesses that frequently anchor neighborhoods and create
new job opportunities. We work with the private sector to enhance
competitive assets.
As the Nation looks to revitalize its industries and communities, the
DOC works as a partner with private entities to build America with an
eye on the future. Through technology, research and development, and
innovation, we are making sure America continues to prosper in the
short term, while also helping industries prepare for long-term
success.
The DOC's considerable information capacities help businesses
understand clearly where our national and world economies are going and
take advantage of that knowledge by planning the road ahead. Armed with
the Department's economic and demographic statistics, businesses can
undertake new ventures, investments, and expansions that make our
economy grow.
The DOC has instituted programs and policies that lead to cutting-edge,
competitive, and better paying jobs. We work every day to boost
exports, to deregulate business, to help smaller manufacturers battle
foreign competition, to advance the technologies critical to our future
prosperity, to invest in our communities, and to fuse economic and
environmental goals.
The DOC is American business' surest ally in job creation, serving as a
vital resource base, a tireless advocate, and its Cabinet-level voice.
The Regulatory Plan tracks the most important regulations that
implement these policy and program priorities, several of which involve
regulation of the private sector by the Department.
Responding to the Administration's Regulatory Philosophy and Principles
The vast majority of the Department's programs and activities do not
involve regulation. Of the Department's 12 primary operating units,
only the National Oceanic and Atmospheric Administration (NOAA) will be
planning actions that are considered the ``most important'' significant
preregulatory or regulatory actions for fiscal year 2009. During the
next year, NOAA plans to publish nine rulemaking actions that are
designated as Regulatory Plan actions. Further information on these
actions is provided below.
Though not principally a regulatory agency, the DOC has long been a
leader in advocating and using market-oriented regulatory approaches in
lieu of traditional command-and-control regulations when such
approaches offer a better alternative. All regulations are designed and
implemented to maximize societal benefits while placing the
[[Page 71135]]
smallest possible burden on those being regulated.
The DOC is also refocusing on its regulatory mission by taking into
account, among other things, the President's regulatory principles. To
the extent permitted by law, all preregulatory and regulatory
activities and decisions adhere to the Administration's statement of
regulatory philosophy and principles, as set forth in section 1 of
Executive Order 12866. Moreover, we have made bold and dramatic
changes, never being satisfied with the status quo. We have emphasized,
initiated, and expanded programs that work in partnership with the
American people to secure the Nation's economic future. At the same
time, we have downsized, cut regulations, closed offices, and
eliminated programs and jobs that are not part of our core mission. The
bottom line is that, after much thought and debate, we have made many
hard choices needed to make this Department ``state of the art.''
The Department has a long-standing policy to prohibit the issuance of
any regulation that discriminates on the basis of race, religion,
gender, or any other suspect category and requires that all regulations
be written so as to be understandable to those affected by them. The
Secretary also requires that the Department afford the public the
maximum possible opportunity to participate in departmental
rulemakings, even where public participation is not required by law.
National Oceanic and Atmospheric Administration
The 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 services vital to public safety and
to the Nation's economy, such as weather forecasts and storm warnings.
It is a source of objective information on the state of the
environment. NOAA plays the lead role in achieving the departmental
goal of promoting stewardship by providing assessments of the global
environment.
Recognizing that economic growth must go hand-in-hand with
environmental stewardship, the Department, through NOAA, conducts
programs designed to provide a better understanding of the connections
between environmental health, economics, and national security.
Commerce's emphasis on ``sustainable fisheries'' is designed to boost
long-term economic growth in a vital sector of the U.S. economy while
minimizing any economic dislocation necessary to ensure long-term
economic growth. The Department is where business and environmental
interests intersect, and the classic debate on the use of natural
resources is transformed into a ``win-win'' situation for the
environment and the economy.
Three of NOAA's major components, the National Marine Fisheries
Services (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 Nation's national
marine sanctuaries; monitors marine pollution; and directs the national
program for deep-seabed minerals and ocean thermal energy. NESDIS
administers the civilian weather satellite program and licenses private
organizations to operate commercial land-remote sensing satellite
systems.
The Administration is committed to an environmental strategy that
promotes sustainable economic development and rejects the false choice
between environmental goals and economic growth. The intent is to have
the Government's economic decisions guided by a comprehensive
understanding of the environment. The Department, through NOAA, has a
unique role in promoting stewardship of the global environment through
effective management of the Nation's marine and coastal resources and
in monitoring and predicting changes in the Earth's environment, thus
linking trade, development, and technology with environmental issues.
NOAA has the primary federal responsibility for providing sound
scientific observations, assessments, and forecasts of environmental
phenomena on which resource management 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 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:
modernizing 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 fiscal year 2009, 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
[[Page 71136]]
individual transferable quotas, which permit quota-holders 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.
The Magnuson-Stevens Act contains ten national standards against which
fishery management measures are evaluated. NMFS has supplemented the
standards with guidelines interpreting each standard, and has updated
and added to those guidelines. One of the national standards requires
that management measures, where practicable, minimize costs and avoid
unnecessary duplication. Under the guidelines, NMFS will not approve
management measures submitted by an FMC unless the fishery is in need
of management. Together, the standards and the guidelines correspond to
many of the Administration's principles of regulation as set forth in
section 1(b) of Executive Order 12866. One of the national standards
establishes a qualitative equivalent to the Executive Order's ``net
benefits'' requirement--one of the focuses of the Administration's
statement of regulatory philosophy as stated in section 1(a) of the
Executive Order.
On January 12, 2007, the President signed into law the Magnuson-Stevens
Fishery Conservation and Management Reauthorization Act of 2006 (MSRA).
This important new law was identified by the President as one of his
priority actions in the U.S. Ocean Plan. The enactment of the law
reaffirms the importance of the goals of the Magnuson-Stevens Act, but
more importantly, it implements important groundbreaking provisions
that could enhance fisheries management. The new measures implemented
by this law would work to end overfishing; promote market-based
management approaches; improve science by providing a stronger role for
peer review and for the Councils' Science and Statistical Committees
(SSC) in decision-making, and improving the collection of accurate and
precise fishing data; and enhance international cooperation by
addressing illegal, unreported and unregulated (IUU) fishing and
bycatch of protected living marine resources. NMFS will be initiating
several rulemakings in the coming year to implement these important
provisions.
Marine Mammal Protection Act
The Marine Mammal Protection Act of 1972 (MMPA) provides the authority
for the conservation and management of marine mammals under U.S.
jurisdiction. It expressly prohibits, with certain exceptions, the take
of marine mammals. Exceptions include 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 Act 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 Act. NMFS manages marine and
``anadromous'' species and FWS manages land and freshwater species.
Together, NMFS and FWS work to protect critically imperiled species
from extinction. Of the 1,310 listed species found in part or entirely
in the United States and its waters, NMFS has jurisdiction over
approximately 60 species. NMFS' rulemaking actions are focused on
determining whether any species under its responsibility is an
endangered or threatened species and whether those species must be
added to the list of protected species. NMFS is also responsible for
designating, reviewing, and revising critical habitat for any listed
species. In addition, under the ESA's procedural framework, federal
agencies consult with NMFS on any proposed action authorized, funded,
or carried out by that agency that may affect one of the listed species
or designated critical habitat, or is likely to jeopardize proposed
species or adversely modify proposed critical habitat that is under
NMFS' jurisdiction.
NOAA's Regulatory Plan Actions
While most of the rulemakings undertaken by NOAA do not rise to the
level necessary to be included in the Department's Regulatory Plan,
NMFS is undertaking nine actions that rise to the level of ``most
important'' of the Departments significant regulatory actions, and thus
are included in this year's Regulatory Plan. Three actions implement
the Marine Mammal Protection Act. Six actions implement provisions of
the Magnuson-Stevens Reauthorization Act (MSRA). One regulation that
may be of particular interest to international trading partners
concerns the Certification of Nations Whose Fishing Vessels are Engaged
in Illegal, Unreported, or Unregulated Fishing or Bycatch of Protected
Living Marine Resources, as described below.
``Certification of Nations Whose Fishing Vessels Are Engaged in IUU
Fishing or Bycatch of Protected Living Marine Resources'' - In this
action, NMFS would establish a process of identification and
certification to address illegal, unreported, or unregulated (IUU)
activities and bycatch of protected species in international fisheries.
Nations whose fishing vessels engage, or have been engaged, in IUU
fishing or bycatch of protected living marine resources would be
identified in a biennial report to Congress. NMFS would subsequently
certify whether identified nations have taken appropriate corrective
action with respect to the activities of its fishing vessels, as
required under Section 403 of MSRA. Negative certification of a
[[Page 71137]]
nation may result in the imposition of trade measures.
``Provide Guidance for the Limited Access Privilege Program Provisions
of the Magnuson-Stevens Fishery Conservation and Management
Reauthorization Act of 2006'' - This action would provide national
guidance on the use of Limited Access Privilege Programs (LAPP) as
fishery management tools. The guidance is intended to assist the
fishery management councils and NMFS headquarters and regional offices
in developing and implementing LAPPs.
``Guidance for Annual Catch Limits and Accountability Measures to End
Overfishing'' - In this action, NMFS would implement provisions that
require fishery management plans to establish a mechanism for
specifying annual catch limits (ACLs) in the plans implementing
regulations or annual specifications, at a level such that overfishing
does not occur in a fishery. In addition, this action would implement
measures to ensure accountability.
``Disaster Assistance Programs'' - This action would govern requests
for determinations of fishery resource disasters as a basis for
acquiring potential disaster assistance. The regulations would
establish definitions and characteristics of commercial fishery
failures, fishery resource disasters, serious disruptions affecting
future production, and harm incurred by fishermen. The intended result
is to clarify and interpret the fishery disaster assistance provisions
of the Magnuson-Stevens Act and the Interjurisdictional Fisheries Act
and thereby ensure consistency and facilitate the processing of
requests.
``Magnuson-Stevens Fishery Conservation and Management Reauthorization
Act Environmental Review Procedure'' - This final rule would revise and
update NMFS procedures for complying with the National Environmental
Policy Act (NEPA) in the context of fishery management actions
developed pursuant to the Magnuson Stevens Fishery Conservation and
Management Act. These regulations are modeled on the Council of
Environmental Quality (CEQ) regulations implementing the procedural
provisions of NEPA, and are designed to conform to the timelines for
review and approval of fishery management plans and plan amendments.
``Amendment to Coastal Migratory Pelagics FMP, Red Drum FMP, Reef Fish
FMP, Spiny Lobster FMP, and Stone Crab FMP to Provide for Regulation of
Marine Aquaculture'' - The Gulf of Mexico Fishery Management Council is
developing an Aquaculture Fishery Management Plan, which if approved,
would establish a regional permitting process for regulating and
promoting environmentally sound and economically sustainable
aquaculture in the Gulf of Mexico exclusive economic zone.
``Taking and Importing Marine Mammals; U.S. Navy's Atlantic Fleet
Active Sonar Training (AFAST)'' - NMFS has received a request from the
U.S. Navy for authorization to take marine mammals incidental to
training activities conducted off the U.S. Atlantic Coast and in the
Gulf of Mexico for the period of January 2009 through January 2014.
