[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)

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                            FINAL RULE STAGE

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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)

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                          PROPOSED RULE STAGE

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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: [email protected]
RIN: 0910-AC15
_______________________________________________________________________



HHS--FDA

                              -----------

                            FINAL RULE STAGE

                              -----------




43. FRUIT AND VEGETABLE JUICES: DEVELOPMENT OF HACCP AND LABEL WARNING 
STATEMENTS FOR JUICES
Priority:


Economically Significant. Major under 5 USC 801.


Legal Authority:


21 USC 321 et seq; 42 USC 264


CFR Citation:


21 CFR 120


Legal Deadline:


None


Abstract:


In an advance notice of proposed rulemaking of August 4, 1994, the Food 
and Drug Administration (FDA) announced its plans to consider the 
development of regulations establishing requirements for a new 
comprehensive food safety assurance program that would be based on the 
principles of Hazard Analysis Critical Control Points (HACCP). The new 
food safety program would respond to new challenges, such as new food 
processing and packaging technologies, new food distribution and 
consumption patterns, exposure to industrial chemicals and chemical 
waste, the increasing importation of foods, new microbial pathogens, 
and resource constraints. Current information shows that the most 
serious of these challenges is presented by food-borne pathogens. The 
number of recognized food-borne pathogens has broadened considerably, 
as has the awareness of long-term complications from certain food-borne 
illnesses such as arthritis, heart disease, and kidney and neurological 
damage. To meet such challenges, FDA intends to shift the focus of its 
food safety assurance program away from periodic visual inspection and 
end-product testing and toward prevention of food safety risks and 
problems, utilizing the state-of-the-art HACCP preventive approach. A 
first step was taken when FDA published a HACCP regulation for fish and 
fishery products on December 18, 1995. Consistent with FDA's HACCP 
efforts, USDA published a HACCP regulation for meat and poultry on July 
25, 1996. FDA proposed on April 24, 1998 to adopt a HACCP regulation 
for the processing of juice. The agency simultaneously proposed to 
require a warning statement on the labels or in labeling for juice 
products that have not been processed to reduce, control, or eliminate 
the presence of harmful bacteria; the warning statement rule was 
finalized in July. Such labeling serves to reduce the risk of food-
borne illness, pending development of a final HACCP rule for juice. As 
part of the development of the HACCP proposal, FDA considered 
information obtained during agency HACCP pilot activities, and comments 
and scientific and technological information relating to fresh juices 
provided during and after an agency public meeting on juice held on 
December 16 and 17, 1996. FDA held two technical scientific workshops, 
one November 12, 1998, in Lake Alfred, Florida and the other November 
29, 1998, in Irvine, California, to discuss and clarify issues related 
to the implementation of the

[[Page 73370]]

agency's rule requiring a warning statement for certain juice products. 
The workshops addressed citrus juice production and the methods for 
measuring and validating such systems. On December 8 and 9, 1999, the 
National Advisory Committee on Microbiological Criteria for Foods 
(NACMCF) met to consider performance criteria for fresh juice. FDA 
specifically requested the NACMCF to make recommendations about the 
efficacy of surface treatments in ensuring the safety of citrus juices.


Statement of Need:


FDA is adopting regulations that would establish requirements for a new 
comprehensive food safety assurance program for both domestically 
produced and imported fruit and vegetable juices that would be based on 
the principles of Hazard Analysis Critical Control Points (HACCP). FDA 
intends to adopt a juice HACCP regulation because there have been a 
number of outbreaks of illnesses associated with juice products, 
including some directly affecting children, and because the agency 
believes that a system of preventive controls is the most effective and 
efficient way to ensure that these products will be safe.


Summary of Legal Basis:


Failure of a processor to have and implement a HACCP system will render 
the food products of that processor adulterated under section 402(a)(4) 
of the Federal Food, Drug, and Cosmetic Act. Whether a processor's 
actions are consistent with ensuring the safety of food will be 
determined through an evaluation of the overall implementation of the 
firm's HACCP system.


Alternatives:


The principal alternative to HACCP is comprehensive current good 
manufacturing practices (CGMPs). FDA has concluded, based on 
information available at this time, that this alternative lacks the 
distinct advantages of a HACCP-based approach. CGMPs are not practical 
because they are plant-wide operating procedures and do not concentrate 
on the identification and prevention of food hazards.


Anticipated Cost and Benefits:


In general terms, HACCP focuses on prevention and is designed to 
prevent the occurrence of hazards affecting food; HACCP permits more 
effective and efficient oversight by Federal, State, and local 
governments; and HACCP appropriately places primary responsibility for 
ensuring food safety on the food manufacturer/distributor to analyze, 
in a rational, scientific manner, its production processes in order to 
identify critical control points and establish critical limits and 
monitoring procedures. FDA anticipates that costs to industry generated 
by implementation of HACCP would be offset in four ways: (1) by 
reducing the amount of food-borne illnesses (for example, total illness 
reduction benefits estimated to result from FDA's HACCP-based 
requirements for seafood regulation are between $15 and $75 million per 
year); (2) by increasing public confidence in the Nation's food supply; 
(3) by enabling U.S. food companies to compete more effectively in the 
world market (for example, current recommendations of the Codex 
Alimentarius Commission's Committee on Food Hygiene encourage the use 
of the HACCP system, and the European Community (EC) has begun to 
require that foods produced within the EC be processed under HACCP 
requirements); and (4) by decreasing the number of future product 
recalls.


Risks:


Any potential for contamination of the food supply with industrial 
chemicals or microbial pathogens 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. FDA made a decision to adopt a 
HACCP-based approach to regulate seafood, based on a considerable body 
of literature and expertise in this area. Likewise, FDA has reviewed 
current information on hazards associated with unprocessed juice, and 
has proposed that juice processors use HACCP in the manufacture of 
certain products.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
ANPRM           59 FR 39888                                    08/04/94
ANPRM Comment Period End                                       12/02/94
Economic Analysis for Juice HACCP and Labeling
PRIA 05/01/98 (63 FR 24254)
PRIA Comment Period End 06/22/98
HACCP for Juice
NPRM 04/24/98 (63 FR 20450)
NPRM Comment Period End 08/07/98
NPRM Comment Period Reopened 12/17/98 (63 FR 69579)
NPRM Reopened Comment Period End 01/19/99
Final Action 12/00/00
Label Warning Statements for Juice
Notice of Intent 08/28/97 (62 FR 45593)
NPRM 04/24/98 (63 FR 20496)
NPRM Comment Period End 06/21/98
Final Action 07/08/98 (63 FR 37029)
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses


Government Levels Affected:


Federal


Additional Information:


Previously reported under RIN 0905-AE60.


Agency Contact:
Shellee Anderson
Food Technologist
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: 202 205-5023
Email: [email protected]
RIN: 0910-AA43
_______________________________________________________________________



HHS--FDA



44. ESTABLISHMENT REGISTRATION AND LISTING OF HUMAN CELLS AND TISSUE
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 264


CFR Citation:


21 CFR 207; 21 CFR 807; 21 CFR 1271


Legal Deadline:


None


Abstract:


This action is a continuation of FDA's approach for the regulation of 
human cells and tissues and is part of FDA's reinventing government 
initiative. The final rule requires manufacturers of human cells and 
tissue to register with the agency and submit a list of all such

[[Page 73371]]

cells and tissue. Future regulations would include the promulgation of 
good tissue practices (GTP) that will provide good manufacturing 
standards and requirements for donor screening and testing, and 
compliance and procedural provisions. The regulatory approach would 
provide a rational, comprehensive, and clear framework under which 
tissue processors can develop and market their products without being 
subjected to unnecessary regulation and without sacrificing the 
protection of the public health.


Statement of Need:


Presently, FDA can only approximate the numbers of manufacturers 
involved in the production of human cells and tissue. Recent 
innovations in the methods of manipulating human cells and tissues for 
therapeutic purposes have resulted in the rapid growth of the industry 
producing human cells and tissue. The growth has occurred in industry 
segments that normally communicate with the agency as well as in 
segments that have not previously had any contact with FDA. In order to 
characterize the industry and establish a basis for communication with 
that industry, FDA is requiring that all manufacturers of human cells 
and tissue register with FDA and submit lists of all their cells and 
tissues to the agency.


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 identify those manufacturers 
participating in activities that may be subject to regulation. FDA is 
establishing the registration and listing as a simple and efficient 
means of acquiring the needed information.


Alternatives:


FDA has considered two alternatives. The first alternative would be an 
information collection undertaken by the agency that would be entirely 
dependent on voluntary compliance. FDA considers this alternative 
inefficient and lacking in inducements to ensure compliance.


The second alternative is to compel the registration of manufacturers 
and require registrants to list their cells and tissues with the 
agency. Such a system has been proposed to industry and gained general 
acceptance. Manufacturers would simply fill out an electronically 
available registration and listing form and fax or mail the completed 
form to the agency with periodic updates. No other paperwork should be 
required.


Anticipated Cost and Benefits:


Registration and listing will enable FDA to characterize the industry 
without imposing any significant procedural or monetary burdens. 
Registration and listing would provide effective means by which FDA can 
monitor the production of human cells and tissue. The costs of 
registration and listing are expected to be minimal because, as stated 
above, the process will require only the information necessary for FDA 
to identify the affected industry.


Risks:


FDA believes that the risks posed by requiring registration and listing 
of human cells and tissue are minimal. In contrast, failure to identify 
manufacturers involved in the production of human cells and tissue 
would subject the public to the great and avoidable risk of contracting 
debilitating communicable diseases. Without any mechanism to target 
regulations intended to reduce the risk of transmission of communicable 
diseases through the use of human cells and tissue, FDA's oversight of 
the industry would be severely hindered and the protection of the 
public health jeopardized.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            63 FR 26744                                    05/14/98
NPRM Comment Period End                                        08/12/98
Final Action                                                   02/00/01
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


Businesses


Government Levels Affected:


None


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-AB05
_______________________________________________________________________



HHS--Health Care Financing Administration (HCFA)

                              -----------

                          PROPOSED RULE STAGE

                              -----------




45. END STAGE RENAL DISEASE (ESRD) CONDITIONS FOR COVERAGE (HCFA-3818-
P) (SECTION 610 REVIEW)
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 1395rr


CFR Citation:


42 CFR 400; 42 CFR 405; 42 CFR 406; 42 CFR 409; 42 CFR 410; 42 CFR 412; 
42 CFR 413; 42 CFR 414; 42 CFR 489; 42 CFR 494


Legal Deadline:


None


Abstract:


This proposed rule would revise the current conditions for coverage for 
end stage renal disease (ESRD) facilities approved to provide ESRD 
service under Medicare. It would update the conditions to reflect 
developments in technology and equipment, emphasize the total patient 
experience and develop performance expectations for the facility that 
result in quality, comprehensive care for the dialysis patient.


Statement of Need:


Section 1881(b)(1) of the Social Security Act stipulates that payment 
is made to individuals, providers of services, and renal dialysis 
facilities

[[Page 73372]]

that met the requirements for institutional dialysis facilities and 
supplies that are determined by the Secretary. These requirements are 
the ESRD conditions for coverage.


Our decision to propose major changes to the existing conditions is 
based on several considerations. Revising the ESRD requirements is part 
of HCFA's effort to move towards a patient outcome-based system that 
focuses on quality assessment and performance improvement. We believe 
that revising the conditions will encourage improved outcomes of care 
for beneficiaries. The ESRD conditions for coverage have not been 
comprehensively revised since their inception in 1976. The existing 
requirements emphasize the policies and procedures that must be in 
place to support good patient care, and they focus on the facility's 
capacity to furnish care rather than on the actual provision of quality 
care to patients and the outcomes of that care. In addition, the 
revised conditions will implement section 4558(b) of the Balance Budget 
Act of 1997, which requires the Secretary to develop and implement a 
method to measure and report on the quality of renal dialysis services 
provided under Medicare.


During the 1980s and 1990s, major changes took place in the delivery of 
services to dialysis patients, and these advances are not reflected in 
the existing requirements. Thus, we have concluded that significant 
revisions to the conditions for coverage for ESRD facilities are 
essential. The regulation would have an emphasis on the patient's total 
experience with dialysis. The proposed changes, which were undertaken 
in a collaborative effort with the renal community, reflect 
improvements in standard care practices, the use of more advanced 
technology and equipment, and most notably, the adoption of 
quantifiable performance measures that are viewed in the renal 
community to be related, at least in part, to the quality of care 
provided to dialysis patients.


Following publication of the proposed rule, we will consult further 
with the industry.


Summary of Legal Basis:


Section 1881(b)(1) of the Act authorizes the Secretary to prescribe 
health and safety requirements (known as conditions for coverage) that 
a facility providing dialysis and transplantation services must meet to 
qualify for Medicare reimbursement. In addition, section 1881(c) of the 
Act establishes ESRD network areas and network organizations to assure 
that dialysis patients are provided appropriate care. The requirements 
from section 1881(b) and (c) are implemented in regulations at 42 CFR 
part 405, subpart U, Conditions for Coverage for ESRD Facilities.


Section 1138(b)(1)(D) of the Act requires hospitals to be members and 
abide by the rules and requirements of the Organ Procurement and 
Transplant Network. Section 1861(s)(2)(F) of the Act describes 
``medical and other health services'' covered under Medicare to include 
home dialysis supplies and equipment, self-care home dialysis support 
services, and institutional dialysis services and supplies, and section 
1862(a) of the Act specifies the exclusion from coverage.


Section 1861(e)(9) of the Act requires hospitals to meet such other 
requirements as the Secretary finds necessary in the interest of health 
and safety of individuals who are furnished services in the 
institution.


Alternatives:


In the past, HCFA has revised sections of the ESRD regulations. 
However, we have determined that a complete and thorough revision would 
be a more effective mechanism for developing a comprehensive approach 
to quality care for the dialysis patient. In addition, this approach 
provides greater potential for successful implementation. Another 
option is to update the current regulations and maintain the process-
oriented standards without focusing on patient outcome. However, for 
the reasons discussed, we believe it is important to move forward with 
a proposed regulation that is patient-centered and intended to 
stimulate improvements in processes and outcomes of care.


Anticipated Cost and Benefits:


The purpose of this proposed rule is to ensure that ESRD beneficiaries 
are receiving quality care dialysis and transplantation. We believe 
that revised regulations are necessary to ensure that all facilities 
are using the most effective technology and equipment. The primary 
benefit of updating the conditions for coverage is the development of 
performance expectations for the facility that would result in the 
comprehensive, integrated care and outcomes the patient needs and 
wants. As a result, the beneficiaries would receive an improved quality 
of care. The revised regulations would also address the issue of 
adequacy of dialysis, which would have a significant impact on ensuring 
that patients are not being under-dialyzed.


Items that have the potential to affect the cost of data gathering, 
infection control, and achieving the specified outcome measure. 
However, at this time the cost or savings to the Medicare program have 
not yet been established, but costs should not be significant.


Risks:


If the ESRD conditions are not updated, our regulations will not 
reflect new developments in the industry, thereby denying the improved 
protections to patients' health care that would result from this 
proposed rule.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           04/00/01
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


Governmental Jurisdictions, Businesses, Organizations


Government Levels Affected:


None


Agency Contact:
Robert Miller
Department of Health and Human Services
Health Care Financing Administration
S3-02-01
Office of Clinical Standards and Quality
7500 Security Boulevard
Baltimore, MD 21244-1850
Phone: 410 786-6797
Email: [email protected]
RIN: 0938-AG82
_______________________________________________________________________



HHS--HCFA



46. CRITERIA FOR MEDICARE COVERAGE OF HEART, LIVER, AND LUNG 
TRANSPLANTS (HCFA-3835-P)
Priority:


Other Significant


Legal Authority:


42 USC 1302; 42 USC 1395hh


CFR Citation:


42 CFR 482


Legal Deadline:


None


Abstract:


The rule establishes conditions of participation for facilities to 
perform Medicare-covered transplants.

[[Page 73373]]

Statement of Need:


HCFA's present criteria for heart, liver and lung transplantation 
centers were developed at a time when the Department's policies were 
intended to promote long-term survival of transplanted organs through 
use of patient selection policies that avoided selection of high risk 
patients and use of unadjusted actuarial survival as a measure of 
outcome and experience. More than 64,000 Americans are waiting for 
organ transplants, yet only about 20,000 receive organs annually. About 
4,000 persons die each year waiting for an organ to become available. 
We consider of paramount importance our role in promoting awareness of 
the organ transplant situation, encouraging increased organ donation, 
fostering proper stewardship of this scarce national resource and 
ensuring that Federal policies result in equitable distribution of 
organs. While the goal of promoting long-term survival is laudable, we 
have subsequently concluded that such criteria deter transplantation of 
high risk patients, may not promote equitable distribution of organs, 
and may potentially increase deaths awaiting transplant.


The existing transplant notices address patient selection, patient 
management, commitment, facility plans, experience and survival rates, 
maintenance of data, organ procurement, laboratory services and 
billing. All policies require facilities to have a minimum of two years 
transplantation experience prior to applying for Medicare approval. The 
issue of setting the standards for Medicare-approved transplant 
facilities is complex and difficult. On one hand, we want to ensure 
that Medicare beneficiaries are treated only in facilities which 
provide quality care. However, as we limit the number of centers we 
approve, we could create limited access to this lifesaving technology. 
We strive to strike a balance between organ allocation and quality of 
care. While we expect facilities to continue to be responsible for 
appropriate organ transplant policies and protocols for these 
components, we do not believe it is essential for facilities to report 
to us on the details of these polices. We strongly believe that 
successful organ transplantation requires the skills and experience of 
an interdisciplinary team. Therefore, we intend to focus regulations on 
the actual care being furnished and outcomes of that care. 
Consequently, we are proposing to evaluate facility survival rates and 
experience. We propose to retain only requirements that are directly 
related to patient outcomes or that are necessary for data purposes. 
These requirements are: (1) Volume - performed 20 transplants minimum 
during past 4 complete calendar years; (2) Data submission - data on 
transplant number, date of transplant, patient diagnosis, patient 
status, donor types, date of most recent ascertained survival, length 
of survival over the past 4 years; (3) Outcomes - unadjusted actuarial 
1-year patient survival is equal to or greater than the mean risk 
adjusted 1-year patient survival for all transplant centers in the 
Nation less 10 percent points calculated during the last reapproved 
period. We believe these standards requirements are in concert with the 
Department's commitment to the equitable organ allocation initiative.


In developing this proposed rule, HCFA has given serious consideration 
to the recommendations from the Institute of Medicine (IOM) as well as 
from the panel of the HCFA Town Hall Meeting held in December, 1999. 
These recommendations have captured the latest thinking in outcome 
measures of transplant centers and they entail, aspects of facilities 
linked to coverage, methodologies for measuring outcomes at transplant 
centers, data used for approving centers and thresholds for approving 
centers.


Summary of Legal Basis:


Section 1102 authorizes the Secretary to make and publish rules and 
regulations, as may be necessary to the efficient administration of the 
functions with each is charged under the Act. Section 1871 of the Act 
states, ``The Secretary shall prescribes such regulations as may be 
necessary to carry out the administration of insurance programs under 
this title.'' Given the concern that the Department has in ensuring 
proper stewardship of the Nation's limited organ supply and the concern 
that we have in ensuring Medicare beneficiaries are afforded high 
quality health care, we believe it is appropriate for the Secretary to 
use this broad authority to regulate Medicare payment for organ 
transplantation.


Alternatives:


For the most part, Medicare transplant center criteria have been 
implemented through a series of notices in the Federal Register. The 
exception is the kidney transplant criteria that have been implemented 
at 42 CFR part 405, subpart U. The use of Federal Register notices to 
announce the criteria has proven difficult for hospitals desiring to 
become Medicare approved transplant centers. Hospitals have difficulty 
in researching the approved criteria, and once it is located, do not 
know if it is current. We believe it is important to codify the 
requirements for Medicare approval of transplant centers in 
regulations. Therefore, we are proposing to include the transplant 
center criteria as a component of the hospital conditions of 
participation, so that the criteria for all five transplant types 
(heart, liver, lung, kidney and pancreas) are located in the same area, 
for ease of reference and understanding. Another option is to update 
the current scattered transplant policies and maintain the process-
oriented standards without focusing on patient outcomes. However, based 
on the rationale discussed, we believe it is important to promulgate 
this rule to fulfill our commitment to equitable organ allocation and 
optimal patient outcomes.


Anticipated Cost and Benefits:


The expected benefits from the proposed rule include easy references 
and enhancement of better understanding of the criteria by facilities, 
improved patient outcomes, and it would facilitate the most equitable 
and medically effective use of organs that are donated in trust for 
transplantation.


We have not yet quantified the costs. Response to the NPRM should help 
to determine the cost of this regulation.


Risks:


If the CoP: Criteria for Approval of Facilities to Perform Medicare-
Covered Transplants is not promulgated, our current transplant policies 
will not allow us to take advantage of continuing advances in the 
health care delivery field, or to keep current with growing demands for 
services, and the distribution of organs will remain inequitable.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           12/00/00
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


Businesses, Organizations


Government Levels Affected:


None

[[Page 73374]]

Federalism:


 Undetermined


Agency Contact:
Marty Abeln
Department of Health and Human Services
Health Care Financing Administration
Center for Health Plans and Providers
7500 Security Boulevard
Baltimore, MD 21244-1850
Phone: 410 786-1032

Kathy Linstromberg
Department of Health and Human Services
Health Care Financing Administration
7500 Security Boulevard
Baltimore, MD 21244
Phone: 410 786-8279

Eva Fung
Health Insurance Specialist
Department of Health and Human Services
Health Care Financing Administration
S3-06-6
7500 Security Boulevard
Baltimore, MD 21244-1850
Phone: 410 786-7539
RIN: 0938-AH17
_______________________________________________________________________



HHS--HCFA



47.  REVISIONS TO MEDICAID UPPER PAYMENT LIMIT REQUIREMENTS FOR 
HOSPITAL, NURSING FACILITY, INTERMEDIATE CARE FACILITY SERVICES FOR THE 
MENTALLY RETARDED AND CLINIC SERVICES (HCFA-2071-P)
Priority:


Economically Significant. Major under 5 USC 801.


Legal Authority:


42 USC 1902(a)(30)


CFR Citation:


42 CFR 447


Legal Deadline:


None


Abstract:


This rule would amend our regulations about the Medicaid upper payment 
limit (UPL) for inpatient hospital services, nursing facility services, 
intermediate care facility services for the mentally retarded, 
outpatient hospital services and clinic services. For each type of 
Medicaid service, current regulations place an upper limit on overall 
aggregate payments to all facilities and, for inpatient services a 
separate aggregate upper limit on payments made to State-operated 
facilities. This proposed rule would establish additional aggregate 
upper limits that would apply to payments made to all other types of 
government facilities that are not State-owned or operated facilities. 
The proposed upper limits are necessary to ensure State Medicaid 
payment systems promote economy and efficiency.


Statement of Need:


On February 18, 1986, we published a proposed rule in the Federal 
Register (51 FR 5728) to clarify and change the upper payment limit 
requirement to address the application of the upper payment limit to 
States that had multiple payment rates for the same class of services. 
Using the flexibility permitted under the Boren Amendment revisions to 
section 1902(a)(13) of the Act, many States changed their payment 
methodologies, to set different payment levels and payments to 
providers who provided the same type of care. States could 
substantially increase payments to one group of providers if they could 
offset the increased payments by making lower payments to another group 
of providers.


In the final rule published in the Federal Register (52 FR 28141) on 
July 28, 1987, we addressed the differential rate issue in the context 
of State-operated facilities because several audits had revealed that 
the circumstances of State-operated facilities resulted in a lack of 
incentives to curb excessive payments. Because costs not reimbursed by 
Medicaid or other liable payers would be borne entirely by a State, 
States had no reason to adopt cost effective payment methodologies for 
State-operated facilities. In contrast, States had a strong incentive 
to use cost effective methodologies for private providers, since 
payments to those providers would not ultimately reduce State 
expenditures. To ensure payments to State-operated facilities would be 
consistent with efficiency and economy, the final rule applied the 
Medicare upper limit test to State-operated facilities.


In this proposed rule, we would expand the application of upper payment 
limits to address an emerging problem of excessive State payment rates 
for Medicaid services furnished by local government providers. The 
changes we propose would result in three upper limit requirements that 
would limit Medicaid payments for inpatient hospital services, nursing 
facility services, intermediate care facility services for the mentally 
retarded, outpatient hospital services, and clinic services. For each 
Medicaid service category, State plans would have to comply with: (1) 
an upper limit on overall aggregate payments; (2) an upper limit on 
aggregate payments to State-owned or operated facilities; and (3) an 
upper limit on aggregate payments to all other types of Government-
owned or operated facilities. The limits would continue to be based on 
Medicare payment principles. We believe these changes are necessary to 
ensure that States adopt payment methods and standards that result in 
rates that are consistent with efficiency and economy.


Under sections 1902(a)(13) and 1902(a)(30) of the Act, States have the 
flexibility to establish different payment methodologies to pay for the 
same type of inpatient services; that is, inpatient hospital services, 
nursing facility services, or intermediate care facility services for 
the mentally retarded. Section 4711 of the Balanced Budget Act of 
1997(BBA)(Pub. L. 105-33) amended section 1902(a)(13) of the Act to 
increase State flexibility in rate setting by replacing the substantive 
requirements of the Boren Amendment with a new public process. Under 
section 4711 of the BBA, States have flexibility to target rate 
increases to particular types of facilities so long as the rates are 
established in accordance with the new public process requirements. 
While a similar public process requirement does not apply to rates set 
for outpatient hospital services or clinic services, under our previous 
interpretation of section 1902(a)(30) of the Act, States could also 
target enhanced rates to particular facilities, provided aggregate 
State payments for these type of services were within the upper limit.


It is apparent that a single upper limit on overall aggregate payments 
is not sufficient to ensure cost-effective rates, because it does not 
control State incentive to make excessive payments to certain 
facilities. Because our previous refinement to the upper payment limit 
was specific to State-operated facilities, States currently are 
permitted to establish payment methodologies that result in excessive 
payments to other types of government facilities such as county or 
city-operated facilities. We recently reviewed several State proposals 
that would pay county providers at levels several hundred times in 
excess of the

[[Page 73375]]

reasonable costs they incur as well as in excess of State payment 
levels set to obtain the same services from non-public facilities. 
Since these government facilities are not State-operated, Medicaid 
service payments to them are limited only by a State's overall 
aggregate expenditure for each type of Medicaid service as established 
under sections 447.272(a) and 447.321. Inpatient services are subject 
to the requirements in section 447.272(a) and outpatient services are 
subject to the requirements in section 447.321.


By developing payment systems for proprietary and nonprofit facilities 
that limit payments to more cost-effective operations, States can set 
rates that pay county or city facilities more than the actual costs 
they incur in providing covered services to Medicaid eligible 
individuals. Payments to these Government-owned or operated facilities 
as a group may substantially exceed amounts that would be determined 
reasonable under Medicare payment principles. Because these facilities 
are public entities, State funds can be transferred from those 
facilities (or the local government units that operate those 
facilities) to the State. Essentially, through such an arrangement, a 
State can increase Federal funding with no net increase in State 
expenditures. This has the effect of circumventing Federal requirements 
for actual expenditures and effectively may result in net provider 
payments that are completely Federally financed.


To correct and prevent these situations, we are proposing to revise the 
regulations at sections 447.272(b) and 447.321 to establish additional 
upper limits that would result in all payments to Government-owned or 
operated facilities being subject to upper payment limits.


We recognize that the new upper payment limits we are proposing could 
disrupt State budget arrangements, therefore our proposed changes will 
solicit comments on a transition period for States that have approved 
rate enhancement payment arrangements that exceed the new UPL.


Summary of Legal Basis:


Section 1902(a)(30) of the Act requires a State plan for medical 
assistance to certain methods and procedures to assure payments for 
care and services are consistent with efficiency, economy and quality 
of care. This provision provides authority for specific upper payment 
limits set forth in Federal regulations at 42 CFR part 477.


Alternatives:


Section 1902(a)(30) of the Act requires, in part, that Medicaid service 
payments be consistent with efficiency and economy. In addition to the 
interpretation we are proposing in this notice of proposed rulemaking, 
we considered several other alternatives to ensure Medicaid service 
payments are consistent with economy and efficiency. We also considered 
regulating State sources of funding. In this section, we will explain 
these other alternatives and why we are not proposing them.


Facility-Specific Upper Payment Limit. Under this option, Medicaid 
spending would be limited on a provider-specific application of 
Medicare payment principles. FFP would not be available on the amount 
of Medicaid service payment in excess of what a provider would have 
been paid using Medicare payment principles. Such limits would be 
applied to all institutions, or just to public institutions where the 
incentives for over-payment are significant. While a facility-specific 
limitation may be the most effective method to ensure State service 
payments are consistent with economy and efficiency, when balanced 
against the additional administrative requirements on States and the 
Congressional intent for States to have flexibility in rate setting, we 
are not sure that the increased amount of savings, if any, justifies 
this approach as a viable option.


Government-Owned or Operated Upper Limit. This proposal would limit, in 
the aggregate, the amount of payment States can make to public 
providers. Under this proposal, State and local government providers 
would be grouped together and payments to them as a group could not 
exceed an aggregate limit. The aggregate limit would continue to be 
based on Medicare payment principles. This option, relative to upper 
payment limitations we are proposing, would have allowed States to 
exercise more flexibility granted to them in the rate setting process. 
While this option permits more flexibility, we believe the aggregation 
of Medicaid service payments by all types of government providers would 
have the unintended consequence of reopening differential rate issues 
between State facilities and other types of government facilities.


Intergovernmental Transfers (IGTs). Because in many cases we believe 
there is a connection between excessive payments and IGTs, we gave some 
limited consideration to formulating policy with respect to them. 
Generally, States have genuine incentive to set Medicaid service rates 
at levels consistent with economy and efficiency since they share the 
financial burden with the Federal Government. We believe that the use 
of IGTs to move funds between government entities is interfering with 
the normal incentive for States to set reasonable service rates. 
However, we note that there are statutory limitations placed on the 
Secretary which limit the authority to place restrictions on IGTs. In 
light of statutory barriers to place restrictions on IGTs, we are not 
proposing any changes to current rules or policies pertaining to IGTs 
at this time. We also note that the Office of the Inspector General is 
examining rates paid to public facilities, the prevalence of 
intergovernmental transfers, and the use of funds that are transferred.


We will invite comment on these alternatives we considered and on other 
possible approaches for achieving our objective to ensure Medicaid 
service payments are consistent with efficiency and economy.


Anticipated Cost and Benefits:


We are unable to provide a specific dollar estimate of the economic 
impact this proposed regulation will have on State and local 
governments and Medicaid participating health care facilities due to 
data limitations and State behavioral responses. This proposed 
regulation does not reduce the overall aggregate amount States can 
spend on Medicaid services or place a fixed ceiling on the amount of 
State spending that will be eligible for Federal matching dollars. 
Under the proposed limitations, States will be able to set reasonable 
rates as determined under Medicare payment principles for Medicaid 
services furnished by public providers to eligible individuals. The 
amount of spending permitted under the proposed limits will vary 
directly with the amount of Medicaid services furnished by public 
providers to eligible individuals. While the proposed regulation does 
not affect the overall aggregate amount States can spend, by setting an 
upper payment limit for government providers, it may impact how States 
distribute available funding to participating health care facilities.


Risks:


We do not believe States will continue to set excessive payment rates 
for Medicaid services furnished by government providers. Generally, 
discontinuing an expenditure should

[[Page 73376]]

not result in new costs, unless the State has to fund the portion of 
the expenditure that is no longer federally funded with all State and 
local dollars. There are no Federal requirements under the Medicaid 
statute that mandate States to make these type of payments to Medicaid 
public providers and therefore we do not believe the proposed limits 
have any unfunded mandate implications.


We anticipate that the majority of State Medicaid programs will be 
unaffected by the upper payment limits we are proposing. With respect 
to affected States, to some degree we will be limiting flexibility in 
the management of their Medicaid programs. If these States wish to 
continue to make payments in excess of the proposed limits, they will 
have to fund the amount in excess with only State and local resources. 
In the absence of FFP, we anticipate States will reinvest these 
resources to support other Medicaid activities to take advantage of and 
maintain Federal resources. Should States realign their payment systems 
or divert State matching dollars to support other Medicaid activities, 
the total amount of available Federal funds should remain unchanged.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            65 FR 60151                                    10/10/00
Final Action                                                   02/00/01
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


Governmental Jurisdictions


Government Levels Affected:


State, Local


Agency Contact:
Robert Weaver
Health Insurance Specialist, Medicaid Bureau
Department of Health and Human Services
Health Care Financing Administration
C4-16-13
7500 Security Boulevard
Baltimore, MD 21244-1850
Phone: 410 786-5914
RIN: 0938-AK12
_______________________________________________________________________



HHS--HCFA



48.  PAYMENT FOR CLINICAL PSYCHOLOGY TRAINING PROGRAMS AND 
PHYSICIAN ASSISTANT TRAINING PROGRAMS (HCFA-1089-P)
Priority:


Other Significant


Legal Authority:


Social Security Act, sec 1861(v); Social Security Act, sec 1886(a)(4); 
PL 105-33


CFR Citation:


42 CFR 413.85


Legal Deadline:


None


Abstract:


This proposed rule would revise our policy on Medicare payment for 
approved nursing and allied health education programs to permit payment 
for the costs incurred by a provider for the clinical training of 
students enrolled in a clinical psychology training program or a 
physician assistant training program. Consistent with the Conference 
Agreement language in the Conference Report accompanying the Balanced 
Budget Act of 1997 (Public Law 105-33), these clinical training costs 
would be paid separately on a reasonable cost basis pursuant to 
sections 1861(v) and 1886(a)(4) of the Social Security Act.


Statement of Need:


We believe we should expand existing Medicare policy to include payment 
for the hospital-based training of this allied health specialty because 
it plays an essential role in providing quality health care to Medicare 
beneficiaries.


Summary of Legal Basis:


Consistent with the Conference Agreement language in the Conference 
Report accompanying the Balanced Budget Act of 1997 (Public Law 105-
33), the clinical training costs of students enrolled in a clinical 
psychology training program would be paid to hospitals separately on a 
reasonable cost basis in accordance with sections 1861(v) and 
1886(a)(4) of the Social Security Act.


Alternatives:


To the extent possible, we were able to consider and incorporate the 
recommendations from various industry groups and affected parties.


Anticipated Cost and Benefits:


Actuarial estimates indicate that the minimal annual costs to the 
Medicare program associated with payment for the clinical training 
portion of clinical psychology training programs would be approximately 
$30 million the first year after payments begin and may grow to $50 
million by the 5th year.


Risks:


None.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           11/00/00
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


None


Agency Contact:
Tzvi Hefter
Center for Health Plans and Providers
Department of Health and Human Services
Health Care Financing Administration
C5-08-27
7500 Security Boulevard
Baltimore, MD 21244-1850
Phone: 410 786-1304
RIN: 0938-AK15
_______________________________________________________________________



HHS--HCFA



49.  PROSPECTIVE FEE SCHEDULE FOR AMBULANCE SERVICES (HCFA-
1002-P)
Priority:


Other Significant. Major under 5 USC 801.


Unfunded Mandates:


This action may affect the private sector under PL 104-4.


Legal Authority:


PL 105-33, sec 4531(b)


CFR Citation:


42 CFR 410


Legal Deadline:


Final, Statutory, January 1, 2002.


Abstract:


The Balanced Budget Act (BBA) of 1997 requires that the Secretary 
establish a fee schedule for ambulance services through negotiated 
rulemaking. The fee schedule is to be effective beginning with services 
furnished on or after January 1, 2000. However, other

[[Page 73377]]

statutory obligations and the scope of systems changes required to 
implement the ambulance fee schedule were so numerous as to make it 
impossible for us to accomplish this concurrent with the critical work 
that we and our contractors had to perform to assure that our 
respective systems were compliant with the year 2000 requirements. 
Therefore, since we were unable to implement the ambulance fee schedule 
on January 1, 2000, we have delayed implementation of the fee schedule 
for ambulance services until January 1, 2001. This action is in keeping 
with our objective to have the ambulance fee schedule become effective 
as soon as possible after the January 1, 2000 statutory date; given our 
year 2000 activities and our other statutory obligations to implement 
various revised payment systems in calendar year 2000. In addition to 
setting the payment rates, the Secretary is to ensure that the 
aggregate amount of payment made for ambulance services in 2001 may not 
exceed the amount of payment that would have been made absent the fee 
schedule. This is a cap on payment, not a budget neutrality adjustment. 
Negotiations were conducted by a committee chartered under the Federal 
Advisory Committee Act (FACA) (5 U.S.C. App. 2). We used the services 
of an impartial conveyer to help identify interests that would be 
significantly affected by the proposed rule (including residents of 
rural areas) and the names of persons who were willing and qualified to 
represent those interests. The Negotiated Rulemaking Committee on the 
Medicare Ambulance Services Fee Schedule consisted of national 
representatives of interests that were likely to be significantly 
affected by the fee schedule. To the extent that this proposed rule 
accurately reflected the Committee Statement as signed on February 14, 
2000, each member to the Committee agreed not to comment on those 
issues on which consensus was reached.


Statement of Need:


The establishment of this fee schedule is required by section 4531 of 
the BBA. In going through the negotiated rulemaking process, a fairer 
payment system will be implemented that is consistent with the services 
furnished and that takes into account the variations caused by regional 
and operational differences among ambulance companies.


Summary of Legal Basis:


Section 4531 of the BBA requires the establishment of this fee 
schedule.


Alternatives:


Because section 4531 of the BBA requires the establishment of this fee 
schedule, no alternatives to this regulation exist.


Anticipated Cost and Benefits:


There is an anticipated savings of $65 million, which will be 
attributed to the savings that would have occurred, if the HCFA 
proposed regulation published on June 17, 1997 at 62 FR 32715 had been 
implemented in final. These savings derived from the proposal to pay 
for ambulance services furnished, rather than paying for the more 
expensive advanced life support (ALS) level of service solely because 
an ALS vehicle was used, even if no ALS service was furnished.


Benefits include establishing a fee schedule that will be commensurate 
with the services furnished, and will take into account the regional 
and operational variations in providing ambulances. The current 
reasonable charge/reasonable cost systems do not result in a fair 
geographic variation in payment allowances, since some areas receive 
two to three times the payment of other areas for the same services.


Risks:


Failing to implement the Medicare ambulance fee schedule would 
perpetuate an inequitable payment system that sometimes overpays and 
other times underpays for this critical aspect of medical care. The 
current system also has unintentional incentives to provide inefficient 
ambulance services in some areas, and inadequate ambulance services in 
areas of low population.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           12/00/00
Regulatory Flexibility Analysis Required:


Undetermined


Government Levels Affected:


Undetermined


Federalism:


 Undetermined


Agency Contact:
Nancy Archer
Office of Clinical Standards and Quality
Department of Health and Human Services
Health Care Financing Administration
S3-05-27
7500 Security Boulevard
Baltimore, MD 21244-1850
Phone: 401 786-0596
RIN: 0938-AK30
_______________________________________________________________________



HHS--HCFA



50.  ELIMINATION OF APPLICATION OF FEDERAL FINANCIAL 
PARTICIPATION LIMITS (HCFA-2086-P)
Priority:


Other Significant. Major status under 5 USC 801 is undetermined.


Legal Authority:


42 USC 1396b(f); 42 USC 1396a(r)(2)


CFR Citation:


42 CFR 435.601; 42 CFR 435.1007


Legal Deadline:


None


Abstract:


This rule eliminates the current requirement that limits on Federal 
Financial Participation (FFP) must be applied when States use less 
restrictive income methodologies than those used by related cash 
assistance programs in determining eligibility for Medicaid.


This regulatory change is necessary because the current regulatory 
interpretation of how the FFP limits apply to income methodologies 
under section 190(r)(2) of the Social Security Act (the Act) 
unnecessarily restricts States' ability to take advantage of the 
authority to use less restrictive income methodologies under that 
section of the statute. While the enactment of section 1902(r)(2) of 
the Act could be read in the limited manner embodied in current 
regulations, the enactment of the Personal Responsibility and Work 
Opportunity Reconciliation Act of 1996 calls into question the current 
regulations approach.


Statement of Need:


States have noted that the application of the FFP limits to less 
restrictive income methodologies unreasonably limits their flexibility 
to expand Medicaid eligibility and simplify program administration by 
modifying cash assistance financial methodologies that do not work well 
in the Medicaid

[[Page 73378]]

context. Thus, this change will give States needed additional 
flexibility in setting Medicaid eligibility requirements. Even though 
section 1902(r)(2) was derived from the Deficit Reduction Act (DRA) of 
1984 moratorium, its own legislative history did not contain any 
similar discussion of its interaction with the FFP section 1903(f) 
limits. As such, we do not believe it is necessary to consider the 
legislative history of DRA to be determinative of Congressional 
understanding of the operation of section 1902(r)(2).


Summary of Legal Basis:


In determining financial eligibility of individuals for the Medicaid 
program, State agencies must apply the financial methodologies and 
requirements of the cash assistance program that is most closely 
categorically-related to the individual's status. Our regulations set 
forth the requirements for State agencies applying less restrictive 
income and resource methodologies when determining Medicaid eligibility 
under the authority of section 1902(r)(2) of the Act. The current 
regulation provides that when States use less restrictive income 
methodologies under section 1902(r)(2), the limits on FFP in section 
1903(f) of the Act apply. We are proposing to amend the regulation to 
eliminate the requirement that FFP limits apply to less restrictive 
income methodologies under section 1902(r)(2) of the Act.


The adoption of this policy would conform the application of the FFP 
limits under section 1902(r)(2) to the policy that we have adopted 
under section 1931 of the Act that less restrictive income 
methodologies used under section 1931 are not subject to FFP limits. We 
do not believe it is appropriate or necessary to continue to apply the 
FFP limits to section 1902(r)(2) income methodologies when they are not 
applied under section 1931. Further, this change gives States 
additional flexibility in setting Medicaid eligibility requirements.


Alternatives:


There are few alternatives to the proposed rule to consider. One 
alternative is to maintain the requirement that the FFP limits apply 
less restrictive income methodologies under section 435.601, but to 
allow additional disregards at a somewhat higher level than is 
permitted under the current regulations. However, this would not 
provide States the level of flexibility to operate their Medicaid 
programs that is provided under the proposed rule, and thus would be of 
only limited value. We rejected this alternative because it would not 
give States what they need to effectively operate their Medicaid 
programs, or the flexibility that Congress intended when it enacted 
section 1902(r)(2) of the Act.


Anticipated Cost and Benefits:


HCFA's Office of the Actuary projects a potential Federal cost of the 
regulation of $860 million over five years. However, the proposed 
change does not mandate any action or program change by the States. Any 
program changes are strictly at State option. Thus, the actual cost of 
the regulation will depend entirely on whether, and to what degree, 
States choose to take advantage of the increased flexibility provided 
by the proposed change.


We believe that this proposed rule would have a direct, positive impact 
on States by providing them greater flexibility in designing and 
operating their Medicaid programs. This proposed change has 
considerable support from States and others involved in the Medicaid 
program. We do not anticipate any public opposition to the proposed 
rule.


Risks:


Failure to publish this regulation would leave in place the current 
rule placing unreasonable limits on States' flexibility to expand 
Medicaid eligibility and simplify program administration by modifying 
cash assistance financial methodologies that do not work well in the 
Medicaid context.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           11/00/00
Regulatory Flexibility Analysis Required:


Undetermined


Small Entities Affected:


No


Government Levels Affected:


Undetermined


Federalism:


 Undetermined


Agency Contact:
Roy Trudel
Department of Health and Human Services
Health Care Financing Administration
C4-20-15
Center for Medicaid and State Operations
7500 Security Boulevard
Baltimore, MD 21244-1850
Phone: 410 786-3417
RIN: 0938-AK32
_______________________________________________________________________



HHS--HCFA

                              -----------

                            FINAL RULE STAGE

                              -----------




51. UPDATE OF RATESETTING METHODOLOGY, PAYMENT RATES AND THE LIST OF 
COVERED SURGICAL PROCEDURES FOR AMBULATORY SURGICAL CENTERS EFFECTIVE 
FOR CALENDAR YEAR 2000 (HCFA-1885-FC)
Priority:


Other Significant. Major under 5 USC 801.


Legal Authority:


42 USC 13951(i)(2)(A)


CFR Citation:


42 CFR 416.61(b); 42 CFR 416.65(a)(4); 42 CFR 416.65(c); 42 CFR 
416.120(c)(1); 42 CFR 416.125; 42 CFR 416.130; 42 CFR 416.140(a); 42 
CFR 416.140(b); 42 CFR 488.1


Legal Deadline:


None


Abstract:


The final rule will update the criteria for determining which surgical 
procedures can be appropriately and safely performed in an Ambulatory 
Surgical Center (ASC); make additions to and deletions from the current 
list of Medicare covered ASC procedures based on the revised criteria; 
rebase the ASC payment rates using charge and utilization data 
collected by a 1994 survey of ASCs; refine the ratesetting methodology 
that was implemented by a final notice published on February 8, 1990 in 
the Federal Register; require that ASC payment, coverage and wage index 
updates be implemented annually on January 1, rather than having these 
updates occur randomly throughout the year; establish a payment rate 
for Extracorporeal Shock Wave Lithotripsy; reduce regulatory burden; 
and make several technical policy changes.

[[Page 73379]]

Statement of Need:


Although we are required by law to update the ASC list biennially, the 
last update to add procedures to, and delete procedures from, the list 
was published on January 26, 1995.


The comment period on the proposed rule was extended several times and 
we received over 14,000 public comments. The comment period was 
extended to coincide with the outpatient hospital prospective payment 
system (PPS) proposed rule comment period. The outpatient PPS rule had 
a statutory deadline, and the rule has since been published and 
implemented. These two rules, when taken together, will achieve a more 
level playing field in payment by the Medicare program for surgical 
services performed on an outpatient basis regardless of site of 
performance.


Summary of Legal Basis:


Section 1832(a)(2)(F)(i) of the Social Security Act (the Act) provides 
that benefits under the Medicare Supplementary Medical Insurance 
program (part B) include payment for facility services furnished in 
connection with surgical procedures specified by the Secretary and 
performed in an ambulatory surgical center (ASC).


The Secretary is to review and update the list of ASC procedures 
biennially.


To participate in the Medicare program as an ASC, a facility must meet 
the standards specified under section 1832(a)(2)(F)(i) of the Act and 
42 CFR 416.25, which sets forth general conditions and requirements for 
ASCs.


Generally, there are two primary elements in the total cost of 
performing a surgical procedure: the cost of the physicians 
professional services for performing the procedure, and the cost of 
services furnished by the facility where the procedure is performed.


We are required to review and update the ASC payment amounts annually.


Alternatives:


None


Anticipated Cost and Benefits:


Undetermined


Risks:


Undetermined


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            63 FR 32290                                    06/12/98
Final Action                                                   12/00/00
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses


Government Levels Affected:


None


Federalism:


 Undetermined


Agency Contact:
Bob Cereghino
Program Analyst
Department of Health and Human Services
Health Care Financing Administration
C4-03-06
7500 Security Boulevard
Baltimore, MD 21244
Phone: 410 786-4645
RIN: 0938-AH81
_______________________________________________________________________



HHS--HCFA



52. EXPANDED COVERAGE FOR DIABETES OUTPATIENT SELF-MANAGEMENT TRAINING 
SERVICES (HCFA-3002-P)
Priority:


Economically Significant


Legal Authority:


42 USC 1302; 42 USC 1395hh; 42 USC 1395x


CFR Citation:


42 CFR 410; 42 CFR 414; 42 CFR 424; 42 CFR 476; 42 CFR 498


Legal Deadline:


NPRM, Statutory, July 1, 1998.


Abstract:


This rule would provide for uniform coverage of diabetes outpatient 
self-management training services. These services include educational 
and training services furnished to a beneficiary with diabetes by an 
entity approved to furnish the services. The physician or qualified 
nonphysician practitioner treating the beneficiary's diabetes would 
certify that these services are needed as part of a comprehensive plan 
of care. This rule proposes the quality standards that an entity would 
be required to meet in order to participate in furnishing diabetes 
outpatient self-management training services. It sets forth proposed 
payment amounts that have been established in consultation with 
appropriate diabetes organizations. It would implement section 4105 of 
the Balanced Budget Act of 1997 (BBA).


Statement of Need:


Section 4105 of the BBA provided for coverage of diabetes self-
management training to include services provided in nonhospital-based 
programs. This proposed rule would expand Medicare coverage for 
diabetes outpatient self-management training; define who may be a 
certified provider of services that may provide diabetes outpatient 
management training services; explain that the physician managing the 
patient's diabetes must certify that the services are needed under a 
comprehensive plan of care; and sets standards for certified providers 
that have been established in consultation with appropriate diabetes 
organizations.


Summary of Legal Basis:


Section 4105(a) of the BBA provides coverage for diabetes outpatient 
self-management training. Under this coverage, training would include 
educational and training services furnished in an outpatient setting 
(according to frequency standards established by the Secretary) to a 
beneficiary with diabetes by a ``certified provider'' that meets 
certain quality standards.


Alternatives:


Coverage is provided for in section 4105(a) of the BBA, therefore, no 
alternatives to issuing this regulation exist.


Anticipated Cost and Benefits:


Projected Budget Impact of New Benefit ($ in millions): $60 in FY 1998; 
$560 in FY 1999; $230 in FY 2000; $80 in FY 2001; and $80 in FY 2002. 
An estimate of benefits has not been established.


Risks:


If the diabetes self-management training is not implemented, our 
diabetic beneficiaries will not receive information for improving their 
long term health that would result from this rule.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            64 FR 6827                                     02/11/99
Final Action                                                   12/00/00
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


Businesses, Organizations

[[Page 73380]]

Government Levels Affected:


None


Federalism:


 Undetermined


Agency Contact:
Betty S. Burrier
Department of Health and Human Services
Health Care Financing Administration
S3-02-01
Office of Chronic Care Insurance Policy, Bureau of Policy Development
7500 Security Boulevard
Baltimore, MD 21244-1850
Phone: 410 786-4649
RIN: 0938-AI96
_______________________________________________________________________



HHS--HCFA



53. PROTECTION FOR WOMEN WHO ELECT RECONSTRUCTION AFTER A MASTECTOMY 
(HCFA-2040-IFC)
Priority:


Other Significant. Major status under 5 USC 801 is undetermined.


Unfunded Mandates:


Undetermined


Legal Authority:


42 USC 300gg-6


CFR Citation:


45 CFR 146; 45 CFR 148


Legal Deadline:


None


Abstract:


The final rule would implement the requirements of the Women's Health 
and Cancer Rights Act of 1998 (WHCRA) (Pub. L. 105-277). The rules will 
provide protection to patients who are receiving benefits in connection 
with a mastectomy and who elect breast reconstruction. WHCRA provides 
coverage for all stages of reconstruction of the breast on which the 
mastectomy has been performed; surgery and reconstruction of the other 
breast to produce a symmetrical appearance; and coverage for prostheses 
and treatment of physical complications of a mastectomy, including 
lymphedema. Group health plans and health insurance issuers that offer 
medical and surgical benefits for mastectomies are subject to WHCRA's 
coverage requirements.


Statement of Need:


The final rule will provide needed guidance to consumers, health 
insurance issuers, employers and group health plans relating to 
coverage for breast reconstruction and related services after a 
mastectomy. A solicitation of comments was published in the Federal 
Register May 28, 1999. The Department received numerous requests from 
consumers, providers, and health insurance issuers for clarification of 
WHCRA's applicability and substantive requirements.


Summary of Legal Basis:


The Women's Health and Cancer Rights Act of 1998 (Pub. L. 105-277) was 
enacted on October 21, 1998 to provide protections for patients who are 
receiving benefits in connection with a mastectomy and who elect breast 
reconstruction. WHCRA was incorporated into the administrative 
framework established by titles I and IV of the Health Insurance 
Portability and Accountability Act of 1996 (Pub. L. 104-191). In the 
individual health insurance market, the protections established by 
WHCRA applied to health insurance coverage offered, sold, issued, 
renewed or in effect on the date of enactment, October 21, 1998. In the 
group market, WHCRA's protections were effective for plan years 
beginning on or after October 21, 1998.


Alternatives:


None


Anticipated Cost and Benefits:


The economic impact analysis of these rules has not yet been completed. 
Estimates of the economic impact that will stem from these rules will 
be made available once analysis has been completed.


Risks:


This final rule is necessary because group health plans and health 
insurance issuers have been required to comply with WHCRA requirements 
since its enactment on October 21, 1998. Consumers, employers, health 
insurance issuers, and group health plans need clarification on a 
number of WHCRA's provisions related to coverage and the 
responsibilities of health insurance issuers and health plans.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
Interim Final Rule                                             12/00/00
Regulatory Flexibility Analysis Required:


Undetermined


Small Entities Affected:


No


Government Levels Affected:


Undetermined


Federalism:


 Undetermined


Agency Contact:
Michael Bussacca
Department of Health and Human Services
Health Care Financing Administration
Center for Health Plans and Providers
7500 Security Boulevard
Baltimore, MD 21244-1850
Phone: 410 786-4602
RIN: 0938-AJ44
_______________________________________________________________________



HHS--HCFA



54. THE CHILDREN'S HEALTH INSURANCE PROGRAM: IMPLEMENTING THE BALANCED 
BUDGET ACT OF 1997 (HCFA-2006-F)
Priority:


Economically Significant. Major under 5 USC 801.


Legal Authority:


42 USC 1396; PL 105-33


CFR Citation:


42 CFR 457


Legal Deadline:


None


Abstract:


This regulation establishes rules for the new Children's Health 
Insurance Program (CHIP). It implements sections 4901 and 4911 of the 
Balanced Budget Act (BBA) of 1997.


Statement of Need:


The Balanced Budget Act of 1997 (Pub. L. 105-33) creates a new title 
XXI of the Social Security Act to establish a Children's Health 
Insurance Program that supplements the Medicaid program and enables 
States to create a new and unique health delivery system for low-income 
children. This regulation will codify a series of policy guidance that 
has been released to the States and other interested parties over the 
past two years.


Summary of Legal Basis:


As established by section 4901 of the BBA, the new title XXI of the 
Social Security Act authorizes $41 billion over the next 10 years for 
States to create separate Children's Health Insurance Programs to 
provide health care coverage to targeted low-income children.

[[Page 73381]]

In order to receive reimbursement through an enhanced matching rate, 
States have three options in developing programs. They may expand 
existing Medicaid programs, create unique and separate children's 
health programs, or establish a combination of the two options. Within 
certain parameters set by the statute, States have flexibility to 
determine eligibility levels, develop benefit packages, and impose 
cost-sharing requirements. The statute also includes provisions for 
meeting strategic objectives, evaluation and data collection. In order 
to codify this authority, we have proposed implementing regulations at 
42 CFR part 457.


Alternatives:


Federal payments under title XXI are based on State expenditures under 
approved plans that could be effective on or after October 1, 1997. The 
short time frame between the enactment of the BBA on August 5, 1997, 
and the availability of funding for States and territories required the 
Department to begin reviewing CHIP plans at the same time as it was 
issuing policy guidance to States on how to operate the CHIP program. 
The Department worked closely with States to disseminate as much 
information as possible, as quickly as possible, so States could begin 
to implement their new programs expeditiously. As a result, 54 States 
and territories have approved CHIP plans. Therefore, CHIP is now in 
operation prior to the completion of regulations.


Anticipated Cost and Benefits:


Estimates of the economic impact that will stem from this rule will be 
made available.


Risks:


This rule will formally establish the Department's policies and 
requirements related to the implementation of this program. It will 
provide States with needed information and also give them and other 
interested parties the opportunity to comment on the feasibility of 
implementing these policies. Failure to publish this rule would 
jeopardize our relationships with the States, advocates and providers 
because it would deprive them of many tools needed for establishing 
concrete programs.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            64 FR 60881                                    11/08/99
NPRM Comment Period End                                        01/07/00
Final Action                                                   12/00/00
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


Organizations


Government Levels Affected:


State, Local


Federalism:


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


Agency Contact:
Cheryl Austein-Casnoff
Department of Health and Human Services
Health Care Financing Administration
7500 Security Boulevard
Baltimore, MD 21244
Phone: 410 786-4196

Cynthia Shirk
Health Insurance Specialist
Department of Health and Human Services
Health Care Financing Administration
Phone: 410 786-6614
RIN: 0938-AJ75
_______________________________________________________________________



HHS--HCFA



55. APPLICATION OF INHERENT REASONABLENESS TO ALL PART B SERVICES OTHER 
THAN PHYSICIAN SERVICES (HCFA-1908-F)
Priority:


Other Significant. Major status under 5 USC 801 is undetermined.


Unfunded Mandates:


Undetermined


Legal Authority:


PL 105-33, sec 4316


CFR Citation:


42 CFR 405


Legal Deadline:


None


Abstract:


This rule implements sections 1842(b)(8) and (9) of the Social Security 
Act, as revised by section 4316 of the Balanced Budget Act of 1997. It 
sets forth the process for establishing realistic and equitable payment 
amounts for all Medicare part B items and services (other than 
physician services) when the existing payment amounts are inherently 
unreasonable because they are either grossly excessive or grossly 
deficient. This rule describes the factors HCFA (or its carriers) will 
consider and the procedures that will be followed in establishing 
realistic and equitable payment amounts.


Statement of Need:


An interim final rule with comment period was published on January 7, 
1998 (63 FR 687) to implement sections 1842(b)(8) and (9) of the Social 
Security Act, as revised by section 4316 of the Balanced Budget Act of 
1997. Congress subsequently rendered this rule invalid, via section 223 
of the Balanced Budget Refinement Act of 1999, by requiring that 
certain steps be completed before HCFA or its contractors can use the 
inherent reasonableness authority to adjust payment allowances. These 
steps will not be completed until HCFA publishes a final rule that 
implements the inherent reasonableness authority, responds to a July 
2000 GAO report on inherent reasonableness, and responds to comments 
received in response to the interim final rule.


Summary of Legal Basis:


Section 223 of the Balanced Budget Refinement Act of 1999 requires the 
Secretary to publish this notice of final rulemaking in order to 
restore the inherent reasonableness authority established by section 
4316 of the Balanced Budget Act of 1997.


Alternatives:


Because section 223 of the Balanced Budget Refinement Act of 1999 
requires the Secretary to publish this notice of final rulemaking in 
order to restore the inherent reasonableness authority, no alternatives 
to this regulation exist. If this rule is not implemented, the inherent 
reasonableness authority for establishing realistic and equitable 
payment amounts for part B items and services, other than physician 
services, would not be restored.


Anticipated Cost and Benefits:


This rule establishes the process for identifying unreasonable payment 
amounts and replacing them with realistic and equitable amounts. It 
will enable future adjustments to be made to grossly excessive and 
grossly deficient payment amounts. There are no specific costs or 
savings associated with this rule because no payment adjustments are 
made using this rule.

[[Page 73382]]

Risks:


This rule will enable HCFA and the Medicare contractors to make 
adjustments to unreasonable payment amounts. Failing to implement this 
rule would eliminate the only process available for adjusting 
unreasonable payment amounts for many part B items and services.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
Interim Final Ru63 FR 687t Period End                          01/07/98
Final Action                                                   08/00/01
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


Undetermined


Federalism:


 Undetermined


Agency Contact:
William J. Long
Department of Health and Human Services
Health Care Financing Administration
C4-12-18
Center for Health Plans and Providers
7500 Security Boulevard
Baltimore, MD 21228
Phone: 410 786-5655
Email: [email protected]
RIN: 0938-AJ97
_______________________________________________________________________



HHS--HCFA



56.  HOSPITAL CONDITIONS OF PARTICIPATION; ANESTHESIA SERVICES 
(HCFA-3049-F)
Priority:


Other Significant. Major status under 5 USC 801 is undetermined.


Legal Authority:


Social Security Act, sec 1861(e)


CFR Citation:


42 CFR 416.42; 42 CFR 482.52; 42 CFR 485.639


Legal Deadline:


None


Abstract:


This final rule will change the policy on supervision of certified 
registered nurse anesthetists (CRNA) in administering anesthesia and 
will defer to State laws regarding CRNA practice. Hospitals would be 
free to require supervision in all incidences if they so choose, when 
State law allows independent CRNA practice.


Statement of Need:


The Health Care Financing Administration (HCFA) received over 20,000 
comments on this issue after publication of the notice of proposed 
rulemaking (NPRM), December 19, 1997. Since that time, interested 
parties (CRNAs vs. anesthesiologists) have urged congressional action 
in support of their respective positions, and public debate has been 
heavy on either side of the issue. In addition, the public has urged 
HCFA to publish a final rule.


Summary of Legal Basis:


Sections 1861(e)(1) through (e)(8) of the Social Security Act (the Act) 
provide that a hospital participating in the Medicare program must meet 
certain specified requirements. Section 1861 (e)(9) of the Act 
specified that a hospital also must meet such other requirements as the 
Secretary finds necessary in the interests of the health and safety of 
the hospital's patients. Section 1820 of the Act contains criteria for 
application for States establishing a Critical Access Hospital. 
Sections 1832(a)(2)(f)(I) and 1833(I) provide coverage requirements for 
ASCs. Section 1861 (bb) of the Act provides definitions for CRNAs and 
their services.


Alternatives:


The only alternative available at this time would be to not publish the 
final rule and maintain the existing requirement. However, in 
consideration of public comments on the NPRM and available scientific 
research studies, we believe it is necessary to publish a final rule 
allowing flexibility by referring to State law on the issue of CRNA 
practice. Sound evidence does not exist to necessitate maintaining the 
current requirement of physician supervision of CRNAs during anesthesia 
delivery in every situation. Nor is there evidence that States have 
been negligent in their duty to regulate health professional practice 
or have failed to protect the safety of their citizens.


Anticipated Cost and Benefits:


There is negligible budget impact on the Medicare and Medicaid programs 
associated with the implementation of this final rule. This rule does 
not change the Medicare payment policies or fee schedules for 
anesthesia services provided by anesthesiologist or CRNAs. 
Anesthesiologists will continue to be paid as they currently are, for 
independent practice or for medical direction of CRNAs. CRNAs will 
continue to be paid on the current fee schedule that allows for 
independent practice.


The flexibility resulting from this rule could provide increased access 
to anesthesia services in some areas in hospitals, critical access 
hospitals (CAHs), and ASCs. It removes the burden of implementing a 
Federal requirement for physician supervision of CRNAs in all cases. It 
will allow hospitals, CAHs, and ASCs the flexibility within the 
authority of State licensing laws to implement best practice protocols 
in providing anesthesia services most associated with positive patient 
outcomes. Moreover, hospitals are free to exercise stricter practice 
standards. This provision does not lend itself to a quantitative impact 
estimate and we do not anticipate a substantial economic impact either 
in cost or savings.


Risks:


If we do not publish the final rule, we anticipate Congress may pass 
legislation in response to pressure from public interest groups.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            62 FR 66726                                    12/19/97
Final Rule                                                     11/00/00
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


Businesses


Government Levels Affected:


State


Federalism:


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


Agency Contact:
Debbie Hattery
Health Insurance Specialist
Department of Health and Human Services
Health Care Financing Administration
S3-02-01
7500 Security Boulevard
Baltimore, MD 21244
Phone: 410 786-1855
RIN: 0938-AK08


_______________________________________________________________________


[[Page 73383]]

HHS--HCFA



57.  PHYSICIANS' REFERRALS TO HEALTH CARE ENTITIES WITH WHICH 
THEY HAVE FINANCIAL RELATIONSHIPS-PHASE II (HCFA-1810-FC)
Priority:


Other Significant. Major status under 5 USC 801 is undetermined.


Unfunded Mandates:


Undetermined


Legal Authority:


PL 103-66, sec 13562; PL 103-432, sec 152


CFR Citation:


42 CFR 411


Legal Deadline:


None


Abstract:


In October 2000, we issued a final rule with comment period (phase I) 
to incorporate into regulations provisions of section 1877 that became 
effective January 1, 1995. The final rule with comment period (phase 
II) will address comments from the January 9, 1998 proposed rule 
concerning the ownership and investment exceptions, many of the 
provisions in the compensation exceptions created by Congress, and 
aspects of the physician referral provisions that apply to the Medicaid 
program. In addition, this final rule will address comments from the 
October 2000 final rule with comment period.


Statement of Need:


Section 1877 of the Social Security Act prohibits a physician from 
referring a patient to an entity for a designated health service for 
which Medicare might otherwise pay, if the physician or an immediate 
family member has a financial relationship with the entity. The statute 
provides for a number of exceptions to the prohibition. Section 1903(s) 
of the Social Security Act prohibits Federal payment of expenditures 
for Medicaid designated health services furnished to an individual on 
the basis of a referral that would result in the denial of payment for 
the service under Medicare. This final rule with comment will include 
all outstanding issues not dealt with in the October 2000 final rule 
with comment.


Summary of Legal Basis:


Section 6204 of OBRA 1989 established the physician referral provisions 
in section 1877 of the Social Security Act. The 1989 legislation 
prohibited a physician from referring a patient to an entity for 
clinical laboratory services for which Medicare might otherwise pay, if 
the physician or an immediate family member of the physician had a 
financial relationship with the entity. The statute provided for 
several exceptions to the prohibition. In addition, the statute imposed 
reporting requirements. It also prohibited an entity from presenting, 
or causing to be presented, a Medicare claim or bill to any individual, 
third party payer, or other entity for clinical laboratory services 
furnished under a prohibited referral, and required refunds for any 
amount collected under a bill for an item or service furnished under a 
prohibited referral. The statute also imposed civil money penalties in 
certain situations.


Section 1877 was amended by section 4207(e) of OBRA 1990 to clarify 
definitions and reporting requirements and to provide an additional 
exception. OBRA 1993 applied the prohibition on referrals to 10 
designated health services in addition to the existing prohibition 
relating to clinical laboratory services. It also added new exceptions, 
modified some existing exceptions, and extended aspects of the law to 
the Medicaid program.


SSA amendments of 1994 amended the list of designated health services, 
changed the reporting requirements and modified some of the effective 
dates. The BBRA of 1999 added to the exception covering services 
furnished by certain prepaid plans services furnished to enrollees of 
coordinated care plans offered by Medicare+Choice organizations.


Alternatives:


If this final rule with comment period is not published, we would not 
implement either the OBRA 1993, or the SSA 1994 provisions that 
expanded and modified the physician referral provisions. We would not 
provide guidance necessary for physicians and other entities that 
furnish Medicare and Medicaid services to enter into appropriate 
financial relationships, which do not violate the physician referral 
provisions. In addition, neither Medicare, Medicaid, nor our 
beneficiaries would benefit from the protections against 
overutilization in the physician referral provisions.


Anticipated Cost and Benefits:


Any estimate of the effect of this final rule with comment period would 
be purely speculative. However, we do not anticipate that the 
provisions of this final rule with comment period will have a 
significant impact on either beneficiaries or entities that furnish 
designated health services. This final rule sets minimum standards for 
financial arrangements, while minimizing the impact on physicians' 
business operations. We believe that based on the statute and the 
October 2000 final rule with comment period, many physicians have 
already taken steps to ensure that their investment and employment 
activities meet these minimum standards.


Risks:


By statute, the prohibition on referrals for designated health services 
became effective on January 1, 1995. Unnecessarily delaying this final 
rule with comment period would cause legal uncertainty and prevent the 
medical community from benefiting from the provisions in this final 
rule. This final rule will promote compliance with Medicare and 
Medicaid requirements, and also prevent abuse of the Medicare and 
Medicaid programs and inappropriate uses of Medicare and Medicaid 
funds.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
Final Action                                                   11/00/00
Regulatory Flexibility Analysis Required:


Undetermined


Government Levels Affected:


State, Local


Federalism:


 Undetermined


Agency Contact:
Joanne Sinsheimer
Technical Assistant, CHPP
Department of Health and Human Services
Health Care Financing Administration
7500 Security Boulevard
Baltimore, MD 21244
Phone: 410 786-4620
RIN: 0938-AK31
BILLING CODE 4150-24-S




[[Page 73384]]

DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT (HUD)



Statement of Regulatory Priorities
 The Regulatory Plan of the Department of Housing and Urban Development 
for Fiscal Year 2001 highlights priority regulations and policy 
initiatives for HUD programs that have been strengthened by Secretary 
Andrew Cuomo's HUD 2020 Management Reform Plan, initiated in 1997. As 
the Department enters its fourth year under the leadership of Secretary 
Cuomo, HUD has much to be proud of in the changes that have taken place 
at HUD under the Secretary's leadership and the accomplishments 
resulting from those changes. The regulations issued under the 
Secretary's leadership put in place many of the HUD 2020 Management 
reforms for HUD programs and operations. The regulations issued during 
the past three years, the regulations highlighted in this Regulatory 
Plan for Fiscal Year 2001 and in the semiannual agenda of regulations, 
published elsewhere in today's Federal Register, provide a solid basis 
for successor leadership to build upon and further strengthen HUD 
programs and operations.
 From the outset of his administration, Secretary Cuomo worked to 
strengthen HUD as an agency by implementing reforms in HUD's management 
structure and in the structure and operations of HUD programs to (1) 
empower people and communities and (2) restore the public trust. The 
Secretary succeeded on both counts.
 Before 1997, HUD was organized and operated strictly along program 
lines rather than by function. Under HUD 2020 Management Reform, HUD 
was reorganized by function, which regrouped program lines by mission 
and responsibility. This eliminated overlapping functions and 
duplication of work. Two examples of how functions were organized for 
operational efficiency can be found in HUD's new Real Estate Assessment 
Center and Departmental Enforcement Center, both established in 1998. 
The Real Estate Assessment Center assesses the physical and financial 
condition of HUD-assisted multifamily housing developments and public 
housing developments. HUD's Departmental Enforcement Center handles 
non-civil rights compliance enforcement actions, particularly the most 
serious violations committed by HUD's program participants. The 
functions now handled by the Real Estate Assessment Center and the 
Departmental Enforcement Center were previously handled by HUD's 
program offices, the Office of Housing, the Office of Public and Indian 
Housing, and the Office of Community Planning and Development. The 
program offices carried out these functions under independent 
processes, operations and requirements. HUD's reorganization not only 
eliminated duplication of work, allowing HUD staff to work more 
efficiently, but provided uniformity and consistency in treatment of 
program participants, to the extent permitted by law.
 HUD rules issued during the past two years in response to these 
organizational changes reflect HUD's increased operational efficiency 
and also uniformity and consistency in the treatment of program 
participants with respect to real estate assessment and enforcement. 
These rules include HUD's rules on Uniform Physical Conditions 
Standards, Uniform Financial Reporting Standards, the Public Housing 
Assessment System, and Multifamily Housing's Administrative Processes 
for Assessment of Insured and Assisted Properties.
 Consolidation of functions also has resulted in HUD's establishment of 
a Grants Management Center, which currently manages the competitive and 
formula programs of HUD's Public and Indian Housing programs. 
Consistent with the consolidation of HUD's grant activities is HUD's 
Super Notice of Funding Availability (SuperNOFA), first issued in 1998. 
HUD's SuperNOFA announces in one document the funding availability for 
the majority of HUD's competitive funded programs. The SuperNOFA 
consolidates and simplifies the application requirements for these 
programs and accelerates the funding process so that funds are awarded 
as early as possible in the Federal fiscal year. The success of HUD's 
first SuperNOFA was followed by publication of a SuperNOFA in fiscal 
years 1999 and 2000, and each year more HUD programs have been added to 
the SuperNOFA. The SuperNOFA has been enthusiastically received by 
HUD's clients as a better way to do business, allowing them to 
strategically plan for the use of Federal funds.
 In addition to the reforms implemented administratively and internally 
by HUD, HUD was also successful in obtaining legislative reform of its 
public housing and Section 8 assistance programs. After six years of 
legislative effort and with progress evident in public housing, the 
Congress and the President agreed upon the Quality Housing and Work 
Responsibility Act of 1998 (referred to as the Public Housing Reform 
Act), which was signed into law on October 21, 1998. The Public Housing 
Reform Act is the largest overhaul of the public housing and Section 8 
voucher programs in the programs' history. The Public Housing Reform 
Act enacted into law many of the reforms originally proposed by 
Secretary Cuomo's HUD 2020 Management Reform Plan, as well as by HUD's 
public housing bill and Congressional bills directed at revitalizing 
and improving HUD's public housing and Section 8 tenant-based programs.
 HUD has implemented the overwhelming majority of the significant 
reforms provided by the Public Housing Reform Act, and HUD and its 
public housing agency partners have begun taking advantage of these 
important program changes. The Public Housing Agency Plan rule, the 
regulation that establishes the annual and 5-year planning mechanisms 
for public housing agencies, planning mechanisms long sought by HUD and 
its public housing agency partners, was issued as a final rule in 
October 1999. The Section 8 Housing Certificate Fund Allocation final 
rule, published in October 1999, developed through the negotiated 
rulemaking process, provides an efficient funding mechanism for the 
Section 8 tenant-based contract renewal needs of public housing 
agencies. The new Capital Fund Formula Allocation rule, published in 
May 2000, also developed through the negotiated rulemaking process, 
provides flexible formula funding that can be used both for renovations 
and replacement housing. The new Operating Fund Formula Allocation rule 
was published as a proposed rule in July 2000. This rule, also 
developed through the negotiated rulemaking process, establishes 
formula allocation funding of a public housing agency's operating 
needs.
 The Public Housing Reform Act also provided for the complete merger of 
HUD's Section 8 tenant-based certificate and voucher programs, a 
program consolidation long sought by HUD. This merger provided for the 
new Housing Choice Voucher Program, implemented by final rule in 
October 1999. HUD's Section 8 Homeownership Program, recently 
implemented by final rule, provides a significant opportunity for low-
income families to purchase their own homes and take an important step 
forward to economic self-sufficiency. HUD's Semiannual Agenda of 
Regulations, published elsewhere in this

[[Page 73385]]

edition of the Federal Register, reflects the many other Public Housing 
Reform Act rules that have been implemented during this past fiscal 
year.
 During the past fiscal year, HUD reforms also led to increased 
homeownership protections and opportunities under HUD's Federal Housing 
Administration (FHA) programs. In recent years, FHA has been the 
driving force behind the increase in homeownership rates for first-time 
homebuyers and low-income and minority families. In pursuing its goal 
to increase homeownership rates, particularly among low-income and 
minority families, HUD issued in March 2000 a proposed rule that would 
increase the housing goal levels for the Federal National Mortgage 
Association (Fannie Mae) and the Federal Home Loan Mortgage Corporation 
(Freddie Mac) (collectively, the Government Sponsored Entities or 
GSEs). Specifically, the rule proposed new goal levels for the purchase 
by the GSEs of mortgages financing low- and moderate-income housing, 
special affordable housing, and housing in central cities, rural areas 
and other underserved areas. The final rule on the new housing goal 
levels is included in HUD's Fiscal Year 2001 Regulatory Plan.
 Accompanying its efforts to increase homeownership, FHA also has 
directed its efforts to protecting homeowners. In April 2000, HUD 
completed final rulemaking that specified its requirements and 
procedures for placement and removal of appraisers on HUD's Appraiser 
Roster. HUD maintains the Appraiser Roster to provide a means by which 
HUD can monitor the quality of appraisals performed on single family 
homes financed through FHA single family programs and to ensure that 
appraisers performing FHA appraisals meet high competency standards. 
Similar to its Appraiser Roster, FHA is strengthening its standards for 
placement and removal of consultants in FHA's Section 203(k) 
Rehabilitation Mortgage Program. Section 203(k) is FHA's primary 
program for the rehabilitation and repair of single family properties. 
A Section 203(k) lender may select a qualified independent consultant 
who is an expert in the field of home inspection and construction to 
perform various tasks required for the rehabilitation of the property. 
The establishment of uniform placement and removal procedures will 
better protect Section 203(k) borrowers and lenders. Additionally, in 
May 2000, Secretary Cuomo announced HUD's Fraud Protection Plan, a 
major consumer protection initiative to prevent millions of families 
who receive new FHA-insured mortgages from being victimized by 
predatory lending practices that can cost individual homeowners 
thousands of dollars each year in unnecessary costs. The plan includes, 
among other things, restructuring inflated mortgages, default 
counseling for FHA borrowers, deploying special teams to pursue 
unscrupulous appraisers and lenders, and removing appraisers involved 
with larger numbers of foreclosures.
 While HUD is proud of the progress it has made in the past three 
years, HUD's Regulatory Plan for Fiscal Year 2001 reflects that there 
is still much that HUD wants to accomplish through regulatory 
initiatives to better serve HUD customers and better support HUD's 
partners. These are regulatory initiatives that reward performance, not 
simply impose penalties; that provide protections, not only prescribe 
prohibitions; and that encourage coordination and cooperation between 
HUD and it partners and HUD's partners and the private sector, not 
dissuade program participation through unnecessary command and control 
requirements. The regulations highlighted in this Regulatory Plan and 
in the Semiannual Agenda of Regulations, published elsewhere in today's 
Federal Register, are directed toward achieving these objectives. These 
regulations also focus on HUD's strategic goals, which are to:
1. Increase the availability of decent, safe, and affordable housing in 
            American communities;
2. Ensure equal opportunity in housing for all Americans;
3. Promote self-sufficiency and asset development of families and 
            individuals;
4. Improve community quality of life and economic vitality; and
5. Restore public trust.
HUD's Regulatory Priorities for Fiscal Year 2001
Regulatory Action: Capital Fund Program
 HUD has run a public housing modernization program since the 1970s. By 
the 1990s, the program had become outmoded. Funds could be used only to 
modernize but not replace public housing, program rules slowed down the 
commitment of funds unnecessarily, and small PHAs had to apply for 
funding on a job-by-job basis. In the past few years, HUD worked to 
change this system by providing PHAs with the additional flexibility to 
commit funds from multiple programs, and shortening the required time 
for obligating funds. The Public Housing Reform Act provided the 
assistance HUD needed in making a more fundamental change to this 
outmoded modernization program. The Public Housing Reform Act creates a 
flexible, formula-based Capital Fund for all PHAs, which can be used 
for the development of replacement housing as well as modernization and 
management improvements.
 This final rule will implement the new Capital Fund Program for the 
capital and management improvement needs of public housing agencies. 
This rule will complement the final rule for the Public Housing Capital 
Fund Program formula allocation funding system that was published on 
March 16, 2000, and provide the regulatory framework for the Capital 
Fund Program that will govern the use of the assistance made available 
from the Capital Fund formula. The new Capital Fund Program regulation 
will replace and remove several other rules that currently govern a 
PHA's use of HUD assistance including HUD's Public Housing Development 
and Public Housing Modernization regulations. The new Capital Fund 
Program regulation will adopt and expand upon the streamlined 
procedures and requirements initiated under the Comprehensive Grant and 
Comprehensive Improvement programs.
[Furthers Strategic Goals 1 and 4]
Regulatory Action: Mixed Finance Development Program
 The success of partnering with the private sector to create new 
communities is apparent through the many new developments that have 
been built across the nation through mixed financing. Leveraging of 
private funds for public housing was first made possible for public 
housing agencies to use administratively in 1994, and HUD and its 
housing partners have taken advantage of this option to offer public 
housing in deconcentrated settings.
 This final rule will implement important long sought changes to HUD's 
Mixed Finance Program made possible by the Public Housing Reform Act. 
This rule will also enhance the Mixed Finance Development Program by 
ensuring that it works in coordination and correlation with HUD's new 
Capital Fund Program. The rule will clarify the specific program 
requirements and procedures that apply to the Mixed Finance Program and 
will establish streamlined submission and HUD review requirements with 
respect to certain types of mixed finance projects

[[Page 73386]]

that HUD believes involve minimal risk to the investment of Federal 
funds in the project.
[Furthers Strategic Goals 1 and 4]
Regulatory Action: Determining Adjusted Income in HUD Programs Serving 
Persons with Disabilities and Requiring Mandatory Deductions for 
Certain Expenses and Disallowance for Earned Income
 HUD is aware that the lack of accessible, affordable housing continues 
to be a barrier to the ability of persons with disabilities to take 
advantage of economic opportunities in many communities across the 
country. The availability of accessible, affordable housing and the 
location of that housing can be the key to persons with disabilities 
who are seeking employment to obtain employment. To minimize the 
barriers to accessible, affordable housing, HUD is continually 
examining its programs to determine ways, through administrative 
initiatives or legislative or regulatory changes, that may assist in 
breaking down these barriers. HUD has identified two changes that HUD 
believes will encourage and facilitate employment of persons with 
disabilities, and that can be implemented in several HUD programs 
through this rulemaking. The first change involves including additional 
HUD programs in the list of programs that must make certain deductions 
in calculating a family's adjusted income. These deductions primarily 
address expenses related to a person's disability, such as medical 
expenses or attendant care expenses. Providing for the calculation of 
these deductions in a family's adjusted income expands the benefits of 
these deductions to persons with disabilities served by HUD programs. 
The second change allows, in certain HUD programs, for the disallowance 
of increases in income as a result of earnings by persons with 
disabilities. HUD believes that making these deductions and earned 
income disallowance available to persons with disabilities through as 
many HUD programs as possible will assist persons with disabilities in 
obtaining and retaining employment, which is an important step toward 
economic self-sufficiency.
[Furthers Strategic Goals 2, 3 and 4]
Regulatory Action: Public Housing Demolition and Disposition
 With the flexibility provided by the Public Housing Reform Act, this 
rule articulates and implements a new strategy for demolition and 
disposition of deteriorating and dilapidated public housing. This rule 
will implement that strategy by establishing the general and specific 
requirements for HUD approval of demolition and disposition 
applications, relocation of residents, resident participation in the 
form of consultation and opportunity to purchase, new requirements 
regarding replacement units and a new authority for a public housing 
agency to demolish a small number of its units without a formal 
application under certain circumstances. This rule, together with HUD's 
rules implementing the Capital Fund Program and Mixed Finance Program, 
will allow HUD and its public housing agency partners to transform 
public housing's severely distressed developments into safe, livable 
communities.
[Furthers Strategic Goals 1 and 4]
Regulatory Action: The Secretary of HUD's Regulation of Fannie Mae and 
Freddie Mac (Government Sponsored Entities) -- New Housing Goal Levels
 Fannie Mae and Freddie Mac are chartered by Congress as Government 
Sponsored Enterprises (GSEs) to provide stability in the secondary 
market for residential mortgages; respond appropriately to the private 
capital market; provide ongoing assistance to the secondary market for 
residential mortgages (including activities relating to mortgages on 
housing for low- and moderate-income families involving a reasonable 
economic return that may be less than the return earned on other 
activities) by increasing the liquidity of mortgage investments and 
improving the distribution of investment capital available for 
residential mortgage financing; and promote access to mortgage credit 
throughout the nation (including central cities, rural areas, and other 
underserved areas While the GSEs have been successful in providing 
stability and liquidity to certain portions of the mortgage market, the 
GSEs' share of the affordable housing market is substantially smaller 
than their share of the total conventional conforming mortgage market.
 Through this final rule, the Department is establishing new housing 
goal levels for the purchase of mortgages by the GSEs through 2003. In 
accordance with the Federal Housing Enterprises Financial Safety and 
Soundness Act of 1992, this rule establishes new goal levels for the 
GSEs for the purchase of mortgages financing low- and moderate-income 
housing, special affordable housing, and housing in central cities, 
rural areas, and other underserved areas. This rule also clarifies 
HUD's guidelines for counting different types of mortgage purchases 
toward those goals. As the GSEs continue to grow their businesses, the 
new goals will provide strong incentives for the two enterprises to 
more fully address the housing finance needs for very low-, low- and 
moderate-income families and residents of underserved areas and 
therefore more fully realize their public purpose.
[Furthers Strategic Goals 2 and 3]
Regulatory Action: The Secretary of HUD's Regulation of Fannie Mae and 
Freddie Mac (Government Sponsored Entities) -- Prohibitions on 
Purchasing Certain Loans with High Costs and/or Predatory Features
 In a report issued by HUD and the Department of Treasury in June 2000 
titled ``Curbing Predatory Home Mortgage Lending,'' HUD and Treasury 
noted that by providing a source of funding, entities operating in the 
secondary mortgage market that purchase or securitize loans with high 
costs and/or predatory features may be supporting the activities of 
predatory loan originators. As pointed out in the HUD/Treasury report: 
``While the secondary market could be viewed as part of the problem of 
abusive practices in the subprime mortgage market, it may also 
represent a large part of the solution to the problem.'' The subprime 
market refers to the mortgage market where most borrowers use the 
collateral in their homes for debt consolidation or other consumer 
credit purposes.
 Although the GSEs currently play a relatively small role in the 
subprime market, they are beginning to reach out with new products in 
that marketplace. While both GSEs have recently pledged not to purchase 
loans with certain identified predatory features, the HUD/Treasury 
report recommended that regulatory restrictions be put in place to help 
curb abusive practices.

[[Page 73387]]

 This rulemaking will establish regulatory restrictions, consistent 
with the GSEs' voluntary restrictions, that will prohibit the GSEs from 
purchasing certain loans with high costs and/or predatory features. 
This rule will ensure that GSEs are not supporting the activities of 
predatory loan originators.
[Furthers Strategic Goals 2, 3 and 5]
Regulatory Action: Prohibition of Predatory Lending Practices in HUD's 
Single Family Mortgage Insurance Programs
 Along with the benefits that have come from the expanded availability 
of credit in the subprime market, there is also evidence of growing 
abuses in lending practices. In many neighborhoods, abusive practices 
threaten to erode the enormous progress that has been made over the 
past several years in revitalizing neighborhoods and expanding 
homeownership. In many instances, the consequence for borrowers is 
foreclosure of their homes. In a predatory lending situation, the party 
that initiates the loan often provides misinformation, manipulates the 
borrower through aggressive sales tactics and/or takes unfair advantage 
of the borrowers' lack of information about the loan terms and their 
consequences. The results are loans with onerous terms and conditions 
that the borrower often cannot repay, leading to foreclosure or 
bankruptcy.
 These predatory lending practices were discussed in more detail in the 
HUD and Department of Treasury report titled ``Curbing Predatory Home 
Mortgage Lending.'' This proposed rule is issued in response to 
recommendations made by that report. This proposed rule would prevent 
property ``flipping,'' which is the practice whereby a property 
recently acquired is resold for a considerable profit, often with 
inflated value abetted by collusion with the appraiser. Additionally, 
this rule would seek to cap the discount points and fees that can be 
charged on a mortgage to be insured by FHA. The purpose of this rule is 
to protect borrowers from becoming unwitting victims of predatory 
lending.
[Furthers Strategic Goals 3 and 5]
_______________________________________________________________________



HUD--Office of the Secretary (HUDSEC)

                              -----------

                          PROPOSED RULE STAGE

                              -----------




58.  DETERMINED ADJUSTED INCOME IN HUD PROGRAMS SERVING PERSONS 
WITH DISABILITIES: REQUIRING MANDATORY DEDUCTIONS FOR CERTAIN EXPENSES; 
AND DISALLOWANCE FOR EARNED INCOME (FR-4608)
Priority:


Other Significant


Legal Authority:


42 USC 1437f; 42 USC 3535(d)


CFR Citation:


24 CFR 5; 24 CFR 92; 24 CFR 200; 24 CFR 236; 24 CFR 574; 24 CFR 582; 24 
CFR 583; 24 CFR 891; 24 CFR 982


Legal Deadline:


None


Abstract:


This final rule will amend HUD's regulations in part 5, subpart F, 
among others, to include additional HUD programs in the list of 
programs that must make certain deductions in calculating a family's 
adjusted income. These deductions primarily address expenses related to 
a person's disability, for example medical expenses or attendant care 
expenses. The purpose of this amendment is to expand the benefits of 
these deductions to persons with disabilities served by HUD programs 
not currently covered by part 5, subpart F. Second, the final rule will 
add a new regulatory section to part 5 to require for some but not all 
of these same programs the disallowance of increases in income as a 
result of earnings by persons with disabilities. HUD believes that 
making these deductions and disallowance available to persons with 
disabilities through as many HUD programs as possible will assist 
persons with disabilities in obtaining and retaining employment, which 
is an important step toward economic self-sufficiency.


Statement of Need:


The regulatory changes proposed by this rule represent an important 
step forward in helping to remove financial barriers that make it 
difficult for persons with disabilities who are seeking to obtain 
employment, and to keep employment once obtained.


Summary of Legal Basis:


Section 508 of the Quality Housing and Work Responsibility Act of 1998 
(Pub.L. 105-276) amended section 3(b) of the U.S. Housing Act of 1937 
to provide for certain income deductions and earned income disregard. 
This rule extends the benefits of these statutorily provided deductions 
and earned income disregard to certain HUD programs.


Alternatives:


HUD has been able to extend, administratively at times, the benefits of 
some measures to HUD programs not specifically identified by the 
statute. The deductions and the disregard of earned income finalized by 
this rule constitute an important step in helping persons with 
disabilities find and retain employment. While these kinds of benefits 
may be possible in the various HUD programs, greater uniformity will 
ensure increased applicability to persons with disabilities.


Anticipated Cost and Benefits:


The financial savings to a person with disabilities that this rule 
would provide presents an incentive to that person to continue working, 
or if not working, to seek employment. Also, owners and entities that 
administer the HUD assisted housing for persons with disabilities will 
benefit because the proposed rule provides greater uniformity in 
determining annual income for HUD programs that serve persons with 
disabilities, and likely minimize the administrative burden that 
results from the different requirements under different programs for 
persons and families in similar or identical circumstances.


Risks:


This rule poses no threat to public safety, health, or the environment.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            65 FR 50842                                    08/21/00
NPRM Comment Period End                                        10/20/00
Final Action                                                   12/00/00
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No

[[Page 73388]]

Government Levels Affected:


None


Agency Contact:
Patricia Arnaudo
Senior Housing Program Manager, Office of Public and Assisted Housing 
Delivery
Department of Housing and Urban Development
Office of Public and Indian Housing
Phone: 202 708-0744

Mary Kolesar
Director, Office of Affordable Housing Programs
Department of Housing and Urban Development
Office of Community Planning and Development
Phone: 202 708-2470
RIN: 2501-AC72
_______________________________________________________________________



HUD--HUDSEC



59.  THE SECRETARY OF HUD'S REGULATION OF FANNIE MAE AND 
FREDDIE MAC; PROHIBITING THE PURCHASE OF CERTAIN LOANS WITH HIGH COSTS 
AND/OR PREDATORY FEATURES (FR-4614)
Priority:


Other Significant. Major under 5 USC 801.


Legal Authority:


12 USC 1451 et seq; 12 USC 1716 et seq; 12 USC 4501 et seq; 42 USC 
3535(d)


CFR Citation:


24 CFR 81


Legal Deadline:


None


Abstract:


A report issued in June 2000 by HUD and the Department of Treasury 
entitled ``Curbing Predatory Home Mortgage Lending,'' noted that by 
providing a source of funding, entities that purchase or securitize 
loans with high cost and/or predatory features are, knowingly or 
unknowingly, supporting the activities of predatory loan originators. 
The report recommended regulatory restrictions that would prohibit the 
two Government-Sponsored Enterprises (GSEs), Fannie Mae and Freddie 
Mac, from purchasing certain types of loans with high costs and/or 
predatory features altogether. Through this rulemaking, HUD will 
establish regulatory restrictions, consistent with the GSEs' voluntary 
restrictions, that will prohibit the GSEs from purchasing certain loans 
with high costs and/or predatory features. Specifically, this rule will 
prohibit the GSEs from purchasing loans that come within the high-cost 
thresholds of the Home Ownership Equity Protection Act, loans with 
excessive fees, loans originated with single-premium credit life 
insurance, and loans with other harmful features. This rule will help 
to ensure that these GSEs are not supporting the activities of 
predatory loan originators.


Statement of Need:


While the GSEs currently play a relatively small role in the market for 
loans with high costs and/or predatory features, their role may 
continue to expand in the future. This rule will help to ensure that 
the GSEs are not providing funding and liquidity to support lenders 
that originate loans with predatory features or that employ 
unacceptable practices. The GSEs' Charters require them to provide 
ongoing assistance to the secondary market for residential mortgages, 
including activities relating to mortgages on housing for low- and 
moderate-income families and to promote access to mortgage credit 
throughout the Nation (including central cities, rural areas, and 
underserved areas). Predatory lending activities are often targeted to 
those families and to borrowers living in those areas, often leading to 
increased indebtedness and foreclosures, depriving these families of 
the equity in their home and weakening their neighborhoods. Financial 
support for such activities undermines the GSEs' Charter missions. This 
rule is necessary to fulfill HUD's authority and responsibility to 
ensure that the purposes of the Charters are accomplished.


Summary of Legal Basis:


Under section 1321 of the Federal Housing Enterprises Financial Safety 
and Soundness Act of 1992 (12 U.S.C. 4541) (the GSE Act), HUD has 
general regulatory power over each GSE and must issue such rules and 
regulations as necessary and proper to ensure that the GSE Act and the 
GSEs' Charters are accomplished. Section 1325(1) of the GSE Act 
requires HUD, by regulation, to prohibit each GSE from discriminating 
in any manner in the purchase of any mortgage because of race, color, 
religion, sex, handicap, familial status, age, or national origin, 
including any consideration of the age or location of the dwelling or 
the age of the neighborhood or census tract where the dwelling is 
located in a manner that has a discriminatory effect.


Alternatives:


The alternative of not prohibiting the GSEs from purchasing loans with 
high costs and/or predatory features was considered. However, after 
thorough examination of this issue by HUD and the Department of 
Treasury in their June 2000 Report, the recommendation was that 
regulatory restrictions should be pursued.


Anticipated Cost and Benefits:


This rule will have the benefit of helping to ensure that the GSEs are 
not supporting the activities of predatory loan originators, which 
undermine homeownership for low-income families and in underserved 
neighborhoods. Since the GSEs currently play a relatively small role in 
the market for these loans, and have already volunteered to restrict 
their purchases of such loans, this rule should not represent a 
substantial cost to the GSEs or other entities in the subprime mortgage 
market.


Risks:


This rule poses no risk to public health, safety, or the environment.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           11/00/00
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


None


Agency Contact:
Janet Tasker
Director, Office of GSE
Department of Housing and Urban Development
Office of Housing
Phone: 202 708-2224

Allen Fishbein
Senior Advisor for GSE
Department of Housing and Urban Development
Office of Housing
Phone: 202 708-3600
RIN: 2501-AC76


_______________________________________________________________________


[[Page 73389]]

HUD--HUDSEC

                              -----------

                            FINAL RULE STAGE

                              -----------




60. SECRETARY OF HUD'S REGULATION OF FANNIE MAE AND FREDDIE MAC: 
PURCHASE GOALS (FR-4494)
Priority:


Economically Significant. Major under 5 USC 801.


Legal Authority:


12 USC 1451 et seq; 12 USC 1716 to 1723h; 12 USC 4501 to 4641; 42 USC 
3535(d); 42 USC 3601 to 3619


CFR Citation:


24 CFR 81


Legal Deadline:


None


Abstract:


Through this rule, the Department is establishing new housing goal 
levels for the purchase of mortgages by Fannie Mae and the Freddie Mac 
(collectively, the Government Sponsored Enterprises, or GSEs) through 
2003. In accordance with the Federal Housing Enterprises Financial 
Safety and Soundness Act of 1992, this rule establishes new goal levels 
for the GSEs for the purchase of mortgages financing low- and moderate-
income housing, special affordable housing, and housing in central 
cities, rural areas, and other underserved areas. This rule also 
clarifies HUD's guidelines for counting different types of mortgage 
purchases toward those goals.


Statement of Need:


Regulations prior to this rulemaking, which were issued in 1995, 
established the GSEs' housing goals for 1995-99. Through this rule, the 
Secretary is establishing new goals through 2003 to reflect the 
Secretary's consideration of the statutory factors for establishment of 
these goals including current economic conditions. The new goals will 
provide strong incentives for the two enterprises to more fully address 
the housing finance needs for very low-, low- and moderate-income 
families and residents of underserved areas and thus, to realize more 
fully their public purposes. Such incentives are consistent with the 
Department's strategic objectives of increasing homeownership 
opportunities and the supply of affordable rental housing in the United 
States.


