[The Regulatory Plan and Unified Agenda of Federal Regulatory and Deregulatory Actions]
[The Regulatory Plan]
[From the U.S. Government Printing Office, www.gpo.gov]
DEPARTMENT OF AGRICULTURE (USDA)
Statement of Regulatory Priorities
The Department of Agriculture continues to implement an ongoing
program to eliminate unnecessary regulations and improve those
remaining by making them easier to understand and more user friendly.
Positive changes resulting from this regulatory reform initiative will
reach into every corner of the country and, both directly and
indirectly, touch the lives of most Americans. Those programs that
offer support to specific rural and urban segments of the economy are
being simplified so that persons who qualify for assistance, or some
other form of participation, will find less burdensome rules. Yet high
standards are in place to ensure efficient and effective program
management that makes the best use of taxpayer dollars. Farmers,
ranchers, and other USDA customers will find significant changes in all
aspects of regulations that govern their interaction with the
Department and its programs. Farm credit, a mainstay of the Nation's
rural economy, is being significantly streamlined by the merger of
cumbersome loan-making regulations with forms and certifications
simplified to facilitate the application process. The Department is
undertaking a number of actions in the regulation of commodities that
will increase efficiency, improve customer service, reduce intervention
in markets, and allow States to assume greater responsibility in
controlling the spread of plant and animal pests or disease. The
Department is also improving the regulations that serve rural
communities. Several changes are being made in rural housing programs
that will facilitate access and simplify the application process.
Nutrition programs are also being strengthened, their efficiency
improved, and their integrity enhanced through regulatory actions. In
the area of food safety, the Department has undertaken significant
revisions to all policies and steps to improve relationships with
industry and the public. There are also several important initiatives
under development in the natural resources and conservation area.
Reducing Paperwork Burden on Farmers
The Department has made substantial progress under the guidance of the
Chief Information Officer in implementing the goal of the Paperwork
Reduction Act of 1995 to reduce the burden of information collection on
the public. USDA continues to work toward full compliance with the law
and to continue reducing burden by an additional 5 percent during
fiscal year 2001. Further reductions will result from program changes,
improved efficiency in the collection and management of information,
and adjustments in the collection burden.
The Government Paperwork Elimination Act (GPEA) is leading all
agencies in the Department to evaluate how they conduct business and
migrate toward electronically oriented methods. The Farm Service
Agency, Natural Resources Conservation Service, Rural Development, and
Risk Management Agency are also working to implement the recently
passed Freedom to E-File Act. Freedom to E-File directs the agencies,
to the maximum extent practicable within 180 days, to modify forms into
user-friendly formats with user instructions and permits those forms to
be downloaded and submitted via facsimile, mail, or similar means.
Within 2 years producers should have the capability to electronically
file forms and all other documentation if they so desire. Underlying
these efforts will be analyses to identify and eliminate redundant data
collections and streamline collection instructions. The end result of
implementing both of these pieces of legislation will be to better
service to our customers so that they can choose when and where to
conduct business with USDA.
The Role of Regulations
The programs of the Department are diverse and far reaching, as are
the regulations that attend their delivery. Regulations codify how the
Department will conduct its business, including the specifics of access
to, and eligibility for, USDA programs. Regulations also specify the
behavior of State and local governments, private industry, businesses,
and individuals that is necessary to comply with their provisions. The
diversity in purpose and outreach of our programs contributes
significantly to the USDA being at or 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 regulations protecting
American agribusiness (the largest 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
departmental programs has accompanying regulatory needs, often with a
significant impact. The Farm Bill of 1996, Public Law 104-127, has
considerable regulatory consequences. This key legislation affects most
agencies of USDA and will result in the addition of new programs, the
deletion of others, and modification to still others. In addition, the
most recently enacted Agricultural Risk Protection Act of 2000, Public
Law 106-224, provides further assurances that agricultural programs
will continue to achieve long-term improvements, particularly in
reforms to the crop insurance programs. This legislation also provides
for improvements in market loss and conservation assistance, crop and
livestock disease pest protection, marketing program enhancements,
child nutrition program measures, pollution control, and research and
development for biomass.
Administration Guidance--USDA Response
In developing and implementing regulations, the Department has been
guided by the regulatory principles and philosophy set forth by the
President in Executive Order 12866 ``Regulatory Planning and Review.''
As prescribed in the Order, the USDA is committed to ``promulgate only
those regulations that are required by law, are necessary to interpret
the law, or are made necessary by compelling public need.'' When
considering a rulemaking action, the Department will assess the costs
and benefits of available regulatory alternatives, including the
alternative of not regulating. Our analysis will consider the costs and
benefits of both quantifiable and qualitative measures and opt for
approaches that maximize net benefits.
Major Regulatory Priorities
Seven agencies are represented in this regulatory plan. They include
the Farm Service Agency, the Food and Nutrition Service, the Forest
Service, the Food Safety and Inspection Service, the Animal and Plant
Health Inspection Service, the Agricultural Marketing Service, and the
Grain Inspection, Packers and Stockyards Administration.
[[Page 73312]]
This document represents summary information on prospective significant
regulations as called for in Executive Order 12866. A brief comment on
each of the six agencies appears below, which summarizes the Agency
mission and its key regulatory priorities. The Agency summaries are
followed by the regulatory plan entries.
Farm Service Agency
Mission: The Farm Service Agency (FSA) administers contract commodity,
conservation, farm loan, commodity purchase, and emergency loan and
disaster programs, as prescribed by various statutes, in order to
support farming certainty and flexibility while ensuring compliance
with farm conservation and wetland protection requirements and to
assist owners and operators of farms and ranches to conserve and
enhance soil, water, and related natural resources.
Priorities: FSA's priority for 2001 will be to continue to implement
these programs with emphasis on enhanced service to our customers. The
most significant FSA regulations are those that operate the contract
commodity programs and farm loans. The farm programs were significantly
changed by the 1996 Farm Bill. The Farm Bill instituted the contract
commodity programs, which utilize production flexibility contracts and
marketing assistance loans in place of the deficiency payments and
production adjustment of past programs. The contracts removed the link
between income support payments and farm prices by providing for seven
annual fixed but declining payments. FSA's farm loan programs make and
guarantee loans to family farmers and ranchers to purchase farmland and
finance agricultural production. While the contract commodity and farm
loan programs have significant economic impact, they are driven by
specific statutory requirements. Therefore, 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, which appears below.
In addition to its normal program operations, FSA is committed to the
Paperwork Reduction Act of 1995's goal of reducing the information
collection burden on the public. FSA is streamlining its farm loan-
making and servicing regulations and reducing the information
collection burden associated with the programs. FSA plans to reduce the
number of CFR parts containing its farm loan program regulations by
approximately 70 percent. In addition, FSA hopes to achieve a
significant reduction in the total number of CFR pages by removing
administrative provisions and internal policy and eliminating
duplicative material. Furthermore, FSA intends to improve the clarity
of the farm loan program regulations by following the guidelines
established in the President's Plain Language in Government Writing
Initiative.
As part of this project, all farm loan program regulations and
internal Agency directives will be completely rewritten. All
application processes and information collections will be reviewed, and
unnecessary or redundant requirements will be eliminated. All forms
associated with the program were reviewed and assigned to one of the
following categories:
Prepared by the public
Prepared by the Agency, reviewed by the public, or
Internal Agency use only.
FLP will concentrate on streamlining forms assigned to the first
category to reduce public burden. In addition, a data base was
developed listing each field contained on the forms. This information
will be used to identify duplicate collections and ensure consistency
in terminology.
FSA plans to publish regulations for direct loan program and
administrative regulations as a proposed rule in December 2000 and as a
final rule in September 2001. While rewriting of the regulations has
begun, it will be a lengthy process because approximately 37 CFR parts
are being consolidated into 3 parts and more than 750 CFR pages must be
rewritten. Revised regulations for special loan programs (including
Indian land acquisition, boll weevil eradication, drainage and
irrigation, and grazing association loans) are planned for publication
as a proposed rule in August 2001 and as a final rule in April 2002.
These programs will be completed last because there are only about 850
borrowers with outstanding special loans in comparison to almost
110,000 borrowers with outstanding direct loans.
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
2001 regulatory plan supports broad goals and objectives in the
Agency's strategic plan, which was extensively revised in fiscal year
2000. The goals are:
Improved nutrition of children and low-income people. This
goal represents FNS's efforts to improve diet quality as
measured by scores on the Healthy Eating Index by providing
access to program benefits (Food Stamps, WIC food vouchers,
commodities and State administrative funds), nutrition
education, and quality meals and other benefits. It
includes three major objectives: 1) Improved food security,
which reflects nutrition assistance benefits issued to
program participants; 2) FNS program participants make
healthy food choices, which represents our efforts to
improve nutrition knowledge and behavior through nutrition
education and breastfeeding promotion; and 3) improved
nutritional quality of meals, food packages, commodities,
and other program benefits, which represents our efforts to
ensure that program benefits meet the appropriate nutrition
standards to effectively improve nutrition for program
participants.
Improved Stewardship of Federal Funds. This goal 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. It includes two major objectives: 1) Improved
benefit accuracy and reduced fraud, which represents the
Agency's effort to reduce participant and Agency errors and
to control Food Stamp and WIC trafficking and participant,
vendor, and administrative Agency fraud; and 2) improved
efficiency of program administration, which represents our
efforts to streamline program operations and improve
program structures as necessary to maximize their
effectiveness.
Forest Service
Mission: The mission of the Forest Service is to sustain the health,
productivity, and diversity of the Nation's forest and rangelands to
meet the needs of present and future generations. This includes
protecting and managing the National Forest and Grasslands; providing
technical and financial assistance to States,
[[Page 73313]]
communities, and private forest landowners; and developing and
providing scientific and technical assistance and scientific exchanges
in support of forest and range conservation.
Priorities: On October 13, 1999, the President issued a memorandum
directing the Forest Service to develop and propose for public comment
regulations to provide appropriate long-term protection for most or all
of the currently inventoried ``roadless'' areas and to determine
whether such protection is warranted for any smaller ``roadless'' areas
not yet inventoried. A notice of intent to prepare an Environmental
Impact Statement to analyze and disclose various alternatives for
meeting the President's directive was published in the Federal Register
on October 19, 1999. The Agency received approximately 500,000 written
responses to the notice of intent.
On May 10, 2000 (65 FR 30276), the Agency published in the Federal
Register a notice of proposed rulemaking for Special Areas; Roadless
Area Conservation. The Agency proposes to prohibit road construction
and reconstruction in most inventoried roadless areas of the National
Forest System and require evaluation of roadless area characteristics
in the context of overall multiple-use objectives during land and
resource management plan revisions. The Agency conducted over 440
public meetings and is maintaining a web page with additional
information. The final rule, Special Areas, Roadless Areas
Conservation, is expected to be published in early winter.
Another Agency priority is to revise its road management rules and
policy to better inventory and analyze the need for existing forest
roads, and to shift the emphasis from building new roads to better
maintaining and managing those already in use. The final rule and final
policy, Administration of the Forest Development Transportation System,
are expected to be published in the fall.
Finally, the last of three Agency priorities is to revise the land
management planning regulations to make sustainability the foundation
for national forest system planning and management and establish
requirements for implementation, monitoring, evaluation, amendment, and
revision of land management plans. A proposed rule was published in the
Federal Register on October 5, 1999 (Part II, 64 FR 54074-54112).
Guided by recommendations of a Committee of Scientists, the proposed
rule provides for science-based planning, ecosystem sustainability, use
of ecoregional and watershed-level assessments, and strengthened
collaboration with individuals or organizations, State, local, tribal
governments, and other Federal agencies. The final rule, National
Forest System Land and Resource Management Planning, is expected to be
published this fall.
Food Safety and Inspection Service
Mission: The Food Safety and Inspection Service (FSIS) is responsible
for ensuring the Nation's meat, poultry, and egg products are safe,
wholesome, and properly marked, labeled, and packaged.
Priorities: FSIS is continuing to review its regulations to eliminate
duplication of and inconsistency with its own and other agencies'
regulations. The review effort is directed, in particular, at improving
the consistency of the regulations with the July 25, 1996, final rule
``Pathogen Reduction; Hazard Analysis and Critical Control Points
(HACCP) Systems.'' HACCP is a science-based process control system for
producing safe food products. The final rule requires official meat and
poultry establishments to develop and implement HACCP plans
incorporating the controls they have determined are necessary and
appropriate to produce safe products. HACCP places the responsibility
for food safety firmly on meat and poultry establishments but enables
them to tailor their control systems to their particular needs and
processes and to take advantage of the latest technological
innovations.
In addition, FSIS must revise its numerous ``command-and-control''
regulations, which prescribe the exact means establishments must use to
ensure the safety of their products, in effect assigning to the Agency
the responsibility for the means used by establishments to comply with
the regulations. As a general matter, command-and-control regulations
are incompatible with HACCP because they deprive plants of the
flexibility to innovate and undercut the clear delineation of
responsibility for food safety. Therefore, FSIS is conducting a
thorough review of its current regulations and, to the maximum extent
possible, converting its command-and-control regulations to performance
standards.
Following are some of the Agency's recent and planned initiatives to
convert command-and-control regulations to performance standards, to
streamline and simplify the regulations and to make the meat, poultry
products, and egg products inspection regulations more consistent with
the pathogen reduction and HACCP systems final rule:
FSIS has proposed new regulations limiting the amount of
processing water that can be retained by raw, single-
ingredient, meat or poultry products and requiring labeling
to indicate the amount of water retention.
FSIS has proposed to clarify and supplement the requirements
that apply to meat products produced by advanced separation
machinery and recovery systems. The proposed rule would
replace the compliance program parameters prescribed in
1994 with a requirement that as a prerequisite to labeling
or using the product as meat, an establishment must
implement and document procedures that ensure the
establishments production process is in control.
FSIS will be proposing generic Escherichia coli process
control criteria, based on the sponge method of sampling,
for cattle, swine, and geese slaughtering establishments,
and for turkey slaughtering establishments based on both
the sponge and the whole-bird rinse sampling methods. The
Agency also will be proposing updated Salmonella
performance standards for all market classes of cattle and
swine.
FSIS also will be proposing a rule to establish food safety
performance standards for all processed ready-to-eat and
partially heat-treated meat and poultry products.
In addition, FSIS will be proposing to require federally
inspected egg product establishments to develop and
implement HACCP systems and sanitation standards operating
procedures. The Agency will be proposing pathogen reduction
performance standards for pasteurizing egg products.
Further, the Agency will be proposing to remove current
requirements for approval by FSIS of egg-product plant
drawings, specifications, and equipment prior to use and to
end the system for premarketing approval of labels for egg
products. The Agency also is planning to propose requiring
safe-handling labels on shell eggs and egg products.
Finally, besides the foregoing initiatives, FSIS will be
proposing requirements for the nutrition labeling of ground
or chopped meat and poultry products and single-ingredient
products. This proposed
[[Page 73314]]
rule would require nutrition labeling, on the label or at
the point-of-purchase, for the major cuts of single-
ingredient, raw products and will require nutrition
information on the label of ground or chopped products.
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 U.S. animal and plant
resources from destructive pests and diseases. APHIS conducts programs
to control and eradicate exotic pests and diseases in the United
States. These activities enhance agricultural productivity and
competitiveness and contribute to the national economy and the public
health.
Priority: APHIS is developing a proposal to strengthen restrictions on
the importation of solid wood packing material (e.g., crates, dunnage,
wooden spools, pallets, packing blocks) into the United States.
Imported solid wood packing material (SWPM) has been linked to
introductions of exotic plant pests such as the pine shoot beetle and
the Asian longhorned beetle. These and other plant pests that could be
carried by imported SWPM pose a serious threat to U.S. agriculture and
to natural, cultivated, and urban forests. SWPM accompanies nearly all
types of imported commodities, from fruits and vegetables to machinery
and electrical equipment.
Agricultural Marketing Service
Mission: The Agricultural Marketing Service (AMS) facilitates the
marketing of agricultural products in domestic and international
markets, while ensuring fair trading practices, and promoting a
competitive and efficient marketplace, to the benefit of producers,
traders, and consumers of U.S. food and fiber products.
Priorities: AMS' top regulatory priority is to establish the National
Organic Program (NOP). The NOP will establish national standards for
the production and handling of organically produced products, including
a National List of substances approved and prohibited for use in
organic production and handling.
On March 17, 2000, AMS published in the Federal Register the
procedures for Mandatory Market News Reporting of Livestock and Meat.
These proposed regulations establish a program that will provide
livestock producers, packers, and other market participants with
information on pricing, contracting for purchase, numbers and quality
marketed for cattle, swine, lambs, and production of livestock
products.
On March 24, 2000, AMS published final regulations updating the
Federal Seed Act to incorporate current seed testing and seed
certification procedures. These regulations will keep the Federal Seed
Act consistent with present technology and prevent conflicts between
Federal and State regulations that could inhibit the free movement of
seed.
On June 6, 2000, AMS published a proposed rule to develop a voluntary,
user-fee-funded program to inspect and certify equipment and utensils
used to process livestock and poultry products. This service will
provide buyers of equipment inspected and certified by this program
with a third-party assurance that the equipment meets minimum
requirements for cleanability, suitability of materials used in
construction, durability, and inspectability. A 60-day comment period
was provided for interested persons to comment on the proposed rule
before issuing a final rule.
AMS Program Rulemaking Pages. Most of AMS' rules as published in the
Federal Register are available on the Internet at: http://
www.ams.usda.gov/rulemaking. This site also includes commenting
instructions and addresses, links to news releases and background
material, and comments received so far on various rules.
Grain Inspection, Packers and Stockyards Administration
Mission: The Grain Inspection, Packers and Stockyards Administration
(GIPSA) facilitates the marketing of livestock, poultry, meat, cereals,
oilseeds, and related agricultural products and promotes fair and
competitive trading practices for the overall benefit of consumers and
American agriculture. The mission of this Agency is carried out in two
different segments of American agriculture. GIPSA's Federal Grain
Inspection Service (FGIS) provides the U.S. grain market with Federal
quality standards and a uniform system for applying them. The Packers
and Stockyards Programs (P&S) ensures open and competitive markets for
livestock, meat, and poultry.
Priorities: GIPSA proposes adding five provisions to regulations under
the Packers and Stockyards Act to address certain trade and anti-
competitive practices in the livestock and poultry sectors. This series
of regulations is intended to increase transparency of market
transactions and allow market participants to compete more effectively
and fairly. The provisions will: (1) Clarify recordkeeping requirements
for packers; (2) mandate disclosure of specific production contract
terms in plain language; (3) prohibit restrictions on the disclosure of
contract terms; (4) require that livestock owned by different people be
purchased or offered for purchase on its own merits; and (5) specify
conditions under which packers may offer premiums and discounts in
carcass merit transactions.
GIPSA will issue an ANPRM in response to an Administration initiative
to strengthen the science-based regulations for biotechnology and to
improve consumer access to information on biotechnology. The ANPRM will
provide a 60-day comment period for input from consumers, industry, and
scientists on how USDA can best facilitate the marketing of grains,
oilseeds, fruits, vegetables, and nuts in today's evolving markets.
GIPSA is proposing regulations under the P&S Act to implement the
Swine Packer Marketing Contracts subtitle of the Livestock Mandatory
Reporting Act of 1999. The proposal is intended to establish a swine
marketing contract library and provide information on the contracting
practices of swine packers.
GIPSA is proposing a regulation that would make purchasing or selling
livestock with the condition that the price not be reported a violation
of the P&S Act.
GIPSA's rulemaking activities as published in the Federal Register are
available on the Internet at: http://www.usda.gov/gipsa/strulreg/
fedreg/fedreg.htm.
_______________________________________________________________________
USDA--Agricultural Marketing Service (AMS)
-----------
FINAL RULE STAGE
-----------
1. NATIONAL ORGANIC PROGRAM
Priority:
Economically Significant. Major under 5 USC 801.
Legal Authority:
PL 101-624, sec 2101 to 2123; 7 USC 6501 to 6522
CFR Citation:
7 CFR 205
[[Page 73315]]
Legal Deadline:
NPRM, Statutory, May 28, 1991.
NPRM, Statutory, May 28, 1992.
Final, Statutory, October 1, 1993.
The Organic Foods Production Act calls for the Secretary to appoint the
National Organic Standards Board 180 days after enactment and convene
it within 60 days thereafter.
Abstract:
The National Organic Program (NOP) would establish national standards
for the organic production and handling of agricultural products. It
establishes the 15-member National Organic Standards Board (NOSB) who
advises the Secretary of Agriculture (Secretary) on all aspects
regarding implementation of the NOP and particularly in developing the
national list of approved and prohibited substances. It also would
establish an accreditation program for State officials and private
persons who want to be accredited to certify farms and handling
operations that comply with the program's requirements. The program
additionally would include labeling requirements for organic products
and products containing organic ingredients and enforcement provisions.
It further provides for the approval of State organic programs and the
importation into the United States of organic agricultural products
from foreign producers that meet or are the equivalent to the national
standard.
Statement of Need:
The purpose of these regulations is to implement the Organic Foods
Production Act (OFPA). The Act requires the establishment of consistent
national standards for products labeled as organic; mandatory
independent, third-party certification of such products; U.S.
Department of Agriculture (USDA) oversight of the independent
certifiers and their inspectors; and assurance that imported organic
food products are produced and processed under practices equivalent to
USDA standards. Establishment of the National Organic Program is
necessary to eliminate the confusion that exists among consumers
because of the variety of standards under which organic foods are
currently produced and the irregular and sometimes unsubstantiated
labeling claims.
Summary of Legal Basis:
This regulatory action is authorized by title XXI of the Food,
Agriculture, Conservation, and Trade Act of 1990 (Public Law 101-624).
Alternatives:
The Board developed recommendations through an open discussion process
with the interested parties. The Board formed six subcommittees to
draft recommendations for the following subject areas: Crop standards;
livestock standards; processing, packaging, and labeling standards;
materials; accreditation of certifying agents; and international
(import) requirements. The Board has held 20 meetings during which they
have accepted public comments. In addition, the Agency held four public
hearings on livestock to develop additional input to the development of
livestock standards. In reviewing the Organic Foods Production Act, the
Board identified about 25 specific topics requiring recommendation
development such as an organic plan, pesticide drift, livestock health,
and materials review. Draft documents were prepared in the specific
subject areas and circulated for comment from the organic industry.
These documents were then further revised with full board-member input
and submitted a final time for public comment. Upon receipt of
comments, revisions were made, and the document was approved as a
recommendation to the Secretary. Approximately 25 of these
recommendations were approved at a Board meeting in June 1994 and
forwarded to the Secretary (after minor editing in the approval
process) in August 1994. In all of the documents, the Board committees
considered alternatives and altered positions based on reasoned public
comments received. The Board continues to provide recommendations for
modification or additions to program recommendations as the program is
implemented and operating. The allowed synthetic substances and
prohibited natural substances on the national list are subject to
review by the Board and the Secretary every 5 years in order for the
national list to be valid according to section 2118(e) of the OFPA. The
Secretary uses the recommendations as the basis for developing proposed
rules for implementing the program. The Secretary may not accept
recommendations that are deemed to be inconsistent with Department
policy or lack a defensible position. In December 1997, the NOP
published a proposed regulation that drew more than 275,000 mostly
negative comments from the public. This intense public concern prompted
the Secretary to call for the rule to be rewritten. The process
included a review of comments, further discussion with the NOSP
regarding their recommendations, and publishing for comment three
options papers--two dealing with organic livestock practices and one
addressing authority of certifying agents. NOP published a second
proposed rule March 12, 2000, that received 40,774 comments, most of
which are favorable. NOP anticipates publishing a final rule by the end
of calendar year 2000.
Anticipated Cost and Benefits:
Implementation of the National Organic Program will benefit certifying
agents, producers, handlers, and consumers. Key benefits include
improved protection of buyers from misleading claims and more
information on organic food, reduced administrative costs, and improved
access to international organic markets. The proposed rule would impose
direct costs on applicants for accreditation. Certifying agents will be
charged fees and related charges when applying for and for annual
reviews of accreditation. Estimated direct costs for accreditation are
$1,530 to $2,050 during the first 18 months following publication of
the final rule. Following the initial 18 months when hourly charges for
accreditation service will be charged, the cost for initial
accreditation will be $3,070 to $4,850. The cost for the annual review
of accreditation is estimated at $190 to $760 depending on the
complexity of the certifying agent's business. Certifying agents are
expected to pass the costs of accreditation and other costs onto their
producer and handler clients. USDA will not impose any direct fees on
producers and handlers. However, all industry participants--certifying
agents, producers, and handlers--will have costs of compliance,
including paperwork and recordkeeping costs. USDA National Organic
Program, States operating State programs, and certifying agents will
all bear enforcement costs. The amount of enforcement costs is unknown.
Risks:
The program does not address food safety issues. Any reduction in risks
to public health, safety, or the environment are indirect benefits of
the management practices and substances used by organic producers.
Organic producers seek to reduce or eliminate practices and materials
that may harm soil life, deplete nonrenewable resources, pose a hazard
to water and air quality, or threaten farmworkers health. The Act
requires the establishment of a ``national list'' of approved synthetic
and prohibited natural materials as an integral part of
[[Page 73316]]
the program. Synthetic materials approved for the national list must
have been determined by the USDA, FDA, and EPA to be not harmful to
human health or the environment.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
Organic Livestoc58 FR 69315 12/30/93
Notice-Procedure60 FR 15744Names of Substances for National Lis03/27/95
NPRM 62 FR 65850 12/16/97
NPRM Comment Period End 04/30/98
Issue Papers Pub63 FR 57624 10/28/98
Issue Papers Comment Period Ends 12/14/98
Second NPRM 65 FR 13512 03/13/00
Second NPRM Comment Period End 06/12/00
Final Action 12/00/00
Regulatory Flexibility Analysis Required:
Yes
Small Entities Affected:
Businesses
Government Levels Affected:
State, Tribal
Agency Contact:
Keith Jones
Program Manager
Department of Agriculture
Agricultural Marketing Service
Rm. 2945 So.
National Organic Program
Transportation & Marketing Program
P.O. Box 96456
Washington, DC 20090-0645
Phone: 202 720-3252
Fax: 202 690-3924
Email: [email protected]
RIN: 0581-AA40
_______________________________________________________________________
USDA--Animal and Plant Health Inspection Service (APHIS)
-----------
PROPOSED RULE STAGE
-----------
2. IMPORTATION OF SOLID WOOD PACKING MATERIAL
Priority:
Economically Significant. Major under 5 USC 801.
Legal Authority:
Title IV of Public Law 106-224; 7 USC 166 and 450
CFR Citation:
7 CFR 319
Legal Deadline:
None
Abstract:
APHIS is undertaking rulemaking to strengthen restrictions on the
importation of solid wood packing material (e.g., crates, dunnage,
wooden spools, pallets, packing blocks) into the United States.
Imported solid wood packing material (SWPM) has been linked to
introductions of exotic plant pests, such as the pine shoot beetle and
the Asian longhorned beetle. These and other plant pests that could be
carried by imported SWPM pose a serious threat to U.S. agriculture and
to natural, cultivated, and urban forests. SWPM accompanies nearly all
types of imported commodities, from fruits and vegetables to machinery
and electrical equipment.
Statement of Need:
Unmanufactured wood articles imported into the United States could pose
a serious threat of introducing plant pests detrimental to agriculture
and to natural, cultivated, and urban forests. Regulations in 7 CFR
319.40-1 through 319.40-11 are intended to mitigate this plant pest
risk. Introductions into the United States of exotic plant pests such
as the pine shoot beetle and the Asian longhorned beetle have been
linked to the importation of solid wood packing material (an
unmanufactured wood article). Solid wood packing material accompanies
nearly all types of imported commodities, from fruits and vegetables to
machinery and electrical equipment. For this reason, we are undertaking
rulemaking to strengthen the regulations that restrict the importation
of solid wood packing material in order to reduce the risk that plant
pests will be introduced into the United States.
Summary of Legal Basis:
The Animal and Plant Health Inspection Service (APHIS) is authorized to
take action under the Plant Protection Act (Pub. L. 106-224).
Alternatives:
APHIS presented three alternatives in an advance notice of proposed
rulemaking. The alternatives were to apply restrictions on the
importation of solid wood packing material based on risk assessment of
regions, apply restrictions on a general basis regardless of origin,
and prohibit importation of any solid wood packing material. We
accepted comments on other alternatives to consider. These and other
alternatives will be considered in analyses prepared in connection with
further rulemaking.
Anticipated Cost and Benefits:
The costs of proposed regulatory changes will be dependent on the
option that is chosen. We anticipate that costs will be alleviated by
utilization of alternative materials, such as nonwood packing material.
The benefits of increased restrictions will be the reduction in the
risk of potentially destructive plant pests being introduced into the
United States and the resulting avoidance of economic losses to forest
and agricultural resources. For the Asian longhorned beetle alone (a
pest detected on solid wood packing material imported from China), we
estimate that, if left unchecked, this pest has the potential to cause
economic losses of $41 billion, affecting the forest products,
commercial fruit, maple syrup, nursery, and tourist industries in the
United States.
Risks:
APHIS will conduct a comprehensive pest risk assessment prior to making
any regulatory changes.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
ANPRM 64 FR 3049 01/20/99
ANPRM Comment Period End 03/22/99
Notice 64 FR 36608 07/07/99
Comment Period End 09/07/99
NPRM 09/00/01
NPRM Comment Period End 11/00/01
Regulatory Flexibility Analysis Required:
Undetermined
Government Levels Affected:
Undetermined
[[Page 73317]]
Agency Contact:
Dr. Robert Flanders
Regulatory Coordination Specialist, Regulatory Coordination Staff, PPQ
Department of Agriculture
Animal and Plant Health Inspection Service
Unit 141
4700 River Road
Riverdale, MD 20737-1228
Phone: 301 734-5930
RIN: 0579-AA99
_______________________________________________________________________
USDA--Grain Inspection, Packers and Stockyards Administration (GIPSA)
-----------
PROPOSED RULE STAGE
-----------
3. REGULATIONS TO ENSURE MORE EQUITABLE COMPETITION IN THE
LIVESTOCK AND MEAT PACKING INDUSTRIES (LIVESTOCK AND POULTRY MARKETING)
Priority:
Other Significant
Legal Authority:
7 USC 181 et seq
CFR Citation:
9 CFR 201
Legal Deadline:
None
Abstract:
GIPSA proposes adding five provisions to regulations under the Packers
and Stockyards Act to address certain trade and anti-competitive
practices in the livestock and poultry sectors. This series of
regulations will increase transparency of market transactions and allow
market participants to compete more effectively and fairly. The
provisions will also facilitate the Department's investigative
procedures and support more effective enforcement of the Packers and
Stockyards (P&S) Act. The provisions will (1) clarify recordkeeping
requirements for packers; (2) mandate disclosure of specific production
contract terms in plain language; (3) prohibit restrictions on the
disclosure of contract terms; (4) require that livestock owned by
different people be purchased or offered for purchase on its own
merits; and (5) specify conditions under which packers may offer
premiums and discounts in carcass merit transactions.
Statement of Need:
1. Clarifying recordkeeping requirements for packers. Recent GIPSA
investigations have shown that packers are not maintaining sufficient
information to fully and correctly describe all business transactions
as required by section 401 of the P&S Act. Differences also exist in
the format in which packers maintain data and what data they maintain,
including when a transaction begins and ends.
2. Mandate disclosure of specific production contract terms in plain
language. Production contracts often are written in such a way that
producers are unable to determine the basic requirements and terms of
the contracts. The need to disclose certain contract terms is important
to ensure that both parties to a contract understand the terms of the
contract (the concept of disclosure of certain terms of contracts has
been well established in lending and real estate transactions). Failure
to disclose contract terms in plain language may be an unfair trade
practice because without plain language disclosure, the contracts may
be misleading or deceptive to producers and therefore may impede market
efficiency.
3. Prohibit restrictions on the disclosure of contract terms. Contracts
frequently contain clauses that prohibit contracting parties from
sharing information about or disclosing contract terms to others,
including their attorneys and accountants. Producers have complained
that such clauses have limited their ability to obtain legal or
financial advice once a contract is executed.