These training activities are classified as military readiness
activities. The final regulations would authorize these activities and
govern the take of marine mammals.
``Taking and Importing Marine Mammals; U.S. Navy Training in the
Southern California Range Complex'' - NMFS has received a request from
the U.S. Navy for authorization to take marine mammals incidental to
training activities conducted in the Southern California Range Complex
, which extends south and southwest off the southern California coast,
for the period of January 2009 through January 2014. These training
activities are classified as military readiness activities. The final
regulations would authorize these activities and govern the take of
marine mammals.
``Taking and Importing Marine Mammals; U.S. Navy Training in the Hawaii
Range Complex'' - NMFS has received a request from the U.S. Navy for
authorization to take marine mammals incidental to training activities
conducted within the Hawaii Range Complex (HRC) for the period of
December 2008 through December 2013. These training activities are
classified as military readiness activities. The final regulations
would authorize these activities and govern the take of marine mammals.
NOAA's nine Regulatory Plan actions support several of the President's
priorities as stated in the U.S. Ocean Action Plan. Specifically, NMFS'
regulatory actions implement the President's ongoing effort to combat
international illegal, unregulated and unreported fishing activities
through its proposed identification and certification process and
support the goal to use market-based systems for fisheries management.
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) promotes U.S. national and
economic security and foreign policy interests by managing and
enforcing the Department's security-related trade and competitiveness
programs. BIS plays a key role in challenging issues involving national
security and nonproliferation, export growth, and high technology. The
Bureau's continuing major challenge is combating the proliferation of
weapons of mass destruction while furthering the growth of U.S.
exports, which are critical to maintaining our leadership in an
increasingly competitive global economy. BIS strives to be the leading
innovator in transforming U.S. strategic trade policy and programs to
adapt to the changing world.
Major Programs and Activities
The Export Administration Regulations (EAR) provide for export controls
on dual-use goods and technology (primarily commercial goods that have
potential military applications) not only to fight proliferation, but
also to pursue other national security, short supply, and foreign
policy goals (such as combating terrorism). Simplifying and updating
these controls in light of the end of the Cold War has been a major
accomplishment of BIS.
BIS is also responsible for:
Enforcing the export control and antiboycott provisions of the
Export Administration Act (EAA), as well as other statutes
such as the Fastener Quality Act. The EAA is enforced
through a variety of administrative, civil, and criminal
sanctions.
Analyzing and protecting the defense industrial and technology
base, pursuant to the Defense Production Act and other
laws. As the Defense Department increases its reliance on
dual-use high technology goods as part of its cost-cutting
efforts, ensuring that we remain competitive in those
sectors and subsectors is critical to our national
security.
Helping Ukraine, Kazakhstan, Belarus, Russia, and other newly
emerging countries develop effective export control
systems. The effectiveness of U.S. export controls can be
severely undercut if ``rogue states'' or terrorists gain
access to
[[Page 71138]]
sensitive goods and technology from other supplier
countries.
Working with former defense plants in the Newly Independent
States to help make a successful transition to profitable
and peaceful civilian endeavors. This involves helping
remove unnecessary obstacles to trade and investment and
identifying opportunities for joint ventures with U.S.
companies.
Assisting U.S. defense enterprises to meet the challenge of
the reduction in defense spending by converting to civilian
production and by developing export markets. This work
assists in maintaining our defense industrial base as well
as preserving jobs for U.S. workers.
_______________________________________________________________________
DOC--National Oceanic and Atmospheric Administration (NOAA)
-----------
PROPOSED RULE STAGE
-----------
20. AMENDMENT TO COASTAL MIGRATORY PELAGICS FMP, RED DRUM FMP, REEF
FISH FMP, SPINY LOBSTER FMP, AND STONE CRAB FMP TO PROVIDE FOR
REGULATION OF MARINE AQUACULTURE
Priority:
Other Significant
Legal Authority:
16 USC 1801 et seq
CFR Citation:
50 CFR 622
Legal Deadline:
None
Abstract:
The purpose of the amendment is to develop a regulatory permitting
process for regulating and promoting environmentally sound and
economically sustainable aquaculture in the Gulf Exclusive Economic
Zone. Possible management actions include: (1) Types of aquaculture
permits required; (2) duration aquaculture permits are effective; (3)
conditions for permit issuance; (4) species allowed for aquaculture;
(5) allowable aquaculture systems; (6) designation of sites or areas
for conducting aquaculture; (7) buffer zones for aquaculture
facilities; (8) recordkeeping and reporting requirements; and (9)
regulations to aid in the enforcement of marine aquaculture facilities.
Statement of Need:
Demand for protein is increasing in the United States and commercial
wild-capture fisheries will not likely be adequate to meet this growing
demand. Aquaculture is one method to meet current and future demands
for seafood. Supplementing the harvest of domestic fisheries with
cultured product will help the U.S. meet consumers' growing demand for
seafood and may reduce the nation's dependence on seafood imports.
Currently, the U.S. imports over 80 percent of the seafood consumed in
the country, and the annual U.S. seafood trade deficit is at an all
time high of over $9 billion.
Summary of Legal Basis:
Magnuson-Stevens Fishery Conservation and Management Act, 16 U.S.C.
1801 et seq.
Alternatives:
The Council's Aquaculture FMP includes 10 actions, each with an
associated range of alternatives. These actions and alternatives are
collectively intended to establish a regional permitting process for
offshore aquaculture. Management actions in the FMP include: 1)
Aquaculture permit requirements, eligibility, and transferability; 2)
duration aquaculture permits are effective; 3) aquaculture application
requirements, operational requirements, and restrictions; 4) species
allowed for aquaculture; 5) allowable aquaculture systems; 6) marine
aquaculture siting requirements and conditions; 7) restricted access
zones for aquaculture facilities; 8) recordkeeping and reporting
requirements; 9) biological reference points and status determination
criteria; and 10) framework procedures for modifying biological
reference points and regulatory measures.
Anticipated Cost and Benefits:
Environmental and social/economic costs and benefits are described in
detail in the Council's Aquaculture FMP. Potential benefits include:
establishing a rigorous review process for reviewing and approving/
denying aquaculture permits, increasing optimum yield by supplementing
the harvest of wild domestic fisheries with cultured products, and
reducing the nation's dependence on imported seafood. Anticipated costs
include: increased administration and oversight of an aquaculture
permitting process and potential negative environmental impacts to wild
marine resources. Approval of an aquaculture permitting system may also
benefit fishing communities by creating new jobs or impact fishing
communities if cultured products economically displace domestic
seafood.
Risks:
National offshore aquaculture legislation has also been previously
proposed by the Administration. This action may reduce the need for
uniform national legislation and allow aquaculture regulations to vary
by region.
Timetable:
_______________________________________________________________________
Action Date FR Cite
_______________________________________________________________________
NPRM 11/00/08
NPRM Comment Period End 12/00/08
Regulatory Flexibility Analysis Required:
Yes
Small Entities Affected:
Businesses
Government Levels Affected:
None
Agency Contact:
Roy Crabtree
Regional Administrator, Southeast Region
Department of Commerce
National Oceanic and Atmospheric Administration
263 Thirteenth Avenue South
St. Petersburg, FL 33701
Phone: 727 570-5305
Fax: 727 570-5583
Email: [email protected]
RIN: 0648-AS65
_______________________________________________________________________
DOC--NOAA
21. CERTIFICATION OF NATIONS WHOSE FISHING VESSELS ARE ENGAGED IN IUU
FISHING OR BYCATCH OF PROTECTED LIVING MARINE RESOURCES
Priority:
Other Significant
Legal Authority:
16 USC 1801 et seq; 16 USC 1826d to 1826k
CFR Citation:
50 CFR 300
Legal Deadline:
None
Abstract:
The National Marine Fisheries Service is establishing a process of
[[Page 71139]]
identification and certification to address illegal, unreported, or
unregulated (IUU) activities and bycatch of protected species in
international fisheries. Nations whose fishing vessels engage, or have
been engaged, in IUU fishing or bycatch of protected living marine
resources would be identified in a biennial report to Congress, as
required under Section 403 of the Magnuson-Stevens Fishery Conservation
and Management Reauthorization Act (MSRA) of 2006. NMFS would
subsequently certify whether identified nations have taken appropriate
corrective action with respect to the activities of its fishing
vessels, as required under Section 403 of MSRA.
Statement of Need:
The National Oceanic and Atmospheric Administration (NOAA) National
Marine Fisheries Service (NMFS) proposes regulations to set forth
identification and certification procedures for nations whose vessels
engage in illegal, unregulated, and unreported (IUU) fishing activities
or bycatch of protected living marine resources pursuant to the High
Seas Fishing Moratorium Protection Act (Moratorium Protection Act).
Specifically, the Moratorium Protection Act requires the Secretary of
Commerce to identify in a biennial report to Congress those foreign
nations whose vessels are engaged in IUU fishing or fishing that
results in bycatch of protected living marine resources. The Moratorium
Protection Act also requires the establishment of procedures to certify
whether nations identified in the biennial report are taking
appropriate corrective actions to address IUU fishing or bycatch of
protected living marine resources by fishing vessels of that nation.
Based upon the outcome of the certification procedures developed in
this rulemaking, nations could be subject to import prohibitions on
certain fisheries products and other measures under the authority
provided in the High Seas Driftnet Fisheries Enforcement Act if they
are not positively certified by the Secretary of Commerce.
Summary of Legal Basis:
NOAA is proposing these regulations pursuant to its rulemaking
authority under sections 609 and 610 of the High Seas Driftnet Fishing
Moratorium Protection Act (16 U.S.C. 1826j to 1826k), as amended by the
Magnuson-Stevens Fishery Conservation and Management Reauthorization
Act.
Alternatives:
NMFS is currently in the process of developing alternatives, and will
provide this information at a later date.
Anticipated Cost and Benefits:
Because this rule is under development, NMFS does not currently have
estimates of the amount of product that is imported into the United
States from other nations whose vessels are engaged in illegal,
unreported, and unregulated (IUU) fishing or bycatch of protected
living marine resources. Therefore, quantification of the economic
impacts of this rulemaking is not possible at this time. This
rulemaking does not meet the $100 million annual economic impact
threshold and thus has not been determined to be economically
significant under EO 12866.
Risks:
The risks associated with not pursuing the proposed rulemaking include
allowing IUU fishing activities and/or bycatch of protected living
marine resources by foreign vessels to continue without an effective
tool to aid in combating such activities.