Summary of Legal Basis:


The Department is authorized to establish housing goals for the GSEs by 
the Federal Housing Enterprises Financial Safety and Soundness Act of 
1992 (12 U.S.C. 4501 et seq.), which sets forth parameters and 
requirements for the housing goals and other issues addressed in this 
rule.


Alternatives:


The alternative of leaving the housing goals unchanged was considered. 
This alternative was not adopted because of HUD's responsibility to 
establish the housing goals in accordance with FHEFSSA and because such 
an approach would fail to meet HUD's strategic objectives of increasing 
the supply of affordable rental housing and homeownership and promoting 
equal housing opportunities for those protected by the law.


Anticipated Cost and Benefits:


This rule will have the benefit of increasing the number of affordable 
housing units for low- and moderate-income families and underserved 
communities through 2003. However, there is no indication that focusing 
the GSEs' attention on the affordable lending market would be costly 
for the GSEs. In fact, HUD's analysis indicates that meeting the new 
housing goals will have little impact on the GSEs' financial returns or 
on the safety and soundness of GSE operations. Additionally, increased 
GSE activity in the affordable lending arena should not lead to 
significant crowding out of traditional portfolio lenders.


Risks:


This rule poses no risk to public health, safety or the environment.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            65 FR 12632                                    03/09/00
NPRM Comment Period End                                        05/08/00
Final Action                                                   10/00/00
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


None


Agency Contact:
Janet Tasker
Director, Office of GSE
Department of Housing and Urban Development
Office of Housing
Phone: 202 708-2224

Allen Fishbein
Senior Advisor for GSE
Department of Housing and Urban Development
Office of Housing
Phone: 202 708-3600
RIN: 2501-AC60
_______________________________________________________________________



HUD--Office of Housing (OH)

                              -----------

                          PROPOSED RULE STAGE

                              -----------




61.  PROHIBITION OF PREDATORY LENDING PRACTICES IN HUD'S SINGLE 
FAMILY MORTGAGE INSURANCE PROGRAM (FR-4615)
Priority:


Other Significant


Legal Authority:


42 USC 3535(d); 12 USC 1709; 12 USC 1710; 12 USC 1715b; 12 USC 1715u


CFR Citation:


24 CFR 203; 24 CFR 206


Legal Deadline:


None


Abstract:


Predatory lending, whether undertaken by creditors, brokers or even 
home improvement contractors, involves engaging in deception or fraud, 
manipulating the borrower through aggressive sales tactics, or taking 
unfair advantage of a borrower's lack of understanding about loan 
terms. These practices are often combined with loan terms that, alone 
or in combination, are abusive or make the borrower more vulnerable to 
abusive practices. Predatory lending generally occurs in the subprime 
mortgage market, where most borrowers use the collateral in their homes 
for debt consolidation or other consumer credit purposes. This proposed 
rule would prohibit two predatory lending practices. This proposed rule 
would prohibit property ``flipping,'' the practice whereby a property 
recently acquired is resold for a considerable profit, often with 
inflated value abetted by collusion with the appraiser. Additionally, 
this rule would seek to cap the discount points

[[Page 73390]]

and fees that can be charged on a mortgage to be insured by HUD's 
Federal Housing Administration (FHA). The purpose of this rule is to 
protect borrowers from becoming unwitting victims of predatory lending 
by capping the total amount of discount points and fees that can be 
charged on mortgages to be insured by FHA.


Statement of Need:


A report issued in June 2000 by HUD and the Department of Treasury 
entitled ``Curbing Predatory Home Mortgage Lending,'' recommends 
proposals for legislative and regulatory action to combat predatory 
lending practices. The recommendations are based, in significant part, 
on information that HUD and Treasury gathered through the National Task 
Force on Predatory Lending. This proposed rule arises from the 
recommendations in the report.


Summary of Legal Basis:


The National Housing Act and HUD's authority under the Department of 
Housing and Urban Development Act authorize HUD to provide a home 
financing system through the insurance of mortgages that would maintain 
and expand homeownership opportunities, particularly to first-time 
homebuyers and low-income families.


Alternatives:


Nonregulatory initiatives to date have not proven to be sufficiently 
successful in curbing predatory lending practices. The HUD/Treasury 
report recommended legislative and regulatory initiatives.


Anticipated Cost and Benefits:


This rulemaking will help to reduce excessive fees and costs of home 
mortgages. The anticipated benefit is that the rule will help to reduce 
foreclosure arising from high costs mortgages.


Risks:


This rule poses no threat to public safety, health, or the environment.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           12/00/00
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


None


Agency Contact:
Vance Morris
Director, Office of Single Family Program Development
Department of Housing and Urban Development
Office of Housing
Phone: 202 708-2700
RIN: 2502-AH57
_______________________________________________________________________



HUD--Office of Public and Indian Housing (PIH)

                              -----------

                          PROPOSED RULE STAGE

                              -----------




62. MIXED-FINANCE PUBLIC HOUSING DEVELOPMENT (FR-4499)
Priority:


Other Significant


Legal Authority:


42 USC 1437g; 42 USC 3535(d)


CFR Citation:


24 CFR 941


Legal Deadline:


None


Abstract:


This proposed rule will implement amendments to the Department's Mixed 
Finance Program to reflect statutory changes enacted on October 21, 
1998. Also, the rule will revise the Mixed Finance Program so that the 
program conforms to HUD's new Capital Fund regulations; will clarify 
the specific program requirements and procedures that apply to the 
Mixed Finance Program; and will establish streamlined submission and 
HUD review requirements with respect to certain types of mixed finance 
projects that the Department believes involve minimal risk to the 
investment of Federal funds in the project.


Statement of Need:


Section 539 of the Quality Housing and Work Responsibility Act of 1998 
(Pub.L. 105-276) (referred to as Public Housing Reform Act) added a new 
section 35 to the U.S. Housing Act of 1937 to permanently authorize the 
leveraging of private resources in the development of public housing 
(the ``mixed finance'' method). The permanent framework provided by the 
Public Housing Reform Act and the significant changes PHRA made to the 
structure of the development program, necessitates a regulation to 
provide appropriate notice of the legal framework for the program and 
clear and uniform guidance for program operation.


Summary of Legal Basis:


Sections 539 and 519 of the Public Housing Reform Act, added section 35 
and amended section 9 respectively, to the U.S. Housing Act of 1937 to 
authorize changes to the Mixed Finance Program.


Alternatives:


The Public Housing Reform Act made statutory changes to HUD's Mixed 
Finance Program that must be implemented through rulemaking.


Anticipated Cost and Benefits:


Costs for entities should be reduced due to the streamlined procedures 
and allowance for longer term planning because of the certainty to be 
provided through issuance of final regulations.


Risks:


This rule poses no threat to public safety, health, or the environment.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           12/00/00
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


None


Agency Contact:
David Sowell
Director, Office of Public Housing Investments
Department of Housing and Urban Development
Office of Public and Indian Housing
Phone: 202 401-8812
RIN: 2577-AC09
_______________________________________________________________________



HUD--PIH



63. PUBLIC HOUSING CAPITAL FUND PROGRAM (FR-4507)
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.

[[Page 73391]]

Legal Authority:


42 USC 1437g; 42 USC 3535(d)


CFR Citation:


24 CFR 905; 24 CFR 941; 24 CFR 968; 24 CFR 969


Legal Deadline:


None


Abstract:


This proposed rule will implement the new Capital Fund Program for the 
capital and management improvement needs of public housing agencies. 
The rule will complement the final rule for the Public Housing Capital 
Fund Program formula allocation funding system published on March 16, 
2000 (65 FR 14422). This rule will implement the regulatory framework 
for the Capital Fund Program that will govern the use of the assistance 
made available through the Capital Fund formula. The new rule at part 
905 will replace and remove several other rules that currently govern a 
PHA's use of HUD assistance including part 941 - Public Housing 
Development and part 968 - Public Housing Modernization. This proposed 
rule will continue and expand the streamlining of procedures and 
requirements initiated under the Comprehensive Grant and Comprehensive 
Improvement programs at part 968.


Statement of Need:


Assistance under the Capital Fund Program is the primary, regular 
source of funding made available by HUD to a PHA for its capital 
activities, including modernization and development of public housing. 
This final rule will implement the requirements for the use of 
assistance made available under the Capital Fund program. The 
regulations will provide the appropriate notice of the legal framework 
for the program, and clear and uniform guidance for program operation.


Summary of Legal Basis:


Sections 518, 519, and 539 of the Quality Housing and Work 
Responsibility Act of 1998 (Pub. L. 105-276) (referred to as the Public 
Housing Act) amended sections 9 and 5, and added section 35(g) of the 
U.S. Housing Act of 1937 (42 U.S.C. 1437g) to establish the Capital 
Fund Formula and Capital Fund Program.


Alternatives:


The Public Housing Reform Act required a formula system to be 
established through rulemaking to govern funding of PHAs' public 
housing capital needs. Guidance for administration of these funds 
necessitates a permanent legal framework.


Anticipated Cost and Benefits:


The costs of the program as administered with one fund from which a PHA 
will fund all of its capital needs is the same as under existing 
provisions. The benefits of having one funding mechanism for all such 
needs, and the provision of additional flexibility to PHAs to manage 
their physical assets provides increased benefits to the PHAs. 
Likewise, uniform program administration of these funds will provide 
increased benefits to the PHAs.


Risks:


This rule poses no threat to public safety, health, or the environment.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           12/00/00
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


State, Local


Agency Contact:
William Flood
Director, Office of Capital Improvements
Department of Housing and Urban Development
Office of Public and Indian Housing
Phone: 202 708-1640
RIN: 2577-AC16
_______________________________________________________________________



HUD--PIH



64.  PUBLIC HOUSING DEMOLITION AND DISPOSITION (FR-4598)
Priority:


Other Significant


Legal Authority:


42 USC 1437p; 42 USC 3535(d)


CFR Citation:


24 CFR 970


Legal Deadline:


None


Abstract:


This proposed rule will revise HUD's regulations regarding demolition 
and disposition of public housing projects, in accordance with section 
531 of the Quality Housing and Work Responsibility Act of 1998 (Pub.L. 
105-276) (referred to as the Public Housing Reform Act). This rule will 
establish the general and specific requirements for HUD approval of 
demolition and disposition applications, relocation of residents, 
resident participation in the form of consultation and opportunity to 
purchase, new requirements regarding replacement units and a new 
authority for a PHA to demolish a small number of their units without a 
formal application under certain circumstances, referred to as ``de 
minimis'' demolition.


Statement of Need:


Section 531 of the Public Housing Reform Act amended the provisions on 
public housing demolition and disposition found in section 18 of the 
U.S. Housing Act of 1937. These amendments changed both the general 
standard for approval of applications for demolition or disposition of 
public housing stock, and many of the specific procedures for these 
actions. The significant changes the Public Housing Reform Act made to 
demolition or disposition of public housing necessitate a regulation to 
provide appropriate notice of the legal framework for the program and 
clear and uniform guidance for program operation.


Summary of Legal Basis:


Section 531 of the Public Housing Reform Act amended section 18 of the 
U.S. Housing Act of 1937 to establish revised demolition and 
disposition requirements.


Alternatives:


Through this rulemaking, the Department will implement the Public 
Housing Reform Act amendments to demolition or disposition of public 
housing developments. Guidance about program administration 
necessitates a permanent legal framework rather than less formal HUD 
notices.


Anticipated Cost and Benefits:


The streamlining procedures for demolition and disposition of public 
housing provided by the statute and regulations will reduce costs for 
PHAs.


Risks:


This rule poses no threat to public safety, health, or the environment.

[[Page 73392]]

Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           11/00/00
Regulatory Flexibility Analysis Required:


No


Government Levels Affected:


None


Agency Contact:
William Flood
Director, Office of Capital Improvements
Department of Housing and Urban Development
Office of Public and Indian Housing
Phone: 202 708-1640
RIN: 2577-AC20
BILLING CODE 4210-01-S




[[Page 73393]]

DEPARTMENT OF THE INTERIOR (DOI)



Statement of Regulatory Priorities
 The Department of the Interior (DOI) is the principal steward of our 
nation's natural resources and guardian of many of our priceless 
cultural resources. We serve as trustee to Native Americans and Alaska 
natives and also are responsible for relations with the island 
territories under United States jurisdiction. As part of our duties, we 
manage more than 430 million acres of Federal lands, approximately 2 
billion acres of the Outer Continental Shelf, and more than 57,000 
buildings. In carrying out our many responsibilities we are committed 
to creative ideas that:
 Ensure the long-term viability of our resources
 Protect the environment in which our resources are found
 Minimize negative effects and maximize benefits to the 
            American people.
 The Department's bureaus and offices seek to ease the burdens imposed 
by regulations while increasing the protection of resources under their 
jurisdiction. Examples of this include:
 Establishing a community approach to maintaining the 
            environmental systems that support native species. We 
            expect this to reduce the rate at which individual species 
            become threatened and endangered. This approach enlists the 
            voluntary support of landowners to achieve environmental 
            goals while potentially reducing the regulatory cost.
 Using performance-based regulations rather than process-based 
            regulations. This gives local entities the options of using 
            the most cost-effective method to meet the spirit and 
            letter of the law while providing the best result for the 
            specific instance and location.
 Incorporating scientific standards, where applicable, into 
            regulations.
 Continuing to reduce the number of regulations and converting 
            those that remain to plain language. This will improve the 
            public's ability to understand regulatory requirements and 
            will result in improved compliance.
 The Department's overall goal is to maintain or improve the quality of 
the environment while:
 Reducing the financial burden on the general public;
 Increasing the flexibility of the public to use the best means 
            available to ensure that the laws are met; and
 Making regulations easy to understand and administer.
 This approach to improving regulations will help us better execute our 
mission and meet the requirements of our eight bureaus and the 
following objectives:
 Conserve, protect, and enhance the Nation's national parks, 
            wilderness, and fish and wildlife resources;
 Manage, develop, and protect the quality of water resources;
 Promote economic opportunity and improve the trust assets of 
            American Indians, Indian tribes, Alaska Natives, and people 
            of the U.S. territories;
 Improve the Federal Government's relationship with State, 
            local, tribal, and territorial governments; and
 Enhance America's ability to meet its needs for domestic 
            energy and mineral resources.
Major Regulatory Areas
 Among the Department's bureaus and offices, the Office of Surface 
Mining Reclamation and Enforcement (OSM) has the highest concentration 
of regulatory responsibilities. OSM, in partnership with the States and 
Indian tribes, has the responsibility for setting and enforcing 
environmental standards during coal mining and reclamation operations. 
Other DOI bureaus rely on regulations to implement legislatively 
mandated programs by focusing on the management of natural resources 
and public or trust lands. Some of these regulatory activities include:
 Management of migratory birds and preservation of certain 
            marine mammals and endangered species;
 Management of dedicated lands, such as national parks, 
            wildlife refuges, and American Indian trust lands;
 Management of public lands open to multiple use;
 Leasing and oversight of development of Federal energy, 
            minerals, and renewable resources;
 Management of revenues from American Indian and Federal 
            minerals;
 Fulfillment of trust and other responsibilities pertaining to 
            American Indian tribes;
 Natural resource damage assessments; and
 Management of financial and nonfinancial assistance programs.
Regulatory Policy
How DOI Regulatory Procedures Relate to the Administration's Regulatory 
Policies 
 Within the requirements and guidance in Executive Orders 12866, 13132, 
and 12630, DOI's regulatory program seeks to:
 Fulfill all legal requirements as specified by statutes or 
            court orders;
 Perform essential functions that cannot be handled by non-
            Federal entities;
 Minimize regulatory costs to society while maximizing societal 
            benefits; and
 Operate programs openly, efficiently, and in cooperation with 
            Federal and non-Federal entities.
 DOI bureaus have taken the initiative in working with other Federal 
agencies, State, local, and tribal governments, private entities, and 
the general public to make our regulations easier to comply with and 
understand. Because regulatory reform is a continuing process that 
requires the participation of all affected parties, we strive 
continually to include all affected entities in the decision making 
process and to issue rules more efficiently. To better manage and 
review the regulatory process, we have revised our internal rulemaking 
guidance. Results have included:
 Increased bureau awareness of and responsiveness to the needs 
            of small businesses and better compliance with the Small 
            Business Regulatory Enforcement Fairness Act (SBREFA);
 A departmentwide effort to evaluate the economic effects of 
            rules and regulations that are planned;
 Issuance of new guidance in the Departmental Manual to ensure 
            the use of plain language in Government writing; and
 Encouragement of public outreach, including negotiated 
            rulemaking.
 We are committed to improving the regulatory process through the use 
of plain language. Simplifying regulations has resulted in a major 
rewrite of the regulations for onshore oil and gas leasing and 
operations in an easily understandable form that: (a) Puts previously 
published rules into one location in a logical sequence; (b) eliminates 
duplication by consolidating existing regulations and onshore orders 
and national notices to lessees; (c) incorporates industry standards by 
reference; and (d) implements performance standards in some of the 
operating regulations. Our regulatory process ensures that bureaus 
share ideas on how to reduce regulatory burden while meeting the 
requirements of the laws they enforce and improving their stewardship 
of the environment and resources under their purview.

[[Page 73394]]

Encouraging Responsible Management of the Nation's Resources
 The Department's mission is to protect and provide access to our 
Nation's natural and cultural heritage and to honor our trust 
responsibilities to tribes. We are committed to this mission and to 
applying laws and regulations fairly and effectively. The Department's 
priorities are compliance, enforcement, prevention, solving problems, 
and protecting public health and safety. To this end, our bureaus 
encourage users of public resources to adopt long-term strategies 
designed to meet current needs while preserving resources for future 
generations.
 An example of this is the ``no surprises'' policy of the U.S. Fish and 
Wildlife Service (FWS). This policy gives property owners an incentive 
to implement voluntary conservation measures for a proposed or 
candidate species, or a species likely to become a candidate or 
proposed in the near future. These property owners will receive 
assurances from FWS that additional conservation measures will not be 
required and additional land, water, or resource use restrictions will 
not be imposed should the species become listed in the future. This 
policy results in fewer fines, no ``surprises'' (in the form of 
unexpected fines) for conforming landowners, and better overall 
compliance with the Endangered Species Act.
Minimizing Regulatory Burdens
 We are using the regulatory process to ease the burdens on various 
entities throughout the country. For instance, the Endangered Species 
Act (ESA) allows for the delisting of threatened and endangered species 
if they no longer need the protection of the ESA. We have identified 
approximately 40 species for which delisting or downlisting 
(reclassification from endangered to threatened) may be appropriate.
 We use performance standards in a variety of regulations. These allow 
the affected entity to choose the most economical method to accomplish 
a goal provided it meets the requirements of the regulations. An 
example of this is Minerals Management Service's (MMS) training rule, 
which will allow companies with operations in the Outer Continental 
Shelf (OCS) to select their own training courses or programs for 
employees. The new rule will allow lessees and contractors to properly 
train the employees by any method they choose as long as the employees 
are competent. We anticipate that this will result in new and 
innovative training techniques and allow companies added flexibility in 
tailoring their training to employees' specific duties.
Encouraging Public Participation and Involvement in the Regulatory 
Procedure Process
 Encouraging increased public participation in the regulatory process 
to make regulatory policies more responsive to our customers' needs is 
one of our top priorities. The Department is reaching out to 
communities to seek public input on a variety of regulatory issues. For 
example, every year FWS establishes migratory bird hunting seasons in 
partnership with ``flyway councils,'' which are made up of State fish 
and wildlife agencies. As the process evolves each year, FWS holds a 
series of public meetings to give other interested parties, including 
hunters and other groups, adequate opportunity to participate in 
establishing the upcoming season's regulations.
 Similarly, the Bureau of Land Management (BLM) uses Resource Advisory 
Councils (RACs) made up of affected parties to help prepare regulations 
that it issues under the Rangeland Reform Act.
 We encourage public consultation during the regulatory process. For 
example:
 OSM is continuing its outreach to interested groups to improve 
            the substance and quality of rules and, to the greatest 
            extent possible, achieve a consensus on regulatory issues.
 The Bureau of Indian Affairs is developing its roads program 
            rule using the negotiated rulemaking process. Because of 
            the importance of the roads program to the individual 
            tribes and because of the varying needs of the tribal 
            governments, the negotiated rulemaking process will result 
            in a rule that better serves the diverse needs of the 
            Native American community.
 The Bureau of Indian Affairs is also developing a rule in 
            response to the Department's Trust Management Improvement 
            Project-High Level Implementation Plan. The rule concerns 
            grazing permits, leases on Indian lands, probate of Indian 
            decedents' estates, and management of tribal and individual 
            Indian money accounts held in trust. Tribal consultations 
            were held prior to the development of the proposed rule and 
            high-level consultations continue throughout Indian country 
            during the ongoing comment period.
 The National Park Service is using the negotiated rulemaking 
            process to revise the nonrecreation off-road driving 
            regulations for Fire Island National Seashore. The existing 
            regulations have evolved over a period of 35 years and have 
            resulted in long-standing and serious controversy. NPS 
            expects the negotiated rulemaking to produce regulations 
            that will enjoy widespread public acceptance.
The Future of DOI
 In compliance with the Government Performance and Results Act of 1993 
(GPRA), we are preparing a comprehensive strategic plan to prepare DOI 
for the 21st century. The plan will cover the period from 2000 through 
2005 and will be a stand-alone plan with five Departmental goals 
supported by the bureau goals. It gives employees and managers clear 
goals and strategies to help the Department meet its mission and 
fulfill its commitment to the nation. We believe that this plan must 
evolve in response to the changing natural and human environments. For 
this reason, our bureaus have already begun their strategic plans to 
respond to those changes and to prepare for others that may take place 
in the future.
 A copy of DOI's current strategic plan (including updates that have 
been made during FY 2000) can be seen on our Web site at this address:
http://www.doi.gov/gpral
Bureaus and Offices Within DOI
 The following brief descriptions summarize the regulatory functions of 
DOI's major regulatory bureaus and offices.
Office of the Secretary, Office of Environmental Policy and Compliance
 The regulatory functions of the Office of Environmental Policy and 
Compliance (OEPC) stem from requirements under section 301(c) of the 
Comprehensive Environmental Response, Compensation, and Liability Act 
of 1980, as amended (CERCLA). Section 301(c) requires the development 
of natural resource damage assessment rules and the biennial review and 
revision, as appropriate, of these rules. Rules have been promulgated 
for the optional use of natural resource trustees to assess 
compensation for damages to natural resources caused by hazardous 
substances. OEPC is overseeing the study and possible promulgation of 
additional rules pursuant to section 301(c)(2) and the review and 
possible revision of the existing rules in compliance with section 
301(c)(3).

[[Page 73395]]

 In undertaking DOI's responsibilities under section 301(c), OEPC is 
striving to meet three regulatory objectives: (a) That the minimum 
amount of regulation necessary be developed; (b) that the assessment 
process provide for tailoring to specific discharges or releases; and 
(c) that the process not be considered punitive, but rather a system to 
achieve fair and just compensation for injuries sustained.
Bureau of Indian Affairs 
 The Bureau of Indian Affairs (BIA) is responsible for managing trust 
responsibilities to the Indian tribes and encouraging tribal 
governments to assume responsibility for BIA programs.
 The Bureau's rulemaking and policy development processes are designed 
to foster public and tribal awareness of the standards and procedures 
that directly affect them. The processes also encourage the public and 
the tribes to participate in developing these standards and procedures. 
The goals of BIA regulatory policies are to: (a) Ensure consistent 
policies within BIA that result in dealing uniformly with the tribal 
governments; (b) facilitate tribal involvement in managing, planning, 
and evaluating BIA programs and services; and (c) ensure continued 
protection of tribal treaties and statutory rights.
Bureau of Land Management
 The Bureau of Land Management manages about 264 million acres of land 
surface and about 570 million acres of Federal mineral estate. These 
lands consist of extensive grasslands, forests, mountains, arctic 
tundra, and deserts. Resources on the lands include energy and 
minerals, timber, forage, wild horse and burro populations, habitat for 
fish and wildlife, wilderness areas, and archeological and cultural 
sites. BLM manages these lands and resources for multiple use and the 
sustained yield of renewable resources. Primary statutes under which 
the Agency must operate include: The Federal Land Policy and Management 
Act of 1976; the General Mining Law of 1872; the Mineral Leasing Act of 
1920, as amended; the Recreation and Public Purposes Act; the Taylor 
Grazing Act; and the Wild, Free-Roaming Horses and Burros Act.
 The regulatory program mirrors statutory responsibilities and Agency 
objectives. Agency objectives include:
 Providing for a wide variety of public uses without 
            compromising the long-term health and diversity of the land 
            and without sacrificing significant natural, cultural, and 
            historical resource values;
 Understanding the arid, semi-arid, arctic, and other 
            ecosystems we manage and committing to using the best 
            scientific and technical information to make resource 
            management decisions;
 Understanding the needs of the public that use BLM-managed 
            lands and providing them with quality service;
 Committing to recovering a fair return for using publicly 
            owned resources and avoiding the creation of long-term 
            liabilities for American taxpayers; and
 Resolving problems and implementing decisions in cooperation 
            with other agencies, States, tribal governments, and the 
            public.
 The regulatory program contains its own objectives. These include 
preparing regulations that:
 Are the product of coordination and consultation with all 
            affected members of the public;
 Are understandable to the general public, especially those to 
            whom they are directly applicable; and
 Are reviewed periodically to determine whether or not BLM 
            still needs them and whether or not they need to be updated 
            to reflect statutory and policy changes.
Minerals Management Service
 The Minerals Management Service (MMS) has two major responsibilities: 
(1) timely and accurate collection, distribution, accounting for, and 
auditing of revenues owed by holders of Federal onshore, offshore, and 
tribal land mineral leases in a manner that meets or exceeds Federal 
financial integrity requirements and recipient expectations, and (2) 
Management of the resources of the Outer Continental Shelf in a manner 
that provides for safety, protection of the environment, and 
conservation of natural resources. These responsibilities are carried 
out under the provisions of the Federal Oil and Gas Royalty Management 
Act, the Minerals Leasing Act, the Outer Continental Shelf Lands Act, 
the Indian Mineral Leasing Act, and other related statutes.
 MMS's regulatory philosophy is to develop clear, enforceable rules 
that support the missions of its programs. MMS plans to issue final 
regulations to establish how it will offer deep water leasing 
incentives after expiration of the mandatory terms set by the Deep 
Water Royalty Relief Act (DWRRA) (Pub. L. 104-58) in 2001. In addition, 
current regulations at 30 CFR 203 give detailed instructions on how 
deep water leases issued before the DWRRA may apply and qualify for 
royalty-suspension on a case-by-case basis. MMS plans to revise and 
extend these instructions to certain additional categories of OCS 
leases, especially those issued after 2000. MMS will also continue to 
review rules and issue amendments in response to new technology and new 
industry practices.
 MMS also plans to continue its review of existing regulations and to 
issue rules to refine the royalty management regulations in chapter II 
of 30 CFR. MMS's revisions to the royalty management regulations cover 
oil and gas valuation of Federal and Indian leases. In addition, the 
Federal Oil and Gas Royalty Simplification and Fairness Act of 1996 
requires numerous changes to royalty management regulations.
Office of Surface Mining Reclamation and Enforcement 
 The Office of Surface Mining Reclamation and Enforcement (OSM) was 
created by the Surface Mining Control and Reclamation Act of 1977 
(SMCRA) to ``strike a balance between protection of the environment and 
agricultural productivity and the Nation's need for coal as an 
essential source of energy.''
 The principal regulatory provisions contained in title V of SMCRA set 
minimum requirements for obtaining a permit for surface coal mining 
operations, set standards for those operations, require land 
reclamation once mining ends, and require rules and enforcement 
procedures to ensure that the standards are met. Under SMCRA, OSM is 
the primary enforcer of SMCRA's provisions until the States achieve 
``primacy''; that is, until they demonstrate that their regulatory 
programs meet all the specifications in SMCRA and have regulations 
consistent with those issued by OSM.
 When a primacy State takes over the permitting, inspection, and 
enforcement activities of the Federal Government. OSM then changes its 
role from regulating mining activities directly to overseeing and 
evaluating State programs. Today, 24 of the 27 key coal-producing 
States have primacy. In return for assuming primacy, States are 
entitled to regulatory grants and to grants for reclaiming abandoned 
mine lands. In addition, under cooperative agreements, some primacy 
States have agreed to regulate mining on Federal lands within their 
borders. Thus, OSM regulates mining directly only in nonprimacy States, 
on Federal lands in States where no cooperative agreements are in 
effect, and on Indian lands.

[[Page 73396]]

 SMCRA charges OSM with the responsibility of publishing rules as 
necessary to carry out the purposes of the Act. The fundamental 
mechanism for ensuring that the purposes of SMCRA are achieved is the 
basic policy and guidance established through OSM's permanent 
regulatory program and related rulemakings. This regulatory framework 
is developed, reviewed, and applied according to policy directives and 
legal requirements.
 Litigation by the coal industry and environmental groups is 
responsible for some of the rules now being considered by OSM. Others 
are the result of efforts by OSM to address areas of concern that have 
arisen during the course of implementing OSM's regulatory program, and 
one is the result of legislation.
 OSM has sought to develop an economical, safe, and environmentally 
sound program for the surface mining of coal by providing a stable and 
consistent regulatory framework. At the same time, however, OSM has 
recognized the need (a) to respond to local conditions, (b) to provide 
flexibility to react to technological change, (c) to be sensitive to 
geographic diversity, and (d) to eliminate burdensome recordkeeping and 
reporting requirements that over time have proved unnecessary to ensure 
an effective regulatory program.
 Major regulatory objectives regarding the mining of surface coal 
include:
 Continuing outreach activities with interested groups during 
            the rulemaking process to increase the quality of the 
            rulemaking process, improve the substance of the rules, 
            and, to the greatest extent possible, reflect consensus on 
            regulatory issues;
 Minimizing the recordkeeping and regulatory compliance burden 
            during rulemaking; and
 Publishing final rules to implement the Energy Policy Act of 
            1992, Public Law 102-486 and section 510(c) of SMCRA.
U.S. Fish and Wildlife Service
 The U.S. Fish and Wildlife Service has three basic mission objectives:
 To develop and apply an environmental stewardship ethic based 
            on ecological principles and scientific knowledge of fish 
            and wildlife;
 To guide the conservation, development, and management of the 
            Nation's fish and wildlife resources; and
 To administer a national program to provide the public with 
            opportunities to understand, appreciate, and wisely use 
            fish and wildlife resources.
 These objectives are met through the following regulatory programs:
 Management of Service lands, primarily national wildlife 
            refuges;
 Management of migratory bird resources;
 Conservation of certain marine mammals and endangered species;
 Allowance of certain activities that would otherwise be 
            prohibited by law; and
 Administration of grant and assistance programs.
 The Service maintains a comprehensive set of regulations in the first 
category--those that govern public access, use, and recreation on more 
than 500 national wildlife refuges and in national fish hatcheries. 
These uses are authorized only if they are compatible with the purpose 
for which each area was established, are consistent with State and 
local laws where practical, and afford the public appropriate economic 
and recreational opportunity. These regulations are developed and 
continually reviewed for improvements, with a substantial amount of 
public input, and are typically of limited geographical interest.
 Management of migratory bird resources is covered by the second 
category of regulations, required by various international treaties. 
Annually, the Department issues a regulation on migratory bird hunting 
seasons and bag limits, developed in partnership with the States, 
American Indian tribal governments, and the Canadian Wildlife Service. 
Although issued annually, regulations such as these have been in 
existence for more than 50 years and have not significantly changed 
over that period of time. The regulations are necessary to permit 
migratory bird hunting that would otherwise be prohibited. Although 
recent declines in waterfowl populations have reduced the numbers of 
birds that may be harvested, the regulations generally do not change 
significantly from one year to another.
 The third category includes regulations to fulfill the statutory 
obligation to identify and conserve species faced with extinction. The 
basis for determining endangered species is limited by law to 
biological considerations, although priorities for allocating Service 
resources are established consistent with the President's policies (by 
directing the Service's efforts to species most threatened and those 
whose protection is of the most benefit to the natural resource). 
Included in this program are regulations to enhance the conservation of 
listed species and of marine mammals for which DOI has management 
responsibility. This program also contains regulations that provide 
guidance to other Federal agencies to assist them in complying with 
section 7 of the Endangered Species Act, which requires them not to 
conduct activities that would jeopardize the existence of endangered 
species or adversely modify critical habitat of listed species. In 
designating critical habitat, the Service considers biological 
information and economic and other impacts of the designation. Areas 
may be excluded from the designation where the benefits of exclusion 
outweigh the benefits of inclusion, provided that the exclusion will 
not result in the extinction of the species.
 The fourth category--the Service's regulatory program that permits 
activities otherwise prohibited by law--entails regulating possession, 
sale or trade, scientific research, and educational activities 
involving fish and wildlife and their parts or products. Generally, 
these regulations are supplemental to State protective regulations and 
cover activities that involve interstate or foreign commerce, which 
must comply with various laws and international obligations. The 
Service works continually with foreign and State governments, the 
affected industries and individuals, and other interested parties to 
minimize the burdens associated with Service-related activities. Easing 
these burdens through regulatory actions continues to balance possible 
benefits with adequate protection for the natural resource. Most of the 
regulatory activities are permissive in nature, and the concerns of the 
public generally center on technical issues.
 The last category--the Service's assistance programs--includes a 
limited number of regulations necessary to ensure that assistance 
recipients comply with applicable laws and Office of Management and 
Budget (OMB) Circulars. Regulations in this program help the affected 
parties to obtain assistance and to comply with requirements imposed by 
Congress and OMB.
National Park Service
 The National Park Service is dedicated to conserving the natural and 
cultural resources and values of the National Park System for the 
enjoyment, education, and inspiration of this and future generations. 
The Service is also responsible for managing a great variety

[[Page 73397]]

of national and international programs designed to help extend the 
benefits of natural and cultural resource conservation and outdoor 
recreation throughout this country and the world.
 There are more than 375 units in the National Park System, including 
national parks and monuments; scenic parkways, preserves, trails, 
riverways, seashores, lakeshores, and recreation areas; and historic 
sites associated with important movements, events, and personalities of 
the American past.
 The National Park Service develops and implements park management 
plans and staffs the areas under its administration. It relates the 
natural values and historical significance of these areas to the public 
through talks, tours, films, exhibits, and other interpretive media. It 
operates campgrounds and other visitor facilities and provides, usually 
through concessions, lodging, food, and transportation services in many 
areas. The National Park Service also administers the following 
programs: The State portion of the Land and Water Conservation Fund, 
Nationwide Outdoor Recreation coordination and information and State 
comprehensive outdoor recreation planning, planning and technical 
assistance for the National Wild and Scenic Rivers System, and the 
National Trails System, natural area programs, the National Register of 
Historic Places, national historic landmarks, historic preservation, 
technical preservation services, Historic American Buildings survey, 
Historic American Engineering Record, and interagency archeological 
services.
 The National Park Service maintains regulations that help manage 
public use, access, and recreation in units of the National Park 
System. The Service provides visitor and resource protection to ensure 
public safety and prevent derogation of resources. The regulatory 
program develops and reviews regulations, maintaining consistency with 
State and local laws, to allow these uses only if they are compatible 
with the purpose for which each area was established.
Bureau of Reclamation 
 The Bureau of Reclamation's mission is to manage, develop, and protect 
water and related resources in an environmentally and economically 
sound manner in the interest of the American public. To accomplish this 
mission, Reclamation applies management, engineering, and scientific 
skills that result in effective and environmentally sensitive 
solutions.
 Reclamation projects provide for some or all of the following 
concurrent purposes: Irrigation water service, municipal and industrial 
water supply, hydroelectric power generation, water quality 
improvement, groundwater management, fish and wildlife enhancement, 
outdoor recreation, flood control, navigation, river regulation and 
control, system optimization, and related uses.
 Reclamation's regulatory program is designed to ensure that its 
mission is carried out expeditiously and efficiently.
_______________________________________________________________________



DOI--Minerals Management Service (MMS)

                              -----------

                          PROPOSED RULE STAGE

                              -----------




65. OUTER CONTINENTAL SHELF OIL AND GAS LEASING-BIDDING SYSTEMS
Priority:


Other Significant


Legal Authority:


30 USC 181 et seq.; 30 USC 351 et seq.; 30 USC 1001 et seq.; 30 USC 
1701 et seq.; 31 USC 3335; 43 USC 1301 et seq.; 43 USC 1331 et seq.; 43 
USC 1337 et seq.; 43 USC 1801 et seq.


CFR Citation:


30 CFR 218; 30 CFR 256; 30 CFR 260


Legal Deadline:


None


Abstract:


This proposed rulemaking establishes the structure the Minerals 
Management Service (MMS) will use to offer deep water leasing 
incentives after expiration of the mandatory terms set by the Deep 
Water Royalty Relief Act (DWRRA) (Pub. L. 104-58) in 2001. This is also 
a plain English rewrite of the existing rules for bidding systems and 
joint bidding restrictions. Further, it extends rental obligations 
after a discovery for all leases issued after 2000.


Statement of Need:


Current deep water leasing incentives expire in November 2000. This 
rulemaking provides for an orderly transition from the generous 
incentives of the DWRRA to eventual elimination of incentives. Rather 
than the fixed royalty-suspension volumes set by the DWRRA, the rule 
establishes a flexible structure whereby MMS may change both water 
depths and royalty-suspension volumes periodically. This flexibility is 
vital because of the rapid change underway in the cost of deep water 
development. The extension of rental obligations responds to concerns 
with the U.S. Department of the Interior, Office of the Inspector 
General. (See Evaluation Report--Opportunity to Increase Offshore Oil 
and Gas Rental Revenues, Minerals Management Service, Report No. 99-I-
387, March 1999.)


Summary of Legal Basis:


The primary legal basis for this rulemaking is the DWRRA, which defines 
the Secretary of the Interior's (1) authority to offer royalty 
suspension to promote development or increased production on producing 
and nonproducing leases, and (2) to encourage production of marginal 
resources on producing and nonproducing leases.


Alternatives:


We consider a range of alternatives such as (1) continue the same 
leasing incentive set by the DWRRA, (2) suddently eliminate deep water 
leasing incentives or (3) codify new levels of leasing incentives in 
regulations. Because of technological progress and a better 
understanding of the deep water Gulf of Mexico (GOM), continuing the 
level of incentive set by the DWRRA would give an unneeded subsidy to 
new leases. Changing the current system under the second alternative 
would cause unnecessary disruption to a successful leasing policy. 
Despite record lease sales under the DWRRA, relatively few leases have 
been issued in ultra deep water areas of the GOM. Leasing incentives 
are still needed there. However, under option three, the program would 
be less flexible than necessary to accommodate changing market 
conditions. While the proposed rule does not commit MMS to specific 
water depths or royalty-suspension volumes, it does guarantee that a 
familiar and responsive structure will be implemented.


Anticipated Cost and Benefits:


We estimate compliance with this rulemaking would cost the oil industry 
approximately $35,000 annually over the next 5 years from extra rental 
payments after royalty-free production begins. Additional costs to 
industry and MMS would be negligible administrative expenses associated 
with notifying MMS when production starts. The benefits of this 
rulemaking would be estimated increases of 50 more tracts

[[Page 73398]]

sold per year; 15 more leases explored per year; and the eventual 
development of 10 to 20 more leases per year. These benefits are 
partially offset by reduced royalty collection in later years. However, 
because only a small percentage of tracts leased ultimately produce oil 
and gas, only a limited number of tracts receive a royalty suspension. 
Additional benefits would include simplification and increased 
certainty of royalty suspension, thereby raising bids per tract leased, 
and reduced dependence on field determinations and associated 
litigation.


Risks:


The risk of not modifying current oil valuation regulations is an 
abrupt decline in leasing and bids associated with termination of the 
deep water incentives program or pressure to continue the outdated, 
overly generous terms of the DWRRA.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           10/00/00
NPRM Comment Period End                                        11/00/00
Proposed Notice of Sale No. 178                                11/00/00
Final Action                                                   11/00/00
Final Action Effective                                         12/00/00
Final Notice of Sale No. 178                                   02/00/01
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses


Government Levels Affected:


Federal


Agency Contact:
Marshall B. Rose
Department of the Interior
Minerals Management Service
381 Elden Street
Herndon, VA 20170
Phone: 703 787-1536
Fax: 703 787-1141
Email: [email protected]
RIN: 1010-AC69
_______________________________________________________________________



DOI--MMS



66. DEEP WATER ROYALTY RELIEF FOR OUTER CONTINENTAL SHELF OIL AND GAS 
LEASES ISSUED AFTER 2000
Priority:


Other Significant


Legal Authority:


30 USC 181 et seq; 30 USC 1001 et seq; 30 USC 1701 et seq; 30 USC 351 
et seq; 31 USC 9701; 43 USC 1301 et seq; 43 USC 1331 et seq; 43 USC 
1801 et seq


CFR Citation:


30 CFR 203


Legal Deadline:


None


Abstract:


The rule explains who is eligible for relief, how they apply for 
relief, and the criteria they must meet to receive relief. The proposed 
rule makes a new class of leases, those sold after 2000 in the central 
and western Gulf of Mexico (GOM), eligible to apply for royalty 
suspensions to supplement any that may have been included in their 
original lease terms. Also, it updates certain requirements and 
authorizes royalty relief in special situations.


Statement of Need:


Because of the variation of geologic and economic circumstance, 
standard leasing terms do not encourage development of all potential 
reserves in the deep water GOM. The Deep Water Royalty Relief Act 
(DWRRA)(Pub. L. 104-58) authorized the Minerals Management Service 
(MMS) to promote development of marginal reserves. The existing 
regulations at 30 CFR 203 give detailed instructions on how deep water 
leases issued before the DWRRA may apply and qualify for royalty-
suspension on a case-by-case basis. This proposed rule revises and 
extends these instructions to certain additional categories of OCS 
leases, especially those issued after 2000. Revisions to the existing 
instructions reflect experience with cases over the last 5 years. Also 
the proposed rule identifies circumstances when MMS may consider 
special royalty relief outside our established end-of-life and DWRR 
programs.


Summary of Legal Basis:


The OCS Lands Act is the basis for our regulations on suspending or 
lowering royalties on producing OCS leases. The DWRRA is the basis for 
regulations to reduce or eliminate royalty on non-producing leases in 
the GOM west of 87 degrees, 30 minutes West longitude. It gives the 
Secretary of the Interior this authority to (1) promote development or 
increased production on producing and non-producing leases or (2) 
encourage production of marginal resources on producing and non-
producing leases.


Alternatives:


The specificity with which the current regulations were written was 
driven by the DWRRA to facilitate planning by potential applicants. 
Those regulations do not leave room for anything but a rulemaking fix. 
Otherwise, those new leases that legitimately need development 
assistance would be relegated to seeking relief under ad hoc special 
relief rules. Alternatively an extension of the DWRRA terms to fill a 
perceived gap may give future deep water lessees royalty-suspension 
terms that are not sufficiently responsive to current market 
conditions. Moreover, it is fairer to both applicants and taxpayers to 
establish clear and coherent rules by which individual leases can 
obtain the amount of royalty relief actually needed to induce 
development.


Anticipated Cost and Benefits:


This rule extends the benefit of discretionary royalty relief to 
certain OCS leases after November 2000 that qualify as marginally 
uneconomic. Lessees who choose to seek this discretionary royalty 
relief pay user fees that range from $12,000 to $49,000 per 
application, in addition to their internal costs of assembling the 
necessary data. Benefits from this rule come from production that 
otherwise would not occur or be deferred indefinitely. To date, one 
field qualifying for relief has gone into production and added 15 
million barrels of oil equivalent to reserves in the GOM. Another on 
the verge of starting development would add 400 billion cubic feet of 
natural gas to reserves that otherwise would not be produced in the 
GOM.


Risks:


The risk of not modifying the discretionary royalty relief rule is that 
some marginal resources will be bypassed. Alternatively, royalty 
receipts could fall because overly generous relief will be given to 
many leases to avoid the loss in production by a few.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           10/00/00
NPRM Comment Period End                                        11/00/00
Final Action                                                   11/00/00
Final Action Effective                                         12/00/00

[[Page 73399]]

Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses


Government Levels Affected:


Federal


Agency Contact:
Marshall B. Rose
Department of the Interior
Minerals Management Service
381 Elden Street
Herndon, VA 20170
Phone: 703 787-1536
Fax: 703 787-1141
Email: [email protected]
RIN: 1010-AC71
_______________________________________________________________________



DOI--MMS

                              -----------

                            FINAL RULE STAGE

                              -----------




67. VALUATION OF OIL FROM INDIAN LEASES
Priority:


Other Significant


Legal Authority:


25 USC 2101 et seq; 25 USC 396 et seq; 30 USC 1001 et seq; 30 USC 1701 
et seq; 30 USC 181 et seq; 30 USC 351 et seq; 25 USC 396a et seq


CFR Citation:


30 CFR 206


Legal Deadline:


None


Abstract:


This rule would modify the regulations that establish royalty value for 
oil produced from Indian leases and create a new form for collecting 
value and value differential data. These changes would decrease 
reliance on oil posted prices and make Indian oil royalty valuation 
more consistent with the terms of Indian leases.


Statement of Need:


Current oil valuation regulations rely primarily on posted prices and 
prices under arm's-length sales to value oil that is not sold at arm's-
length. Over time, posted prices have become increasingly suspect as a 
fair measure of market value. This rulemaking would modify valuation 
regulations to place substantial reliance on the higher of crude oil 
spot prices, major portion prices, or gross proceeds, and eliminate any 
direct reliance on posted prices. This rulemaking would also add more 
certainty to valuation of oil produced from Indian leases.


Summary of Legal Basis:


The primary legal basis for this rulemaking is the Federal Oil and Gas 
Royalty Management Act of 1982, as amended, which defines the Secretary 
of the Interior's (1) authority to implement and maintain a royalty 
management system for oil and gas leases on Indian lands, and (2) trust 
responsibility to administer Indian oil and gas resources.


Alternatives:


We considered a range of valuation alternatives such as making minor 
adjustments to the current gross proceeds valuation method, using 
futures prices, using index-based prices with fixed adjustments for 
production from specific geographic zones, relying on some type of 
field pricing other than posted prices, and taking oil in-kind. We 
chose the higher of the average of the high daily applicable spot 
prices for the month, major portion prices in the field or area, or 
gross proceeds received by the lessee or its affiliate. We chose spot 
prices as one of the three value measures because (1) they represent 
actual trading activity in the market, (2) they mirror New York 
Mercantile Exchange futures prices, and (3) they permit use of an index 
price in proximity to the actual production whose value is being 
measured.


Anticipated Cost and Benefits:


We estimate compliance with this rulemaking would cost the oil and gas 
industry approximately $46,000 annually. Additional costs to industry 
and MMS would be up-front computer programming and other administrative 
costs associated with processing the new form. The benefits of this 
rulemaking would be an estimated $3.6 million increase in annual 
royalties collected on oil produced from Indian leases. Additional 
benefits would include simplification and increased certainty of oil 
pricing, reduced audit efforts, and reduced valuation determinations 
and associated litigation.


Risks:


The risk of not modifying current oil valuation regulations is that 
Indian recipients may not receive royalties based on the highest price 
paid or offered for the major portion of oil produced--a common 
requirement in most Indian leases. These modifications ensure that the 
Department fulfills its trust responsibilities for administering Indian 
oil and gas leases under governing mineral leasing laws, treaties, and 
lease terms.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
ANPRM           60 FR 65610                                    12/20/95
ANPRM Comment Period End                                       03/19/96
NPRM            63 FR 7089                                     02/12/98
NPRM Comment Period Extended                                   04/09/98
NPRM Comment Period End                                        05/13/98
Supplementary NP65 FR 403                                      01/05/00
NPRM Comment Period Extended                                   02/28/00
Final Action                                                   11/00/00
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses, Governmental Jurisdictions


Government Levels Affected:


Tribal


Agency Contact:
David S. Guzy
Chief Rules and Publications Staff
Department of the Interior
Minerals Management Service
MS 3021
P.O. Box 25165
Denver, CO 80225-0165
Phone: 303 231-3432
Fax: 303 231-3385
Email: [email protected]
RIN: 1010-AC24
_______________________________________________________________________



DOI--Bureau of Land Management (BLM)

                              -----------

                            FINAL RULE STAGE

                              -----------




68. OIL AND GAS LEASING AND OPERATIONS
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:


30 USC 181 et seq

[[Page 73400]]

CFR Citation:


43 CFR 3100 to 3160


Legal Deadline:


None


Abstract:


This rule will revise BLM's current Federal oil and gas leasing and 
operations regulations, except those concerning drainage (section 
3100.2-2), combined hydrocarbon leasing (part 3140) and oil and gas 
leasing in the National Petroleum Reserve--Alaska (part 3130). The rule 
will: (1) Cite industry standards and incorporate them by reference 
rather than repeat those standards in the rule; (2) incorporate the 
requirements of the Onshore Oil and Gas Orders and national notices to 
lessees into the regulations to eliminate overlap with current 
regulations; (3) use performance standards in certain places instead of 
prescriptive requirements to allow more flexibility for operators and 
to protect the environment and Federal royalty interests; (4) increase 
certain bonding requirements; and (5) eliminate redundancies, clarify 
procedures and regulatory requirements and streamline procedures.


Statement of Need:


This rulemaking complies with the requirements of the Government 
Performance and Results Act, the recommendations of the National 
Performance Review, and other initiatives. It will be presented in a 
user-friendly format, presented by process rather than by subject 
matter.


Summary of Legal Basis:


The Mineral Leasing Act gives BLM the authority to issue and administer 
the terms of oil and gas leases on Federal lands, to conduct 
inspections of drilling operations and to promulgate and enforce 
regulations pertaining to oil and gas leasing and operations. BLM is 
the only Federal agency with authority to issue leases for publicly 
owned oil and gas resources.


Alternatives:


The only alternative to the proposed regulations would be to continue 
to operate under the existing regulations. These regulations are not 
performance-based and are at times ambiguous and hard to understand. 
Further, the important information found in Onshore Operating Orders is 
published separately from the regulations and at irregular intervals.


Anticipated Cost and Benefits:


BLM anticipates the following benefits: (1) More clearly written rules 
will be better understood by both oil and gas lessees and operators and 
members of the general public; (2) performance standards, rather than 
prescriptive requirements, will allow lessees and operators and BLM 
greater flexibility to deal with unique geological or engineering 
circumstances within the standards set by the rule; and (3) 
streamlining and clarifying procedures will result in better customer 
service and decreased time and money for both BLM and the user public.


Risks:


The public may misunderstand one or more performance standards. BLM 
will publish user guides that explain in detail the standards and will 
provide examples of how operators might meet specific standards.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            63 FR 66840                                    12/03/98
NPRM Comment Period End                                        07/19/99
Final Action                                                   10/00/00
Regulatory Flexibility Analysis Required:


No


Government Levels Affected:


Local


Agency Contact:
Ian Senio
Regulatory Analyst
Department of the Interior
Bureau of Land Management
MS 401
Regulatory Management Team (WO-630)
1849 C Street NW.
Washington, DC 20240
Phone: 202 452-5049
Email: [email protected]
RIN: 1004-AC94
_______________________________________________________________________



DOI--BLM



69. SURFACE MANAGEMENT (LOCATABLE MINERALS)
Priority:


Other Significant. Major status under 5 USC 801 is undetermined.


Legal Authority:


18 USC 1001; 18 USC 3571 et seq; 30 USC 22; 30 USC 42; 30 USC 612; 43 
USC 1061 et seq


CFR Citation:


43 CFR 3809


Legal Deadline:


None


Abstract:


The rule would improve the clarity and organization of the regulations, 
address technical advances in mining, incorporate policies BLM 
developed after we issued the previous regulations, reinstate certain 
financial guarantee provisions, and better protect natural resources 
and our Nation's natural heritage lands from the adverse impacts of 
mining.


Statement of Need:


This rulemaking reflects the Secretary of the Interior's judgment of 
the regulations required to prevent unnecessary or undue degredation of 
the public lands. Areas where the existing rules require upgrading 
include financial guarantees (to require financial guarantees for all 
operations greater than casual use, thereby ensuring the availability 
of resources for the completion of reclamation); enforcement (to 
implement section 302(c) of FLPMA and provide administrative 
enforcement tools and penalties); threshold for notice operations (to 
require plans of operations for operations more likely to pollute the 
land and those in sensitive areas); withdrawn areas (to require 
validity exams before allowing plans of operations to be approved in 
such areas); casual use (to clarify which activities do or do not 
constitute casual use); performance standards and the definition of 
unnecessary or undue degredation (to establish objective standards to 
reflect current mining technology); and others. Many of these 
shortcomings have been pointed out since 1986 in a series of 
congressional hearings, GAO reports, and DOI Inspector General reports.


Summary of Legal Basis:


This rulemaking is based on the Secretary of the Interior's non-
delegable and independent responsiblility under FLPMA to take any 
action necessary to prevent unnecessary or undue degredation of the 
public lands, and a recognition that BLM's current rules may not be 
adequate to ensure this result. In enacting FLPMA, Congress intended 
that the Secretary determine what constitutes unnecessary or undue 
degredation and not that the States would do so on a State-by-State 
basis. Sections 302(b), 303(a), and 310 of FLPMA reflect this 
responsibility.

[[Page 73401]]

Alternatives:


In addition to the proposed rule, BLM is considering four alternatives. 
The first is to make no changes to the regulations. The second is to 
defer totally to the States for regulation of exploration and mining. 
The third is a maximum protection approach that would contain 
prescriptive design requirements. The fourth is to address only the six 
regulatory ``gaps'' identified by the National Research Council in a 
recent report.


Anticipated Cost and Benefits:


The Department has prepared a cost-benefit analysis. On balance the 
general public is expected to benefit by decreasing the public health 
and safety costs associated with the clean-up of hazardous and toxic 
substances generated by the mining of various locatable minerals (acid, 
draining, etc.). There may be slightly increased costs to operators on 
mining claims from their exploration, development, and reclamation 
activities, if the surface management regulations require using the 
best available technology in exploration, mining, and reclamation 
activities.


Risks:


Claimants unable to comply with increased mining costs could cease 
operations and go out of business. Some portion of the mining industry 
could cease exploration and mining operations in the United States and 
begin or increase mining operations in other countries whose policies 
are less stringent.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            64 FR 6422                                     02/09/99
NPRM Comment Period End                                        05/10/99
Supplementary Pr64 FR 57613                                    10/26/99
NPRM Comment Period End                                        02/23/00
Final Action                                                   11/00/00
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Governmental Jurisdictions


Government Levels Affected:


Local


Agency Contact:
Robert Anderson
Minerals Resources
Department of the Interior
Bureau of Land Management
Phone: 202 208-4201
Email: [email protected]
RIN: 1004-AD22
BILLING CODE 4310-10-S




[[Page 73402]]

DEPARTMENT OF JUSTICE (DOJ)



Statement of Regulatory Priorities
 The Department of Justice is not a major regulatory agency, and it 
carries out its vital investigative, prosecutorial, and other law 
enforcement activities principally through means other than the 
regulatory process. Even so, the Department does have significant 
responsibilities for implementing the Americans with Disabilities Act 
(ADA), as well as the immigration laws, including the Immigration 
Reform and Control Act of 1986 and the Immigration Act of 1990. The 
Department's key regulatory goals and initiatives are set forth in 
detail below.
 The Department has worked actively to implement the general regulatory 
principles of Executive Order 12866. Relatively few of the Department's 
rules are significant regulatory actions requiring review by the Office 
of Management and Budget (OMB) under the Executive order. Accordingly, 
the orientation of the OMB review process to focus on significant rules 
has required the Department to increase its own efforts to ensure that 
all of its regulations are carefully reviewed for consistency with the 
Administration's regulatory principles, including the large majority of 
rules that are not reviewed directly by OMB as significant regulatory 
actions.
 Pursuant to section 4(c) of Executive Order 12866, the Department of 
Justice provides the following statement of regulatory priorities, 
focusing in particular on three regulatory initiatives in the areas of 
civil rights and immigration.
 In addition to the specific initiatives set forth below, several other 
components of the Department carry out important responsibilities 
through the regulatory process. Although their regulatory efforts are 
not singled out for specific attention in this regulatory plan, those 
components carry out key roles in implementing the Department's law 
enforcement priorities. In particular, the Drug Enforcement 
Administration (DEA) is responsible for controlling abuse of narcotics 
and dangerous drugs by restricting the aggregate supply of those drugs. 
DEA accomplishes its objectives through coordination with State, local, 
and other Federal officials in drug enforcement activities, development 
and maintenance of drug intelligence systems, regulation of legitimate 
controlled substances, and enforcement coordination and intelligence-
gathering activities with foreign government agencies. DEA continues to 
develop and enhance regulatory controls relating to the diversion 
control requirements and to the requirements of the Comprehensive 
Methamphetamine Control Act of 1996, which regulates certain drug 
products that are being diverted for the production of methamphetamine. 
In addition, DEA has initiated an e-commerce study to identify the 
regulatory means under which legitimate handlers of controlled 
substances can use electronic technologies and signatures in the course 
of distributing and dispensing controlled substances.
 Also, on March 20, 1997, the Federal Bureau of Investigation 
promulgated final cost recovery regulations under the Communications 
Assistance for Law Enforcement Act of 1994 (CALEA). Congress enacted 
CALEA to address the recent and continuing advances in 
telecommunications technology, which have impaired and, in some 
instances, precluded law enforcement agencies from fully conducting 
various types of court-authorized electronic surveillance. The Attorney 
General is authorized to reimburse carriers for all of the reasonable 
costs directly associated with the modifications they perform on 
equipment, facilities, and services deployed on or before January 1, 
1995. These regulations provide the cost accounting standards for the 
reimbursements.
 In response to public comments during the cost recovery rulemaking, 
the FBI published on April 20, 1998, a proposed rule defining the terms 
``significant upgrade'' and ``major modification.'' The FBI plans to 
publish a supplemental notice of proposed rulemaking, which will define 
the terms replaced and significantly upgraded or otherwise undergone 
major modification.
 On March 12, 1998, the FBI, on behalf of law enforcement, published a 
Final Notice of Capacity (following two previously published notices on 
the same subject) informing telecommunications carriers offering local 
exchange services and certain commercial mobile radio services 
(specifically cellular service and broadband PCS) of the estimated 
actual and maximum number of simultaneous interceptions that law 
enforcement might conduct on or after specified dates.
 On December 18, 1998, the FBI published a Notice of Inquiry (NOI) 
soliciting information and suggestions from interested parties for 
developing reasonable capacity methodologies for characterizing the 
capacity requirements for telecommunications services other than those 
covered by the March 12, 1998, Final Notice of Capacity. The FBI issued 
a Further Notice of Inquiry (FNOI) on June 30, 2000. Information 
gathered in response to the FNOI will be used in the publication of an 
Initial Notice of Capacity for developing reasonable capacity 
methodologies for the paging, mobile satellite, specialized mobile 
radio, and enhanced specialized radio services.
Civil Rights
 The Department and its Civil Rights Division are deeply committed to a 
rigorous and revitalized approach to the enforcement of this Nation's 
civil rights laws. In keeping with that commitment, the Division will 
be reviewing and updating its civil rights regulations implementing the 
Americans with Disabilities Act of 1990 (ADA).
 The Department is planning to make revisions in its regulations 
implementing titles II and III of the ADA to amend the ADA Standards 
for Accessible Design (28 CFR part 36, appendix A) to be consistent 
with the revised ADA accessibility guidelines proposed by the U.S. 
Architectural and Transportation Barriers Compliance Board (Access 
Board) in November 1999. Title II of the ADA prohibits discrimination 
on the basis of disability by public entities, and title III prohibits 
such discrimination by places of public accommodation and requires 
accessible design and construction of places of public accommodation 
and commercial facilities. In implementing these provisions, the 
Department of Justice is required by statute to publish regulations 
that include design standards that are consistent with the guidelines 
developed by the Access Board.
 The Access Board has been engaged in a multi-year effort to revise and 
amend its accessibility guidelines. The goals of this project have 
been: 1) to address issues such as unique State and local facilities 
(e.g., prisons, courthouses), recreation, play areas, and building 
elements specifically designed for children's use that were not 
addressed in the initial guidelines; 2) to promote greater consistency 
between the Federal accessibility requirements and the model codes; and 
3) to provide greater consistency between the ADA guidelines and the 
guidelines that implement the Architectural Barriers Act. The Access 
Board has proposed and/or adopted guidelines that address all of these 
issues. Therefore, to comply

[[Page 73403]]

with the ADA requirement that the ADA standards remain consistent with 
the Access Board's guidelines, the Department will propose to adopt the 
changes previously proposed by the Access Board.
 At the same time, the Department also plans to review its regulations 
implementing title II and title III (28 CFR parts 35 and 36) to ensure 
that the requirements applicable to new construction and alterations 
under title II are consistent with those applicable under title III, to 
review and update the regulations to reflect the current state of law, 
and to ensure the Department's compliance with applicable provisions of 
the Small Business Regulatory Enforcement Fairness Act (SBREFA).
Immigration
 The Immigration and Naturalization Service (INS) is responsible for 
facilitating the entry of persons legally admissible as visitors or as 
immigrants to the United States, for preventing unlawful entry or 
receipt of immigration benefits by those who are not entitled to 
receive them and for apprehending or removing those aliens who enter or 
remain illegally in the United States. Though many of the 
Administration's goals for more effective immigration process flow from 
either new statutory authority or increased resources, the regulatory 
process is a vital aspect of carrying out the goals of the immigration 
laws.
 Certainly, one of the regulatory challenges facing the Department of 
Justice is to improve the effectiveness of those regulatory efforts. 
Commissioner Meissner established three fundamental goals at the time 
of her confirmation: To increase the professionalism of the Service, to 
provide immigration control with compassion, and to build the Service's 
role in immigration policy leadership and communication. The regulatory 
priorities for the Service follow those priorities, though other 
desired improvements may require legislative action. Two INS 
initiatives are included in this regulatory plan.
 First, the Service will publish a proposed rule to implement the new 
grounds of inadmissibility and their waivers, especially those 
established under the Illegal Immigration Reform and Immigrant 
Responsibility Act of 1996 (IIRIRA). This regulation will clarify the 
interplay between the new grounds of inadmissibility and existing law 
and will set forth changes in procedures and policies. Second is the 
Service's ongoing effort to facilitate the U.S. business community's 
ability to comply with the employer sanctions provisions of the 
Immigration Control and Reform Act.
 The Service anticipates additional progress in its efforts to simplify 
the employers' compliance with employment verification (Form I-9) 
requirements of the Act. The Service published a proposed rule on 
February 2, 1998. This proposal reflected numerous changes stemming 
from IIRIRA and from a comprehensive review of the 10-year-old 
verification regulations, as required by the Regulatory Flexibility 
Act. The result was a comprehensive overhaul of the regulations. The 
Service adopted a ``plain language'' approach and simplified the 
structure of the regulation. Both steps were well received by the 
public. In addition, the list of documents acceptable for employment 
verification was shortened, and several other requirements were 
clarified. The Service received thoughtful comments from the public on 
the proposal. Those are now being reviewed, and the Service anticipates 
publishing a final rule during the coming fiscal year.
_______________________________________________________________________



DOJ--Civil Rights Division (CRT)

                              -----------

                          PROPOSED RULE STAGE

                              -----------




70. NONDISCRIMINATION ON THE BASIS OF DISABILITY IN STATE AND LOCAL 
GOVERNMENT SERVICES
Priority:


Economically Significant. Major status under 5 USC 801 is undetermined.


Legal Authority:


5 USC 301; 28 USC 509, 510; 42 USC 12134; PL 101-336


CFR Citation:


28 CFR 35


Legal Deadline:


None


Abstract:


On July 26, 1991, the Department published its final rule implementing 
title II of the Americans with Disabilities Act (ADA). In late 1999, 
the U.S. Architectural and Transportation Barriers Compliance Board 
(Access Board) will issue its first comprehensive review of the ADA 
Accessibility Guidelines, which form the basis of the Department's ADA 
Standards for Accessible Design. The ADA (section 204(c)) requires the 
Department's standards to be consistent with the Access Board's 
guidelines. Therefore, the Civil Rights Division will publish a Notice 
of Proposed Rulemaking (NPRM) proposing to adopt the revisions proposed 
by the Access Board.


In addition to the statutory requirement for the rule, the social and 
economic realities faced by Americans with disabilities dictate the 
need for the rule. Individuals with disabilities cannot participate in 
the social and economic activities of the Nation without being able to 
access the programs and services of State and local governments. 
Further, amending the Department's ADA regulations will: Improve the 
format and usability of the ADA Standards for Accessible Design; 
harmonize the differences between the ADA standards and national 
consensus standards and model codes; update the ADA standards to 
reflect technological developments that meet the needs of persons with 
disabilities; and coordinate future ADA standards revisions with 
national standards and model code organizations. As a result, the 
overarching goal of improving access for persons with disabilities so 
that they can benefit from the goods, services, and activities provided 
to the public by covered entities will be met.


This rulemaking will also address changes to the ADA standards 
previously proposed in RIN 1190-AA26 and RIN 1190-AA38, which have been 
withdrawn. These changes will include technical specifications for 
facilities designed for use by children and accessibility standards for 
State and local government facilities that have previously been 
published by the Architectural and Transportation Barriers Compliance 
Board.


Statement of Need:


Section 504 of the ADA requires the Access Board to issue supplemental 
minimum guidelines and requirements for accessible design of buildings 
and facilities subject to the ADA, including titles II and III. 
Sections 204(c) and 306(c) of the ADA provide that the Attorney General 
shall promulgate regulations implementing titles II and III that are 
consistent with the Access Board's ADA guidelines. Because the 
Department of Justice is required by statute to promulgate regulations 
that do not go below the Access Board's minimum guidelines, and because 
this rule will adopt standards that are consistent with the guidelines 
issued by the Access Board, as also required

[[Page 73404]]

by statute, this rule is required by statute. Similarly, the 
Department's review of its title III regulation is being undertaken to 
comply with the requirements of the Regulatory Flexibility Act as 
amended by the Small Business Regulatory Enforcement Fairness Act 
(SBREFA).


Summary of Legal Basis:


The summary of the legal basis of authority for this regulation is set 
forth above in the Legal Authority and in the Statement of Need.


Alternatives:


The Department is required by the ADA to issue this regulation as 
described in the Statement of Need above. Pursuant to SBREFA, the 
Department's title III regulation will consider whether alternatives to 
the currently published requirements are appropriate.


Anticipated Cost and Benefits:


The Clinton Administration is deeply committed to ensuring that the 
goals of the ADA are met. Promulgating this amendment to the 
Department's ADA regulations will ensure that entities subject to the 
ADA will have one comprehensive regulation to follow. 
Currently,entities subject to title II of the ADA (State and local 
governments) have a choice between following the Department's ADA 
standards for title III, which were adopted for places of public 
accommodation and commercial facilities and which do not contain 
standards for common State and local government buildings (such as 
courthouses and prisons), or the Uniform Federal Accessibility 
Standards (UFAS). By developing one comprehensive standard, the 
Department will eliminate the confusion that arises when governments 
try to mesh two different standards. As a result, the overarching goal 
of improving access to the built environment to persons with 
disabilities will be better served.


The Access Board has analyzed the impact of applying its proposed 
amendments to ADAAG to entities covered by titles II and III of the ADA 
and has determined that they are a significant regulatory action for 
purposes of Executive Order 12866. The Access Board has prepared a 
regulatory assessment, which includes a cost impact analysis for 
certain accessibility elements and a discussion of the regulatory 
alternatives considered. The Access Board determined that its NPRM is 
an economically significant action. A summary of the Board's regulatory 
assessment is published at 64 FR 62282 (November 16, 1999). That 
assessment will also apply to the Department's proposed rule.


The Access Board's determination will apply as well to the revised ADA 
standards published by the Department. The Department's proposed 
procedural amendments will not have a significant impact on small 
entities.


The Access Board has made every effort to lessen the impact of its 
proposed guidelines on State and local governments but recognizes that 
the guidelines will have some federalism impacts. These impacts are 
discussed in the Access Board's Regulatory Assessment, which also 
applies to the Department's proposed rule.


Risks:


Without this amendment to the Department's ADA regulations, regulated 
entities will be subject to confusion and delay as they attempt to sort 
out the requirements of conflicting design standards. This amendment 
should eliminate the costs and risks associated with that process.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM (RIN 1190-A59 FR 31808                                    06/20/94
NPRM (RIN 1190-AA26) Comment Period End                        08/19/94
RIN 1190-AA26 Me65 FR 22968190-AA46                            02/15/00
Supplemental NPRM                                              12/00/00
Supplemental NPRM Comment Period End                           02/00/01
Final Action                                                   04/00/01
Regulatory Flexibility Analysis Required:


Undetermined


Small Entities Affected:


Governmental Jurisdictions


Government Levels Affected:


Local, State


Federalism:


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


Additional Information:


RIN 1190-AA46 is related to another rulemaking of the Civil Rights 
Division (RIN 1190-AA44), which will address changes to the ADA 
standards previously proposed in RINs 1190-AA26 and 1190-AA38. These 
latter two rulemakings have been withdrawn and merged into RINs 1190-
AA44 and 1190-AA46. The changes to be made in RIN 1190-AA44 will 
include technical specifications for facilities designed for use by 
children and accessibility standards for State and local government 
facilities that have been previously been published by the 
Architectural and Transportation Barriers Compliance Board.


Agency Contact:
John L. Wodatch
Chief, Disability Rights Section
Department of Justice
Civil Rights Division
P.O. Box 66738
Washington, DC 20035-6738
Phone: 800 514-0301
TDD Phone: 800 514-0383
Fax: 202 307-1198
RIN: 1190-AA46
_______________________________________________________________________



DOJ--Immigration and Naturalization Service (INS)

                              -----------

                          PROPOSED RULE STAGE

                              -----------




71. REVISED GROUNDS OF INADMISSIBILITY, WAIVERS FOR IMMIGRANTS AND 
NONIMMIGRANTS, AND EXCEPTIONS
Priority:


Other 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:


5 USC 552; 8 USC 1158; 8 USC 1159; 8 USC 1160; 8 USC 1182; 8 USC 1183; 
8 USC 1184; 5 USC 552a; 8 USC 1101; 8 USC 1102; 8 USC 1103; 8 USC 1151; 
8 USC 1153; 8 USC 1154; 8 USC 1157


CFR Citation:


8 CFR 103; 8 CFR 207; 8 CFR 208; 8 CFR 209; 8 CFR 210; 8 CFR 212; 8 CFR 
214; 8 CFR 232; 8 CFR 235; 8 CFR 240; 8 CFR 241; 8 CFR 245; 8 CFR 245a; 
8 CFR 248; 8 CFR 249; 8 CFR 274a; 8 CFR 299; ...


Legal Deadline:


None


Abstract:


This regulation covers the grounds of inadmissibility applicable to 
those

[[Page 73405]]

aliens seeking admission to the United States temporarily or 
permanently. On September 30, 1996, the President signed the Illegal 
Immigration Reform and Immigrant Responsibility Act of 1996 (IIRIRA), 
which substantially revised most grounds of inadmissibility under 
section 212 of the Act and the waivers available to both immigrants and 
nonimmigrants. The Immigration and Naturalization Service will publish 
regulations implementing these new grounds of inadmissibility and new/
revised waiver provisions. In addition, this rule will incorporate the 
changes made to the grounds of inadmissibility and waivers provided for 
in the Immigration Act of 1990 (IMMACT 90), Public Law 101-649; the 
Miscellaneous and Technical Immigration and Naturalization Amendments 
of 1991 (MTINA), Public Law 102-232; the National Institutes of Health 
Revitalization Act of 1993, Public Law 103-43; the Immigration and 
Nationality Technical Corrections Act of 1991 (INTCA), Public Law 103-
416; and the Anti-Terrorism and Effective Death Penalty Act of 1996 
(AEDPA), Public Law 104-132, among others.


Statement of Need:


This regulation is necessary to implement the IIRIRA and IMMACT 90, 
Public Law 101-649; the MTINA, Public Law 102-232; the National 
Institutes of Health Revitalization Act of 1996, Public Law 103-43; and 
the AEDPA, Public Law 104-132.


Summary of Legal Basis:


See Statement of Need.


Alternatives:


None


Anticipated Cost and Benefits:


The INS anticipates a relatively low cost for staff time and resources 
necessary to conduct training and disseminate new guidelines to the 
field on implementation of the revised grounds of inadmissibility and 
waivers available to both immigrants and nonimmigrants. With respect to 
certain waivers for the new vaccination requirements that fall under 
the health-related grounds of inadmissibility, the blanket waiver 
procedures (that entail a delegation of authority from INS to 
Department of State consular officers) minimize the administrative 
burdens not only on the agencies responsible for administering this 
requirement--Centers for Disease Control, Department of State, and 
INS--but also the administrative burden on the alien applicant for such 
waiver. This, in turn, reduces the incentive for fraud that enhances 
the public health initiative contemplated by the newly enacted 
vaccination requirements. Moreover, the new application for waiver, 
Form I-724, that will be implemented concurrently with the promulgation 
of the regulation, will consolidate numerous forms currently used to 
determine eligibility for such classes of aliens.


Risks:


This regulatory initiative is critical for complete and clear 
implementation of the new grounds of inadmissibility and their waivers, 
especially those established under IIRIRA. The regulation will clarify 
the confusion that presently exists due to the interplay between the 
new grounds of inadmissibility and existing law. It will also clarify 
changes in procedures or policies.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM-INS No. 12355 FR 438 Period End 2/5/90                    01/05/90
NPRM-INS No. 1413                                              04/00/01
Regulatory Flexibility Analysis Required:


No


Government Levels Affected:


Federal


Additional Information:


INS No. 1413-92


Consolidated INS Rules 1304, RIN 1115-AC01; 1235, RIN 1115-AB39; 1232, 
RIN 1115-AB45; and 1648, RIN 1115-AD62.


Agency Contact:
Sophia Cox
Staff Officer, Adjudications Division
Department of Justice
Immigration and Naturalization Service
Room 3214
425 I Street NW
Washington, DC 20536
Phone: 202 514-3228
RIN: 1115-AB45
_______________________________________________________________________



DOJ--INS

                              -----------

                            FINAL RULE STAGE

                              -----------




72. REDUCTION OF THE NUMBER OF ACCEPTABLE DOCUMENTS AND OTHER CHANGES 
TO EMPLOYMENT VERIFICATION REQUIREMENTS (SECTION 610 REVIEW)
Priority:


Other 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:


8 USC 1324a; PL 104-208


CFR Citation:


8 CFR 274a


Legal Deadline:


Final, Statutory, March 31, 1998, An interim rule, published September 
30, 1997, makes the minimal changes required by statute. The provisions 
will remain in effect until completion of this rulemaking.


Abstract:


On September 30, 1996, the President signed the Illegal Immigration 
Reform and Immigrant Responsibility Act of 1996 (IIRIRA). Section 
412(a) of IIRIRA requires a reduction in the number of documents that 
may be accepted in the employment verification process. Section 412(d) 
clarifies the applicability of section 274A to the Federal Government. 
Section 610 of the Regulatory Flexibility Act requires agencies to 
review rules that have a significant economic impact on a substantial 
number of small entities every 10 years. The Service is conducting this 
review in conjunction with IIRIRA implementation. The proposed 
rulemaking published 2/12/98 implements sections 212(a) and (d) of 
IIRIRA and proposes other changes to the employment verification 
process identified through that review. A revised Form I-9 was included 
with the proposed rulemaking.


The comment period closed on 4/3/98. The Service is analyzing the 
comments and taking into consideration issues raised by the Alien 
Registration (MD) (I-551) program amending 10/1/99. It should be noted 
that this action

[[Page 73406]]

supersedes the previously published regulatory plan titled ``Reduction 
in the Number of Documents Accepted for Employment Verification.'' In 
order to avoid confusion, this regulatory action is being referenced 
under the current RIN, which captures all prior actions related to 
employment verification.


INS No. 1947-98, Interim Rule published 2/9/99 (64 FR 6187). The 
``Receipt Rule'' permits employees to present their employer certain 
types of ``receipts'' in lieu of a document listed on the Form I-9. 
(Previously under RIN 1115-AE94, which was withdrawn and placed under 
AB73 due to the relationship of the regulations.)


Statement of Need:


The Immigration Reform and Control Act of 1986 amended the Immigration 
and Nationality Act (INA) to require employers to hire only persons who 
are eligible to work in the United States and to verify the work 
eligibility of all new hires. Form I-9 was designated for that purpose. 
Newly hired individuals must attest to the status that makes them 
eligible to work and present documents that establish their identity 
and eligibility to work. In its third review of employer sanctions 
regulations, the GAO reported that employer confusion over the 
``multiplicity'' of acceptable documents contributed to discrimination 
against authorized workers. See GAO/GGD Report No. 90-62, dated March 
29, 1990. Section 412(a) of IIRIRA requires a reduction in the number 
of documents that may be accepted in the employment verification 
process. Implementation of these provisions, along with other 
simplifications and clarifications, will reduce potential employment 
discrimination based upon misapplication of the verification 
requirements.


Summary of Legal Basis:


The legal basis of authority for this regulation is set forth above in 
Legal Authority. Parts of this regulatory action are required by 
IIRIRA.


Alternatives:


The lists of documents for employment verification have been 
controversial throughout the 10 years that employer sanctions have been 
in effect. When the INS first published implementing regulations in 
1987, the supplementary information noted that the list of identity 
documents had been expanded in response to public comment. When the law 
was new, a consensus emerged that an inclusive list of documents would 
ensure that all persons who are eligible to work could easily meet the 
requirements. As early as 1990, there was evidence that some employers 
found the list confusing. As noted in the ``Statement of Need,'' GAO 
linked employer confusion over the ``multiplicity'' of acceptable 
documents to discrimination against authorized workers. The INS has 
taken steps to address this criticism. In July 1988, INS committed to 
the establishment of a uniform employment authorization policy. First 
the INS limited the number and types of ``paper'' documents on which 
employment could be authorized. Second, a standardized Employment 
Authorization Document (EAD) I-688B was introduced in 1989. In February 
1997, a more secure EAD Form (I-766) was produced with state of the art 
technology.


Anticipated Cost and Benefits:


Employment is often the magnet that attracts individuals to come to or 
stay in the United States illegally. The employer sanctions provisions 
help reduce the strength of this magnet by requiring employers to hire 
only those individuals who may legally work in the United States. This 
rule, by reducing the number of documents that are acceptable for 
employment eligibility verification purposes and clarifying other 
requirements, will reduce confusion on the part of employers. This, in 
turn, will increase employer compliance, preserving jobs for persons 
who are eligible to work in the United States.


Risks:


An employment eligibility verification system that relies on a wide 
range of documents may result in employment discrimination based upon 
misapplication of the employment eligibility verification requirements. 
In addition, a complicated system may encourage fraud and result in 
individuals who are authorized to work in the United States being 
displaced by unauthorized individuals.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM-INS No. 13958 FR 61846eriod End 12/23/93                  11/23/93
NPRM-INS No. 13360 FR 32472Period End 07/24/95                 06/22/95
Notice-INS No. 160 FR 61630 1713 Applications Due 01/29/96     11/30/95
Appl. Extension Through 3/8/96 Notice Pilot Demonstration Program-INS 
        No. 171361 FR 4378                                     02/06/96
Final Rule-INS N61 FR 46534                                    09/04/96
Interim Final Ru62 FR 510011818                                09/30/97
NPRM-INS No. 18963 FR 5287nt Period End 04/03/98               02/02/98
Final Rule INS No. 1890-97                                     04/00/01
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses, Governmental Jurisdictions, Organizations


Government Levels Affected:


Federal, State, Local, Tribal


Additional Information:


The deadline for implementing section 412(a) of IIRIRA was extended to 
March 31, 1998, by Public Law 105-54. This rulemaking has been delayed 
by the need to coordinate implementation with other provisions of 
IIRIRA, by several complex policy and regulatory issues that have taken 
time to resolve, and by the review required by section 610 of the 
Regulatory Flexibility Act.


INS No. 1890-97; PL 104-208, title 4.


INS Nos. 1399 and 1399S-94, Control of Employment of Aliens, 
Supplemental Rule; Action for INS No. 1399 and 1399S is canceled as a 
result of IIRIRA requirements.


INS No. 1399E is an extracted portion of INS No. 1399, published 
separately to allow for the production of a new, more secure Employment 
Authorization Document.


INS No. 1713-95, Demonstration Project for Electronic I-9s, contact Bob 
Reed, (202) 514-2998.


Interim Rule INS No. 1818 was published on 9/30/97 at 62 FR 51001 to 
maintain the status quo as much as possible until the Service completes 
the more comprehensive document reduction initiative designated by INS 
No. 1890-97.

[[Page 73407]]

Agency Contact:
Linda Dodd-Major
Director, Business Liaison Branch, Adjudications Division
Department of Justice
Immigration and Naturalization Service
425 I Street NW
Washington, DC 20536
Phone: 202 305-2529
Fax: 202 305-2523
Email: [email protected]
RIN: 1115-AB73
BILLING CODE 4410-BP-S




[[Page 73408]]

DEPARTMENT OF LABOR (DOL)



2000 Regulatory Plan
Executive Summary
 The Secretary of Labor has set three strategic goals for the 
Department of Labor (DOL): first, to enhance opportunities for 
America's workforce; second, to promote the economic security of 
workers and their families; and third, to foster quality workplaces 
that are safe, healthy, and fair. The 180 labor laws and related 
regulations that DOL administers advance these goals.
 Regulations that implement newly enacted legislation help DOL and its 
stakeholders work together to achieve that statute's goal by providing 
clear, effective, flexible plans of action. Updating existing 
regulations promotes DOL's goals by removing ineffective standards and 
making old rules easier to understand and use. DOL has always 
recognized that changes in the workplace, such as new business 
practices, improved or safer technologies, or new hazards, can make 
existing rules ineffective or demand the creation of new ones.
 In keeping with the President's Plain Language Memorandum of June 1, 
1998, the Department remains committed to issuing regulations that are 
both easy to understand and effective and that minimize burdens on the 
regulated community. Regulations that are easy to understand promote 
voluntary compliance and improve customer satisfaction. Most employers 
comply with workplace regulations if given the information they need. 
When writing or revising rules, DOL will also explore new approaches 
that would achieve our regulatory goals at lower costs and with greater 
flexibility for the regulated community. DOL's policy is to ensure that 
those who are protected by the new rules or must abide by them are 
given the opportunity to participate in the rulemaking process and are 
provided timely, user-friendly compliance assistance materials.
 DOL's 2000 Regulatory Plan highlights the Department's 20 most 
important, significant regulations from five of our agencies: 
Employment Standards Administration (ESA), Employment and Training 
Administration (ETA), Mine Safety and Health Administration (MSHA), 
Occupational Safety and Health Administration (OSHA), and Pension and 
Welfare Benefits Administration (PWBA). The entries in the Regulatory 
Plan were carefully selected as the most important; that is, they are 
essential to the fulfillment of the Department's three strategic goals.
The Secretary of Labor's Strategic Goals
 A Prepared Workforce: This first goal is to assure that American 
workers have the opportunity to obtain the information and tools they 
will need throughout their careers to enhance their productivity and 
raise their standard of living. The new economy requires workers to 
continue their education beyond a high school diploma, or even a 
college degree -- education must mean lifelong learning and ongoing 
skill development.
 Secure Workforce: The rapidly changing global economy imposes economic 
security concerns on both employers and employees. The life cycles of 
many products are shorter and shorter, requiring quick adjustments by 
both industry and labor. Competitive forces can lead to plant closures 
and layoffs, plant and employee relocations, and in some cases, to 
attempts to avoid legal obligations. The Department will continue to do 
all it can to increase compliance with worker protection laws, protect 
worker benefits, and provide worker retraining.
 Quality Workplaces: The intensely competitive global economy offers 
unparalleled opportunities for both business and labor, but also can 
pressure some employers to ignore their responsibilities to their 
employees. Smart employers recognize that they must utilize all of the 
talent that is available to them and that a quality workplace is a 
productive workplace. The Department works with employers to prevent 
workplace discrimination and to help them recognize the benefits of 
ensuring equal opportunity and equal pay for all workers. DOL also is 
committed to doing all it can to guarantee safety and health in the 
workplace and to obtain compliance with other important labor standards 
such as the minimum wage, overtime, child labor rules, and family and 
medical leave requirements. Safe and healthful workplaces not only 
benefit employees, but also benefit employers. Fewer accidents and 
injuries result in less downtime as well as lower workers' compensation 
costs. The Department's ultimate goal is full compliance with 
employment laws which will ensure workers a safe, healthy, and fair 
workplace.
The Department's Regulatory Priorities
 Section 5001 of the Balanced Budget Act of 1997 authorized the 
Department of Labor to provide Welfare-to-Work Grants to State and 
local communities to create additional job opportunities for the 
hardest-to-employ recipients of the Temporary Assistance for Needy 
Families (TANF) -- the new system of block grants created by the 
welfare reform legislation. The Employment and Training Administration 
(ETA) has issued interim final regulations and other guidance under 
this legislation. Moving people from welfare to work is not only a 
primary goal of Federal welfare to work opportunities, but also 
responds to the Secretary's goal of a Prepared Workforce. Guidance and 
regulations reflect minimal amplification of the law, and were written 
only when further information or clarification was needed to make the 
program operational. Reporting requirements assure program integrity 
and provide timely information for tracking performance against 
established measures. Performance measures will be consistent with 
long-term goals. Wherever possible, existing regulations and systems 
will be used. ETA will issue a final rule based on the comments 
received on the November 18, 1997 Interim Final Rule. A new Interim 
Final Rule will be issued for comment at the same time based on the 
Welfare-to-Work and Child Support Amendments that were enacted in 
November 1999.
 The Pension and Welfare Benefits Administration (PWBA) administers and 
enforces the provisions of the Employee Retirement Income Security Act, 
as amended (ERISA). ERISA establishes reporting, disclosure and other 
standards applicable to an estimated 700,000 private-sector employee 
pension benefit plans, covering approximately 92 million participants 
and an estimated 2.5 million group health benefit plans covering 131 
million participants and dependents, and 3.4 million other welfare 
benefit plans covering approximately 190 million participants.
 PWBA's regulatory priorities continue to focus on efforts to simplify 
and otherwise facilitate compliance with benefit laws, to improve 
pension and welfare plan coverage, and to protect the benefits of 
American workers. PWBA's top regulatory priorities involve 
implementation of enhanced standards for group health plans, including 
strengthening the claims review processes and improving the disclosure 
of health care benefit information. PWBA also will continue to work 
with the Department of Health and Human Services, the Department of 
Treasury,

[[Page 73409]]

and the Internal Revenue Service to issue final regulatory guidance 
under the Health Insurance Portability and Accountability Act.
 The Employment Standards Administration's (ESA's) Wage and Hour 
Division enforces several statutes establishing minimum labor standards 
that protect the Nation's work force, including the Fair Labor 
Standards Act (FLSA), the Migrant and Seasonal Agricultural Worker 
Protection Act, the Family and Medical Leave Act, the Service Contract 
Act, the Davis-Bacon Act, the Employee Polygraph Protection Act, and 
certain provisions of the Immigration and Nationality Act. These labor 
standards include requirements for payment of minimum wages and 
overtime pay, protections for working youth under child labor 
standards, job protection for employees who take leave for certain 
family or medical reasons, and minimum working conditions for 
agricultural workers. The regulatory activities required to implement 
these statutory responsibilities represent an important aspect of the 
Division's work -- affecting over 100 million employees in the work 
force. When developing regulatory proposals, the Division's focus is to 
assure fair, safe and healthful workplaces for the Nation's workers, 
while at the same time providing clear compliance guidance and 
minimizing burdens on the regulated community.
 Updating the child labor regulations issued under the FLSA will help 
guarantee a safe, healthy, and fair workplace for the Nation's working 
youth and help them balance their education with job-related 
experiences. Many workers first gain job-related skills through their 
exposure to work as teenagers. Updated child labor regulations that 
better reflect today's workplace will assist young workers in having 
safe jobs and enhance their opportunity to gain the skills to find and 
hold good jobs. Ensuring safe and reasonable work hours for working 
youth will also ensure that top priority is given to education.
 Updating and clarifying the criteria that define the minimum wage and 
overtime exemptions for executive, administrative, professional, and 
outside sales employees under the FLSA, and clarifying when helpers may 
be used on federally funded and assisted construction contracts covered 
by the prevailing wage requirements of the Davis-Bacon and related 
acts, will help guarantee workers a secure and quality workplace. 
Revising and updating these regulations will help employers meet their 
obligations voluntarily and enhance employees' understanding of their 
rights and benefits.
 ESA's Office of Federal Contract Compliance Programs (OFCCP) is 
charged with enforcing the requirements of Executive Order 11246, 
selected provisions of the Vietnam Era Veterans' Readjustment 
Assistance Act of 1974 (VEVRAA), and Section 503 of the Rehabilitation 
Act of 1973. Regulations issued under the Executive Order and the two 
acts cover nondiscrimination and affirmative action obligations for 
federal contractors and subcontractors. They help to ensure that 
workplace policies and practices are fair and provide equal opportunity 
to all workers. OFCCP's regulatory plan entry, the proposed amendments 
to regulations implementing Executive Order 11246, some of which became 
effective in 1997, will streamline and clarify the existing regulatory 
language and reduce paperwork requirements of covered Federal 
contractors while ensuring that their obligations under the Executive 
Order and the two acts are met. This final rule encourages contractors 
to analyze their own compensation and other employment practices to 
ensure that all employees are fairly treated. In addition, this plan 
entry will help fulfill the Administration's Equal Pay and Civil Rights 
initiative to eliminate wage discrimination by identifying and 
remedying compensation discrimination by Federal contractors.
 The mission of the Mine Safety and Health Administration (MSHA) is to 
protect the safety and health of the nation's miners. The Federal Mine 
Safety and Health Act of 1977 (Mine Act) places primary responsibility 
for preventing unsafe and unhealthy working conditions in mines on the 
operators, with the assistance of miners. The Mine Act requires MSHA to 
determine compliance with Federal safety and health standards through 
inspections and investigations, and to work cooperatively with States 
and the mining industry to improve training programs aimed at 
preventing accidents and occupationally caused diseases.
 MSHA is committed to providing the nation's miners a safer and 
healthier workplace. Despite MSHA past efforts, miners face safety and 
health hazards daily at levels unknown in most other occupations. 
Government intervention alone cannot eliminate occupational deaths, 
injuries, and illnesses in mining. The commitment of miners, mine 
operators and government is needed. MSHA's Regulatory Plan reflects 
this commitment. It will continue to concentrate on improving existing 
health standards and addressing emerging health hazards in mining.
 Several significant regulatory actions exemplify MSHA's commitment to 
improving workplace health for miners. MSHA intends to issue final 
rules for diesel particulate matter in underground coal and metal and 
nonmetal mines to reduce the potential health hazards associated with 
the exhaust emitted by diesel-powered equipment. Those hazards range 
from headaches and nausea to respiratory disease and cancer.
 While there have been significant reductions in levels of respirable 
coal mine dust over the years, some miners exposed to respirable coal 
mine dust at certain mine operations continue to develop coal workers' 
pneumoconiosis. MSHA intends to issue final rules to provide a means to 
verify operators' coal dust control plans and to prevent overexposure 
to respirable coal mine dust on each and every working shift. MSHA has 
also proposed that the Agency take over the operator coal mine dust 
sampling program.
 MSHA has identified the above actions for the October 2000 Regulatory 
Plan because occupational lung disease is the most serious and 
pervasive occupational illness in mining. MSHA believes these combined 
initiatives will greatly improve health protection for miners and, 
therefore, they are tied directly and significantly to the Agency's 
mission and strategic plan.
 Several years ago, the Occupational Safety and Health Administration 
(OSHA) recognized the need to find a better way to carry out its 
mission -- to save the lives and improve the safety and health of 
America's working men and women. In the regulatory arena, this meant 
that OSHA had to change its regulatory approach to establish clear and 
sensible priorities, emphasize consensus-based approaches to 
rulemaking, and focus on developing an ergonomics rule.
 The seven rules in OSHA's Regulatory Plan directly support OSHA's 
mission as well as the Secretary's goal for assuring America's workers 
a quality workplace. Each rule is designed to reduce occupational 
deaths, injuries, and illnesses among America's workers or to simplify 
OSHA recordkeeping requirements for employers. OSHA's Plan entries 
address the causes of the most dangerous occupational injuries, i.e., 
those with fatal or disabling consequences, those affecting a large

[[Page 73410]]

number of workers, those for which recognized solutions are available, 
or those identified as the top priorities by the Agency's Strategic 
Planning process.
 Some of OSHA's standards, particularly those adopted wholesale from 
national consensus standards in 1971, are written in highly detailed, 
specification-driven language that limits compliance flexibility. To 
address this problem, OSHA has launched a series of initiatives aimed 
at streamlining and rationalizing the Agency's regulations and ensuring 
that all future OSHA rules will pass plain language and common sense 
tests. In addition, the Agency is actively soliciting input from 
stakeholders -- business, labor, small employers, professional 
associations, and affected government entities -- as it moves forward 
on these rule initiatives. The OSHA rules in the Regulatory Plan 
reflect the rulemaking approach that is being followed by the New OSHA. 
For example, the Agency is involving stakeholders throughout the 
development of its rules. In 1999 and 2000, OSHA held several meetings 
with stakeholders interested in the forthcoming silica standard and the 
electric power transmission and distribution standard for the 
construction industry.
 One of the most important regulatory initiatives ever undertaken by 
OSHA -- development of an ergonomics program rule -- is the centerpiece 
of the Agency's current Regulatory Plan. This rule will ensure that 
employers in general industry whose employees experience a work-related 
musculoskeletal disorder (MSD) implement ergonomics programs. Evidence 
of the effectiveness of ergonomics programs in achieving OSHA's 
ultimate goal -- the prevention of musculoskeletal disorders on the job 
-- is widespread and growing daily, as more and more companies report 
that their accident rates and their workers' compensation costs have 
fallen after the implementation of such programs. OSHA proposed an 
ergonomics program standard in November 1999. The Agency then held nine 
weeks of public hearings, at which more than 500 witnesses testified. 
The Agency is reviewing the extensive record for this rulemaking at the 
present time. If the evidence in the record supports a final rule, OSHA 
plans to issue one late in 2000.
 The Department believes that, by actively involving both employers and 
employees in the implementation of ergonomics programs, this standard 
will help to produce the high-performance workplace of tomorrow. In 
sum, OSHA's regulatory strategy is designed to achieve a body of 
standards that will make sense to ordinary people, protect the safety 
and health of the U.S. workforce, and enhance the productivity of 
American businesses.
_______________________________________________________________________



DOL--Employment Standards Administration (ESA)

                              -----------

                          PROPOSED RULE STAGE

                              -----------




73. DEFINING AND DELIMITING THE TERM ``ANY EMPLOYEE EMPLOYED IN A BONA 
FIDE EXECUTIVE, ADMINISTRATIVE, OR PROFESSIONAL CAPACITY'' (ESA/W-H)
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:


29 USC 213(a)(1)


CFR Citation:


29 CFR 541


Legal Deadline:


None


Abstract:


These regulations set forth the criteria for exemption from the Fair 
Labor Standards Act's minimum wage and overtime requirements for 
``executive,'' ``administrative,'' ``professional'' and ``outside sales 
employees.'' To be exempt, employees must meet certain tests relating 
to duties and responsibilities and be paid on a salary basis at 
specified levels. A final rule increasing the salary test levels was 
published on January 13, 1981 (46 FR 3010), to become effective on 
February 13, 1981, but was indefinitely stayed on February 12, 1981 (46 
FR 11972). On March 27, 1981, a proposal to suspend the final rule 
indefinitely was published (46 FR 18998), with comments due by April 
28, 1981. As a result of numerous comments and petitions from industry 
groups on the duties and responsibilities tests, and as a result of 
case law developments, the Department concluded that a more 
comprehensive review of these regulations was needed. An ANPRM 
reopening the comment period and broadening the scope of review to 
include all aspects of the regulations was published on November 19, 
1985, with the comment period subsequently extended to March 22, 1986.