4. Require that livestock owned by different people be purchased or
offered for purchase on its own merits. Some dealers, packers, and
market agencies make the purchase of one consignment or lot of
livestock conditional on a purchaser's agreement to purchase another
lot of livestock (typically of lower quality) being offered by another
seller. These transactions, also known as string sales, result in
average pricing for different qualities of livestock offered by more
than one seller. Many industry observers believe that selling on
averages reduces incentives for sellers to improve livestock quality
and for packers to pay premiums for higher quality livestock.
5. Specify conditions under which packers may offer premiums and
discounts in carcass merit transactions. Some packers purchasing
livestock on a carcass merit (grade and yield) basis offer premiums or
discounts (prices differences) for the same quality livestock. Prices
for livestock purchased on a carcass merit basis reflect differences in
animal quality. Any further differences in price may represent undue or
unreasonable preferences or disadvantage unless packers provide a valid
business justification for the price differences.
Summary of Legal Basis:
The Grain Inspection, Packers and Stockyards Administration is
authorized to make regulations under the Packers and Stockyards Act (7
U.S.C. 181 et seq.)
Alternatives:
GIPSA considered several alternatives, including providing
specifications for recordkeeping requirements and contract language.
These alternatives may be too burdensome on the livestock and poultry
industries. Alternatives considered in the analysis will be presented
in the proposed rule(s) for public comment.
Anticipated Cost and Benefits:
Livestock producers and poultry growers are expected to benefit from
these regulations. The benefits include increased transparency and
efficiency in the livestock and poultry markets. Packers and live
poultry dealers may incur additional costs to comply with these
regulations.
Risks:
Not applicable. These regulations do not address risks related to
public health, safety, or the environment.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 02/00/01
Regulatory Flexibility Analysis Required:
Undetermined
Government Levels Affected:
Undetermined
[[Page 73318]]
Agency Contact:
Sharon L. Vassiliades
Regulatory Liaison
Department of Agriculture
Grain Inspection, Packers and Stockyards Administration
Room 1647-S
1400 Independence Avenue SW
Washington, DC 20250
Phone: 202 720-1738
Fax: 202 690-2755
Email: [email protected]
RIN: 0580-AA72
_______________________________________________________________________
USDA--Food and Nutrition Service (FNS)
-----------
PROPOSED RULE STAGE
-----------
4. CHILD AND ADULT CARE FOOD PROGRAM: IMPROVING MANAGEMENT AND PROGRAM
INTEGRITY
Priority:
Other Significant
Unfunded Mandates:
Undetermined
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 proposes to
revise: State agency criteria for approving and renewing institution
applications; program training and other operating requirements for
child care institutions and facilities; State- and institution-level
monitoring requirements; and criteria for terminating agreements with
institutions. 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 mis-categtorized 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:
Most of the changes proposed in the rule are discretionary changes
being made in response to deficiencies found in program reviews and OIG
audits. Other proposed 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 proposed
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:
Continuing to operate the CACFP under existing provisions of the
regulations that do not sufficiently protect against fraud and abuse in
CACFP puts the program at significant risk. This rule includes changes
designed to strengthen current program regulations to reduce the risk
associated with the program.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 65 FR 55103 09/12/00
NPRM Comment Period End 12/11/00
Final Action 05/00/01
Final Action Effective 06/00/01
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
Organizations
Government Levels Affected:
State, Local
[[Page 73319]]
Agency Contact:
Sheri Ackerman
Agency Regulatory Officer
Department of Agriculture
Food and Nutrition Service
Room 910
3101 Park Center Drive
Alexandria, VA 22302
Phone: 703 305-2246
Email: [email protected]
RIN: 0584-AC24
_______________________________________________________________________
USDA--FNS
5. SPECIAL SUPPLEMENTAL NUTRITION PROGRAM FOR WOMEN, INFANTS, AND
CHILDREN (WIC): REVISIONS IN THE WIC FOOD PACKAGES
Priority:
Economically Significant. Major under 5 USC 801.
Legal Authority:
42 USC 1786
CFR Citation:
7 CFR 246
Legal Deadline:
None
Abstract:
This proposed rule will amend regulations governing the WIC food
packages to disallow low-iron WIC formulas in food packages for
infants; revise the maximum monthly allowances and minimum requirements
for certain WIC foods; revise the substitution rates for certain WIC
foods and allow additional foods as alternatives; make technical
adjustments in all of the food packages to accommodate newer packaging
and physical forms of the WIC foods; add vegetables as a food category
in Food Packages III-VII for women and children; require that State
agencies make available the full maximum foods allowed in each package;
revise the criteria for developing State agency proposals for
alternative food packages to accommodate participant food preferences
more effectively; revise the purpose, content, and requirements for
Food Package III; and address general provisions that apply to all the
food packages. These revisions will improve the likelihood that WIC
recipients achieve the food servings recommendations of the Dietary
Guidelines for Americans and nutritional recommendations, providing WIC
participants with a wider variety of foods, accommodating newer
packaging and physical forms of WIC foods, and providing WIC State
agencies with greater flexibility in prescribing food packages,
especially to accommodate participants with hardships or cultural/food
preferences. (99-006)
Statement of Need:
While WIC has been successful in many areas, obesity and inappropriate
dietary patterns have become equal, if not greater, problems for many
in WIC's target population. WIC food packages and nutrition education
are the chief means by which WIC affects the dietary quality and habits
of participants. Results of a recent WIC study found that the
supplemental food package is consistently ranked by pregnant and
postpartum women as the leading positive attribute of the program.
Therefore, revised food packages, which will foster greater consistency
with the Dietary Guidelines for Americans, are an appropriate response
to further increase the positive effects of the program among the WIC
eligible population.
The overarching objective of this rule is to improve disease prevention
and nutritional status by improving dietary quality and nutritional
adequacy of the WIC food packages by:
1. Improving the manner in which the nutrients lacking in the target
population's diet are provided by revising food packages to reflect
more closely the Dietary Guidelines for Americans as represented by the
diet recommendations of the Food Guide Pyramid; and
2. Increasing the nutritional adequacy of the WIC food packages for
medically needy participants by providing a large proportion of the
Recommended Energy Allowances (REA) and Recommended Dietary Allowances
(RDA) under the revised Food Package III, which is generally comprised
of special nutritional formulas for this extremely vulnerable group.
Summary of Legal Basis:
The WIC Program was established to provide nutritious supplemental
foods, nutrition education, and referrals to related health and social
services to low-income pregnant, breastfeeding and non-breastfeeding
postpartum women, infants, and children up to age 5. Section 17 of the
Child Nutrition Act of 1966 (as amended, 42 USC 1786) clearly
established the WIC Program as a supplemental nutrition program
designed to provide nutrients determined by nutritional research to be
lacking in the diets of the WIC target population. WIC law requires
that, to the extent possible, the fat, sugar, and salt content of WIC
foods be appropriate. The law gives substantial latitude to the
Department in designing WIC food offerings but obligates the Department
to prescribe foods that effectively and economically supply the target
nutrients.
Alternatives:
The Food and Nutrition Service (FNS) has based its decisions to propose
certain changes in the WIC food packages on several considerations,
such as nutritional benefit to WIC participants in terms of meeting
their dietary needs more effectively, nutrient density in terms of the
WIC target nutrients and/or other nutrients of concern to the WIC
population, versatility in terms of meal planning or food preparation,
year-round availability, broad participant appeal, cost impact, WIC
agency administrative manageability, and the supplemental nature of the
WIC food packages. Overall, the selection of changes FNS is proposing
are among those most frequently requested by WIC agencies and
participants. FNS also believes that these changes will have the most
positive impact on improving the nutritional integrity of the food
packages considering the associated costs.
Anticipated Cost and Benefits:
The revisions of the WIC food packages, apart from the revisions to
Food Package III for medically needy participants, have been analyzed
as a group for the purposes of cost-effectiveness because together they
attain the overall goal of improving dietary patterns and offering
alternatives to meet dietary needs. These changes would help
participants achieve dietary patterns that are more consistent with the
Dietary Guidelines for Americans. The changes include the addition of
vegetables; the reduction of fluid milk, cheese, juice, and powdered
formula; the substitution of canned beans for dried beans and soy-based
beverages for fluid milk; and small changes in the evaporated milk
reconstitution rate and the maximum allowance for eggs. In addition,
these changes must be viewed as a group because available research on
cost-effectiveness and cost/benefit analysis of diet tend to focus on
the dietary pattern as a whole.
As proposed, these changes would save the WIC Program a total of $77
million in the first year. The cost-effectiveness
[[Page 73320]]
of achieving food packages which are more balanced, lower in fat, and
which provide alternatives to people with food intolerances, cultural
preferences, and certain hardships is significant. Achieving the
intended outcomes through these food package changes is extremely cost-
effective as they are achieved at a net savings of approximately $10.45
per year for every WIC participant whose food package and diet are
improved by the changes.
The benefits from changes in the food package for medically needy WIC
participants (Food Package III) come in the form of avoided medical
interventions such as moving from less expensive enteral feeding
methods to more expensive parental feeding (ADA, 1995),
hospitalization, or surgery. FNS cannot determine the number or
seriousness of the interventions that may be averted by this rule.
However, it is constructive to consider the size of the increases in
the maximum allowances, and thus the additional proportion of medically
fragile participants' dietary needs that the revised rule will provide
and ensure. The increases in maximum allowances of medical formulas of
up to 188 percent for women and children are achieved at a cost of
between $21 and $95 million, or between $362 and $1639 per medically
needy woman and child, per year. The increases of up to 63 percent for
infants are achieved at a cost of between $44 and $75 million, or
between $584 and $996 per medically needy infant, per year.
The net cost/savings, including medical foods and other changes, is
estimated to range from -7 million to +94 million the first year, with
5-year totals ranging from -30 million to +501 million.
Risks:
This rule is intended to improve the nutritional status and dietary
patterns of the WIC target population, as a response to the threat of
increasing risk factors for nutrition-related diseases--obesity,
diabetes, coronary heart disease, stroke, and cancer, to name a few--in
the WIC eligible population.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 10/00/00
NPRM Comment Period End 01/00/01
Final Action 09/00/01
Final Action Effective 11/00/01
Regulatory Flexibility Analysis Required:
Yes
Small Entities Affected:
Businesses
Government Levels Affected:
State, Local, Tribal, Federal
Federalism:
This action may have federalism implications as defined in EO 13132.
Agency Contact:
Sheri Ackerman
Agency Regulatory Officer
Department of Agriculture
Food and Nutrition Service
Room 910
3101 Park Center Drive
Alexandria, VA 22302
Phone: 703 305-2246
Email: [email protected]
RIN: 0584-AC90
_______________________________________________________________________
USDA--FNS
-----------
FINAL RULE STAGE
-----------
6. SPECIAL SUPPLEMENTAL FOOD PROGRAM FOR WOMEN, INFANTS, AND CHILDREN
(WIC): FOOD DELIVERY SYSTEMS
Priority:
Other Significant
Legal Authority:
42 USC 1786
CFR Citation:
7 CFR 246
Legal Deadline:
NPRM, Statutory, March 1, 1999.
Final, Statutory, March 31, 2000.
Abstract:
A proposed rule addressing WIC Food Delivery Systems was published on
December 28, 1990 (55 FR 53446). The Department provided a 120-day
comment period for the proposed rule, which closed on April 28, 1991.
Nearly 1,100 comments were received from a wide variety of sources.
Despite the degree of preliminary input to the December 28, 1990,
proposed rule, many of the commenters responding during the formal
comment period suggested that the Department's food delivery
regulations be proposed again, rather than proceeding directly to a
final rule. In addition, several members of Congress requested that the
rule be reproposed in light of its impact on State agency food delivery
systems. On June 16, 1999, the Department issued a second proposed rule
addressing WIC food delivery systems and requirements. This second rule
addresses many of the provisions contained in the previous rulemaking
and contains modifications to some of the proposed provisions, as well
as clarifications of several provisions that may not have been clearly
understood in the earlier rule. See also RIN 0584-AC50 for related
provisions that fulfill the statutory deadline.
Statement of Need:
On December 28, 1990, the Department published a proposed rule designed
primarily to strengthen State agency operations in vendor management
and related food delivery areas for the WIC Program. This proposal was
developed with input over several years' time from State agency experts
in food delivery and with the full support of and encouragement from
Congress and the Department's Office of Inspector General (OIG). The
Department provided a 120-day comment period for the proposed rule,
which closed on April 28, 1991. During this comment period, nearly
1,100 comments were received from State and local WIC agencies,
vendors, and associated groups, public interest groups, members of
Congress, members of the public, and WIC participants.
Despite the degree of preliminary input to the December 28, 1990,
proposed rule, many of the commenters suggested that the Department's
food delivery regulations needed to be proposed again, rather than
proceeding directly to a final rule. In addition, several members of
Congress requested that the rule be reproposed in light of its impact
on State agency food delivery systems.
The Department has therefore issued a second proposed rule addressing
WIC food delivery systems integrity and procedural requirements. This
second rule addresses many of the provisions contained in the previous
rulemaking and contains significant modifications to some of the
proposed revisions, as well as clarifications to a number of provisions
that may not have been clearly understood in the earlier rule. The rule
is intended to provide for more cost effective and efficient management
of WIC vendors by State agencies. The Department provided a 120-day
public comment period for this proposed rule. The Department intends to
publish a final rule, based on all of the comments received, by the end
of calendar year 2000.
[[Page 73321]]
Although this rule does not have a direct impact on reducing risks to
public health, safety, or the environment, it will significantly
improve the operation and accountability of the WIC Program nationwide.
Alternatives:
Given the intensive input that has been gathered for the development of
this rule since it was recommended by the General Accounting Office in
1988 and the comments that were received pertaining to the first
proposed version of the rule in December 1990, the Department has
determined that there were no viable alternatives to the provisions
included in the reproposal. The alternative of proceeding directly to
promulgation of a final rule based on the 1990 proposal has been
rejected by Congress.
Anticipated Cost and Benefits:
The costs of this action include costs due to vendor overcharges and
costs associated with the proposal. The estimated costs for
implementation of the proposal included a shift of not more than $2.0
million in WIC Program Nutrition Services and Administration (NSA)
funds within the 87 State agencies, partially from reduced requirements
for management evaluations of local agencies and reduced costs due to
elimination of representative on-site monitoring. They also include
$0.5 million in additional costs to vendors to meet the proposed
minimum training and authorization requirements. It should be noted
that all the vendors are currently required to participate in some type
of training and complete an application form for program authorization.
The estimated $0.5 million in additional costs therefore represents
those instances where current training and authorization requirements
are below the level established in the proposal. In these instances,
vendors may incur costs in attending more frequent training sessions or
may be required to complete an application form at more frequent
intervals. The estimated cost does not represent charges to the vendor
for training or authorization. Rather, the cost represents the
estimated cost of the vendor's time to participate in the training
session and to complete the application form.
The gross benefit results from a significant reduction in vendor
overcharges. A significant net benefit of $37 million is expected, as
vendor overcharges are estimated at $39.5 million and costs associated
with the proposal are a maximum of $2.5 million.
Risks:
This rule is intended to ensure greater program accountability and
efficiency in food delivery and related areas and to promote a decrease
in vendor violations of program requirements and loss of program funds.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 64 FR 32308 06/16/99
NPRM Comment Per64 FR 32308 10/14/99
Final Action 10/00/00
Regulatory Flexibility Analysis Required:
Yes
Small Entities Affected:
Businesses
Government Levels Affected:
State, Local, Tribal
Federalism:
This action may have federalism implications as defined in EO 13132.
Agency Contact:
Sheri Ackerman
Agency Regulatory Officer
Department of Agriculture
Food and Nutrition Service
Room 910
3101 Park Center Drive
Alexandria, VA 22302
Phone: 703 305-2246
Email: [email protected]
RIN: 0584-AA80
_______________________________________________________________________
USDA--FNS
7. FOOD STAMP PROGRAM: REVISIONS TO THE RETAIL FOOD STORE DEFINITION
AND PROGRAM AUTHORIZATION GUIDANCE
Priority:
Other Significant
Legal Authority:
PL 103-225; 7 USC 2012; 7 USC 2018
CFR Citation:
7 CFR 271; 7 CFR 278
Legal Deadline:
Final, Statutory, March 25, 1994.
Abstract:
This rule would implement provisions of Public Law 103-225 requiring
firms to offer a variety of staple food items for sale or to have more
than 50 percent of gross retail sales in staple foods. This rule also
addresses the requirement in Public Law 103-225 to provide periodic
notices to participating firms, clarifying certain eligibility
criteria. (95-003)
Statement of Need:
Public Law 103-225 amends the Food Stamp Act of 1977 to make changes in
eligibility requirements for retail food stores to participate in the
Food Stamp Program. Prior to enactment of these changes, a retail food
store qualified to participate in the Food Stamp Program if more than
50 percent of its total eligible food sales were in staple foods. The
new law changes that to require 50 percent of its total gross sales in
staple foods. It also provides another option for stores not meeting
the new 50 percent rule. Those stores can now qualify if they offer for
sale, on a continuous basis, a variety of food in each of four
categories of staple foods. The staple food categories are defined as
``(1) meat, poultry, or fish; (2) bread or cereals; (3) vegetables or
fruits; or (4) dairy products.'' This statutory change in eligibility
will require developing policy definitions for the terms ``continuous
basis,'' ``variety,'' and ``perishable.''
Alternatives:
None. The new law also requires the Secretary to issue new rules
providing for the periodic reauthorization of retail food stores and
wholesale food concerns. This must include providing periodic notice of
the definitions for ``retail food stores,'' ``staple foods,'' and
``perishable foods.''
Anticipated Cost and Benefits:
It is not anticipated that this rule will impact program costs. It is
anticipated that the clarifications of program eligibility criteria in
this rule will make it easier for firms to understand and for the Food
and Nutrition Service to administer.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 64 FR 35082 06/30/99
NPRM Comment Per64 FR 35082 08/30/99
Final Action 11/00/00
Regulatory Flexibility Analysis Required:
No
Government Levels Affected:
None
[[Page 73322]]
Agency Contact:
Sheri Ackerman
Agency Regulatory Officer
Department of Agriculture
Food and Nutrition Service
Room 910
3101 Park Center Drive
Alexandria, VA 22302
Phone: 703 305-2246
Email: [email protected]
RIN: 0584-AB90
_______________________________________________________________________
USDA--FNS
8. FSP: PERSONAL RESPONSIBILITY PROVISIONS OF THE PERSONAL
RESPONSIBILITY AND WORK OPPORTUNITY RECONCILIATION ACT OF 1996
Priority:
Economically Significant. Major under 5 USC 801.
Reinventing Government:
This rulemaking is part of the Reinventing Government effort. It will
revise text in the CFR to reduce burden or duplication, or streamline
requirements.
Legal Authority:
PL 104-193
CFR Citation:
7 CFR 271; 7 CFR 272; 7 CFR 273
Legal Deadline:
Other, Statutory, August 22, 1996, for PL 104-193 sec 813, 814, 820,
821, 837, and 911.
Other, Statutory, November 22, 1996, for PL 104-193 sec 824.
Other, Statutory, July 1, 1997, for PL 104-193 sec 115.
Abstract:
This rule will implement 13 provisions of the Personal Responsibility
and Work Opportunity Reconciliation Act of 1996. (96-019)
Statement of Need:
Public Law 104-193, the Personal Responsibility and Work Opportunity
Reconciliation Act of 1996, amends the Food Stamp Act of 1977, to add
some new eligibility requirements and disqualifiers and increase some
existing penalties for noncompliance with food stamp rules. The new
law: (1) Makes individuals convicted of drug-related felonies
ineligible for food stamps; (2) doubles the penalties for violating
food stamp program requirements; (3) permanently disqualifies
individuals convicted of trafficking in food stamp benefits of $500 or
more; (4) allows States to disqualify an individual from food stamps if
the individual is disqualified from another means-tested program for
failure to perform an action required by that program; (5) makes
individuals ineligible for 10 years if they misrepresent their identity
or residence in order to receive multiple food stamp benefits; (6)
makes fleeing felons and probation and parole violators ineligible for
the food stamp program; (7) allows States to require food stamp
recipients to cooperate with child support agencies as a condition of
food stamp eligibility; (8) allows States to disqualify individuals who
are in arrears in court-ordered child support payments; (9) limits the
food stamp participation of most able-bodied adults without dependents
to 3 months in a 3-year period during times the individual is not
working or participating in a work program; (10) prohibits an increase
in food stamp benefits when households' income is reduced because of a
penalty imposed under a Federal, State, or local means-tested public
assistance program for failure to perform a required action; (11)
requires States to provide households' addresses, social security
numbers, or photographs to law enforcement officers to assist them in
locating fugitive felons or probation or parole violators; (12)
prohibits an increase in food stamp benefits when households' income is
reduced because of a penalty imposed under a Federal, State, or local
means-tested public assistance program for an act of fraud by the
individual under the program; and (13) clarifies that States may not
impose a separate food stamp sanction on individuals who are
disqualified from TANF for failure to send their children to school or
failure to attain a high school diploma or a GED.
Summary of Legal Basis:
All of the provisions of this rule are mandated by Public Law 104-193,
the Personal Responsibility and Work Opportunity Reconciliation Act of
1996.
Alternatives:
None.
Anticipated Cost and Benefits:
Over 5 years, the provisions are expected to reduce the cost of the
Food Stamp Program by approximately $1.81 billion.
Risks:
None.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 64 FR 70920 12/17/99
NPRM Comment Period End 02/15/00
Final Action 10/00/00
Regulatory Flexibility Analysis Required:
No
Government Levels Affected:
Federal, State, Local
Agency Contact:
Sheri Ackerman
Agency Regulatory Officer
Department of Agriculture
Food and Nutrition Service
Room 910
3101 Park Center Drive
Alexandria, VA 22302
Phone: 703 305-2246
Email: [email protected]
RIN: 0584-AC39
_______________________________________________________________________
USDA--FNS
9. FSP: NONCITIZEN ELIGIBILITY AND CERTIFICATION PROVISIONS OF PUBLIC
LAW 104-193 (PREVIOUSLY ENTITLED STATE FLEXIBILITY AND CERTIFICATION
PROVISIONS)
Priority:
Economically Significant. Major under 5 USC 801.
Reinventing Government:
This rulemaking is part of the Reinventing Government effort. It will
revise text in the CFR to reduce burden or duplication, or streamline
requirements.
Legal Authority:
PL 104-193; PL 104-208; 7 USC 2011 to 2032
CFR Citation:
7 CFR 272.3; 7 CFR 273.11(e); 7 CFR 273.11(j); 7 CFR 273.13; 7 CFR
273.14(b); 7 CFR 273.14(e); 7 CFR 273.1; 7 CFR 273.2; 7 CFR 273.4; 7
CFR 273.9(c); 7 CFR 273.9(d); 7 CFR 273.10(a); 7 CFR 273.10(c) to
273.10(f); 7 CFR 273.11(a) to 273.11(c)
Legal Deadline:
Other, Statutory, August 22, 1996, for PL 104-193 sec 813, 814, 820,
821, 837, and 911.
Other, Statutory, November 22, 1996, for PL 104-193 sec 824.
Other, Statutory, July 1, 1997, for PL 104-193 sec 115.
[[Page 73323]]
For provisions effective upon enactment, the statutory implementation
date is August 22, 1996.
Abstract:
This rule proposes to amend Food Stamp Program regulations to implement
14 provisions of the Personal Responsibility and Work Opportunity
Reconciliation Act of 1996 and one provision of the Omnibus
Consolidated Appropriations Act of 1996. These provisions would
increase State agency flexibility in processing applications for the
Food Stamp Program and allow greater use of standard amounts for
determining deductions and self-employment expenses. The provisions
would also give State agencies options to issue partial allotments for
households in treatment centers, issue combined allotments to certain
expedited service households, and certify elderly or disabled
households for 24 months. Other changes would revise requirements for
determining noncitizen eligibility and the eligibility and benefits of
sponsored noncitizens, eliminate the exclusion of certain transitional
housing payments and State and local energy assistance, exclude the
earnings of students under 18, and require proration of benefits
following any break in certification. The rule would also add vehicles
to the assets which may be covered under the inaccessible resources
provisions of the Food Stamp Act of 1977. (96-020)
Statement of Need:
This action is required by Public Law 104-193, Public Law 104-208,
Public Law 105-53, and Public Law 105-185.
Summary of Legal Basis:
This rule is required to implement the provisions of sections 402, 421,
801, 807, 808, 809, 811, 812, 818, 827, 828, 830, and 835 of Public Law
104-193; section 552 of Public Law 104-208; sections 5302, 5305, 5306,
5562, 5563, 5571, 5572, and 5573 of Public Law 105-53; and section 503
of Public Law 105-185.
Anticipated Cost and Benefits:
The provision of this rule would reduce Food Stamp Program costs for FY
1997-2002 by approximately $6.605 billion.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 65 FR 10856 02/29/00
NPRM Comment Period End 05/01/00
Final Action 10/00/00
Regulatory Flexibility Analysis Required:
No
Government Levels Affected:
Federal, State, Local
Agency Contact:
Sheri Ackerman
Agency Regulatory Officer
Department of Agriculture
Food and Nutrition Service
Room 910
3101 Park Center Drive
Alexandria, VA 22302
Phone: 703 305-2246
Email: [email protected]
RIN: 0584-AC40
_______________________________________________________________________
USDA--FNS
10. FSP: NONDISCRETIONARY PROVISIONS OF THE PERSONAL RESPONSIBILITY AND
WORK OPPORTUNITY RECONCILIATION ACT OF 1996
Priority:
Economically Significant. Major under 5 USC 801.
Reinventing Government:
This rulemaking is part of the Reinventing Government effort. It will
revise text in the CFR to reduce burden or duplication, or streamline
requirements.
Legal Authority:
PL 104-193, sec 803; PL 104-193, sec 804; PL 104-193, sec 805; PL 104-
193, sec 809; PL 104-193, sec 810; PL 104-193, sec 838; PL 104-193, sec
109; PL 104-193, sec 826
CFR Citation:
7 CFR 271.2; 7 CFR 273.1; 7 CFR 273.2; 7 CFR 273.8; 7 CFR 273.9; 7 CFR
273.10; 7 CFR 276.2(e)
Legal Deadline:
Other, Statutory, August 22, 1996, for PL 104-193 sec 803, 805 and 838.
Other, Statutory, October 1, 1996, for PL 104-193 sec 804 and 810.
Other, Statutory, January 1, 1997, for PL 104-193 sec 809.
For provisions effective upon enactment, the statutory implementation
date is August 22, 1996.
Abstract:
This final rule amends the Food Stamp Program regulations to implement
eight provisions of the Personal Responsibility and Work Opportunity
Reconciliation Act of 1996. These provisions require no interpretation
or discretion: 1) Freeze the minimum allotment at $10; 2) change the
way the maximum allotments are calculated to use 100 percent of the
Thrifty Food Plan as opposed to 103 percent; 3) freeze the standard
deduction at current level and eliminate the adjustment procedures; 4)
cap the excess shelter expense deduction; 5) change the household
composition definition so that children under 22 years of age and
living with their parents cannot be a separate household; 6) increase
the timeframe from 5 to 7 days for expedited service; 7) set a time
limit of not more than 90 days living in another person's house for
considering a person homeless; and 8) set the fair market value of
vehicles at $4,600 through 9/30/96 and raise it to $4,650 effective 10/
1/96 and eliminate future adjustments. (96-021)
Statement of Need:
This action is required by Public Law 104-193.
Summary of Legal Basis:
This rule is required to implement the provisions of sections 109, 803,
804, 805, 809, 810, 826, and 838 of Public Law 104-193, the Personal
Responsibility and Work Opportunity Reconciliation Act of 1996.
Alternatives:
None. The provisions are mandated by statute.
Anticipated Cost and Benefits:
The provisions of this rule would reduce Food Stamp Program costs for
FY 1997-2002 by $11.2 billion.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 64 FR 37454 07/12/99
NPRM Comment Period End 09/10/99
Final Action 10/00/00
Regulatory Flexibility Analysis Required:
No
Government Levels Affected:
State, Local
[[Page 73324]]
Agency Contact:
Sheri Ackerman
Agency Regulatory Officer
Department of Agriculture
Food and Nutrition Service
Room 910
3101 Park Center Drive
Alexandria, VA 22302
Phone: 703 305-2246
Email: [email protected]
RIN: 0584-AC41
_______________________________________________________________________
USDA--FNS
11. FOOD STAMP PROGRAM: WORK PROVISIONS OF THE PERSONAL RESPONSIBILITY
AND WORK OPPORTUNITY RECONCILIATION ACT OF 1996 AND THE FOOD STAMP
PROVISIONS OF THE BALANCED BUDGET ACT OF 1997
Priority:
Other Significant
Legal Authority:
PL 104-193
CFR Citation:
7 CFR 273.7; 7 CFR 273.22
Legal Deadline:
None
Abstract:
This proposed rule will implement revisions to the Food Stamp Program's
work and employment and training requirements, as well as new
provisions for a work supplementation or support program and an
employment initiative program. (96-025)
Statement of Need:
This rule is necessary to implement revisions to the Food Stamp
Program's work requirements.
Summary of Legal Basis:
All provisions of this proposed rule are mandated by Public Law 104-193
and the Balanced Budget Act of 1997.
Alternatives:
The alternative is not to revise current rules. This is not practical.
The current rules have been superseded by changes brought about by
Public Law 104-193.
Anticipated Cost and Benefits:
Federal costs will increase by $1.4 billion between fiscal year 1997
and fiscal year 2002. State agencies will benefit by achieving greater
flexibility to encourage work and foster personal responsibility and
independence.
Risks:
An increase in food stamp rolls would result by not implementing this
rule.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 64 FR 72196 12/23/99
NPRM Comment Period End 02/22/00
Final Action 12/00/00
Regulatory Flexibility Analysis Required:
No
Government Levels Affected:
State, Local
Agency Contact:
Sheri Ackerman
Agency Regulatory Officer
Department of Agriculture
Food and Nutrition Service
Room 910
3101 Park Center Drive
Alexandria, VA 22302
Phone: 703 305-2246
Email: [email protected]
RIN: 0584-AC45
_______________________________________________________________________
USDA--Food Safety and Inspection Service (FSIS)
-----------
PROPOSED RULE STAGE
-----------
12. PERFORMANCE STANDARDS FOR READY-TO-EAT MEAT AND POULTRY PRODUCTS
Priority:
Other Significant. Major status under 5 USC 801 is undetermined.
Unfunded Mandates:
Undetermined
Legal Authority:
21 USC 451 et seq; 21 USC 601 et seq
CFR Citation:
9 CFR 317; 9 CFR 381; 9 CFR 430
Legal Deadline:
None
Abstract:
FSIS is proposing to establish pathogen reduction performance standards
for all ready-to-eat meat and poultry 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. Along with HACCP, food safety performance standards will
give establishments the incentive and flexibility to adopt innovative,
science-based food safety processing procedures and controls, while
providing objective, measurable standards that can be verified by
Agency inspectional oversight. This set of performance standards will
include and be consistent with those already in place for certain
ready-to-eat meat and poultry products. FSIS also is proposing testing
and labeling requirements intended to reduce the incidence of Listeria
in ready-to-eat meat and poultry products.
Statement of Need:
This proposed action is compelled by recent outbreaks of foodborne
illness related to the consumption of adulterated ready-to-eat meat and
poultry products, as well as the need to provide objective, measurable
pathogen reduction standards that can be met by official establishments
and compliance with which can be established through Agency inspection.
Although FSIS routinely samples and tests some ready-to-eat products
for the presence of pathogens prior to distribution, there are no
specific regulatory performance standards for most of these products.
The proposed performance standards will 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:
This action is authorized by the Federal Meat Inspection Act (21 USC
601 et seq.) and the Poultry Product Inspection Act (21 USC 45 et
seq.). Exercise of the Secretary of Agriculture's function under these
laws has been delegated to the Under Secretary for Food Safety (7 CFR
2.18) and by the Under Secretary to the Administrator of FSIS (7 CFR
2.53).
Alternatives:
No action.
Anticipated Cost and Benefits:
This regulation may require producers to incur additional operating
costs, mostly to meet labeling, testing, and performance standard
validation requirements of the proposed rule. Some of these potential
costs are one-
[[Page 73325]]
time costs incurred in the first year and consists mostly of validation
costs and expenses incurred to remedy Listeria-related problems.