Timetable:
_______________________________________________________________________
Action Date FR Cite
_______________________________________________________________________
ANPRM 06/11/07 72 FR 32052
ANPRM Comment Period End 07/26/07
NPRM 12/00/08
Regulatory Flexibility Analysis Required:
Yes
Small Entities Affected:
Businesses
Government Levels Affected:
None
Agency Contact:
Christopher Rogers
Division Chief
Department of Commerce
National Oceanic and Atmospheric Administration
1315 East West Highway
Silver Spring, MD 20910
Phone: 301 713-9090
Email: [email protected]
RIN: 0648-AV51
_______________________________________________________________________
DOC--NOAA
22. MAGNUSON-STEVENS FISHERY CONSERVATION AND MANAGEMENT ACT PROVISIONS
AND INTERJURISDICTIONAL FISHERIES ACT DISASTER ASSISTANCE PROGRAMS
Priority:
Other Significant
Legal Authority:
16 USC 1861; 16 USC 4107
CFR Citation:
50 CFR 600
Legal Deadline:
None
Abstract:
In accordance with the Magnuson-Stevens Fishery Conservation and
Management Act (MSA), as amended, and the Interjurisdicational
Fisheries Act (IFA), the National Marine Fisheries Service (NMFS)
proposes regulations to govern the application for and determination of
commercial fishery failures as a basis for acquiring potential disaster
assistance. The regulations would establish definitions,
characteristics of commercial fishery failures and fishery resource
disasters, requirements for initiating a review by NMFS, and the
administrative process it will follow in processing such applications.
The intended effect of these procedures and requirements is to clarify
the fishery disaster assistance provisions of the MSA and the IFA
through rulemaking and thereby facilitate the processing of requests.
Statement of Need:
The National Oceanic and Atmospheric Administration (NOAA) National
Marine Fisheries Service (NMFS) intends to propose this rule to govern
the requests for determinations of fishery resource disasters as a
basis for acquiring potential disaster assistance. The regulations
would establish definitions, and characteristics of commercial fishery
failures, fishery resource disasters, serious disruptions affecting
future production, and harm incurred by fishermen, as well as
requirements for initiating a review by NMFS, and the administrative
process it will follow in processing such applications. The intended
result of these procedures and requirements is to clarify and interpret
the fishery disaster assistance provisions of the Magnuson-Stevens
Fishery Conservation and Management Act (MSA) and the
Interjurisdictional
[[Page 71140]]
Fisheries Act (IFA) through rulemaking and thereby ensure consistency
and facilitate the processing of requests.
Summary of Legal Basis:
NMFS is proposing these regulations pursuant to its rulemaking
authority under sections 312(a) or 315 of the MSA (16 U.S.C. 1861,
1864), as amended, and sections 308(b) or 308(d) of the IFA (16 U.S.C.
4107).
Alternatives:
Because this rule is presently in the beginning stages of development,
no alternatives have been formulated or analyzed at this time.
Anticipated Cost and Benefits:
Because this rule is presently in the beginning stages of development,
no analysis has been completed at this time to assess the amount that
would be saved or imposed as a result of this rule. However, this rule
does not meet the $100 million annual economic impact threshold and
thus has not been determined to be economically significant under EO
12866.
Risks:
Without this rulemaking, there is a risk that disaster determinations
can be made on an ad hoc basis, without regard to any standardized
guidelines or procedures.
Timetable:
_______________________________________________________________________
Action Date FR Cite
_______________________________________________________________________
NPRM 11/00/08
NPRM Comment Period 01/00/09
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
No
Government Levels Affected:
Local, State, Tribal
Agency Contact:
Charles L. Cooper
Program Leader
Department of Commerce
National Oceanic and Atmospheric Administration
1315 East-West Highway
Silver Spring, MD 20910
Phone: 301 713-2396
Email: [email protected]
RIN: 0648-AW38
_______________________________________________________________________
DOC--NOAA
23. PROVIDE GUIDANCE FOR THE LIMITED ACCESS PRIVILEGE PROGRAM
PROVISIONS OF THE MAGNUSON-STEVENS FISHERY CONSERVATION AND MANAGEMENT
REAUTHORIZATION ACT OF 2006
Priority:
Other Significant
Legal Authority:
16 USC 1801 et seq
CFR Citation:
50 CFR 600
Legal Deadline:
None
Abstract:
This rule will provide regions with interpretive guidance on the use of
Limited Access Privilege Programs as fishery management tools. The
guidance is intended to assist the fishery management councils and the
National Marine Fisheries Service regional offices in developing and
implementing LAPPs.
Statement of Need:
The National Oceanic and Atmospheric Administration (NOAA) National
Marine Fisheries Service (NMFS) intends to propose this rulemaking to
create national guidance for the new Limited Access Privilege Program
(LAPP) provisions found in section 303(A) of the Magnuson-Stevens
Fishery Conservation and Management Act (MSA), as amended by the
Magnuson-Stevens Fishery Conservation and Management Reauthorization
Act of 2006 (MSRA). The LAPP provisions provide new incentive-based
options for fisheries management. NMFS has received numerous requests
from constituent groups, Regional Fishery Management Councils
(Councils), and Congress to develop such guidance. This guidance will
assist Councils in developing LAPPs with full consideration of national
perspectives and concerns.
Summary of Legal Basis:
NMFS is proposing these regulations pursuant to its rulemaking
authority under the MSA. 5 U.S.C. 561, 16 U.S.C. 773, et seq., and 16
U.S.C. 1801 et seq.
Alternatives:
Because this rule is presently in the beginning stages of development,
no alternatives have been formulated or analyzed at this time.
Anticipated Cost and Benefits:
Because this rule is presently in the beginning stages of development,
no analysis has been completed at this time to asses the amount that
would be saved or imposed as a result of this rule. However, this rule
does not meet the $100 million annual economic impact threshold and
thus has not been determined to be economically significant under EO
12866.
Risks:
Without this rulemaking, there is a risk that new LAPPs will be
developed that do not meet the requirements of section 303(A), and
therefore may detrimentally impact the fish stocks that they are
designed to manage, the fisheries, or the human environment. Properly
designed LAPPs mitigate environmental risk, ensure fair and equitable
initial allocations, prevent excessive shares, protect the basic
cultural and social framework of the fisheries and fishing communities,
and contribute to public safety and economic prosperity.
Timetable:
_______________________________________________________________________
Action Date FR Cite
_______________________________________________________________________
NPRM 04/00/09
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
No
Government Levels Affected:
None
Agency Contact:
Alan Risenhoover
Director, Office of Sustainable Fisheries
Department of Commerce
National Oceanic and Atmospheric Administration
1315 East-West Highway
Room 13362
Silver Spring, MD 20910
Phone: 301 713-2334
RIN: 0648-AX13
[[Page 71141]]
_______________________________________________________________________
DOC--NOAA
-----------
FINAL RULE STAGE
-----------
24. MAGNUSON-STEVENS FISHERY CONSERVATION AND MANAGEMENT
REAUTHORIZATION ACT (MSRA) ENVIRONMENTAL REVIEW PROCEDURE
Priority:
Other Significant
Legal Authority:
16 USC 1801
CFR Citation:
50 CFR 700
Legal Deadline:
NPRM, Statutory, July 11, 2007.
Final, Statutory, January 11, 2008.
Abstract:
Section 107 of the Magnuson-Stevens Fishery Conservation and Management
Reauthorization Act (MSRA) (Pub. L. 109-479) requires NOAA Fisheries to
revise and update agency procedures for complying with the National
Environmental Policy Act (NEPA) in context of fishery management
actions. It further requires that NOAA Fisheries consult with the
Council on Environmental Quality (CEQ) and the Regional Fishery
Management Councils (Councils), and involve the public in the
development of the revised procedures. The MSRA provides that the
resulting procedures will be the sole environmental impact assessment
procedure for fishery management actions, and that they must conform to
the time lines for review and approval of fishery management plans and
plan amendments; and integrate applicable environmental analytical
procedures, including the time frames for public input, with the
procedure for the preparation and dissemination of fishery management
plans, plan amendments and other actions taken or approved pursuant to
this Act in order to provide for timely, clear and concise analysis
that is useful to decision makers and the public, reduce extraneous
paperwork, and effectively involve the public.
NOAA Fisheries is currently consulting with the councils, the Public
and CEQ to develop a proposed procedure.
Statement of Need:
In December 2006, the U.S. Congress amended the Magnuson-Stevens Act,
which was signed into law by the President on January 12, 2007 (Public
Law 109-479). Section 107 requires NMFS to better integrate and more
closely align applicable environmental analytical procedures with the
Magnuson Stevens Act's fishery management process.
Congress directed the Secretary, acting through NMFS, and in
consultation with the regional fishery management councils (Councils)
and CEQ, to revise and update agency procedures to comply with NEPA.
Congress stated that the procedures shall:
(A) conform to the [Magnuson-Stevens Act's] time lines for review and
approval of fishery management plans and amendments under this section;
and (B) integrate applicable environmental analytical procedures,
including the time frames for public input, with the procedure for the
preparation and dissemination of fishery management plans, plan
amendments, and other actions taken or approved pursuant to this Act in
order to provide for timely, clear and concise analysis that is useful
to decision makers and the public, reduce extraneous paperwork and
effectively involving the public. 16 U.S.C. 1854(i)(1)(A) and (B).
Moreover, Congress stated that the revised and updated procedures are
to be the sole environmental impact assessment procedure for fishery
management actions (e.g., FMPs, FMP amendments, or other actions taken
or approved pursuant to the Magnuson Stevens Act) used by the Councils
or NMFS. 16 U.S.C. 1854(i)(2). Finally, Congress authorized and
directed NMFS, in cooperation with CEQ and the Councils, to involve the
affected public in the development of the revised procedures.
Summary of Legal Basis:
Magnuson-Stevens Fishery Conservation and Management Act, 16 U.S.C.
1801 et seq.
Alternatives:
In the process of developing the proposed rule NMFS identified
alternatives for possible fisheries-specific improvements in several
general categories: form of NEPA documentation; roles and
responsibilities of Councils and NMFS in the NEPA process; timing and
flow of process; and other elements (experimental fishing, emergencies,
page limits, and the range of alternatives to be analyzed). The NMFS
preferred alternative as expressed in the proposed rule was developed
after serious consideration of input received through extensive
internal and external outreach. NMFS also considered the ``No Action''
alternative. Under the ``no action'' alternative, NMFS would not issue
a final rule and the environmental review process for Magnuson-Stevens
Act actions would proceed under the status quo.
Anticipated Cost and Benefits:
The modifications to the NEPA procedures for fishery management actions
are intended to allow for more efficient response to fishery management
needs while ensuring continued compliance with NEPA requirements.
Because these provisions would create a new approach to NEPA
compliance, litigation challenges would be likely as implementation
progressed. Additional costs may also be incurred, for example, where
the conflict of interest provisions require use of a more expensive
contractor. However, it is impossible to predict such additional costs,
if any.
Risks:
The risk of not taking action would be that NMFS would not meet its
statutory mandate under the Magnuson-Stevens Act.
Timetable:
_______________________________________________________________________
Action Date FR Cite
_______________________________________________________________________
NPRM 05/14/08 73 FR 27997
NPRM Comment Period End 06/13/08
Final Action 11/00/08
Regulatory Flexibility Analysis Required:
Yes
Small Entities Affected:
Businesses, Governmental Jurisdictions, Organizations
Government Levels Affected:
None
Agency Contact:
Roy Crabtree
Regional Administrator, Southeast Region
Department of Commerce
National Oceanic and Atmospheric Administration
263 Thirteenth Avenue South
St. Petersburg, FL 33701
Phone: 727 570-5305
Fax: 727 570-5583
Email: [email protected]
RIN: 0648-AV53
[[Page 71142]]
_______________________________________________________________________
DOC--NOAA
25. GUIDANCE FOR ANNUAL CATCH LIMITS AND ACCOUNTABILITY MEASURES TO END
OVERFISHING
Priority:
Other Significant
Legal Authority:
16 USC 1853
CFR Citation:
50 CFR 600.310
Legal Deadline:
None
Abstract:
Section 104(b) of the Magnuson-Stevens Fishery Conservation and
Management Reauthorization Act of 2006 (MSRA), requires that in fishing
year 2010, for fisheries determined by the Secretary to be subject to
overfishing, and in fishing year 2011, for all other fisheries, that
fishery management plans establish annual catch limits (ACLs),
including regulations and annual specifications, at a level such that
overfishing does not occur in a fishery, including measures to ensure
accountability.