The Department has revised these regulations since the ANPRM to address 
specific issues. In 1991, as the result of an amendment to the Fair 
Labor Standards Act (FLSA), the regulations were revised to permit 
certain computer systems analysts, computer programmers, software 
engineers, and other similarly skilled professional employees to 
qualify for the exemption, including those paid on an hourly basis if 
their rates of pay exceed 6 1/2 times the applicable minimum wage. 
Also, in 1992 the Department issued a final rule which modified the 
exemption's requirement for payment on a ``salary basis'' for otherwise 
exempt public sector employees.


Statement of Need:


These regulations contain the criteria used to determine if an employee 
is exempt from the FLSA as an ``executive,'' ``administrative,'' 
``professional,'' or ``outside sales'' employee. The existing salary 
test levels used in determining which employees qualify as exempt were 
adopted in 1975 on an interim basis. These salary level tests are 
outdated and offer little practical guidance in applying the exemption. 
In addition, numerous comments and petitions have been received from 
industry groups regarding the duties and responsibilities tests in the 
regulations, requesting a review of these regulations.


These regulations have been revised to deal with specific issues. In 
1991, as the result of an amendment to the FLSA, the regulations were 
revised to permit certain computer systems analysts, computer 
programmers, software engineers, and other similarly skilled 
professional employees to qualify for the exemption, including those 
paid on an hourly basis if their rates of pay exceed 6 1/2 times the 
applicable minimum wage. Also in 1991, the Department undertook 
separate rulemaking on another aspect of the regulations, the 
definition of ``salary basis'' for public-sector employees. Because of 
the limited nature of these revisions, the regulations are still in 
need of updating and clarification.

[[Page 73411]]

Summary of Legal Basis:


These regulations are issued under the statutory exemption from minimum 
wage and overtime pay provided by section 13(a)(1) of the Fair Labor 
Standards Act, 29 USC 213(a)(1), which requires the Secretary of Labor 
to issue regulations that define and delimit the terms ``any employee 
employed in a bona fide, executive, administrative, or professional 
capacity ..., or in the capacity of outside salesman...,'' for purposes 
of applying the exemption to employees who meet the specified criteria.


Alternatives:


The Department will involve affected interest groups in developing 
regulatory alternatives. Following completion of these outreach and 
consultation activities, full regulatory alternatives will be 
developed.


Although legislative proposals have been introduced in Congress to 
address certain aspects of these regulations, the Department continues 
to believe revisions to the regulations are the appropriate response to 
the concerns raised. Alternatives likely to be considered range from 
particular changes to address ``salary basis'' and salary level issues 
to a comprehensive overhaul of the regulations that also addresses the 
duties and responsibilities tests.


Anticipated Cost and Benefits:


Some 32 million employees are estimated to be within the scope of these 
regulations. Legal developments in court cases are changing the guiding 
interpretations under this exemption and creating law without 
considering a comprehensive analytical approach to current compensation 
concepts and workplace practices. Clear, comprehensive, and up-to-date 
regulations would provide for central, uniform control over the 
application of these regulations and ameliorate many concerns. In the 
public sector, State and local government employers contend that the 
rules are based on production workplace environments from the 1940s and 
1950s that do not readily adapt to contemporary government functions. 
The Federal Government also has concerns regarding the manner in which 
the courts and arbitration decisions are applying the exemption to the 
Federal workforce. Resolution of confusion over how the regulations are 
to be applied in the public sector will ensure that employees are 
protected, that employers are able to comply with their 
responsibilities under the law, and that the regulations are 
enforceable. Preliminary estimates of the specific costs and benefits 
of this regulatory action will be developed once the various regulatory 
alternatives are identified.


Risks:


This action does not affect public health, safety, or the environment.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
Indefinite Stay 46 FR 11972le                                  02/12/81
Proposal To Susp46 FR 18998definitely                          03/27/81
ANPRM           50 FR 47696                                    11/19/85
Extension of ANP51 FR 2525 Period From 01/21/86 to 03/22/86    01/17/86
ANPRM Comment Pe51 FR 2525                                     03/22/86
NPRM                                                           09/00/01
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses, Governmental Jurisdictions, Organizations


Government Levels Affected:


Local, State, Federal


Federalism:


 Undetermined


Agency Contact:
John R. Fraser
Deputy Administrator (WHD)
Department of Labor
Employment Standards Administration
Room S3502
200 Constitution Avenue NW
FP Building
Washington, DC 20210
Phone: 202 693-0051
Fax: 202 693-1432
RIN: 1215-AA14
_______________________________________________________________________



DOL--ESA

                              -----------

                            FINAL RULE STAGE

                              -----------




74. GOVERNMENT CONTRACTORS: NONDISCRIMINATION AND AFFIRMATIVE ACTION 
OBLIGATIONS, EXECUTIVE ORDER 11246 (ESA/OFCCP)
Priority:


Economically 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:


EO 11246, as amended


CFR Citation:


41 CFR 60-1; 41 CFR 60-2


Legal Deadline:


None


Abstract:


These regulations cover nondiscrimination and affirmative action 
obligations of Federal contractors under Executive Order (E.O.) 11246 
as amended. The part 60-1 final rule, published 8/19/97, revised 
portions of the regulations implementing E.O. 11246. OFCCP's review of 
regulatory options continues with emphasis on streamlining and 
clarifying the regulatory language and reducing paperwork requirements 
associated with compliance. OFCCP plans to issue revisions to written 
affirmative action program (AAP) requirements to reduce burdens on the 
regulated community and to improve the enforcement of the Executive 
order.


Statement of Need:


Portions of the regulations implementing E.O. 11246 need to be revised 
to reflect changes in the law that have occurred over time, and other 
portions need to be streamlined and clarified. E.O. 11246 requires all 
Federal contractors and subcontractors and federally assisted 
construction contractors and subcontractors to apply a policy of 
nondiscrimination and affirmative action in employment with respect to 
race, color, religion, sex, and national origin. The regulatory 
revisions are necessary in order to allow the DOL to effectively and 
efficiently enforce the provisions of the Executive order. As a first 
step in updating its Executive order regulations, the Department 
published changes to the provisions that govern preaward review 
requirements; recordkeeping and record retention requirements; 
certification requirements; and related provisions. In addition, other 
revisions have been made that conform E.O. 11246 regulations to the 
recent changes made in the Department's regulations implementing 
section 503 of the Rehabilitation Act.

[[Page 73412]]

A second phase of revision will change provisions that govern 
requirements for written affirmative action plans and the provisions 
concerning evaluation of contractor procedures.


Summary of Legal Basis:


No aspect of this action is required by statute or court order.


Alternatives:


After careful review, it was decided that the most effective way to 
improve compliance with the E.O. 11246 provisions and reduce burdens on 
contractors was to revise these regulations. Administrative actions 
alone could not produce the desired results.


Anticipated Cost and Benefits:


It is anticipated that the net effect of the changes will increase 
compliance with the nondiscrimination and affirmative action 
requirements of the Executive Order and reduce compliance costs to 
Federal contractors. The Department will also be able to utilize its 
resources more efficiently and more effectively.


Risks:


Failure to move forward with OFCCP's regulatory agenda could cause the 
continuation of outdated methods of evaluating contractor compliance 
and impede effective enforcement of E.O. 11246.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM Affirmative65 FR 26088ns (60-2)                           05/04/00
NPRM Comment Period End                                        07/03/00
Final Rule                                                     12/00/00
Regulatory Flexibility Analysis Required:


No


Government Levels Affected:


Undetermined


Additional Information:


Under the Reinventing Government initiative, OFCCP's emphasis is on 
regulatory reform, e.g., to revise the E.O. 11246 regulations to reduce 
paperwork burdens, eliminate unnecessary regulations, and simplify and 
clarify the regulations while improving the efficiency and 
effectiveness of the contract compliance program.


Agency Contact:
James I. Melvin
Director, Division of Policy, Planning, and Program Development, OFCCP
Department of Labor
Employment Standards Administration
Room N3424
200 Constitution Avenue NW
FP Building
Washington, DC 20210
Phone: 202 693-0102
TDD Phone: 202 693-1308
Fax: 202 693-1304
Email: [email protected]
RIN: 1215-AA01
_______________________________________________________________________



DOL--ESA



75. CHILD LABOR REGULATIONS, ORDERS, AND STATEMENTS OF INTERPRETATION 
(ESA/W-H)
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:


29 USC 203(e)


CFR Citation:


29 CFR 570


Legal Deadline:


None


Abstract:


Section 3(l) of the Fair Labor Standards Act requires the Secretary of 
Labor to issue regulations with respect to minors between 14 and 16 
years of age ensuring that the periods and conditions of their 
employment do not interfere with their schooling, health, or well-
being. The Secretary is also directed to designate occupations that may 
be particularly hazardous for minors 16 and 17 years of age. Child 
Labor Regulation No. 3 sets forth the permissible industries and 
occupations in which 14- and 15-year-olds may be employed, and 
specifies the number of hours in a day and in a week, and time periods 
within a day, that such minors may be employed. The Department has 
invited public comment in considering whether changes in technology in 
the workplace and job content over the years require new hazardous 
occupation orders, and whether changes are needed in some of the 
applicable hazardous occupation orders. Comment has also been solicited 
on whether revisions should be considered in the permissible hours and 
time-of-day standards for 14- and 15-year-olds. Comment has been sought 
on appropriate changes required to implement school-to-work transition 
programs. Additionally, Congress enacted Public Law 104-174 (August 6, 
1996), which amended FLSA section 13(c) and requires changes in the 
regulations under Hazardous Occupation Order No. 12 regarding power-
driven paper balers and compactors, to allow 16- and 17-year-olds to 
load, but not operate or unload, machines meeting applicable American 
National Standards Institute (ANSI) safety standards and certain other 
conditions. Congress also passed the Drive for Teen Employment Act, 
Public Law 105-334 (October 31, 1998), which prohibits minors under age 
17 from driving automobiles and trucks on public roads on the job and 
sets criteria for 17-year- olds to drive such vehicles on public roads 
on the job.


Statement of Need:


Because of changes in the workplace and the introduction of new 
processes and technologies, the Department is undertaking a 
comprehensive review of the regulatory criteria applicable to child 
labor. Other factors necessitating a review of the child labor 
regulations are changes in places where young workers find employment 
opportunities, the existence of differing Federal and State standards, 
and the divergent views on how best to correlate school and work 
experiences.


Under the Fair Labor Standards Act, the Secretary of Labor is directed 
to provide by regulation or by order for the employment of youth 
between 14 and 16 years of age under periods and conditions which will 
not interfere with their schooling, health and well-being. The 
Secretary is also directed to designate occupations that may be 
particularly hazardous for youth between the ages of 16 and 18 years or 
detrimental to their health or well-being. The Secretary has done so by 
specifying, in regulations, the permissible industries and occupations 
in which 14- and 15-year-olds may be employed, and the number of hours 
per day and week and the time periods within a day in which they may be 
employed. In addition, these regulations designate the occupations 
declared particularly hazardous for minors between 16 and 18 years of 
age or detrimental to their health or well-being.

[[Page 73413]]

Public comment has been invited in considering whether changes in 
technology in the workplace and job content over the years require new 
hazardous occupation orders or necessitate revision to some of the 
existing hazardous orders. Comment has also been invited on whether 
revisions should be considered in the permissible hours and time-of-day 
standards for the employment of 14- and 15-year-olds, and whether 
revisions should be considered to facilitate school-to-work transition 
programs. When issuing the regulatory proposals (after review of public 
comments on the advance notice of proposed rulemaking), the 
Department's focus will be on assuring healthy, safe and fair 
workplaces for young workers, and at the same time promoting job 
opportunities for young people and making regulatory standards less 
burdensome to the regulated community.


Summary of Legal Basis:


These regulations are issued under sections 3(1), 11, 12, and 13 of the 
Fair Labor Standards Act, 29 USC sections 203(1), 211, 212, and 213 
which require the Secretary of Labor to issue regulations prescribing 
permissible time periods and conditions of employment for minors 
between 14 and 16 years old so as not to interfere with their 
schooling, health, or well-being, and to designate occupations that may 
be particularly hazardous or detrimental to the health or well-being of 
minors under 18 years old.


Alternatives:


Regulatory alternatives developed based on recent legislation and the 
public comments responding to the advance notice of proposed rulemaking 
included specific proposed additions or modifications to the paper 
baler, teen driving, explosive materials, and roofing hazardous 
occupation orders, and proposed changes to the permissible cooking 
activities that 14- and 15-year-olds may perform in retail 
establishments.


Anticipated Cost and Benefits:


Preliminary estimates of the anticipated costs and benefits of this 
regulatory action indicated that the rule was not economically 
significant. Benefits will include safer working environments and the 
avoidance of injuries with respect to young workers.


Risks:


The child labor regulations, by ensuring that permissible job 
opportunities for working youth are safe and healthy and not 
detrimental to their education as required by the statute, produce 
positive benefits by reducing health and productivity costs employers 
may otherwise incur from higher accident and injury rates to young and 
inexperienced workers. Given the limited nature of the changes in the 
proposed rule, a detailed assessment of the magnitude of risk was not 
prepared.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
Final Action HOS56 FR 5862612                                  11/20/91
Final Rule Effec56 FR 58626                                    12/20/91
ANPRM           59 FR 25167                                    05/13/94
ANPRM Comment Period End                                       08/11/94
NPRM            64 FR 67130                                    11/30/99
NPRM Comment Period End                                        01/31/00
Final Action                                                   11/00/00
Regulatory Flexibility Analysis Required:


No


Government Levels Affected:


None


Agency Contact:
John R. Fraser
Deputy Administrator (WHD)
Department of Labor
Employment Standards Administration
Room S3502
200 Constitution Avenue NW
FP Building
Washington, DC 20210
Phone: 202 693-0051
Fax: 202 693-1432
RIN: 1215-AA09
_______________________________________________________________________



DOL--ESA



76. PROCEDURES FOR PREDETERMINATION OF WAGE RATES (29 CFR PART 1) AND 
LABOR STANDARDS PROVISIONS APPLICABLE TO CONTRACTS COVERING FEDERALLY 
FINANCED AND ASSISTED CONSTRUCTION (29 CFR PART 5)
Priority:


Economically Significant


Legal Authority:


40 USC 276a to 276a(7)


CFR Citation:


29 CFR 1; 29 CFR 5


Legal Deadline:


None


Abstract:


The Department attempted to implement revised rules governing the 
circumstances in which ``helpers'' may be used on federally funded and 
assisted construction contracts subject to the Davis-Bacon Act in May 
1982 (see 47 FR 23644, 23658 (May 28, 1982); 47 FR 32090 (July 20, 
1982)). After protracted litigation, a final rule was published in 
January 1989 (see 54 FR 4234) which became effective on February 4, 
1991. Thereafter, on two occasions Congress acted to prevent the 
Department from expending any funds to implement these revised helper 
regulations--through the Dire Emergency Supplemental Appropriations Act 
of 1991, PL 102-27, 105 Stat. 130,151 (1991), and then through section 
104 of the DOL Appropriations Act of 1994, PL 103-112. Given the 
uncertainty of continuation of such moratoriums, the Department 
determined that the helper issue needs to be addressed through further 
rulemaking. A notice inviting public comment on a proposal to continue 
the suspension of the former helper regulations while the Department 
conducts additional rulemaking proceedings was published August 2, 1996 
(61 FR 40366). A final rule continuing the suspension while further 
rulemaking is considered was published December 30, 1996 (61 FR 68641). 
A notice of proposed rulemaking was published April 9, 1999 (64 FR 
17442).


Statement of Need:


The current helper rules are difficult to administer and enforce and--
as evidenced by the prolonged litigation history and subsequent 
congressional actions--are highly controversial. In May 1982, the 
Department attempted to implement revised rules governing the 
circumstances in which ``helpers'' may be used on federally funded and 
assisted construction contracts subject to the Davis-Bacon Act. After 
protracted litigation, a final rule was published in January 1989 and 
became effective on February 4, 1991. Thereafter, on two occasions, 
Congress acted to prevent the Department from expending any funds to 
implement these revised helper regulations through appropriations 
riders. Given the uncertainty of continuation of such moratoriums, the 
Department determined that the helper issue needs to be addressed 
through further rulemaking.

[[Page 73414]]

Summary of Legal Basis:


These regulations are issued under the authority conferred upon the 
Secretary of Labor by Reorganization Plan No. 14 of 1950 (64 Stat. 
1267, 5 USC Appendix) and the Copeland Act (40 USC 276c) in order to 
provide coordinated enforcement of the prevailing wage provisions of 
the Davis-Bacon Act (40 USC 276a-276a-7) and several additional Federal 
statutes that require payment of prevailing wages as determined by the 
Secretary of Labor according to the Davis-Bacon Act to laborers and 
mechanics working on federally funded or assisted construction 
contracts (see list of statutes in 29 CFR sec. 5.1).


Alternatives:


The Administration has determined that there are only limited 
alternatives to addressing this issue through rulemaking, in addition 
to possible legislative changes.


Anticipated Cost and Benefits:


A new final rule regarding the helper criteria will seek to make 
administration of the Davis-Bacon Act more efficient by establishing 
reasonable ``helper'' criteria and methodology--thus resolving the 
controversy and uncertainty currently experienced by interested 
parties. Changes in the helper regulations may affect prior estimates 
of potential construction procurement cost savings anticipated from the 
earlier rulemaking. Estimates of the financial impacts of revised 
``helper'' regulations included in the NPRM range from $72.8 million to 
$296 million, depending upon the alternative considered and the data 
sources used.


Risks:


This action does not affect public health, safety, or the environment.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM Continue Su61 FR 40367                                    08/02/96
Final Continue S61 FR 68641                                    12/30/96
NPRM            64 FR 17442                                    04/09/99
NPRM Comment Per64 FR 17442                                    06/08/99
Final Action                                                   11/00/00
Regulatory Flexibility Analysis Required:


No


Government Levels Affected:


Federal, State, Local, Tribal


Agency Contact:
John R. Fraser
Deputy Administrator (WHD)
Department of Labor
Employment Standards Administration
Room S3502
200 Constitution Avenue NW
FP Building
Washington, DC 20210
Phone: 202 693-0051
Fax: 202 693-1432
RIN: 1215-AA94
_______________________________________________________________________



DOL--Employment and Training Administration (ETA)

                              -----------

                            FINAL RULE STAGE

                              -----------




77. WELFARE-TO-WORK (WTW) GRANTS
Priority:


Other Significant


Legal Authority:


42 USC 603(a)(5)(c)(ix); PL 106-113, Division B, sec 1000(a)(4)


CFR Citation:


20 CFR 645


Legal Deadline:


Final, Statutory, November 3, 1997, 90 days from enactment.


Other, Statutory, January 1, 2000, for 1999 amendments.


Abstract:


The Employment and Training Administration published interim final 
regulations on November 18, 1997, implementing the Welfare-to-Work 
Grants Program. The Personal Responsibility and Work Opportunity 
Reconciliation Act reformed the Nation's welfare laws, when enacted in 
August 1996, by creating a new system of block grants to the States for 
Temporary Assistance for Needy Families (TANF). Moving people from 
welfare to work is one of the primary goals of Federal welfare policy 
as well as one of five goals the Secretary of Labor has identified for 
the Department of Labor. Section 5001 of the Balanced Budget Act of 
1997 authorized the Department of Labor to provide Welfare-to-Work 
Grants to States and local communities to create additional job 
opportunities for the hardest-to-employ recipients of TANF and certain 
noncustodial parents. The Welfare-to-Work Grants will be provided to 
the States through the use of a formula, and in a competitive process 
to local communities. A small amount of total grant funds will be set 
aside for special purposes: one percent for Indian tribes; 0.8 percent 
for evaluation; and $50 million for performance bonuses to successful 
States.


The interim final regulations and other guidance focus on providing 
maximum local flexibility. Guidance and regulations reflect minimal 
amplification of the law and provide further information or 
clarification as needed to make the program operational. Existing 
regulations and systems are used wherever possible. Reporting 
requirements will assure program integrity and provide timely 
information for tracking performance. Products provided link welfare 
agencies and workforce development system agencies at the operational 
level in order to maximize resources available and avoid duplication 
and overlap. Leveraging of non-Federal resources at the State and local 
level is encouraged.


These funds will allow States and local communities to help move 
eligible individuals into jobs by: job creation through public or 
private sector wage subsidies; on-the-job training; contracts with 
public or private providers of job readiness, job placement, and post-
employment services; job vouchers for similar services; community 
service or work experience; or job retention and supportive services 
(if such services are not otherwise available).


Statement of Need:


Since the passage of the Personal Responsibility and Work Opportunity 
Reconciliation Act, the President and the Congress recognized the need 
for a measure to complement the Temporary Assistance for Needy Families 
(TANF) block grant created as a result of the Act. On August 5, 1997, 
President Clinton signed into law the Balanced Budget Act of 1997, 
which authorized the Department of Labor to provide Welfare-to-Work 
Grants to States and local communities to create additional job 
opportunities for the hardest-to-employ recipients of TANF. The basic 
goal of the program is to move welfare recipients into unsubsidized 
jobs with good career potential for economic self-sufficiency. Welfare-
to-Work formula and competitive grants provide States and local 
communities with an array of tools to help them accomplish this goal in 
ways that make sense and are most effective for their particular 
population needs. The Employment and Training Administration will issue 
final

[[Page 73415]]

regulations and other guidance, provide technical assistance, and 
establish performance standards which will drive State and local 
efforts towards the program's goal while still allowing maximum local 
flexibility. The passage of the Welfare-to-Work and Child Support 
Amendments of 1999 will necessitate the publication of a new interim 
final rule to reflect the changes in eligibility and certain other 
areas.


Summary of Legal Basis:


Promulgation of these regulations is authorized by SSA section 403 
(a)(1)(5)(C)(ix). Section 801(f) of HR 3424, the Welfare-to-Work and 
Child Support Amendments of 1999, enacted by section 1000(a)(4) of 
Division B of the Consolidated Appropriations Act for August 2000 (PL 
106-113) authorizes interim final regulations to implement the changes 
made by those amendments.


Anticipated Cost and Benefits:


Preliminary estimates of the anticipated costs of this regulatory 
action have not been determined at this time and will be determined at 
a later date. Welfare recipients will receive job placement and 
temporary, transitional employment opportunities leading to lasting 
employment and self-sufficiency. Employers will have ready access to a 
large pool of motivated hard-working entry-level workers who will be 
eligible for job retention and support services to maintain employment. 
Businesses will be eligible to receive wage and on-the-job training 
subsidies when they hire the hard-to-employ welfare recipients.


Risks:


This action does not affect public health, safety, or the environment.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
Interim Final Ru62 FR 61587                                    11/18/97
Interim Final Rule                                             10/00/00
Final Rule                                                     10/00/00
Regulatory Flexibility Analysis Required:


No


Government Levels Affected:


State, Local, Tribal


Agency Contact:
Dennis Lieberman
Director, Division of Welfare to Work
Department of Labor
Employment and Training Administration
200 Constitution Avenue NW
N4671, FP Building
Washington, DC 20210
Phone: 202 219-7694
RIN: 1205-AB15
_______________________________________________________________________



DOL--Pension and Welfare Benefits Administration (PWBA)

                              -----------

                            FINAL RULE STAGE

                              -----------




78. REGULATIONS IMPLEMENTING THE HEALTH CARE ACCESS, PORTABILITY AND 
RENEWABILITY PROVISIONS OF THE HEALTH INSURANCE PORTABILITY AND 
ACCOUNTABILITY ACT OF 1996
Priority:


Other Significant. Major status under 5 USC 801 is undetermined.


Unfunded Mandates:


Undetermined


Legal Authority:


PL 104-91 section 101; 29 USC 1027; 29 USC 1059; 29 USC 1135; 29 USC 
1171; 29 USC 1172; 29 USC 1177


CFR Citation:


29 CFR 2590


Legal Deadline:


Other, Statutory, April 1, 1997, Interim Final Rule.


Per section 734 of ERISA as added by section 101 of HIPAA.


Abstract:


The Health Insurance Portability and Accountability Act of 1996 (HIPAA) 
amended title I of ERISA by adding a new part 7, designed to improve 
health care access, portability and renewability. This rulemaking will 
provide regulatory guidance to implement these provisions.


Statement of Need:


HIPAA added a new part 7 to title I of ERISA, containing provisions 
designed to improve the availability and portability of health 
insurance coverage. Part 7 includes provisions limiting exclusions for 
preexisting conditions and providing credit for prior coverage, 
guaranteeing availability of health coverage for small employers, 
prohibiting discrimination against employees and dependents based on 
health status, and guaranteeing renewability of health coverage to 
employers and individuals.


Summary of Legal Basis:


Promulgation of these regulations is authorized by sections 505 and 734 
of ERISA.


Alternatives:


Regulatory alternatives will be developed once determinations have been 
made, in conjunction with other concerned agencies with regard to the 
scope and nature of the final regulatory guidance which will be 
necessary to carry out the new provisions.


Anticipated Cost and Benefits:


Preliminary estimates of the anticipated costs and benefits of the 
regulatory actions found to be necessary to implement the new provision 
will be developed once decisions are reached on which specific actions 
are necessary.


Risks:


Failure to provide regulatory guidance necessary to carry out these 
important health care reforms would adversely impact the availability 
and portability of health insurance coverage for American families.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
Interim Final Ru62 FR 16894                                    04/08/97
Interim Final Rule Effective                                   06/07/97
Interim Final Rule Comment Period End                          07/07/97
Request for Info64 FR 57520                                    10/25/99
Comment Period End                                             01/25/00
Final Rule                                                     07/00/01
Regulatory Flexibility Analysis Required:


No


Government Levels Affected:


None


Agency Contact:
Daniel J. Maguire
Director, Office of Health Plan Standards
Department of Labor
Pension and Welfare Benefits Administration
Room N5677
200 Constitution Avenue NW
FP Building
Washington, DC 20210
Phone: 202 219-4592
RIN: 1210-AA54


_______________________________________________________________________


[[Page 73416]]

DOL--PWBA



79. AMENDMENT OF SUMMARY PLAN DESCRIPTION AND RELATED ERISA REGULATIONS 
TO IMPLEMENT STATUTORY CHANGES IN THE HEALTH INSURANCE PORTABILITY AND 
ACCOUNTABILITY ACT OF 1996
Priority:


Other Significant


Legal Authority:


PL 104-191 sec 101; PL 104-204 sec 603


CFR Citation:


29 CFR 2520.102-3; 29 CFR 2520.104b-1; 29 CFR 2520.104b-3


Legal Deadline:


NPRM, Statutory, April 1, 1997, Per sections 707 and 734 of ERISA as 
added by section 101 of HIPAA.


Abstract:


The Health Insurance Portability and Accountability Act of 1996 (HIPAA) 
amended ERISA's summary plan description (SPD) and related reporting 
and disclosure provisions to require that participants and 
beneficiaries receive from their group health plans: (i) more timely 
notice if there is a material reduction in services or benefits under 
the plan; (ii) more information regarding the financing and 
administration of the plan; and (iii) specific identification of 
Department of Labor offices through which they can seek assistance or 
information about HIPAA. The Newborns' and Mothers' Health Protection 
Act of 1996 (NMHPA) also amended ERISA's SPD and related reporting and 
disclosure provisions. This rulemaking will amend the Department's SPD 
and related regulations to implement those statutory changes.


Statement of Need:


The existing SPD and related reporting and disclosure provisions need 
to be revised to reflect the changes made by HIPAA. HIPAA's statutory 
changes modify the requirements concerning the manner and timing of how 
certain important plan information is communicated to participants and 
beneficiaries by plan administrators. Without revised regulatory 
guidance administrators may not be able to improve the timely 
disclosure of plan information on both a quantitative and qualitative 
basis. HIPAA also requires the Secretary to issue regulations within 
180 days after its enactment providing alternative mechanisms to 
delivery by mail through which group health plans may notify 
participants and beneficiaries of material reductions in covered 
services or benefits.


Summary of Legal Basis:


Promulgation of these regulations is authorized by sections 104(b), 505 
and 734 of ERISA.


Alternatives:


Regulatory alternatives will be developed once determinations have been 
made with regard to the scope and nature of the regulatory guidance 
which will be necessary to carry out the new provisions.


Anticipated Cost and Benefits:


There is estimated to be no capital/start-up cost. Total burden cost 
for operating/maintenance is estimated to average $73,000,000 annually 
for the years 1997, 1998, and 1999. However, the Department believes 
that the regulation, which implements requirements under HIPAA, assures 
that participants have better access to more complete information about 
their benefit plans.


Risks:


The SPD is a critical plan document for participants and beneficiaries. 
Without access to accurate and timely information participants and 
beneficiaries will not be able to protect their rights under ERISA. 
Improved disclosure requirements also should serve to facilitate 
compliance by plan administrators, thereby reducing litigation and 
penalty risks to plan administrators. The failure to issue revised 
disclosure regulations also may result in a failure to achieve HIPAA's 
objective of improving the disclosure of plan information.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
Interim Final Ru62 FR 16979                                    04/08/97
Interim Final Rule Comment Period End                          05/31/97
Interim Final Rule Effective                                   06/01/97
Second Interim F63 FR 48372                                    09/09/98
Interim Final Rule Effective                                   11/09/98
Comment Period End                                             11/09/98
Final Action                                                   11/00/00
Regulatory Flexibility Analysis Required:


No


Government Levels Affected:


None


Agency Contact:
Eric A. Raps
Pension Law Specialist
Department of Labor
Pension and Welfare Benefits Administration
Room N5669
200 Constitution Avenue NW
FP Building
Washington, DC 20210
Phone: 202 219-8521
RIN: 1210-AA55
_______________________________________________________________________



DOL--PWBA



80. AMENDMENTS TO EMPLOYEE BENEFIT PLAN CLAIMS PROCEDURES REGULATION
Priority:


Other Significant. Major under 5 USC 801.


Unfunded Mandates:


This action may affect the private sector under PL 104-4.


Legal Authority:


29 USC 1133; 29 USC 1135


CFR Citation:


29 CFR 2560.503-1


Legal Deadline:


None


Abstract:


The Department has proposed to amend the regulation governing the 
establishment and maintenance of benefit claims procedures by employee 
benefit plans covered by title I of the Employee Retirement Income 
Security Act (ERISA). The amendment would establish new standards for 
the processing of group health and other employee benefit plan claims 
filed by participants and beneficiaries. In the case of group health 
plans, as well as certain plans providing disability benefits, the new 
standards are intended to ensure more timely benefit determinations, 
improved access to information on which a benefit determination is 
based, and greater assurance that participants and beneficiaries will 
be afforded a full and fair review of denied claims.


Statement of Need:


This regulation is necessary to insure more timely benefit 
determinations, improve access to information on which a benefit 
determination is made, and provide greater assurance that participants 
and beneficiaries will be afforded a full and fair review of denied 
claims.

[[Page 73417]]

Summary of Legal Basis:


Promulgation of this regulation is authorized by sections 503 and 505 
of ERISA.


Alternatives:


Regulatory alternatives will be developed once determinations have been 
made with regard to the scope and nature of the amendments necessary to 
update the rules that implement section 503 of ERISA.


Anticipated Cost and Benefits:


In publishing the proposed regulations, the Department estimated that 
the projected benefits of the proposal would outweigh its projected 
costs. In particular, updating the existing regulation to address 
recent changes in the delivery and financing of health care services 
would improve health care quality by averting harmful, inappropriate 
delays and denials of health benefits thereby yielding substantial 
social benefits.


Risks:


Failure to issue this regulation would deprive many plan participants 
and beneficiaries of the benefits of an improved claims review process.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
Request for Information--Amendment of Regulations on Plan Claims 
        Procedur62 FR 47262                                    09/08/97
Comment Period End                                             11/07/97
NPRM            63 FR 48390                                    09/09/98
NPRM Comment Period End                                        11/09/98
Notice of Public64 FR 65 Held on Feb. 17,18 & 19, 1999         01/04/99
Final Action                                                   11/00/00
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses


Government Levels Affected:


None


Federalism:


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


Agency Contact:
Susan M. Halliday
Pension Law Specialist
Department of Labor
Pension and Welfare Benefits Administration
Room N5669
200 Constitution Avenue NW
FP Building
Washington, DC 20210
Phone: 202 219-8671
RIN: 1210-AA61
_______________________________________________________________________



DOL--PWBA



81. AMENDMENTS TO SUMMARY PLAN DESCRIPTION REGULATIONS
Priority:


Other Significant. Major under 5 USC 801.


Unfunded Mandates:


Undetermined


Legal Authority:


29 USC 1024; 29 USC 1135


CFR Citation:


29 CFR 2520.102-3; 29 CFR 2520.102-5


Legal Deadline:


None


Abstract:


These amendments to the regulations governing the contents of summary 
plan descriptions (SPD) will ensure that all participants in group 
health plans are provided, consistent with the recommendations of the 
President's Advisory Commission on Consumer Protection and Quality in 
the Health Care Industry, understandable information concerning their 
plan; provider network composition; preauthorization and utilization 
review procedures; whether, and under what circumstances, coverage is 
provided for existing and new drugs; and whether, and under what 
circumstances, coverage is provided for experimental drugs, devices, 
and procedures. These amendments will repeal special rules limiting the 
information that must be included in summary plan descriptions with 
respect to certain health maintenance organizations. In addition, the 
amendments include provisions that update or clarify the application of 
certain SPD content requirements affecting both pension and welfare 
benefit plans.


Statement of Need:


This regulation is necessary to improve the disclosure of group health 
plan benefit information, consistent with the recommendations of the 
President's Advisory Commission on Consumer Protection and Quality in 
the Health Care Industry, as set forth in its November 20, 1997 report. 
The amendments will also update the general SPD content requirements 
and update other relevant regulatory provisions.


Summary of Legal Basis:


Promulgation of this regulation is authorized by sections 101(a), 
102(b), and 505 of ERISA.


Alternatives:


Regulatory alternatives will be developed once determinations have been 
made with regard to the scope and nature of the amendments which are 
necessary to improve the disclosure of benefit information to 
participants and beneficiaries of group health plans under the 
applicable ERISA regulations.


Anticipated Cost and Benefits:


The Department estimates that the regulation's benefits will exceed its 
costs. The regulation would assure that participants have better access 
to more complete information on their benefit plans. Better information 
will lead both participants and plan sponsors to make more economically 
efficient decisions regarding benefit plans. This enhanced value and 
efficiency from better information constitute the benefits of the 
regulation.


Risks:


Failure to issue the regulation would deprive participants, 
beneficiaries, and plan sponsors of the improvements in health care 
market efficiency which would be generated by the regulatory amendments 
specified therein.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            63 FR 48376                                    09/09/98
NPRM Comment Period End                                        11/09/98
Final Action                                                   11/00/00
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Organizations


Government Levels Affected:


None

[[Page 73418]]

Agency Contact:
John J. Canary
Supervisory Pension Law Specialist
Department of Labor
Pension and Welfare Benefits Administration
Room N5669
200 Constitution Avenue NW
FP Building
Washington, DC 20210
Phone: 202 219-8521
RIN: 1210-AA69
_______________________________________________________________________



DOL--Mine Safety and Health Administration (MSHA)

                              -----------

                            FINAL RULE STAGE

                              -----------




82. DIESEL PARTICULATE MATTER (EXPOSURE OF UNDERGROUND COAL MINERS)
Priority:


Other Significant


Legal Authority:


30 USC 811; 30 USC 813


CFR Citation:


30 CFR 72; 30 CFR 75


Legal Deadline:


None


Abstract:


Epidemiological studies indicate that diesel exhaust presents potential 
health risks to workers ranging from headaches and nausea to 
respiratory disease and cancer. The National Institute for Occupational 
Safety and Health considers whole diesel exhaust to be a potential 
occupational carcinogen. The International Agency for Research on 
Cancer found that diesel engine exhaust is probably carcinogenic to 
humans.


The rule as proposed for underground coal mines requires the use of 
filtration to remove diesel particulate matter, and requires the use of 
``best practice controls'' to reduce diesel particulate matter.


Statement of Need:


The use of diesel-powered equipment in underground mines has increased 
significantly and rapidly during the past decade. We estimate that 
approximately 13,000 miners are occupationally exposed to diesel 
exhaust emissions in underground coal mines.


Several epidemiological studies have shown a positive carcinogenic risk 
associated with exposure to diesel exhaust. Other reported health 
effects associated with exposure to diesel exhaust include dizziness, 
drowsiness, headaches, nausea, decreased visual acuity, and decreased 
forced expiratory volume. In addition, studies by MSHA and the former 
Bureau of Mines show that miners working in underground mining 
operations that use diesel equipment are probably the most heavily 
exposed workers of any occupational group. Based on the levels of 
diesel particulate measured in underground mining operations and the 
evidence of adverse health effects associated with exposure to diesel 
exhaust, we are concerned about the potential health risk to miners.


Summary of Legal Basis:


Promulgation of these regulations is authorized by sections 101, 103, 
and 508 of the Federal Mine Safety and Health Act of 1977.


Alternatives:


In the fall of 1995, we held a series of public workshops to gather 
suggestions for possible approaches to limit miners' exposure to diesel 
particulate. In addition, over the past 10 years, MSHA and the former 
Bureau of Mines have conducted research on methodologies for the 
measurement and control of diesel particulate in the mining 
environment. This research has demonstrated that the use of low sulfur 
fuel, good engine maintenance, exhaust after-treatment, new engine 
technology, and optimized application of ventilating air all play a 
role in reducing miners' exposure to diesel exhaust particulate matter.


We considered establishing a PEL for diesel particulate in coal mines, 
but found that technology for measuring it in the presence of coal mine 
dust is not currently feasible. Therefore, the use of filtration to 
remove diesel particulate matter is required by the proposed rule.


Anticipated Cost and Benefits:


We estimate that the per year compliance costs are just over $10 
million, of which underground coal mine operators would incur about $10 
million and manufacturers of diesel engines and equipment would incur 
about $14,000.


The proposed rule would reduce a significant health risk to underground 
miners, reducing the potential for acute sensory irritations and 
respiratory symptoms, lung cancer, and premature death, along with the 
attendant suffering and costs to the miners, their families, and 
society. In addition to savings related to acute health effects, we 
estimate that some lung cancers would also be avoided.


Risks:


Several epidemiological studies have found that exposure to diesel 
exhaust presents potential health risks to workers. These potential 
adverse health effects range from headaches and nausea to respiratory 
disease and cancer. In the confined space of the underground mine 
environment, occupational exposure to diesel exhaust may present a 
greater hazard due to ventilation limitations and the presence of other 
airborne contaminants, such as toxic mine dusts or mine gases. We 
believe that the health evidence forms a reasonable basis for reducing 
miners' exposure to diesel particulate.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
ANPRM           57 FR 500                                      01/06/92
ANPRM Comment Period End                                       07/10/92
NPRM            63 FR 17492                                    04/09/98
Notice Significa63 FR 37796ent Impact                          07/14/98
Extension of Com63 FR 41755; Notice of Hearings; Close of Recor08/05/98
Notice of Hearin63 FR 55811f Record                            10/19/98
Extension of Com64 FR 7144d; Availability of Studies; Close of 02/12/99
Extension of Com64 FR 2259d; Close of Record                   04/27/99
Corrections     64 FR 36826                                    07/08/99
Availability of 65 FR 40557Request for Comments                06/30/00
Final Action                                                   01/00/01
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses


Government Levels Affected:


None

[[Page 73419]]

Agency Contact:
Carol J. Jones
Director, Office of Standards
Department of Labor
Mine Safety and Health Administration
Room 631
4015 Wilson Boulevard
Arlington, VA 22203
Phone: 703 235-1910
Fax: 703 235-5551
Email: [email protected]
RIN: 1219-AA74
_______________________________________________________________________



DOL--MSHA



83. DIESEL PARTICULATE MATTER (EXPOSURE OF UNDERGROUND METAL AND 
NONMETAL MINERS)
Priority:


Other Significant


Legal Authority:


30 USC 811; 30 USC 813


CFR Citation:


30 CFR 57


Legal Deadline:


None


Abstract:


Epidemiological studies indicate that diesel exhaust presents potential 
health risks to workers ranging from headaches and nausea to 
respiratory disease and cancer. The National Institute for Occupational 
Safety and Health considers whole diesel exhaust to be a potential 
occupational carcinogen. The International Agency for Research on 
Cancer found that diesel engine exhaust is probably carcinogenic to 
humans.


The rule as proposed for underground metal and nonmetal mines would 
establish a concentration limit for diesel particulate matter and 
require the use of engineering and work practice controls to reduce 
diesel particulate matter.


Statement of Need:


The use of diesel-powered equipment in underground mines has increased 
significantly and rapidly during the past decade. We estimate that 
about 7,500 miners working in production or development areas are 
occupationally exposed to diesel exhaust emissions in underground metal 
and nonmetal mines.


Several epidemiological studies have shown a positive carcinogenic risk 
associated with exposure to diesel exhaust. Other reported health 
effects associated with exposure to diesel exhaust include dizziness, 
drowsiness, headaches, nausea, decreased visual activity, and decreased 
forced expiratory volume. In addition, studies by MSHA and the former 
Bureau of Mines show that miners working in underground mining 
operations that use diesel equipment are probably the most heavily 
exposed workers of any occupational group. Based on the levels of 
diesel particulate measured in underground mining operations and the 
evidence of adverse health effects associated with exposure to diesel 
exhaust. We are concerned about the potential health risk to miners.


Summary of Legal Basis:


Promulgation of these regulations is authorized by sections 101 and 103 
of the Federal Mine Safety and Health Act of 1977.


Alternatives:


In the fall of 1995, we held a series of public workshops to gather 
suggestions for possible approaches to limit miners' exposure to diesel 
particulate. In addition, over the past 10 years, MSHA and the former 
Bureau of Mines have conducted research on methodologies for the 
measurement and control of diesel particulate in the mining 
environment. This research has demonstrated that the use of low sulfur 
fuel, good engine maintenance, exhaust after-treatment, new engine 
technology, and optimized application of ventilating air all play a 
role in reducing miners' exposure to diesel exhaust particulate matter.


Anticipated Cost and Benefits:


We estimate that the compliance costs for underground metal and 
nonmetal operators would be approximately $19 million. The compliance 
costs to manufacturers are assumed to be passed through to underground 
metal and nonmetal operators and therefore, they would not incur any 
direct costs as a result of the rule.


The proposed rule would reduce a significant health risk to underground 
miners, reducing the potential for acute sensory irritations and 
respiratory symptoms, lung cancer, and premature death, along with the 
attendant suffering and costs to the miners, their families, and 
society. In addition to savings related to acute health effects, we 
estimate that some lung cancer would also be avoided.


Risks:


Several epidemiological studies have found that exposure to diesel 
exhaust presents potential health risks to workers. These potential 
adverse health effects range from headaches and nausea to respiratory 
disease and cancer. In the confined space of the underground mine 
environment, occupational exposure to diesel exhaust may present a 
greater hazard due to ventilation limitations and the presence of other 
airborne contaminants, such as toxic mine dusts or mine gases. We 
believe that the health evidence forms a reasonable basis for reducing 
miners' exposure to diesel particulate.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
ANPRM           57 FR 500                                      01/06/92
ANPRM Comment Period End                                       07/10/92
NPRM            63 FR 58104                                    10/29/98
Extension of Com64 FR 7144d; Availability of Studies; Close of 02/12/99
Notice of Hearin64 FR 14200f Record                            03/24/99
Corrections     64 FR 36826                                    07/08/99
Availability of 65 FR 40557Request for Comments                06/30/00
Final Action                                                   01/00/01
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses


Government Levels Affected:


None


Agency Contact:
Carol J. Jones
Director, Office of Standards
Department of Labor
Mine Safety and Health Administration
Room 631
4015 Wilson Boulevard
Arlington, VA 22203
Phone: 703 235-1910
Fax: 703 235-5551
Email: [email protected]
RIN: 1219-AB11
_______________________________________________________________________



DOL--MSHA



84. VERIFICATION OF UNDERGROUND COAL MINE OPERATORS' DUST CONTROL PLANS 
AND COMPLIANCE SAMPLING FOR RESPIRABLE DUST
Priority:


Other Significant

[[Page 73420]]

Legal Authority:


30 USC 811


CFR Citation:


30 CFR 70; 30 CFR 75; 30 CFR 90


Legal Deadline:


None


Abstract:


Our current regulations require that all underground coal mine 
operators develop and follow a mine ventilation plan that we approve 
for each mechanized mining unit. However, we do not have a requirement 
that provides for verification of each plan's effectiveness under 
typical mining conditions. Consequently, plans may be implemented by 
mine operators that could be inadequate to control respirable dust. The 
proposed rule provides for MSHA to verify the effectiveness of mine 
ventilation plans to control respirable dust under typical mining 
conditions. For longwall mine operators, we proposed to permit the 
limited use of either approved loose-fitting powered, air purifying 
respirators (PAPRS) or verifiable administrative controls as a 
supplemental means of compliance if we have determined that further 
reduction in respirable dust levels cannot be achieved using all 
feasible engineering controls. Furthermore, MSHA proposed to assume 
responsibility for all compliance sampling for respirable dust in 
underground coal mines as required under CFR parts 70 and 90. The 
proposed rule also discusses our long term objective to use continuous 
monitoring for sampling.


Statement of Need:


Respirable coal mine dust levels in this country are significantly 
lower than they were two decades ago. Despite this progress, there 
continues to be concern about the respirable coal mine dust sampling 
program and its effectiveness in maintaining exposure levels in mines 
at or below the applicable standard. Our regulations require that all 
underground coal mine operators develop and follow a mine ventilation 
plan approved by us. The dust control portion of the mine ventilation 
plan is the key element of an operator's strategy to control respirable 
dust in the work environment. Although such plans are required to be 
designed to control respirable dust, there is no current requirement 
that provides for verification of each proposed plan's effectiveness 
under typical mining conditions. Consequently, plans may be implemented 
that may be inadequate to control respirable dust.


Therefore, we proposed to revoke existing operator respirable dust 
sampling and to implement new regulations that would require each 
underground coal mine operator to have a verified ventilation plan. 
MSHA would verify the effectiveness of the mine ventilation plan for 
each mechanical mining unit in controlling respirable dust under 
typical mining conditions.


Summary of Legal Basis:


Promulgation of these regulations is authorized by section 101 of the 
Federal Mine Safety and Health Act of 1977.


Alternatives:


In developing the proposed rule, we considered alternatives related to 
typical production levels and the use of appropriate dust control 
strategies, use of supplemental controls for mining entities other than 
longwalls, and the level of protection of loose-fitting powered air 
purifying respirators (PAPRS) in underground coal mines.


Anticipated Cost and Benefits:


Benefits sought are eliminating coal workers' pneumoconiosis by 
reducing over-exposures to respirable coal dust on each and every 
production shift. Additional benefits include: reduced health care 
costs, disability and black lung benefit payments. There would be a 
cost savings for mine operators when MSHA completely takes over 
compliance and abatement sampling for respirable dust once this rule is 
promulgated. We developed estimates and made them available for public 
review.


Risks:


Respirable coal mine dust is one of the most serious occupational 
hazards in the mining industry. Long-term exposure to excessive levels 
of respirable coal mine dust can cause black lung and silicosis, which 
are potentially disabling and can cause death. We are pursuing both 
regulatory and nonregulatory actions to eliminate these diseases 
through the control of coal mine respirable dust levels in mines and 
the reduction of miners' exposure.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            65 FR 42122                                    07/07/00
Notice of Hearin65 FR 42186f Record                            07/07/00
Extension of Com65 FR 49215; Close of Record                   08/11/00
Final Action                                                   01/00/01
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses


Government Levels Affected:


None


Additional Information:


This rulemaking is related to RIN 1219-AB18.


Agency Contact:
Carol J. Jones
Director, Office of Standards
Department of Labor
Mine Safety and Health Administration
Room 631
4015 Wilson Boulevard
Arlington, VA 22203
Phone: 703 235-1910
Fax: 703 235-5551
Email: [email protected]
RIN: 1219-AB14
_______________________________________________________________________



DOL--MSHA



85. DETERMINATION OF CONCENTRATION OF RESPIRABLE COAL MINE DUST
Priority:


Other Significant


Legal Authority:


30 USC 811


CFR Citation:


30 CFR 72


Legal Deadline:


None


Abstract:


The National Institute for Occupational Safety and Health and the Mine 
Safety and Health Administration jointly determined that a single, 
full-shift measurement (``single, full-shift sample'') would accurately 
represent the atmospheric conditions to which a miner is exposed. The 
proposed rule will address the U.S. Court of Appeals' final decision 
and order in National Mining Association v. Secretary of Labor, 153 F3d 
1264 (11th Cir. 1998).


Statement of Need:


Respirable coal mine dust levels in this country are significantly 
lower than

[[Page 73421]]

they were two decades ago. Despite this progress, there continues to be 
concern about our current sampling programs'ability to accurately 
measure and maintain respirable coal mine dusts exposure at or below 
the applicable standard on each shift. For as long as miners have taken 
coal from the ground, many have suffered respiratory problems due to 
their exposures to respirable coal mine dust. These respiratory 
problems affect the current workforce and range from mild impairment of 
respiratory function to more severe diseases, such as silicosis and 
pulmonary massive fibrosis. For some miners, the impairment of their 
respiratory systems is so severe, they die prematurely. Since there is 
a clear relationship between a miner's cumulative exposure to 
respirable coal mine dust and the severity of the resulting respiratory 
conditions it is imperative that each miner's exposure not exceed the 
applicable standard on each and every shift.


Summary of Legal Basis:


Promulgation of these regulations is authorized by section 101 of the 
Federal Mine Safety and Health Act of 1977.


Alternatives:


The requirements of this rule (``single, full-shift sample rule'') will 
work in tandem with those of the proposed rule (RIN 1219-AB14) in which 
MSHA would verify the effectiveness of ventilation plans as well as 
conduct all compliance sampling in underground coal mines.


Anticipated Cost and Benefits:


Benefits sought are eliminating coal workers pneumoconiosis by over-
exposures to respirable coal dust on each and every production shift. 
Additional benefits include: reduced health care costs, disability and 
black lung benefit payments. There would be a cost savings for mine 
operators when MSHA completely takes over compliance and abatement 
sampling for respirable dust once this rule is promulgated. We have 
developed cost estimates and have made them available for public 
review.


Risks:


Respirable coal mine dust is one of the most serious occupational 
hazards in the mining industry. Occupational exposure to excessive 
levels of respirable coal mine dust can cause coal workers' 
pneumoconiosis and silicosis, which are potentially disabling and can 
cause death. We are pursuing both regulatory and nonregulatory actions 
to eliminate these diseases through the control of coal mine respirable 
dust levels in mines and reduction of miners' exposure.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            65 FR 42068                                    07/07/00
Notice of Hearin65 FR 42185f Record                            07/07/00
Extension of Com65 FR 49215; Close of Record                   08/11/00
Final Action                                                   01/00/01
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses


Government Levels Affected:


None


Additional Information:


This rulemaking is related to RIN 1219-AB14 (Verification of 
Underground Coal Mine Operators' Dust Control Plans and Compliance 
Sampling for Respirable Dust).


Agency Contact:
Carol J. Jones
Director, Office of Standards
Department of Labor
Mine Safety and Health Administration
Room 631
4015 Wilson Boulevard
Arlington, VA 22203
Phone: 703 235-1910
Fax: 703 235-5551
Email: [email protected]
RIN: 1219-AB18
_______________________________________________________________________



DOL--Occupational Safety and Health Administration (OSHA)

                              -----------

                          PROPOSED RULE STAGE

                              -----------




86. SAFETY AND HEALTH PROGRAMS (FOR GENERAL INDUSTRY AND THE MARITIME 
INDUSTRIES)
Priority:


Economically Significant. Major under 5 USC 801.


Unfunded Mandates:


Undetermined


Legal Authority:


29 USC 651; 29 USC 655; 29 USC 657


CFR Citation:


29 CFR 1910; 29 CFR 1915; 29 CFR 1917; 29 CFR 1918


Legal Deadline:


None


Abstract:


The Occupational Safety and Health Administration (OSHA), many of the 
States, members of the safety and health community, insurance 
companies, professional organizations, companies participating in the 
Agency's Voluntary Protection Programs, and many proactive employers in 
all industries recognize the value of worksite-specific safety and 
health programs in preventing job-related injuries, illnesses, and 
fatalities. The reductions in job-related injuries and illnesses, 
workers' compensation costs, and absenteeism that occur after employers 
implement such programs dramatically demonstrate the effectiveness of 
these programs. In 1989, OSHA published nonmandatory guidelines to help 
employers establish safety and health programs (54 FR 3904). Those 
guidelines were based on a distillation of the best safety and health 
management practices observed by OSHA in the years since the Agency was 
established. OSHA has decided to expand on these guidelines by 
developing a safety and health programs rule because occupational 
injuries, illnesses, and fatalities are continuing to occur at an 
unacceptably high rate. For example, an average of about 17 workers 
were killed each day in 1997. This number does not include an estimated 
137 daily deaths associated with job-related chronic illnesses.


Safety and health programs include the following core elements: 
management leadership; active employee participation; hazard 
identification and assessment; hazard prevention and control; 
information and training; and program evaluation. In response to 
extensive stakeholder involvement, OSHA has, among other things, 
focused the proposed rule on significant hazards and reduced burdens on 
small business to the extent consistent with the goals of the OSH Act.


Statement of Need:


Worksite-specific safety and health programs are increasingly being 
recognized as the most effective way of reducing job-related accidents, 
injuries, and illnesses. Many States have to date passed legislation 
and/or regulations mandating such programs

[[Page 73422]]

for some or all employers, and insurance companies have also been 
encouraging their client companies to implement these programs, because 
the results they have achieved have been dramatic. In addition, all of 
the companies in OSHA's Voluntary Protection Programs have established 
such programs and are reporting injury and illness rates that are 
sometimes only 20 percent of the average for other establishments in 
their industry. Safety and health programs apparently achieve these 
results by actively engaging front-line employees, who are closest to 
operations in the workplace and have the highest stake in preventing 
job-related accidents, in the process of identifying and correcting 
occupational hazards. Finding and fixing workplace hazards is a cost-
effective process, both in terms of the avoidance of pain and suffering 
and the prevention of the expenditure of large sums of money to pay for 
the direct and indirect costs of these injuries and illnesses. For 
example, many employers report that these programs return between $5 
and $9 for every dollar invested in the program, and almost all 
employers with such programs experience substantial reductions in their 
workers' compensation premiums. OSHA believes that having employers 
evaluate the job-related safety and health hazards in their workplace 
and address any hazards identified before they cause occupational 
injuries, illnesses, or deaths is an excellent example of ``regulating 
smarter,'' because all parties will benefit: workers will avoid the 
injuries and illnesses they are currently experiencing; employers will 
save substantial sums of money and increase their productivity and 
competitiveness; and OSHA's scarce resources will be leveraged as 
employers and employees join together to identify, correct, and prevent 
job-related safety and health hazards.


Summary of Legal Basis:


The legal basis for the proposed rule is a preliminary finding by the 
Secretary of Labor that unacceptably high injury, illness, and fatality 
rates can be substantially reduced by getting employers to 
systematically comply with their existing duty to control hazards under 
sections 5(a)(1) and 5(a)(2) of the OSH Act. The rule is also 
reasonably related to achieving the purposes of the Act, and would 
essentially require employers to conduct periodic inspections of the 
workplace and to inform employees about the hazards they find.


Alternatives:


In the last few years, OSHA has considered both nonregulatory and 
regulatory alternatives in the area of safety and health program 
management. First, in 1989, OSHA published a set of voluntary 
management guidelines designed to help employers set up and maintain 
safety and health programs. Although these guidelines have received 
widespread praise from many employers and professional safety and 
health associations, they have not been adequately effective in 
reducing job-related deaths, injuries, and illnesses, which have 
continued to occur at unacceptably high levels. Many States have also 
recognized the value of these programs and have mandated that some or 
all employers establish them; this has led to inconsistent coverage 
from State to State, with many States having no coverage and others 
imposing stringent program requirements.


Anticipated Cost and Benefits:


OSHA preliminarily estimated the overall program costs of the draft 
proposed rule provided to the SBREFA Panel for this rule for all 
covered employers to be about $2.3 billion per year. The Agency also 
preliminarily estimated that 580,000 to 1,300,000 injuries and 
illnesses and 416 to 918 fatalities would be avoided each year as a 
result of the rule. OSHA preliminarily anticipates that employers will 
have direct cost savings associated with this reduction in the number 
of injuries and illnesses of approximately $7.3 billion to $16.5 
billion per year.


Risks:


Workers in all major industry sectors in the United States continue to 
experience an unacceptably high rate of occupational fatalities, 
injuries, and illnesses. For 1996, the Bureau of Labor Statistics 
reported that 6.2 million injuries and illnesses occurred within 
private industry. For 1997, BLS reported that 6,218 workers lost their 
lives on the job. There is increasing evidence that addressing hazards 
in a piecemeal fashion, as employers tend to do in the absence of a 
comprehensive safety and health program, is considerably less effective 
in reducing accidents than a systematic approach. Dramatic evidence of 
the seriousness of this problem can be found in the staggering workers' 
compensation bill paid by America's employers and employees: about $54 
billion annually. These risks can be reduced by the implementation of 
safety and health programs, as evidenced by the experience of OSHA's 
Voluntary Protection Program participants, who regularly achieve injury 
and illness rates averaging one-fifth to one-third those of competing 
firms in their industries. Because the proposed rule addresses 
significant job-related hazards, the rule will be effective in ensuring 
a systematic approach to the control of long-recognized hazards, such 
as lead, which are covered by existing OSHA standards, and emerging 
hazards, such as lasers and violence in the workplace, where conditions 
in the workplace would require control under the General Duty Clause of 
the Act.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           09/00/01
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses


Government Levels Affected:


State


Federalism:


 Undetermined


Additional Information:


A separate rule is being developed for the construction industry (29 
CFR 1926). OSHA will coordinate the development of the two rules.


Agency Contact:
Marthe B. Kent
Director, Directorate of Safety Standards Programs
Department of Labor
Occupational Safety and Health Administration
Room N3609
200 Constitution Avenue NW
FP Building
Washington, DC 20210
Phone: 202 693-2222
Fax: 202 693-1663
RIN: 1218-AB41
_______________________________________________________________________



DOL--OSHA



87. OCCUPATIONAL EXPOSURE TO CRYSTALLINE SILICA
Priority:


Economically Significant. Major status under 5 USC 801 is undetermined.


Unfunded Mandates:


Undetermined


Legal Authority:


29 USC 655(b); 29 USC 657

[[Page 73423]]

CFR Citation:


29 CFR 1910; 29 CFR 1926; 29 CFR 1915; 29 CFR 1916; 29 CFR 1917; 29 CFR 
1918


Legal Deadline:


None


Abstract:


Silica exposure remains a serious threat to nearly 2 million U.S. 
workers, including more than 100,000 workers in high risk jobs such as 
abrasive blasting, foundry work, stonecutting, rock drilling, quarry 
work and tunneling. The seriousness of the health hazards associated 
with silica exposure is demonstrated by the fatalities and disabling 
illnesses that continue to occur in sandblasters and rock drillers and 
by recent studies that demonstrate a statistically significant increase 
in lung cancer among silica-exposed workers. In October 1996, the 
International Agency for Research on Cancer classified crystalline 
silica as ``carcinogenic to humans.'' Exposure studies indicate that 
some workers are still exposed to very high levels of silica. Although 
OSHA currently has a permissible exposure limit for crystalline silica 
(10 mg/m3 divided by the percent of silica in the dust (respirable + 
2)), more than 30 percent of OSHA-collected silica samples from 1982 
through 1991 exceeded this limit. Additionally recent studies suggest 
that the current OSHA standard is insufficient to protect against 
silicosis. OSHA plans to publish a proposed rule on crystalline silica 
under section 6(b)(5) of the Act. The standard would protect silica-
exposed workers in general industry, construction and maritime.


Statement of Need:


The current OSHA permissible exposure limit for silica is 10 mg/m3 
divided by the percent of silica in the dust + 2 (respirable) and 30 
mg/m3 divided by the percent of silica in the dust + 2 (total dust). In 
the interval since this limit was promulgated there have been a number 
of studies of workers that have estimated that close to 50 percent of 
workers exposed to silica at the current limit for a 45-year working 
lifetime would develop silicosis, a disabling, progressive and 
sometimes fatal disease involving scarring of the lung, coughing, and 
shortness of breath. There are currently about 300 deaths reported per 
year from silicosis. However, the actual number of cases and the true 
risk is unknown due to inadequate case identification, which means that 
the number of deaths is probably underreported. Also, since the 
promulgation of OSHA's permissible exposure limit, studies have 
demonstrated a statistically significant, dose-related increase in lung 
cancer in several occupational groups.


Because of these recent findings, OSHA believes that it will be 
necessary to conduct a risk assessment to determine whether the current 
permissible exposure limit is protective of worker health. OSHA also 
believes that, in addition to the permissible exposure limit, the 
ancillary provisions, such as engineering controls, provided by a 
comprehensive standard will be necessary to reduce worker exposure to 
crystalline silica.


Summary of Legal Basis:


The legal basis for the proposed rule is a preliminary determination by 
the Secretary of Labor that exposure to silica at the Agency's current 
permissible exposure limits poses a significant risk of material 
impairment of health and that a standard will substantially reduce that 
risk.


Alternatives:


OSHA has considered or conducted several programs designed to reduce 
worker exposure to crystalline silica. The OSHA Special Emphasis 
Program for Silicosis provides inspection targeting to reduce or 
eliminate workplace exposures to crystalline silica. The National 
Campaign to Eliminate Silicosis being conducted by OSHA (in conjunction 
with the National Institute for Occupational Safety and Health, the 
Mine Safety and Health Administration, and the American Lung 
Asssociation) is an ongoing program involving outreach and education 
and the dissemination of materials on methods to reduce worker exposure 
to crystalline silica. Other nonregulatory approaches might include the 
issuance of nonmandatory guidelines, enforcing lower limits through the 
``general duty'' clause of the OSH Act in cases where substantial 
evidence exists that exposure presents a recognized hazard of death or 
serious physical harm, and the issuance of hazard alerts. Although 
these approaches may be partially effective in reducing worker exposure 
to crystalline silica and reducing disease risk, OSHA believes that 
progress in the prevention of silica-related diseases demands the 
issuance of a comprehensive silica standard.


Anticipated Cost and Benefits:


The scope of the proposed rule is currently under development and thus 
quantitative estimates of costs and benefits have not been determined 
at this time.


Risks:


OSHA has not yet completed an assessment of the risks of exposure to 
crystalline silica. Other studies have shown risks ranging from 35 to 
47 percent among workers exposed over a working lifetime and have 
additionally identified silica as a potential occupational carcinogen.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           09/00/01
Regulatory Flexibility Analysis Required:


Undetermined


Government Levels Affected:


Undetermined


Agency Contact:
Marthe B. Kent
Acting Director, Directorate of Health Standards Programs
Department of Labor
Occupational Safety and Health Administration
Room N3718
200 Constitution Avenue NW
FP Building
Washington, DC 20210
Phone: 202 693-1950
Fax: 202 693-1678
RIN: 1218-AB70
_______________________________________________________________________



DOL--OSHA

                              -----------

                            FINAL RULE STAGE

                              -----------




88. STEEL ERECTION (PART 1926) (SAFETY PROTECTION FOR IRONWORKERS)
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:


29 USC 655; 40 USC 333

[[Page 73424]]

CFR Citation:


29 CFR 1926.750 (Revision); 29 CFR 1926.751 (Revision); 29 CFR 1926.752 
(Revision)


Legal Deadline:


None


Abstract:


In 1992, OSHA announced that it would develop a proposal for revising 
steel erection safety requirements using the negotiated rulemaking 
process. In negotiated rulemaking, OSHA, public, industry and employee 
representatives meet as an advisory committee and attempt to forge a 
consensus on a proposed standard. An advisory committee for this rule 
was formed in 1994. Its work resulted in the publication of a proposed 
rule on August 13, 1998. The written comment period ended November 17, 
1998. A public hearing was held in Washington, DC, on December 1-11, 
1998. The post-hearing comment period closed April 12, 1999. OSHA is 
close to completing a final rule.


Statement of Need:


In 1989, the Ironworkers International Union and National Erectors 
Association petitioned OSHA to revise the steel erection standard 
through negotiated rulemaking. In light of the significant number of 
steel erection fatalities and injuries and concerns that the Agency's 
existing rule fails to adequately address a number of factors affecting 
safety, OSHA determined that the current rule needed to be revised.


Summary of Legal Basis:


The legal basis for the proposed steel erection rule is a preliminary 
finding that workers engaged in steel erection work are at significant 
risk of serious injury or death as a result of that work.


Alternatives:


OSHA considered continuing to rely on the existing rule. The Agency 
also considered issuing a proposed rule without negotiated rulemaking. 
Leaving the existing rule unchanged was rejected because of the 
apparent inadequacies of the standard. Negotiated rulemaking was chosen 
to help resolve conflicts and produce a proposal sooner.


Anticipated Cost and Benefits:


OSHA expects compliance with the proposal to impose annualized costs of 
about $50 million per year. Benefits are expected to include the 
prevention of about 14 fatalities and 824 lost workday injuries per 
year.


Risks:


OSHA estimates that at least 28 workers die each year while engaged in 
steel erection. Falls continue to be the leading cause of job-related 
deaths among construction workers, and steel erection involves a 
significant degree of exposure to fall hazards.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
Notice of Commit59 FR 24389shment                              05/11/94
NPRM            63 FR 43451                                    08/13/98
NPRM Comment Per63 FR 43451                                    11/17/98
Public Hearing                                                 12/01/98
Final Rule                                                     12/00/00
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses


Government Levels Affected:


None


Agency Contact:
Russell B. Swanson
Director, Directorate of Construction
Department of Labor
Occupational Safety and Health Administration
Room N3468
200 Constitution Avenue NW
FP Building
Washington, DC 20210
Phone: 202 693-2020
Fax: 202 693-1689
Email: [email protected]
RIN: 1218-AA65
_______________________________________________________________________



DOL--OSHA



89. RECORDING AND REPORTING OCCUPATIONAL INJURIES AND ILLNESSES 
(SIMPLIFIED INJURY/ILLNESS RECORDKEEPING REQUIREMENTS)
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:


29 USC 657; 29 USC 673


CFR Citation:


29 CFR 1904; 29 CFR 1952.4


Legal Deadline:


None


Abstract:


OSHA requires employers to keep records of occupational illnesses and 
injuries. These records are used by OSHA and the Bureau of Labor 
Statistics (BLS), among others, to develop data on workplace safety and 
health by industry and across industries. Over the years concerns about 
the reliability and utility of these data have been raised by Congress, 
the National Institute for Occupational Safety and Health (NIOSH), the 
National Academy of Sciences, the Office of Management and Budget 
(OMB), the General Accounting Office, business and labor, as well as 
BLS and OSHA. In the late 1980s, OSHA contracted with the Keystone 
Center to bring together representatives of industry, labor, 
government, and academia in a year-long effort to discuss problems with 
OSHA's injury and illness recordkeeping system. Keystone issued a 
report with specific recommendations on how to improve the system. In 
1995, OSHA held several meetings with stakeholders from business, labor 
and government to obtain feedback on a draft OSHA recordkeeping 
proposal and to gather related information.


OSHA published a Notice of Proposed Rulemaking (NPRM) in the February 
2, 1996 Federal Register that contained revised recordkeeping 
requirements and recordkeeping forms. The original 90-day public 
comment period was extended another 60 days and ended July 2, 1996. 
During that comment period, the public submitted over 450 written 
comments to OSHA Docket R-02. In addition, OSHA held two public 
meetings in Washington, DC (March 26-29 and April 30-May 1) resulting 
in 1,200 pages of transcripts from nearly 60 presentations. OSHA is now 
planning to issue a final rule that incorporates changes based on an 
analysis of the public comments and testimony.


Statement of Need:


The occupational injury and illness records maintained by employers are 
an important component of OSHA's program. The records are used by 
employers and employees to identify and evaluate workplace safety and 
health hazards, and they provide OSHA personnel with necessary 
information during workplace inspections. The records also provide the 
source data for the Annual Survey of Occupational

[[Page 73425]]

Injuries and Illnesses conducted by the BLS.


All of these uses of the data are affected by the quality of the 
records employers maintain. Higher quality data lead to higher quality 
analyses, which in turn lead to better decisions about occupational 
safety and health matters. To improve the quality of the records and 
enhance the use of the information, OSHA needs to provide clearer 
regulatory guidance to employers and simplify the recordkeeping forms.


Summary of Legal Basis:


The legal basis for issuance of this final rule is section 8(c)(1) of 
the OSH Act, which requires employers to record and report such records 
as are necessary for the enforcement of the Act and for developing 
information on the causes and prevention of occupational accidents and 
illnesses, as required by regulation, and section 24(a) of the Act, 
which requires OSHA to develop an effective program of occupational 
safety and health statistics to further the purposes of the Act.


Alternatives:


The alternative to publication of a final rule is to take no action and 
continue to administer the injury and illness recordkeeping system 
using the current regulation, forms and guidelines. This alternative is 
unacceptable because it does not address the problems with the current 
system identified by participants in the Keystone dialogue and other 
OSHA stakeholders.


Anticipated Cost and Benefits:


OSHA has not determined the costs and benefits of the final rule.


Risks:


Not applicable.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            61 FR 4030                                     02/02/96
NPRM Comment Period End                                        07/02/96
Final Action                                                   12/00/00
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses, Organizations


Government Levels Affected:


None


Agency Contact:
Marthe B. Kent
Director, Directorate of Safety Standards Programs
Department of Labor
Occupational Safety and Health Administration
Room N3609
200 Constitution Avenue NW
FP Building
Washington, DC 20210
Phone: 202 693-2222
Fax: 202 693-1663
RIN: 1218-AB24
_______________________________________________________________________



DOL--OSHA



90. ERGONOMICS PROGRAMS: PREVENTING MUSCULOSKELETAL DISORDERS
Priority:


Economically Significant. Major under 5 USC 801.


Unfunded Mandates:


This action may affect the private sector under PL 104-4.


Legal Authority:


29 USC 651; 29 USC 652; 29 USC 655; 29 USC 657; 33 USC 941; 40 USC 333


CFR Citation:


29 CFR 1910


Legal Deadline:


None


Abstract:


Work-related musculoskeletal disorders (MSDs) are a leading cause of 
pain, suffering, and disability in American workplaces. Since the 
1980s, the Occupational Safety and Health Administration (OSHA) has had 
a number of initiatives related to addressing these problems, including 
enforcement under the general duty clause, issuance of guidelines for 
the meatpacking industry, and development of other compliance-
assistance materials.


The Agency decided that, given the magnitude and persistence of the 
problem, a regulatory approach was appropriate to ensure that the 
largest possible number of employers and employees become aware of the 
problems and ways of preventing work-related musculoskeletal disorders. 
OSHA has examined and analyzed the extensive scientific literature 
documenting the problem of work-related musculoskeletal disorders, the 
causes of the problem, and effective solutions; conducted a telephone 
survey of over 3,000 establishments regarding their practices to 
prevent work-related musculoskeletal disorders; and completed a number 
of site visits to facilities with existing programs. The Agency has 
also held numerous stakeholder meetings to solicit input from 
individuals regarding the provisions of a program standard to prevent 
work-related musculoskeletal disorders.


The Agency believes that the scientific evidence supports the need for 
a standard and that the availability of effective and reasonable means 
to control these hazards has been demonstrated. The Agency, therefore, 
issued a proposed rule for ergonomics late in 1999 and is currently 
working on a final rule.


Statement of Need:


OSHA estimates that work-related musculoskeletal disorders in the 
United States account for over 600,000 injuries and illnesses that are 
serious enough to result in days away from work (34 percent of all lost 
workday injuries reported by employers to the Bureau of Labor 
Statistics (BLS)). These disorders now account for one out of every 
three dollars spent on workers' compensation. It is estimated that 
employers spend as much as $15 billion a year in direct costs for MSD-
related workers' compensation, and up to three to four times that much 
for the indirect costs of these disorders, such as those associated 
with hiring and training replacement workers. In addition to these 
monetary effects, MSDs often impose a substantial personal toll on 
affected workers who may no longer be able to work or perform simple 
personal tasks like buttoning their clothes or brushing their hair.


Scientific evidence associates MSDs with stresses to various body parts 
caused by the way certain tasks are performed. The positioning of the 
body and the type of physical work that must be done to complete a job 
may cause persistent pain and lead to deterioration of the affected 
joints, tissues, and muscles. The longer the worker must maintain a 
fixed or awkward posture, exert force, repeat the same movements, 
experience vibration, or handle heavy items, the greater the chance 
that such a disorder will occur. These job-related stresses are 
referred to as ``ergonomic risk factors,'' and the scientific 
literature demonstrates that exposure to these risk factors, 
particularly in combination, significantly increases an

[[Page 73426]]

employee's risk of developing a work-related musculoskeletal disorder. 
Jobs involving exposure to ergonomic risk factors appear in all types 
of industries and in all sizes of facilities.


Musculoskeletal disorders occur in all parts of the body--the upper 
extremity, the lower extremity, and the back. An example of the 
increasing magnitude of the problem involves repeated trauma to the 
upper extremity, or that portion of the body above the waist, in forms 
such as carpal tunnel syndrome and shoulder tendinitis. In industries 
such as meatpacking and automotive assembly, approximately 10 out of 
100 workers report work-related MSDs from repeated trauma each year. 
The number of work-related back injuries occurring each year is even 
larger than the number of upper extremity disorders. Industries 
reporting a large number of cases of back injuries include hospitals 
and nursing homes.


The evidence OSHA has assembled and analyzed indicates that 
technologically and economically feasible measures are available to 
significantly reduce exposures to ergonomic risk factors and the risk 
of developing work-related musculoskeletal disorders. Many companies 
that have voluntarily implemented ergonomics programs have demonstrated 
that effective ergonomic interventions are available to reduce MSDs. 
Many of these interventions are simple and inexpensive, but 
nevertheless have a significant effect on the occurrence of work-
related musculoskeletal disorders. Benefits include substantial savings 
in workers' compensation costs, increased productivity, and decreased 
turnover.


Summary of Legal Basis:


The legal basis for the rule is a finding by the Secretary of Labor 
that workers in workplaces within OSHA's jurisdiction are at 
significant risk of incurring work-related musculoskeletal disorders.


Alternatives:


OSHA has considered many different regulatory alternatives. These 
include variations in the scope of coverage, particularly with regard 
to industrial sectors, work processes, and degree of hazard.


Anticipated Cost and Benefits:


Implementation costs of an ergonomics program standard would include 
those related to identifying and correcting problem jobs using 
engineering and administrative controls. Benefits expected include 
reduced pain and suffering, both from prevented disorders as well as 
reduced severity in those disorders that do occur, decreased numbers of 
workers' compensation claims, and reduced lost work time. Secondary 
benefits may accrue from improved quality and productivity due to 
better designed work systems.


Risks:


The data OSHA has obtained and analyzed indicate that employees are at 
significant risk of developing or aggravating musculoskeletal disorders 
due to exposure to risk factors in the workplace. In addition, 
information from site visits, the scientific literature, the Agency's 
compliance experience, and other sources indicates that there are 
economically and technologically feasible means of addressing and 
reducing these risks to prevent the development or aggravation of such 
disorders, or to reduce their severity. These data and analyses were 
presented in the preamble to the proposed standard published in the 
Federal Register.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
ANPRM           57 FR 34192                                    08/03/92
ANPRM Comment Period End                                       02/01/93
SBREFA Panel                                                   03/02/99
NPRM            64 FR 65768                                    11/23/99
Final Action                                                   12/00/00
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses, Governmental Jurisdictions, Organizations


Government Levels Affected:


Undetermined


Agency Contact:
Marthe B. Kent
Acting Director, Directorate of Health Standards Programs
Department of Labor
Occupational Safety and Health Administration
Room N3718
200 Constitution Avenue NW
FP Building
Washington, DC 20210
Phone: 202 693-1950
Fax: 202 693-1678
RIN: 1218-AB36
_______________________________________________________________________



DOL--OSHA



91. OCCUPATIONAL EXPOSURE TO TUBERCULOSIS
Priority:


Economically Significant. Major under 5 USC 801.


Unfunded Mandates:


This action may affect the private sector under PL 104-4.


Legal Authority:


29 USC 655(b)


CFR Citation:


29 CFR 1910.1035


Legal Deadline:


None


Abstract:


On August 25, 1993, the Labor Coalition to Fight TB in the Workplace 
petitioned the Occupational Safety and Health Administration (OSHA) to 
develop an occupational health standard to protect workers against the 
transmission of tuberculosis (TB). The Coalition stated that although 
the Centers for Disease Control and Prevention (CDC) had developed 
guidelines for controlling the spread of TB, many of the TB outbreak 
investigations conducted by CDC showed that many employers were not 
fully implementing the CDC guidelines. After reviewing the available 
information, OSHA preliminarily concluded that a significant risk of 
occupational transmission of TB exists for some workers in some work 
settings and began rulemaking on a proposed standard.


To assist in the development of the proposed standard, OSHA consulted 
with parties outside the Agency. The preliminary risk assessment was 
peer-reviewed by four experts with specific knowledge in the areas of 
TB disease and risk assessment. In addition, OSHA conducted stakeholder 
meetings with representatives of various groups that might be affected 
by the proposed standard. The draft proposed standard was also reviewed 
and commented on by affected small business entities under the Small 
Business Advocacy Review Panel requirements of the Small Business 
Regulatory Enforcement Fairness Act of 1996 (SBREFA) and by the Office 
of Management and Budget (OMB) under Executive Order 12866.


On October 17, 1997, OSHA published its proposed standard for 
occupational exposure to TB (62 FR 54160). The proposed standard would 
cover

[[Page 73427]]

workers in hospitals, nursing homes, hospices, correctional facilities, 
homeless shelters, and certain other work settings where workers are at 
significant risk of becoming infected with TB while caring for their 
patients or clients or performing certain procedures. The proposed 
standard would require employers to protect TB-exposed workers using 
infection control measures that have been shown to be highly effective 
in reducing or eliminating work-related TB infections. Such measures 
include procedures for early identification of individuals with 
infectious TB, isolation of individuals with infectious TB using 
appropriate ventilation, use of respiratory protection in certain 
situations, and skin testing and training of employees.


After the close of the written comment period for the proposed standard 
on February 17, 1998, informal public hearings were held in Washington, 
DC (April 7-17), Los Angeles, CA (May 5-7), New York City, NY (May 19-
21), and Chicago, IL (June 2-4). At the end of the public hearings a 
post-hearing comment period was established. The post-hearing comment 
period closed on October 5, 1998. On June 17, 1999 OSHA reopened the 
rulemaking record to submit the Agency's report on homeless shelters 
and certain other documents that became available to the Agency after 
the close of the post-hearing comment period. During this limited 
reopening of the rulemaking record, OSHA also requested interested 
parties to submit comments and data on the Agency's preliminary risk 
assessment in order to obtain the best, most recent data for providing 
the most accurate estimates of the occupational risk of tuberculosis.


Statement of Need:


TB is a contagious disease caused by the bacterium Mycobacterium 
tuberculosis. Infection is acquired by the inhalation of airborne 
particles carrying the bacterium. These airborne particles, called 
droplet nuclei, can be generated when persons with pulmonary TB in the 
infectious stage of the disease cough, sneeze, or speak. In some 
individuals who inhale the droplet nuclei, TB bacteria establish an 
infection. In most cases, the bacteria are contained by the 
individual's immune system. However, in some cases, the bacteria are 
not contained by the immune system and continue to grow and invade the 
tissue, leading to the progressive destruction of the organ involved. 
In most cases, this organ is the lung, although other organs may also 
become infected.


From 1953, when active cases began to be reported in the United States, 
until 1984, the number of annual reported cases declined 74 percent, 
from 84,304 cases to 22,255 cases. However, this steady decline did not 
continue. Instead, from 1985 to 1992, the number of reported cases 
increased 20.1 percent. TB control efforts were re-initiated in some 
areas of the country and from 1993 to 1998, the number of cases in the 
United States again declined. A large portion of the decrease occurred 
in high incidence areas, such as New York City, where intervention 
efforts were focused. However, despite the recent decrease in active 
cases, there were still 18,371 reported TB cases in 1998. Outbreaks of 
TB continue to occur and multidrug-resistant forms of TB disease 
continue to spread to new States. In addition, more than 10 to 15 
million persons in the United States have latent TB infection and are 
at risk of developing TB disease sometime in the future. Moreover, the 
factors that led to the resurgence from 1985 to 1992 (e.g., increases 
in homelessness, HIV infection, immigration from countries with high 
rates of infection) still exist.


Providing health care for individuals with TB increases the risk of 
occupational exposure among healthcare workers. Many of the outbreaks 
of TB have occurred in health care facilities, resulting in the 
transmission of TB to both patients and health care workers. CDC found 
that the factors contributing to these outbreaks included delayed 
diagnosis of TB, delayed initiation of effective therapy, delayed 
initiation and inadequate duration of TB isolation, inadequate 
ventilation of isolation rooms, lapses in TB isolation practices, and 
lack of adequate respiratory protection. CDC analyzed data from several 
of the outbreaks and found that the transmission of TB decreased 
significantly when recommended TB control measures were implemented. 
Workers outside health care also provide services to patient or client 
populations that have an increased rate of TB disease. For example, 
occupational transmission of TB has been documented in correctional 
facilities, and the standard would cover such workers.


Summary of Legal Basis:


The legal basis for the proposed TB standard is a preliminary finding 
by the Secretary of Labor that workers in hospitals, nursing homes, 
hospices, correctional facilities, homeless shelters, and certain other 
work settings are at a significant risk of incurring TB infection while 
caring for their patients and clients or performing certain procedures.


Alternatives:


Prior to a decision to publish a proposal, OSHA considered a number of 
options, including whether or not to develop an emergency temporary 
standard, publish an advance notice of proposed rulemaking, or to 
enforce existing regulations.


Anticipated Cost and Benefits:


Costs will be incurred by employers for engineering controls, 
respiratory protection, medical surveillance, training, exposure 
control, recordkeeping, and work practice controls. Benefits will 
include the prevention of work-related TB transmissions and infections, 
and a corresponding reduced risk of exposure among the general 
population. OSHA estimates that more than 5 million workers are exposed 
to TB in the course of their work. The Agency estimates that the 
proposed provisions will result in annual costs of $245 million. 
Implementation of the standard is estimated to reduce the number of 
work-related cases of TB by 70 to 90 percent in the work settings 
covered, thus preventing approximately 21,400 to 25,800 work-related 
infections per year, 1,500 to 1,700 active cases of TB resulting from 
these infections, and approximately 115 to 136 deaths resulting from 
these active cases.


Risks:


From 1985 to 1992, the number of reported cases of TB in the United 
States increased, reversing a previous 30-year downward trend. While 
there has been a recent decrease in the reported number of cases of TB 
in the general population, a large part of this decrease can be 
attributed to focused intervention efforts in areas of high incidence 
of TB. Fourteen states showed an increase or no change in the number of 
reported cases in 1998, and the factors that contributed to the 
resurgence continue to exist, along with exposure of certain workers to 
patient or client populations with an increased rate of TB. In 
addition, TB outbreaks continue to occur and multidrug-resistant 
strains of TB continue to spread to new States. Therefore, employees in 
work settings such as health care or correctional facilities, who have 
contact with infectious individuals, are at high risk of occupational 
transmission of TB. OSHA estimates that the average lifetime

[[Page 73428]]

occupational risk of TB infection ranges from 30 to 386 infections per 
1000 workers exposed to TB on the job and that the average lifetime 
occupational risk of TB disease ranges from 3 to 39 cases of active TB 
disease per 1000 workers exposed to TB. Active disease can cause signs 
and symptoms such as fatigue, weight loss, fever, night sweats, loss of 
appetite, persistent cough, and shortness of breath, and may result in 
serious respiratory illness or death.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
SBREFA Panel                                                   09/10/96
NPRM            62 FR 54160                                    10/17/97
NPRM Comment Period End                                        02/17/98
Post Hearing Comment End                                       10/05/98
Record Reopening64 FR 32447                                    06/17/99
Second Reopening64 FR 34625riod End                            06/28/99
Reopening Comment Period End                                   08/02/99
Final Rule                                                     04/00/01
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses, Governmental Jurisdictions, Organizations


Government Levels Affected:


Federal, State, Local, Tribal


Additional Information:


During this rulemaking, OSHA met with small business stakeholders to 
discuss their concerns, and conducted an initial Regulatory Flexibility 
Analysis to identify any significant impacts on a substantial number of 
small entities. In addition, OSHA conducted a special study of homeless 
shelters and set aside certain hearing dates for persons who wished to 
testify on homeless shelter issues.


Agency Contact:
Marthe B. Kent
Acting Director, Directorate of Health Standards Programs
Department of Labor
Occupational Safety and Health Administration
Room N3718
200 Constitution Avenue NW
FP Building
Washington, DC 20210
Phone: 202 693-1950
Fax: 202 693-1678
RIN: 1218-AB46
_______________________________________________________________________



DOL--OSHA



92. EMPLOYER PAYMENT FOR PERSONAL PROTECTIVE EQUIPMENT
Priority:


Other Significant


Legal Authority:


29 USC 655(b); 29 USC 657; 33 USC 941; 40 USC 333


CFR Citation:


29 CFR 1910.132; 29 CFR 1915.152; 29 CFR 1917.96; 29 CFR 1918.106; 29 
CFR 1926.95


Legal Deadline:


None


Abstract:


Generally, OSHA standards require that protective equipment (including 
personal protective equipment (PPE)) be provided and used when 
necessary to protect employees from hazards that can cause them injury, 
illness, or physical harm. In this discussion, OSHA uses the 
abbreviation ``PPE'' to cover both personal protective equipment and 
other protective equipment. The Agency has proposed to revise its PPE 
standards to clarify who is required to pay for required PPE and under 
what circumstances. According to the proposal, employers would be 
required to provide all OSHA-required PPE at no cost to employees, with 
the following exceptions: the employer would not need to pay for 
safety-toe protective footwear or prescription safety eyewear if all 
three of the following conditions are met: (1) The employer permits 
such footwear or eyewear to be worn off the job-site; (2) the footwear 
or eyewear is not used in a manner that renders it unsafe for use off 
the job-site (for example, contaminated safety-toe footwear would not 
be permitted to be worn off a job-site); and (3) such footwear or 
eyewear is not designed for special use on the job. Employers are also 
not required to pay for the logging boots required by 29 CFR 
1910.266(d)(1)(v).


Statement of Need:


The regulatory language used in OSHA standards has generally clearly 
stated that the employer must provide PPE and ensure that employees 
wear it. However, the regulatory language regarding the employer's 
obligation to pay for the PPE has varied.


OSHA attempted to clarify its position on the issue of payment for 
required PPE in a compliance memorandum to its field staff dated 
October 18, 1994. The memorandum stated that it was the employer's 
obligation to provide and pay for PPE except in limited situations.


Recently, the Occupational Safety and Health Review Commission declined 
to accept this interpretation (Secretary of Labor v. Union Tank Car, 
OSHRC No. 96-0563). The Commission vacated a citation against an 
employer who failed to pay for OSHA-required PPE, finding that the 
Secretary had failed to adequately explain the policy outlined in the 
1994 memorandum in light of several inconsistent earlier letters of 
interpretation from OSHA. Therefore, the Agency needs to clarify who is 
to pay for PPE under what conditions.


Summary of Legal Basis:


The legal basis for this proposed rule is the need to clarify OSHA's 
intent with regard to the payment for protective equipment required by 
OSHA standards.


Alternatives:


OSHA has considered several alternative approaches to resolving this 
issue, including leaving this as a labor-management issue, issuing 
compliance directives to identify what PPE the employer must pay for, 
or requiring the employer to pay for all PPE. OSHA believes that, in 
this case, revising the standard to clarify who is to pay for the PPE 
is the most appropriate way to proceed. It is the only approach that 
will assure significant public participation in the resolution of this 
issue, and the codification of that resolution.


Anticipated Cost and Benefits:


It is estimated that the proposed rule will shift, at most, annualized 
costs to employers of no more than $62 million across all affected 
industries. It is also estimated that the proposed rule will prevent 
over 47,000 injuries and seven fatalities that occur annually as a 
result of the non-use or misuse of personal protective equipment by 
employees required to pay for their own PPE.


Risks:


Substantive requirements for protective equipment are included in other 
OSHA standards. This proposed rule is designed solely to clarify OSHA's 
intent as to what protective equipment must be paid for by the 
employer. Accordingly, no assessment of risk is required.