Recuring costs would be for increased testing, labeling, and product
treatment.
FSIS estimate benefits accruing from this action will be based on the
reduction in annual cases of listeriosis that should result from the
proposed testing and labeling requirements.
Risks:
None.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 12/00/00
Regulatory Flexibility Analysis Required:
Undetermined
Government Levels Affected:
Undetermined
Agency Contact:
Daniel L. Engeljohn
Director, Regulations Development and Analysis Division
Department of Agriculture
Food Safety and Inspection Service
Washington, DC 20250
Phone: 202 720-5276
RIN: 0583-AC46
_______________________________________________________________________
USDA--FSIS
13. SHELL EGG AND EGG PRODUCTS INSPECTION REGULATIONS
Priority:
Economically Significant. Major status under 5 USC 801 is undetermined.
Unfunded Mandates:
Undetermined
Reinventing Government:
This rulemaking is part of the Reinventing Government effort. It will
revise text in the CFR to reduce burden or duplication, or streamline
requirements.
Legal Authority:
21 USC 1031-1056
CFR Citation:
9 CFR 590.570; 9 CFR 590.575; 9 CFR 590.146; 9 CFR 590.10; 9 CFR
590.411; 9 CFR 590.502; 9 CFR 590.504; 9 CFR 590.580; 9 CFR 591; ...
Legal Deadline:
None
Abstract:
The Food Safety and Inspection Service (FSIS) is proposing to require
shell egg packers and egg products plants to develop and implement
Hazard Analysis and Critical Control Points (HACCP) systems and
Sanitation Standard Operating Procedures (SOPs). FSIS also is proposing
pathogen reduction performance standards that would be applicable to
pasteurized shell eggs and egg products. Plants would be expected to
develop HACCP systems that ensure products meet the pathogen reduction
performance standards. Finally, FSIS is proposing to amend the Federal
egg and egg products inspection regulations by removing current
requirements for prior approval by FSIS of egg products plant drawings,
specifications, and equipment prior to their use in official plants.
The Agency also plans to eliminate the prior label approval system for
egg products.
The actions being proposed are part of FSIS's regulatory reform effort
to improve FSIS's egg and egg products food safety regulations, better
define the roles of Government and the regulated industry, encourage
innovations that will improve food safety, remove unnecessary
regulatory burdens on inspected egg products plants, and make the egg
and egg products regulations as consistent as possible with the
Agency's meat and poultry products regulations. FSIS is also taking
these actions in light of changing inspection priorities and recent
findings of salmonella in pasteurized egg products.
Statement of Need:
The actions being proposed are part of FSIS's regulatory reform effort
to improve FSIS's egg and egg products food safety regulations, better
define the roles of Government and the regulated industry, encourage
innovations that will improve food safety, remove unnecessary
regulatory burdens on inspected egg products plants, and make the egg
and egg products regulations as consistent as possible with the
Agency's meat and poultry products regulations. FSIS is also taking
these actions in light of changing inspection priorities and recent
findings of salmonella in pasteurized egg products.
Summary of Legal Basis:
This rulemaking is proposed under the authority of the Egg Products
Inspection Act, as amended, 21 U.S.C. 1031-1056.
Alternatives:
FSIS is engaged in a thorough review of its current regulations and,
where possible, will eliminate overly prescriptive regulations and
replace them with regulations that embody performance standards.
Performance standards establish requirements in terms of the objective
to be achieved. They specify, the ends, but do not detail the means to
achieve those ends. Performance standards allow food processing
establishments to develop and employ innovative and more effective
sanitation or processing procedures customized to the nature and volume
of their production.
To address hazards that can be presented by shell eggs and processed
egg products, FSIS now is considering (1) requiring all shell egg
packers and egg products plants to develop, adopt, and implement
written Sanitation SOPs and HACCP plans and (2) converting to a
lethality-based pathogen reduction performance standard many of the
current highly prescriptive egg products processing requirements. The
implementation of HACCP and Sanitation SOP requirements by shell egg
packers and egg products plants would reduce the occurrence and numbers
of pathogenic microorganisms in egg products. FSIS inspection program
personnel would be better able to ensure that shell egg packers and egg
products processing plants have the flexibility needed to properly
implement HACCP and Sanitation SOPs and encourage innovation in shell
egg and egg products processing.
The Agency will also propose to require that shell egg packers and egg
products plants adopt sanitation SOP and HACCP plans. Plants will have
significant latitude in identifying the Sanitation SOP and HACCP plan
suitable for their process. The egg products industry has indicated its
desire to adopt HACCP on an industry-wide basis. About 30 percent of
egg products plants have already implemented HACCP or HACCP-like
programs. The pathogen reduction performance standard that egg product
plants will have to achieve under their HACCP plans would likely have a
more economically significant impact than the requirement of Sanitation
SOPs or HACCP plans.
Anticipated Cost and Benefits:
Costs
The expected costs of the proposal will depend on a number of factors,
including the following:
[[Page 73326]]
Required Lethality. The level of lethality required in the pathogen
reduction performance standard will have a significant impact on the
cost of the proposal. The expected type of performance standard may
specify a uniform level of pathogen reduction for a target organism.
Alternatively, different reduction levels may be specified for white,
yolk, and whole egg products, or production processes, reflecting the
relative level of risk. As the level of lethality increases, the
ability to utilize the egg for different products and formulations is
diminished. The Agency will investigate the level of lethality that
provides an acceptable balance between risk and egg utilization.
HACCP and Sanitation Standard Operating Procedures. Implementing a
HACCP plan and Sanitation SOPs requires the preparation of a plan,
employee training, documentation and recordkeeping, and testing
procedures. The costs associated with HACCP implementation are reduced
by the extent to which quality assurance or similar programs are
utilized by shell egg packers and egg products firms and the
availability of off-the-shelf HACCP plans. The types of Sanitation SOPs
being considered are essentially the same as those for meat and
poultry, and costs would be similar.
Plant Compliance/Enforcement. FSIS costs for monitoring and enforcement
are expected to be lower than those for current comparable activities
as the program moves from continuous inspection (inspector on duty
throughout the entire shift) to eventually being monitored on a patrol
assignment. We are not aware of any estimates of FSIS costs for
verifying process control and pathogen reduction for egg products. They
would probably be similar in costs to those for meat and poultry
inspection. The monitoring costs for some plants may increase,
especially those reliant on the inspector to be the quality control
expert.
Benefits
The types of potential benefits associated with this rule are:
Improvements in human health due to pathogen reduction; improved
utilization of FSIS inspection program resources; and cost savings
resulting from the flexibility of egg products plants in achieving a
lethality-based pathogen reduction performance standard. Once specific
alternatives are identified, economic analysis will identify the
quantitative and qualitative benefits associated with each.
Human health benefits are based on changes from a baseline level of
illnesses and the health cost per illness. FSIS egg products testing
results indicate either some pasteurization processes are inadequate,
or that egg products are being contaminated with salmonella after
pasteurization, prior to, or during packaging. The results indicate a
very low level of contamination. Pasteurized egg products have not been
identified/associated with any known outbreaks; however, unpasteurized
egg products have been implicated in foodborne outbreaks. Salmonella
would principally be found in unpasteurized product. However, there
have been a few instances when SE has been isolated from egg products
found to be positive for the presence of salmonella. In the majority of
these cases, the salmonella contamination can be attributed to post-
pasteurization product contamination. Sanitation SOP and HACCP
requirements could remedy this problem by enhancing the effectiveness
of pasteurization by minimizing microbiological hazards before and
after pasteurization.
Risks:
None.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 11/00/00
Regulatory Flexibility Analysis Required:
Yes
Small Entities Affected:
Businesses, Governmental Jurisdictions
Government Levels Affected:
None
Agency Contact:
Daniel L. Engeljohn
Director, Regulations Development and Analysis Division
Department of Agriculture
Food Safety and Inspection Service
Washington, DC 20250
Phone: 202 720-5276
RIN: 0583-AC58
_______________________________________________________________________
USDA--FSIS
14. NUTRITION LABELING OF GROUND OR CHOPPED MEAT AND POULTRY PRODUCTS
AND SINGLE-INGREDIENT PRODUCTS
Priority:
Other Significant. Major status under 5 USC 801 is undetermined.
Legal Authority:
21 USC 601 et seq; 21 USC 451 et seq
CFR Citation:
9 CFR 317; 9 CFR 381
Legal Deadline:
None
Abstract:
FSIS is proposing to amend the Federal meat and poultry products
inspection regulations to require nutrition labeling of the major cuts
of single-ingredient, raw meat and poultry products. The Agency is
proposing to require that nutrition information be provided for these
products either on their label or at their point-of-purchase. FSIS is
proposing to require nutrition labeling of the major cuts of single-
ingredient, raw meat and poultry products because during the most
recent surveys of retailers, the Agency did not find significant
participation in the voluntary nutrition labeling program for single-
ingredient, raw meat and poultry products.
In this proposed rule, FSIS is also proposing to amend its regulations
to extend mandatory labeling to single-ingredient ground or chopped
products. Under this proposal, individual retail packages of ground or
chopped meat and ground or chopped poultry products would bear
nutrition labeling. The Agency has determined that ground or chopped
products are different from other single-ingredient products in several
important respects. Thus, FSIS is proposing to make nutrition labeling
requirements for ground or chopped products consistent with those for
multi-ingredient products.
Finally, FSIS is proposing to amend the nutrition labeling regulations
to provide that when a ground or chopped product does not meet the
criteria to be labeled ``low fat,'' a lean percentage claim may be
included on the product label as long as a statement of the fat
percentage also is displayed on the label.
Statement of Need:
The Agency is proposing to require that nutrition information be
provided for the major cuts of single-ingredient, raw meat and poultry
products, either on their label or at their point-of-purchase, because
during the most recent surveys of retailers, the Agency did not find
significant participation in the voluntary nutrition labeling program
for single-ingredient, raw meat and poultry products. Without the
nutrition information for the major cuts of single-
[[Page 73327]]
ingredient, raw meat and poultry products that would be provided if
significant participation in the voluntary nutrition labeling program
existed, FSIS believes that these products would be misbranded.
FSIS is also proposing to amend its regulations to require nutrition
labels on the packages of all ground or chopped meat and poultry
products. The Agency has determined that single-ingredient, raw ground
or chopped products are different from other single-ingredient, raw
products in several important respects. Thus, FSIS is proposing to make
nutrition labeling requirements for all ground or chopped products
consistent with those for multi-ingredient products.
Finally, FSIS is proposing to amend the nutrition labeling regulations
to provide that when a ground or chopped product does not meet the
criteria to be labeled ``low fat,'' a lean percentage claim may be
included on the product as long as a statement of the fat percentage is
also displayed on the label or in labeling. FSIS is proposing this
provision because many consumers have become accustomed to this
labeling on ground beef products, and because this labeling provides
quick, simple, accurate means of comparing all ground or chopped meat
and poultry products.
Summary of Legal Basis:
During the most recent surveys of retailers, FSIS did not find
significant participation in the voluntary nutrition labeling program
for single-ingredient, raw meat and poultry products. These surveys
assessed whether retailers were providing nutrition labeling
information for at least 90 percent of the major cuts of single-
ingredient, raw meat and poultry products sold. Without the nutrition
information for the major cuts of single-ingredient, raw meat and
poultry products that would be provided if significant participation in
the voluntary nutrition labeling program existed, FSIS believes that
these products would be misbranded under section 1(n) of the Federal
Meat Inspection Act (FMIA) or section 4(h) of the Poultry Products
Inspection Act (PPIA). In addition, the nutrient and fat content of
single-ingredient, raw ground or chopped products varies significantly,
and consumers cannot readily detect the differences in nutrient and fat
content in these products. For these reasons, FSIS believes that ground
or chopped meat and poultry products that do not include nutrition
information would be misbranded under section 1(n) of the FMIA or
section 4(h) of the PPIA.
Alternatives:
No action; nutrition labels required on all single-ingredient, raw
products (major cuts and non-major cuts) and all ground or chopped
products; nutrition labels required on all major cuts of single-
ingredient, raw products (but not on nonmajor cuts) and all ground or
chopped products; nutrition information at the point-of-purchase
required for all single-ingredient, raw products (major and nonmajor
cuts) and for all ground or chopped products.
Anticipated Cost and Benefits:
Costs would include the equipment for making labels, labor, and
materials used for labels for ground or chopped products. FSIS believes
that the cost of providing nutrition labeling for the major cuts of
single-ingredient, raw meat and poultry products should be negligible.
Retail establishments would have the option of providing nutrition
information through point-of-purchase materials. These materials are
available for a nominal fee through the Food Marketing Institute. Also,
FSIS intends to make point-of-purchase materials available, free of
charge, on the FSIS web site.
Benefits of the nutrition labeling rule would result from consumers
modifying their diets in response to new nutrition information
concerning ground or chopped products and the major cuts of single-
ingredient, raw products. Reductions in consumption of fat and
cholesterol are associated with reduced incidence of cancer and
coronary heart disease.
Risks:
None.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 12/00/00
Regulatory Flexibility Analysis Required:
Yes
Small Entities Affected:
Businesses
Government Levels Affected:
None
Agency Contact:
Daniel L. Engeljohn
Director, Regulations Development and Analysis Division
Department of Agriculture
Food Safety and Inspection Service
Washington, DC 20250
Phone: 202 720-5276
RIN: 0583-AC60
_______________________________________________________________________
USDA--FSIS
15. PATHOGEN REDUCTION; HAZARD ANALYSIS AND CRITICAL CONTROL POINTS
(HACCP) SYSTEMS; ADDITIONS TO E. COLI CRITERIA AND SALMONELLA
PERFORMANCE STANDARDS
Priority:
Other Significant
Legal Authority:
21 USC 601 to 695; 21 USC 451 to 470
CFR Citation:
9 CFR 310; 9 CFR 381
Legal Deadline:
None
Abstract:
FSIS is proposing to add generic E. coli criteria and salmonella
performance standards to the regulations. In addition, FSIS is
proposing to revise the terms used to identify and define certain
classes of product listed in the salmonella tables.
FSIS is proposing to delay making the proposed criteria and standards
applicable for 1 year for small establishments and for 2 years for very
small establishments.
Statement of Need:
FSIS is proposing to update its pathogen reduction (PR)/Hazard Analysis
and Critical Control Point (HACCP) Systems regulations by adding
generic Eschericha coli (E. coli) criteria for cattle, swine, and goose
carcasses based on the sponging method of sample collection and for
turkey carcasses based on the sponging and rinse methods of sample
collection. FSIS is also proposing new pathogen reduction performance
standards for Salmonella in cattle, swine, young turkey, and goose
carcasses by the sponging method and fresh pork sausage by direct
sampling. The new cattle performance standard would replace the
existing Salmonella performance standards for steers/heifers and cows/
bulls. The new swine
[[Page 73328]]
standard would replace the existing standard for hogs. These new
standards apply to all market classes of cattle and swine,
respectively.
In addition, FSIS is proposing to revise the terms used to identify and
define certain classes of product listed in the Salmonella tables to
more accurately reflect the products sampled in the baseline studies
that are the basis for the standards. The Agency also intends to
correct some errors in the E. coli and Salmonella tables and to change
the footnotes to the tables for greater clarity.
These changes would ensure that the pathogen reduction performance
standards and process control criteria applying to products and
establishments regulated by FSIS are appropriate and accurate. E. coli
criteria will help establishments to improve process controls for
certain classes of raw product. Improved process controls will help
reduce pathogens on certain raw products and may result in the
reduction of foodborne illness. The provision of E. coli criteria based
on the sponge method of sampling would provide affected establishments
with flexibility in complying with the rule.
In addition, to the need to update and add flexibilty to existing PR/
HACCP requirements, the rule is needed to help address the market
failure associated with the consumer's lack of information about
pathogens that may be present in certain classes of meat and poultry
products and to help meet the commitments made by FSIS in its PR/HACCP
and associated regulatory reform initiatives.
Summary of Legal Basis:
This rulemaking was proposed under the authorities of the Federal Meat
Inspection Act, as amended (21 U.S.C. 601-695), and the Poultry
Products Inspection Act, as amended (21 U.S.C. 451-470).
Alternatives:
No action.
Anticipated Cost and Benefits:
The costs of the proposal are estimated to be in the $18 million to $20
million range and are attribute to the need for some firms to modify
their processes to meet the new standards.
Benefits would accrue from reductions in pathogen levels, which, in
turn, might lead to reductions in foodborne illness. There is, however,
a great deal of uncertainty associated with the human health benefits
estimates, including data reflecting a decline in foodborne illness
after implementation of the PR/HACCP regulations because of the lack of
prevalence data for the period before and after implementation of the
regulations.
Risks:
None.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
Proposed Rule 03/00/01
Regulatory Flexibility Analysis Required:
No
Government Levels Affected:
None
Sectors Affected:
None
Agency Contact:
Daniel L. Engeljohn
Director, Regulations Development and Analysis Division
Department of Agriculture
Food Safety and Inspection Service
Washington, DC 20250
Phone: 202 720-5276
RIN: 0583-AC63
_______________________________________________________________________
USDA--FSIS
16. POULTRY INSPECTION: REVISION OF FINISHED PRODUCT STANDARDS
WITH RESPECT TO INGESTA
Priority:
Economically Significant. Major status under 5 USC 801 is undetermined.
Legal Authority:
21 USC 451-470 et seq
CFR Citation:
9 CFR 381
Legal Deadline:
None
Abstract:
FSIS is seeking to clarify its Poultry Inspection Regulations regarding
visible ingesta on poultry carcasses and parts. A preliminary
regulatory impact analysis conducted by FSIS determined that costs to
achieve zero tolerance far outweighed benefits. This action was
precipitated by a civil suit filed against USDA.
Statement of Need:
FSIS is seeking to clarify the regulations respecting visible ingesta
on poultry carcasses and parts. In 1997, FSIS issued a final rule
removing the process tolerance level for fecal contamination on poultry
carcasses, in effect, adopting a zero process tolerance for poultry
fecal matter. During the comment period on the final rule, several
commenters supported a zero tolerance for ingesta. As a result, FSID
solicited comments and information on ingesta to determine whether
there was a need for additional regulatory measures regarding ingesta.
No comments were received. Lacking any information to suggest the
current tolerance standards were inadequate, FSIS let stand the current
process tolerance for ingesta contamination. However, partly in view of
a civil suit alleging disparate regulation of the meat and poultry
industries by FSIS and challenging the existing process tolerance for
ingesta contamination of poultry carcasses, FSIS is issuing an ANPRM to
determine how it should proceed on this issue.
Summary of Legal Basis:
This action is authorized by the Poultry Products Inspection Act (21
U.S.C. 451 et seq.). Exercise of the Secretary of Agriculture's
functions under these laws has been delegated to the Under Secretary of
Food Safety (7 CFR 2.18) and by the Under Secretary to the
Administrator of FSIS (7 CFR 2.53). This action also is being taken in
the context of proceedings in the matter of Kenney v. Glickman.
Alternatives:
No action.
Anticipated Cost and Benefits:
FSIS is seeking information and data from the public about the costs of
establishing any of several alternative tolerance levels for ingesta
and the effects on operations of large and small poultry
establishments. In addition, we are soliciting comments on the
availability of new technology that would reduce the levels of
contamination of birds and on improvements in on-farm, or
``preharvest,'' husbandry practices. FSIS is interested in having
information on new research that identifies microbial hazards and
determines whether or not their presence results in pathogen
contamination of the poultry.
Risks:
None.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 12/00/00
[[Page 73329]]
NPRM Comment Period End 02/00/01
Regulatory Flexibility Analysis Required:
Yes
Small Entities Affected:
Businesses
Government Levels Affected:
None
Agency Contact:
Daniel L. Engeljohn
Director, Regulations Development and Analysis Division
Department of Agriculture
Food Safety and Inspection Service
Washington, DC 20250
Phone: 202 720-5276
RIN: 0583-AC77
_______________________________________________________________________
USDA--FSIS
-----------
FINAL RULE STAGE
-----------
17. RETAINED WATER IN RAW MEAT AND POULTRY PRODUCTS; POULTRY-CHILLING
PERFORMANCE STANDARDS
Priority:
Economically Significant. Major under 5 USC 801.
Reinventing Government:
This rulemaking is part of the Reinventing Government effort. It will
revise text in the CFR to reduce burden or duplication, or streamline
requirements.
Legal Authority:
21 USC 451 et seq; 21 USC 601 et seq
CFR Citation:
9 CFR 317; 9 CFR 381; 9 CFR 440
Legal Deadline:
None
Abstract:
FSIS is developing a rule to limit the amount of water absorbed and
retained by single-ingredient raw meat and poultry products to the
amount that is unavoidable in carrying out washing or chilling
procedures. Such products include immersion-chilled poultry carcasses
and raw meat byproducts that are chilled in water. A requirement for
raw products to bear a labeling statement on absorbed water content is
being considered. However, establishments having data that demonstrate
their raw products do not gain weight as a result of washing or
chilling would not have to label the products with such a statement.
The rule also is intended to replace the command-and-control provisions
of the regulations on poultry chilling and moisture control with
performance standards. This rule is intended to further the Agency's
regulatory reform effort and responds to a July 23, 1997, U.S. District
Court order setting aside current moisture limits for frozen, cooked,
or consumer-packaged whole poultry. The labeling provisions of this
rule are intended to provide consumers with additional information for
making purchasing decisions.
Statement of Need:
FSIS is planning to issue regulations under which meat and poultry
carcasses and parts will not be permitted to retain water unless the
establishment preparing the products demonstrates, with data collected
under a protocol available for FSIS review, that the water retention is
an avoidable consequence of such processing. In addition, the
establishment will be required to state on the product label the
maximum percentage of retained water in a product. The statement could
appear contiguous to the product name or elsewhere conspicuously on the
label. An establishment having data demonstrating that there is no
retained water in its products can choose not to label the products
with the retained-water statement or to make a no-retained-water claim
on the product label. FSIS will accept data generated from an approved,
appropriately designed protocol to support water retention levels for
multiple establishments using similar post-evisceration processing
techniques and equipment.
FSIS is revising the poultry chilling regulations, including the
regulation limiting moisture retention in ready-to-cook whole chickens
and turkeys, which was set aside by Federal court order. The existing
general requirement for establishments to minimize moisture absorption
by raw poultry will remain, along with the requirement for them to
furnish equipment necessary for moisture tests to be conducted on
inspected product. The tables setting moisture absorption and retention
limits for the various kinds and weight classes of poultry and the
requirements for daily moisture testing by FSIS inspectors will be
removed.
FSIS is also revising or eliminating various ``command-and-control''
requirements governing poultry chilling, including the regulations on
thawing procedures and water use and reconditioning, to improve
consistency with the HACCP regulations and reflect current
technological capabilities and good manufacturing practice. FSIS will
give affected establishments the flexibility they need to choose the
most appropriate means of carrying out their HACCP plans for protecting
the safety of raw product while minimizing the potential for economic
adulteration.
FSIS will apply the same retained-moisture standard to both livestock
and poultry carcasses and parts. Raw, single-ingredient meat and
poultry products intended for use as human food will have to bear
labeling indicating the amount of retained moisture they contain as a
percentage of product weight. The regulations will require post-
evisceration processing of livestock or poultry carcasses and parts,
including washing, chilling, and draining practices, to minimize both
the growth of pathogens on edible product and moisture absorption and
retention by the product.
Even if FSIS accepts the data supporting a moisture retention limit
higher than zero and regulates accordingly, raw products that contain
more than zero percent retained moisture will have to be labeled to
reflect that fact. FSIS envisions that the final rule will require the
statement ``may contain up to ---------- percent retained water'' or
some similar statement to appear in prominent letters contiguous to the
product name or elsewhere conspicuously on the product label. The
labeling statement would provide additional information to consumers of
raw meat and poultry products to help them in their purchasing
decisions.
This rule has been prompted by longstanding industry petitions and by
the Agency's need to reform its regulations to make them more
consistent with its PR/HACCP regulations, in accordance with its
regulatory reform agenda. A July 1997 Federal Court decision vacating
the regulations in 9 CFR 381 that contain the water-retention tables
for whole birds lent further impetus to this rulemaking project.
Summary of Legal Basis:
This action is authorized by the Federal Meat Inspection Act (21 USC
601 et seq.) and the Poultry Products Inspection Act (21 USC 451 et
seq.).
[[Page 73330]]
Exercise of the Secretary of Agriculture's functions under these laws
has been delegated to the Under Secretary for Food Safety (7 CFR 2.18)
and by the Under Secretary to the Administrator of FSIS (7 CFR 2.53).
This action also is being taken partly in response to a U.S. Court
decision in the matter of Kenney v. Glickman.
Alternatives:
This rule resulted from an analysis of six alternative regulatory
approaches for addressing retained water in raw meat products and
poultry products. The six alternatives include: (1) No limit on
retained water but mandatory labeling that identifies the percentage of
retained water in the product; (2) a requirement that all
establishments meet a water limit based on best available technology,
with mandatory labeling to indicate any retained water; (3) a moisture
limit based on best performance with existing equipment, with mandatory
labeling to show any retained water; (4) a standard of zero retained
moisture; (5) a requirement that no retained water could be included in
net weight; and (6) a requirement of zero retained water unless the
water retention is unavoidable in processes necessary to meet food
safety requirements, e.g., to reduce pathogens, with product labeling
to indicate the presence of retained moisture, where applicable. For
all alternatives where a limit on retained water is established, the
analysis assumed that the limits would be established by the regulated
industry associations or other groups.
FSIS chose the last alternative. The selected option does not allow
retained water in an affected product unless it is an inevitable
consequence of the process or processes used to meet applicable food-
safety requirements. By ``inevitable consequence,'' the Agency means an
unavoidable and irreducible side effect. Under this option, levels of
unavoidable retained water must be established by inspected
establishments, associations, or other groups, using acceptable
protocols. Also, the maximum amount of retained water that can be
present must be indicated on the product label. FSIS has found that
this option provides more benefits and fewer cost than other options
allowing retained water.
Anticipated Cost and Benefits:
In analyzing the impacts of this rule, FSIS has estimated a range of
costs the industry will incur. If establishments are able to
demonstrate that current levels of retained water are unavoidable in
achieving applicable food safety standards, establishments would not
incur costs for reducing retained water. These establishments would
only incur costs for establishing limits and costs for labeling the
product. The costs of establishing limits for the poultry industry are
estimated to be $1.5 million. This estimate is based on each
establishment's conducting its own tests. The cost should be lower if
associations or other groups establish limits for different types of
chiller systems. Labeling costs are estimated to be $18.4 million if
all raw, single-ingredient poultry continues to retain water.
To the extent that establishments cannot demonstrate that current
retained water levels are necessary for achieving applicable food
safety standards, significant costs could be incurred as establishments
modify processes to minimize retained water levels. Reducing retained
water could entail a wide range of processing modifications, depending
on the type of chilling equipment currently used and amount of retained
water that would have to be removed. FSIS estimates that, if extensive
modifications to chilling systems were needed throughout the industry,
the fixed costs associated with removing a substantial portion of the
existing retained water could run well over $100 million. However, if
extensive modifications were not needed, the industry would only incur
the costs of establishing retained water limits and meeting the
labeling requirements of the final rule. The average retained water for
chicken as a percentage of net weight is currently estimated to be in
the 5.0 to 6.5 percent range. The corresponding level for turkey is 4.0
to 4.5 percent.
The final rule should not have a significant impact on a large number
of small businesses. Fifty to 60 poultry slaughter establishments
process under a million birds annually. Many of these smaller
operations do not use continuous immersion chillers. They use ice or
slush to meet the existing chilling requirements. Few, if any, would
have to reduce the current level of retained water. The establishments
most affected by this final rule are the firms operating immersion
chillers in a manner so as to target the maximum allowable retained
water.
The Agency's calculations show the benefits of reducing retained water
to be about $72.4 million. Subtracting cost estimates ranging from
$18.4 million to $44 million yields expected net benefits of from $28
million to $54 million.
Indirect benefits of this rule could not be quantified. One of the
indirect benefits of the rule is the value of consumer information
associated with retained water labels. These labels help consumers make
informed purchasing decisions and restore consumer sovereignty in
retail purchasing.
Another indirect benefit of the rule is the value of reduced cleaning
of potential spillage of retained water by consumers. A concomitant
effect of reducing spillage is the reduction in bacteria-contaminated
water and the associated health hazards to consumers.
An additional indirect benefit is the potential reduction in economic
adulteration and misbranding associated with excessive retained water.
Finally, the rule will also provide all affected establishments with
the flexibility and market incentives to implement new procedures for
meeting pathogen reduction performance standards. In addition, by
replacing command-and-control requirements with HACCP-consistent
performance standards, the final rule will eliminate some recordkeeping
and reporting burdens, provide for increased flexibility, and reduce
the costs of HACCP implementation.
Risks:
FSIS has identified, as a potential indirect benefit of the rule,
reduced spillage of retained water by consumers handling raw products.
Reducing the amount of bacteria-contaminated water spilled in consumer
households would reduce associated health hazards to consumers. FSIS
has not attempted to quantify the reduction of such hazards or any
associated foodborne illness.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 63 FR 48961 09/11/98
NPRM Comment Period End 12/10/98
Final Action 12/00/00
Regulatory Flexibility Analysis Required:
No
Government Levels Affected:
None
[[Page 73331]]
Agency Contact:
Daniel L. Engeljohn
Director, Regulations Development and Analysis Division
Department of Agriculture
Food Safety and Inspection Service
Washington, DC 20250
Phone: 202 720-5276
RIN: 0583-AC26
_______________________________________________________________________
USDA--FSIS
18. MEAT PRODUCED BY ADVANCED MEAT/BONE SEPARATION MACHINERY AND
RECOVERY SYSTEMS
Priority:
Other Significant
Legal Authority:
21 USC 601 to 695
CFR Citation:
9 CFR 301.2; 9 CFR 318.24 (Revision); 9 CFR 320.1(b)(10)
Legal Deadline:
None
Abstract:
In 1994, the Food Safety and Inspection Service amended its regulations
to recognize that product resulting from advanced meat/bone separation
machinery comes within the definition of meat when recovery systems are
operated to assure that the characteristics and composition of the
resulting product are consistent with those of meat. Subsequent
compliance problems and other concerns have made it apparent that the
regulations are confusing and inadequate to prevent misbranding and
economic adulteration. Therefore, FSIS is developing a rule to clarify
the regulations and supplement the rules for assuring compliance. The
Agency is reviewing information obtained since publication of the
proposal.
Statement of Need:
In 1998, FSIS proposed to clarify the meat inspection regulations
regarding mechanically separated meat contained in a final rule issued
on December 6, 1994. The proposal would replace the compliance program
parameters in the 1994 rule with non-compliance criteria for bone
solids, bone marrow, and spinal cord tissue. The proposal would require
that, as a prerequisite to labeling or using the product derived by
mechanically separated skeletal muscle tissue from livestock bones as
meat, establishments implement and document procedures for ensuring
that their production processes are under control. FSIS expects that
the industry would have to modify the manufacturing process it now uses
to comply with the proposed criteria and prevent the distribution in
commerce of misbranded and economically adulterated meat products.
Summary of Legal Basis:
This action is authorized by the Federal Meat Inspection Act (21 U.S.C.
601 et seq). Exercise of the Secretary of Agriculture's functions under
this Act has been delegated to the Under Secretary for Food Safety (7
CFR 2.18) and by the Under Secretary to the Administrator of FSIS (7
CFR 2.53).
Alternatives:
No action.
Anticipated Cost and Benefits:
Although the 1998 proposed rule was considered to be not economically
significant, FSIS is restudying the projected costs. The Agency is
conducting a new cost-benefit analysis using information from various
FSIS data bases and other sources to develop an improved estimate of
the costs and benefits and the effect the final rule will have on small
entities.