The National Marine Fisheries Service intends to prepare guidance on
how to establish adequate ACLs and AMs by revising its National
Standard 1 (NS1) guidelines at 50 CFR 600.310. This is because NS1 of
the Magnuson-Stevens Act states that ``Conservation and management
measures shall prevent overfishing while achieving, on a continuing
basis, the optimum yield from each fishery for the United States
fishing industry.''
Statement of Need:
The Magnuson-Stevens Fishery Conservation and Management Act (MSA), as
amended by the Magnuson-Stevens Fishery Conservation and Management
Reauthorization Act of 2006 (MSRA) (Pub. L. 109-479), requires that
``any fishery management plan which is prepared by any [Fishery
Management] Council, or by the Secretary [of Commerce], with respect to
any fishery, shall-establish a mechanism for specifying annual catch
limits in the plan (including a multiyear plan), implementing
regulations, or annual specifications, at a level such that overfishing
does not occur in the fishery, including measures to ensure
accountability'' (see MSA section 303(a)(15)). NMFS, on behalf of the
Secretary, has decided to revise the National Standard 1 (NS1)
guidelines to include guidance about how to use annual catch limits
(ACLs) and accountability measures (AMs) to end and prevent
overfishing. NMFS believes that revisions to the NS1 guidelines will
assist the Councils and the Secretary in addressing new MSA
requirements, ensure greater consistency in approaches to ending
overfishing and rebuilding stocks, increase efficiency in reviewing
actions and tracking annual management performance, and improve
communication between NMFS and the Councils.
Summary of Legal Basis:
Magnuson-Stevens Fishery Conservation and Management Act, 16 U.S.C.
1801 et seq.
Alternatives:
No Action. Do not revise the current NS1 guidelines to include guidance
for ACLs and AMs. Councils are statutorily required to implement ACLs
and AMs. Without guidelines, Councils may develop and submit fishery
management plan (FMP) amendments that the Secretary may determine to be
inadequate. Secretarial disapproval of an FMP amendment would be
followed by a request that the Council modify and resubmit their
amendment, making it unlikely that the ACLs and AMs can be implemented
by the first statutory deadline of 2010, for stocks undergoing
overfishing, and 2011, for all other stocks.
Preferred Action. Revise the current NS1 guidelines to include guidance
for ACLs and AMs. Councils and the Secretary are more likely to prepare
adequate ACLs and AMs for ending and preventing overfishing, if NMFS
provides guidance through the NS1 guidelines, than by relying on
statutory language alone. Secretarial approval of FMP amendments that
contain adequate ACLs and AMs for ending overfishing is more likely if
NMFS provides new guidance on NS1, ACLs and AMs. Also, if NMFS provides
such guidance, it is more likely that FMPs will have ACLs and AMs in
place for stocks undergoing overfishing by the first statutory deadline
of 2010, and the second statutory deadline of 2011, for all other
stocks.
Anticipated Cost and Benefits:
There are no economic, social or environmental impacts of the proposed
guideline revisions themselves. When the Councils and/or the Secretary
revise FMPs per the guidelines, they will develop specific management
actions and evaluate the economic, social, and environmental impacts of
those measures at that time.
Risks:
The National Marine Fisheries Service intends to revise the NS1
guidelines to combine requirements for ACLs and AMs, and new rebuilding
plan provisions with current NS1 guidelines that cover topics such as
maximum sustainable yield, optimum yield, and status determination
criteria for overfishing and overfished definitions. NMFS believes that
by combining new guidance about how to use ACLs and AMs to end or
prevent overfishing, along with the various principles already
contained in the MSA such as overfishing, rebuilding overfished stocks,
and achieving optimum yield, the Councils and stakeholders of fisheries
would experience less confusion than they would in the absence of new
guidelines.
Timetable:
_______________________________________________________________________
Action Date FR Cite
_______________________________________________________________________
NPRM 06/09/08 73 FR 32526
Notice 06/26/08 73 FR 36300
Comment Period End 08/13/08 73 FR 47125
NPRM Comment Period End 09/08/08
Comment Period Extended 09/22/08
Final Action 03/00/09
Regulatory Flexibility Analysis Required:
Yes
Small Entities Affected:
Businesses
Government Levels Affected:
None
Agency Contact:
Alan Risenhoover
Director, Office of Sustainable Fisheries
Department of Commerce
National Oceanic and Atmospheric Administration
1315 East-West Highway
Room 13362
Silver Spring, MD 20910
Phone: 301 713-2334
RIN: 0648-AV60
_______________________________________________________________________
DOC--NOAA
26. TAKING AND IMPORTING MARINE MAMMALS; U.S. NAVY TRAINING IN
THE HAWAII RANGE COMPLEX
Priority:
Other Significant
[[Page 71143]]
Legal Authority:
16 USC 1361 et seq
CFR Citation:
50 CFR 216
Legal Deadline:
None
Abstract:
The National Marine Fisheries Service (NMFS) is proposing the issuance
of regulations and subsequent Letters of Authorization (LOAs) for the
Navy to take individuals of 24 species of marine mammals incidental to
upcoming Navy training activities to be conducted within the Hawaii
Range Complex, which covers 235,000 nm2 around the Main Hawaiian
Islands, over the course of 5 years. These training activities are
classified as military readiness activities. These training activities
may incidentally take (by Level B Harassment) marine mammals present
within the HRC by exposing them to sound from mid-frequency or high
frequency active sonar (MFAS/HFAS) or to underwater detonations at
levels that NMFS associates with the take of marine mammals. Further,
though we do not expect it to occur, NMFS proposes to authorize the
Navy to take, by injury or mortality, up to 10 individuals each of 10
species over the course of the 5-year period (bottlenose dolphin, Kogia
spp., melon-headed whale, pantropical spotted dolphin, pygmy killer
whale, short-finned pilot whale, striped dolphin, and Cuvier's,
Longman's, and Blainville's beaked whale). Because of the public
interest and likelihood of litigation, this application and proposal is
considered controversial.
Statement of Need:
NMFS has received a request from the U.S. Navy (Navy) for authorization
to take marine mammals incidental to training activities conducted
within the Hawaii Range Complex (HRC) for the period of December 2008
through December 2013. These training activities are classified as
military readiness activities. The Navy states that these training
activities may incidentally take marine mammals present within the HRC
by exposing them to sound from mid-frequency or high frequency active
sonar or to underwater detonations at levels that NMFS associates with
the take of marine mammals. The final regulations would authorize these
activities and govern the take of marine mammals.
The Navy's mission is to maintain, train, and equip combat-ready naval
forces capable of winning wars, deterring aggression, and maintaining
freedom of the seas. Title 10, U.S. Code (U.S.C.) section 5062 directs
the Chief of Naval Operations to train all naval forces for combat. The
Chief of Naval Operations meets that direction, in part, by conducting
at-sea training exercises and ensuring naval forces have access to
ranges, operating areas and airspace where they can develop and
maintain skills for wartime missions and conduct research, development,
test, and evaluation of naval weapons systems. The HRC, where the Navy
has, for more than 40 years, routinely conducted training and major
exercises in the waters around the Hawaiian Islands, is a critical part
of the Navy's mission, especially as it relates to training. Centrally
located in the Pacific Ocean between the west coast of the United
States and the naval stations in the western Pacific, and surrounding
the most isolated islands in the world, the HRC has the infrastructure
(i.e., extensive existing range assets and training capabilities) to
support a large number of forces in a location both remote and under
U.S. control. The range surrounds the major homeport of Naval Station
Pearl Harbor, enabling re-supply and repairs to submarines and surface
ships alike. The isolation of the range offers an invaluable facility
on which to conduct missile testing and training. Able to link with the
U.S. Army's Pohakuloa Training Area, as well as U.S. Air Force and U.S.
Marine Corps bases where aircraft basing and amphibious training may
occur, the HRC provides a superior joint training environment for all
the U.S. armed services and advanced missile testing capability.
Summary of Legal Basis:
Marine Mammal Protection Act, 16 U.S.C. 1371(a)(5)(A).
Alternatives:
A number of alternatives were analyzed in the Draft Environmental
Impact Statement prepared for this action, published in April 2007, and
available at http://www.nmfs.noaa.gov/pr/permits/incidental.htm
Anticipated Cost and Benefits:
Because the Navy is the only entity that will be directly affected by
this rulemaking, NMFS did not perform an analysis of the anticipated
costs and benefits.
Risks:
This rule addresses the risk of take incidental to Navy training
activities. The rule analyzes the risk of such take.
Timetable:
_______________________________________________________________________
Action Date FR Cite
_______________________________________________________________________
NPRM 06/23/08 73 FR 35510
NPRM Comment Period End 07/23/08
Final Action 01/00/09
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
No
Government Levels Affected:
Federal
Agency Contact:
James H. Lecky
Director, Office of Protected Resources
Department of Commerce
National Oceanic and Atmospheric Administration
1315 East-West Highway
Silver Spring, MD 20910
Phone: 301 713-2332
Fax: 301 427-2520
Email: [email protected]
RIN: 0648-AW86
_______________________________________________________________________
DOC--NOAA
27. TAKING AND IMPORTING MARINE MAMMALS; U.S. NAVY'S ATLANTIC
FLEET ACTIVE SONAR TRAINING (AFAST)
Priority:
Other Significant
Legal Authority:
16 USC 1361
CFR Citation:
50 CFR 216
Legal Deadline:
None
Abstract:
In February 2008, the National Marine Fisheries Service (NMFS) received
an application from the Navy for MMPA Letters of Authorization (LOAs)
to take individuals of 39 species of marine mammals incidental to Navy
Atlantic Fleet Active Sonar Training (AFAST) to be conducted off the
Atlantic Coast of the U.S. and in the Gulf of Mexico over the course of
5 years. These military readiness training activities may incidentally
take marine mammals
[[Page 71144]]
present in the area by exposing them to sound from mid-frequency or
high frequency active sonar (MFAS/HFAS) or to underwater explosive
detonations that may take marine mammals. Further, though we do not
anticipate it to occur, the Navy requests authorization to take, by
injury or mortality, up to 10 total beaked whales over the course of 5
years (any combination of six species).
NMFS participated as a cooperating agency on the Environmental Impact
Statement (EIS) analyzing the effects on the environment from the
Navy's proposed activity. Take of marine mammals will be minimized
through: (1) Powerdown and shutdown of sonar when marine mammals are
detected within ranges where the received sound level is likely to
result in temporary threshold shift (TTS) or injury, (2) the use of
exclusion zones that avoid exposing marine mammals to explosives likely
to result in injury or death of marine mammals, and (3) the
implementation of a Stranding Response Plan for the HRC, which includes
a shutdown provision in and requires NMFS and the Navy develop an MOA
to allow the Navy to assist NMFS in stranding response/investigation
through in-kind services. NMFS is still working with the Navy to
determine if additional protective measures are appropriate.