[[Page 73429]]

Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            64 FR 15401                                    03/30/99
NPRM Comment Per64 FR 15401                                    06/14/99
Informal Public Hearing End                                    08/13/99
Final Rule                                                     04/00/01
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


Businesses


Government Levels Affected:


State, Local, Federal


Agency Contact:
Marthe B. Kent
Director, Directorate of Safety Standards Programs
Department of Labor
Occupational Safety and Health Administration
Room N3609
200 Constitution Avenue NW
FP Building
Washington, DC 20210
Phone: 202 693-2222
Fax: 202 693-1663
RIN: 1218-AB77
BILLING CODE 4510-23-S




[[Page 73430]]

DEPARTMENT OF TRANSPORTATION (DOT)



Statement of Regulatory Priorities
 The Department of Transportation (DOT) consists of ten operating 
administrations, the Bureau of Transportation Statistics and the Office 
of the Secretary, each of which has statutory responsibility for a wide 
range of regulations. For example, DOT regulates safety in the 
aviation, motor carrier, railroad, mass transit, motor vehicle, 
maritime, commercial space, and pipeline transportation areas. DOT 
regulates aviation consumer and economic issues and provides financial 
assistance and writes the necessary implementing rules for programs 
involving highways, airports, mass transit, the maritime industry, 
railroads, and motor vehicle safety. It writes regulations carrying out 
such disparate statutes as the Americans with Disabilities Act and the 
Uniform Time Act. It regulates the construction and operation of 
bridges over navigable waters, the prevention of oil pollution, and the 
security of commercial aviation and passenger vessels. Finally, DOT has 
responsibility for developing policies that implement a wide range of 
regulations that govern internal programs such as acquisition and 
grants, access for the disabled, environmental protection, energy 
conservation, information technology, property asset management, 
seismic safety, security, and the use of aircraft and vehicles.
 Although it carries this heavy regulatory workload, the Department has 
long been recognized as a leader in Federal efforts to improve and 
streamline the regulatory process and ensure that regulations do not 
impose unnecessary burdens. The Department's regulatory policies and 
procedures provide a comprehensive internal management and review 
process for new and existing regulations and ensure that the Secretary 
and other appropriate appointed officials review and concur in all 
significant DOT rules.
 The Department has adopted a regulatory philosophy that applies to all 
its rulemaking activities. This philosophy is articulated as follows: 
DOT regulations must be clear, simple, timely, fair, reasonable, and 
necessary. They will be issued only after an appropriate opportunity 
for public comment, which must provide an equal chance for all affected 
interests to participate, and after appropriate consultation with other 
governmental entities. The Department will fully consider the comments 
received. It will assess the risks addressed by the rules and their 
costs and benefits, including the cumulative effects. The Department 
will consider appropriate alternatives, including nonregulatory 
approaches. It will also make every effort to ensure that legislation 
does not impose unreasonable mandates.
 DOT continually seeks to improve its regulatory process. The 
Department's creation of an electronic, Internet-accessible docket that 
can also be used to submit comments electronically; the use of direct 
final rulemaking; and the use of regulatory negotiation are three 
examples of this.
 The Department has engaged in a wide variety of activities to help 
cement the partnerships between its agencies and its customers that 
will produce good results for transportation programs and safety. These 
have included summits with front-line regulators and representatives of 
regulated industries. In addition, the Department's agencies have 
established a number of continuing partnership mechanisms in the form 
of rulemaking advisory committees.
 Throughout the Department, we are also actively engaged in the review 
of existing rules to determine whether they need to be revised or 
revoked. These reviews are in accordance with section 610 of the 
Regulatory Flexibility Act, the Department's regulatory policies and 
procedures, Executive Order 12866, and/or the President's directive to 
``consider writing existing regulations in plain language....'' 
Appendix D to our Regulatory Agenda highlights our efforts in this 
area.
Office of the Secretary of Transportation (OST)
 The Office of the Secretary (OST) oversees the regulatory process for 
the Department. OST implements the Department's regulatory policies and 
procedures and is responsible for ensuring the involvement of top 
management in regulatory decisionmaking. Through the General Counsel's 
office, OST is also responsible for ensuring that the Department 
complies with Executive Order 12866 and other legal and policy 
requirements affecting rulemaking, including a number of new statutes 
and Executive orders. Although OST's principal role concerns the review 
of the Department's significant rulemakings, this office also plays an 
important role in the substance of projects concerning aviation 
economic rules and those affecting the various elements of the 
Department.
 OST provides guidance and training regarding compliance with 
regulatory requirements and process for use by personnel throughout the 
Department. OST also plays an instrumental part in the Department's 
efforts to improve our economic analyses, risk assessment, and 
regulatory flexibility analyses. In addition, OST has a leadership role 
in implementing the President's plain language initiatives.
 OST also leads and coordinates the Department's response to 
Administration and congressional proposals that concern the regulatory 
process. The General Counsel's Office works closely with 
representatives of other agencies, the Office of Management and Budget, 
the White House, and congressional staff to provide information on how 
various proposals would affect the ability of the Department to perform 
its safety, infrastructure, and other missions.
 OST is continually incorporating new technology into its rulemaking 
process through the docket management system (DMS). The DMS stores 
electronic images in unalterable form. It includes all rulemaking and 
support documents, public comments, and other documents included in the 
public docket. This electronic docket is accessible via the Internet, 
and now accepts electronic filing of comments. OST and the General 
Counsel's Office includes hyperlinks to other useful DOT regulatory web 
sites, including the public rulemaking dockets, and contacts for many 
issues of special interest to the public (http://regs.dot.gov/).
United States Coast Guard (USCG)
 The United States Coast Guard's statutory responsibilities include 
protecting the marine environment; enforcing U.S. laws and 
international treaties; performing search and rescue; and ensuring 
marine safety and security.
 The majority of the regulatory actions issued by the Coast Guard are 
classified as routine and frequent because they take effect for a 
limited time and at specific locations. These temporary actions allow 
local Coast Guard units to ensure safety during marine events. The 
Coast Guard issues approximately 30 regulations annually that set 
national standards or respond to specific statutory mandates. The 
Marine Safety Council, a board of senior Coast Guard Leaders, approves 
each of these rulemaking projects, monitors the Coast Guard's 
regulatory program, and advises the Commandant on regulatory matters. 
The following are significant aspects of the Coast Guard's regulatory 
program:
 The Coast Guard is an active member of the Vice President's 
            Plain Language

[[Page 73431]]

            Action Network. It has used plain language, including 
            question/answer format to issue rules directly affecting 
            the public, such as raising the threshold of property 
            damage for reports of accidents involving recreational 
            vessels. The Coast Guard issues all new regulations and 
            revisions to whole parts of the CFR in plain language to 
            meet the Presidential Memorandum on Plain Language. Plain 
            language updates will be an important part of the Coast 
            Guard's review of all regulations under the Regulatory 
            Flexibility Act.
 The Coast Guard encourages early public involvement in 
            rulemaking through a variety of public meetings and the 
            ongoing work of ten advisory committees. In addition, 
            public comments are requested on existing rules identified 
            for analysis each year and identified in Appendix D of the 
            fall agenda.
 Recognizing that it should issue only necessary regulations 
            tailored to impose the least burden on society, the Coast 
            Guard has developed a broad Prevention Through People 
            Program, which develops and encourages a wide variety of 
            voluntary actions by industry and individuals to improve 
            marine safety. To support this effort, the Coast Guard has 
            several Quality Partnerships.
 Finally, to ensure that all regulations are necessary, each 
            agenda item specifies how it supports at least one of the 
            goals of the Coast Guard's Strategic Plan. Strategic goals 
            include maritime safety, protection of natural resources, 
            maritime security, maritime mobility, and national defense.
Federal Aviation Administration (FAA)
 The FAA issues regulations to provide a safe, secure, and efficient 
global aviation system for civil aircraft.
 In response to the June 1, 1998, Presidential Memorandum regarding the 
use of plain language in regulations, the FAA re-examined the use of 
plain language in regulations. The result of this review was revisions 
to 14 CFR Part 11, which delineates the process for rulemaking changes. 
This rulemaking effort is only the first of several planned revisions 
to make the regulations more concise and easier to understand. Other 
actions include:
 Supporting the FAA's Safety Agenda on Safer Skies. This agenda 
            is based on a comprehensive review of the causes of 
            aviation accidents and is designed to bring about a five-
            fold (80 percent) reduction in fatal accidents. The 
            reformed rulemaking process supports this agenda by 
            ensuring that appropriate resources are available to 
            support those rulemaking projects identified as the 
            agency's highest priority. Projects related to controlled 
            flight into terrain, loss of control of an aircraft, 
            uncontained engine failures, runway incursions, weather, 
            pilot decisionmaking, and cabin safety are some of the 
            focus areas identified that may result in rulemaking, 
            advisory and guidance materials.
 Continuing to involve the aviation community early in the 
            regulatory process. The FAA obtains input, both on the rule 
            and the economics, from affected parties prior to 
            publishing a proposed regulation by using the Aviation 
            Rulemaking Advisory Committee, which represents members 
            from all aviation interests. It is presently working on the 
            resolution of more than 70 issues. In 1999, the ARAC 
            submitted recommendations on more than 35 rulemaking 
            documents.
 Continuing to harmonize the U.S. aviation regulations with 
            those of other countries. The harmonization of the U.S. 
            regulations with the European Joint Aviation Regulations 
            (JAR) is the FAA's most comprehensive long-term rulemaking 
            effort. The differences worldwide in certification 
            standards, practices and procedures, and operating rules 
            must be identified and minimized to reduce the regulatory 
            burden on the international aviation system. The 
            differences between the FAA regulations and the 
            requirements of other nations impose a heavy burden on U.S. 
            aircraft manufacturers and operators. Harmonization and 
            standardization should help the U.S. aerospace industry 
            remain internationally competitive. While the overall 
            effort to achieve this is global, it will be accomplished 
            by many small, individual, nonsignificant rulemaking 
            projects. The ARAC completed more than 90 reports that will 
            lead to harmonizing FAA and JAA certification regulations.
 Implementing the recommendations of the White House Commission 
            on Aviation Safety and Security. FAA rulemaking actions are 
            continuing in the areas of: 1) revising repair station 
            requirements; and 2) improving security of checked baggage 
            on flights within the United States.
 Continuing to recognize the needs of small entities by 
            complying with the Small Business Regulatory Enforcement 
            Fairness Act and addressing small entity concerns whenever 
            appropriate in rulemaking documents. In response to the 
            Act, the FAA has established a Small Entity Contact, a web 
            site on FAA's home page, a toll free number, and an e-mail 
            address for receipt of inquiries.
 Ensuring that the congressional mandates for rulemaking 
            deadlines established by the FAA Reauthorization Act of 
            1996 are met. One mandate is the issuance of a final rule 
            16 months after the close of the comment period on the 
            proposed rule.
 Top regulatory priorities for 2000-2001 include a duty limitations and 
rest requirements rule to ensure that pilots are sufficiently rested 
for duty, certification of airports, and a flight operational quality 
assurance program proposal to allow for the voluntary disclosure of 
operational safety information.
Federal Highway Administration (FHWA)
 The FHWA anticipates that its priority for fiscal year 2001 will be 
continuing implementation of the Transportation Equity Act for the 21st 
Century (TEA-21), which reauthorizes the surface transportation 
programs administered by the FHWA. The FHWA will continue to implement 
this legislation in the least burdensome and restrictive way possible 
consistent with the FHWA's mission. The FHWA will also pursue 
regulatory reform in areas where project development can be streamlined 
or accelerated, duplicative requirements can be consolidated, 
recordkeeping requirements can be reduced or simplified, and the 
decisionmaking authority of our State and local partners can be 
increased.
 An example of this reform can be found in the FHWA's issuance of 
notices of proposed rulemaking for National Environmental Policy Act 
(NEPA) and Related Procedures for Transportation Decisionmaking and 
Statewide Metropolitan Planning.
Federal Motor Carrier Safety Administration (FMCSA)
 The FMCSA is the newest agency in the Department of Transportation. It 
was established on January 1, 2000 by the Motor Carrier Safety 
Improvement Act of 1999 (MCSIA) (Pub. L.106-159). As required by MCSIA, 
FMCSA has developed a strong Safety Action Plan to guide it towards the 
goal of reducing the number of fatalities resulting from crashes 
involving large trucks by 50 percent from the 1998 baseline by the year 
2010. Setting new performance standards for vehicles, drivers, and 
motor carriers through regulation will

[[Page 73432]]

raise the bar for safety in commercial operations. The FMCSA now is 
responsible for most of the functions of the former Office of Motor 
Carriers in the Federal Highway Administration. These include the 
reform of hours-of-service requirements and the longstanding zero-based 
review of the Federal Motor Carrier Safety Regulations. Other 
regulatory initiatives are required by MCSIA. Over the next year, the 
new FMCSA is committed to developing an effective and efficient 
regulatory program that meets the expectations of Congress, its 
stakeholders and partners, and the general public. This will assist the 
new agency in meeting one of the stated goals of MCSIA to reduce the 
number and severity of large-truck involved crashes through expedited 
completion of rulemaking proceedings.
National Highway Traffic Safety Administration (NHTSA)
 The statutory responsibilities of the National Highway Traffic Safety 
Administration (NHTSA) relating to motor vehicles include reducing the 
number of and mitigating the effects of motor vehicle crashes and 
related fatalities and injuries, providing motor vehicle information to 
consumers, and improving automotive fuel efficiency. NHTSA pursues 
policies that encourage the development of nonregulatory approaches 
when feasible in meeting its statutory mandates. It issues new 
standards and regulations or amendments to existing standards and 
regulations when appropriate. It ensures that regulatory alternatives 
reflect a careful assessment of the problem and a comprehensive 
analysis of the benefits, costs, and other impacts associated with the 
proposed regulatory action. Finally, it considers alternatives 
consistent with the Administration's regulatory principles.
 In addition to numerous programs that focus on the safety and 
performance of the motor vehicle, the Agency is engaged in a variety of 
programs to improve driver behavior. These programs emphasize the human 
aspects of motor vehicle safety and recognize the important role of the 
States in this common pursuit. This goal is accomplished through a 
number of means, including encouraging initiatives in such areas as 
safety belt use, child safety-seat use, activities aimed at combating 
impaired driving and aggressive driving, and consumer information 
activities.
 NHTSA is conducting several program evaluations that are designed to 
review and evaluate the actual benefits, costs, and overall 
effectiveness of existing standards and regulations. For example, it 
will continue evaluating Standard 208's new measures to improve the 
safety performance of air bags, Standard 214's dynamic side-impact 
requirements, and Standard 108's requirement for reflective marking on 
heavy truck trailers to enhance their detection at night or under other 
conditions of reduced visibility. NHTSA will continue evaluating the 
implementation of the American Automobile Labeling Act, which requires 
new passenger cars, pickup trucks, vans, and sport utility vehicles to 
carry labels providing information on their domestic and foreign parts 
content. It is also evaluating the efficacy of child safety seat 
registration for increasing consumer response to recalls of defective 
seats. NHTSA is starting two evaluations of safety equipment for heavy 
trucks and tractor trailers: antilock brake systems (Standard 121) and 
rear impact guards (Standards 223 and 224).
 NHTSA's regulatory program includes additional proposals that will be 
undertaken in order to allow design flexibility, promote new 
technology, and encourage market competition and consumer choice.
Federal Railroad Administration (FRA)
 The Federal Railroad Administration (FRA) exercises regulatory 
authority over all areas of railroad safety.
 Fashioning regulations that have favorable benefit-to-cost ratios, and 
that where feasible, incorporate flexible performance standards, 
requires cooperative action by all affected parties. In order to foster 
an environment of collaborative rulemaking, FRA established the 
Railroad Safety Advisory Committee (RSAC). The purpose of RSAC is to 
develop consensus recommendations for regulatory action on issues 
referred to it by FRA. Where consensus is achieved, and FRA believes it 
serves the public interest, the resulting rule is very likely to be 
better understood, more widely accepted, more cost-beneficial, and more 
correctly applied. Where consensus cannot be achieved, however, FRA 
will fulfill its regulatory role without the benefit of RSAC's 
recommendations.
 The RSAC has met on a quarterly basis so far and currently has working 
groups addressing the following tasks: 1) The development of 
regulations governing track and railroad maintenance equipment; 2) the 
review of FRA regulations for their applicability to historic 
railroads; 3) the development of safety standards for locomotive 
crashworthiness; 4) the development of safety standards for locomotive 
working conditions; 5) the development of locomotive event recorder 
accident survivability standards; 6) the development of regulations 
governing the use of positive train control (PTC) systems; 7) the 
development of a new accident reporting threshold; and 8) revision of 
regulations governing the use of utility employees.
 In addition to RSAC, FRA continues to use collaborative rulemaking to 
address passenger safety issues. FRA established a working group to 
address Passenger Equipment Safety Standards and published a final rule 
in the first phase of this rulemaking initiative in May 1999 based on 
its recommendations. FRA continues to conduct research related to the 
second phase of the rule, and expects to reconvene the working group on 
Passenger Equipment Safety Standards in late 2000. FRA also engaged in 
extensive public outreach to develop regulations regarding the use of 
train whistles, and published an NPRM in January 2000.
Federal Transit Administration (FTA)
 The Federal Transit Administration (FTA) provides financial assistance 
to State and local governments for mass transportation purposes. The 
regulatory activity of FTA focuses on establishing the terms and 
conditions of Federal financial assistance available under the Federal 
transit laws.
 FTA's policy regarding regulations is to:
 Implement statutory authorities in ways that provide the 
            maximum net benefits to society;
 Keep paperwork requirements to a minimum;
 Allow for as much local flexibility and discretion as is 
            possible within the law;
 Ensure the most productive use of limited Federal resources;
 Protect the Federal interest in local investments; and
 Incorporate good management principles into the grant 
            management process.
 As mass transportation needs have changed over the years, so have the 
requirements for Federal financial assistance under the Federal transit 
laws and related statutes. FTA's regulatory priorities for 2000-2001 
are to continue to issue rulemakings required under the

[[Page 73433]]

Transportation Equity Act for the 21st Century (TEA-21), to amend 
existing regulations as needed, and to update existing regulations for 
plain language.
 Of particular importance to FTA is the publication of the Major 
Capital Investment Projects (New Starts) rule which is required by TEA-
21 and will detail how the agency will evaluate and rate proposed 
transit projects as ``recommended,'' ``highly recommended'' or ``not 
recommended.'' FTA will use these ratings to recommend to Congress 
which of the more than 190 projects authorized in TEA-21 should be 
federally funded.
 TEA-21 also requires that FTA and FHWA amend the joint Environmental 
and Statewide and Metropolitan Transportation Planning rules which will 
be of significant interest to States, transit agencies, local 
governmental bodies, and environmental groups.
 The proposed planning rules included provisions for achieving 
consistency with Intelligent Transportation Systems (ITS) projects and 
the National ITS architecture and approved standards.
 In addition FTA will issue a third-party procurement rule. FTA had 
previously issued guidance on the subject in the form of a FTA 
circular. Recipients of FTA funding followed the circular, but as a 
guidance document, the circular did not have the force and effect of 
law. The proposed rule will correct that problem
Maritime Administration (MARAD)
 MARAD administers Federal laws and programs designed to promote and 
maintain an U.S. merchant marine capable of meeting the Nation's 
shipping needs for both national security and domestic and foreign 
commerce.
 MARAD's regulatory objectives and priorities reflect the Agency's 
responsibility of ensuring the availability of adequate and efficient 
water transportation services for American shippers and consumers. To 
advance these objectives, MARAD issues regulations, which are 
principally administrative and interpretive in nature, when 
appropriate, in order to provide a net benefit to the U.S. maritime 
industry.
 MARAD's regulatory priorities are to update existing regulations and 
to reduce unnecessary burden on the public. For example, MARAD remains 
committed to updating and streamlining existing regulations and 
administrative practices governing the following areas: 1) the ship 
financing guarantee process; 2) standards for evaluation and approval 
of applications; and 3) the process and documentation for closing of 
commitments to guarantee obligations issued under these regulations.
Research and Special Programs Administration (RSPA)
 The Research and Special Programs Administration (RSPA) has 
responsibility for rulemaking under two programs. Through the Associate 
Administrator for Hazardous Materials Safety, RSPA administers 
regulatory programs under Federal hazardous materials transportation 
law and the Federal Water Pollution Control Act, as amended by the Oil 
Pollution Act of 1990. Through the Associate Administrator for Pipeline 
Safety, RSPA administers regulatory programs under the Federal pipeline 
safety laws and the Federal Water Pollution Control Act, as amended by 
the Oil Pollution Act of 1990.
 In the area of hazardous materials transportation, the regulatory 
priority is to clarify through rulemaking the applicability of 
regulations to the loading, unloading, and storage of hazardous 
materials incidental to their movement in commerce. Clarifying the 
applicability of the regulations will facilitate compliance with them 
and also clarify when other requirements of Federal, State, local, and 
tribal governments apply.
 The regulatory priority for gas and hazardous liquid pipeline 
transportation is to improve safety and environmental protection by 
managing the risks inherent in pipeline transportation. The key 
regulatory initiatives are to require pipelines to develop integrity 
management programs to validate pipe integrity of pipelines in high-
density population areas, waters where currently commercial navigation 
exists, and areas unusually sensitive to environmental damage. Specific 
regulatory actions to implement this risk-based strategy in high-
consequence areas include definition of areas unusually sensitive to 
environmental damage in the event of a pipeline rupture and integrity 
management rules requiring increased inspection, evaluation, and 
interventions to prevent and mitigate pipeline leaks.
Bureau of Transportation Statistics (BTS)
 The Bureau of Transportation Statistics (BTS) is responsible for 
collecting, compiling, analyzing, and making accessible information on 
the Nation's transportation systems; identifying needs for new 
information and analysis and implementing programs to meet those needs; 
and enhancing the quality and effectiveness of the Department's 
statistical programs through research, the development of guidelines, 
coordination with related information-gathering activities conducted by 
other Federal agencies, and the promotion of improvements in data 
acquisition, archiving, dissemination, and use.
 BTS's Office of Airline Information (OAI), collects airline financial 
and operating statistical data, covering both passenger and cargo 
traffic. This information gives the Government consistent and 
comprehensive economic and market data on individual airline operations 
and is used, for instance, in supporting policy initiatives, 
negotiating international bilateral aviation agreements, awarding 
international route authorities, and meeting international treaty 
obligations. The aviation, travel, and tourism communities value this 
information for a variety of purposes, such as conducting analyses of 
on-time performance, denied boardings, market trends, and economic 
analyses.
 BTS's long-range regulatory priority in the aviation area is to 
conduct a complete review and modernization of the Passenger Origin and 
Destination Survey. BTS can make significant improvements by providing 
data to meet the needs of DOT and other users in a way that takes 
advantage of the information revolution and matches the dramatically 
changing airline industry.
 BTS, in conjunction with the Office of the Secretary, is in the 
process of performing a zero-base review of the financial and traffic 
data to determine what, if any, revisions can be made to the current 
data collections to ensure that these collections fully support the 
Department's mandated aviation responsibilities. Moreover, the review 
will seek to identify potential savings to the affected air carriers 
and the Government that can be accomplished through the application of 
advanced information technologies to the collection, processing, 
validation, and dissemination of aviation data. BTS's review and 
modernization of the Passenger Origin and Destination Survey will be 
incorporated as part of this zero-base review.
Saint Lawrence Seaway Development Corporation (SLSDC)
 The Saint Lawrence Seaway Development Corporation (SLSDC) is a wholly 
owned Government corporation

[[Page 73434]]

created by Congress in 1954. The primary operating service of the SLSDC 
is to ensure the safe transit of commercial and noncommercial vessels 
through the two U.S. locks and navigation channels of the Saint 
Lawrence Seaway System. The SLSDC works jointly with its Canadian 
counterpart to operate and maintain this deep draft waterway between 
the Great Lakes and the Atlantic Ocean. The SLSDC also works jointly 
with its Canadian counterpart on all matters related to rules and 
regulations, overall operations, vessel inspection, traffic control, 
navigation aids, safety, operating dates, and trade development 
programs.
 The regulatory priority of the SLSDC is to provide its customers with 
the safest, most reliable, and most efficient Seaway System possible.
_______________________________________________________________________



DOT--U.S. Coast Guard (USCG)

                              -----------

                          PROPOSED RULE STAGE

                              -----------




93. MARINE TRANSPORTATION-RELATED FACILITY RESPONSE PLANS FOR 
HAZARDOUS SUBSTANCES (USCG-1999-5705)
Priority:


Other Significant


Legal Authority:


33 USC 1321(j); PL 101-380


CFR Citation:


33 CFR 154


Legal Deadline:


None


Abstract:


This project would implement provisions of the Oil Pollution Act of 
1990 that require an owner or operator of a marine transportation-
related facility transferring bulk hazardous substances to develop and 
operate in accordance with an approved response plan. The regulations 
would apply to marine transportation-related facilities that, because 
of their location, could cause harm to the environment by discharging a 
hazardous substance into or on the navigable waters or adjoining 
shoreline. A separate rulemaking, under RIN 2115-AE88, was developed in 
tandem with this rulemaking and addresses hazardous substances response 
plan requirements for tank vessels. This project supports the Coast 
Guard's strategic goals of maritime safety and protection of natural 
resources by reducing the amount of chemicals entering the environment, 
as well as reducing the consequence of pollution incidents. This action 
is considered significant because of substantial public and industry 
interest.


Statement of Need:


This rulemaking is intended to reduce the impact from hazardous 
substance spills from vessels and marine transportation-related 
facilities.


Summary of Legal Basis:


Section 4202(a) of the Oil Pollution Act of 1990 (OPA 90), codified at 
33 U.S.C. 1321(j)(5), mandates that the President issue regulations 
requiring the preparation of oil and hazardous substance discharge 
response plans. Although section 4202(b)(4) of OPA 90 established an 
implementation schedule for these response plans for oil, it did not 
establish a deadline for submission or approval of hazardous substances 
response plans. The Coast Guard has issued separate final rules 
governing response plan requirements for vessels carrying oil in bulk 
as cargo and facilities that handle, store, or transport oil in bulk. 
Under 33 U.S.C. 1321, ``hazardous substances'' are designated by the 
Administrator of the Environmental Protection Agency. The Administrator 
has designated 297 chemicals as hazardous substances under this 
section. The Coast Guard has identified 82 hazardous substances 
currently carried in bulk by vessels, and transferred to or from marine 
transportation-related facilities.


Alternatives:


The Coast Guard intends to determine what types of response strategies 
would be required to address spills of different types of hazardous 
substances. For some substances, containment and recovery may be the 
appropriate response. However, some of the spilled substances may not 
be recoverable from the water and other actions may be necessary. Plans 
would be required, by statute, to address responses to a ``worst case 
discharge.'' For facilities, a ``worst case discharge'' is ``the 
largest foreseeable discharge in adverse weather conditions.''


Anticipated Cost and Benefits:


The potential costs of this rulemaking may include the costs of 
developing and implementing a hazardous substance response plan, 
maintaining contracts for response resources, reviewing and updating 
hazardous substance response plans, maintaining any required equipment, 
and training and exercising response personnel. Potential benefits 
include reduced risk of human exposure and enhanced environmental 
quality from improved ability to respond to, contain, and recover 
spilled hazardous substances. The analysis indicates that this project 
will not be economically significant. A regulatory assessment 
addressing costs and benefits of this rule is available in the public 
docket.


Risks:


Response plans are required by statute. A response plan will not 
prevent a discharge of a hazardous substance, but it may improve the 
response and help to minimize personal injury and damage to the 
environment. This rule should not affect the economic viability of 
facilities involved in transferring hazardous substances in bulk or 
have a significant impact on the volume of hazardous substances shipped 
by marine transportation-related facilities. Most facilities involved 
in transferring hazardous substances in bulk have developed plans, but 
there have not been requirements for standardization.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
ANPRM           61 FR 20084                                    05/03/96
Notice of Public61 FR 34775                                    07/03/96
ANPRM Comment Period End                                       09/03/96
NPRM            65 FR 17416                                    03/31/00
NPRM Comment Period End                                        06/29/00
Final Rule                                                     04/00/01
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


None


Additional Information:


Public hearings regarding this rulemaking were held in Washington, DC, 
on July 30, 1996; Houston, TX, on August 5, 1996; and Houston, TX, on 
February 26 and 27, 1997. Public meetings for the NPRM were held in New 
Orleans, LA, on May 10 and 11, 2000.

[[Page 73435]]

Agency Contact:
LT Michael Roldan
Project Manager, G-MSO
Department of Transportation
U.S. Coast Guard
2100 Second St. SW.
Washington, DC 20593-0001
Phone: 202 267-0106
RIN: 2115-AE87
_______________________________________________________________________



DOT--USCG



94. TANK VESSEL RESPONSE PLANS FOR HAZARDOUS SUBSTANCES (USCG-
1998-4354)
Priority:


Other Significant


Legal Authority:


33 USC 1231; 33 USC 1321(j); PL 101-380


CFR Citation:


33 CFR 155


Legal Deadline:


None


Abstract:


This project would implement provisions of the Oil Pollution Act of 
1990 that require an owner or operator of a tank vessel carrying bulk 
hazardous substances to develop and operate in accordance with an 
approved response plan. The regulations would apply to vessels 
operating on the navigable waters or within the Exclusive Economic Zone 
(EEZ) of the U.S. that carry bulk hazardous substances. A separate 
rulemaking under RIN 2115-AE87 would address hazardous substances 
response plan requirements for marine transportation-related 
facilities. This project supports the Coast Guard's strategic goals of 
maritime safety and protection of natural resources by reducing the 
amount of chemicals entering the environment, as well as reducing the 
consequences of pollution incidents. This project is considered 
significant because of substantial public and industry interest.


Statement of Need:


This rulemaking is intended to reduce the impact from hazardous 
substance spills from vessels.


Summary of Legal Basis:


Section 4202(a) of the Oil Pollution Act of 1990 (OPA 90), codified at 
33 U.S.C. 1321(j)(5), mandates that the President issue regulations 
requiring the preparation of oil and hazardous substance discharge 
response plans. Although 4202(b)(4) of OPA 90 established an 
implementation schedule for these response plans for oil, it did not 
establish a deadline for submission or approval of hazardous substances 
response plans. The Coast Guard has issued separate final rules 
governing response plan requirements for vessels carrying oil in bulk 
as cargo and facilities that handle, store, or transport oil in bulk. 
Under section 1321, ``hazardous substances'' are designated by the 
Administrator of the Environmental Protection Agency. The Administrator 
has designated 297 chemicals as hazardous substances under this 
section. The Coast Guard has identified 82 hazardous substances 
currently carried in bulk by vessels.


Alternatives:


The Coast Guard intends to determine what types of response strategies 
would be required to address spills of different types of hazardous 
substances. For some substances, containment and recovery may be the 
appropriate response. However, some spilled substances may not be 
recoverable from the water and other actions may be necessary. Plans 
would be required, by statute, to address responses to a ``worst case 
discharge.'' For vessels, a ``worst case discharge'' is ``a discharge 
in adverse weather conditions of its entire cargo.''


Anticipated Cost and Benefits:


The potential costs of this rulemaking may include the costs of 
developing and implementing a hazardous substance response plan, 
maintaining contracts for spill-response resources, reviewing and 
updating hazardous substance response plans, maintaining any required 
equipment, and training and exercising response personnel. Potential 
benefits include reduced risk to human health, enhanced environmental 
quality from improved ability to respond to, contain, and recover 
spilled hazardous substances and a reduction in the severity of the 
impact of accidental hazardous substance discharges. A regulatory 
assessment addressing costs and benefits of this rule is available in 
the public docket.


Risks:


Response plans are required by statute. A response plan will not 
prevent a discharge of a hazardous substance, but it may improve the 
response and help to minimize personal injury and damage to the 
environment. This rule should not affect the economic viability of 
vessels involved in transferring hazardous substances in bulk, or have 
a significant impact on the volume of hazardous substances shipped by 
vessel. Most vessels carrying hazardous substances in bulk have 
developed response plans, but there have not been requirements for 
standardization.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
ANPRM           61 FR 20084                                    05/03/96
Notice of Public61 FR 34775                                    07/03/96
ANPRM Comment Period End                                       09/03/96
NPRM            64 FR 13734                                    03/22/99
Notice of Public64 FR 31994                                    06/15/99
NPRM Comment Per64 FR 31994d                                   06/15/99
NPRM Comment Period End                                        06/21/99
NPRM Extended Comment Period End                               08/30/99
Final Rule                                                     04/00/01
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


None


Additional Information:


A public hearing on this rulemaking was held in Houston, TX, on August 
12 and 13, 1999.


Agency Contact:
LT Michael Roldan
Project Manager, G-MSO
Department of Transportation
U.S. Coast Guard
2100 Second St. SW.
Washington, DC 20593-0001
Phone: 202 267-0106
RIN: 2115-AE88
_______________________________________________________________________



DOT--USCG



95. SALVAGE AND FIREFIGHTING EQUIPMENT; VESSEL RESPONSE PLANS 
(USCG-1998-3417)
Priority:


Other Significant


Legal Authority:


33 USC 1321


CFR Citation:


33 CFR 155

[[Page 73436]]

Legal Deadline:


None


Abstract:


Current vessel response plan regulations require that the owners or 
operators of vessels carrying groups I through V petroleum oil as a 
primary cargo identify in their response plans a salvage company with 
expertise and equipment, and a company with firefighting capability 
that can be deployed to a port nearest to the vessel's operating area 
within 24 hours of notification (groups I-IV) or a discovery of a 
discharge (group V). Numerous requests for clarification revealed 
widespread misunderstanding and confusion regarding the regulatory 
language, which will make the implementation of this requirement 
difficult. Based on comments received after the Vessel Response Plan 
final rule publication (61 FR 1052; January 12, 1996) and during a 
Coast Guard hosted workshop, the Coast Guard intends to better define 
the terms ``salvage expertise and equipment'' and ``vessel firefighting 
capability'' requirements and will reconsider the 24-hour deployment 
requirement which was scheduled to go into effect on February 18, 1998. 
Therefore, the Coast Guard suspended the effective dates of the 24-hour 
deployment requirements as published in the final rule. The Coast Guard 
will continue with this project to better define the requirements. This 
rulemaking supports the Coast Guard's strategic goals of maritime 
safety and protection of the natural resources. This rulemaking is DOT-
significant because it concerns a matter of substantial public interest 
or controversy.


Statement of Need:


This rulemaking is intended to reduce the impact of oil spills from 
vessels.


Summary of Legal Basis:


The statutory authority for this rulemaking is 33 U.S.C. 1321.


Alternatives:


The Coast Guard hosted a workshop to solicit comments from the public 
on potential alternatives to the marine salvage and firefighting 
requirements contained in the vessel response plan rule.


Anticipated Cost and Benefits:


Undetermined


Risks:


The purpose of this rulemaking is to better define the terms ``salvage 
expertise and equipment'' and ``vessel firefighting capability'' 
requirements and to reconsider the 24-hour deployment requirement. The 
objective is to improve response and reduce environmental damage from 
oil spills.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
Final Rule - Par63 FR 7069nsion                                02/18/98
NPRM                                                           12/00/00
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


Businesses


Government Levels Affected:


None


Additional Information:


Partial suspension of regulations created through the Vessel Response 
Plan final rule, docket no. 91-034, RIN 2115-AD81


Agency Contact:
LT Douglas Lincoln
Project Manager
Department of Transportation
U.S. Coast Guard
2100 Second Street SW,
Washington, DC 20593-0001
Phone: 202 267-0448
RIN: 2115-AF60
_______________________________________________________________________



DOT--Federal Aviation Administration (FAA)

                              -----------

                          PROPOSED RULE STAGE

                              -----------




96. FLIGHT OPERATIONAL QUALITY ASSURANCE PROGRAM
Priority:


Other Significant


Legal Authority:


49 USC 44101; 49 USC 44701 to 44702; 49 USC 44705; 49 USC 44709 to 
44711; 49 USC 44712; 49 USC 44713; 49 USC 44715; 49 USC 44716 to 44717; 
49 USC 44722; 49 USC 44901; 49 USC 44903 to 44904; 49 USC 44912; 49 USC 
106(g); 49 USC 40113; 49 USC 40119


CFR Citation:


14 CFR 121; 14 CFR 125; 14 CFR 135


Legal Deadline:


None


Abstract:


The FAA proposes to codify an FAA policy encouraging the voluntary 
implementation of Flight Operational Quality Assurance (FOQA) programs 
for the routine analysis of flight data generated during line 
operations that reveal situations which require corrective action to 
prevent safety problems. The rule would also clarify the circumstances 
under which information obtained from voluntary FOQA programs could be 
used in enforcement actions against air carriers, commercial operators, 
or airmen. The rule would require air carriers participating in FOQA 
program to submit aggregate FOQA data to the FAA for use in monitoring 
safety trends. Under the proposed rule, the FAA may use aggregate FOQA 
data as a basis to promulgate safety rulemakings or to address 
situations calling for remedial enforcement action, e.g., a lack of 
qualification on the part of an operator or aircraft. This rulemaking 
is significant because of substantial public interest.


Statement of Need:


The primary purpose of a FOQA program is the enhancement of safety. It 
involves the routine analysis of line operational data to reveal 
situations that require corrective action and to enable early action 
before problems occur. Data is collected and aggregated from numerous 
operations, which is of more value than the assessment of a single 
situation or event. A secondary benefit of FOQA is a cost savings to 
the carriers. The collection of aggregated data may point to certain 
inefficiencies in operations, such as fuel management.


Summary of Legal Basis:


The FAA has broad authority and responsibility to regulate the 
operation of aircraft and the use of the airspace and to establish 
safety standards for and regulate the certification of airmen, 
aircraft, and air carriers. Additionally, on April 5, 2000, the 
President signed the Wendell H. Ford Aviation Investment and Reform Act 
for the 21st Century. Section 510 of the Act requires the Administrator 
to issue a notice of proposed rulemaking proposing ``Flight Operations 
Quality Assurance Rules''. The proposed rules in this NPRM respond to 
section 510 and provide safeguards that will ensure that aviation 
safety is not compromised.


Alternatives:


One alternative is not to propose such a program. This, however, would 
mean

[[Page 73437]]

that the FAA would not be able to collect valuable data that could lead 
to correction or prevention of safety problems. Another alternative is 
to obtain the data by other than voluntary means, e.g., monitoring of 
flight data recorders. This alternative is less desirable since it 
could lead to an atmosphere of mistrust between the carriers and the 
FAA. One benefit of FOQA is a communicative and share interest in 
safety.


Anticipated Cost and Benefits:


The FAA has determined that the costs associated with this rulemaking 
would be minimal.


Risks:


The costs associated with this rulemaking would be minimal.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
Policy Statement63 FR 67505                                    12/07/98
NPRM            65 FR 41528                                    07/05/00
NPRM Comment Period End                                        10/03/00
Final Action                                                   01/00/01
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


Businesses


Government Levels Affected:


None


Additional Information:


Project Number: AFS-93-154R


Agency Contact:
Dan Meier
Flight Standards Service, Regulations Branch
Department of Transportation
Federal Aviation Administration
800 Independence Avenue SW.
Washington, DC 20591
Phone: 202 267-3789
RIN: 2120-AF04
_______________________________________________________________________



DOT--FAA



97. OVERFLIGHTS OF UNITS OF THE NATIONAL PARK SYSTEM
Priority:


Other Significant


Legal Authority:


49 USC 106(g); 49 USC 40103; 49 USC 40113; 49 USC 40120; 49 USC 44101; 
49 USC 44701; 49 USC 44702; 49 USC 44705; 49 USC 44709; 49 USC 44711 to 
44713; 49 USC 44715; 49 USC 44716; 49 USC 44717; 49 USC 44722; 49 USC 
46306


CFR Citation:


14 CFR 91; 14 CFR 93; 14 CFR 121; 15 CFR 135


Legal Deadline:


None


Abstract:


The FAA and National Park Service (NPS) established a joint working 
group which is tasked with developing a notice of proposed rulemaking 
to reduce or prevent adverse effects of aircraft noise over our 
national park system. At the same time, the working group is charged 
with affording those persons who wish to visit our national parks from 
the air the opportunity to do so. The working group met from May to 
November 1997, and developed a concept paper that was approved by the 
Aviation Rulemaking Advisory Committee and the NPS Advisory Board in 
December 1997. A notice of proposed rulemaking has been developed and 
is now being reviewed by the FAA and NPS. In April 1999, the FAA issued 
a disposition of comments to the ANPRM. That document summarizes those 
comments to the ANPRM and provides an update to the public on matters 
concerning air tours over units of the national park system. In 
response to Public Law 106-181, April 5, 2000, the FAA and NPRS are 
developing an NPRM proposing to codify the language of the legislation 
and to adopt an altitude that would define a commercial air tour. This 
rulemaking is significant because of substantial public interest.


Statement of Need:


The need to reduce or prevent the adverse effects of aircraft noise 
over the national parks is apparent for the preservation of a valuable 
national resource. In its Report to Congress, the National Park Service 
identified 98 parks that potentially have an overflight problem. The 
FAA recognizes its role both to provide for the safe and efficient use 
of airspace and to enhance the environment by minimizing the adverse 
effects of aviation in the national parks.


Summary of Legal Basis:


The FAA has broad authority and responsibility to regulate the 
operation of aircraft and the use of the airspace and to establish 
safety standards for and regulate the certification of airmen, 
aircraft, and air carriers. (49 U.S.C. 40101 et seq.) The FAA also has 
responsibility to protect persons and property on the ground. The 
President's Memorandum of April 22, 1996, directed the FAA, working 
with the National Park Service, to issue a notice of proposed 
rulemaking for the management of sightseeing aircraft in those National 
Parks where it is deemed necessary to reduce or prevent the adverse 
effects of noise from such aircraft. Finally, title VIII of Public Law 
106-181, National Parks Air Tour Management Act of 2000 gives the FAA 
the authority to minimize, mitigate or prevent the adverse effect of 
aircraft over national parks.


Alternatives:


During its working sessions, the working group considered a variety of 
criteria for defining an air tour, various triggering events for 
determining which parks are at risk, and various means for the NPS and 
FAA to work together to develop an air tour management plan.


Anticipated Cost and Benefits:


Undetermined.


Risks:


This rulemaking addresses the risk of destruction of valuable national 
resources and the right to enjoy the natural quiet in our national 
parks. At the same time, taking this risk has to be balanced against 
any potential safety problems that restrictions on overflights might 
create. Both the National Park Service and FAA are confident that a 
solution can be reached whereby all visitors to the park may be 
accommodated through an agreed upon park airspace management plan.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
ANPRM           59 FR 12740                                    03/17/94
ANPRM Correction59 FR 15350                                    04/01/94
ANPRM Comment Period End                                       06/15/94
Comment Period E59 FR 31883                                    06/20/94
Notice of Public62 FR 31187                                    06/06/97
Notice of Public63 FR 17040                                    04/07/98
Disposition of C64 FR 17293                                    04/09/99
NPRM                                                           12/00/00
Regulatory Flexibility Analysis Required:


Undetermined


Small Entities Affected:


Businesses

[[Page 73438]]

Government Levels Affected:


None


Additional Information:


Refer to 1999 Regulatory Plan entry RIN 2120-AF93, Airspace Management: 
Special Flight Rules in the Vicinity of the Grand Canyon and also RIN 
2120-AG11, Special Flight Rules in the Vicinity of the Rocky Mountain 
National Park. Project Number: ARM-97-318A


ANALYSIS: Regulatory Evaluation, 12/00/2000


Agency Contact:
Howard Nesbitt
Flight Standards Service
Department of Transportation
Federal Aviation Administration
800 Independence Avenue SW
Washington, DC 20591
Phone: 202 493-4981
RIN: 2120-AF46
_______________________________________________________________________



DOT--FAA



98. FLIGHT CREWMEMBER DUTY PERIOD LIMITATIONS, FLIGHT TIME 
LIMITATIONS, AND REST REQUIREMENTS
Priority:


Other Significant


Legal Authority:


49 USC 106(g); 49 USC 40113; 49 USC 40119; 49 USC 44101; 49 USC 44701 
to 44701; 49 USC 44705; 49 USC 44709 to 44711; 49 USC 44712; 49 USC 
44713; 49 USC 44715; 49 USC 44716 to 44717; 49 USC 44722; 49 USC 44901; 
49 USC 44903 to 44904; 49 USC 44912


CFR Citation:


14 CFR 121; 14 CFR 135


Legal Deadline:


None


Abstract:


This rulemaking would amend the regulations on duty period limitations, 
flight time limitations, and rest requirements for flight crewmembers 
engaged in air transportation. The FAA proposes additional changes in 
response to comments received on the NPRM. The changes are necessary to 
ensure that the rules will continue to provide the minimum level of 
safety. This rulemaking responds to public and congressional interest 
in regulating flight crewmember rest requirements, NTSB Safety 
Recommendations, petitions for rulemaking, and scientific data. This 
action is considered significant because of substantial public 
interest.


Statement of Need:


The aviation community requires 24-hour activities to meet operational 
demands. Growths in long-haul, regional, overnight cargo, and short-
haul domestic operations are increasing. Therefore, shift work, night 
work, irregular work schedules, and time zone changes will continue to 
be commonplace.


With this growth, the scientific knowledge about sleep, sleep 
disorders, circadian physiology, fatigue, and performance decrements 
has also grown. Some of the scientific knowledge has indicated that 
aviators experience performance-impairing fatigue from sleep loss 
resulting from current flight and duty practices.


In addition, industry and individuals have told the FAA that the 
current regulations are confusing and difficult to enforce. Therefore, 
a second purpose of the rulemaking is to establish consistent and clear 
duty period limitations and rest requirements for all types of 
operations.


Summary of Legal Basis:


Section 44701, Title 49 of the United States Code states that the 
Administrator shall promote safety of flight of civil aircraft in air 
commerce by prescribing minimum standards required in the interest of 
safety.


Alternatives:


One obvious alternative would be to continue with the current rules, 
however, these regulations are rapidly becoming obsolete. As a second 
alternative, one commenter asked that the FAA develop a standard and 
then allow each carrier to design a rest/duty program that would meet 
that standard while accommodating differences in operations. While this 
works for certain rules, such as training regulations where the 
standard is training to proficiency, there is no way to apply this 
application to individual pilots on a daily basis.


Anticipated Cost and Benefits:


Undetermined.


Risks:


Although there has been only one identifiable accident due to pilot 
fatigue, fatigue is increasingly becoming the focus of possible causes 
following all accidents. Pilot reports of being fatigued to the point 
of incapacity are not uncommon, and intuitively, it is reasonable, 
given the sheer volume of air traffic, to expect fatigue to be a factor 
in future accidents if the regulations are not corrected.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            60 FR 65951                                    12/20/95
NPRM Comment Period End                                        03/19/96
Comment Period E61 FR 11492                                    03/20/96
SNPRM                                                          03/00/01
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses


Government Levels Affected:


None


Additional Information:


Project Number: AFS-94-443R


ANALYSIS: Regulatory Evaluation, 12/20/95, 60 FR 65951


Agency Contact:
Alberta Brown
Air Transportation Division
Department of Transportation
Federal Aviation Administration
800 Independence Avenue SW
Washington, DC 20591
Phone: 202 267-8321

Quentin Smith
Department of Transportation
Federal Aviation Administration
800 Independence Avenue SW.
Washington, DC 20591
Phone: 202 267-8166
RIN: 2120-AF63
_______________________________________________________________________



DOT--FAA

                              -----------

                            FINAL RULE STAGE

                              -----------




99. CERTIFICATION OF AIRPORTS
Priority:


Other Significant


Legal Authority:


49 USC 106(g); 49 USC 40113; 49 USC 40119; 49 USC 44101; 49 USC 44701 
to 44706; 49 USC 44709 to 40711; 49 USC 44713; 49 USC 44716 to 44717; 
49 USC 44719; 49 USC 44722; 49 USC 44901; 49 USC 44903 to 44904; 49 USC 
44912; 49 46105

[[Page 73439]]

CFR Citation:


14 CFR 121; 14 CFR 139


Legal Deadline:


None


Abstract:


This action proposes to revise the current airport certification 
regulation and to establish certification requirements for airports 
serving scheduled air carrier operations in aircraft with 10-30 seats. 
In addition, changes are proposed to address National Transportation 
Safety Board recommendations and petitions for exemptions and 
rulemaking. A section of an air carrier operation regulation also would 
be amended to conform with proposed changes to airport certification 
requirements. The FAA believes that these proposed revisions are 
necessary to ensure safety in air transportation and to provide a 
comparable level of safety at all certificated airports. This action is 
significant because of substantial public interest.


Statement of Need:


The last major revision to the airport certification regulation 
occurred in 1987, and since then, industry practices, and technology 
have changed. To respond to such changes, the FAA is proposing to 
revise the regulation to clarify and update several requirements. 
Additionally, with the passage of the 1996 FAA Reauthorization Act, 
Congress provided the FAA the necessary authority to certificate 
airports serving scheduled air carrier operations with 10 to 30 seat 
aircraft, except in the State of Alaska (in addition to existing 
authority to regulate airports serving air carrier operations using 
aircraft with more than 30 seats). To achieve a comparable level of 
safety at all covered airports, FAA now proposes to exercise this 
authority and amend the regulation to incorporate airports serving 
smaller air carrier aircraft into the FAA's airport certification 
program. Also, the 2000 FAA Reauthorization Act (P.L. 106-181) mandates 
publication of the NPRM within 60 days of the Act's enactment; and 
publication of the final rule within one year of the close of comment 
period for airports serving smaller air carrier aircraft.


Summary of Legal Basis:


FAA has general and specific authority to regulate airports as set out 
in 49 USC 106(g) and 44701.


Alternatives:


The FAA has considered several alternative approaches to this proposed 
rulemaking and has attempted to minimize the potential economic impact 
of the proposal; especially the impact on small entities. In addition, 
this action fulfills the FAA's responsiblilty to meet deadlines 
established by Congress to certificate airports serving scheduled air 
carrier operations with 10-30 seat aircraft, except for the State of 
Alaska. The FAA considered alternatives based on two issues. Issue 1 
was the revision of 14 CFR 139, and Issue 2 was the certification of 
airports serving scheduled operations of small air carrier aircraft 
with 10-30 passenger seats. The FAA determined that it was necessary to 
revise 14 CFR 139 and that the revised part 139 should include the 
certification of airports serving scheduled air carrier operations with 
10-30 passenger seat aircraft.


Anticipated Cost and Benefits:


Most of the costs of this proposed rule are associated with the 
proposed improvements to safety and operational requirements. Most of 
these costs result from the expansion of ARFF services. The present 
value of the total cost of the rule over a 10-year period is 
approximately $46 million, which includes training, additional 
emergency response protection, wildlife management, and an updated 
airport certification manual that better reflects current best 
practices. With the tremendous cost of aviation accidents, the proposed 
rule provides the potential for enhanced safety for a reasonable cost. 
The expected benefit of this proposed rule is an enhanced level of 
safety resulting in reduced fatalities, injuries, and property damage 
at airports with scheduled air carrier operations, particularly 
operations in aircraft configured with 10 to 30 passenger seats. The 
cost of a single accident of a 30-seat scheduled passenger aircraft is 
greater than the total cost of the proposa. Other benefits of this 
proposal include provisions for snow and ice control, wildlife 
management, and training.


Risks:


The purpose of this rulemaking is to expand and enhance the safety 
benefits of the current regulation by providing, to the extent 
possible, a comparable level of safety at all airports used by air 
carriers.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            65 FR 38636                                    06/21/00
NPRM Comment Period End                                        09/19/00
Final Action                                                   09/00/01
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


None


Additional Information:


Project Number: AAS-97-072R.


ANALYSIS: Regulatory Evaluation, 06/21/00


Agency Contact:
Linda Bruce
Office of Civil Aviation Security
Department of Transportation
Federal Aviation Administration
800 Independence Avenue SW
Washington, DC 20591
Phone: 202 267-8553
RIN: 2120-AG96
_______________________________________________________________________



DOT--Federal Highway Administration (FHWA)

                              -----------

                            FINAL RULE STAGE

                              -----------




100. STATEWIDE METROPOLITAN PLANNING
Priority:


Other Significant


Legal Authority:


23 USC 104(f); 23 USC 134; 23 USC 135; 23 USC 217; 23 USC 315; 42 USC 
7410 et seq; 49 USC 5305 to 5309


CFR Citation:


23 CFR 450; 49 CFR 613; 49 CFR 1.48(b); 49 CFR 1.51


Legal Deadline:


None


Abstract:


In this action, the FHWA and the FTA are jointly proposing to revise 
the regulations governing the development of transportation plans and 
programs for urbanized (metropolitan) areas and States. These revisions 
are the product of statutory changes made by the Transportation Equity 
Act for the 21st

[[Page 73440]]

Century (TEA-21), which requires a continuous, comprehensive and 
coordinated process in metropolitan areas and States. The regulation at 
23 CFR part 450 is being modified to reflect the impacts of the TEA-21. 
These changes are being proposed in concert with revisions to 
regulations concerning environmental impact and related procedures and 
ITS architecture consistency.


The intent of these changes is to more effectively link planning 
regulations and environmental streamlining regulations to facilitate 
integration of decisions, reduce paperwork and analytical activity, 
where feasible, and to refine procedures and processes to achieve 
greater efficiency in decisionmaking.


In addition, the agencies believe that an integrated approach to 
planning and project development will contribute to more effective and 
environmentally sound decisions regarding investment choices.


Statement of Need:


The Transportation Equity Act for the 21st Century (TEA-21) amended 23 
U.S.C. 134 and 135, which require a continuing, comprehensive and 
coordinated transportation planning process in metropolitan areas and 
States. Revisions have been proposed for existing regulatory language 
to make it consistent with current statutory requirements.


Summary of Legal Basis:


Sections 1203, 1204, and 1308 of the TEA-21(Public Law 105-178), 
amended 23 U.S.C. 134 and 135. Similar changes were made by sections 
3004, 3005, and 3006 of the TEA-21 to 49 U.S.C. 5303-5306 which address 
the metropolitan planning process in the context of the FTA's 
responsibilities.


Revisions to the current regulation at 23 CFR part 450 have been 
proposed to reflect the impacts of the TEA-21. The agencies have 
adopted an approach to the proposed revisions that will rely heavily on 
guidance and good practice. The proposed regulatory language attempts 
to respond to legislative mandates and changes with minimal 
amplification where feasible. In some cases, other factors, e.g., 
recent court cases, presidential directives, etc., have provided a 
stimulus for change and amplification. In these instances, the agencies 
have tried to keep the regulatory language to a minimum except where 
clarification would assist appropriate agencies and groups in 
complying.


Alternatives:


Recent court decisions and statutory changes direct at least some 
modification of existing regulations (e.g., reduction in planning 
factors from 16 to 7). If regulatory changes are restricted to only 
those required to reconcile existing law and regulations, the remaining 
changes could be accomplished through guidance.


Anticipated Cost and Benefits:


The agencies sought comments regarding the potential economic impacts 
of these proposed rules on small entities and governments. Of specific 
concern are the additional costs of the incremental changes in 
regulatory requirements. The agencies believe that these costs have 
been off-set largely by reduced statutory requirements and the 
flexibility built into the regulations. The agencies have requested 
comments on these issues.


Risks:


A failure to issue a regulation could generate increased implementation 
challenges in working with affected agencies, i.e., difficulty in 
achieving compliance with expected regulatory outcomes.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            65 FR 33958                                    05/25/00
Final Action                                                   12/00/00
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


Governmental Jurisdictions


Government Levels Affected:


State


Agency Contact:
Sheldon M. Edner
Team Leader
Department of Transportation
Federal Highway Administration
Room 3232
400 Seventh Street SW
Washington, DC 20590
Phone: 202 366-4066
Email: [email protected]
RIN: 2125-AE62
_______________________________________________________________________



DOT--FHWA



101. NEPA AND RELATED PROCEDURES FOR TRANSPORTATION 
DECISIONMAKING; PROTECTION OF PUBLIC PARKS, WILDLIFE AND WATERFOWL 
REFUGES AND HISTORIC SITES
Priority:


Other Significant


Legal Authority:


42 USC 4321 et seq.; 49 USC 303; 23 USC 109; 23 USC 128; 23 USC 134; 23 
USC 138; 23 USC 315; ...


CFR Citation:


23 CFR 530; 23 CFR 540


Legal Deadline:


None


Abstract:


The Federal Highway Administration and the Federal Transit 
Administration are issuing an NPRM to propose updating and revising the 
National Environmental Policy Act implementing regulation for FHWA and 
FTA funded or approved projects. The current regulations were issued in 
1987 (23 CFR part 771, August 28, 1987) and experience since that time, 
as well as changes in legislation, most recently by the Transportation 
Equity Act for the 21st Century (TEA-21), call for an updated approach 
to implementation of NEPA for FHWA and FTA projects and actions.


Under this proposed rulemaking, the FHWA/FTA regulation for 
implementing NEPA would be moved to a new part (23 CFR part 1420) and 
would be revised to further emphasize using the NEPA process to 
facilitate effective and timely decisionmaking. Regulatory provisions 
relating to protection of parkland, wildlife and waterfowl refuges and 
historic sites would become a separate part (23 CFR 1430).


Statement of Need:


The current NEPA regulation was issued in 1987 and experience since 
that time, as well as changes in legislation, most recently by the 
Transportation Equity Act for the 21st Century (TEA-21), call for an 
updated approach to implementation of NEPA for FHWA and FTA projects 
and actions.


Summary of Legal Basis:


By including the environmental streamlining provision in section 1309

[[Page 73441]]

of the TEA-21, (Public Law 105-178, 112 Stat. 108 at 232), the Congress 
intended that transportation planning and environmental considerations 
be better coordinated and that project delivery schedules be improved 
through a process that is efficient, comprehensive, and streamlined.


Alternatives:


The existing regulation has not been revised since 1987 and has been 
overtaken by at least two transportation reauthorization bills. It 
needs to be comprehensively updated to ensure consistency with current 
statutes and legal precedent. A minimal nonregulatory approach might 
achieve some desired outcomes, but would be insufficient. Environmental 
streamlining outcomes will be achieved largely through interagency 
coordination among Federal resource and permit agencies, but would be 
more effective if supported by this revision.


Anticipated Cost and Benefits:


It is anticipated that the economic impact of this rulemaking will be 
minimal. Most costs associated with these rules are attributable to the 
provisions of the TEA-21, the Intermodal Surface Transportation 
Efficiency Act of 1991 (ISTEA), the Clean Air Act (as amended) and 
other statutes, including earlier highway acts. The agencies consider 
this proposal to be a means to simplify, clarify, and reorganize 
existing regulatory requirements.


Risks:


Statutory directives require at least some regulatory changes. 
Environmental streamlining may be achieved through interagency 
collaboration, but would be substantially enhanced by the issuance of a 
final rule.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            65 FR 33960                                    05/25/00
Comment Period E65 FR 41892                                    07/07/00
Comment Period End                                             09/23/00
Final Action                                                   12/00/00
Regulatory Flexibility Analysis Required:


No


Government Levels Affected:


None


Additional Information:


This action will incorporate the issues contained in RIN 2125-AD32.


Agency Contact:
Fred Skaer
Office of Environment and Planning
Department of Transportation
Federal Highway Administration
400 Seventh Street SW.
Washington, DC 20590
Phone: 202 366-2058
RIN: 2125-AE64
_______________________________________________________________________



DOT--National Highway Traffic Safety Administration (NHTSA)

                              -----------

                          PROPOSED RULE STAGE

                              -----------




102. FRONTAL OFFSET PROTECTION
Priority:


Other Significant. Major under 5 USC 801.


Legal Authority:


49 USC 322; 49 USC 30111; 49 USC 30115; 49 USC 30117; 49 USC 30166


CFR Citation:


49 CFR 571.208


Legal Deadline:


None


Abstract:


The agency is considering establishing a Federal motor vehicle safety 
standard for high speed frontal offset crash testing. The frontal 
offset test is a crash test for automobiles and light trucks in which 
the subject vehicles are run into a deformable honeycomb barrier. The 
barrier contacts only 40 percent of the front of the vehicle simulating 
off-center frontal collision. The agency is considering adding the 
offset test to the frontal occupant protection standard to measure 
vehicle structural integrity and reduce the number and severity of 
lower-body injuries.


Statement of Need:


While the Federal motor vehicle safety standards already contain a 
frontal crash test, injuries and fatalities still occur in various 
types of frontal crashes. The European Union determined that the best 
test for frontal occupant protection would be an offset test with 
belted test dummies. As part of the House of Representatives Conference 
Report 104-785, to accompany H.R. 3675, the National Highway Traffic 
Safety Administration was directed on September 16, 1996, to conduct 
research ``...toward establishing a Federal motor vehicle safety 
standard for frontal offset crash testing.'' Such a standard would 
harmonize with the European Union frontal crash standard. Subsequent 
research results with the 50th percentile male and the 5th percentile 
female Hybrid III dummies suggest that additional safety benefits would 
be provided for the neck and the upper and lower tibia under the offset 
test conditions.


Summary of Legal Basis:


Section 30111,Title 49 of the United States Code, states the Secretary 
shall prescribe motor vehicle safety standards. As part of the House of 
Representatives Conference Report 104-785, to accompany H.R. 3675, the 
National Highway Traffic Safety Administration was directed on 
September 16, 1996, to conduct research ``...toward establishing a 
Federal motor vehicle safety standard for frontal offset crash 
testing.''


Alternatives:


Since this program is oriented primarily toward adopting an existing 
European standard, the agency will focus on existing test procedures. 
However, the agency is working through the national and international 
biomechanical engineering community to develop better test devices such 
as improved dummy legs. Comments will be sought on the best dummy 
designs in the agency's proposal.


Anticipated Cost and Benefits:


A report prepared for the Australian Government estimates that adding 
an offset test may result in a 15 percent reduction in ``Harm.'' Harm 
is a calculation of the cost of trauma and is the product of the 
frequency of injury and cost to the community. Most of these benefits 
would be seen in reduction in lower body and leg injuries. The agency 
has not determined the specific benefits of this test procedure.


The agency estimates that for vehicles that cannot currently pass this 
test, vehicle modifications would cost $14 per vehicle. Based on an 
estimate that 25 percent of the fleet would need to be modified, the 
total annual cost to the consumers would be $60 million dollars.


Risks:


Current motor vehicles provide numerous occupant protection systems, 
such as safety belts and strategically-placed energy absorption 
materials such as foam padding. However, an estimated 3,300 people per 
year are

[[Page 73442]]

killed and 400,000 people per year are injured in frontal offset 
crashes.


The agency knows of no disadvantages to implementing this requirement.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           12/00/00
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


Businesses


Government Levels Affected:


None


Agency Contact:
Clarke Harper
Division Chief, Light Duty Vehicle Division
Department of Transportation
National Highway Traffic Safety Administration
400 Seventh Street SW.
Washington, DC 20590
Phone: 202 366-2264
Fax: 202 366-4329
Email: [email protected]
RIN: 2127-AH73
_______________________________________________________________________



DOT--Federal Railroad Administration (FRA)

                              -----------

                          PROPOSED RULE STAGE

                              -----------




103. POSITIVE TRAIN CONTROL
Priority:


Other Significant


Legal Authority:


49 USC 20103


CFR Citation:


49 CFR 234; 49 CFR 236


Legal Deadline:


None


Abstract:


Consistent with Congressional mandate, FRA has continued its commitment 
to identifying high risk corridors which may better support PTC 
investment; supporting PTC technology development, testing and 
compatibility; and promoting deployment of PTC technology on high risk 
corridors in the near future. In September, 1997, FRA initiated joint 
fact finding efforts through the Railroad Safety Advisory Committee 
(RSAC) Working Group on PTC. The advice and recommendations of RSAC 
will form the basis for proceeding to an NPRM. The rulemaking will 
address technical standards for PTC, amending 49 CFR part 236.


Statement of Need:


Current FRA regulations do not adequately address the use of signal and 
train control technology which is processor-based. In fact, application 
of current regulations to processor-based systems can create absurdly 
burdensome requirements. Recently, use of this technology has begun to 
increase on the general system of North American railroads, placing new 
demands on agency resources to ensure the safety objectives 
contemplated by the current regulations are achieved. The existence of 
federal regulations addressing this subject matter would further 
encourage safe use of the technology, which would reduce the risk of 
train-to-train collisions, better enforce speed restrictions, and 
increase the level of protection to roadway workers and their 
equipment. These improvements will likely result in fewer fatalities, 
injuries, and economic damage associated with such risks. Given the 
potential for substantial safety benefits across the spectrum that this 
program represents, this initiative is extremely important to the 
agency.


Summary of Legal Basis:


FRA is issuing this proposal pursuant to its general rulemaking 
authority. 49 U.S.C. 20103(a). Currently, railroads may discontinue or 
materially alter a signal system initially required by the Secretary of 
Transportation only with approval from the Secretary. 49 U.S.C. 20502. 
Exercise of both of these powers has been delegated to the FRA 
Administrator. 49 C.F.R. 1.49.


Alternatives:


Currently, FRA accepts waiver applications from railroads that seek 
relief from FRA safety regulations in order to test new signal and 
train control equipment. Since FRA must consider the safety 
ramifications of each application on a case-by-case basis, this 
procedure can take years.


Prior to this action, FRA has considered:(1) leaving the existing 
regulatory requirements as is, (2) eliminating all regulation of signal 
and train control systems, and (3) adopting a specification standard 
for the design of processor-based signal and train control systems. 
However, agency inaction would hinder introduction of new, safer 
technology into railroad signal and train control, elimination of all 
railroad signal and train control system regulation would be a total 
abdication of the agency's statutory duties, and a specification 
standard would inhibit innovative signal and train control system 
designs.


Anticipated Cost and Benefits:


The proposed rule would provide standards for the design of processor-
based signal and train control systems, but would not mandate their 
usage. FRA believes that a railroad would adopt such a system under one 
or more of the following conditions: (1) the new system is safer; (2) 
the new system is less expensive; and (3) continued maintenance of the 
existing system is no longer feasible. The proposed rule would ensure 
that any replacement system is at least as safe as the current system. 
Concerning existing processor-based systems, the proposed rule would 
require railroads to adopt a software management plan, which will 
ensure proper software configuration, resulting in decreased risk of 
train accidents due to signal malfunction. FRA has not quantified these 
benefits because of the difficulties in estimating how many systems are 
likely to be affected by this rule, what the incremental cost would be, 
and when the benefits would occur.


Most of the costs of this proposed rule are associated with Safety 
documentation required to demonstrate compliance with the performance 
standard. As with many performance standards, this rule would require 
substantial safety documentation from the railroad to demonstrate 
compliance, both up front and during the life cycle of the system. It 
appears that the primary cost involved in this proposed rule will be 
the product risk assessment, a one-time expense presently incurred by 
product suppliers. For current processor-based systems, railroads face 
the cost of implementing a software management control plan, which is 
less expensive than attempting to satisfy current requirements, which 
did not contemplate the use of processor-based technology.


Overall, it appears that the benefits of the proposed rule outweigh the 
costs.


Risks:


The risk category addressed by the proposed rule is that of accidents 
which occur due to improper signaling or train control. This may result 
in train-to-train collisions, derailments due to excessive train speed, 
and trains

[[Page 73443]]

penetrating the work limits of roadway workers.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           01/00/01
Regulatory Flexibility Analysis Required:


Undetermined


Small Entities Affected:


Businesses


Government Levels Affected:


Undetermined


Federalism:


 Undetermined


Additional Information:


FRA has separated out of this rulemaking its action entitled Radio 
Communication, which revised its radio rules for more flexibility and 
to include requirements for the presence of radios and/or some means of 
wireless communication (RIN 2130-AB19).


Agency Contact:
David T. Matsuda
Trial Attorney
Department of Transportation
Federal Railroad Administration
400 Seventh Street SW.
Washington, DC 20590
Phone: 202 493-6046
RIN: 2130-AA94
_______________________________________________________________________



DOT--FRA

                              -----------

                            FINAL RULE STAGE

                              -----------




104. WHISTLE BANS AT HIGHWAY-RAIL GRADE CROSSINGS
Priority:


Other Significant


Legal Authority:


49 USC 20153


CFR Citation:


49 CFR 222


Legal Deadline:


Final, Statutory, November 2, 1996.


Abstract:


This action would govern when and how train whistles at grade crossings 
must be sounded. FRA has found that failing to use the locomotive horn 
can significantly increase the number of collisions with motorists 
using the crossing. This action is considered significant because of 
substantial public interest. This action is being taken pursuant to 
statutory mandate. FRA studied the consequences of the proposed action 
and prepared a draft environmental impact statement (EIS) for the 
proposed rule.


Statement of Need:


This rule is required by the Swift Development Act of 1994 (Act). The 
Act requires the use of locomotive horns at every public highway-rail 
grade crossing but gives FRA the authority to make reasonable 
exceptions. Congress amended this law in 1996 to require that FRA take 
into account the interest of the communities with pre-existing 
restrictions on locomotive horns.


Summary of Legal Basis:


Issuance of this rule is required by 49 USC 20153.


Alternatives:


There was no alternative to initiating this rulemaking, as it is 
required by statute. However, the rule would provide a list of 
supplementary measures the FRA has determined to be effective 
substitutes for the locomotive horn in the prevention of highway-rail 
grade crossing casualties. The rule would also allow for whistle bans 
if there are alternative safety measures that compensate for the lack 
of a locomotive horn.


Anticipated Cost and Benefits:


The problems considered by this rule are collisions and their 
associated casualties and property damage involving vehicles on public 
highways and the front ends of trains at whistle-ban grade crossings.


The costs of this rulemaking will be incurred predominantly by 
communities. However, there are also costs to railroads and to the 
Federal government. At this time, FRA does not know how many businesses 
would be impacted or the severity of the impact if a community elects 
to follow the mandate and become subject to whistleblowing at 
crossings. Nevertheless, the estimated benefits in terms of lives saved 
and injuries prevented will exceed the costs imposed on society for the 
proposed rule. Even under the best case scenario (falling collision 
rates over time) the safety benefits alone, excluding any benefit to 
railroads, exceed the most costly realistic scenario for community 
safety enhancements.


Risks:


As a result of studies conducted on accident rates at crossings at 
which locomotive horns are banned, FRA has concluded that such 
crossings generally result in a higher risk of accident than at 
crossings at which horns are sounded. FRA has compared the number of 
collisions occurring within ten different groups of crossings grouped 
by risk and found that the risk of a collision was 62 percent greater 
at crossings equipped with automatic gates and flashing lights than at 
similarly equipped crossings across the nation without bans. FRA 
analysis also indicated that whistle ban crossings without gates, but 
equipped with flashing light signals and/or other types of active 
warning devices, on average, experienced 119 percent more collisions 
than similarly equipped crossings without whistle bans. Congress 
requires that FRA issue a regulation requiring the sounding of 
locomotive horns at all public highway rail grade crossings. However, 
an exception to the requirement is permissible in circumstances in 
which there is not a significant risk of loss of life or serious 
personal injury, use of the locomotive horn is impractical, or 
supplementary safety measures fully compensate for the absence of the 
warning provided by the horn. Issuance of the rule would lower the 
increased collision risk associated with crossings at which no 
locomotive horns are sounded.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            65 FR 2230                                     01/13/00
NPRM Comment Period End                                        05/26/00
Final Action                                                   01/00/01
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses


Government Levels Affected:


State, Local


Federalism:


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

[[Page 73444]]

Agency Contact:
Mark Tessler
Trial Attorney
Department of Transportation
Federal Railroad Administration
400 Seventh Street SW.
Washington, DC 20590
Phone: 202 493-6061
RIN: 2130-AA71
_______________________________________________________________________



DOT--Research and Special Programs Administration (RSPA)

                              -----------

                          PROPOSED RULE STAGE

                              -----------




105. APPLICABILITY OF THE HAZARDOUS MATERIALS REGULATIONS TO 
LOADING, UNLOADING, AND STORAGE
Priority:


Other Significant


Legal Authority:


49 USC 5101 to 5127


CFR Citation:


49 CFR 106 to 107; 49 CFR 171 to 180


Legal Deadline:


None


Abstract:


This rulemaking proposes to better define the applicability of the 
Federal Hazardous Materials Regulations (HMR) in order to clarify the 
relationship among Federal, State, local, and tribal agencies in the 
regulation of hazardous materials. Under circumstances specified in 
Federal statutes, the regulations of other Federal agencies (EPA and 
OSHA) and non-Federal governments (States, localities, and Indian 
tribes) must be consistent with or defer to RSPA's regulation of the 
transportation of hazardous materials in commerce. However, other 
Federal and non-Federal requirements are generally not limited where 
hazardous materials are not in transportation. Activities relating to 
loading, unloading, and storage of hazardous materials have become 
areas of particular uncertainty and concern to both industry and non-
Federal governments. This action is significant because of the 
substantial public interest in reducing uncertainty and avoiding 
conflicting regulations.


Statement of Need:


In recent years, RSPA has issued interpretations and administrative 
decisions on a case-by-case basis about whether particular activities 
are in ``transportation'' and therefore subject to regulation under the 
HMR. Because of increasing State and local regulation of hazardous 
materials, RSPA concluded that an overall rulemaking is appropriate, 
rather than just case-by-case decisions. RSPA believes that better 
overall definitions of the applicability of the HMR will reduce 
uncertainty by the regulated community and other regulatory agencies 
(both Federal and non-Federal) as to which agency has regulatory 
authority. Greater certainty in this regard should promote improved 
compliance with the HMR and also with the requirements of other 
regulatory agencies.


Summary of Legal Basis:


Section 5103 of title 49 U.S.C. specifies that the Secretary shall 
prescribe regulations for the safe transportation of hazardous 
materials in intrastate, interstate, and foreign commerce applicable 
to, among others, any person who offers hazardous materials for 
transportation or who transport hazardous materials in commerce. In 
addition, section 5125 of title 49 U.S.C. sets forth the circumstances 
under which differing non-Federal requirements are preempted.


Alternatives:


Commenters to the ANPRM and SANPRM suggested alternative ways to 
describe the applicability of the HMR. One suggestion is to describe 
the applicability of the HMR in relationship to specific transportation 
functions. Another is to describe the applicability of the HMR over 
specific regulated entities, such as those who offer hazardous 
materials for transportation or those who transport hazardous 
materials. RSPA is considering each of the alternatives proposed.


Anticipated Cost and Benefits:


The potential costs and benefits of this action have not been 
determined. A preliminary regulatory evaluation will be developed.


Risks:


Clarifying the applicability of the HMR should reduce uncertainty as to 
which regulatory agency's requirements apply to any particular activity 
involving hazardous materials and improve compliance with the HMR, the 
requirements of EPA and OSHA, and non-Federal requirements. This should 
result in improved compliance with the applicable regulatory 
requirements, and improve hazardous materials transportation safety, 
reduce risks to the environment from hazardous materials, and promote 
workplace safety at facilities that manufacture or handle hazardous 
materials.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
ANPRM           61 FR 39522                                    07/29/96
ANPRM Comment Period End                                       11/30/96
SANPRM          64 FR 22718                                    04/27/99
Extension Comment Period Published for SANPRM                  07/26/99
SANPRM Comment Period End                                      08/25/99
NPRM                                                           12/00/00
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses


Government Levels Affected:


Federal, State, Local, Tribal


Federalism:


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


Additional Information:


Docket No. HM-223. As a result of comments received to the ANPRM, we 
have upgraded this rulemaking to significant.


Agency Contact:
Susan Gorsky
Senior Regulations Specialist
Department of Transportation
Research and Special Programs Administration
400 Seventh Street SW.
Washington, DC 20590
Phone: 202 366-8553
Email: [email protected]
RIN: 2137-AC68
BILLING CODE 4910-62-S




[[Page 73445]]

DEPARTMENT OF THE TREASURY (TREAS)



Statement of Regulatory Priorities
 The primary missions of the Department of the Treasury are: promoting 
domestic economic growth and maintaining our Nation's leadership in 
global economic issues; protecting and collecting the revenue under the 
Internal Revenue Code and customs laws; financing the Federal 
government and managing its fiscal operations; supervising national 
banks and thrift institutions; enforcing laws relating to 
counterfeiting, Federal government securities, firearms and explosives, 
money laundering, foreign commerce in goods and financial instruments, 
and smuggling and trafficking in contraband; administering the 
Community Development Financial Institutions Fund and its programs; 
protecting the President, Vice President, certain foreign diplomatic 
personnel, and others; training Federal, State, and local law 
enforcement officers; and producing coins and currency.
 Consistent with these missions, most regulations of the Department and 
its constituent bureaus are promulgated to interpret and implement the 
laws as enacted by the Congress and signed by the President. Unless 
circumstances require otherwise, it is the policy of the Department to 
issue a notice of proposed rulemaking (NPRM) and carefully consider 
public comments before adopting final regulations. Also, in particular 
cases, the Department invites interested parties to submit views on 
rulemaking projects while the NPRM is being developed, and holds public 
hearings to discuss proposed rules.
 To the extent permitted by law, it is the policy of the Department to 
adhere to the regulatory philosophy and principles set forth in 
Executive Order 12866, and to develop regulations that maximize 
aggregate net benefits to society, while minimizing the economic and 
paperwork burdens imposed on persons and businesses subject to those 
regulations.
Internal Revenue Service
 The Internal Revenue Service (IRS), working with the Office of the 
Assistant Secretary (Tax Policy), promulgates regulations that 
interpret and implement the Internal Revenue Code and related tax 
statutes. The purpose of these regulations is to carry out the tax 
policy determined by Congress in a fair, impartial and reasonable 
manner, taking into account the intent of Congress, the realities of 
relevant transactions, the need for the Government to administer the 
rules and monitor compliance, and the overall integrity of the Federal 
tax system. The goal is to make the regulations practical and as clear 
and simple as possible.
 Most IRS regulations interpret tax statutes to resolve ambiguities or 
fill gaps in the tax statutes. This includes interpreting particular 
words, applying rules to broad classes of circumstances, and resolving 
apparent and potential conflicts between various statutory provisions.
 During fiscal year 2001, the IRS will accord priority to the following 
regulatory projects:
 Hope Scholarship and Lifetime Learning Credits. The Taxpayer 
            Relief Act of 1997 added section 25A to the Internal 
            Revenue Code. Section 25A authorizes the allowance of Hope 
            Scholarship and Lifetime Learning tax credits with respect 
            to certain qualified tuition and related expenses incurred 
            after 1997. Proposed regulations were issued under section 
            25A in 1999. The IRS will issue final regulations to 
            provide rules for taxpayers that claim the nonrefundable 
            Hope Scholarship and the Lifetime Learning tax credits 
            against their Federal income taxes for certain post-
            secondary education expenses. The regulations will, among 
            other things: provide rules regarding eligibility for, and 
            calculation of, the credits; provide definitions for 
            certain statutory terms; describe the adjustments required 
            for certain excludable educational assistance; and set 
            forth the time for claiming an education credit. The IRS 
            will also issue final regulations under section 6050S to 
            provide guidance to educational institutions so they can 
            provide information reporting to students and the IRS with 
            respect to amounts eligible for the Hope Scholarship and 
            Lifetime Learning tax credits.
 Recognition of Gain on Certain Distributions of Stock or 
            Securities under Section 355(e). Congress enacted section 
            355(e) of the Internal Revenue Code as part of the Taxpayer 
            Relief Act of 1997 and made technical corrections to that 
            section in the Internal Revenue Service Restructuring and 
            Reform Act of 1998. Section 355(e) provides that the 
            distributing corporation will recognize gain on certain 
            distributions that are part of a plan (or series of related 
            transactions) pursuant to which one or more persons 
            acquires directly or indirectly stock representing a 50-
            percent or greater interest in the distributing or 
            controlled corporation. Regulations will be issued 
            concerning the interpretation of the phrase plan (or series 
            of related transactions).
 Source of Income Received from Space or Ocean-Based 
            Activities. The IRS will issue regulations under Internal 
            Revenue Code section 863 addressing the source of income 
            received by U.S. and foreign persons for activities 
            conducted in space, or on or under water outside of the 
            jurisdiction of any country. The regulations will address 
            the source of income received from the transmission of 
            communications or data from the United States to a foreign 
            country, or from a foreign country to the United States. 
            Since the existing rules under section 863 were issued in 
            1986, there have been many technological developments in 
            the space and communications industry. Regulations are 
            needed to conform the existing source rules to these 
            technological developments.
 Excise Taxes on Excess Benefit Transactions. Internal Revenue 
            Code section 4958 imposes excise taxes on non-fair market 
            value transactions between certain tax-exempt organizations 
            and persons in positions to exercise substantial influence 
            over those organizations (disqualified persons). 
            Disqualified persons who benefit economically from the 
            excess benefit transactions (and in certain instances, the 
            organization managers) are liable for the taxes. The IRS 
            expects to issue regulations that will clarify various 
            rules, definitions, and safe harbors under section 4958.
 Payment by Credit Card and Debit Card. The Taxpayer Relief Act 
            of 1997 authorized the Secretary to issue regulations under 
            Internal Revenue Code section 6311 to receive payment of 
            internal revenue taxes by commercially acceptable means, 
            including payment by credit cards and debit cards. 
            Temporary regulations were issued in 1998 to implement 
            these new payment mechanisms. In FY 2001, the IRS intends 
            to issue final regulations concerning payment of taxes by 
            credit cards (including charge cards) and debit cards.
Office of the Comptroller of the Currency
 The Office of the Comptroller of the Currency (OCC) charters, 
regulates, and supervises national banks to ensure a

[[Page 73446]]

safe, sound, and competitive national banking system that supports the 
citizens, communities, and economy of the United States. The 
substantive content of the OCC's regulations reflects four organizing 
principles that support this mission:
 The OCC's regulations help ensure safety and soundness by 
            establishing standards that set the limits of acceptable 
            conduct for national banks.
 The OCC's regulations promote competitiveness by facilitating 
            a national bank's ability to develop new lines of business, 
            subject to any safeguards that are necessary to ensure that 
            the bank has the expertise to manage risk effectively and 
            adapt its business practices to deal responsibly with its 
            customers.
 Regulations can also affect national banks' ability to compete 
            by contributing significantly to their costs. The OCC's 
            goal is to improve efficiency and reduce burden by updating 
            and streamlining its regulations and eliminating those that 
            no longer contribute significantly to the fulfillment of 
            its mission.
 The OCC's regulations help assure fair access to financial 
            services for all Americans by removing unnecessary 
            impediments to the flow of credit to consumers and small 
            businesses, by encouraging national banks' involvement in 
            community development activities, and by implementing 
            Federal laws designed to protect consumers of financial 
            services.
 The OCC's regulatory workload and plans are affected directly by new 
statutes. Possible statutory changes are not addressed in this 
Regulatory Plan, but may affect some of the planned rules directly, and 
likely would affect how the OCC prioritizes its regulatory workload.
 Important final and interim rules issued during fiscal year 2000 (or 
expected to be issued before publication of this Regulatory Plan) 
include:
 National Bank Financial Subsidiaries (12 CFR part 5). The OCC 
            amended its regulations to implement section 121 of the 
            Gramm-Leach-Bliley Act (GLBA) (Pub. L. 106-102), which 
            authorizes national banks to conduct expanded financial 
            activities through financial subsidiaries. The OCC also 
            revised its operating subsidiary rule to make conforming 
            changes and streamline procedures for banks that engage in 
            activities through operating subsidiaries. Finally, the OCC 
            revised its regulation governing other equity investments 
            to make corresponding changes to the procedures for certain 
            types of non-controlling investments.
 Financial Privacy (12 CFR part 40). This rule, issued jointly 
            with the other Federal banking agencies and prepared in 
            consultation with the Department of the Treasury, the 
            Securities and Exchange Commission, the Federal Trade 
            Commission, and the National Credit Union Administration, 
            implemented the notice and opt out provisions in title V of 
            the GLBA.
 Privacy-Safety and Soundness Standards (12 CFR part 30). This 
            rulemaking, conducted jointly with the other banking 
            agencies, will establish standards governing the 
            administrative, technical, and physical safeguards of bank 
            and customer records.
 Fair Credit Reporting Act (12 CFR part 41). This rule, also to 
            be issued with the other Federal banking agencies, will 
            implement the affiliate sharing provisions of the Fair 
            Credit Reporting Act. In order to minimize the burden of 
            this rule, the agencies expect that it will adopt many of 
            the provisions governing content of disclosures and the 
            method of delivery that were adopted in the financial 
            privacy rule.
 Risk-Based Capital Treatment of Recourse and Direct Credit 
            Substitutes (12 CFR part 3). Among other things, this rule 
            would: (1) treat recourse obligations and direct credit 
            substitutes comparably; (2) use credit ratings to assign 
            risk weights to credit enhancements and asset-backed 
            securities; and (3) permit the use of bank internal risk 
            ratings for certain limited purposes.
 Insurance-Customer Protections (12 CFR part 14). This rule, 
            published jointly with the other Federal banking agencies 
            pursuant to section 47 of the GLBA, prescribes consumer 
            protection regulations that apply to retail sales 
            practices, solicitations, advertising, or offers of any 
            insurance product by a depository institution or any person 
            that is engaged in such activities at an office of the 
            institution or on behalf of the institution.
 Insurance-Debt Cancellation Contracts (12 CFR part 14). The 
            OCC issued an advance notice of proposed rulemaking (ANPRM) 
            inviting comments on whether the OCC should issue 
            regulations that would provide consumer-related protections 
            for debt cancellation contracts (which are contracts 
            between borrowers and creditors that suspend a debt because 
            of events such as death, unemployment, etc.).
 Community Reinvestment Act-Disclosure (12 CFR part 25). The 
            OCC, along with the other Federal banking agencies, issued 
            proposed rules that would require procedures to ensure 
            compliance with the sunshine requirements of the Community 
            Reinvestment Act. Pursuant to these requirements, 
            nongovernmental entities or persons, insured depository 
            institutions, and affiliates of insured depository 
            institutions that are parties to certain agreements that 
            are in fulfillment of the Community Reinvestment Act of 
            1977 must make the agreements available to the public and 
            the appropriate agency and file annual reports concerning 
            the agreements with the appropriate agency.
 Electronic Banking. The OCC published an ANPRM inviting 
            interested parties to comment on a wide range of issues 
            involving national bank involvement in electronic banking. 
            The goal of the ANPRM is to determine whether the OCC's 
            regulations should be revised to remove regulatory 
            impediments and unnecessary burdens, if any, to bank use of 
            technology, or add new provisions that would facilitate 
            national banks' use of new technologies.
 Community Banks. The OCC has published another ANPRM inviting 
            interested parties to comment on whether there are ways the 
            OCC could reduce burden on community banks in, among other 
            areas, capital, lending limits, corporate governance, and 
            applications processing.
The OCC's regulatory priorities for fiscal year 2001 include projects 
in the following areas:
 Risk-Based Capital Standards (12 CFR part 3). The OCC will 
            continue to work with the other Federal banking agencies to 
            update the risk-based capital standards to maintain, and, 
            where necessary, improve consistency in the agencies' 
            rules. Regulatory projects in this area may include the 
            following:
    Collateralized Transactions. The rule would conform the rules of 
            the other banking agencies to the OCC's rule regarding the 
            risk-based capital treatment of loans collateralized in 
            cash or government securities issued by members of the 
            Organization for Economic Cooperation and Development 
            (OECD). The rule would assign a zero risk weight for the 
            portion of claims collateralized by cash on deposit in a 
            bank or securities issued or guaranteed by the U.S.

[[Page 73447]]

            Government or its agencies or the central government of an 
            OECD country, provided that certain conditions are met.
    Risk-Based Capital Treatment of Recourse Transactions and Direct 
            Credit Substitutes. The OCC intends to finalize the 
            rulemaking summarized above in which the OCC and other 
            Federal banking agencies have sought comment on changes 
            that would result in more consistent treatment of recourse 
            obligations and similar transactions among the agencies, 
            more consistent risk-based capital treatment for certain 
            types of transactions involving similar risk, and capital 
            requirements that more closely reflect a banking 
            organization's relative exposure to credit risk.
    Residual Interests. The OCC is considering proposing a dollar-for-
            dollar capital charge on all subordinated positions, either 
            retained or purchased by a bank, that serve as credit 
            enhancement on a securitization. The dollar-for-dollar 
            capital charge would apply to interests totaling up to 25 
            percent of Tier 1 capital, after which any remaining 
            interest would be directly deducted from Tier 1 capital.
 Bank Activities and Operations (12 CFR part 7). The OCC 
            intends to publish a notice of proposed rulemaking (NPRM) 
            inviting comment on several proposed amendments to part 7, 
            possibly including amendments addressing bank holidays, the 
            ability of a bank to participate in financial education 
            programs with schools without the school being treated as a 
            branch of the bank, and a clarification of the OCC's fee 
            regulation.
 Fiduciary Activities of National Banks (12 CFR part 9). The 
            OCC is considering possible amendments to its regulation to 
            address issues confronted by national banks that engage in 
            fiduciary activities on an interstate basis. These 
            amendments might include, for instance, a codification of 
            recent OCC Interpretive Letters that analyzed the effect of 
            State laws that would have the effect of preventing 
            national banks to establish trust offices and trust 
            representative offices.
 Real Estate Lending and Appraisals (12 CFR part 34). The OCC 
            intends to evaluate its rules governing adjustable rate 
            mortgage loans to determine whether the rule continues to 
            implement the Alternative Mortgage Transaction Parity Act 
            of 1982 effectively and whether additional safeguards 
            against predatory lending are needed.
 Electronic Banking. Pursuant to comments and suggestions made 
            in response to the ANPRM summarized above, the OCC will 
            address ways to facilitate national banks in their efforts 
            to engage in various forms of electronic banking. These 
            might include, by way of illustration, provisions affecting 
            digital certificates, electronic data storage, and the 
            establishment of transactional Web sites.
Office of Thrift Supervision
 As the primary Federal regulator of the thrift industry, the Office of 
Thrift Supervision (OTS) has established regulatory objectives and 
priorities to supervise thrift institutions effectively and 
efficiently. These objectives include maintaining and enhancing the 
safety and soundness of the thrift industry; a flexible, responsive 
regulatory structure that enables savings associations to provide 
credit and other financial services to their communities, particularly 
housing mortgage credit; and a risk-focused, proactive approach to 
supervision.
 OTS is reviewing its lending regulations, including the rules 
implementing the Alternative Mortgage Parity Act, to determine whether 
and how they may be improved to encourage responsible lending to 
underserved markets and address predatory lending practices. OTS also 
plans to revise its lending regulations to enable thrifts to better 
serve their communities and compete with national and state banks.
 OTS also plans to issue a final rule revising its regulations 
governing conversion from mutual to stock or mutual holding company 
form and a proposed rule that would require certain holding companies 
to notify OTS before they engage in significant new activities.
 In addition, OTS intends to publish a number of proposed rules as part 
of its ongoing effort to review and streamline its regulations. These 
proposals, which will be drafted in the plain language format, include 
rules revising the application processing procedures, regulations on 
types of offices, and rules on directors and officers.
 OTS also has a number of regulatory projects underway implementing new 
legislation in the Gramm-Leach-Bliley Act (GLBA) (Pub. L. 106-102). 
These projects include:
 Community Reinvestment Act-Disclosure. OTS intends to issue 
            joint final rules with the other Federal banking agencies 
            requiring disclosure and reporting of Community 
            Reinvestment Act agreements.
 Insurance Customer Protections. The four Federal banking 
            agencies also plan to issue proposed and final rules 
            providing customer protections relating to sales practices, 
            disclosures, and advertising insurance products and 
            annuities by depository institutions, at the offices of 
            depository institutions, and on behalf of depository 
            institutions.
 Fair Credit Reporting. OTS and the other Federal banking 
            agencies will issue joint proposed and final rules 
            implementing provisions of the Fair Credit Reporting Act 
            concerning information sharing with affiliates
 Safeguarding Customer Information. The Federal banking 
            agencies will also issue joint proposed and final rules 
            setting standards for administrative, technical, and 
            physical safeguards for customer records and information.
 Holding Companies. OTS is reviewing its current holding 
            company regulations to determine how they should be 
            modified to reflect statutory changes made by GLBA.
 OTS also will continue to work with the other Federal banking agencies 
to update capital standards to maintain, and, where necessary, improve 
consistency in the agencies' rules. Regulatory projects in this area 
may include the following:
 Risk-Based Capital Treatment of Recourse and Direct Credit 
            Substitutes. Among other things, OTS plans to issue a final 
            rule jointly with the other Federal banking agencies that 
            would: (1) treat recourse obligations and direct credit 
            substitutes comparably; (2) use credit ratings and certain 
            other alternative mechanisms to match risk-based capital 
            requirements more closely to a depository institution's 
            risk of loss in asset securitizations; and (3) require the 
            sponsor of a revolving credit securitization that involves 
            an early amortization feature to hold capital against the 
            amount of assets under management.
 Capital Adequacy. OTS, along with the other Federal banking 
            agencies, plans to issue a joint advance notice of proposed 
            rulemaking seeking comment on ways to simplify the capital 
            adequacy framework for small, noncomplex institutions.
 Residuals in Securitizations. OTS and the other Federal 
            banking agencies plan to issue a proposed rule that would 
            better align regulatory capital requirements with the risk 
            exposure of certain residual interests in asset

[[Page 73448]]

            securitizations and other transfers of assets.
 Claims on Securities Firms. The four Federal banking agencies 
            plan to issue a proposed rule that would reduce the risk 
            weight assigned to claims on, and claims guaranteed by, 
            qualifying securities firms.
 Collateralized Transactions. This final rule would conform the 
            rules of OTS and the other banking agencies to the OCC's 
            rule regarding the risk-based capital treatment of loans 
            collateralized in cash or OECD government securities. The 
            rule would assign a zero risk weight for the portion of 
            claims collateralized by cash on deposit in a bank or 
            securities issued or guaranteed by the U.S. government or 
            its agencies or the central government of an OECD country, 
            provided that certain conditions are met.
 Miscellaneous Capital Revisions. OTS also plans to issue a 
            proposed rule to make miscellaneous amendments to update 
            its capital rules.
United States Customs Service
 The United States Customs Service (Customs) is responsible, among 
other things, for administering laws concerning the importation of 
goods into the United States. This includes inspecting imports, 
collecting applicable duties, overseeing the activities of persons and 
businesses engaged in importing, and enforcing the laws concerning 
smuggling and trafficking in contraband. The regulatory priorities of 
Customs for fiscal year 2001 are to continue to facilitate procedures 
for legitimate commercial transactions and to provide further obstacles 
to the flow of narcotics and other contraband into the United States.
 During fiscal year 2000, one of Customs' priorities was to continue to 
move forward with amendments reinventing its regulatory procedures that 
began under the authority granted by the Customs Modernization 
provisions of the North American Free Trade Implementation Act (Customs 
Mod Act). Customs' reinvention efforts, in accordance with the 
principles of Executive Order 12886, have involved and will continue to 
involve significant input from the importing public. Customs' 
reinvention efforts also involve testing of programs to see if they 
work before proceeding with proposed rulemaking to permanently 
establish the programs. Many final rules implementing the Customs Mod 
Act were published during the past fiscal year. These rules included:
 Customs Brokers. This rule made significant revisions to the 
            regulations concerning the licensing and conduct of customs 
            brokers in the performance of customs business on behalf of 
            others.
 Drawback. This rule established new procedures applicable to 
            the filing of false drawback claims that result in the 
            imposition of penalties.
 Underpayments and Overpayments. This rule conformed Customs' 
            regulations to statutory provisions and judicial precedent 
            regarding the assessment of interest as a result of 
            underpayments or overpayments duties, taxes and fees 
            pertaining to imported merchandise.
 Penalties. This rule established guidelines for the imposition 
            and mitigation of penalties for violations of 19 U.S.C. 
            1592
 Customs also expects to propose in late FY 2000 or early FY 2001 
revisions to the procedures by which Customs will issue administrative 
rulings responding to requests from prospective importers concerning 
how Customs will treat their transactions. Customs plans to finalize 
these rules during FY 2001.
 During fiscal year 2001, Customs will continue implementing the 
Customs Mod Act. Customs plans to finalize revisions to its procedures 
regarding protests. Customs will also be developing and publishing 
regulations to implement provisions of the Trade and Development Act of 
2000. These projects will include amendments to existing regulations 
concerning the Caribbean Basin Initiative (CBI) and the Generalized 
System of Preferences, as well as new regulations concerning the 
African Growth and Development and the CBI enhancement provisions of 
the Trade and Development Act.
 During the fiscal year 2001, Customs also plans to undertake several 
other regulatory projects that will affect the traveling and importing 
public, customs brokers, carriers and commercial importers. Customs 
will accord priority to several projects to foster the development of a 
more automated environment to expedite the entry, processing, and 
release of imported commercial merchandise, and the clearance of 
merchandise for export. These regulations will benefit the importing 
and exporting public by streamlining the work of Customs officers and 
the trade community through improved efficiency and reduced paperwork 
and administrative costs. Among these projects are:
 Liquidations. Customs will propose regulations allowing 
            paperless procedures for extension and suspension of 
            liquidation notices, improving and clarifying the 
            administrative process and simplifying the regulations 
            pertaining to liquidations and extensions and suspensions 
            of liquidation.
 Entry Reconciliation. Customs will continue to develop through 
            testing a ``reconciliation'' process that will allow the 
            delayed submission to Customs of information that is 
            undetermined at the time an entry summary or an import 
            activity summary statement is required to be submitted. 
            This process will facilitate the movement of imported 
            merchandise. After Customs is satisfied with the testing, 
            regulations will be proposed to allow reconciliation on a 
            permanent basis.
 Remote Location Filing. Customs will propose regulations 
            allowing electronic filing of entries from locations in the 
            United States other than the port of arrival of the 
            merchandise or the place at which the merchandise is 
            examined. Remote location filing will provide entry filers 
            (such as brokers and couriers) with greater flexibility and 
            will allow Customs to make more efficient use of its 
            resources.
Bureau of Alcohol, Tobacco and Firearms
 The Bureau of Alcohol, Tobacco and Firearms (ATF) issues regulations 
to enforce the Federal laws relating to the manufacture and commerce of 
alcohol products, tobacco products, firearms, and explosives. ATF's 
regulations carry out these missions and are designed to:
 Curb illegal traffic in, and criminal use of, firearms; and to 
            assist State, local, and other Federal law enforcement 
            agencies in reducing crime and violence;
 Facilitate investigations of violations of Federal explosives 
            laws and arson-for-profit schemes;
 Regulate the alcohol, tobacco, firearms, and explosives 
            industries, including the issuance of licenses and permits;
 Assure the collection of all alcohol, tobacco, firearms, and 
            ammunition taxes, and obtain a high level of voluntary 
            compliance with all laws governing those industries;
 Suppress commercial bribery, consumer deception and other 
            prohibited practices in the alcoholic beverage industry; 
            and
 Assist the States in their efforts to eliminate interstate 
            trafficking in, and the sale and distribution of, 
            cigarettes in avoidance of State taxes.

[[Page 73449]]

 ATF intends to streamline its regulations applying to the brewing 
industry by simplifying its brewery reports and operations and 
eliminating obsolete regulatory provisions. Also, ATF will propose 
minimum production standards for beer, thereby reducing formula filings 
and a revised statement of net contents requirement for certain 
container sizes.
 ATF will continue, as a priority during Fiscal Year 2001, the 
multifaceted regulatory project governing various modifications to its 
regulations governing commerce in explosives. ATF is further analyzing 
its regulations governing storage requirements for explosives, 
including fireworks explosive materials, and plans to issue the notice 
of proposed rulemaking described in detail in part II of this 
Regulatory Plan.
Financial Crimes Enforcement Network
 The regulations of the Financial Crimes Enforcement Network (FinCEN) 
constitute the core of Treasury's anti-money laundering initiatives and 
are an essential component of Treasury's anti-narcotics effort. The 
Bank Secrecy Act (BSA) authorizes the Secretary of the Treasury to 
issue regulations requiring financial institutions to keep records and 
file reports that are determined to have a high degree of usefulness in 
criminal, tax or regulatory proceedings, and to implement counter-money 
laundering programs and compliance procedures.
 Since mid-1994, FinCEN has been engaged in a thorough review of its 
regulatory policies and has been building a partnership between 
government and the financial sector to fight money laundering. The 
cornerstone of that partnership is the recognition that only a 
cooperative relationship between government and industry can provide a 
way to implement a three-pronged strategy of prevention, detection, and 
enforcement against those who seek to use the financial system to 
promote or further illegal activity. FinCEN recognizes that BSA 
compliance imposes costs on the financial community and that 
recordkeeping and reporting should be required only when the benefits 
to law enforcement efforts are clear.
 During fiscal year 2001, FinCEN will continue to review and revise its 
existing regulations. FinCEN will continue to work with the financial 
community to reduce administrative burdens associated with complying 
with the law while enhancing the usefulness of BSA information for law 
enforcement, financial regulators and policymakers. FinCEN is 
continuing a general revision and simplification of all of its 
regulations and will accord priority to the issuance of a final rule 
based on a 1998 notice of proposed rulemaking requiring the reporting 
of suspicious transactions by casinos and card clubs. FinCEN will also 
publish for public comment a proposal to require brokers and dealers in 
securities to report suspicious transactions.
Bureau of the Public Debt
 The Bureau of the Public Debt (BPD) administers regulations governing 
transactions in government securities by government securities brokers 
and dealers and regulations that implement Treasury's borrowing 
authority, including rules governing the sale and issue of marketable 
Treasury securities. BPD also administers the rules issued in January 
2000 that set out the terms and conditions by which Treasury may redeem 
(buyback) outstanding, unmatured marketable Treasury securities through 
debt buyback operations. BPD also is responsible for administering the 
regulatory provisions governing the types and valuations of collateral 
that are acceptable to secure deposits of public monies and other 
financial interests of the Federal Government.
 The Government Securities Act of 1986 (GSA) authorizes the Secretary 
of the Treasury to prescribe rules governing financial responsibility, 
the protection of customer funds and securities, recordkeeping, 
reporting, audit, and large position reporting for all government 
securities brokers and dealers, including financial institutions. These 
rules fulfill the Treasury's statutory responsibility to safeguard the 
efficient functioning of the government securities market and are 
designed to prevent fraudulent and manipulative acts and practices and 
to protect the integrity, efficiency, and liquidity of the market. The 
Department and BPD are committed to implementing rules that make sense 
from both a regulatory and market efficiency perspective. Accordingly, 
the Department and BPD seek to balance the benefits of regulation with 
the compliance costs imposed on the government securities market and 
its participants.
 The rules setting out the terms and conditions for the sale and issue 
of marketable book-entry Treasury bills, notes and bonds are known as 
the uniform offering circular. These rules apply to securities held in 
accounts in the book-entry system established by the Department and 
operated by the Federal Reserve Banks, known as the commercial book-
entry system, as well as to securities held in accounts directly with 
Treasury in the Treasury Direct system. The uniform offering circular 
describes the types of securities offered for sale, the auction methods 
by which they are sold, the process by which bidders submit bids, the 
process for awarding securities to successful bidders and the 
authorized payment methods.
 During fiscal year 2001, BPD will accord priority to rewriting the 
uniform offering circular in plain language. This will communicate the 
auction rules in a more direct and effective manner. Also, BPD will 
propose technical revisions to its GSA regulations to conform to the 
amendment to the definition of government securities in the Securities 
Exchange Act of 1934 that was enacted by section 208 of the Gramm-
Leach-Bliley Act.
Financial Management Service
 The Financial Management Service (FMS) issues regulations to improve 
the quality of Government financial management and to administer its 
payments, collections, debt collection, and Governmentwide accounting 
programs. During fiscal year 2001, FMS will update its regulations that 
implement the Cash Management Improvement Act of 1990 (CMIA). The CMIA 
requires the head of each executive agency, under regulations 
prescribed by the Secretary of the Treasury, to provide for the timely 
disbursement of Federal funds through cash, checks, electronic funds 
transfer, or any other means identified by the Secretary of the 
Treasury. FMS issued an implementing regulation in December 1992. FMS 
intends to issue a notice of proposed rulemaking to update the CMIA in 
early fiscal year 2001 and expects to finalize the rule later in the 
year.
 Also in fiscal year 2001, FMS will revise its rule concerning the 
payment of Federal taxes and the Treasury Tax and Loan Program. FMS 
plans to revise its rule to support operational changes to the system 
used for the collection of corporate withholding taxes, as well as to 
streamline the rule and convert it to the plain language standard. FMS 
intends to issue a notice of proposed rulemaking to implement these 
revisions in late 2000, and expects to publish a final rule by mid 
2001.
 Finally, FMS will continue to implement provisions of the Debt 
Collection Improvement Act of 1996.