Risks:
None.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 63 FR 17959 04/13/98
NPRM Comment Period End 06/12/98
Final Action 10/00/00
Regulatory Flexibility Analysis Required:
No
Government Levels Affected:
None
Agency Contact:
Daniel L. Engeljohn
Director, Regulations Development and Analysis Division
Department of Agriculture
Food Safety and Inspection Service
Washington, DC 20250
Phone: 202 720-5276
RIN: 0583-AC51
_______________________________________________________________________
USDA--Forest Service (FS)
-----------
FINAL RULE STAGE
-----------
19. NATIONAL FOREST SYSTEM LAND AND RESOURCE MANAGEMENT PLANNING
Priority:
Other Significant
Reinventing Government:
This rulemaking is part of the Reinventing Government effort. It will
revise text in the CFR to reduce burden or duplication, or streamline
requirements.
Legal Authority:
16 USC 1600 et seq; 5 USC 301
CFR Citation:
36 CFR 219
Legal Deadline:
None
Abstract:
On October 5, 1999, the Forest Service published a proposed rule to
guide land and resource management planning for the National Forest
System. The proposed planning framework makes sustainability the
foundation for National Forest System planning and management and
establishes requirements for implementation, monitoring, evaluation,
amendment, and revision of land and resource management plans. The
intended effects are to simplify, clarify, and otherwise improve the
planning process to reduce burdensome and costly procedural
requirements and to strengthen collaborative relationships with the
public and other government entities. The comment period ended on
January 4, 2000.
Statement of Need:
The need for the rule arises from having completed the first round of
forest plans as required by the National Forest Management Act. The
Forest Service contracted with the Conservation Foundation and Purdue
University to conduct a comprehensive critique of the planning process
and plan decisions. The critique involved both Agency employees and
external participants--State and local governments, businesses,
environmental organizations, and others--and resulted in several
volumes of findings and recommendations. Key recommendations were to
strengthen
[[Page 73332]]
the emphasis on ecosystem sustainability and health; to incorporate
ecoregional and watershed-level assessments; and to strengthen
opportunities for public participation in the planning process and for
greater interaction and dialog with Federal, State, local, and Indian
tribal governments. Building on those recommendations, the Agency
published an advance notice of proposed rulemaking in 1991 and a
proposed rule in 1995. During the comment period, a strong concern that
the Agency had not chartered a committee of scientists as was required
by the statute for the initial planning regulations was identified. In
response, the Secretary of Agriculture decided to appoint a committee
of scientists to provide advice in the development of a science-based
approach to the planning process. The proposed rule was built on the
committee's recommendations for achieving more collaborative, dynamic,
science-based planning that fosters collaboration among Forest Service
officials, State, local, and Indian governments, organizations, and the
public at large.
Summary of Legal Basis:
The legal basis for the planned regulatory action is the National
Forest Management Act, which requires that regulations be promulgated.
This final action will revise the existing regulation which was
finalized in 1982.
Alternatives:
Alternatives to this rule that were considered include continuing under
existing regulations or staying with the concepts embodied in a 1995
rulemaking effort. The Agency determined that the committee's
recommendations should be the basis for a new proposed rule.
Anticipated Cost and Benefits:
A cost-benefit analysis has been completed as part of an Environmental
Assessment. Since this regulation governs a process and does not
determine an end result, many of the changes from the existing
regulation do not lend themselves to a cost-benefit analysis. The cost-
benefit analysis identified calculable as well as non-monatized costs
and benefits. Based on that analysis, it is anticipated that
streamlined planning procedures will result in a reduction in the cost
of amending and revising forest plans relative to the same procedures
under the existing regulation. In addition, the non-monatized benefits
of the rule are expected to be substantial and result in an overall
improvement in the public's understanding, use of and benefits from the
National Forest System. The rule's emphasis on ecological, economic,
and social sustainability collaborative citizen participation and
science support of resource decisions provides a framework for
increasing public knowledge and understanding of the National Forest
System.
Risks:
The planned regulatory action addresses Agency planning procedures and
would not directly cause specific risks to public health, safety, or
the environment.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
ANPRM 56 FR 6508 02/15/91
NPRM 60 FR 18886 04/13/95
NPRM Comment Period End 08/17/95
Second NPRM 64 FR 54074 10/05/99
Comment Period E64 FR 72064 12/23/99
Second NPRM Comment Period End 01/04/00
Final Action 10/00/00
Final Action Effective 11/00/00
Regulatory Flexibility Analysis Required:
No
Government Levels Affected:
None
Agency Contact:
Marian P. Connolly
Regulatory Officer
Department of Agriculture
Forest Service
P.O. Box 96090
Washington, DC 20090-6090
Phone: 703 605-4533
Fax: 703 605-5111
Email: [email protected]
RIN: 0596-AB20
_______________________________________________________________________
USDA--FS
20. ADMINISTRATION OF THE FOREST DEVELOPMENT TRANSPORTATION SYSTEM
Priority:
Other Significant
Legal Authority:
16 USC 551; 23 USC 205
CFR Citation:
36 CFR 212
Legal Deadline:
None
Abstract:
This final action consists of adoption of a final rule at 36 CFR part
212 and a final administrative policy to be issued as instruction to
Forest Service employees in the Forest Service Manual Title 7700.
It is part of a strategic effort to change how the National Forest road
system is improved, maintained, and operated to support the resource
objectives of the national forest and grasslands. The intended effect
is to shift the focus of the national forest road system from
development to restoration and maintenance of those roads needed for
recreation, rural access, and the sustainable flow of goods and
services, commensurate with the health and productivity of the lands
and waters of the National Forest System. An equal objective is to
apply science-based analytical tools that will help local forest
managers make better informed decisions about road construction,
reconstruction, maintenance, and decommissioning. Finally, the rule
would redesignate the forest transportation plan as the forest
transportation atlas, which would be a repository of important
information about the National Forest Transportation System, especially
roads.
Key features of the proposed policy include establishing a policy of
providing the minimum forest transportation system that will best serve
the current and anticipated forest management objectives and public
uses, considering both current and likely funding levels. The policy
also would adopt the Forest Service report, Roads Analysis Process,
Informing Decisions About Managing the National Forest Transportation
System 1999, Miscellaneous Report FS-643, as the current standard for a
science-based road analysis procedure to help inform decisions about
the scope, scale, and need for national forest roads in the context of
forest planning, as well as at the site-specific project level. The
process will help forest officers set priorities within available
funding for construction, reconstruction, maintenance, and
decommissioning of roads.
Finally, the proposed policy would establish transitional procedures to
ensure more careful consideration when building or reconstructing roads
in unroaded portions of inventoried roadless areas and other roadless
areas.
[[Page 73333]]
These proposed transitional procedures would set a higher standard for
road construction in these areas of national forests than in other
areas--namely, that any such proposal must meet a compelling need and
must be accompanied by an environmental impact statement with the
Regional Forester as the responsible official.
Statement of Need:
Few natural resource issues have attracted as much public scrutiny in
recent years as the management of the National Forest road system. Few
marks on the land are more lasting than those created by road
construction. The 380,000 miles of classified National Forest System
roads have been funded and constructed primarily through timber
harvesting and the development of other resources to provide long-term
access for use, management, and protection. In addition, the Agency
estimates more than 60,000 miles of unauthorized, unplanned, and
temporary roads exist on National Forest System lands. In the last 10
years, public interest in the national forest has shifted substantially
toward recreation use and resource protection, while the level of
commercial timber sold from the national forests has been reduced
significantly.
Consistent with this shift and in light of the backlog of road
maintenance needs that are unfunded, and in concert with simultaneous
revision of road management administrative direction, this final action
will help ensure that additions to the National Forest road system will
be those deemed essential for resource management and use; that, to the
extent practicable, construction, reconstruction, and maintenance of
roads will minimize adverse environmental impact; and finally, that
unneeded roads will be decommissioned and, where indicated, ecological
processes will be restored.
Alternatives:
Six alternatives were identified through the scoping process and
responses to the advance notice of proposed rulemaking, but four of
those were considered to be outside the scope or inconsistent with the
Agency objectives and were not analyzed in the Environmental
Assessment. Only the proposed rule and policy with the transition
requirements regarding road construction in roadless areas and a no-
action alternative were analyzed in depth.
Anticipated Cost and Benefits:
In most cases, the anticipated costs and benefits associated with the
proposed strategy are qualitative, as the proposal provides guidance
for transportation planning, but does not dictate land management
decisions. Therefore, for the most part, only the expected direction of
change can be described. The only exception to this are the potential
effects on timber harvest, in which case the maximum potential effects
were estimated, assuming for the sake of comparison that no road
construction or reconstruction would occur in inventoried roadless and
certain unroaded areas.
A qualitative assessment found more factors with expected net positive
benefits than expected negative benefits (Table E1 of the cost benefit
analysis). The proposed road strategy would clearly result in net
benefits through improvements in water quality, wildlife and fish
habitat, protection of wilderness areas and passive use values, and
reductions of the spread of noxious weeds and invasive plants. More
mixed effects are expected for recreation and heritage resources, with
likely reductions in some types of roaded access and some improvements
or maintenance of more wilderness-type environments. Access for public
safety, law enforcement, and access would not be affected. Negative
effects are expected from reduced timber harvest and reduced mineral
exploration and extraction, particularly during the transition phase.
Risks:
The final rule and policy would not directly cause specific risks to
public health, safety, or the environment. However, especially during
the interim period in which higher standards apply to any decision
authorizing road construction in roadless and unroaded areas, the
policy should reduce risks to certain environmental values.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
ANPRM 63 FR 4350 01/28/98
ANPRM Comment Period End 03/30/98
ANPRM Comment Pe65 FR 11676ed 03/03/00
NPRM 65 FR 11680 03/03/00
NPRM Comment Period End 05/02/00
Final Action 10/00/00
Final Action Effective 11/00/00
Regulatory Flexibility Analysis Required:
No
Government Levels Affected:
None
Agency Contact:
Marian P. Connolly
Regulatory Officer
Department of Agriculture
Forest Service
P.O. Box 96090
Washington, DC 20090-6090
Phone: 703 605-4533
Fax: 703 605-5111
Email: [email protected]
RIN: 0596-AB67
_______________________________________________________________________
USDA--FS
21. SPECIAL AREAS: ROADLESS AREA CONSERVATION
Priority:
Other Significant
Legal Authority:
16 USC 472; 16 USC 551; 16 USC 1604; 42 USC 4321
CFR Citation:
36 CFR 294
Legal Deadline:
None
Abstract:
On October 13, 1999, the President directed the Forest Service to begin
a public rulemaking process to address roadless areas in the National
Forest System. This initiative responded to strong public sentiment for
protecting roadless areas and the public benefits those areas provide,
including clean water, biological diversity, wildlife habitat, forest
health, dispersed recreational opportunities, and other benefits. It
also responded to budgetary concerns about the National Forest road
system. The public has long questioned the logic of building new roads
in roadless areas when the Forest Service receives insufficient funding
to maintain its existing road system. The Agency published a notice of
intent to prepare an environmental impact statement in the Federal
Register on October 19, 1999 (64 FR 56306). The Agency received
approximately 365,000 written responses to the notice of intent,
including approximately 336,000 form letters, from individuals, groups,
organizations, and other government agencies. Following the scoping
period in which the Agency held regional public meetings to facilitate
public comment on the scope of the environmental analysis and
alternatives, the Agency published a
[[Page 73334]]
proposed rule in the Federal Register on May 10, 2000 (65 FR 30376). A
Draft Environmental Impact Statement was prepared to analyze the
preferred and other alternatives. The environmental analysis analyzed
(1) the effect of eliminating certain activities, such as road
construction in the remaining unroaded portions of inventoried roadless
areas on the National Forest System and (2) the effect of establishing
criteria and procedures to ensure that the social and ecological values
are considered and protected through the forest planning process. The
Agency provided copies of the proposed rule, the DEIS, and other
relevant information through mailings and the Internet. The comment
period ended July 17, 2000. During the comment period, the Agency held
over 500 local public meetings to provide information and to receive
public comment. The Agency is reviewing the comments and is preparing
to publish a final rule in the early winter.
Statement of Need:
Areas that are without roads have inherent values that are increasingly
scarce and highly desirable. Under present management policies, the
maintenance of areas with these values cannot be guaranteed. At the
same time, present and foreseeable funding for road maintenance is
expected to be only a small fraction of the total needed to meet
environmental and safety standards. Therefore, it is necessary for the
Agency to change its policies and practices for roadless area
management to reflect different resource priorities and realistic
funding levels.
Summary of Legal Basis:
The Forest Service's proposal to initiate a rulemaking process to
protect roadless areas comes under applicable administrative and
environmental laws, including the Organic Act, the Multiple-Use
Sustained-Yield Act, the National Forest Management Act, and the
National Environmental Policy Act.
Alternatives:
The Agency could either continue under existing regulations or propose
regulations to address the protection of roadless areas.
Anticipated Cost and Benefits:
A cost-benefit analysis has been completed as part of the development
of the proposed rule. The benefits of the rule are to preserve the
value of areas without roads, including biological diversity, clean
water, and other social, economic, and ecological values. Without this
protection, the cost to the taxpayer in the future may be considerable,
in terms of the loss of desirable aesthetic qualities that are becoming
increasingly scarce.
Risks:
The planned regulatory action addresses the protection of roadless
areas and would not directly cause specific risks to public health,
safety, or the environment.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
ANPRM 64 FR 56306 10/19/99
ANPRM Comment Period End 12/20/99
NPRM 65 FR 30288 05/10/00
NPRM Comment Period End 07/17/00
Final Action 12/00/00
Final Action Effective 01/00/01
Regulatory Flexibility Analysis Required:
No
Government Levels Affected:
Undetermined
Agency Contact:
Marian P. Connolly
Regulatory Officer
Department of Agriculture
Forest Service
P.O. Box 96090
Washington, DC 20090-6090
Phone: 703 605-4533
Fax: 703 605-5111
Email: [email protected]
RIN: 0596-AB77
BILLING CODE 3410-90-S
[[Page 73335]]
DEPARTMENT OF COMMERCE (DOC)
Statement of Regulatory and Deregulatory Priorities
Sustainable, long-term economic growth is a central focus of the
President's policies and priorities. The mission of the Department of
Commerce (DOC) is to promote job creation and improved standards of
living for all Americans through economic growth, technological
competitiveness and sustainable development. The Department has
strategic goals in three areas related to its mission. They are:
Expand economic growth, trade, and prosperity;
Stimulate innovation for American competitiveness; and
Advance sustainable development.
The Commerce mission statement, containing our three strategic themes,
provides the vehicle for understanding Commerce's aims, how they
interlock, and how they are to be implemented through our programs.
Working collectively, the bureaus of the Department (including the
Office of the Secretary) developed this mission statement, 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 one of the
smallest Cabinet agencies, 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. As a Department, we aspire 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 those 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. We are able to do this
effectively by functioning in accordance with the legislation that
undergirds our programs and by working closely with the President and
the committees in Congress, which have programmatic and financial
oversight for our programs.
Commerce 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.
Commerce encourages development in every community, clearing the way
for private-sector growth by rebuilding and improving 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,
Commerce 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.
Commerce'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 this information, businesses can undertake the new ventures,
investments, and expansions that make our economy grow.
The capacity for managing the Nation's assets and resources is another
key policy driver for Commerce, an essential one in our ability to help
the Nation succeed in the future. These activities--ranging from
protecting our fisheries to controlling the radio frequency spectrum to
protecting intellectual property--affect the economy directly.
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 Department's Regulatory Plan directly tracks these policy and
program priorities, only a few 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 five--the Bureau of Export Administration (BXA), the International
Trade Administration (ITA), the Economic Development Administration
(EDA), the National Oceanic and Atmospheric Administration (NOAA), and
the Patent and Trademark Office (PTO)--plan significant preregulatory
or regulatory actions for this Regulatory Plan year. Only one of these
operating units, NOAA, has a regulatory action rising to the level of
the most important of the Department's significant regulatory actions
planned for the Regulatory Plan year.
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 73336]]
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. Over the past seven
years 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 Secretary has prohibited 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 in
simple, plain English and 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.
Improving the Regulatory Environment for Small Business
The DOC remains committed to its goal of providing small businesses
with the least burdensome regulatory environment possible. While we
believe small business should remain free from the constraints of
regulation whenever possible, the Department realizes that there are
times where these entities must be subject to regulation of some kind.
But in all cases where small businesses will be affected by DOC
regulations, we make every effort to provide them with all relevant and
necessary information at the earliest possible time, while making
representatives of the Department available to discuss any problems or
questions that may arise in complying with these regulations.
Additionally, the Department remains committed to providing small
businesses with the greatest amount of warning prior to the issuance of
any regulation that could affect them directly or indirectly.
Within the Department, the two agencies that regulate activities of
small business are the National Oceanic and Atmospheric Administration
(NOAA) and the Bureau of Export Administration (BXA). Both NOAA and BXA
have taken numerous actions to comply with the Departmental goal of
providing small businesses with the least burdensome regulatory
environment, while working with small business to ensure that when
regulations are issued, small businesses are informed as early as
possible and prepared to meet regulatory requirements.
National Oceanic and Atmospheric Administration
When NOAA issues regulations that impact small business, NOAA Special
Agents and officers begin an information outreach campaign to educate
the regulated community on the new or amended regulations. This
outreach campaign involves boarding vessels and visiting fish dealers
to explain the new regulations and answer questions regarding
compliance. Special Agents and officers educate the regulated community
on the technical aspects of the regulations and the conservation value
of the management plan and regulations.
It has long been NOAA's practice to answer inquiries by small entities
whenever appropriate in the interest of administering statutes and
regulations. Inquiries are received via telephone, mail, and electronic
mail; during public hearings, town hall meetings, and workshops held by
NOAA throughout the year; and in the day-to-day interactions that small
entities have with NOAA personnel. As a result, NOAA answers tens of
thousands of inquiries from small entities each year.
NOAA also issues written warnings rather than penalties for many minor
violations. Since March 1996, NOAA has issued approximately 1,216
written warnings. In addition, NOAA has a ``Summary Settlement System''
that allows violators, including small entities, to choose not to
contest an alleged violation and to pay a reduced penalty within a
specified time period following receipt of the Summary Settlement
Notice. Since March 1996, approximately 708 Summary Settlement offers
were extended by NOAA.
NOAA has also established a Fix-It Notice (FIN) program for the
reduction or waiver of civil penalties under several of the natural
resource protection statutes NOAA enforces, including the Marine Mammal
Protection Act, the Endangered Species Act, and the Magnuson-Stevens
Fishery Conservation and Management Act. Under the FIN program, dozens
of minor, first-time violations that are of a technical nature and do
not have a direct natural resource impact, receive a FIN, which allows
the violation to be corrected in lieu of a penalty. The FIN identifies
the violation and allows the violator a specified amount of time to
``fix'' the violation. At this time, there are over 130 types of
violations that have been included in the FIN program. NOAA's Civil
Administrative Penalty Schedule has been amended to reflect the FIN
program. The FIN program has helped NOAA achieve compliance and has
elicited a positive response from the regulated community, which
includes small entities.
Bureau of Export Administration
BXA administers a classification and advisory opinion program. Under
the Export Administration Regulations (EAR), which set the criteria for
export of dual-use items, commercial items with potential military or
weapons proliferation applications, an exporter has the responsibility
of classifying the item it seeks to export to determine if an export
license is required. In light of this responsibility, BXA has
established a program whereby an exporter can ask BXA whether the item
is subject to the EAR and, if so, the correct classification of that
item. Further, for a given end-use, end-user, or destination, BXA will
advise an exporter whether an export license is required, or likely to
be granted.
BXA has continually used technological advances in order to provide
information and customer service to those entities that may be affected
by BXA activities. Through its ``Fax-on-Demand'' system, BXA enables
exporters to access useful information by facsimile 24-hours a day, and
this service has been expanded to provide over 60 documents, including
recent regulatory changes, upcoming workshops, useful points of
contact, and a wide variety of other competitiveness and trade-related
information. BXA also uses its broadcast subscription and broadcast e-
mail services, known as ``netFacts,'' combined with its longstanding
facsimile service, ``First Facts,'' to provide regular and timely
updates regarding regulatory and policy changes and other items of
interest to exporters.
[[Page 73337]]
In addition, BXA spends a great deal of time educating industry about
the export control provisions of the EAR. BXA has an extensive outreach
program, conducting seminars throughout the United States and overseas.
For example, as a standard part of the seminar, BXA provides a set of
guidelines, Export Management System Guidelines, to assist firms in
ensuring that their exports and export decisions are consistent with
the EAR. The EAR also contains ``Know Your Customer'' guidelines and
``red flag'' indicators, designed to assist exporters in complying with
regulatory requirements.
The BXA Web site offers those with Internet access to a wide range of
export control information, including frequently asked questions, free
access to the full text of Export Administration Regulations, and links
to other government sites. BXA's Simplified Network Application Process
(SNAP) allows submission of license applications and classification
requests through the Internet.
Description of Agency Regulations
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 DOC, 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 saving fisheries and
confronting short-term economic dislocation, while boosting long-term
economic growth. The Department of Commerce is where business and
environmental interests intersect, and the classic debate on the use of
natural resources is transformed into a ``win-win'' situation for the
environment and the economy.
Three of NOAA's major components, the National Marine Fisheries
Service (NMFS), the National Ocean Service (NOS), and the National
Environmental Satellite, Data, and Information Service (NESDIS),
exercise regulatory authority.
NMFS oversees the management and conservation of the Nation's marine
fisheries, protects 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 be guided by a comprehensive
understanding of the environment. The DOC, 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 U.S. fisheries by refocusing policies and fishery management
planning on increased scientific information; increasing the
populations of depleted, threatened, or endangered species of 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 Act Rulemakings
Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-
Stevens Act) rulemakings concern the conservation and management of
fishery resources in the United States 3-to-200-mile Exclusive Economic
Zone (EEZ). Among the several hundred rulemakings that NOAA plans to
issue in the Regulatory Plan year, 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. Once a rulemaking is triggered by an FMC, the Magnuson-Stevens
Act places stringent deadlines upon NMFS by which it must exercise its
rulemaking responsibilities. Most of these rulemakings will be minor,
involving only the opening or closing of a fishery under an existing
FMP. While no one Magnuson-Stevens Act rulemaking is among the
Department's most important significant regulatory actions, and,
therefore, none is specifically described below, the sum of these
actions, and a few of the individual actions themselves, are highly
significant.
The Magnuson-Stevens Act, which is the primary legal authority for
Federal regulation to conserve and manage fishery resources,
establishes eight regional FMCs, responsible for preparing FMPs and FMP
amendments. NMFS issues regulations to implement FMPs and FMP
amendments. FMPs address a variety of fishery matters, including
depressed stocks, overfished stocks, gear conflicts, and foreign
fishing. One of the problems that FMPs may address is preventing
overcapitalization (preventing excess fishing capacity) of fisheries.
This may be resolved by limiting access to those dependent on the
fishery in the past and/or by allocating the resource through
individual transferable quotas, which can be sold on the open market
[[Page 73338]]
to other participants or those wishing access. Quotas set on sound
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.
NMFS favors the concept of framework FMPs where applicable. Such FMPs
provide ranges, boundaries, and decision rules within which NMFS can
change management measures without formally amending the FMP. Further,
consistent with the recommendations on improving regulatory systems,
which accompany the Report of the National Performance Review, NMFS
favors using market-oriented approaches in managing fisheries. Open-
access fisheries are destined to have too many people investing too
much money in vessels and equipment. Access controls (e.g., a limited
number of permits) represent a rational approach for managing fishery
resources; they can be used to control fishing mortality levels and to
prevent overfishing, economic dissipation, and subsequent economic and
social dislocation. Of course overall quotas will need to be set based
on the best scientific information available as to such things as stock
status and optimum yields.
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, 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 judged. NMFS has supplemented the
standards with guidelines interpreting each standard, and is currently
in the process of updating and adding 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 Order.
Tortugas Ecological Reserve Regulations, Florida Keys National Marine
Sanctuary
Consistent with Executive Order 13089, Coral Reef Protection, which
directs the Federal Government to strengthen its stewardship of this
Nation's coral reefs and coral reef ecosystems, and the U.S. Coral Reef
Task Force's National Action Plan to Conserve Coral Reefs, NOAA has
issued a proposed rule to establish the Tortugas Ecological Reserve.
The Tortugas region is located in and just outside the westernmost
portion of the Florida Keys National Marine Sanctuary (FKNMS)
approximately 70 miles west of Key West, a very strategic position
oceanographically that makes it an ideal location for an ecological
reserve. It contains the healthiest coral reefs found in the Florida
Keys. Coral pinnacles as high as forty feet with the highest coral
cover (greater than 30 percent) found in the Keys jut up from the ocean
floor. These coral formations are bathed by some of the clearest and
cleanest waters found in the Keys. This occurs where the tropical
waters of the Caribbean mingle with the more temperate waters of the
Gulf of Mexico.
Recent studies reveal that the Tortugas region is unique in its
location and the extent to which oceanographic processes impact the
area. The Tortugas region plays a dynamic role in supporting marine
ecosystems throughout south Florida and the Florida Keys. Larvae that
are spawned from adult populations in the Tortugas region are spread
throughout the Keys and south and southwest Florida by a persistent
system of currents and eddies that provide the retention and current
pathways necessary for successful recruitment of both local and foreign
spawned juveniles with larval stages remaining from hours for some
coral species up to one year for spiny lobster. In addition, the
upwellings and convergences of the current systems provide the
necessary food supplies in concentrated frontal regions to support
larval growth stages.
The intent of the regulations is to expand the existing boundary of
the FKNMS by 96 square nautical miles in the remote westernmost portion
of the Sanctuary to ensure that sensitive coral habitats lying outside
the existing boundary of the Sanctuary are protected and to establish a
151 square nautical mile no-take ecological reserve within that 96
square nautical mile area and within a 55 square nautical mile area of
the existing Sanctuary to protect exceptional coral reefs and other
habitat, fish, and marine life at the western end of the Florida Keys.
The regulations would prohibit consumptive activities, such as fishing
and spearfishing, in order to preserve the marine resources of the
area. It is anticipated that the creation of the reserve and the
related prohibitions will increase the amount of marine life such as
lobsters and fish that would be dispersed throughout the Florida Keys.
Despite its beauty and productivity, the Tortugas has been exploited
for decades, greatly diminishing its potential as a source of larval
recruits to the downstream portion of the Florida Keys and to itself.
Fish and lobster populations have been significantly depleted thus
threatening the integrity and natural dynamics of the ecosystem.
Currently large freighters use Riley's Hump, a significant coral reef
structure lying outside the existing Sanctuary boundary as a secure
place to anchor between port visits. The several-ton anchors and chains
of these ships are devastating large areas of fragile coral reef
habitat that provide the foundation for economically important
fisheries. By designating this area an ecological reserve, NOAA hopes
to create a seascape of promise--a place where the ecosystem's full
potential can be realized and a place that humans can learn from and
experience.
_______________________________________________________________________
[[Page 73339]]
DOC
-----------
FINAL RULE STAGE
-----------
22. FLORIDA KEYS NATIONAL MARINE SANCTUARY; TORTUGAS
ECOLOGICAL RESERVE
Priority:
Other Significant
Legal Authority:
16 USC 1431 et seq
CFR Citation:
15 CFR 922 et seq
Legal Deadline:
None
Abstract:
The final rule will make effective the proposed rule published on May
18, 2000, that would establish a 151 square nautical mile no-take
ecological reserve in the Tortugas region of the Florida Keys to
protect nationally significant coral reef resources and to protect an
area that serves as a source of biodiversity for the Florida Keys
National Marine Sanctuary (FKNMS) as well as for the southwest shelf of
Florida. The rule would expand the boundary of the FKNMS by 96 square
nautical miles in the remote westernmost portion of the FKNMS to ensure
that sensitive coral habitats lying outside the existing boundary of
the Sanctuary are protected and would establish the reserve within that
96 square nautical mile area and within a 55 square nautical mile area
of the existing Sanctuary.
Statement of Need:
This action is consistent with E.O. 13089, Coral Reef Protection, which
directs the Federal Government to strengthen its stewardship of this
Nation's coral reefs and coral reef ecosystems. Establishment of the
Tortugas ecological reserve is consistent with and is one of the key
components of the U.S. Coral Reef Task Force's National Action Plan to
Conserve Coral Reefs. The Task Force includes the major Federal
agencies responsible for the various aspects of coral reef
conservation, plus the States and territories.
The Tortugas region is located in and just outside the westernmost
portion of the FKNMS approximately 70 miles west of Key West, a very
strategic position oceanographically that makes it an ideal location
for an ecological reserve. It contains the healthiest coral reefs found
in the Florida Keys. Coral pinnacles as high as 40 feet with the
highest coral cover (greater than 30%) found in the Keys jut up from
the ocean floor. These coral formations are bathed by some of the
clearest and cleanest waters found in the Keys. This occurs where the
tropical waters of the Caribbean mingle with the more temperate waters
of the Gulf of Mexico.
Recent studies reveal that the Tortugas region is unique in its
location and the extent to which oceanographic processes impact the
area. The Tortugas region plays a dynamic role in supporting marine
ecosystems throughout south Florida and the Florida Keys. Larvae that
are spawned from adult populations in the Tortugas region are spread
throughout the Keys and south and southwest Florida by a persistent
system of currents and eddies that provide the retention and current
pathways necessary for successful recruitment of both local and foreign
spawned juveniles with larval stages remaining from hours for some
coral species up to one year for spiny lobster. In addition, the
upwellings and convergences of the current systems provide the
necessary food supplies in concentrated frontal regions to support
larval growth stages.
The intent of the regulations is to expand the existing boundary of the
FKNMS by 96 square nautical miles in the remote westernmost portion of
the Sanctuary to ensure that sensitive coral habitats lying outside the
existing boundary of the Sanctuary are protected and to establish a 151
square nautical mile no-take ecological reserve within that 96 square
nautical mile area and within a 55 square nautical mile area of the
existing Sanctuary to protect exceptional coral reefs and other
habitat, fish, and marine life at the western end of the Florida Keys.
The regulations would prohibit consumptive activities, such as fishing
and spearfishing, in order to preserve the marine resources of the
area. It is anticipated that the creation of the reserve and the
related prohibitions will increase the amount of marine life such as
lobsters and fish that would be dispersed throughout the Florida Keys.
Despite its beauty and productivity, the Tortugas has been exploited
for decades, greatly diminishing its potential as a source of larval
recruits to the downstream portion of the Florida Keys and to itself.
Fish and lobster populations have been significantly depleted thus
threatening the integrity and natural dynamics of the ecosystem.
Currently large freighters use Riley's Hump, a significant coral reef
structure lying outside the existing Sanctuary boundary as a secure
place to anchor between port visits. The several-ton anchors and chains
of these ships are devastating large areas of fragile coral reef
habitat that provide the foundation for economically important
fisheries. By designating this area an ecological reserve, NOAA hopes
to create a seascape of promise--a place where the ecosystem's full
potential can be realized and a place that humans can learn from and
experience.
Summary of Legal Basis:
The National Marine Sanctuaries Act, 16 U.S.C. 1431, et seq.,
authorizes the Secretary of Commerce to identify and designate areas of
the marine environment that are of special national significance as
national marine sanctuaries, and to maintain, restore, and enhance
living resources by providing places for species that depend upon these
marine areas to survive and propagate. The Act authorizes the Secretary
to issue such regulations as may be necessary and responsible to
implement such designations.
Alternatives:
A no-action and four boundary alternatives for the reserve have been
identified. The boundary alternatives vary in size and areas in which
they would apply. The smallest would be within the existing FKNMS
boundary, would not require a boundary expansion and would consist of
approximately 55 square nautical miles. The largest boundary
alternative would be approximately 190 square nautical miles in area
and would include approximately 135 square nautical miles outside the
current FKNMS boundary.
Four regulatory alternatives have been considered, ranging from
application of current Sanctuary regulations in the reserve to a
proposal that would close part of the reserve to all access and uses
except for scientific research and monitoring, and would restrict
access to the remainder of the reserve to noncomsumptive activities,
with access being controlled by a call-in permit system.
Anticipated Cost and Benefits:
Ecologically, the reserve would provide significant protection of coral
reef resources, deepwater fish habitats, and known fish spawning areas.
[[Page 73340]]
Socioeconomic impacts, determined by analyzing the costs and benefits
of no-take regulations on various industries, indicate moderate impacts
on fishermen, mostly lobster and handline fishers, and minimal impacts
on recreational fishers. The potential for benefits to nonconsumptive
users and the scientific community is high due to the educational and
research value of an ecological reserve. Positive effects to
surrounding areas through long-term fisheries replenishment are also
likely.