Additionally, NMFS and the Navy have worked to develop a robust
monitoring plan to help further determine the effects that MFAS/HFAS
have on marine mammals.
Statement of Need:
NMFS has received a request from the U.S. Navy (Navy) for authorization
to take marine mammals incidental to training activities conducted off
the U.S. Atlantic Coast and in the Gulf of Mexico for the period of
January 2009 through January 2014. The final regulations would
authorize these activities and govern the take of marine mammals.
These training activities are classified as military readiness
activities. The Navy states, and NMFS concurs, that these training
activities may incidentally take marine mammals present within the
AFAST Study Area by exposing them to sound from mid-frequency or high
frequency active sonar or to employment of the improved extended echo
ranging (IEER) system. The IEER consists of an explosive source
sonobuoy (AN/SSQ-110A) and an air deployable active receiver (ADAR)
sonobuoy (AN/SSQ-101).
The purpose of the Navy's proposed action is to provide mid- and high-
frequency active sonar and IEER system training for U.S. Navy Atlantic
Fleet ship, submarine, and aircraft crews, as well as to conduct
research, development, testing, and evaluation (RDT&E) activities to
support the requirements of the Fleet Readiness Training Plan (FRTP)
and stay proficient in anti-submarine warfare and mine warfare skills.
The FRTP is the Navy's training cycle that requires naval forces to
build up in preparation for operational deployment and to maintain a
high level of proficiency and readiness while deployed. All phases of
the FRTP training cycle are needed to meet Title 10 requirements.
Specifically, the Navy's need for training and RDT&E is found in Title
10 of the United States Code (U.S.C.), Section 5062 (10 U.S.C. 5062).
Title 10 U.S.C. 5062 requires the Navy to be ``organized, trained, and
equipped primarily for prompt and sustained combat incident to
operations at sea.''
Summary of Legal Basis:
Marine Mammal Protection Act, 16 U.S.C. 1371(a)(5)(A).
Alternatives:
A number of alternatives were analyzed in the Draft Environmental
Impact Statement prepared for this action, published on February 15,
2008, and available at http://www.nmfs.noaa.gov/pr/permits/
incidental.htm
Anticipated Cost and Benefits:
Because the Navy is the only entity that will be directly affected by
this rulemaking, NMFS did not perform an analysis of the anticipated
costs and benefits.
Risks:
This rule addresses the risk of take incidental to Navy training
activities. The rule analyzes the risk of such take.
Timetable:
_______________________________________________________________________
Action Date FR Cite
_______________________________________________________________________
NPRM 10/14/08 73 FR 60754
NPRM Comment Period End 11/13/08
Final Action 01/00/09
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
No
Government Levels Affected:
Federal
Agency Contact:
James H. Lecky
Director, Office of Protected Resources
Department of Commerce
National Oceanic and Atmospheric Administration
1315 East-West Highway
Silver Spring, MD 20910
Phone: 301 713-2332
Fax: 301 427-2520
Email: [email protected]
RIN: 0648-AW90
_______________________________________________________________________
DOC--NOAA
28. TAKING AND IMPORTING MARINE MAMMALS; U.S. NAVY TRAINING IN
THE SOUTHERN CALIFORNIA RANGE COMPLEX (SOCAL)
Priority:
Other Significant
Legal Authority:
16 USC 1361
CFR Citation:
50 CFR 216
Legal Deadline:
None
Abstract:
On April 1, 2008, NMFS received an application from the Navy requesting
authorization for the take of individuals of 37 species of marine
mammals incidental to upcoming Navy training activities, maintenance,
and research, development, testing, and evaluation (RDT&E) activities
to be conducted within the Southern California Range Complex, which
extends southwest approximately 600 nm in the general shape of a 200-nm
wide rectangle (see the Navy's application), over the course of 5
years. These training activities are classified as military readiness
activities. The Navy states, and NMFS concurs, that these military
readiness activities may incidentally take marine mammals present
within SOCAL by exposing them to sound from mid-frequency or high
frequency active sonar (MFAS/HFAS) or underwater detonations. The Navy
requests authorization to take individuals of 37 species of marine
mammals by Level B Harassment. Further, though they do not anticipate
it to occur, the Navy requests authorization to take, by injury or
mortality, up to 10 beaked whales over the course of the 5-yr
regulations.
[[Page 71145]]
In order to issue an incidental take authorization (ITA) under Section
101(a)(5)(A) of the MMPA, NMFS must set forth the ``permissible methods
of taking pursuant to such activity, and other means of effecting the
least practicable adverse impact on such species or stock and its
habitat, paying particular attention to rookeries, mating grounds, and
areas of similar significance.'' NMFS reviewed the proposed SOCAL
activities and the proposed SOCAL mitigation measures presented in the
Navy's application to determine whether the activities and mitigation
measures were capable of achieving the least practicable adverse effect
on marine mammals. NMFS determined that further discussion was
necessary regarding the potential relationship between the operation of
MFAS/HFAS and marine mammal strandings. NMFS worked with the Navy to
identify additional practicable and effective mitigation measures,
which included a careful balancing of the likely benefit of any
particular measure to the marine mammals with the likely effect of that
measure on personnel safety, practicality of implementation, and impact
on the activity.
Statement of Need:
NMFS has received a request from the U.S. Navy (Navy) for authorization
to take marine mammals incidental to training activities conducted in
the Southern California Range Complex (SOCAL), which extends south and
southwest off the southern California coast, for the period of January
2009 through January 2014. The final regulations would authorize these
activities and govern the take of marine mammals.
These training activities are classified as military readiness
activities. The Navy states, and NMFS concurs, that these military
readiness activities may incidentally take marine mammals present
within SOCAL by exposing them to sound from mid-frequency or high
frequency active sonar or underwater detonations.
The Navy's mission is to maintain, train, and equip combat-ready naval
forces capable of winning wars, deterring aggression, and maintaining
freedom of the seas. Title 10, U.S. Code (U.S.C.) 5062 directs the
Chief of Naval Operations to train all naval forces for combat. The
Chief of Naval Operations meets that direction, in part, by conducting
at-sea training exercises and ensuring naval forces have access to
ranges, operating areas and airspace where they can develop and
maintain skills for wartime missions and conduct research, development,
testing, and evaluation (RDT&E) of naval weapons systems.
The Navy proposes to implement actions within the SOCAL Range Complex
to: Increase training and RDT&E operations from current levels as
necessary to support the Navy-wide training plan, known as the Fleet
Readiness Training Plan (FRTP); accommodate mission requirements
associated with force structure changes and introduction of new weapons
and systems to the Fleet; and implement enhanced range complex
capabilities.
Summary of Legal Basis:
Marine Mammal Protection Act, 16 U.S.C. 1371(a)(5)(A).
Alternatives:
A number of alternatives were analyzed in the Draft Environmental
Impact Statement prepared for this action, published in April 2008, and
available at http://www.nmfs.noaa.gov/pr/permits/incidental.htm
Anticipated Cost and Benefits:
Because the Navy is the only entity that will be directly affected by
this rulemaking, NMFS did not perform an analysis of the anticipated
costs and benefits.
Risks:
This rule addresses the risk of take incidental to Navy training
activities. The rule analyzes the risk of such take.
Timetable:
_______________________________________________________________________
Action Date FR Cite
_______________________________________________________________________
NPRM 10/14/08 73 FR 60836
NPRM Comment Period End 11/13/08
Final Action 01/00/09
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
No
Government Levels Affected:
Federal
Agency Contact:
James H. Lecky
Director, Office of Protected Resources
Department of Commerce
National Oceanic and Atmospheric Administration
1315 East-West Highway
Silver Spring, MD 20910
Phone: 301 713-2332
Fax: 301 427-2520
Email: [email protected]
RIN: 0648-AW91
BILLING CODE 3510-BW-S
[[Page 71146]]
DEPARTMENT OF DEFENSE (DOD)
Statement of Regulatory Priorities
Background
The Department of Defense (DoD) is the largest Federal Department
consisting of three Military Departments (Army, Navy, and Air Force),
nine Unified Combatant Commands, eighteen Defense Agencies, and twelve
DoD Field Activities. It has 1,385,122 military personnel and 692,176
civilians assigned as of June 30, 2008, 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 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 Executive Order 12866, there must be
coordination of proposed regulations among the regulatory agencies and
the affected DoD Components. Coordinating the proposed regulations in
advance throughout an organization as large as DoD is straightforward,
yet a formidable undertaking.
DoD is not a regulatory agency, but occasionally it issues regulations
that have an effect on the public. These regulations, while small in
number compared to the regulating agencies, can be significant as
defined in Executive Order 12866. In addition, some of DoD's
regulations may affect the regulatory agencies. DoD, as an integral
part of its program, not only receives coordinating actions from the
regulating agencies, but coordinates with the agencies that are
affected by its regulations as well.
Overall Priorities
The Department needs to function at a reasonable cost, while ensuring
that it does not impose ineffective and unnecessarily burdensome
regulations on the public. The rulemaking process should be responsive,
efficient, cost-effective, and both fair and perceived as fair. This is
being done in DoD while reacting to the contradictory pressures of
providing more services with fewer resources. The Department of
Defense, as a matter of overall priority for its regulatory program,
fully incorporates the provisions of the President's priorities and
objectives under Executive Order 12866.
Administration Priorities:
1. Rulemakings that Support the Administration's Regulation Agenda to
Streamline Regulations and Reporting Requirements
The Department plans to:
Simplify Defense Federal Acquisition Regulation Supplement
(DFARS) policy relating to acquisition of Government
property, consistent with the recent significant revisions
to the Federal Acquisition Regulation (FAR) part 45.
Implement in the FAR and DFARS the waiver of certain statutory
requirements when acquiring commercially available off-the-
shelf items.
Simplify and clarify the DFARS coverage of multiyear
acquisitions.
Simplify and clarify the DFARS coverage of patents, data, and
copyrights, dramatically reducing the amount of regulatory
text and the number of required clauses.
Improve the contract closeout process.
2. Regulations of Particular Interest to Small Business
Of interest to Small Businesses are regulations to:
Revise the FAR to clarify the relationship among small
business programs.
Revise the FAR to implement changes in the HUBZone Program, in
accordance with Small Business Administration regulations.
Add a procurement goal for Native Hawaiian-serving
institutions and Alaska Native-serving institutions.
3. Regulations with International Effects or Interest
Of international effect or interest are regulations to:
Provide authority to limit competition in the acquisition of
products or services, other than small arms, acquired in
support of operations in Iraq or Afghanistan.
Revise the DFARS to implement the pending Defense Procurement
Trade Cooperation Treaties with the United Kingdom and
Australia, upon ratification.
Remove from the FAR the prohibition of imports from North
Korea.
Revise the FAR and DFARS list of least developed countries
that are designated countries under the Trade Agreements
Act to add Liberia and remove Cape Verde.