[[Page 73450]]

FMS, in conjunction with the Department of Justice, will finalize the 
rule containing Federal Claims Collection Standards, which establishes 
standards for Governmentwide debt collection.
Community Development Financial Institutions Fund
 The Community Development Financial Institutions Fund (Fund) was 
established by the Community Development Banking and Financial 
Institutions Act of 1994 (12 U.S.C. 4701 et seq.). The primary purpose 
of the Fund is to promote economic revitalization and community 
development through investments in, and assistance to, community 
development financial institutions (CDFIs), principally through the 
CDFI Program.
 The Fund administers the Bank Enterprise Award (BEA) Program, which 
encourages insured depository institutions to engage in eligible 
development activities and to make equity investments in CDFIs. The 
Fund also administers the Presidential Awards for Excellence in 
Microenterprise Development, which recognize outstanding 
microenterprise development and support programs in an effort to 
advance an understanding of best practices in the field of domestic 
microenterprise development.
 The Fund's regulatory priority for fiscal year 2001 is to continue to 
streamline the application and review processes for the BEA Program.
_______________________________________________________________________



TREAS

                              -----------

                          PROPOSED RULE STAGE

                              -----------




106. REVISION OF BREWERY REGULATIONS AND ISSUANCE OF REGULATIONS FOR 
TAVERNS ON BREWERY PREMISES (BREWPUBS)
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:


26 USC 5051 to 5056; 26 USC 5401 to 5417; 27 USC 205


CFR Citation:


27 CFR 7; 27 CFR 25


Legal Deadline:


None


Abstract:


ATF intends to streamline regulations applying to breweries. ATF will 
eliminate obsolete regulatory provisions. A formula system for 
manufactured beer products will replace statements of process attached 
to the brewers notice. The annual notice for small brewers to pay the 
reduced rate of tax will be eliminated. Separate regulations for 
brewpubs will be added to part 25. A section will be added to part 25 
to authorize and regulate the alternating use of brewery premises by 
different brewers. Regulations authorizing the operation of brew-on-
premises facilities will be added to part 25.


Statement of Need:


ATF intends to streamline its regulations applying to the brewing 
industry. These changes will simplify brewery reports and operations 
and eliminate obsolete regulatory provisions. Specific changes would 
include the implementation of a formula system for the breweries to 
replace the statement of process; the establishment of a separate 
subpart containing simplified regulations for brewpubs; authorizing 
alternating brewery premises among different proprietors; eliminating 
the annual notice to pay the reduced rate of tax for most breweries; 
authorizing brewers to file the Brewer's Report of Operations on a 
quarterly basis; and authorizing many brewers to take inventories 
quarterly rather than monthly. The rule will also propose minimum 
production standards for beer thereby reducing formula filings and a 
revised statement of net contents requirement for certain container 
sizes.


Summary of Legal Basis:


ATF has undertaken this review of brewery regulations as part of the 
President's Regulatory Initiative. These regulations are issued under 
the general authority of the Secretary of the Treasury to promulgate 
regulations to implement the Internal Revenue Code and the Federal 
Alcohol Administration Act.


Alternatives:


Not applicable. ATF believes that industry will support these 
regulatory changes because they will streamline regulatory requirements 
applying to the brewing industry.


Anticipated Cost and Benefits:


The proposed regulations will benefit the brewing industry by reducing 
required inventories, notices, and other submissions to ATF.


Risks:


Not applicable.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           12/00/00
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses


Government Levels Affected:


None


Agency Contact:
William Foster
Program Manager
Department of the Treasury
Bureau of Alcohol, Tobacco and Firearms
650 Massachusetts Avenue NW.
Washington, DC 20226
Phone: 202 927-8210
RIN: 1512-AB37
_______________________________________________________________________



TREAS



107. COMMERCE IN EXPLOSIVES (INCLUDING EXPLOSIVES IN THE FIREWORKS 
INDUSTRY)
Priority:


Other Significant


Legal Authority:


5 USC 552(a); 31 USC 9303 to 9304; 40 USC 304(k); 18 USC 847; 18 USC 
921 to 930; 18 USC 1261; 19 USC 1612 to 1613; 19 USC 1618; 26 USC 7101; 
26 USC 7322 to 7326; 31 USC 9301


CFR Citation:


27 CFR 55


Legal Deadline:


None


Abstract:


Pursuant to section 610 of the Regulatory Flexibility Act, ATF 
published a notice on January 10, 1997, seeking public comments on 
whether it should revise its regulations, codified at 27 CFR part 55, 
governing Commerce in Explosives (Including Explosives in the Fireworks 
Industry). Based on

[[Page 73451]]

comments received, ATF plans to initiate a rulemaking to revise these 
regulations in 2001.


Statement of Need:


This notice of proposed rulemaking will address many of the issues in 
part 55, Commerce in Explosives, especially the issues in requirements 
for explosives, including fireworks explosive materials. Pursuant to 
the periodic review requirements of the Regulatory Flexibility Act (5 
U.S.C. 610), ATF published on January 10, 1997 a General Notice 
initiating the review of a final rule published in 1990 concerning the 
storage of fireworks explosives materials. The 1990 rule, which was 
issued as a result of the number and severity of explosions occurring 
on the premises of special fireworks plants, amended certain 
regulations codified at 27 CFR part 55, generally concerning the 
recordkeeping and storage of fireworks explosive materials. The 
regulations also codified two fireworks related rulings issued in 1979 
and 1985, and the provisions of Public Law 99-308 relating to black 
powder. As a result of the public comments received in response to the 
General Notice and further study of this issue, ATF will issue a notice 
of proposed rulemaking covering this and related commerce and storage 
of explosives issues.


Summary of Legal Basis:


18 U.S.C. 847 grants the Secretary of the Treasury broad discretion to 
promulgate regulations necessary for the importation, manufacture, 
distribution, and safe storage of explosives materials. 18 U.S.C. 846 
authorizes the Secretary to prescribe precautionary measures to prevent 
the recurrence of accidental explosions in which explosive materials 
were involved. The General Notice and upcoming notice of proposed 
rulemaking are also being issued pursuant to section 610 of the 
Regulatory Flexibility Act (5 U.S.C. 610), which requires an agency to 
review within 10 years of publication rules for which an agency 
prepared a final regulatory flexibility analysis addressing the impact 
of the rule on small businesses or other small entities.


Alternatives:


Alternatives will be examined in the context of public comments to the 
notice of proposed rulemaking.


Anticipated Cost and Benefits:


Unknown at this time.


Risks:


Not applicable.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
General Notice o62 FR 1386ry Review                            01/10/97
NPRM                                                           01/00/01
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses


Government Levels Affected:


None


Agency Contact:
James Ficaretta
Program Manager
Department of the Treasury
Bureau of Alcohol, Tobacco and Firearms
650 Massachusetts Avenue NW.
Washington, DC 20226
Phone: 202 927-8210
RIN: 1512-AB48
BILLING CODE 4810-25-S




[[Page 73452]]

DEPARTMENT OF VETERANS AFFAIRS (VA)



Statement of Regulatory Priorities
 The Department of Veterans Affairs (VA) administers benefit programs 
that recognize the important public obligations to those who served 
this Nation. VA's regulatory responsibility is almost solely confined 
to carrying out mandates of the laws enacted by Congress relating to 
programs for veterans and their beneficiaries. VA's major regulatory 
objective is to implement these laws with fairness, justice, and 
efficiency.
 Most of the regulations issued by VA involve at least one of three VA 
components: The Veterans Benefits Administration, the Veterans Health 
Administration, and the National Cemetery Administration. The primary 
mission of the Veterans Benefits Administration is to provide high-
quality and timely nonmedical benefits to eligible veterans and their 
beneficiaries. The primary mission of the Veterans Health 
Administration is to provide high-quality health care on a timely basis 
to eligible veterans through its system of medical centers, nursing 
homes, domiciliaries, and outpatient medical and dental facilities. The 
primary mission of the National Cemetery Administration is to bury 
eligible veterans, members of the Reserve components, and their 
dependents in VA National Cemeteries and to maintain those cemeteries 
as national shrines in perpetuity as a final tribute of a grateful 
Nation to honor the memory and service of those who served in the Armed 
Forces.
BILLING CODE 8320-01-S




[[Page 73453]]

ENVIRONMENTAL PROTECTION AGENCY (EPA)



Statement of Regulatory and Deregulatory Priorities
Meeting the Challenge of the 21st Century
 In the thirty years since the formation of EPA, the United States has 
made steady progress in cleaning up our water, air, and land. Though 
serious challenges remain, a remarkable national consensus has fueled 
continuous efforts throughout our society to protect the environment 
despite the growing stress we have placed upon it through rapid 
population growth and unprecedented economic expansion. Much of this 
success is attributable to the system of Federal and State regulation 
that has directed and coordinated private investment in pollution 
control and prevention. Indeed, EPA is known foremost as a regulatory 
agency because of its historic reliance on this most visible tool, and 
the document before you lays out the key regulatory actions in the 
coming year that will address the most significant environmental 
problems, and, in some instances, require substantial investment.
 But while regulation will certainly remain at the core of American 
environmental policy in the foreseeable future, EPA has learned that we 
cannot consider ourselves merely a regulatory agency if we are to be 
what the public expects and requires, the principal administrator for 
environmental protection in our society. Instead, in the twenty-first 
century EPA must increasingly act as an innovator, educator, and leader 
in managing a broad set of new tools - including new methods to design 
and administer regulations - that engage all segments of our society in 
enlightened behaviors that protect the environment while promoting 
appropriate economic growth.
 Both the President and Vice President have called for a government 
that works better and costs less, and EPA has been hard at work to meet 
that challenge. Under Administrator Browner, EPA has been working to 
make regulations cheaper, cleaner, and smarter in order to produce 
important environmental improvements at lower cost for the American 
people. We have been enhancing our partnerships with States, Tribes, 
and industry to place decisionmaking responsibility where it will best 
balance the twin goals of national consistency and local 
responsiveness. And we have been expanding the power of individuals to 
recognize and respond to environmental challenges in their own 
communities.
Cheaper, Cleaner, Smarter Regulation
 Because of EPA innovations during the past decade, the environment is 
cleaner - with less pollution of the Nation's air, water, and land. 
Some regulations are cheaper - with lower costs associated with 
environmental protection. Environmental management is smarter - 
experimenting with better means to solve existing and emerging 
environmental problems. Improvements are apparent in regulatory 
programs where we've introduced more flexibility, reduced costs, and 
made it easier for businesses to understand and comply with 
requirements.
 Cleanup of Superfund sites is now faster, fairer, and less expensive. 
As a result of administrative reforms that began in 1995, the average 
time and costs associated with cleanup have fallen by as much as 20 
percent. Moreover, as much as $1.4 billion has been saved as a result 
of actions that make it possible to select and use the most efficient 
remedy for cleanup.
 Brownfields - properties that have been abandoned or neglected because 
of real or perceived contamination problems - are being revitalized and 
returned to productive use. Cleanup and redevelopment are now underway 
at more than 300 sites. With seed money from EPA, communities have 
leveraged almost $2 billion in public and private sector investments, 
returned hundreds of properties to productive reuse, and created more 
than 6,000 jobs.
 EPA is taking aggressive steps to address remaining threats to public 
health and the environment from air pollution. Recent regulations will 
ensure that a new generation of technology will soon be in place to 
control harmful emissions from motor vehicles and that the low-sulfur 
fuel needed to support new clean-air technology will be readily 
available. The Agency has accelerated its action to promulgate 
essential, industry-specific rules to control toxic air pollutants. And 
the Administrator has acted to protect children and asthma patients 
from the harmful effects of smog, even as we argue before the Supreme 
Court for the Agency's responsibility to provide even greater 
regulatory protection under the law.
 In many respects, new clean air requirements are more flexible and 
less expensive than they would have been earlier in our history, and 
they yield better environmental results. Market-based trading has been 
successful in controlling acid rain: between 1990 and 1998, national 
sulfur dioxide emissions fell by more than 4 million tons; rainfall in 
the eastern United States is now about 25 percent less acidic, and some 
New England ecosystems show signs of recovery. Recently, the Chicago 
Board of Trade announced the sale of sulfur dioxide credits had 
realized $25 million in proceeds, meaning that companies purchasing 
these credits were realizing impressive savings from the transactions, 
even while emissions contributing to acid rain formation were being 
reduced nationally. EPA's acid rain program has also been successful at 
reducing emissions of nitrogen oxide, the prime ingredient in smog 
formation. NOx emissions from electric utilities affected by the 
program have dropped 35 percent.
 Working to keep up with population growth and economic expansion means 
that we need to constantly adapt our strategies to achieve needed 
results. Despite great progress in controlling point sources of 
pollution over thirty years, more than a third of American waterways 
assessed by States are still too dirty for fishing and swimming. Runoff 
from agricultural lands and urban areas remains the primary source of 
the leading pollutants: siltation, bacteria, the nutrients phosphorus 
and nitrogen, and metals. To address this need, EPA is working to 
integrate water quality permitting, monitoring, and reporting into 
broader strategies that focus on individual watersheds, a move that 
brings greater efficiency, more attention to local priorities, and 
better understanding of local conditions. Today, all 50 States, six 
territories, and 80 tribal governments have completed comprehensive 
watershed assessments, creating the first coordinated overview of water 
quality priorities in the Nation's history.
 The way we prepare and implement new rules may be as important as the 
rules themselves. For instance, under Administrator Browner, EPA has 
emphasized the protection of children, who may frequently be more 
vulnerable to environmental contaminants than their parents, in all our 
program areas. In 1998 the Vice President called for a bold new 
initiative to assess toxic characteristics of hundreds of chemicals, 
particularly as to their effects on children. And just recently EPA 
completed an agreement with the manufacturer of Dursban, the most 
widely used household pesticide product in the United States, to

[[Page 73454]]

eliminate it from the market for nearly all household purposes. The 
action was designed in part to significantly reduce residues of the 
active ingredient chlorphyrifos on several foods that children eat 
routinely.
 EPA has also stepped up its traditionally aggressive outreach to small 
businesses and communities subject to our rules. The Agency recognizes 
that these small entities often lack the resources or sophistication of 
their larger counterparts to comply with complex and expensive 
regulations. EPA routinely considers the potential impact of its rules 
on small entities and seeks to minimize unnecessary burden on those 
parties, while still meeting the requirements of the environmental 
statute. Working with the Small Business Administration and the Office 
of Management and Budget, EPA has conducted more than 20 Small Business 
Advocacy Review Panels under the Regulatory Flexibility Act (RFA). On 
those more frequent occasions when the Panel provision is not invoked, 
EPA has still found myriad ways to simplify rules for small parties.
 Related to the effort to write cheaper, cleaner, smarter rules, is the 
need to ensure that people subject to them understand and carry out 
their responsibilities. To that end, EPA is writing its new regulations 
in an easy-to-understand, reader-friendly format known as Plain 
Language. New compliance assistance programs and incentives complement 
EPA's traditionally strong environmental enforcement. Environmental 
managers in different business sectors, local governments, and Federal 
agencies can now find information on environmental requirements and 
pollution prevention by going online to Web-based compliance assistance 
centers. During the past four years, 670 companies have identified 
potential environmental violations at more than 2,700 facilities - 
voluntarily - based on EPA's offer to reduce or eliminate penalties for 
facilities that routinely audit their operations, disclose violations, 
and quickly correct problems.
Partnerships for Better Results
 EPA has broadened its impact and effectiveness by working in 
partnership with public and private sectors. Today, more than ever, EPA 
recognizes that it must involve everyone - other government agencies, 
businesses, communities, and individuals - to meet environmental goals.
 The National Environmental Performance Partnership system, established 
in 1995, gives States and EPA a more flexible process for setting 
priorities, clarifying responsibilities, and making the most effective 
use of taxpayer dollars. Forty States have signed partnership 
agreements, and 44 States have opted to consolidate EPA grants. In 1997 
we reached agreement with the States on how they can pursue innovations 
while maintaining the nationwide protection provided by Federal 
environmental standards. EPA's partnership with States is rapidly 
expanding our national capability to oversee environmental improvement, 
with States taking on an increasing share of the responsibility for 
environmental action. Today, States have assumed authority for 
approximately 70 percent of the EPA programs eligible for delegation. 
Further, States now conduct about 75 percent of all enforcement actions 
taken by State and Federal government combined. The EPA-State 
partnership has come of age, with EPA providing policy and technical 
leadership, while States carry out the lion's share of the daily work 
of environmental protection.
 EPA and business are working better together based on a growing 
realization that environmental and economic performance can go hand-in-
hand. Today, more than 7,000 organizations participate in one or more 
of EPA's voluntary partnership programs. Along with significant 
environmental benefits, annual savings for participants are estimated 
at $3.3 billion. Some of America's most well known corporations, along 
with smaller, innovative organizations, are using the flexibility in 
Project XL to test alternatives to the current regulatory system. Under 
Project XL, which stands for eXcellence and Leadership, businesses 
enter into a formal agreement to meet a level of environmental 
performance beyond current requirements in exchange for procedural 
flexibility not otherwise available under rule or permit. Today, 50 
projects are underway, all of which have potential for more efficient 
and effective environmental management.
 One example of how Project XL works is the Final Project Agreement 
(FPA) with Lucent Technologies, which will afford the company 
substantial permit flexibility in return for superior environmental 
performance and systematic improvements that may be applicable 
elsewhere. This FPA defines a five-year experiment to test whether, 
over time, a high-quality Environmental Management System (EMS) can 
generate a single governing environmental document for use in the 
microelectronics industry that delivers superior environmental 
performance, allows environmental managers and the public a clearer, 
better understanding of the environmental management program, and 
achieves a more efficient interaction with environmental policy than 
the traditional environmental permitting system affords. The FPA allows 
Lucent to use its EMS as a framework for developing specific proposals 
to simplify permitting, record keeping, and reporting requirements, 
while driving continual improvement and pollution-prevention programs. 
The FPA provides a ``test bed'' for the use of a high-quality EMS for 
determining and managing regulatory flexibility while achieving 
superior environmental performance.
 Based on these and other partnership experiences, industry 
representatives are now working with EPA to introduce another 
innovative program, called the National Environmental Performance 
Track, to encourage, recognize, and reward environmental stewardship. 
EPA has offered to endorse companies which exceed minimum regulatory 
requirements and take extra steps to reduce and prevent pollution. 
Performance Track is intended for top-performing facilities and 
companies with a proven record of regulatory compliance, an operational 
Environmental Management System, and a demonstrated commitment to 
continued environmental improvement and outreach to the local community 
and the public. The program has two tiers, the first of which is 
already in operation. The National Achievement Track rewards facilities 
that have a strong compliance record and have raised the bar by setting 
up an Environmental Management System, voluntarily reducing pollution, 
and making commitments to further environmental improvement. The 
National Environmental Stewardship track, which is still being 
developed, will move the bar even higher with a corporate commitment 
for stronger environmental improvement throughout its operations. 
Benefits for participants include national recognition, regulatory and 
administrative flexibility, a more cooperative relationship with EPA, a 
reduction in both record keeping and reporting requirements, and 
flexibility in meeting certain regulatory requirements.
 EPA is providing leadership to help communities grow and prosper in 
ways that preserve environmental quality. Through involvement in the 
national

[[Page 73455]]

Smart Growth Network and other initiatives, we provide technical tools 
and information that allow communities to understand the environmental 
consequences of growth. This is critical assistance at a time when the 
nation's forests, crop lands, and other open spaces are being lost to 
development at an alarming rate.
 We are working more effectively with other Federal agencies, pooling 
our resources, and making best use of our respective strengths to 
address a number of national priorities, including protecting 
children's health. Through a combined strategy of research, public 
education, and regulatory action, we have made significant strides in 
reducing risks for some of society's most vulnerable populations.
A Stronger Public Role
Well informed citizens who are actively involved in environmental 
decisions are a powerful new force in achieving environmental results. 
Increasingly, Americans are getting involved in environmental issues, 
and it's clear they want a say in decisions that affect them. But to 
participate effectively, they need high-quality information that they 
can understand and use. They need access to decision-makers and 
opportunities to express their views.
 Today, EPA is using new technology to improve the quality of 
environmental information and make it easier to obtain. After just a 
little over five years of operation, EPA's site on the World Wide Web 
is now receiving over 70 million hits each month - which involves the 
display of over 15 million Web pages - typically at the request of 
members of the public seeking access to a rich assortment of national 
and community-level data and other descriptive information. We also 
routinely involve the public in our work - gathering data, developing 
new regulations and standards, and experimenting with new ideas.
 To meet Clean Air Act deadlines for developing control standards for 
174 categories of toxic air pollution sources, EPA turned to the 
industries to be regulated and other interested parties to gather data 
and consider appropriate action. This move reduced the time and costs 
of developing the standards, laying the groundwork for faster, smoother 
implementation. The Common Sense Initiative was one of our broadest and 
most ambitious experiments in public participation. Representatives 
from industry, State and local government, and citizen-supported 
environmental groups came together to identify ways of making 
environmental protection more efficient and effective for all parties. 
The experiment resulted in regulatory changes, greater experience with 
public participation processes, and in one industry - metal finishing - 
a model for environmental stewardship that goes far beyond what is 
required by law. Sector-based approaches are now being considered for 
other industry groupings.
 EPA supported the public's right to know about environmental 
conditions by significantly expanding the national Toxics Release 
Inventory. A new rule described in this Regulatory Plan will ensure 
that communities know whether and how much lead is being released in 
their vicinity. Citizens now have more information about releases of 
toxic emissions in their communities, which provides incentives for 
facilities to drive their emissions down. Between 1988 and 1998, at the 
same time that TRI required reporting on chemical releases, national 
air releases declined by 58 percent, and water releases declined by 73 
percent. Over the same period 29 percent less waste was injected 
underground nationwide, while facilities disposed of 24 percent less 
waste on-site, and increased off-site disposal by just a half percent. 
The numbers of facilities and kinds of chemicals subject to TRI have 
changed over time, but there can be little doubt that heightened 
awareness, by both industry and the public, of chemicals in our midst 
has caused nationwide releases of reported chemical releases to decline 
dramatically since the TRI was established.
The Challenges Ahead
The actions listed in today's Regulatory Plan are designed to meet the 
environmental problems of today and tomorrow. They address the 
challenge of residual pollution of our water, air, and land, and the 
ubiquity of toxic chemicals in our environment. They represent part of 
the foundation of a new generation of environmental protection for the 
people and natural resources of the United States. EPA will continue to 
explore and introduce new ways of preparing cheaper, cleaner, smarter 
regulations, of forming effective partnerships in a broad, societal 
effort to protect ourselves and our children, and of involving citizens 
in understanding and representing their crucial stake in a clean 
environment in their own communities.
Highlights of EPA's Regulatory Plan for 2000
 EPA's regulatory plan for 2000 reflects the Agency's continuing 
commitment to create new environmental protection strategies that 
better protect public health and the environment at lower cost.
 Here are highlights of our upcoming rules:
Office of Air and Radiation Highlights 
 One of the most significant recent events for the Office of Air and 
Radiation (OAR) was an adverse court decision regarding EPA's air 
quality standards. As summarized below, EPA is appealing this decision, 
and is re-evaluating its implementation program while it awaits legal 
resolution of this situation. Meanwhile, EPA remains committed to 
taking advantage of the flexibility granted by the Clean Air Act that 
enables companies, States, and communities to meet clean air goals with 
low-cost approaches. The following paragraphs summarize the most 
significant of OAR's activities.
 In 1997, EPA established new, more stringent air quality 
            standards for ozone and particulate matter based on new 
            scientific and technical information. The new standards 
            were designed to offer increased protection for public 
            health and the environment, and EPA began pursuing a 
            commonsense implementation strategy that would give States 
            and industry flexibility with which they can meet these air 
            quality goals. However, on May 14, 1999, a three-judge 
            panel of the D.C. Circuit found that the Clean Air Act 
            provision authorizing the new standards is unconstitutional 
            as EPA applied it. This decision did not call into question 
            the scientific basis for the new standards, only the 
            procedure by which they were established. EPA has appealed 
            this decision and intends to vigorously defend the 
            standards in court. However, until the matter is resolved 
            in court, EPA must defer to the panel's decision, and is 
            re-evaluating this implementation strategy to decide which 
            parts of it can continue and which parts must be put on 
            hold during the litigation.
 To address the problem of ozone and nitrogen oxides (NOx) 
            pollution blowing across State boundaries and interfering 
            with clean-air attainment in other States, EPA is 
            implementing a program of regional NOx control. Reductions 
            from this program are scheduled to begin in May of 2003.

[[Page 73456]]

 To achieve further emission reductions mandated by the Clean 
            Air Act, EPA is developing new standards for diesel 
            engines. EPA has also proposed limitations on the sulfur 
            content of diesel fuel available nationwide. Sulfur in 
            diesel fuel has a detrimental impact on catalyst 
            performance and could be a limiting factor in the 
            introduction of advanced technologies on diesel engines.
 In accordance with Section 801 of the Energy Policy Act of 
            1992, EPA is developing health and safety standards for 
            protection of the public from releases from radioactive 
            materials stored or disposed of by the Department of Energy 
            in the nuclear waste repository being constructed at Yucca 
            Mountain in Nevada.
 The Agency has proposed changes to simplify and streamline the 
            New Source Review Program, which requires newly built 
            facilities or those undergoing major modification to obtain 
            a permit to ensure that emissions will not cause or 
            contribute to air pollution problems. A final rulemaking is 
            expected late in 2000.
 EPA, building on successful State programs, has been working 
            with stakeholders to develop a more streamlined way for 
            facilities to get operating permit updates from State or 
            local agencies. Depending on the environmental significance 
            of the change, States would have greater flexibility to 
            decide the appropriate amount of EPA and public review for 
            most permit revisions.
 In August of 1997, EPA completed a comprehensive revision to 
            streamline its regulations on transportation conformity. On 
            March 2, 1999, the U.S. District Court for the District of 
            Columbia overturned parts of that 1997 revision, including 
            the provisions governing which projects can proceed without 
            a conforming transportation plan and when States can use 
            State Implementation Plans that EPA has not approved. The 
            Administration's initial response to this court decision 
            was to issue guidance from EPA and the Department of 
            Transportation dealing with the issues in question. EPA is 
            now developing a rule to respond to these court decisions 
            that will formalize this guidance and deal definitively 
            with all the issues raised by the court.
 To date, our air toxics program has focused primarily on 
            getting broad emission reductions from large industrial 
            sources through technology-based standards. Since 1990, EPA 
            has issued standards affecting 77 different industries, 
            such as petroleum refineries and chemical manufacturing 
            plans. When fully implemented, these standards will reduce 
            more than one million tons of toxic air emissions per year. 
            Additionally, through other efforts such as the phase-out 
            of lead in gasoline, we have significantly reduced air 
            toxics from cars and trucks. We are continuing to set 
            technology-based standards for large industries, and will 
            complete more than 80 additional standards over the next 
            few years. The rules listed in this year's Regulatory Plan 
            -- covering industrial boilers, institutional/commercial 
            boilers, wood manufacturing, reciprocating engines, and 
            combustion turbines -- are among the most significant 
            remaining categories to be regulated under this program. 
            While working on these standards, we are beginning to 
            evaluate those sources with standards already in place to 
            determine if the remaining risk from these sources warrants 
            additional regulation. We are also implementing our Urban 
            Air Toxics Strategy, which focuses on 33 air toxics that 
            pose the greatest risk in the largest number of urban areas 
            and presents our plan, both nationally and more locally, to 
            reduce those toxics. Finally, to better understand and 
            measure risks from air toxics, we are also conducting 
            important health research and improving our emissions 
            inventories, modeling capability, and monitoring network.
 On May 22, 1996, EPA published its final decision not to 
            revise the primary sulfur dioxide NAAQS. The notice stated 
            that EPA would shortly propose a new implementation 
            strategy to help States in addressing short-term peaks of 
            sulfur dioxide. The new implementation strategy - the 
            Intervention Level Program - was proposed on January 2, 
            1997. In July 1996, the American Lung Association and the 
            Environmental Defense Fund petitioned the U.S. Court of 
            Appeals for the D.C. Circuit for a judicial review of EPA's 
            decision not to establish a new 5-minute NAAQS. On January 
            30, 1998, the court found that EPA did not adequately 
            explain its decision and remanded the case so EPA could 
            explain its rationale more fully. EPA published a schedule 
            for responding to the remand in the May 5, 1998 Federal 
            Register. Since that notice, EPA has continued to work on 
            the proposed response to the remand by reviewing additional 
            SO2 air quality information. EPA intends to publish an 
            informational notice in the Federal Register by December 
            2000.
Office of Water Highlights
 On August 6, 1996, President Clinton signed the Safe Drinking Water 
Act (SDWA) Amendments of 1996 which laid out requirements to strengthen 
the Nation's drinking water program. These amendments directed EPA to 
further improve the quality of drinking water and protect public health 
by requiring the following actions:
 On November 2, 1999, EPA published the proposed National 
            Primary Drinking Water Regulation (NPDWR) for Radon that 
            will reduce exposure to radon in homes. The regulation 
            recognizes that the public health problem from radon in 
            indoor air typically far exceeds the health risks of 
            breathing radon released to the air from showers, sinks, or 
            drinking water. The rule, therefore, lays out a unique 
            framework that allows States and/or systems to adopt 
            multimedia programs which reduce radon risks from indoor 
            air and drinking water in combination. States and systems 
            that choose this option will focus risk reduction on the 
            greatest threat (indoor air), while spending much less 
            money to comply with these rules than if they focused on 
            drinking water alone.
 On May 10, 2000, EPA published the NPDWR for Ground Water that 
            sets in place an increasingly targeted strategy to identify 
            ground water systems that are vulnerable to microbial 
            contamination. The multiple barrier approach, of this rule 
            relies on 5 major components (inspections, source water 
            monitoring, corrective action, treatment, and compliance 
            monitoring) which, in combination, EPA believes strikes an 
            appropriate balance between the intensity or burden of 
            protective measures against microbial contamination and 
            follow-up action to the risk being addressed.
 One June 22, 2000, EPA published the NPDWR for Arsenic which 
            is another rule mandated by the 1996 SDWA Amendments. This 
            rule will establish an enforceable maximum contaminant 
            level (MCL) as close to the health based maximum level 
            contaminant level goal as possible. Presently, the arsenic 
            standard is 50 ug/l. The National Academy of Science, 
            however, issued a report in March 1999 that urged EPA to 
            lower the drinking water standard, based on conclusive 
            evidence that inorganic arsenic causes bladder, lung and 
            skin cancer in humans. EPA proposed an MCL of 5 ug/L for 
            arsenic and

[[Page 73457]]

            requested comment on MCL options of 3, 10, and 20 ug/L. EPA 
            will consider comments received on the proposal and any 
            additional data that may become available in order to 
            decide what that appropriate level is, balancing health 
            risk reduction benefits and the costs.
 EPA is also required to publish a Stage 2 Disinfectants/
            Disinfection Byproducts Rule which will reduce the 
            potential health risks posed by disinfection byproducts 
            (DBPs). The regulation, along with the Long Term 2 Enhanced 
            Surface Water Treatment Rule (LT2ESWTR), is intended to 
            expand existing public health protections and address 
            concerns about risk trade-offs between pathogens and 
            disinfection byproducts. Although the LT2ESWTR is not 
            required, publishing these two rules together will help to 
            ensure that drinking water utilities do not compromise 
            adequate microbial protection while they take steps to 
            control DBPs. In addition, the LT2ESWTR will develop 
            monitoring requirements to identify systems at high risk 
            for the pathogen Cryptosporidium (which is highly resistant 
            to disinfection) and prescribe an appropriate level of 
            additional treatment.
 The Clean Water Act (CWA) requires EPA to establish effluent 
limitations guidelines and standards to regulate the quality of point 
source discharges. Pollution from concentrated animal feeding 
operations (CAFOs) potentially can reach waters of the United States 
through discharges from waste storage and animal confinement areas and 
from areas where waste is applied to the land as a nutrient or soil 
amendment. The potential for polluted discharges from these areas is 
especially high during periods of heavy rain when waste storage and 
disposal systems and the soil's assimilation capacity are likely to be 
overwhelmed. Discharges from CAFOs can lead to degradation of surface 
waters due to the addition of nutrients, metals, salts, BOD, various 
pathogens and other pollutants.
 Currently, certain CAFOs are regulated through permits issued under 
the National Pollutant Discharge Elimination System (NPDES). These 
permits specify appropriate discharge standards based on either 
promulgated effluent limitations guidelines and/or permit writers' best 
professional judgment. EPA promulgated the regulations describing the 
NPDES regulatory process for CAFOs in 1976. It also promulgated 
effluent limitation guidelines applicable to feedlots in 1974 and 1975.
 EPA is reexamining and plans to revise the existing NPDES and effluent 
guideline regulations related to CAFOs due to changes within the animal 
agriculture industry since the rules were promulgated in the 1970s; new 
animal and waste management techniques; improved understanding of the 
water quality impacts associated with CAFO waste management; and issues 
associated with implementing the existing regulations. The types of 
changes that are being considered, but may not necessarily be adopted, 
include requirements to develop and implement nutrient management 
plans; requirements regarding land application of manure; requirements 
regarding treatment of manure, litter and wastewater to reduce manure 
constituent concentrations; installation of controls to contain animal 
waste; Best Management Practices; additional sampling and monitoring, 
reporting and recordkeeping; and revising the regulatory scope.
Office of Prevention, Pesticides, and Toxic Substances
 The Food Quality Protection Act (FQPA) overhauled U.S. 
            pesticides laws, enhancing protections related to pesticide 
            residues in food by requiring aggregate and cumulative risk 
            assessments, with a special emphasis on children and 
            infants. EPA currently has underway the Pesticide Tolerance 
            Reassessment Program, a ten year program to reevaluate the 
            safety of all pesticide residues in food. Under this 
            program, EPA has now completed reassessment of the first 
            third of the pesticide residues in foods. Implementation of 
            the Food Quality Protection Act has required an increase of 
            the FIFRA Scientific Advisory Panel (FIFRA/SAP) activities. 
            Significant risk assessment methodology issues continue to 
            be addressed by the FIFRA/SAP. Methodology issues addressed 
            by the FIFRA/SAP include drinking water assessment 
            methodologies, approaches for conducting cumulative and 
            aggregate risk assessments, use of 10x safety factors, and 
            guidelines for assessing protein plant pesticides. The 
            FIFRA/SAP also jointly sponsored with the Science Advisory 
            Board several meetings on ethical considerations of the 
            testing of human subjects.
 Because of the potentially serious consequences of human 
            exposure to endocrine disrupting chemicals, Congress 
            included specific language on endocrine disruption in the 
            Food Quality Protection Act and amended Safe Drinking Water 
            Act in 1996, mandating EPA to develop an endocrine 
            disruptor screening program and to screen endocrine 
            disruptors found in drinking water sources. A variety of 
            chemicals are known to disrupt the endocrine systems of 
            animals in laboratory studies, and compelling evidence has 
            accumulated that endocrine systems of certain fish and 
            wildlife have been affected by chemical contaminants, 
            resulting in developmental abnormalities and reproductive 
            impairment. The Endocrine Disruptor Screening Program 
            focuses on providing methods and procedures to detect and 
            characterize endocrine activity of pesticides, commercial 
            chemicals, and environmental contaminants. While we do have 
            extensive data - including some endocrine-related data - on 
            pesticides, there currently is not enough scientific data 
            available on most of the estimated 87,000 chemicals in 
            commerce to allow us to evaluate all potential risks. The 
            Endocrine Disruptor Screening Program will enable EPA to 
            gather the information necessary to identify endocrine 
            disruptors and take appropriate regulatory action. The 
            Agency has established an Endocrine Disruptor Screening and 
            Testing Program based on the recommendations of the 
            advisory committee established by EPA to consider human 
            health and ecological effects; and hormonal effects of 
            pesticides, industrial chemicals and drinking water 
            contaminants.
 In April 1998, a national initiative, known as the Chemical 
            Right-To-Know (ChemRTK) Program, was announced in order to 
            empower citizens with knowledge about the most widespread 
            chemicals in commerce -- chemicals that people may be 
            exposed to in the places where they live, work, study, and 
            play. EPA's ChemRTK Program is being designed in such a way 
            as to make certain basic information about HPV chemicals 
            available to the public. A major component of the Agency's 
            ChemRTK activity is the HPV Initiative, which is a data 
            collection and development program established by OPPTS for 
            existing U.S. HPV chemicals. Under this Initiative, HPV 
            chemicals are defined as organic chemicals manufactured 
            (including imported) at or above 1 million pounds per year 
            based on

[[Page 73458]]

            information submitted under the 1990 TSCA Inventory Update 
            Rule. Through the HPV Initiative, which includes a 
            voluntary component (the HPV Challenge Program), certain 
            international efforts, and rulemaking under TSCA such as 
            this proposed rule, basic screening level hazard data 
            necessary to provide critical information about the 
            environmental fate and potential hazards associated with 
            HPV chemicals will be collected or, where necessary, 
            developed. Data collected and/or developed under the HPV 
            Initiative will provide critical basic information about 
            the environmental fate and potential hazards associated 
            with these chemicals which, when combined with information 
            about exposure and uses, will allow the Agency and others 
            to evaluate and prioritize potential health and 
            environmental effects and take appropriate follow up 
            action.
 With almost a million children under 5 years of age with 
            blood-lead levels exceeding the Center for Disease 
            Control's level of concern (10 ug/dl), reducing the 
            opportunities for childhood lead poisoning resulting from 
            activities associated with lead-based paint activities 
            continues to be a priority for the Agency. Elevated blood-
            lead levels can lead to reduced intelligence and neuro-
            behavioral problems in young children, and can cause other 
            health problems in children and adults. EPA is working on a 
            final regulation to replace the existing interim guidance 
            that identifies lead-based paint, lead-contaminated dust, 
            and lead-contaminated soil hazards. EPA is considering 
            proposed approaches to address lead risks associated with 
            renovation and remodeling activities. To help reduce the 
            costs related to the abatement of lead-based paint hazards, 
            EPA is working on final rules which would address the 
            disposal of lead-based paint debris.
 EPA expects to finalize a rule which would require EPA-
            approved Pesticide Management Plans (PMPs) for certain 
            pesticides that have a high groundwater contamination 
            potential. Through a PMP, a State or tribe may commit to 
            both EPA and the public that they will manage the use of a 
            particular pesticide in a way that avoids unreasonable 
            risks to groundwater that would otherwise warrant the 
            cancellation of the use of that particular pesticide. The 
            PMP program was developed in partnership with State and 
            tribal representatives.
Office of Environmental Information Highlights
 The Chemical Right-to-Know Initiative, which was announced by 
            the Vice President in April 1998, included a directive to 
            the Agency to list and lower the reporting thresholds for 
            persistent, bioaccumulative, toxic (PBT) chemicals reported 
            under section 313 of the Emergency Planning and Community 
            Right-to-Know Act (EPCRA). This information will better 
            enable communities to understand the nature of toxic 
            releases and potential risks at the local level, as well as 
            establish local priorities. EPCRA section 313 currently 
            requires reporting from facilities which manufacture or 
            process at least 25,000 pounds of a listed chemical, or 
            otherwise use 10,000 pounds of a listed chemical. These 
            thresholds were initially established under the Emergency 
            Planning and Community Right-To-Know Act (EPCRA) section 
            313(f)(1). Section 313(f)(2) of EPCRA gives the 
            Administrator the power to establish a threshold amount for 
            a toxic chemical different from the amount established by 
            paragraph(1) and that such altered thresholds may be based 
            on classes of chemicals. Since PBT chemicals persist in the 
            environment and accumulate organisms, even small releases 
            of PBT chemicals are of concern. Therefore, lower EPCRA 
            section 313 reporting thresholds are appropriate for PBT 
            chemicals
 In accord with the Vice President's directive, EPA has set out 
            the criteria that will be used for determining if a 
            chemical is persistent and bioaccumulative under EPCRA 
            section 313 and has lowered the EPCRA section 313 reporting 
            thresholds for certain PBT chemicals (64 FR 58666, October 
            of 1999). EPA has also conducted an analysis to determine 
            if lead and lead compounds meet the criteria for 
            persistence and bioaccumulation and whether the EPCRA 
            section 313 reporting thresholds should be lowered. On 
            August 3, 1999 (64 FR 42222), EPA issued a proposed rule to 
            lower the EPCRA.
 EPA is considering a proposal to address electronic reporting 
            and record-keeping by regulated companies under all of 
            EPA's environmental programs - air, water, hazardous waste, 
            toxic substances, pesticides and emergency response. The 
            Cross-Media Electronic Reporting and Record-keeping Rule 
            (CROMERRR) would remove existing regulatory obstacles to 
            electronic reporting or record-keeping under any of our 
            programs, and it would set requirements for companies 
            choosing to report and/or keep records electronically. In 
            addition, the rule would set the conditions for allowing 
            electronic reporting or record-keeping under State, tribal 
            or local environmental programs that operate under EPA 
            authorization or delegation.
Office of Solid Waste and Emergency Response Highlights 
The Office of Solid Waste and Emergency Response (OSWER) is planning a 
number of actions to streamline, simplify, and ensure compliance under 
the Resource Conservation and Recovery Act (RCRA), the Federal law 
governing hazardous waste management. As part of its effort to refocus 
hazardous waste regulation on high-risk wastes, EPA is undertaking a 
number of actions to tailor standards to the nature or degree of risk 
posed by particular wastes.
 EPA is streamlining the regulation of listed hazardous wastes. 
            Certain regulations are overly broad in that they apply 
            regardless of the concentrations of the listed wastes. As a 
            result, they regulate certain low-risk wastes (in 
            particular, treatment residuals) as if they posed high 
            risk. EPA's common-sense approach would exempt these low-
            risk wastes from the full management requirements designed 
            for high-risk hazardous wastes.
 The Agency is considering revisions to the RCRA Hazardous 
            Waste Manifest system to reduce the paperwork burden 
            associated with the manifest. The chief goal of the 
            manifest system is to facilitate the safe transportation of 
            hazardous waste shipments to appropriate RCRA management 
            facilities. Reduction in paperwork burden is part of the 
            Administration's Regulatory Reinvention goal of cutting 
            Government red tape. The Agency wants to standardize the 
            manifest program across the states by introducing a truly 
            uniform manifest tracking form that can be completed either 
            manually or electronically.
 Radioactive wastes that are also hazardous wastes under RCRA 
            are mixed wastes. The Agency is seeking to provide 
            increased flexibility to facilities that manage low-level 
            mixed waste (LLMW) and naturally occurring and/or 
            accelerator-produced Radioactive Material (NARM) mixed with 
            hazardous waste.

[[Page 73459]]

            EPA is trying to reduce dual regulation of LLMW, which is 
            subject to the Resource Conservation and Recovery Act 
            (RCRA) and to the Atomic Energy Act (AEA). On November 19, 
            1999, EPA published a proposed rule that would lower cost 
            and reduce paperwork burden, while improving or maintaining 
            protection of human health (including worker exposure to 
            radiation) and the environment. The Agency is seeking to 
            allow on-site storage and treatment of these wastes at the 
            generator's site. The use of tanks/containers to solidify, 
            neutralize, or otherwise stabilize the waste would be 
            required and would apply only to generators of low-level 
            mixed waste who are licensed by the Nuclear Regulatory 
            Commission (NRC) or an Agreement State. The Agency is also 
            seeking to exempt LLMW and hazardous NARM waste from RCRA 
            manifest, transportation, and disposal requirements when 
            certain conditions are met. Under this conditional 
            exemption, generators and treaters must still comply with 
            manifest, transport, and disposal requirements under the 
            NRC (or NRC-Agreement State) regulations for these types of 
            wastes.
 Over the past several years, the Agency has worked with 
            stakeholders from state agencies, industry, and the 
            environmental community to develop recommendations to 
            improve the Agency's permitting programs. These 
            stakeholders concluded that permitting activities should be 
            commensurate with the complexity of the activity and that 
            permit programs should be flexible enough to allow 
            streamlined procedures for routine permitting activities. 
            The stakeholders recommended that regulations be developed 
            to allow standardized permits for on-site storage and non-
            thermal treatment of hazardous waste in tanks, containers, 
            and containment buildings. As a result of this 
            recommendation, the Agency is considering revisions to the 
            RCRA regulations to allow this type of permit.
 On April 25, 2000, EPA issued a regulatory determination to 
            retain an exemption from hazardous waste management for 
            fossil fuel combustion wastes. The utility industry has 
            made significant improvements in its waste management 
            practices over recent years, and most State regulatory 
            programs are similarly improving. Nevertheless, coal 
            combustion wastes could pose risks to human health and the 
            environment if they are not properly managed. There is 
            sufficient evidence that adequate controls may not be in 
            place. For example, while most States can now require newer 
            waste management units that accept coal combustion wastes 
            to include liners and groundwater monitoring, 62 percent of 
            existing utility surface impoundments (a type of waste 
            management unit) do not have groundwater monitoring. EPA 
            acknowledges that some waste management units may not 
            warrant liners, depending on site-specific characteristics. 
            To address those circumstances that warrant further 
            environmental controls, the Agency is looking into 
            developing and issuing appropriate RCRA subtitle D 
            standards for the management of coal combustion wastes in 
            landfills and surface impoundments that are generated by 
            the electric power producers, including electric utilities 
            and independent power producers.
Office of Administration and Resources Management Highlights
 In 1995, EPA and the States agreed to develop and carry out the 
National Environmental Performance Partnership System (NEPPS) to: 
Promote joint planning and priority setting by EPA and the States; give 
States greater flexibility to direct resources where they need them 
most; foster use of integrated and innovative strategies for solving 
water, air, and waste problems; achieve a better balance in the use of 
environmental indicators and traditional activity measures for managing 
programs; and improve public understanding of environmental conditions 
and the strategies being used to address them.
 EPA is announcing its intent to publish two new subparts under 40 CFR 
part 35. The first subpart governs Environmental Program Grants to 
States, Interstate, and Local Agencies (40 CFR 35, subpart A) and 
includes rules applicable to the Performance Partnership Grant (PPG) 
program. The second subpart contains Tribal-specific provisions for 
environmental program grants and a new Performance Partnership Grant 
(PPG) program for Tribes and Intertribal Consortia (40 CFR 35, subpart 
B). Under the PPG program, eligible applicants can combine 
environmental program grants into a single grant in order to improve 
environmental performance, increase programmatic flexibility, and 
achieve administrative savings. The proposed rules were published in 
the Federal Register on July 23, 1999. The Agency anticipates that the 
regulations will be made final in January 2001.
Office of Policy, Economics, and Innovations Highlights
 The National Environmental Performance Track Program is being 
implemented initially with the Achievement Track program. In order to 
attract a large number of higher-performing facilities from various 
industry sectors, EPA has designed a variety of incentives. These 
include actions which recognize and highlight the achievements of the 
facilities that successfully fulfill the requirements for entry, but 
also include other incentives. Some of those incentives are being 
implemented by administrative actions, but others will require changes 
in existing Federal regulations. OPEI has convened an Agency work group 
to develop the rulemaking changes required. One part of this is changes 
in the regulations specifying reporting by facilities covered by the 
MACT provisions of the Clean Air Act. Facilities meeting the criteria 
for membership in Achievement Track would be eligible for reduced 
reporting and some other provisions, and facilities that more than meet 
goals for emissions reductions under MACT via pollution prevention 
means would qualify for some additional reduced reporting. A second 
part of the rulemaking will be reductions in reporting requirements for 
publicly owned treatment works (POTWs), under the Clean Water Act. A 
third would allow POTWs to notify the public of any violations of 
permits by the indirect dischargers using the POTWs' services by 
placing notices on the internet (rather than using paid newspaper 
advertisements). The last part of the rulemaking would be a pilot test 
of consolidated reporting (an idea explored extensively in the past 
several years). This is likely to begin with one or two industry 
sectors, and to be modeled on pilot efforts explored in EPA's Common 
Sense Initiative, and is likely to roll various periodic reports 
required under CAA, CWA, RCRA, and other statutes into one report, 
eliminating duplicate reporting and other difficulties. If this test is 
successful, EPA will consider widening the applicability to Achievement 
Track facilities in other industry sectors.
Summary
 In developing all of these actions, EPA is committed to flexible, 
cost-effective regulatory programs that offer increased protections for 
public health and the environment. EPA welcomes

[[Page 73460]]

suggestions from the public to help the Agency in this effort.
_______________________________________________________________________



EPA

                              -----------

                             PRERULE STAGE

                              -----------




108. CHEMICAL RIGHT-TO-KNOW INITIATIVE - HIGH PRODUCTION VOLUME (HPV) 
CHEMICALS
Priority:


Other Significant


Legal Authority:


15 USC 4 TSCA; 15 USC 8 TSCA; 42 USC 313 TRI; 7 USC 136 FIFRA


CFR Citation:


40 CFR 700 et seq


Legal Deadline:


Other, Judicial, December 31, 1999, Final Actions must be completed by 
12/31/99.


Abstract:


The Chemical RTK Initiative was announced by the Vice President on 
EPA's Earth Day 1998 in response to the finding that most commercial 
chemicals have very little, if any, publicly available toxicity 
information on which to make sound judgments about potential risks. 
There are three key components to this initiative, each of which is 
being implemented by EPA. These are: collecting and making public 
screening level toxicity data for 2,800 widely used commercial 
chemicals; additional health effects testing for chemicals to which 
children are substantially exposed; and the listing and lowering of 
thresholds for persistent, bioaccumulative, toxic chemicals reported to 
TRI. This initiative will involve several separate activities, with any 
regulatory related actions included as separate entries in the 
regulatory agenda.


Statement of Need:


The Chemical Right-to-Know Initiative grew out of the finding of an EPA 
study that there is very little basic publicly available information on 
the health and environmental effects of even the most widely used 
commercial chemicals. Less than 7 percent of the 2,800 high production 
volume chemicals have a full set of baseline testing information 
readily available, while almost 50 percent have no public information 
whatsoever. The Chemical Right-to-Know Initiative is designed to close 
these information gaps, and to make both new and existing information 
available to the public.


Summary of Legal Basis:


To the extent that rulemaking is required to implement the Chemical 
Right-to-Know Initiative, EPA will utilize the testing authorities 
available under TSCA and the chemical reporting authorities of EPCRA 
section 313 (the Toxics Release Inventory).


Alternatives:


The Chemical Right-to-Know Initiative will rely on a combination of 
partnership programs and rulewriting to accomplish its goals. For 
instance, an HPV Challenge Program will ask industry to voluntarily 
provide both new and existing data on high production volume chemicals, 
while an HPV test rule would require testing of specific HPV chemicals 
of concern.


Anticipated Cost and Benefits:


The benefits of the Chemical Right-to-Know Initiative are substantial, 
as no one in the environmental community -- whether in industry, 
government or the public -- can make reasoned risk management decisions 
in the absence of reliable health and environmental information. The 
cost of baseline testing is well established, and runs about $200,000 
per chemical for a full set of tests, for those chemicals on which data 
do not already exist. More detailed testing, as envisioned for the 
Children's Health testing portion of this initiative, may be more 
expensive, but has not yet been costed out.


Risks:


None.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
Notice - HPV                                                   10/00/00
Initiative Completed - HPV Data To Be Received by 06/2005      06/00/05
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


Businesses, Governmental Jurisdictions


Government Levels Affected:


Federal


Additional Information:


SAN No. 4176


This initiative includes the following regulatory agenda activities: 
TRI's Reporting Threshold Rule (SAN 3880; RIN 2070-AD09); Test Rule; 
Multi-Chemicals Test Rule for High Production Volume Chemicals (SAN 
3990; RIN 2070-AD16); Children's Health Test Initiative (SAN 2865; RIN 
2070-AC27).


Sectors Affected:


32411 Petroleum Refineries; 325 Chemical Manufacturing


Agency Contact:
Mary Dominiak
Environmental Protection Agency
Office of Prevention, Pesticides and Toxic Substances
7405
Washington, DC 20460
Phone: 202 260-7768
Fax: 202 260-1096
Email: [email protected]

Barbara Leczynski
Environmental Protection Agency
Office of Prevention, Pesticides and Toxic Substances
7405
Washington, DC 20460
Phone: 202 260-3945
Fax: 202 260-1096
Email: [email protected]
RIN: 2070-AD25
_______________________________________________________________________



EPA

                              -----------

                          PROPOSED RULE STAGE

                              -----------




109.  REGULATORY INCENTIVES FOR THE NATIONAL ENVIRONMENTAL 
ACHIEVEMENT TRACK PROGRAM
Priority:


Other Significant


Legal Authority:


Not Yet Determined


CFR Citation:


Not Yet Determined


Legal Deadline:


None


Abstract:


The National Environmental Achievement Track is designed to recognize 
facilities that consistently meet their legal requirements and have 
implemented high-quality environmental management systems, and to 
encourage them to achieve more by continuously improving their 
environmental performance and

[[Page 73461]]

informing and involving the public. Facilities gain entrance to 
Achievement Track by submitting an application that documents that four 
specific criteria are met. To promote participation in the program and 
the environmental and other benefits that will come with it, EPA 
intends to offer several incentives. Among those incentives are the 
adjustments in current regulatory requirements that are the subjects of 
this rulemaking. These include reducing the frequency of reports 
required under the Maximum Achievable Control Technology (MACT) 
provisions of the Clean Air Act; streamlined by publically owned 
treatment works (POTWs) under the Clean Water Act; and opportunity for 
Achievement Track facilities to consolidate reporting under various 
environmental statutes into a single report.


Statement of Need:


The Administrator of EPA has announced the National Environmental 
Performance Track Program, of which the Achievement Track program is 
the first element to be implemented. By identifying facilities that 
have better environmental performance than others, and by requiring 
them to commit to goals for sustained improvements, EPA expects the 
environment to greatly benefit. Facilities that are able to qualify for 
the program will make a public commitment to reducing specific aspects 
of their impacts on the environment, and the program is likely to 
induce other facilities to make changes in their operations that will 
bring about analogous reductions in their environmental impacts. In 
order to attract significant numbers of facilities, Achievement Track 
will provide incentives for joining, in the form of substantial 
benefits to the facilities that qualify. EPA is considering alterations 
in reporting and other requirements (to be available only to 
Achievement Track facilities) that would be made available as a result 
of this rulemaking. Extensive input (written comments and several 
public meetings) from stakeholders has convinced EPA that benefits such 
as these are crucial to achieving the intended environmental benefits 
of the Achievement Track program.


Summary of Legal Basis:


All of the modifications under consideration are modifications of 
existing regulations, promulgated over the past several years under 
statutes that include the CAA, CWA, EPCRA, SDWA, and others. Within 
these statutes, EPA has discretion to set reporting frequencies, the 
contents of reports, monitoring, and other specifics, based on an 
assessment of the need for information to implement the statutes.


Alternatives:


Deliberations within the Agency, and among stakeholders and EPA, have 
convinced EPA that a full and robust set of incentives is crucial to 
the successful implementation of Achievement Track. EPA developed a 
list of over forty different candidate incentives, and discussed many 
of these during a set of public meetings held during the design phase 
of the National Environmental Performance Track. Several incentives can 
be implemented through EPA administrative actions, but some potential 
incentives would require changes in existing regulations. The specific 
incentives being considered here resulted from intense analysis and 
debate within EPA and the Administrator's judgment that they contribute 
to achieving the program's aims. During the rulemaking process, EPA 
will consider various alternatives for these incentives, ranging from 
substantial changes in reporting frequency and content to no changes. 
EPA is also considering initiating rulemaking on other incentives 
beyond the ones discussed here.


Anticipated Cost and Benefits:


Overall, EPA expects there to be a net reduction in compliance costs 
for facilities that participate in Achievement Track. Facilities would 
have direct reductions in the efforts required to collect, summarize 
and report various data elements, and would potentially benefit from a 
streamlining of their environmental reporting information systems and 
from an integration of those data systems into company environmental 
management systems. EPA and some State regulatory authorities are 
likely to see modest increases in workload (and therefore in costs), 
mostly in the revising permits. This effect would be moderated by the 
fact that only a fraction of regulated facilities are expected to 
qualify for Achievement Track. Finally, because Achievement Track is 
designed to induce environmental improvements among those facilities 
that seek and obtain entrance to the program, EPA anticipates tangible 
environmental benefits to be realized.


Risks:


The risks of the intended rulemaking appear minimal. The criteria and 
the screening process for Achievement Track will identify and admit 
only facilities that operate significantly above the norm of other 
facilities. Because facilities must carry out their Achievement Track 
actions in the public spotlight, and because EPA expects that 
facilities will strive to stay qualified for the program, there is only 
a very small likelihood that mistakes would be made, and any such 
mistakes could easily be reversed. The actions being contemplated in 
this rulemaking entail mostly reporting changes, not substantive 
changes in permitted release rates or other actions that would directly 
impinge on the environment. All of these factors serve to limit the 
risks to the environment from the intended rulemaking.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           12/00/00
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


Businesses, Governmental Jurisdictions


Government Levels Affected:


State


Federalism:


 Undetermined


Additional Information:


SAN No. 4473


Agency Contact:
Frederick W. Talcott
Environmental Protection Agency
Office of the Administrator
2129
Washington, DC 20460
Phone: 202 260-2768
Fax: 202 401-3998
Email: [email protected]

Daniel J. Fiorino
Environmental Protection Agency
Office of the Administrator
2129
Phone: 202 260-2749
Fax: 202 401-3998
Email: [email protected]
RIN: 2090-AA13


_______________________________________________________________________


[[Page 73462]]

EPA



110. NAAQS: SULFUR DIOXIDE (RESPONSE TO REMAND)
Priority:


Other Significant


Legal Authority:


42 USC 7409 CAA sec 109


CFR Citation:


40 CFR 50.4; 40 CFR 50.5


Legal Deadline:


Final, Judicial, December 31, 2000.


Abstract:


On November 15, 1994, the Environmental Protection Agency (EPA) 
proposed not to revise the existing 24-hour and annual primary 
standards. The EPA sought public comment on the need to adopt 
additional regulatory measures to address the health risk to asthmatic 
individuals posed by short-term peak sulfur dioxide exposure. On March 
7, 1995, EPA proposed implementation strategies for reducing short-term 
high concentrations of sulfur dioxide emissions in the ambient air. On 
May 22, 1996, EPA published its final decision not to revise the 
primary sulfur dioxide NAAQS. The notice stated that EPA would shortly 
propose a new implementation strategy to assist States in addressing 
short-term peaks of sulfur dioxide. The new implementation strategy - 
the Intervention Level Program - was proposed on January 2, 1997. In 
July 1996, the American Lung Association and the Environmental Defense 
Fund petitioned the U.S. Court of Appeals for the D.C. Circuit for a 
judicial review of EPA's decision not to establish a new five-minute 
NAAQS. On January 30, 1998, the court found that EPA did not adequately 
explain its decision and remanded the case so EPA could explain its 
rationale more fully. EPA published a schedule for responding to the 
remand in the May 5, 1998 Federal Register. Since that notice, EPA has 
continued to work on the proposed response to the remand by reviewing 
additional SO2 air quality information. EPA intends to publish an 
informational notice in the Federal Register by December 2000.


Statement of Need:


Brief exposures to elevated concentrations of sulfur dioxide, while at 
exercise, may cause bronchoconstriction, sometimes accompanied by 
symptoms (coughing, wheezing, and shortness of breath), in mild to 
moderate asthmatic individuals. The existing sulfur dioxide National 
Ambient Air Quality Standard (NAAQS) provides substantial protection 
against short-term peak sulfur dioxide levels. At issue is whether 
additional measures are needed to further reduce the health risk to 
asthmatic individuals.


Summary of Legal Basis:


Title I of the Clean Air Act.


Alternatives:


The March 7, 1995, proposal notice sought public comment on three 
alternatives to further reduce the public health risk to asthmatic 
individuals posed by short-term peak sulfur dioxide exposures. These 
included: (a) a new 5-minute NAAQS; (b) a new program under section 303 
of the Act; and (c) a targeted monitoring program to ensure sources 
likely to cause or contribute to high 5-minute peaks are in attainment 
with the existing standard. The January 2, 1997, notice proposed an 
alternative program under section 303 of the Act that will assist 
States in addressing high 5-minute peaks.


Anticipated Cost and Benefits:


A draft regulatory impact analysis was completed and made available for 
public comment at the time of the January 2, 1997 proposal.


Risks:


Exposure analyses indicate from the national perspective that the 
likelihood of exposure to high 5-minute sulfur dioxide concentrations 
is very low. Asthmatic individuals in the vicinity of certain sources 
or source categories, however, may be at higher risk of exposure than 
the population as a whole.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM - NAAQS Rev59 FR 58958                                    11/15/94
NPRM - NAAQS Imp60 FR 12492 (Part 51)                          03/07/95
Final Rule - NAA61 FR 25566                                    05/22/96
NPRM - Revised N62 FR 210ementation (Part 51)                  01/02/97
Notice - Schedul63 FR 24782nse to NAAQS Remand                 05/05/98
Notice - Informational FR Notice                               12/00/00
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


Federal, State, Local


Federalism:


 Undetermined


Additional Information:


SAN No. 1002


Agency Contact:
Gary Blais (Implementation)
Environmental Protection Agency
Air and Radiation
MD-15
Research Triangle Park, NC 27711
Phone: 919 541-3223
Email: [email protected]

Susan Stone
Environmental Protection Agency
Air and Radiation
MD-15
Research Triangle Park, NC 27711
Phone: 919 541-1146
Fax: 919 541-0237
Email: [email protected]
RIN: 2060-AA61
_______________________________________________________________________



EPA



111. NEW SOURCE REVIEW (NSR) IMPROVEMENT
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:


CAA as amended, title I


CFR Citation:


40 CFR 51.160 to 51.166; 40 CFR 52.21; 40 CFR 52.24


Legal Deadline:


None


Abstract:


This action is to revise the CAA new source review (NSR) regulations, 
which govern the preconstruction air quality review and permitting 
programs that are implemented by States and the Federal Government for 
new and

[[Page 73463]]

modified major stationary sources of air pollution. This rulemaking 
will deregulate, that is, exclude from major NSR program requirements, 
those activities of sources that, with respect to air pollution, have 
little environmental impact. The rulemaking will encourage pollution 
control and pollution prevention projects at existing sources. Control 
technology requirements will be clarified with respect to when and how 
they apply to sources that are covered. The action seeks to more 
clearly define the appropriate roles and requirements of sources, 
permitting authorities and Federal land managers and EPA in the 
protection of air-quality-related values in Federal Class I areas 
(i.e., certain national parks and wilderness areas) under the NSR 
regulations. State, local, and tribal permitting agencies will be given 
more flexibility to implement program requirements in a manner that 
meets their specific air quality management needs. Consequently, the 
rulemaking decreases the number of activities that are subject to NSR 
requirements and also expedites the permitting process for those 
sources that are subject to NSR. This action is designed to reduce the 
regulatory burden over all industries without respect to commercial 
size or capacity; therefore, it should have no detrimental impact on 
small businesses. This action also addresses several pending petitions 
for judicial review and administrative action pertaining to NSR 
applicability requirements and control technology review requirements. 
Regulations that will be affected are State implementation plan 
requirements for review of new sources and modifications to existing 
sources (40 CFR 51.160-166), the Federal prevention of significant 
deterioration program (40 CFR 52.21), and Federal restriction on new 
source construction (40 CFR 52.24). Finally, this NSR Improvement 
effort also includes a separate rulemaking (SAN 4390, NSR Improvement: 
Utility Sector Offramp Program), which will provide industries with the 
flexibility to focus more on existing pollution sources, with the goal 
of achieving as good or better environmental results than could be 
achieved by focusing strictly on new sources.


Statement of Need:


In August 1992, EPA voluntarily initiated a comprehensive effort to 
reform the NSR process. This effort was initiated to examine complaints 
from the regulated community that the current regulatory scheme is too 
complex, needlessly delays projects, and unduly restricts source 
flexibility. Currently there are no applicable statutory or judicial 
deadlines for the NSR reform rulemaking effort. The goal of this effort 
is to address industry's concerns without sacrificing the environmental 
benefits embodied in the present approach; that is, protecting and 
improving local air quality, and stimulating pollution prevention and 
advances in control technologies.


In July 1993, the New Source Review (NSR) Reform Subcommittee of the 
Clean Air Act Advisory Committee was formed. The Subcommittee's purpose 
is to provide independent advice and counsel to EPA on policy and 
technical issues associated with reforming the NSR rules. The 
Subcommittee was composed of representatives from industry, State/local 
air pollution control agencies, environmental organizations, EPA 
headquarters and regions, and other Federal agencies (National Park 
Service and Forest Service, Department of Energy, and the Office of 
Management and Budget).


Summary of Legal Basis:


There are no applicable statutory or judicial deadlines for the NSR 
reform rulemaking effort. However, the rule will address three 
outstanding settlement agreements: CMA Exhibit B, Top-down BACT, and 
the applicability test for modifications at utilities.


Alternatives:


The Subcommittee discussed numerous options for implementing NSR 
reform. However, EPA's primary focus has been to consider the specific 
recommendations developed by the Subcommittee and, where appropriate, 
use them in this rulemaking effort. In January 1996, EPA, as part of 
another regulatory streamlining measure, merged portions of a separate 
rulemaking to implement the 1990 CAA Amendments with the Reform effort. 
The combined package was proposed in the Federal Register on July 23, 
1996. On July 24, 1998, EPA issued another Federal Register notice 
seeking comment on two applicability provisions. On February 2-3, 1999, 
EPA convened a public meeting to listen to new stakeholder proposals 
for streamlining NSR applicability and control technology requirements. 
Stakeholder groups submitted written proposals during May and June 
1999. Discussions on these proposals will conclude by October 1999.


Anticipated Cost and Benefits:


From a cost perspective, the proposed rulemaking represents a decrease 
in applications and recordkeeping costs to industry of at least $13 
million per year, as compared to the preexisting program, based 
primarily on the fact that fewer sources will need to apply for major 
source permits. In addition, the cost to State and local agencies will 
be reduced by approximately $1.4 million per year. The Federal 
Government should realize a savings of approximately $116,000 per year. 
Additional cost reductions, which are difficult to quantify, will be 
realized due to the streamlining effect of the rulemaking on the 
permitting process, for example, the opportunity costs for shorter time 
periods between permit application and project completion and reduced 
uncertainty in planning for future source growth.


Risks:


This is a procedural rule applicable to a wide variety of source 
categories. Moreover, it applies to criteria pollutants for which NAAQS 
have been established. This action is considered environmentally 
neutral. However, any potential risks are considered in the NAAQS 
rulemaking from a national perspective.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            61 FR 38249                                    07/23/96
NPRM - Utility Sector Offramp Program                          11/00/00
Final Action                                                   12/00/00
Final Action - Utility Sector Offramp Program                  04/00/01
Regulatory Flexibility Analysis Required:


No


Government Levels Affected:


Federal, State


Additional Information:


SAN No. 3259


See also SAN 4390


Agency Contact:
Dennis Crumpler
Environmental Protection Agency
Air and Radiation
MD-12
Research Triangle Park, NC 27711
Phone: 919 541-0871
Fax: 919 541-5509
Email: [email protected]
RIN: 2060-AE11


_______________________________________________________________________


[[Page 73464]]

EPA



112. OPERATING PERMITS: REVISIONS (PART 70)
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 7661 et seq


CFR Citation:


40 CFR 51; 40 CFR 52; 40 CFR 70


Legal Deadline:


None


Abstract:


In response to litigation on the operating permits rule regulations, 40 
CFR part 70, to provide more effective implementation of part 70, and 
to address comments provided in response to notices of proposed 
rulemaking, parts 70, 51 and 52 are being revised. The changes 
streamline the procedures for revising stationary-source operating 
permits issued by State and local permitting authorities under title V 
of the Clean Air Act.


Statement of Need:


These revised rules will allow more streamlined procedures for revising 
operating permits. These revisions reflect the principles articulated 
in the President's and the Vice President's March 16, 1995 report 
Reinventing Environmental Regulation. That report established as goals 
for environmental regulation the building of partnerships between EPA 
and State and local agencies, minimizing costs, providing flexibility 
in implementing programs, tailoring solutions to the problem, and 
shifting responsibility to State and local programs.


Alternatives:


In response to concerns expressed in comments on the draft final 
rulemaking, the EPA discussed alternatives with representatives from 
State and local permitting authorities and industry and environmental 
groups, and desires public comment on some of the proposed 
alternatives. EPA will then consider public comments before 
promulgating a final rule.


Anticipated Cost and Benefits:


The administrative cost of implementing these proposed rules by 
permitting authorities, EPA, and permitted sources has not yet been 
estimated, but is expected to be lower than the cost of the current 
rule. Administrative costs include a range of costs which cover the 
source's preparing an application through EPA's and the permitting 
authority's effort to complete the process.


Risks:


All major sources of air pollution are required to have a permit to 
operate by the Clean Air Act. No adverse effect on the public health or 
ecosystems should result from this action, because the rule will 
require permit revisions with significant environmental impact to 
undergo public and EPA review.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            59 FR 44460                                    08/29/94
Supplemental NPR60 FR 20804                                    04/27/95
Supplemental NPR60 FR 45530                                    08/31/95
Direct Final Int63 FR 40054al Extension                        07/27/98
NPRM Interim App63 FR 40053sion                                07/27/98
NPRM                                                           12/00/00
Final Action                                                   12/00/01
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


Businesses, Governmental Jurisdictions


Government Levels Affected:


State, Local


Additional Information:


SAN No. 3412


Agency Contact:
Ray Vogel
Environmental Protection Agency
Air and Radiation
MD-12
Research Triangle Park, NC 27711
Phone: 919 541-3153
Fax: 919 541-5509
Email: [email protected]
RIN: 2060-AF70
_______________________________________________________________________



EPA



113. NESHAP: PLYWOOD AND COMPOSITE WOOD PRODUCTS
Priority:


Economically Significant. Major under 5 USC 801.


Legal Authority:


42 USC 7412(d)


CFR Citation:


40 CFR 63


Legal Deadline:


Final, Statutory, November 15, 2000.


Abstract:


This project is to develop national emission standards for hazardous 
air pollutants (NESHAP) by establishing maximum achievable control 
technology (MACT) for facilities manufacturing wood panels and 
engineered wood products. MACT standards are under development to 
reduce the release of hazardous air pollutants (HAP) from all 
industries to protect the public health and environment. Emissions of 
HAP from this industry have been associated with, but are not limited 
to, the drying of wood and binders. This rule is anticipated to apply 
to the manufacture of products involving wood and some kind of binder 
or bonding agent. This project may include, but is not limited to, 
facilities that manufacture waferboard, hardboard fiber board, oriented 
strandboard (OSB), medium density fiberboard (MDF), particleboard, 
strawboard, hardwood and softwood plywood, glue-laminated lumber, 
laminated veneer lumber, and engineered wood products. The source 
category may also include lumber drying kilns at sawmills which are 
located on the same site as a facility that manufactures any of the 
wood products mentioned above. The project may also include some 
coatings operations. The name of the source category was formerly 
Plywood and Particleboard MACT.


Statement of Need:


Plywood and Composite Wood Products is a source category listed to be 
regulated under Section 112 of the Clean Air Act


Summary of Legal Basis:


Clean Air Act Section 112


Alternatives:


The principal alternatives are to set standards at or beyond the 
``floor'' level of stringency. The ``floor'' is the

[[Page 73465]]

minimum stringency implied by the congressionally given formula in 
section 112 of the Clean Air Act.


Anticipated Cost and Benefits:


It is expected that this rule will result in significant costs to the 
affected industry, including costs for recordkeeping and reporting. 
These costs will be identified as the proposal is developed.


Risks:


In Section 112 of the Clean Air Act, Congress found that there is 
sufficient evidence of risk to warrant a broad, technology-based MACT 
program to reduce toxic emissions nationwide. Therefore, separate risk 
analyses are not conducted for individual rulemakings within the MACT 
program.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           12/00/00
Final Action                                                   12/00/01
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


Businesses


Government Levels Affected:


Federal, State, Local


Additional Information:


SAN No. 3820


Sectors Affected:


32121 Veneer, Plywood, and Engineered Wood Product Manufacturing


Agency Contact:
Mary Tom Kissell
Environmental Protection Agency
Air and Radiation
MD-13
Research Triangle Park, NC 27711
Phone: 919 541-4516
Fax: 919 541-0246
Email: [email protected]

Kent C. Hustvedt
Environmental Protection Agency
Air and Radiation
MD-13
Research Triangle Park, NC 27711
Phone: 919 541-5395
Fax: 919 541-0246
Email: [email protected]
RIN: 2060-AG52
_______________________________________________________________________



EPA



114. NESHAP: RECIPROCATING INTERNAL COMBUSTION ENGINE
Priority:


Economically Significant. Major under 5 USC 801.


Legal Authority:


42 USC 7412 CAA sec 112; PL 101-549


CFR Citation:


40 CFR 63


Legal Deadline:


Final, Statutory, November 15, 2000.


Abstract:


The stationary reciprocating internal combustion engine source category 
is listed as a major source of hazardous air pollutants (HAPs) under 
section 112 of the Clean Air Act (CAA). A major source is one which 
emits more than 10 tons/yr of one HAP or more than 25 tons/yr of a 
combination of 189 HAPs. The EPA will gather information on HAP 
emissions from internal combustion engines and determine the 
appropriate maximum achievable control technology (MACT) to reduce HAP 
emissions, if any. The EPA will also gather information for NOx, SO2, 
CO, and PM and decide whether standards are required to reduce these 
emissions. The EPA will use information that has already been 
developed, if possible, by gathering information by working with State/
local agencies, vendors, manufacturers of internal combustion engines, 
owners and operators of internal combustion engines, and 
environmentalists.


Statement of Need:


Reciprocating Internal Combustion Engines is a source category listed 
to be regulated under section 112 of the Clean Air Act.


Summary of Legal Basis:


Section 112 of the Clean Air Act


Alternatives:


The principal alternatives are to set standards at or beyond the 
``floor'' level of stringency. The ``floor'' is the minimum stringency 
implied by the congressionally given formula in section 112 of the 
Clean Air Act.


Anticipated Cost and Benefits:


It is expected that this rule will result in significant costs to the 
affected industry, including costs for recordkeeping and reporting. 
These costs will be identified as the proposal is developed.


Risks:


In Section 112 of the Clean Air Act, Congress found that there is 
sufficient evidence of risk to warrant a broad, technology-based MACT 
program to reduce toxic emissions nationwide. Therefore, separate risk 
analyses are not conducted for individual rulemakings within the MACT 
program.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           12/00/00
Final Action                                                   11/00/01
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


Businesses, Governmental Jurisdictions


Government Levels Affected:


None


Additional Information:


SAN No. 3656


Agency Contact:
Sims Roy
Environmental Protection Agency
Air and Radiation
MD-13
Research Triangle Park, NC 27711
Phone: 919 541-5263
Fax: 919 541-5450
Email: [email protected]

Robert J. Wayland
Environmental Protection Agency
Air and Radiation
MD-13
Research Triangle Park, NC 27711
Phone: 919 541-1045
Fax: 919 541-5450
Email: [email protected]
RIN: 2060-AG63
_______________________________________________________________________



EPA



115. NESHAP: COMBUSTION TURBINE
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 7412 CAA sec 112


CFR Citation:


44 CFR 63

[[Page 73466]]

Legal Deadline:


Final, Statutory, November 15, 2000.


Abstract:


The combustion turbine source category is listed as a major source of 
hazardous air pollutants (HAPs) under section 112 of the Clean Air Act 
(CAA). A major source is one which emits more than 10 tons/yr of one 
HAP or more than 25 tons/yr of a combination of 189 HAPs. Combustion 
turbines also emit NOx, SO2, CO, and PM. Combustion turbines are 
already regulated for NOx and SO2 emissions under section 111 of the 
CAA. The EPA will gather information on HAP emissions from combustion 
turbines and determine the appropriate maximum achievable control 
technology (MACT) to reduce HAP emissions, if any. The EPA will also 
gather information to revise the 1979 NSPS for NOx and SO2 and decide 
whether CO and PM standards are required for combustion turbines. The 
EPA information that has already been developed will be used if 
possible and additional information will be gathered by working with 
State/local agencies, vendors, manufacturers of combustion turbines, 
owners and operators of combustion turbines, and environmentalists.


Statement of Need:


Combustion Turbines is a source category listed to be regulated under 
Section 112 of the Clean Air Act.


Summary of Legal Basis:


Section 112 of the Clean Air Act


Alternatives:


The principal alternatives are to set standards at or beyond the 
``floor'' level of stringency. The ``floor'' is the minimum stringency 
implied by the congressionally-given formula in section 112 of the 
Clean Air Act.


Anticipated Cost and Benefits:


It is expected that this rule will result in significant costs to the 
affected industry, including costs for recordkeeping and reporting. 
These costs will be identified as the proposal is developed.


Risks:


In Section 112 of the Clean Air Act, Congress found that there is 
sufficient evidence of risk to warrant a broad, technology-based MACT 
program to reduce toxic emissions nationwide. Therefore, separate risk 
analyses are not conducted for individual rulemakings within the MACT 
program.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           11/00/00
Final Action                                                   09/00/01
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


Businesses, Governmental Jurisdictions


Government Levels Affected:


Local


Additional Information:


SAN No. 3657


Agency Contact:
Sims Roy
Environmental Protection Agency
Air and Radiation
MD-13
Research Triangle Park, NC 27711
Phone: 919 541-5263
Fax: 919 541-5450
Email: [email protected]

Robert J. Wayland
Environmental Protection Agency
Air and Radiation
MD-13
Research Triangle Park, NC 27711
Phone: 919 541-1045
Fax: 919 541-5450
Email: [email protected]
RIN: 2060-AG67
_______________________________________________________________________



EPA



116. NESHAP: INDUSTRIAL, COMMERCIAL AND INSTITUTIONAL BOILERS AND 
PROCESS 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 7412


CFR Citation:


40 CFR 63


Legal Deadline:


Final, Statutory, November 15, 2000.


Abstract:


The Clean Air Act, as amended in 1990, requires EPA to develop emission 
standards for sources of hazardous air pollutants (HAPs). Industrial 
boilers, institutional/commercial boilers and process heaters are among 
the potential source categories to be regulated under section 112 of 
the CAA. Emissions of HAPs will be addressed by this rulemaking for 
both new and existing sources. EPA promulgated an NSPS for these source 
categories in 1987 and 1990. The standards for the NESHAP are to be 
technology-based and are to require the maximum achievable control 
technology (MACT) as described in section 112 of the CAA.


Statement of Need:


Industrial boilers, institutional/commercial boilers, and process 
heaters are source categories listed to be regulated under section 112 
of the Clean Air Act.


Summary of Legal Basis:


Section 112 of the Clean Air Act


Alternatives:


Alternatives will be explored as the proposal is developed. At this 
early stage, no alternatives have yet been identified.


Anticipated Cost and Benefits:


It is expected that this rule will result in significant costs to the 
affected industry, including costs for recordkeeping and reporting. 
These costs will be identified as the proposal is developed.


Risks:


The risks from this industry are expected to be those normally 
associated with combustion, such as exposure to particulate matter and 
sulfur oxides. These will be addressed as the proposal is developed.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           01/00/01
Final Action                                                   02/00/02
Regulatory Flexibility Analysis Required:


Undetermined


Small Entities Affected:


Businesses


Government Levels Affected:


Federal, State, Local


Federalism:


 Undetermined


Additional Information:


SAN No. 3837

[[Page 73467]]

Agency Contact:
James Eddinger
Environmental Protection Agency
Air and Radiation
MD-13
Research Triangle Park, NC 27711
Phone: 919 541-5426
Fax: 919 541-5450
Email: [email protected]

William Maxwell
Environmental Protection Agency
Air and Radiation
MD-13
Research Triangle Park, NC 27711
Phone: 919 541-5430
Fax: 919 541-5450
Email: [email protected]
RIN: 2060-AG69
_______________________________________________________________________



EPA



117. REVIEW OF THE NATIONAL AMBIENT AIR QUALITY STANDARDS FOR 
PARTICULATE MATTER
Priority:


Economically Significant


Unfunded Mandates:


Undetermined


Legal Authority:


42 USC 7408; 42 USC 7409


CFR Citation:


40 CFR 50


Legal Deadline:


Final, Statutory, July 18, 2000, Completion of review.


Abstract:


On July 18, 1997, the EPA published a final rule revising the national 
ambient air quality standards (NAAQS) for particulate matter (PM) (62 
FR 38652). While retaining the PM10 standard levels, new standards were 
added for fine particles (PM2.5) to provide increased protection 
against both health and environmental effects of PM. On the same day, a 
Presidential Memorandum (62 FR 38421, July 16, 1997) was published 
that, among other things, directed EPA to complete the next review of 
the PM NAAQS by July 2002. The EPA's plans and schedule for the next 
periodic review of the PM NAAQS were published on October 23, 1997 (62 
FR 55201). As with other NAAQS reviews, a rigorous assessment of 
relevant scientific information will be presented in a Criteria 
Document (CD), and the preparation of this document is currently under 
way by the EPA's National Center for Environmental Assessment. The 
EPA's Office of Air Quality Planning and Standards will also prepare a 
Staff Paper (SP) for the Administrator which will evaluate the policy 
implications of the key studies and scientific information contained in 
the CD and additional technical analyses and identify critical elements 
that EPA staff believe should be considered in reviewing the standards. 
The SP and CD will be reviewed by the Clean Air Scientific Advisory 
Committee (CASAC) and the public; both will reflect the input received 
through these reviews. As the PM NAAQS review is completed, the 
Administrator's proposal to revise or reaffirm the PM NAAQS will be 
published with a request for public comment. Input received during the 
public comment period will be reflected in the Administrator's final 
decision which will be published in July 2002.


Statement of Need:


As established in the Clean Air Act, the national ambient air quality 
standards for particulate matter are to be reviewed every five years.


Summary of Legal Basis:


Section 109 of the Clean Air Act (42 USC 7409) directs the 
Administrator to propose and promulgate ``primary'' and ``secondary'' 
national ambient air quality standards for pollutants identified under 
section 108 (the ``criteria'' pollutants). The ``primary'' standards 
are established for the protection of public health, while 
``secondary'' standards are to protect against public welfare or 
ecosystem effects.


Alternatives:


The main alternatives for the Administrator's decision on the review of 
the national ambient air quality standards for particulate matter are 
whether to reaffirm or revise the existing standards.


Anticipated Cost and Benefits:


Costs and benefits of revising or reaffirming the national ambient air 
quality standards for particulate matter cannot be determined at 
present; a regulatory impact analysis will be conducted along with the 
review of the standards.


Risks:


The current national ambient air quality standards for particulate 
matter are intended to protect against public health risks associated 
with morbidity or premature mortality from cardiopulmonary disease. 
During the course of this next review, a risk assessment will be 
conducted to evaluate health risks associated with retention or 
revision of the particulate matter standards.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           08/00/01
Final Action                                                   07/00/02
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


Federal, State, Local, Tribal


Additional Information:


SAN No. 4255


Agency Contact:
Mary A. Ross
Environmental Protection Agency
Air and Radiation
MD-15
Research Triangle Park, NC 27711
Phone: 919 541-5170
Fax: 919 541-0237
Email: [email protected]

Karen Martin
Environmental Protection Agency
Air and Radiation
MD-13
Research Triangle Park, NC 27711
Phone: 919 541-5274
Fax: 919 541-0877
Email: [email protected]
RIN: 2060-AI44
_______________________________________________________________________



EPA



118. TRANSPORTATION CONFORMITY AMENDMENTS: RESPONSE TO MARCH 2, 1999, 
COURT DECISION
Priority:


Other Significant


Legal Authority:


42 USC 7401-7671q


CFR Citation:


40 CFR 93


Legal Deadline:


None


Abstract:


The Clean Air Act requires EPA to promulgate rules that establish the 
criteria and procedures for determining whether highway and transit 
plans,

[[Page 73468]]

programs, and projects conform to State air quality plans. 
``Conformity'' means that the transportation actions will not cause or 
worsen violations of air quality standards or delay timely attainment 
of the standards. The original conformity rule was finalized on 
November 24, 1993, and most recently amended on August 15, 1997. On 
March 2, 1999, the U.S. Court of Appeals overturned certain provisions 
of the 1997 conformity amendments. This rulemaking will amend the 
conformity rule in compliance with the court decision. The rulemaking 
will formalize the May 14, 1999 EPA guidance and the June 18, 1999 DOT 
guidance that was issued to guide action on this issue until a 
rulemaking could be issued. Specifically, the rulemaking will clarify 
the types of projects that can be implemented in the absence of a 
conforming transportation plan. It will also explain EPA's process for 
reviewing newly submitted air quality plans and when those submissions 
can be used for conformity purposes.


Statement of Need:


The U.S. Court of Appeals remanded some provisions of EPA's conformity 
rule. The conformity rule must be amended in compliance with the court 
decision.


Summary of Legal Basis:


The Clean Air Act requires transportation plans, programs, and projects 
to conform to state air quality plans. The Clean Air Act also requires 
EPA to establish rules for how to determine the conformity of 
transportation actions.


Alternatives:


EPA's alternatives are constrained by the court decision.


Anticipated Cost and Benefits:


This amendment will not change the results of the economic analysis 
performed for the original transportation conformity rule, which was 
summarized in the preamble to that rule on 11/24/93 at 58 FR 62214.


Risks:


Transportation conformity is a process designed to help achieve 
attainment with the National Ambient Air Quality Standards. The risks 
addressed by the rule are therefore those risks associated with non-
achievment of such standards.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           03/00/01
Final Rule                                                     12/00/01
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


Federal, State, Local, Tribal


Additional Information:


SAN No. 4340


Agency Contact:
Kathryn Sargeant
Environmental Protection Agency
Air and Radiation
RSPD
Washington, DC 20460
Phone: 734 214-4441
Fax: 734 214-4052
Email: [email protected]
RIN: 2060-AI56
_______________________________________________________________________



EPA



119.  RULEMAKINGS FOR THE PURPOSE OF REDUCING INTERSTATE OZONE 
TRANSPORT
Priority:


Economically Significant. Major under 5 USC 801.


Legal Authority:


Not Yet Determined


CFR Citation:


40 CFR 51


Legal Deadline:


None


Abstract:


The Clean Air Act (CAA) requires that a State implementation plan (SIP) 
contain provisions to prevent a State's facilities or sources from 
contributing significantly to air pollution that is ``transported'' 
downwind to other States, exacerbating their inability to meet the 
national ambient air quality standards for ozone. Through a 2-year 
effort known as the Ozone Transport Assessment Group (OTAG), EPA worked 
in partnership with the 37 easternmost States and the District of 
Columbia, industry representatives, and environmental groups to address 
ozone transport. This multiyear collaboration resulted in the most 
comprehensive analysis of ozone transport ever conducted. The OTAG 
States voted in favor of a range of strategies to reduce nitrogen oxide 
emissions from utilities and other major sources. Building on the 
recommendations of OTAG, EPA issued a rule known as the NOx SIP Call 
(10/27/98, 63 FR 57355) requiring 22 States and the District of 
Columbia to submit revisions to their SIPs to address the regional 
transport of nitrogen oxides (a precursor to ozone formation known as 
NOx). By reducing emissions of NOx, the actions directed by these plans 
will decrease the formation and transport of ozone across State 
boundaries in the eastern half of the United States. The U.S. Court of 
Appeals upheld most provisions of the rule earlier this year. The court 
did remand certain minor provisions which EPA is now addressing in a 
separate rulemaking -- see SAN 4433 in today's regulatory agenda.) In 
addition to the SIP Call provisions, Federal Implementation Plans 
(FIPs) may also be needed to reduce regional transport if any affected 
State fails to adequately revise its SIP to comply with the NOx SIP 
call (see SAN 4096 in today's regulatory agenda). In addition to the 
SIP Call remedy, the Clean Air Act also gave States the right to 
petition EPA to take other Federal action to prevent ozone transport 
that affects downwind States. Accordingly, under section 126 of the 
CAA, eight northeastern States filed petitions requesting EPA to make 
findings and require decreases in NOx emissions from certain stationary 
sources in upwind States that may significantly contribute to ozone 
nonattainment problems in the petitioning State. After analysis, EPA 
found the petitions from eight States to be meritorious in whole or in 
part (5/25/99, 64 FR 28250). Subsequently, EPA issued a final rule on 
the petitions, specifying a NOx emissions trading program as the 
required Federal remedy (1/18/00, 65 FR 2764). EPA is coordinating all 
three approaches to regional ozone control -- i.e., SIP Call, FIPs, and 
section 126 actions -- to avoid duplication and maximize effectiveness.


Statement of Need:


It has long been recognized that ozone transport is a major factor in 
the difficulty many States are having in attaining the clean-air 
standards for ozone. This was made more clear by the OTAG analysis 
outlined above.


Summary of Legal Basis:


Clean Air Act Sections 110 and 126

[[Page 73469]]

Alternatives:


The Clean Air Act specifies the SIP Call process, the FIP process, and 
the section 126 petition process as alternate approaches to remedying 
the problem of ozone transport. EPA intends to use these alternatives 
as appropriate in an integrated program.


Anticipated Cost and Benefits:


As outlined in the Regulatory Impact Analysis for the NOx SIP Call, the 
rule will result in significant improvements in premature mortality, 
chronic asthma, chronic and acute bronchitis, upper and lower 
respiratory symptoms, work days lost, decreased worker productivity, 
visibility in urban and suburban areas, increases in yields of 
commercial forests currently exposed to elevated ozone levels, and 
reductions in loadings of nitrogen to sensitivity estuaries, helping 
State and local government reach target reduction goals for estuaries 
such as Chesapeake Bay, Albermarle-Pamlico Sound and Long Island Sound. 
Due to practical analytical limitations, we cannot quantify and/or 
monetize all potential benefits of this action. Within these 
limitations, the quantified and monetized benefits were estimated in 
the Regulatory Impact Analysis to range from $1.1 billion to $4.2 
billion annually. Annual costs were estimated at $1.7 billion. All 
figures are in 1990 dollars.


Risks:


The risks addressed by this action are the likelihood of experiencing 
increased health and environmental effects associated with 
nonattainment of the National Ambient Air Quality Standard for ozone. 
These effects are briefly described above in the ``costs and benefits'' 
section, and they are outlined in detail in the Regulatory Impact 
Analysis for the NOx SIP Call.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM - NOx FIPs 63 FR 56393                                    10/21/98
Final Action - N63 FR 57355                                    10/27/98
Final Action - S64 FR 28250Findings                            05/25/99
Final Action - S65 FR 2674 Approvals and Remedy                01/18/00
NPRM - Response to NOx SIP Call Court Decision (SAN 4433)      10/00/00
Final Action - Response to NOx SIP Call Court Decision (SAN 44312/00/00
Final Action - NOx FIPs (SAN 4096)                             12/00/00
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


State


Additional Information:


SAN No. 4466


Agency Contact:
Carla Oldham
Environmental Protection Agency
Air and Radiation
MD-15
Research Triangle Park, NC 27711
Phone: 919 541-3347
Fax: 919 541-0824
Email: [email protected]

Kimber Scavo
Environmental Protection Agency
Air and Radiation
MD-15
Research Triangle Park, NC 27711
Phone: 919 541-3354
Fax: 919 541-0824
Email: [email protected]
RIN: 2060-AJ20
_______________________________________________________________________



EPA



120. LEAD-BASED PAINT ACTIVITIES; TRAINING AND CERTIFICATION FOR 
RENOVATION AND REMODELING SECTION 402(C)(3)
Priority:


Other Significant. Major status under 5 USC 801 is undetermined.


Unfunded Mandates:


Undetermined


Legal Authority:


15 USC 2603 TSCA Title IV; PL 102-550 Sec 402(c)(3)


CFR Citation:


40 CFR 745


Legal Deadline:


Final, Statutory, October 28, 1996.


Abstract:


Under section 402(c)(2) of the Toxic Substances Control Act (TSCA) 
title IV, EPA conducted a study of the extent to which persons engaged 
in renovation and remodeling activities in target housing are exposed 
to lead in the conduct of such activities or disturb lead and create a 
lead-based paint hazard. EPA must use the results of this study and 
consult with interested parties to determine which categories of 
renovation and remodeling activities require training and 
certification. EPA must then revise the training and certification 
regulations originally developed for individuals performing lead-based 
paint abatement under section 402(c)(a) of TSCA title IV to apply them 
to the renovation and remodeling categories. If EPA determines that any 
category does not require certification, EPA must publish an 
explanation of the basis for that determination.


Statement of Need:


Childhood lead poisoning is a pervasive problem in the United States, 
with almost a million young children having more than 10 ug/dl of lead 
in their blood, (Center for Disease Control's level of concern). 
Although there have been dramatic declines in blood-lead levels due to 
reductions of lead in paint, gasoline, and food sources, remaining 
paint in older houses continues to be a significant source of childhood 
lead poisoning. These rules will help insure that individuals and firms 
conducting lead-based paint activities will do so in a way that 
safeguards the environment and protects the health of building 
occupants, especially children under 6 years old.


Summary of Legal Basis:


This regulation is mandated by TSCA section 402(c). TSCA section 402(c) 
directs EPA to address renovation and remodeling activities by first 
conducting a study of the extent to which persons engaged in various 
typed of renovation and remodeling activities are exposed to lead in 
the conduct of such activities or disturb lead and create a lead-based 
paint hazard on a regular basis. Section 402(c) further directs the 
Agency to revise the lead-based paint activities regulations (40 CFR 
part 745 subpart L) to include renovation or remodeling activities that 
create lead-based paint hazards. In order to determine which 
contractors are engaged in such activities the Agency is directed to 
utilize the results of the study and consult with the representatives 
of labor organizations, lead-based paint activities contractors, 
persons engaged

[[Page 73470]]

in remodeling and renovation, experts in health effects, and others.


Alternatives:


TSCA section 402(c) states that should the Administrator determine that 
any category of contractors engaged in renovation or remodeling does 
not require certification; the Administrator may publish an explanation 
of the basis for that determination.


Anticipated Cost and Benefits:


EPA's quantitative cost estimates fall into four categories: Training 
Costs, Work Practice Costs, Clearance Testing Costs, and Administrative 
Costs. The estimates vary depending upon the option selected. In most 
cases we expect that requirements related to Clearance Testing and Work 
Practices will contribute the most to overall rule cost. The benefits 
analysis will not provide direct quantitative measures of each (or any) 
option. EPA does not have a complete risk assessment (with dose-
response functions) that would permit direct quantitative estimates. We 
do have other data, such as estimated loadings of lead generated by 
renovation work, number and type of renovation events, demographics of 
the exposed population, and the costs of various health effects 
previously linked to lead exposure. With the available information we 
are able utilize several qualitative approaches to frame the benefits 
associated with an effective renovation rule.