Risks:
Despite its beauty and productivity, the Tortugas has been exploited
for decades, greatly diminishing its potential as a source of larval
recruits to the downstream portion of the Florida Keys and to itself.
Fish and lobster populations have been significantly depleted thus
threatening the integrity and natural dynamics of the ecosystem.
Currently large freighters use Riley's Hump, a significant coral reef
structure lying outside the existing Sanctuary boundary as a secure
place to anchor between port visits. The several-ton anchors and chains
of these ships are devastating large areas of fragile coral reef
habitat that provide the foundation for economically important
fisheries. By designating this area an ecological reserve, NOAA hopes
to create a seascape of promise--a place where the ecosystem's full
potential can be realized and a place that humans can learn from and
experience.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 65 FR 31634 05/18/00
Draft EIS 65 FR 31898 05/19/00
Final EIS 10/00/00
Final Rule 10/00/00
Regulatory Flexibility Analysis Required:
Yes
Small Entities Affected:
Businesses
Government Levels Affected:
Federal, State
Agency Contact:
Billy Causey
Superintendent, Florida Keys National Marine Sanctuary
Department of Commerce
National Oceanic and Atmospheric Administration
P.O. Box 500368
Marathon, FL 33050
Phone: 305 743-2437
RIN: 0648-AO18
BILLING CODE 3510-BW-S
[[Page 73341]]
DEPARTMENT OF DEFENSE (DOD)
Statement of Regulatory Priorities
Background
The Department of Defense (DoD) is the largest Federal department
consisting of 3 military departments (Army, Navy and Air Force), 9
unified combatant commands, 15 Defense agencies, and 7 DoD field
activities. It has over 1,360,000 military personnel and 680,000
civilians assigned as of May 31, 2000, and over 500 military
installations and properties in the continental United States, U. S.
territories, and foreign countries. The overall size, composition, and
dispersion of the Department of Defense, 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 impacted 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 regulating agencies and
the affected Defense 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 issues regulations
that have an impact 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 impact 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
impacted by its regulations as well.
The regulatory program within DoD fully incorporates the provisions of
the President's priorities and objectives under Executive Order 12866.
Promulgating and implementing the regulatory program throughout DoD
presents a unique challenge to the management of our regulatory
efforts.
Coordination
Interagency
DoD annually receives regulatory plans from those agencies that impact
the operation of the Department through the issuance of regulations. A
system for coordinating the review process is in place, regulations are
reviewed, and comments are forwarded to the Office of Management and
Budget. The system is working in the Department, and the feedback from
the Defense components is most encouraging, since they are able to see
and comment on regulations from the other agencies before they are
required to comply with them. The coordination process in DoD continues
to work as outlined in Executive Order 12866.
Internal
Through regulatory program points of contact in the Department, we
have established a system that provides information from the Vice
President and the Administrator of the Office of Information and
Regulatory Affairs (OIRA) to the personnel responsible for the
development and implementation of DoD regulations. Conversely, the
system can provide feedback from DoD regulatory personnel to the
Administrator, OIRA. DoD continues to refine its internal procedures,
and this ongoing effort to improve coordination and communication
practices is well received and supported within the Department.
Overall Priorities
The Department of Defense 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 at a time when there is a significant ongoing
downsizing in the Department and it must react 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, adheres to the general principles set forth in
Executive Order 12866 as amplified below.
Problem Identification
Congress typically passes legislation to authorize or require an
agency to issue regulations and often is quite specific about the
problem identified for correction. Therefore, DoD does not generally
initiate regulations as a part of its mission.
Conflicting Regulations
Since DoD plans to issue just one significant regulation this year,
the probability of developing conflicting regulations is low.
Conversely, DoD is impacted to a great degree by the regulating
agencies. From that perspective, DoD is in a position to advise the
regulatory agencies of conflicts that appear to exist using the
coordination processes that exist in the DoD and other Federal agency
regulatory programs. It is a priority in the Department to communicate
with other agencies and the affected public to identify and proactively
pursue regulatory problems that occur as a result of conflicting
regulations both within and outside the Department.
Alternatives
DoD will identify feasible alternatives that will obtain the desired
regulatory objectives. Where possible, the Department encourages the
use of incentives to include financial, quality of life, and others to
achieve the desired regulatory results.
Risk Assessment
Assessing and managing risk is a high priority in the DoD regulatory
program. The Department is committed to risk prioritization and an
``anticipatory'' approach to regulatory planning which focuses
attention on the identification of future risk. Predicting future
regulatory risk is exceedingly difficult due to rapid introduction of
new technologies, side effects of Government intervention, and changing
societal concerns. These difficulties can be mitigated to a manageable
degree through the incorporation of risk prioritization and
anticipatory regulatory planning into DoD's decisionmaking process,
which results in an improved regulatory process and increases the
customer's understanding of risk.
Cost-Effectiveness
One of the highest priority objectives of DoD is to obtain the desired
regulatory objective by the most cost-effective method available. This
may or may not be through the regulatory process. When a regulation is
required, DoD considers incentives for innovation to achieve desired
results, consistency in the application of the regulation,
predictability of the activity outcome (achieving the expected
results), and the costs for regulation development, enforcement, and
compliance. These will include costs to the public, Government, and
regulated entities, using the best available data or parametric
analysis methods, in the
[[Page 73342]]
cost-benefit analysis and the decisionmaking process.
Cost-Benefit
Conducting cost-benefit analyses on regulation alternatives is a
priority in the Department of Defense so as to ensure that the
potential benefits to society outweigh the costs. Evaluations of these
alternatives are done quantitatively or qualitatively or both,
depending on the nature of the problem being solved and the type of
information and data available on the subject. DoD is committed to
considering the most important alternative approaches to the problem
being solved and providing the reasoning for selecting the proposed
regulatory change over the other alternatives.
Information-Based Decisions
The Defense Department uses the latest technology to provide access to
the most current technical, scientific, and demographic information in
a timely manner through the world-wide communications capabilities that
are available on the ``information highway.'' Realizing that increased
public participation in the rulemaking process improves the quality and
acceptability of regulations, DoD is committed to exploring the use of
Information Technology (IT) in rule development and implementation. IT
provides the public with easier and more meaningful access to the
processing of regulations. Furthermore, the Department endeavors to
increase the use of automation in the Notice and Comment rulemaking
process in an effort to reduce time pressures in the regulatory
process.
Performance-Based Regulations
Where appropriate, DoD is incorporating performance-based standards
that allow the regulated parties to achieve the regulatory objective in
the most cost-effective manner.
Outreach Initiatives
DoD endeavors to obtain the views of appropriate State, local, and
tribal officials and the public in implementing measures to enhance
public awareness and participation both in developing and implementing
regulatory efforts. Historically, this has included such activities as
receiving comments from the public, holding hearings, and conducting
focus groups. This reaching out to organizations and individuals that
are affected by or involved in a particular regulatory action remains a
significant regulatory priority of the Department and, we feel, results
in much better regulations.
Coordination
DoD has enthusiastically embraced the coordination process between and
among other Federal agencies in the development of new and revised
regulations. Annually, DoD receives regulatory plans from key
regulatory agencies and has established a systematic approach to
providing the plans to the appropriate policy officials within the
Department. Feedback from the DoD components indicates that this
communication among the Federal agencies is a major step forward in
improving regulations and the regulatory process, as well as in
improving Government operations.
Minimize Burden
In the regulatory process, there are more complaints concerning burden
than anything else. In DoD, much of the burden is in the acquisition
area. Over the years, acquisition regulations have grown and become
burdensome principally because of legislative action. But, in
coordination with Congress, the Office of Federal Procurement Policy,
and the public, DoD is initiating significant reforms in acquisition so
as to effect major reductions in the regulatory burden on personnel in
Government and the private sector. DoD has implemented a multi-year
strategy for reducing the paperwork burden imposed on the public. This
plan shows that DoD has met and will exceed the goals set forth in the
Paperwork Reduction Act. During fiscal year (FY) 2000, the Department
achieved a significant reduction in the burden imposed on the public as
a result of the review of the information collection requirement in
support of the solicitation phase of the Department of Defense
acquisition process. The information collection requirement pertains to
information that an offeror must submit to DoD in response to DoD
solicitations not covered by another Office of Management and Budget
(OMB) clearance. DoD reviewed the information being collected under
this requirement and reduced the burden hours by 18.4 million hours for
an estimated 15 percent reduction during FY 2000.
One significant reduction in burden imposed on the public is planned
as a result of the review of the information collection requirement
associated with rights in technical data and computer software. We have
updated the estimates for the number of respondents and the number of
actions to reflect fiscal year 1999 historical data available in the
DoD data base. As a result of these reviews, DoD plans to reduce the
burden hours imposed on the public under this information collection
requirement by an estimated 1.2 million hours per year. It is the goal
of the Department of Defense to impose upon the public the smallest
burden viable, as infrequently as possible, and for no longer than
absolutely necessary.
Plain Language
Ensuring that regulations are simple and easy to understand is a high
regulatory priority in the Department of Defense. All too often, the
regulations are complicated, difficult to understand, and subject to
misinterpretation, all of which can result in the costly process of
litigation. The objective in the development of regulations is to write
them in clear, concise language that is simple and easy to understand.
DoD recognizes that it has a responsibility for drafting clearly
written rules that are reader-oriented and easily understood. Rules
will be written for the customer using natural expressions and simple
words. Stilted jargon and complex construction will be avoided. Clearly
written rules will tell our customers what to do and how to do it. DoD
is committed to a more customer-oriented approach and uses plain
language rules thereby improving compliance and reducing litigation.
One planned initiative that implements the White House memorandum Plain
Language in Government Writing, dated June 1, 1998, focuses on DoD's
supplement to the Federal Acquisition Regulation (FAR). The goal of
this initiative is to clarify the applicability of definitions,
eliminate redundant or conflicting definitions, and make definitions
easier to find.
In summary, the rulemaking process in DoD should produce a rule that
addresses an identifiable problem, implements the law, incorporates the
President's policies defined in Executive Order 12866, is in the public
interest, is consistent with other rules and policies, is based on the
best information available, is rationally justified, is cost-effective,
can actually be implemented, is acceptable and enforceable, is easily
understood, and stays in effect only as long as is necessary. Moreover,
the proposed rule or the elimination of a rule should simply make
sense.
Specific Priorities
For this regulatory plan, there are three specific DoD priorities, all
of
[[Page 73343]]
which reflect the established regulatory principles. One of these,
Closed, Transferred, and Transferring Ranges Containing Military
Munitions, is a significant regulatory action as defined by E.O. 12866.
In those areas where rulemaking or participation in the regulatory
process is required, DoD has studied and developed policy and
regulation which incorporate not only the provisions of the President's
priorities and objectives under the Executive order but also the
National Performance Review, dated September 1993.
DoD has focused its regulatory resources on the most serious
environmental, health, and safety risks. Perhaps most significant is
that each of the three 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 base realignment and closure activities,
acquisition, and munitions ranges.
Revitalizing Base Closure Communities - Base Closure Community
Assistance (32 CFR Part 175)
Following the July 1993 announcement of the President's program to
revitalize base closure communities, Congress created a new property
conveyance authority, designed specifically to ease the economic
hardship caused by base closures and realignments and to foster rapid
job creation in the adversely impacted communities. This authority is
referred to as the Economic Development Conveyance (EDC), giving DoD
the ability to transfer property to Local Redevelopment Authorities
(LRAs) for consideration at or below estimated fair market value to
spur economic redevelopment and job creation.
On April 21, 1999, the President and the Secretary of Defense
announced their intent to submit legislation that provided for no-cost
transfers of EDC property to further stimulate economic redevelopment
and long-term job creation and to eliminate delays resulting from
prolonged negotiations over fair market value. The initiative also
provided for modifying existing EDC agreements, where appropriate,
consistent with this new authority. By September 22, 1999, Congress had
passed the legislation as part of the National Defense Authorization
Act for Fiscal Year 2000, and the President signed it into law on
October 5, 1999.
The legislation was designed to directly address the two major hurdles
base closure communities currently face, while attempting to
effectively reuse closed or realigned bases. First, delays in obtaining
control or possession of former base assets delay planning,
rehabilitation, modernization, infrastructure improvements, and
marketing efforts and, thus, job creation. Second, the costs of basic
infrastructure work at a former base necessary to allow these assets to
successfully compete for new economic activity is typically extremely
high. The no-cost EDC authority provides an opportunity for a
collaborative relationship by assisting communities to create jobs on
the former installation and relieve DoD of needless caretaker expenses.
To implement this expanded EDC legislative authority, DoD is
proceeding to revise DoDI 4165.67 Revitalizing Base Closure
Communities-Base Closure Community Assistance, which established
policies and procedures for implementing provisions in the National
Defense Authorization Act for Fiscal Year 1994 regarding base closure
and reuse. Because the March 4, 1996, DoD instruction was published in
the Federal Register and codified in the Code of Federal Regulations,
this revision will be published in the Federal Register as an Interim
Final Rule.
Reform Defense Acquisition
The Department continues its efforts to reengineer its acquisition
system to achieve its vision of an acquisition system that is
recognized as being the smartest, most efficient, most responsive buyer
of best value goods and services, which meet the warfighter's needs
from a globally competitive base. To achieve this vision, the
Department will focus in the acquisition regulations arena during this
next year on implementing and institutionalizing initiatives that may
include additional changes to existing and recently modified
regulations to ensure that we are achieving the outcomes we desire
(continuous process improvement). The Department will focus on
reengineering the process by which it acquires services, focusing on
the use of performance-based work statements. The Department also
intends to improve its use of electronic commerce/electronic data
interchange.
The Department is committed to acquisition reform and continues to
make significant improvements in this area, consistent with the
National Performance Review and Executive Order 12866. DoD is leading
the following initiatives to reform the acquisition process, which
include integrating commercial and military facilities and expanding
the ability to buy commercial products and expanding the use of
commercial procedures.
Integration of commercial and military facilities is critical to
enable the Department to capitalize on and access commercial technology
and generate funds for modernization, all within a balanced-budget
environment. In addition to the need to integrate commercial and
military facilities, the Department must expand the use of commercial
procedures. Acquisition Reform's Commercial Practices Initiative is
geared to providing learning opportunities on key techniques,
strategies, and negotiating/pricing tools used in the commercial
business environment. Modern, technology-based learning methods and
enterprise models of change management are available to meet the needs
for both individual and team training. Based on the knowledge gained,
the workforce will be enabled to adopt best practices, implement
reforms, and understand better how to work with commercial businesses,
including ones that are not themselves accustomed to doing business
with DoD.
DoD continuously reviews its supplement to the Federal Acquisition
Regulation (FAR) and continues to lead Government efforts to simplify
the following acquisition processes:
Rewrite of FAR part 45, Government Property. The goals of the
FAR part 45 rewrite are to reduce contractor and Government
costs to manage property in the possession of contractors
by streamlining recordkeeping requirements; to eliminate
requirements to track, report, and inventory property
valued at $5,000 or less during contract performance; to
replace five inventory schedules with a single inventory
disposal schedule; and to shorten screening times prior to
disposal. The FAR part 45 rewrite also encourages the dual
use of Government property introducing commercial rental
practices and reducing property rental rates.
Review various definitions. The goal of this initiative is to
clarify the applicability of definitions, eliminate
redundant or conflicting definitions, and make definitions
easier to find. This initiative implements the White House
memorandum Plain Language in Government Writing, dated June
1, 1998.
[[Page 73344]]
Review of various FAR cost principles. The goal of this
initiative is to determine whether certain FAR cost
principles are still relevant in today's business
environment, whether they place an unnecessary
administrative burden on contractors and the Government,
and whether they can be streamlined or simplified.
Review of FAR guidance pertaining to progress payments and
other related financing policies. The goal of this
initiative is to simplify the progress payments process; to
minimize the burdens imposed on contractors and contracting
officers; and to expand the use of performance-based
payments or commercial financing payments.
Revise policy on the applicability of cost accounting
standards. The goal of this initiative is to modify and
streamline the applicability of the Federal cost accounting
standards.
Revise policy on the use of the Governmentwide commercial
purchase card. The goal of this initiative is to increase
the use of the purchase card for small dollar purchases.
Revise policy to expand the use of the procedures in FAR part
12, Acquisition of Commercial Items. The goal of this
initiative is to expand the use of streamlined procedures
for the acquisition of commercial items.
Revise policy on profit. The goal of this initiative is to
make changes to DoD profit policy that would reduce and
eventually eliminate emphasis on facilities investment,
increase emphasis on performance risk, and encourage
contractor cost efficiency.
Closed, Transferred, and Transferring Ranges Containing Military
Munitions
The proposed rule, called the Range Rule identifies a process for
evaluating appropriate response actions on Closed, Transferred, and
Transferring Military Ranges. Response actions will address explosives
safety, human health, and the environment. This rule is a process that
is consistent with the Comprehensive Environment Response,
Compensation, and Liability Act (CERCLA) and tailored to the special
risks posed by military munitions and military ranges. This regulation
is proposed under the authorities of the Defense Environmental
Restoration Program (DERP), 10 U.S.C. 2701 et seq.; the DoD Explosive
Safety Board (DDESB), 10 U.S.C. 172 et seq.; and section 104 of the
CERCLA, 42 U.S.C. 9601 et seq., as delegated to the DoD by E.O. 12580
(59 FR 2923 (January 23, 1987)).
The proposed rule was developed with extensive input from the public
and other Federal agencies. A draft version of the rule was placed on
the World Wide Web; meetings with representatives from State
organizations, meetings with public groups, and meetings with other
Federal agencies were critical in the formulation of the current draft
version of the proposed rule. The public comment period on the rule
ended on December 28, 1997, and since that time, DoD has been working
with other agencies within the Administration to fully address these
comments and to finalize the rule. Currently, a draft final rule is
undergoing intra-Administration review as required by E.O. 12866.
_______________________________________________________________________
DOD
-----------
FINAL RULE STAGE
-----------
23. CLOSED, TRANSFERRED, AND TRANSFERRING RANGES CONTAINING MILITARY
MUNITIONS
Priority:
Other Significant
Legal Authority:
10 USC 172 et seq; 10 USC 2701 et seq; 42 USC 9601 et seq; EO 12580
CFR Citation:
32 CFR 178
Legal Deadline:
None
Abstract:
The proposal for this Department of Defense (DoD) rule addresses the
unique explosives safety considerations associated with military
munitions (including UXO) and the need for environmental protection,
and it does so under DERP, 10 USC 172 et seq., and CERCLA authorities.
Statement of Need:
The Department of Defense proposed rule identifies a process for
evaluating appropriate response actions on closed, transferred, and
transferring military ranges. Response actions will address explosives
safety, human health, and the environment. The rule is a process
consistent with the Comprehensive Environmental Response, Compensation,
and Liability Act (CERCLA) and is tailored to the special risks posed
by military munitions and military ranges.
Summary of Legal Basis:
This regulation is proposed under the authorities of the Defense
Environmental Restoration Program (DERP) in 10 USC 2701 et seq.; the
DOD Explosive Safety Board (DDESB) in 10 USC 172 et seq.; and section
104 of the CERCLA in 42 USC 9601 et seq., as delegated to the DOD by EO
12580 (59 FR 2923, January 23, 1987).
Alternatives:
A single, specific, and fully integrated process is necessary to avoid
confusion and to ensure that effective response activities are
undertaken in a fiscally responsible manner. That process must
recognize and consider the unique explosives safety hazards associated
with military munitions, and concomitantly, with any response activity
conducted on closed, transferred, or transferring ranges. The process
must ensure that the public and regulators are fully informed and
engaged at every stage of the process, including substantial and
meaningful public and regulator participation in the response selection
and implementation. The process must be accessible and consistent, and
lead to informed decisionmaking. DOD considered several alternatives to
address military munitions on closed, transferred, or transferring
ranges. In doing so, DOD examined the relative merits of conducting
responses under any one of the statutorily based processes (DERP,
CERCLA, RCRA, 10 USC 172 et seq.) or the status quo in meeting the goal
of establishing a single, logical, and comprehensive process that
addresses explosives safety, human health, and environmental concerns.
Anticipated Cost and Benefits:
Based on the proposed rule, implementing the proposed rule equates to
national incremental costs totaling $709,000,000 over a period of 10 to
15 years with estimated annual costs of $71,000,000 per year for a 10-
year period or $47,000,000 per year for a 15-year period. These costs
are less than those of other alternatives. Benefits include: Increased
protection of the public; increased protection to unexploded ordnance
response workers; consistent process; increased public involvement in
responses; substantial role for regulatory agencies; and substantial
role for other Federal land managers. Implementing a comprehensive
approach to respond to these ranges while ensuring public safety,
worker safety, and protection of human health and the environment is
[[Page 73345]]
essential and would be a beneficial outcome of this rule. Analysis of
the anticipated costs and benefits of the draft final rule is ongoing.
Risks:
The degree of risk to the public is lessened by assuring a single,
comprehensive process to respond to potential risks to safety, human
health, and the environment at all closed, transferred, and
transferring ranges. Public and regulatory acceptance of the rule is
heightened through pre-proposal dialogue with stakeholders. DoD will
continue to work with both public and governmental stakeholders and
regulators in developing this proposed rule.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 62 FR 50796 09/26/97
Public Meetings Begin 10/22/97
Public Meetings End 12/10/97
NPRM Comment Per62 FR 50796 12/26/97
Final Action 01/00/01
Final Action Effective 03/00/01
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
No
Government Levels Affected:
Undetermined
Agency Contact:
Col John Selstrom
Department of Defense
Office of the Secretary
Room 3E787
Deputy Under Secretary of Defense (Environmental Security)
3400 Defense Pentagon
Washington, DC 20301-3400
Phone: 703 697-5372
RIN: 0790-AG46
BILLING CODE 5001-10-S
[[Page 73346]]
DEPARTMENT OF EDUCATION (ED)
Statement of Regulatory and Deregulatory Priorities
General
The Department supports States, local communities, and institutions of
higher education and others to improve education nationwide. The
Department's roles include leadership and financial support for
education to agencies, institutions, and individuals in situations
where there is a national interest; monitoring and enforcing of civil
rights in the area of education; and supporting research, evaluation,
and dissemination of findings to improve the quality of education. ED
works in partnership with parents, neighborhoods, schools, colleges,
educators, business leaders, communities, and States across the
country. Since the announcement of President Clinton's ``Regulatory
Reinvention Initiative'' on March 4, 1995, the Department has conducted
a comprehensive review of its programs, legislation, and implementing
regulations to enhance partnerships, increase flexibility, and improve
accountability. In response to this initiative, the Department has
eliminated or simplified most of its regulations--including the
elimination of 2/3 of the regulations applicable to elementary and
secondary education programs. The Department has accomplished these
results through a departmentwide effort that recognizes that students
and educational partners are best served by regulations that focus on
critical steps and results, allow as much flexibility as possible
consistent with statutory and program goals, and impose the least
possible burden.
As part of its regulatory reinvention efforts and in response to the
President's memorandum of June 1, 1998, on ``Plain Language in
Government Writing,'' the Department also seeks to draft all of its
regulations and related documents clearly and concisely in plain
language, so that potential program beneficiaries will better
understand benefits and requirements. Woven throughout the Department's
reinvention is a commitment to provide quality customer service in the
spirit of continuous improvement to assure that we are truly ``putting
people first.'' The Department listens to our customers to identify
their needs and incorporates their suggestions into program goals and
strategies.
In order to provide information and support enhanced exchange, the
Department instituted 1-800-USA-LEARN (1-800-872-5327) to connect our
customers to a ``one-stop-shopping'' center for information about
departmental programs and initiatives; 1-800-4FED-AID (1-800-433-3243)
for information on student aid; and an on-line library of information
on education legislation, research, statistics, and promising programs.
Internet address:
http://www.ed.gov.
More than 10,000 people take advantage of these resources every week.
The Department has forged effective partnerships with customers and
others to develop policies, regulations, guidance, technical
assistance, and compliance approaches. The Department has an impressive
record of successful communication and shared policy development with
affected persons and groups, including parents, representatives of
State and local government, institutions of higher education, school
administrators, teachers, students, special education and
rehabilitation service providers, professional associations, advocacy
organizations, business, and labor.
In particular, the Department continues to seek greater and more
useful customer participation in its rulemaking activities through the
use of consensual rulemaking and new technology. When rulemaking is
determined to be absolutely necessary, customer participation is
essential and sought at all stages--in advance of formal rulemaking,
during rulemaking, and after rulemaking is completed in anticipation of
further improvements through statutory or regulatory changes. The
Department has expanded its outreach efforts through the use of
satellite broadcasts, electronic bulletin boards, and teleconferencing.
For example, the Department invites comments on all proposed rules
through the Internet.
The Department is streamlining information collections, reducing
burden on information providers involved in ED programs, and making
information maintained by the Department easily available to the
public. Coordinating similar information collections across programs
may be one approach to reduce overlapping and inconsistent paperwork
requirements. To the extent permitted by statute, regulations will be
revised to eliminate barriers that inhibit coordination across programs
(such as by creating common definitions), to reduce the frequency of
reports, and to eliminate unnecessary data requirements. ED has reduced
the information collection burden imposed on the public by 14.7 percent
in fiscal year (FY) 1996, by 11 percent in FY 1997, and by more than 5
percent in FY 1998. Our goal for FYs 1999-2000 is a further 10 percent
reduction.
The Department's Principles for Regulating, developed in October 1994
during planning to implement the Improving America's Schools Act of
1994, determine when and how it will regulate. Through aggressive
application of the following principles, the Department has eliminated
outdated or unnecessary regulations and identified situations in which
major programs could be implemented without any regulations or with
only limited regulations.
Principles for Regulating
The Department will regulate only if regulating improves the quality
and equality of services to the Department's customers, learners of all
ages. The Department will regulate only when absolutely necessary and
then in the most flexible, most equitable, and least burdensome way
possible.
Whether to Regulate:
When essential to promote quality and equality of opportunity
in education.
When a demonstrated problem cannot be resolved without
regulation.
When necessary to provide legally binding interpretation to
resolve ambiguity.
Not if entities or situations to be regulated are so diverse
that a uniform approach does more harm than good.
How to regulate:
Regulate no more than necessary.
Minimize burden and promote multiple approaches to meeting
statutory requirements.
Encourage federally funded activities to be integrated with
State and local reform activities.
Ensure that benefits justify costs of regulation.
Establish performance objectives rather than specify
compliance behavior.
Encourage flexibility so institutional forces and incentives
achieve desired results.
Regulatory and Deregulatory Priorities for the Next Year
The State Vocational Rehabilitation Services Program
The State Vocational Rehabilitation (VR) Services Program is a $2.5
billion
[[Page 73347]]
program that provides funds to State VR agencies to assist individuals
with disabilities to achieve employment. These regulations would amend
the existing program regulations in 34 CFR part 361 to implement
various changes in recently enacted statutes.
_______________________________________________________________________
ED
-----------
FINAL RULE STAGE
-----------
24. THE STATE VOCATIONAL REHABILITATION SERVICES PROGRAM (SECTION 610
REVIEW)
Priority:
Other Significant
Legal Authority:
29 USC 711(C)
CFR Citation:
34 CFR 361
Legal Deadline:
None
Abstract:
These regulations are needed to implement changes made by the
Rehabilitation Act Amendments of 1998, the Reading Excellence Act, the
Carl D. Perkins Vocational and Applied Technology Education Act
Amendments of 1998, and the Workforce Investment Act of 1998. This
action also results from a review of the existing regulations for this
program under section 610 of the Regulatory Flexibility Act (5 U.S.C.
610). The purpose of this review was to determine if these regulations
should be continued without change, or should be amended or rescinded,
to minimize any significant economic impact upon a substantial number
of small entities.
Statement of Need:
These regulations are necessary to implement new legislation. The
Department is also completing its review of these regulations under
section 610(c) of the Regulatory Flexibility Act. In developing the
regulations, the Department will seek to reduce regulatory burden and
increase flexibility to the extent possible.
Summary of Legal Basis:
Public Law 105-220, enacted August 7, 1998.
Alternatives:
In addition to implementing the new legislation, the purpose of
reviewing these regulations is to determine whether there are
appropriate alternatives.
Anticipated Cost and Benefits:
Existing regulatory provisions may be eliminated or improved as a
result of this review.
Risks:
These regulations would not address a risk to public health, safety, or
the environment.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 65 FR 10620 02/28/00
NPRM Comment Period End 04/28/00
Final Action 11/00/00
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
No
Government Levels Affected:
None
Agency Contact:
Beverlee Stafford
Director, Planning, Policy, and Evaluation Services
Department of Education
Office of Special Education and Rehabilitative Services
Room 3014
Switzer Building
400 Maryland Avenue SW
Washington, DC 20202-2531
Phone: 202 205-8831
RIN: 1820-AB50
BILLING CODE 4000-01-S
[[Page 73348]]
DEPARTMENT OF ENERGY (DOE)
Statement of Regulatory and Deregulatory Priorities
The Department makes vital contributions to the Nation's welfare
through its extraordinary scientific and technical capabilities in
energy research, environmental remediation, and national security. The
Department's mission is to:
Enhance the Nation's energy security by developing and
deploying clean and affordable energy supplies and by
improving the energy efficiency of our economy;
Maintain the safety, security and reliability of the Nation's
nuclear weapons stockpile and reduce the global nuclear
danger;
Clean up former nuclear weapons sites and address the complex
challenge of disposing of nuclear wastes; and
Leverage science and technology to advance fundamental
knowledge and our country's competitiveness with stronger
partnership with the private sector.
The Department of Energy's regulatory plan reflects the Department's
continuing commitment to enhance safety, cut costs, reduce regulatory
burden, and increase responsiveness to the public. While not primarily
a major Federal regulatory agency, the Department's regulatory
activities are essential to achieving its critical mission.
Energy Efficiency Program for Consumer Products and Commercial
Equipment
In January 1997, the Department established an Advisory Committee on
Appliance Energy Efficiency Standards to assist the Department on
issues related to the rulemaking process. The Advisory Committee
continues to meet twice a year. During its March 2000 meeting, the
Advisory Committee recommended that the Department better inform
consumers of the costs and benefits of proposed changes to appliance
standards and improve the availability of manufacturer's data on
appliance energy efficiency and energy use to the public by making such
data accessible electronically. The Department is actively pursuing the
first recommendation by adding a summary consumer statement to each
consumer rulemaking, which would address the background and rationale
for the rulemaking, and address relevant consumer issues. In response
to the second recommendation, the Department is attempting, through
cooperative efforts with other public and private organizations, to
make data on appliance energy efficiency and energy use available to
the public over the Internet.
The Department's rulemaking activities, related to energy efficiency
standards and determinations, have been categorized as high, medium, or
low priority. The schedules in The Regulatory Plan and the Unified
Agenda of Federal Regulatory and Deregulatory Actions reflect
priorities established with significant input from the public. The
standards rulemakings incorporate the process improvements established
in July 1996, which include more workshops to collect public input, and
new more transparent forecasting models developed with the help of
industry experts, including manufacturers.
The Department made substantial progress during fiscal year 2000 with
its high priority standards rulemakings (i.e., clothes washers,
fluorescent lamp ballasts, water heaters, and residential central air
conditioners and heat pumps). On September 19, 2000, the Department
published a final rule for fluorescent lamp ballasts, which was based
on a consensus of recommendations from manufacturers and energy
conservation advocates. The Department also published a proposed rule
for water heaters in April.
During fiscal year 2001, the Department expects to publish final rules
establishing energy efficiency standards for clothes washers,
residential water heaters, and residential central air conditioners and
heat pumps. Additional information and timetables for these actions can
be found below.
The Department expects to publish in the coming months proposed rules
concerning test procedures for commercial air conditioners and heat
pumps, furnaces and boilers, and water heaters. The Department also
plans to publish a final rule adopting efficiency standards for certain
types of commercial equipment that fall under the scope of the American
Society for Heating, Refrigerating, and Air Conditioning Engineers
(ASHRAE) Standard 90.1, and to begin a separate rulemaking for the
other equipment under ASHRAE Standard 90.1, where it appears more
stringent standards are justified. Information and timetables
concerning these actions, other medium and low priority standards
rulemakings, and other test procedures can be found in the Department's
regulatory agenda, which appears elsewhere in this issue of the Federal
Register.