4. Suggestions From the Public for Reform-Status of DoD Items
Rulemaking Actions in Response to Public Nominations
The Army Corps of Engineers has not undertaken any rulemaking actions
in response to the public nominations submitted to the Office of
Management and Budget in 2001, 2002, or 2004. Those nominations were
discussed in:
Making Sense of Regulation: 2001 Report to Congress on the
Costs and Benefits of Regulations and Unfunded Mandates on
State, Local, and Tribal Entities.
Stimulating Smarter Regulation: 2002 Report to Congress on the
Costs and Benefits of Regulations and Unfunded Mandates on
State, Local, and Tribal Entities.
Progress in Regulatory Reform: 2004 Report to Congress on the
Costs and Benefits of Federal Regulations and Unfunded
Mandates on State, Local, and Tribal Entities.
Specific DoD Priorities:
For this Regulatory Plan, there are four specific DoD priorities, all
of which reflect the established regulatory principles. In those areas
where rulemaking or participation in the regulatory process is
required, DoD has studied and developed policy and regulations that
incorporate the provisions of the President's priorities and objectives
under the Executive Order.
DoD has focused its regulatory resources on the most serious
environmental, health, and safety risks. Perhaps most significant is
that each of the priorities described below promulgates regulations to
offset the resource impacts of Federal decisions on the public or to
improve the quality of public life, such as those regulations
concerning civil functions of the U.S. Army Corps of Engineers,
acquisition, health affairs, and the National Security Personnel
System.
1. Regulatory Program of the U.S. Army Corps of Engineers
[[Page 71147]]
Army Regulatory Program's Compliance with the National Historic
Preservation Act
In 1990, the Army Corps of Engineers published as appendix C of 33 CFR
part 325, a rule that governs compliance with the National Historic
Preservation Act (NHPA) for the Army's Regulatory Program. Over the
years, there have been substantial changes in policy, and the NHPA was
amended in 1992, leading to the publication in December 2000 of new
implementing regulations at 36 CFR part 800, issued by the Advisory
Council on Historic Preservation (ACHP). Those regulations were amended
on July 6, 2004. The ACHP's regulations allow Federal agencies to
utilize alternate procedures in lieu of the regulations at 36 CFR part
800. In 2005 and 2007, the Corps Headquarters issued supplemental
guidance on compliance with the NHPA while efforts were underway to
revise or replace Appendix C. To solicit public comment on the
appropriate mechanism for revising the Army Regulatory Program's
process for considering effects to historic properties resulting from
activities authorized by DA permits, the Army Corps of Engineers
published an Advance Notice of Proposed Rulemaking (ANPRM) to obtain
the views of interested parties. After reviewing the comments received
in response to the ANPRM, the Army Corps of Engineers held facilitated
stakeholder meetings to determine the best course of action for
revising its procedures to comply with the requirements of Section 106
of the National Historic Preservation Act. The Corps also held
additional focus group meetings facilitated by our eight division
offices to gather input from federally recognized tribes on their
recommendations concerning how government-to-government consultation
could occur. After reviewing those recommendations, the Corps developed
a consultation plan, and is currently in the process of conducting
government-to-government consultation with federally recognized tribes.
Also, our division offices have solicited information on topics that
any new alternative procedure should address.
2. Defense Procurement and Acquisition Policy
The Department of Defense continuously reviews the DFARS and continues
to lead Government efforts to:
Establish a new restriction on acquisition of specialty metals
under 10 U.S.C. 2533b, as amended by the FY08 National
Defense Authorization Act. Provides exemption from domestic
source requirements for all electronics; commercially
available off-the-shelf items, except high performance
magnets and fasteners; for fasteners and commercial
derivative military articles when using market basket
approach; minimal amounts of specialty metals; and,
national security requirements.
Revise the FAR and the DFARS to require contractor personnel
who are authorized to accompany the U.S. Armed Forces
deployed outside the United States or are performing
outside the United States in a theater of operations during
contingency or certain other operations, or at a diplomatic
or consular mission to report human rights violations, as
well as kidnapping and sexual assault violations. Implement
the DoD Law of War Program, requiring contractors to be
trained in the Law of War and to report violations.
Revise the FAR to make requirements for Government contractor
internal control systems more similar of U.S. Sentencing
Guidelines; mandate timely disclosure of civil or criminal
wrongdoing related to the award, performance, or closeout
of a Government contract or subcontract thereunder; mandate
full cooperation with Government investigators; make
failure to timely disclose significant overpayments or
violations of civil or criminal wrongdoing a cause for
suspension/debarment.
Revise the FAR to address service contractor employee personal
conflicts of interest and organizational conflicts of
interest and limit contractor access to information.
Revise the FAR to require contractors to verify, through the
use of the E-Verify System, that certain of their employees
are eligible to work in the United States.
Enhance competition by:
-- Limiting the length of contracts awarded non-competitively under
``unusual and compelling urgency'' circumstances to the minimum
contract period necessary to meet requirements, not to exceed one year,
unless approved by the head of the contracting activity.
-- Requiring publication of notices on FedBizOpps of all sole source
task or delivery orders in excess of the simplified acquisition
thresholds that are placed against multiple award contracts or multiple
award blanket purchase agreements.
-- Requiring post-award debriefings be provided, as requested, to
disappointed offerors on task and delivery orders in excess of $5
million (including options).
-- Requiring public disclosure of justification and approval documents
for noncompetitive contracts.
Providing enhanced competition for task and delivery order
contracts and additional market research before awarding a
task or delivery order in excess of the simplified
acquisition threshold.
3. 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 plans to submit the following rules:
Final rule on CHAMPUS/TRICARE: Inclusion of TRICARE Retail
Pharmacy Program in Federal Procurement of Pharmaceuticals.
This rule implements changes directed by the enactment of
National Defense Authorization Act for Fiscal Year 2008
(NDAA-08), Pub. L. 110-181, to the extent necessary to
ensure pharmaceuticals, paid for by the DoD that are
provided by pharmacies under the TRICARE Retail Pharmacy
Program (TRRx) to eligible beneficiaries, are subject to
the pricing standards under section 8126 of title 38 United
States Code. This is an economically significant rule. The
proposed rule was published July 25, 2008 (73 FR 43394).
The comment period ends September 23, 2008.
Proposed rule on CHAMPUS/TRICARE: Pharmacy Benefits Program.
This rule implements several changes enacted by the John
Warner National Defense Authorization Act for Fiscal Year
2007 (NDAA-07), Pub. L. 109-364, and accompanying
recommendations of the Conference Committee, set forth in
H. Conf. Rept. 109-702.
[[Page 71148]]
Specifically, this rule recommends changes to adopt state-
of-the-art pharmacy benefit management practices to
encourage greater use of the TRICARE Mail Order Pharmacy
(TMOP) Program, generic drugs, formulary drugs, and over-
the-counter (OTC) drugs. This rule will not affect retail
pharmacy copayment amounts (currently under a statutory
cap). The proposed rule should publish before the end of
2008.
Final rule on TRICARE: Relationship Between the TRICARE
Program and Employer-Sponsored Group Health Coverage. This
rule implements section 1097c of title 10, United States
Code. This law prohibits employers from offering incentives
to TRICARE-eligible employees to not enroll, or to
terminate enrollment, in an employer-offered Group Health
Plan (GHP) that is or would be primary to TRICARE.
Cafeteria plans that comport with section 125 of the
Internal Revenue Code will be permissible so long as the
plan treats all employees the same and does not illegally
take TRICARE eligibility into account. This is an
economically significant rule. The proposed rule was
published March 28, 2008 (73 FR 16612). The comment period
ended May 27, 2008.
Final rule on TRICARE: Outpatient Prospective Payment System
(OPPS). The rule implements a prospective payment system
for hospital outpatient services similar to that furnished
to Medicare beneficiaries, as set forth in section 1833(t)
of the Social Security Act. The rule also recognizes
applicable statutory requirements and changes arising from
Medicare's continuing experience with its system, including
certain related provisions of the Medicare Prescription
Drug, Improvement, and Modernization Act of 2003. While
TRICARE intends to remain as true as possible to Medicare's
basic OPPS methodology (i.e., adoption and updating of the
Medicare data elements used in calculating the prospective
payment amounts), there will be some significant deviations
required to accommodate the uniqueness of the TRICARE
program. These deviations have been designed to accommodate
existing TRICARE benefit structure and claims processing
procedures implemented under the TRICARE Next Generation
Contracts (T-NEX) while at the same time eliminating any
undue financial burden to TRICARE Prime, Extra and Standard
beneficiary populations. The proposed rule was published
April 1, 2008 (73 FR 17271). The comment period ended June
2, 2008.
4. National Security Personnel System, Department of Defense
On November 1, 2005 (70 FR 66115-66164), the Department of Defense and
the Office of Personnel Management (OPM) issued final regulations to
establish the National Security Personnel System (NSPS), a human
resources management system, within DoD, as authorized by the National
Defense Authorization Act (Pub. L. 108-136, November 24, 2003). These
regulations govern basic pay, staffing, classification, performance
management, labor relations, adverse actions, and employee appeals.
These regulations are designed to ensure that the DoD's human resources
management and labor relations systems align with its critical mission
requirements and protect the civil service rights of its employees.
Subsequent legislation in the National Defense Authorization Act (Pub.
L. 110-181, January 28, 2008) require revision of the NSPS regulation.
DoD and OPM published a proposed rule on May 22, 2008 (73 FR 29882-
29927). The period for public comment ended on June 23, 2008. The final
rule should be published by the end of 2008.
_______________________________________________________________________
DOD--Office of Assistant Secretary for Health Affairs (DODOASHA)
-----------
PROPOSED RULE STAGE
-----------
29. CIVILIAN HEALTH AND MEDICAL PROGRAM OF THE UNIFORMED
SERVICES (CHAMPUS); TRICARE PHARMACY BENEFITS PROGRAM
Priority:
Other Significant
Legal Authority:
5 USC 301; 10 USC ch 55
CFR Citation:
32 CFR 199
Legal Deadline:
None
Abstract:
This rule implements several changes enacted by the John Warner
National Defense Authorization Act for Fiscal Year 2007 (NDAA-07), Pub.
L. 109-364, and accompanying recommendations of the Conference
Committee, set forth in H. Conf. Rept. 109-702. Specifically, this rule
recommends changes to adopt state-of-the-art pharmacy benefit
management practices to encourage greater use of the TRICARE Mail Order
Pharmacy (TMOP) Program, generic drugs, formulary drugs, and over-the-
counter (OTC) drugs. The rule would not affect retail pharmacy
copayment amounts (currently under a statutory cap).
Statement of Need:
This rule implements congressionally directed changes to adopt state-
of-the art pharmacy benefit management practices to encourage greater
use of the TRICARE Mail Order Pharmacy Program (TMOP), generic drugs,
formulary drugs, and over-the-counter drugs.
Summary of Legal Basis:
This rule implements several changes enacted by the John Warner
National Defense Authorization Act for Fiscal Year 2007, Pub. L. 109-
364, and accompanying recommendations of the Conference Committee, set
forth in H. Conf. Rept. 109-702. Legal authority includes 10 U.S.C.
Sec. 1074g.