Risks:


These rules are aimed at reducing the prevalence and severity of lead 
poisoning, particularly in children. The Agency has concluded that many 
R&R work activities can produce or release large quantities of lead and 
may be associated with elevated blood lead levels. These activities 
include, but are not limited to: sanding, cutting, window replacement, 
and demolition. Lead exposure to R&R workers appears to be less of a 
problem than to building occupants (especially young children). Some 
workers (and homeowners) are occasionally exposed to high levels of 
lead. Any work activity that produces dust and debris may create a lead 
exposure problem.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           08/00/01
Final Action                                                   02/00/03
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses


Government Levels Affected:


Federal, State, Local, Tribal


Additional Information:


SAN No. 3557


Sectors Affected:


23321 Single Family Housing Construction; 23322 Multifamily Housing 
Construction; 23521 Painting and Wall Covering Contractors; 23551 
Carpentry Contractors; 23599 All Other Special Trade Contractors; 53111 
Lessors of Residential Buildings and Dwellings; 531311 Residential 
Property Managers; 54138 Testing Laboratories


Agency Contact:
Lin Moos
Environmental Protection Agency
Office of Prevention, Pesticides and Toxic Substances
7404
Washington, DC 20460
Phone: 202 260-1866
Fax: 202 260-0770
Email: [email protected]

Mike Wilson
Environmental Protection Agency
Office of Prevention, Pesticides and Toxic Substances
7404
Washington, DC 20460
Phone: 202 260-4664
Fax: 202 260-0770
Email: [email protected]
RIN: 2070-AC83
_______________________________________________________________________



EPA



121. ENDOCRINE DISRUPTOR SCREENING PROGRAM
Priority:


Other Significant


Legal Authority:


15 USC 2603 TSCA; 21 USC 346(a) FFDCA; 42 USC 300(a)(17) SDWA; 7 USC 
136 FIFRA


CFR Citation:


Not Yet Determined


Legal Deadline:


NPRM, Statutory, August 3, 1998, EDSP must be Developed.


Final, Statutory, August 3, 1999, Agency must Implement.


Other, Statutory, August 3, 2000, Agency must report to Congress on 
EDSP.


Abstract:


This final policy statement will set forth EPA's Endocrine Disruptor 
Screening Program. EPA published a proposed policy statement setting 
forth the Screening Program on December 28, 1998. In the final policy 
statement, EPA will describe the screens and tests that it will require 
as part of the program. It also will describe the universe of chemicals 
that will be included in the program, the priority-setting mechanism 
that used to determine the order in which those chemicals will be 
tested, and certain issues related to implementing the program. The 
major actions in 2000 and 2001 will be the standardization and 
validation of assays in the screening battery and the completion of the 
priority-setting system.


Statement of Need:


The Endocrine Disruptor Screening Program fulfills the statutory 
direction and authority to screen pesticide chemicals and drinking 
water contaminants for their potential to disrupt the endocrine system 
and adversely affect human health.


Summary of Legal Basis:


The mandate to screen pesticide chemicals for estrogenic effects that 
may affect human health is the Federal Food, Drug and Cosmetic Act 
(FFDCA) as amended in the Food Quality Protection Act (21 U.S.C. 
346a(p)). FFDCA also provides EPA authority to require testing of 
substances that may have an effect that is cumulative to that of a 
pesticide chemical. Discretionary authority to test contaminants in 
sources of drinking water is in the Safe Drinking Water Act as amended 
in 1996 (42 U.S.C. 300j-17). General authority to test chemicals and 
pesticides is in TSCA (15 U.S.C. 2603) and FIFRA (7 U.S.C. 136) 
respectively.


Alternatives:


A Federal role is mandated under cited authority. There is no 
alternative to the role of the Federal Government on this issue to 
ensure that pesticides, commercial chemicals and contaminants are 
screened and tested for endocrine disruption potential. A limited 
amount of testing may be conducted voluntarily, but this will fall far 
short of the systematic screening which is necessary to protect public 
health and the environment and ensure the public that all important 
substances have been adequately evaluated.

[[Page 73471]]

Anticipated Cost and Benefits:


It is too early to project the costs and benefits of this program 
accurately. However, as a rough estimate, the screening battery is 
estimated to cost $200,000 per chemical. It is also too early to 
quantify the benefits of this program mathmetically. The goal of the 
program is to reduce the risks identified below.


Risks:


Evidence is continuing to mount that wildlife and humans may be at risk 
from exposure to chemicals operating through an endocrine mediated 
pathway. Preliminary studies show decreases on IQ tests and increases 
in aggression in children. Severe malformations of the genitals of boys 
have increased steadily over the last two decades. Wildlife effects 
have been more thoroughly documented. Abnormalities in birds, marine 
mammals, fish and shellfish have been documented in the United States, 
Europe, Japan, Canada, and Australia which have been linked to specific 
chemical exposures. Evidence is sufficient for the United States to 
proceed on a two-track strategy: research on the basic science 
regarding endocrine disruption and screening to identify which 
chemicals are capable of interacting with the endocrine system. The 
combination of research and test data developed by this program will 
enable EPA to take action to reduce chemical risks.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
Notice - Outline63 FR 42852ng Program                          08/11/98
Notice - Propose63 FR 71542 Program & Request for Comment      12/28/98
NPRM - Proposed Procedural Rule                                12/00/01
Final Action - Final Screening Program                         12/00/02
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


Federal


Additional Information:


SAN No. 4143


In August 2000, the Agency submited the required Status Report to 
Congress.


Agency Contact:
Gary Timm
Environmental Protection Agency
Office of Prevention, Pesticides and Toxic Substances
7201
Washington, DC 20460
Phone: 202 260-3573
Fax: 202 401-1282
Email: [email protected]

Anthony Maciorowski
Environmental Protection Agency
Office of Prevention, Pesticides and Toxic Substances
7201
Washington, DC 20460
Phone: 202 260-3573
Fax: 202 401-1282
Email: [email protected]
RIN: 2070-AD26
_______________________________________________________________________



EPA



122. HAZARDOUS WASTE MANIFEST REGULATION
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 6922 RCRA sec 3002; 42 USC 6923 RCRA sec 3003; 42 USC 6926 RCRA 
sec 3006


CFR Citation:


40 CFR 260; 40 CFR 262; 40 CFR 263; 40 CFR 264; 40 CFR 265; 40 CFR 271


Legal Deadline:


None


Abstract:


The Uniform Hazardous Waste Manifest (Form 8700-22) is a multicopy form 
used to identify the quantity, composition, origin, routing, and 
destination of hazardous waste during its transportation. The manifest 
system's reliance on paper results in significant paperwork and cost 
burden to waste handlers and States who choose to collect manifest 
information. The Agency is considering an optional approach to redesign 
the manifest system so that it utilizes automated technologies to 
increase access to manifest-related information, and to facilitate the 
manifest process, including the form's preparation, transmission, and 
recordkeeping, thereby lessening the total burden on waste handlers and 
States that choose to collect manifests. In addition, the Agency is 
considering further standardizing further the manifest form itself by 
eliminating several optional data fields and by specifying one format 
that may be used in all States.


Statement of Need:


The Agency is considering revising the RCRA manifest system because of 
the amount of paperwork burden associated with the manifest. Reduction 
in paperwork burden is part of the Administration's Regulatory 
Reinvention goal of cutting government red tape. The Agency wants to 
further standardize the manifest program across States by introducing a 
more uniform manifest tracking form. The chief goal of the manifest 
system is to facilitate the safe transportation of offsite shipments of 
hazardous waste to appropriate RCRA management facilities. Furthermore, 
the manifest promotes accountability throughout the generation, 
transportation, and disposal cycle of a hazardous waste shipment; and 
the manifest also provides essential hazard information to handlers and 
emergency responders.


Summary of Legal Basis:


RCRA section 3002(a)(5) authorizes EPA to issue regulations applicable 
to generators of hazardous waste regarding the use of a manifest system 
to describe waste, its origin, and its routing to ensure waste arrives 
at designated off-site facilities. RCRA sections 3003 and 3004 
authorize EPA to issue regulations applicable to transportors of 
hazardous waste and to treatment, storage, and disposal facilities 
regarding compliance with the manifest system.


Alternatives:


The Agency has looked at two alternatives to revising the manifest 
system. The first alternative is to revise and standardize the manifest 
form itself. The second alternative is to introduce the option of 
automated technologies (electronic commerce) to reduce paperwork and 
make the manifest system more efficient. The Agency is considering 
combining these alternatives in a proposed rule.


Anticipated Cost and Benefits:


EPA is considering actions that should impose minimal costs on the 
regulated industry, since the Agency is evaluating a reduction in the 
overall number of elements on the manifest form. Additionally, greater 
uniformity in data

[[Page 73472]]

required across the United States would benefit waste handlers by 
reducing the burden associated with obtaining multiple manifests from 
different States, as well as being aware of various uses of optional 
fields. Other hazardous waste handlers would benefit from having the 
option to use automation to complete, send, receive, and store manifest 
information. Some States may have to modify their data systems in 
response to changes in the manifest form. The Agency is currently 
conducting an analysis to determine the costs and benefits of revisions 
to the manifest system.


Risks:


This proposed rule is intended to reduce the paperwork burden of the 
manifest on the public without reducing protectiveness of human health 
or the environment.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           11/00/00
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


Federal, State


Additional Information:


SAN No. 3147


Sectors Affected:


2111 Oil and Gas Extraction; 2122 Metal Ore Mining; 2211 Electric Power 
Generation, Transmission and Distribution; 3221 Pulp, Paper, and 
Paperboard Mills; 323 Printing and Related Support Activities; 325 
Chemical Manufacturing; 326 Plastics and Rubber Products Manufacturing; 
331 Primary Metal Manufacturing; 332 Fabricated Metal Product 
Manufacturing; 482 Rail Transportation; 483 Water Transportation; 484 
Truck Transportation; 5621 Waste Collection; 5622 Waste Treatment and 
Disposal


Agency Contact:
Rich Lashier
Environmental Protection Agency
Solid Waste and Emergency Response
5304W
Washington, DC 20460
Phone: 703 308-8796
Fax: 703 308-0522
Email: [email protected]
RIN: 2050-AE21
_______________________________________________________________________



EPA



123. STANDARDIZED PERMIT FOR RCRA HAZARDOUS WASTE MANAGEMENT FACILITIES
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 6905; 42 USC 6912; 42 USC 6924; 42 USC 6925; 42 USC 6927; 42 USC 
6939; 42 USC 6974


CFR Citation:


40 CFR 124; 40 CFR 267; 40 CFR 270


Legal Deadline:


None


Abstract:


EPA is considering allowing a type of general permit, called a 
standardized permit, for facilities that generate waste and routinely 
manage the waste on-site in tanks, containers, and containment 
buildings. Under the standardized permit, facility owners and operators 
would certify compliance with generic design and operating conditions 
set on a national basis. The permitting agency would review the 
certifications submitted by the facility owners or operators. The 
permitting agency would also be able to impose additional site-specific 
terms and conditions for corrective action or other purposes, as called 
for by RCRA. Ensuring compliance with the standardized permit's terms 
and conditions would occur during inspection of the facility after the 
permit has been issued.


Statement of Need:


The Agency convened a special task force in 1994 to look at permitting 
activities throughout its different programs and to make specific 
recommendations to improve these permitting programs. This task force, 
known as the Permits Improvement Team (PIT), spent two years working 
with stakeholders from the Agency, State-permitting agencies, industry, 
and the environmental community. The PIT stakeholders mentioned, among 
other things, that permitting activities should be commensurate with 
the complexity of the activity. The stakeholders felt that current 
Agency permitting programs were not flexible enough to allow 
streamlined procedures for routine permitting activities.


Currently, facilities that store, treat, or dispose of hazardous waste 
must obtain site-specific ``individual'' permits prescribing conditions 
for each ``unit'' (e.g., tank, container area, etc.) in which hazardous 
waste is managed. Experience gained by the Agency and States over the 
past 16 years has shown that not all waste management activities are at 
the same level of complexity. Some activities, such as thermal 
treatment or land disposal of hazardous waste, are more complex than 
storage of hazardous waste. The Agency believes that thermal treatment 
and land disposal activities continue to warrant ``individual'' 
permits, prescribing unit-specific conditions. However, the Agency 
believes that some accommodation can be made for hazardous waste 
management practices in standardized units such as tanks, container 
storage areas, and containment buildings. The Agency's Permit 
Improvement Team tentatively recommended, among other things, that 
regulations be developed to allow ``standardized permits'' for on-site 
storage and nonthermal treatment of hazardous waste in tanks, 
containers, and containment buildings. The Agency is considering 
revising the RCRA regulations to allow this type of permit.


Summary of Legal Basis:


Facilities that manage hazardous waste are required under RCRA to 
obtain a permit and carry out corrective action as necessary (see RCRA 
sections 3004, 3005, 3008 and 3010). EPA has discretion under these 
statutory provisions to apply different permitting procedures to 
different types of facilities, as EPA is proposing to do here. No 
aspect of this streamlining action is required by court order.


Alternatives:


EPA has considered several significant alternatives or options 
regarding RCRA permits and corrective action issues. The Agency intends 
to limit the scope of the proposed rule to facilities that generate 
waste and manage it on-site. The Agency considered, however, and plans 
to ask for comment on, whether coverage of the rule should be expanded 
to facilities that generate waste at operations in more than one 
location and want to manage the waste at one location. The Agency also 
plans to ask for comment on the option of allowing a facility's RCRA 
corrective action activities to be postponed if corrective action is 
being carried out

[[Page 73473]]

under an approved State remedial program.


Anticipated Cost and Benefits:


The following cost/benefit information is based on preliminary 
estimates and is being provided for informational purposes only; it is 
subject to change. The RCRA standardized permit proposal is an optional 
rule designed to streamline the regulatory burden to EPA/States as well 
as to private sector facilities covered by the rule, by reducing the 
amount of information collected, submitted and reviewed for permit 
actions (i.e., new permit applications, permit modifications, and 
permit renewals). Because the rule proposes to streamline existing RCRA 
regulation, rather than add new RCRA regulation, implementation of the 
rule by the EPA and by States with EPA-authorized permitting programs 
is expected to result in economic benefits in the form of national cost 
savings from reducing both government and private sector resources 
required for the RCRA permit process. Based on a preliminary economic 
analysis, the EPA estimates that the potential average annual cost 
savings to eligible facilities resulting from implementation of this 
rule, will range from approximately $100 to $5,800 per permit action, 
depending on such things as the type of permit and the type of storage 
equipment. EPA estimates potential national cost savings of $360,000 to 
$530,000 per year based upon an assumed average rate of about 120 
eligible permit actions per year.


Risks:


A description of risks is not applicable to the rule. The purpose of 
this rule is to streamline existing RCRA permit application and 
issuance procedures. Since facilities covered by this proposed rule are 
currently already required to obtain RCRA permits, this proposed rule 
will have minimal effects on incremental risks.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           11/00/00
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


Federal, State


Federalism:


 Undetermined


Additional Information:


SAN No. 4028


Sectors Affected:


32411 Petroleum Refineries; 3251 Basic Chemical Manufacturing; 3252 
Resin, Synthetic Rubber, and Artificial and Synthetic Fibers and 
Filaments Manufacturing; 325211 Plastics Material and Resin 
Manufacturing; 32532 Pesticide and Other Agricultural Chemical 
Manufacturing; 32551 Paint and Coating Manufacturing; 332813 
Electroplating, Plating, Polishing, Anodizing and Coloring


Agency Contact:
Vernon Myers
Environmental Protection Agency
Solid Waste and Emergency Response
5303W
Washington, DC 20460
Phone: 703 308-8660
Fax: 703 308-8609
Email: [email protected]
RIN: 2050-AE44
_______________________________________________________________________



EPA



124.  STANDARDS FOR THE MANAGEMENT OF COAL COMBUSTION WASTES 
GENERATED BY ELECTRIC POWER PRODUCERS
Priority:


Economically Significant


Unfunded Mandates:


This action may affect the private sector under PL 104-4.


Legal Authority:


42 USC 6907(a)(3); 42 USC 6944(a)


CFR Citation:


40 CFR 257


Legal Deadline:


None


Abstract:


This action is for the development of proposed and final RCRA subtitle 
D regulations for the management of coal combustion wastes in landfills 
and surface impoundments that are generated by producers of electric 
power, including electric utilities and independent power producers.


On April 25, 2000, EPA issued a regulatory determination for fossil 
fuel combustion wastes (65 FR 32214, May 22, 2000). The purpose of the 
determination was to decide whether certain wastes from the combustion 
of fossil fuels (including coal, oil and natural gas) should remain 
exempt from subtitle C (management as hazardous waste) of the Resource 
Conservation and Recovery Act (RCRA) for the coal, oil and natural gas 
combustion wastes that were addressed. The Agency's decision was to 
retain the exemption from hazardous waste management for all of the 
fossil fuel combustion wastes. However, the Agency also determined and 
announced that waste management regulations under RCRA subtitle D 
(management as nonhazardous wastes) are appropriate for certain coal 
combustion wastes that are disposed of in landfills and surface 
impoundments. We also announced that we would consult with the 
Department of the Interior on appropriate measures under the Surface 
Mining Control and Reclamation Act (SMCRA) or RCRA or some combination 
of both to address the disposal of coal combustion wastes when used for 
minefill in surface and underground mines.


The utility industry has made significant improvements in its waste 
management practices over recent years, and most State regulatory 
programs are similarly improving. Nevertheless, public comments and 
other analyses have convinced the Agency that coal combustion wastes 
could pose risks to human health and the environment if they are not 
properly managed. There is sufficient evidence that adequate controls 
may not be in place. For example, while most States can now require 
newer waste management units to include liners and groundwater 
monitoring, 62 percent of existing utility surface impoundments do not 
have groundwater monitoring. In the Agency's view, this justifies the 
development of national regulations. EPA acknowledges that some waste 
management units may not warrant liners and/or groundwater monitoring, 
depending on site-specific characteristics. The Agency is initiating 
this action to develop and issue appropriate waste management 
regulations under subtitle D of RCRA.


Statement of Need:


EPA's regulatory determination for fossil fuel combustion wastes (65 FR 
32214, May 22, 2000) concluded that these wastes do not require 
management as hazardous wastes. However, EPA determined that certain of 
the coal combustion wastes have been managed improperly as indicated by 
identified damage cases. Although all of the proven damage cases 
involved past waste management practices and were appropriately 
addressed by either State or Federal authorities, we are

[[Page 73474]]

concerned about the potential risks posed via the groundwater pathway 
from improper management of the wastes, and lack of groundwater 
monitoring at more than half of the active coal combustion waste 
management units. While most States can now require newer waste 
management units to include liners and groundwater monitoring, 62 
percent of existing utility surface impoundments, for example, do not 
have groundwater monitoring. Although not all sites may warrant the 
same measures, the Agency believes that the lack of groundwater 
monitoring and liners justifies the development of national 
regulations. Therefore, the Agency is initiating this action to develop 
and issue appropriate management regulations under subtitle D of RCRA 
for these wastes.


Summary of Legal Basis:


This action is not required by statute or court order.


Alternatives:


The Agency considered the need for more stringent hazardous waste 
management requirement for these wastes, but rejected the option. 
Rather, the Agency believes that any management and performance 
standards issued under nonhazardous waste authorities (RCRA subtitle D) 
would adequately protect human health and the environment.


Anticipated Cost and Benefits:


EPA has not yet developed a regulatory approach to address coal 
combustion wastes. Therefore, costs and benefits of potential 
management and performance standards have not been quantified. The 
costs of any regulation could be high, given the large amount of coal 
combustion wastes generated per year. However, those costs could be 
mitigated by ongoing trends in industry management and State oversight 
of these wastes. As EPA develops national regulations, the Agency will 
try to minimize disruptions to operation of existing waste management 
units.


Risks:


For EPA's regulatory determination for fossil fuel combustion wastes, 
we did not rely on a quantitative groundwater risk assessment to assess 
potential risks to human health or the environment. We are unable at 
this time to draw quantitative conclusions regarding the risks due to 
arsenic or other contaminants posed by improper waste management. EPA 
is currently reviewing its groundwater model and plans to reevaluate 
groundwater risks after any necessary changes to the model are 
completed. Based on a screening analysis that compared drinking water 
standards to leach test data from coal combustion waste samples, the 
Agency identified a potential for risks from arsenic that cannot be 
dismissed at this time. An EPA ecological risk assessment found the 
potential for risk to various fauna.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           09/00/01
Final Action                                                   08/00/02
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


Federal, State, Local, Tribal


Federalism:


 Undetermined


Additional Information:


SAN No. 4470


Any Federal, state, local or tribal governments that own coal-burning 
electric power generating facilities will be subject to this rule.


Sectors Affected:


221112 Fossil Fuel Electric Power Generation


Agency Contact:
Dennis Ruddy
Environmental Protection Agency
Solid Waste and Emergency Response
5306W
Washington, DC 20460
Phone: 703 308-8430
Fax: 703 308-8686
Email: [email protected]
RIN: 2050-AE81
_______________________________________________________________________



EPA



125. EFFLUENT GUIDELINES AND STANDARDS FOR THE METAL PRODUCTS AND 
MACHINERY CATEGORY, PHASES 1 AND 2
Priority:


Economically Significant. Major under 5 USC 801.


Unfunded Mandates:


This action may affect the private sector under PL 104-4.


Legal Authority:


33 USC 1311 CWA sec 301; 33 USC 1314 CWA sec 304; 33 USC 1316 CWA sec 
306; 33 USC 1317 CWA sec 307; 33 USC 1317 CWA sec 308; 33 USC 1317 CWA 
sec 402; 33 USC 1361 CWA sec 501


CFR Citation:


40 CFR 438


Legal Deadline:


NPRM, Judicial, October 31, 2000.


Final, Judicial, December 31, 2002.


Abstract:


EPA is developing effluent limitations guidelines for facilities that 
generate wastewater while processing metal parts; metal products; and 
machinery, including manufacture, assembly, rebuilding, repair, and 
maintenance. A proposed rule in 1995 covered seven industrial groups: 
aircraft, aerospace, hardware, ordnance, stationary industrial 
equipment, mobile industrial equipment, and electronic equipment. EPA 
has consolidated this rulemaking with a second phase, and coverage will 
include additional industrial groups such as: bus and truck, household 
equipment, instruments, motor vehicles, office machines, precious 
metals and jewelry, railroads, job shops, printed circuit boards, and 
ships and boats. The deadlines and timetable apply to the consolidated 
Phase 1 and 2 rulemaking.


Statement of Need:


Only 25 percent of the facilities in this industry are currently 
regulated by national effluent limitations. Most of the industry has 
wastewater treatment that is inadequate, in terms of the best available 
technology. Those facilities that do have wastewater treatment designed 
those systems to meet effluent limits established by EPA over 20 years 
ago. The proposed MP&M limitations are based on technologies that 
achieve much lower levels of pollutants -- for example, an 80 percent 
reduction in cyanide and chromium.


Summary of Legal Basis:


The Clean Water Act requires EPA to establish effluent limitations 
guidelines and standards to limit the pollutants discharged from point 
sources. In addition, EPA is bound by a provision in a consent decree 
entered in settlement of Natural Resources Defense Council et al. v. 
Reilly (D.D.C. No. 89-2980) to propose regulations for this industry by 
October 2000.

[[Page 73475]]

Alternatives:


The Clean Water Act directs EPA to establish a technology basis for the 
effluent guidelines. Limitations are based on the performance of 
specific technology levels, such as the best available technology 
economically achievable. EPA is considering a range of pollution 
control technologies and is also considering flow exemptions to reduce 
the impact on small dischargers.


Anticipated Cost and Benefits:


EPA expects effluent reduction benefits from more than 10,000 
facilities. The estimated cost of the proposed rule is $1.9 billion, 
including operating and maintenance costs and annualized capital costs. 
For more than half of the facilities, the costs are less than $50,000 
per facility. Higher costs are concentrated among a small segment of 
the industry. Estimated annual benefits range from $1.0 billion to $2.5 
billion. These monetized benefits include health benefits (reduction in 
cancer and other illness), recreational benefits, and administrative 
savings from reduced pollutant loadings in biosolids.


Risks:


EPA estimates that compliance with this regulation will reduce the 
annual discharge of conventional pollutants by at least 115 million 
pounds, priority pollutants by 12 million pounds, and non-conventional 
metal and organic pollutants by 43 million pounds. These reductions 
represent significant improvements in water quality. The amounts are 
substantial in terms of point source controls.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM (Phase 1)  60 FR 28210                                    05/30/95
NPRM (Consolidated Phase 1 and 2)                              10/00/00
Final Action                                                   12/00/02
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses


Government Levels Affected:


Federal, State, Local


Additional Information:


SAN No. 2806


For more information on Metal Products and Machinery on the Internet, 
please visit:


http://www.epa.gov/ost/guide/mpm/index.html


Sectors Affected:


332 Fabricated Metal Product Manufacturing; 333 Machinery 
Manufacturing; 334 Computer and Electronic Product Manufacturing; 335 
Electrical Equipment, Appliance and Component Manufacturing; 336 
Transportation Equipment Manufacturing; 337 Furniture and Related 
Product Manufacturing; 339 Miscellaneous Manufacturing


Agency Contact:
Shari Barash
Environmental Protection Agency
Water
4303
Washington, DC 20460
Phone: 202 260-7130
Fax: 202 260-7185
Email: [email protected]

Mike Ebner
Environmental Protection Agency
Water
4303
Washington, DC 20460
Phone: 202 260-5397
Fax: 202 260-7185
Email: [email protected]
RIN: 2040-AB79
_______________________________________________________________________



EPA



126. EFFLUENT GUIDELINES AND STANDARDS FOR FEEDLOTS POINT SOURCE 
CATEGORY, AND NPDES REGULATION FOR CONCENTRATED ANIMAL FEEDING 
OPERATIONS
Priority:


Economically Significant. Major under 5 USC 801.


Unfunded Mandates:


This action may affect the private sector under PL 104-4.


Legal Authority:


33 USC 1318 CWA sec 308; 33 USC 1342 CWA sec 402; 33 USC 1317 CWA sec 
307; 33 USC 1311 CWA sec 301; 33 USC 1314 CWA sec 304; 33 USC 1316 CWA 
sec 306; 33 USC 1361 CWA sec 501


CFR Citation:


40 CFR 412; 40 CFR 122.23


Legal Deadline:


NPRM, Judicial, December 15, 2000.


Final, Judicial, December 15, 2002.


Abstract:


Feedlot operations are covered by existing effluent guidelines at 40 
CFR 412 and concentrated animal feeding operations (CAFOs) are covered 
by permitting regulations at 40 CFR 122.23. This action will revise the 
existing effluent guidelines to address swine, poultry, beef, and dairy 
cattle operations and the NPDES regulation for concentrated animal 
feeding operations. The existing regulations, which require the largest 
confined animal feeding operations to achieve zero discharge of wastes 
to surface waters except for certain storm related discharges, have not 
been sufficient to resolve water quality impairment from feedlot 
operations. Feedlot operations are substantial contributors of 
nutrients in surface waters that have severe anoxia (low levels of 
dissolved oxygen) and problem algae blooms.


Statement of Need:


Since the existing CAFO regulations were promulgated in the 1970s, the 
animal production industry has changed significantly, rendering the 
regulations less effective in protecting water quality than is needed. 
Contamination of surface water results from breaches of lagoons, runoff 
from feedlots, direct contact of animals with surface water, and manure 
applied to land in excess of crop nutrient needs. Nutrients, most 
notably nitrogen and phosphorus, are essential for profitable crop and 
animal agriculture. However, nitrogen and phosphorus export in 
watershed runoff can accelerate the eutrophication of surface waters. 
Rapid growth and intensification of animal production in many areas has 
created regional imbalances in nutrient inputs and nutrient output. In 
many of these areas, nutrients produced in animal manure exceed crop 
needs and pose risks to the environment.


Summary of Legal Basis:


The Clean Water Act (CWA) authorizes EPA to establish and to revise, if 
appropriate, effluent limitations guidelines and standards to regulate 
the quality of point source discharges. The Act also authorizes EPA to 
promulgate implementing regulations for the NPDES permitting program. 
EPA is also required to revisit these effluent guidelines to satisfy a 
provision in a consent decree entered in settlement of Natural 
Resources Defense Council et al. v. Reilly, (D.D.C. No. 89-2980). In 
addition, the proposed revisions to the NPDES implementing regulations 
for CAFOs will satisfy an obligation in a settlement agreement 
associated with the same case.

[[Page 73476]]

Alternatives:


The CWA requires effluent guidelines to be established on a technology 
basis. Limitations are generally based on the performance of specific 
technology levels, such as the best available technology economically 
achievable. For animal feeding operations, EPA is considering a range 
of regulatory alternatives that includes management practices, 
traditional pollution control technologies, and alternative 
technologies/practices that recover the energy value or alter the 
handling/marketability characteristics of animal wastes. EPA is also 
considering whether alternative pollution control requirements should 
be established for smaller animal feeding operations.


The NPDES regulation for CAFOs defines which facilities are covered by 
the permit regulation, and will specify the permit requirements 
necessary to protect water quality. EPA is considering adding 
additional animal types to its definition, and is considering amending 
the size facility or conditions that define which facilities are CAFOs 
subject to permitting. Permit requirements that address land 
application of manure are also being considered.


Anticipated Cost and Benefits:


The types of benefits associated with revisions to effluent guidelines 
for animal feeding operations chiefly involve improvements to surface 
water quality. Reduced risks to human health are expected to result 
from these improvements. Surface water benefits will principally derive 
from reduced loadings of nutrients in runoff from animal confinement, 
manure storage, and land applications areas. Discharges of metals and 
pathogens to surface waters will also be reduced. This reduction in 
pathogens will result in fewer beach and shellfish bed closings. The 
costs associated with this regulation will include capital expenses to 
purchase or install facility upgrades to the existing manure storage 
structures and feedlot stormwater diversions; transportation of manure 
off-site; and fees for preparation of nutrient management plans. There 
may be capital expenditures associated with manure application 
equipment.


Risks:


The changes under consideration for effluent guidelines will reduce 
adverse water quality impacts caused by runoff from animal feeding 
operations, thereby reducing risks to aquatic habitat and public 
health.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           12/00/00
Final Action                                                   12/00/02
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses


Government Levels Affected:


Federal, State, Local, Tribal


Federalism:


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


Additional Information:


SAN No. 4153


Sectors Affected:


11221 Hog and Pig Farming; 11232 Broilers and Other Meat Type Chicken 
Production; 11231 Chicken Egg Production; 112112 Cattle Feedlots; 11212 
Dairy Cattle and Milk Production; 11241 Sheep Farming; 11233 Turkey 
Production; 11292 Horse and Other Equine Production; 11239 Other 
Poultry Production


Agency Contact:
Jan Goodwin
Environmental Protection Agency
Water
4303
Washington, DC 20460
Phone: 202 260-7152
Fax: 202 260-7185
Email: [email protected]

Karen Metchis
Environmental Protection Agency
Water
4203
Washington, DC 20460
Phone: 202 260-7069
Fax: 202 260-1460
Email: [email protected]
RIN: 2040-AD19
_______________________________________________________________________



EPA



127. NATIONAL PRIMARY DRINKING WATER REGULATIONS: LONG-TERM 2 ENHANCED 
SURFACE WATER TREATMENT RULE
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:


40 USC 300g-1(b); SDWA 1412(b); 42 USC 300f; 42 USC 300g-1; 42 USC 
300g-2; 42 USC 300g-3; 42 USC 300g-4; 42 USC 300g-5; 42 USC 300g-6; 42 
USC 300j-4; 42 USC 300j-9; 42 USC 300j-11


CFR Citation:


40 CFR 141 to 142; 40 CFR 9


Legal Deadline:


None


Abstract:


The Long Term 2 Enhanced Surface Water Treatment Rule (LT2ESWTR) will 
control risk from microbial pathogens in drinking water. It is being 
developed simultaneously with the Stage 2 Disinfectants and 
Disinfection Byproducts Rule (DBPR) which will address risk caused by 
the use of disinfectants in drinking water. This rule could affect all 
public water systems that use surface water as a source. Promulgating 
the LT2ESWTR and the Stage 2 DBPR as a paired rulemaking is necessary 
to ensure that adequate protection from microbial risk is maintained 
while EPA manages risk from disinfection byproducts. EPA is required to 
promulgate the Stage 2 DBPR by May 2002, under the 1996 Safe Drinking 
Water Act amendments. In developing the LT2ESWTR, EPA will analyze a 
significant body of new survey data on microbial pathogens in source 
and finished waters, as well as data on parameters which could serve as 
indicators of microbial risk. This survey data, which was collected 
under the Information Collection Rule (ICR), Supplemental Surveys to 
the ICR, and additional research projects, will provide a substantially 
more comprehensive and complete picture of the occurrence of waterborne 
pathogens than was available previously. EPA will also use significant 
new data on the efficiency of treatment processes for the removal and 
inactivation of microorganisms, as well as new information on the 
pathogenicity of certain pathogens, to determine effective regulatory 
requirements for controlling microbial risk. On March 30, 1999, EPA 
established a committee of stakeholders under the Federal Advisory 
Committee Act (FACA) to assist in the development of these rules. The 
FACA committee is scheduled to make recommendations

[[Page 73477]]

on rule options to EPA in September 2000.


Statement of Need:


The purpose of the Long Term 2 Enhanced Surface Water Treatment Rule 
(LT2ESWTR) is to reduce health risks posed by Cryptosporidium and other 
microbial pathogens in drinking water. Cryptosporidium is a protozoon 
which causes cryptosporidiosis, a severe gastrointestinal disease. 
While cryptosporidiosis is generally self-limiting in healthly 
individuals, it can be fatal for people with compromised immune 
systems. Cryptosporidium is removed to a degree by filtration but is 
highly resistant to conventional drinking water disinfectants, 
including chlorine and chloramines. EPA has recently collected a 
significant amount of data on occurrence of Cryptosporidium in drinking 
water sources through the Informaction Collection Rule (ICR) and ICR 
Supplemental Surveys. These data indicate that a subset of drinking 
water systems have an unacceptably high risk for Cryptosporidium in 
their treated water. The LT2ESWTR is intended to identify systems at 
high risk for Cryptosporidium through monitoring and prescribe an 
appropropriate level of additional treatment. In addition, the LT2ESWTR 
will be promulgated simultaneously with the Stage 2 Disinfectants and 
Disinfection Byproducts Rule (DBPR). This will help to ensure that 
drinking water utilities do not compromise adequate microbial 
protection while they take steps to control DBPs.


Summary of Legal Basis:


Section 1412(b)(7)(A) of SDWA allows the Administrator to promulgate a 
national primary drinking water regulation that requires the use of a 
treatment technique in establishing a maximum contaminant level if the 
Adminsitrator makes a finding that it is not feasible to ascertain the 
level of the contaminant. The MCLG for Cryptosporidium is zero and it 
is not feasible for public water systems to measure Cryptosporidium 
concentrations in treated water. Consequently, under section 
1412(b)(1)(A), the Administrator may establish a treatment technique 
for Cryptosporidium if this presents a meaningful opportunity for 
health risk reduction. In addition, section 1412(b)(2)(C) of SDWA, as 
amended in 1996, requires EPA to promulgate a Stage 2 Disinfectants/
Disinfection Byproducts Rule no later than May 2002. Although the 1996 
Amendments do not require EPA to finalize a Long Term 2 Enhanced 
Surface Water Treatment Rule along with the Stage 2 Disinfectants and 
Disinfection Byproducts Rule, Congress did emphasize the importance of 
ensuring proper balance between microbial and DBP risks and, therefore, 
EPA believes it is important to finalize these rules together.


Alternatives:


The major components of the LT2ESWTR are being developed by a committee 
convened under the Federal Advisory Committee Act (FACA). The FACA has 
considered various rule scenarios to reduce risk from Cryptosporidium. 
These scenarios have included treatment requirements that would apply 
to all systems, such as requiring all conventional plants to acheive 2-
log inactivation of Crpytosporidium. Alternative scenarios have 
involved assigning systems to bins based on mean Crypto source water 
concentrations. Additional treatment requirements would then depend on 
the bin to which a system was assigned. Issues associated with the 
binning approach include: amount of monitoring necessary to assign 
systems to bins, appropriate Crypto concentrations to demarcate bin 
boundaries, and appropriate level of additional treatment for a given 
bin. EPA and the FACA are exploring analyses that evaluate the impact 
of these issues on costs and benefits. EPA has also considered options 
to reduce the impact on small systems.


Anticipated Cost and Benefits:


EPA estimates that the LT2ESWTR will have an annual economic impact of 
$100 million or more. The majority of people (approximately 67 percent) 
are served by public water systems that use a surface water or 
groundwater under the direct influence of surface water. Thus, a large 
number of people will benefit from the LT2ESWTR. In addition, EPA has 
recently identified UV light as a technology that can achieve high 
levels of Cryptosporidium inactivation at relatively low cost.


Risks:


Approximately 67 percent of consumers are served by drinking water 
systems that use surface water sources. Survey data indicate that 
Cryptosporidium is high prevalent in drinking water sources and current 
levels of treatment may not be adequate to control highly resistant 
pathogens like Cryptosporidium. Cryptosporidiosis is a potentially 
fatal disease in people with weak immune systems, such as infants, the 
elderly, people with AIDS, and people taking immune suppressing drugs 
like cancer and transplant patients. By requiring additional treatment 
for those systems with the highest concentrations of Cryptosporidium in 
their source waters, EPA expects to significantly reduce current risk.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           05/00/01
Final Action                                                   05/00/02
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses, Governmental Jurisdictions, Organizations


Government Levels Affected:


Federal, State, Local, Tribal


Federalism:


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


Additional Information:


SAN No. 4341


Sectors Affected:


22131 Water Supply and Irrigation Systems


Agency Contact:
Thomas Grubbs
Environmental Protection Agency
Water
4607
Washington, DC 20460
Phone: 202 260-7270
Fax: 202 401-6135
Email: [email protected]

Dan Schmelling
Environmental Protection Agency
Water
4607
Washington, DC 20460
Phone: 202 260-1439
Fax: 202 401-6135
Email: [email protected]
RIN: 2040-AD37
_______________________________________________________________________



EPA



128. NATIONAL PRIMARY DRINKING WATER REGULATIONS: STAGE 2 
DISINFECTANTS/DISINFECTION BYPRODUCTS RULE
Priority:


Economically Significant. Major under 5 USC 801.

[[Page 73478]]

Unfunded Mandates:


This action may affect State, local or tribal goverments and the 
private sector.


Legal Authority:


42 USC 300j-11; 42 USC 300g-5; 42 USC 300g-6; 42 USC 300j-4; 42 USC 
300j-9; 42 USC 300g-4; 40 USC 300g-1(b); SDWA 1412(b); 42 USC 300f; 42 
USC 300g-2; 42 USC 300g-3


CFR Citation:


40 CFR 141 to 142; 40 CFR 9


Legal Deadline:


Final, Statutory, May 31, 2002, SDWA 1412(b)(2)(A) imposes date for 
final rule promulgation.


Abstract:


The 1996 Safe Drinking Water Act Amendments require EPA to promulgate a 
Stage 2 Disinfectants/Disinfection Byproducts Rule (Stage 2 DBPR) by 
May 2002. EPA plans to propose this rule in May 2001. The regulation, 
along with a Long Term 2 Enhanced Surface Water Treatment Rule 
(LT2ESWTR) that will be promulgated simultaneously, is intended to 
expand existing public health protections and address concerns about 
risk trade-offs between pathogens and disinfection byproducts. This 
rule could affect all public water systems that add a disinfectant to 
the drinking water during any part of the treatment process although 
the impacts may be limited to community water systems (CWSs) and 
nontransient noncommunity water systems (NTNCWSs). Promulgating the 
LT2ESWTR and the Stage 2 DBPR as a paired rulemaking is necessary to 
ensure that adequate protection from microbial risk is maintained while 
EPA manages risk from disinfection byproducts. In developing the Stage 
2 DBPR, EPA will analyze a significant body of new survey data on 
source water quality parameters, treatment data and disinfection 
byproduct occurrence. This survey data, which was collected under the 
Information Collection Rule (ICR), Supplemental Surveys to the ICR, and 
additional research projects, will provide a substantially more 
comprehensive and complete picture of the occurrence of DBPs and 
microbiological pathogens than was available previously. EPA will also 
use new information on the health effects of exposure to DBPs to 
determine effective regulatory requirements for controlling risk. On 
March 30, 1999, EPA established a committee of stakeholders under the 
Federal Advisory Committee Act (FACA) to assist in the development of 
these rules. The FACA committee is scheduled to make recommendations on 
rule options to EPA in September 2000.


Statement of Need:


The purpose of the Stage 2 Disinfectants/Disinfection Byproducts Rule 
(DBPR) is to reduce potential health risks posed by disinfection 
byproducts (DBPs). Certain DBPs have been shown in laboratory tests to 
be carcinogens or to cause adverse reproductive and developmental 
health effects. In addition, epidemiology studies have indicated that 
exposure to chlorinated water may increase the risk of bladder cancer, 
miscarriage, and certain developmental defects. The Stage 2 DBPR is 
designed to reduce peak events in DBP exposure in order to mitigate 
these potential health risks.


Summary of Legal Basis:


Section 1412(b)(2)(C) of SDWA, as amended in 1996, requires EPA to 
promulgate a Stage 2 Disinfectants/Disinfection Byproducts Rule no 
later than May 2002. Although the 1996 Amendments do not require EPA to 
finalize a Long Term 2 Enhanced Surface Water Treatment Rule along with 
the Stage 2 Disinfectants and Disinfection Byproducts Rule, Congress 
did emphasize the importance of ensuring proper balance between 
microbial and DBP risks and, therefore, EPA believes it is important to 
finalize these rules together.


Alternatives:


The major components of the Stage 2 DBPR are being developed by a 
committee convened under the Federal Advisory Committee Act (FACA). The 
FACA has considered various rule scenarios to achieve reductions in 
disinfection byproduct exposure. These alternatives have included: 
decreasing the standard set in the Stage 1 DBPR (0.080 mg/L total 
trihalomethanes (TTHM) and 0.060 mg/L the sum of 5 haloacetic 
acids(HAA5)) by half and maintaining a running annual average 
compliance calculation; maintaining 80/60 TTHM/HAA5 standards but 
revising the compliance calculation to a stricter locational running 
annual average; setting the 80/60 TTHM/HAA5 standard as a never-to-be-
exceeded maximum; and revising the standard for bromate which is 
currently 0.010 mg/L. EPA has also considered options to reduce the 
impact on small systems.


Anticipated Cost and Benefits:


EPA estimates that the Stage 2 DBPR will have an annual economic impact 
of $100 million or more. Over 200 million people are served by public 
water systems that apply a disinfectant (e.g., chlorine) to water in 
order to provide protection against microbial contaminants and 
potentially exposed to DBPs. Thus, a large number of people will 
benefit from the Stage 2 DBPR.


Risks:


Over 200 million people are served by public water systems that apply a 
disinfectant (e.g., chlorine) to water in order to provide protection 
against microbial contaminants. Due to the the large number of people 
exposed to DBPs, there is a substantial concern for any risks 
associated with DBPs that may impact public health. EPA estimates that 
the Stage 2 DBPR will decrease exposure to DBPs on average but more 
importantly, the rule will significantly reduce exposure to peak 
occurrences of DBPs.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           05/00/01
Final Action                                                   05/00/02
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Governmental Jurisdictions, Organizations, Businesses


Government Levels Affected:


Tribal, Federal, State, Local


Federalism:


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


Additional Information:


SAN No. 4342


Sectors Affected:


22131 Water Supply and Irrigation Systems

[[Page 73479]]

Agency Contact:
Thomas Grubbs
Environmental Protection Agency
Water
4607
Washington, DC 20460
Phone: 202 260-7270
Fax: 202 401-6135
Email: [email protected]

Jennifer McLain
Environmental Protection Agency
Water
4607
Washington, DC 20460
Phone: 202 260-0431
Fax: 202 401-6135
Email: [email protected]
RIN: 2040-AD38
_______________________________________________________________________



EPA



129.  MINIMIZING ADVERSE ENVIRONMENTAL IMPACT FROM COOLING 
WATER INTAKE STRUCTURES AT EXISTING FACILITIES UNDER SECTION 316(B) OF 
THE CLEAN WATER ACT
Priority:


Economically Significant


Unfunded Mandates:


This action may affect the private sector under PL 104-4.


Legal Authority:


33 USC 1311 CWA sec 301; 33 USC 1316 CWA sec 306; 33 USC 1326 CWA sec 
316; 33 USC 1361 CWA sec 501


CFR Citation:


40 CFR 9, 122, 123, 124 and 125


Legal Deadline:


NPRM, Judicial, July 20, 2001, See additional information.


Abstract:


This proposed rulemaking will apply to the intake of water by existing 
facilities with cooling water intake structures. Section 316(b) of the 
Clean Water Act provides that any standard established pursuant to 
sections 301 or 306 of the Clean Water Act and applicable to a point 
source shall require that the location, design, construction, and 
capacity of cooling water intake structures reflect the best technology 
available for minimizing adverse environmental impact. A primary 
purpose of the rulemaking is to minimize the impingement and 
entrainment of fish and other aquatic organisms by cooling water intake 
structures. Impingement refers to trapping fish and other aquatic life 
against cooling water intake screens. Entrainment occurs when aquatic 
organisms, eggs, and larvae are drawn into the cooling system through 
the heat exchanger, and then pumped back out, often with significant 
injury or mortality to the entrained organisms.


Statement of Need:


In the absence of the required national regulations, permit directors 
have implemented cooling water intake limitations incompletely and 
inconsistently. Literally tons of fish and other aquatic organisms may 
be cropped annually as a result of cooling water intake structures at a 
single large facility.


Summary of Legal Basis:


This action is required under consent decree in settlement of Cronin, 
et al. v. Reilly, 93 Civ. 0314 (AGS) (U.S.D.C., Southern District of 
New York, October 10, 1995).


Alternatives:


The analysis will cover various sizes and types of potentially 
regulated facilities. EPA is considering whether to regulate site-by-
site, nationally, or on the basis of broad categories of water body 
types.


Anticipated Cost and Benefits:


Costs are undetermined. A qualitative assessment of benefits at several 
large facilities indicates the potential for significant benefits when 
large intakes are controlled. Costs and benefits are generally expected 
to be smaller at facilities that use smaller amounts of cooling water.


Risks:


Cooling water intake structures may pose significant risks for aquatic 
ecosystems.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           07/00/01
Final Action                                                   05/00/02
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


Businesses, Governmental Jurisdictions


Government Levels Affected:


Federal, State, Local, Tribal


Additional Information:


SAN No. 4474


Split from RIN 2040-AC34.


Deadline for final action is the subject of settlement discussions.


Sectors Affected:


331111 Iron and Steel Mills; 331221 Cold-Rolled Steel Shape 
Manufacturing; 331222 Steel Wire Drawing; 33121 Iron and Steel Pipes 
and Tubes Manufacturing from Purchased Steel; 331315 Aluminum Sheet, 
Plate and Foil Manufacturing; 331521 Aluminum Die-Castings; 331524 
Aluminum Foundries; 331525 Copper Foundries; 322121 Paper (except 
Newsprint) Mills; 32213 Paperboard Mills; 32411 Petroleum Refineries; 
325311 Nitrogenous Fertilizer Manufacturing; 325199 All Other Basic 
Organic Chemical Manufacturing


Agency Contact:
Deborah Nagle
Environmental Protection Agency
Water
4303
Washington, DC 20460
Phone: 202 260-2656
Fax: 202 260-7185
Email: [email protected]

J. T. Morgan
Environmental Protection Agency
Water
4303
Washington, DC 20460
Phone: 202 260-6015
Fax: 202 260-7185
Email: [email protected]
RIN: 2040-AD62
_______________________________________________________________________



EPA



130.  CROSS-MEDIA ELECTRONIC REPORTING (ER) AND RECORDKEEPING 
RULE
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:


PL 104-13; PL 105-277


CFR Citation:


40 CFR 3 (New); 40 CFR 9 (Revision)


Legal Deadline:


None


Abstract:


The Cross-Media Electronic Reporting (ER) and Recordkeeping Rule will

[[Page 73480]]

provide a uniform legal framework for paperless electronic reporting 
and recordkeeping, including electronic signature/certification, across 
EPA's environmental compliance programs. The rule will both remove 
current legal requirements for paper that create obstacles to 
electronic reporting and recordkeeping and provide for mechanisms to 
assure the legal validity and authenticity of electronic documents and 
associated electronic signatures, whether transmitted as reports or 
maintained as records. This rule is important because the legal and 
electronic signature issues remain the chief obstacle to implementation 
of paperless electronic reporting, and affect the overall 
enforceability of environmental programs both federally and under State 
delegation/ authorization. Also, the Government Paperwork Elimination 
Act of 1998 requirements and the Administrator's Reinventing 
Environmental Information (REI) Action Plan goal of universal ER 
availability by 2003 can only be met if this rulemaking has active 
participation by the AA-ships and moves on a fast track.


Statement of Need:


EPA is required by the Government Paperwork Elimination Act (GPEA) of 
1998 to provide electronic reporting and recordkeeping as an option to 
its regulated community by 2003. To meet this deadline and comply with 
GPEA, the legal framework for electronic reporting must be in place by 
that time. The CROMERR rule is necessary to establish the legal 
framework to: (1) remove legal obstacles to electronic reporting and 
recordkeeping under most EPA regulations; and (2) assure that these 
electronic documents will have the same legal and evidentiary force as 
their paper counterparts. Electronic Reporting is also a capstone of 
the Administration's Reinventing Government Initiative and the 
Administrator's Integrated Information Initiative (I3).


Summary of Legal Basis:


(1) Government Paperwork Elimination Act (GPEA) of 1998. GPEA requires 
Federal agencies to provide electronic reporting and recordkeeping to 
its regulated community by 2003. (2) Electronic Signature National and 
Global Commerce Act (ESIGN), June 30, 2000. This law eliminates legal 
barriers to the use of electronic technology to form and sign 
contracts, collect and store documents, and send and receive notices 
and disclosures. ESIGN applies broadly to Federal statutes and 
regulations governing private sector (including business-to-business 
and business-to-consumer) activities. In general, it does not cover 
activities that are primarily governmental, which are governed by GPEA. 
ESIGN begins to take effect on October 1, 2000.


Alternatives:


The alternative to an EPA cross-media rule that applies to most 
compliance reports under 40 CFR, would be individual rulemakings by 
each of the program offices. EPA's past experience with such 
rulemakings has demonstrated that such a course of action would not 
bring EPA in compliance with GPEA by the 2003 deadline.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           11/00/00
Final Action                                                   11/00/01
Regulatory Flexibility Analysis Required:


No


Government Levels Affected:


Federal, State, Local, Tribal


Additional Information:


SAN No. 4270


Fomerly listed as RIN 2020-AA41.


Agency Contact:
Evi Huffer
Environmental Protection Agency
Office of Environmental Information
2823
Washington, DC 20460
Phone: 202 260-8791
Fax: 202 401-0182
Email: [email protected]

David Schwarz
Environmental Protection Agency
Office of Environmental Information
2823
Washington, DC 20460
Phone: 202 260-2710
Fax: 202 401-0182
Email: [email protected]
RIN: 2025-AA07
_______________________________________________________________________



EPA

                              -----------

                            FINAL RULE STAGE

                              -----------




131. REVISION TO 40 CFR 35 SUBPART A AND PROMULGATION OF PERFORMANCE 
PARTNERSHIP (STATE) GRANT REGULATION
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:


PL 104-134; PL 105-65


CFR Citation:


40 CFR 35


Legal Deadline:


None


Abstract:


This proposed regulation: (1) updates, clarifies, and streamlines 
requirements governing environmental program grants; (2) establishes 
requirements for the new Performance Partnership Grant (PPG) program; 
and (3) establishes requirements for grant programs that began after 
the original rule was published. (A regulation governing environmental 
program grants to Indian tribes and tribal consortia is published 
elsewhere in this issue of the Federal Register.)


Statement of Need:


Since EPA was formed in 1970, State capacity and responsibility for 
implementing environmental and public health protection programs has 
grown steadily. Until 1996, State and interstate agencies could receive 
EPA assistance in carrying out their environmental programs only 
through a variety of categorical environmental grants, such as grants 
for water pollution control, air pollution control, and hazardous 
substance control. Meanwhile, environmental problems and their 
solutions have grown more complex and solutions to these complex 
problems often crossed EPA program lines. In light of this complexity, 
State and EPA leaders recognized that continued environmental progress 
could be best achieved if EPA and States worked together more 
effectively as partners

[[Page 73481]]

and environmental programs were made more flexible in terms of their 
coverage.


In response, EPA asked Congress for new authority that would provide 
that needed flexibility. In 1996, Congress authorized the award of 
Performance Partnership Grants (PPGs), in which State and interstate 
agencies can choose to combine two or more environmental program 
grants.


This proposed rule will implement the PPG program which promotes State-
EPA collaboration; provides opportunities for innovation; and reduces 
paperwork. EPA expects the rule will foster joint planning and 
priority-setting by explicitly requiring that State priorities and 
needs be considered, along with national and regional guidance, in 
negotiating grant work plans, consistent with the National 
Environmental Performance Partnership System (NEPPS). Under this rule, 
a State can choose to organize its grant work plans in accord with 
environmental goals and objectives or in other new ways rather than 
using categories predefined by EPA. The length of a grant budget period 
will be negotiable. These opportunities afforded by the PPG program and 
this rule are available to all States.


This rule accommodates all potential variations in how EPA and 
individual States work to build partnerships. The rule also minimizes 
duplicative effort by allowing for multiple uses of information or 
processes wherever appropriate. The regulation advances ongoing efforts 
to build more effective State-EPA partnerships and to improve 
environmental conditions by providing States with increased flexibility 
to direct resources where they are needed most to address environmental 
and public health needs.


Summary of Legal Basis:


Not required by law or court order.


Alternatives:


EPA can continue to award PPGs under guidance prepared by the agency 
and announced in the Federal Register.


Anticipated Cost and Benefits:


The rule does not result in any new costs. It is expected to allow cost 
and administrative savings for States by reducing the amount of grant 
paperwork and by simplifying accounting requirements that do not 
require recipients to account for expenditures in accordance with their 
original funding sources. With PPGs, recipients can negotiate work 
plans with EPA that direct Federal funds where the recipients need them 
most to address environmental and public health problems. Recipients 
can also try new multimedia approaches and initiatives, such as 
children's health protection programs, multimedia inspections, 
compliance assistance programs, and ecosystem management, that were 
difficult to fund under traditional categorical grants.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            64 FR 63731                                    07/23/99
Final Action                                                   01/00/01
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


Governmental Jurisdictions, Organizations


Government Levels Affected:


Federal, State, Local


Procurement:


This is a procurement-related action for which there is no statutory 
requirement. There is no paperwork burden associated with this action.


Additional Information:


SAN No. 3736


Agency Contact:
Scott McMoran
Environmental Protection Agency
Administration and Resources Management
3903R
Washington, DC 20460
Phone: 202 564-5376
RIN: 2030-AA55
_______________________________________________________________________



EPA



132. REVISION TO 40 CFR 35 SUBPART A AND PROMULGATION OF PERFORMANCE 
PARTNERSHIP (TRIBAL) GRANT RULE
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:


PL 104-134; PL 105-65


CFR Citation:


40 CFR 35


Legal Deadline:


None


Abstract:


This proposed regulation will: (1) update, clarify, and streamline 
requirements governing environmental program grants; (2) establish 
requirements for the new Performance Partnership Grant (PPG) program; 
and (3) establish requirements for grant programs that were developed 
after the original rule was published. (EPA is also issuing a 
regulation governing environmental program grants to State and 
interstate agencies.)


Statement of Need:


This regulation provides a tribal-specific subpart which is intended to 
be easy to use; optimizes the administration of tribal assistance 
programs through increased flexibility; and removes procedural 
impediments to effective environmental programs for Indian tribes.


Since EPA was formed in 1970, tribal capacity and responsibility for 
implementing environmental and public health protection programs has 
grown steadily. Until 1996, tribes and intertribal consortia could 
receive EPA assistance in carrying out their environmental programs 
only through a variety of categorical environmental grants, such as 
grants for water pollution control, air pollution control, and safe 
drinking water. During that time, environmental problems and their 
solutions grew more complex and solutions to those complex problems 
often crossed EPA program lines. In light of this complexity, tribal 
and EPA leaders recognized that continued environmental progress could 
be best achieved if EPA and the tribes worked together more effectively 
as partners and environmental programs were made more flexible in terms 
of their coverage.


In response, EPA asked Congress for new authority that would provide 
that needed flexibility. In 1996, Congress authorized the award of 
Performance Partnership Grants (PPGs), in which tribes and intertribal 
consortia can choose to combine two or more environmental program 
grants.


This proposed rule will implement the PPG program which promotes 
tribal-EPA collaboration; provides opportunities for innovation; and 
reduces paperwork. EPA expects the rule will foster joint planning and 
priority-setting by explicitly requiring that tribal priorities and 
needs be considered, along with national and

[[Page 73482]]

regional guidance, in negotiating grant work plans, consistent with the 
National Environmental Performance Partnership System (NEPPS). Under 
this rule, a tribe can choose to organize its grant work plans in 
accord with environmental goals and objectives or in other new ways 
rather than using categories predefined by EPA. The length of a grant 
budget period will be negotiable. These opportunities afforded by the 
PPG program and this rule are available to all tribes which receive 
grants under more than one EPA environmental program.


This rule accommodates all potential variations in how EPA and 
individual tribes work to build partnerships. The rule also minimizes 
duplicative effort by allowing for multiple uses of information or 
processes wherever appropriate. The regulation advances ongoing efforts 
to build more effective tribal-EPA partnerships and to improve 
environmental conditions by providing tribes with increased flexibility 
to direct resources where they are needed most to address environmental 
and public health needs.


Summary of Legal Basis:


Not required by law or court order.


Alternatives:


EPA can continue to award PPGs under guidance prepared by the agency 
and announced in the Federal Register.


Anticipated Cost and Benefits:


The rule does not result in any new costs. It is expected to achieve 
cost and administrative savings for tribes by reducing the amount of 
grant paperwork and by simplifying accounting requirements that do not 
require recipients to account for expenditures in accordance with their 
original funding sources. With PPGs, recipients can negotiate work 
plans with EPA that direct Federal funds where the recipients need them 
most to address environmental and public health problems. Recipients 
can also try new multimedia approaches and initiatives, such as 
children's health protection programs, multimedia inspections, 
compliance assistance programs, and ecosystem management, that were 
difficult to fund under traditional categorical grants.


Risks:


There are no known risks.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            64 FR 63732                                    07/23/99
Final Action                                                   01/00/01
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


Governmental Jurisdictions, Organizations


Government Levels Affected:


Federal, Tribal


Procurement:


This is a procurement-related action for which there is no statutory 
requirement. There is no paperwork burden associated with this action.


Additional Information:


SAN No. 4128


Agency Contact:
Michelle McClendon
Environmental Protection Agency
Administration and Resources Management
3903R
Washington, DC 20460
Phone: 202 564-5357
Fax: 202 565-2470
Email: [email protected]
RIN: 2030-AA56
_______________________________________________________________________



EPA



133. IMPLEMENTATION OF OZONE AND PARTICULATE MATTER (PM) NATIONAL 
AMBIENT AIR QUALITY STANDARDS (NAAQS) AND REGIONAL HAZE REGULATIONS
Priority:


Other Significant


Legal Authority:


Clean Air Act, title I


CFR Citation:


40 CFR 50; 40 CFR 51; 40 CFR 52; 40 CFR 81


Legal Deadline:


None


Abstract:


On July 18, 1997, EPA issued new, updated air quality standards for 
ozone (62 FR 38856) and particulate matter (PM) (62 FR 38652). Pursuant 
to President Clinton's implementation strategy as outlined in a July 
16, 1997 memorandum to EPA Administrator Carol Browner, EPA had been 
developing guidance and rules for sensibly and cost-effectively meeting 
the new standards. On November 17, 1998, EPA made available for comment 
proposed implementation guidance on implementing the revised ozone and 
PM NAAQS and regional haze program. On May 14, 1999, however, the U.S. 
Court of Appeals for the D.C. Circuit issued an opinion concerning the 
revised ozone and particulate matter NAAQS (American Trucking Assoc., 
Inc. et al. v. USEPA, No. 97-1440 (May 14, 1999)) in which the Court 
stated, among other things, that the revised 8-hour ozone standard 
``cannot be enforced.'' The Court also vacated the revised PM10 NAAQS 
and remanded the PM2.5 NAAQS. On June 28, 1999, EPA requested a 
rehearing of the case before the Court, but the request was denied. The 
Department of Justice then filed a petition in January 2000 seeking 
U.S. Supreme Court review, and the Court subsequently agreed to review 
the case. EPA expects a decision from the Supreme Court in early to 
mid-2001. Until the appeals process is exhausted, EPA does not intend 
to issue final guidance for implementation of the standards affected by 
the Appeals Court's decision. Once the Supreme Court renders a 
decision, EPA will determine what actions may be appropriate. 
Meanwhile, to assure that areas were not left without an air-quality 
standard, EPA took action on 7/6/00 to reinstate the previous 1-hr 
standard in approximately 3000 counties across the United States. EPA 
is also developing guidelines for determining Best Available Retrofit 
Technology (BART) under the Regional Haze Regulations through a formal 
rulemaking proposal (see SAN 4450 in today's regulatory agenda).


Statement of Need:


Development of programs for ozone and PM are necessary to implement any 
revised NAAQS under title 1 of the Clean Air Act.


Summary of Legal Basis:


Title I of the Clean Air Act


Alternatives:


This entry comprises the set of actions the Agency plans to take to 
implement the new ozone and fine particulate standards. The major 
alternative facing the Agency was whether to implement the standards 
strictly on a state-by-state basis, as has been the norm in the past, 
or to take Federal action to address the fact that emissions from one 
State affect the ability of other States to achieve the standards. The 
other major set of alternatives involved various possible strategies 
for infrastructure design, such as the designations of nonattainment 
areas and the requirements that will apply to them. The major issues in 
this

[[Page 73483]]

area were settled by the July 1997 issuance of a Presidential Directive 
setting out a flexible implementation policy, the elements of which are 
summarized in the abstract above.


Anticipated Cost and Benefits:


EPA prepared a regulatory impact analysis (RIA) for the final ozone and 
PM NAAQS, as well as the regional haze reduction program.


Risks:


The risks addressed by this implementation plan are those of not 
attaining the National Ambient Air Quality Standards for Ozone and 
Particulate Matter.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
ANPRM           61 FR 65764                                    12/13/96
Notice Proposed 61 FR 65752                                    12/13/96
NPRM Regional Ha62 FR 41138                                    07/31/97
Notice Review Sc62 FR 55201PM2.5 Standard                      10/23/97
Final Rule - Are63 FR 310131-Hour Ozone Standard               06/05/98
Final Rule - Add63 FR 39432as Meeting 1-Hour Ozone Standard    07/22/98
Draft Guidance -63 FR 65593tion Planning                       11/17/98
Final Rule - Add64 FR 30911as Meeting 1-Hour Ozone NAAQS: 96-9806/09/99
Final Rule - Reg64 FR 35713                                    07/01/99
Final Action - R65 FR 45182t of 1-Hour Standard                07/20/00
Final Guidance oDeterminedding Court Action                       To Be
Regulatory Flexibility Analysis Required:


No


Government Levels Affected:


State


Additional Information:


SAN No. 3553


Agency Contact:
Denise Gerth
Environmental Protection Agency
Air and Radiation
MD-15
Research Triangle Park, NC 27711
Phone: 919 541-5550
Fax: 919 541-0824
Email: [email protected]

John Silvasi
Environmental Protection Agency
Air and Radiation
MD-15
Research Triangle Park, NC 27711
Phone: 919 541-5666
Fax: 919 541-0824
Email: [email protected]
RIN: 2060-AF34
_______________________________________________________________________



EPA



134. ENVIRONMENTAL RADIATION PROTECTION STANDARDS FOR YUCCA MOUNTAIN, 
NEVADA
Priority:


Other Significant


Legal Authority:


Energy Policy Act sec 801


CFR Citation:


40 CFR 197


Legal Deadline:


NPRM, Statutory, August 1, 1996.


Abstract:


This rulemaking is in response to section 801 of the Energy Policy Act 
of 1992 which directs the Administrator to promulgate public health and 
safety standards for protection of the public from releases from 
radioactive materials stored or disposed of in the repository at the 
Yucca Mountain site. The only regulated entity is the U.S. Department 
of Energy.


Statement of Need:


In 1985, the Agency issued generic standards for the management and 
disposal of spent nuclear fuel and high-level radioactive waste. The 
Nuclear Waste Policy Amendments Act of 1987 mandated the study of Yucca 
Mountain, Nevada, to determine its suitability to be a repository for 
spent nuclear fuel and high-level radioactive waste. The Waste 
Isolation Pilot Plant Land Withdrawal Act of 1992 exempted Yucca 
Mountain from coverage under the 1985 generic standards. Concurrently, 
the Energy Policy Act of 1992 gave EPA the responsibility of setting 
site-specific, radiation-protection standards for Yucca Mountain.


Summary of Legal Basis:


The legal authority is derived from the Energy Policy Act of 1992.


Alternatives:


Since this action is legally mandated, there are no alternatives.


Anticipated Cost and Benefits:


Since the potential cost is dependent upon several factors whose 
determination has not yet been made, a precise assessment of the 
economic impact of the rulemaking is not possible at this time. 
Likewise, the benefits, i.e., the adverse effects averted (which are 
required to complete a cost-benefit analysis), cannot be determined in 
a meaningful manner at this time since the effect of these standards is 
to avert potential adverse health effects that may occur during very 
long periods into the future and are, therefore, quantifiable only with 
a high degree of uncertainty.


Risks:


The maximum allowable lifetime risk which would be allowed under these 
standards is 3 chances in 10,000 in contracting a fatal cancer, which 
is the upper end of what the Agency deems an acceptable risk. In 
addition, we have proposed a seperate protection for ground water 
resources at levels established by the Safe Drinking Water Act.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            64 FR 46976                                    08/27/99
Final Action                                                   12/00/00
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


Federal


Additional Information:


SAN No. 3568

[[Page 73484]]

Agency Contact:
Ray Clark
Environmental Protection Agency
Air and Radiation
6608J
Washington, DC 20460
Phone: 202 564-9198
Fax: 202 565-2065
Email: [email protected]
RIN: 2060-AG14
_______________________________________________________________________



EPA



135. CONSOLIDATED FEDERAL AIR RULE FOR THE SYNTHETIC ORGANIC CHEMICAL 
MANUFACTURING INDUSTRY
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 7401 et seq


CFR Citation:


40 CFR 60; 40 CFR 61; 40 CFR 63; 40 CFR 65


Legal Deadline:


None


Abstract:


Over the past 25 years, EPA has issued a series of national air 
regulations, many of which affect the same facility. Each rule has 
emission control requirements as well as monitoring, recordkeeping, and 
reporting requirements. All existing Federal air rules applicable to an 
industry sector will be reviewed to determine whether their provisions 
can be consolidated into a single new rule. Affected industries, State 
agencies, and other stakeholders will be consulted to identify 
duplicative provisions. The chemical industry and State representatives 
have agreed to work on a pilot project with EPA's air programs to 
explore this approach. If the approach is successful with the chemical 
industry, it may be expanded to air rules for other industry sectors.


Statement of Need:


Both industry and regulatory agencies have expressed a great desire to 
streamline and simplify rules. This rule streamlines and simplifies by 
consolidating and collapsing the numerous Federal rules that apply to 
the chemical industry, with resulting improved compliances.


Summary of Legal Basis:


Clean Air Act sections 111 and 112


Alternatives:


The main alternative is to do nothing and let the many rules with their 
many provisions remain the only compliance mechanism.


Anticipated Cost and Benefits:


This rule will result in considerable savings to the affected industry. 
There is significant burden reduction associated with recordkeeping and 
reporting. The rule will be easier to follow and understand. There will 
be no change in applicability of the rules being consolidated.


Risks:


This rulemaking deals with consolidated reporting to simplify existing 
rules. The risks addressed by each of these existing rules were 
addressed in those individual rulemakings.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            63 FR 57748                                    10/28/98
Final Action                                                   10/00/00
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


None


Additional Information:


SAN No. 3748


Agency Contact:
Susan Wyatt
Environmental Protection Agency
Air and Radiation
MD-13
Research Triangle Park, NC 27711
Phone: 919 541-5674
Fax: 919 541-0942
Email: [email protected]

Rick Colyer
Environmental Protection Agency
Air and Radiation
MD-13
Research Triangle Park, NC 27711
Phone: 919 541-5262
Fax: 919 541-0942
Email: [email protected]
RIN: 2060-AG28
_______________________________________________________________________



EPA



136. HEAVY-DUTY ENGINE EMISSION STANDARDS AND DIESEL FUEL SULFUR 
CONTROL REQUIREMENTS
Priority:


Economically Significant. Major under 5 USC 801.


Unfunded Mandates:


This action may affect the private sector under PL 104-4.


Legal Authority:


Not Yet Determined


CFR Citation:


Not Yet Determined


Legal Deadline:


None


Abstract:


This rulemaking will set new quality requirements for fuel used in 
diesel engines in order to bring about large environmental benefits 
through the enabling of a new generation of diesel emission control 
technologies. Improving the quality of diesel fuel will enable advanced 
technologies for diesel emission control. These advanced sulfur-
sensitive technologies have the potential to reduce diesel engine NOx 
emissions by 75 percent and PM emissions by 80 percent or more. A key 
approach taken in developing the ``Tier II'' standards (Tier II Light-
Duty Vehicle and Light-Duty Truck Emission Standards and Gasoline 
Sulfur Standards -- see RIN 2060-AI23 in this Regulatory Plan) was 
``fuel-neutrality'' -- applying standards equally to diesel- and 
gasoline-powered vehicles. Reducing sulfur levels in highway diesel 
fuel will help facilitate development of diesel-powered vehicles that 
meet these standards. This rulemaking will also set new heavy duty NOx 
and PM engine standards. Low-sulfur diesel fuel is needed so that 
advanced technology for diesel engines will be available to meet new 
more stringent standards. There are also additional air quality 
benefits such as particulate matter and sulfate reductions associated 
with reducing sulfur levels in diesel fuel.


Statement of Need:


Ozone and particulate pollution pose a serious threat to the health and 
well-being of millions of Americans and a large burden to the U.S. 
economy. This rulemaking will address additional national control 
measures to reduce emissions, including emissions of nitrogen oxides, 
hydrocarbons, and

[[Page 73485]]

particulate matter, from heavy-duty diesel engines, and will also 
require reduced sulfur levels in diesel fuel, in order to protect the 
public health and welfare.


Summary of Legal Basis:


42 USC 7521; 42 USC 7545


Alternatives:


EPA analyzed several alternatives. These are discussed in the notice of 
proposed rulemaking.


Anticipated Cost and Benefits:


EPA's analysis of the costs and emission reductions is described in the 
proposed rule.


Risks:


The risks addressed by this program are primarily those associated with 
nonattainment of the National Ambient Air Quality Standards for ozone 
and particulate matter. There are also serious public health and 
environmental problems associated with toxic air pollution, acid rain, 
reduced visibility, and nitrogen loading of estuaries.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
ANPRM           64 FR 32209                                    06/16/99
NPRM            65 FR 35429                                    06/02/00
Final Action                                                   12/00/00
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses


Government Levels Affected:


None


Federalism:


 Undetermined


Additional Information:


SAN No. 4355


Agency Contact:
Paul Machiele
Environmental Protection Agency
Air and Radiation
Ann Arbor, MI 48105
Phone: 734 214-4264
Fax: 734 214-4050
Email: [email protected]

Don Kopinski
Environmental Protection Agency
Air and Radiation
OMS EPCD
Ann Arbor, MI 48105
Phone: 734 214-4229
Fax: 734 214-4816
Email: [email protected]
RIN: 2060-AI69
_______________________________________________________________________



EPA



137. PLANT-INCORPORATED PROTECTANTS; FIFRA RULE AND FFDCA TOLERANCE 
ACTIONS
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 346(a) et seq; 7 USC 136 et seq


CFR Citation:


40 CFR 152.20; 40 CFR 174


Legal Deadline:


None


Abstract:


Substances that plants produce to protect themselves against pests are 
pesticides under FIFRA if humans intend to use them to destroy, 
prevent, repel or mitigate any pest. The Agency designates these 
substances, along with the genetic material necessary to produce them, 
plant-pesticides. This rulemaking will change the name of these 
pesticides to plant-incorporated protectants and will clarify the 
relationship between plants and plant-incorporated protectants and 
exempt conventional breeding. It will establish a new part in title 40 
of the CFR, part 174, which consolidates regulations specific for 
plant-pesticides in one part of the CFR. The proposed consolidation is 
expected to benefit the public by providing greater focus, enhanced 
clarity and ease of use. These actions may reduce burden on both the 
regulated community and EPA.


Statement of Need:


In 1986, the Federal Government announced in the Coordinated Framework 
for Regulation of Biotechnology (51 FR 23302 June 26, 1986) that it 
would use existing laws in a coordinated fashion to regulate products 
of biotechnology. Thus, the EPA, which is responsible for regulating 
the use of pesticides, would be responsible for products of 
biotechnology that are to be used as pesticides. The rule is part of a 
program to implement fully the Coordinated Framework. The rule is 
needed to ensure the safe application of biotechnology to produce 
pesticidal products. Some of the pesticides produced and used in the 
living plant (plant-incorporated protectants) may pose the same types 
of environmental and human health risks as do the chemical, 
biochemical, and microbial pesticides that are regulated by EPA. Other 
risks may be unique to plant-incorporated protectants. On the other 
hand, all plant varieties have some ability to resist pests and a 
frequent aim of traditional plant breeding is development of plant 
varieties for pest resistance. Each of these abilities is linked to 
plant-incorporated protectants, if humans intend to use the ability to 
prevent, destroy, repel or mitigate pests. Without the exemption in the 
rule, all plant-incorporated protectants would have to be registered 
under FIFRA. EPA evaluated for risk plant-incorporated protectants in 
the categories described in the options set forth in the economic 
analysis. EPA was able to determine that those plant-incorporated 
protectants exempted under option 3 of this economic analysis warranted 
exemption at this time.


Summary of Legal Basis:


The EPA regulates pesticides in the United States. The principal legal 
authority is established by the FIFRA. This rule is promulgated under 
the authority of FIFRA section 3 and section 25(a) and (b) (7 U.S.C. 
136a and 136w(a) and (b)). FIFRA section 3(a) provides, with some 
exceptions, that no person may distribute or sell in the United States 
any pesticide that is not registered under the Act (7 U.S.C. 136(a)). 
FIFRA section 2(u) defines ``pesticide'' as: ``(1) any substance or 
mixture of substances intended for preventing, destroying, repelling, 
or mitigating any pest, (2) any substance or mixture of substances 
intended for

[[Page 73486]]

use as a plant regulator, defoliant, or desiccant, and (3) any nitrogen 
stabilizer'' (7 U.S.C. 136(u)). Under FIFRA section 2(t), the term 
``pest'' includes ``(1) any insect, rodent, nematode, fungus, weed, or 
(2) any other form of terrestrial or aquatic plant or animal life or 
virus, bacteria, or other microorganism'' with certain exceptions (7 
U.S.C. 136(t)) Before EPA may register a pesticide under FIFRA, the 
applicant must show that the pesticide ``when used in accordance with 
widespread and commonly recognized practice, . . . will not generally 
cause unreasonable adverse effects on the environment'' (7 U.S.C. 
136(a)(c)(5)). Section 25(b)(2) of FIFRA allows EPA to exempt, by 
regulation, any pesticide from some or all the requirements of FIFRA, 
if the pesticide is of a character which is unnecessary to be subject 
to FIFRA in order to carry out the purposes of that Act (7 U.S.C. 
136w(b)(2)). EPA interprets FIFRA section 25(b)(2) to authorize EPA to 
exempt a pesticide or category of pesticides that EPA determines poses 
a low probability of risk to the environment, and that is not likely to 
cause unreasonable adverse effects to the environment even in the 
absence of regulatory oversight under FIFRA.


Alternatives:


Four alternatives are analyzed in this economic analysis:: (1) an 
option with a broad range of exemptions that removes three more 
categories of plant-incorporated protectants than the rule from the 
FIFRA requirements; (2) an option that exempts a more narrow scope of 
plant-incorporated protectants than option 1 but more categories than 
option 3; (3) an option representing the exemption promulgated in the 
final rule; and (4) an option with no exemptions, i.e., regulating all 
plant-incorporated protectants. The alternatives analyzed in this 
economic analysis (EA) differ from the proposed EA in the number and 
types of submissions of plant-incorporated protectants that the Agency 
anticipates will be received for registration annually over the next 10 
years. The projected data requirements associated with the various 
types of plant-incorporated protectants in the various alternative case 
studies have also been recalculated in light of the Agency's experience 
with plant-incorporated protectants since the proposed EA was developed 
in 1994. The exemptions in some of the options differ slightly from the 
options in the proposal in order to be consistent with the exemption in 
the rule.


Anticipated Cost and Benefits:


The total direct compliance costs for option 3, which represents the 
scope of EPA's final rule, are estimated to be $2.4 million for year 1 
increasing to $7.9 million in year 10. The rule exempts one specific 
category of plant-incorporated protectants from FIFRA requirements 
because EPA assessments determined that plant-incorporated protectants 
in this category present low probability of risk to the environment and 
are not likely to pose unreasonable adverse effects to the environment 
even in the absence of regulatory oversight. The exemption may lower 
cost to industry and the Agency while providing safety and assurance to 
the public and protection of the environment. The rule allows the 
Agency to focus resources on the plant-incorporated protectants that 
may present a higher potential for risk to human health or the 
environment, especially those with novel exposures. Industry may also 
benefit from greater certainty regarding the regulatory status of their 
plant-incorporated protectants. With the promulgation of the Rule, 
affected firms will be able to plan ahead for timely product 
development and commercialization.


Risks:


With the plant-incorporated protectants not exempted by the rule, there 
is a possibility of new dietary exposures. For example, a qualitatively 
different exposure could occur if a food plant was modified to produce 
a pesticidal substance derived from a nonfood source (e.g., 
microorganisms or insects). Modern biological and genetic techniques 
enable developers to greatly expand the range of sources of genetic 
information introduced into plants and thus into foods, and thus 
increase the possibility that substances significantly different from a 
substance historically consumed safely might be in food. With plant-
incorporated protectants for which there is no record of prior 
significant human exposure, there may be no documentation demonstrating 
that residues of such plant-incorporated protectants consumed in food 
will not have adverse or toxic effects. Also to be considered is the 
potential for risk to be associated with quantitative changes in levels 
of substances that occur naturally in plants, generally at very low 
levels in the food portion, that are toxic when ingested. These same 
considerations apply in terms of environmental risk and new or 
significantly different exposures of nontarget organisms to the 
pesticide. Another environmental risk consideration associated with 
plant-incorporated protectants is the possible transfer through 
outcrossing of an introduced plant-incorporated protectant, from a crop 
plant to a cultivated or wild relative.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            59 FR 60496                                    11/23/94
Supplemental NPR61 FR 37891                                    07/22/96
Supplemental NPR62 FR 27132                                    05/16/97
Supplemental NPR64 FR 19958or Comment on Alternate Name        04/23/99
Supplemental NPRM                                              12/00/00
Final Action                                                   12/00/00
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


Businesses


Government Levels Affected:


Federal


Additional Information:


SAN No. 2684


Agency Contact:
Elizabeth Milewski
Environmental Protection Agency
Office of Prevention, Pesticides and Toxic Substances
7201
Washington, DC 20460
Phone: 202 260-3573
Fax: 202 260-0949
Email: [email protected]

Janet Andersen
Environmental Protection Agency
Office of Prevention, Pesticides and Toxic Substances
7501W
Washington, DC 20460
Phone: 703 308-8712
Email: [email protected]
RIN: 2070-AC02
_______________________________________________________________________



EPA



138. GROUNDWATER AND PESTICIDE MANAGEMENT PLAN
Priority:


Economically Significant


Legal Authority:


7 USC 136(a) FIFRA sec 3; 7 USC 136(w)


CFR Citation:


40 CFR 152.170

[[Page 73487]]

Legal Deadline:


None


Abstract:


This regulation would establish Pesticide Management Plans (PMPs) as a 
new regulatory requirement for certain pesticides. Unless a State or 
tribal authority has an EPA-approved plan specifying risk-reduction 
measures, use of the chemical would be prohibited. The rule would also 
specify procedures and deadlines for development, approval and 
modification of plans by States and tribal authorities.


Statement of Need:


EPA proposed to make specific pesticides subject to the provisions of 
EPA-approved Pesticide Management Plans (PMPs) because of their strong 
groundwater contamination potential. The rule intends to establish PMPs 
as an other regulatory restriction and to define the minimum 
requirements and procedures for developing, approving and managing 
PMPs. Upon promulgation of this rule, the labels of the designated 
pesticides will be changed to require use in conformance with EPA-
approved PMPs, and to prohibit sale and use in States or Indian Country 
without such approved Plans (after a period allowed for development and 
EPA review of these Plans). A PMP is a State's or tribe's commitment to 
EPA and the public to manage the use of a certain pesticide in such a 
way as to avoid unreasonable risks to groundwater that would otherwise 
warrant cancellation of the use. An approved plan will embody a 
combination of educational, scientific, and regulatory tools to fulfill 
the State's groundwater protection goals, developed through a process 
of public participation. A plan will include a process for 
disseminating this information to pesticide users and marketers, and 
for monitoring the effectiveness of the plan through the development of 
appropriate indicators of environmental improvement and/or protection.


Summary of Legal Basis:


The Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) 
generally requires EPA to regulate pesticide use in such a manner as to 
prevent unreasonable risks to human health and the environment. 
Specifically, 7 USC 136a authorizes EPA to prescribe by regulation 
``other regulatory restrictions'' for pesticides that may generally 
cause unreasonable risks to the environment (such as those that are 
associated with groundwater contamination potential) without those 
restrictions.


Alternatives:


This rule is a direct outgrowth of the Pesticides and Groundwater 
Strategy, published in October 1991 (after extensive consultation with 
States, localities, and other affected stakeholders). In publishing the 
strategy EPA conducted an analysis of three different alternatives to 
the regulation of pesticides' groundwater risks. One option was to rely 
exclusively on orthodox national-level pesticide regulatory tools 
(tantamount to a ``baseline''), which would entail tolerating or 
remediating a certain level of groundwater contamination. At the other 
extreme, outright cancellation of candidate pesticides with significant 
groundwater contamination potential was considered to provide full 
assurance that no further groundwater contamination would occur (taking 
into account the high economic losses due to the removal of the 
pesticide from the market). The analysis concluded that a 
``partnership'' approach, providing a mechanism for more tailored 
management of pesticide use (i.e., taking into account the prevailing 
influence of highly variable hydrologic ``sensitivity'' factors), would 
be simultaneously a more effective and least costly alternative.


Anticipated Cost and Benefits:


EPA anticipates four categories of costs entailed in requiring PMPs. 
Federal Program Costs are those of administering groundwater protection 
activities, such as the review of State or tribal proposals. State 
Program Costs entail both capital and annual costs. Registrant and user 
impacts are the economic losses ascribed to the reduced use of the 
classified pesticides, as well as the costs (to the registrants) of 
complying with Federal, State and tribal provisions. Benefits accrue 
from the reduced levels of pesticide residues in groundwater, and a 
corresponding reduction in: (1) human and ecological risk (see below); 
and (2) threats to the economic and intrinsic values of the groundwater 
resource. Significant uncertainties attend the quantification of these 
benefits, however.


Risks:


The pesticides under consideration are those most frequently detected 
(sometimes at concentrations exceeding health-based reference points) 
of currently-registered Pesticides, and display physical and chemical 
characteristics associated with a ground-water contamination potential. 
The level of potential contamination (and related risk to both human 
health and the environment) represent a potential unreasonable risk to 
the environment in the absence of local management measures. State 
management measures are expected to avert these risks substantially. 
Because the Food Quality Protection Act (FQPA) requires that EPA 
consider drinking water as part of dietary exposure, the Agency is 
analyzing implications for this regulation.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            61 FR 33259                                    06/26/96
Notice of Availa65 FR 8925arding Metolachlor                   02/23/00
Supplemental NPRM - Notice of Availability & Extension of Comment 
        Period  65 FR 15885                                    03/24/00
Final Action                                                   01/00/01
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


Federal, State, Tribal


Additional Information:


SAN No. 3222


Sectors Affected:


9241 Administration of Environmental Quality Programs


Agency Contact:
Arthur-Jean B. Williams
Environmental Protection Agency
Office of Prevention, Pesticides and Toxic Substances
7506C
Washington, DC 20460
Phone: 703 305-5239
Fax: 703 308-3259
Email: [email protected]

Jean Frane
Environmental Protection Agency
Office of Prevention, Pesticides and Toxic Substances
7506C
Washington, DC 20460
Phone: 703 305-5944
Email: [email protected]
RIN: 2070-AC46


_______________________________________________________________________


[[Page 73488]]

EPA



139. TSCA INVENTORY UPDATE RULE AMENDMENTS
Priority:


Other Significant


Legal Authority:


15 USC 2607(a) TSCA 8(a)


CFR Citation:


40 CFR 710


Legal Deadline:


None


Abstract:


This action would amend the current Toxic Substances Control Act (TSCA) 
Inventory Update Rule (IUR) to require chemical manufacturers to report 
to EPA data on exposure-related information and the industrial and 
consumer end uses of chemicals they produce or import. Currently, EPA 
requires chemical manufacturers to report the names of the chemicals 
they produce, as well as the locations of manufacturing facilities and 
the quantities produced. About 3,000 facilities reported data on about 
9,000 unique chemicals during the last reporting cycle under the IUR. 
Data obtained would be used by EPA and others to: better understand the 
potential for chemical exposures; screen the chemicals now in commerce 
and identify those of highest concern; establish priorities and goals 
for their chemical assessment, risk management and prevention programs, 
and monitor the programs' progress; encourage pollution prevention by 
identifying potentially safer substitute chemicals for uses of 
potential concern; and enhance the effectiveness of chemical risk 
communication efforts. Additionally, EPA will consider other amendments 
to the IUR. These include removing the inorganic chemicals exemption; 
providing the information to better assess and manage risks of 
inorganic chemicals; improving the linkages of IUR data to other data 
sources to enhance the data's usefulness; and altering the confidential 
business information (CBI) claim procedures to reduce the frequency of 
CBI claims, allowing the public greater access to relevant information 
on toxic chemicals. EPA has held meetings with representatives of the 
chemical industry, environmental groups, environmental justice leaders, 
labor groups, State governments and other Federal agencies to ensure 
public involvement in the TSCA Inventory Update Rule Amendments 
Project.


Statement of Need:


There are more than 75,000 chemicals in commerce listed on the TSCA 
Inventory. EPA faces the challenge of sorting through these chemicals 
to identify the ones of most concern, then taking the appropriate steps 
to mitigate unreasonable risks of those chemicals. The current IUR 
collects some key data, such as production volume, used to identify the 
chemicals of most concern. However, other exposure-related information 
is essential to more accurately identify the chemicals with the greater 
risk potential. Information on how a chemical is manufactured, 
processed, and used is needed to determine possible exposure routes and 
scenarios of these chemicals. This action will propose to modify the 
inventory update process to collect the exposure-related data necessary 
for an effective TSCA Inventory Screening program; the information will 
be collected in a format that makes the information easy to use to 
screen thousands of chemicals. A national report will make data 
collected via the amended IUR publicly available. This report will not 
contain any information claimed to be confidential.


Summary of Legal Basis:


Toxic Substances Control Act (TSCA) section 8


Alternatives:


Although data on the use of specific chemicals can be found in varying 
sources, there is no national, comprehensive, current searchable 
database providing consistent information on a wide variety of 
chemicals. EPA has examined alternate sources of the information 
including State information, Federal databases and privately collected 
information. EPA can find no information comparable to the data 
anticipated to be collected through amendments to the IUR.


Anticipated Cost and Benefits:


EPA anticipates costs of this action to be well under $100 million for 
the first year of reporting. Total costs of this action depend on the 
amendments to IUR that are contained in a proposed rule. The amended 
IUR will assist EPA in screening chemicals in commerce and identifying 
those of highest concern; establishing priorities and goals for 
chemical assessment, risk management and prevention programs and to 
monitor their progress; identifying potentially safer substitute 
chemicals for uses of potential concern; and enhancing the 
effectiveness of chemical risk communication efforts.


Risks:


This action will secure data on describing how chemicals in commerce 
are used; this data is essential to determine possible exposure routes 
and scenarios. Using these exposure estimates, EPA's toxics program 
will be able to better focus on chemical risks of most concern.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            64 FR 46771                                    08/26/99
Notice Comment E64 FR 56998                                    10/22/99
Final Action                                                   12/00/00
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


Businesses


Government Levels Affected:


Federal


Additional Information:


SAN No. 3301


Sectors Affected:


324 Petroleum and Coal Products Manufacturing; 325 Chemical 
Manufacturing


Agency Contact:
Susan Krueger
Environmental Protection Agency
Office of Prevention, Pesticides and Toxic Substances
7406
Washington, DC 20460
Phone: 202 260-1713
Fax: 202 260-1661
Email: [email protected]

Robert Lee
Environmental Protection Agency
Office of Prevention, Pesticides and Toxic Substances
7406
Washington, DC 20460
Phone: 202 260-0676
Fax: 202 260-1661
Email: [email protected]
RIN: 2070-AC61
_______________________________________________________________________



EPA



140. LEAD; IDENTIFICATION OF DANGEROUS LEVELS OF LEAD PURSUANT TO TSCA 
SECTION 403
Priority:


Economically Significant

[[Page 73489]]

Legal Authority:


15 USC 2683


CFR Citation:


40 CFR 745


Legal Deadline:


None


Abstract:


The Residential Lead-Based Paint Hazard Reduction Act of 1992 (title X) 
amended TSCA by adding a new title IV. TSCA section 403 requires EPA to 
promulgate regulations that identify lead-based paint hazards, lead-
contaminated dust and lead-contaminated soil for the purposes of TSCA 
title IV as well as for the entire title X. EPA developed an interim 
guidance document in July 1994, to provide public and private decision-
makers with guidance on identifying and prioritizing lead-based paint 
hazards for control. This interim guidance, which was subsequently 
published in 1995 (60 FR 47248, 9/11/95), will continue to serve as 
EPA's official policy until the final TSCA section 403 rule is 
promulgated.


Statement of Need:


Childhood lead poisoning is a pervasive problem in the United States, 
with almost a million young children having more than 10 ug/dl of lead 
in their blood, (Center for Disease Control's level of concern). 
Elevated blood-lead levels can lead to reduced intelligence and 
neurobehavioral problems in young children, as well as causing other 
adverse health effects in children and adults. Although there have been 
dramatic declines in blood-lead levels due to reductions of lead in 
paint, gasoline, and food sources, remaining paint in older houses 
remains the significant source of childhood lead poisoning. This 
regulation is a focal point of the Federal lead program and supports 
the implementation of regulations already promulgated (e.g., lead 
hazard disclosure in real estate transactions) as well as others under 
development (e.g., renovation and remodeling). By supporting the 
implementation of the national lead program, this rule would help 
prevent lead poisoning in children under the age of six.


Summary of Legal Basis:


This action is mandated by TSCA section 403.


Alternatives:


Alternatives were discussed in the proposed rule. Alternatives will be 
further considered as part of the proposed rule's comment review.


Anticipated Cost and Benefits:


The costs associated with the establishment of these levels were 
estimated in a draft economic impact analysis that was prepared for the 
proposed rule. Since benefits depend on private sector implementation 
of certain lead hazard abatement activities which are not mandated by 
any of these rules, benefits will be difficult to quantify. During its 
review of the NPRM under Executive Order 12866, OMB attributed the 
potential impact of all of the lead regulations to this rule and 
determined that this action should be classified as economically 
significant.


Risks:


This rule is aimed at reducing the prevalence and severity of lead 
poisoning, particularly in children.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            63 FR 30301                                    06/03/98
Notice - Comment63 FR 39262ended to 10/01/98                   07/22/98
Notice - Comment63 FR 52662ended to 11/30/98                   10/01/98
NPRM Correction 63 FR 70087                                    12/18/98
Notice Reopens C64 FR 2460iod to 03/01/99                      01/14/99
Final Action - Identification of Dangerous Levels of Lead      12/00/00
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


Businesses, Governmental Jurisdictions, Organizations


Government Levels Affected:


Federal, State, Local, Tribal


Additional Information:


SAN No. 3243


Sectors Affected:


2332 Residential Building Construction; 235 Special Trade Contractors; 
2352 Painting and Wall Covering Contractors; 23551 Carpentry 
Contractors; 23599 All Other Special Trade Contractors; 53111 Lessors 
of Residential Buildings and Dwellings; 531311 Residential Property 
Managers; 54135 Building Inspection Services; 54138 Testing 
Laboratories; 61151 Technical and Trade Schools; 92511 Administration 
of Housing Programs; 61171 Educational Support Services; 54161 
Management Consulting Services


Agency Contact:
Lin Moos
Environmental Protection Agency
Office of Prevention, Pesticides and Toxic Substances
7404
Washington, DC 20460
Phone: 202 260-1866
Fax: 202 260-0770
Email: [email protected]

Dave Topping
Environmental Protection Agency
Office of Prevention, Pesticides and Toxic Substances
7404
Washington, DC 20460
Phone: 202 260-7737
Fax: 202 260-0770
Email: [email protected]
RIN: 2070-AC63
_______________________________________________________________________



EPA



141. HAZARDOUS WASTE IDENTIFICATION RULE (HWIR): IDENTIFICATION AND 
LISTING OF HAZARDOUS WASTES
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 6912(a) RCRA sec 2002(a); 42 USC 6921 RCRA sec 3001; 42 USC 6922 
RCRA sec 3002; 42 USC 6922 RCRA sec 3004; 42 USC 6926 RCRA sec 3006


CFR Citation:


40 CFR 261


Legal Deadline:


Other, Judicial, October 31, 1999, Reproposal.


Final, Judicial, April 30, 2001.


Abstract:


This action would amend regulations governing solid wastes that are 
designated as hazardous because they have been mixed with or derived 
from listed hazardous wastes. The Agency proposed to retain the mixture 
and derived-from rules promulgated under

[[Page 73490]]

the Resource Conservation and Recovery Act (RCRA). These rules are 
currently in effect on an emergency basis. The Agency proposed their 
retention.


The Agency also proposed two revisions to the mixture and derived-from 
rules. The first was an exemption for wastes and their residuals listed 
solely for the ignitability, corrosivity, and/or reactivity 
characteristics. The second, which EPA proposed in a separate notice, 
was a conditional exemption from the mixture and derived-from rules for 
mixed wastes (that is, wastes that are both hazardous and radioactive).


Because this action is deregulatory, it is not expected to have adverse 
impacts on small business. This action will be implemented by EPA and 
authorized States.


Statement of Need:


EPA has proposed to retain and amend the mixture rule and the derived-
from rule in the hazardous waste identification regulations under the 
Resource Conservation and Recovery Act (RCRA). The mixture and derived-
from rules ensure that hazardous wastes that are mixed with other 
wastes or that result from the treatment, storage or disposal of 
hazardous wastes do not escape regulation and thereby cause harm to 
human health and the environment. EPA proposed two revisions to the 
mixture and derived-from rules. The first is an exemption for mixtures 
and/or derivatives of wastes listed solely for the ignitability, 
corrosivity, and/or reactivity characteristics. The second is a 
conditional exemption from the mixture and derived-from rules for mixed 
wastes, (that is, wastes that are both hazardous and radioactive). 
These revisions would narrow the scope of the mixture and derived-from 
rules, tailoring the rules to more specifically match the risks posed 
by particular wastes.


Summary of Legal Basis:


This regulation will amend the mixture and derived-from rules, 40 CFR 
261.3(a)(2)(iii) and (iv) and (c)(2)(i), and will create an exemption 
for low-risk waste. EPA is required to revise the mixture and derived-
from rules under Public Law No. 102-389, 106 Stat. 1571. The mixture 
and derived-from rules and the exemption are exercises of EPA's 
authority under RCRA section 3001, 42 U.S.C. section 6921.