Nuclear Safety Regulations
The Department is committed to openness and public participation as it
addresses one of its greatest challenges--managing the environment,
health, and safety risks posed by its nuclear activities. A key element
in the management of these risks is to establish the Department's
expectations and requirements relative to nuclear safety and to hold
its contractors accountable for safety performance. The 1988 Price-
Anderson Amendments Act revisions to the Atomic Energy Act of 1954
(AEA) provide for the imposition of civil and criminal penalties for
violations of DOE nuclear safety requirements. As a result, new nuclear
safety requirements were initiated with the publication of four notices
of proposed rulemaking for review and comment in 1991. The Department's
nuclear safety procedural regulations (10 CFR Part 820) were published
as a final rule in 1993. Substantive DOE nuclear safety requirements
were issued as 10 CFR Parts 830 and 835 (Parts 830 and 835) in 1994 and
1993, respectively. On November 4, 1998, DOE published an amendment to
10 CFR Part 835 to revise Part 835 based on a comprehensive evaluation
of the Department's radiation protection program.
In August 1995, the Department published a notice of limited reopening
of the comment period to request public comments on the remaining Part
830 and Part 834 rulemakings. The Department has substantially
completed the comment resolution process and has addressed the major
issues raised by the Defense Nuclear Facilities Safety Board and is
engaged in a dialog with the Environmental Protection Agency concerning
its comments on Part 834.
The Department recently established an integrated safety management
initiative to ensure that safety activities at a DOE site or facility
are integrated and appropriate for the work and hazards. One outcome of
this initiative, incorporated as part of the contract reform final rule
published on June 27, 1997, requires contractors to manage and perform
work in accordance with a documented safety management system that
ensures that consideration of environment, safety and health issues are
integrated into all phases of work. The Department intends to ensure
that its nuclear safety regulations are consistent with the integrated
safety management process and avoid duplication and counterproductive
[[Page 73349]]
efforts. An interim final rule on Part 830 was published on October 10,
2000. The Department expects to issue final rulemakings on Part 830 in
December and on Part 834 by April 2001.
Worker Safety Regulations
The Department has a long history of beryllium use because of the
element's broad application to many nuclear operations and processes.
Beryllium metal and ceramics are used in nuclear weapons, as nuclear
reactor moderators or reflectors, and as nuclear reactor fuel element
cladding. Inhalation of beryllium dust or particles may cause chronic
beryllium disease (CBD) and beryllium sensitization. CBD is a chronic,
often debilitating, and sometimes fatal lung condition. Beryllium
sensitization is a condition in which a person's immune system becomes
highly responsive (allergic) to the presence of beryllium in the body.
Based on the number of confirmed cases of CBD and the expected future
increase in the number of workers potentially exposed to beryllium
during decontamination and decommissioning activities, the Department
concluded that there was a compelling need for a chronic beryllium
disease prevention program (CBDPP).
In 1996, the Department surveyed its contractors to characterize the
extent of beryllium usage, the types of tasks involving beryllium
usage, the controls in place for each task, the estimated number of
workers exposed during each task, and the estimated exposure levels
associated with each task. In addition, the Department established the
Beryllium Rule Advisory Committee (BRAC) in June 1997, to advise the
DOE on issues pertinent to the proposed rulemaking. The BRAC, which
consisted of a diverse set of stakeholders and recognized experts from
DOE, other Federal agencies, industry, labor, medicine, and academia,
explored issues and generated recommendations for consideration in the
development of a chronic beryllium disease prevention rule.
On December 8, 1999, the Department published a final rule in the
Federal Register (64 FR 68854) establishing the CBDPP, 10 CFR Part 850.
This program, which became effective January 7, 2000, will reduce the
number of workers at DOE facilities exposed to beryllium, minimize the
levels of and potential for exposure to beryllium, and establish
medical surveillance requirements to ensure early detection and
treatment of disease.
Polygraph Examination Program
Presidential Decision Directive (PDD) 61, Department of Energy
Counterintelligence Program, dated February 11, 1998, requires DOE to
do more to protect the highly sensitive and classified information at
its facilities. The President instructed DOE to develop and implement
specific measures to reduce the threat to such information, including
implementation of a polygraph program.
A counterintelligence-scope polygraph examination both serves as a
means to deter unauthorized disclosures of classified information and
provides a means for possible early detection of disclosures to enable
DOE to take steps promptly to prevent further harm to the national
security. Although The Employee Polygraph Protection Act generally
prohibits the use of polygraph examinations in private employment
settings, it specifically allows for polygraph examinations
administered by DOE in the performance of its counterintelligence
function to expert, consultant, or contractor employees of DOE in
connection with atomic energy defense activities.
As an initial step toward developing and implementing a polygraph
examination program, the Department issued an internal directive, DOE
Notice 472.2, Use of Polygraph Examinations, that establishes a
polygraph requirement for Federal employees who occupy or seek to
occupy certain sensitive positions at DOE. On December 17, 1999, the
Department published a final rule in the Federal Register (64 FR 70961)
that expanded the polygraph examination program to cover all employees,
contractors as well as federal employees, who are in positions with
access to the most sensitive categories of classified information and
materials. Applicants for such positions were covered as well.
_______________________________________________________________________
DOE--Energy Efficiency and Renewable Energy (EE)
-----------
PROPOSED RULE STAGE
-----------
25. ENERGY EFFICIENCY STANDARDS FOR CLOTHES WASHERS
Priority:
Economically Significant. Major under 5 USC 801.
Unfunded Mandates:
This action may affect the private sector under PL 104-4.
Reinventing Government:
This rulemaking is part of the Reinventing Government effort. It will
revise text in the CFR to reduce burden or duplication, or streamline
requirements.
Legal Authority:
42 USC 6295
CFR Citation:
10 CFR 430
Legal Deadline:
Final, Statutory, May 14, 1996.
Abstract:
The Energy Policy and Conservation Act (EPCA), as amended, establishes
initial energy efficiency standard levels for most types of major
residential appliances and generally requires DOE to undergo two
subsequent rulemakings, at specified times, to determine whether the
current standard for a covered product should be amended.
This is the second review of the standard for clothes washers.
Statement of Need:
This rulemaking is required by statute. Experience has shown that the
choice of residential appliances and commercial equipment being
purchased by both builders and building owners is generally based on
the initial cost rather than on life-cycle cost. Thus, the law requires
minimum energy efficiency standards for appliances to eliminate
inefficient appliances and equipment from the market.
Summary of Legal Basis:
The Energy Policy and Conservation Act (EPCA), as amended, establishes
initial energy efficiency standard levels for most types of major
residential appliances and certain types of commercial equipment and
generally requires DOE to undergo rulemakings, at specified times, to
determine whether the standard for a covered product should be made
more stringent.
Alternatives:
The statute requires DOE to conduct rulemakings to review standards and
to revise standards to achieve the maximum improvement in energy
efficiency that the Secretary determines is technologically feasible
and economically justified. In making this
[[Page 73350]]
determination, the Department conducts a thorough analysis of
alternative standard levels, including the existing standard, based on
criteria specified by statute. The process improvements that were
recently announced (61 FR 36974, July 15, 1996) further enhance the
analysis of alternative standards. For example, DOE will ask
stakeholders and private sector technical experts to review its
analyses of the likely impacts, costs, and benefits of alternative
standard levels. In addition, the Department will solicit and consider
information on non-regulatory approaches for encouraging the purchase
of energy efficient products.
Anticipated Cost and Benefits:
On May 23, 2000, major stakeholders, including manufacturers and energy
efficiency advocates, announced a joint agreement proposing clothes
washer efficiency standards to the Department that they both felt were
technically feasible and economically justified. The proposed standard
would go into effect in two stages. The first stage would begin January
1, 2004, and require that all new residential clothes washers be 22
percent more efficient than today's baseline clothes washer efficiency
level. The second stage would begin January 1, 2007, and require that
all new residential clothes washers be 35 percent more efficient than
today's baseline clothes washer efficiency level. The Department
estimates that this proposal would save over 5 quadrillion Btu's of
energy over 27 years, while cutting greenhouse gas emissions by an
amount equal to that produced by three million cars every year. The
water savings would reach up to 11 trillion gallons, enough to supply
the needs of 6.6 million households for 25 years.
Risks:
Without appliance efficiency standards, energy use will continue to
increase with resulting damage to the environment caused by atmospheric
emissions. Enhancing appliance energy efficiency reduces atmospheric
emissions of carbon dioxide and nitrogen oxides. Establishing standards
that are too stringent could result in excessive increases in the cost
of the product, possible reductions in product utility and may place an
undue burden on manufacturers that could result in a loss of jobs or
other adverse economic impacts.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
ANPRM 59 FR 56423 11/14/94
Supplemental ANP63 FR 64343 11/18/98
Workshop 12/15/98
NPRM 65 FR 59549 10/05/00
NPRM Comment Period End 12/04/00
Final Action 12/00/00
Regulatory Flexibility Analysis Required:
No
Government Levels Affected:
State, Local
Additional Information:
Due to the Department's limited staff and financial resources,
regulatory actions related to energy efficiency standards have been
categorized as high, medium, and low priority based on significant
input from the public. This action is a high priority, and the
Department is working actively on this action.
Agency Contact:
Bryan Berringer, EE-41
Office of Building Research and Standards
Department of Energy
Energy Efficiency and Renewable Energy
1000 Independence Avenue SW.
Washington, DC 20585
Phone: 202 586-0371
Fax: 202 586-4617
Email: [email protected]
RIN: 1904-AA67
_______________________________________________________________________
DOE--EE
26. ENERGY EFFICIENCY STANDARDS FOR CENTRAL AIR CONDITIONERS AND HEAT
PUMPS
Priority:
Economically Significant. Major under 5 USC 801.
Unfunded Mandates:
This action may affect the private sector under PL 104-4.
Legal Authority:
42 USC 6295
CFR Citation:
10 CFR 430.32
Legal Deadline:
Final, Statutory, January 1, 1994.
Abstract:
The Energy Policy and Conservation Act, as amended, establishes initial
energy-efficiency standard levels for most types of major residential
appliances and generally requires DOE to undergo two subsequent
rulemakings, at specified times, to determine whether the extant
standard for a covered product should be amended.
This is the initial review of the statutory standards for central air
conditioners and heat pumps.
Statement of Need:
This rulemaking is required by statute. Experience has shown that the
choice of residential appliances and commercial equipment being
purchased by both builders and building owners is generally based on
the initial cost rather than on life-cycle cost. Thus, the law requires
minimum energy efficiency standards for appliances to eliminate
inefficient appliances and equipment from the market.
Summary of Legal Basis:
The Energy Policy and Conservation Act (EPCA), as amended, establishes
initial energy efficiency standard levels for most types of major
residential appliances and certain types of commercial equipment and
generally requires DOE to undergo rulemakings, at specified times, to
determine whether the standard for a covered product should be made
more stringent.
Alternatives:
The statute requires DOE to conduct rulemakings to review standards and
to revise standards to achieve the maximum improvement in energy
efficiency that the Secretary determines is technologically feasible
and economically justified. In making this determination, the
Department conducts a thorough analysis of alternative standard levels,
including the existing standard, based on criteria specified by
statute. The process improvements that were announced (61 FR 36974,
July 15, 1996) further enhance the analysis of alternative standards.
For example, DOE will ask stakeholders and private sector technical
experts to review its analyses of the likely impacts, costs, and
benefits of alternative standard levels. In addition, the Department
will solicit and consider information on nonregulatory approaches for
encouraging the purchase of energy efficient products.
Anticipated Cost and Benefits:
The proposed energy efficiency standards for central air conditioners
would provide significant energy savings to the Nation. Over a 25-year
[[Page 73351]]
period more than 4 quadrillion Btus of energy would be saved,
equivalent to all the energy consumed by nearly 12 million Americans in
a single year. These energy savings would also significantly reduce the
emissions of air pollutants and greenhouse gases associated with
electricity production by avoiding the emission of 60 million tons of
carbon and 150 thousand tons of nitrogen oxide. Also, the standards
would eliminate the need for the construction of at least 6 new 500-
megawatt power plants.
Risks:
Without appliance efficiency standards, energy use will continue to
increase with resulting damage to the environment caused by atmospheric
emissions. Enhancing appliance energy efficiency reduces atmospheric
emissions of carbon dioxide and nitrogen oxides. Establishing standards
that are too stringent could result in excessive increases in the cost
of the product, possible reductions in product utility and may place an
undue burden on manufacturers that could result in a loss of jobs or
other adverse economic impacts.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
ANPRM 58 FR 47326 09/08/93
Screening Workshop 06/30/98
Supplemental ANP64 FR 66305 11/24/99
NPRM 65 FR 59589 10/05/00
NPRM Comment Period End 12/04/00
Final Action 12/00/00
Regulatory Flexibility Analysis Required:
Undetermined
Government Levels Affected:
Local, State
Additional Information:
Due to the Department's limited staff and financial resources, the
regulatory actions related to energy efficiency standards have been
categorized as high, medium, and low priority based on significant
input from the public. This action is a high priority, and the
Department is actively working on this action.
Agency Contact:
Michael Raymond, EE-41
Program Manager, Office of Building Research and Standards
Department of Energy
Energy Efficiency and Renewable Energy
1000 Independence Avenue SW.
Washington, DC 20585
Phone: 202 586-9611
Email: [email protected]
RIN: 1904-AA77
_______________________________________________________________________
DOE--EE
-----------
FINAL RULE STAGE
-----------
27. ENERGY EFFICIENCY STANDARDS FOR WATER HEATERS
Priority:
Economically Significant. Major under 5 USC 801.
Unfunded Mandates:
This action may affect the private sector under PL 104-4.
Legal Authority:
42 USC 6295
CFR Citation:
10 CFR 430.32
Legal Deadline:
Final, Statutory, January 1, 1992.
Abstract:
The Energy Policy and Conservation Act as amended, establishes initial
energy-efficiency standard levels for most types of major residential
appliances and generally requires DOE to undergo two subsequent
rulemakings, at specified times, to determine whether the extant
standard for a covered product should be amended.
This is the initial review of the statutory standards for electric
water heaters.
Statement of Need:
This rulemaking is required by statute. Experience has shown that the
choice of residential appliances and commercial equipment being
purchased by both builders and building owners is generally based on
the initial cost rather than on life-cycle cost. Thus, the law requires
minimum energy efficiency standards for appliances to eliminate
inefficient appliances and equipment from the market.
Summary of Legal Basis:
The Energy Policy and Conservation Act (EPCA), as amended, establishes
initial energy efficiency standard levels for most types of major
residential appliances and certain types of commercial equipment and
generally requires DOE to undergo rulemakings, at specified times, to
determine whether the standard for a covered product should be made
more stringent.
Alternatives:
The statute requires DOE to conduct rulemakings to review standards and
to revise standards to achieve the maximum improvement in energy
efficiency that the Secretary determines is technologically feasible
and economically justified. In making this determination, the
Department conducts a thorough analysis of alternative standard levels,
including the existing standard, based on criteria specified by
statute. The process improvements that were recently announced (61 FR
36974, July 15, 1996) further enhance the analysis of alternative
standards. For example, DOE will ask stakeholders and private sector
technical experts to review its analyses of the likely impacts, costs,
and benefits of alternative standard levels. In addition, the
Department will solicit and consider information on non-regulatory
approaches for encouraging the purchase of energy efficient products.
Anticipated Cost and Benefits:
The Department estimates that the proposed standard will save 4.75
quadrillion Btu's of energy over a 27-year period. The estimated net
present value of expected savings is $3.4 billion over the same period.
The proposed standard would also produce cumulative greenhouse gas
reductions of 83 million metric tons of carbon equilvalent and 229
thousand metric tons of nitrous oxides.
Risks:
Without appliance efficiency standards, energy use will continue to
increase with resulting damage to the environment caused by atmospheric
emissions. Enhancing appliance energy efficiency reduces atmospheric
emissions of carbon dioxide and nitrogen oxides. Establishing standards
that are too stringent could result in excessive increases in the cost
of the product, possible reductions in product utility and may place an
undue burden on manufacturers that could result in a loss of jobs or
other adverse economic impacts.
[[Page 73352]]
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
ANPRM 55 FR 39624 09/28/90
NPRM 59 FR 10464 03/04/94
Screening Workshop 06/24/97
Notice of Availa63 FR 2186 01/14/98
Impact Workshop 11/09/98
Workshop 07/23/99
Reissue NPRM 65 FR 25041 04/28/00
Final Action 12/00/00
Regulatory Flexibility Analysis Required:
No
Government Levels Affected:
Local, State
Additional Information:
Due to the Department's limited staff and financial resources,
regulatory actions related to energy efficiency standards have been
categorized as high, medium, and low priority based on significant
input from the public. This action is a high priority, and the
Department is working actively on this action.
Agency Contact:
Terry Logee, EE-41
Program Manager, Office of Building Research and Standards
Department of Energy
Energy Efficiency and Renewable Energy
1000 Independence Avenue SW.
Washington, DC 20585
Phone: 202 586-1689
Email: [email protected]
RIN: 1904-AA76
_______________________________________________________________________
DOE--Departmental and Others (ENDEP)
-----------
FINAL RULE STAGE
-----------
28. NUCLEAR SAFETY MANAGEMENT
Priority:
Other Significant
Reinventing Government:
This rulemaking is part of the Reinventing Government effort. It will
revise text in the CFR to reduce burden or duplication, or streamline
requirements.
Legal Authority:
42 USC 2201; 42 USC 7191
CFR Citation:
10 CFR 830
Legal Deadline:
None
Abstract:
This action will add regulations under 10 CFR 830 to establish nuclear
safety management requirements for the Department's nuclear facilities.
These requirements stem from the Department's obligations to assure
adequate protection and to hold contractors who manage and operate
these facilities accountable and responsible for safe operations.
Statement of Need:
The purpose of this rule is to ensure that the Department's obligation
to protect health and safety is fulfilled and to provide, if needed, a
basis for the imposition of civil and criminal penalties consistent
with the Price-Anderson Amendments Act of 1988. This action is
consistent with the Department's commitment to the issuance of nuclear
safety requirements using notice and comment rulemaking.
Summary of Legal Basis:
Under the Atomic Energy Act of 1954, as amended, the Department of
Energy has the authority to regulate activities at facilities under its
jurisdiction. The Department is committed to honoring its obligation to
ensure the health and safety of the public and workers affected by its
operations.
Alternatives:
The Department could continue to impose nuclear safety requirements
through directives made applicable to DOE contractors through the terms
of their contracts.
Anticipated Cost and Benefits:
The incremental costs of the proposed rules should be minimal because
contractors are currently bound by comparable contractual obligations.
Full compliance by contractors with nuclear safety standards will
result in substantial societal benefits.
Risks:
This rulemaking should reduce the risk of nuclear safety problems by
clarifying safety requirements applicable to DOE contractors and
improving compliance.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 56 FR 64316 12/01/91
Second NPRM 60 FR 45381 08/31/95
Interim Final Ru65 FR 60292 10/10/00
Interim Final Rule Comment Period End 11/09/00
Final Action 12/00/00
Regulatory Flexibility Analysis Required:
No
Government Levels Affected:
None
Agency Contact:
Richard L. Black
Director, Office of Nuclear Safety and Policy Standards
Department of Energy
1000 Independence Avenue SW.
Washington, DC 20585
Phone: 301 903-3465
RIN: 1901-AA34
_______________________________________________________________________
DOE--ENDEP
29. RADIATION PROTECTION OF THE PUBLIC AND THE ENVIRONMENT
Priority:
Other Significant
Legal Authority:
42 USC 2201; 42 USC 7191
CFR Citation:
10 CFR 834
Legal Deadline:
None
Abstract:
This action would add a new 10 CFR 834 to DOE's regulations
establishing a body of rules setting forth the basic requirements for
ensuring radiation protection of the public and environment in
connection with DOE nuclear activities. These requirements stem from
the Department's ongoing effort to strengthen the protection of health,
safety, and the environment from the nuclear and chemical hazards posed
by these DOE activities. Major elements of the proposal included a dose
limitation system for protection of the public; requirements for liquid
discharges; reporting and monitoring requirements; and residual
radioactive material requirements.
Statement of Need:
The purpose of this rule is to ensure that the Department's obligation
to protect health and safety is fulfilled and to provide, if needed, a
basis for the imposition of civil and criminal penalties consistent
with the Price-
[[Page 73353]]
Anderson Amendments Act of 1988. This action is consistent with the
Department's commitment to the issuance of nuclear safety requirements
using notice and comment rulemaking.
Summary of Legal Basis:
Under the Atomic Energy Act of 1954, as amended, the Department of
Energy has the authority to regulate activities at facilities under its
jurisdiction. The Department is committed to honoring its obligation to
ensure the health and safety of the public and workers affected by its
operations and the protection of the environs around its facilities.
Alternatives:
The Department could continue to impose nuclear safety requirements
through directives made applicable to DOE contractors through the terms
of their contracts.
Anticipated Cost and Benefits:
The incremental costs of the proposed rules should be minimal because
contractors are currently bound by comparable contractual obligations.
Full compliance by contractors with nuclear safety standards will
result in substantial societal benefits.
Risks:
This rulemaking should reduce the risk of nuclear safety problems by
clarifying safety requirements applicable to DOE contractors and
improving compliance.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 58 FR 16268 03/25/93
Second NPRM 60 FR 45381 08/31/95
Final Action 04/00/01
Regulatory Flexibility Analysis Required:
No
Government Levels Affected:
Federal
Agency Contact:
Andrew Wallo III
Director, Air, Water and Radiation Division
Department of Energy
Office of Environmental Guidance
1000 Independence Avenue SW.
Washington, DC 20585
Phone: 202 586-4996
RIN: 1901-AA38
BILLING CODE 6450-01-S
[[Page 73354]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Statement of Regulatory Priorities
The Department of Health and Human Services (HHS) is the United States
Government's principal agency for protecting the health of all
Americans and for providing essential human services, especially for
those who are least able to help themselves. To carry out its multiple
responsibilities, the Department works through ten major operating
divisions that manage over 300 programs. This spectrum of activities
includes:
Medicare (health insurance for elderly and disabled
Americans);
Medicaid (health insurance for low-income people);
Medical and social science research;
Preventing outbreaks of infectious disease, including
immunization services;
Assuring food and drug safety;
Financial assistance for low-income families;
Child support enforcement;
Improving maternal and infant health;
Head Start (preschool education and services);
Preventing child abuse and domestic violence;
Substance abuse treatment and prevention;
Services for older Americans, including home-delivered meals;
and
Comprehensive health services delivery for American Indians
and Alaskan Natives.
HHS is the largest grant-making agency in the Federal Government,
providing some 60,000 grants per year. The Medicare program is the
Nation's largest health insurer, handling more than 900 million claims
per year. The Department works closely with State and local
governments, and many HHS-funded services are provided by State- or
local-government agencies, or through private-sector grantees. HHS
programs provide for equitable treatment of beneficiaries nationwide,
and they enable the collection of national health and other data.
For the foreseeable future, the Department's regulatory priorities, as
reflected in the specific Plan entries that follow, involve:
Protecting the privacy of patients' medical and health
insurance records;
Continuing efforts to strengthen and modernize Medicare, as
mandated in recent legislation;
Several undertakings to assure the safety and efficacy of
prescription drugs and medical devices so that consumers
may use FDA-regulated products more efficaciously,
including new measures reflecting the President's food-
safety initiative; and
New efforts in substance-abuse treatment and prevention.
Underlying the Department's efforts to move forward in these areas in
FY 2000 and beyond, there endures the policy framework established by
the President's Executive Order 12866, Regulatory Planning and Review.
Under the principles set out in this order, the Department assures that
its rulemakings: (1) emphasize performance standards and market
incentives over prescriptive, command-and-control requirements; (2)
reflect the use of cost-benefit and risk assessment analyses to achieve
policy objectives in the most efficient manner possible; (3) are
developed in consultation with those most affected, especially our
partners in the Federal system at the State and local levels; and (4)
focus specifically on clearly identified problems, avoiding overly
broad, one-size-fits-all approaches to these problems. Efforts to
comply with these principles have been a continuing HHS priority since
1993.
The bulk of HHS's regulatory activity emanates from programs of the
Food and Drug Administration and the Health Care Financing
Administration. The Statement of Regulatory Priorities for these
components of the Department follows, below, along with a summary of
specific Plan entries.
Food and Drug Administration
The Food and Drug Administration's (FDA) regulatory strategy involves
three main goals: (1) to reflect new technologies or programs that will
benefit the public, affected industries, and the agency or further
protect the public health; (2) to provide more information to consumers
so that they may use FDA-regulated products more safely or effectively;
and (3) to eliminate unnecessary burdens on industry. The following
illustrative examples reflect the agency's efforts to carry out this
strategy.
On November 17, 1999, FDA proposed to amend its regulations on
nutrition labeling to require that the amount of trans fatty acids
present in a food, including dietary supplements, be included in the
amount and percent Daily Value (%DV) declared for saturated fatty
acids. FDA is proposing that when trans fatty acids are present, the
declaration of saturated fatty acids shall bear a symbol that refers to
a footnote at the bottom of the nutrition label, which states the
number of grams of trans fatty acids present in a serving of the
product. FDA also proposed that, wherever saturated fat limits are
placed on nutrient content claims, health claims, or disclosure and
disqualifying levels, the amount of trans fatty acids be limited as
well. This action was also taken to prevent misleading claims and to
provide information to assist consumers in maintaining healthy dietary
practices.
On December 1, 1999, FDA proposed to revise the status reports section
of the postmarketing annual reporting requirements for drug and
biological products, and to require applicants to submit annual status
reports for certain postmarketing studies of licensed biological
products. The proposed rule would describe the types of postmarketing
studies covered by these status reports, the information to be included
in the reports, and the type of information that FDA would consider
appropriate for public disclosure.
On January 26, 2000, FDA amended its regulations governing reporting
by manufacturers, importers, distributors and health care (user)
facilities of adverse events related to medical devices.
FDA amended its regulations to require that all prescription and over-
the-counter (OTC) aqueous-based drug products for oral inhalation be
manufactured sterile (May 26, 2000). This rule applies to aqueous-based
oral inhalation drug products in both single-dose and multiple-use
primary packaging. Pressurized metered-dose inhalers are not subject to
this rule. Based on reports of adverse drug experiences from
contaminated nonsterile inhalation drug products and recalls of these
products, FDA is taking this action to help ensure the safety and
effectiveness of these products.
FDA amended its regulations on petitions for the use of food
ingredients and sources of radiation (August 25, 2000). The change will
permit an efficient, joint review by both FDA and the Food Safety and
Inspection Service, U.S. Department of Agriculture, of petitions for
approval to use a food ingredient or source of radiation in or on meat
or poultry products.
A final rule is in the last stages of completion, which is part of the
joint FDA and FSIS farm-to-table food safety system for shell eggs to
reduce the risk of foodborne illness. This final rule would establish
refrigeration requirements for shell eggs held at retail and labeling
requirements instructing egg preparers and consumers on safe
[[Page 73355]]
handling of shell eggs. This initiative is in response to the continued
reports of outbreaks of foodborne illness and death caused by
salmonella enteritidis.
The year 2000 Regulatory Plan entries for FDA include actions as
described below.
The agency plans to propose a regulation that would require sponsors
of human trials involving human gene therapy or xenotransplantation to
submit a redacted version of the original for public disclosure, with
an investigational new drug application (IND), an amendment to an IND,
or other related documents. Trade secret and personal information would
be excluded from the redacted information and made available to the
general public.
FDA is proposing to require the submission to the agency of data and
information regarding plant-derived bioengineered foods that would be
consumed by humans or animals. FDA is taking this action to ensure that
it has the appropriate amount of information about bioengineered foods
to help to ensure that all market entry decisions by the industry are
made consistently and in full compliance with the law.
Another initiative would require manufacturers of human cellular and
tissue-based products to register with FDA and to submit a list of all
products. The final rule is designed to provide a rational,
comprehensive, and clear framework for a rapidly growing industry that
produces human cellular and tissue based products.
FDA is also placing on the Regulatory Plan a proposed rule that would,
as part of implementing the proposed regulatory approach to human
cellular and tissue-based products, require manufacturers of human
cells and tissue to follow current good tissue practice.
FDA is considering whether to propose to establish regulations that
prescribe current good manufacturing practice (CGMP) for dietary
supplements and dietary supplement ingredients. CGMP regulations would
ensure that consumers are provided with safe dietary supplement
products, which meet the quality specifications that the supplements
are represented to meet.
A proposed rule would amend the regulations governing the format and
content of professional labeling for human prescription drug and
biologic products. The proposal would also eliminate certain
unnecessary statements that are currently required to appear on
prescription drug labels and move certain information to professional
labeling.
Another proposed rule would clarify for pharmacies the roles of FDA
and the States in regulating pharmacy compounding activities, and
define prescription drug compounding activities that fall within FDA's
jurisdiction and describe the requirements applicable to those
activities. It has been FDA's policy not to interfere with the
traditional practice of pharmacy compounding at the retail level.
However, changes in the drug delivery system, including the expansion
of pharmacy compounding activities, have heightened agency concern for
the safety of consumers receiving medications prepared by pharmacy
compounding.
A proposed rule would amend the biologics regulations to require that
blood establishments prepare and follow written procedures for
appropriate action when it is determined that blood and blood
components at increased risk for transmitting HCV infection have been
collected from a donor who, at a later date, tested repeatedly reactive
for evidence of HCV. For a complete listing of the rulemakings
associated with the Blood Initiative see the Unified Agenda section.
These actions are intended to help ensure the continued safety of the
nation's blood supply.
As part of its Food Safety Initiative, FDA and FSIS are committed to
developing an action plan to address the presence of salmonella
enteritidis in shell eggs and egg products using a farm-to-table
approach. FDA will propose to codify egg-relevant provisions of the
1999 Food Code.
Under consideration is a final rule that would establish requirements
for a comprehensive food safety assurance program for domestically
produced and imported juices based on Hazard Analysis Critical Control
Points (HACCP) principles. This initiative is in response to several
outbreaks of illness associated with juice products. FDA's current view
is that a HACCP system of preventative controls would be an effective
and efficient way to ensure that these products are safe.
A proposal would amend the regulation for hearing aids. Current
regulations require consumers to be examined by a physician before they
purchase a hearing aid, but also allow for a waiver. Because this
waiver provision may be misused, FDA is considering whether to
eliminate the waiver provision and instead require a medical evaluation
when certain previously undiagnosed conditions are found or when the
prospective hearing aid user is under 18 years of age. In addition, the
agency is considering whether to restrict the dispensing of a hearing
aid to patients who have undergone a comprehensive hearing assessment
within the past 12 months. This proposal reflects changes in the nature
of the causes of hearing loss and the technology of hearing aids. Due
to the aging of the population, far fewer cases of hearing loss today
are caused by medically treatable conditions, so there may be less need
for a medical examination. However, advances in hearing aid technology
necessitate proper testing in order for a hearing aid to be effective.
Section 121 of the Food and Drug Administration Modernization Act of
1997 directed FDA to establish requirements for CGMPs for positron
emission tomography (PET) drugs, a type of radiopharmaceutical. A
proposed rule would adopt CGMPs that reflect the unique characteristics
of PET drugs, such as their short half-lives and the fact that they are
often, though not always, produced and administered at the same
facility. The proposed CGMPs for PET drugs are less detailed and less
burdensome than the CGMPs applicable to conventional drugs under 21 CFR
parts 210 and 211.
The final document under consideration by FDA is a proposal that would
amend the expedited and periodic safety reporting regulations for human
drugs and biological products: (1) to revise certain definitions and
reporting formats, as recommended by the International Conference on
Harmonization, and to define new terms; (2) to add to, or revise
current reporting requirements; (3) to revise certain reporting time
frames; and (4) to make other revisions to these regulations to enhance
the quality of safety reports received by FDA.
Health Care Financing Administration
The Health Care Financing Administration (HCFA) has worked, and
continues to work diligently to provide guidance on the many provisions
of the Balanced Budget Act legislation. The agency is developing
additional appropriate regulations to address provisions that have not
yet been implemented in their entirety. HCFA's focus during this coming
fiscal year is diverse, encompassing payment issues, program integrity,
the children's health insurance program, and managed care.