Alternatives:
The Department is initiating the changes consistent with Congressional
direction and the recommendations from the Task Force on the Future of
Military Health Care. Current statutory restrictions, including a cap
on retail pharmacy co-payments, limit available alternatives.
Anticipated Cost and Benefits:
The rule is part of an overall strategy to encourage the use of value-
based pharmaceutical agents and cost-effective dispensing venues.
Allowing beneficiaries to receive non-formulary pharmaceutical agents
through only the TMOP allows the Department to reinforce the
encouragement to use more cost-effective pharmaceutical agents. The
overall effect of the rule is expected to be a degree of moderation in
the rapid growth of the TRICARE Pharmacy Benefits Program.
Risks:
The primary risk this rule seeks to address is what the GAO recently
called ``the fiscal sustainability of'' DoD's pharmacy benefits
program. Pharmacy benefits, particularly retail pharmacy benefits,
represent the segment of the TRICARE program that has experienced the
most uncontrolled increase in costs. The GAO said retail pharmacy costs
from FY-2000 to FY-
[[Page 71149]]
2006 rose ``almost ninefold from $455 million to $3.9 billion.'' The
rule will address this problem, to an extent, by encouraging greater
use of more cost-effective drugs, particularly formulary drugs, generic
drugs, and, when appropriate, over-the-counter drugs.
Timetable:
_______________________________________________________________________
Action Date FR Cite
_______________________________________________________________________
NPRM 12/00/08
Regulatory Flexibility Analysis Required:
No
Government Levels Affected:
None
Additional Information:
The TRICARE Retail Pharmacy rule is now being reported as RIN 0720-
AB22.
Agency Contact:
Captain William Blanche
Department of Defense
Office of Assistant Secretary for Health Affairs
1200 Defense Pentagon
Washington, DC 20301-1200
Phone: 703 681-2890
Email: [email protected]
Related RIN: Previously reported as 0720-AB22
RIN: 0720-AB27
_______________________________________________________________________
DOD--DODOASHA
-----------
FINAL RULE STAGE
-----------
30. TRICARE: RELATIONSHIP BETWEEN THE TRICARE PROGRAM AND EMPLOYER-
SPONSORED GROUP HEALTH COVERAGE
Priority:
Economically Significant. Major under 5 USC 801.
Legal Authority:
5 USC 301; 10 USC ch 55
CFR Citation:
32 CFR 199
Legal Deadline:
Other, Statutory, January 8, 2008.
John Warner National Defense Authorization Act for Fiscal Year 2007
directed the Secretary of Defense to report to the House and Senate
Armed Services committees on the treatment of cafeteria plans and non-
TRICARE exclusive employer-provided incentives under the Department's
implementation of section 707 of the Act regarding employer-sponsored
group health care plans.
Abstract:
This rule implements section 1097c of title 10, United States Code.
This law prohibits employers from offering incentives to TRICARE-
eligible employees to not enroll, or to terminate enrollment, in an
employer-offered Group Health Plan (GHP) that is or would be primary to
TRICARE. Cafeteria plans that comport with section 125 of the Internal
Revenue Code will be permissible so long as the plan treats all
employees the same and does not illegally take TRICARE eligibility into
account.
Statement of Need:
Section 707 of the 2007 National Defense Authorization Act, directed
the Department of Defense to establish section 1097c for addition to
Chapter 55 of title 10, Untied States Code. Section 1097c will act to
prohibit employers from offering incentives to TRICARE-eligible
employees not to enroll, or to terminate enrollment, in an employer-
offered Group Health Plan (GHP). Many employers, including state and
local governments, have begun to offer their employees who are TRICARE
eligible a TRICARE Supplement as an incentive not to enroll in the
employer's primary GHP. These actions shift thousands of dollars of
annual health costs per employee to the Defense Department, draining
resources from higher national security priorities. This is what 10
U.S.C. 1097c is designed to stop.
Summary of Legal Basis:
The National Defense Authorization Act (NDAA) for Fiscal Year 2007,
directed the Secretary of Defense to report to the House and Senate
Armed Services committees on the treatment of cafeteria plans and non-
TRICARE exclusive employer-provided incentives under the Department's
implementation of section 707 of the Act regarding employer sponsored
group health care plans. As enacted, section 707 added to title 10,
United States Code, section 1097c, which extends to TRICARE the same
prohibition on offering financial or other incentives not to enroll in
a Group Health Plan (GHP) that currently applies to Medicare under
section 1862(b)(3)(C) of the Social Security Act (42 U.S.C.
1395y(b)(3)(C)).
Alternatives:
This rule complies with a Congressional mandate. No other alternatives
were developed.
Anticipated Cost and Benefits:
There are no additional or anticipated Government cost associated with
prohibiting employers from offering incentives to TRICARE-eligible
employees not to enroll in an employer-offered GHP. There are no
additional or anticipated cost for current beneficiaries enrolled in
TRICARE. Any additional cost associated with this rule will be borne
entirely by the employers who are currently offering such incentives
and placing their current health cost on the Defense Department.
Risks:
There is no anticipated risk accompanying this action.
Timetable:
_______________________________________________________________________
Action Date FR Cite
_______________________________________________________________________
NPRM 03/28/08 73 FR 16612
NPRM Comment Period End 05/27/08
Final Action 10/00/09
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
No
Government Levels Affected:
Undetermined
Agency Contact:
Jody Donehoo
Department of Defense
Office of Assistant Secretary for Health Affairs
1200 Defense Pentagon
Washington, DC 20301
Phone: 703 681-0039
RIN: 0720-AB17
_______________________________________________________________________
DOD--DODOASHA
31. TRICARE: OUTPATIENT HOSPITAL PROSPECTIVE PAYMENT SYSTEM (OPPS)
Priority:
Other Significant
Legal Authority:
5 USC 301; 10 USC ch 55
CFR Citation:
32 CFR 199
[[Page 71150]]
Legal Deadline:
None
Abstract:
This rule implements a prospective payment system for hospital
outpatient services similar to that furnished to Medicare
beneficiaries, as set forth in section 1833(t) of the Social Security
Act. The rule also recognizes applicable statutory requirements and
changes arising from Medicare's continuing experience with this system
including certain related provisions of the Medicare Prescription Drug,
Improvement, and Modernization Act of 2003.
Statement of Need:
This final rule implements the TRICARE Hospital Outpatient Prospective
Payment System (OPPS) as mandated under section 707 of the National
Defense Authorization Act of Fiscal Year 2002 (NDAA-02), Pub. L. 107-
107 (December 28, 2001), changing the statutory authorization in 10
U.S.C. 1079(j)(2) to provide that TRICARE payment methods for
institutional care be determined, to the extent practicable, in
accordance with the same reimbursement rules used by Medicare. Under
the above Congressional mandate, TRICARE will be paying for hospital
outpatient services in accordance with the provisions outlined in
section 1833(t) of the Social Security Act and its implementing
Medicare regulation (42 CFR Sec. 419).
Summary of Legal Basis:
There is a statutory basis for this final rule: Section 707 of the
National Defense Authorization Act of Fiscal Year 2002 (NDAA-02), Pub.
L. 107-107.
Alternatives:
This is a statutory change; consequently, no alternatives were
considered.
Anticipated Cost and Benefits:
Anticipated costs of implementation are $20 million. Anticipated cost-
savings for first full year of implementation are $80 - $90 million.
Risks:
Failure to publish this final rule would result in noncompliance with a
statutory provision--the NDAA-02/Public Law 107-107.
Timetable:
_______________________________________________________________________
Action Date FR Cite
_______________________________________________________________________
NPRM 04/01/08 73 FR 17271
NPRM Comment Period End 06/02/08
Final Action 12/00/08
Regulatory Flexibility Analysis Required:
No
Government Levels Affected:
None
Agency Contact:
David E. Bennett
Department of Defense
Office of Assistant Secretary for Health Affairs
1200 Defense Pentagon
Washington, DC 20301
Phone: 303 676-3494
Email: [email protected]
RIN: 0720-AB19
_______________________________________________________________________
DOD--DODOASHA
32. CHAMPUS/TRICARE: INCLUSION OF TRICARE RETAIL PHARMACY PROGRAM IN
FEDERAL PROCUREMENT OF PHARMACEUTICALS
Priority:
Economically Significant. Major under 5 USC 801.
Legal Authority:
5 USC 301; 10 USC ch 55
CFR Citation:
32 CFR 199
Legal Deadline:
None
Abstract:
Section 703 of the National Defense Authorization Act for Fiscal Year
2008 (NDAA-08) (Public Law 110-181) states with respect to any
prescription filled on or after the date of enactment of the NDAA, the
TRICARE retail pharmacy program (TRRx) shall be treated as an element
of the DoD for purposes of procurement of drugs by Federal agencies
under section 8126 of title 38, United States Code (U.S.C.), to the
extent necessary to ensure pharmaceuticals paid for by the DoD that are
provided by network retail pharmacies under the program to eligible
covered beneficiaries are subject to the pricing standards in such
section 8126. NDAA-08 was enacted on January 28, 2008. The statute
requires implementing regulations. This proposed rule is to implement
section 703.
Statement of Need:
This proposed rule implements changes as directed by the enactment of
NDAA for FY08 (January 28, 2008) to the extent necessary to ensure
pharmaceuticals paid for by the DoD that are provided by pharmacies
under the TRICARE Retail Pharmacy Program (TRRx) to eligible
beneficiaries are subject to the pricing standards under section 8126
of title 38 United States Code.
Summary of Legal Basis:
This proposed rule implements Section 703 of the National Defense
Authorization Act for Fiscal Year 2008 (NDAA-08) (Public Law 110-181).
Alternatives:
The Department is initiating the proposed changes consistent with clear
congressional direction.
Anticipated Cost and Benefits:
This regulation will extend federal ceiling prices (FCP) to eligible
prescriptions dispensed through the TRICARE retail pharmacy network.
This change represents hundreds of millions of dollars annually in
government savings while remaining transparent to beneficiaries and the
retail pharmacy network. The cost to administer this program is very
small compared to the cost savings it will generate.
Risks:
This regulation helps to mitigate the long term financial risks
associated with sustaining the TRICARE pharmacy benefit. By obtaining
consistent and favorable pricing at the retail, mail, and MTF points of
service, the overall growth in program costs should slow. Price
normalization among military treatment facilities, TRICARE Mail Order
Pharmacy (TMOP), and the TRRx is possible; maintaining a competitive
Uniform Formulary process mitigates this risk. We believe there is
sufficient competition among pharmaceutical manufacturers to keep
acquisition costs low for all points of service available through the
TRICARE Pharmacy Benefits Program.