Alternatives:


EPA has considered a variety of alternatives for revising the mixture 
and derived-from rules, including developing a concentration-based 
generic exemption for low-risk listed waste and a specific exemption 
for wastes disposed of in a landfill. EPA will continue to explore 
these and other alternatives as appropriate.


Anticipated Cost and Benefits:


Revisions to the mixture and derived-from rules are expected to reduce 
the cost of shipping and disposing exempted wastes. Potential annual 
industry cost savings is estimated at $4.59 million, while annual 
reduction in truck shipment manifesting cost is estimated at $.45 
million. After considering uncertainty factors (-15 percent to +30 
percent), these two cost savings components represent a total annual 
cost savings estimate of $4.29 to $6.56 million per year.


Risks:


This rule would maintain current levels of risk protection.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            57 FR 21450                                    05/20/92
NPRM Withdrawn  57 FR 49280                                    10/30/92
NPRM Reproposal 60 FR 66344                                    12/21/95
NPRM Reproposal 64 FR 63381                                    11/19/99
Notice of Data A65 FR 44491                                    07/18/00
Final Action                                                   05/00/01
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


Federal, State


Additional Information:


SAN No. 3328


Sectors Affected:


334 Computer and Electronic Product Manufacturing; 333 Machinery 
Manufacturing; 332 Fabricated Metal Product Manufacturing; 325 Chemical 
Manufacturing; 324 Petroleum and Coal Products Manufacturing; 331 
Primary Metal Manufacturing; 335 Electrical Equipment, Appliance and 
Component Manufacturing; 336 Transportation Equipment Manufacturing


Agency Contact:
Tracy Atagi
Environmental Protection Agency
Solid Waste and Emergency Response
5304W
Washington, DC 20460
Phone: 703 308-8672
Fax: 703 308-0514
Email: [email protected]

Adam Klinger
Environmental Protection Agency
Solid Waste and Emergency Response
5304W
Washington, DC 20460
Phone: 703 308-3267
Fax: 703 308-0514
Email: [email protected]
RIN: 2050-AE07
_______________________________________________________________________



EPA



142. STORAGE, TREATMENT, TRANSPORTATION, AND DISPOSAL OF MIXED WASTE
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 6905; 42 USC 6912(a); 42 USC 6921; 42 USC 6922; 42 USC 6924; 42 
USC 6926; 42 USC 6927; 42 USC 6934


CFR Citation:


40 CFR 261.4; 40 CFR 262.34; 40 CFR 266


Legal Deadline:


NPRM, Judicial, October 31, 1999.


Final, Judicial, April 30, 2001.


Abstract:


The focus of the final rule is to provide flexibility under RCRA 
subtitle C to generators of eligible mixed waste. We intend to finalize 
a proposal for a conditional exemption from the definition of hazardous 
waste applicable to: low-level mixed waste (LLMW) for storage; and LLMW 
or Naturally Occurring and/or Accelerator-Produced Radioactive Material 
(NARM) for transportation and disposal. The rule is expected to reduce 
dual regulation for generators in the management and disposal of their 
wastes. This flexibility would enable generators of LLMW who are 
licensed by the Nuclear Regulatory Commission

[[Page 73491]]

(NRC) to claim an exemption for storing and treating these wastes in 
tanks or containers (using solidification, neutralization, or other 
stabilization processes) without a RCRA permit. This rule would also 
provide flexibility for the manifesting, transportation and disposal of 
eligible mixed waste. Waste meeting the conditions would be exempted 
from certain RCRA subtitle C hazardous waste requirements and managed 
as low-level radioactive waste in accordance with NRC regulations.


Statement of Need:


The final rulemaking is needed due to: industry concerns regarding the 
potential for duplication under EPA and NRC regulatory requirements; 
the lack of mixed waste treatment and disposal facilities nationwide; 
and follow through on comments relating to mixed waste management 
received from industry on the Hazardous Waste Identification Rule 
(HWIR) proposal of December 1995, and the mixed waste storage guidance 
of August 1995.


Summary of Legal Basis:


The final rulemaking is an outgrowth of the consent decree reached with 
the Edison Electric Institute, and other litigants and intervenors, in 
April 1997.


Alternatives:


EPA is considering a number of alternatives including: (1) use of LDR 
treatment standards for chemical constituents in conjunction with NRC 
disposal requirements for LLW; (2) applicability of HWIR exit 
concentration levels and associated requirements for chemical 
constituents; (3) a conditional exemption for stored mixed waste 
subject to NRC regulatory requirements; and (4) allowing decay-in-
storage as provided by NRC for some mixed wastes to limit worker 
exposures to radionuclides.


Anticipated Cost and Benefits:


EPA anticipates that implementation of this rule could result in net 
cost savings of at least $1 to 3 million annually; unquantified cost 
savings from administrative and permitting burdens could be much 
higher. In addition, EPA anticipates possible risk reductions from 
reduced human exposure to radionuclides.


Risks:


The purpose of this rule is not risk reduction. The rule will maintain 
current level of protection as required by NRC for radionuclides under 
alternatives 1 and 3, and also provide protection for human health and 
the environment from chemical hazards. For alternative 2 the risk will 
be similar to HWIR risk benchmarks for carcinogens and non-carcinogens. 
For alternative 4, there would be a reduction in risk due to reduced 
exposure of workers to radionuclides mixed with hazardous wastes.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
ANPRM           64 FR 10063                                    03/01/99
NPRM            64 FR 63463                                    11/19/99
Final Action                                                   04/00/01
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


Federal, State, Tribal


Additional Information:


SAN No. 4017


SIC Codes: Nuclear Electric Power Generation (4911); Federal Facilities 
(9431) and (9511); Mixed Waste Treatment, Storage and Disposal 
Facilities (4953); Commercial Low Level Radioactive Waste Disposal 
Facilities (4953); Universities (8221); Medical Facilities (8071); 
Pharmaceutical Companies (2834); Research Laboratories (8731, 8734)


Sectors Affected:


3254 Pharmaceutical and Medicine Manufacturing; 562 Waste Management 
and Remediation Services; 562219 Other Nonhazardous Waste Treatment and 
Disposal; 61131 Colleges, Universities and Professional Schools; 6215 
Medical and Diagnostic Laboratories; 622 Hospitals; 92 Public 
Administration; 8112 Electronic and Precision Equipment Repair and 
Maintenance


Agency Contact:
Nancy Hunt
Environmental Protection Agency
Solid Waste and Emergency Response
5303W
Washington, DC 20460
Phone: 703 308-8762
Fax: 703 308-8638
Email: [email protected]

Grace Ordaz
Environmental Protection Agency
Solid Waste and Emergency Response
5304W
Washington, DC 20460
Phone: 703 308-1130
Fax: 703 605-0744
Email: [email protected]
RIN: 2050-AE45
_______________________________________________________________________



EPA



143. NATIONAL PRIMARY DRINKING WATER REGULATIONS: RADON
Priority:


Economically Significant. Major under 5 USC 801.


Unfunded Mandates:


This action may affect State, local or tribal goverments.


Legal Authority:


42 USC 300(f) SDWA sec 1412


CFR Citation:


40 CFR 141; 40 CFR 142


Legal Deadline:


Other, Statutory, February 6, 1999, Publish radon health risk reduction 
and cost analysis.


NPRM, Statutory, August 6, 1999.


Final, Statutory, August 6, 2000.


Abstract:


EPA proposed new regulations for radon in drinking water which will 
provide States flexibility in how to manage the health risks from 
radon, in both drinking water and in indoor air. States would be able 
to focus their efforts on the highest radon risks to the public - in 
indoor air - while reducing the highest risks from radon in drinking 
water. Breathing indoor radon in homes is the primary public health 
risk from radon, contributing to about 20,000 lung cancer deaths each 
year in the United States, according to a landmark report this year by 
the National Academy of Sciences. That makes radon in indoor air the 
second leading cause of lung cancer in the United States. Based on a 
second NAS report, EPA estimates that radon in drinking

[[Page 73492]]

water causes about 168 cancer deaths per year, of which about 89 
percent are lung cancer from breathing radon released from water. The 
remaining 11 percent of the risk is for stomach cancer from drinking 
radon-containing water.


The proposal is based on the unique framework outlined in the 1996 Safe 
Drinking Water Act (SDWA). The proposed new regulation will provide two 
options to States and water systems for reducing public health risks 
from radon. Under the first option, States can choose to develop 
enhanced state programs to address the health risks from indoor radon 
while water systems reduce radon levels in drinking water to the 
higher, alternative maximum contaminant level MCL of 4,000 pCi/L 
(picoCuries per liter, a standard unit of radiation) or lower, ensuring 
protection from the highest risks from radon in drinking water. EPA is 
encouraging the States to adopt this approach as the most cost-
effective way to achieve the greatest radon risk reduction. If a State 
does not elect this option, the second option would require water 
systems in that State to either reduce radon in drinking water levels 
to the MCL of 300 pCi/L, or to develop a local indoor radon program and 
reduce levels in drinking water to 4000 pCi/L. Those systems initially 
at the MCL or lower will not need to treat their water for radon.


Statement of Need:


Radon in drinking water increases risk to public health, both from 
inhalation of radon discharged through normal water use, such as 
showering, and from ingestion of water.


Summary of Legal Basis:


Pursuant to the Safe Drinking Water Act, as amended in 1996 [sec. 1412 
(b)(13)], EPA is required to: (1) withdraw the 1991 proposed radon in 
drinking water rule; (2) work with the National Academy of Sciences to 
conduct a risk assessment for radon in drinking water, and an 
assessment of the health risk reduction benefits associated with 
various mitigation methods of reducing radon in indoor air; (3) publish 
a radon health risk reduction and cost analysis for possible radon 
Maximum Contaminant Levels (MCLs) for public comment, by February 1999; 
(4) propose a Maximum Contaminant Level Goal (MCLG) and National 
Primary Drinking Water Regulation (NPDWR) for radon by August 1999; and 
(5) publish an MCLG and Final NPDWR for radon by August 2000.


In addition, if EPA promulgates an MCL more stringent than necessary to 
reduce the contribution to radon in indoor air from drinking water to a 
concentration that is equivalent to the national average concentration 
of radon in outdoor air, the Agency must establish an alternative MCL 
(AMCL). The AMCL is to be set at a level which would result in a 
contribution of radon from drinking water to radon levels in indoor air 
equivalent to the national average concentration of radon in outdoor 
air. If an alternative MCL is established, EPA must publish guidelines 
and criteria for States to develop multimedia radon mitigation 
programs. EPA shall approve State multimedia mitigation programs if 
they are expected to achieve equal or greater health risk reduction 
benefits than would be achieved through compliance with the MCL. If EPA 
approves a State multimedia mitigation program, public water supply 
systems within the State may comply with the AMCL. If a State does not 
have an approved multimedia mitigation program, any public water system 
may submit a program for approval by EPA according to the same 
criteria, conditions, and approval process that would apply to a State 
program. EPA shall evaluate multimedia mitigation programs every 5 
years.


Alternatives:


EPA considered a range of MCL options for radon in drinking water in 
the Health Risk Reduction and Cost Analysis (HRRCA) (published in 
February 1999). The primary alternative is for a State or public water 
system to develop a multimedia mitigation program in order for it to 
comply with the AMCL. The National Academy of Sciences provided 
information on key factors (the water to air transfer factor and the 
national average outdoor radon level) that EPA will use in setting the 
AMCL.


Anticipated Cost and Benefits:


The total annual costs of compliance with the MCL of 300 pCi/l for 
radon in drinking water and the associated information collection and 
reporting requirements is estimated at $407 million. In complying with 
300 pCi/l, an estimated 62.0 fatal and 0.2 nonfatal cancer cases are 
avoided each year. Because EPA expects that most States and systems 
will choose to comply with the alternative maximum contaminant level 
(AMCL) of 4,000 pCi/l and implement a Multi-Media Mitigation (MMM) 
program, EPA expects the total annual costs of compliance with the 
radon rule to be significantly less than $407 million. If most States 
and systems comply with the AMCL and implement an MMM program, the 
total annual costs of compliance are estimated at approximately $86 
million. The quantifiable benefits of the health risk reduction are 
estimated to be $362 million for either implementation scenario. EPA 
expects compliance with the AMCL and implementation of an MMM program 
to achieve equal or greater risk reduction than is expected with strict 
compliance with the MCL.


Risks:


Radon is a naturally occurring volatile gas formed from the normal 
radioactive decay of uranium. It is colorless, odorless, tasteless, 
chemically inert, and radioactive. Exposure to radon and its progeny is 
believed to be associated with increased risks of several kinds of 
cancer. When radon or its progeny are inhaled, lung cancer accounts for 
most of the total incremental cancer risk. Ingestion of radon in water 
is suspected of being associated with increased risk of tumors of 
several internal organs, primarily the stomach. As required by the 
SDWA, as amended, EPA arranged for the National Academy of Sciences 
(NAS) to assess the health risks of radon in drinking water. The NAS 
released the pre-publication draft of a report on the Risks of Radon in 
Drinking Water, (NAS Report) in September 1998 and published the Report 
in July 1999. The analysis in this RIA uses information from the 1999 
NAS Report. The NAS Report represents a comprehensive assessment of 
scientific data gathered to date on radon in drinking water. The 
report, in general, confirms earlier EPA scientific conclusions and 
analyses of radon in drinking water.


NAS estimated individual lifetime unit fatal cancer risks associated 
with exposure to radon from domestic water use for ingestion and 
inhalation pathways. The results show that inhalation of radon progeny 
accounts for most (approximately 88 percent) of the individual risk 
associated with domestic water use, with almost all of the remainder 
(11 percent) resulting from directly ingesting radon in drinking water. 
Inhalation of radon progeny is associated primarily with increased risk 
of lung cancer, while ingestion exposure is associated primarily with 
elevated risk of stomach cancer.


The NAS Report confirmed that indoor air contamination arising from 
soil gas

[[Page 73493]]

typically accounts for the bulk of total individual risk due to radon 
exposure. Usually, most radon gas enters indoor air by diffusion from 
soils through basement walls or foundation cracks or openings. Radon in 
domestic water generally contributes a small proportion of the total 
radon in indoor air. However, NAS recognized that radon in water is the 
largest source of cancer risk in drinking water compared to other 
regulated chemicals in water.


The NAS Report is one of the most important inputs used by EPA in its 
regulatory impact analysis. EPA has used the NAS's assessment of the 
cancer risks from radon in drinking water to estimate both the health 
risks posed by existing levels of radon in drinking water and also the 
cancer deaths prevented by reducing radon levels.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
ANPRM           51 FR 34836                                    09/30/86
NPRM            56 FR 33050                                    07/18/91
Notice          64 FR 9560                                     02/26/99
NPRM            64 FR 59245                                    11/02/99
Final Action                                                   06/00/01
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses, Governmental Jurisdictions


Government Levels Affected:


Federal, State, Local, Tribal


Federalism:


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


Additional Information:


SAN No. 2281


Sectors Affected:


22131 Water Supply and Irrigation Systems


Agency Contact:
Michael Osinski
Environmental Protection Agency
Water
4607
Washington, DC 20460
Phone: 202 260-6252
Fax: 202 260-3762
Email: [email protected]

Sylvia Malm
Environmental Protection Agency
Water
4607
4607
Washington, DC 20460
Phone: 202 260-0417
Fax: 202 260-3762
Email: [email protected]
RIN: 2040-AA94
_______________________________________________________________________



EPA



144. NATIONAL PRIMARY DRINKING WATER REGULATIONS: GROUND WATER RULE
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 300(f) SDWA sec 1412


CFR Citation:


40 CFR 141; 40 CFR 142


Legal Deadline:


Final, Statutory, May 31, 2002.


Abstract:


The Safe Drinking Water Act, as amended in 1996, directs EPA to 
promulgate regulations requiring disinfection, as necessary, for 
groundwater systems. The intention is to develop a protective public 
health approach which assures a baseline of protection for all 
consumers of ground water. It sets in place an increasingly targeted 
strategy to identify high risk or high priority systems that require 
greater scrutiny or further action. Development and implementation of 
the rule has involved local, tribal, State and Federal governments. The 
structure of the rule is a series of barriers to microbial 
contamination. The multiple-barrier approach relies upon five major 
components: (1) periodic onsite inspections of ground water systems 
requiring the evaluation of eight key areas and the identification of 
significant deficiencies; (2) source water monitoring for systems 
drawing from sensitive aquifers without treatment or with other 
indications of risk; (3) a requirement for correction of significant 
deficiencies; (4) a requirement for treatment where contamination or 
significant deficiencies are not or cannot be corrected, and 
alternative sources of drinking water are not available; and, (5) 
compliance monitoring to insure disinfection treatment is reliable and 
effective. EPA believes that the combination of these elements strikes 
an appropriate regulatory balance which tailors the intensity or burden 
of protective measures and follow-up action to the risk being 
addressed.


Statement of Need:


Public water systems (PWSs) that use groundwater as their sole source 
of water, as opposed to surface water PWSs, are not federally regulated 
as to treatment for microorganisms. There is data that indicates that a 
number of groundwater PWSs are contaminated with microorganisms of 
fecal origin that can and have caused illness.


Summary of Legal Basis:


Section 1412(b)(8) of the Safe Drinking Water Act requires that EPA 
develop regulations specifying the use of disinfectants for groundwater 
systems as necessary and ``...(as part of the regulations) promulgate 
criteria...to determine whether disinfection shall be required as a 
treatment technique for any public water system served by 
groundwater.''


Alternatives:


EPA considered four regulatory alternatives in the development of the 
GWR proposal: the proposed regulatory alternative (multibarrier 
option); the sanitary survey option; the sanitary survey and triggered 
monitoring option; and the across-the-board disinfection option. All 
options include the sanitary survey provision. The sanitary survey 
option would require the primary agency to perform surveys every three 
to five years, depending on the type of system. If any significant 
deficiency is identified, a system is required to correct it. The 
sanitary survey and triggered monitoring option adds a source water 
fecal indicator monitoring requirement triggered by a total coliform 
positive sample in the distribution system. The multibarrier option, 
which was proposed by EPA, adds a hydrogeologic sensitivity assessment 
to these elements which, if a system is found to be sensitive,

[[Page 73494]]

results in a routine source water fecal indicator monitoring 
requirement. The multibarrier option and the sanitary survey and 
triggered monitoring options are both a targeted regulatory approach 
designed to identify wells that are fecally contaminated or are at a 
high risk for contamination. The across-the-board disinfection option 
would require all systems to install treatment instead of trying to 
identify only the high risk systems; therefore, it has no requirement 
for sensitivity assessment or microbial monitoring.


Anticipated Cost and Benefits:


EPA estimates the cost of the proposed GWR will be $183 million dollars 
per year (using a 3 percent discount rate). More than half of the 
estimated costs are for corrective actions which systems will be 
required to take to fix or prevent fecal contamination. The remainder 
of the costs are due to increased scope and frequency of sanitary 
surveys, hydrogeologic sensitivity assessments and source water 
monitoring. System costs are expected to be $162 million per year for 
implementation of the GWR. States are expected to incur costs of $21 
million per year. Cost estimates do not include land acquisition, 
public notification or the potential cost of illness due to exposure to 
disinfection byproducts. The total estimated value of these benefits is 
$205 million per year, $139 million from avoided illness and $66 
million from avoided deaths. These benefits are monetized based on a 
cost of illness and a value of statistical life. These estimates do not 
include pain and suffering associated with viral and bacterial illness, 
avoided outbreak response costs (such as the costs of providing public 
health warnings and boiling drinking water), and possibly the avoided 
costs of averting behavior and reduced uncertainty about drinking water 
quality.


Risks:


EPA estimates that currently over 200,000 illnesses and 18 deaths occur 
each year due to viral and bacterial contamination of public ground 
water systems. Children, the elderly and the immunocompromised are 
particularly sensitive to the waterborne pathogens and account for 
between 20 and 30 percent of the illnesses and deaths. The proposed GWR 
is expected to reduce the total number of illness by 115,000 and the 
total number of deaths by 11 each year. The GWR in conjunction with the 
Surface Water Treatment Rule (SWTR), Total Coliform Rule (TCR) the 
Interim Enhanced Surface Water Treatment Rule (IESWTR), the Filter 
Backwash Rule (FBR) and the Long Term Enhanced Surface Water Treatment 
Rules (LT1ESWTR & LT2ESWTR) will provide protections to the consumers 
of public water supply systems from waterborne pathogens.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            65 FR 30194                                    05/10/00
Final Action                                                   06/00/01
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses, Governmental Jurisdictions, Organizations


Government Levels Affected:


Federal, State, Local, Tribal


Federalism:


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


Additional Information:


SAN No. 2340


Statutory deadline for final: After August 6, 1999 but before May 31, 
2002.


Sectors Affected:


22131 Water Supply and Irrigation Systems


Agency Contact:
Eric Burneson
Environmental Protection Agency
Water
4607
Washington, DC 20460
Phone: 202 260-1445
Fax: 202 401-6135
Email: [email protected]

Tracy Bone
Environmental Protection Agency
Water
4607
Washington, DC 20460
Phone: 202 260-2954
Fax: 202 401-6135
Email: [email protected]
RIN: 2040-AA97
_______________________________________________________________________



EPA



145. NATIONAL PRIMARY DRINKING WATER REGULATIONS: ARSENIC AND 
CLARIFICATIONS TO COMPLIANCE AND NEW SOURCE CONTAMINANT MONITORING
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 300(f) SDWA sec 1412


CFR Citation:


40 CFR 141(Revision); 40 CFR 142 (Revision)


Legal Deadline:


NPRM, Statutory, January 1, 2000.


Final, Statutory, January 1, 2001.


Abstract:


The Safe Drinking Water Act (SDWA) Amendments of 1996 require EPA to 
develop a plan and research health risks of low levels of arsenic. In 
addition, EPA must propose a revised drinking water regulation for 
arsenic by January 1, 2000, and issue a final rule by January 1, 2001. 
Currently the drinking water standard for arsenic is 0.05 mg/L or 50 
ug/L. A March 1999 National Academy of Sciences report urged EPA to 
lower the drinking water standard, because inorganic arsenic causes 
bladder, lung and other internal cancers in humans. The report 
recommended additional studies to characterize health effects at low 
doses for cancers, cardiovascular disease, diabetes, reproductive 
effects, and children.


EPA generally sets the enforceable maximum contaminant level (MCL) as 
close to the health-based maximum contaminant level goal (MCLG) as 
feasible, considering treatment efficacy and costs, but may set an 
alternative level depending on the balance of costs and benefits in 
certain cases. EPA must list affordable technologies or treatment 
techniques that achieve compliance with the MCL for three categories of 
small systems considering the quality of the source water. Furthermore, 
alternatives to central treatment, such as point-of-use and point-of-
entry devices, can be considered for small systems that maintain 
control over operation and maintenance.

[[Page 73495]]

In addition, in this final rule, EPA intends to clarify compliance 
monitoring requirements for new public water systems and new water 
sources. These clarifications would apply to inorganic, volatile 
organic, and synthetic organic contaminants.


Statement of Need:


The U.S. Public Health Service first established a drinking water 
standard for arsenic at 50 ug/L in 1942. The Safe Drinking Water Act of 
1974 (SDWA) which amended the Public Health Service Act specified that 
EPA set drinking water standards. In 1975 EPA issued a National Interim 
Primary Drinking Water Regulation for arsenic at 50 ug/L, noting no 
illness. After EPA's risk assessment approach calculated a much lower 
arsenic criteria to protect humans from skin cancer for surface water 
quality criteria under the Clean Water Act, the drinking water program 
retained its 50 ug/L standard. EPA did not revise the standard as 
required by 1986 amendments to SDWA, based on the need to better 
characterize health effects and assess arsenic removal technologies. At 
that time, EPA's analysis estimated it would cost $2.1 billion a year 
to comply with a standard protective of health (skin cancer). The 1996 
amendments to the Safe Drinking Water Act require EPA to determine 
whether the costs of regulation would justify the benefits, including 
consideration of nonquantifiable benefits. In addition, EPA must 
determine the incremental costs and benefits of alternatives considered 
that do not include what would occur from compliance with other 
proposed or final regulations. If the costs do not justify the 
benefits, the Administrator may choose to raise the MCL to a level 
still protective of health at which costs do justify the benefits. As 
noted in 17 above, the 1999 report issued by the National 
Academy of Sciences definitely implicated inorganic arsenic's effects 
on bladder, lung, and skin cancer. Based on existing data, EPA is urged 
to lower the drinking water standard as soon as possible.


Summary of Legal Basis:


1412(b)(12) CERTAIN CONTAMINANTS.


(A) ARSENIC.: (i) SCHEDULE AND STANDARD.-- Notwithstanding the 
deadlines set forth in paragraph (1), the Administrator shall 
promulgate a national primary drinking water regulation for arsenic 
pursuant to this subsection, in accordance with the schedule 
established by this paragraph.


(ii) STUDY PLAN.-- Not later than 180 days after the date of enactment 
of this paragraph, the Administrator shall develop a comprehensive plan 
for study in support of drinking water rulemaking to reduce the 
uncertainty in assessing health risks associated with exposure to low 
levels of arsenic. In conducting such study, the Administrator shall 
consult with the National Academy of Sciences, other Federal agencies, 
and interested public and private entities.


(iii) COOPERATIVE AGREEMENTS.-- In carrying out the study plan, the 
Administrator may enter into cooperative agreements with other Federal 
agencies, State and local governments, and other interested public and 
private entities.


(iv) PROPOSED REGULATIONS.-- The Administrator shall propose a national 
primary drinking water regulation for arsenic not later than January 1, 
2000.


(v) FINAL REGULATIONS.-- Not later than January 1, 2001, after notice 
and opportunity for public comment, the Administrator shall promulgate 
a national primary drinking water regulation for arsenic.


(vi) AUTHORIZATION.-- There are authorized to be appropriated $2.5 
million for each of fiscal years 1997 through 2000 for the studies 
required by this paragraph.


Also see: 1412(b)(4)(E)(ii) for listing small system technologies 
1412(b)(4)(C) for requiring analysis of whether costs justify benefits 
1412(b)(3)(C)(i) for other requirements for the cost-benefit analyses 
1412(b)(15) for small system variance technologies, if, considering the 
source water, no treatment technology is listed.


Alternatives:


EPA proposed an MCL of 5 ug/L for arsenic and requested comment on MCL 
options of 3, 10, and 20 ug/L. EPA provided benefit analyses of each of 
these alternatives, measured as reducing drinking water arsenic from 
the current standard of 50 ug/L. This proposal lists affordable 
technologies for small systems, as required by the 1996 amendments to 
the statute. Because EPA identified affordable compliance technologies 
for all small system sizes, EPA did not list small system variance 
technologies.


Anticipated Cost and Benefits:


Estimated Costs:


Over 98 percent of the cost of the arsenic rule comes from adding 
treatment equipment, chemicals, and oversight of the new treatment. At 
the proposed level of 5 ug/L for arsenic in drinking water: the total 
annualized costs of treatment, monitoring, reporting, recordkeeping, 
and administration for the 6,600 CWSs needing to reduce arsenic will be 
$379 million a year at 3 percent discount rates and $445 million a year 
at 7 percent discount rates; State and Federal administrative costs are 
projected to be $3 million per year (at a 3 percent discount rate) to 
$5 million per year (at a 7 percent discount rate).


At the regulatory option of 3 ug/L, total annualized costs of 
treatment, monitoring, reporting, recordkeeping, and administration 
will be $645 million a year at 3 percent discount rates and $756 
million a year at 7 percent discount rates. At the regulatory option of 
10 ug/L, total costs of treatment, monitoring, reporting, 
recordkeeping, and administration will be $166 million a year at 3 
percent discount rates and $195 million a year at 7 percent discount 
rates. At the regulatory option of 20 ug/L, total costs of treatment, 
monitoring, reporting, recordkeeping, and administration will be $65 
million a year at 3 percent discount rates and $77 million a year at 7 
percent discount rates.


Estimated Benefits:


Reducing arsenic from 50 ug/L to 5 ug/L - protects an additional 22.5 
million Americans and will prevent about 20 cases of bladder cancer per 
year and approximately 5 bladder cancer deaths per year.


At a regulatory option of 3 ug/L, reducing arsenic from 50 ug/L to 3 
ug/L - protects an additional 35.7 million Americans and will prevent 
about 25 cases of bladder cancer and approximately 7 bladder cancer 
deaths per year.


At a regulatory option of 10 ug/L, reducing arsenic from 50 ug/L to 10 
ug/L - protects an additional 10.7 million Americans and will prevent 
about 13 cases of bladder cancer and approximately 3 bladder cancer 
deaths per year.


Under a regulatory option of 20 ug/L, reducing arsenic from 50 ug/L to 
20 ug/L - protects an additional 4.4 million Americans and will prevent 
about 7 cases of bladder cancer and approximately 2 bladder cancer 
deaths per year.


EPA expects that arsenic-related lung cancers (that could number as 
many as two to five times the number of bladder cancers) and 
cardiovascular diseases

[[Page 73496]]

will be reduced with a lower standard as well.


The estimated values of the benefits of this rule range from as high as 
$90 million for bladder cancer to $384 million for lung cancer.


Risks:


According to the report issued by the National Academy of Sciences, the 
risk of male bladder cancer at the current standard is 1 to 1.5 
additional cancers per thousand people, or 1-1.5 x 10-3, based on a 
linear approach.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
Plan Arsenic Res61 FR 67800s for Funding                       12/24/96
NPRM            65 FR 38888                                    06/22/00
Final Action                                                   06/00/01
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses, Organizations, Governmental Jurisdictions


Government Levels Affected:


Federal, State, Local, Tribal


Federalism:


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


Additional Information:


SAN No. 2807


Sectors Affected:


22131 Water Supply and Irrigation Systems


Agency Contact:
Irene Dooley
Environmental Protection Agency
Water
4607
Washington, DC 20460
Phone: 202 260-9531
Fax: 202 260-3762
Email: [email protected]
RIN: 2040-AB75
_______________________________________________________________________



EPA



146.  TRI; LOWERING OF EPCRA SECTION 313 REPORTING THRESHOLDS 
FOR LEAD AND LEAD COMPOUNDS
Priority:


Economically Significant. Major under 5 USC 801.


Legal Authority:


42 USC 11001 et seq


CFR Citation:


40 CFR 372


Legal Deadline:


None


Abstract:


The Toxics Release Inventory (TRI) currently requires reporting from 
facilities which manufacture or process at least 25,000 pounds of a 
listed chemical, or otherwise use 10,000 pounds of a listed chemical. 
These thresholds were initially established under the Emergency 
Planning and community Right-To-Know Act (EPCRA) section 313(f)(1). 
Section 313(f)(2) of EPCRA gives the Administrator the power to 
establish a threshold amount for a toxic chemical different from the 
amount established by paragraph (1), and that such altered thresholds 
may be based on classes of chemicals. EPA is considering lowering the 
thresholds for certain persistent bioaccumulative toxic (PBT) chemicals 
and has issued a proposed rule that sets out the criteria EPA intends 
to use for determining if a chemical is persistent and bioaccumulative 
under EPCRA section 313. EPA is currently conducting analysis to 
determine if lead and lead compounds meet the proposed criteria for 
persistence and bioaccumulation and whether the EPCRA section 313 
reporting thresholds should be lowered. EPA is also evaluating the 
environmental fate of lead.


Statement of Need:


TRI is the most complete and accessible source of information for the 
public on toxic chemical releases in communities across the United 
States. The intention of Congress was for TRI, and indeed all of EPCRA, 
to provide information to local communities. Communities need this 
information to better understand the nature of the releases at the 
local level. The intent of TRI has been to share information on 
releases with local communities to help in their assessments of the 
risks. This basic local empowerment is the cornerstone of the right-to-
know program. Yet because of the current reporting thresholds, TRI does 
not collect release and transfer data on small quantities of lead and 
lead compounds that may persist and bioaccumulate in the environment. 
Even small releases of lead and lead compounds can have significant 
impacts on human health and the environment. Congress gave EPA the 
authority to adjust reporting thresholds, because it recognized that 
this might be necessary in order to address the American public's right 
to know what is happening to the environment near their homes, schools, 
and businesses.


Summary of Legal Basis:


42 USC 11023(f)(2); 42 USC 11048; EPCRA S313; EPCRA S328.


Alternatives:


EPA recognizes the reporting burden inherent in TRI, and is continuing 
to take every reasonable opportunity to minimize this burden while 
ensuring the public's right to know. As such, all available 
alternatives will be identified and evaluated.


Anticipated Cost and Benefits:


EPA has proposed to lower the EPCRA section 313 reporting thresholds 
for lead and lead compounds to 10 pounds. Under this proposal the 
estimated aggregate industry cost in the first year would be $116 
million and in subsequent years would be $60 million. The information 
reported in TRI increases the knowledge levels of lead and lead 
compounds released to the environment and pathways to exposure, 
improving scientific understanding of the health and environmental 
risks of toxic chemicals; allows the public to make informed decisions 
on where to work and live; enhances the ability of corporate lenders 
and purchasers to more accurately gauge a facility's potential 
liability; and assists Federal, State, and local authorities in making 
better decisions on acceptable levels of toxics in communities.


Risks:


Currently communities do not have access to TRI data on lead and lead 
compounds that, although released in relatively small quantities, pose 
a potential risk to human health and the environment because they 
persist and bioaccumulate. By lowering the reporting thresholds for 
lead and lead compounds the public will be able to determine if these 
chemicals are being released into their communities and whether any 
action should be taken to reduce potential risks.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            64 FR 42222                                    08/03/99
Notice Extension64 FR 51093 Period to 11/01/99                 09/21/99
Notice Extension64 FR 58370 Period to 12/16/99                 10/29/99
Final Action                                                   10/00/00

[[Page 73497]]

Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


Businesses


Government Levels Affected:


Federal, State


Additional Information:


SAN No. 4259


Fomerly listed as RIN 2070-AD38.


By statute and regulation, this rule will affect SIC codes 20-39, 10 
(except SIC codes 1011, 1081, 1094), 12 (except SIC code 1241), 4911, 
4931, 4939, 4953, 5169, 5171, and 7389.


Agency Contact:
Maria Doa
Environmental Protection Agency
Office of Environmental Information
2844
Washington, DC 20460
Phone: 202 260-9592
Fax: 202 401-8142
Email: [email protected]

Daniel R. Bushman
Environmental Protection Agency
Office of Environmental Information
2844
Washington, DC 20460
Phone: 202 260-3882
Fax: 202 401-8142
Email: [email protected]
RIN: 2025-AA05
BILLING CODE 6560-50-S




[[Page 73498]]

EQUAL EMPLOYMENT OPPORTUNITY COMMISSION (EEOC)



Statement of Regulatory and Deregulatory Priorities
 The Equal Employment Opportunity Commission (EEOC) enforces six 
statutes prohibiting discrimination in employment. Title VII of the 
Civil Rights Act of 1964, as amended, prohibits employment 
discrimination on the basis of race, color, sex, religion, or national 
origin. The Equal Pay Act of 1963, as amended, prohibits the payment of 
different wages to women and men working in the same establishment, 
performing equal work that requires equal skill, effort, and 
responsibility under similar working conditions, unless the pay 
differential is based on a factor(s) other than sex. The Age 
Discrimination in Employment Act of 1967 (ADEA), as amended, prohibits 
employment discrimination on the basis of age against people age 40 and 
older. Title I of the Americans with Disabilities Act of 1990 (ADA), as 
amended, prohibits employment discrimination against qualified 
individuals with disabilities. Sections 501 and 505 of the 
Rehabilitation Act of 1973, as amended, prohibit Federal agencies from 
discriminating in employment against qualified individuals with 
disabilities and require agencies to accommodate the special needs of 
persons with disabilities. The Government Employee Rights Act of 1991 
extends protections against employment discrimination to certain 
employees who were not previously covered.
 The mission of the Agency is to ensure equality of opportunity by 
vigorously enforcing Federal legislation prohibiting discrimination in 
employment. Enforcement is accomplished through investigation, 
conciliation, alternative methods of dispute resolution, litigation, 
coordination, and regulation, as well as by education, policy research, 
and technical assistance. In pursuing its mission of eradicating 
discrimination in the workplace, the Commission intends that its 
enforcement be certain and predictable and that its remedies be 
preventive and remedial in scope.
 One important step toward these ends is to make sure that employees, 
employers, and union representatives understand their rights and 
obligations under the Federal laws prohibiting employment 
discrimination. In accordance with the President's national regulatory 
principles, EEOC develops regulations necessary to inform employees and 
employers of their rights and obligations under the statutes it 
enforces. EEOC further educates the public on an ongoing and proactive 
basis through interpretive guidelines, policy documents, management 
directives, and other public guidance programs.
 EEOC is currently considering two significant actions of a regulatory 
nature. Both have been published for public comment.
 One of the significant actions the Commission proposes is to issue 
legislative regulations to provide detailed guidance for employers and 
employees on tender back of consideration paid for a waiver of rights 
and claims under the ADEA. These issues were addressed by the United 
States Supreme Court's decision in Oubre v. Entergy Operations, Inc., 
522 U.S. 422 (1998). The proposed rule is titled Waivers of Rights and 
Claims: Tender Back of Consideration and was published for public 
comment (NPRM) on April 23, 1999, 64 FR 19952. The Commission is 
assessing all comments received in response to this NPRM.
 The second significant action of a regulatory nature that the 
Commission proposes is amendment of its regulation governing Federal 
sector equal employment opportunity, 29 CFR 1614.203, to reflect the 
1992 amendment of section 501 of the Rehabilitation Act of 1973. 
Congress amended section 501 to state that the nondiscrimination 
standards of title I of the Americans with Disabilities Act apply to 
complaints under section 501 of the Rehabilitation Act. The proposed 
rule is titled Federal Sector Equal Employment Opportunity and was 
published for public comment (NPRM) on March 1, 2000, 65 FR 11019.
 (Consistent with section 4(c) of Executive Order 12866, this statement 
was reviewed and approved by the Chairwoman of the Agency. The 
statement has not been reviewed or approved by the other members of the 
Commission).
_______________________________________________________________________



EEOC

                              -----------

                            FINAL RULE STAGE

                              -----------




147. FEDERAL SECTOR EQUAL EMPLOYMENT OPPORTUNITY
Priority:


Other Significant


Legal Authority:


PL 102-569, The Rehabilitation Act Amendments of 1992; 42 USC 2000e-16; 
29 USC 794a


CFR Citation:


29 CFR 1614


Legal Deadline:


None


Abstract:


The Commission proposes to change its Federal sector equal employment 
opportunity regulations to implement the Rehabilitation Act Amendments 
of 1992. The 1992 amendments provide that the standards used to 
determine if title I of the Americans with Disabilities Act has been 
violated will apply to complaints of nonaffirmative action employment 
discrimination under section 501 of the Rehabilitation Act.


Statement of Need:


The Commission promulgated its latest regulation under section 501 of 
the Rehabilitation Act in April 1992, several months before Congress 
enacted the 1992 Rehabilitation Act Amendments. The Commission is thus 
proposing to amend its section 501 regulation, found at 29 CFR 
1614.203, to implement the Rehabilitation Act Amendments.


Summary of Legal Basis:


Pursuant to sections 501 and 505 of the Rehabilitation Act, the 
Commission is authorized to issue such regulations as it deems 
necessary to carry out its responsibilities under the Act. The proposed 
regulatory revisions are not required by statute or court order.


Alternatives:


The Commission has consulted with stakeholders and has considered their 
suggested alternatives in developing this regulatory proposal. The 
Commission will consider all alternatives offered by public commenters.


Anticipated Cost and Benefits:


The proposed regulatory changes will enhance enforcement of the 
statutory requirements. Federal agencies and individuals will have a 
clearer understanding of their respective obligations and rights under 
the Rehabilitation Act. It is not anticipated that this proposal will 
result in increased costs.


Risks:


The proposed regulatory changes will lessen the risk of noncompliance 
with

[[Page 73499]]

statutory requirements by identifying and providing detailed guidance 
on the appropriate legal standards governing Federal sector claims of 
nonaffirmative action employment discrimination under section 501 of 
the Rehabilitation Act. This proposal does not address risks to public 
health, safety, or the environment.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            65 FR 11019                                    03/01/00
NPRM Comment Period End                                        05/01/00
Final Action                                                   01/00/01
Regulatory Flexibility Analysis Required:


No


Government Levels Affected:


Federal


Agency Contact:
Carol Miaskoff
Assistant Legal Counsel, Office of Legal Counsel
Equal Employment Opportunity Commission
Room 6037
1801 L Street NW
Washington, DC 20507
Phone: 202 663-4689
TDD Phone: 202 663-7026
Fax: 202 663-4639
RIN: 3046-AA57
_______________________________________________________________________



EEOC



148. WAIVERS OF RIGHTS AND CLAIMS: TENDER BACK OF CONSIDERATION
Priority:


Other Significant


Legal Authority:


5 USC 522; 29 USC 628; 42 USC 2000e; 42 USC 12101; 29 USC 206(d)


CFR Citation:


29 CFR 1625


Legal Deadline:


None


Abstract:


Following the United States Supreme Court's decision in Oubre v. 
Entergy Operations, Inc., 522 U.S. 422 (1998), the Commission has 
developed proposed regulatory guidance on the status of consideration 
paid for a waiver of rights and claims under the ADEA.


Statement of Need:


The Equal Employment Opportunity Commission (EEOC or Commission) is 
proposing to adopt legislative regulations addressing issues relating 
to the ``tender back of consideration'' in connection with waivers of 
rights and claims under the Age Discrimination in Employment Act of 
1967 (ADEA). This issue was addressed by the United States Supreme 
Court in Oubre v. Entergy Operations, Inc., 522 U.S. 422 (1998). In 
that decision, the Supreme Court held that an individual was not 
required to return (tender back) consideration (such as improved 
severance benefits, extra money, or early retirement) for a waiver in 
order to allege a violation of the ADEA. Prior to the Supreme Court's 
decision in Oubre, the Federal courts of appeals were split on the 
issue of whether an individual who signed a waiver agreement was 
required to tender back any consideration paid by the employer in order 
to bring a claim under the ADEA. The Commission's proposed legislative 
rule would provide detailed regulatory guidance to the public on the 
tender back issue addressed by the Supreme Court's Oubre decision.


The ADEA was amended by title II of the Older Worker Benefits 
Protection Act of 1990 (OWBPA) to regulate the use of waivers for 
employees 40 years of age or older. Title II of OWBPA sets forth the 
statutory requirements for a valid waiver of rights under the ADEA. The 
Commission conducted a negotiated rulemaking in 1995 and 1996 on ADEA 
waivers under OWBPA. The Rulemaking Committee considered, but agreed 
not to resolve, the tender back issue, and it was not included in the 
regulatory language recommended by the Committee to the Commission. 
EEOC promulgated a final regulation on ADEA waivers at 29 CFR 1625.22 
on June 5, 1998, 63 FR 30624. The preamble to the final regulation 
confirmed that the issues raised in the Supreme Court's Oubre decision 
would not be addressed in that regulation, but that the tender back 
issue would be covered in other EEOC guidance.


Since the enactment of OWBPA, employer and employee representatives 
have expressed continuing interest in receiving guidance on the issue 
of waiver agreements. The use of waiver agreements in the workplace is 
an increasingly common practice, particularly in connection with 
layoffs and reductions-in-force. The Supreme Court recognized in Oubre 
that requiring tender back of consideration, as a condition of bringing 
an ADEA suit, could frustrate the purposes of the statute and lead to 
evasion of OWBPA's waiver requirements. Because of the importance of 
the tender back issue to both employers and employees, the Commission 
believes that the public would benefit from regulatory guidance in this 
area.


Summary of Legal Basis:


Section 9 of ADEA authorizes the Commission to issue such rules and 
regulations as it may consider necessary or appropriate for carrying 
out the Act. This regulatory proposal is not required by statute or 
court order.


Alternatives:


The Commission considers all alternatives offered by public commenters.


Anticipated Cost and Benefits:


Providing a clear outline of what is and is not permissible concerning 
issues raised by the Supreme Court's Oubre decision will reduce 
employment disputes and save both employers and employees time and 
unnecessary costs. In addition, regulatory guidance on the issue of 
waiver agreements should result in increased voluntary resolution of 
potential employment disputes, and thereby reduce the likelihood of 
protracted and costly litigation. Finally, when necessary, regulatory 
guidance on tender back of consideration paid under waiver agreements 
will ensure that employees are able to challenge the validity of such 
agreements. It is not anticipated that any costs will arise from 
issuing the proposed regulatory guidance.


Risks:


Regulatory guidance on tender back issues will lessen the risk that 
employees will be forestalled from challenging the validity of waivers 
under the laws enforced by EEOC in the event that they are unable to 
tender back consideration. The Commission has a substantial interest in 
addressing this risk. The right of individual employees to challenge 
waiver agreements is essential to implement the strong public interest 
in eradicating discrimination in the workplace and is also a vital part 
of the statutory enforcement scheme of the ADEA, as well as the other 
laws enforced by the Commission. The proposed regulation does not 
address risks to public health, safety, or the environment.

[[Page 73500]]

Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            64 FR 19952                                    04/23/99
NPRM Comment Period End                                        06/22/99
Final Action                                                   12/00/00
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


State, Local, Federal


Agency Contact:
Carol Miaskoff
Assistant Legal Counsel, Office of Legal Counsel
Equal Employment Opportunity Commission
Room 6037
1801 L Street NW
Washington, DC 20507
Phone: 202 663-4689
TDD Phone: 202 663-7026
Fax: 202 663-4639
RIN: 3046-AA68
BILLING CODE 6570-01-S




[[Page 73501]]

GENERAL SERVICES ADMINISTRATION (GSA)



Statement of Regulatory and Deregulatory Priorities
 The General Services Administration (GSA) establishes Governmentwide 
policy for acquisition, management, utilization and disposal of real 
property and personal property, and administrative services. More 
specifically, these policies address travel and transportation, the 
construction and operation of buildings, information technology, the 
use of advisory committees, and developing electronic Government.
 GSA's fiscal year 2001 regulatory priorities are to complete 
production of the Federal Management Regulation (FMR) and to finish 
rewriting the Federal Travel Regulation. The FMR is being written to 
replace the Federal Property Management Regulations (FPMR); as each 
part of the FMR is published, the corresponding parts of the FPMR will 
be removed.
 The new FTR and FMR are intended to make GSA's regulations consistent 
and sensible and to limit the regulatory burden on Government officials 
and the public. They are being written in a question and answer format 
to make them easier to read and understand, and non-regulatory guidance 
is being moved into other, less formal publications.
BILLING CODE 6820-34-S




[[Page 73502]]

NATIONAL AERONAUTICS AND SPACE ADMINISTRATION (NASA)



Statement of Regulatory Priorities
 The National Aeronautics and Space Administration (NASA) was 
established by the National Aeronautics and Space Act of 1958 (the 
Act), 42 United States Code (U.S.C.) 2451 et seq., which laid the 
foundation for NASA's mission. The Act authorizes NASA, among other 
things, to conduct space activities devoted to peaceful purposes for 
the benefit of humankind; to preserve the leadership of the United 
States in aeronautics and space science and technology; and to expand 
knowledge of the Earth and space. To carry out this mission, NASA is 
authorized to conduct research for the solution of problems of flight 
within and outside the Earth's atmosphere; to develop, construct, test, 
and operate aeronautical and space vehicles for research purposes; to 
operate space transportation systems, including the Space Shuttle and 
the International Space Station; and to perform such other activities 
as may be required for the exploration of space. NASA conducts 
activities required for the exploration of space with human tended, 
robotic, and expendable vehicles and arranges for the most effective 
utilization of the scientific and engineering resources of the United 
States with other nations engaged in aeronautical and space activities 
for peaceful purposes.
 NASA's mission, as documented in its 1998 Strategic Plan (with 1999 
Interim Adjustments), is to advance and communicate scientific 
knowledge and understanding of the Earth, the solar system, and the 
universe; to advance human exploration, use, and development of space; 
and to research, develop, verify, and transfer advanced aeronautics and 
space technologies.
 The following are narrative descriptions of the most important 
regulations being planned for publication in the Federal Register 
during fiscal year (FY) 2001.
 The Federal Acquisition Regulation (FAR), 48 CFR chapter 1, contains 
procurement regulations that apply to NASA and other Federal agencies. 
NASA implements and supplements FAR requirements through the NASA FAR 
Supplement (NFS), 48 CFR chapter 18. Major revisions are not expected 
in FY 2001, except to conform to FAR changes that are currently being 
promulgated in part 12, Acquisition of Commercial Items, and part 45, 
Government Property.
 In a continuing effort to keep the NFS current with NASA initiatives 
and Federal procurement policy, minor revisions to the NFS will be 
published. For instance, NASA has promulgated an interim rule on a 
risk-centered approach to acquisition that will affect acquisition 
planning, contract structure, contractor surveillance, and other 
contract management areas, which will result in NFS revisions.
 To reduce the time and cost spent by the Agency and by our science and 
industry partners in the procurement of basic and applied research, 
NASA is focusing on streamlining our processes. To go forward in this 
effort, regulations governing Grant and Cooperative Agreements at 14 
CFR parts 1260, 1273, and 1274, were rewritten and published as a 
proposed rule. Numerous comments were received and are being addressed 
in the formulation of the final rule.
 NASA is continuing consideration of revisions to the cross-waiver of 
liability regulation at 14 CFR part 1266. Specifically, NASA is 
considering implementation of the cross-waiver of liability provision 
of the intergovernmental agreement of the International Space Station 
and refinement and clarification of contractual cross-waivers in NASA 
agreements involving launch services.
 NASA is also continuing consideration of a new regulation that would 
clarify and provide procedures for exercising its claims authority 
under 42 U.S.C. 2473 (c)(13), section 203 (c) (13) of the Act, as 
amended, especially as applied to Agency functions such as launches of 
NASA missions.
 NASA is amending 14 CFR part 1214 to add a new subpart 1214.4 entitled 
International Space Station Crew. This subpart will implement certain 
provisions of the International Space Station (ISS) Intergovernmental 
Agreement regarding ISS crew members' observance of an ISS Code of 
Conduct.
_______________________________________________________________________



NASA

                              -----------

                            FINAL RULE STAGE

                              -----------




149.  CODE OF CONDUCT FOR INTERNATIONAL SPACE STATION CREW
Priority:


Other Significant


Legal Authority:


42 USC 2455, 2473, 2475; 18 USC 799


CFR Citation:


14 CFR 1214, subpart 1214.4


Legal Deadline:


None


Abstract:


NASA is amending the title of 14 CFR and adding subpart 1214.4 to 
implement certain provisions of the International Space Station 
Intergovernmental Agreement regarding crew members' observance of a 
Code of Conduct.


Statement of Need:


To establish and implement a Code of Conduct for crew members of the 
International Space Station (ISS).


Summary of Legal Basis:


Required by the provisions of the ISS Intergovernmental Agreement 
(IGA), entered into pursuant to 42 U.S.C. 2455, 2473, and 2475.


Alternatives:


None or Not Applicable (N/A).


Anticipated Cost and Benefits:


Costs-N/A; benefits-compliance with our international agreement, the 
IGA.


Risks:


Violation of the IGA.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
Interim Final Rule                                             10/00/00
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


None


Agency Contact:
John F. Hall Jr.
Senior Counsel (Commercial International)
National Aeronautics and Space Administration
Office of the General Counsel, Code GS
NASA Headquarters
Washington, DC 20546
Phone: 202 358-2432
Fax: 202 358-4355
Email: [email protected]
RIN: 2700-AC40
BILLING CODE 7510-01-S




[[Page 73503]]

NATIONAL ARCHIVES AND RECORDS ADMINISTRATION (NARA)



Statement of Regulatory Priorities
 The National Archives and Records Administration (NARA) issues 
regulations directed to other Federal agencies and to the public. 
Records management regulations directed to Federal agencies concern 
proper management and disposition of Federal records. Through the 
Information Security Oversight Office (ISOO), NARA also issues 
Governmentwide regulations concerning information security 
classification and declassification programs. NARA regulations directed 
to the public address access to and use of our historically valuable 
holdings, including archives, donated historical materials, Nixon 
Presidential materials, and Presidential records. NARA also issues 
regulations relating to the National Historical Publications and 
Records Commission (NHPRC) grant programs.
 NARA's regulatory priorities for fiscal year 2001 are: (1) developing 
regulations relating to storage standards for archival records; (2) 
reviewing 36 CFR part 1230, Micrographic Records Management, to update 
industry standards and to consider expanding the part to address other 
imaging technologies; (3) revising regulations on transfer of 
electronic records to the National Archives of the United States to 
allow additional transfer media; and (4) updating and streamlining NARA 
regulations relating to the National Historical Publications and 
Records Commission grant program.
BILLING CODE 7515-01-S




[[Page 73504]]

OFFICE OF PERSONNEL MANAGEMENT (OPM)



Statement of Regulatory Priorities
 The Office of Personnel Management's (OPM) regulatory priorities for 
the coming year will continue to focus on human resource management 
improvements that will enable the Federal Government to recruit, 
manage, and retain the high quality, diverse workforce needed by 
agencies to deliver their respective missions to the American public.
 An unqualified success story of the Clinton Administration has been 
the historic transformation of our Federal workforce; a workforce that 
is the smallest it has been since the Eisenhower Administration as a 
result of needed Government workforce restructuring, yet one that 
operates with increased efficiency. It is managed with concern for 
balancing the work and family needs of its employees with a renewed 
commitment for getting results for the American people. It is focused 
on innovation and aggressively seeking ways to incorporate e-learning 
into the training of its employees. It is a workforce made infinitely 
stronger by its diversity, the very diversity that helped make this 
country great. The Federal Government that is now charging into the new 
millennium is one focused on quality, effectiveness and customer 
service, and one that is better equipped to recruit and retain a high 
quality workforce of the future.
 In the coming year, we will continue focusing on ways to give Federal 
managers the tools they need to recruit and retain a high quality 
workforce. The Federal Government must have effective strategies for 
competing in the strong labor market. An important step in improving 
the Federal Government recruitment position was taken by President 
Clinton on July 7, 2000, in signing Executive Order 13162, establishing 
the Federal Career Intern Program. This program is designed to attract 
exceptional men and women to the Federal workforce who have a variety 
of experiences, academic disciplines and competencies, and to prepare 
them for careers in the analysis and execution of public programs. OPM 
will issue regulations to implement this important program, which will 
offer participants unrivaled professional experiences and training 
opportunities that are tailored to meet their professional goals.
 To further enhance the Federal Government's ability to recruit and 
retain highly qualified professional, technical and administrative 
personnel, we will finalize regulations authorizing agencies to 
establish a program under which they may agree to repay all or part of 
any outstanding federally insured student loans, both for current 
agency employees and new recruits. These regulations will provide 
agencies with another important new tool for recruiting and retaining 
the best and brightest workers in today's competitive labor market.
 We will propose regulations to give agencies greater flexibility to 
use recruitment and relocation bonuses and retention allowances by 
authorizing them to make such payments to their Federal Wage System 
employees. The regulations will also give agencies the flexibility to 
pay retention allowances to employees who are likely to leave their 
position for other Federal employment under a different pay system 
under certain limited conditions.
 As the Federal Government continues to set the standard for 
compassionate, family-focused work environments, anticipated passage of 
supporting legislation will allow us to extend regulations authorized 
by the Child Care Tuition Assistance Program to permit agency use of 
appropriated funds for child care costs for lower income employees. 
Good quality child care can be prohibitively expensive, and we need to 
do everything we can to reduce costs and bring employees the peace of 
mind that comes with knowing their children are safe and in good hands. 
When human resource systems are designed to address employee needs such 
as assistance with child care costs, agencies immediately benefit by 
better recruitment and retention of qualified personnel, resulting in 
significant recruitment and training cost savings, lower absenteeism 
and improved employee morale.
 We were pleased to announce recently that Federal employees will soon 
be able to use pretax dollars to pay for their health insurance 
premiums under the Federal Employees' Health Benefits Program. The 
President's FY 2001 Budget endorsed health insurance premium conversion 
to recognize that Federal employees are the key to effective Government 
performance and to enable the Government to attract and retain a high-
quality work force.
 Premium conversion will enable Executive Branch employees to pay their 
Federal Employees' Health Benefits Program premiums on a pretax basis. 
These regulations will take advantage of current tax law to allow more 
than 1.5 million Federal employees, representing over 3 million lives 
including dependents, to enjoy a benefit already available to most 
employees in the private sector and in State and municipal governments. 
As a result, the Federal Government will be a more competitive employer 
and health insurance will become more affordable for Federal employees 
and their families.
 OPM also expects to introduce legislation to provide additional tools 
and flexibilities to enhance Federal human resource management for the 
future. As new legislation is enacted, OPM will prepare the necessary 
implementing regulations.
 Under the leadership of President Clinton and Vice President Gore, our 
Government is more effective and responsive to the needs of the people 
we serve. Federal employees are focused like never before on innovation 
and productivity because they work for an employer that seeks and 
encourages excellence, an employer that demonstrates by its actions 
that it values their contributions, and an employer that understands 
the needs of the American worker in this new century.
 The Office of Personnel Management will continue to accept the 
challenge of improving our human resource management systems in order 
to attract and keep the best possible talent, to promote fairness and 
diversity, to preserve the merit-based civil service system that serves 
as the cornerstone of our democracy, and to create a Government that 
truly serves our citizens.
_______________________________________________________________________



OPM

                              -----------

                          PROPOSED RULE STAGE

                              -----------




150. RECRUITMENT AND RELOCATION BONUSES AND RETENTION ALLOWANCES
Priority:


Other Significant


Legal Authority:


5 USC 5753; 5 USC 5754


CFR Citation:


5 CFR 575


Legal Deadline:


None


Abstract:


These proposed regulations would provide agencies with greater 
flexibility

[[Page 73505]]

in the use of recruitment and relocation bonuses and retention 
allowances. This proposal would amend the regulations to allow agencies 
to pay recruitment, relocation, and retention payments to Federal Wage 
System employees. The proposed regulations would also provide agencies 
with the flexibility to pay retention allowances to employees who are 
likely to leave their position for other Federal employment under a 
different pay system under certain limited conditions.


Statement of Need:


Agencies have specifically requested these proposed regulatory changes 
to provide them with additional flexibility to help recruit and retain 
Federal employees.


Summary of Legal Basis:


The governing United States Code provisions are 5 U.S.C. 5753 and 5 
U.S.C. 5724.


Alternatives:


Other alternatives, such as authorizing the use of special salary 
rates, were considered and rejected because they were either 
inappropriate, too costly, or did not offer the flexibility agencies 
were seeking.


Anticipated Cost and Benefits:


The proposed regulations would help agencies recruit and retain 
critical employees and avoid the costs related to employee turnover 
(e.g., reduced productivity, increased or prolonged recruitment 
actions, training new employees). Because the proposed regulations 
expand the circumstances under which recruitment and relocation bonuses 
and retention allowances may be paid, it is possible that the costs 
associated with these payments may increase. However, since agencies 
have the discretion to use these recruitment and retention incentives, 
we cannot specifically predict or quantify these costs.


Risks:


These proposed regulations would delegate to agencies increased 
authority to pay recruitment and retention incentives to employees 
under certain, limited circumstances. We will continue to ensure 
agencies do not violate the merit systems principles and prohibited 
personnel practices under 5 U.S.C. 2301 and 2302 when using these new 
authorities through our monitoring and oversight responsibilities.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           10/00/00
Final Action                                                   12/00/00
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


None


Agency Contact:
Jeanne D. Jacobson
Workforce Compensation and Performance Service
Office of Personnel Management
Office of Compensation Administration
1900 E Street NW.
Washington, DC 20415
Phone: 202 606-2858
Fax: 202 606-0824
Email: [email protected]
RIN: 3206-AJ08
_______________________________________________________________________



OPM

                              -----------

                            FINAL RULE STAGE

                              -----------




151.  REPAYMENT OF STUDENT LOANS
Priority:


Other Significant


Legal Authority:


5 USC 5379


CFR Citation:


5 CFR 537


Legal Deadline:


None


Abstract:


These regulations implement Public Law 101-510 (codified as 5 U.S.C. 
5379), which authorizes agencies to establish a program under which 
they may agree to repay all or part of any outstanding Federally 
insured student loan(s) in order to recruit or retain highly qualified 
professional, technical, or administrative personnel. The regulation 
will provide agencies with a tool for recruiting and retaining the best 
and brightest workers from today's competitive labor market.


Statement of Need:


These regulations will help agencies compete for highly qualified 
employees in today's competitive labor market.


Summary of Legal Basis:


These provisions are governed by title 5, United States Code, section 
5379.


Alternatives:


These regulations are one of several flexibilitities agencies may use 
when trying to attract or retain individuals to Federal service for 
whom the government has a special need.


Anticipated Cost and Benefits:


As a retention incentive, the proposed regulations will help agencies 
avoid the costs related to employee turnover (e.g., reduced 
productivity, increased or prolonged recruitment actions, training new 
employees).


Agency use of this incentive is discretionary (both in terms of the 
number of employees receiving the benefit and the amount each employee 
may receive). Therefore, we cannot quantify the costs associated with 
implementation of these regulations.


Risks:


These proposed regulations give agencies the authority to use a new 
recruitment and retention incentive. The regulations require that 
agencies do not violate the merit systems principles and prohibited 
personnel practices under 5 U.S.C. 2301 and 2302 when using this new 
authority.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            65 FR 38791                                    06/22/00
Final Action                                                   12/00/00
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


None


Agency Contact:
Mike Mahoney
Employment Service, Staffing Policy Division
Office of Personnel Management
1900 E Street NW.
Washington, DC 20415
Phone: 202 606-0830
Fax: 202 606-0023
RIN: 3206-AJ12


_______________________________________________________________________


[[Page 73506]]

OPM



152.  IMPLEMENTATION OF PREMIUM CONVERSION FOR EXECUTIVE BRANCH 
FEDERAL EMPLOYEES PARTICIPATING IN THE FEDERAL EMPLOYEES' HEALTH 
BENEFITS (FEHB) PROGRAM
Priority:


Economically Significant. Major under 5 USC 801.


Legal Authority:


26 USC 125


CFR Citation:


5 CFR 890


Legal Deadline:


None


Abstract:


At the President's direction, the Office of Personnel Management (OPM) 
is issuing regulations under the Federal Employees' Health Benefits 
(FEHB) Program to enable employees of all Executive Branch agencies to 
pay their share of FEHB premiums with pre-tax dollars in accordance 
with section 125 of the Internal Revenue Code. OPM is simultaneously 
amending salary allotment regulations at 5 CFR 550, because employees 
participating in premium conversion must allot a portion of salary to 
their employing agency that agencies will then use to pay the employee 
share of FEHB premiums. The regulations establish the basic rules under 
which premium conversion will operate beginning in October 2000.


Statement of Need:


In his 2001 Budget, the President directed OPM to implement health 
insurance premium conversion to bring the Federal Government in line 
with common private-sector employer practices. Over 60 million private 
sector employees with employment-based health insurance pay their 
premiums with pre-tax dollars. These regulations will take advantage of 
current tax law to allow more than 1.5 million Federal employees, 
representing more than 3 million lives including dependents, to have 
the same benefit as private sector workers. As a result, the Federal 
Government will be a more competitive employer and health insurance 
will become more affordable for Federal employees.


Summary of Legal Basis:


Premium conversion plans are a type of ``cafeteria plan'' that 
qualifies for special tax treatment under section 125 of the Internal 
Revenue Code.


Alternatives:


OPM met with those Federal agencies that have previously implemented a 
premium conversion plan: the U.S. Postal Service, the Federal 
Judiciary, and some small Executive Branch agencies with independent 
compensation-setting authority. OPM studied the range of implementation 
issues that these organizations encountered; from payroll system 
changes and educational outreach, to complying with tax code 
requirements. OPM also hired a contractor with substantial experience 
in employee benefits tax compliance to write a plan document that 
conforms to IRS section 125 rules. These regulations reflect the ``best 
practices'' of other employers in terms of premium conversion program 
development and implementation.


Anticipated Cost and Benefits:


Given the present tight labor market conditions, the Federal 
Government, like all employers, must use every means possible to 
attract and retain highly skilled employees. Premium conversion plans 
are a widely available employee benefit that lowers individual tax 
liability. This regulation will eliminate a competitive disadvantage in 
the Federal Government's compensation package and will increase 
employee satisfaction.


The costs associated with this regulation are the start-up costs to 
implement the premium conversion program; the decrease in Medicare, 
Social Security, and income taxes paid by Federal employees; and the 
decrease in Federal employer payments to the Medicare and Social 
Security trust funds.


OPM estimates the start-up cost to be $3 million in 2001, with $2.5 
million coming from agency costs to update payroll systems to 
accommodate the program and $5 million from educational outreach 
programs. In fiscal year 2001, the tax benefit to employees is 
estimated to be about $670 million: $550 million in Federal income 
taxes; $85 million in Social Security taxes; and $35 million in 
Medicare taxes. The decrease in Federal employer payments to Social 
Security and Medicare trust funds is estimated to be $85 million and 
$35 million, respectively. Assuming that health insurance premiums will 
continue to increase at recent rates, the decrease in tax revenues 
attributable to premium conversion is expected to grow at a 
proportional rate in each subsequent year


Risks:


Premium conversion will assist the Federal Government in remaining 
competitive with other employers in attracting and retaining highly 
skilled employees. OPM has established a strategic compensation policy 
center to look at the best practices in pay, benefits and other forms 
of compensation in Federal, State and local governments, the private 
sector and foreign governments. OPM held a Strategic Compensation 
Conference 2000 on August 28-29 in Washington, D.C.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
Interim Final Ru65 FR 44644                                    07/19/00
Interim Final Rule Effective                                   09/18/00
Final Action                                                   11/00/00
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


None


Agency Contact:
Abby L. Block
Chief, Insurance Policy Division, Retirement and Insurance Group
Office of Personnel Management
Office of Insurance Programs
1900 E Street NW.
Washington, DC 20415
Phone: 202 606-0191
RIN: 3206-AJ17
_______________________________________________________________________



OPM



153.  EXCEPTED SERVICE; CAREER AND CAREER-CONDITIONAL 
EMPLOYMENT
Priority:


Other Significant


Legal Authority:


EO 13162


CFR Citation:


5 CFR 213; 5 CFR 315


Legal Deadline:


None


Abstract:


These regulations implement Executive Order 13162, which establishes 
the

[[Page 73507]]

Federal Career Intern Program. This program will be used to attract 
exceptional men and women to the Federal workforce who have diverse 
professional experiences, academic training, or competencies and 
prepare them for careers in analyzing and implementing public programs.


This regulation supports the Administration's effort to recruit the 
highest caliber people to the Federal Government, develop their 
professional abilities, and retain them in Federal departments and 
agencies.


Statement of Need:


Agencies have specifically requested an appointing authority that will 
enable them to attract and appoint exceptional individuals, who have a 
variety of experience, academic disciplines, or competencies necessary 
for the analysis and execution of their programs.


Summary of Legal Basis:


OPM has the authority under Civil Service Rule 6.1 to except positions 
from the competitive service when it determines that appointments to 
these positions through competitive examination is not practicable. 
Conversion to competitive civil service status is authorized under 
Executive Order 13162.


Alternatives:


Agencies are encouraged to utilize all available appointing 
authorities. These regulations provide agencies with one of several 
mechanisms to appoint individuals to Federal service at the entry 
level.


Anticipated Cost and Benefits:


Agencies will have the discretion to use this appointing authority for 
hiring individuals at a variety of grade levels. Therefore, we cannot 
quantify the costs associated with implementation of these regulations.


Risks:


These proposed regulations give agencies the authority to appoint 
individuals in the excepted service and noncompetitively convert them 
to the competitive service. The regulations require that agencies do 
not violate the merit systems principles and prohibited personnel 
practices under 5 U.S.C. 2301 and 2302 when using this new authority.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
Interim Final Rule                                             12/00/00
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


None


Agency Contact:
Karen Jacobs
Employment Service, Staffing Policy Division
Office of Personnel Management
1900 E Street NW.
Washington, DC 20415
Phone: 202 606-0830
Fax: 202 606-0023
RIN: 3206-AJ28
BILLING CODE 6325-01-S




[[Page 73508]]

PENSION BENEFIT GUARANTY CORPORATION (PBGC)



Statement of Regulatory and Deregulatory Priorities
PBGC Insurance Programs
 The Pension Benefit Guaranty Corporation (PBGC) administers two 
insurance programs for private defined benefit plans under title IV of 
the Employee Retirement Income Security Act of 1974 (ERISA): A single-
employer plan termination insurance program and a multiemployer plan 
insolvency insurance program. The PBGC protects the pensions of nearly 
43 million working men and women in about 39,000 private defined 
benefit plans, including about 1,800 multiemployer plans.
 Under the single-employer program, the PBGC pays guaranteed and 
certain other pension benefits to participants and beneficiaries if 
their plan terminates with insufficient assets (distress and 
involuntary terminations). At the end of fiscal year 1999, the PBGC was 
trustee of almost 2,800 plans, and paid $902 million in benefits to 
about 230,000 people during 1999. Another 217,000 people will receive 
benefits when they retire in the future.
 Most terminating single-employer plans terminate with sufficient 
assets to pay all benefits. The PBGC has administrative responsibility 
for these terminations (standard terminations), but its role is limited 
to seeing that proper procedures are followed and participants and 
beneficiaries receive their plan benefits.
 The multiemployer program (which covers about 9 million workers and 
retirees in about 1,800 insured plans) is funded and administered 
separately from the single-employer program and differs in several 
significant ways. The multiemployer program covers only collectively 
bargained plans involving more than one unrelated employer. The PBGC 
provides financial assistance (in the form of a repayable loan) to the 
plan if the plan is unable to pay benefits at the guaranteed level. 
Guaranteed benefits are generally less than a participant's full 
benefit under the plan (and less than the single-employer guaranteed 
benefit). PBGC financial assistance occurs infrequently.
 The PBGC receives no funds from general tax revenues. Operations are 
financed by insurance premiums, investment income, assets from pension 
plans trusteed by the PBGC, and recoveries from the companies formerly 
responsible for the trusteed plans.
 To carry out these functions, the PBGC must issue regulations 
interpreting such matters as the termination process, establishment of 
procedures for the payment of premiums, and assessment and collection 
of employer liability.
Objectives and Priorities
 PBGC regulatory objectives and priorities are developed in the context 
of the statutory purposes of title IV: (1) to encourage voluntary 
private pension plans, (2) to provide for the timely and uninterrupted 
payment of pension benefits to participants and beneficiaries, and (3) 
to maintain the premiums that support the insurance programs at the 
lowest possible levels consistent with carrying out the PBGC's 
statutory obligations (ERISA section 4002(a)).
 The PBGC implements its statutory purposes by developing regulations 
designed: (1) to assure the security of the pension benefits of 
workers, retirees, and beneficiaries; (2) to improve services to 
participants; (3) to ensure that the statutory provisions designed to 
minimize losses for participants in the event of plan termination are 
effectively implemented; (4) to encourage the establishment and 
maintenance of defined benefit pension plans; (5) to facilitate the 
collection of monies owed to plans and to the PBGC, while keeping the 
related costs as low as possible; and (6) to simplify the termination 
process.
Legislative Initiatives
 Since the early 1980s, there has been a gradual shift away from 
defined benefit pension plans in the private sector. The number of 
PBGC-insured defined benefit plans peaked in 1985 at about 112,000. 
Since then, there has been a sharp decline to about 40,000 plans in 
1999.
 This reduction has not been proportional across all plan sizes. Plans 
with fewer than 100 participants have shown the most marked decline, 
from about 90,000 in 1985 to less than 24,000 in 1999. There also has 
been a sharp decline for plans with between 100 and 999 participants, 
from more than 19,000 in 1985 to about 11,000 in 1999.
 In marked contrast to the trends for plans with fewer than 1,000 
participants, the number of plans with more than 1,000 participants has 
shown modest growth. Since 1980, the number of plans with between 1,000 
and 9,999 participants has grown by about 6 percent, from 4,017 to 
4,257 in 1999. The number of plans with at least 10,000 participants 
has grown from 469 in 1980 to 749 in 1999, an increase of nearly 60 
percent.
 The growth in the number of large plans is attributable to two 
factors. First, the rapid increase in inactive participants (retirees 
and separated vested participants) has pushed some plans into higher 
size categories. Second, there has been considerable plan merger 
activity over the 13-year period from 1985 through 1997.
 In contrast to the dramatic reduction in the total number of plans, 
the total number of participants in PBGC-insured defined benefit plans 
has shown modest growth. In 1980, there were 35.5 million participants. 
By 1999, this number had increased to almost 43 million.
 These numbers, however, mask the downward trend in the defined benefit 
system because total participants include not only active workers but 
also retirees (or their surviving spouses) and separated vested 
participants. The latter two categories of participants reflect past 
coverage patterns in defined benefit plans. A better forward-looking 
measure is the trend in the number of active participants, workers 
currently earning pension accruals. Here, the numbers continue to 
decline.
 In 1988, there were 27.3 million active participants in defined 
benefit plans; by 1996 (the latest data available), this number had 
fallen to 22.6 million, a decrease of more than 17 percent. At the same 
time, the number of inactive participants has been growing. In 1980, 
inactive participants accounted for only 23 percent of total 
participants in defined benefit plans. By 1988, this number had 
increased to 31 percent; and by 1996, more than 45 percent of the 
participants in defined benefit plans were inactive participants. If 
this trend continues, by the year 2003, the number of inactive 
participants will exceed the number of active workers.
 The President's budget for fiscal year 2001 includes numerous 
provisions to encourage the expansion of retirement plan coverage, 
including under defined benefit plans. These provisions include:
 A simplified defined benefit plan called SMART (Secure Money 
            Annuity or Retirement Trust) for small businesses with 100 
            or fewer employees;
 A reduced PBGC premium of $5 per participant for the first 5 
            years of a small business's new plan and phase-in of the 
            variable-rate premium over 5 years for new plans of all 
            sizes;
 Expansion of the missing participants clearinghouse for 
            terminating single-employer defined benefit plans

[[Page 73509]]

            insured by the PBGC to other terminating plans--
            multiemployer defined benefit pension plans insured by the 
            PBGC, certain other defined benefit pension plans not 
            insured by the PBGC, and defined contribution plans;
 Simplified rules governing the PBGC's guarantee of benefits 
            for a partial owner of a company and the allocation of plan 
            assets to the benefits of these owner-employees; and
 Increasing the PBGC's benefit guarantee for multiemployer 
            plans, which has been at the same level since 1980, from 
            the current maximum guarantee of $5,850 to $12,870 (the 
            guarantee increase would require no change in the 
            multiemployer premium rate).
Regulatory and Deregulatory Initiatives
 The PBGC has focused on changes that would simplify the rules and 
reduce regulatory burden. For example, over the past few years, the 
PBGC has reduced penalties for late premiums that are paid before the 
PBGC notifies the plan of the delinquency, extended the time limits for 
various actions required to terminate a fully funded single-employer 
plan in a standard termination, stopped the reduction of monthly 
benefits under its actuarial recoupment method once the nominal amount 
of the benefit overpayment is repaid, provided participants with 
benefits valued up to $5,000 in PBGC-trusteed plans with the choice of 
receiving their benefit in the form of an annuity or a lump sum, and 
extended the filing date for PBGC premiums to match the latest Form 
5500 filing date.
 In FY 2000, the PBGC:
 Amended its premium regulation to encourage self-correction of 
            premium underpayments by making it easier to qualify for 
            safe-harbor penalty relief (final rule, November 26, 1999).
 Simplified its valuation assumptions by adopting a single set 
            of assumptions for allocation purposes (final rule, March 
            17, 2000).
 Assured the public that it intended to continue to calculate 
            and publish its lump sum interest rates indefinitely and 
            amended its regulations to make it easier for practitioners 
            to refer to those rates (final rule, March 17, 2000).
 Solicited public comment on benefit valuation and payment 
            issues relating to terminated cash balance plans that use 
            variable indices to determine future retirement benefits 
            (request for comments, July 6, 2000).
 The PBGC is continuing to review its regulations to look for further 
simplification opportunities. The PBGC's regulatory plan for October 1, 
2000, to September 30, 2001, consists of one significant regulatory 
action.
_______________________________________________________________________



PBGC

                              -----------

                          PROPOSED RULE STAGE

                              -----------




154. ALLOCATION OF ASSETS IN SINGLE-EMPLOYER PLANS; VALUATION OF 
BENEFITS AND ASSETS
Priority:


Other Significant


Legal Authority:


29 USC 1302(b)(3); 29 USC 1341; 29 USC 1301(a); 29 USC 1344; 29 USC 
1362


CFR Citation:


29 CFR 4044 subpart B


Legal Deadline:


None


Abstract:


The Pension Benefit Guaranty Corporation is considering amending its 
benefit valuation and asset allocation regulations by adopting more 
current mortality tables and otherwise simplifying and improving its 
valuation assumptions and methods.


Statement of Need:


The PBGC's regulations prescribe rules for valuing a terminating plan's 
benefits for several purposes, including (1) determining employer 
liability and (2) allocating assets to determine benefit entitlements. 
The PBGC's interest assumption for valuing benefits, when combined with 
the PBGC's mortality assumption, is intended to reflect the market 
price of single-premium, nonparticipating group annuity contracts for 
terminating plans. In developing its interest assumptions, the PBGC 
uses data from surveys conducted by the American Council of Life 
Insurance. The PBGC currently uses a mortality assumption based on the 
1983 Group Annuity Mortality Table in its benefit valuation and asset 
allocation regulations (29 CFR parts 4044 and 4281).


In May 1995, the Society of Actuaries Group Annuity Valuation Table 
Task Force issued a report that recommends new mortality tables for a 
new Group Annuity Reserve Valuation Standard and a new Group Annuity 
Mortality Valuation Standard. In December 1996, the National 
Association of Insurance Commissioners adopted the new tables as models 
for determining reserve liabilities for group annuities. The PBGC is 
considering incorporating these tables into its regulations and making 
other modifications.


Summary of Legal Basis:


The PBGC has the authority to issue rules and regulations necessary to 
carry out the purposes of title IV of ERISA.


Alternatives:


Not yet determined.


Anticipated Cost and Benefits:


Cost estimates are not yet available. However, the PBGC expects that 
this regulation will not have a material effect on costs.


Risks:


Not applicable.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
ANPRM           62 FR 12982                                    03/19/97
ANPRM Comment Period End                                       05/19/97
NPRM                                                           07/00/01
NPRM Comment Period End                                        09/00/01
Regulatory Flexibility Analysis Required:


No


Government Levels Affected:


None


Agency Contact:
James L. Beller
Attorney
Pension Benefit Guaranty Corporation
Office of the General Counsel
1200 K Street NW
Washington, DC 20005-4026
Phone: 202 326-4024
TDD Phone: 800 877-8339
Fax: 202 326-4112
RIN: 1212-AA55
BILLING CODE 7708-01-S




[[Page 73510]]

SMALL BUSINESS ADMINISTRATION (SBA)



Statement of Regulatory Priorities
Overview
 The Small Business Administration (SBA) continues to focus its 
regulatory efforts towards delivering sound economic development 
programs to small businesses through streamlined, customer-oriented 
regulations.
 SBA began its efforts to streamline SBA regulations in 1994 in 
response to a Presidential directive to all agencies to review, revise, 
and eliminate regulations. SBA followed the directive, thoroughly 
reviewed all regulations, and by 1996, revised the bulk of SBA's 
regulations. The revised regulations are less burdensome, more ``user-
friendly,'' and provide for more efficient operations. The regulations 
incorporate SBA's mission to ensure access to capital to our Nation's 
small businesses.
SBA's Regulatory Plan
Program for Investment in Microentrepreneurs Act (PRIME)
 The SBA is proposing regulations that set forth PRIME's requirements 
for qualified Microenterprise Development Organizations (MDOs) to: (1) 
Train and provide technical assistance to disadvantaged 
microentrepreneurs; (2) build MDOs' capacity to give disadvantaged 
microentrepreneurs such training and technical assistance; (3) research 
and develop best practices for training and technical assistance; and 
(4) perform such other activities as the Administrator or designee 
determines are consistent with the Act. SBA will award a minimum of 75 
percent of available funds to MDOs to use for training and technical 
assistance to disadvantaged microentrepreneurs. At a minimum, another 
15 percent will be used to build MDOs' capacity to give more training 
and technical assistance. SBA will use the remaining funds to make 
grants for research and development on best practices or other purposes 
to improve MDOs' services to PRIME's ultimate beneficiaries-
disadvantaged microentrepreneurs.
_______________________________________________________________________



SBA

                              -----------

                          PROPOSED RULE STAGE

                              -----------




155.  PRIME ACT GRANTS
Priority:


Other Significant


Legal Authority:


15 USC 634(b)(6); PL 106-102


CFR Citation:


13 CFR 119


Legal Deadline:


None


Abstract:


The U.S. Small Business Administration is proposing regulations to add 
a new part 119 to set up the Program for Investment in 
Microentrepreneurs Act (``PRIME'' or ``the Act''). The proposed 
regulation sets forth the Act's grant requirements for qualified 
Microenterprise Development Organizations (``MDOs'') to: (1) Train and 
provide technical assistance to disadvantaged microentrepreneurs; (2) 
build MDOs' capacity to give disadvantaged microentrepreneurs such 
training and technical assistance; (3) research and develop best 
practices for training and technical assistance; and (4) perform such 
other activities as the Administrator or designee determines are 
consistent with the Act. SBA will award a minimum of 75 percent of 
available funds to MDOs to use for training and technical assistance to 
disadvantaged microentrepreneurs. At a minimum, another 15 percent will 
be used to build MDOs' capacity to give more training and technical 
assistance. SBA will use the remaining funds to make grants for 
research and development on best practices or other purposes to improve 
MDOs' services to PRIME's ultimate beneficiaries-disadvantaged 
microentrepreneurs.


Statement of Need:


Congress recognized that many disadvantaged microentrepreneurs lack 
sufficient training and education to gain access to capital and to 
conduct other activities necessary to establish, maintain, and expand 
their businesses. It enacted the Program for Investment in 
Microentrepreneurs Act (``PRIME'' or ``the Act'') to augment training 
and technical assistance under the Small Business Act and other 
legislation. PRIME grants to qualified Microenterprise Development 
Organizations (MDOs) will help meet training and technical assistance 
needs for disadvantaged microentrepreneurs, thereby encouraging 
entrepreneurship and capital formation at the community level.


Summary of Legal Basis:


The Program for Investment in Microentrepreneurs Act (``PRIME'' or 
``the Act'') was created by title VII of the Gramm-Leach-Bliley Act, 
Public Law 106-102, enacted November 12, 1999 (113 Stat. 1471). The Act 
sets forth requirements for qualified Microenterprise Development 
Organizations (``MDOs'') to: (1) Train and provide technical assistance 
to disadvantaged microentrepreneurs; (2) build MDOs' capacity to give 
disadvantaged microentrepreneurs such training and technical 
assistance; (3) research and develop best practices for training and 
technical assistance; and (4) perform such other activities as the 
Administrator or designee determines are consistent with the Act.


The Act directs SBA to award a minimum of 75 percent of available funds 
to MDOs to use for training and technical assistance to disadvantaged 
microentrepreneurs and, at a minimum, another 15 percent to be used to 
build MDOs' capacity to give more training and technical assistance. 
The remaining funds are for grants for research and development on best 
practices or other purposes to improve MDOs' services to PRIME's 
ultimate beneficiaries-disadvantaged microentrepreneurs.


Alternatives:


Not applicable.


Anticipated Cost and Benefits:


PRIME grants will enable MDOs to reach more disadvantaged 
microentrepreneurs with training and technical assistance, which will 
make a difference in their ability to start, grow, and sustain 
microenterprises in economically distressed, high unemployment areas.


Risks:


Not applicable.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            65 FR 60256                                    10/10/00
NPRM Comment Period End                                        11/09/00
Final Action                                                   01/00/01
Regulatory Flexibility Analysis Required:


No

[[Page 73511]]

Small Entities Affected:


Businesses


Government Levels Affected:


Federal


Agency Contact:
Jane Palsgrove Butler
Associate Administrator for Financial Assistance
Small Business Administration
409 Third Street SW
Washington, DC 20416
Phone: 202 205-6490
RIN: 3245-AE52
BILLING CODE 8025-01-S




[[Page 73512]]

SOCIAL SECURITY ADMINISTRATION (SSA)



Statement of Regulatory Priorities
 The Social Security Administration (SSA) administers the retirement, 
survivors, and disability insurance programs under title II of the 
Social Security Act (the Act), and the Supplemental Security Income 
(SSI) program under title XVI of the Act. Generally, SSA's regulations 
do not impose burdens on the private sector or on State or local 
governments. Our regulations codify the requirements for eligibility 
and entitlement to benefits under the programs that we administer.
 Our eight entries for the Regulatory Plan represent areas of major 
importance to the administration of the retirement, survivors, 
disability, and SSI benefit programs.
 One of SSA's most important initiatives is to assure that Social 
Security (SSDI) and Supplemental Security Income (SSI) beneficiaries 
with disabilities who want to work have the opportunity to do so. 
Included in this year's Plan are two final regulations that will 
provide more choices for people with disabilities who seek Return-to-
Work services so that they may become self-sufficient. One regulation 
implements legislation, The Ticket to Work and Work Incentives 
Improvement Act of 1999, which removes barriers to work for individuals 
with disabilities. The other increases the monthly substantial gainful 
activity amount and the minimum amount that we consider as showing that 
a person is performing services, and then automatically increases both 
these amounts each year based on the national average wage index. This 
same regulation also increases the maximum monthly Student Earned 
Income Exclusion Amount and then increases that maximum amount annually 
using the consumer price index.
 We are currently preparing two proposed regulations to improve the 
disability process. One would implement elements of the redesigned 
disability claims process that have been tested and found to further 
redesign goals. The other will update the cardiovascular listing to 
reflect advances in medical knowledge, treatment, and methods of 
evaluating cardiovascular impairments.
 Providing world-class service to our customers remains a principal 
objective of SSA. One of the items in the Plan, Expansion of the Use of 
Video Teleconference Technology in Hearings Before Administrative Law 
Judges of the Social Security Administration, is expected to improve 
customer service by providing faster access to a hearing.
 Effective stewardship of SSA programs requires mechanisms to assure 
that benefits are used to meet the needs of beneficiaries who are not 
able to manage their own benefits due to legal incompetence or medical 
infirmity. A proposed regulation will make improvements to the 
representative payment procedures needed to assure program integrity. 
This regulation reflects certain provisions of Public Laws 101-508, 
103-296, 104-121, and 105-33.
 We have also included in this year's Plan, two regulations that 
provide SSA with additional tools to strengthen the integrity of the 
Social Security and SSI programs. One is a proposed regulation that 
implements a provision of the Foster Care Independence Act of 1999, 
authorizing SSA to obtain information from financial institutions in 
order to determine initial or continuing eligibility for SSI benefits. 
The other is a final regulation that permits SSA to recover SSI 
overpayments by adjusting the amount of Social Security benefits 
payable to the individual under title II of the Act.
 We continue to work diligently to improve our program benefit 
regulations and to develop partnerships with large segments of the 
community of stakeholders interested in Social Security programs. We 
expect that these partnerships will contribute to the successful 
development of our Regulatory Plan entries.
_______________________________________________________________________



SSA

                              -----------

                          PROPOSED RULE STAGE

                              -----------




156. OASDI AND SSI; EXPANSION OF THE USE OF VIDEO TELECONFERENCE 
TECHNOLOGY IN HEARINGS BEFORE ADMINISTRATIVE LAW JUDGES OF THE SOCIAL 
SECURITY ADMINISTRATION (737P)
Priority:


Other Significant


Legal Authority:


42 USC 205(a); 42 USC 205(b); 42 USC 902(a)(5); 42 USC 1383


CFR Citation:


20 CFR 404.929; 20 CFR 404.936(b); 20 CFR 404.936(c); 20 CFR 
404.936(d)(8)(New); 20 CFR 404.938; 20 CFR 416.1429; 20 CFR 
416.1436(b); 20 CFR 416.1436(c); 20 CFR 416.1436(d)(8)(New); 20 CFR 
416.1438


Legal Deadline:


None


Abstract:


We propose to amend our regulations to permit us to conduct hearings 
before an administrative law judge (ALJ) by video teleconference (VTC). 
We also propose to add new sections to the regulations that will state 
the conditions for an ALJ to find good cause to change the time and 
place of a hearing if we schedule a VTC hearing, and the individual 
tells us he/she does not want a VTC hearing.


Statement of Need:


Our regulations provide for a hearing in person before an ALJ. 
Traditionally, this has meant that the individual requesting a hearing 
and the ALJ were present in the same room. The proposed changes will 
allow us to schedule a VTC hearing without requiring prior written 
consent, and set out the right to decline such a hearing. We believe 
that conducting hearings by VTC will improve our efficiency and allow 
us to serve our customers better.


Providing VTC hearings is one initiative of the Hearings Process 
Improvement Plan we issued in August 1999. We expect that the plan, 
when fully implemented, will reduce the average processing time for 
hearings from 314 days in Fiscal Year 1999 to less than 200 days in 
Fiscal Year 2002, and allow us to issue hearing decisions to 30 percent 
of requestors within 120 days from the date of the request for hearing. 
The VTC provision would aid in this reduction by eliminating much of 
the time some ALJ's must spend to travel to remote sites to conduct 
hearings face-to-face.


Summary of Legal Basis:


None.


Alternatives:


Require participation in a scheduled VTC hearing, i.e., no right to 
decline a VTC hearing.


Anticipated Cost and Benefits:


Improved customer service by providing faster access to a hearing.


Risks:


None.

[[Page 73513]]

Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           10/00/00
Final Action                                                   04/00/01
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


None


Agency Contact:
Lawrence V. Dudar
Social Insurance Specialist
Social Security Administration
Office of Process and Innovation Management
6401 Security Boulevard
Baltimore, MD 21235-6401
Phone: 410 966-5995
RIN: 0960-AE97
_______________________________________________________________________



SSA



157. TICKET TO WORK AND SELF-SUFFICIENCY PROGRAM (TICKET TO WORK AND 
WORK INCENTIVES IMPROVEMENT ACT OF 1999) (767P)
Priority:


Economically Significant. Major under 5 USC 801.


Unfunded Mandates:


Undetermined


Legal Authority:


42 USC 902(a)(5); 42 USC 1320b-19; PL 106-170, sec 101


CFR Citation:


20 CFR 404.316; 20 CFR 404.337; 20 CFR 404.352; 20 CFR 404.401; 20 CFR 
404.902; 20 CFR 404.1586; 20 CFR 404.1590; 20 CFR 404.1596; 20 CFR 
404.1597; 20 CFR 404.2101; 20 CFR 416.101; 20 CFR 416.213; 20 CFR 
416.708; 20 CFR 416.990; 20 CFR 416.1321; 20 CFR 416.1328; 20 CFR 
416.1331; 20 CFR 416.1338; 20 CFR 416.1402; 20 CFR 416.1701 to 
416.1715; 20 CFR 416.2040; 20 CFR 416.2201


Legal Deadline:


Final, Statutory, December 17, 2000, One year after the date of 
enactment of Public Law 106-170.


Sec. 1148(l) of the Social Security Act (42 USC 1320b-19(1), as added 
by sec. 101(a) of PL 106.170, requires SSA to prescribe regulations to 
carry out the Ticket to Work and Self-Sufficiency Program.


Abstract:


These proposed regulations would implement the Ticket to Work and Self-
Sufficiency Program under section 1148 of the Act, as added by section 
101(a) of Public Law 106-170. They also will carry out provisions of 
sections 101(d) and (e) of Public Law 106-170 relating to the 
implementation of that program and section 101(b) providing conforming 
amendments to the Act. One of SSA's most important initiatives is to 
assure that Social Security (SSDI) and Supplemental Security Income 
(SSI) beneficiaries with disabilities who want to work have the 
opportunity to do so. Individuals with disabilities face multiple 
barriers in attempting to return to work. The Ticket to Work and Self-
Sufficiency Program, under section 1148 of the Act, removes such 
barriers by providing beneficiaries with disabilities with the 
opportunity to obtain rehabilitation, employment and support services 
from an approved vocational rehabilitation provider of their choice.


Statement of Need:


This regulatory action is necessary to implement Ticket to Work and 
Self-Sufficiency Program under section 1148 of the Act, as added by 
section 101(a) of Public Law 106-170. Changes to existing regulations 
also are needed to reflect amendments to the Act made by section 101(b) 
of Public Law 106-170.


Regulations to implement the Ticket to Work and Self-Sufficiency 
Program are required under section 1148(1) of the Act and section 
101(e) of Public Law 106-170. Section 101(e)(2) of Public Law 106-170 
provides that the matters to be addressed in the regulations shall 
include the following:


(1) The form and manner in which tickets to work and self-sufficiency 
may be distributed to beneficiaries pursuant to section 1148(b)(1) of 
the Act;


(2) The format and wording of such tickets, which shall incorporate by 
reference any contractual terms governing service by employment 
networks under the Program;


(3) The form and manner in which State agencies may elect participation 
in the Ticket to Work and Self-Sufficiency Program pursuant to section 
1148(c)(1) of the Social Security Act and provision for periodic 
opportunities for exercising such elections;


(4) The status of State agencies under section 1148(c)(1) at the time 
that State agencies exercise elections under that section;


(5) The terms of agreements to be entered into with program managers 
pursuant to section 1148(d) of the Act, including:


(a) The terms by which program managers are precluded from direct 
participation in the delivery of services pursuant to section 
1148(d)(3) of the Act;


(b) Standards that must be met by quality assurance measures referred 
to in paragraph (6) of section 1148(d) of the Act and methods of 
requirement of employment networks; and


(c) The format under which dispute resolution will operate under 
section 1148(d)(7) of the Act;


(6) The terms of agreements to be entered into with employment networks 
pursuant to section 1148(d)(4) of the Act, including:


(a) The manner in which service areas are specified pursuant to section 
1148(f)(2)(A) of the Act;


(b) The general selection criteria and the specific selection criteria 
that are applicable to employment networks under section 1148(f)(1)(C) 
of the Act in selecting service providers;


(c) Specific requirements relating to annual financial reporting by 
employment networks pursuant to section 1148(f)(3) of the Act; and


(d) The national model to which periodic outcomes reporting by 
employment networks must conform under section 1148(f)(4) of the Act;


(7) Standards that must be met by individual work plans pursuant to 
section 1148(g) of the Act, including:


(a) The form and manner in which elections by employment networks of 
payment systems are to be exercised pursuant to section 1148(h)(1)(A) 
of the Act;


(b) The terms that must be met by an outcome payment system under 
section 1148(h)(2) of the Act;


(c) The terms that must be met by an outcome-milestone payment system 
under section 1148(h)(3) of the Act;


(d) Any revision of the percentage specified in paragraph (2)(C) of 
section 1148(h) of the Act or the period of time specified in paragraph 
(4)(B) of such section 1148(h) of the Act; and


(e) Annual oversight procedures for such systems; and


(8) Procedures for effective oversight of the Program by the 
Commissioner of Social Security, including periodic reviews and 
reporting requirements.

[[Page 73514]]

Regulations also are needed to implement section 1148(i) of the Act, 
which provides for the suspension of continuing disability reviews 
during any period for which an individual is using, as defined by the 
Commissioner, a ticket to work and self-sufficiency issued under 
section 1148.


Summary of Legal Basis:


Section 1148(i) of the Act, as added by section 101(a) of Public Law 
106-170, and sections 101(d)(5) and (e) of Public Law 106-170 require 
this regulatory action.


Alternatives:


None. This regulatory action is necessary to implement provisions of 
section 101 of Public Law 106-170.


Anticipated Cost and Benefits:


We anticipate substantial costs to start up the program and potential 
savings in later years. The anticipated benefits of this legislation 
include allowing individuals with disabilities to seek the services 
necessary to obtain employment and reduce their dependency on cash 
benefit programs, including SSI and SSDI.