[[Page 73356]]
Payment Regulations
Ambulance Fee Schedule
The Balanced Budget Act of 1997 (BBA) requires the establishment of a
fee schedule for ambulance services under the Medicare Program.
Policies are being developed through negotiated rulemaking. The
negotiated rulemaking committee, representing varied public and private
interests related to ambulance services, was scheduled to conclude in
February 2000, after taking into account such factors as cost control,
geographic and operational differences. Publication of the proposed
rule will take place as soon as practical thereafter.
Prospective Payment Systems
Home Health Agencies are currently being paid under an interim payment
system in accordance with requirements of the BBA. As also required by
the BBA, HCFA is developing a proposed rule to establish requirements
for the new Home Health prospective payment system. The same
legislation requires a prospective payment system for rehabilitation
facilities, now being formulated as a proposed rule. HCFA published a
notice of proposed rulemaking on September 8, 1998 for a hospital
outpatient prospective payment system, and is drafting a final rule
that takes into consideration the comments that we received on the
September 1998 document.
Qualifications for Establishing and Maintaining Medicare Billing
Privileges
The BBA and other laws require the furnishing of information and the
identification of individuals or entities that furnish medical services
to beneficiaries before payment can be made. HCFA seeks to ensure that
those that provide services to our beneficiaries are qualified to do
so. In addition, the agency is responsible for protecting the Trust
Funds by ensuring that any duplicate or overpayments are recouped.
Through the gathering of information, and the use of unique identifiers
for those that furnish services for which Medicare payment may be made,
better protection of beneficiaries and public funds can be effected.
HCFA is developing a notice of proposed rulemaking to address the use
of an information collection instrument that would provide the
necessary information before we make a determination of whether a
provider or supplier should be granted billing privileges.
Children's Health Insurance Program (CHIP) Regulations
Under this optional program, created as title XXI of the Social
Security Act under the BBA, States may initiate and expand child health
assistance to uninsured, low-income children. Because of the short
timeframe between the enactment of the BBA and the effective date of
the legislation, and our interest in ensuring that States could take
advantage of the opportunity to better serve their vulnerable youthful
populations, HCFA developed guidance that permitted 54 States and
territories to have approved CHIP plans. Thus, operation of the CHIP
program has begun, prior to the completion of regulations, but
pertinent guidance materials will be codified in regulation over the
coming year.
Managed Care Regulations
Medicare+Choice
HCFA published an interim final regulation implementing the
Medicare+Choice program on June 26, 1998, and a final rule on February
17, 1999, addressing selected issues raised by commenters on the June
1998 regulation. The next final rule under development will be more
comprehensive, and it will respond to all comments and implement other
changes as necessary.
Medicaid Managed Care
HCFA published a notice of proposed rulemaking on September 29, 1998;
addressing the BBA modifications of the Medicaid managed care programs.
The publication proposed enhanced enrollee protections and emphasized
the quality of health care delivered to Medicaid enrollees. The final
rule, under development, will respond to public comments, and make any
appropriate revisions necessary to finalize the Medicaid Managed Care
programs.
Additional Regulations
HCFA continues to focus on the importance of updating physician
payments. A notice of proposed rulemaking was published on July 22,
1999, addressing the updating of physician payments by Medicare,
including a provision to change the method of determining malpractice
insurance relative value units (RVUs) from the current charge-based
system to a resource-based system. The proposal continues the
refinement of the practice-expense RVUs that are transitioning from
charge-based to resource-based, and it addresses new and revised
procedure codes for the year 2000. The final rule, addressing comments
received in response to the July 1999 publication, will be published
shortly.
_______________________________________________________________________
HHS--Office of the Secretary (OS)
-----------
FINAL RULE STAGE
-----------
30. STANDARDS FOR PRIVACY OF INDIVIDUALLY INDENTIFIABLE HEALTH
INFORMATION
Priority:
Economically Significant. Major under 5 USC 801.
Unfunded Mandates:
This action may affect State, local or tribal goverments and the
private sector.
Legal Authority:
42 USC 1320d-2; 42 USC 1320d-4; PL 104-191, sec 264
CFR Citation:
45 CFR 160; 45 CFR 164
Legal Deadline:
Final, Statutory, February 21, 2000.
Abstract:
The final rule would implement part of the Administrative
Simplification requirements of Public Law 104-191 by establishing
standards for health plans, health care clearinghouses and certain
health care providers to protect the privacy of individually
identifiable health information.
Statement of Need:
The Health Insurance Portability and Accountability Act of 1996 (HIPAA)
(Pub. L. 104-191) requires the Department to issue final standards for
the privacy of individually identifiable health information by February
21, 2000. The confidentiality of such information varies significally.
The standards will establish national protections applicable to
individually identifiable health information created or maintained by
health plans, health clearinghouses, and health providers that conduct
transactions electronically.
Summary of Legal Basis:
The Health Insurance Portability and Accountability Act of 1996 (HIPAA)
(Pub. L. 104-191) directed the Department to issue several standards to
facilitate the electronic exchange of information with respect to
financial and administrative transactions. It also
[[Page 73357]]
directed the Department to develop and submit to Congress
recommendations for privacy legislation. In addition, if Congress did
not enact legislation governing privacy standards with respect to
individually identifiable health information by August 21, 1999, HIPAA
directed the Department to promulgate final regulations containing such
standards by February 21, 2000. A proposed rule was published in the
fall of 1999. A final regulation reflecting the public comments to the
proposal will be issued to satisfy the statutory requirement.
Alternatives:
The Department is required by statute to issue final regulations by
February 21, 2000. Therefore, no alternatives to regulatory action have
been considered.
Anticipated Cost and Benefits:
The proposal was esimated to cost $3.8 billion. Estimates of the
economic impact that will stem from this rule will be revised based on
the public comments. A final anaylsis will be included with the final
regulation.
Risks:
The extensive comments on the proposed rule provided detailed
information on a wide range of important and complex information. The
final rule will reflect these insights. Publication of the final rule
will enable the Department to meet its statutuary deadline.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 64 FR 59967 11/03/99
Final Action 11/00/00
Regulatory Flexibility Analysis Required:
Yes
Small Entities Affected:
Businesses, Governmental Jurisdictions, Organizations
Government Levels Affected:
State, Local, Tribal, Federal
Federalism:
This action may have federalism implications as defined in EO 13132.
Agency Contact:
Roxanne Gibson
Senior Administrative Assistant
Department of Health and Human Services
Office of the Secretary
Room G-322A, Attention: Privacy-P
200 Independence Avenue SW.
Washington, DC 20201
Phone: 202 260-5083
RIN: 0991-AB08
_______________________________________________________________________
HHS--Substance Abuse and Mental Health Services Administration (SAMHSA)
-----------
FINAL RULE STAGE
-----------
31. FINAL AND DELEGATION OF AUTHORITY TO IMPLEMENT SAMHSA'S
ACCREDITATION BASED SYSTEM FOR OPIOD TREATMENT PROGRAM MONITORING
Priority:
Other Significant
Reinventing Government:
This rulemaking is part of the Reinventing Government effort. It will
revise text in the CFR to reduce burden or duplication, or streamline
requirements.
Legal Authority:
21 USC 823; 42 USC 257a; 42 USC 290aa(d); 42 USC 290dd-2; 42 USC 300x-
23; 42 USC 300x-27(a); 42 USC 3007-11
CFR Citation:
42 CFR 8
Legal Deadline:
None
Abstract:
The regulations are divided into three parts. The first establishes the
procedures and criteria for becoming an approved accreditation body
under the regulations. There are three existing organizations that
currently accredit narcotic treatment programs. SAMHSA envisions
several authorized accreditation bodies, including some State
authorities. This will address the Institute of Medicine (IOM)
recommendation to consolidate multiple Federal, State, and local
authority inspections.
The second part establishes the criteria and procedures for
certification. The Department of Health and Human Services (HHS)
certification will form the basis for ``determining the
qualifications'' of practitioners under section 303(g) of the
Controlled Substances Act, which in turn, will allow DEA to register
the program to dispense narcotic drugs. HHS certification will be based
primarily upon successful accreditation. This section also sets forth
those Federal opiod treatment standards that were identified by the IOM
as necessary to prevent substandard treatment. The final rule
substantially revises the provisions relating to opiod treatment
medications provided for unsupervised use in a manner that will enable
stabilized patients to be treated in office-based settings.
The third and final section of the regulations provides a notice and
hearing procedure for the Department's suspension or revocation of a
treatment program's certification. The procedure is based on the
procedure already in place for review of SAMHSA's certification
decisions for Federal Workplace Testing Laboratories. This part also
provides a procedure for accreditation bodies to use for review of an
adverse action taken regarding withdrawal of the accreditation body.
Statement of Need:
The Institute of Medicine completed a study of Federal oversight of
methadone clinics. As a direct result of the study, the Food and Drug
Administration (FDA) and SAMHSA in collaboration with the National
Institute on Drug Abuse, the Drug Enforcement Agency, the Office of
National Drug Control Programs, and the Department of Verteran's
Affairs, met on several occasions to implement some of the
recommendations of that study. Among the recommendations, was a
proposal that is implemented, here, which would change the current
system for regulating opiod treatment programs from a direct inspection
system enforced by the FDA to an accreditation-based system monitored
by SAMHSA.
Summary of Legal Basis:
As a narcotic drug intended for the treatment of opiod addiction,
methadone is subject to the requirements of the Narcotic Addict
Treatment Act (NATA). Under NATA, practitioners who use approved
narcotic treatment medications must register separately with the Drug
Enforcement Administration (DEA). The DEA registration is based upon
the Secretary's determination that the applicant is qualified, under
treatment
[[Page 73358]]
standards established by the Secretary, to provide such treatment. The
Secretary's standards under NATA exist as regulations enforced by the
FDA.
Alternatives:
Because FDA's inspection system was established through regulatory
action, there is no available alternative to implementing the Institute
of Medicine's recommendations regarding an accreditation-based system
monitored by SAMHSA without accomplishing the system change through new
regulatory action.
Anticipated Cost and Benefits:
The net costs of the new system over the existing FDA system, factoring
in SAMHSA's annual oversight costs of $3.4 million, is estimated at an
annual $4.4 million level. Additional information on accreditation
costs will be derived from SAMHSA's ongoing accreditation project.
Risks:
None.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 64 FR 39810 07/22/99
Final Rule 02/00/01
Regulatory Flexibility Analysis Required:
Yes
Small Entities Affected:
Businesses
Government Levels Affected:
None
Agency Contact:
Joseph D. Faha
Director, DLEA, SAMHSA
Department of Health and Human Services
Substance Abuse and Mental Health Services Administration
Room 12C-15
5600 Fishers Lane
Rockville, MD 20857
Phone: 301 443-4640
RIN: 0930-AA06
_______________________________________________________________________
HHS--Food and Drug Administration (FDA)
-----------
PROPOSED RULE STAGE
-----------
32. HEARING AIDS; PROFESSIONAL AND PATIENT LABELING; CONDITIONS FOR
SALE
Priority:
Other Significant. Major status under 5 USC 801 is undetermined.
Unfunded Mandates:
This action may affect State, local or tribal goverments and the
private sector.
Reinventing Government:
This rulemaking is part of the Reinventing Government effort. It will
revise text in the CFR to reduce burden or duplication, or streamline
requirements.
Legal Authority:
21 USC 351; 21 USC 352; 21 USC 360d; 21 USC 371; 21 USC 360j(e)
CFR Citation:
21 CFR 801.420; 21 CFR 801.421
Legal Deadline:
None
Abstract:
FDA is considering revising its present regulation governing the
labeling and conditions for sale of hearing aids. The present rule
requires an examination by a physician before purchase of a hearing
aid, but permits an informed adult to waive that requirement. There is
some evidence that this waiver provision is being misused.
Statement of Need:
FDA has become aware of changes in the nature of the causes of hearing
loss and the technology of hearing aids that necessitate
reconsideration of the regulations governing hearing aids. In the past,
hearing loss often was caused by medically treatable conditions. Today,
medical and/or surgical intervention will correct hearing loss in only
5 to 10 percent of the cases. Therefore, there may be less of a need
for medical evaluation. FDA believes, however, that patients should
receive proper testing in order for a hearing aid to be effective.
Summary of Legal Basis:
Under 21 U.S.C. 360j(e), FDA has the authority to restrict the sale,
distribution, or use of a medical device, if FDA determines that,
without such restrictions, there cannot be reasonable assurance of its
safety and effectiveness. Under 21 U.S.C. 352, FDA has the authority to
require that the labeling of a medical device include adequate
directions for use.
Alternatives:
FDA considered applying the rule only to first time purchasers of
hearing aids. FDA believes, however, that this would not adequately
protect present users of inappropriate or unneeded hearing aids. FDA
also considered requiring additional tests, but has preliminarily
determined to list these tests as recommended only in order to provide
additional flexibility.
Anticipated Cost and Benefits:
FDA is still developing an estimate of the cost of the proposed rule.
FDA expects that the benefits from the rule would include: (1)
improving the quality of life of hearing aid users; (2) avoiding the
cost of inappropriate hearing aid purchase; (3) reducing doctor visits
for hearing aid evaluations; (4) lowering treatment costs due to early
detection of serious conditions; and (5) encouraging the dissemination
of accurate information concerning the benefits and limitations of
hearing aids.
Risks:
If the hearing aid purchaser inappropriately waives the medical
evaluation requirement under the existing rule, treatable causes of
hearing loss may go undetected. Many purchasers who have not had proper
testing before a hearing aid purchase will forego the use of a hearing
aid because the one purchased does not adequately improve their hearing
ability. At this time, FDA believes that many hearing impaired people
who may benefit from a hearing aid do not purchase one because they
fear that they will not benefit from one due to inaccurate information.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
ANPRM 58 FR 59695 11/10/93
ANPRM Comment Period End 01/10/94
NPRM 12/00/00
Regulatory Flexibility Analysis Required:
Yes
Small Entities Affected:
Businesses
[[Page 73359]]
Government Levels Affected:
State
Federalism:
This action may have federalism implications as defined in EO 13132.
Additional Information:
Previously reported under RIN 0905-AE46.
Agency Contact:
Joseph M. Sheehan
Chief, Regulations Staff
Department of Health and Human Services
Food and Drug Administration
HFZ-215
Center for Devices and Radiological Health
1350 Piccard Drive
Rockville, MD 20850
Phone: 301 827-2974
RIN: 0910-AA39
_______________________________________________________________________
HHS--FDA
33. LABELING FOR HUMAN PRESCRIPTION DRUGS; REVISED FORMAT
Priority:
Other Significant. Major status under 5 USC 801 is undetermined.
Unfunded Mandates:
Undetermined
Reinventing Government:
This rulemaking is part of the Reinventing Government effort. It will
revise text in the CFR to reduce burden or duplication, or streamline
requirements.
Legal Authority:
21 USC 321; 21 USC 360gg to 360ss; 21 USC 371; 21 USC 374; 21 USC 379e;
21 USC 331; 21 USC 351; 21 USC 352; 21 USC 353; 21 USC 355; 21 USC 358;
21 USC 360; 21 USC 360b; 42 USC 216; 42 USC 241; 42 USC 262; 42 USC 264
CFR Citation:
21 CFR 201
Legal Deadline:
None
Abstract:
The proposed regulation would amend the regulations governing the
format and content of professional labeling for human prescription drug
and biologic products, 21 CFR 201.56 and 201.57. The proposal would
require that professional labeling include a section containing
highlights of prescribing information and a section containing an index
to prescribing information, reorder currently required information and
make minor changes to its content, and establish minimum graphical
requirements for professional labeling. The proposal would also
eliminate certain unnecessary statements that are currently required to
appear on prescription drug labels and move certain information to
professional labeling.
Statement of Need:
The current format and content requirements in sections 201.56 and
201.57 were established to help ensure that labeling includes adequate
information to enable health care practitioners to prescribe drugs
safely and effectively. However, various developments in recent years,
such as technological advances in drug product development, have
contributed to an increase in the amount, detail, and complexity of
labeling information. This has made it harder for practitioners to find
specific information and to discern the most critical information in
product labeling.
FDA took numerous steps to evaluate the usefulness of prescription drug
labeling for its principal audience and to determine whether, and how,
its format and content can be improved. The agency conducted focus
groups and a national survey of office-based physicians to ascertain
how prescription drug labeling is used by health care practitioners,
what labeling information is most important to practitioners, and how
professional labeling should be revised to improve its usefulness to
prescribing practitioners.
Based on the concerns cited by practitioners in the focus groups and
physician survey, FDA developed and tested two prototypes of revised
labeling formats designed to facilitate access to important labeling
information. Based on this testing, FDA developed a third revised
prototype that it made available to the public for comment. Ten written
comments were received on the prototype. FDA also presented the revised
prototype at an informal public meeting held on October 30, 1995. At
the public meeting, the agency also presented the background research
and provided a forum for oral feedback from invited panelists and
members of the audience. The panelists generally supported the
prototype.
The proposed rule attempts to establish format and content requirements
for prescription drug labeling that incorporate information and ideas
gathered during this process.
Summary of Legal Basis:
The agency has broad authority under sections 502, 505, and 701 of the
Federal Food, Drug, and Cosmetic Act (the Act)(21 U.S.C. 352, 355 and
371) and section 351 of the Public Health Service Act (42 U.S.C. 262)
to regulate the content and format of prescription drug labeling to
help ensure that products are safe and effective for their intended
uses. A major part of FDA's efforts regarding the safe and effective
use of drug products involves FDA's review, approval, and monitoring of
drug labeling. Under section 502(f)(1) of the Act, a drug is misbranded
unless its labeling bears ``adequate directions for use'' or it is
exempted from this requirement by regulation. Under section 201.100 (21
CFR 201.100), a prescription drug is exempted from the requirement in
section 502(f)(1) only if, among other things, it contains the
information required, in the format specified, by sections 201.56 and
201.57.
Under section 502(a) of the Act, a drug product is misbranded if its
labeling is false or misleading in any particular. Under section 505(d)
and 505(e) of the Act, FDA must refuse to approve an application and
may withdraw the approval of an application if the labeling for the
drug is false or misleading in any particular. Section 201(n) of the
Act provides that in determining whether the labeling of a drug is
misleading, there shall be taken into account not only representations
or suggestions made in the labeling, but also the extent to which the
labeling fails to reveal facts that are material in light of such
representations or material with respect to the consequences which may
result from use of the drug product under the conditions of use
prescribed in the labeling or under customary usual conditions of use.
These statutory provisions, combined with section 701(a) of the Act and
section 351 of the Public Health Service Act, clearly authorize FDA to
promulgate a regulation designed to help ensure that practitioners
prescribing drugs (including biological products) will receive
information essential to their safe and effective use in a format that
makes the information easier to access, read, and use.
[[Page 73360]]
Alternatives:
The alternatives to the proposal include not amending the content and
format requirements in sections 201.56 and 201.57 at all, or amending
them to a lesser extent. The agency has determined that although drug
product labeling, as currently designed, is useful to physicians, many
find it difficult to locate specific information in labeling, and some
of the most frequently consulted and most important information is
obscured by other information. In addition, the agency's research
showed that physicians strongly support the concept of including a
highlights section of the most important prescribing information, an
index and numbering system that permits specific information to be
easily located, and other proposed requirements, such as the
requirement for a minimum type size. Thus, the agency believes that the
proposed requirements will greatly facilitate health care
practitioners' access and use of prescription drug and biological
labeling information.
Anticipated Cost and Benefits:
The expected benefits from the proposed rule include reduced time
needed for health care professionals to read or review labeling for
desired information, increased effectiveness of treatment, and a
decrease in adverse events resulting from avoidable drug-related
errors. For example, the proposed revised format is expected to
significantly reduce the time spent on reading labeling by highlighting
often used information at the beginning of labeling and facilitating
access to detailed information.
The potential costs associated with the proposed rule include the cost
of redesigning labeling for previously approved products to which the
proposed rule would apply and submitting the new labeling to FDA for
approval. In addition, one-time and ongoing incremental costs would be
associated with printing the longer labeling that would result from
additional required sections. These costs would be minimized by
applying the amended requirements only to newer products and by
staggering the implementation date for previously approved products.
Risks:
None.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 11/00/00
Regulatory Flexibility Analysis Required:
Yes
Small Entities Affected:
Businesses
Government Levels Affected:
Undetermined
Federalism:
Undetermined
Agency Contact:
Lee D. Korb
Regulatory Counsel, Regulatory Policy Staff
Department of Health and Human Services
Food and Drug Administration
Suite 3037 (HFD-7)
Center for Drug Evaluation and Research
1451 Rockville Pike
Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
Nancy M. Ostrove
Division of Drug Marketing, Advertising, and Communications
Department of Health and Human Services
Food and Drug Administration
(HFD-42)
Center for Drug Evaluation and Research
5600 Fishers Lane
Rockville, MD 20857
Phone: 301 827-2828
RIN: 0910-AA94
_______________________________________________________________________
HHS--FDA
34. SAFETY REPORTING REQUIREMENTS FOR HUMAN DRUG AND BIOLOGICAL
PRODUCTS
Priority:
Other Significant. Major status under 5 USC 801 is undetermined.
Unfunded Mandates:
Undetermined
Legal Authority:
42 USC 216; 42 USC 241; 42 USC 242a; 42 USC 262; 42 USC 263; 42 USC
263a-n; 42 USC 264; 42 USC 300aa; 21 USC 321; 21 USC 331; 21 USC 351 to
353; 21 USC 355; 21 USC 360; 21 USC 360b-j; 21 USC 361a; 21 USC 371; 21
USC 374; 21 USC 375; 21 USC 379e; 21 USC 381
CFR Citation:
21 CFR 310; 21 CFR 312; 21 CFR 314; 21 CFR 600; 21 CFR 320; 21 CFR 601;
21 CFR 606
Legal Deadline:
None
Abstract:
The proposed rule would amend the expedited and periodic safety
reporting regulations for human drugs and biological products to revise
certain definitions and reporting formats as recommended by the
International Conference on Harmonization and to define new terms; to
add to or revise current reporting requirements; to revise certain
reporting time frames; and to make other revisions to these regulations
to enhance the quality of safety reports received by FDA.
Statement of Need:
FDA currently has safety reporting requirements in section 21 CFR
312.32 for sponsors of investigational drugs for human use. FDA also
has safety reporting requirements in sections 21 CFR 310.305, 314.80,
314.90 and 600.80 for applicants, manufacturers, packers and
distributors of approved human drug and biological products. FDA has
undertaken a major effort to clarify and revise these regulations to
improve the management of risks associated with the use of these
products. For this purpose, the agency is proposing to implement
definitions and reporting formats and standards recommended by the
International Conference on Harmonisation of Technical Requirements for
Registration of Pharmaceuticals for Human Use (ICH) to provide more
effective and efficient safety reporting to regulatory authorities
worldwide. Currently, the United States, European Union, and Japan
require submission of safety information for marketed drug and
biological products using different reporting formats and different
reporting intervals.
In order to strengthen the agency's ability to monitor the safety of
marketed human drug and biological products, FDA is proposing, on its
own initiative, certain revisions to its postmarketing safety reporting
requirements. For this purpose, the Agency is proposing to require that
certain postmarketing safety information that is not currently
submitted to FDA in an expedited manner be submitted expeditiously
(e.g., domestic reports of medication errors). The Agency is also
proposing to revise its existing postmarketing safety reporting
regulations to improve the quality of these safety reports (e.g.,
submission of complete safety information for serious suspected
[[Page 73361]]
adverse drug reactions). These changes would enable the Agency to
better protect and promote public health.
Summary of Legal Basis:
The agency has broad authority under sections 505 and 701 of the
Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 355 and 371)
and section 351 of the Public Health Service Act (42 U.S.C. 262) to
monitor the safety of drug and biological products for human use.
Alternatives:
The alternatives to the proposal include not amending our existing
safety reporting requirements. This alternative would be inconsistent
with FDA's efforts to harmonize its safety reporting requirements with
international initiatives and with its mission to protect public health
Anticipated Cost and Benefits:
Manufacturers of human drug and biological products currently have
limited incentives to invest capital and resources in standardized
global safety reporting systems because individual firms acting alone
cannot attain the economic gains of harmonization. This proposed rule
would harmonize FDA's safety reporting requirements with certain
international initiatives, thereby providing the incentive for
manufacturers to modify their safety reporting systems. Initial
investments made by manufacturers to comply with the rule are likely to
ultimately result in substantial savings to them over time.
The impact on industry includes costs associated with revised safety
reporting and recordkeeping requirements. The benefits of the proposed
rule are public health benefits and savings to the affected industries.
The expected public health benefits would result from the improved
timeliness and quality of the safety reports and analyses; making it
possible for health care practitioners and consumers to expedite
corrective actions and to make more informed decisions about
treatments. Savings to the affected industry would accrue from more
efficient allocation of resources resulting from international
harmonization of the safety reporting requirements.
Risks:
None
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 12/00/00
Regulatory Flexibility Analysis Required:
Undetermined
Government Levels Affected:
Undetermined
Agency Contact:
Audrey Thomas
Policy Analyst, Regulatory Policy Staff
Department of Health and Human Services
Food and Drug Administration
Suite 3047 (HFD-7)
Center for Drug Evaluation and Research
1451 Rockville Pike
Rockville, MD 20852
Phone: 301 594-2041
RIN: 0910-AA97
_______________________________________________________________________
HHS--FDA
35. CURRENT GOOD TISSUE PRACTICE FOR MANUFACTURERS OF HUMAN CELLULAR
AND TISSUE-BASED PRODUCTS
Priority:
Other Significant
Reinventing Government:
This rulemaking is part of the Reinventing Government effort. It will
revise text in the CFR to reduce burden or duplication, or streamline
requirements.
Legal Authority:
42 USC 216; 42 USC 243; 42 USC 262; 42 USC 263a; 42 USC 264; 42 USC 271
CFR Citation:
21 CFR 1271
Legal Deadline:
None
Abstract:
As part of implementing the proposed regulatory approach to human
cellular and tissue-based products, the Food and Drug Administration
(FDA) is proposing to require manufacturers of human cells and tissue
to follow current good tissue practice (GTP), which includes proper
handling, processing, and storage of human cells and tissue,
recordkeeping, and the maintenance of a quality program. FDA is also
proposing to amend the current good manufacturing practice regulations
that apply to human cellular and tissue-based products, and/or
biological products in order to incorporate the new GTP requirements
into existing good manufacturing practice regulations.
Statement of Need:
Donor screening and testing, although crucial, are not sufficient to
prevent the transmission of disease by human cellular and tissue-based
products. Each step in the manufacturing process needs to be
controlled. Errors in labeling and testing records, failure to
adequately clean work areas, and faulty packaging are examples of
improper practices that could lead to a product capable of transmitting
disease to a recipient. The agency is concerned about the spread of
communicable disease through the use of products whose function and
integrity have been impaired. The GTP regulations would govern the
method used in, and the facilities and controls used for, the
manufacture of human cellular and tissue-based products. GTP
requirements are a fundamental component of FDA's risk-based approach
to regulating human cellular and tissue-based products.
Summary of Legal Basis:
The Public Health Service Act (42 U.S.C. 216 et seq.) and the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 321 et seq.) authorize FDA to
regulate biological products and to ensure that the products are safe,
pure, potent, and effective. The Public Health Service Act also
contains the authority under which FDA can promulgate regulations
designed to prevent the spread of communicable diseases. In order to
meet these objectives, FDA must be able to prevent the use of human
cellular and tissue-based products whose function and integrity have
been impaired by improper and inconsistent manufacturing practices and,
which may transmit disease.
Alternatives:
An alternative to the proposed approach would be to continue with the
use of industry standards. However, this alternative fails to provide
fundamental aspects of product safety. Reliance on industry's voluntary
standards for good tissue practice, rather than establishing a
regulatory requirement, would not ensure uniform or consistent
compliance and would preclude the agency's ability to effectively
monitor tissue products to ensure public health and safety.
Anticipated Cost and Benefits:
FDA has estimated that this rule would impose a total annualized cost
of $10,613,367 for the entire industry. The primary beneficiaries of
the proposed GTP would be the patients who receive the cellular and
tissue-based products.
[[Page 73362]]
Benefits to patients would result from the reduced risk of communicable
disease by avoiding product contamination or product failure through
GTP.
Risks:
FDA believes that the risks posed by requiring GTP are minimal. In
contrast, failure to reduce the risk of transmission of communicable
disease through the use of human cellular and tissue-based products
would jeopardize the public health.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 12/00/00
Regulatory Flexibility Analysis Required:
Undetermined
Small Entities Affected:
Businesses
Government Levels Affected:
Undetermined
Federalism:
This action may have federalism implications as defined in EO 13132.
Agency Contact:
Valerie A. Butler
Consumer Safety Officer
Department of Health and Human Services
Food and Drug Administration
Suite 200N (HFM-17)
Center for Biologics Evaluation and Research
1401 Rockville Pike
Rockville, MD 20852-1448
Phone: 301 827-6210
RIN: 0910-AB28
_______________________________________________________________________
HHS--FDA
36. PHARMACY AND PHYSICIAN COMPOUNDING OF DRUG PRODUCTS
Priority:
Other Significant. Major status under 5 USC 801 is undetermined.
Unfunded Mandates:
Undetermined
Legal Authority:
21 USC 331; 21 USC 351; 21 USC 352; 21 USC 353a; 21 USC 355; 21 USC
360; 21 USC 371
CFR Citation:
21 CFR 216
Legal Deadline:
None
Abstract:
Section 503A of the Federal Food, Drug, and Cosmetic Act (the Act) (21
U.S.C. 353a) describes the circumstances under which compounded drugs
may qualify for exemption from three requirements of the Act: (1) that
a drug be manufactured according to current good manufacturing
practice; (2) that a drug have adequate directions for use; and (3)
that a marketing application be approved by FDA before a new drug
product is introduced for sale (i.e., sections 501(a)(2)(B), 502(f)(1),
and 505 of the Act (21 U.S.C. 351(a)(2)(B), 352(f)(1), and 355)). To
qualify for the exemption, a pharmacist or physician must meet
statutory conditions for compounding, including the following: (1)
there generally must be a prescription for an identified individual
patient before compounding; (2) compounding before receiving a
prescription is allowed only under limited circumstances; (3) the
quantity of drugs that may be shipped out of state is limited and may
vary depending on whether the compounder is located in a state that has
entered into a memorandum of understanding (MOU) with FDA; (4) drug
products may only be compounded using a bulk drug substance (which is
essentially the active ingredient) that is listed in the United States
Pharmacopoeia (USP) or National Formulary (NF), or a bulk drug
substance that is a component of an FDA-approved drug product, or a
bulk drug substance that is listed in the regulation as one that FDA
has found to be suitable for compounding; (5) the bulk drug substance
must be made in a facility registered with FDA and the bulk drug
substance must be accompanied by a certificate of analysis; (6) limited
quantities of copies of commercially manufactured drug products may be
compounded only in special circumstances; (7) drug products may not be
compounded if they are listed in a regulation as having been removed
from the market or had their FDA-approval withdrawn because they were
found to be not safe or not effective; (8) drug products that are
listed in the regulations as ``demonstrably difficult to compound'' may
not be compounded. The regulations will amplify and explain the
statutory requirements as well as execute tasks Congress assigned FDA
in section 503A. This proposed rule will be one of several rulemakings
implementing section 503A. Related regulatory initiatives are described
below: (1) FDA has issued a final rule listing drug products that may
not be compounded because they were found to be not safe or not
effective and were removed from the market or had their FDA approval
withdrawn; (2) FDA has also issued a proposed rule and is preparing a
final rule listing drugs that are not the subject of a USP or NF
monograph, and are not components of an FDA-approved drug product but
are suitable for compounding; (3) FDA is currently preparing a proposed
rule listing those drugs that are demonstrably difficult to compound
and are not allowed to be compounded; and (4) FDA has published a
Federal Register notice announcing the availability of a draft MOU
between FDA and State boards of pharmacy.
Statement of Need:
Pharmacy compounding can provide substantial benefits to the public
health. It can give to patients, who are allergic to inactive
ingredients found in commercially available drug products, versions of
those drug products from which the allergenic ingredient has been
omitted. Patients who have difficulty taking a commercially available
drug product may obtain a compounded version of the drug product in a
different dosage form. In certain instances, pharmacy compounding can
also enable physicians to access certain drugs that are not
commercially available.