Timetable:
_______________________________________________________________________
Action Date FR Cite
_______________________________________________________________________
NPRM 07/25/08 73 FR 43394
NPRM Comment Period End 09/23/08
Final Action 12/00/08
Regulatory Flexibility Analysis Required:
No
[[Page 71151]]
Government Levels Affected:
None
Agency Contact:
Captain William Blanche
Department of Defense
Office of Assistant Secretary for Health Affairs
1200 Defense Pentagon
Washington, DC 20301-1200
Phone: 703 681-2890
Email: [email protected]
RIN: 0720-AB22
BILLING CODE 5001-06-S
[[Page 71152]]
DEPARTMENT OF EDUCATION (ED)
Statement of Regulatory and Deregulatory Priorities
General
We support 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. Our roles include
providing leadership and financial assistance for education to
agencies, institutions, and individuals in situations in which there is
a national interest, such as in helping all students to reach grade-
level standards in reading/language arts and mathematics; assisting
students in their pursuit of postsecondary education; monitoring and
enforcing the implementation of Federal civil rights laws in programs
and activities that receive Federal financial assistance; and
supporting research, evaluation, and dissemination of findings to
improve the quality of education.
We administer programs that affect nearly every American during his or
her life. For the 2008-2009 school year, we project that about 50
million students will attend some 97,000 elementary and secondary
schools in approximately 14,000 public school districts, and that about
18.3 million students will enroll in degree-granting postsecondary
schools.
We have worked effectively with a broad range of interested parties and
the general public to develop regulations, guidance, technical
assistance, and approaches to compliance. In developing and
implementing regulations, we are committed to working closely with
affected persons and groups, including parents, students, and
educators; State, local, and tribal governments; and neighborhood
groups, schools, colleges, rehabilitation service providers,
professional associations, advocacy organizations, businesses, and
labor organizations.
In particular, we 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 the development of regulations is necessary, we
seek public participation at all 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), a new, electronic single
Governmentwide access point (www.regulations.gov) that enables the
public to search, read, download, and submit comments on different
types of Federal regulatory documents. In the case of our Department,
this system provides the public with the opportunity to file a comment
electronically on any notice of proposed rulemaking or interim final
regulations open for comment, as well as read and print any supporting
regulatory documents. In addition, FDMS enables the public to read
comments filed by other members of the public during the public comment
period and to respond to those comments.
We are continuing our efforts to streamline information collections,
reduce the burden on information providers involved in our programs,
and make information maintained by us easily accessible to the public.
No Child Left Behind
We look forward to congressional reauthorization of the Elementary and
Secondary Education Act of 1965, and to building on the results of its
most recent reauthorization through the No Child Left Behind Act of
2001. No Child Left Behind has increased accountability for States,
school districts, and schools; provided greater choice for parents and
students, particularly those students attending low-performing schools;
provided more flexibility for States and local educational agencies in
the use of Federal education dollars; and placed a stronger emphasis on
using scientifically based research to guide instruction, especially in
reading for our youngest children.
As necessary, we intend to amend current regulations to reflect the
reauthorization of this statute.
Higher Education
The Higher Education Opportunity Act (P.L. 110-135), signed by the
President on August 14, 2008, amends and extends the Higher Education
Act of 1965 (HEA). This major piece of legislation made a wide variety
of changes to the student financial aid and institutional aid programs
under the HEA, including--
Extensive new reporting requirements and consumer disclosures,
particularly regarding student loan terms and conditions;
A new ``Adjunct Teacher Corps'' that would draw on the skills
of well-qualified individuals outside of the public
education system to meet specialized teaching needs in
secondary schools;
A new maintenance-of-effort requirement regarding State
funding of higher education;
A new appeals process under which TRIO applicants may appeal
scoring decisions, and new requirements regarding the
methodologies that ED may use to evaluate the Upward Bound
and other TRIO programs;
The availability of two Pell Grants in one year to students
who are attending an institution of higher education year-
round, and an 18-semester overall limitation on a student's
eligibility to receive Pell Grants;
Changes undoing ED's regulations regarding mandatory
assignment to ED of defaulted Federal Perkins Loans held by
institutions that have been unable to collect on those
loans for seven or more years;
Several time-sensitive corrections to changes made by the
Ensuring Continuing Access to Student Loans Act of 2008
(P.L. 110-227, ECASLA) to the eligibility and deferment
requirements for PLUS Loans, loan limits for unsubsidized
student loans, and eligibility requirements for the
Academic Competitiveness Grant and National SMART Grant
programs; and
Changes to the so-called ``90-10'' rule (which requires a
proprietary institution of higher education participating
in the Title IV student aid programs to derive at least 10
percent of its total revenues from non-Title IV sources).
This legislation also creates more than 60 new programs, many of which
will require implementing regulations if Congress appropriates funds
for them.
Unless subject to an exemption, regulations to carry out changes to the
student financial aid programs under Title IV of the HEA must generally
go through the negotiated rulemaking process. In the coming year we
will be conducting negotiated rulemaking to implement the law's new
requirements.
Individuals with Disabilities Education Act
We plan to issue later this year final regulations that would address
issues in part B of the Individuals with Disabilities Education Act
(IDEA) that were not covered by final regulations issued in August
2006. We also plan to issue later this year final regulations
implementing changes to the part C program--the early intervention
[[Page 71153]]
program for infants and toddlers with disabilities -- under the IDEA.
Student Privacy
In March 2008, we issued a notice of proposed rulemaking to amend the
regulations governing education records maintained by educational
agencies and institutions under section 444 of the General Education
Provisions Act, which is also known as the Family Educational Rights
and Privacy Act of 1974, as amended. We plan to issue later this fall
final regulations addressing several key privacy issues, including
permissible disclosures of student information in health and safety
emergencies, disclosures to contractors and other outside parties in
connection with the outsourcing of institutional services and
functions, and redisclosures by State and Federal officials.
Other Potential Regulatory Activities
Congress is considering legislation to reauthorize the Adult Education
and Family Literacy Act (AEFLA) (Title II of the Workforce Investment
Act of 1998)--including the National Institute for Literacy--and the
Rehabilitation Act of 1973. The Administration is working with Congress
to ensure that any changes to these laws improve and streamline the
State grant and other programs providing assistance for adult basic
education under the AEFLA and for vocational rehabilitation and
independent living services for persons with disabilities under the
Rehabilitation Act of 1973, and that they 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.
During the coming year, other regulations may be necessitated by
legislation or programmatic experience. In developing and promulgating
any additional regulations we will be guided by the following
Principles for Regulating:
Principles for Regulating
Our Principles for Regulating 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 any regulations or with
only limited regulations.
We will regulate only if regulating improves the quality and equality
of services to our customers. We will regulate only if absolutely
necessary and then in the most flexible, most equitable, and least
burdensome way possible.
In deciding when to regulate, we consider:
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 to be regulated are so diverse
that a uniform approach through regulation does more harm
than good.
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 when possible.
Encourage federally funded activities to be coordinated with
State and local reform activities.
Ensure that benefits justify costs of regulation.
To the extent possible, establish performance objectives
rather than specify compliance behavior.
Encourage flexibility to the extent possible so institutional
forces and incentives achieve desired results.
_______________________________________________________________________
ED--Office of Postsecondary Education (OPE)
-----------
PROPOSED RULE STAGE
-----------
33. TITLE IV AND TITLE II OF THE HIGHER EDUCATION ACT OF 1965,
AS AMENDED
Priority:
Economically Significant. Major under 5 USC 801.
Legal Authority:
20 USC 1098a
CFR Citation:
34 CFR Chapter VI
Legal Deadline:
None
Abstract:
The Secretary will propose regulations to implement the student
financial aid and other provisions of Title IV, and possibly Title II,
of the Higher Education Act of 1965, as amended by the Higher Education
Opportunity Act of 2008, P.L. 110-315.
Statement of Need:
These regulations are needed to implement certain provisions of the
Higher Education Opportunity Act of 2008, P.L. 110-315, which amended
the Higher Education Act of 1965.
Summary of Legal Basis:
These regulations are proposed to implement provisions of the Higher
Education Opportunity Act of 2008, P.L. 110-315.
Alternatives:
To be determined.
Anticipated Cost and Benefits:
To be determined.
Risks:
None.
Timetable:
_______________________________________________________________________
Action Date FR Cite
_______________________________________________________________________
NPRM 07/00/09
Regulatory Flexibility Analysis Required:
Undetermined
Government Levels Affected:
Undetermined
Federalism:
Undetermined
Agency Contact:
David Bergeron
Department of Education
Office of Postsecondary Education
Room 8022
1990 K Street NW
Washington, DC 20006
Phone: 202 502-7815
RIN: 1840-AC95
BILLING CODE 4000-01-S
[[Page 71154]]
DEPARTMENT OF ENERGY (DOE)
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;
Foster energy efficiency and conservation;
Provide responsible stewardship of the Nation's nuclear
weapons;
Clean up the Department's sites and facilities, which include
sites dating back to the Manhattan Project;
Lead in the physical sciences and advance the biological,
environmental and computational sciences; and
Provide premier instruments of science for the Nation's
research enterprise.
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 (Plan) and the Unified Agenda of Federal Regulatory and
Deregulatory Actions (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 Plan and Agenda also reflect
the Department's continuing commitment to cut costs, reduce regulatory
burden, and increase responsiveness to the public.
Energy Efficiency Program for Consumer Products and Commercial
Equipment
The Energy Policy and Conservation Act (EPCA) requires DOE to set
energy efficiency standards for residential appliances and commercial
equipment at levels that achieve the maximum improvement in energy
efficiency that is both technologically feasible and economically
justified. Standards already in place for residential products are
expected to save consumers nearly $93 billion by 2020, and to save
enough energy to operate all U.S. homes for approximately two years.
On January 31, 2006, the Department released a schedule for setting new
energy efficiency standards that will save American consumers billions
of dollars in energy costs. The five-year plan outlined how DOE would
address the energy efficiency standards rulemaking backlog and meet the
statutory requirements established in EPCA and the Energy Policy Act of
2005 (EPACT 2005). The 2006 plan has been updated to address energy
efficiency standards requirements included in the Energy Independence
and Security Act of 2007 (EISA 2007). The plan provides for the
issuance of one rulemaking for each of the 18 products in the backlog.
The plan also provides for setting energy efficiency standards for
products required under EPACT 2005 and EISA 2007.
The overall plan for implementing the schedule is contained in the
periodic Report to Congress required under section 141 of EPACT 2005.
The plan was last updated in August 2008. All of the reports are posted
at:
http://www.eere.energy.gov/buildings/appliance--standards/schedule--
setting.html.
The report identifies all products for which DOE has missed the
deadlines established in EPCA (42 U.S.C. Sec. 6291 et seq.) and the
Department's plan for expeditiously prescribing new or amended
standards. Information and timetables concerning these actions can also
be found in the Department's Agenda, which is posted online at:
www.reginfo.gov.
Estimate of Combined Aggregate Costs and Benefits
The regulatory action on energy efficiency standards for fluorescent
and incandescent reflector lamps is in the early stages of rulemaking,
and the Department has not yet proposed candidate standards levels for
the covered products or equipment. Consequently, DOE cannot provide an
estimate of combined aggregate costs and benefits for these actions.
However, and in compliance with law, the Department will 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. The notice of proposed rulemaking for commercial
refrigeration equipment contains standard levels that, if adopted,
would result in energy savings of .83 quadrillion BTUs (quads) of
energy over the course of 30 years (73 FR 50071). The standard levels
for residential electric and gas ranges and ovens, microwave ovens, and
commercial clothes washers, set forth in the notice of proposed
rulemaking (73 FR 62034), if adopted, would result in energy savings of
.75 quads over 30 years.
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