Risks:


None.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           10/00/00
Final Action                                                   12/00/00
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


State


Agency Contact:
Suzanne DiMarino
Social Insurance Specialist
Social Security Administration
Office of Process and Innovation Management
6401 Security Boulevard
Baltimore, MD 21235-6401
Phone: 410 965-1769

Geoffrey Funk
Social Insurance Specialist
Social Security Administration
Office of Employment Support Programs
6401 Security Boulevard
Baltimore, MD 21235-6401
Phone: 410 965-9010
RIN: 0960-AF11
_______________________________________________________________________



SSA



158. TITLE XVI, CROSS-PROGRAM RECOVERY (746F)
Priority:


Other Significant


Legal Authority:


42 USC 1320b-17


CFR Citation:


20 CFR 404.401; 20 CFR 416.558; 20 CFR 416.570; 20 CFR 416.572


Legal Deadline:


None


Abstract:


These final regulations deal with the recovery of overpayments under 
the Supplemental Security Income (SSI) Program. They will permit SSA to 
recover SSI overpayments by adjusting the amount of Social Security 
benefits payable to the individual under title II of the Act. This 
collection practice will be limited to individuals who are not 
currently eligible to receive an SSI cash benefit. Also, the amount of 
the title XVI overpayment recoverable in a month would be limited to 10 
percent of the amount payable under title II, unless the overpaid 
person (or his or her spouse) willfully misrepresented or concealed 
material information about the overpayment. In that case, the entire 
title II benefit amount would be adjusted to recover the overpayment.


Statement of Need:


Section 8 of Public Law 105-306, effective October 28, 1998, added a 
new section 1147 to the Act that gives SSA an additional debt 
collection tool to recover title XVI overpayments. Under section 1147, 
SSA is permitted to recover SSI overpayments by adjusting the amount of 
any benefits payable to the overpaid person under title II of the Act, 
without his or her consent.


Summary of Legal Basis:


Section 8 of Public Law 105-306, effective October 28, 1998, added a 
new section 1147 to the Act that gives SSA an additional debt 
collection tool to recover title XVI overpayments.


Alternatives:


None.


Anticipated Cost and Benefits:


The program savings from increased collections as a result of 
implementation of Public Law 105-306 are $15 million in each of FY 2001 
through FY 2003, $40 million in FY 2004, and $30 million in FY 2005, 
for a total increase of $115 million over 5 years. The administrative 
savings estimate for FY 2001 through FY 2005 is less than $5 million.


Risks:


There are no significant concerns, since the proposed changes reflect 
the current law with respect to recovery of title XVI overpayments from 
title II benefits.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            65 FR 58970                                    10/03/00
Final Action                                                   01/00/01
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


None


Agency Contact:
Edward Johns
Financial Management Analyst
Social Security Administration
6401 Security Boulevard
Baltimore, MD 21235-6401
Phone: 410 965-0392

Robert J. Augustine
Social Insurance Specialist
Social Security Administration
Office of Process and Innovation Management
6401 Security Boulevard
Baltimore, MD 21235-6401
Phone: 410 966-5121
RIN: 0960-AF13
_______________________________________________________________________



SSA



159.  ACCESS TO INFORMATION HELD BY FINANCIAL INSTITUTIONS 
(815P)
Priority:


Other Significant. Major status under 5 USC 801 is undetermined.


Unfunded Mandates:


Undetermined


Legal Authority:


42 USC 1383(e); PL 106-169, sec 213


CFR Citation:


20 CFR 416.200; 20 CFR 416.206 to 416.208; 20 CFR 416.217


Legal Deadline:


None

[[Page 73515]]

Abstract:


We are proposing to implement a new law that will enhance our access to 
bank account information of Supplemental Security Income (SSI) 
applicants or recipients and other individuals whose income and 
resources we treat as belonging to the applicant or recipient.


Statement of Need:


This proposed regulation is required to implement section 213 of Public 
Law 106-169, the Foster Care Independence Act of 1999.


Summary of Legal Basis:


Required by section 213 of Public Law 106-169.


Alternatives:


None.


Anticipated Cost and Benefits:


Costs and benefits are undetermined at this time.


Risks:


Undetermined at this time.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           12/00/00
Final Action                                                   06/00/01
Regulatory Flexibility Analysis Required:


Undetermined


Small Entities Affected:


No


Government Levels Affected:


None


Federalism:


 Undetermined


Agency Contact:
Kathy Branch
Social Insurance Specialist
Social Security Administration
Office of Program Benefits
6401 Security Boulevard
Baltimore, MD 21235-6401
Phone: 410 965-8766

Lawrence V. Dudar
Social Insurance Specialist
Social Security Administration
Office of Process and Innovation Management
6401 Security Boulevard
Baltimore, MD 21235-6401
Phone: 410 966-5995
RIN: 0960-AF43
_______________________________________________________________________



SSA



160.  IMPLEMENTING THE REDESIGNED DISABILITY PROCESS (816P)
Priority:


Other Significant. Major status under 5 USC 801 is 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:


42 USC 301


CFR Citation:


20 CFR 404; 20 CFR 416


Legal Deadline:


None


Abstract:


We propose to implement elements of the redesigned disability claims 
process that have been tested and found to further redesign goals. 
Specifically, we propose to revise the disability determination process 
by: (1) eliminating the reconsideration step of the appeals process; 
(2) enhancing the roles of the disability examiner and medical/
psychological consultant to streamline the process and make more 
effective use of the doctor's knowledge and expertise; and (3) 
increasing claimant contact and explanation of the requirements for 
disability. We propose to implement the redesigned process in phases; 
the existing process will remain in effect for States that have not yet 
adopted the redesigned process.


Statement of Need:


This regulation is necessary to make most effective use of resources in 
order to ensure that disabled claimants are found disabled at the 
earliest point in the claims process, and to better communicate the 
basis for our determinations.


Summary of Legal Basis:


None.


Alternatives:


The Agency is considering various options for phasing in the 
implementation of the redesigned disability claims process.


Anticipated Cost and Benefits:


Unknown at present--the cost/benefit analysis has not yet been 
completed.


Risks:


Not yet established.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           01/00/01
Final Action                                                   10/00/01
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


State, Federal


Additional Information:


RIN 0960-AE73 was merged into this regulation on August 14, 2000.


Agency Contact:
Robert J. Augustine
Social Insurance Specialist
Social Security Administration
Office of Process and Innovation Management
6401 Security Boulevard
Baltimore, MD 21235-6401
Phone: 410 966-5121

Phillip Landis
Director, Disability Process Redesign Staff
Social Security Administration
Office of Disability
6401 Security Boulevard
Baltimore, MD 21235-6401
Phone: 410 965-7414
RIN: 0960-AF44
_______________________________________________________________________



SSA



161.  REVISED MEDICAL CRITERIA FOR DETERMINATION OF DISABILITY, 
CARDIOVASCULAR SYSTEM AND RELATED CRITERIA (826P)
Priority:


Other Significant. Major status under 5 USC 801 is undetermined.


Unfunded Mandates:


Undetermined


Legal Authority:


42 USC 405; 42 USC 1302; 42 USC 1383


CFR Citation:


20 CFR 404.1500, app 1


Legal Deadline:


None


Abstract:


Listings 4.00 and 104.00 of appendix 1 to the disability regulation at 
20 CFR

[[Page 73516]]

404.1501 through 404.1599 describe those cardiovascular impairments 
that are considered severe enough to prevent a person from doing any 
gainful activity or, for a child claiming SSI payments under title XVI, 
that causes marked and severe functional limitations. Comprehensive 
revisions to these listings are being made to ensure that the medical 
evaluation criteria are up to date and consistent with the latest 
advances in medicine. The SSI program incorporates by reference and 
uses the same medical criteria as the old-age, survivors, and 
disability insurance program.


Statement of Need:


These regulations are necessary to update the cardiovascular listing to 
reflect advances in medical knowledge, treatment, and methods of 
evaluating cardiovascular impairments.


Summary of Legal Basis:


Administrative--not required by statute or court order.


Alternatives:


None.


Anticipated Cost and Benefits:


The proposed changes will have negligible program and administrative 
cost impact because, despite changes in terminology and emphasis, the 
proposed cardiovascular system listings describe a level of severity 
comparable to the level of severity contained in the current listings.


Risks:


None.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           06/00/01
Final Action                                                   09/00/01
Regulatory Flexibility Analysis Required:


Undetermined


Small Entities Affected:


No


Government Levels Affected:


None


Federalism:


 Undetermined


Agency Contact:
Lawrence V. Dudar
Social Insurance Specialist
Social Security Administration
Office of Process and Innovation Management
6401 Security Boulevard
Baltimore, MD 21235-6401
Phone: 410 966-5995

Bonnie Davis
Social Insurance Specialist
Social Security Administration
Office of Disability
6401 Security Boulevard
Baltimore, MD 21235-6401
Phone: 410 965-4172
RIN: 0960-AF48
_______________________________________________________________________



SSA



162.  REPRESENTATIVE PAYMENT UNDER TITLE II AND XVI OF THE 
SOCIAL SECURITY ACT
Priority:


Other Significant. Major status under 5 USC 801 is undetermined.


Unfunded Mandates:


Undetermined


Legal Authority:


42 USC 401(j); 42 USC 902(a)(5); 42 USC 405 note; 42 USC 421 note; 42 
USC 1383(a)(2); 42 USC 1383(d)(1); 42 USC 404(f); 42 USC 405(a); 42 USC 
405(b); 42 USC 405(d) to 405(h); 42 USC 405(j); 42 USC 405(k); 42 USC 
421; 42 USC 425


CFR Citation:


20 CFR 404.902; 20 CFR 404.2011; 20 CFR 404.2022; 20 CFR 404.2024; 20 
CFR 404.2025; 20 CFR 404.2030; 20 CFR 404.2041; 20 CFR 404.2050; 20 CFR 
416.611; 20 CFR 416.622; 20 CFR 416.624; 20 CFR 416.625; 20 CFR 416.630


Legal Deadline:


None


Abstract:


Effective stewardship of SSA programs requires mechanisms to assure 
that benefits are used to meet the needs of beneficiaries who are not 
able to manage their own benefits due to legal incompetence or medical 
infirmity. Congress determined that improvements to the representative 
payment procedures were needed to assure program integrity. These 
regulations are required to further our program integrity efforts.


Statement of Need:


These regulations, which reflect certain provision of Public Law 101-
508, 103-296, 104-121, and 105-33, modify existing representative payee 
procedures by: (1) requiring the Social Security Administration to do a 
more extensive investigation of representative payee applicants, 
generally limiting to 1 month the deferral or suspension of direct 
payment of benefits pending selection of a payee; (2) providing 
stricter standards in determining the fitness of representative payee 
applicants to manage benefit payments on behalf of beneficiaries; (3) 
requiring SSA to repay the beneficiary or an alternate payee, an amount 
equal to any misused funds resulting from SSA's negligent failure to 
investigate or monitor a representative payee; (4) granting certain 
payees the authority to collect a fee from beneficiaries, changing how 
SSA treats persons with a drug addition or an alcohol condition; and 
(5) requiring SSA to compile and maintain a centralized file of certain 
beneficiary and payee information.


These regulations are needed to reflect certain provisions of Public 
Law 101-508 (OBRA '90), 103-296, 104-121 and 105-33. Sections 205(a), 
1102 and 1631(d) of the Act give the Commissioner broad power to make 
rules and carry out these provisions.


Summary of Legal Basis:


These regulations implement section 5105 of Public Law 101-508, section 
210 of Public Law 103-296, section 105 of Public Law 104-121, section 
5525 of Public Law 105-33.


Alternatives:


None.


Anticipated Cost and Benefits:


Any costs associated with these regulations are reflected in the 
President's budget as part of legislative implementation. They are 
required to further our program integrity efforts.


Risks:


None.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           10/00/00
Final Action                                                   06/00/01
Regulatory Flexibility Analysis Required:


Undetermined


Small Entities Affected:


No

[[Page 73517]]

Government Levels Affected:


None


Federalism:


 Undetermined


Agency Contact:
Betsy Byrd
Program Policy Specialist
Social Security Administration
Office of Program Benefits
6401 Security Boulevard
Baltimore, MD 21235-6401
Phone: 410 965-7981

Lawrence V. Dudar
Social Insurance Specialist
Social Security Administration
Office of Process and Innovation Management
6401 Security Boulevard
Baltimore, MD 21235-6401
Phone: 410 966-5995
RIN: 0960-AF49
_______________________________________________________________________



SSA

                              -----------

                            FINAL RULE STAGE

                              -----------




163. OASDI, AND SSI FOR THE AGED, BLIND AND DISABLED; SUBSTANTIAL 
GAINFUL ACTIVITY AMOUNTS; ``SERVICES'' FOR TRIAL WORK PERIOD PURPOSES--
MONTHLY AMOUNTS; STUDENT-EARNED INCOME EXCLUSION (777F)
Priority:


Other Significant


Legal Authority:


42 USC 402; 42 USC 405(a); 42 USC 405(b); 42 USC 405(d) to 405(h); 42 
USC 416(i); 42 USC 421(a); 42 USC 421(i); 42 USC 422(c); 42 USC 423; 42 
USC 425; 42 USC 902(a)(5); 42 USC 1382; 42 USC 1382c; 42 USC 1382h; 42 
USC 1383(a); 42 USC 1383(c); 42 USC 1383(d)(1); 42 USC 1383b


CFR Citation:


20 CFR 404.1574; 20 CFR 404.1592; 20 CFR 416.974; 20 CFR 1112


Legal Deadline:


None


Abstract:


These final regulations will automatically increase the average monthly 
earnings guide used to determine whether work done by persons with 
impairments other than blindness is substantial gainful activity (SGA). 
As of July 1999, average monthly earnings above $700 are considered 
SGA. These final regulations increase the minimum monthly amount of 
earnings that demonstrate that a person is performing services during a 
trial work period, and automatically increase the amount each 
subsequent year. Additionally, these final regulations update the 
amount of the student-earned-income exclusion (SEIE) and adjust the 
SEIE for inflation annually, using the consumer price index.


Statement of Need:


This regulation fulfills SSA's promise to the public that was provided 
in conjunction with the regulation that increased the SGA level 
effective July 1999, that SSA would consider adopting appropriate 
changes to SGA in the future. Additionally, this regulation should 
encourage SSA beneficiaries with disabilities to return to work; a 
major initiative of the Agency.


Summary of Legal Basis:


None


Alternatives:


None


Anticipated Cost and Benefits:


This regulation has been determined to have a negligible cost for the 
Agency. The public will be able to enjoy the benefits of having the 
various items addressed in the regulation: the monthly SGA amount; the 
amount of the TWP service month; and the SEIE automatically increased 
each year, if appropriate, rather than waiting for SSA to take steps to 
increase these items.


Risks:


None


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            65 FR 49208                                    08/11/00
Final Action                                                   01/00/01
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


None


Agency Contact:
Robert J. Augustine
Social Insurance Specialist
Social Security Administration
Office of Process and Innovation Management
6401 Security Boulevard
Baltimore, MD 21235-6401
Phone: 410 966-5121

Ray Marzoli
Social Insurance Specialist
Social Security Administration
Office of Employment Support Systems
6401 Security Boulevard
Baltimore, MD 21235-6401
Phone: 410 965-9826
RIN: 0960-AF12
BILLING CODE 4191-02-S




[[Page 73518]]

COMMODITY FUTURES TRADING COMMISSION (CFTC)



Statement of Regulatory Priorities
The mission of the Commodity Futures Trading Commission is to protect 
market users and the public from fraud, manipulation, and abusive 
practices related to the sale of commodity futures and options and to 
foster open, competitive, and financially sound commodity futures and 
option markets. The Commission's objectives are to: (1) Foster futures 
and option markets that accurately reflect the forces of supply and 
demand for the underlying commodity and are free of disruptive 
activity; (2) oversee markets which can be used effectively by 
producers, processors, financial institutions, and other firms for the 
purposes of price discovery and risk shifting; (3) promote compliance 
with, and deter violations of, Federal commodities laws; (4) require 
commodities professionals to meet high standards; (5) provide a forum 
for effectively and expeditiously handling customer complaints against 
persons or firms registered under the Commodity Exchange Act; (6) 
ensure sound financial practices of clearing organizations and firms 
holding customer funds; (7) promote and enhance effective self-
regulation of the commodity futures and option markets; (8) facilitate 
the continued development of an effective, flexible regulatory 
environment responsive to evolving market conditions; and (9) promote 
markets free of trade practice abuses.
_______________________________________________________________________



CFTC

                              -----------

                            FINAL RULE STAGE

                              -----------




164.  NEW REGULATORY FRAMEWORK FOR MULTILATERAL TRANSACTION 
EXECUTION FACILITIES, INTERMEDIARIES, AND CLEARING ORGANIZATIONS
Priority:


Other Significant


Legal Authority:


7 USC 6, 6c, 6i, 7, 7a, 8, 12a


CFR Citation:


17 CFR 1.37; 17 CFR 1.41; 17 CFR 5; 17 CFR 15; 17 CFR 20; 17 CFR 36 to 
38


Legal Deadline:


None


Abstract:


The Commission is proposing a new regulatory framework to apply to 
multilateral transaction execution facilities that trade futures and 
commodity options. Specifically, the Commission is proposing to replace 
the current ``one-size-fits-all'' regulation for futures markets with 
broad, flexible ``Core Principles,'' and to establish three regulatory 
tiers for markets: recognized futures exchanges, derivatives 
transaction facilities, and exempt multilateral transaction facilities. 
The Core Principles are tailored to match the degree and manner of 
regulation to the varying nature of the products traded thereon, and to 
the sophistication of customers.


Statement of Need:


The futures markets are poised to undergo rapid change as they continue 
to meet the competitive challenges posed by technological advances. The 
new framework will provide U.S. futures exchanges the flexibility to 
respond to these challenges by offering a level of regulation tailored 
to three alternative types of markets.


Summary of Legal Basis:


The new framework constitutes a broad exemption under the authority of 
Section 4(c) of the Commodity Exchange Act, 7 USC 6(c). The Commission 
was encouraged in this undertaking by the other Federal financial 
regulators that comprise the President's Working Group on Financial 
Markets and by the Chairmen of the Commission's oversight committees.


Alternatives:


In the absence of this proposed new regulatory framework, the exchanges 
would continue to be governed by a ``one-size-fits-all'' regulatory 
scheme.


Anticipated Cost and Benefits:


The anticipated benefits of the proposed framework are that it will 
promote innovation and competition in the trading of derivatives and 
permit futures markets the flexibility to respond to technological and 
structural changes. At the same time, the framework is designed to 
reduce systemic risk and protect customers.


Risks:


The U.S. futures exchanges currently face competitive challenges which 
the new regulatory framework is intended to help the exchanges address. 
The new regulatory framework is also designed to reduce systemic risk 
and protect customers.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            65 FR 38986                                    06/22/00
NPRM Comment Per65 FR 49208d                                   08/11/00
NPRM Comment Period End                                        08/21/00
Final Action                                                   10/00/00
Final Active Effective                                         12/00/00
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


None


Agency Contact:
Paul M. Architzel
Chief Counsel, Division of Economic Analysis
Commodity Futures Trading Commission
Three Lafayette Centre
1155 21st Street NW
Washington, DC 20581
Phone: 202 418-5260
Fax: 202 418-5527
Email: [email protected]

Riva Spear Adriance
Attorney Advisor, Division of Trading and Markets
Commodity Futures Trading Commission
Three Lafayette Centre
1155 21st Street, NW
Washington, DC 20581
Phone: 202 418-5494
Fax: 202 418-5536
Email: [email protected]

Alan L. Seifert
Deputy Director, Division of Trading and Markets
Commodity Futures Trading Commission
Three Lafayette Centre
1155 21st Street, NW
Washington, DC 20581
Phone: 202 418-5490
Email: [email protected]
RIN: 3038-AB55
_______________________________________________________________________



CFTC



165.  RULES RELATING TO INTERMEDIARIES OF COMMODITY INTEREST 
TRANSACTIONS
Priority:


Other Significant

[[Page 73519]]

Legal Authority:


7 USC 2; 7 USC 6; 7 USC 6b; 7 USC 6d; 7 USC 6f; 7 USC 6m; 7 USC 6n; 7 
USC 12a; 7 USC 23


CFR Citation:


17 CFR 1.3, 1.10, 1.17, 1.20, 1.25-1.29; 17 CFR 1.33, 1.46, 1.52, 1.55; 
17 CFR 3.1, 3.10, 3.32, 3.34; 17 CFR 4.10, 4.24, 4.34; 17 CFR 140.91; 
17 CFR 3 app B; 17 CFR 155.6; 17 CFR 166.5


Legal Deadline:


None


Abstract:


The Commission has undertaken an extensive review of the rules 
promulgated under the Commodity Exchange Act. As part of this 
regulatory reform process, the Commission is proposing to amend several 
of its rules relating to intermediation of commodity interest 
transactions. If adopted, these rule amendments would provide for: (1) 
An expanded range of instruments in which FCMs may invest customer 
funds; (2) simplified registration procedures for FCMs and IBs 
operating exclusively on recognized derivatives transaction facilities 
(DTFs) for institutional customers; (3) elimination of the required 
submission of a certified financial report as part of FCM or IB 
registration procedures; (4) effective replacement of the required 
ethics training for Commission registrants with a Statement of 
Acceptable Practices; (5) amendment of the definition of ``principal'' 
in Rule 3.1(a) to exclude certain officers of a firm; (6) 
simplification of account opening procedures by permitting a single 
signature for all documents (except for a predispute arbitration 
agreement in the case of a non-institutional customer) and elimination 
of the prescribed disclosure statement delivery requirement for 
governmental entities; (7) codification of a previous interpretation 
permitting electronic transmission of account statements; and (8) 
greater customer choice concerning the close-out of offsetting 
positions.


Statement of Need:


U.S. futures markets are poised to undergo rapid change as they 
continue to meet the competitive challenges posed by technological 
advances and increasing globalization. These technological advances 
allow for greater trading opportunities through electronic platforms as 
opposed to traditional floor-based exchanges. Consequently, the role 
and functions of intermediaries in futures transactions are subject to 
change. To facilitate the continued development of an effective, 
flexible regulatory environment responsive to evolving market 
conditions, the Commission is proposing a package of rule amendments 
applicable to intermediaries. These rule amendments are being proposed 
in conjunction with proposals for new regulatory frameworks for 
multilateral transaction execution facilities and for clearing 
organizations. Taken together, these regulatory initiatives are 
intended to promote innovation and to maintain U.S. competitiveness, 
and at the same time reduce systemic risk and protect customers.


Summary of Legal Basis:


Section 8a(5) of the Commodity Exchange Act authorizes the Commission 
to promulgate such rules as, in the judgment of the Commission, are 
reasonably necessary to effectuate any of the provisions or to 
accomplish any of the purposes of the Act. Various other provisions of 
the Act grant the Commission general rulemaking authority concerning 
registration, recordkeeping, and investment of customer funds.


Alternatives:


Absent the Commission's regulatory reform initiative, U.S. 
intermediaries would face increasingly greater challenges from 
technological advances and global competition. U.S. intermediaries 
would also be deprived of the advantages of a modernized, flexible, and 
streamlined regulatory environment.


Anticipated Cost and Benefits:


As a financial regulator, the Commission is acutely aware of the costs 
of regulation. Throughout its history, the Commission has been 
sensitive to the costs of its proposed rules as compared to the 
benefits of such rules.


Risks:


In addition to the formal comment period on the proposals, the 
Commission held an open hearing on the proposals. Further, prior to the 
drafting of the proposals, a Commission staff task force engaged in 
extensive consultations with interested parties in developing a report 
to the Commission's Congressional oversight committees entitled A New 
Regulatory Framework. All of these efforts are intended to minimize the 
risk that the Commission's rules are not sufficiently flexible to 
respond to evolving market conditions.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            65 FR 39008                                    06/22/00
NPRM Comment Per65 FR 49208d                                   08/11/00
NPRM Comment Period End                                        08/21/00
Final Action                                                   10/00/00
Final Action Effective                                         12/00/00
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


None


Agency Contact:
Lawrence B. Patent
Associate Chief Counsel, Division of Trading and Markets
Commodity Futures Trading Commission
Three Lafayette Centre
1155 21st Street NW.
Washington, DC 20581
Phone: 202 418-5439
Email: [email protected]
RIN: 3038-AB56
_______________________________________________________________________



CFTC



166.  NEW REGULATORY FRAMEWORK FOR CLEARING ORGANIZATIONS
Priority:


Other Significant


Legal Authority:


7 USC 2; 7 USC 6(c); 7 USC 7a; 7 USC 12a(5)


CFR Citation:


17 CFR 39


Legal Deadline:


None


Abstract:


The Commission is proposing new part 39 of its rules that would apply 
to clearing organizations, as defined in the proposed rules. This 
proposal, centered on broad, flexible core principles, is part of an 
initiative proposing a new regulatory framework applicable to 
multilateral transaction execution facilities and market intermediaries 
in addition to clearing organizations. The new regulatory framework is 
designed to promote innovation, maintain U.S. competitiveness, and move 
the Commission from a direct to an oversight regulator. Part 39 of this

[[Page 73520]]

framework will establish core principles, supplemented with statements 
of guidance, that must be met by organizations that clear or desire to 
clear futures and options contracts executed on derivatives transaction 
execution facilities or recognized futures exchanges.


Statement of Need:


The performance of the functions involved in clearing for futures and 
options markets can raise concerns regarding concentration of financial 
risk and credit risk in a single entity. Organizations clearing 
contracts executed on derivatives transaction facilities and recognized 
futures exchanges should be subject to regulatory oversight to ensure 
that such facilities are capitalized sufficiently and that they 
establish and implement a risk management program that is designed to 
control the credit concentration risk associated with centralized 
clearing.


Summary of Legal Basis:


The Commission currently oversees the clearing organizations that are 
associated or affiliated with U.S. futures and option exchanges. The 
Commission was encouraged in this undertaking by the President's 
Working Group on Financial Markets and by the Chairmen of the 
Commission's Congressional oversight committees.


Alternatives:


In the absence of this proposed new regulatory framework and Part 39, 
the Commission would continue to oversee U.S. futures and options 
clearing organizations and otherwise carry out its Congressional 
mandate in its current style as a direct, design-based regulator.


Anticipated Cost and Benefits:


As a financial regulator, the Commission is acutely aware of the costs 
of regulation. Throughout its history, the Commission has taken into 
account the costs of its proposed regulations in order to ensure that 
the benefits of its regulations outweigh the costs. No aspect of Part 
39 would adversely affect small entities as defined under the 
Regulatory Flexibility Act, 5 U.S.C. 601-611 (1988).


Risks:


By promulgating broad, flexible, core principles for organizations that 
clear futures and options contracts on derivatives transaction 
facilities and recognized futures exchanges, the Commission is able to 
effectively ensure that such facilities are adequately capitalized, 
implement satisfactory risk management programs, and are otherwise 
subject to an appropriate level of regulatory oversight.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            65 FR 39027                                    06/22/00
NPRM Comment Period Extended                                   08/11/00
NPRM Comment Period End                                        08/21/00
Final Action                                                   10/00/00
Final Action Effective                                         12/00/00
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


None


Agency Contact:
Lois J. Gregory
Special Counsel, Division of Trading and Markets
Commodity Futures Trading Commission
Three Lafayette Centre
1155 21st Street NW
Washington, DC 20581
Phone: 202 418-5260
Fax: 202 418-5536
Email: [email protected]
RIN: 3038-AB57
_______________________________________________________________________



CFTC



167.  EXEMPTION FOR BILATERAL TRANSACTIONS
Priority:


Other Significant


Legal Authority:


7 USC 2; 7 USC 6; 7 USC 6c; 7 USC 12a


CFR Citation:


17 CFR 35


Legal Deadline:


None


Abstract:


The Commission is proposing to expand and to clarify the operation of 
the Part 35 Swaps Exemption, including the availability of clearing for 
these transactions. These proposed amendments would provide greater 
legal certainty to the OTC markets and reduce systemic risk.


Statement of Need:


The Part 35 amendments respond to changes that have occurred in the 
over-the-counter market since the Commission adopted its swaps policy 
statement in 1989, and its subsequent Part 35 swaps exemption in 1993.


Summary of Legal Basis:


The amendments are being proposed under Section 4(c) of the Commodity 
Exchange Act, 7 USC 6(c), which grants the Commission broad exemptive 
authority. The Commission was encouraged in this undertaking by the 
other Federal financial regulators that comprise the President's 
Working Group on Financial Markets and by the Chairmen of the 
Commission's oversight committees.


Alternatives:


In the absence of the proposed amendments, the Commission's regulations 
would not be responsive to the changes that have occurred in the OTC 
market over the past decade.


Anticipated Cost and Benefits:


The anticipated benefits of the proposed rules are to enhance legal 
certainty and reduce systemic risk for transactions entered into in the 
OTC market.


Risks:


The proposal is designed to enhance legal certainty and reduce systemic 
risk for transactions entered into in the OTC market.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            65 FR 39033                                    06/22/00
NPRM Comment Period Extended                                   08/11/00
NPRM Comment Period End                                        08/21/00
Final Action                                                   10/00/00
Final Action Effective                                         12/00/00
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


None

[[Page 73521]]

Agency Contact:
Paul M. Architzel
Chief Counsel, Division of Economic Analysis
Commodity Futures Trading Commission
Three Lafayette Centre
1155 21st Street NW
Washington, DC 20581
Phone: 202 418-5260
Fax: 202 418-5527
Email: [email protected]
RIN: 3038-AB58
BILLING CODE 6351-01-S




[[Page 73522]]

CONSUMER PRODUCT SAFETY COMMISSION (CPSC)



Statement of Regulatory Priorities
 The U.S. Consumer Product Safety Commission is charged with protecting 
the public from unreasonable risks of death and injury associated with 
consumer products. To achieve this goal, the Commission:
 participates in the development or revision of voluntary 
            product safety standards;
 develops mandatory product safety standards or banning rules 
            when other, less restrictive, efforts are inadequate to 
            address a safety hazard;
 obtains repairs, replacement, or refund of the purchase price 
            for defective products that present a substantial product 
            hazard; and
 develops information and education campaigns about the safety 
            of consumer products.
 When deciding which of these approaches to take in any specific case, 
the Commission gathers the best available data about the nature and 
extent of the hazard presented by the product. The Commission then 
analyzes this information to determine the best way to reduce the 
hazard in each case. The Commission's rules require the Commission to 
consider, among other factors, the following criteria when deciding the 
level of priority for any particular project:
 frequency and severity of injury;
 causality of injury;
 chronic illness and future injuries;
 costs and benefits of Commission action;
 unforeseen nature of the risk;
 vulnerability of the population at risk;
 probability of exposure to the hazard.
 Additionally, if the Commission proposes a mandatory safety standard 
for a particular product, the Commission is generally required to make 
statutory cost/benefit findings and adopt the least burdensome 
requirements that adequately protect the public.
 The Commission's statutory authority requires it to rely on voluntary 
standards rather than mandatory standards whenever a voluntary standard 
is likely to result in the elimination or adequate reduction of the 
risk of injury and it is likely that there will be substantial 
compliance with the voluntary standard. As a result, much of the 
Commission's work involves cooperative efforts with other participants 
in the voluntary standard-setting process rather than promulgating 
mandatory standards.
 In fiscal year 2001, the Commission's significant rulemaking 
activities will involve: (1) addressing risks of fire associated with 
ignition of upholstered furniture by small open flames, and (2) a 
requirement that drugs, when switched by the Food and Drug 
Administration from prescription to over-the-counter status, remain in 
child-resistant packaging to protect children from being poisoned by 
gaining access to the drugs.
 The emphasis on these rulemaking activities in the Commission's FY 
2001 regulatory plan is consistent with the Commission's statutory 
mandate and its criteria for setting priorities.
_______________________________________________________________________



CPSC

                              -----------

                          PROPOSED RULE STAGE

                              -----------




168. FLAMMABILITY STANDARD FOR UPHOLSTERED FURNITURE
Priority:


Economically Significant. Major status under 5 USC 801 is undetermined.


Legal Authority:


15 USC 1193, Flammable Fabrics Act


CFR Citation:


16 CFR 1640


Legal Deadline:


None


Abstract:


On June 15, 1994, the Commission published an advance notice of 
proposed rulemaking (ANPRM) to begin a proceeding for development of a 
flammability standard to address risks of death, injury, and property 
damage from fires associated with ignition of upholstered furniture by 
small open-flame sources such as matches, lighters, or candles. This 
ANPRM was issued after the Commission granted part of a petition 
requesting development of a mandatory flammability standard to address 
risks of injury from ignition of upholstered furniture by: (1) small 
open-flame sources; (2) large open-flame sources; and (3) cigarettes. 
The Commission voted to deny that part of the petition requesting 
development of a mandatory standard to address hazards associated with 
ignition of upholstered furniture by large open-flame sources. The 
Commission also voted to defer a decision on that part of the petition 
requesting development of a standard to address cigarette ignition, and 
directed the staff to report to the Commission on the effectiveness of, 
and the extent of industry compliance with, a voluntary program to 
reduce risks of ignition of upholstered furniture by cigarettes. The 
Commission staff developed a draft standard to address ignition of 
upholstered furniture by small open-flame sources.


On March 2, 1998, the Commission voted to defer action on small open-
flame sources and gather additional information on the potential 
toxicity of flame-retardant chemicals that might be used to meet a 
standard. A public hearing on this subject was held May 5-6, 1998. The 
staff is analyzing data from the hearing and completing other technical 
studies. In CPSC's 1999 appropriations legislation, Congress directed 
the Commission to contract with the National Academy of Sciences (NAS) 
for an independent study of potential health hazards associated with 
the use of flame retardant chemicals that might be used in upholstered 
furniture fabrics to meet a CPSC standard. The draft NAS report was 
completed and forwarded to Congress in April 2000; the final NAS report 
was published in July 2000. The report concluded that of 16 flame-
retardant chemicals reviewed, 8 could be used in upholstered furniture 
fabrics without presenting health hazards to consumers. Additional 
exposure studies were recommended for the remaining eight chemicals. 
The report indicates that a number of suitable flame-retardant 
treatments are available; these include treatments already in use in 
various textile products, including upholstered furniture sold in the 
United Kingdom to meet existing U.K. flammability regulations.


CPSC is also considering possible impacts of flame-retardant chemical 
use on worker safety and the environment. At the CPSC staff's request, 
the National Institute of Occupational Safety and Health is assessing 
potential worker exposure to and risks from certain flame-retardant 
chemicals that may be used by textile and furniture producers to comply 
with an upholstered furniture flammability standard. The CPSC staff is 
also working with the Environmental Protection Agency to consider 
possible controls on flame-retardant compounds used in residential 
upholstered furniture fabrics under that agency's Toxic Substances 
Control Act Authority. Upon completion of its chemical risk assessment 
and other technical activities, the CPSC staff will

[[Page 73523]]

present alternatives for future action by the Commission.


Statement of Need:


In 1997, approximately 650 deaths, more than 1,500 injuries, and about 
$225 million in property damage resulted from 11,500 residential fires 
in the United States in which upholstered furniture was the first item 
to ignite. The total societal cost attributable to upholstered 
furniture fires was approximately $3.75 billion in 1997. This total 
includes fires ignited by small open-flame sources, large open-flame 
sources, and cigarettes. Of these, open-flame fires accounted for 
approximately 80 deaths, 500 injuries and $64 million in property 
losses.


Summary of Legal Basis:


Section 4 of the Flammable Fabrics Act (FFA) (15 USC 1193) authorizes 
the Commission to issue a flammability standard or other regulation for 
a product of interior furnishing if the Commission determines that such 
a standard is ``needed to adequately protect the public against 
unreasonable risk of the occurrence of fire leading to death or 
personal injury, or significant property damage.''


The Commission's regulatory proceeding could result in several actions, 
one of which could be the development of a mandatory standard requiring 
that upholstered furniture sold in the United States meet mandatory 
labeling requirements, resist ignition, or meet other performance 
criteria under test conditions specified in the standard.


Alternatives:


The ANPRM stated that the Commission was considering the following 
alternatives:


(1) The Commission could issue a mandatory flammability standard if the 
Commission finds that such a standard is needed to address an 
unreasonable risk of the occurrence of fire from ignition of 
upholstered furniture by small open-flame sources;


(2) The Commission could issue mandatory requirements for labeling of 
upholstered furniture, in addition to, or as an alternative to, the 
requirements of a mandatory flammability standard;


(3) The Commission could terminate the proceeding for development of a 
flammability standard and rely on a voluntary standard if a voluntary 
standard would adequately address the risk of fire and substantial 
compliance with such a standard is likely to result; and


(4) The Commission could terminate the proceeding and withdraw the 
ANPRM.


Anticipated Cost and Benefits:


The estimated annual cost of imposing a mandatory standard to address 
ignition of upholstered furniture by small open-flame sources will 
depend upon the test requirements imposed by the standard and the steps 
manufacturers take to meet those requirements. Again, depending upon 
the test requirements, a small open-flame standard could also reduce 
cigarette-ignited fire losses, the societal cost of which was over $2 
billion in 1997. For this reason, the potential benefits of a mandatory 
standard to address the risk of ignition of upholstered furniture by 
small open-flame sources could be significant, even if the standard did 
not prevent all such fires started by open-flame sources.


Risks:


The estimated total cost to society from all residential fires 
associated with upholstered furniture was $3.75 billion in 1997.


Societal costs associated with upholstered furniture fires are among 
the highest associated with any product subject to the Commission's 
authority. A standard has the potential to reduce these societal costs.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
ANPRM           59 FR 30735                                    06/15/94
ANPRM Comment Period End                                       08/15/94
Staff Briefing of Commission on NPRM                           12/18/97
Commission Voted To Defer Action Pending Results of Toxicity He03/02/98
Commission Hearing May 5 & 6, 1998 on Possible Toxicity of Flame 
        Retardan63 FR 13017                                    03/17/98
NAS Study Completed (Required by Congress)                     07/10/00
Staff Sends Briefing Package to Commission                     02/00/01
Regulatory Flexibility Analysis Required:


Undetermined


Government Levels Affected:


Undetermined


Federalism:


 Undetermined


Agency Contact:
Dale R. Ray
Project Manager, Directorate for Economic Analysis
Consumer Product Safety Commission
Washington, DC 20207
Phone: 301 504-0962
Email: [email protected]
RIN: 3041-AB35
_______________________________________________________________________



CPSC



169.  REQUIREMENT FOR SPECIAL PACKAGING OF ORAL PRESCRIPTION 
DRUGS THAT ARE GRANTED OVER-THE-COUNTER STATUS BY THE FOOD AND DRUG 
ADMINISTRATION
Priority:


Other Significant. Major status under 5 USC 801 is undetermined.


Unfunded Mandates:


Undetermined


Legal Authority:


15 USC 1471, Poison Prevention Packaging Act


CFR Citation:


Not Yet Determined


Legal Deadline:


None


Abstract:


On June 23, 2000, the Commission directed the CPSC staff to draft a 
notice of proposed rulemaking to require that the child-resistant 
packaging requirements for oral prescription drugs continue when the 
active chemicals are granted over-the-counter (OTC) status by the Food 
and Drug Administration (FDA). The current regulations under the Poison 
Prevention Packaging Act (PPPA) require child-resistant packaging of 
most oral prescription drugs. However, when the FDA allows an oral 
prescription drug to be sold OTC, child-resistant packaging of that 
drug is no longer required. When the Commission finds that a particular 
switched OTC drug requires child-resistant packaging because it may 
cause serious injury or serious illness, it must issue an individual 
rule, which may not take effect for several years after the switch.


On August 30, 2000, the Commission issued a proposed rule that would 
automatically require drugs that have been switched after the effective 
date

[[Page 73524]]

of the rule to be in child-resistant packaging. Under the proposed 
rule, drugs switched by FDA from prescription to OTC before the 
effective date of the rule would not automatically have to be in child-
resistant packaging. This proposed rule provides that those companies 
that believe their drug product does not need to be in child-resistant 
packaging can provide information to the Commission, as they do 
currently under the PPPA oral prescription drug rule, to demonstrate 
either: (1) that the drug product will not injure children if it is 
marketed in non-child-resistant packaging, or (2) that child-resistant 
packaging is not technically feasible, practicable, or appropriate for 
the oral drug when marketed as an OTC product. If the Commission 
agrees, it will by rule exempt the drug product from the PPPA 
requirements. The Federal Register notice also proposes to revoke 16 
CFR 1702.16(b) to allow petitions for exemptions from child-resistant 
packaging requirements to be submitted and considered by the Commission 
before the new drug applications (NDA) are approved by the FDA. This 
would decrease the potential financial and regulatory burdens to the 
drug company associated with a post-marketing package change.


The notice issued by the Commission includes proposed findings that 
child-resistant packaging for these products is technically feasible, 
practicable, and appropriate, as well as necessary to protect children 
from serious personal injury and illness resulting from handling, 
using, or ingesting the drug products. It is anticipated that this 
proposed rule would not create a financial burden on small companies.


Statement of Need:


Currently CPSC must issue a separate child-resistant packaging 
requirement for each oral prescription drug that the FDA allows to be 
sold OTC in order to maintain child-resistant packaging for that drug. 
This proposed rule would require that children have the same protection 
when the drugs are more widely available as OTC products as they had 
when the drugs were available only by prescription.


Summary of Legal Basis:


Section 3 of the PPPA, 15 U.S.C. 1472, authorizes the Commission to 
issue special packaging standards for household substances if it finds 
that special packaging is necessary to protect children from serious 
injury or illness and that special packaging is technically feasible, 
practicable, and appropriate.


Alternatives:


The Commission can either: (1) issue a final rule requiring that oral 
prescription drugs continue to require child-resistant packaging when 
they are granted OTC status by the FDA, or (2) continue to issue 
regulations on a case-by-case basis after the status of the drug 
products has been switched to OTC.


Anticipated Cost and Benefits:


This project supports the Commission's strategic goal of keeping 
children safe from poisoning hazards. Children would have the same 
protection when drugs are more widely available as OTC preparations as 
they had when the drugs were available only by prescription. In 
general, the incremental cost of child-resistant packaging is mimimal 
($0.005-$0.02).


Risks:


For prescription medicines and aspirin alone, CPSC estimates that about 
800 children's lives have been saved by the requirement for child-
resistant packaging. However, there continues to be about 30 deaths and 
1 million calls to poison control centers about poisonings to young 
children each year. Without this rule, there is the potential for 
certain oral drugs to be sold without child-resistant packaging when 
they are available as OTC drugs, even though they required special 
packaging as prescription drugs. Children are at risk for serious 
injury from ingesting these products if child-resistant packaging is 
not required.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
Staff Briefing of Commission on Whether to Issue an NPRM       06/07/00
Commission Decision to Prepare a Draft NPRM                    06/23/00
NPRM            65 FR 52678                                    08/30/00
NPRM Comment Period End                                        11/13/00
Staff Sends Briefing Package to Commission                     03/00/01
Regulatory Flexibility Analysis Required:


No


Government Levels Affected:


None


Agency Contact:
Suzanne Barone Ph.D.
Project Manager
Consumer Product Safety Commission
Directorate for Health Sciences
Washington, DC 20207
Phone: 301 504-0477
Email: [email protected]
RIN: 3041-AB92
BILLING CODE 6355-01-S




[[Page 73525]]

FEDERAL ENERGY REGULATORY COMMISSION (FERC)



Statement of Regulatory Priorities
 The Federal Energy Regulatory Commission regulates key interstate 
aspects of the electric power, natural gas pipeline, oil pipeline, and 
hydroelectric industries. The Commission seeks to protect customers 
using regulatory approaches that foster competitive markets whenever 
possible, assure access to reliable service at a reasonable price, and 
give full and fair consideration to environmental and community impacts 
in assessing the public interest of energy projects.
 The 2000 regulatory priorities reflect the Commission's commitment to 
its strategic goals:
 promoting competitive markets;
 protecting customers;
 respecting the environment; and
 serving and safeguarding the public.
 While much of the Commission's regulatory activity continues to be 
done in case-specific adjudications, the Commission has increasingly 
employed generic rulemakings to pursue its strategic goals and carry 
out its statutory responsibilities. With respect to many of the 
Commission's major policy initiatives, the Commission has completed the 
rulemaking process by issuing final rules and orders on rehearing in 
the past year. These important initiatives are now in the equally 
important rule implementation stage.
 The industries the Commission regulates are changing very rapidly in 
response to increasing competition and environmental awareness. The 
Commission is responding by implementing the following key initiatives:
 Energy Markets:
 Final Rule on Formation of Regional Transmission Organizations 
            (Order No. 2000)
 Final Rule on Regulation of Natural Gas Transportation 
            Services (Order No. 637)
 Energy Projects:
 Policy Statement on Determining Need for New Pipeline 
            Facilities
 Final Rule on Landowner Notification
 Procedural Reforms:
 Rulemaking on Electronic Filing
 Rulemakings to Reengineer Reporting Requirements
 The Commission has been innovative in using active outreach efforts to 
inform its generic policy development and its rulemaking efforts. For 
example, the Commission has had great success in using informal 
meetings with a wide variety of stakeholders to inform the development 
of its major rulemakings on regional transmission organizations (Order 
No. 2000) and on natural gas transportation policy (Order No. 637). The 
Commission has also used active outreach as a tool in promoting 
constructive implementation of Order No. 2000, assisting regional 
groups, as requested, in the development of regional transmission 
organization (RTO) proposals. Moreover, it has committed, in Order No. 
637, to an ongoing dialogue with interested parties on possible further 
reforms for natural gas regulation.
Energy Markets
 In carrying out its statutory responsibilities for economic regulation 
of interstate aspects of electricity and natural gas pipeline markets, 
the Commission is pursuing policies designed to promote competitive 
markets and protect customers. To support competition in electricity 
and natural gas markets, the Commission regulates access to and pricing 
of essential electricity transmission and natural gas transportation 
services so as to eliminate undue discrimination and mitigate market 
power. The Commission is implementing two major rulemaking initiatives 
to advance these important goals: one relating to formation of regional 
transmission organizations in the electric industry, and the other 
reforming regulation of the natural gas industry.
 Regional Transmission Organizations; 1902-AB77, Docket No. RM99-2-000 
(Order No. 2000). In December 1999, the Commission issued a Final Rule 
on Regional Transmission Organizations (RTOs). This rule is often 
referred to as Order 2000. The Commission supports the creation of RTOs 
to promote efficient operation of the transmission grid, eliminate 
residual discrimination by transmission owners, promote grid 
reliability, and facilitate regional grid planning. This rulemaking 
advances the Commission goal of promoting competition in bulk power 
markets as a means of encouraging efficient operation of, and 
investment in, generation and transmission facilities, and thereby 
reducing consumer prices.
 The Commission added regulations under the Federal Power Act to 
facilitate the formation of RTOs. The Commission required each public 
utility that owns, operates or controls facilities for the transmission 
of electric energy in interstate commerce to make certain filings with 
respect to forming and participating in an RTO. The Commission also 
established certain minimum characteristics (independent governance; 
appropriate scope and regional configuration; adequate operational 
authority; and responsibility for short-term reliability) and functions 
(designing and administering tariffs; managing transmission congestion; 
addressing parallel path flow; providing ancillary services; operating 
an Open Access Same-Time Information System and determining available 
transmission capacity; monitoring markets; regional planning and 
expansion; and interregional coordination) that must be satisfied in 
order to be considered to be an RTO. The rule establishes a framework 
for supporting and encouraging voluntary RTO formation, including a 
commitment to consider applications for innovative ratemaking 
treatments from RTOs.
 In February 2000, the Commission issued an order on rehearing making 
only minor changes to the rule (Order 2000-A). In Spring 2000, the 
Commission staff held five regional workshops to kick-off RTO formation 
efforts and staff has, where requested on an ongoing basis, provided 
assistance to regional efforts. This collaborative process to 
facilitate RTO formation has involved jurisdictional and 
nonjurisdictional utilities, state officials and other affected 
interest groups across the country.
 Implementation of this rule to enable prompt RTO operation is expected 
to be a top priority on the Commission's agenda over the next year. 
Filings to establish RTOs or explaining why RTOs have not been formed 
are due in October 2000 and January 2001. Timely Commission action on 
these filings will be critical to enable RTOs to begin operation by 
December 2001 as contemplated by the rule.
 Natural Gas Policy Initiative; 1902-AB74, Docket No. RM98-10-000 
(Order No. 637). The Commission is implementing a natural gas policy 
initiative to improve the efficiency, transparency, and competitiveness 
of natural gas markets. Further, it is exploring expanded reliance on 
competitive market forces in its oversight of the natural gas 
transportation market.
 As part of the natural gas initiative, the Commission issued a Final 
Rule in February 2000 establishing a more market-based approach to 
regulation of aspects of the short-term transportation market, while at 
the same time

[[Page 73526]]

continuing to protect captive customers against the exercise of market 
power. In the Final Rule, the Commission revised its pricing policy to 
enhance efficiency by temporarily lifting the price cap for short-term 
releases of capacity, and permitting pipelines to propose rates that 
vary seasonally or based on the duration of contracts. The Final Rule 
also adopted changes to the regulations regarding scheduling 
procedures, capacity segmentation and pipeline penalties to improve 
competition and efficiency across the pipeline grid. Finally, the Rule 
improves the Commission's reporting requirements to permit more 
effective market monitoring. The Commission affirmed and clarified the 
Final Rule in its orders on rehearing in May 2000 (Order No. 637-A) and 
July 2000 (Order No. 637-B)
 In the year ahead the focus is expected to be on implementation of 
Order No. 637 and a more fundamental review of the approach to natural 
gas transportation regulation. Order No. 637 directed the pipelines to 
modify their tariffs to comply with Order No. 637, and the Commission 
is currently in the process of reviewing these compliance filings. In 
addition, the Final Rule states that the Commission will undertake, 
outside of this proceeding, a new process to evaluate the direction of 
future natural gas regulation. This process will involve Commission 
monitoring of the market (including an assessment of the temporary 
lifting of the price cap for short-term releases of capacity), 
technical conferences and other dialogue with the various industry 
segments, and, if appropriate, the establishment of new docketed 
proceedings.
Energy Projects
 The Commission's rulemaking activities in the area of authorizing gas 
pipeline and hydroelectric project development are aimed at protecting 
the environment and the public, while at the same time serving customer 
interests and promoting competition. The key rulemakings in the energy 
projects area are: (1) a policy statement articulating the Commission's 
approach to determining need for new pipeline development; and (2) a 
rulemaking to give earlier notification to landowners affected by 
pipeline project proposals, to facilitate their participation in 
project review. The Commission has also adopted procedural rules 
designed to support constructive collaboration between pipeline 
developers and affected parties before the certificate application is 
filed.
 Policy Statement on Determination of Need; 1902-AB86, Docket No. PL-3-
000. In deciding whether a proposed pipeline project is required by the 
public convenience and necessity, the Commission has adopted a policy 
of considering not only the interests of the applicant and potential 
new customers, but also the interests of the applicant's existing 
customers, the captive customers of other pipelines that serve the 
market, landowners, and communities. One key element of the policy is 
that a project must not rely on subsidies from existing customers. With 
a policy against subsidies by captive ratepayers, the market will 
discipline projects that are not economically viable. Moreover, under 
this policy, construction projects that will have unmitigated adverse 
effects on relevant interests, including landowners and community 
interests, will be approved only if on balance the benefits outweigh 
the harm.
 The new policy is designed to provide incentives for pipelines to 
eliminate or minimize adverse effects before filing, through correctly 
structured financial arrangements, careful project design, and 
negotiations with landowners. By working out contentious issues in 
advance and mitigating impacts where impacts cannot be avoided, the 
applicant can develop a record in support of the project, reducing time 
required for the Commission's deliberative process. This policy was 
adopted in September 1999, and was the subject of clarification in 
subsequent orders in February and July of 2000.
 Landowner Notification, Expanded Categorical Exclusions, and Other 
Environmental Filing Requirements; 1902-AB83, Docket No. RM98-17-000. 
In October 1999, the Commission issued a final rule amending its 
regulations under the Natural Gas Act by adding certain early landowner 
notification requirements that will ensure that landowners who may be 
affected by a pipeline's proposal to construct natural gas pipeline 
facilities have sufficient opportunity to participate in the 
Commission's certificate process. The Commission also amended its 
regulations to provide pipelines with greater flexibility and to 
further expedite the certificate process. The Commission issued 
rehearing orders on this rule in March and June 2000.
Procedural Reforms
 The Commission has recently undertaken several important initiatives 
to reform and streamline its procedures, with the goals of expediting 
Commission action, emphasizing use of alternative dispute resolution 
(ADR), and improving access to information. In 1999, for instance, the 
Commission adopted final rules reforming its complaint procedures to 
facilitate expedited review and encourage use of ADR; and its rules 
governing off-the-record communications designed to enhance the 
Commission's access to information consistent with preserving the 
fairness and integrity of the decisional process. The Commission is 
actively pursuing electronic filing as a means of cutting costs and 
improving access to information. The Commission also expects to 
undertake a systematic review of its reporting requirements to ensure 
that it has access to the information it needs for effective market 
oversight and eliminates the burden of filing information that is no 
longer needed for regulatory purposes.
 Electronic Filing; 1902-AB-89, Docket No. PL98-1-001. The Commission 
has begun implementation of its electronic filing initiative by 
amending its rules to permit electronic service of documents. In 
October 2000 the Commission expects to expand this initiative to allow 
electronic filing of certain types of filings. These steps will reduce 
expenses involved with paper filings, such as copying and messenger 
services, and make information available more quickly.
 Besides reducing the filing burden on industry, electronic filing will 
generate information more quickly for industry by making the content of 
filings available within minutes or hours, rather than days. Electronic 
notification of filings will take much less time than is necessary for 
paper notification, giving companies earlier access to filed 
information.
 Reengineering of Reporting Requirements. The Commission is required to 
review its reporting requirements every three years pursuant to the 
Paperwork Reduction Act. Recently, these reviews have led to questions 
about whether certain reported information is needed for regulatory 
purposes and, if so, whether it can be submitted confidentially. 
Simultaneously, the Commission's new approach to energy market 
monitoring and oversight will likely require access to and assessment 
of new types of data. As a consequence, the Commission expects to 
undertake a systematic review of its current reporting requirements to 
determine what reported information is no longer needed and what 
unreported information is now needed for its

[[Page 73527]]

regulatory purposes. This effort may include multiple rulemakings. The 
Commission has committed to undertake one element of this review, 
related to Form 1 reports filed by electric utilities, by summer 2001.
BILLING CODE 6717-01-S




[[Page 73528]]

FEDERAL HOUSING FINANCE BOARD (FHFB)



Statement of Regulatory and Deregulatory Priorities
 The Federal Housing Finance Board (Finance Board) is an independent 
agency that is charged under the Federal Home Loan Bank Act (Bank Act) 
with supervising and regulating the Nation's Federal Home Loan Bank 
(Bank) System. The Bank System comprises 12 regional Banks that are 
each owned by their member financial institutions and provide wholesale 
credit to members and certain nonmembers to be used for mortgage 
lending and related community lending activities. The Bank System also 
includes the Office of Finance, which issues Bank System consolidated 
obligations. The Finance Board is required to prepare the following 
Regulatory Plan pursuant to section 4 of Executive Order 12866.
 As always, the Finance Board's highest regulatory priorities during 
the coming year are to ensure the safety and soundness of the Bank 
System and to ensure that the Banks fulfill their housing finance and 
community investment mission. In furtherance of these statutory 
mandates, the Finance Board plans one significant regulatory action 
during 2000-2001; that is, the finalization of regulations establishing 
a new capital structure for the Banks. This rulemaking is mandated by 
the Federal Home Loan Bank Modernization Act of 1999 (Modernization 
Act) and is described in detail below.
_______________________________________________________________________



FHFB

                              -----------

                          PROPOSED RULE STAGE

                              -----------




170. MINIMUM CAPITAL REQUIREMENTS FOR THE FEDERAL HOME LOAN BANKS
Priority:


Other Significant. Major status under 5 USC 801 is undetermined.


Legal Authority:


12 USC 1426; 12 USC 1422b(a)


CFR Citation:


12 CFR 917; 12 CFR 925; 12 CFR 930; 12 CFR 931; 12 CFR 932; 12 CFR 933; 
12 CFR 956; 12 CFR 960


Legal Deadline:


Final, Statutory, November 12, 2000.


Abstract:


The Finance Board issued a proposed rule to adopt regulations mandating 
a new capital structure for the Banks, as required by the Modernization 
Act. The rule would replace the Banks' existing ``subscription 
capital'' structure with a more modern, flexible risk-based capital 
structure for each of the Banks.


The Modernization Act requires that the Banks' existing subscription 
capital structure be replaced by a structure that may consist of two 
classes of capital stock: Class A, redeemable on six months' written 
notice to the Bank, and Class B, redeemable on five years' written 
notice to the Bank. Under the proposed rule, each Bank would be able to 
decide whether to issue either Class A or Class B stock, or both, and 
would have significant latitude in specifying the terms, voting rights 
and dividend preferences of each class of stock.


The proposed rule also reflects the requirement of the Modernization 
Act that each Bank maintain a ratio of total capital to total assets of 
at least five percent. Thereunder, each Bank would be permitted to 
weight its permanent capital (the amount of Class B stock plus retained 
earnings) at 1.5 times paid-in value, as long as its total capital, 
excluding such weighting, is not less than four percent of its total 
assets. The proposed rule would also require that each Bank have 
permanent capital at all times in amounts sufficient to meet the rule's 
risk-based capital requirements for credit risk, market risk and 
operations risk.


Finally, the proposed rule describes the required content of each 
Bank's ``capital structure plan.'' The Modernization Act requires that 
each Bank submit such a plan to the Finance Board for approval within 
270 days of the publication of a final rule. The Modernization Act 
further provides for a transition period to the new capital structure 
of up to three years from the effective date of each Bank's capital 
structure plan.


Statement of Need:


Since the enactment of the Federal Home Loan Bank Act (Bank Act) in 
1932, there has been a ``subscription'' structure for the 
capitalization of the Banks. Under this structure, the amount of 
capital stock each Bank issues to its member institutions is determined 
either as a percentage of the total mortgage assets of each member of 
the Bank, or the dollar amount of advances outstanding to each member, 
whichever is greater. Under the subscription capital structure, the 
amount of capital each Bank is required to hold bears no relationship 
to any risks posed by its operations.


The subscription capital structure has resulted in significant 
overcapitalization of the Banks in relation to their current operating 
risks. The amount of excess capital is a factor contributing to the 
increase in the amount of arbitrage investments made by the Banks; such 
as investments in money market instruments or mortgage-backed 
securities that do not advance the housing and community lending 
mission of the Banks. The substantial amount of nonmission investments 
held by the Banks collectively, though decreasing in recent years as a 
percentage of their assets, has been the subject of much criticism from 
the Administration and Congress, and was one issue that Congress 
intended to address by reforming the capital structure and other 
aspects of the Bank System as part of the Modernization Act.


The new statutory provisions mandate the replacement of the existing 
subscription capital structure over a period of up to several years 
with a more modern capital structure, incorporating risk-based and 
leverage capital requirements that are similar to those for depository 
institutions and the other housing government-sponsored enterprises 
(GSEs). The Modernization Act provides for a transition period to the 
new capital structure of up to approximately five years from the date 
of enactment, during which time the prior capital provisions are to 
remain in effect.


Summary of Legal Basis:


Under section 6(a) of the Bank Act, 12 U.S.C. 1426(a), as amended by 
the Modernization Act, the Finance Board is required to issue 
regulations prescribing uniform capital standards applicable to each 
Bank no later then November 12, 2000. These regulations must conform to 
the leverage capital, risk-based capital and capital stock requirements 
set forth in section 6(a). In addition, section 2B(a) of the Bank Act 
generally authorizes the Finance Board to promulgate such regulations 
as are necessary to carry out the provisions of the Bank Act. See 12 
U.S.C. 1422b(a)(1).


The proposed rule originally provided for a 90-day comment period, 
ending on October 11, 2000, to allow for the adoption of a final rule 
by the November 12, 2000 statutory deadline. However, numerous 
commenters

[[Page 73529]]

requested that the agency extend the comment period to allow for more 
comments on and consideration of the complex issues addressed in the 
proposed rule. While mindful of the requirements of the Modernization 
Act, the Finance Board determined that it is in the best interest of 
the Banks, their members and the public to extend the comment period to 
November 20, 2000.


Alternatives:


To a significant extent, the parameters of the proposed capital 
regulations have been established by Congress and, therefore, are not 
subject to alternative resolutions devised by the Finance Board. 
However, the Finance Board will consider alternative approaches to a 
number of definitions and other issues that are not addressed expressly 
by statute.


As required by the Moderization Act, the regulations would establish 
risk-based capital requirements under which each Bank must maintain 
permanent capital in an amount sufficient to meet the credit, market 
and operations risks to which the Bank is exposed. Regarding credit 
risk, the proposed rule would assign to each category of the Bank 
investment a risk factor, weighted according to the estimated risk 
exposure. The market risk requirement would be determined using a 
portfolio stress test model devised by each Bank in accordance with the 
requirements of the rule. The Finance Board has solicited comments on 
the specific credit risk-weightings proposed for each asset category 
and on the requirements pertaining to the market risk model that each 
Bank must develop. The agency will consider any suggested alternative 
approches to these issues as it is developing a final rule.


As mandated by the Modernization Act, the proposed rule also would 
permit each Bank to issue either Class A stock or Class B stock (the 
characteristics of which are described above), or both, and would 
define the essential characteristics of both types of stock. The 
Finance Board has proposed that Class A stock have a par value of $100 
per share, be issued at par value, and pay a stated dividend that has a 
priority over the payment of dividends on Class B stock. The agency has 
proposed that Class B stock have a par value that is determined by each 
Bank. In order to give each Bank the flexibility to inure its Class B 
stock with greater permanence by setting par value below the issue 
price, the Finance Board has proposed to permit Class B stock to be 
issued at a price determined by the Bank, which could be different from 
the par value.


Under the Act and the proposed rule, the Class B stock would confer an 
ownership interest in the retained earnings of the Bank upon payment of 
the issue price by a member. No member institution would be allowed to 
cast more than 20 percent of the votes in any election for the board of 
directors, but a Bank could establish a lower percentage limit in its 
capital structure plan. In addition, under the proposed rule, no member 
institution could hold more than 40 percent of any class of a Bank's 
stock. The Finance Board has requested comments on these elements of 
the capital stock voting structure and will consider any suggested 
alternative approaches in drafting the final rule.


Anticipated Cost and Benefits:


Because, under the proposed rule, each Bank would submit its own 
capital structure plan, the Finance Board cannot quantify precisely the 
costs and benefits of the rulemaking at this time. Generally, there may 
be significant initial costs associated with the development of each 
Bank's capital structure plan and with each Bank's conversion to its 
new capital structure. However, the agency anticipates that the new 
capital regulations, in combination with other recently-adopted 
regulations that will become fully effective once the new capital 
structure is in place, ultimately will benefit both the Banks and their 
members by giving the Banks greater operational flexibility. This will 
enable the Banks to help their members to compete more effectively in 
the housing finance and community lending marketplace, which, in turn, 
will assure that the GSE benefit will accrue more efficiently and 
effectively to consumers.


Risks:


As the safety and soundness regulator of the Banks, the Finance Board 
is responsible for ensuring that the Banks are managing their risks 
adequately. As mentioned above, under the proposed capital rule, each 
Bank would be required at all times to hold risk-based capital in an 
amount commensurate with the level of credit risk, market risk and 
operations risk to which the Bank is exposed through its business 
activities. Consistent with the Modernization Act, the Finance Board 
has recently enacted a number of regulations under which the Banks will 
be permitted to undertake a broader range of business activities and to 
make a broader range of investments than they have in the past. These 
new authorities will become fully effective for each Bank as that 
Bank's new capital structure is put into place.


The risk-based capital requirements, as proposed, are intended to 
permit the Banks to incur the risks associated with these new 
activities so long as these risks are adequately capitalized. This is 
consistent with the manner in which depository institutions and the 
other housing GSEs are required to manage their risk and contrasts with 
the old regime under which risk was managed through detailed 
restrictions on business and investment activity imposed upon the Banks 
by the Finance Board. The agency believes that, under the new regime, 
the Banks would be able to expand their business operations to more 
fully serve their member institutions and, ultimately, the American 
consumer, while at the same time adequately managing the risks that may 
arise from these business activities.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            65 FR 43408                                    07/13/00
NPRM Comment Period End                                        11/20/00
Final Action                                                   01/00/01
Final Action Effective                                         03/00/01
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


None


Agency Contact:
Thomas E. Joseph
Attorney-Advisor
Federal Housing Finance Board
1777 F Street NW.
Washington, DC 20006
Phone: 202 408-2512
Fax: 202 408-2580
Email: [email protected]
RIN: 3069-AB01
BILLING CODE 6725-01-S




[[Page 73530]]

FEDERAL MARITIME COMMISSION (FMC)



Statement of Regulatory and Deregulatory Priorities
 The Federal Maritime Commission's (Commission) regulatory objectives 
are guided by the Agency's basic mission. The Commission's mission is 
to administer the shipping statutes as effectively as possible to 
provide an efficient, economic, and nondiscriminatory ocean 
transportation system in an environment free of unfair foreign maritime 
trade practices. The Commission's regulations are designed to implement 
each of the various statutes the Agency administers in a manner 
consistent with this mission and in a way that minimizes regulatory 
costs, fosters economic efficiencies, relies on the marketplace to 
determine industry growth, and promotes international harmony.
 Recent legislation altered significantly the Federal regulatory scheme 
regarding international ocean shipping. The legislation required new 
regulations, as well as the revision of many of the Commission's 
substantive regulations. One of the principal changes was the 
elimination of the requirement that carriers file tariffs with the 
Commission listing their rates and charges. Carriers are now required 
to publish their rates in private automated systems. The Commission 
continues to assess its regulations implementing this requirement, as 
well as other requirements of the new legislation.
 The recent rulemaking process uncovered concern by common carriers as 
to the content requirements of agreements filed with the Commission. 
Carriers have expressed a desire for better delineation as to what 
matters do or do not have to be filed and have suggested that the 
Commission's rules should provide protections for confidential business 
information, provide maximum flexibility for carriers to modify 
cooperative arrangements, and include guidance tailored for different 
types of agreements. Therefore, the Commission initiated an inquiry to 
solicit comments from the ocean transportation industry and the general 
public to assist the Commission in formulating new rules governing 
content requirements. This matter will be considered during calendar 
year 2000.
 The principal objective or priority of the Agency's current regulatory 
plan will be to continue to assess major existing regulations for 
continuing need, effectiveness, burden on the regulated industry, 
fairness, and clarity.
 The Commission continues to have under review, inter alia, regulations 
regarding passenger vessel operator financial responsibility and co-
loading arrangements between non-vessel-operating common carriers. The 
Commission's review of existing regulations exemplifies its objective 
to regulate fairly and effectively while imposing a minimum burden on 
the regulated entities, following the principles stated by the 
President in Executive Order 12866.
Description of the Most Significant Regulatory Actions
 The Commission currently has no actions under consideration that 
constitute ``significant regulatory actions'' under the definition in 
Executive Order 12866.
BILLING CODE 6730-01-S




[[Page 73531]]

FEDERAL TRADE COMMISSION (FTC)



Statement of Regulatory Priorities
Background
 The Federal Trade Commission (FTC or Commission) is an independent 
agency charged with protecting American consumers from ``unfair methods 
of competition'' and ``unfair or deceptive acts or practices'' in the 
marketplace. The Commission strives to ensure that consumers benefit 
from a vigorously competitive marketplace. The Commission's work is 
rooted in a belief that free markets work -- that competition among 
producers and information in the hands of consumers brings the best 
products at the lowest prices for consumers, spurs efficiency and 
innovation, and strengthens the economy.
 The Commission pursues its goal of promoting competition in the 
marketplace through two different, but complementary, approaches. 
First, for competition to thrive, curbing deception and fraud is 
critical. Through its consumer protection activities, the Commission 
seeks to ensure that consumers receive accurate, not false or 
misleading, information in the marketplace. At the same time, for 
consumers to have a choice of products and services at competitive 
prices and quality, the marketplace must be free from anticompetitive 
business practices. Thus, the second part of the Commission's basic 
mission -- antitrust enforcement -- is to prohibit anticompetitive 
mergers or other anticompetitive business practices without unduly 
interfering with the legitimate activities of businesses. These two 
complementary missions make the Commission unique insofar as it is the 
Nation's only Federal agency to be given this combination of statutory 
authority to protect consumers.
 The Commission is, first and foremost, a law enforcement agency. It 
pursues its mandate primarily through case-by-case enforcement of the 
Federal Trade Commission Act and other statutes. The Commission, 
however, is also charged with the responsibility of issuing and 
enforcing regulations under a number of statutes. Pursuant to the FTC 
Act, for example, the Commission currently has in place 13 trade 
regulation rules. The Commission also has adopted a number of voluntary 
industry guides. Most of the regulations and guides pertain to consumer 
protection matters, and are generally intended to ensure that consumers 
receive the information necessary to evaluate competing products and 
make informed purchasing decisions.
Gramm-Leach-Bliley Initiative
The Gramm-Leach-Bliley Act, Pub. L. No. 106-102, was enacted on 
November 12, 1999.\1\ Title V (Privacy) Subtitle A (Disclosure of 
Nonpublic Personal Information), sections 501(b) and 505(b), require 
the Federal Trade Commission and the Securities and Exchange Commission 
to implement and enforce appropriate standards for financial 
institutions to safeguard customers' records and information 
(safeguards standards) by rule. The Commission has published a request 
for comments and, after the comments are reviewed, plans to publish a 
Notice of Proposed Rulemaking to further implement the statutorily 
mandated safeguards standards.
Ten-Year Review Program
 In 1992, the Commission implemented a program to review its rules and 
guides regularly. The Commission's review program is patterned after 
provisions in the Regulatory Flexibility Act, 5 USC 601 et seq. Under 
the Commission's program, however, rules are continually reviewed at 
least every ten years, not just once as usually required by section 610 
of the Regulatory Flexibility Act. This program is also broader than 
the review contemplated under the Regulatory Flexibility Act, in that 
it provides the Commission with an ongoing systematic approach for 
seeking information about the costs and benefits of its rules and 
guides and whether there are changes that could minimize any adverse 
economic effects, not just a ``significant economic impact upon a 
substantial number of small entities.'' The program's goal is to ensure 
that all of the Commission's rules and guides remain beneficial and in 
the public interest.
 As part of the 10-year plan, the Commission examines the effect of 
rules and guides on small businesses and on the marketplace in general. 
These reviews often lead to the revision or rescission of rules and 
guides to ensure that the Commission's consumer protection and 
competition goals are achieved efficiently and at the least cost to 
business. In a number of instances, the Commission has determined that 
existing rules and guides were no longer necessary or in the public 
interest. As a result of the review program, the Commission has 
repealed 48 percent of its trade regulation rules and 52.5 percent of 
its guides since 1992.
Calendar Year 2000 Reviews
 As part of the Commission's 10-year review program, in 2000 the 
Commission initiated reviews of one rule and one industry guide. They 
are: the Telemarketing Sales Rule, 16 CFR part 310, and the Guides for 
the Household Furniture Industry, 16 CFR part 250. Three additional 
Guide reviews, previously scheduled to commence in 2000 under the 
Commission's tentative review schedule, have been deferred. \2\ The 
Commission will commence its review of these Guides at a later date.
 All of the matters scheduled for review this year pertain to consumer 
protection and are intended to ensure that consumers receive the 
information necessary to evaluate competing products and make informed 
purchasing decisions. For example, the Telemarketing Sales Rule (TSR), 
16 CFR part 310, was adopted pursuant to the Telemarketing and Consumer 
Fraud and Abuse Prevention Act, 15 USC 6101-6108. The Rule requires 
telemarketers to disclose certain material information; prohibits 
misrepresentations; limits the times of day telemarketers may call 
consumers; prohibits calls to a consumer who has asked not to be called 
again; and sets payment restrictions for the sale of certain goods and 
services. The Commission began its review of the Rule by holding a 
forum on the do-not-call provision, followed by a request for comments 
and a public forum on July 27-28, 2000. The staff will make its 
recommendations to the Commission concerning the review by the end of 
the calendar year. In addition, the Commission will report to the 
Congress on the results of its evaluation of the Rule's operation.
 This year, the Commission also began its review of the Guides for the 
Household Furniture Industry (Furniture Guides), 16 CFR part 250, which 
were issued on December 21, 1973. The Commission requested comments 
about the overall costs and benefits and the continuing need for the 
Furniture Guides. See 65 FR 18933 (Apr. 10, 2000). The Furniture Guides 
generally advise members of the furniture industry to make affirmative

[[Page 73532]]

disclosures of product facts, which, if known by a purchaser, would 
influence the purchasing decision. The specific disclosures concern 
identification of the types of wood and outer coverings or stuffings 
used in furniture. These disclosures are designed to prevent consumers 
from being misled that the product is different from that which is 
actually being offered. To that end, the Commission's request for 
comments included eleven questions concerning the continued utility of 
the Furniture Guides. The comment period, originally scheduled to close 
on June 9, 2000, was extended until July 10, 2000, at the request of 
the American Furniture Manufacturers Association. See 65 FR 37317 (Jun. 
14, 2000).
Reviews in Process
 In 1999, the Commission began its regulatory review of certain aspects 
of the Funeral Industry Practices Rule (Funeral Rule), 16 CFR part 453. 
The Funeral Rule, which became effective in 1984, and was amended in 
1994, requires providers of funeral goods and services to give 
consumers itemized lists of funeral goods and services that not only 
state price and descriptions, but also contain specific disclosures. 
The rule enables consumers to select and purchase only the goods and 
services they want, except for those which may be required by law and a 
basic services fee. Also, funeral providers must seek authorization 
before performing some services, such as embalming. In addition to an 
assessment of the rule's overall costs and benefits and continuing need 
for the rule, the Commission's review will examine whether changes in 
the funeral industry warrant broadening the scope of the rule to 
include non-traditional providers of funeral goods or services and 
revising or clarifying certain prohibitions in the rule. See 64 FR 
24249 (May 5, 1999). In response to requests of industry members, the 
Commission determined to extend the comment period. A public workshop 
conference was held on November 18, 1999, to explore issues raised in 
the comments submitted. Staff expects to forward its recommendation to 
the Commission this fall.
 The Commission's review of the Franchise Rule, 16 CFR part 436, is 
also continuing. The Commission accepted comments on a Notice of 
Proposed Rule Making with the text of a revised rule until December 21, 
1999, and rebuttal comments until January 31, 2000. The proposal 
addresses issues including: (1) changing the timing for making 
disclosures; (2)clarifying the application of the rule to international 
franchise sales; (3) expanding the rule to require additional 
disclosures, including pending franchisor initiated lawsuits involving 
the franchise relationship, franchisor use of gag clauses and, in some 
instances, trademark specific franchisee associations; (4) permitting 
disclosures through electronic media, including the Internet; and (5) 
expanding the rule's exemptions to address sophisticated investors. 
Staff expects to forward its report to the Commission next spring.
 In addition, the Commission's review of the Pay-Per-Call Rule, 16 CFR 
part 308, is proceeding. The Commission has held workshops to discuss 
proposed amendments to its Pay-Per-Call Rule including provisions to 
combat telephone bill cramming -- inserting unauthorized charges on 
consumers' phone bills -- and other abuses in the sale of products and 
services that are billed to the telephone including voicemail, 900-
number services, and other telephone base information and entertainment 
services. The most recent workshop, held May 20 and 21, 2000, focused 
on discussions of the use of 800 and other toll-free numbers to offer 
pay-per-call services, the scope of the Rule, the dispute resolution 
process, and the need for obtaining authorization from consumers before 
placing charges on their telephone bills. Staff anticipates forwarding 
its recommendation to the Commission this winter.
 The reviews of the Amplifier Rule, 16 CFR part 432, the Ophthalmic 
Practice Rule, 16 CFR Part 456, and the R-Value Rule, 16 CFR part 460, 
are proceeding. Staff has forwarded its recommendation to the 
Commission regarding the Amplifier Rule and expects to forward a 
recommendation to the Commission regarding the Ophthalmic Practice Rule 
in fall 2000.
 With respect to Industry Guides, the Commission also has solicited 
comments on its Guide Concerning Fuel Advertising for New Automobiles 
(Fuel Economy Guide), 16 CFR part 259, effective in 1975. See 64 FR 
19720 (Apr. 22, 1999). The Fuel Economy Guide is designed to prevent 
deceptive fuel economy advertising and to facilitate the use of fuel 
economy claims in advertising. Since its issuance, the Fuel Economy 
Guide has advised marketers to disclose the established fuel economy of 
the vehicle as determined by EPA under the Automobile Information 
Disclosure Act, 15 U.S.C. 2206, in advertisements that make 
representations regarding the fuel economy of a new vehicle. These EPA 
fuel economy numbers also appear on window labels attached to new 
automobiles. The Commission amended the Fuel Economy Guide in 1978 and 
1995 to make it consistent with the Information Disclosure Act changes 
regarding fuel economy disclosures.
 Finally, in response to a petition from industry members, the 
Commission is reviewing a portion of the Guides for the Jewelry, 
Precious Metals and Pewter Industry, 16 CFR part 23, to determine 
whether an amendment is necessary. Although these Guides were reviewed 
in 1992 under the 10-year plan, the Commission is responding to this 
petition for revisions to the Guides to address whether there should be 
additional disclosures to consumers resulting from technological 
developments in the treatments of diamonds and gemstone jewelry 
products. See 64 FR 30448 (Jun. 8, 2000).
Final Actions 
 Since publication of the 1999 Regulatory Plan, the Commission has 
completed several regulatory reviews. The Commission has completed its 
review of the Care Labeling Rule, 16 CFR part 423, as part of the 
Reinventing Government effort to revise text in the CFR to reduce 
burden or duplication and to streamline requirements. On August 2, 
2000, the Commission issued its final amended rule, 65 FR 47261. The 
final rule amendments clarify the reasonable basis standard and update 
the water temperature definitions to ensure that they conform to 
current industry standards. The rulemaking record did not support two 
proposed revisions. The first would have made it mandatory that washing 
instructions be given in all instances where garments can be washed at 
home. This change would have mandated a particular instruction rather 
than leaving it to the manufacturer's discretion. The Commission also 
concluded that the effect of the proposed amendment was speculative and 
that changes in the marketplace suggested that regulatory revision may 
not be needed or appropriate. The second proposed amendment that was 
not adopted would have allowed a care label for professional 
wetcleaning. The Commission concluded that amending the rule to allow 
for professional wetcleaning would be premature because neither a 
definition nor a test procedure has been developed. The Commission also 
issued final Appliance Labeling Rules concerning front-loading and top-
loading clothes washers, 65 FR 16132 (Mar. 27, 2000), and permitting 
use of the Energy Star logo on qualifying

[[Page 73533]]

energy efficiency labels, 65 FR 17554 (April 3, 2000).
 As discussed more fully below, the Commission has determined to 
rescind two industry guides that were either outdated or unnecessary in 
light of industry self regulation: (1) Guides for the Law Book 
Industry, 16 CFR part 256; and (2) Guides for the Dog and Cat Food 
Industry, 16 CFR part 241. The Commission rescinded the Guides for the 
Law Book Industry, 16 CFR part 256, because the Guides were overly 
regulatory and no longer necessary. In rescinding the Guides for the 
Law Book Industry, the Commission noted that these guides provide 
overly detailed suggestions regarding presale disclosures, were too 
narrowly focused, and did not include electronic media and licensing 
techniques, and thus were outdated. The Commission further noted that 
rescission of the guides may provide an incentive for associations such 
as the American Association of Law Libraries (AALL) or Association of 
American Law Schools (AALS) to adopt their own guides to address their 
members' most important concerns. Further, if future deceptive 
practices prove to be a problem in this industry, the Commission can 
pursue enforcement actions under Section 5 of the FTC Act, 15 U.S.C. 
45, as needed on a case-by-case basis. See 65 FR 2628 (Jan. 19, 2000).
 The Commission also rescinded the Guides for the Dog and Cat Food 
Industry, 16 CFR part 241. (Dog and Cat Food Guides). The Dog and Cat 
Food Guides, effective since 1969, advised industry members not to 
misrepresent dog or cat food in any material respect, including the 
composition, quality, dietary and nutritional value, or processing 
methods used in the manufacture or processing of dog or cat food. See 
64 FR 57372 (Oct. 25, 1999). Industry members were also advised, inter 
alia, against misrepresenting information about the dog or cat food 
company (e.g., length of time in business, ranking in the industry or 
ownership of laboratory or other testing facilities) and using 
deceptive endorsements or testimonials or deceptively claiming that any 
dog or cat food had received an award. The Commission published a 
Federal Register notice seeking comment on several questions concerning 
the Guides' provisions. See 64 FR 13368 (Mar. 18, 1999). As a result of 
the comments filed and other information, the Commission determined 
that the Dog and Cat Food Guides were no longer needed and therefore 
should be rescinded. Specifically, the Commission stated that guides 
are particularly useful when they resolve uncertainty over what claims 
are likely to be considered deceptive. However, the Commission 
determined that the Dog and Cat Food Guides did not provide such 
specific guidance except for topics already addressed by pet food model 
regulations drafted by the Association of American Feed Control 
Officials (AAFCO) or animal food regulations issued by the Food and 
Drug Administration. In addition, the Guides do not appear to cover 
areas where industry members would have difficulty in determining 
whether specific claims are likely to be deceptive. The Commission also 
articulated its enforcement policy with respect to this industry and 
stated that it will evaluate substantiation for dog and cat food claims 
on a case-by-case basis.
Calendar Year 2001 Reviews
 In calendar year 2001, the Commission expects to initiate certain 
previously scheduled reviews of two rules and two industry guides. \3\ 
Specifically, the agency plans to begin its regulatory review of the 
Retail Food Store Advertising and Marketing Practices Rule, 16 CFR part 
424, and Preservation of Consumers Claims and Defenses Rule, 16 CFR 
part 433. The Commission also plans to review the Tire Advertising and 
Labeling Guides, 16 CFR part 228, and the Guides concerning use of 
Endorsements and Testimonials in Advertising, 16 CFR part 255.
Summary
 With regard to both content and process, the FTC's ongoing and 
proposed regulatory actions are compatible with the President's 
priorities. The actions under consideration inform and protect 
consumers and reduce the regulatory burdens on businesses. The 
Commission will continue working toward these goals. The Commission's 
10-year review program is patterned after provisions in the Regulatory 
Flexibility Act and complies with the Small Business Regulatory 
Enforcement Fairness Act of 1996. The Commission's 10-year program also 
is consistent with President Clinton's National Regulatory Reinvention 
Initiative, which, among other things, urges agencies to eliminate 
obsolete or unnecessary regulations. The program corresponds as well to 
section 5(a) of Executive Order 12866, 58 FR 51735 (Sept. 30, 1993), 
which directs Executive branch agencies to develop a plan to reevaluate 
periodically all of their significant existing regulations. In 
addition, the Children's Online Privacy Protection Rule is consistent 
with the President's Statement of Regulatory Philosophy and Principles, 
E.O. 12866 section l(a), which directs agencies to promulgate only such 
regulations as are, inter alia, required by law or are made necessary 
by compelling public need, such as material failures of private markets 
to protect or improve the health and safety of the public.
 As set forth in Executive Order 12866, the Commission continues to 
identify and weigh the costs and benefits of proposed actions and 
possible alternative actions, and to receive the broadest practicable 
array of comment from affected consumers, businesses, and the public at 
large. As stated above, since 1992 the Commission has repealed 48 
percent of its trade regulation rules and 52.5 percent of its industry 
guides that existed in 1992 because they had ceased to serve a useful 
purpose. In sum, the Commission's regulatory actions are aimed at 
efficiently and fairly promoting the ability of private markets to 
protect or improve the health and safety of the public, the 
environment, or the well-being of the American people. Executive Order 
12866, sec. 1.
Regulatory Actions
The Commission has no rules that constitute significant regulatory 
actions under the definition in Executive Order 12866.
---------------------------------------------------------------------------
\1\ The Commission previously published its final rule implementing 
other Gramm-Leach-Bliley requirements in its Rule on Privacy of 
Consumer Financial Information, 16 CFR Part 313. See  65 FR 33646 (May 
24, 2000).
\2\ In publishing the regulatory review schedule each year, the 
Commission indicates that the tentative timetable may be modified in 
the future to incorporate new legislative rules, or to respond to 
external factors (such as changes in the law) or other considerations. 
See, e.g., 64 FR 3668 (Jan. 25, 1999).
\3\ See 64 FR 3668-69 (Jan. 25, 1999).
---------------------------------------------------------------------------
BILLING CODE 6750-01-S




[[Page 73534]]

NATIONAL INDIAN GAMING COMMISSION (NIGC)



Statement of Regulatory Priorities
 The Indian Gaming Regulatory Act (IGRA or the Act), 25 U.S.C. 2701 et 
seq., was signed into law on October 17, 1988. The Act established the 
National Indian Gaming Commission (NIGC or the Commission). The stated 
purpose of the Commission is to regulate the operation of gaming by 
Indian tribes as a means of promoting tribal economic development, 
self-sufficiency, and strong tribal governments. It is the Commission's 
intention to provide regulation of Indian gaming to adequately shield 
it from organized crime and other corrupting influences, to ensure that 
the Indian tribe is the primary beneficiary of the gaming operation, 
and to assure that gaming is conducted fairly and honestly by both the 
operator and players.
 The NIGC's regulatory priorities for the next fiscal year are to:
 1. Develop standards for constructing and maintaining gaming 
facilities operated on Indian lands.
 2. Develop regulations to establish processes for the classification, 
review, and approval of games and devices used in tribal gaming.
 3. Establish a process for the assessment, notification, and 
collection of debts owed the NIGC resulting from fines assessed by the 
Chairman for violations of the IGRA.
_______________________________________________________________________



NIGC

                              -----------

                          PROPOSED RULE STAGE

                              -----------




171. ENVIRONMENT AND PUBLIC HEALTH AND SAFETY
Priority:


Other Significant


Unfunded Mandates:


Undetermined


Legal Authority:


25 USC 2710(b)(2)(E)


CFR Citation:


25 CFR 573


Legal Deadline:


None


Abstract:


It is necessary for the National Indian Gaming Commission to promulgate 
regulations, which ensure that tribal gaming facilities are constructed 
and maintained in a manner that protects the environment and the public 
health and safety.


Statement of Need:


The Indian Gaming Regulatory Act (IGRA) requires that an approved 
tribal gaming ordinance contain a provision requiring each tribal 
gaming facility to be constructed and maintained in a manner that 
adequately protects the environment and the public health and safety 
(25 U.S.C. 2710(b)(2)(E)). The Commission has determined that standards 
are needed to ensure compliance with this statutory requirement.


Summary of Legal Basis:


IGRA expressly authorizes the Commission to ``promulgate such 
regulations and guidelines as it deems appropriate to implement the 
provisions of the [Act].'' (25 U.S.C. 2706(b)(10)). The Commission 
relies on this section of the statute to authorize the promulgation of 
standards for constructing and maintaining gaming facilities operated 
on Indian lands in a manner that adequately protects the environment 
and the public health and safety.


Alternatives:


The Commission has no alternative but to promulgate these 
environmental, health and safety standards for gaming facilities 
operated on Indian lands.


Anticipated Cost and Benefits:


The potential benefits to this regulatory action are to establish and 
define for the regulated community the environmental, health, and 
safety standards it must follow in order to comply with the IGRA, 
regulations promulgated thereunder, and tribal gaming ordinances. This 
regulatory action will provide the regulated public with guidance as to 
the standards the Chairman will use to determine what constitutes an 
environmental, health, or safety problem sufficient to warrant an 
enforcement action.


Risks:


There are no known risks to this regulatory action.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
ANPRM           64 FR 22588                                    04/27/99
ANPRM Comment Period End                                       06/28/99
NPRM            65 FR 45558                                    07/24/00
NPRM Comment Period End                                        11/30/00
Final Action                                                   08/00/01
Regulatory Flexibility Analysis Required:


No


Government Levels Affected:


Tribal


Agency Contact:
Christine Nagle
National Indian Gaming Commission
9th Floor
1441 L Street NW.
Washington, DC 20005
Phone: 202 632-7003
Fax: 202 632-7066
Email: [email protected]
RIN: 3141-AA17
_______________________________________________________________________



NIGC



172.  DEBT COLLECTION
Priority:


Other Significant


Unfunded Mandates:


Undetermined


Legal Authority:


25 USC 2713(a)(1)


CFR Citation:


25 CFR 580


Legal Deadline:


None


Abstract:


This regulation will establish a process for the assessment, 
notification, and collection of debts owed the National Indian Gaming 
Commission resulting from fines assessed by the Chairman for violations 
of the Indian Gaming Regulatory Act.


Statement of Need:


The Indian Gaming Regulatory Act (IGRA) provides that the Chairman 
shall have the authority to levy and collect civil fines against a 
tribal operator or management contractor of an Indian gaming operation 
for any violation of IGRA, any regulation prescribed by the Commission, 
or tribal regulations, ordinances, resolutions approved by the 
Chairman. The Commission has determined that regulations are necessary 
for the assessment, notification, and collection of debts owed the NIGC 
resulting from fines assessed by the Chairman.

[[Page 73535]]

Summary of Legal Basis:


IGRA expressly authorizes the Commission to ``promulgate such 
regulations and guidelines as it deems appropriate to implement the 
provisions of the [Act].'' (25 U.S.C. 2706(b)(10)). The Commission 
relies on this section of the statute to authorize the promulgation of 
standards for collecting civil fines assessed by the Chairman for 
violations of the IGRA, NIGC regulations, or tribal regulations, 
ordinances, or resolutions approved by the Chairman.


Alternatives:


The Commission has no alternative but to promulgate this debt 
collection procedure for gaming facilities operated on Indian lands.


Anticipated Cost and Benefits:


The potential benefits to this regulatory action are to establish and 
define for the regulated community the procedure by which the 
Commission will enforce the collection of civil fines assessed by the 
Chairman. This regulatory action will provide the Commission with a 
process for the efficient and effective collection of civil fines.


Risks:


There are no known risks to this regulatory action.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           02/00/01
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


Tribal


Agency Contact:
Lisa L. Atkinson
Office of General Counsel
National Indian Gaming Commission
Suite 9100
1441 L Street NW.
Washington, DC 20005
Phone: 202 632-7003
Fax: 202 632-7066
Email: [email protected]
RIN: 3141-AA25
BILLING CODE 7565-01-S




[[Page 73536]]

SURFACE TRANSPORTATION BOARD (STB)



Statement of Regulatory Priorities
 The Surface Transportation Board (STB or Board) has as its goal, the 
exercise of regulatory oversight only when necessary to respond to 
imperfections in the marketplace. Where regulatory oversight is 
necessary, the STB seeks to ensure that such oversight is exercised 
efficiently and effectively, integrating market forces, where possible, 
into the overall regulatory model. In this regard, the STB works to 
resolve matters brought before it fairly and expeditiously. Through use 
of its regulatory exemption authority, encouragement of private-sector 
solutions to disputes, where possible, streamlining of its decisional 
process, and consistent application of legal and equitable principles, 
the STB seeks to facilitate commerce by providing an effective forum 
for dispute resolution and the approval of appropriate business 
transactions.
 The STB continues to develop, through rulemakings and case 
disposition, new and better ways to analyze unique and complex 
problems, to reach fully justified decisions more quickly, and to 
reduce the costs associated with regulatory oversight. In this regard, 
the STB continues to streamline applicable regulations and the process 
for handling matters within its jurisdiction.
 Set forth as follows is STB's most important regulatory action 
proposed in FY 2001, Major Rail Consolidation Procedures, STB Ex Parte 
No. 582 (Sub-No.1). The Board seeks public comment on, and detailed 
proposals for, modifications to its regulations governing proposals for 
major rail consolidations.
_______________________________________________________________________



STB

                              -----------

                          PROPOSED RULE STAGE

                              -----------




173.  MAJOR RAIL CONSOLIDATION PROCEDURES, STB EX PARTE NO. 582 
(SUB-NO. 1)
Priority:


Other Significant. Major status under 5 USC 801 is undetermined.


Legal Authority:


49 USC 721; 49 USC 11323; 49 USC 11324; 49 USC 11325


CFR Citation:


49 CFR 1180


Legal Deadline:


None


Abstract:


The Surface Transportation Board seeks public comment on, and detailed 
proposals for, modifications to its regulations governing proposals for 
major rail consolidations.


Statement of Need:


The action proposed (adoption of new rules to govern the STB's 
processing and consideration of major railroad merger proposals) is 
needed because the pertinent existing rules are not adequate to permit 
the Board to make appropriate public interest determinations regarding 
major mergers in a railroad industry that is now more concentrated than 
when the existing rules were adopted. New guidelines and procedures are 
necessary so that the record in any major railroad merger proceeding 
filed in the future will have sufficient information to permit 
interested persons to participate in the process by stating and 
supporting their positions and to permit the Board to assess the 
ramifications of the merger proposal in the light of both the input of 
interested parties and the relevant statutory criteria.


Summary of Legal Basis:


The action is not directly required by statute. Under 49 U.S.C. 11324, 
however, in considering a major rail merger proposal, the Board is to 
be guided by the public interest and must consider, at a minimum: the 
effect of the proposal on the adequacy of transportation to the public; 
the effect of including, or not including, other rail carriers in 
particular proposed mergers; the financial aspects of the proposal; the 
interest of rail carrier employees affected by the proposed 
transaction; and the effect of the proposed transaction on competition. 
The rail transportation policy of 49 U.S.C. 10101, which guides the 
Board in its regulatory activities, also directs it, among other 
things, to promote safety, efficiency, good working conditions, an 
economically sound and competitive rail transportation system, and a 
transportation system that meets the needs of the public and the 
national defense. The action is necessary to establish revised 
guidelines to permit the Board to carry out its statutory mandate and 
to permit members of the public, as well as other governmental 
entities, to meaningfully participate in the process of assessing major 
railroad merger proposals in a railroad industry that is now more 
concentrated than it was when the current regulations were fashioned.


Alternatives:


Action is necessary to establish guidelines and procedures that would 
permit the STB to make requisite public interest determinations in its 
review of major railroad merger proposals. The principal alternative 
was to attempt to have future major rail merger proposals processed 
under the outdated existing rules.


Anticipated Cost and Benefits:


Costs. The action anticipates some increase in initial costs for merger 
applicants. The costs would not be incurred on a regular and routine 
basis but would only be incurred by the carrier applicants when they 
choose to seek Board approval for a major merger proposal. If focused, 
relevant information is provided early in the process, however, the 
development of an adequate record with input from all interested 
parties should proceed most efficiently, with parties less likely to 
incur unexpected costs later in the record development and review 
process.


Benefits. The principal benefit should be a more focused record with 
fewer extraneous materials, with up-front understanding by parties to 
the proceedings of what evidence and arguments need to be presented and 
when. The action should enhance the predictability of the merger review 
process and of the outcome of that process.


Risks:


The action would reduce the risk of protracted record development with 
extraneous materials. The risks associated with the action relate to 
the difficulty for the Board and involved parties with the necessary 
broad view of a proposed transaction and its anticipated effects. The 
goal of the action, however, is to permit the needed broad input, 
review, and consideration to occur in as organized, orderly, and 
efficient manner as possible.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
ANPRM           65 FR 18021                                    03/31/00
ANPRM Comment Period End                                       06/05/00
NPRM            65 FR 58974                                    10/03/00

[[Page 73537]]

NPRM Comment Period End                                        01/11/01
Final Rule                                                     06/00/01
Regulatory Flexibility Analysis Required:


Undetermined


Government Levels Affected:


None


Agency Contact:
Julia Farr
Chief Counsel, Office of Proceedings
Surface Transportation Board
1925 K Street NW.
Washington, DC 20423-0001
Phone: 202 565-1613
TDD Phone: 800 877-8339
Fax: 202 565-9002
Email: [email protected]
RIN: 2140-AA56
BILLING CODE 4915-00-S