Just as compounded drugs may present significant benefits to health,
they can also present significant risks. Compounded drugs are generally
not evaluated by FDA for safety or effectiveness. They are not made
according to current good manufacturing practices and have generally
not been tested for strength, quality, or purity. Stability testing, to
establish the useful shelf life of the products, has generally not been
performed on compounded drug products. Compounders have made illicit
copies of FDA-approved drug products, threatening the integrity of the
drug approval process. FDA is attempting to maximize the public health
benefits of pharmacy compounding, while minimizing the potential threat
to the public health.
Summary of Legal Basis:
Section 127 of the Food and Drug Administration Modernization Act of
1997 (FDAMA) adds section 503A to the Act. Sections
503A(b)(1)(A)(i)(III) and (d)(2) direct FDA to publish regulations
establishing a list of drugs that are suitable for compounding. Section
503A(b)(1)(C) directs FDA to publish in the Federal Register a list
[[Page 73363]]
of drug products that have been withdrawn or removed from the market
because such drug products or components of such drug products have
been found to be unsafe or not effective. Section 503A(b)(1)(D) directs
FDA to define the term ``compound regularly or in inordinate amounts''
relating to compounding drug products that are essentially copies of a
commercially available drug product. Section 503A(b)(3)(A) directs FDA
to develop a list of drug products that may not be compounded because
they are demonstrably difficult to compound. Efficient enforcement of
section 503A would benefit from publication of a substantive rule that
interprets and applies the statutory language.
Alternatives:
Section 127 of FDAMA directs FDA to develop regulations, so no
alternatives to regulations have been considered. FDA has considered a
wide range of options and approaches within the framework of a
regulation. FDA has convened and consulted the Pharmacy Compounding
Advisory Committee, which consists of representatives of the United
States Pharmacopoeia, the National Association of Boards of Pharmacy,
and a consumer organization, as well as members of the pharmacy and
pharmaceutical manufacturing industries, physicians and academics.
Anticipated Cost and Benefits:
FDA has not yet quantified the costs and benefits of any regulatory
approach. FDA has not been significantly involved in the regulation of
pharmacy compounding, and does not have any economic data on the
industry at this time. Responses to the NPRM will be important in
determining the costs and benefits of any regulation.
Risks:
None.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 04/00/01
Regulatory Flexibility Analysis Required:
Yes
Small Entities Affected:
Businesses
Government Levels Affected:
Federal, State
Federalism:
Undetermined
Additional Information:
See RINs 0910-AB57, 0910-AB59
Agency Contact:
Wayne H. Mitchell
Regulatory Counsel, Regulatory Policy Staff
Department of Health and Human Services
Food and Drug Administration
Suite 3037 (HFD-7)
Center for Drug Evaluation and Research
1451 Rockville Pike
Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
Email: [email protected]
RIN: 0910-AB58
_______________________________________________________________________
HHS--FDA
37. POSITRON EMISSION TOMOGRAPHY DRUGS; CURRENT GOOD MANUFACTURING
PRACTICES
Priority:
Other Significant. Major status under 5 USC 801 is undetermined.
Unfunded Mandates:
Undetermined
Legal Authority:
PL 105-115, sec 121
CFR Citation:
21 CFR 220
Legal Deadline:
Final, Statutory, November 21, 1999.
Abstract:
Positron emission tomography (PET) is a medical imaging modality
involving the use of a unique type of radiopharmaceutical drug. PET
drugs are usually injected intravenously into patients for diagnostic
purposes. Most PET drugs are produced using cyclotrons at locations
that are in close proximity to the patients to whom the drugs are
administered (e.g., in hospitals or academic institutions). Each PET
drug is compounded under a physician's prescription and, due to the
short half-lives of PET drugs, is administered to the patient within a
few minutes or hours.
Under section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act
(the Act) (21 U.S.C. 351(a)(2)(B)), a drug is adulterated if the
methods used in, or the facilities or control used for, its
manufacture, processing, packing, or holding do not conform to or are
not operated or administered in conformity with current good
manufacturing practice (CGMP) to assure that the drug meets the
requirements of the Act as to safety and has the identity and strength,
and meets the quality and purity characteristics, that it purports or
is represented to possess. FDA's CGMP requirements for drug products
are set forth in 21 CFR parts 210 and 211.
On November 21, 1997, the President signed into law the Food and Drug
Administration Modernization Act (Modernization Act) (Pub. L. 105-115).
Section 121 of the Modernization Act contains several provisions
affecting the regulation of PET drugs. Section 121(c)(1)(A) of the
Modernization Act directs FDA to establish, within two years after
enactment, appropriate approval procedures and CGMP requirements for
PET drugs. Section 121(c)(1)(B) requires FDA to consult with patient
advocacy groups, professional associations, manufacturers, and other
interested persons as the agency develops PET drug CGMP requirements
and approval procedures. FDA's proposed rule on PET drug CGMP's will be
designed to reflect the unique nature of PET drug products.
Statement of Need:
Congress directed FDA to establish appropriate CGMP requirements for
PET drugs. FDA's proposed rule on PET drug CGMP's will be designed to
reflect the unique nature of PET drug products. Conformance with these
CGMP's should ensure that each PET drug meets the requirements of the
Act as to safety and has the identity and strength, and meets the
quality and purity characteristics, that it purports or is represented
to possess, in accordance with section 501(a)(2)(B) of the Act.
Summary of Legal Basis:
As noted above, section 121(c)(1)(A) of the Modernization Act directs
FDA to establish appropriate CGMP requirements for PET drugs. FDA
interprets this as a directive to establish regulations on CGMP's for
PET drugs because only by adopting regulations can the agency create
legally binding requirements.
Alternatives:
FDA has considered several different approaches to establishing CGMP's
for PET drugs. In addition, the agency has held public meetings on this
matter and has received extensive input from the PET community and
other interested persons on what CGMP requirements would be appropriate
for PET drugs.
[[Page 73364]]
Anticipated Cost and Benefits:
FDA has not yet quantified the costs and benefits of any regulatory
approach. The agency has been working with the PET community to develop
CGMP's that are appropriately suited to the production of PET drugs
while still being consistent with statutory requirements for current
good manufacturing practice for drug products. Responses to the
proposed rule likely will provide more information on the potential
costs and benefits of the proposed CGMP's.
Risks:
None.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 06/00/01
Regulatory Flexibility Analysis Required:
Undetermined
Government Levels Affected:
Undetermined
Federalism:
Undetermined
Agency Contact:
Wayne H. Mitchell
Regulatory Counsel, Regulatory Policy Staff
Department of Health and Human Services
Food and Drug Administration
Suite 3037 (HFD-7)
Center for Drug Evaluation and Research
1451 Rockville Pike
Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
Email: [email protected]
RIN: 0910-AB63
_______________________________________________________________________
HHS--FDA
38. CGMPS FOR BLOOD AND BLOOD COMPONENTS: NOTIFICATION OF CONSIGNEES
AND TRANSFUSION RECIPIENTS RECEIVING BLOOD AND BLOOD COMPONENTS AT
INCREASED RISK OF TRANSMITTING HCV (LOOKBACK)
Priority:
Economically Significant. Major under 5 USC 801.
Legal Authority:
21 USC 321; 42 USC 216; 42 USC 262; 42 USC 263; 42 USC 263a; 42 USC
264; 42 USC 300aa-25; 21 USC 331; 21 USC 351; 21 USC 352; 21 USC 353;
21 USC 355; 21 USC 360; 21 USC 371; 21 USC 374
CFR Citation:
21 CFR 606; 21 CFR 610
Legal Deadline:
None
Abstract:
This rulemaking is one of a number of actions being taken to amend the
biologics regulations to remove, revise, or update the regulations
applicable to blood, blood components, and blood derivatives. These
actions are based on a comprehensive review of the regulations
performed by FDA, and are also based on reports by the U.S. House of
Representatives Committee on Government Reform and Oversight,
Subcommittee on House Resources and Intergovernmental Relations, the
General Accounting Office, and the Institute of Medicine, as well as
public comments. In this rulemaking, FDA will propose to amend the
biologics regulations to require that blood establishments prepare and
follow written procedures for appropriate action when it is determined
that blood and blood components pose an increased risk for transmitting
hepatitis C virus (HCV) infection because they have been collected from
a donor who, at a later date, tested repeatedly reactive for evidence
of HCV.
Statement of Need:
In the Federal Register of October 23, 1998 (63 FR 56198), FDA
announced the availability of guidance, which updated previous
guidance, providing recommendations for donor screening and further
testing for antibodies to HCV, notification of consignees, transfusion
recipient tracing and notification, and counseling by physicians
regarding transfusion with blood components at increased risk for
transmitting HCV (often called ``lookback''). While available evidence
indicates that blood establishments are following these
recommendations, FDA believes that regulations should be codified,
consistent with the previous recommendations, to assure there is clear
enforcement authority in case deficiencies in an establishment's
lookback program are found and to provide clear instructions for
continuing lookback activities.
Summary of Legal Basis:
The Public Health Service Act (21 U.S.C. 216 et seq.) and the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 321 et seq.) authorize FDA to
regulate biological products and to ensure that the products are safe,
pure, potent, and effective. The Public Health Service Act also
contains the authority under which FDA can promulgate regulations to
prevent the spread of communicable diseases. These regulations would
assure that appropriate action is taken when blood components have been
transfused which may potentially be capable of transmitting HCV, that
persons who have been transfused with such blood components are
notified so that they receive proper counseling and treatment, and to
help prevent the further transmission of HCV.
Alternatives:
FDA has considered permitting the continued voluntary compliance with
the recommendations that have already issued. However, the ability of
FDA to enforce appropriate lookback procedures would be unclear. In
addition, because lookback will remain appropriate for the foreseeable
future, FDA believes that the procedures should be clearly established
in the regulations.
Anticipated Cost and Benefits:
FDA is in the process of analyzing the costs related to the rulemaking.
Monetary burdens will be associated to the tracing of previous
donations of donors, identifying the recipients of these previous blood
donations, and notifying these recipients, as appropriate. FDA believes
these costs will be more than compensated by the public health
benefits, including benefits related to the notification of past
transfusion recipients who may be unaware that they may be infected
with HCV.
Risks:
FDA believes there are minimum risks posed by requiring that
appropriate lookback procedures for HCV be prepared and followed.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 10/00/00
Regulatory Flexibility Analysis Required:
Yes
Small Entities Affected:
Businesses
Government Levels Affected:
None
Additional Information:
See RIN 0910-AB26.
[[Page 73365]]
Agency Contact:
Steven F. Falter
Director, Regulations and Policy Staff
Department of Health and Human Services
Food and Drug Administration
Suite 200N (HFM-17)
Center for Biologics Evaluation and Research
1401 Rockville Pike
Rockville, MD 20852-1448
Phone: 301 827-6210
Fax: 301 594-1944
Email: [email protected]
RIN: 0910-AB76
_______________________________________________________________________
HHS--FDA
39. CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, OR
HOLDING DIETARY SUPPLEMENTS
Priority:
Other Significant. Major under 5 USC 801.
Legal Authority:
21 USC 342; 21 USC 371; 21 USC 374; 42 USC 264
CFR Citation:
21 CFR 111
Legal Deadline:
None
Abstract:
The Food and Drug Administration (FDA) announced in an advance notice
of proposed rulemaking (ANPRM) of February 6, 1997 (62 FR 5700), its
plans to consider developing regulations establishing current good
manufacturing practices (CGMP) for dietary supplements and dietary
ingredients. The ANPRM was published in order for FDA to solicit
comments on whether it should initiate action to establish CGMP
regulations and if so, what constitutes CGMP for these products. FDA
announced that this effort was in response to the section of the
Federal Food, Drug, and Cosmetic Act (the Act) that provides authority
to the Secretary of Health and Human Services to promulgate CGMP
regulations and to a submission from the dietary supplement industry
asking that FDA consider an industry-proposed CGMP framework as a basis
for CGMP regulations. The ANPRM also responds to concerns that such
regulations are necessary to ensure that consumers are provided with
dietary supplement products which have not been adulterated as a result
of manufacturing, packing, or holding; which have the identity and
provide the quantity of dietary ingredients declared in labeling; and
which meet the quality specifications that the supplements are
represented to meet.
Statement of Need:
FDA intends to publish a proposed rule to establish current good
manufacturing practices (CGMP) for dietary supplements and dietary
ingredients for several reasons. First, FDA is concerned that some
firms may not be taking appropriate steps during the manufacture of
dietary supplements and dietary ingredients to ensure that products are
not adulterated as a result of manufacturing, packing, or holding.
There have been cases of misidentified ingredients harming consumers
using dietary supplements. FDA is also aware of products that contain
potentially harmful contaminants because of apparently inadequate
manufacturing controls and quality control procedures. The agency
believes that a system of CGMP is the most effective and efficient way
to ensure that these products will not be adulterated during
manufacturing, packing, or holding.
Summary of Legal Basis:
If CGMP regulations were adopted by FDA, failure to manufacture, pack,
or hold dietary supplements or dietary ingredients under CGMP
regulations would render the dietary supplement or dietary ingredients
adulterated under section 402(g) of the Act.
Alternatives:
The two principal alternatives to comprehensive CGMP are end-product
testing and Hazard Analysis Critical Control Points (HACCP). In the
ANPRM, FDA asked for public comment on approaches to ensure that
dietary supplements and dietary ingredients are not adulterated during
the manufacturing process. The agency asked whether HACCP may be a more
effective approach than a comprehensive CGMP, and whether different
approaches may be better able to address the needs of the broad
spectrum of firms that conduct one or more distinct operations, such as
the manufacture of finished products, or solely the distribution and
sale of finished products at the wholesale or retail level. FDA will
consider the information it received in response to the ANPRM and from
other sources, such as public meetings and small business outreach
meetings, in its consideration of whether CGMP or other approaches are
most appropriate.
Anticipated Cost and Benefits:
A comprehensive CGMP (or other system of ensuring that dietary
supplements and dietary ingredients are not adulterated during
manufacturing, packing, or holding) would permit more effective and
efficient oversight by Federal, State, and local governments. It would
place primary responsibility for ensuring that these products are not
adulterated during manufacturing, packing, or holding on the
manufacturer, packer or holder by requiring that they implement a
system to control their processes. FDA anticipates that costs to
industry generated by implementing a comprehensive manufacturing
process, whether CGMP or other plan, would be offset in four ways: (1)
by reducing the amount of supplement-associated illnesses or adverse
events; (2) by increasing public confidence in dietary supplements
marketed in the United States; (3) by enabling U.S. supplements
companies to compete more effectively in the world market; and (4) by
decreasing the number of future product recalls.
Risks:
Any potential for consumers to be provided adulterated (contaminated
with industrial chemicals, pesticides, microbial pathogens, or
dangerous misidentified ingredients or toxic components of ingredients)
products must be considered a very serious risk because of the
possibility that such contamination could be widespread, affecting
whole segments of the population, causing some severe long-term effects
and even loss of life. Dietary supplements are used by a large segment
of the American public. Moreover they are often used by segments of the
population that are particularly vulnerable to adulterated products,
such as the elderly, young children, pregnant and nursing women, and
persons who may have serious illnesses or are taking medications that
may adversely interact with dietary supplements. FDA has adopted or
proposed manufacturing controls for a number of foods and commodities
that present potential health hazards to consumers if not processed
properly, including seafood, juice products, and fruits and vegetables
and it is appropriate that FDA consider whether manufacturing controls
are necessary to assure consumers that dietary supplements are not
adulterated during the manufacturing, packing, or holding process.
[[Page 73366]]
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
ANPRM 62 FR 5700 02/06/97
ANPRM Comment Period End 06/06/97
NPRM 11/00/00
Regulatory Flexibility Analysis Required:
Yes
Small Entities Affected:
Businesses
Government Levels Affected:
Undetermined
Federalism:
Undetermined
Agency Contact:
Karen Strauss
Consumer Safety Officer
Department of Health and Human Services
Food and Drug Administration
(HFS-820)
200 C Street SW
Washington, DC 20204
Phone: 202 205-5372
Fax: 202 260-8957
Email: [email protected]
RIN: 0910-AB88
_______________________________________________________________________
HHS--FDA
40. AVAILABILITY FOR PUBLIC DISCLOSURE AND SUBMISSION TO FDA FOR PUBLIC
DISCLOSURE OF CERTAIN DATA AND INFORMATION RELATED TO GENE THERAPY OR
XENOTRANSPLANTATION
Priority:
Other Significant
Legal Authority:
5 USC 552; 21 USC 331(j); 21 USC 355
CFR Citation:
21 CFR 20.100; 21 CFR 312.42; 21 CFR 312.130; 21 CFR 601.50; 21 CFR
601.51; 21 CFR 601.52; 21 CFR 601.53
Legal Deadline:
None
Abstract:
The proposed regulation would require sponsors of human trials
involving human gene therapy or xenotransplantation to submit a
redacted version of the original for public disclosure, with an
investigational New Drug Application (IND), an amendment to an IND, or
other related documents. The submission would be redacted to exclude
trade secret information and personal information, the disclosure of
which would constitute a clearly unwarranted invasion of personal
privacy. FDA would then make the redacted documents available to the
general public and the information may be discussed in open session at
scientific advisory committee meetings and at other suitable fora.
Statement of Need:
Information concerning investigational new drugs, including those
biological drugs related to human gene therapy and xenotransplantation,
are generally held as confidential by the Food and Drug Administration
pending completion of the clinical studies and approval of the new
drug. For clinical studies, involving either human gene therapy or
xenotransplantation, there are multiple complex and controversial
issues that must be fully discussed by scientists and the general
public. These issues include both safety concerns and ethical
questions, which must be fully discussed, understood, and resolved on
an international level before these promising therapies may be fully
studied and implemented. FDA is issuing this proposed rule to assure
that information that is necessary for these discussions are available
to the public.
Summary of Legal Basis:
Under the Freedom of Information Act (FOIA), 5 U.S.C. 552, Federal
agencies must, with certain exceptions, disclose information in their
files to the public on request. One exemption protects trade secrets
and confidential commercial information from public disclosure. (See 5
U.S.C. 552(b)(4)). The information that may be made publicly available
as a result of this rulemaking includes information currently made
public by Federal agencies other than FDA, at Federal advisory
committee meetings or other public workshops, and through general
commercial disclosure. Thus, this information is no longer considered
to be ``confidential commercial information.'' Trade secrets would
continue to be protected under the regulations. In addition, under
FDA's broad rulemaking authority (21 U.S.C. 201, et seq.), and under
section 505(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355(i)), FDA has the authority to issue regulations imposing conditions
on the investigation of new drugs as necessary ``relating to the public
health.'' Because of the public health issues related to these
therapies, and the necessity that these issues be fully aired and the
public fully informed, these regulations are intended to promote the
public health.
Alternatives:
FDA considered providing for the voluntary disclosure of this
information by study sponsors, without a regulatory requirement to do
so. This alternative would not be less burdensome, unless an
establishment failed to voluntarily disclose, and the agency would have
no means of assuring the quality, consistency, and timeliness of the
information disclosed.
FDA also considered assuming the responsibility for redaction of
documents already being submitted by study sponsors and providing the
redacted information to the public. Although this alternative would
reduce direct costs to the sponsors, FDA has limited resources to
perform this task, resulting in delays in providing the public this
important information and possibly causing delays in research.
Anticipated Cost and Benefits:
FDA has estimated that this rule would cost a total of approximately
$120,000 per year for a total of approximately 150 sponsors
(approximately $800 per sponsor). The proposed rule would provide an
improved means of managing public health risks, including by informing
potential study subjects of potential risks and by assuring that public
health and ethical issues are fully considered by those concerned with
the public health.
Risks:
There is a risk that the information that would be disclosed may be
misinterpreted or misunderstood by some in the public. However, by
providing for complete disclosure of relevant information, FDA believes
that such misunderstandings are less likely to occur than under current
practice where complete information may not be made available.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 12/00/00
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
Businesses
Government Levels Affected:
None
[[Page 73367]]
Agency Contact:
Steven F. Falter
Director, Regulations and Policy Staff
Department of Health and Human Services
Food and Drug Administration
Suite 200N (HFM-17)
Center for Biologics Evaluation and Research
1401 Rockville Pike
Rockville, MD 20852-1448
Phone: 301 827-6210
Fax: 301 594-1944
Email: [email protected]
RIN: 0910-AC00
_______________________________________________________________________
HHS--FDA
41. CONTROL OF SALMONELLA ENTERITIDIS IN SHELL EGGS DURING
PRODUCTION AND RETAIL
Priority:
Economically Significant. Major under 5 USC 801.
Unfunded Mandates:
This action may affect the private sector under PL 104-4.
Legal Authority:
21 USC 342(a)(4); 21 USC 371(a); 42 USC 264
CFR Citation:
Not Yet Determined
Legal Deadline:
None
Abstract:
The President's Council on Food Safety was established in August 1998
to improve the safety of the food supply through science-based
regulations and well-coordinated inspection, enforcement, research, and
education programs. The Council has identified egg safety as one
component of the public health issue of food safety that warrants
immediate Federal, interagency action.
In July 1999, FDA and FSIS committed to developing an action plan to
address the presence of salmonella enteritidis (SE) in shell eggs and
egg products using a farm-to-table approach. FDA and FSIS held a public
meeting on August 26, 1999, to obtain stakeholder input on the draft
goals, as well as to further develop the objectives and action items
for the action plan. The Egg Safety Action Plan was announced by the
President on December 11, 1999. The goal of the Action Plan is to
reduce egg-related SE illnesses by 50 percent by 2005 and eliminate
egg-related SE illnesses by 2010.
The Egg Safety Action Plan consists of eight objectives covering all
stages of the farm-to-table continuum as well as support functions. On
March 30, 2000 (Columbus, OH), and April 6, 2000 (Sacramento, CA),
joint public meetings were held by FDA and FSIS to solicit and discuss
information related to the implementation of the objectives in the Egg
Safety Action Plan.
In accordance with discussions at the public meetings, FDA intends to
publish a proposed rule to require that shell eggs be produced under an
SE risk reduction plan that is designed to prevent transovarian SE from
contaminating eggs at the farm during production.
Because egg safety is a farm-to-table effort, FDA intends to include in
its proposal certain provisions of the 1999 Food Code that are relevant
to how eggs are handled, prepared, and served at retail establishments.
In addition, the agency intends to propose specific requirements for
retail establishments that serve populations most at-risk of egg-
related illness (i.e., the elderly, children, and the
immunocompromised).
Statement of Need:
FDA is proposing regulations as part of the farm-to-table safety system
for eggs outlined by the President's Council on Food Safety in its Egg
Safety Action Plan to require that shell egg producers implement SE
risk reduction plans at the farm and that retail establishments
institute certain egg-relevant provisions of the 1999 Food Code. FDA
intends to propose these regulations because of the continued reports
of outbreaks of foodborne illness and death caused by SE that are
associated with the consumption of shell eggs. The agency believes
these regulations can have significant effect in reducing the risk of
illness from SE-contaminated eggs and will contribute significantly to
the interim public health goal of the Egg Safety Action Plan of a 50
percent reduction in egg-related SE illness by 2005.
Summary of Legal Basis:
FDA's legal basis for the proposed rule derives in part from sections
402(a)(4), and 701(a) of the Federal Food, Drug and Cosmetic Act
(FDCA)((21 U.S.C. 342(a)(4) and 371(a)). Under section 402(a)(4) of the
Act, a food is adulterated if it is prepared, packed, or held in
insanitary conditions whereby it may have been contaminated with filth
or may have been rendered injurious to health. Under section 701(c) of
the Act, FDA is authorized to issue regulations for the efficient
enforcement of the Act. FDA also intends to rely on section 361 of the
Public Health Service Act (PHSA), which gives FDA authority to
promulgate regulations to control the spread of communicable disease.
Scientific reports in published literature and data gathered from
existing voluntary egg quality assurance programs indicates that
measures designed to prevent SE from entering a poultry house (e.g.,
rodent/pest control, use of chicks from SE-monitored breeders, and
biosecurity programs) can be very effective in reducing SE-
contamination of eggs and related foodborne illness.
Moreover, the use of shell eggs or egg products that have been treated
to destroy SE or thorough cooking of untreated eggs in retail
establishments will significantly contribute to the reduction of egg-
related SE illnesses.
Alternatives:
There are several alternatives that the agency intends to consider in
the proposed rule. The principal alternatives include: (1) no new
regulatory action; (2) alternative testing requirements; (3)
alternative on-farm mitigation measures; (4) alternative retail
requirements; and (5) HAACP. FDA will consider the information that it
receives in response to the public meetings in its consideration of the
various alternatives.
Anticipated Cost and Benefits:
The benefits from a regulation designed to reduce the risk of SE
contamination on the farm and at retail derive from better farming
practices and safer handling and cooking of eggs at the retail level.
While numerical estimates of benefits currently are not yet available,
FDA believes that the benefits of the proposed rule will be
significant. FDA plans to estimate benefits using data from the USDA
Risk Assessment for SE in Eggs, the Layers `99 study of on-farm SE
controls, and from other available information on the effectiveness of
SE controls.
The costs of the proposed rule are expected to be over $100 million. It
is likely that many farms and retail establishments would have to make
significant alterations to their current practices. Furthermore, the
proposed rule is likely to have a significant impact on small entities
and will have effects that vary greatly by region.
[[Page 73368]]
Risks:
Any potential for contamination of eggs with SE and its subsequent
survival or growth must be considered a very serious risk because of
the possibility that such contamination, survival and growth could
cause widespread foodborne illness, including some severe long-term
effects and even loss of life. FDA made a decision to publish a
proposed rule to require that shell egg producers have on-farm SE risk
reduction plans and that retail establishments institute certain egg-
relevant provisions of the 1999 Food Code based on a considerable body
of evidence, literature and expertise in this area. In addition, this
decision was also based on the USDA risk assessment on SE in shell eggs
and egg products and the identified public health benefits associated
with controlling SE in eggs at the farm and retail levels.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 12/00/00
Regulatory Flexibility Analysis Required:
Yes
Small Entities Affected:
Businesses
Government Levels Affected:
Undetermined
Federalism:
Undetermined
Agency Contact:
Rebecca Buckner
Consumer Safety Officer
Department of Health and Human Services
Food and Drug Administration
HFS-306
Center for Food Safety and Applied Nutrition
200 C Street SW.
Washington, DC 20204
Phone: 202 205-4081
Fax: 202 205-4422
Email: [email protected]
Nancy Bufano
Consumer Safety Officer
Department of Health and Human Services
Food and Drug Administration
HFS-306
Center for Food Safety and Applied Nutrition
200 C Street SW.
Washington, DC 20204
Phone: 202 401-2022
Fax: 202 205-4422
Email: [email protected]
RIN: 0910-AC14
_______________________________________________________________________
HHS--FDA
42. PREMARKET NOTICE CONCERNING BIOENGINEERED FOODS
Priority:
Other Significant
Legal Authority:
21 USC 342; 21 USC 343; 21 USC 348; 21 USC 321; 21 USC 371
CFR Citation:
21 CFR 192; 21 CFR 592
Legal Deadline:
None
Abstract:
The Food and Drug Administration (FDA) is proposing to require the
submission to the agency of data and information regarding plant-
derived bioengineered foods that would be consumed by humans or
animals. FDA is proposing that this submission be made at least 120
days prior to the commercial distribution of such foods. FDA is taking
this action to ensure that it has the appropriate amount of information
about bioengineered foods to help to ensure that all market entry
decisions by the industry are made consistently and in full compliance
with the law. The proposed action will permit the agency to assess on
an ongoing basis whether plant-derived bioengineered foods comply with
the standards of the Federal Food, Drug, and Cosmetic Act.
Statement of Need:
In the Federal Register of May 29, 1992 (57 FR 22984), FDA published
its ``Statement of Policy: Foods Derived from New Plant Varieties''
(the 1992 policy), which clarified the agency's interpretation of the
application of the Federal Food, Drug, and Cosmetic Act (the Act) with
respect to human foods and animal feeds, including bioengineered foods
and feeds, derived from new plant varieties. The 1992 policy provided
guidance to industry on safety and other regulatory issues related to
such foods. Since that time, developers have actively consulted with
FDA regarding plant-derived bioengineered foods. That process has
worked well, and FDA believes that it has been consulted on all plant-
derived bioengineered foods and feeds currently marketed in the United
States.
FDA is confident that the guidance articulated in the 1992 policy
adequately addressed the scientific and regulatory issues raised by the
products that were approaching commercialization in 1992. However, FDA
is aware that bioengineering technology is evolving rapidly and that it
is not possible for the agency to anticipate all of the novel
scientific and regulatory issues that may arise as the number and
nature of foods developed using the technology expand. Therefore, FDA
is proposing to require a premarket notice regarding plant-derived
bioengineered foods so that the agency has the appropriate amount of
information about these foods to help ensure that all market entry
decisions by the industry are made consistently and in full compliance
with the law. The proposed action will permit the agency to assess on
an ongoing basis whether these foods comply with the standards of the
act. FDA is proposing that this submission be made at least 120 days
prior to the commercial distribution of such foods.
Summary of Legal Basis:
FDA is authorized by section 701 of the Act (21 U.S.C. 371) to issue
regulations for the efficient enforcement of the Act. This proposed
rule will assist FDA in the agency's enforcement of the following
provisions of the Act: section 403 of the Act (21 U.S.C. 343), which
prohibits the misbranding of food; section 402 of the Act (21 U.S.C.
342), which prohibits the adulteration of food, and section 409 of the
Act (21 U.S.C. 348), which establishes a premarket approval requirement
for ``food additives,'' as defined in section 201(s) of the Act (21
U.S.C. 321(s)).
[[Page 73369]]
Alternatives:
FDA considered whether to continue with the current voluntary process
or to issue the attached proposed rule. FDA has decided to issue the
proposed rule because the agency is concerned that the current
voluntary consultation process may not be adequate in the future to
ensure that bioengineered foods introduced into U.S. commerce comply
with all applicable statutory requirements. The proposed rule will
enable the agency to efficiently enforce the Act and protect public
health while imposing minimal burdens to the industry.
Anticipated Cost and Benefits:
For developers who would have gone through FDA's consultation process,
the costs associated with the proposed required process would include
only costs of the additional provisions of the proposed rule. The
required process will be modeled on the experience and knowledge gained
from the current consultation process, but there will be a number of
new provisions that will have costs for notifiers. FDA estimates that
the annual cost per notice would be $6,444 to $7,796 and that the total
annual cost to the industry (assuming 8 to 20 notices per year) would
be $51,551 to $154,658.
The proposed rule will help to ensure that bioengineered foods are
adequately evaluated for potential allergenicity and toxicity, and for
the potential that they contain a food additive. The proposed rule also
will help to ensure that potential safety, nutritional, or other
regulatory issues are addressed before the foods reach the market.
Risks:
FDA is aware that bioengineering technology is evolving rapidly and
that it is not possible for the agency to anticipate all of the novel
scientific and regulatory issues that may arise as the number and
nature of foods developed using the technology expands. FDA believes
that advances in biotechnology can, more often than in the past, lead
to the introduction of significant changes into foods, such that they
may be adulterated or require special labeling. FDA also believes that
advances in identification of potentially useful genes in many
different organisms can lead to more novel substances being introduced
into foods that may be food additives or allergens. Further, FDA
believes that as more countries abroad make use of biotechnology, more
of the food we import may be bioengineered or may contain bioengineered
substances about which we would not have been consulted. Thus, the
agency believes that a voluntary consultation process may not be
adequate in the future to ensure that bioengineered foods introduced
into U.S. commerce comply with all applicable statutory requirements.
Timetable:
_______________________________________________________________________
Action DFR Cite
_______________________________________________________________________
NPRM 11/00/00
Regulatory Flexibility Analysis Required:
Yes
Small Entities Affected:
Businesses
Government Levels Affected:
None
Agency Contact:
Linda Kahl
Consumer Safety Officer
Department of Health and Human Services
Food and Drug Administration
HFS-206
Center for Food Safety and Applied Nutrition
200 C Street SW
Washington, DC 20204
Phone: 202 418-3101
Fax: 202 418-3131
Email: