[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]


[[Page 61133]]



DEPARTMENT OF AGRICULTURE (USDA)



Statement of Regulatory Priorities
 The Department of Agriculture, consistent with its reputation as the 
``people's Department,'' will pursue regulations that enhance and 
protect the quality of American agriculture, assist and promote 
America's farmers and ranchers, and benefit the lives of all Americans. 
USDA will remain vigilant to ensure the safety of our Nation's food 
supply and to address the potential threats posed by bioterrorism.
 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. Existing forms and procedures are also being 
            reviewed for their applicability to electronic submission 
            and collection. The Department is undertaking a number of 
            actions in the regulation of commodities that will increase 
            efficiency, improve customer service, and reduce 
            intervention in markets.
 USDA will develop new regulations and review existing ones 
            that address the potential threats posed by domestic 
            outbreaks of exotic animal diseases such as Foot-and-Mouth 
            Disease (FMD) and Bovine Spongiform Encephalopathy (BSE).
 In the area of food safety, the Department will continue to 
            refine existing regulations to assist industry in 
            implementing a consistent, science-based process control 
            system while developing new regulations that address 
            emerging and exotic threats to the safety of the Nation's 
            meat, poultry, and egg products supply.
 The Department is also improving the regulations that serve 
            rural communities. Regulations are being streamlined and 
            simplified so that they will be more customer friendly 
            while providing for more efficient and effective program 
            management.
 Nutrition programs are being improved to strengthen dietary 
            quality by providing a wider variety of food packages to 
            children and low-income participants while also improving 
            the efficiency and integrity of program operations.
Reducing Paperwork Burden on Farmers
 The Department has made substantial progress in implementing the goal 
of the Paperwork Reduction Act of 1995 to reduce the burden of 
information collection on the public. 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 Freedom to E-File Act. Freedom to E-File 
directs the agencies, to the maximum extent practicable, 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. As a result, 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 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 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 Federal Agriculture Improvement and Reform Act 
of 1996 (the 1996 Act), the Farm Bill of 1996, Public Law 104-127, had 
considerable regulatory consequences. This key legislation affects most 
agencies of USDA and resulted in the addition of new programs, the 
deletion of others, and modification to still others. In addition, the 
``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.
Major Regulatory Priorities
 Five agencies are represented in this regulatory plan. They include 
the Farm Service Agency, the Food and Nutrition Service, the Food 
Safety and Inspection Service, the Animal and Plant Health Inspection 
Service, and the Agricultural Marketing Service. This document 
represents summary information on prospective significant regulations 
as called for in Executive Order 12866. A brief comment on each of the 
five 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 Agency56
 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. The 
Agency's objective is to support farming certainty and flexibility, 
ensure compliance with highly erodible land, 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.

[[Page 61134]]

 Priorities: FSA's priority for 2002 will be to continue to emphasize 
service to our customers. As Administration initiatives and changes in 
law require revisions to the Agency's regulations, the Agency's focus 
will be to implement the changes in such a way as to provide benefits 
for, while minimizing program complexity and regulatory burden for, 
program participants. As regulations are revised for program changes, 
opportunities will be taken to clarify, simplify, and reduce confusion 
whenever possible. The FSA regulations that operate the contract 
commodity programs, such as production flexibility contracts and 
marketing assistance loans, were revised a few years ago to remove the 
link between income support payments and farm prices and provide for 
seven annual payments. More changes to the laws governing those 
programs and the related regulations changes are anticipated in 2002. 
However, the Agency's ability to promote new policy initiatives when 
implementing these regulations is limited, due to the need to adhere to 
legislative intent. Therefore, due to their economic magnitude, they 
are noted here to acknowledge their significance in the overall USDA 
regulatory plan but are not further listed in the body of the plan that 
appears below.
 A primary mission of FSA is to administer commodity payment and 
commodity marketing assistance loan programs. Generally, these programs 
are authorized by the 1996 Act with respect to the 1996 through 2002 
crop years. Accordingly, FSA envisions no major changes in the last 
year of the regulations used to administer these programs but 
anticipates major initiatives once legislation is enacted which would 
authorize such programs for the 2003 and subsequent crops.
 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 Plain Language in Government Writing 
Initiative.
 As part of this project, all farm 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 programs 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.
 FSA 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 has completed the streamlining of the Guaranteed Loan Program, 
Indian Tribal Land Acquisition Loan Program, and portions of the direct 
loan program. The balance of the direct loan program will be published 
in three separate rulemaking packages. A final rule streamlining the 
loan-making process for emergency loans should be published by the end 
of the 2001 calendar year. A proposed rule streamlining the loan-making 
process for farm ownership and operating loans and servicing of direct 
loans will be published in the spring of 2002. A proposed rule 
streamlining special loan programs, including boll weevil eradication, 
drainage and irrigation, and grazing associations is planned for the 
fall of 2002.
 Finally, FSA is a full participant in the USDA Electronic Access 
Initiative and is taking the lead on the implementation of the 
Government Paperwork Elimination Act. All FSA information collections, 
forms, and procedures are reviewed for their applicability to 
electronic submission and collection.
Food and Nutrition Service56
 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' 
2002 regulatory plan supports the broad goals and objectives in the 
Agency's strategic plan, which include:
 Improved nutrition of children and low-income people. This 
            goal represents FNS' efforts to improve nutrition 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) improved ability of FNS 
            program participants to 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.
In support of this goal, FNS plans to propose a rule mandated under 
Public Law 106-387 to increase food stamp benefits for household with 
high shelter costs and to make it easier for low-income working 
families to receive food stamps and own a reliable vehicle. The Agency 
also plans a proposed rule to amend regulations governing food packages 
provided in WIC to improve their variety and consistency with the 
Dietary Guidelines for Americans and to increase the nutritional 
adequacy of food packages for those with special medical needs.
 Improved Stewardship of Federal Funds. This goal represents 
            FNS' 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

[[Page 61135]]

            operations and improve program structures as necessary to 
            maximize their effectiveness.
In support of this goal, FNS plans to publish a final rule making 
changes in Child and Adult Care Food Program (CACFP) rules designed to 
improve management and financial integrity in this important program. 
FNS also plans to publish a final rule, mandated under the Personal 
Responsibility and Work Opportunity Reconciliation Act of 1996 and the 
Balanced Budget Act of 1997, which is designed to provide State 
agencies that administer the Food Stamp Program greater flexibility to 
support personal responsibility and independence and encourage work.
Food Safety and Inspection Service56
 Mission: The Food Safety and Inspection Service (FSIS) is 
responsible for ensuring that meat, poultry, and egg products in 
commerce are safe and not adulterated or misbranded.
 Priorities: Since the mid-1990's, FSIS has been reviewing its 
regulations to eliminate duplication of and inconsistency with its own 
and other agencies' regulations and to convert ``command-and-control'' 
regulations to performance standards. The review effort is directed, in 
particular, at improving the consistency of the regulations with the 
Agency's pathogen reduction and hazard analysis and critical control 
point (PR/HACCP) regulations. HACCP is a science-based process control 
system for producing safe food products. FSIS-inspected meat and 
poultry establishments are required to develop and implement HACCP 
plans incorporating the controls the establishments have determined are 
necessary and appropriate to produce safe products. Under the HACCP 
regulations, establishments assume the responsibility for producing 
meat and poultry products that are safe, but they are able to tailor 
their control systems to their particular needs and processes and to 
take advantage of the latest technological innovations.
 FSIS is continuing to revise its numerous command-and-control 
regulations, which prescribe the exact means establishments must use to 
ensure the safety of their products. Some of these regulations specify 
precise time-and-temperature combinations for processing meat, poultry, 
or egg products. Others require the prior approval by FSIS of equipment 
and procedures, in effect assigning to the Agency the responsibility 
for determining the means used by establishments to comply with the 
regulations. As a general matter, such command-and-control regulations 
are incompatible with HACCP because they deprive plants of the 
flexibility to innovate, and they undercut the clear delineation of 
responsibility for food safety.
 In addition to undertaking regulatory amendments based on the results 
of its review activities, FSIS has been developing regulations for 
emergency use. Such regulations are an outcome of the Agency's 
proactive, risk-based policy toward emerging and exotic threats to the 
safety of the Nation's meat, poultry, and egg product supply.
 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 a rule clarifying requirements for meat produced 
using advanced recovery systems by replacing the compliance program 
parameters in the current regulations with non-compliance criteria for 
bone solids, bone marrow, and neural tissue. Establishments would have 
to have process control procedures in place before labeling or using 
the product derived by use of such systems.
 FSIS has proposed a rule to establish food safety performance 
standards for all processed ready-to-eat meat and poultry products and 
partially heat-treated meat and poultry products that are not ready-to-
eat.
 FSIS plans to propose generic Eshcerichia coli process control 
criteria based on the sponge method of sampling, for cattle, wine, and 
geese slaughtering establishments and for turkey slaughtering 
establishments based on both the sponge and the whole-bird rinse 
sampling methods. The Agency also plans to propose updated Salmonella 
performance standards for all market classes of cattle and swine.
 FSIS will propose removing from the poultry products inspection 
regulations the requirement for ready-to-cook poultry products to be 
chilled to 40 degrees or below within certain time periods according to 
the weight of the dressed carcasses.
 In addition, FSIS will be proposing to require federally inspected egg 
product establishments to develop and implement HACCP systems and 
sanitation standard operating procedures. The Agency will be proposing 
pathogen reduction performance standards for pasteurized egg products. 
Further, the Agency will be proposing to remove requirements for 
approval by FSIS of egg-product plant drawings, specifications, and 
equipment prior to use and to end the system for pre-marketing approval 
of labels for egg products.
 Besides the foregoing initiatives, FSIS has proposed requirements for 
the nutrition labeling of ground or chopped meat and poultry products 
and single-ingredient products. This proposed rule would require 
nutrition labeling, on the label or at the point-of-purchase, for 
themajor cuts of single-ingredient, rawproducts and will require 
nutrition information on the label of ground or chopped products.
 Finally, FSIS is planning to propose stand-by emergency procedures for 
dealing with any occurrences of bovine spongiform encephalopathy (BSE), 
known as mad-cow disease, to prevent any meat or meat products of 
animals affected by BSE from entering commerce. To date, no cases of 
BSE have been found in the United States herd. Any final rule that may 
be developed after the proposal would become effective when and if a 
native case of BSE is detected in the United States.
Animal and Plant Health Inspection Service56
 Mission: The 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 prevent the introduction of exotic pests and diseases into the 
United States and monitors and manages pests and diseases existing in 
this country. These activities enhance agricultural productivity and 
competitiveness and contribute to the national economy and the public 
health.
 Priorities: APHIS is reviewing its existing regulations and developing 
new regulatory initiatives to ensure that a comprehensive framework is 
in place to address the threats posed by exotic and endemic animal 
diseases. Prompted in part by recent outbreaks of foot-and-mouth 
disease elsewhere in the world, APHIS is developing a proposed rule to 
amend its regulations for the cooperative control and eradication of 
animal diseases to ensure their adequacy with regard to the valuation 
of animals and materials, as well as the payment of indemnity, should 
an

[[Page 61136]]

outbreak of foot-and-mouth disease occur in the United States. APHIS 
has also published, or is developing, proposed and final rules 
pertaining to the group of neurological diseases known as transmissible 
spongiform encephalopathies, which includes scrapie (a disease of sheep 
and goats), bovine spongiform encephalopathy (BSE, which affects 
cattle), and chronic wasting disease (a disease of deer and elk). APHIS 
has recently established an expanded regulatory program incorporating 
interstate movement restrictions and compensation for scrapie, 
strengthened its restrictions on the importation of ruminant-derived 
animal products that present a risk of introducing BSE, and is in the 
early stages of developing a cooperative eradication program for 
chronic wasting disease. In addition, APHIS, in coordination with the 
Department's Food Safety and Inspection Service, has begun developing 
an advance notice of proposed rulemaking to solicit public comment on 
BSE-related issues, including mandatory testing of down/dead/dying 
animals and requirements for the disposal of the carcasses of such 
animals.
 APHIS documents published in the Federal Register and related 
information, including the names of organizations and individuals who 
have commented on APHIS dockets, are available on the Internet at 
http://www.aphis.usda.gov/ppd/rad/webrepor.html.
Agricultural Marketing Service56
 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: (1) AMS is proposing to develop a Lamb Promotion, 
Research, and Information Order (Order). The proposed Order, if 
implemented, would establish an industry-funded program that would be 
subject to a referendum within 3 years after assessments begin under 
the Order. The proposed Order provides for an assessment of one-half 
per pound of live lambs sold to be paid by producers, seedstock 
producers, feeders, and exporters and remitted to a 12-member industry 
board by the first handler or exporter. The program would generate an 
estimated $3 million annually, all from the domestic lamb industry. 
Importers of lamb would not be assessed.
 (2) AMS plans to amend the National Organic Program (NOP) to add 
practice standards for Organic Certification of Wild Captured Aquatic 
Animals. The Organic Foods Production Act states that an organic 
certification program be established for producers and handlers of 
agricultural products that have been produced using organic methods. 
The NOP has been reviewing organic certification of fish including wild 
captured and aquaculture operations in response to a FY 2000 
congressional mandate to develop regulations for the certification of 
seafood. The NOP has engaged in public meetings and workshops and 
conducted public comment proceedings on this subject. The NOP considers 
it advantageous to proceed with a proposed rule for wild capture 
operations prior to issuing a proposed rule for aquaculture systems 
because of the significant impact that wild capture standards will have 
on the production and use of fish meal confined systems.
 (3) AMS published in the Federal Register on July 13, 2001, a proposed 
rule implementing the Hass Avocado Promotion, Research, and Information 
Order (Order) and a proposed rule containing referendum procedures for 
the program. Under the proposed Order, producers and importers would 
pay an assessment to the proposed Hass Avocado Board (Board). The Board 
would use the assessment collected to conduct a promotion, research, 
and information program to maintain, develop, and expand markets for 
Hass avocados in the United States. The comment period ended August 27, 
2001. On August 28, 2001, AMS published a notice extending the comment 
period until September 12, 2001, due to several requests that were 
received. AMS plans to publish a final rule before the end of this 
calendar year.
 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.
_______________________________________________________________________



USDA--Agricultural Marketing Service (AMS)

                              -----------

                          PROPOSED RULE STAGE

                              -----------




1. '  ESTABLISHING A LAMB PROMOTION, RESEARCH, AND INFORMATION ORDER 
(LS-01-12)
Priority:


Other Significant


Legal Authority:


7 USC 7401 through 7425


CFR Citation:


7 CFR 1280


Legal Deadline:


None


Abstract:


The Agricultural Marketing Service (AMS) is planning to issue a 
proposed rule establishing an industry-funded promotion, research, and 
information program for lamb and lamb products including pelts but 
excluding wool and wool products. In response to an invitation 
published in the Federal Register to submit proposals for a Lamb 
Promotion, Research, and Information (Order), AMS received a proposal 
from the lamb industry.


Statement of Need:


The United States sheep industry has identified this program as a key 
to its future viability. Due to the negative impact on producer prices 
caused by high levels of imports, the sheep industry has sought 
Government assistance and is seeking to fund this self-help program to 
improve industry profitability. A $100 million trade adjustment 
assistance package has been provided based on a Presidential 
Proclamation. The proposed Lamb Promotion, Research, and Information 
Program would be a self-help program funded through assessments on 
sales of live lambs. The assessments would be paid by producers, 
feeders, and lamb slaughters.


Summary of Legal Basis:


Section 512(b) of the Commodity Promotion, Research, and Information 
Act (Act) of 1996 indicates that the purpose of the Act is to authorize 
the Secretary to establish programs of promotion, research, and 
information for agricultural commodities to strengthen their position 
in domestic and foreign markets. Section 514 of the Act provides that 
to carry out the

[[Page 61137]]

purpose of the Act, the Secretary may issue orders applicable to 
producers of an agricultural commodity and others in the marketing 
chain.


Alternatives:


Not issue a proposed Order.


Anticipated Cost and Benefits:


The proposed program would generate approximately $3 million annually 
for promotion, research, and information activities designed to benefit 
the sheep and lamb industry. These funds would be generated from 
assessments on sales of lamb paid by producers, feeders, and lamb 
slaughters. The Department of Agriculture costs associated with the 
implementation and oversight of the program would be reimbursed from 
the assessments collected under the program. The activities funded 
under the program would likely increase the demand for lamb and lamb 
products and have a positive impact on producer profitability.


Risks:


None.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           12/00/01
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses


Government Levels Affected:


Federal


Agency Contact:
Ralph L. Tapp
Chief, Marketing Programs Branch, Livestock and Seed Division
Department of Agriculture
Agricultural Marketing Service
Room 2624
P.O. Box 96456, Room 2748-So. Bldg.
Washington, DC 20090-6456
Phone: 202 720-1115
RIN: 0581-AC06
_______________________________________________________________________



USDA--AMS

                              -----------

                            FINAL RULE STAGE

                              -----------




2. HASS AVOCADO PROMOTION, RESEARCH, AND INFORMATION ORDER (FV-01-705)
Priority:


Other Significant


Legal Authority:


7 USC 7801 to 7813


CFR Citation:


7 CFR 1219


Legal Deadline:


None


Abstract:


Under the Hass Avocado Promotion, Research, and Information Order, Hass 
avocado producers and importers will pay an assessment of 2.5 cents per 
pound on Hass avocados produced and imported into the U.S. The funds 
will be used by the Hass Avocado Board to increase demand for Hass 
avocados in the U.S.


Statement of Need:


The Agricultural Marketing Service (AMS) is proposing an industry-
funded research, promotion, industry information, and consumer 
information program for Hass avocado. A proposed program--the Hass 
Avocado Research, Promotion, and Consumer Information Order (Order)--
was submitted to AMS by the California Avocado Commission. In addition, 
Mexican, Chilean, and New Zealand producers and associations submitted 
partial proposals. Under the proposed order, producers and importers 
would pay an initial assessment of 2.5 cents per pound of Hass domestic 
and imported avocados to the Hass Avocado Board (Board). The Board 
would be appointed by the Secretary of Agriculture to conduct research, 
promotion, industry information, and consumer information needed for 
the maintenance, expansion, and development of domestic markets for 
Hass avocados. The purpose of the program is to increase consumption of 
Hass avocados in the United States.


Summary of Legal Basis:


The proposed Order is issued under the Hass Avocado Research, 
Promotion, and Consumer Information Act (Pub.L. 104-127), enacted on 
October 23, 2000.


Alternatives:


Not issue a proposed Order.


Anticipated Cost and Benefits:


The proposed Order would authorize assessments on producers (to be 
collected by first handlers) and on importers (collected by Customs) of 
Hass avocados at an initial rate of 2.5 cents a pound. Exports of 
domestic Hass avocados are exempt from assessment. At the initial rate 
of assessment, about $10 million will be collected to administer the 
program--about 65 percent from domestic production and 35 percent from 
imports. All costs of program administration, including conducting the 
program, AMS oversight, and collection of assessments by Customs will 
be covered by the collected assessments.


Risks:


None.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            66 FR 36869                                    07/13/01
NPRM Comment Period End                                        08/27/01
Final Action                                                   12/00/01
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


Businesses


Government Levels Affected:


None


Agency Contact:
Margaret B. Irby
Assistant Branch Chief
Department of Agriculture
Agricultural Marketing Service
Stop 0244, Fruit & Vegetable Programs
14th & Independence Avenue SW
Washington, DC 20250-0244
Phone: 202 720-9915
Fax: 202 205-2800
Email: [email protected]
RIN: 0581-AB92
_______________________________________________________________________



USDA--Animal and Plant Health Inspection Service (APHIS)

                              -----------

                          PROPOSED RULE STAGE

                              -----------




3. '  FOOT-AND-MOUTH DISEASE; PAYMENT OF INDEMNITY
Priority:


Other Significant


Legal Authority:


21 USC 111; 21 USC 114 to 114a; 21 USC 134a to 134h


CFR Citation:


9 CFR 53


Legal Deadline:


None


Abstract:


APHIS is proposing to amend its regulations for the cooperative control

[[Page 61138]]

and eradication of livestock or poultry diseases. These changes would 
provide APHIS with much needed flexibility in responding in an 
effective manner in the event of an outbreak of foot-and-mouth disease 
so that eligible claimants may be compensated while at the same time 
protecting the U.S. livestock and poultry population from the further 
spread of this highly contagious disease.


Statement of Need:


APHIS has recently reviewed these regulations to determine their 
sufficiency should an occurrence of foot-and-mouth disease occur in the 
United States. This review has been prompted, in part, by the series of 
outbreaks of foot-and-mouth disease that have taken place in the United 
Kingdom and elsewhere around the world. Based on this review, APHIS has 
determined that changes to the regulations are needed with regard to 
the valuation of animals and materials, as well as the payment of an 
indemnity to those persons who suffer loss of property as a result of 
foot-and-mouth disease.


Summary of Legal Basis:


The Secretary of Agriculture, either independently or in cooperation 
with States or political subdivisions, farmers' associations and 
similar organizations, and individuals, is authorized to control and 
eradicate any communicable diseases of livestock or poultry and 
contagious or infectious diseases of animals that, in the opinion of 
the Secretary, constitute an emergency and threaten the livestock 
industry of the country, including the payment of claims growing out of 
destruction of animals (including poultry), and of materials affected 
by or exposed to any such disease, in accordance with such regulations 
as the Secretary may prescribe (21 U.S.C. 114a).


Alternatives:


The proposed rule would comprise several regulatory changes, each of 
which is intended to facilitate the control and eradication of foot-
and-mouth disease, should an outbreak of this disease occur in the 
United States. Reasonable alternatives to the proposed rule would be to 
(1) not make any changes at all or (2) to provide alternative levels of 
compensation.


Anticipated Cost and Benefits:


The proposed rule is expected to affect livestock operations and 
Federal and State government agencies. The vast majority of livestock 
operations are small entities. The potential costs and benefits would 
depend upon the degree of compensation provided should a compensation 
alternative be chosen.


Risks:


The changes contained in the proposed rule would be particularly 
important in facilitating early and effective intervention should an 
outbreak of foot-and-mouth disease occur in the United States. An 
effective response in the early stages of such an outbreak greatly 
reduces the risk of the disease's wider dissemination.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           12/00/01
NPRM Comment Period End                                        02/00/02
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses


Government Levels Affected:


Undetermined


Additional Information:


APHIS documents published in the Federal Register and related 
information, including the names of organizations and individuals who 
have commented on APHIS dockets, are available on the Internet at 
http://www.aphis.usda.gov/ppd/rad/webrepor.html.


Agency Contact:
Dr. Mark Teachman
Senior Staff Veterinarian, Emergency Programs, VS
Department of Agriculture
Animal and Plant Health Inspection Service
Unit 41
4700 River Road
Riverdale, MD 20737-1231
Phone: 301 734-8073
RIN: 0579-AB34
_______________________________________________________________________



USDA--APHIS



4. '  CHRONIC WASTING DISEASE IN ELK; INTERSTATE MOVEMENT RESTRICTIONS 
AND PAYMENT OF INDEMNITY
Priority:


Other Significant


Legal Authority:


21 USC 111 to 114a-1; 21 USC 120 to 121; 21 USC 125; 21 USC 134b


CFR Citation:


9 CFR 55; 9 CFR 81


Legal Deadline:


None


Abstract:


APHIS is proposing to establish minimum requirements for the interstate 
movement of farmed elk and to provide indemnity for the depopulation of 
farmed elk that have been infected with, or exposed to, chronic wasting 
disease (CWD).


Statement of Need:


CWD has been confirmed in free-ranging deer and elk in a limited number 
of counties in northeastern Colorado and southeastern Wyoming and has 
also been diagnosed in farmed elk herds in South Dakota, Nebraska, 
Oklahoma, Montana, and Colorado. The proposed rule is intended to 
prevent the spread of, and perhaps eliminate altogether, CWD in farmed 
elk herds in the United States. APHIS believes that establishing 
restrictions on the interstate movement of infected and exposed farmed 
elk, coupled with the payment of some level of indemnity for infected 
and exposed animals, will encourage elk producers who are not yet 
engaging in surveillance activities to begin doing so. To date, the 
level of support from States and the farmed elk industry for such a 
program has been high. Without a Federal program in place to depopulate 
infected and exposed animals, the movement of infected elk into new 
herds and States with no known infection will continue or may even 
accelerate. APHIS needs to take action to document the prevalence of 
the disease and to prevent its further spread.


Summary of Legal Basis:


The Secretary of Agriculture, either independently or in cooperation 
with States or political subdivisions, farmers' associations and 
similar organizations, and individuals, is authorized to control and 
eradicate any communicable diseases of livestock or poultry and 
contagious or infectious diseases of animals that, in the opinion of 
the Secretary, constitute an emergency and threaten the livestock 
industry of the country, including the payment of claims growing out of 
destruction of animals (including poultry), and of materials affected 
by or exposed to any such disease, in

[[Page 61139]]

accordance with such regulations as the Secretary may prescribe (21 
U.S.C. 114a).


Alternatives:


APHIS has identified two alternatives to the proposed rule. The first--
to maintain the status quo--was rejected because it would not address 
the animal disease risks associated with CWD. The second option would 
have been to provide financial and technical assistance to the elk 
industry for continuation and expansion of a variety of herd management 
practices to reduce or eliminate CWD. Although this option may be less 
costly than the option chosen by APHIS (i.e., the proposed rule), this 
option was not selected because it would not advance CWD eradication as 
quickly or effectively as the chosen option. However, APHIS will 
continue to work with industry to develop voluntary herd management 
practices to preserve and increase the reduction in CWD levels that the 
proposed program is expected to achieve.


Anticipated Cost and Benefits:


The presence of CWD in elk causes significant economic and market 
losses to U.S. producers. Recently Canada has begun to require, as a 
condition for importing U.S. elk into Canada, that the animals be 
accompanied by a certificate stating that the herd of origin is not 
located in Colorado or Wyoming, and CWD has never been diagnosed in the 
herd of origin. The Republic of Korea recently suspended the 
importation of deer and elk and their products from the United States 
and Canada. The domestic prices for elk are severely affected by fear 
of CWD; it is extremely difficult for producers to sell elk that are 
associated with any hint of exposure to CWD.


Risks:


Aggressive action in controlling this disease now will decrease the 
chance of having to deal with a much larger, widespread, and costly 
problem later, such as the situation with bovine spongiform 
encephalopathy (``mad cow disease'') in Europe. Although there is 
currently no evidence that CWD is linked to disease in humans, or in 
domestic animals other than deer and elk, a theoretical risk of such a 
link exists.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           01/00/02
NPRM Comment Period End                                        03/00/02
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses


Government Levels Affected:


Undetermined


Additional Information:


APHIS documents published in the Federal Register and related 
information, including the names of organizations and individuals who 
have commented on APHIS dockets, are available on the Internet at 
http://www.aphis.usda.gov/ppd/rad/webrepor.html.


Agency Contact:
Dr. Lynn Creekmore
Staff Veterinarian/Wildlife Diseases Liaison, NAHPS, VS
Department of Agriculture
Animal and Plant Health Inspection Service
4101 Laporte Avenue
Fort Collins, CO 80521
Phone: 970 266-6128
RIN: 0579-AB35
_______________________________________________________________________



USDA--Food and Nutrition Service (FNS)

                              -----------

                          PROPOSED RULE STAGE

                              -----------




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

[[Page 61140]]

2. Increasing the nutritional adequacy of the WIC food packages for 
medically needy participants.


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 U.S.C. 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:


None.


Anticipated Cost and Benefits:


None.


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                                                           05/00/02
NPRM Comment Period End                                        08/00/02
Final Action                                                   02/00/03
Final Action Effective                                         06/00/03
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:
Sharon Ackerman
Agency Regulatory Officer
Department of Agriculture
Food and Nutrition Service
Room 910
3101 Park Center Drive
Alexandria, VA 22302
Phone: 703 305-2246
Fax: 703 605-0220
Email: [email protected]
RIN: 0584-AC90
_______________________________________________________________________



USDA--FNS



6.   FOOD STAMP PROGRAM: VEHICLE AND MAXIMUM EXCESS SHELTER 
EXPENSE DEDUCTION PROVISIONS OF PUBLIC LAW 106-387
Priority:


Economically Significant. Major under 5 USC 801.


Legal Authority:


PL 106-387


CFR Citation:


7 CFR 272.1; 7 CFR 273.8; 7 CFR 273.9


Legal Deadline:


None


Abstract:


This proposed rule will (1) implement a revision of the Food Stamp 
Program's resource eligibility standards regarding vehicle ownership 
and (2) set the maximum excess shelter expense deduction for fiscal 
year 2001 and, for future years, index it to the Consumer Price Index. 
(01-006)


Statement of Need:


This rule is necessary to implement revisions to the Food Stamp 
Program's resource eligibility standards regarding vehicle ownership 
and maximum excess shelter expense deduction.


Summary of Legal Basis:


All provisions of this proposed rule are mandated by Public Law 106-
387.


Alternatives:


The alternative would be not to revise current rules, which have been 
superseded by changes brought about by Public Law 106-387.


Anticipated Cost and Benefits:


Low-income households will benefit by claiming larger income deductions 
for shelter expenses, thereby obtaining higher food stamp benefits. The 
new vehicle ownership provisions will make more low-income households 
eligible for food stamps and make it easier for them to own a reliable 
vehicle. States will benefit by having more flexibility and simpler 
administrative options for determining the effect of vehicle ownership 
upon food stamp eligibility.


Risks:


Not implementing this proposed rule would ignore the mandates contained 
in Public Law 106-387.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           02/00/02
NPRM Comment Period End                                        04/00/02
Final Action                                                   11/00/02
Final Action Effective                                         01/00/03
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


State, Local


Agency Contact:
Sharon Ackerman
Agency Regulatory Officer
Department of Agriculture
Food and Nutrition Service
Room 910
3101 Park Center Drive
Alexandria, VA 22302
Phone: 703 305-2246
Fax: 703 605-0220
Email: [email protected]
RIN: 0584-AD13
_______________________________________________________________________



USDA--FNS

                              -----------

                            FINAL RULE STAGE

                              -----------




7. CHILD AND ADULT CARE FOOD PROGRAM: IMPROVING MANAGEMENT AND PROGRAM 
INTEGRITY
Priority:


Other Significant


Legal Authority:


42 USC 1766; PL 103-448; PL 104-193; PL 105-336


CFR Citation:


7 CFR 226


Legal Deadline:


None

[[Page 61141]]

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 will 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 and day care homes. 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), the William F. Goodling 
Child Nutrition Reauthorization Act of 1998 (Pub. L. 105-336), the 
Agricultural Risk Protection Act of 2000 (Pub. L. 106-224), and the 
Grain Standards and Warehouse Improvement Act of 2000 (Pub. L. 106-
472).


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-categorized or 
incomplete income eligibility statements. In addition, audits and 
investigations conducted by the Office of Inspector General (OIG) have 
raised serious concerns regarding the adequacy of financial and 
administrative controls in CACFP. Based on its findings, OIG 
recommended changes to CACFP review requirements and management 
controls.


Summary of Legal Basis:


Some of the changes proposed in the rule are discretionary changes 
being made in response to deficiencies found in program reviews and OIG 
audits. Other changes codify statutory changes made by the Healthy 
Meals for Healthy Americans Act of 1994 (Pub. L. 103-448), the Personal 
Responsibility and Work Opportunities Reconciliation Act of 1996 (Pub. 
L. 104-193), the William F. Goodling Child Nutrition Reauthorization 
Act of 1998 (Pub. L. 105-336), the Agricultural Risk Protection Act of 
2000 (Pub. L. 106-224), and the Grain Standards and Warehouse 
Improvement Act of 2000 (Pub. L. 106-472).


Alternatives:


In developing the proposal, the Agency considered various alternatives 
to minimize burden on State agencies and institutions while ensuring 
effective program operation. Key areas in which alternatives were 
considered include State agency reviews of institutions and sponsoring 
organization oversight of day care homes.


Anticipated Cost and Benefits:


This rule contains changes designed to improve management and financial 
integrity in the CACFP. When implemented, these changes would affect 
all entities in CACFP, from USDA to participating children and 
children's households. These changes will primarily affect the 
procedures used by State agencies in reviewing applications submitted 
by, and monitoring the performance of, institutions which are 
participating or wish to participate in the CACFP. Those changes which 
would affect institutions and facilities will not, in the aggregate, 
have a significant economic impact.


Data on CACFP integrity is limited, despite numerous OIG reports on 
individual institutions and facilities that have been deficient in 
CACFP management. While program reviews and OIG reports clearly 
illustrate that there are weaknesses in parts of the program 
regulations and that there have been weaknesses in oversight, neither 
program reviews, OIG reports, nor any other data sources illustrate the 
prevalence and magnitude of CACFP fraud and abuse. This lack of 
information precludes USDA from estimating the amount of money lost due 
to fraud and abuse or the reduction in fraud and abuse the changes in 
this rule will realize.


Risks:


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
Interim Final Rule                                             07/00/02
Interim Final Rule Effective                                   08/00/02
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


State, Local


Agency Contact:
Sharon Ackerman
Agency Regulatory Officer
Department of Agriculture
Food and Nutrition Service
Room 910
3101 Park Center Drive
Alexandria, VA 22302
Phone: 703 305-2246
Fax: 703 605-0220
Email: [email protected]
RIN: 0584-AC24
_______________________________________________________________________



USDA--FNS



8. 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:


Economically Significant. Major under 5 USC 801.


Legal Authority:


PL 104-193


CFR Citation:


7 CFR 273.7; 7 CFR 273.22


Legal Deadline:


None

[[Page 61142]]

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:


None.


Risks:


None.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            64 FR 72196                                    12/23/99
NPRM Comment Period End                                        02/22/00
Final Action                                                   12/00/01
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


State, Local


Agency Contact:
Sharon Ackerman
Agency Regulatory Officer
Department of Agriculture
Food and Nutrition Service
Room 910
3101 Park Center Drive
Alexandria, VA 22302
Phone: 703 305-2246
Fax: 703 605-0220
Email: [email protected]
RIN: 0584-AC45
_______________________________________________________________________



USDA--Food Safety and Inspection Service (FSIS)

                              -----------

                             PRERULE STAGE

                              -----------




9. 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 to 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 a zero tolerance for ingesta 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, FSIS 
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, now dismissed, that alleged disparate regulation of the 
meat and poultry industries by FSIS and challenged 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 under the Poultry Products Inspection Act (21 
U.S.C. 451-470).


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. 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

_______________________________________________________________________
ANPRM                                                          07/00/02
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses


Government Levels Affected:


None


Agency Contact:
Daniel L. Engeljohn
Director, Regulations and Directives Development Staff
Department of Agriculture
Food Safety and Inspection Service
Washington, DC 20250
Phone: 202 720-5627
RIN: 0583-AC77
_______________________________________________________________________



USDA--FSIS

                              -----------

                          PROPOSED RULE STAGE

                              -----------




10. PERFORMANCE STANDARDS FOR BACON
Priority:


Other Significant


Legal Authority:


21 USC 601 et seq; 21 USC 451 et seq


CFR Citation:


9 CFR 424.22(b)


Legal Deadline:


None

[[Page 61143]]

Abstract:


FSIS is proposing to revise the regulatory provisions concerning the 
production and testing of bacon (9 CFR 424.22(b)). FSIS is proposing to 
remove provisions that require the Agency to test bacon for 
nitrosamines and to remove provisions that prescribe the substances and 
amounts of such substances that must be used to produce bacon. FSIS is 
proposing to replace these provisions with performance standards that 
establishments producing bacon must meet. To meet these proposed 
performance standards, the process used would be required to limit the 
presence of nitrosamines when the product is cooked. Under the hazard 
analysis and critical control points (HACCP) system, establishments 
would incorporate the proposed performance standards into their HACCP 
plans.


Statement of Need:


FSIS is proposing to replace restrictive provisions concerning the 
processing of bacon with a performance standard. The proposed 
performance standard concerns limiting the presence of volatile 
nitrosamines in bacon products. The Agency is also proposing to remove 
provisions that require the Agency to sample and test bacon for the 
presence of nitrosamines. These proposed changes are necessary to make 
the bacon regulations consistent with those governing Hazard Analysis 
and Critical Control Point (HACCP) systems.


Summary of Legal Basis:


Under the Federal Meat Inspection Act (21 U.S.C. 601-695) a meat or 
meat food product is adulterated ``if it bears or contains any 
poisonous or deleterious substance which may render it injurious to 
health; but in case the substance is not an added substance, such 
article shall not be considered adulterated under this clause if the 
quantity of such substance in or on such article does not ordinarily 
render it injurious to health'' (21 U.S.C. 601(m)(1)). Volatile 
nitrosamines are deleterious because carcinogenic and, though not added 
directly to bacon, they may be produced when the bacon is fried. 
Processors can control the levels of nitrosamines that may be present 
when the product is fried by controlling the levels of nitrite and 
nitrosamine inhibitors that are used in the bacon curing process. In 
1978, USDA stated that nitrosamines present at confirmable levels in 
bacon after preparation for eating were deemed to be adulterative. FSIS 
still maintains that bacon with confirmable levels of nitrosamines 
after preparation for eating is adulterated. In this proposed rule, 
processors would control the levels of nitrosamines by complying with a 
performance standard.


Alternatives:


No action; performance standards for all types of bacon (not just 
pumped bacon, as proposed); removal of the FSIS testing provisions 
without converting prescriptive regulations to performance standard.


Anticipated Cost and Benefits:


Because FSIS is proposing to convert existing regulations to a 
performance standard and is not proposing any new requirements for 
establishments producing bacon, FSIS does not anticipate that this 
proposed rule would result in any significant costs or benefits. Bacon-
processing establishments whose HACCP plans do not address nitrosamines 
as hazards reasonably likely to occur may incur some costs. Also, 
establishments that choose to test their products for nitrosamines may 
incur some costs. Because this rule provides establishments the 
flexibility to develop new procedures for producing bacon, this rule 
may result in profits to processors who develop cheaper means of 
producing product or who develop a product with wide consumer appeal.


Risks:


None.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           07/00/02
Regulatory Flexibility Analysis Required:


No


Government Levels Affected:


None


Agency Contact:
Daniel L. Engeljohn
Director, Regulations and Directives Development Staff
Department of Agriculture
Food Safety and Inspection Service
Washington, DC 20250
Phone: 202 720-5627
RIN: 0583-AC49
_______________________________________________________________________



USDA--FSIS



11. EGG AND EGG PRODUCTS INSPECTION REGULATIONS
Priority:


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


Unfunded Mandates:


Undetermined


Legal Authority:


21 USC 1031 to 1056


CFR Citation:


9 CFR 590.570; 9 CFR 590.575; 9 CFR 590.146; 9 CFR 590.10; 9 CFR 
590.411; 9 CFR 590.502; 9 CFR 590.504; 9 CFR 590.580; 9 CFR 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.

[[Page 61144]]

Statement of Need:


FSIS is proposing to require egg products plants to develop and 
implement HACCP systems and Sanitation Standard Operating Procedures 
(SSOPs). FSIS also is proposing a pathogen reduction performance 
standard that would be applicable to pasteurized egg products. Plants 
would be expected to develop HACCP systems that ensure egg products 
meet the lethality required by the pathogen reduction performance 
standard. In addition, FSIS is proposing to amend the Federal shell egg 
and egg products inspection regulations by removing current 
requirements for approval by FSIS of egg product plant drawings, 
specifications, and equipment prior to their use in official (FSIS-
inspected) plants. Finally, the Agency plans to eliminate the pre-
marketing label approval system for egg products but to require safe-
handling labels on shell eggs and egg products.


The actions being proposed are part of FSIS's regulatory reform effort 
to improve FSIS's shell 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 shell 
egg and egg products regulations as consistent as possible with the 
Agency's meat and poultry products regulations. FSIS also is taking 
these actions in light of changing inspection priorities and recent 
findings of Salmonella in pasteurized egg products.


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


Summary of Legal Basis:


This proposed rule is authorized under the Egg Products Inspection Act 
(21 U.S.C. 1031-1056). It is not the result of any specific mandate by 
the Congress or a Federal court.


Alternatives:


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


Anticipated Cost and Benefits:


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


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


FSIS has cooperative agreements with six States and the Commonwealth of 
Puerto Rico under which they provide inspection services to egg 
processing plants under Federal jurisdiction. FSIS reimburses the 
States for staffing costs and expenses for full-time State inspectors. 
HACCP implementation may result in a reduction of staffing resource 
requirements in the States and a corresponding reduction of the Federal 
reimbursement. As a result, some States may decide to stop providing 
inspection services and convert to Federal inspection of egg products 
plants.


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


This proposal is not likely to have a significant impact on small 
entities. The entities that would be directly affected by this proposal 
would be the approximately 75 federally inspected egg-processing 
establishments, most of which are small businesses, according to Small 
Business Administration criteria. If necessary, FSIS will develop 
compliance guides to assist these small firms in implementing the 
proposed requirements.


The impacts on the FSIS budget will be influenced by the alternatives 
proposed and industry responses. Most likely, fewer FSIS inspection 
personnel will be required over time as more uniform inspection 
practices are employed among the meat, poultry, and egg products 
industries.


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


Human health benefits from this rulemaking are likely to be small 
because of the low level of (chiefly post-processing) contamination of 
pasteurized egg products. In light of recent scientific studies that 
raise questions about the efficacy of current regulations, however, it 
is likely that measurable reductions will be achieved in the risk of 
foodborne illness.


Risks:


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


To assess the potential risk-reduction impacts of this rulemaking on 
the public, an interagency panel of scientific and technical experts is 
conducting a risk management analysis. The panel has been charged with 
identifying the lethality requirement sufficient to ensure the safety 
of egg products and the alternative methods for implementing the 
requirement. The egg products processing and distribution module of the 
Salmonella enteritidis Risk Assessment, made public June 12, 1998, will 
be appropriately modified to evaluate the risk associated with the 
regulatory alternatives.

[[Page 61145]]

Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           12/00/01
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses, Governmental Jurisdictions


Government Levels Affected:


None


Agency Contact:
Daniel L. Engeljohn
Director, Regulations and Directives Development Staff
Department of Agriculture
Food Safety and Inspection Service
Washington, DC 20250
Phone: 202 720-5627
RIN: 0583-AC58
_______________________________________________________________________



USDA--FSIS



12. PATHOGEN REDUCTION; HAZARD ANALYSIS AND CRITICAL CONTROL POINTS 
(HACCP) SYSTEMS; ADDITIONS TO GENERIC E. COLI CRITERIA
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 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) System 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 standard would replace the existing standard for 
hogs. These new standards apply to all market classes of cattle and 
swine, respectively.


The National Academy of Sciences and the National Advisory Committee on 
Microbiological Criteria for Foods are examining the Salmonella 
performance standards and generic E. coli criteria. FSIS will take into 
account their findings and concerns before issuing rules on this 
matter.


 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. The 
additional performance standards for Salmonella and criteria for E. 
coli 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 flexibility 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 action is authorized under the Federal Meat Inspection Act (21 
U.S.C. 601-695) and the Poultry Products Inspection Act (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 attributable 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

_______________________________________________________________________
NPRM                                                           07/00/02
Regulatory Flexibility Analysis Required:


No


Government Levels Affected:


None


Agency Contact:
Daniel L. Engeljohn
Director, Regulations and Directives Development Staff
Department of Agriculture
Food Safety and Inspection Service
Washington, DC 20250
Phone: 202 720-5627
RIN: 0583-AC63
_______________________________________________________________________



USDA--FSIS



13.   ELIMINATION OF CHILLING TIME AND TEMPERATURE REQUIREMENTS 
FOR READY-TO-COOK POULTRY (SECTION 610 REVIEW)
Priority:


Other Significant


Legal Authority:


21 USC 451 to 470


CFR Citation:


9 CFR 381.66

[[Page 61146]]

Legal Deadline:


None


Abstract:


FSIS is proposing to eliminate the time and temperature requirements 
for chilling ready-to-cook poultry carcasses and giblets. The Agency is 
taking this action because the requirements are inconsistent with the 
Agency's Pathogen Reduction/Hazard Analysis and Critical Control Point 
(HACCP) System regulations, with its final rule further restricting 
retained water in raw meat and poultry, and with the Agency's 
regulatory reform program. Moreover, because of these regulations, the 
meat and poultry industries receive disparate regulatory treatment: No 
regulations that apply to the chilling of poultry apply to the chilling 
of meat. This proposal responds to longstanding petitions by industry 
trade associations.


Statement of Need:


This proposed rule addresses Federal regulations that are inconsistent 
with the PR/HACCP regulations because they restrict the ability of 
poultry processors to choose appropriate and effective measures to 
eliminate, reduce, or control biological hazards identified in their 
hazard analyses. The regulations also complicate efforts by 
establishments to comply with the terms of the January 9, 2001, final 
rule further restricting the amount of water that may be retained in 
raw meat or poultry products after post-evisceration processing; some 
establishments may have to use chilling procedures that result in 
higher levels of retained water in carcasses than may be necessary to 
achieve the same food safety objective. For example, establishments 
that operate automated chillers may have to subject poultry carcasses 
to higher agitation rates or longer dwell times in the chillers. Also, 
as discussed above, the time/temperature chilling regulations for 
poultry result in disparate regulatory treatment of the meat and 
poultry industries.


Summary of Legal Basis:


This regulatory action is authorized under the Poultry Products 
Inspection Act (21 U.S.C. 451-470).


Alternatives:


FSIS evaluated five regulatory alternatives: (1) taking no regulatory 
action; (2) replacing the command-and-control requirements with a 
performance standard; (3) requiring meatpackers, as well as poultry 
processors, to comply with such a performance standard; (4) requiring 
all establishments that prepare raw meat or poultry products or handle, 
transport, or receive the products in transportation to comply with a 
performance standard; or (5) removing the command-and-control 
requirements from the poultry products inspection regulations. The 
Agency chose the fifth alternative.


Anticipated Cost and Benefits:


Poultry processors would gain the flexibility to choose the best 
processing techniques and procedures for achieving production 
efficiencies, meeting HACCP food safety objectives, and preventing 
economic adulteration of raw product with retained water in amounts 
greater than unavoidable for food-safety purposes. They would be able 
to operate with a wider range of chilling temperatures consistently 
with the requirements of the PR/HACCP regulations. The poultry products 
industry could achieve energy efficiencies resulting in annual savings 
of as much as $2.8 million.


The industry could also reduce carcass ``dwell times'' in immersion 
chillers and thereby reduce the amount of water absorbed and retained 
by the carcasses. The reduction in dwell time might enable some 
establishments, particularly those currently operating at the 
throughput capacity of their chillers, to increase production by 
installing additional evisceration lines. Poultry establishments would 
therefore be able to operate more efficiently to provide consumers with 
product that is not adulterated.


FSIS also would gain some flexibility by being able to reallocate some 
inspection resources from measuring the temperature of chilled birds to 
such activities as HACCP system verification.


This proposed rule would directly impose no new costs on the regulated 
industry. It would relieve burdens arising from the disparate impacts 
of the current regulations on the meat and poultry industries.


Risks:


None


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           02/00/02
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


Businesses


Government Levels Affected:


None


Agency Contact:
Daniel L. Engeljohn
Director, Regulations and Directives Development Staff
Department of Agriculture
Food Safety and Inspection Service
Washington, DC 20250
Phone: 202 720-5627
RIN: 0583-AC87
_______________________________________________________________________



USDA--FSIS



14. ' EMERGENCY REGULATIONS TO PREVENT MEAT FOOD AND MEAT PRODUCTS THAT 
MAY CONTAIN THE BSE AGENT FROM ENTERING COMMERCE
Priority:


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


Legal Authority:


21 USC 601 et seq


CFR Citation:


Not Yet Determined


Legal Deadline:


None


Abstract:


FSIS is proposing to amend the meat inspection regulations to add 
emergency regulations to prevent meat and meat food products that may 
contain the bovine spongiform encephalopathy (BSE) agent from entering 
commerce. The emergency regulations would become effective when, and 
if, BSE is diagnosed in native cattle in the United States. The 
proposed regulations provide for periodic review by FSIS to determine 
their effectiveness and to evaluate the need to modify or remove some 
measures or impose additional measures.


Statement of Need:


FSIS is proposing to amend the meat inspection regulations to add 
provisions to prevent meat and meat products that may contain the BSE 
agent from entering commerce in the event that BSE is diagnosed in 
native cattle in the U.S. Any final rule that is developed as a result 
of this proposal will become effective when, and if, a native case of 
BSE is detected in the U.S.


BSE is a chronic, degenerative, neorological disorder of cattle. 
Worldwide, there have been more than

[[Page 61147]]

178,000 cases since the disease was first diagnosed in 1986 in Great 
Britain. There have been no cases of BSE detected in the United States 
despite 10 years of active surveillance for the disease. Recent 
laboratory and epidemiological research indicate that there is a causal 
association between BSE and variant Creutzfeldt-Jakob Disease (vCJD), a 
slow degenerative disease that affects the central nervous system of 
humans. Like BSE, vCJD has not been detected in the United States. Both 
BSE and vCJD are always fatal.


Although BSE has not been detected in the U.S., USDA policy in regard 
to BSE has been to be proactive and preventive. Therefore, FSIS is 
proposing these regulations so that the Agency will have an immediate 
regulatory response in the event that BSE is detected in the U.S. Once 
finalized, the proposed measures will be incorporated in the meat 
inspection regulations but would only become effective when, and if, 
BSE is detected in native cattle.


Summary of Legal Basis:


Under the Federal Meat Inspection Act (21 U.S.C. 601-695), FSIS issues 
regulations governing the production of meat and meat food products. 
The regulations, along with FSIS inspection programs, are designed to 
ensure that meat food products are safe, not adulterated, and properly 
marked, labeled, and packaged.


Alternatives:


As an alternative to the proposed requirements, FSIS considered taking 
no action. FSIS rejected this option because, as previously mentioned, 
USDA policy in regard to BSE has been to be proactive and preventive. 
Publishing a proposed rule will inform the public of the type of 
regulatory response it can expect from FSIS when, and if, BSE is 
detected in native cattle.


In addition to the proposed requirements, FSIS is considering taking 
actions prior to the detection of BSE in the U.S. to minimize human 
exposure to materials from cattle that could potentially contain the 
BSE agent. The measures under consideration are targeted at the 
materials of cattle that are most likely to contain the BSE agent, if 
such animals have been infected with BSE, and those cattle that have 
consumed feed prohibited by Food and Drug Administration's (FDA) 
regulations (i.e., mammalian meat and bone meal in ruminant feed).


Anticipated Cost and Benefits:


None.


Risks:


Although vCJD is a rare condition, the symptoms are severe, and it is 
always fatal. This proposed rule is intended to reduce the risk of 
humans developing vCJD in the U.S. in the event BSE is detected in 
native cattle. The measures proposed by FSIS are intended to minimize 
human exposure to materials from cattle that could potentially contain 
the BSE agent. In April 1998, USDA entered into a cooperative agreement 
with Harvard University's School of Public Health to conduct a risk 
analysis to assess the potential pathways for entry into U.S. cattle 
and the U.S. food supply, to evaluate existing regulations and 
policies, and to identify any additional measures that could be taken 
to protect human and animal health. FSIS will use the findings of the 
risk assessment to evaluate the level of risk reduction associated with 
the proposed measures.


Unlike bacterial and viral pathogens that may be found in or on meat 
food products, the BSE agent cannot be destroyed by conventional 
methods, such as cooking or irradiation. Also, although it is rare, 
vCJD, the human disease associated with exposure to the BSE agent, is 
generally more severe than the human illnesses associated with exposure 
to bacterial and viral pathogens. Thus, if BSE were detected in the 
U.S., additional measures to reduce the risk of human exposure to the 
BSE agent are necessary to protect public health.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           09/00/02
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses


Government Levels Affected:


Undetermined


Federalism:


 Undetermined


Agency Contact:
Daniel L. Engeljohn
Director, Regulations and Directives Development Staff
Department of Agriculture
Food Safety and Inspection Service
Washington, DC 20250
Phone: 202 720-5627
RIN: 0583-AC88
_______________________________________________________________________



USDA--FSIS

                              -----------

                            FINAL RULE STAGE

                              -----------




15. MEAT PRODUCED BY ADVANCED MEAT/BONE SEPARATION MACHINERY AND 
RECOVERY SYSTEMS
Priority:


Economically 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 inadequate to prevent misbranding and economic 
adulteration. Therefore, FSIS is developing a rule to clarify the 
regulations and supplement the rules for assuring compliance.


Statement of Need:


In 1998, FSIS proposed to clarify the meat inspection regulations 
regarding mechanically separated meat contained in a final rule issued 
in December 1994. The proposed rule would replace the present 
compliance program parameters with non-compliance criteria for bone and 
bone-related material. The proposed rule would require, as a 
prerequisite to labeling or using product derived by mechanically 
separating skeletal muscle tissue from cattle bones as meat, that

[[Page 61148]]

establishments implement and document procedures for ensuring that 
their production process is in control. FSIS intends to issue a final 
rule in the first quarter of 2002 that prohibits central nervous system 
tissue in meat produced by advanced meat separation and recovery 
systems.


Summary of Legal Basis:


This action is authorized under the Federal Meat Inspection Act (21 
U.S.C. 601-695).


Alternatives:


No action.


Anticipated Cost and Benefits:


Although the 1998 proposed rule was determined to be not economically 
significant, FSIS restudied the projected costs using data from various 
FSIS data bases and other sources to develop an improved estimate of 
the benefits and costs of implementing the final rule. To date, it 
appears that the final rule will not be economically significant, but 
data evaluation continues. The benefit of publishing a rule that 
prohibits central nervous system tissue is that the meat industry would 
be producing a product that is not misbranded or economically 
adulterated.


Risks:


None.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            63 FR 17959                                    04/13/98
NPRM Comment Period End                                        06/12/98
Final Action                                                   02/00/02
Regulatory Flexibility Analysis Required:


Undetermined


Government Levels Affected:


None


Agency Contact:
Daniel L. Engeljohn
Director, Regulations and Directives Development Staff
Department of Agriculture
Food Safety and Inspection Service
Washington, DC 20250
Phone: 202 720-5627
RIN: 0583-AC51
_______________________________________________________________________



USDA--FSIS



16. PERFORMANCE STANDARDS FOR ON-LINE ANTIMICROBIAL REPROCESSING OF 
PRE-CHILL POULTRY CARCASSES
Priority:


Other Significant


Legal Authority:


21 USC 451 to 470


CFR Citation:


9 CFR 381; 9 CFR 424


Legal Deadline:


None


Abstract:


This rule is proposing to allow, on a voluntary basis, the on-line 
reprocessing of pre-chill poultry carcasses that are accidentally 
contaminated with digestive tract contents during slaughter. The 
treated carcasses must meet pre-chill performance standards that are 
substantially lower than the current performance standard and criteria.


Statement of Need:


On December 1, 2000, FSIS issued a proposed rule to permit on-line 
antimicrobial reprocessing of pre-chill poultry carcasses on a 
voluntary basis. It is estimated that approximately 90 poultry 
slaughter establishments are now engaged in on-line processing. 
Permitting pre-chill poultry to be reprocessed on-line rather than off-
line yields great benefits to industry and reduces microbial loads on 
visibly contaminated and visibly clean birds.


Summary of Legal Basis:


This action is authorized by the Poultry Products Inspection Act (21 
U.S.C. 456 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:


Executive Order 12866 requires that FSIS identify and assess 
alternative forms of regulation. FSIS considered two alternatives to 
this proposed rule: (1) not proposing to allow for the on-line 
reprocessing of contaminated carcasses and (2) proposing to require 
plants to perform on-line reprocessing of pre-chill contaminated 
carcasses and establishing specific numerical performance standards 
that the reprocessed poultry must meet using a mandated antimicrobial 
treatment or process. FSIS rejected both alternatives for the reasons 
explained below.


Failing To Propose


 FSIS is committed to reducing the levels of microbial pathogens in 
poultry products. On-line reprocessing of poultry in commercial trials 
using solutions of TSP/chlorine and acidified sodium chlorite has been 
shown to be a highly effective method of reducing the microbial levels 
of raw poultry to levels substantially below the performance standards 
and criteria established by the pathogen reduction/HACCP final rule.


Mandating Procedures, Materials, and Methods


 FSIS is proposing to give all establishments the option of adopting 
on-line reprocessing of visibly contaminated birds. By not mandating 
that all plants adopt on-line reprocessing, FSIS is recognizing that 
there are other solutions to reducing bacterial loads that may be more 
appropriate and cost-effective for small plants. There are many 
possible solutions for pathogen reduction of raw poultry and poultry 
products, and the industry continues to seek out new products and 
equipment that will be effective.


 Pathogen reduction is central to the FSIS food safety strategy. 
However, eliminating as many prescriptive or command-and-control 
regulations as possible also is an important part of the overall 
strategy for updating and improving inspection in light of HACCP. 
Therefore, there will be no mandate proposed for establishments to use 
TSP or any other substance as the antimicrobial reprocessing aid. 
Various substances have undergone trials to determine their potential 
as antimicrobial processing agents. Such substances include acidified 
sodium chlorite; organic acids such as lactic, acetic, and formic 
acids; chlorine dioxides; and ozone. Plants will be free to use other 
products that have demonstrated their efficacy in reducing levels of 
microorganisms in in-plant commercial trials. This is consistent with 
the Agency's strategy of encouraging the industry to take advantage of 
new technology to reduce the risks associated with the consumption of 
meat and poultry products.


Anticipated Cost and Benefits:


The economic impact of this rule is likely to be minimal because of the 
voluntary nature of the practice this

[[Page 61149]]

proposal would authorize. An establishment will use on-line 
reprocessing if it is consistent with the objectives of the firm, 
conforms with plant configuration, provides increased efficiency in 
achieving product standards, improves product characteristics, and 
other factors. The poultry industry is highly competitive; an increase 
in product price by a single producer is likely to result in a loss of 
market share. A firm is not likely to purchase new equipment that will 
increase overall production costs or reduce profits.


 The cost for a poultry plant to adopt an acceptable on-line 
reprocessing system will vary from plant to plant and will be 
contingent on the location, physical structure, and age of the plant 
and the adaptability of the equipment. Available information indicates 
that the capital cost per line ranges from $10,000 to more than 
$55,000, with an average cost of $35,600, which is close to the 
manufacturer's estimate for a single line cost of $30,000.


 Operating costs associated with on-line reprocessing systems also can 
vary significantly as a result of plant size, number of lines, 
processing capacity, plant configuration, and other factors. Rhodia 
estimates that the TSP application cost will be about 0.2 cents per 
pound for an average chicken slaughter plant. The application of other 
antimicrobial substances may vary slightly in cost. Plant data suggest 
that total annual operating costs, which include labor, water softener, 
TSP, and water, are very close to the manufacturer's estimate. 
Available information suggests annual operating costs of about $125,000 
per line for an average plant. Costs associated with off-line 
reprocessing would be expected to decline following installation of on-
line reprocessing equipment because of reduced labor and other 
operating requirements. Available data suggest the decrease in 
operating costs because of reduced off-line reprocessing is about 
$70,000 per line, somewhat more than half of the increase in operating 
costs associated with TSP on-line reprocessing. The available plant 
information suggests that about two-thirds of the plants would not 
experience any change in sewage treatment. The remaining third would be 
required to perform additional treatment at the plant to meet discharge 
limits. Two-thirds of the plants would show no change in water use, 
while the remaining plants will have to increase use by 1 to 2 gallons 
per bird, or about 10 percent.


 For the average plant, the net present value of capital costs and the 
net change in operating costs of TSP on-line reprocessing is about $1.2 
million over a 10-year period using a discount rate of 7 percent. Based 
on the assumptions that the average plant processes about 200,000 birds 
per day, that an average bird has a dressed weight of 3.6 pounds, and 
the plant operates an average of 255 days per year over the next 10 
years, the increase in total production costs is slightly more than .2 
cents per pound. The capital costs amortized over a 10-year period are 
minimal on a per pound basis. The costs to the poultry processing 
industry would accrue to plants engaged in slaughter, either 
exclusively or in combination with processing. In 1996, there were 281 
federally inspected plants of this description. Only one Federal-State 
cooperative inspection plant is currently engaged in poultry slaughter. 
If all such plants voluntarily install an on-line reprocessing system, 
the total cost to the poultry industry would be about $345 million over 
a 10-year period.


Risks:


The cost of a TSP on-line reprocessing system represents an 
insignificant portion of the retail price per pound of poultry. If 
there is any increase in the retail price of poultry, it will be modest 
and offset by consumer confidence that the product presents lower 
microbial risks.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            65 FR 75187                                    12/01/00
NPRM Comment Period End                                        01/30/01
Final Action                                                   03/00/02
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


None


Agency Contact:
Daniel L. Engeljohn
Director, Regulations and Directives Development Staff
Department of Agriculture
Food Safety and Inspection Service
Washington, DC 20250
Phone: 202 720-5627
RIN: 0583-AC73
BILLING CODE 3410-90-S



DEPARTMENT OF COMMERCE (DOC)

[[Page 61150]]




Statement of Regulatory and Deregulatory Priorities
Enhancing long-term economic growth is a central focus of the 
President's policies and priorities. The mission of the Department of 
Commerce is to promote job creation, economic growth, technological 
competitiveness, sustainable development, and improved living standards 
for all Americans by working in partnership with businesses, 
universities, communities, and workers to:
 Build for the future and promote U.S. economic competitiveness 
            in the global marketplace by strengthening and safeguarding 
            the Nation's economic infrastructure;
 Keep America competitive with cutting-edge science and 
            technology and an unrivaled information base; and
 Provide effective management and stewardship of our Nation's 
            resources and assets to ensure sustainable economic 
            opportunities.
 The DOC mission statement, containing our three strategic themes, 
provides the vehicle for understanding the Department's aims, how they 
interlock, and how they are to be implemented through our programs. 
This statement was developed with the intent that it serves as both a 
statement of departmental philosophy and as the guiding force behind 
the Department's programs.
 The importance that this mission statement and these strategic themes 
have for the Nation is amplified by the vision they pursue for 
America's communities, businesses, and families. Commerce is the 
smallest Cabinet agency, yet our presence is felt, and our 
contributions are found, in every State.
 The DOC touches Americans, daily, in many ways--we make possible the 
weather reports that all of us hear every morning; we facilitate the 
technology that all of us use in the workplace and in the home each 
day; we support the development, gathering, and transmitting of 
information essential to competitive business; we make possible the 
diversity of companies and goods found in America's (and the world's) 
marketplace; and we support environmental and economic health for the 
communities in which Americans live.
 The DOC has a clear and powerful vision for itself, for its role in 
the Federal Government, and for its roles supporting the American 
people, now and in the future. We confront the intersection of trade 
promotion, civilian technology, economic development, sustainable 
development, and economic analysis, and we want to provide leadership 
in these areas for the Nation.
 We work to provide programs and services that serve our country's 
businesses, communities, and families, as initiated and supported by 
the President and the Congress. We are dedicated to making these 
programs and services as effective as possible, while ensuring that 
they are being delivered in the most cost-effective ways. We seek to 
function in close concert with other agencies having complementary 
responsibilities so that our collective impact can be most powerful. We 
seek to meet the needs of our customers quickly and efficiently, with 
programs, information, and services they require and deserve.
 As a permanent part of the Federal Government, but serving an 
Administration and Congress that can vary with election results, we 
seek to serve the unchanging needs of the Nation, according to the 
priorities of the President and the Congress. The President's 
priorities for the Department range from issues concerning the economy 
to the environment. For example, the President directs the Department 
to promote and develop alternative sources of energy that conserve the 
environment; promote electronic commerce activities; encourage open and 
free trade; represent American business interests abroad; and assist 
small businesses expand and create jobs. We are able to address these 
priorities 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.
 Among the President's priorities, the DOC works to advance alternative 
energy sources as discussed in the President's national energy policy. 
In his State of the Union address, the President acknowledged that many 
citizens were struggling with the high cost of energy. In response to 
the energy crisis, the President charged Vice President Cheney and 
Cabinet secretaries to develop a national energy policy that encourages 
production of energy while protecting our environment. In doing so, the 
President emphasized the need to promote alternative energy to ensure 
that ``future generations of Americans will have access to the energy 
they need.''
 The DOC is working to reform the hydropower licensing process so that 
applicants will encounter less uncertainty. Hydropower ranks as the 
fourth largest source of the Nation's energy; it accounted for 7 
percent of the Nation's total energy needs in 2000. To promote the use 
of this renewable source of power, the Department is streamlining the 
licensing process to ensure more public participation, adopt more 
effective fish and wildlife conditions, and provide interagency 
resolution before conflicting mandatory license conditions are 
implemented.
 The DOC also promotes and expedites American exports, helps nurture 
business contacts abroad, protects U.S. firms from unfair foreign 
competition, and makes how-to-export information accessible to small 
and mid-sized companies throughout the Nation, thereby ensuring that 
U.S. market opportunities span the globe.
 The DOC encourages development in every community, clearing the way 
for private-sector growth by building and rebuilding economically 
deprived and distressed communities. We promote minority 
entrepreneurship to establish businesses that frequently anchor 
neighborhoods and create new job opportunities. We work with the 
private sector to enhance competitive assets.
 As the Nation looks to revitalize its industries and communities, The 
DOC works as a partner with private entities to build America with an 
eye on the future. Through technology, research and development, and 
innovation, we are making sure America continues to prosper in the 
short-term, while also helping industries prepare for long-term 
success.
 The DOC's considerable information capacities help businesses 
understand clearly where our national and world economies are going, 
and take advantage of that knowledge by planning the road ahead. Armed 
with the Department's economic and demographic statistics, businesses 
can undertake the new ventures, investments, and expansions that make 
our economy grow.
 The DOC has instituted programs and policies that lead to cutting-
edge, competitive, and better paying jobs. We work every day to boost 
exports, to deregulate business, to help smaller manufacturers battle 
foreign competition, to advance the technologies critical to our future 
prosperity, to invest in our

[[Page 61151]]

communities, and to fuse economic and environmental goals.
 The DOC is American business' surest ally in job creation, serving as 
a vital resource base, a tireless advocate, and its Cabinet-level 
voice.
 The Regulatory Plan 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 two--the Bureau of Export Administration (BXA) and the National 
Oceanic and Atmospheric Administration (NOAA)--plan significant 
preregulatory or regulatory actions for this Regulatory Plan year. 
However, none of these significant actions rise to the level of ``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 smallest 
possible burden on those being regulated.
 The DOC is also refocusing on its regulatory mission by taking into 
account, among other things, the President's regulatory principles. To 
the extent permitted by law, all preregulatory and regulatory 
activities and decisions adhere to the Administration's statement of 
regulatory philosophy and principles, as set forth in section 1 of 
Executive Order 12866. Moreover, we have made bold and dramatic 
changes, never being satisfied with the status quo. We have emphasized, 
initiated, and expanded programs that work in partnership with the 
American people to secure the Nation's economic future. At the same 
time we have downsized, cut regulations, closed offices, and eliminated 
programs and jobs that are not part of our core mission. The bottom 
line is that, after much thought and debate, we have made many hard 
choices needed to make this Department ``state of the art.''
 The 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 so as to 
be understandable to those affected by them. The Secretary also 
requires that the Department afford the public the maximum possible 
opportunity to participate in departmental rulemakings, even where 
public participation is not required by law.
National Oceanic and Atmospheric Administration
 The National Oceanic and Atmospheric Administration (NOAA) establishes 
and administers Federal policy for the conservation and management of 
the Nation's oceanic, coastal, and atmospheric resources. It provides a 
variety of essential environmental services vital to public safety and 
to the Nation's economy, such as weather forecasts and storm warnings. 
It is a source of objective information on the state of the 
environment. NOAA plays the lead role in achieving the departmental 
goal of promoting stewardship by providing assessments of the global 
environment.
 Recognizing that economic growth must go hand-in-hand with 
environmental stewardship, the Department, through NOAA, conducts 
programs designed to provide a better understanding of the connections 
between environmental health, economics, and national security. 
Commerce's emphasis on ``sustainable fisheries'' is saving fisheries 
and confronting short-term economic dislocation, while boosting long-
term economic growth. The Department is where business and 
environmental interests intersect, and the classic debate on the use of 
natural resources is transformed into a ``win-win'' situation for the 
environment and the economy.
 Three of NOAA's major components, the National Marine Fisheries 
Services (NMFS), the National Ocean Service (NOS), and the National 
Environmental Satellite, Data, and Information Service (NESDIS), 
exercise regulatory authority.
 NMFS oversees the management and conservation of the Nation's marine 
fisheries, protects marine mammals, and promotes economic development 
of the U.S. fishing industry. NOS assists the coastal states in their 
management of land and ocean resources in their coastal zones, 
including estuarine research reserves; manages the Nation's national 
marine sanctuaries; monitors marine pollution; and directs the national 
program for deep-seabed minerals and ocean thermal energy. NESDIS 
administers the civilian weather satellite program and licenses private 
organizations to operate commercial land-remote sensing satellite 
systems.
 The Administration is committed to an environmental strategy that 
promotes sustainable economic development and rejects the false choice 
between environmental goals and economic growth. The intent is to have 
the Government's economic decisions guided by a comprehensive 
understanding of the environment. The Department, through NOAA, has a 
unique role in promoting stewardship of the global environment through 
effective management of the Nation's marine and coastal resources and 
in monitoring and predicting changes in the Earth's environment, thus 
linking trade, development, and technology with environmental issues. 
NOAA has the primary Federal responsibility for providing sound 
scientific observations, assessments, and forecasts of environmental 
phenomena on which resource management and other societal decisions can 
be made.
 In the environmental stewardship area, NOAA's goals include: 
rebuilding 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 U.S. 3-to-200-mile Exclusive Economic Zone 
(EEZ). Among the several hundred

[[Page 61152]]

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-Steven 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 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.
 The FMCs provide a forum for public debate and, using the best 
scientific information available, make the judgments needed to 
determine optimum yield on a fishery-by-fishery basis. Optional 
management measures are examined and selected in accordance with the 
national standards set forth in the Magnuson-Stevens Act. This process, 
including the selection of the preferred management measures, 
constitutes the development, in simplified form, of an FMP. The FMP, 
together with draft implementing regulations and supporting 
documentation, is submitted to NMFS for review against the national 
standards set forth in the Magnuson-Stevens Act, in other provisions of 
the Act, and other applicable laws. The same process applies to 
amending an existing approved FMP.
 The Magnuson-Stevens Act contains ten national standards against which 
fishery management measures are judged. NMFS has supplemented the 
standards with guidelines interpreting each standard, and has updated 
and added to those guidelines. One of the national standards requires 
that management measures, where practicable, minimize costs and avoid 
unnecessary duplication. Under the guidelines, NMFS will not approve 
management measures submitted by an FMC unless the fishery is in need 
of management. Together, the standards and the guidelines correspond to 
many of the Administration's principles of regulation as set forth in 
section 1(b) of Executive Order 12866. One of the national standards 
establishes a qualitative equivalent to the Executive Order's ``net 
benefits'' requirement--one of the focuses of the Administration's 
statement of regulatory philosophy as stated in section 1(a) of the 
Order.
Bureau of Export Administration
 The Bureau of Export Administration (BXA) promotes U.S. national and 
economic security and foreign policy interests by managing and 
enforcing the Department's security-related trade and competitiveness 
programs. BXA plays a key role in challenging issues involving national 
security and nonproliferation, export growth, and high technology. The 
Bureau's continuing major challenge is combating the proliferation of 
weapons of mass destruction while furthering the growth of U.S. 
exports, which are critical to maintaining our leadership in an 
increasingly competitive global economy. BXA strives to be the leading 
innovator in transforming U.S. strategic trade policy and programs to 
adapt to the changing world.
Major Programs and Activities
 The Export Administration Regulations (EAR) provide for export 
controls on dual use goods and technology (primarily commercial goods 
that have potential military applications) not only to fight 
proliferation, but also to pursue other national security, short 
supply, and foreign policy goals (such as combating terrorism). 
Simplifying and updating these controls in light of the end of the Cold 
War has been a major accomplishment of BXA.
BXA is also responsible for:
 Enforcing the export control and antiboycott provisions of the 
            Export Administration Act (EAA), as well as other statutes 
            such as the Fastener Quality Act. The EAA is enforced 
            through a variety of administrative, civil, and criminal 
            sanctions.
 Analyzing and protecting the defense industrial and technology 
            base, pursuant to the Defense Production Act and other 
            laws. As the Defense Department increases its reliance on 
            dual-use high technology goods as part of its cost-cutting 
            efforts, ensuring that we remain competitive in those 
            sectors and sub-sectors is critical to our national 
            security.
 Helping Ukraine, Kazakstan, Belarus, Russia, and other newly 
            emerging countries develop effective export control 
            systems. The effectiveness of U.S. export controls can be 
            severely undercut if ``rogue states'' or terrorists gain 
            access to sensitive goods and technology from other 
            supplier countries.
 Working with former defense plants in the Newly Independent 
            States to help make a successful transition to profitable 
            and peaceful civilian endeavors. This involves helping 
            remove unnecessary obstacles to trade and investment and 
            identifying opportunities for joint ventures with U.S. 
            companies.
 Assisting U.S. defense enterprises to meet the challenge of 
            the reduction in defense spending by converting to civilian 
            production and by developing export markets. This work 
            assists in maintaining our defense industrial base as well 
            as preserving jobs for U.S. workers.
BILLING CODE 3510-BW-S

[[Page 61153]]




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 1,370,000 military personnel and 670,000 
civilians assigned as of May 31, 2001, 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
Interagency56
 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.
Internal56
 Through regulatory program points of contact in the Department, 
we have established a system that provides information from 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 in the Department while 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 Identification56
 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 Regulations56
 Since DoD plans to issue just two significant regulations 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.
Alternatives56
 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 Assessment56
 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-Effectiveness56
 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 61154]]

cost-benefit analysis and the decisionmaking process.
Cost-Benefit56
 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 Decisions56
 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 Internet. 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 Regulations56
 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 Initiatives56
 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.
 The Department is actively engaged in addressing the requirements of 
the Government Paperwork Elimination Act (GPEA) in implementing 
electronic government and in achieving IT accessibility for individuals 
with disabilities. One of the Department's regulatory priorities, 
specifically Defense Acquisition, will, as a goal, establish 
acquisition policy on electronic and IT accessibility.
Coordination56
 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 Burden56
 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. 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 Language56
 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.
 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 which reflect the established regulatory principles. One of these, 
``Improve Health Care Delivery in the Defense Department,'' will have 
two significant regulatory actions 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 regulations that 
incorporate not only the provisions of the President's priorities and 
objectives under the Executive order.
 DoD has focused its regulatory resources on the most serious 
environmental, health, and safety risks. Perhaps most significant is 
that each of the 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 civil functions of the U.S. Army Corps of 
Engineers, acquisition, and improving health care delivery in the 
Department of Defense.
U.S. Army Corps of Engineers, Directorate of Civil Works56
Preserve Quality and Quantity of Wetlands
 During Fiscal Year (FY) 2002, the U.S. Army Corps of Engineers is not

[[Page 61155]]

proposing any significant regulations as defined by Executive Order 
12866. The Office of the Assistant Secretary of the Army (Civil Works) 
and the Corps have completed one regulation.
 On May 10, 1999, the Corps issued a Final Rule in the Federal Register 
(64 FR 25120) modifying our definition of ``discharge of dredged 
material'' in response to the Court of Appeals holding in National 
Mining Association v. United States Army Corps of Engineers, 145 F.3rd 
1339 (D.C. Cir. 1998) (``NMA'') and to ensure compliance with the 
District Court's injunction. That rule made those changes that were 
necessary to conform the Corps' regulations to the Court's decision. 
The preamble to the Corps' May 10, 1999, rulemaking stated that they 
would be undertaking additional notice and comment rulemaking to 
further the Clean Water Act's objective to ``restore and maintain the 
chemical, physical, and biological integrity of the Nation's waters.'' 
On April 17, 2001, the Corps published a Final Rule in the Federal 
Register (66 FR 10367) amending the Clean Water Act section 404 
regulations defining the term ``discharge of dredged material.'' This 
action was coordinated with the Office of Management and Budget.
 On April 20, 2001, the Corps also proposed revisions to the Clean 
Water Act regulatory definitions of ``Fill Material'' and ``Discharge 
of Fill Material'' (65 FR 21292). This proposal would revise the 
definitions in order to clarify those pollutants that are regulated by 
the Corps. The Corps intends to issue a Final Rule in late FY 2001 or 
early FY 2002. Development of the rule is being facilitated by the 
Office of Management and Budget.
Natural Disaster Procedures
 The President's Federal Response Plan, developed through the efforts 
of 27 departments and agencies, describes the basic methodology by 
which the Federal Government will mobilize resources and conduct 
activities to assist States in coping with the consequences of 
significant disasters. Within the Plan, the Department of Defense has 
designated the U.S. Army Corps of Engineers as the primary agency for 
planning, preparedness, and response under the Emergency Support 
Function 3, Public Works and Engineering. The purpose of this 
Emergency Support Function is to provide lifesaving or life protecting 
assistance to augment efforts of the affected State(s) and local 
response efforts following a major or catastrophic disaster.
 The Corps supports the Nation and other agencies during times of 
crisis by providing ``All Hazards Response,'' while maintaining a high 
level of preparedness. The Corps is proposing revisions to 33 CFR 203 
(Natural Disaster Procedures: Preparedness, Response, and Recovery 
Activities of the Corps of Engineers). This revision is necessary to 
reflect current policy, add features required by the Water Resources 
Development Act of 1996 (Public Law 104-303), and streamline procedures 
regarding Corps authority.
Defense Acquisition56
 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 of Defense is committed to acquisition reform and 
continues to make significant improvements in this area, consistent 
with Executive Order 12866. 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 primary 
            objectives of the rewrite are to: Reduce the amount of 
            Government property in the possession of contractors; rely 
            to a greater extent on the contractors' own processes and 
            procedures; eliminate Government reviews; hold the 
            contractor accountable and liable for property provided for 
            their use; rely on the Government's own internal records as 
            the official recordkeeping and reporting mechanism for 
            compliance with the Chief Financial Officers Act and 
            related legislation; and make greater use of property 
            management contracts for long-term storage or use 
            concurrently on multiple contracts.
 Rewrite of FAR part 27, Patents, Data, and Copyrights. The 
            goals of the FAR part 27 rewrite are to clarify, 
            streamline, and update guidance and clauses on patents, 
            data, and copyrights.
 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.
 Establish policy on Electronic Commerce in Federal 
            Procurement. The goal of this initiative is to establish 
            policies and procedures to employ electronic commerce in 
            the conduct and administration of the procurement system.
Improve Health Care Delivery in the Defense Department56
 The Military Health System (MHS) supports the Department of 
Defense and our Nation's security by providing health support for the 
full range of military deployments and sustaining the health of members 
of the Armed Forces, their families, and others to advance our national 
security interests. Major goals of the Military Health System emphasize 
readiness, wellness and fitness, managed care growth, and integration 
of technologies to enable the best possible and most cost beneficial 
clinical and management outcomes.
 The principal health-related regulatory publications of the Department 
involve CHAMPUS, the Civilian Health and Medical Program of the 
Uniformed Services (32 CFR part 199). CHAMPUS regulations 
comprehensively address such issues as eligibility, benefits, 
authorized providers, claims payment, appeals procedures, and similar 
topics. Amendments to the CHAMPUS regulations generally focus on 
program changes arising from revisions to the statutory base or from 
DoD initiatives to improve the program, such as TRICARE.
 During FY 2001, the Department submitted two Interim Final Rules, 
affecting the Military Health System, which are categorized as 
economically significant, as defined by E.O. 12866. Both are 
promulgated to comply with statutory requirements. One action, 
``Civilian Health and Medical Program of the Uniformed Services 
(CHAMPUS)/TRICARE; Partial Implementation of Pharmacy Benefits Program; 
Implementation of National Defense Authorization Act Medical Benefits 
for Fiscal Year 2001,'' implements several sections of the Floyd D. 
Spence National Defense Authorization Act. Specifically, the rule: 
Allows coverage of physical examinations for beneficiaries ages 5

[[Page 61156]]

through 11 that are required in connection with school enrollment; 
provides an additional 2-year period for survivors of deceased active-
duty members to remain eligible for TRICARE medical and dental benefits 
at active-duty dependent rates; extends eligibility for medical and 
dental benefits to Medal of Honor recipients and their immediate 
dependents in the same manner as if the recipient were entitled to 
retired pay; partially implements the Pharmacy Benefits Program 
establishing revised copays and cost-shares for the prescription drug 
benefit; and implements the TRICARE Senior Pharmacy Program by 
establishing a new eligibility for prescription drug benefits for 
Medicare-eligible retirees. Additionally the rule: Allows a waiver of 
copayments, cost-shares, and deductibles for all Uniformed Services 
TRICARE eligible active duty family members residing with their sponsor 
within a TRICARE Prime Remote designated area; provides for the 
elimination of TRICARE Prime copayments for active duty family members 
enrolled in TRICARE Prime; provides for the reimbursement of reasonable 
travel expenses for TRICARE Prime beneficiaries referred by a primary 
care provider; and reduces the maximum amount which retirees, their 
family members, and survivors would be liable.
 The other significant action, ``TRICARE; Civilian Health and Medical 
Program of the Uniformed Services (CHAMPUS); Eligibility and Payment 
Procedures for CHAMPUS Beneficiaries Age 65 and Over,'' implements 
section 712 of the National Defense Authorization Act for Fiscal Year 
2001. Section 712 extends TRICARE eligibility to persons age 65 and 
over who would otherwise have lost their TRICARE eligibility due to 
attainment of entitlement to hospital insurance benefits under Part A 
of Medicare. In order for these individuals to retain their TRICARE 
eligibility, they must be enrolled in the supplementary medical 
insurance program under part B of Medicare. In general, in the case of 
medical or dental care provided to these individuals for which payment 
may be made under both Medicare and TRICARE, Medicare is the primary 
payer and TRICARE will normally pay the actual out-of-pocket costs 
incurred by the person. This rule prescribes TRICARE payment procedures 
and makes revisions to TRICARE rules to accommodate Medicare-eligible 
CHAMPUS beneficiaries.
_______________________________________________________________________



DOD

                              -----------

                            FINAL RULE STAGE

                              -----------




17.   CHAMPUS/TRICARE; PARTIAL IMPLEMENTATION OF PHARMACY 
BENEFITS PROGRAM; IMPLEMENTATION OF NATIONAL DEFENSE AUTHORIZATION ACT 
MEDICAL BENEFITS FOR FISCAL YEAR 2001
Priority:


Economically Significant. Major under 5 USC 801.


Legal Authority:


10 USC 55; 5 USC 301


CFR Citation:


32 CFR 199


Legal Deadline:


Final, Statutory, April 1, 2001, Implements Public Law 106-398.


Provisions of act effective October 30, 2000, or 180 days thereafter.


Abstract:


This rule implements several sections of the Floyd D. Spence National 
Defense Authorization Act for Fiscal Year 2001. The rule allows 
coverage of physical examinations for beneficiaries ages 5 through 11 
that are required in connection with school enrollment; provides an 
additional 2-year period for survivors of deceased active-duty members 
to remain eligible for TRICARE medical and dental benefits at active-
duty dependent rates; extends eligibility for medical and dental 
benefits to Medal of Honor recipients and their immediate dependents in 
the same manner as if the recipient were entitled to retired pay; 
partially implements the Pharmacy Benefits Program establishing revised 
copays and cost-shares for the prescription drug benefit; implements 
the TRICARE Senior Pharmacy Program by establishing a new eligibility 
for prescription drug benefits for Medicare-eligible retirees; allows a 
waiver of copayments, cost-shares, and deductibles for all Uniformed 
Services TRICARE eligible active duty family members residing with 
their TRICARE Prime Remote eligible Active Duty Service Member Sponsor 
within a TRICARE Prime Remote designated area until implementation of 
the TRICARE Prime Remote for Family Member Program or October 30, 2001, 
whichever is later; provides for the elimination of TRICARE Prime 
copayments for active-duty family members enrolled in TRICARE Prime; 
provides for the reimbursement of reasonable travel expenses for 
TRICARE Prime beneficiaries referred by a primary care provider to a 
specialty care provider who provides services over 100 miles away; and 
reduces the maximum amount which retirees, their family members, and 
survivors would be liable from $7,500 to $3,000. The Department is 
publishing this rule as an interim final rule in order to meet 
statutorily required effective dates.


Statement of Need:


The rule implements requirements of the Floyd D. Spence National 
Defense Authorization Act for Fiscal Year 2001. In addition, because of 
the effect on the overall pharmacy program of the new statutorily 
required TRICARE Senior Pharmacy Program and the change in TRICARE 
Prime active duty dependent copayments, this rule also partially 
implements the Pharmacy Benefits Program.


Summary of Legal Basis:


The rule implements provisions of the Floyd D. Spence National Defense 
Authorization Act for Fiscal Year 2001 that were effective upon the 
date of enactment or a date within 180 days thereafter. Specifically, 
the rule implements the following sections of the Act:


Section 703, school required physicals, which was effective on the date 
of enactment;


Section 704, 2-year extension of benefits for survivors, which was 
effective on the date of enactment;


Section 706, benefits for Medal of Honor recipients, which was 
effective on the date of enactment;


Section 711, TRICARE Senior Pharmacy Program, which was effective April 
1, 2001;


Section 722, that portion of TRICARE Prime Remote for Family Members 
that was effective on the date of enactment;


Section 752, elimination of copayments for active-duty dependents in 
TRICARE Prime, which the statute requires be implemented within 180 
days;


Section 758, reimbursement of certain travel expenses for TRICARE Prime 
beneficiaries, which was effective on the date of enactment; and


Section 759, reduction of retiree catastrophic cap, which was effective 
on the date of enactment.

[[Page 61157]]

Alternatives:


The rule implements statutorily required provisions to expand TRICARE 
benefits. No other alternatives are applicable.


Anticipated Cost and Benefits:


For FY02, it is anticipated that costs for the programs covered by this 
rule will be about $900 million. Provides for coverage of physical 
examinations in connection with school enrollment; extends eligibility 
for medical and dental benefits; partially implements the Pharmacy 
Benefits Program; allows a waiver of copayments, cost-shares, and 
deductibles for members within a TRICARE Prime Remote designated area; 
provides for the elimination of TRICARE Prime copayments; provides for 
the reimbursement of reasonable travel expenses; and reduces the 
maximum amount which retirees, their family members, and survivors 
would be liable from $7,500 to $3,000.


Risks:


The rule implements statutorily required provisions to expand TRICARE 
benefits. No risk to the public is applicable.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
Interim Final Ru66 FR 9651                                     02/09/01
Interim Final Ru66 FR 16400ion                                 03/26/01
Interim Final Ru66 FR 10367in Effective Date                   04/01/01
Interim Final Ru66 FR 9651 Period End                          04/10/01
Interim Final Rule Effective                                   04/10/01
Final Action                                                   12/00/01
Final Action Effective                                         01/00/02
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


Federal


Agency Contact:
Tariq Shahid
Department of Defense
Office of Assistant Secretary for Health Affairs
Phone: 303 676-3801
RIN: 0720-AA62
_______________________________________________________________________



DOD



18.   TRICARE; CIVILIAN HEALTH AND MEDICAL PROGRAM OF THE 
UNIFORMED SERVICES (CHAMPUS); ELIGIBILITY AND PAYMENT PROCEDURES FOR 
CHAMPUS BENEFICIARIES AGE 65 AND OVER
Priority:


Economically Significant. Major under 5 USC 801.


Legal Authority:


10 USC 55; 5 USC 301


CFR Citation:


32 CFR 199


Legal Deadline:


Final, Statutory, October 1, 2001, Implements section 712 of FY 2001 
NDAA.


Abstract:


This rule implements section 712 of the Floyd D. Spence National 
Defense Authorization Act for Fiscal Year 2001. Section 712 extends 
TRICARE eligibility to persons age 65 and over who would otherwise have 
lost their TRICARE eligibility due to attainment of entitlement to 
hospital insurance benefits under Part A of Medicare. In order for 
these individuals to retain their TRICARE eligibility, they must be 
enrolled in the supplementary medical insurance program under Part B of 
Medicare. In general, in the case of medical or dental care provided to 
these individuals for which payment may be made under both Medicare and 
TRICARE, Medicare is the primary payer and TRICARE will normally pay 
the actual out-of-pocket costs incurred by the person. This rule 
prescribes TRICARE payment procedures and makes revisions to TRICARE 
rules to accommodate Medicare-eligible CHAMPUS beneficiaries. The 
Department is publishing this rule as an interim final rule in order to 
meet the statutorily required effective date.


Statement of Need:


This rule is necessary to comply with the statutory requirement. It 
implements procedures which help to ensure that military retirees do 
not incur substantial out-of-pocket expenses for necessary health care.


Summary of Legal Basis:


This rule is required by section 712 of the Floyd D. Spence National 
Defense Authorization Act for Fiscal Year 2001 (Pub. L. 106-398), as 
codified at section 1086(d) of title 10, United States Code.


Alternatives:


The rule implements statutorily required provisions to expand TRICARE 
benefits. No other alternatives are applicable.


Anticipated Cost and Benefits:


The provisions of this rule will affect an estimated 1.5 million 
beneficiaries. In most cases, these beneficiaries will have no out-of-
pocket expenses for health care. For FY01 we expect to incur about $90 
million in start-up costs, and we estimate FY02 health care and 
administration costs will be about $3 billion.


Risks:


The provisions of this rule will ensure that beneficiaries have a 
seamless coordination of benefits between two Federal entitlement 
programs. This coordination will minimize the risk of any personal 
liability or out-of-pocket costs on the part of the beneficiary when 
the service or supply is payable under both plans.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
Interim Final Ru66 FR 40601                                    08/03/01
Interim Final Rule Effective                                   10/01/01
Interim Final Rule Comment Period End                          10/02/01
Final Action                                                   12/00/01
Final Action Effective                                         01/00/02
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


Federal


Agency Contact:
Stephen Isaacson
Department of Defense
Office of Assistant Secretary for Health Affairs
Phone: 303 676-3572
Email: [email protected]
RIN: 0720-AA66
BILLING CODE 5001-10-S

[[Page 61158]]




DEPARTMENT OF EDUCATION (ED)



Statement of Regulatory and Deregulatory Priorities
General
 We support States, local communities, institutions of higher 
education, and others to improve education nationwide. Our roles 
include providing leadership and financial assistance for education to 
agencies, institutions, and individuals in situations in which there is 
a national interest; monitoring and enforcing Federal civil rights laws 
in programs and activities that receive Federal financial assistance; 
and supporting research, evaluation, and dissemination of findings to 
improve the quality of education.
 To connect our customers to a ``one-stop-shopping'' center for 
information about our programs and initiatives, we instituted 1-800-
USA-LEARN (1-800-872-5327). We also set up 1-800-4FED-AID (1-800-433-
3243) for information on student aid; and we provide an on-line library 
of information on education legislation, research, statistics, and 
promising programs at the following Internet address:
http://www.ed.gov
 More than 660,000 people take advantage of these resources every week. 
We have forged effective partnerships with customers and others to 
develop policies, regulations, guidance, technical assistance, and 
approaches to compliance. We have a record of successful communication 
and shared policy development with affected persons and groups, 
including parents, students, educators, representatives of State and 
local governments, neighborhood groups, schools, colleges, special 
education and rehabilitation service providers, professional 
associations, advocacy organizations, business, and labor.
 In particular, we continue to seek greater and more useful customer 
participation in our rulemaking activities through the use of 
consensual rulemaking and new technology. If we determine that the 
development of regulations is absolutely necessary, we seek customer 
participation 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. We have 
expanded our outreach efforts through the use of satellite broadcasts, 
electronic bulletin boards, and teleconferencing. For example, we 
invite comments on all proposed regulations through the Internet.
 We are streamlining information collections, reducing burden on 
information providers involved in our programs, and making information 
maintained by us easily available to the public. We are looking into 
coordinating similar information collections across programs as one 
possible approach to reduce overlapping or inconsistent paperwork 
requirements. To the extent permitted by statute, we'll revise 
regulations to eliminate barriers that inhibit coordination across 
programs (such as by creating common definitions). This should help 
reduce the frequency of reports and eliminate unnecessary data 
requirements.
 Recently, we have piloted two new Internet-based software 
applications, e-Application and e-Reports. These enable applicants, 
grantees, and grant teams to process applications and file performance 
reports online. We have received positive feedback from participants in 
the pilot programs. Our goal over time is to encourage applicants and 
grantees to make electronic commerce, or the process of conducting 
business over the Internet, their preferred method of doing business.
New Initiatives56
 The Secretary's initiatives include No Such Thing as a Vacation 
from Reading, our campaign to encourage families to read together 
during the summer to help school-aged children develop and strengthen 
reading skills and prevent summer fall-off. The Secretary has designed 
this initiative to counter the documented loss of reading skills that 
can take place when children do not practice through the extended 
vacation from school. No Such Thing as a Vacation from Reading is 
supported by our Partnership for Family Involvement in Education, which 
we initially formed to involve businesses, community organizations, 
faith-based organizations, foundations, schools, and other groups in 
building and supporting strong relationships between children and 
adults.
 Also, at the National Summit on the 21st Century Workforce, the 
Secretary announced a partnership between our Department and the 
Department of Labor to enhance the quality of basic skills training in 
reading and math offered to young adults and adults through workforce 
training programs.
 One of the Secretary's first initiatives, the management improvement 
initiative, has resulted in actions to address and close more than 300 
audit and management recommendations. This initiative focuses on 
strengthening financial management, addressing audit deficiencies, 
modernizing student aid delivery and management, and reducing student 
loan default costs to taxpayers. In addition to recovering $65 million 
in student loan default costs through the use of a new data base, we 
have recovered almost $350 million in Department funds previously 
called into question by our Inspector General.
Principles for Regulating 56
 Our Principles for Regulating determine when and how we will 
regulate. Through aggressive application of the following principles, 
we have eliminated outdated or unnecessary regulations and identified 
situations in which major programs could be implemented without any 
regulations or with only limited regulations:
 We will regulate only if regulating improves the quality and equality 
of services to our customers, learners of all ages. We will regulate 
only if 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.

[[Page 61159]]

Regulatory and Deregulatory Priorities for the Next Year
Making No Child Left Behind a Reality56
 Reauthorization of the Elementary and Secondary Education Act of 
1965 will reflect President Bush's No Child Left Behind plan for 
reforming our public schools. Our priorities include amending existing 
regulations in 34 CFR chapter II (Office of Elementary and Secondary 
Education) to make the No Child Left Behind plan a reality and to 
implement various changes in statutes as they are enacted.
_______________________________________________________________________



ED

                              -----------

                          PROPOSED RULE STAGE

                              -----------




19. REAUTHORIZATION OF THE ELEMENTARY AND SECONDARY EDUCATION ACT OF 
1965 (SECTION 610 REVIEW)
Priority:


Other Significant


Legal Authority:


20 USC 6301 to 8962


CFR Citation:


34 CFR 299


Legal Deadline:


None


Abstract:


These regulations would implement changes made by the reauthorization 
of the Elementary and Secondary Education Act of 1965. This action is a 
notice that ED is reviewing the regulations in 34 CFR chapter II under 
section 610 of the Regulatory Flexibility Act (5 U.S.C. 610). The 
purpose of this review is 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. We are requesting comment on the continued need for the 
regulations; the complexity of the regulations; the extent to which 
they overlap, duplicate, or conflict with other Federal, State, or 
local government rules; and the degree to which technology, economic 
conditions, or other relevant factors have changed since the 
regulations were promulgated.


Statement of Need:


These regulations may be 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 any 
regulations, the Department will seek to reduce regulatory burden and 
increase flexibility to the maximum extent possible.


Summary of Legal Basis:


Anticipated legislation.


Alternatives:


In addition to implementing 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                                                           05/00/02
Regulatory Flexibility Analysis Required:


Undetermined


Small Entities Affected:


No


Government Levels Affected:


Undetermined


Agency Contact:
William A. Wooten
Office of the Assistant Secretary
Department of Education
Office of Elementary and Secondary Education
Room 3W308
400 Maryland Avenue SW
Washington, DC 20202-6123
Phone: 202 260-1922
RIN: 1810-AA91
BILLING CODE 4000-01-S

[[Page 61160]]




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:
 Foster a secure and reliable energy system that is 
            environmentally and economically sustainable;
 Provide responsible stewardship of the Nation's nuclear 
            weapons;
 Clean up the Department's facilities;
 Lead in the physical sciences and advance the biological, 
            environmental and computational sciences; and,
 Provide premiere instruments of science for the Nation's 
            research enterprise.
 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 and to 
implementing major initiatives in the President's National Energy Plan.
Energy Efficiency Program for Consumer Products and Commercial 
Equipment
 The Department's rulemaking activities, related to energy efficiency 
standards and determinations, have been categorized as high, medium, or 
low priority. These priorities were established with significant input 
from the public and are reflected in the rulemaking schedules set forth 
in The Regulatory Plan and the Unified Agenda of Federal Regulatory and 
Deregulatory Actions.
 During the past year, the Department published final rules that 
revised existing energy efficiency standards for clothes washers and 
for residential water heaters. It is estimated that the revised 
standards will reduce energy consumption by an amount equivalent to 1.7 
billion barrels of oil over the next 27 years. Once fully implemented, 
the revised standards also will reduce annual greenhouse gas emissions 
by an amount equal to that produced by 7.8 million cars and conserve 
enough water to meet the annual needs of 6.6 million households. The 
Department also published a final rule that set 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.
 During the coming year, the Department expects to publish a final rule 
that would establish new energy efficiency standards for residential 
central air conditioners and heat pumps. The Department will also begin 
action to revise the existing statutory standards for residential 
furnaces, boilers and mobile home furnaces, for electric distribution 
transformers, and for commercial central air conditioners and heat 
pumps rated 65-240 kBtu's/hr. Additional information and timetables for 
these high priority actions can be found below.
 The Department also expects to publish in the coming months final 
rules concerning test procedures for dishwashers, residential central 
air conditioners and heat pumps, electric distribution transformers, 
commercial warm air furnaces and air conditioning equipment, package 
boilers, and commercial water heaters. 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. The Department's substantive nuclear safety 
requirements (10 CFR parts 830 and 835) were finalized in 2001 and 
1998, respectively. The remaining action, 10 CFR part 834, Radiation 
Protection and the Environment, is scheduled for publication by the end 
of fiscal year 2002.
_______________________________________________________________________



DOE--Energy Efficiency and Renewable Energy (EE)

                              -----------

                             PRERULE STAGE

                              -----------




20. ENERGY EFFICIENCY STANDARDS FOR RESIDENTIAL FURNACES, BOILERS, AND 
MOBILE HOME FURNACES
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


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 furnaces, 
boilers and mobile home furnaces.


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 costs. 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

[[Page 61161]]

appliances and certain commercial equipment. The EPCA 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 the Department to conduct rulemakings to review 
standards and to revise standards to achieve the maximum improvement in 
energy efficiency that the Secretary determines is technologically 
feasible and economically justified. In making this determination, the 
Department conducts a thorough analysis of the alternative standard 
levels, including the existing standard, based on criteria specified by 
statute. The process improvements that were recently announced (61 FR 
36974, July 15, 1996) further enhance the analysis of alternatives in 
the appliance standards development process. For example, under this 
process, the Department 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 specific costs and benefits for these rulemakings have not been 
established because the final standard levels have not been determined. 
Nevertheless, existing appliance standards are projected to save 23 
quadrillion Btu's from 1993 to 2015, resulting in estimated consumer 
savings of $1.7 billion per year in 2000 and estimated annual emission 
reductions of 107 million tons of carbon dioxide and 280 thousand tons 
of nitrogen oxides in that year. Under the existing standards, the 
discounted energy savings for consumers are 2.5 times greater than the 
up-front price premium paid for the appliance.


Risks:


Without appliance standards, energy use will continue to increase with 
resulting damage to the environment caused by atmospheric emissions. 
Enhancing appliance energy efficiency reduces atmospheric emissions 
such as CO2 and NOx. 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 loss of jobs or other adverse 
economic impacts


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
ANPRM           58 FR 47326                                    09/08/93
Screening Workshop                                             07/17/01
Supplemental ANPRM                                             09/00/02
NPRM                                                           09/00/03
Final Action                                                   09/00/04
Regulatory Flexibility Analysis Required:


No


Government Levels Affected:


State, Local


Agency Contact:
Cyrus Nasseri, 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: 202 586-9138
Email: [email protected]
RIN: 1904-AA78
_______________________________________________________________________



DOE--EE



21.   ENERGY EFFICIENCY STANDARDS FOR ELECTRIC DISTRIBUTION 
TRANSFORMERS
Priority:


Economically Significant. Major under 5 USC 801.


Legal Authority:


42 USC 6317


CFR Citation:


10 CFR 430


Legal Deadline:


None


Abstract:


The Energy Policy and Conservation Act, as amended, (EPCA) establishes 
initial energy efficiency standard levels for most types of major 
residential appliances and certain types of commercial equipment. The 
EPCA 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 initial review of the statutory standards for electric 
distribution transformers


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:


EPCA 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 nonregulatory 
approaches for encouraging the purchase of energy efficient products.


Anticipated Cost and Benefits:


The specific costs and benefits for these rulemakings have not been 
established because the final standard levels have not been determined. 
Nevertheless, existing appliance standards are projected to save 23 
quadrillion Btu's of energy from 1993 to 2015, resulting in estimated 
consumer savings of $1.7 billion per year in the year 2000 and 
estimated annual emission reductions of 107 million tons of carbon 
dioxide and 280 thousand tons of nitrogen oxides in the year 2000. 
Under the existing standards, the discounted energy savings for 
consumers are 2.5

[[Page 61162]]

times greater than the up-front price premium paid for the appliance.


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

_______________________________________________________________________
Determination No62 FR 54809                                    10/22/97
ANPRM                                                          09/00/02
NPRM                                                           09/00/03
Regulatory Flexibility Analysis Required:


Undetermined


Government Levels Affected:


None


Agency Contact:
Antonio Bouza
Department of Energy
Energy Efficiency and Renewable Energy
1000 Independence Avenue SW.
Washington, DC 20676
Phone: 202 586-4563
Email: [email protected]
RIN: 1904-AB08
_______________________________________________________________________



DOE--EE



22.   ENERGY EFFICIENCY STANDARDS FOR COMMERCIAL CENTRAL AIR 
CONDITIONING UNITS AND HEAT PUMPS RATED 65-240 KBTU'S/HR
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 6293


CFR Citation:


10 CFR 431


Legal Deadline:


None


Abstract:


The Energy Policy and Conservation Act, as amended, (EPCA) establishes 
initial energy efficiency standard levels for most types of major 
residential appliances and certain types of commercial equipment. The 
EPCA 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 initial review of the statutory standards for these 
products.


Statement of Need:


These rulemakings are 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:


EPCA 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 nonregulatory 
approaches for encouraging the purchase of energy efficient products.


Anticipated Cost and Benefits:


The specific costs and benefits for this rulemaking has not been 
established because the final standard levels have not been determined.


Risks:


Without energy efficiency standards, energy use will continue to 
increase with resulting damage to the environment caused by atmospheric 
emissions. Enhancing 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

_______________________________________________________________________
Screening Workshop                                             09/12/01
ANPRM                                                          09/00/02
NPRM                                                           12/00/03
Final Action                                                   12/00/04
Regulatory Flexibility Analysis Required:


Undetermined


Government Levels Affected:


None


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-AB09
_______________________________________________________________________



DOE--EE

                              -----------

                            FINAL RULE STAGE

                              -----------




23. 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.

[[Page 61163]]

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 
period more than 4 quadrillion Btu's 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
Final Rule      66 FR 7170                                     01/22/01
Supplemental NPR66 FR 38821sal to Withdraw Final Rule          07/25/01
Final Action                                                   02/00/02
Regulatory Flexibility Analysis Required:


No


Government Levels Affected:


State, Local


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--Departmental and Others (ENDEP)

                              -----------

                            FINAL RULE STAGE

                              -----------




24. 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-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.

[[Page 61164]]

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                                                   09/00/02
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 61165]]




DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
When it comes to serving the American people, the status quo just isn't 
good enough. That's why, when it comes to regulations, we need to move 
aggressively to streamline, revise and, where necessary, to cut those 
rules that keep us from fulfilling our most fundamental mission -- 
enhancing the health and quality of life for every American.

Tommy G. Thompson



Statement of Regulatory Priorities
 The Department of Health and Human Services (HHS) is responsible for a 
vast array of programs designed to protect and promote the health and 
the social and economic well being of the American public. These 
programs affect some of the Nation's most vulnerable populations, 
including children, the elderly and persons with disabilities. In one 
way or another, HHS programs and activities touch the lives of 
virtually every person in our country, citizens and non-citizens alike.
 HHS' programs and activities include: Medicare, Medicaid, the State 
Children's Health Insurance Program (SCHIP), support for biomedical 
research, substance abuse and mental health treatment, assuring food 
safety, assuring safe and effective drugs and other medical products, 
financial assistance to low income families, Head Start, services to 
older Americans and direct health services delivery. These programs and 
activities are essential to the well-being of millions of Americans 
across our country--people of every age, in every location and in every 
walk of life.
 To improve the administration and conduct of these programs and 
activities, Secretary Thompson has made it clear that the Department 
must operate under a culture of responsiveness, where listening and 
responding to those we serve--State, Local and Tribal governments, our 
business partners and stakeholders--is our cornerstone. For example, 
Secretary Thompson has launched a nationwide series of community 
listening sessions to give voice to persons receiving benefits from the 
Temporary Assistance for Needy Families (TANF) program. This will help 
HHS better meet the needs of those on the downside of advantage as they 
work to become productive members of our society, and to prepare for 
major policy discussions about TANF reauthorization that will occur 
this fiscal year.
 In the same way, we will hold listening sessions to provide 
individuals across the country with an opportunity to offer personal 
input concerning their health needs, their problems with the existing 
system and their ideas for how to make the delivery of health care 
simpler, better and more efficient. From health care to child welfare 
to food safety, the Secretary is committed to widening communication 
between consumers, beneficiaries and Federal administrators.
 Given the size and scope of the Department's responsibilities, 
effective program regulations are critical. Yet too often, excessive 
regulation can be more of a hindrance than a help. Programs become 
caught in a web of mandates, rules and paperwork. And those the 
programs were intended to serve fail to receive the help they need. 
Regulations do not exist for their own sake. They exist to help 
implement good policies. If they deter that implementation, they have 
to change--or be eliminated altogether.
 Earlier this year, Secretary Thompson announced an initiative to 
reduce regulatory burdens. A major part of his initiative is to 
encourage a more rapid response to those affected by HHS rules and to 
listen to their concerns more closely. Consequently, the Department is 
establishing the Secretary's Advisory Committee on Regulatory Reform to 
provide recommendations regarding potential regulatory changes.
 These changes will enable HHS programs to reduce burdens and costs 
associated with Departmental regulations, while at the same time 
maintaining or enhancing the effectiveness, efficiency, impact and 
accessibility of HHS programs. Over the next year, the Advisory 
Committee will hold public hearings, listen to public concerns and make 
recommendations for beneficial changes in four broad areas: health care 
delivery; health systems operations; biomedical and health research, 
and the development of pharmaceuticals and other medical products. 
While the Department will strive to reduce regulatory burdens on the 
public, to fulfill its mission, it must also issue new regulations to 
protect the public from health hazards, other threats and to improve 
the lives of all Americans.
FY 2002 Themes
 The Secretary has adopted four overarching regulatory themes for FY 
2002:
 Improving America's health and well-being;
 Protecting America's consumers;
 Improving the Department's ability to respond to emergencies 
            and disasters; and
 Modernizing and simplifying the Department's programs.
 The Department's regulatory priorities for this fiscal year will fall 
under these themes. It should be noted, however, that the Secretary's 
overall priorities go beyond these four regulatory categories, and 
include for example: Medicare modernization; disease prevention; long-
term care improvement; children's health and development, and intra-
Departmental management reform.
Improving America's Health and Well Being56
 The 20th century brought remarkable and unprecedented 
improvements in the health of the American people. We saw the infant 
mortality rate plummet and life expectancy increase by 30 years. The 
challenge for the 21st century is twofold. First, we must ensure that 
significant health advances continue. Second, we must make certain that 
quality of life applies throughout this extended life span for all 
Americans.
 Over the years, it has become clear that individual health is closely 
linked to community health--the health of the communities and 
environments in which individuals live, work, and play. Consequently, 
the Secretary plans to work to improve not only the health of 
individuals, but also the health of America's communities.
 Regulations in the Plan that address this theme include:
 A proposed rule to establish a Medicare prescription drug 
            discount card program;
 A proposed rule establishing new conditions of coverage and 
            performance measures for organ procurement organizations;
 A proposed rule that would improve services to long-term care 
            facility residents;
 Medicare and Medicaid managed care rules that will enhance 
            these programs for beneficiaries, potential beneficiaries, 
            providers and States;
 A final rule designed to make it easier for certain 
            prescription drugs to be purchased over-the-counter, 
            thereby providing increased access to a number of drugs.
Protecting America's Consumers56
 Consumer safety is a major concern for the public and the 
Secretary. A

[[Page 61166]]

recent Institute of Medicine report highlighted the risks of medical 
errors in the health delivery system. Similarly, ensuring a safer food 
supply is paramount. Every year, tens of thousands of Americans become 
sick and many die from food borne pathogens. The size of vulnerable 
populations (e.g., the elderly and those with compromised immune 
systems) is growing. The Secretary is especially interested in 
identifying opportunities that exist to make patient care and the food 
supply safer.
 Regulations under this theme include:
 A proposed rule controlling the manufacturing and packaging of 
            dietary supplements;
 A final rule to require that amounts of trans fatty acids be 
            included in food labeling because such information has 
            significant potential to reduce the risk of coronary heart 
            disease;
 Several proposed rules designed to reduce the frequency of 
            medical errors associated with prescription drug use; and
 Several regulations addressing the importation and re-
            importation of foods and drugs.
Improving the Ability of HHS to Respond to Emergencies and 
Disasters56
 HHS is responsible for directing and coordinating the medical 
and public health response to natural disasters, terrorism, major 
accidents and other events that can result in mass casualties. Timely 
and well-focused responses to such events are key to limiting mortality 
and morbidity. The Department and its partners must be able to react 
quickly, and tailor responses to the specific emergency without being 
encumbered by unnecessary or counter productive activities.
 Regulations in the Plan that are designed to help ensure that HHS has 
appropriate authority and flexibility to address emergencies and 
disasters include:
 A final rule on new procedures for establishing the efficacy 
            of a new drug or biologic product designed to combat 
            chemical or biological terrorism, (e.g. new anti-viral 
            drugs to treat smallpox);
 A proposed rule to permit use of an investigational medical 
            product during a potential chemical or biological terrorism 
            event;
 A proposed rule issued by the Centers for Disease Control and 
            Prevention to update provisions dealing with the spread of 
            communicable disease; and
 A set of proposed rules that will implement Administration 
            sponsored legislation dealing with bioterrorism. These 
            rules would address, among other things: biological agents 
            that could pose a threat to national security; detention 
            and recall of foods presenting a serious health threat; 
            tampering with food products; record keeping regarding the 
            distribution of foods, food-shipment importation procedures 
            and related matters.
Modernizing and Simplifying the Department's Programs56
 To ensure that beneficiaries and taxpayers continue to receive 
the most effective and highest quality services, we need to streamline 
program requirements and bring openness and responsiveness into the 
regulatory process. Payment systems and regulatory requirements need to 
be modernized to reflect the significant advances in today's changing 
health care delivery system.
 While the impressive improvements made in health information 
technology have helped make the American health care system the best in 
the world, new and updated requirements are needed so that the health 
care system can capture the full benefit of these technological 
advances. At the same time, patients are concerned about unwanted and 
invasive access to their health records. Rules are needed to ensure 
that all Americans have confidence that their medical records will 
remain private.
 Most of the regulations under this theme are associated with either 
Medicare reimbursement issues, or implementation of provisions under 
the Health Insurance Portability and Accountability Act of 1996 
(HIPAA). Priority Medicare reimbursement rules include:
 A new prospective payment scheme for long-term care hospitals;
 A fee schedule for ambulance services; and
 A variety of other prospective payment revisions and updates.
 With regard to HIPAA, the law requires the Secretary to adopt a series 
of regulations. While some of these have already been issued, others 
are expected during FY 2002. These include regulations addressing:
 Security of information held by providers;
 National provider and employer ID's; and
 Modifications to existing electronic transaction requirements.
Public Comments and Reactions56
 The Secretary welcomes comments not only on specific regulations 
as they are published in the Federal Register, but also on the themes 
he has established for 2002 and the regulatory priorities noted above. 
The regulations we issue affect a wide array of health care consumers, 
providers and others, and the Secretary wants to hear from those 
affected by the rules most directly. Comments, as well as ideas and 
specific suggestions for regulatory improvements and initiatives should 
be sent to: The Honorable Tommy G. Thompson, Secretary of Health and 
Human Services, Attention Ann Agnew, Executive Secretary to the 
Department, Room 603, Hubert H. Humphrey Building, 200 Independence 
Avenue SW., Washington, DC 20201.
Listing of Priority Regulations by Theme
1. Improving America's Health and Well Being
 Program to Endorse Prescription Drug Discount Programs
 Organ Procurement Organizations Condition for Coverage
 Requirement for Paid Feeding Assistants in Long-Term Care 
            Facilities
 Additional Criteria and Procedures for Classifying Over-the-
            Counter Drugs as Generally Recognized as Safe and Effective 
            and Not Misbranded
 Medicaid Managed Care
 Modification to Medicare Managed Care Rules Based on 
            Provisions of BIPA and Technical Corrections
2. Protecting America's Consumers
 Current Good Manufacturing Practice in Manufacturing, Packing 
            or Holding Dietary Ingredients and Dietary Supplements
 Food Labeling: Trans Fatty Acids in Nutrition Labeling, 
            Nutrient Content Claims, and Health Claims;
 Control of Salmonella Enteritidis in Shell Eggs During 
            Production and Retail
 Marking Requirements for and Prohibitions on the Reimportation 
            of Imported Food Products That Have Been Refused Admission 
            into the United States
 Foreign Establishment Registration and Listing
 Labeling for Human Prescription Drugs, Revised Format

[[Page 61167]]

 Safety Reporting Requirements for Human Drug and Biological 
            Products
 CGMPs for Blood and Blood Components: Notification of 
            Consignees and Transfusion Recipients Receiving Blood and 
            Blood Components at Increased Risk of Transmitting HCV 
            (Lookback)
 Bar Code Label Requirements for Human Drug Products
3. Improving the Department's Ability to Respond to Emergencies and 
            Disasters
 Implementing the Bioterrorism Prevention Response Act of 2001
 Control of Communicable Diseases
 Efficacy Evidence Needed for Products to be Used Against Toxic 
            Substances When Human Studies are Unethical
 Exception from General Requirements for Informed Consent; 
            Request for Comments and Information
4. Modernizing and Simplifying the Department's Programs, Rules and 
            Systems
HIPAA Administrative Simplification Regulations
 Modifications to the Standards for Privacy of Individually 
            Identifiable Health Information
 Health Insurance Reform: Standards for Electronic Claims 
            Attachments
 Health Insurance Reform: Modifications to Standards for 
            Electronic Transactions
 Revisions to Transaction and Code Set Standards for Electronic 
            Transactions
 Health Insurance Reform: Standard Unique Health Care Provider 
            Identifier
 National Standard Employer Identifier
 Security Standards
 National Standard for Identifiers of Health Plans
Payment Modernization Rules
 Prospective Payment System for Long Term Care Hospitals for FY 
            2003
 Fee Schedule for the Payment of Ambulance Services and 
            Revisions to the Physician's Certification Requirements for 
            Coverage of Non-emergency Ambulance Services
 Home Health Prospective Payment System Refinements
 Home Health Prospective Payment System Rate Update for FY 2003
 Hospital Inpatient Prospective Payment System for FY 2003
 Hospital Outpatient Prospective Payment System for CY 2003
 Revisions to Payment Policies Under the Physician Fee Schedule 
            for CY 2003
 Hospital Inpatient Rehabilitation Prospective Payment System 
            FY 2003
 Tribal Self-Governance Amendments
 Prospective Payment System and Consolidated Billing for 
            Skilled Nursing Facilities-Update
 Modification of the Medicaid Upper Payment Limit for Inpatient 
            Hospital Services and Outpatient Hospital Services
_______________________________________________________________________



HHS--Office of the Secretary (OS)

                              -----------

                          PROPOSED RULE STAGE

                              -----------




25.   MODIFICATIONS TO STANDARDS FOR PRIVACY OF INDIVIDUALLY 
IDENTIFIABLE HEALTH INFORMATION
Priority:


Other Significant. Major under 5 USC 801.


Unfunded Mandates:


This action may affect State, local or tribal goverments.


Legal Authority:


42 USC 1320d-2; 42 USC 1320d-3; PL 104-191, sec 262; PL 104-191, sec 
264


CFR Citation:


45 CFR 160; 45 CFR 164


Legal Deadline:


None


Abstract:


The Health Insurance Portability and Accountability Act of 1996 (HIPAA) 
required the Department of Health and Human Services (the Department) 
to issue standards for health plans, health care clearinghouses, and 
certain health care providers to protect the privacy of individually 
identifiable health information. The Department published these 
standards, entitled ``Standards for Privacy of Individually 
Identifiable Health Information,'' (the Privacy Rule) as a final rule 
on December 28, 2000. The final rule was effective on April 14, 2001. 
The proposed rule would amend the Privacy Rule to, among other things, 
support the delivery of the highest quality of health care to patients 
and address concerns regarding the workability of the rule for entities 
subject to its requirements.


Statement of Need:


The Department received many inquires from Congress, industry, and 
private citizens about how the rule will operate, and concerns over the 
complexity and workability of the rule. On July 6, 2001, in response to 
these and other comments, the Department issued guidance to address 
some of the misunderstandings regarding the rule, and to provide 
clarifications on various provisions. The Department has preliminarily 
determined that some modifications to the Privacy Rule would be 
appropriate. Entities covered by the Privacy Rule have until April 14, 
2003 to come into compliance (and until April 14, 2004 for small health 
plans). Timely action is needed so that covered entites can implement 
these modifications to meet these deadlines with minimal cost and 
disruption.


Summary of Legal Basis:


Section 262 of the Health Insurance Portability and Accountability Act 
of 1996, adding Section 1174 to the Social Security Act (42 U.S.C. 
1320d-3), generally provides that the Department, in reference to the 
privacy and other standards, ``shall review the standards ... and shall 
adopt modifications to the standards (including additions to the 
standards), as determined appropriate .... Any addition or modification 
to a standard shall be completed in a manner which minimizes the 
disruption and cost of compliance.''


Alternatives:


Modifications to the Privacy Rule requires rulemaking. Therefore, there 
are no alternatives to regulatory action.


Anticipated Cost and Benefits:


The anticipated cost and benefits are not known at this time because 
decisions have not been made regarding specific changes in the Privacy 
Rule. The options being considered to address workability are expected 
to reduce cost and to remove barriers to access to or the quality of 
health care.


Risks:


Not applicable.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            Determined                                        To Be
Regulatory Flexibility Analysis Required:


Yes

[[Page 61168]]

Small Entities Affected:


Businesses


Government Levels Affected:


Federal, State, Local, Tribal


Federalism:


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


Agency Contact:
Susan McAndrew
Senior Health Information, Policy Specialist
Department of Health and Human Services
Office of the Secretary
Office for Civil Rights
200 Independence Avenue SW.
Washington, DC 20201
Phone: 202 205-8725
RIN: 0991-AB14
_______________________________________________________________________



HHS--OS



26.   IMPLEMENTING THE BIOTERRORISM PREVENTION AND RESPONSE ACT 
OF 2001
Priority:


Other Significant


Legal Authority:


Not Yet Determined


CFR Citation:


None


Legal Deadline:


None


Abstract:


A variety of regulations will be required once the Bioterrorism 
Prevention and Response Act has been signed into law. These regulations 
would among other things address: biological agents that have the 
potential to pose a national security threat; detention and recall of 
foods presenting a serious health threat; tampering with food products; 
recordkeeping regarding the distribution of foods, food-shipment 
importation procedures and related matters. For example, laboratories 
possessing certain biological agents would have to adhere to strict 
safety and security provisions.


Statement of Need:


The Secretary has testified before Congress that, while the Nation is 
currently prepared to respond to a biological attack, we must 
accelerate current efforts to build the strongest, most coordinated 
capacity possible for responses to acts of terrorism involving 
biological agents. He stressed that a strong and flexible public health 
infrastructure is the best defense against any disease outbreak.


Summary of Legal Basis:


Congressional enactment of the Bioterrorism Prevention and Response Act 
of 2001 is required.


Alternatives:


Not applicable.


Anticipated Cost and Benefits:


Not applicable.


Risks:


Regulations implementing legislation to protect the health of citizens 
against biological terrorism would advance the development, 
organization and enhancement of public health prevention systems and 
tools. The magnitude of the risks addressed by such systems and tools 
is at least as great as the other risk reduction efforts within HHS's 
jurisdiction.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           01/00/02
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


State, Tribal, Federal


Agency Contact:
Alex Azar
General Counsel
Department of Health and Human Services
Office of the Secretary
Phone: 202 690-7741
RIN: 0991-AB15
_______________________________________________________________________



HHS--Centers for Disease Control and Prevention (CDC)

                              -----------

                          PROPOSED RULE STAGE

                              -----------




27. CONTROL OF COMMUNICABLE DISEASES
Priority:


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


Legal Authority:


42 USC 216; 42 USC 243; 42 USC 264; 42 USC 271


CFR Citation:


42 CFR 70; 42 CFR 71


Legal Deadline:


None


Abstract:


This proposal updates existing regulations related to prevention of the 
introduction, transmission, or spread of communicable diseases from 
foreign countries to the U.S. and from State to State. The regulation 
addresses the: process by which persons infected with, or who have been 
exposed to, modern communicable diseases should be quarantined; 
surveillance of quarantined persons; and requirements for carriers 
(e.g., airlines, etc.) to maintain passenger manifests for a determined 
period of time.


Statement of Need:


The quarantine of persons believed to be infected with communicable 
diseases is a long-term prevention measure that has been used 
effectively to contain the spread of disease. As diseases evolve due to 
the natural occurrences or bioterrorist events, it is important to 
assure procedures reflect new threats and uniform ways to contain them.


The existing regulations are outdated and do not address communicable 
diseases that currently pose a substantial public health threat.


Summary of Legal Basis:


USC 42 section 264 authorizes the Surgeon General, with the approval of 
the Secretary, to make and enforce regulations as are necessary to 
prevent the introduction, transmission, or spread of communicable 
diseases from foreign countries into the States or possessions, or from 
one State or possession into any other State or possession.


Alternatives:


In the absence of this regulation, uniform application of procedures 
for the quarantine of individuals exposed to or infected with a 
communicable disease would be unavailable.


Anticipated Cost and Benefits:


It is anticipated that there will be a cost to carriers to maintain 
passenger manifests for an extended period of time. However, these 
costs are undetermined.


Risks:


This rule would allow for improvements to existing quarantine

[[Page 61169]]

procedures and clarify due process procedures.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           12/00/01
Regulatory Flexibility Analysis Required:


Undetermined


Government Levels Affected:


State


Federalism:


 Undetermined


Agency Contact:
John Moore
Department of Health and Human Services
Centers for Disease Control and Prevention
1600 Clifton Road NE
Atlanta, GA 30333
Phone: 404 639-7070
RIN: 0920-AA03
_______________________________________________________________________



HHS--Food and Drug Administration (FDA)

                              -----------

                          PROPOSED RULE STAGE

                              -----------




28. 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:


This regulation is one component of the Secretary's initiative to 
reduce medical errors. 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 Harmonisation and to 
define new terms; to possibly add to or revise current reporting 
requirements; to consider revising certain reporting time frames; and 
to suggest 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, 
314.98 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 
certain 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.


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                                                           02/00/02
Regulatory Flexibility Analysis Required:


Undetermined


Government Levels Affected:


Undetermined


Agency Contact:
Audrey Thomas
Regulatory Policy Analyst, Office of Regulatory Policy
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
RIN: 0910-AA97

[[Page 61170]]

_______________________________________________________________________



HHS--FDA



29. CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, OR 
HOLDING DIETARY INGREDIENTS AND DIETARY SUPPLEMENTS
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 321; 21 USC 342; 21 USC 343; 21 USC 348; 21 USC 371; 21 USC 374; 
21 USC 381; 21 USC 393; 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 (e.g., 
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.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
ANPRM           62 FR 5700                                     02/06/97
ANPRM Comment Period End                                       06/06/97
NPRM                                                           12/00/01
Regulatory Flexibility Analysis Required:


Yes

[[Page 61171]]

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: 202 205-4168
Fax: 202 205-5295
Email: [email protected]
RIN: 0910-AB88
_______________________________________________________________________



HHS--FDA



30. 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 321; 21 USC 342; 21 USC 371; 21 USC 381; 21 USC 393; 42 USC 264; 
42 USC 243; 42 USC 264; 42 USC 271; ...


CFR Citation:


21 CFR 16; 21 CFR 116; 21 CFR 118


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, the Food and Drug Administration (FDA) and the Food 
Safety Inspection Service (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 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), April 6, 2000 (Sacramento, CA), and July 
31, 2000 (Washington, DC), 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 certain retail 
establishments. In addition, the agency plans to propose specific 
requirements for certain 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 (the 
Act)((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(a) 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 (42 U.S.C. 264), 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) HACCP. 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 United

[[Page 61172]]

States Department of Agriculture (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 undetermined at this time.


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                                                           03/00/02
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



31.   EXCEPTION FROM GENERAL REQUIREMENTS FOR INFORMED CONSENT; 
REQUEST FOR COMMENTS AND INFORMATION
Priority:


Other Significant


Legal Authority:


21 USC 321; 21 USC 346; 21 USC 346a; 21 USC 348; 21 USC 352; 21 USC 
353; 21 USC 355; 21 USC 360; 21 USC 360bbb; 21 USC 360c; 21 USC 360d; 
21 USC 360e; 21 USC 360f; 21 USC 360h; 21 USC 360i; 21 USC 360j; 21 USC 
371; 21 USC 379e; 21 USC 381; 42 USC 241; 42 USC 262; 42 USC 263b-263n


CFR Citation:


21 CFR 50.23(e)


Legal Deadline:


None


Abstract:


FDA is proposing to add a new exception from the general requirement 
for informed consent to address situations associated with preparedness 
and response to chemical and biological terrorism, when investigational 
products regulated by FDA need to be used.


Statement of Need:


The agency is proposing this action because it is concerned that during 
a potential chemical or biological terrorism event, delaying the use of 
investigational products may threaten the lives of subjects. In many 
instances, there may also be others who have been exposed to or be at 
risk of exposure to a dangerous chemical or biological agent.


Summary of Legal Basis:


FDA believes the statutory authority provided in the Federal Food, 
Drug, and Cosmetic Act (the Act) would permit a limited exception to 
obtaining informed consent for chemical or biological terrorism events. 
The Act specifically states when an exception from informed consent is 
permissible. The statutory provision governing informed consent for 
investigational devices 520(g)(3)(D) of the Act, provides that informed 
consent is required unless the clinical investigator determines in 
writing that: (1) there exists a life-threatening situation involving 
the human subject of such testing which necessitates the use of such 
device; (2) it is not feasible to obtain informed consent from the 
subject; and (3) there is not sufficient time to obtain such consent 
from his representative. Further, a licensed physician uninvolved in 
the testing must agree with this three-part determination in advance of 
using the product unless immediate use of the device is required to 
save the life of the human subject of such testing and there is not 
sufficient time to obtain such concurrence. The statute states that the 
exceptions to requiring informed consent are subject to such conditions 
as the Secretary may prescribe. This proposed rule is not required by 
statute or court order.


Alternatives:


The only other option open to the agency is to do nothing. FDA believes 
that this option is not acceptable because it could result in improper 
treatment or no treatment for persons with serious illnesses because 
the health professionals could not use these investigational products 
in absence of informed consent.


Anticipated Cost and Benefits:


The minimal burdens imposed by this rule are offset by the fact that, 
in the absence of this rule, the sponsor would be required to obtain 
informed consent, which is just as burdensome, if not more so. The rule 
would permit use of investigational products without

[[Page 61173]]

which patients' lives might be threatened. Because of uncertainty about 
the nature or extent of any chemical or biological terrorism event, FDA 
cannot estimate the extent of the benefits of this rule.


Risks:


The primary risk addressed by this rule is the risk that patients may 
go untreated or may be improperly treated because health professionals 
could not use an investigational product in the absence of informed 
consent. FDA cannot determine the extent of this risk without knowing 
the nature or extent of any chemical or biological terrorism event.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           03/00/02
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


None


Agency Contact:
Claudia M. Gaffey
Medical Officer
Department of Health and Human Services
Food and Drug Administration
Room 314/HFZ-314
Center for Devices and Radiological Health
2098 Gaither Road
Rockville, MD 20850
Phone: 301 594-2096
Fax: 301 594-5941
Email: [email protected]
RIN: 0910-AC25
_______________________________________________________________________



HHS--FDA



32.   BAR CODE LABEL REQUIREMENTS FOR HUMAN DRUG PRODUCTS
Priority:


Other Significant. Major under 5 USC 801.


Legal Authority:


21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 358; 21 
USC 360; 21 USC 360b; 21 USC 360gg to 360ss; 21 USC 371; 21 USC 374; 21 
USC 379e; 42 USC 216; 42 USC 241; 42 USC 262; 42 USC 264


CFR Citation:


21 CFR 201.25; 21 CFR 601.67


Legal Deadline:


None


Abstract:


This regulation is one component of the Secretary's initiative to 
reduce medical errors. The proposal would require human drug products 
and biological products to have a bar code. The bar code would contain 
certain information about the product and, when used in conjunction 
with bar code scanners and computer equipment, will help reduce the 
number of medication errors.


Statement of Need:


In 1999, the Institute of Medicine (IOM) report titled, To Err Is 
Human: Building a Safer Health System, cited studies and articles 
estimating that between 44,000 and 98,000 Americans may die each year 
due to medical mistakes made by health care professionals, with most 
deaths attributable to medication errors. The report also indicated 
that, between 1983 and 1993, the medication error rate leading to a 
patient's death may have increased by over 2.5 times. While later 
medical articles have questioned the IOM's estimates, other studies 
have indicated that, regardless of the medication error rate, many 
medication errors are or were preventable.


Medication errors are a significant economic cost to the United States. 
An article published in 1995 estimated the direct cost of preventable 
drug-related mortality and morbidity to be $76.6 billion, with drug-
related hospital admissions accounting for much of the cost. The 
authors suggested that indirect costs, such as those relating to lost 
productivity, might be two to three times greater than the direct 
costs, making the total cost of all preventable, drug-related mortality 
and morbidity range from $138 to $182 billion. Another article, 
published in 2001, used updated cost estimates derived from current 
medical and pharmaceutical literature to revise the $76.6 billion 
estimate to exceed $177.4 billion; hospital admissions accounted for 
$121.5 billion in costs, and long-term care admissions accounted for 
another $32.8 billion.


Various organizations and health professional associations have 
advocated the use of bar codes as a method for reducing medication 
errors. For example, if a health professional could use a bar code 
scanner to compare the bar code on a human drug product to a specific 
patient's drug regimen, the health professional would be able to verify 
that the patient is receiving the right drug, at the right dose, and at 
the right time. Most organizations and associations have recommended 
that the bar code contain the drug's National Drug Code number (a 
unique numerical code identifying the manufacturer, product, and 
package size or type), lot number, and expiration date.


Thus, FDA is proposing to require human drug products and biological 
products to be bar coded. The bar code would contain certain 
information about the product, such as its National Drug Code number. 
The agency is considering whether to require other information, such as 
the drug's expiration date and lot number, to make it easier to 
identify expired drugs and recalled drugs that may not be safe and 
effective for use. The bar code, when used in conjunction with bar code 
scanners and computer equipment, will enable health professionals to 
decrease the medication error rate.


Summary of Legal Basis:


Section 502 of the Federal Food, Drug, and Cosmetic Act (the Act) 
considers a drug to be misbranded unless it bears a label containing 
(in part) the name of the manufacturer and the drug's name (see 
sections 502(b) and 502(e)(1)(A) of the Act).


Section 501(a)(1) of the Act considers a drug to be adulterated if, 
among other things, the methods used in, or the facilities and controls 
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 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, which it 
purports or is represented to possess....''


Section 701(a) of the Act, in turn, authorizes FDA to issue regulations 
for the efficient enforcement of the Act.


A bar code requirement for human drug products and biological products 
would be consistent with, and aid in the efficient enforcement of, 
sections 501 and 502 of the Act. For example, if the bar code merely 
contained the drug's National Drug Code number, the bar code would 
identify the manufacturer and the drug, and this would be consistent 
with sections 502(b) and 502(e)(1)(A) of the Act. If the bar code 
contained other information, such as lot

[[Page 61174]]

number and expiration date (pieces of information required under FDA's 
good manufacturing practice regulations (see 21 CFR 211.130 and 
211.137), this would be consistent with section 501(a)(1) of the Act.


Therefore, using its general rulemaking authority at section 701(a) of 
the Act, the agency finds that it has sufficient authority to propose 
requiring human drug products to have a bar code.


Alternatives:


FDA considered a voluntary bar coding program, but this would be akin 
to a ``no action'' alternative as many products are not bar coded or 
not coded in a manner that would help health professionals. A voluntary 
bar coding system might also lead to the adoption of incompatible bar 
coding formats on human drug products and biological products, thereby 
deterring hospitals and health care professionals from buying bar code 
scanners and computer equipment.


FDA also considered decreasing the amount of information it would 
require on the bar code. This would decrease bar coding costs to drug 
manufacturers and labelers, but also decrease the usefulness of the bar 
code and its ability to reduce medication errors.


Anticipated Cost and Benefits:


FDA is continuing to examine the potential costs and benefits 
associated with bar coding. The anticipated costs may vary greatly 
depending on the amount of information required in a bar code and the 
products to be bar coded. FDA's preliminary estimate is that the rule 
would cost between $500 million and $1.4 billion over a 10-year period; 
the wide range in the cost estimate reflects the agency's uncertainty 
as to the costs associated with various pieces of information that 
might go into a bar code, whether all or some human drug products and 
biological products are bar coded, and possible changes in labeling 
operations.


The rule's principal benefit would be a reduction in the number of 
medication errors, including reduced mortality and morbidity. As stated 
earlier, medication error costs have been estimated in the billions of 
dollars, and the agency is trying to determine the extent to which 
medication errors would be reduced.


Risks:


There is a possible risk that some manufacturers and repackagers, if 
required to bar code individual unit dose packages, would eliminate 
such types of packaging and only supply their products in bulk 
containers. Individual unit dose packages are convenient for hospitals, 
health professionals, and patients, but are expensive to produce, and 
bar coding may increase production costs. Consequently, a manufacturer 
or repackager who wanted to reduce its expenses might decide to reduce 
the number of packages, particularly individual unit dose packages, 
that would be subject to a bar coding requirement.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           04/00/02
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses


Government Levels Affected:


None


Agency Contact:
Philip L. Chao
Senior Policy Analyst
Department of Health and Human Services
Food and Drug Administration
Room 15-61 (HF-23)
Office of Policy, Planning and Legislation
5600 Fishers Lane
Rockville, MD 20857
Phone: 301 827-0587
Fax: 301 827-4774
Email: [email protected]
RIN: 0910-AC26
_______________________________________________________________________



HHS--FDA

                              -----------

                            FINAL RULE STAGE

                              -----------




33. LABELING FOR HUMAN PRESCRIPTION DRUGS; REVISED FORMAT
Priority:


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


Unfunded Mandates:


Undetermined


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 to 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:


This regulation is one component of the Secretary's initiative to 
reduce medical errors. The 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 
regulation 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 
regulation 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

[[Page 61175]]

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 discribed format and content requirements for 
prescription drug labeling that incorporate information and ideas 
gathered during this process. The agency has received several comments 
on the proposal and the comment period was extended until June 22, 
2001.


Summary of Legal Basis:


The agency has broad authority under sections 201, 301, 501, 502, 503, 
505, and 701 of the Federal Food, Drug, and Cosmetic Act (the Act)(21 
U.S.C. 321, 331, 351, 352, 353, 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 final 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.


Alternatives:


The alternatives to the final rule 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 requirements, such as the requirement for a 
minimum type size. Thus, the agency believes that the requirements in 
the final rule 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 final 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 final 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            65 FR 81082                                    12/22/00
Final Action                                                   09/00/02
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses


Government Levels Affected:


Undetermined


Federalism:


 Undetermined


Agency Contact:
Lee D. Korb
Regulatory Counsel, Office of Regulatory Policy
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. FOREIGN ESTABLISHMENT REGISTRATION AND LISTING
Priority:


Other Significant

[[Page 61176]]

Legal Authority:


21 USC 321; 21 USC 331; 21 USC 351; 21 USC 352; 21 USC 355; 21 USC 360; 
21 USC 360b; 21 USC 360c; 21 USC 360i; 21 USC 360j; 21 USC 371; 21 USC 
374; 21 USC 381; 21 USC 393; 42 USC 262; 42 USC 264; 42 USC 271


CFR Citation:


21 CFR 207.3; 21 CFR 207.7; 21 CFR 207.10; 21 CFR 207.20; 21 CFR 
207.21; 21 CFR 207.25; 21 CFR 207.37; 21 CFR 207.40; 21 CFR 607.3; 21 
CFR 607.7; 21 CFR 607.20; 21 CFR 607.22; 21 CFR 607.25; 21 CFR 607.26; 
21 CFR 607.31; 21 CFR 607.35; 21 CFR 607.37; 21 CFR 607.40; 21 CFR 
607.65; 21 CFR 807.3; 21 CFR 807.20; 21 CFR 807.25; 21 CFR 807.40


Legal Deadline:


None


Abstract:


The final rule requires persons who manufacture, prepare, propagate, 
compound, or process a drug or device that is imported or offered for 
import into the United States to register the name and place of 
business of the establishment and to identify a United States agent for 
the establishment.


Statement of Need:


Section 417 of the Food and Drug Modernization Act (PL 105-115) 
requires any establishment in any foreign country that is engaged in 
the manufacture, preparation propagation, compounding, or processing of 
a drug or device that is imported or offered for import into the United 
States to register the name and place of business of the establishment 
and to identify a United States agent.


The final rule implements the statutory requirement by amending the 
establishment registration and listing regulations for human drugs and 
biological products (21 CFR part 207), blood and blood products (21 CFR 
part 607), and devices (21 CFR part 807). The final rule also discusses 
the duties of the United States agent. The United States agent's 
duties, under the final rule, include facilitating communications with 
the foreign establishment and responding to inquiries about the foreign 
establishment's products that are imported or offered for import into 
the United States. The final rule will strengthen FDA's procedures for 
ensuring that products imported or offered for import into the United 
States are safe and effective.


Summary of Legal Basis:


The principal legal basis can be summarized as follows. Section 510 of 
the Federal Food, Drug, and Cosmetic Act (the Act) requires 
establishment registration and listing. Section 417 of the Food and 
Drug Modernization Act amended section 510 by requiring foreign 
establishments to register, to list their products, and to identify a 
United States agent.


Section 701(a) of the Act gives FDA authority to promulgate regulations 
for the efficient enforcement of the Act. Thus, the final rule 
represents FDA's effort to enforce section 510 of the Act, as amended 
by section 417 of the Food and Drug Modernization Act.


Alternatives:


FDA considered requiring less establishment registration information, 
but the information required by the rule is quite minimal, consisting 
largely of the establishment's address, names of owners or responsible 
officials, and additional identifying information (such as the type of 
establishment). An alternative that would have required less 
information would not give FDA sufficient information to identify a 
foreign establishment's location, type, or responsible persons, and 
this would complicate efforts to locate or contact the foreign 
establishment.


FDA also rejected requiring less frequent registration by foreign 
establishments because this would increase the likelihood that the 
information would become incorrect or obsolete and would hinder 
regulatory actions involving foreign establishments.


FDA also considered comments seeking an exemption from the United 
States agent requirement or to allow the United States agent to be in a 
foreign country. However, the statute requires foreign establishments 
to have a United States agent, and the most logical interpretation of 
the statute is that the United States agent must be in the United 
States rather than in a foreign country. FDA did state that the United 
States agent may be an entity or a person.


Anticipated Cost and Benefits:


FDA examined the potential costs and benefits associated with foreign 
establishment registration. Given its experience with establishment 
registration for domestic firms, FDA estimates the total registration 
costs for foreign establishments to be $809,820. Recordkeeping costs 
are estimated at $810,000.


The rule's principal benefit would be the creation of an accurate, 
comprehensive list of foreign establishments. This list will make it 
easier for FDA to identify foreign establishments, schedule 
inspections, and contact foreign establishments when needed. The United 
States agent is another benefit as the United States agent will help 
FDA in communications with the foreign establishment, respond to 
questions regarding the foreign establishment's products that are 
imported or offered for import into the United States, and help 
schedule inspections of the foreign establishment.


Risks:


Before the enactment of the Food and Drug Modernization Act, Federal 
law required domestic establishments to register with FDA and to list 
their products. Foreign manufacturers could register their 
establishments voluntarily, but were required to list their products. 
The different treatment between domestic and foreign establishments 
created some confusion among foreign establishments. Some foreign 
establishments erroneously believed that listing was voluntary; others 
neither registered their establishments nor listed their products.


Establishment registration enables FDA to identify manufacturers and 
other FDA-regulated entities for inspection, communication, and other 
administrative or regulatory action. For example, if a foreign product 
presented a health or safety concern, FDA would contact the foreign 
manufacturer, but if the foreign establishment was not registered, the 
agency might find it difficult to contact the foreign manufacturer 
promptly or to contact the manufacturer at all.


Requiring foreign establishments to register will facilitate FDA's 
regulatory and enforcement actions and treat domestic and foreign 
establishments alike. Moreover, the regulation implements section 417 
of the Food and Drug Modernization Act.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            64 FR 26330                                    05/14/99
NPRM Comment Period Reopen                                     08/09/99
NPRM Comment Period End                                        10/08/99
Final Action                                                   11/00/01
Regulatory Flexibility Analysis Required:


No

[[Page 61177]]

Small Entities Affected:


No


Government Levels Affected:


None


Agency Contact:
Philip L. Chao
Senior Policy Analyst
Department of Health and Human Services
Food and Drug Administration
Room 15-61 (HF-23)
Office of Policy, Planning and Legislation
5600 Fishers Lane
Rockville, MD 20857
Phone: 301 827-0587
Fax: 301 827-4774
Email: [email protected]
RIN: 0910-AB21
_______________________________________________________________________



HHS--FDA



35. FOOD LABELING: TRANS FATTY ACIDS IN NUTRITION LABELING, NUTRIENT 
CONTENT CLAIMS, AND HEALTH CLAIMS
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 321; 21 USC 331; 21 USC 342; 21 USC 343; 21 USC 348; 21 USC 371; 
...


CFR Citation:


21 CFR 101


Legal Deadline:


None


Abstract:


Section 403(q) of the Federal Food, Drug, and Cosmetic Act, which was 
added by the Nutrition Labeling and Education Act of 1990 (NLEA), 
requires that the label or labeling of food products bear nutrition 
information. Among other things, section 403(q) of the Act authorizes 
the Food and Drug Administration (FDA) to add or delete nutrients that 
are to be declared on the labels or labeling of food products by 
regulation if it finds such action necessary to assist consumers in 
maintaining healthy dietary practices. FDA issued final regulations 
implementing NLEA in 1993. FDA subsequently received a citizen petition 
requesting that FDA amend its regulations on food labeling to require 
that the amount of trans fatty acids be listed in the nutrition label 
and be limited wherever saturated fat limits are placed on nutrient 
content claims, health claims, or disqualifying levels and disclosure 
levels. In response to this petition and based on new evidence, FDA 
proposed the actions requested in the petition on November 17, 1999 (64 
FR 62746). In addition, FDA proposed to define the claim ``trans fat 
free.''


Statement of Need:


FDA intends to publish a final rule amending its nutrition labeling 
regulations to incorporate requirements for trans fatty acids in 
labeling, nutrient content and health claims for several reasons. 
First, this final rule responds, in part, to a citizen petition on 
trans fatty acids in food labeling from the Center for Science in the 
Public Interest. Also, recent research shows that dietary trans fatty 
acids raise low density lipoprotein cholesterol (LDL-C), the major diet 
related risk factor for coronary heart disease (CHD). Finally, the 
information on trans fatty acids in nutrition labeling is needed to 
assist consumers in maintaining healthy dietary practices.


Summary of Legal Basis:


The NLEA (Pub. L. 101-535) amended the Federal Food, Drug, and Cosmetic 
Act (the Act) to provide, among other things, that certain nutrients 
and food components be included in nutrition labeling. Sections 
403(q)(2)(A) and (q)(2)(B) of the Act provide the agency with authority 
to, by regulation, add or delete nutrients included in the food label 
or labeling if the agency finds that such action will assist consumers 
in maintaining healthy dietary practices.


Alternatives:


FDA proposed, in the November 1999 proposal, that when trans fatty 
acids are present in a food, the declaration of saturated fat must bear 
a symbol that refers to a footnote at the bottom of the nutrition label 
that states the number of grams of trans fatty acids present in a 
serving of the product, i.e., ``Includes ------ g trans fat.'' In 
addition to the proposed option, the agency considered a variety of 
other options for the declaration of trans fatty acids in the Nutrition 
Facts panel. The other options were: (1) include trans fatty acids with 
saturated fat and call the total value ``saturated fat;'' (2) include 
trans fatty acids with saturated fat and call the total value 
``saturated fat,'' and add an asterisk after the term ``saturated fat'' 
when the food contains trans fatty acids that refers to a footnote 
stating ``Contains -------- g trans fat;'' (3) include trans fatty 
acids with saturated fat and call the total value ``saturated + trans 
fat;'' and (4) list trans fatty acids separately under saturated fat.


Anticipated Cost and Benefits:


FDA has estimated the benefits of the proposed rule in the range of $25 
to $50 billion compared with costs in the range of $400 to $900 million 
(discounted at 7 percent for 20 years). The value of the benefits were 
estimated based on CHD morbidity and mortality prevented. The costs 
were estimated based on a formula that included costs for testing, 
decisionmaking, information panel reprinting, relabeling of the 
principal display panels and product reformulation.


Risks:


The American Heart Association estimates that CHD causes 1.1 million 
heart attack cases annually, with 33 percent of them fatal. FDA used 
these estimates as the baseline to estimate the number of cases and 
fatalities prevented by this rule. The agency estimated the rule would 
annually prevent 6,300 to 17,100 cases of CHD and 2,100 to 5,600 
deaths, using three different methods to estimate these benefits. Thus, 
the labeling changes resulting from this rule are expected to reduce 
the risk of CHD, preventing, at a minimum, 6,300 cases of CHD and 2,100 
deaths annually.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            64 FR 62746                                    11/17/99
NPRM Comment Per65 FR 75887d                                   12/05/00
NPRM Comment Period End                                        01/19/01
Final Rule                                                     09/00/02
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses


Government Levels Affected:


None

[[Page 61178]]

Agency Contact:
Susan Thompson
Chemist
Department of Health and Human Services
Food and Drug Administration
(HFS-832)
Center for Food Safety and Applied Nutrition
200 C Street SW.
Washington, DC 20204
Phone: 202 205-5587
Fax: 202 205-5532
Email: [email protected]
RIN: 0910-AB66
_______________________________________________________________________



HHS--FDA



36. 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 to 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 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 June 22, 1999 (64 FR 33309), 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, lookback will 
remain appropriate for the foreseeable future, and 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            65 FR 69377                                    11/16/00
NPRM Comment Period End                                        02/14/01
Final Action                                                   09/00/02
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses


Government Levels Affected:


None


Additional Information:


See RIN 0910-AB26.


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



37. MARKING REQUIREMENTS FOR AND PROHIBITIONS ON THE REIMPORTATION OF 
IMPORTED FOOD PRODUCTS THAT HAVE BEEN REFUSED ADMISSION INTO THE UNITED 
STATES
Priority:


Other Significant


Legal Authority:


15 USC 145; 15 USC 1454; 15 USC 1455; 21 USC 321; 21 USC 343; 21 USC

[[Page 61179]]

352; 21 USC 355; 21 USC 360b; 21 USC 362; 21 USC 371; 21 USC 374; 21 
USC 381; 21 USC 382; 21 USC 393; 42 USC 216; 42 USC 241; 42 USC 243; 42 
USC 262; 42 USC 264


CFR Citation:


21 CFR 1.98


Legal Deadline:


None


Abstract:


The rule would require food products that have been refused entry into 
the United States for safety reasons to be marked, ``United States 
Refused Entry.'' The proposed rule is intended to protect the public 
health against contaminated or unsafe imported food products and to 
facilitate FDA's examination of imported products.


Statement of Need:


In 1998, the General Accounting Office issued a report titled, ``Food 
Safety: Federal Efforts to Ensure the Safety of Imported Foods Are 
Inconsistent and Unreliable.'' The report stated that some food 
importers evade import controls and are able to introduce contaminated, 
adulterated, or unsafe food into the United States even after FDA 
refused to admit the food and the Customs Service ordered the food to 
be reexported or destroyed.


Additionally, in 1998, the Senate Permanent Subcommittee on 
Investigations conducted hearings on the safety of food imports. The 
subcommittee heard testimony about reimporting refused foods through 
another port (a practice known as ``port shopping).'' On July 3, 1999, 
the President issued a memorandum to the Secretary of Health and Human 
Services and the Secretary of the Treasury directing them, in part, to 
take all actions available to ``prohibit the reimportation of food that 
has been previously refused admission and has not been brought into 
compliance with United States laws and regulations'' by requiring the 
marking of shipping containers and/or papers of imported food that is 
refused admission for safety reasons.


Consequently, FDA and the Department of the Treasury jointly prescribed 
a rule to require that imported food that has been refused admission 
for safety reasons be marked as ``UNITED STATES REFUSED ENTRY.'' The 
mark will make it easier to detect previously refused food and reduce, 
if not eliminate, ``port shopping.''


Summary of Legal Basis:


Section 801(a) of the Federal Food, Drug, and Cosmetic Act (the Act) 
authorizes FDA to refuse to admit imported food if the food has been 
manufactured, processed, or packed under insanitary conditions, is 
forbidden or restricted in sale in the country in which is was 
produced, or is adulterated or misbranded. Sections 402 and 403 of the 
Act describe when a food is adulterated or misbranded respectively. 
Section 701(a) of the Act authorizes FDA to issue regulations for the 
efficient enforcement of the Act, while section 701(b) of the Act 
authorizes FDA and the Department of the Treasury to jointly prescribe 
regulations for the efficient enforcement of section 801 of the Act.


The final rule is within FDA's authority at sections 402, 403, 701, and 
801 of the Act. In general, unsafe food is often adulterated under 
section 402 of the Act, and may also be misbranded under section 403 of 
the Act if the food purports to meet a particular definition, standard 
of identity, or standard of quality. Marking refused foods will make it 
easier for FDA to refuse to admit previously-refused, adulterated or 
misbranded food imports into the United States.


Additionally, section 301 of the Public Health Service Act (PHS Act) 
authorizes FDA to ``render assistance'' to appropriate health 
authorities in the conduct of or to promote coordination of research, 
investigations, experiments, demonstrations, and studies relating to 
the causes, diagnosis, treatment, control, and prevention of disease. 
Section 361 of the PHS Act authorizes FDA to issue regulations to 
prevent the introduction, transmission, or spread of communicable 
diseases into the United States. Marking refused food products will 
help foreign health officials determine whether to take regulatory 
action against a particular product. It would also alert foreign 
officials to previously refused food and help prevent the introduction, 
transmission, or spread of communicable diseases into the United States 
by making it more difficult for unsafe food to reenter the United 
States.


Alternatives:


FDA considered exempting small businesses from the rule, but, because 
most importers and consignees would qualify as small businesses, this 
would negate the rule's purpose.


The agency also considered ordering the destruction of all refused food 
imports, but this would not be feasible because it would divert federal 
resources to supervising or otherwise ensuring that the refused food 
imports are stored until they can be destroyed and that they are 
destroyed.


A ``no action'' alternative was rejected because it would allow illegal 
practices, such as port shopping, to continue, resulting in unsafe food 
entering the United States.


FDA also rejected marking some, but not all, imported food refused 
entry for safety reasons. While this alternative would be less costly, 
it would also be less efficient because some refused food imports would 
be able to reenter the United States and because a previously-refused, 
but unmarked, food would be difficult to detect compared to a 
previously-refused and marked food. This alternative would also result 
in arguments as to the criteria to be applied and whether a particular 
food should be marked.


Anticipated Cost and Benefits:


FDA examined the potential costs and benefits associated with marking 
refused food imports. Importers and consignees would bear the costs 
associated with marking refused food imports. If these importers and 
consignees use labeling (an inexpensive and time efficient method) as 
their marking method, the annual cost to importers and consignees would 
be $398,663 with an additional $39,600 in costs for labeling equipment. 
FDA would incur an estimated $308,131 in hourly wage costs associated 
with refusals to admit an imported food and for supervising the marking 
process.


The rule's principal benefit would be a reduction in the number of 
illnesses and injuries caused by unsafe imported food. The agency is 
unable to quantify the amount of illegal importation of previously 
refused foods, so it cannot accurately predict the value of reduced 
illnesses and injury.


Risks:


There is a possible risk that previously refused, unpackaged food (such 
as loose grain in a railroad car) would be able to enter the United 
States because the food itself cannot be marked, although the final 
rule would require the importer or consignee to affix the mark on 
papers accompanying the product.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            66 FR 6502                                     01/22/01

[[Page 61180]]

NPRM Comment Period End                                        04/09/01
Final Rule                                                     04/00/02
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses


Government Levels Affected:


None


Agency Contact:
Philip L. Chao
Senior Policy Analyst
Department of Health and Human Services
Food and Drug Administration
Room 15-61 (HF-23)
Office of Policy, Planning and Legislation
5600 Fishers Lane
Rockville, MD 20857
Phone: 301 827-0587
Fax: 301 827-4774
Email: [email protected]
RIN: 0910-AB95
_______________________________________________________________________



HHS--FDA



38. EFFICACY EVIDENCE NEEDED FOR PRODUCTS TO BE USED AGAINST TOXIC 
SUBSTANCES WHEN HUMAN STUDIES ARE UNETHICAL
Priority:


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


Legal Authority:


15 USC 1451 to 1561; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 
360; 21 USC 360c to 360f; 21 USC 360h to 360j; 21 USC 371; 21 USC 374; 
21 USC 379e; 21 USC 381; 42 USC 216; 42 USC 241; 42 USC 262; 42 USC 
263b; 21 USC 321; PL 105-115, sec 122, 111 stat 2322 (21 USC 355 note)


CFR Citation:


21 CFR 314; 21 CFR 601


Legal Deadline:


None


Abstract:


The agency plans to publish a final rule that would amend its new drug 
and biological product regulations to identify the information needed 
to provide substantial evidence of the efficacy of new drug and 
biological products used to reduce or prevent the toxicity of chemical, 
biological, radiological, or nuclear substances when adequate and well-
controlled efficacy studies in humans ethically cannot be conducted. 
Efficacy studies in humans cannot be conducted ethically if: 1) the 
studies would involve administering a potentially lethal or permanently 
disabling toxic substance or organism to healthy human volunteers 
without a proven treatment; and 2) field trials (assessment of use of 
the product after accidental or hostile exposure to the substance) are 
not feasible. FDA is taking this action because it recognizes the 
importance of improving medical responses to the use of lethal or 
permanently disabling chemical, biological, radiological, and nuclear 
substances in order to protect individuals exposed to these substances.


Statement of Need:


A distinct possibility exists that American military personnel and 
civilians may be exposed to lethal or permanently disabling chemical, 
biological, or radiological substances in the course of conventional or 
unconventional warfare, as a result of terrorist actions, or as a 
consequence of an industrial accident. Significant difficulties are 
presented in conducting efficacy studies on drug and biological 
products intended to reduce or prevent the toxicity of these substances 
in humans. The incidence of exposure is so low that field efficacy 
studies cannot be conducted and the toxicity of the substances prevents 
them from being ethically given to healthy volunteers. The only 
practical and ethical means of evaluating the efficacy of drugs and 
biological products in these situations is to rely on data from animal 
studies that are an adequate model for the action of both the toxin and 
the drug or biological product in humans.


Summary of Legal Basis:


FDA approves new drugs under the authority of the Federal, Food, Drug, 
and Cosmetic Act (the Act) and biological products under section 351 of 
the Public Health Service Act. Section 505(d) (21 USC 355(d)) of the 
Act authorizes the Secretary of Health and Human Services to issue an 
order refusing to approve a new drug application if the Secretary finds 
that ``there is a lack of substantial evidence that the drug will have 
the effect it purports or is represented to have under the conditions 
of use prescribed, recommended, or suggested in the proposed labeling 
thereof ....'' The term substantial evidence is defined in section 
505(d) of the Act as``... evidence consisting of adequate and well-
controlled investigations, including clinical investigations, by 
experts qualified by scientific training and experience to evaluate the 
effectiveness of the drug involved, on the basis of which it could 
fairly and responsibly be concluded by such experts that the drug will 
have the effect it purports or is represented to have under the 
conditions of use prescribed, recommended, or suggested in the labeling 
or proposed labeling thereof.''


In interpreting the term ``substantial evidence,'' FDA has viewed the 
phrase ``adequate and well-controlled investigations, including 
clinical investigations'' as meaning that efficacy determinations must 
include studies of efficacy in humans. The agency's regulations did not 
contemplate situations in which efficacy studies cannot ethically be 
conducted in humans, and FDA believes that it would be inconsistent 
with the statute's public health objectives to conclude that FDA cannot 
use some other basis for considering the efficacy of such products. The 
legislative history does not address this issue. Concluding that such 
products cannot ever be approved because human efficacy trials cannot 
be conducted is contrary to the public interest and inconsistent with 
the Act's purpose of public health protection.


FDA has therefore concluded that, where definitive human efficacy 
studies cannot ethically be conducted because they would necessarily 
expose healthy subjects to a potentially lethal or permanently 
disabling substance, the statutory standard permits efficacy to be 
based on adequate and well-controlled investigations that are not 
conducted in humans. This conclusion is consistent with the recognition 
by Congress of the importance of ethical behavior in the study of 
unapproved products. For FDA to approve products where definitive 
efficacy studies cannot be conducted in humans there must be sufficient 
data available to meet the statutory standard. The data must be such 
that experts are able to fairly and responsibly conclude ``that the 
drug will have the effect it purports or is represented to have ...'' 
in humans. Where data from adequate and well-controlled animal studies 
meet this standard, FDA may approve the product.


Alternatives:


FDA did not identify any valid alternatives to using efficacy data from 
animal studies to approve drug and biological products used to treat or

[[Page 61181]]

prevent the toxicity of chemical, biological, or radiological 
substances where the normal incidence of exposure is so low that normal 
clinical trials would be impractical and the deliberate exposure of 
volunteers to the substances would be unethical. The rule would not 
apply if product approval can be based on standards described elsewhere 
in FDA's regulations (for example, accelerated approval based on human 
surrogate markers or clinical endpoints other than survival or 
irreversible morbidity).


Anticipated Cost and Benefits:


The potential public health benefits of having new drugs and biological 
products approved under this rule are difficult to measure. The cost of 
approving new drugs and biological products under this rule should not 
exceed the cost of approving similar drugs based on clinical efficacy 
data.


Risks:


Risks from the use of drugs and biological products approved under this 
rule should be minimal. The safety of these products will be studied in 
human volunteers comparable to the people who would be exposed to the 
product.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            64 FR 53960                                    10/05/99
Final Action                                                   04/00/02
Regulatory Flexibility Analysis Required:


No


Government Levels Affected:


None


Agency Contact:
Wayne H. Mitchell
Regulatory Counsel, Office of Regulatory Policy
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-AC05
_______________________________________________________________________



HHS--FDA



39.   ADDITIONAL CRITERIA AND PROCEDURES FOR CLASSIFYING OVER-
THE-COUNTER DRUGS AS GENERALLY RECOGNIZED AS SAFE AND EFFECTIVE AND NOT 
MISBRANDED
Priority:


Economically Significant


Legal Authority:


21 USC 321; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371


CFR Citation:


21 CFR 330


Legal Deadline:


None


Abstract:


The OTC drug review establishes conditions under which OTC drugs are 
generally recognized as safe and effective and not misbranded. After a 
final monograph (i.e., final rule) is issued, only OTC drugs meeting 
the conditions of the monograph, or having an approved new drug 
application, may be legally marketed. This final rule establishes 
additional criteria and procedures by which other OTC conditions may 
become eligible for consideration in the OTC drug monograph system. The 
additional criteria and procedures describe how OTC drugs marketed in 
the United States after the OTC drug review began in 1972 and OTC drugs 
without any U.S. marketing experience may become eligible and, if found 
eligible, how the drug would be evaluated for general recognition of 
safety and effectiveness.


Statement of Need:


This final rule establishes additional criteria and procedures by which 
over-the-counter (OTC) conditions (e.g., ingredients, combinations of 
ingredients, uses) may become eligible for inclusion in the OTC drug 
monograph system. This rule benefits manufacturers and consumers 
because it provides for increased access to certain OTC drugs under 
certain conditions.


Summary of Legal Basis:


The legal basis is the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 
sections 321, 351, 352, 353, 355, 360 and 371. No aspect of the action 
is required by statute or court order.


Alternatives:


Without this final rule, the only alternative to marketing approval for 
drugs subject to the rule would be an NDA.


Anticipated Cost and Benefits:


The major benefit of this rule will be increased over the counter 
access to drugs, and potential cost savings to consumers. Considering 
potential one-time cost savings associated with prescription drug user 
fees and reduced reporting requirements of marketing under an OTC drug 
monograph vs. an NDA, the agency calculates a one-time cost savings to 
industry of around $300,000 per submission. Future yearly cost savings 
could total around $21,000 per product and $142,000 per establishment 
if the submitted product were the establishment's only product. If FDA 
receives 25 to 50 submissions a year, industry would save between $7.3 
and $14.5 million in one-time costs alone.


Risks:


There are minimal risks associated with this final rule. The 
flexibility to market drug products under FDA's OTC drug monogreaph 
system provides an overall net benefit to the companies seeking to use 
this approach, as well as to the American public. One important benefit 
to sponsoring companies is the saving of NDA user fees (see Anticipated 
Costs and Benefits above). The American public benefits by having OTC 
drugs without any U.S. marketing experience but sufficient foreign 
marketing experience become available in the U.S.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
ANPRM           61 FR 51625                                    10/03/96
ANPRM Comment Period End                                       01/02/97
NPRM            64 FR 71062                                    12/20/99
NPRM Comment Period End                                        03/22/00
Final Action                                                   04/00/02
Regulatory Flexibility Analysis Required:


Undetermined


Small Entities Affected:


No


Government Levels Affected:


None

[[Page 61182]]

Agency Contact:
Gerald M. Rachanow
Regulatory Counsel, Division of Over-the-Counter Drug Products
Department of Health and Human Services
Food and Drug Administration
HFD-560
Center for Drug Evaluation and Research
5600 Fishers Lane
Rockville, MD 20857
Phone: 301 827-2241
Fax: 301 827-2315
Email: [email protected]
RIN: 0910-AC22
_______________________________________________________________________



HHS--Indian Health Service (IHS)

                              -----------

                          PROPOSED RULE STAGE

                              -----------




40. TRIBAL SELF-GOVERNANCE AMENDMENTS
Priority:


Other Significant


Legal Authority:


PL 106-260, sec 517(a)(2); 25 USC 450, Tribal Self-Governance 
Amendments


CFR Citation:


None


Legal Deadline:


NPRM, Statutory, August 18, 2001, Expiration of authority to promulgate 
final rule: May 18, 2002.


Abstract:


Title V of the Tribal Self-Governance Amendments of 2000 (Pub. L. 106-
260) made permanent the demonstration program which allowed tribes full 
control over the operation and redesign of various activities 
historically managed by IHS. The proposal includes provisions that 
govern how IHS and Tribes will carry out their responsibilities under 
the Act.


Statement of Need:


Given the success of the Self-Governance demonstration program that had 
been in operation since 1992, Congress elected to make the program 
permanent. Under the Act, Tribal compacts initiated under the 
demonstration program will continue with up to 50 additional compact 
awards each year. Currently, almost 44 percent of IHS funds are 
allocated for tribally controlled programs.


Summary of Legal Basis:


Section 517(a) of the Act requires the Secretary to initiate procedures 
to negotiate and promulgate the regulations.


Alternatives:


Negotiated rulemaking is prescribed by the Act and is consistent with 
Federal policy on coordination and consultation with tribal 
governments. Given the number of Indian and Alaska Native Tribes and 
extent of the provisions covered by the Act, absence of this regulation 
would have a substantial negative impact on the implementation of title 
V. The proposed rule represents a consensus of Tribal and Federal 
representatives on most of the provisions. Failure to implement the 
rule would result in wide variation in interpretation of the provisions 
and potential for increased litigation. Further, failure to implement 
the rule would be received poorly by Tribal leaders who have worked in 
good faith to reach consensus on the provisions.


Anticipated Cost and Benefits:


Not appicable.


Risks:


Not applicable.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           12/00/01
Final Rule                                                     05/00/02
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


Federal, Tribal


Agency Contact:
Paula K. Williams
Director of Tribal Self-Governance
Department of Health and Human Services
Indian Health Service
Suite 240
Thompson Building
801 Thompson Avenue
Rockville, MD 20852
Phone: 301 443-7821
RIN: 0917-AA05
_______________________________________________________________________



HHS--Centers for Medicare & Medicaid Services (CMS)

                              -----------

                          PROPOSED RULE STAGE

                              -----------




41. NATIONAL STANDARD FOR IDENTIFIERS OF HEALTH PLANS (CMS-4145-P)
Priority:


Other Significant. Major under 5 USC 801.


Unfunded Mandates:


This action may affect State, local or tribal goverments.


Legal Authority:


42 USC 1320d-2(b)(1) of the Social Security Act


CFR Citation:


45 CFR 160.103; 45 CFR 162


Legal Deadline:


Final, Statutory, February 21, 1998.


Abstract:


This rule would implement a standard identifier to identify health 
plans that process and pay certain electronic health care transactions. 
It would implement one of the requirements for administrative 
simplification in section 262 of the Health Insurance Portability and 
Accountability Act of 1996.


Statement of Need:


This rule would implement the national health plan identifier; one of 
the requirements for administrative simplification in section 262 of 
the Health Insurance Portability and Accountability Act of 1996.


Summary of Legal Basis:


Health Insurance Portability and Accountability Act of 1996 (Pub. L. 
104-191, August 21, 1996, sec. 1173).


Alternatives:


Three alternatives were considered:


Option 1: Federal and State Medicaid Agencies Cost : $38.1M


Option 2: Private Organizations Cost : $38.1M


Option 3: Registry Cost : $34.9M


Duration: Every option is required to complete the enumeration process 
within two years of the promulgation and effective date of the Final 
Rule for all health plans, except that small health plans have three 
years to comply.

[[Page 61183]]

Option 1: Two or more coordinating entities will share responsibility 
for enumerating health plans. The entities would consist of Federal and 
State Medicaid programs.


Option 2: Same as option one, except that coordinating entities would 
consist of private organizations.


Option 3: CMS, acting through a contractor, would be the single entity 
enumerating all health plans and maintaining the registry.


Decision: The Secretary has selected option three, not only because its 
costs are lower, but also because it would result in less burden on 
organization in coordinating enumeration, less confusion for health 
plans, better quality control of data control, and better management of 
the enumeration process.


Anticipated Cost and Benefits:


A benefit/cost analysis was conducted with three contribution rates of 
PlanID toward overall HIPPA cost savings. Given a 1 percent 
contribution rate, the PlanID project shows a net present value of over 
$12.8 M and a benefit/cost ratio of 1.45. For 5 and 15 percent rates, 
the net present values are $179.2M and $595.3M, respectively, and the 
benefit cost ratios are 7.23 and 21.69, respectively. These values 
indicate that the implementation of the PlanID project will result in a 
considerable positive return on investment.


Risks:


There are three categories of risk:


Technical and Operational--physical/logical system


Schedule--delays/slippage


Cost/Budget--cost overruns, funding shortfalls, unexpected funding 
needs


An assessment and mitigation of risks was conducted as part of the 
information technology documentation. The subsequent risk analysis 
determined the project to be a low risk endeavor.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            Determined                                        To Be
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses


Government Levels Affected:


State


Federalism:


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


Agency Contact:
Helen Dietrick
Department of Health and Human Services
Centers for Medicare & Medicaid Services
S1-07-17
7500 Security Boulevard
Baltimore, MD 21244-1850
Phone: 410 786-7448
RIN: 0938-AH87
_______________________________________________________________________



HHS--CMS



42. HEALTH INSURANCE REFORM: STANDARDS FOR ELECTRONIC CLAIMS 
ATTACHMENTS (CMS-0050-P)
Priority:


Other Significant. Major under 5 USC 801.


Unfunded Mandates:


This action may affect State, local or tribal goverments.


Legal Authority:


42 USC 1320d-2(a)(2)(B)


CFR Citation:


45 CFR 162


Legal Deadline:


Final, Statutory, August 21, 1998.


Abstract:


This rule proposes an electronic standard transmissions for claims 
attachments. The standard is required by HIPAA. It would be used to 
transmit clinical data, beyond those data contained in the claims 
standard, to help establish medical necessity or coverage.


Statement of Need:


The Administrative Simplification subtitle of the Health Insurance 
Portability and Accountability Act (HIPAA) of 1996 requires the 
Secretary of Health and Human Services to adopt standards for 
electronically requesting and supplying additional information to 
support submitted claims data. This rule stipulates the requirements 
necessary to comply with the law.


Summary of Legal Basis:


The Administrative Simplification provisions of HIPAA require the 
Secretary to establish standards that additionally support information 
attached to claims.


Alternatives:


In the absence of this regulation, claims attachments in electronic 
form would be left with the private industry to develop. This action 
may create an inconsistent standard use of electronic claims 
attachments within the health care industry.


Anticipated Cost and Benefits:


As the effect of any one of the HIPAA standards is affected by the 
implementation of other standards, it is misleading to discuss the 
impact of one standard by itself. Therefore, an Impact Analysis on the 
total effect of all standards was published in the proposed rule 
concerning the national provider identifier (HCFA-0045-P) which was 
published on May 7, 1998 (63 FR 25320).


Risks:


Failure to publish this rule would mean that no standard for electronic 
claims attachments would be established for use within the health care 
system. Lack of a standard electronic claims attachments would decrease 
the amount of savings in health care costs.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            Determined                                        To Be
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


Businesses


Government Levels Affected:


State, Local, Federal, Tribal


Federalism:


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


Procurement:


This is a procurement-related action for which there is a statutory 
requirement. There is a paperwork burden associated with this action.


Agency Contact:
James Krall
Health Insurance Specialist
Department of Health and Human Services
Centers for Medicare & Medicaid Services
7500 Securtiy Boulevard
Baltimore, MD 21244
Phone: 410 786-6999
RIN: 0938-AK62

[[Page 61184]]

_______________________________________________________________________



HHS--CMS



43. HEALTH INSURANCE REFORM: MODIFICATIONS TO STANDARDS FOR ELECTRONIC 
TRANSACTIONS (CMS-0003-P)
Priority:


Other Significant


Unfunded Mandates:


Undetermined


Legal Authority:


Social Security Act, sec 1871


CFR Citation:


45 CFR 162


Legal Deadline:


None


Abstract:


This proposed rule would adopt modifications to certain standards for 
retail pharmacies adopted in our regulations entitled ``Health 
Insurance Reform: Standards for Electronic Transactions'' published in 
the Federal Register on August 17, 2000 (65 FR 50312), which 
implemented some of the requirements of the Administrative 
Simplification subtitle of the Health Insurance Portability and 
Accountability Act of 1996. This rule proposes to adopt the National 
Council for Prescription Drug Programs Batch Standard Batch 
Implementation Guide, Version 1, Release 1 (Version 1.1), January 2000 
for the following standards for retail pharmacy transactions: health 
care claims or equivalent encounter information; eligibility for a 
health plan; referral certification and authorization; and coordination 
of benefits. Additionally, we propose to modify the standard for the 
health care claim payment and remittance advice transaction as the 
standard for the retail pharmacy sector by adopting, in place of the 
current standard, the ASC X12N 835, Health Care Claim Payment/Advice, 
as the standard for the retail pharmacy transaction.


This rule also proposes to repeal the adoption of National Drug Codes 
as the standard medical data code set for reporting drugs and biologics 
in all standard transactions, except those for retail pharmacy 
transactions, for which standards have been adopted.


Statement of Need:


The Administrative Simplification subtitle of the Health Insurance 
Portability and Accountability Act (HIPAA) of 1996 requires the 
Secretary of Health and Human Services to adopt standards for 
electronic transactions. This rule modifies previous adopted standards 
to standards that are currently in use throughout the health care 
industry.


Summary of Legal Basis:


The Administrative Simplification provisions of HIPAA require the 
Secretary to establish standards of electronic transactions for health 
plans, health care clearing houses, and certain health care providers.


Alternatives:


Failure to publish this rule would cause non-compliance with standards 
that are already in widespread use throughout the health care industry.


Anticipated Cost and Benefits:


The estimated costs and benefits of this rule would not change the 
impact of the Standard for Electronic Transaction final rule published 
on August 17, 2000 (65 FR 50312).


Risks:


This rule would permit compliance with standards currently used within 
the health care industry.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           12/00/01
Regulatory Flexibility Analysis Required:


Undetermined


Government Levels Affected:


Undetermined


Agency Contact:
Marilyn Abramovitz
Health Insurance Specialist
Department of Health and Human Services
Centers for Medicare & Medicaid Services
N2-14-26
7500 Security Boulevard
Baltimore, MD 21244
Phone: 410 786-5939
RIN: 0938-AK64
_______________________________________________________________________



HHS--CMS



44. PROSPECTIVE PAYMENT SYSTEM FOR LONG-TERM CARE HOSPITALS FOR FY 2003 
(CMS-1177-P)
Priority:


Other Significant


Unfunded Mandates:


Undetermined


Legal Authority:


BBRA, sec 123; BIPA, sec 307; PL 105-33, sec 4422; PL 106-113, sec 123; 
PL 106-544, sec 307(b)


CFR Citation:


42 CFR 412


Legal Deadline:


NPRM, Statutory, December 31, 2001, Final rule 4/30/02.


Abstract:


This rule would implement a prospective payment system for long-term 
care hospitals.


Statement of Need:


The Medicare inpatient hospital acute-care PPS was established by the 
Social Security Amendments of 1983 (Pub. L. 98-21). This prospective 
payment system (PPS) generally applies to all hospitals participating 
in the Medicare program with certain exclusions, exemptions, and 
adjustments specifically set out under the law. Long-term care 
hospitals (LTCHs), established under section 101 of Tax Equity and 
Fiscal Responsibility Act (TEFRA) of 1982, which amended section 
1886(b) of the Social Security Act, was one of four classes of 
specialty hospitals (the others being children's, psychiatric, 
rehabilitation, and psychiatric and rehabilitation units in acute-care 
hospitals) that were excluded from the inpatient acute-care PPS. These 
classes of hospitals and cancer hospitals, which were added to the 
category of, excluded hospitals beginning in fiscal year 1990, under 
section 6004 of the Omnibus Budget Reconciliation Act (OBRA) of 1989, 
continued to be paid for under TEFRA. The exemption of these facilities 
from the PPS was intended to be a temporary measure, pending the 
development of more appropriate systems to pay these providers under a 
PPS.


Section 123 of Public Law 106-113, the Balanced Budget Refinement Act 
of 1999 (BBRA), requires the establishment and implementation of a 
prospective payment system (PPS) for long-term care hospitals (LTCHs) 
by October 1, 2002. Section 307(b) of Public Law 106-554, the Benefits 
Improvement and Protection Act of 2000 (BIPA), authorized the Secretary 
to examine and evaluate a number of adjustment factors for inclusion in 
the LTCH PPS. Congressional intent regarding a timely implementation of 
the LTCH PPS is reflected in the statutory establishment of a default 
model under which LTCHs will receive

[[Page 61185]]

Medicare payments for services furnished on or after October 1, 2002.


Summary of Legal Basis:


Section 123 of Public Law 106-113, the BBRA, requires that the 
Secretary develops and implements the PPS for LTCHs by October 1, 2002. 
Section 307(b) of Public Law 106-554 confers broad authority on the 
Secretary to determine whether and which payment adjustments should be 
included in the system.


Alternatives:


None.


Anticipated Cost and Benefits:


Section 123(a) of the BBRA requires that the PPS for LTCH maintain 
budget neutrality. Payment will be estimated using the excluded 
hospitals' market basket update. The ability to pay for long-term care 
prospectively at LTCHs will have a direct, positive impact on the 
Medicare system by controlling the increase in costs for services that 
these hospitals provide. Although some hospitals will benefit more than 
others during the first year of the PPS due to variations in individual 
case mix indices, we anticipate that the system to ``self-correct'' 
within two years, because the more accurate coding and data-reporting 
required by a PPS will affect payment rates. Operating under a PPS will 
also have a beneficial impact on the efficient management and planning 
capability of individual LTCHs.


Risks:


Failure to develop and implement the PPS for LTCHs by October 1, 2002 
would place us in violation of the BBRA and BIPA. Moreover, failure to 
meet the deadlines imposed by the notice and comment rulemaking process 
(citation) would make it impossible to comply with statutory 
requirements for implementation.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            Determined                                        To Be
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses


Government Levels Affected:


Local, Federal


Federalism:


 Undetermined


Agency Contact:
Judith H. Richter
Department of Health and Human Services
Centers for Medicare & Medicaid Services
C4-07-07
7500 Security Boulevard
Baltimore, MD 21244
Phone: 410 786-2590
RIN: 0938-AK69
_______________________________________________________________________



HHS--CMS



45. MODIFICATIONS TO MEDICARE MANAGED CARE RULES BASED ON PROVISIONS OF 
BIPA AND TECHNICAL CORRECTIONS (CMS-1180-P)
Priority:


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


Legal Authority:


BIPA, sec 601 to 608; BIPA, sec 611 to 621; BIPA, sec 623; BIPA, sec 
634


CFR Citation:


Not Yet Determined


Legal Deadline:


None


Abstract:


This regulation would implement certain Medicare payment provisions of 
the Medicare, Medicaid and SCHIP Benefits Improvement and Protection 
Act (BIPA) of 2000. The policy changes include premium reductions for 
M+C enrollees, uniform coverage for M+C plans in multiple locations, 
eliminating health disparities, M+C program compatibility with employer 
or union group plans, ESRD enrollees, and increased civil money 
penalties for M+C organizations that terminate contracts mid-year. 
Moreover, this regulation describes CMS' authority to waive or modify 
requirements that hinder the design of, the offering of, or the 
enrollment in such M+C plans offered to employers or labor unions.


Statement of Need:


This rule would implement changes to the Social Security Act (the Act) 
enacted in sections 606, 612, 615, 616, 617, 620, 621, and 623 of the 
Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act 
of 2000 (BIPA), relating to the Medicare+Choice (M+C) program. These 
changes include permitting premium reductions as additional benefits, 
restricting implementation of significant new regulatory requirements 
midyear, allowing a uniform local coverage policy for M+C plans 
covering multiple localities, and allowing us to waive or modify 
certain requirements that hinder the offering of M+C plans to employers 
or labor unions.


Summary of Legal Basis:


Sections 606, 612, 615, 616, 617, 620, 621, and 623 of BIPA.


Alternatives:


None.


Anticipated Cost and Benefits:


These changes to the M+C regulations, implementing the provisions of 
BIPA pertaining to the M+C program would result in more flexibility for 
the M+C plans, enabling them to better serve their Medicare enrollees, 
including ESRD enrollees. The changes would also assist the M+C 
organizations in the marketplace by allowing them to waive or modify 
certain regulatory requirements that hinder the offering of M+C plans 
to employers or labor unions.


Risks:


If not published timely, the regulations will not implement changes 
mandated by the Congress. With the exception of one, all of the 
provisions of BIPA have already taken effect consistent with the 
effective dates established by the BIPA.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           03/00/02
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses


Government Levels Affected:


Federal


Agency Contact:
Alfred G. D'Alberto
Office of Managed Care
Department of Health and Human Services
Centers for Medicare & Medicaid Services
S3-02-01
7500 Security Boulevard
Baltimore, MD 21244-1850
Phone: 410 786-1100
RIN: 0938-AK71

[[Page 61186]]

_______________________________________________________________________



HHS--CMS



46. REVISIONS TO TRANSACTION AND CODE SET STANDARDS FOR ELECTRONIC 
TRANSACTIONS (CMS-0005-P)
Priority:


Other Significant


Legal Authority:


Social Security Act, sec 1171 to 1179; PL 104-191


CFR Citation:


45 CFR 162


Legal Deadline:


None


Abstract:


This rule would adopt modifications to the standards for electronic 
health care transactions adopted by the Secretary in regulations 
published August 2000. These modifications enable covered entities to 
comply with the standards and area result of the Designated Standard 
Maintenance Organization (DSMO) process.


Statement of Need:


The Administrative Simplification subtitle of the Health Insurance 
Portability and Accountability Act (HIPAA) of 1996 requires the 
Secretary of Health and Human Services to adopt standards for 
electronic transactions. This rule modifies previous adopted standards 
as a result of the Designated Standard Maintenance Organization (DSMO) 
process.


Summary of Legal Basis:


The Administrative Simplification provisions of HIPAA require the 
Secretary to establish standards of electronic transactions for health 
plans, health care clearing houses, and certain health care providers.


Alternatives:


In the absence of this regulation, standard for electronic transactions 
would be left with the private industry to develop. This action may 
create an inconsistent standard use of electronic claims attachments 
within the health care industry.


Anticipated Cost and Benefits:


The estimated costs and benefits of this rule would not change the 
impact of the Standard for Electronic Transaction Final Rule published 
on August 17, 2000 (65 FR 50312).


Risks:


Modifying standards established in the Standard for Electronic 
Transaction Final Rule (65 FR 50312), as a result of the Designated 
Standard Maintenance Organization (DSMO) process, will allow the health 
care industry to be in compliance with regulations under HIPAA. This 
proposed rule would enable providers, health plans, and clearinghouses 
to utilize a consistent set of electronic standards that are in 
compliance throughout the entire health care community.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           03/00/02
Regulatory Flexibility Analysis Required:


Undetermined


Small Entities Affected:


Businesses, Governmental Jurisdictions, Organizations


Government Levels Affected:


State, Local, Tribal, Federal


Agency Contact:
Stanley B. Nachimson
Senior Technical Advisor
Department of Health and Human Services
Centers for Medicare & Medicaid Services
N2-16-03
7500 Security Boulevard
Baltimore, MD 21244
Phone: 410 786-6153
RIN: 0938-AK76
_______________________________________________________________________



HHS--CMS



47. ORGAN PROCUREMENT ORGANIZATION CONDITION FOR COVERAGE (CMS-3064-
IFC)
Priority:


Other Significant


Legal Authority:


42 USC 1320b-8(b)(1)(A)(i); 42 USC 273(b)(2)


CFR Citation:


42 CFR 486.301


Legal Deadline:


Final, Statutory, January 1, 2002, Requires promulgation of new 
conditions.


Abstract:


This rule would establish conditions for coverage for organ procurement 
organizations (OPOs) to be certified by the Secretary to receive 
payment from Medicare and Medicaid for organ procurement costs and to 
be designated by the Secretary for a specific geographic service area.


Statement of Need:


This rule contains new conditions for coverage for organizations OPOs, 
including new performance standards. This rule would also increase the 
rectification cycle for OPOs from two years to four years.


Summary of Legal Basis:


Section 1138(b) of the Social Security Act (the Act) provides the 
statutory qualifications and requirements that an OPO must meet in 
order to receive payment for organ procurement costs associated with 
procuring organs for hospitals under the Medicare and Medicaid 
programs. This section gives the Secretary broad authority to establish 
performance-related standards for OPOs. Under this authority, the 
Secretary established conditions for coverage for OPOs at 42 CFR 
486.301, et seq. Section 1138(b) of the Act specifies that an OPO must 
be certified or rectified by the Secretary as meeting the standards to 
be a qualified OPO as described in section 371(b) of the Public Health 
Service (PHS) Act. The PHS Act requirements were established by the 
National Organ Transplant Act of 1984 and include provisions for OPO 
board membership, staffing, agreements with hospitals, and membership 
in the OPTN. The Organ Procurement Organization Certification Act of 
2000 (section 701 of Pub. L. 106-505, 42 U.S.C. section 273(b)(1)(D)) 
amended section 371(b) of the PHS Act to require CMS to increase the 
certification cycle for OPOs from two years to four years and 
promulgate new performance standards for OPOs.


Alternatives:


CMS is considering various alternatives in the development of 
performance measures and additional conditions for coverage and will 
solicit public comments in order to identify additional alternatives.


Anticipated Cost and Benefits:


Undetermined.


Risks:


Undetermined.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           12/00/01
Regulatory Flexibility Analysis Required:


No

[[Page 61187]]

Small Entities Affected:


Businesses


Government Levels Affected:


None


Agency Contact:
Jacqueline Morgan
Health Insurance Specialist
Department of Health and Human Services
Centers for Medicare & Medicaid Services
S3-02-01
7500 Security Boulevard
Baltimore, MD 21244
Phone: 410 786-4282
RIN: 0938-AK81
_______________________________________________________________________



HHS--CMS



48.   HOME HEALTH PROSPECTIVE PAYMENT SYSTEM REFINEMENTS (CMS-
1161-P)
Priority:


Other Significant. Major under 5 USC 801.


Legal Authority:


PL 105-33, sec 4603(a); PL 105-277, sec 5101(c); PL 105-277, sec 
5101(d); PL 106-113, sec 305 to 306; PL 106-554, sec 502; PL 106-554, 
sec 508; 42 USC 1395ff


CFR Citation:


Not Yet Determined


Legal Deadline:


None


Abstract:


This rule proposes refinements to the case-mix policies governing the 
home health prospective payment system (PPS) for FY 2004.


Statement of Need:


This rule proposes refinements to the PPS case-mix for FY 2004. Future 
refinements may include, but are not limited to, accuracy, modification 
of existing adjustments to the PPS to improve distributional integrity 
of the system, and changes to improve case-mix.


Summary of Legal Basis:


Section 1895 of the Social Security Act allows the Secretary to 
establish a prospective payment system for payment of all costs of 
Medicare home health services. Section 1895(b)(3)(B) allows the 
Secretary to adjust the standards prospective payment amount (or 
amounts) for subsequent fiscal years so as to eliminate the effect of 
coding or classification changes that do not reflect real changes in 
case mix.


Alternatives:


In this regulation, we will explore the possibility of PPS refinements 
based on an analysis of the appropriateness and accuracy of payments 
for different case mixes and the overall distributional effects of PPS.


Anticipated Cost and Benefits:


At this point, it is too early to determine any specific costs and 
benefits of this regulatory action. We believe the overall effect of 
such refinements will be a more equitable distribution of payments to 
home health agencies.


Risks:


The home health industry will benefit from refinements that will result 
in more precise and equitable payments based on ongoing analysis of the 
PPS environment and refinements to the case mix methodology. 
Beneficiaries will similarly benefit from payment methodology 
improvements which more accurately distribute Medicare payments based 
on relative patient needs. We believe any risk will be minimized by 
assuring that proposed refinements are based on objective analysis of 
ongoing data reflecting HHA behavior and beneficiary impacts under the 
current system.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           06/00/02
Final Action                                                   05/00/03
Regulatory Flexibility Analysis Required:


Undetermined


Small Entities Affected:


Businesses


Government Levels Affected:


None


Agency Contact:
Susan Levy
Health Insurance Specialist
Department of Health and Human Services
Centers for Medicare & Medicaid Services
C5-08-27
7500 Security Boulevard
Baltimore, MD 21244
Phone: 410 786-9364
RIN: 0938-AK93
_______________________________________________________________________



HHS--CMS



49.   MEDICAID MANAGED CARE (CMS-2104-F)
Priority:


Economically Significant. Major under 5 USC 801.


Unfunded Mandates:


Undetermined


Legal Authority:


Sec 4701 to 4710, Balanced Budget Act of 1997; sec 1932, Social 
Security Act


CFR Citation:


42 CFR 400; 42 CFR 430; 42 CFR 431; 42 CFR 434; 42 CFR 435; 42 CFR 438; 
42 CFR 440; 42 CFR 447


Legal Deadline:


None


Abstract:


This rule will revise recently published provisions for the Medicaid 
Managed Care program. It would also address quality of care and 
services under Medicaid managed care arrangements. In addition, this 
rule would affect enrollee rights and responsibilities, as well as 
contracts between State agencies and managed care organizations.


Statement of Need:


This regulation is necessary in order to implement the Medicaid managed 
care provisions of the Balanced Budget Act of 1997 (BBA). The Secretary 
has committed to releasing this final regulation as soon as possible so 
that States can begin to make necessary changes to their systems and 
operations.


Summary of Legal Basis:


Section 4701 through 4710 of the Balanced Budget Act of 1997; Section 
1932 of the Social Security Act.


Alternatives:


To not publish a final regulation, which will leave States with no 
guidance for implementing the BBA's managed care provisions.


Anticipated Cost and Benefits:


This regulation is economically significant. However, the regulation 
includes new managed care rate setting provisions that will be of great 
benefit to States and health plans. We have heard repeatedly from 
States and health plans that they are in support of the rate setting 
provisions as they will help offset the cost of other provisions within 
the regulation.

[[Page 61188]]

Risks:


If we do not publish a final regulation by August 16, 2002, the final 
rule with comment period that was published on January 19, 2001 will 
take effect.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            66 FR 43613                                    08/20/01
NPRM Comment Period End                                        10/19/01
Final Action                                                   02/00/02
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


Businesses


Government Levels Affected:


State, Federal


Agency Contact:
Bruce Johnson
Center for Medicaid and State Operations
Department of Health and Human Services
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD
Phone: 410 786-0615

Deirdre Duzor
Health Insurance Specialist
Department of Health and Human Services
Centers for Medicare & Medicaid Services
S3-13-15
7500 Security Boulevard
Baltimore, MD 21244
Phone: 410 786-4626
RIN: 0938-AK96
_______________________________________________________________________



HHS--CMS



50.   MEDICAID UPPER PAYMENT LIMIT FOR NON-STATE GOVERNMENT-
OWNED OR OPERATED HOSPITALS (CMS-2134-P)
Priority:


Economically Significant. Major under 5 USC 801.


Legal Authority:


Sec 1902(a)(30), Social Security Act


CFR Citation:


42 CFR 447.321


Legal Deadline:


None


Abstract:


This rule concerns the Medicaid upper payment limit (UPL) for inpatient 
hospital services and outpatient hospital services furnished by non-
State government-owned or operated hospitals.


Statement of Need:


This rule addresses the Medicaid upper payment limit for inpatient and 
outpatient hospitals furnished by non-State government-owned or 
operated facilities.


Summary of Legal Basis:


Section 1902(a)(30)(A) of the Social Security Act requires the State 
plan provide such methods and procedures relating to the utilization 
of, and the payment for, care and services available under the plan as 
may be necessary to safeguard against unnecessary utilization of such 
care and services and to assure that payments are consistent with 
efficiency, economy, and quality of care and are sufficient to enlist 
the plan at least to the extent that such care and services are 
available to the general population in the geographic area.


Alternatives:


None.


Anticipated Cost and Benefits:


Undetermined.


Risks:


Undetermined.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           12/00/01
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


State


Agency Contact:
Larry Reed
Chief, Medicaid Noninstitutional Payment Policy Branch
Department of Health and Human Services
Centers for Medicare & Medicaid Services
S2-01-16
7500 Security Boulevard
Baltimore, MD 21244
Phone: 410 786-3325
RIN: 0938-AL05
_______________________________________________________________________



HHS--CMS



51.   HOME HEALTH PROSPECTIVE PAYMENT SYSTEM RATE UPDATE FOR FY 
2003 (CMS-1198-NC)
Priority:


Other Significant


Legal Authority:


Balanced Budget Act, PL 105-33, sec 460.3(a); OCESAA, PL 105-277, sec 
5101(c); OCESAA, PL 105-277, sec 5101(d); Balanced Budged Act 
Refinement Act of 1999, PL 100-113, sec 305; Balanced Budget Act 
Refinement Act of 1999, PL 100-113, sec 306; Medicare, Medicaid & SCHIP 
Benefits Improve.& Protection Act of 2000, PL 106-544; ...


CFR Citation:


Not Yet Determined


Legal Deadline:


Other, Statutory, October 1, 2002, Publish by 07/01/2002.


Abstract:


This notice with comment period updates rates for the home health 
prospective payment system for FY 2003.


Statement of Need:


This annual rate update is required by section 1895(b)(3)(B) of the 
Social Security Act.


Summary of Legal Basis:


Section 1895 of the Social Security Act allows the Secretary to 
establish a prospective payment system for payment of all costs of 
Medicare home health services. Section 1895(b)(3)(B) provides for the 
Secretary's adjustment of the standard prospective payment amount (or 
amounts) for subsequent fiscal years.


Alternatives:


There are no alternatives to a home health prospective payment system 
rate update for FY 2003 without new legislation.


Anticipated Cost and Benefits:


At this time, the data are not available to determine the specific rate 
updates for FY 2003.


Risks:


We risk being out of compliance with the statutory requirement that the 
home health prospective payment system rates be updated annually for 
inflation.

[[Page 61189]]

Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
Notice                                                         07/00/02
Regulatory Flexibility Analysis Required:


Undetermined


Small Entities Affected:


Businesses


Government Levels Affected:


None


Agency Contact:
Susan Levy
Health Insurance Specialist
Department of Health and Human Services
Centers for Medicare & Medicaid Services
C5-08-27
7500 Security Boulevard
Baltimore, MD 21244
Phone: 410 786-9364
RIN: 0938-AL16
_______________________________________________________________________



HHS--CMS



52.   REQUIREMENTS FOR PAID FEEDING ASSISTANTS IN LONG-TERM 
CARE FACILITIES (CMS-2131-P)
Priority:


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


Unfunded Mandates:


Undetermined


Legal Authority:


Sec 1819(a) to (f) of the Social Security Act; sec 1919(a) to (g) of 
the Social Security Act; PL 100-203


CFR Citation:


42 CFR 483.73; 42 CFR 483.75(c)


Legal Deadline:


None


Abstract:


This rule would permit long-term care facilities to use paid feeding 
assistants to supplement the services of certified nurse aids. If 
facilities choose this option, feeding assistants must complete a 
specified training program. This proposed rule would benefit residents 
by ensuring that more of them will receive the help with eating and 
drinking that they need.


Statement of Need:


The Secretary wants to revise the policy in order to permit long term 
care facilities to employ paid feeding assistants.


Summary of Legal Basis:


Sections 1819(a) through (f) and 1919(a) through (g) of the Social 
Security Act, PL 100-203.


Alternatives:


None.


Anticipated Cost and Benefits:


This rule may help nursing homes to supplement staffing in order to 
help more residents who have eating and drinking difficulties.


Risks:


This rule may cause confusion in State survey agencies, which have the 
responsibility for surveying long-term care facilities. It may also 
cause concerns for nursing home resident advocates.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           03/00/02
Regulatory Flexibility Analysis Required:


Undetermined


Small Entities Affected:


Businesses


Government Levels Affected:


State, Federal


Agency Contact:
Nola Petrovich
Department of Health and Human Services
Centers for Medicare & Medicaid Services
S2-14-26
7500 Security Boulevard
Baltimore, MD 21244
Phone: 410 786-4671
RIN: 0938-AL18
_______________________________________________________________________



HHS--CMS



53.   HOSPITAL OUTPATIENT PROSPECTIVE PAYMENT SYSTEM FOR 
CALENDAR YEAR 2003 (CMS-1206-P)
Priority:


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


Legal Authority:


42 USC 1395 L; BBA'97; BBRA' 99; BIPA' 00


CFR Citation:


Not Yet Determined


Legal Deadline:


None


Abstract:


These rules would revise the Medicare hospital outpatient department 
prospective payment system for the January 2, 2003 update.


Statement of Need:


Annual updates to the hospital outpatient prospective payment systems 
rates are required by section 1833 of the Social Security Act (the 
Act), as amended by the Medicare, Medicaid, and SCHIP Balanced Budget 
Refinement Act of 1999 (BBRA), and the Medicare, Medicaid, and SCHIP 
Benefits Improvement and Protection Act of 2000 (BIPA), relating to 
Medicare payments for hospital outpatient department patient 
prospective payment systems.


Summary of Legal Basis:


Section 1833(t) of the Act sets forth a system of payment for hospital 
outpatient department services furnished to Medicare beneficiaries 
based on prospectively set rates.


Alternatives:


None.


Anticipated Cost and Benefits:


Undetermined.


Risks:


Failure to update the hospital outpatient department prospective 
payment systems would place us in violation of the Act. Moreover, 
failure to meet the publication deadline imposed by the Act would also 
constitute a violation.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           05/00/02
Final Action                                                   10/00/02
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses


Government Levels Affected:


Federal

[[Page 61190]]

Agency Contact:
Nancy Edwards
Center for Medicare Mangement
Department of Health and Human Services
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244-1850
Phone: 410 786-0378
Email: [email protected]
RIN: 0938-AL19
_______________________________________________________________________



HHS--CMS



54.   PROSPECTIVE PAYMENT SYSTEM AND CONSOLIDATED BILLING FOR 
SKILLED NURSING FACILITIES-UPDATE FOR FY 2003 (CMS-1202-P)
Priority:


Other Significant. Major under 5 USC 801.


Legal Authority:


Sec 1888(e) of the Social Security Act


CFR Citation:


42 CFR 410; 42 CFR 411; 42 CFR 413; 42 CFR 424; 42 CFR 489


Legal Deadline:


NPRM, Statutory, March 29, 2002.


Final, Statutory, July 31, 2002.


Abstract:


This rule sets forth updates to the payment rates under the prospective 
payment system (PPS) for skilled nursing facilities (SNFs) for fiscal 
year (FY) 2003.


Statement of Need:


The Medicare SNF PPS was established by section 4432 of the Balances 
Budged Act of 1997 (BBA). The PPS applies to all costs (routine, 
ancillary, and capital) of covered SNF services furnished to 
beneficiaries under part A of the Medicare program, effective for cost 
reporting periods beginning on or after July 1, 1998. Annual updates to 
the PPS rates are required by section 1888(e) of the Social Security 
Act (the Act), as amended by the Medicare, Medicaid, and SCHIP Balanced 
Budged Refinement Act of 1999 (BBRA), and the Medicare, Medicaid, and 
SCHIP Benefits Improvement and Protection Act of 2000 (BIPA), relating 
to Medicare payments and consolidated billing for SNFs.


Summary of Legal Basis:


Section 1888(e)(4)(H) requires that annual updates to the SNF PPS rates 
be published in the Federal Register before August 1 of each year, to 
be effective on the first day of the fiscal year.


Alternatives:


None.


Anticipated Cost and Benefits:


Section 1888(e) of the Act established the SNF PPS for the payment of 
Medicare SNF services for cost reporting periods beginning on or after 
July 1, 1998. This section also specifies that the base year cost date 
to be used in computing the Resource Utilization Group III (RUG-III) 
payment rates must be from FY 1995. The Act also requires that a number 
of elements be incorporated into the SNF PPS, such as case-mix 
classification methodology, the Minimum Data Set (MDS) assessment 
schedule, a market basket index, a wage index, and the urban and rural 
distinction used in the development or adjustment of the Federal rates. 
Payment for SNF care prospectively has a direct, positive impact on the 
Medicare program by controlling the increase in costs for services 
provided by SNFs. Operating under a PPS also has a beneficial impact on 
the efficient management and planning capability of individual SNFs.


Risks:


Failure to update the SNF PPS by October 1, 2002 would place us in 
violation of the Act. Moreover, failure to meet the publication 
deadline imposed by the Act would also constitute a violation.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           03/00/02
NPRM Comment Period End                                        05/00/02
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses, Organizations


Government Levels Affected:


None


Agency Contact:
William Ullman
Department of Health and Human Services
Centers for Medicare & Medicaid Services
C4-13-15
7500 Security Boulevard
Baltimore, MD 21244-1850
Phone: 401 786-5667
RIN: 0938-AL20
_______________________________________________________________________



HHS--CMS



55.   REVISIONS TO PAYMENT POLICIES UNDER THE PHYSICIAN FEE 
SCHEDULE FOR CALENDAR YEAR 2003 (CMS-1204-P)
Priority:


Other Significant. Major under 5 USC 801.


Legal Authority:


42 USC 1395W-4


CFR Citation:


Not Yet Determined


Legal Deadline:


None


Abstract:


This rule would make several changes affecting Medicare part B payment.


Statement of Need:


Since January 1, 1992, Medicare has paid for physicians' services under 
section 1848 of the Social Security Act (the Act), ``Payment for 
Physicians' Services.'' This section provides for three major elements: 
1) a fee schedule for the payment of physicians' services; 2) a 
sustainable growth rate for the rates of increase in Medicare 
expenditures for physicians' services; and 3) limits on the amounts 
that nonparticipating physicians can charge beneficiaries. The Act 
requires that payments under the fee schedule be based on national 
uniform relative value units (RVUs) based on the resources used in 
furnishing a service. Section 1848(c) of the Act requires that national 
RVUs be established for physician work, practice expense, and 
malpractice expense.


Summary of Legal Basis:


Section 6102 of the Omnibus Reconciliation Act of 1989 (Pub. L. 101-
239) amended the Act by adding section 1848, ``Payment for Physicians' 
Services'' that requires Medicare to pay for physicians' services under 
a fee schedule. Section 4644 of the Balanced Budget Act of 1997 (Pub. 
L. 105-33)

[[Page 61191]]

amended section 1848(b)(1) of the Act by requiring that we publish fee 
schedules that establish payment amount of all physicians' services 
before November 1 of the preceding year, each year.


Alternatives:


None.


Anticipated Cost and Benefits:


The statute requires that annual adjustments to physician fee schedule 
RVUs not cause annual payments to differ by more than $20 million from 
what they would have been had the adjustments not been made. If this 
threshold is exceeded, we would make adjustments to the conversion 
factor (the dollar amount that converts relative values into a payment 
amount for a physician's service) to preserve budget neutrality.


Because changes to RVUs must be budget neutral, if we increase a 
service's RVUs, we must reduce the overall multiplier (or the actual 
RVUs) that converts the RVUs to a dollar amount. Therefore, certain 
physician specialty groups may experience an increase in payment and 
some may experience a decrease in payment.


Risks:


Failure to establish payment amounts for physicians' services would 
place us in violation of section 1848 of the Act.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           05/00/02
Final Action                                                   10/00/02
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses


Government Levels Affected:


Federal


Agency Contact:
Diane Milstead
Department of Health and Human Services
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244
Phone: 410 786-3355
RIN: 0938-AL21
_______________________________________________________________________



HHS--CMS



56.   HOSPITAL INPATIENT REHABILITATION PROSPECTIVE PAYMENT 
SYSTEM FOR FY 2003 (CMS-1205-P)
Priority:


Economically Significant. Major under 5 USC 801.


Legal Authority:


PL 105-33, sec 4421; 42 USC 1395ww(j), sec 1886(j) of the Social 
Security Act


CFR Citation:


Not Yet Determined


Legal Deadline:


None


Abstract:


We will revise the Medicare inpatient rehabilitation hospital PPS to 
implement statuary requirements and incorporate changes that arise from 
our experience with the system. We will also review the amounts and 
factors used to determine rates for Medicare rehabilitation hospitals 
and rehabilitation units of a hospital.


The provision specified in the prospective payment system inpatient 
rehabilitation for hospitals 2002 final regulation will become 
effective for cost reporting periods on or after January 2002.


Statement of Need:


The Balanced Budget Act (BBA) significantly changed the way we will pay 
for Medicare covered services furnished to a Medicare inpatient in a 
rehabilitation facility. The BBA requires payments to be based on the 
inpatient operating and capital costs of rehabilitation facilities and 
adjusted for: 1) case mix using patient classification groups; 2) area 
wages; 3) inflation; 4) outlier and special payments; and 5) other 
factors necessary to reflect variations in costs of treatment. Total 
payments made under the system to rehabilitation facilities during 
fiscal year 2002 are required to equal 100 percent of the estimated 
payments that would have been made under the current TEFRA payment 
system. Outlier payments in a fiscal year may not exceed five percent 
of the total projected payments for the fiscal year.


The BBA gives us considerable discretion in designing the prospective 
payment system. Payment rates must be based on the discharge. The case 
mix classification groups may be based on those factors as the 
Secretary deems appropriate such as impairment, age, related prior 
hospitalization, co-morbidities, and functional capability of the 
patient.


Summary of Legal Basis:


Section 1886(j) to the Social Security Act, as added by section 4421 of 
the BBA, and as amended by section 125 of BBRA and section 305 of BIPA, 
to provide prospective payment for inpatient rehabilitation facilities 
(freestanding and units).


Alternatives:


None.


Anticipated Cost and Benefits:


Based on the results of implementation of other Medicare prospective 
payment systems, CMS believes that the implementation of the 
prospective payment system, as the method to pay for the services 
furnished to Medicare beneficiaries who are inpatients in 
rehabilitation facilities, will yield significant savings to the 
Medicare program. We estimate that the inpatient rehabilitation 
facilities prospective payment system costs for FY 2003 will be $10 
million. The FY 2003 estimated costs of $10 million are associated with 
the portion of inpatient rehabilitation facilities cost reporting 
periods between October 1, 2002, and September 30, 2003 using the FY 
2002 rates. However, we have not completed our analysis, so we can not 
be specific about the expected full costs and benefits of the FY 2003 
rates.


Risks:


Altering the method that we pay rehabilitation facilities for the 
services they furnish to Medicare inpatients has the potential to 
affect a beneficiary's access to care and the quality of care furnished 
to a beneficiary. Therefore, we will be implementing methods to monitor 
the effect of the prospective payment system on these two associated 
patient care concerns.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           05/00/02
Final Action                                                   10/00/02
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


Businesses, Organizations


Government Levels Affected:


None

[[Page 61192]]

Agency Contact:
Laurence Wilson
Center for Medicare Management
Department of Health and Human Services
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244-1850
Phone: 410 786-4603
RIN: 0938-AL22
_______________________________________________________________________



HHS--CMS



57.   HOSPITAL INPATIENT PROSPECTIVE PAYMENT SYSTEM FOR FY 2003 
(CMS-1203-P)
Priority:


Economically Significant. Major under 5 USC 801.


Unfunded Mandates:


Undetermined


Legal Authority:


Sec 1886(d) of the Social Security Act


CFR Citation:


Not Yet Determined


Legal Deadline:


NPRM, Statutory, April 1, 2002.


Final, Statutory, August 2, 2002.


Abstract:


We would revise the Medicare hospital inpatient prospective payment 
system for operating costs to implement changes arising from our 
continuing experience with the system. In addition, in the Addendum, we 
describe changes to the amounts and factors used to determine the rates 
for Medicare hospital inpatient services for operating costs and 
capital-related costs. These changes apply to discharges occurring on 
or after October 2, 2002.


Statement of Need:


Annual updates to the hospital inpatient prospective payment system 
rates are required by section 1886 of the Social Security Act (the 
Act), as amended by the Medicare, Medicaid, and SCHIP Balanced Budged 
Refinement Act of 1999 (BBRA), and the Medicare, Medicaid, and SCHIP 
Benefits Improvement and Protection Act of 2000 (BIPA), relating to 
Medicare payments for hospital inpatient prospective payment systems.


We are proposing to revise the Medicare hospital inpatient prospective 
payment systems for operating and capital costs to: describe proposed 
changes to the amounts and factors used to determine the rates for 
Medicare hospital inpatient services for operating costs and capital-
related costs. These changes would be applicable to discharges 
occurring on or after October 1, 2002. We also are setting forth 
proposed rate-of-increase limits as well as proposed policy changes for 
hospitals and hospital units excluded from the prospective payment 
systems.


Summary of Legal Basis:


Section 1886(d) of the Social Security Act sets forth a system of 
payment for the operating costs of the acute care hospital inpatient 
system under Medicare part A based on prospectively set rates. Section 
1866(g) of the Act requires the Secretary to pay for the capital-
related costs of hospital inpatient stays under a prospective payment 
system.


Section 1886(e)(5)(B) requires that annual updates to the hospital 
inpatient prospective payment systems rates be published in the Federal 
Register before August 1 of each year, to be effective on the first day 
of the fiscal year (FY).


Alternatives:


None.


Anticipated Cost and Benefits:


The cost and benefits of this regulation will depend upon the market 
basket projection by the Office of the Actuary. Under current law, the 
update for FY 2003 will be market basket minus .55 percentage points. A 
one percent change in payments under the inpatient prospective payment 
system represents an approximately $760 million change.


Risks:


Inadequately paying for the services hospitals furnish to Medicare 
beneficiaries has the potential to affect a beneficiary's access to 
care and the quality of care furnished to a beneficiary. Therefore, we 
will carefully assess the impacts of all of the changes we implement 
through this regulation to mitigate these risks.


Failure to update the hospital inpatient prospective payment systems by 
October 1, 2003 would place us in violation of the Act. Moreover, 
failure to meet the publication deadline imposed by the Act would also 
constitute a violation.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           03/00/02
Final Action                                                   07/00/02
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses


Government Levels Affected:


None


Federalism:


 Undetermined


Agency Contact:
Stephen Phillips
Center for Health Plans and Providers
Department of Health and Human Services
Centers for Medicare & Medicaid Services
C4-05-27
7500 Security Boulevard
Baltimore, MD 21244
Phone: 410 786-4548
RIN: 0938-AL23
_______________________________________________________________________



HHS--CMS



58.   INITIATIVE TO ENDORSE PRESCRIPTION DRUG DISCOUNT PROGRAMS 
(CMS-4027-P)
Priority:


Economically Significant


Legal Authority:


42 USC 1395b-3; 42 USC 1302; 42 USC 1302b-10


CFR Citation:


None


Legal Deadline:


None


Abstract:


The proposed rule would set forth a Department of Health and Human 
Services' initiative for a Medicare endorsement to entities currently 
offering prescription drug discounts to the general public to offer 
prescription drug discount cards to Medicare beneficiaries. The 
proposed rule would set forth the criteria the Department proposes to 
establish for participation in the initiative, including qualifications 
for entities for endorsement, and the proposed method by which entities 
could apply for Medicare endorsement. The proposed rule would request 
public comment on all aspects of the prescription drug discount card 
initiative.


Statement of Need:


Currently, Medicare beneficiaries have limited opportunities to obtain

[[Page 61193]]

discounts on prescription drugs, and lack information on how to pursue 
such opportunities that exist. The proposed rule would propose a 
program, among other things: (1) to educate Medicare beneficiaries 
about private market methods available for securing discounts on the 
purchase of prescription drugs; (2) to provide a mechanism for Medicare 
beneficiaries to gain access to the effective tools widely used in the 
private sector to receive lower priced, quality pharmaceuticals; (3) to 
endorse qualified private sector prescription drug discount card 
programs; and (4) to provide Medicare beneficiaries an opportunity to 
enroll in a prescription drug discount card program.


Because of the limited opportunities Medicare beneficiaries have to 
obtain discounts on prescription drugs, on July 12, 2001, President 
George W. Bush and Secretary Tommy Thompson announced an initiative to 
provide Medicare beneficiaries with a way to obtain a Medicare-endorsed 
prescription drug discount card and to educate them about such discount 
card programs. On September 11, 2001, a District Court judge 
preliminarily enjoined the Secretary from implementing that Medicare-
Endorsed Prescription Drug Discount Card initiative, published in the 
Federal Register on July 18, 2001. The judge's order was based in part 
on a preliminary finding that the Secretary should have issued the 
initiative through notice and comment rulemaking. This proposed rule 
would open to public comment the discount card initiative as a whole, 
as well as the qualifications necessary for the Medicare endorsement.


Summary of Legal Basis:


There are a number of legal authorities that support the Secretary's 
endorsement of available prescription drug discount programs, including 
42 U.S.C. 1395b-3; 42 U.S.C. 1302 (authority to make and publish such 
rules and regulations as are necessary to the efficient administration 
of the functions charged under the Social Security Act); and 42 U.S.C. 
1320b-10.


Alternatives:


Rather than offering Medicare endorsement to entities that meet defined 
qualifications, the Secretary could perform a study of prescription 
drug discount cards currently available in the market and provide 
recommendations to Medicare beneficiaries regarding which prescription 
drug discount cards provide the highest-quality services.


The Secretary could also serve as a clearinghouse for currently 
available prescription drug discount card sponsors to provide 
information on their products. Such information could include 
information on enrollment fees, the names or types of drugs for which 
discounts are offered, the discounts available on such drugs, and the 
scope of discount cards' networks of pharmacies.


Anticipated Cost and Benefits:


The benefits of this proposed initiative will be: (1) the education of 
Medicare beneficiaries about private market methods available for 
securing discounts on the purchase of prescription drugs, and (2) the 
provision of a mechanism for Medicare beneficiaries to gain access to 
the effective tools widely used by prescription benefit managers and by 
discount card programs to get lower drug prices and higher quality 
pharmaceutical care. The Department anticipates that, as a result of 
this proposed initiative, Medicare recipients could obtain prescription 
drugs they currently may be unable to afford and may, thus, remain 
healthier. The Department anticipates that this, in turn, may 
ultimately lead to cost-savings for Medicare.


The Department will incur some program costs associated with developing 
educational materials on discount programs and providing such 
information to Medicare beneficiaries, evaluating applicants, and 
assisting the start-up of a consortium of prescription drug programs to 
run the program. Applicants and entities offering endorsed prescription 
drug discount cards will incur certain costs, but such costs are 
voluntary since participation in the program is voluntary.


Risks:


Undetermined.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           12/00/01
Regulatory Flexibility Analysis Required:


Undetermined


Small Entities Affected:


Businesses


Government Levels Affected:


None


Agency Contact:
Paula Stannard
Department of Health and Human Services
Centers for Medicare & Medicaid Services
Room 707F
200 Independence Avenue SW.
Washington, DC 20201
Phone: 202 690-7741

Teresa Decaro
Department of Health and Human Services
Centers for Medicare & Medicaid Services
C5-17-14
7500 Security Boulevard
Baltimore, MD 21244
Phone: 410 786-6604
Email: [email protected]
RIN: 0938-AL28
_______________________________________________________________________



HHS--CMS

                              -----------

                            FINAL RULE STAGE

                              -----------




59. HEALTH INSURANCE REFORM: STANDARD UNIQUE HEALTH CARE PROVIDER 
IDENTIFIER (CMS-0045-F)
Priority:


Other Significant. Major under 5 USC 801.


Legal Authority:


42 USC 1320D-2(b)(1)


CFR Citation:


42 CFR 160; 42 CFR 162


Legal Deadline:


Final, Statutory, February 21, 1998.


Abstract:


This rule addresses the health care industry's need for a standardized 
provider identifier. It implements one of the requirements for 
administrative simplification in section 262 of the Health Insurance 
Portability and Accountability Act of 1996. A standard provider 
identifier will save the health insurance industry significant costs 
incurred in maintaining multiple identifier systems.


Statement of Need:


The Health Insurance Portability and Accountability Act of 1996 (HIPAA) 
(Pub. L. 104-191) creates a new part C, entitled ``Administrative 
Simplification,'' to title XI of the Social Security Act. One of the 
standards for health identifiers that is mandated by part C is a 
standard unique health care provider identifier, to be used in the

[[Page 61194]]

health care system. This regulation announces the adoption of the 
National Provider Identifier (NPI) as the standard unique health care 
provider identifier. It also provides information on how health care 
providers will be assigned NPIs and defines the requirements of health 
plans, health care providers, and health care clearinghouses with 
respect to obtaining and using this standard. Implementation of the NPI 
and the other Administrative Simplification standards will increase the 
efficiency of the processing of standard transactions within the health 
care system.


Summary of Legal Basis:


Currently, health plans assign identification numbers to their member 
health care providers. Different health plans assign different numbers 
to the same health care providers. The identifiers are frequently not 
standard within a health plan or across health plans. This results in 
health care providers having different identification numbers for 
different health programs, often having multiple billing numbers issued 
within a single health program. This complicates the health care 
providers' claims submissions and other transactions and increases the 
costs incurred by health care providers in conducting those 
transactions.


The Administrative Simplification provisions of HIPAA were designed to 
improve the efficiency and effectiveness of the health care system by 
encouraging the development of a health information system through the 
establishment of the standard unique health care provider identifier 
and other standards and requirements to facilitate the electronic 
transmission of certain health information.


Alternatives:


This regulation announces the NPI as the standard unique health care 
provider identifier. The NPI is a 10-position all numeric identifier, 
with a check-digit in the tenth position. There is no intelligence in 
the number. This design and our assignment strategy will allow more 
than 200 million NPIs to be issued. The NPI meets the principles 
established by the Department of Health and Human Services (HHS) for 
designation as a national standard. This final regulation defines 
``health care provider'' in terms of the entities that will receive 
NPIs.


Health care providers will be enumerated by a federally directed 
registry (the enumeration contractor). The enumeration contractor will 
use the National Provider System (NPS) to uniquely identify a health 
care provider and issue it an NPI. The NPS will be developed by CMS. 
Health care providers must supply updates to their NPS data to the 
enumeration contractor within 30 days of the effective dates of the 
changes.


The NPS will establish the National Provider File (NPF), which will 
contain information collected from health care providers in order to 
assign them NPIs. The NPS will assign a single, unique NPI to a health 
care provider. Upon the dissolution of an organization health care 
provider or the death of a individual health care provider, the NPS 
will deactivate the NPI that had been issued to that health care 
provider and will not assign a deactivated NPI to any other health care 
provider.


Anticipated Cost and Benefits:


Our analysis of the costs and savings of the HIPAA Administrative 
Simplification standards is an aggregate impact of all the standards. 
Assessing the impact of each standard independently would inflate the 
costs and would yield inaccurate results. While each individual 
standard is beneficial, the standards as a whole have a synergistic 
effect on savings. A difficulty in this analysis was the fact that we 
have no historical experience in assessing the costs and benefits of 
such a sweeping change. The costs of implementing the standards 
specified in HIPAA are primarily one-time or short-term costs related 
to conversion. These costs will be incurred during the first three 
years of implementation. Benefits will accrue almost immediately, but 
will not exceed costs for health care providers until after the third 
year of implementation. After the third year, the benefits will 
continue to accrue into the fourth year and beyond. The impact analysis 
for the costs and benefits associated with all the Administrative 
Simplification standards indicates that the combined net savings for 
health plans and health care providers would amount to $1.5 billion 
dollars after five years.


Risks:


This rule will formally establish the standard for the unique health 
care provider identifier and will communicate the requirements for 
health plans, health care providers, and health care clearinghouses in 
implementing this standard.


Failure to publish this rule would jeopardize the benefits of 
administrative simplification. Payers would continue to maintain their 
own system of enumerating providers, and providers would need to 
maintain systems to store the different identifiers. Additional costs 
would thus be incurred.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            63 FR 25320                                    05/07/98
NPRM Comment Period End                                        07/06/98
Final Action    Determined                                        To Be
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:


None


Agency Contact:
Patricia Peyton
Office of Information Services
Department of Health and Human Services
Centers for Medicare & Medicaid Services
N3-20-05
7500 Security Boulevard
Baltimore, MD 21224-1850
Phone: 410 786-1812
RIN: 0938-AH99
_______________________________________________________________________



HHS--CMS



60. SECURITY STANDARDS (CMS-0049-F)
Priority:


Economically Significant. Major under 5 USC 801.


Legal Authority:


PL 104-191; 42 USC 1320d-2(d)


CFR Citation:


45 CFR 162


Legal Deadline:


Final, Statutory, February 21, 1998.


Abstract:


This rule implements some of the requirements of the Administrative 
Simplification subtitle of the Health Insurance Portability and 
Accountability Act of 1996. It establishes standards for the security 
of health information used by health

[[Page 61195]]

plans, health care clearinghouses, and certain health care providers. 
These entities would use the security standards to develop and maintain 
the security of all electronic health information.


Statement of Need:


The Health Insurance Portability and Accountability Act of 1996 
requires the Secretary of Health and Human Services to adopt security 
standards that require reasonable and appropriate administrative, 
technical and physical safeguards to: 1) ensure the integrity and 
confidentiality of health information; 2) protect against any 
reasonably anticipated threats or hazards to the security or integrity 
of the information; and 3) protect against unauthorized uses or 
disclosures of the information. This rule stipulates the requirements 
necessary to comply with the law.


Summary of Legal Basis:


The Administrative Simplification provisions of HIPAA require the 
Secretary to establish standards for the security of health information 
use by health plans, health care clearing houses, and certain health 
care providers.


Alternatives:


In the absence of Federal regulations, the security of health care 
information in electronic form would be left to the private sector to 
develop. It is believed that this course of action would result in an 
extremely uneven level of protection (ranging from none to excessive) 
for electronic health information pertaining to individuals and make it 
difficult, if not impossible, to provide for privacy of this 
information.


Anticipated Cost and Benefits:


As the effect of any one of the HIPAA standards is affected by the 
implementation of other standards, it is misleading to discuss the 
impact of one standard by itself. Therefore, an Impact Analysis on the 
total effect of all the standards was published in the proposed rule 
concerning the national provider identifier (HCFA-0045-P) which was 
published on May 7, 1998 (63 FR 25320). Security protection for health 
care information is not a ``stand alone'' type requirement. Appropriate 
security protections will be a business enabler, encouraging the growth 
and use of electronic data interchange. The synergistic effect of the 
employment of the recommended security practices, procedures and 
technologies will enhance all aspects of HIPAA's Administrative 
Simplification requirements.


Risks:


The storage, handling and transmission of health information has long 
been a paper process. However, the transition from paper to electronic 
media has begun and is increasing at a rapid pace. This transition has 
brought on a significantly increased risk to the security and 
confidentiality of health information, particularly for information 
pertaining to individuals. This rule formally establishes a baseline 
set of requirements for security that must be adopted by health care 
providers, health plans and health care clearinghouses. Compliance with 
these requirements will greatly decrease risk to the security, 
integrity and confidentiality of health information.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            63 FR 43242                                    08/12/98
NPRM Comment Period End                                        10/13/98
Final Action    Determined                                        To Be
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses


Government Levels Affected:


State, Local, Tribal, Federal


Federalism:


 Undetermined


Agency Contact:
Barbara Clark
Office of Information Services
Department of Health and Human Services
Centers for Medicare & Medicaid Services
N2-14-10
7500 Security Boulevard
Baltimore, MD 21244-1850
Phone: 410 786-3017
RIN: 0938-AI57
_______________________________________________________________________



HHS--CMS



61. NATIONAL STANDARD EMPLOYER IDENTIFIER (CMS-0047-F)
Priority:


Economically Significant. Major under 5 USC 801.


Legal Authority:


PL 104-191; 42 USC 1320d to 1320-d-8


CFR Citation:


45 CFR 162


Legal Deadline:


Final, Statutory, February 21, 1998.


Abstract:


This rule institutes the employer identification number (EIN) as the 
standard for identifying employers for purposes of administrative 
simplification, as required by the Health Insurance Portability and 
Accountability Act of 1996. Use of one standard in the health care 
industry will reduce the cost of identifying employers in electronic 
health care transactions.


Statement of Need:


The Health Insurance Portability and Accountability Act of 1996 (Pub. 
L. 104-191) includes Subtitle F-Administrative Simplification, whose 
purpose is to improve the Medicare and Medicaid programs under the 
Social Security Act, and the efficiency and effectiveness of the health 
care system, by the establishment of standards and requirements for the 
electronic transmission of certain health information. This regulation 
establishes the standard for a unique employer identifier, as required 
by the Administrative Simplification provisions of Public Law 104-191.


Summary of Legal Basis:


The Administrative Simplification provisions of HIPAA require the 
Secretary of HHS to adopt a standard unique health identifier for each 
employer for use in the health care system and to specify the purposes 
for which a unique health identifier may be used.


Alternatives:


HHS examined several existing identifiers that might be adopted for the 
standard. In keeping with the requirements of HIPAA, because no 
standard setting organization had developed, adopted, or modified a 
standard for an employer identifier, HHS consulted with the National 
Uniform Billing Committee, the National Uniform Claim Committee, the 
Workgroup for Electronic Data Interchange and the American Dental 
Association in selecting this standard. HHS also relied on the 
recommendations of the National Committee on Vital and Health 
Statistics.

[[Page 61196]]

Anticipated Cost and Benefits:


As the effect of any one standard is affected by the implementation of 
other standards, it can be misleading to discuss the impact of one 
standard by itself. Therefore HHS did an impact analysis showing total 
costs and savings of all the HIPAA standards in the proposed rule 
concerning the national provider identifier (HCFA-0045-P), which can be 
found at 63 FR 25320. HHS determined that the requirements concerning 
the employer identifier would have a one time impact on those 
providers, clearinghouses, and health plans that have to convert to use 
the EIN, and on those employers that would have to disclose the EIN to 
covered entities.


Risks:


Failure to publish this rule would mean that no standard employer 
identifier would be established for use in the health care system. Lack 
of a standard employer identifier would decrease the savings in health 
care costs to be realized from administrative simplification.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            63 FR 32784                                    06/16/98
NPRM Comment Period End                                        08/17/98
Final Action    Determined                                        To Be
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses


Government Levels Affected:


State


Federalism:


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


Agency Contact:
Mary Emerson
Office of Information Services
Department of Health and Human Services
Centers for Medicare & Medicaid Services
N2-12-22
7500 Security Boulevard
Baltimore, MD 21244
Phone: 410 786-7065
Email: [email protected]
RIN: 0938-AI59
_______________________________________________________________________



HHS--CMS



62. FEE SCHEDULE FOR PAYMENT OF AMBULANCE SERVICES AND REVISIONS TO THE 
PHYSICIAN'S CERTIFICATION REQUIREMENTS FOR COVERAGE OF NONEMERGENCY 
AMBULANCE SERVICES (CMS-1002-FC)
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; 42 CFR 414


Legal Deadline:


Final, Statutory, January 1, 2000.


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 was to be effective beginning with 
services furnished on or after January 1, 2000. However, other 
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.


In the September 12, 2000 proposed rule, we indicated our intention to 
implement the fee schedule beginning January 1, 2001. However, although 
the proposed rule was largely based on an agreement reached as part of 
a negotiated rulemaking process with representatives of the ambulance 
industry and other interests, we received over 340 public comments. We 
did not have sufficient time to carefully consider all comments and 
publish a final rule in time to implement the fee schedule by January 
1, 2001. This final rule establishes an implementation date of January 
1, 2002. Our objective is to have the ambulance fee schedule become 
effective as soon as feasibly possible after the statutory date, in 
this case, April 1, 2002.


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.


In our proposed rule (65 FR 55078), we discussed the negotiated 
rulemaking procedure used to formulate our policy for the ambulance fee 
schedule. We also proposed additions to part 414, based on 
recommendations of the Committee. We discussed operational and regional 
variations, cost of living differences, services furnished in rural 
areas and mileage. The structure of the fee schedule, the ambulance 
inflation factor and phase-in methodology were also covered.


In addition, we proposed changes not based on the negotiated 
rulemaking, on matters including coverage of ambulance services, 
physician certification requirements, payment during the first year, 
and billing method. We discussed local or State ordinances, mandatory 
assignment, and miscellaneous payment policies, including multiple 
patients, pronouncement of death, multiple arrivals, and BLS services 
furnished in an ALS vehicle.


We presented our methodology for determining the conversion factor (CF) 
and for implementing the fee schedule. We discussed expenditure control 
for ambulance services, adjustments to account for inflation and the 
medical conditions list.


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

[[Page 61197]]

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:


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            65 FR 55078                                    09/12/00
Final Action                                                   04/00/02
Regulatory Flexibility Analysis Required:


Undetermined


Government Levels Affected:


Undetermined


Federalism:


 Undetermined


Agency Contact:
Glenn McGuirk
Department of Health and Human Services
Centers for Medicare & Medicaid Services
S3-05-27
Office of Clinical Standards and Quality
7500 Security Boulevard
Baltimore, MD 21244-1850
Phone: 410 786-5723
RIN: 0938-AK30
BILLING CODE 4150-24-S

[[Page 61198]]




DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT (HUD)



Statement of Regulatory Priorities
 The Department of Housing and Urban Development is the Federal agency 
responsible for national policy and programs that address Americans' 
housing needs, work to improve and develop the Nation's communities, 
and enforce fair housing laws. HUD's mission is to help to provide a 
decent, safe and sanitary home and suitable living environment for 
every American. HUD also plays a major role in supporting homeownership 
by underwriting homeownership for lower- and moderate-income families 
through its mortgage insurance programs.
 HUD's regulatory plan for fiscal year 2002 reflects the leadership of 
Secretary Mel Martinez, who has called upon HUD to focus on activities 
that support its core mission. By concentrating on its basic 
responsibilities of helping to provide and maintain affordable housing 
and homeownership opportunities and promote economic growth in our 
Nation's communities, HUD minimizes the number of initiatives and 
programs that are not central to its mission, that consume critical 
resources, and consequently undermine HUD's ability to administer 
programs that are key to the success of achieving its mission.
 Consistent with the Secretary's direction, the regulations highlighted 
in this regulatory plan and in the semiannual agenda of regulations, 
published elsewhere in today's Federal Register, are directed to 
implementing policies, procedures and programs that support HUD's core 
mission.
Priority: Expand Homeownership Opportunities
 Homeownership plays a vital role in creating strong communities by 
giving families a stake in their neighborhoods and helping them to 
build wealth. Although a period of sustained economic growth has helped 
to raise the overall homeownership rate to a record level, the 
homeownership rates for minorities and low-income families lag far 
behind those of other families. For example, while more than two-thirds 
of Americans own their own homes, fewer than half of African-American 
and Hispanic families are homeowners.
 While many of HUD's core programs, including the HOME Investment 
Partnerships Program, Federal Housing Administration mortgage insurance 
and the Community Development Block Grant program, help low-income 
families achieve the goal of homeownership, Secretary Martinez is 
moving forward with regulatory initiatives to create homeownership 
opportunities for low-income residents of public and assisted housing.
Regulatory Action: Implement the Section 8 Downpayment Initiative and 
Improve the Section 8 Homeownership Program
 This initiative expands the use of Section 8 vouchers for 
homeownership. Section 301 of the American Homeownership and Economic 
Opportunity Act of 2000 authorizes the public housing agency to 
provide, in lieu of paying a monthly homeownership assistance payment, 
a single downpayment assistance grant to be used toward the purchase of 
a home. The final rule to be published in fiscal year 2002 follows 
publication of a June 2001 proposed rule, and will take into 
consideration public comment received on the proposed rule.
Regulatory Action: Implement the Public Housing Homeownership Program
 This program, authorized by the Quality Housing and Work 
Responsibility Act of 1998, allows a public housing agency to make 
public housing dwelling units, public housing developments, and other 
housing developments available for purchase by low-income families as 
their principal residence. The final rule to be published in fiscal 
year 2002 follows publication of a September 1999 proposed rule, and 
will take into consideration public comment received on the proposed 
rule.
Priority: Maintaining Homeownership--Prohibiting Predatory Lending 
Practices
 Over the last several years, our Nation has made enormous progress in 
expanding access to capital for previously underserved borrowers. 
Despite this progress, however, too many families are suffering today 
because of a growing incidence of predatory lending practices in this 
segment of the mortgage lending market. Predatory lending 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 are abusive or make the borrower more 
vulnerable to abusive practices. Predatory lending threatens 
homeownership by placing on borrowers loans that are so expensive or 
have such high rates that borrowers are unable to repay and risk 
default. This significantly undercuts the Department's efforts to 
revitalize communities and expand homeownership for millions of 
Americans.
 To address predatory lending, the Department is pursuing several 
regulatory initiatives.
Regulatory Action: Prohibition of Property Flipping in HUD's Single 
Family Mortgage Insurance Programs
 This rule will prohibit ``property flipping,'' a practice whereby 
recently acquired properties are immediately resold at an artificially 
inflated value, often abetted by collusion with the appraiser. The rule 
is designed to protect FHA borrowers from becoming unwitting victims of 
property flipping. The final rule to be published in fiscal year 2002 
follows publication of a September 2001 proposed rule and ngle Family 
Loan Feestakes into consideration public comment received on the 
proposed rule.
Regulatory Action: Limitation on FHA Single Family Loan Fees
 This proposed rule would cap the total amount of expenses and fees 
that can be charged on a mortgage insured by FHA. The cap would vary 
depending on the original principal amount of the mortgage. The cap 
would not include legitimate fees paid to service providers (such as 
settlement attorneys, property inspectors, appraisers), reasonable and 
customary discount points, and prepaid expenses (including escrows for 
taxes and insurance).
Regulatory Action: Appraiser Qualifications for Placement on FHA Single 
Family Appraiser Roster
 This rule is designed to strengthen the integrity of FHA appraisals by 
requiring that appraisers have the minimum professional credentials 
required by the Appraiser Qualifications Board of the Appraisal 
Foundation. This rule helps ensure that homebuyers seeking FHA-insured 
mortgages receive accurate and complete appraisal of the homes they 
seek to purchase.
Priority: Providing and Maintaining Affordable Rental Housing
 While seeking to expand homeownership opportunities, HUD recognizes 
that homeownership may not be practical for all families. To assist 
these families obtain safe, decent and affordable housing, HUD's 
regulatory plan will strengthen its current rental assistance programs 
rather than proposing any new ones. HUD will

[[Page 61199]]

focus in particular on improving housing agencies utilization of 
assistance.
Regulatory Action: Fully Implement the Capital Fund Program
 The Capital Fund Program rule will fully implement the primary 
``bricks and mortar'' program assisting public housing. The Capital 
Fund Program addresses the capital and management improvement needs of 
public housing agencies through the use of assistance made available 
under the Capital Fund Formula. The Capital Fund Formula was 
established by a final rule published on March 16, 2000. This Capital 
Fund Program rule continues and expands the streamlining of procedures 
and requirements initiated under the Comprehensive Grant and CIAP 
(Comprehensive Improvement Assistance Program) programs, and will 
remove and replace those program regulations as well as the existing 
development program requirements. The new Capital Fund Program Rule 
will govern not only the modernization of public housing, but the 
development of replacement housing and public housing management 
improvements as well as more flexible use of funds allowed by the 
Quality Housing and Work Responsibility Act of 1998.
Regulatory Action: Implement the Final Requirements for the Operating 
Fund Formula
 This final rule will complete the rulemaking that establishes the new 
Operating Fund Formula, which began with a proposed rule developed 
through the negotiated rulemaking process. The Operating Fund Formula 
rule governs the payment of operating subsidies to public housing 
agencies. The interim rule, published on March 29, 2001, followed 
publication of a June 20, 2000 proposed rule, and took into 
consideration the public comments received on the proposed rule. The 
policies and procedures described in the interim rule will govern the 
determination of funding distributions to public housing agencies under 
the Operating Fund until a final rule, reflecting the results of a 
congressionally requested public housing cost study is developed and 
published.
Regulatory Action: Implement the Project-Based Voucher Program
 This proposed rule will begin the rulemaking process to implement the 
new Project-Based Voucher Program. The Project-Based Voucher Program 
will extensively revise the existing project-based voucher program and 
further the Department's efforts to provide affordable housing to very 
low-income families. The rule will also implement congressional intent 
to make project-basing of voucher assistance more flexible.
Regulatory Action: Improve the Public Housing Assessment System
 This proposed rule will propose changes to the Public Housing 
Assessment System (PHAS) and the regulations implementing that system. 
The PHAS, established in 1998, assesses the management performance of 
public housing agencies and resident management corporations in four 
critical areas of public housing operations: the physical condition of 
public housing; the financial condition of the public housing agency or 
resident management corporation; the management operations of the 
public housing agency or resident management corporation; and the 
satisfaction of the residents with the housing and services. The 
Department has begun meeting with public housing agencies, residents, 
representatives of these groups and other interested parties, to 
solicit input on how the PHAS can be improved and expects to put PHAS 
into effect on an interim basis shortly. The proposed rule to be issued 
will incorporate the input from these important stakeholders. 
Improvements made to the PHAS will in turn promote maintaining 
affordable rental housing.
Priority: Building Assets and Skills Among Low-Income Families
 Central to HUD's mission of promoting strong communities are 
activities to help low-income working families acquire skills that will 
increase their earnings and to help families on welfare make progress 
towards self-sufficiency. HUD also seeks to help low-income families 
accumulate assets so that they can achieve homeownership, pursue 
educational opportunities, start a new business, and attain other 
important goals.
Regulatory Action: Revisions to Resident Participation Regulation
 This rule will help promote building assets and skills among public 
housing residents. Among other changes, the proposed rule would 
establish policies, procedures, and requirements for participating in 
the Resident Opportunities and Self-Sufficiency Program. Overall, the 
rule will promote effective resident participation in public housing 
and assist in creating and maintaining a positive living environment.
Priority: Supporting Community and Economic Development
Regulatory Action: Making Brownfields Activities a CDBG-Eligible 
Activity
 This rule will improve the ability of entitlement communities and 
States' grant recipients to use Community Development Block Grant 
(CDBG) funds for brownfields activities. By making eligible under the 
CDBG Program the cleanup and development of environmentally 
contaminated properties, the Department will move toward achieving one 
of the objectives under the CDBG Program, which is eliminating slums or 
blighting conditions.
The Priority Regulations That Comprise HUD's FY 2002 Regulatory Plan
 A more detailed description of the priority regulations that comprise 
HUD's FY 2002 Regulatory Plan follows.
_______________________________________________________________________



HUD--Office of Housing (OH)

                              -----------

                          PROPOSED RULE STAGE

                              -----------




63. PROHIBITION OF PROPERTY FLIPPING IN HUD'S SINGLE FAMILY MORTGAGE 
INSURANCE PROGRAMS (FR-4615)
Priority:


Other Significant


Legal Authority:


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


CFR Citation:


24 CFR 203


Legal Deadline:


None


Abstract:


This rule addresses property ``flipping,'' the practice whereby a 
property recently acquired is resold for a considerable profit with an 
artificially inflated value, often abetted by a lender's collusion with 
the appraiser. Specifically, the proposed rule would establish certain 
new requirements regarding the eligibility of properties for FHA 
mortgage insurance. The regulatory amendments made by this rule will 
protect FHA borrowers from becoming unwitting victims of property 
flipping. Further, the proposed changes comply with congressional 
mandates to maintain the FHA Insurance Fund in a sound actuarial 
manner.

[[Page 61200]]

Statement of Need:


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 combined with loan terms that, alone or 
in combination, are abusive or make the borrower more vulnerable to 
abusive practices. A major example of predatory lending is property 
``flipping,'' the practice whereby a recently acquired property is 
resold for a considerable profit with an artificially inflated value, 
often abetted by a lender's collusion with the appraiser. Most property 
flipping occurs within a matter of days after acquisition, and usually 
with only minor cosmetic improvements, if any.


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.


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-cost mortgages.


Risks:


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


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            66 FR 46502                                    09/05/01
NPRM Comment Period End                                        11/05/01
Final Action                                                   05/00/02
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


Businesses, Organizations


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: 202 708-2121
RIN: 2502-AH57
_______________________________________________________________________



HUD--OH



64. APPRAISER QUALIFICATIONS FOR PLACEMENT ON FHA SINGLE FAMILY 
APPRAISER ROSTER (FR-4620)
Priority:


Other Significant


Legal Authority:


12 USC 1701 to 1715z-18; 42 USC 3535(d)


CFR Citation:


24 CFR 200


Legal Deadline:


None


Abstract:


This rule makes several regulatory changes designed to strengthen the 
licensing and certification requirements for placement on the Federal 
Housing Administration (FHA) Appraiser Roster. First, the rule requires 
that appraisers on the Appraiser Roster must have professional 
credentials that are based on the minimum licensing/certification 
standards issued by the Appraiser Qualifications Board of the Appraisal 
Foundation. The rule also clarifies that an appraiser may be removed 
from the Appraiser Roster if the appraiser loses his or her license or 
certification in any State due to disciplinary action, even if the 
appraiser continues to be licensed or certified in another State. 
Finally, the rule provides that an appraiser who is licensed or 
certified in a single State and whose license or certification has 
expired, or has been revoked, suspended or surrendered as a result of a 
State disciplinary action, will be automatically suspended from the 
Appraiser Roster until HUD receives evidence demonstrating renewal or 
that the State-imposed sanction has been lifted.


Statement of Need:


HUD's Appraiser Roster lists those appraisers who are eligible to 
perform FHA single family appraisals. 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 the FHA 
single family programs and to ensure that appraisers performing FHA 
appraisals meet high competency standards. The Appraiser Roster is an 
important part of the FHA Single Family Mortgage Insurance program 
because accurate appraisals are vital to the success of the program and 
HUD's ability to protect the FHA Insurance Fund. The changes made by 
this final rule are necessary to ensure that homebuyers seeking FHA-
insured mortgages receive accurate and complete appraisals of the homes 
they seek to purchase.


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. This authority includes the 
regulation of appraisers participating in the FHA single family 
mortgage insurance programs.


Alternatives:


HUD has established codified placement and removal procedures for the 
FHA Appraiser Roster. The changes made by this final rule would modify 
these requirements and, therefore, must also be promulgated through 
regulation. Furthermore, nonregulatory alternatives (such as 
promulgation through mortgagee letter) would not be binding upon 
appraisers.


Anticipated Cost and Benefits:


This rulemaking will strengthen the FHA Appraiser Roster licensing and 
certification requirements. The anticipated benefit is that the rule 
will enhance the accuracy and integrity of FHA appraisals, thereby 
reducing opportunities for fraud and predatory lending abuses conducted 
with the collusion of unscrupulous appraisers, such as property 
flipping.


Risks:


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


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           01/00/02
Final Action                                                   03/00/02

[[Page 61201]]

Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


Businesses


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: 202 708-2121
RIN: 2502-AH59
_______________________________________________________________________



HUD--OH



65.   LIMIT ON FHA SINGLE FAMILY LOAN FEES (FR-4700)
Priority:


Other Significant


Legal Authority:


12 USC 1709; 12 USC 1710; 12 USC 1715b; 12 USC 1715u; 12 USC 1715z to 
1720; 42 USC 3535(d); ...


CFR Citation:


24 CFR 203; 24 CFR 206


Legal Deadline:


None


Abstract:


This proposed rule would implement one of several new HUD initiatives 
to combat predatory lending in the Federal Housing Administration (FHA) 
single family mortgage insurance programs. The proposed rule would cap 
the total amount of charges and fees that may be charged on FHA-insured 
single family mortgages. This maximum amount would vary depending on 
the original principal amount of the mortgage. If the original 
principal amount of the mortgage is $20,000 or less, the total 
allowable charges and fees may not exceed 6 percent of the original 
principal amount or $1,000, whichever is the greater. If the original 
principal amount of the mortgage is greater than $20,000, the total 
allowable charges and fees may not exceed 5 percent of the original 
principal amount. The cap would not include legitimate fees paid to 
service providers (such as settlement attorneys, property inspectors, 
appraisers, credit reporting agencies and title insurers), reasonable 
and customary discount points, and prepaid expenses (including escrows 
for taxes and insurance).


Statement of Need:


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 combined with loan terms that, alone or 
in combination, are abusive or make the borrower more vulnerable to 
abusive practices. While no one set of abusive lending practices or 
terms characterizes a predatory mortgage loan, a loan can be predatory 
when lenders or brokers charge borrowers excessive, often hidden fees 
or make loans without regard to a borrower's ability to repay.


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.


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-cost mortgages.


Risks:


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


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           02/00/02
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


Businesses


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: 202 708-2121
RIN: 2502-AH70
_______________________________________________________________________



HUD--Office of Community Planning and Development (CPD)

                              -----------

                          PROPOSED RULE STAGE

                              -----------




66.   CDBG BROWNFIELDS/SLUM/BLIGHT (FR-4699)
Priority:


Other Significant


Legal Authority:


42 USC 3535(d); 42 USC 5301 et seq


CFR Citation:


24 CFR 570


Legal Deadline:


None


Abstract:


This rule will improve the ability of entitlement communities and 
States' grant recipients to use Community Development Block Grant 
(CDBG) funds for brownfields activities. The rule will clarify the 
eligibility of activities involving the cleanup and development of 
environmentally contaminated properties under section 105(a) of the 
Housing and Community Development Act of 1974, as amended. The rule 
also will increase CDBG recipients' flexibility to undertake activities 
meeting the national objective of preventing or eliminating slums or 
blighting conditions. The criteria for meeting the slum/blight national 
objective will be revised to specifically recognize economic 
obsolescence of buildings and the presence of environmental 
contaminants as blighting influences on an area or property. This rule 
will further clarify the list of activities that may be undertaken to 
address the slum/blight national objective criteria on a spot basis. 
Finally, this rule makes corresponding changes in the eligibility 
regulations governing the Section 108 Loan Guarantee component of the 
CDBG program.

[[Page 61202]]

Statement of Need:


Current CDBG regulations concerning the slum/blight national objective 
only recognize the presence of physically deteriorated buildings or 
public improvements as blighting influences on an area or property. 
Professional practice and thinking in the community development field 
is evolving toward a more encompassing view of the factors that 
influence urban decay. Failure to update and streamline CDBG program 
rules would hinder grantees' efforts to redevelop underutilized 
properties and improve physical conditions in neighborhoods. In the FY 
1999 HUD Appropriations Act (Public Law 105-276), Congress included 
language clarifying the eligibility of activities to clean up and 
develop environmentally contaminated properties; this rule will revise 
the eligible activities discussion in the CDBG regulations to reflect 
this statutory language. In addition, the rule will respond to a HUD 
OIG audit recommendation by adding clarifying language regarding 
activities that may be undertaken to address the slum/blight national 
objective on a spot basis.


Summary of Legal Basis:


Under 42 U.S.C. 3535(d), the Department may make such rules and 
regulations as may be necessary to carry out its functions, powers, and 
duties. The Department's regulations governing the Community 
Development Block Grant program are found at 24 CFR part 570, and are 
promulgated pursuant to the statutory authority to administer the 
program vested by the Housing and Community Development Act of 1974, as 
amended (42 U.S.C. 5301 et seq.).


Alternatives:


The Department has considered a number of options regarding the 
regulatory approach to take in issuing this rule; the Department has 
commissioned a number of independent studies on the use of CDBG funds 
to remediate and develop brownfields, and has consulted with 
practitioners in the community development and brownfields professional 
fields. In 1994, the Department sought comment from the public on how 
to proceed with such a rule. The Department plans to pursue a rule that 
provides as much flexibility as possible to grantees in determining 
what types of remediation/development activities may be undertaken. The 
Department has also considered the ``no rule'' option; however, 
grantees and other interested parties continue to voice support for 
issuance of such a rule.


Anticipated Cost and Benefits:


Costs: None. The rule simply adds flexibility to grantees in their 
choice of activities with which to assist with CDBG funding; no 
additional cost or burden is imposed on grantees that choose to take 
advantage of this flexibility.


Benefits: Grantees will gain the flexibility to use CDBG funds to 
assist in redeveloping a larger universe of properties whose conditions 
negatively influence the condition of the surrounding area.


Risks:


This rule poses no threat to public safety, health or the environment. 
Any cleanup of contaminated sites will be governed by existing Federal 
and State standards for environmental remediation.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           12/00/01
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


State, Local


Agency Contact:
Steve Johnson
Director, State and Small Cities Division
Department of Housing and Urban Development
Office of Community Planning and Development
Phone: 202 708-1322
RIN: 2506-AC12
_______________________________________________________________________



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

                              -----------

                          PROPOSED RULE STAGE

                              -----------




67. PUBLIC HOUSING CAPITAL FUND PROGRAM (FR-4507)
Priority:


Other Significant


Legal Authority:


42 USC 1437g; 42 USC 3535(d)


CFR Citation:


24 CFR 905


Legal Deadline:


None


Abstract:


This rule will implement the new Capital Fund Program for the capital 
and management improvement needs of public housing agencies. The rule 
will complement the 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 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).


Alternatives:


The QHWRA required a formula system to be established through 
negotiated rulemaking to govern funding of PHAs' public housing capital 
needs. Guidance for administration of these funds necessitates a 
permanent legal framework rather than informal and sporadic HUD 
notices.

[[Page 61203]]

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                                                           12/00/01
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


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-AC16
_______________________________________________________________________



HUD--PIH



68. PROJECT-BASED VOUCHER PROGRAM (FR-4636)
Priority:


Other Significant


Legal Authority:


42 USC 1437f; 42 USC 3535(d)


CFR Citation:


24 CFR 983


Legal Deadline:


None


Abstract:


The rule will implement the new Section 8 project-based voucher 
program. It is based on comprehensive legislation that Congress passed 
along with HUD's FY 2001 appropriation. Among the many changes made by 
the law, the rule will cover requirements on: competition, consistency 
of the PHA plan and deconcentration efforts, definition of supportive 
services, and HQS inspections.


Statement of Need:


This rule proposes an extensive revision of the Section 8 project-based 
assistance program to eliminate the differences between the current 
project-based assistance regulations and the new law (Pub.L. 106-377) 
which implements the new Section 8 project-based assistance voucher 
program. Additionally, this rule will implement Congress' intent to 
make Section 8 project-basing of voucher assistance more flexible and 
further the Department's efforts to provide affordable housing for 
very-low-income families.


Summary of Legal Basis:


Section 232 of the FY 2001 Departments of Veterans Affairs and Housing 
and Urban Development and Independent Agencies Appropriations Act 
(Pub.L. 106-377) substantially revised the provisions of the U.S. 
Housing Act of 1937 that govern the authority of a public housing 
agency to designate a portion of its available tenant-based voucher 
funds for project-based assistance.


Alternatives:


None.


Anticipated Cost and Benefits:


This rule will have the benefit of increasing the number of affordable 
housing units for very low-income families. Increasing the flexibility 
of the project-based requirements will make the project-based voucher 
program more flexible and more workable. Because the revised regulation 
would be a refinement or improvement of existing procedures, and should 
result in no additional, or a decrease in, monitoring or reporting 
burdens, additional costs to PHAs and to HUD are negligible.


Risks:


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


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           12/00/01
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


State, Local


Agency Contact:
Gerald J. Benoit
Director, Real Estate and Housing Performance Division
Department of Housing and Urban Development
Office of Public and Indian Housing
Phone: 202 708-0477
RIN: 2577-AC25
_______________________________________________________________________



HUD--PIH



69. RESIDENT PARTICIPATION IN PUBLIC AND SECTION 8 HOUSING (FR-4657)
Priority:


Other Significant


Legal Authority:


42 USC 1437c-1; 42 USC 1437r; 42 USC 1437t; 42 USC 1437z-6; 42 USC 
3535(d); 42 USC 1437d; 42 USC 1437g; 42 USC 1437l;; 12 USC 1715z-1b(a)


CFR Citation:


24 CFR 964


Legal Deadline:


None


Abstract:


This rule would update existing provisions of 24 CFR 964 and 
incorporate new provisions of the Quality Housing and Work 
Responsibility Act of 1998 related to resident/tenant participation. In 
particular, the rule would establish policies, procedures, and 
requirements for participating in the Resident Opportunities and Self-
Sufficiency (ROSS) Program. Additionally, the proposed rule contains 
expanded definitions and other general information sections as part of 
HUD's long-standing efforts to support resident organizations and 
resident self-sufficiency.


Statement of Need:


Various sections of QHWRA provide statutory authority for permanent 
programs. These regulations will provide appropriate notice of the 
legal framework for these programs, and clear and uniform instructions 
and procedures for implementation.


Summary of Legal Basis:


Various sections of QHWRA provide statutory authority for permanent 
programs. These regulations will provide appropriate notice of the 
legal

[[Page 61204]]

framework for these programs, and clear and uniform instructions and 
procedures for implementation.


Alternatives:


The programs authorized under QHWRA need a long-term legal framework. 
Therefore regulations are required as an alternative to short-term 
program notices or notices of funding availability (NOFAs).


Anticipated Cost and Benefits:


The establishment of regulations will bring certainty to the resident 
related programs authorized by QHWRA, to confirm their permanency. The 
regulations when issued will provide the legal basis for these resident 
related programs. The certainty to be provided through issuance of 
regulations should reduce costs by providing longer-term participation 
and planning on the part of program participants.


Risks:


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


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           12/00/01
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


Organizations


Government Levels Affected:


None


Agency Contact:
Jeraldene White
Senior Program Manager
Department of Housing and Urban Development
Office of Public and Indian Housing
Phone: 202 708-4214
RIN: 2577-AC26
_______________________________________________________________________



HUD--PIH



70.   AMENDED PUBLIC HOUSING ASSESSMENT SYSTEM (PHAS) RULE (FR-
4707)
Priority:


Other Significant


Legal Authority:


42 USC 1437d(j); 42 USC 3535(d)


CFR Citation:


24 CFR 902


Legal Deadline:


None


Abstract:


Through this rule, the Department will be revising the regulations that 
govern the Public Housing Assessment System (PHAS). This rule will 
incorporate the input of public housing stakeholders groups in the 
public housing assessment process.


Statement of Need:


Per the directive of the Secretary of HUD, the Department has agreed to 
consider changes to the current PHAS rule based on consultation with 
public housing stakeholders including industry representatives, 
resident groups and other interested Federal and congressionally 
chartered agencies. As most PHAS Indicators have been in an advisory 
status since its inception, the Department believes that the entire 
PHAS system needs to be reevaluated and modified.


Summary of Legal Basis:


The Secretary of HUD is directed under section 6(j) of the United 
States Housing Act of 1937 (42 U.S.C. 1437 et seq.) to develop and 
publish in the Federal Register indicators to assess the management 
performance of public housing agencies and resident management 
corporations. Such indicators shall enable the Secretary to evaluate 
the performance of public housing agencies and resident management 
corporations in all major areas of management operations.


Alternatives:


An interim rule is an alternative currently under consideration. 
However, the intent of the interim rule is to provide the Department 
with a fully implemented assessment system while the amended PHAS rule 
is being rewritten. Other alternatives that have been considered, such 
as utilizing the Management Indicator (MASS) only, fails to meet the 
Department's strategic goal of ensuring that public housing agencies 
provide decent, safe and sanitary housing.


Anticipated Cost and Benefits:


This rule will have the benefit of promoting the success of PHAS by 
ensuring the buy-in of public housing stakeholder groups in the public 
housing assessment process. The new rule will soon be in the 
development phase; therefore, accurate cost estimates cannot be 
provided at this time.


Risks:


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


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           03/00/02
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


None


Agency Contact:
Wanda Funk
Real Estate Assessment Center
Department of Housing and Urban Development
Office of Housing
Phone: 202 708-4932

Judy Wojciechowski
Director, PHAS Operations, Office of Troubled Agency Recovery
Department of Housing and Urban Development
Office of Public and Indian Housing
Phone: 202 708-4932
RIN: 2577-AC32
_______________________________________________________________________



HUD--PIH

                              -----------

                            FINAL RULE STAGE

                              -----------




71. OPERATING FUND ALLOCATION FORMULA (FR-4425)
Priority:


Other Significant


Legal Authority:


42 USC 1437g; 42 USC 3535(d)


CFR Citation:


24 CFR 990


Legal Deadline:


None


Abstract:


This final rule will follow publication of a March 29, 2001 interim 
rule that governs the determination of funding distribution to public 
housing agencies under the Operating Fund and will reflect the results 
of a Congressionally mandated cost study. The Conference Report to 
HUD's FY 2000 Appropriations Act (Pub.L. 106-74, approved October 20, 
1999) directs HUD to contract with the Harvard University Graduate 
School of Design to conduct a study of the cost incurred

[[Page 61205]]

in operating well-fund public housing and provides the results to the 
negotiated rulemaking committee and the appropriate congressional 
committees). As portions of the study are completed, HUD is meeting 
with representatives of the negotiated rulemaking committee that helped 
HUD develop the Operating Fund proposed rule, as well as other 
interested parties. These meetings have also been open to the public. 
HUD will develop the final rule based on the results of the cost study, 
the comments on the interim rule and further input from the members of 
the Operating Fund proposed rule negotiating committee and other 
interested members of the public.


Statement of Need:


Section 519 of the Quality Housing and Work Responsibility Act requires 
HUD to develop this rule to govern funding of PHAs' operating and 
management needs.


Summary of Legal Basis:


Section 519 of the Quality Housing and Work Responsibility Act amending 
section 9 of the U.S. Housing Act of 1937, codified at 42 USC 1437g.


Alternatives:


The Quality Housing and Work Responsibility Act of 1998 requires that 
this new formula system be developed through negotiated rulemaking.


Anticipated Cost and Benefits:


The costs of the program as administered with one fund from which a PHA 
will fund all of its operating and management needs will be the same as 
under existing provisions. The benefits of having this new formula 
system developed through negotiated rulemaking is that it allows those 
entities and individuals directly affected -- public housing agencies 
and their residents -- to have a say in how the formula will operate, 
and consequently to help foster constructive, creative and acceptable 
solutions to difficult problems.


Risks:


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


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
Notice          64 FR 5570                                     02/03/99
Notice Comment Period End                                      03/05/99
NPRM            65 FR 42488                                    07/10/00
NPRM Comment Period End                                        08/09/00
Interim Final Ru66 FR 17276                                    03/29/01
Interim Final Rule Effective                                   04/30/01
Interim Final Rule Comment Period End                          05/29/01
Final Action                                                   08/00/02
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


None


Agency Contact:
Stephen Sprague
Funding and Financial Management Division, Office of Public and 
Assisted Housing Delivery
Department of Housing and Urban Development
Office of Public and Indian Housing
Phone: 202 708-1872
RIN: 2577-AB88
_______________________________________________________________________



HUD--PIH



72. PUBLIC HOUSING HOMEOWNERSHIP PROGRAMS (FR-4504)
Priority:


Other Significant


Legal Authority:


42 USC 1437z-4; 42 USC 3535(d)


CFR Citation:


24 CFR 906


Legal Deadline:


None


Abstract:


This rule will set forth the requirements and procedures governing a 
new statutory homeownership program to be administered by public 
housing agencies. Under this rule, a PHA makes public housing dwelling 
units available for purchase by low-income families as their principal 
residences.


Statement of Need:


This rulemaking is needed to implement the public housing homeownership 
program authorized by section 32 of the U.S. Housing Act of 1937.


Summary of Legal Basis:


Section 536 of the Quality Housing and Work Responsibility Act of 1998 
(QHWRA) amended title I of the U.S. Housing Act of 1937 (42 U.S.C. 1437 
et seq.) by adding a new section 32, which authorized a new public 
housing homeownership program to replace the program formerly 
authorized under section 5(h) of the 1937 Act.


Alternatives:


There are no alternatives to rulemaking in order to implement the 
program.


Anticipated Cost and Benefits:


The rule provides the parameters for the use of public housing 
properties to create homeownership opportunities for low-income 
residents of public housing and other low-income families should a 
public housing agency choose to do so. The rule's major effect is on 
individuals; any incidental effect on other entities would be limited 
to their cooperative efforts in promoting homeownership among public 
housing residents and other low-income families.


Risks:


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


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            64 FR 49932                                    09/14/99
NPRM Comment Period End                                        11/15/99
Final Action                                                   12/00/01
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


None


Agency Contact:
David Sowell
Director, Office of Public Housing Partnerships
Department of Housing and Urban Development
Office of Public and Indian Housing
Phone: 202 401-8812
RIN: 2577-AC15

[[Page 61206]]

_______________________________________________________________________



HUD--PIH



73.   SECTION 8 DOWNPAYMENT INITIATIVE (FR-4670)
Priority:


Other Significant


Legal Authority:


42 USC 1437f; 42 USC 3535(d)


CFR Citation:


24 CFR 982


Legal Deadline:


None


Abstract:


Section 301 of the American Homeownership and Economic Assistance Act 
of 2000 authorizes an alternative form of assistance under the Section 
8 homeownership option by providing for assistance in the form of a 
single downpayment assistance grant. Under section 301, a public 
housing agency (PHA) may, in lieu of paying a monthly homeownership 
assistance payment on behalf of a family, provide homeownership 
assistance for the family in the form of a single grant to be used 
toward the downpayment required in connection with the purchase of the 
home.


Statement of Need:


This rulemaking is needed to implement section 301 and complete the 
Section 8 Homeownership Program regulation at 24 CFR part 982, which 
currently only provides for monthly homeownership assistance payments.


Summary of Legal Basis:


Under 42 U.S.C. 3535(d), the Department may make such rules and 
regulations as may be necessary to carry out its functions, powers, and 
duties. Section 301 of the American Homeownership and Economic 
Assistance Act of 2000 (Public Law 106-569, 114 Stat. 2944, 2952, 
approved December 27, 2000) amends the ``homeownership option'' under 
section 8(y) of the United States Housing Act of 1937 (42 U.S.C. 
1437f(y)) to permit downpayment assistance and provides specific 
authority for this rule.


Alternatives:


This additional statutory authority expands the use of Section 8 
assistance for homeownership and compliments an existing rule which 
must be amended to address the new form of assistance made available.


Anticipated Cost and Benefits:


This rule adds a new eligible use of Housing Choice Vouchers as 
authorized by statute. A PHA may choose whether or not to make 
assistance available for this new use, and local conditions on the 
relative benefits of eligible uses will influence its determination to 
make such assistance available, thereby maximizing the benefit.


Risks:


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


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            66 FR 32198                                    06/13/01
NPRM Comment Period End                                        08/13/01
Final Action                                                   12/00/01
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


State, Local


Agency Contact:
Gerald J. Benoit
Director, Real Estate and Housing Performance Division
Department of Housing and Urban Development
Office of Public and Indian Housing
Phone: 202 708-0477
RIN: 2577-AC28
BILLING CODE 4210-01-S

[[Page 61207]]




DEPARTMENT OF THE INTERIOR (DOI)



Statement of Regulatory Priorities
 The Department of the Interior (DOI) is the principal Federal steward 
of our Nation's public lands and resources, including many of our 
cultural treasures. We serve as trustee to Native Americans and Alaska 
natives and also are responsible for relations with the island 
territories under United States jurisdiction. We manage more than 450 
million acres of Federal lands, including 384 park units, 537 wildlife 
refuges, and 24,000 miles of trails, and approximately 1.7 billion 
acres in submerged waters in offshore waters. The Department recovers 
endangered species, manages water projects, fights wildland fires, 
leases coal, oil and gas to meet the Nation's energy needs, educates 
children in Indian schools and provides recreational opportunities for 
almost 300 million visitors annually in our national parks.
In carrying out these responsibilities, the Department:
 Manages natural resources on public lands, including energy 
            and mineral resources, water and grazing lands;
 Provides recreation opportunities;
 Protects the environment and preserves our Nation's natural 
            and cultural resources;
 Meets our trust responsibilities to Indian tribes and our 
            commitments to the people of the U.S. territories; and
 Provides science relating to land and resource management.
 The Department is committed to achieving its stewardship objectives in 
partnership with States, communities, and others through consultation, 
cooperation, and communication.
 We will review and update the Department's regulations and policies to 
ensure that they are effective, efficient, and promote accountability. 
Special emphasis will be given to regulations and policies that:
 Adopt performance-based approaches focusing on achieving 
            results in the most cost-effective and timely manner;
 Incorporate the best available science, including peer review 
            wherever appropriate;
 Promote partnerships with States and other groups and 
            individuals;
 Provide incentives for private landowners to achieve 
            conservation goals; and
 Minimize regulatory and procedural burdens, promoting fairness 
            and accountability by agency regulators while maintaining 
            performance goals.
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 56
 Within the requirements and guidance in Executive Orders 12866, 
12630, and 13132, 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, non-Federal government agencies, and public entities to make 
our regulations easier to comply with and understand. Because 
regulatory improvement is a continuing process that requires the 
participation of all affected parties, we strive continually to include 
all affected entities in the decisionmaking 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; and
 Issuance of new guidance in the Departmental Manual to ensure 
            the use of plain language in Government writing.
 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.
Encouraging Responsible Management of the Nation's Resources56
 The Department's mission includes protecting and providing 
access to our Nation's natural and cultural heritage and honoring our 
trust responsibilities to tribes. We are committed to this mission and 
to applying laws and regulations fairly and effectively. The 
Department's priorities include protecting public health and safety, 
restoring and maintaining public lands, solving land and resource-
management problems on public lands, and ensuring accountability and 
compliance with Federal laws and regulations.

[[Page 61208]]

 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 endangered or threatened 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 more involvement by landowners in 
species protection, fewer fines, no ``surprises'' (in the form of 
unexpected fines) for conforming landowners, better overall protection 
of species, and better compliance with the Endangered Species Act.
Minimizing Regulatory Burdens56
 We are using the regulatory process to ease the burdens on 
various entities throughout the country while improving results. 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 to improve 
compliance and achievement of regulatory goals. 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 Process56
 Encouraging increased public participation in the regulatory 
process to improve results by ensuring that regulatory policies take 
into account the knowledge and ideas of our customers, regulated 
community, and other interested participants. 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, opportunities 
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 land 
management plans 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 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 Future of DOI
 Interior plans to develop a single Departmentwide strategic plan 
during FY 2002 in response to congressional, OMB, and other appraisals 
indicating that Interior's ten separate strategic planning documents 
are too long and lack the appropriate agency-level focus. Interior also 
intends to use the single Strategic Plan as the basis for preparing a 
single Departmentwide Annual Performance Plan beginning with the plan 
for FY 2004. The Interior bureaus will continue to prepare internal 
plans to support their budget initiatives and to meet management 
excellence and accountability needs. However, in the future we plan to 
submit only Departmentwide strategic and annual plans to the Congress. 
Finally, the process of developing a single strategic plan also will 
provide the Secretary with an opportunity to:
 Set an agenda for Interior that reflects the Administration's 
            and the Secretary's priorities,
 Consult with key interested constituents on the future 
            direction of the Department, and
 Make Interior programs more ``results-oriented'' and 
            accountable to citizens.
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, Natural Resource Damage Assessment and 
Restoration Program56
 The regulatory functions of the Natural Resource Damage 
Assessment and Restoration Program (Restoration Program) 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. The Restoration Program 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 rule in compliance with section 301(c)(3).
 In undertaking DOI's responsibilities under section 301(c), the 
Restoration Program is striving to meet three regulatory objectives: 
(a) make the regulation user friendly through the use of plain language 
so that the assessment and restoration process can be followed by all 
interested parties; (b) move towards a restoration bases approach for 
determining compensation rather than monetizing economic damages, and 
(c) follow a process that is based on facilitating negotiated 
settlements rather than litigation over natural resource damages.
Bureau of Indian Affairs 56
 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

[[Page 61209]]

standards and procedures. The goals of BIA regulatory policies are to: 
(a) ensure consistent policies within BIA that result in uniform 
interactions 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 Management56
 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 purposes 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 while maintaining 
            the long-term health and diversity of the land and while 
            preserving 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, whether or not they need to be updated to 
            reflect statutory and policy changes, and whether they are 
            achieving desired results.
Minerals Management Service56
 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.
 Our regulatory philosophy is to develop clear, enforceable rules that 
support the missions of each program. For the Offshore Minerals 
Management program, as authorized by the Deep Water Royalty Relief Act 
(DWRRA) (P.L. 104-58), we plan to issue a final regulation to revise 
current regulations at 30 CFR 203. The revised rule would provide 
detailed instructions on how deep water leases issued before the DWRRA 
may apply and qualify for royalty-suspension on a case-by-case basis. 
We plan to revise and extend these instructions to certain additional 
categories of OCS leases, especially those issued after 2000. We will 
also continue to review rules and issue amendments in response to new 
technology and new industry practices.
 We also plan to continue our review of existing regulations and to 
issue rules to refine the Minerals Revenue Management (MRM) regulations 
in chapter II of 30 CFR. MRM is in the process of issuing regulations 
to: (1) revise its oil valuation regulations for Indian leases; and (2) 
codify provisions in the Federal Oil and Gas Royalty Simplification and 
Fairness Act of 1996; and (3) implement new financial and compliance 
procedures resulting from a major reengineering initiative.
Office of Surface Mining Reclamation and Enforcement 56
 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.
 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

[[Page 61210]]

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, 
consistent regulatory, results-focused 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 mission of the U.S. Fish and Wildlife Service is working with 
others to conserve, protect, and enhance fish, wildlife, and plants and 
their habitats for the continuing benefit of the American people. Four 
principal mission goals include:
 The sustainability of fish and wildlife populations. We 
            conserve, protect, restore, and enhance fish, wildlife, and 
            plant populations entrusted to our care. We carry out this 
            mission goal through migratory bird conservation at home 
            and abroad; native fisheries restoration; recovery and 
            protection of threatened and endangered species; prevention 
            and control of invasive species; and work with our 
            international partners.
 Habitat conservation -- a network of lands and waters. 
            Cooperating with others, we strive to conserve an 
            ecologically diverse network of lands and waters -- of 
            various ownerships -- providing habitats for fish, 
            wildlife, and plant resources. This mission goal emphasizes 
            two kinds of strategic actions: (1) the development of 
            formal agreements and plans with our partners who provide 
            habitat for multiple species, and (2) the actual 
            conservation work necessary to protect, restore, and 
            enhance those habitats vital to fish and wildlife 
            populations. Our habitat conservation strategy uses an 
            ecosystem approach to focus on the interaction and balance 
            of people, lands, and waters, and fish and wildlife.
 Public use and enjoyment. We provide opportunities to the 
            public to enjoy, understand, and participate in the use and 
            conservation of fish and wildlife resources. The Service 
            directs activities on national wildlife refuges and 
            national fish hatcheries that increase opportunities for 
            public involvement with fish and wildlife resources. Such 
            opportunities include hunting, fishing, wildlife 
            observation and photography, and environmental education 
            and interpretation, as well as affording the public hands-
            on experiences through volunteer conservation activities on 
            Service lands.
 Partnerships in natural resources. We support and strengthen 
            partnerships with tribal, State, and local governments and 
            others in their efforts to conserve and enjoy fish, 
            wildlife, and plants and habitats. We administer Federal 
            grants to States and territories for restoration of fish 
            and wildlife resources and have a continuing commitment to 
            work with tribal governments. We also promote partnerships 
            with other Federal agencies where common goals can be 
            developed.
 The Service carries out these mission goals through several types of 
regulations and programs. The Service works continually with foreign 
and State governments, affected industries and individuals, and other 
interested parties to minimize any burdens associated with Service-
related activities. We attempt to ensure a balance between any possible 
public burdens and adequate protection for the natural resource.
 We implement and enforce regulations that govern public access, use 
and recreation on more than 500 national wildlife refuges and in 
national fish hatcheries. We authorize those uses that 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, recreational, and conservation opportunities.
 We administer regulations to manage migratory bird resources. 
Annually, the Service issues a regulation on migratory bird hunting 
seasons and bag limits that is developed in partnership with the 
States, tribal governments, and the Canadian Wildlife Service. These 
regulations are necessary to permit migratory bird hunting that would 
otherwise be prohibited by various international treaties.
 The Service enforces regulations to fulfill our statutory obligation 
to identify and conserve species faced with extinction. The Endangered 
Species Act (ESA) dictates that the basis for determining endangered 
species is limited to biological considerations. Regulations enhance 
the conservation of listed species and certain marine mammals. 
Regulations also help other Federal agencies comply with the ESA, which 
prohibits them from conducting 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 if the benefits of exclusion 
outweigh the benefits of inclusion, provided that such exclusion will 
not result in the extinction of the species.
 Some Service regulations permit activities otherwise prohibited by 
law. These regulations allow possession, sale or trade, scientific 
research, and educational activities involving fish and wildlife and 
their parts or products. In general, these regulations supplement State 
regulations and cover activities that involve interstate or foreign 
commerce. In carrying out our assistance programs, we administer 
regulations to help interested parties obtain Federal assistance and 
also to help assistance recipients comply with applicable laws and 
Federal requirements.
National Park Service56
 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 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 384 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

[[Page 61211]]

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 degradation 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 56
 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, efficiently, and with an emphasis 
on cooperative problem-solving.
_______________________________________________________________________



DOI--Minerals Management Service (MMS)

                              -----------

                            FINAL RULE STAGE

                              -----------




74. VALUATION OF OIL FROM INDIAN LEASES
Priority:


Other Significant


Legal Authority:


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

[[Page 61212]]

NPRM Comment Per63 FR 17349d                                   04/09/98
NPRM Comment Period End                                        05/13/98
Supplementary NP65 FR 403                                      01/05/00
NPRM Comment Per65 FR 10436d                                   02/28/00
Final Action                                                   01/00/02
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses, Governmental Jurisdictions


Government Levels Affected:


Tribal


Agency Contact:
Carol Shelby
Regulatory Specialist
Department of the Interior
Minerals Management Service
MS 320B2
P.O. Box 25165
Denver, CO 80225-0165
Phone: 303 231-3151
Fax: 303 231-3385
Email: [email protected]
RIN: 1010-AC24
_______________________________________________________________________



DOI--MMS



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


Other Significant


Legal Authority:


30 USC 1001 et seq; 30 USC 1701 et seq; 30 USC 181 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            65 FR 69259                                    11/16/00
Comment Period E65 FR 78431                                    12/15/00
Final Action    Determined                                        To Be
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,
Phone: 703 787-1536
Fax: 703 787-1141
Email: [email protected]
RIN: 1010-AC71

[[Page 61213]]

_______________________________________________________________________



DOI--Bureau of Land Management (BLM)

                              -----------

                            FINAL RULE STAGE

                              -----------




76. OIL AND GAS LEASING AND OPERATIONS
Priority:


Other Significant


Legal Authority:


30 USC 181 et seq


CFR Citation:


43 CFR 3100 to 3180


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 Per64 FR 29256                                    07/19/99
Final Action    Determined                                        To Be
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 N.W.
Washington, DC 20240
Phone: 202 452-5049
Email: [email protected]
RIN: 1004-AC94
BILLING CODE 4310-RK-S

[[Page 61214]]




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. In 
addition, the Department is currently engaged in a comprehensive effort 
to focus its resources on the prevention of future terrorist acts and 
the prosecution of terrorists responsible for past attacks. 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 review efforts to 
ensure that all of its regulations are consistent with the 
Administration's regulatory principles.
 Pursuant to section 4(c) of Executive Order 12866, the Department of 
Justice provides the following statement of regulatory priorities, 
focusing in particular on four 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. The Drug Enforcement Administration (DEA) is 
responsible for controlling abuse of narcotics and dangerous drugs, 
while ensuring adequate supplies for legitimate medical purposes, by 
regulating 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 a project to propose regulations to 
provide an electronic alternative to the present paper-based system of 
distributing and dispensing Schedule II, III, IV, and V controlled 
substances. These rulemakings will permit DEA registrants to transmit 
controlled substances orders and prescriptions electronically using 
digital signature technology. These rulemakings will permit many DEA 
registrants to conduct business electronically, while maintaining 
appropriate security within the closed system of distribution of 
controlled substances mandated by the Controlled Substances Act of 
1970.
 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.
 Several proposed changes in the National Instant Criminal Background 
Check System regulations are being considered by the Department. The 
changes include: (1) requiring the FBI to destroy information about 
approved firearm transfers before the beginning of the next business 
day following the approval; (2) allowing the FBI to retain for up to 90 
days by individual gun dealer information about dates of NICS checks 
and the NICS transaction numbers on approved firearm transfers for the 
purpose of sharing such information with the ATF for use in inspections 
of gun dealers; (3) creating a new definition of ``unresolved'' 
transaction, i.e., transactions in which the NICS is unable to resolve 
within 3 business days whether a record identified by a NICS check 
demonstrates that a prospective gun purchaser is disqualified, and 
allowing the FBI to retain for up to 90 days information about 
unresolved transactions so that steps can be taken to retrieve a 
firearm from a prohibited person if information demonstrating that a 
person is prohibited is received within the 90-day time period; (4) 
requiring state Points of Contact (POCs) that conduct NICS checks for 
the system to provide to the FBI information about whether the POC 
determined that the gun transfer may proceed, is denied, or that the 
check is unresolved; and (5) allow a lawful firearm purchaser to 
consent to the FBI retaining personal information in a voluntary 
appeals file to avoid confusion or delay in future purchases.

[[Page 61215]]

Civil Rights
 The Department and its Civil Rights Division are deeply committed to 
the rigorous enforcement of this Nation's civil rights laws. In keeping 
with that commitment, the Division will review and update its 
regulations implementing the Americans with Disabilities Act of 1990 
(ADA), as well as issue a rule pertaining to the Department's authority 
to review police departments for a pattern or practice of unlawful 
conduct under the Violent Crime Control and Law Enforcement Act of 
1994.
 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 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.
 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).
 Pursuant to the Violent Crime Control and Law Enforcement Act of 1994, 
42 U.S.C. section 14141 (``section 14141''), the Attorney General is 
authorized to file lawsuits seeking court orders to reform police 
departments engaging in a pattern or practice of conduct that deprives 
persons of rights, privileges, or immunities secured by the 
Constitution or laws of the United States. To date, the Department of 
Justice has conducted reviews of police departments pursuant to section 
14141 using informal procedures. The Department plans to issue a rule 
to formalize the procedures by which the Department reviews police 
departments for a pattern or practice of unlawful conduct.
Immigration
 The Immigration and Naturalization Service (INS) will advance the 
President's objectives with regulatory initiatives that minimize 
regulatory burdens on the public and increase the efficiency of Agency 
operations. INS administers regulations governing the admission of 
legal immigrants and temporary visitors, apprehension and deportation 
of illegal aliens, alien employment authorization and verification, and 
asylum and naturalization.
 During the next 12 months, under new direction by Commissioner James 
W. Ziglar, INS will implement rulemaking for:
 Implementing the new Public Law 107-56, Uniting and 
            Strengthening America by Providing Appropriate Tools 
            Required to Intercept and Obstruct Terrorism Act, which 
            amends provisions of the Immigration and Nationality Act 
            concerning the detention and removal of aliens who engage 
            in terrorist activities.
 Strengthening INS law enforcement authority by extending the 
            time period for which aliens who are arrested for 
            immigration violations can be held in detention facilities.
 Restructuring of the INS to modernize existing systems, to 
            streamline procedures to provide for more efficiency in 
            service delivery, and to provide better customer service to 
            the public.
 Eliminating the immigration benefit application backlog and 
            obtaining a 6-month processing standard for all 
            applications.
 Building and maintaining an immigration services system that 
            provides immigration information and benefits in a timely, 
            accurate, consistent, courteous, and professional manner.
 Reviewing policies related to detention of children and asylum 
            seekers to ensure that INS only detains individuals who 
            absolutely require detention and determining alternatives 
            to detention where alternatives would be more appropriate.
 The Victims of Trafficking and Violence Protection Act of 2000 
            and the LIFE Act.
 Streamlining the immigration process faced by foreign health 
            care workers especially to relieve the significant nursing 
            shortage in many rural parts of the United States and 
            examining whether current INS regulations prevent much 
            needed physicians from settling in medically under-served 
            areas.
 INS has recently issued regulations to carry out recent legislation 
such as the Legal Immigration Family Equity Act of 2000 (LIFE Act). To 
implement the Victims of Trafficking and Violence Protection Act of 
2000, INS will issue an interim final rulemaking to implement the new 
``T'' nonimmigrant visa for victims of severe forms of trafficking. 
This final rule also provides both immigrant and nonimmigrant visa 
categories, the new grounds of inadmissibility and corresponding waiver 
requirements, and is one of two key regulatory priorities of the INS.
 The INS will soon publish a proposed rule to implement the provisions 
of the American Competitiveness and Workforce Improvement Act of 1998 
(ACWIA) and the American Competitiveness in the Twenty-first Century 
Act of 2000 (AC21) to reflect changes made to the H-1B nonimmigrant 
classification. These changes include an increase in the number of 
visas available annually, an increase in the fee for certain petitions, 
a new portability provision allowing H-1B non-immigrants to commence 
employment with a new H-1B employer prior to approval of a subsequent 
petition by the Service, and improvements which will help the Service 
deter fraud in the H-1B nonimmigrant classification.

[[Page 61216]]

 In addition, over the past year, INS has promulgated critical interim 
final rulemakings to implement the LIFE Act, which are included in the 
fall 2001 Unified Agenda of Federal Regulatory and Deregulatory 
Actions. For instance, INS prepared rulemaking for LIFE Act benefits 
that provide:
 For adjustment of status under section 245(i) of the 
            Immigration and Nationality Act that allows certain persons 
            who have an immigrant visa available but entered without 
            inspection or otherwise violated their status (and thus are 
            ineligible to apply for adjustment of status in the U.S.) 
            to apply if they pay a $1,000 penalty (Interim rule, 66 FR 
            16383, March 26, 2001).
 A new status, temporary ``V'' non-immigrant classification, 
            pending rule publication, which will be available to the 
            spouses and minor children of lawful permanent residents 
            waiting more than 3 years for an immigrant visa based upon 
            an immigrant petition filed on or before the enactment date 
            of the LIFE Act. Persons granted ``V'' status would receive 
            employment authorization and are protected from removal.
 The expansion of a new temporary ``K'' visa non-immigrant 
            classification available to include spouses of U.S. 
            citizens (and their children) living abroad. Previously the 
            K visa was only available to fiances of U.S. citizens who 
            were coming to the United States to get married within 90 
            days of arrival. (Interim rule, 66 FR 42587, August 14, 
            2001).
 Adjustment of status for class membership in one of three 
            ``late amnesty'' lawsuits (CSS v. Meese, LULAC v. INS, and 
            Zambrano v. INS). They are eligible to apply for adjustment 
            of status during a 12-month period that began on July 1, 
            2001. The family unity provision allows spouses and 
            unmarried children of the class action claimants will be 
            protected from certain categories of removal and will be 
            eligible for work authorization if they entered the United 
            States before December 1, 1988, and resided in the United 
            States on that date. (Interim rule, 66 FR 29661, June 1, 
            2001).
 Technical amendments to section 202 of the Nicaragua 
            Adjustment and Central American Relief Act (NACARA) and 
            section 902 of the Haitian Refugee Immigration Fairness Act 
            of 1998 (HRFIA). Previously, certain aliens were barred 
            from seeking adjustment of status under these provisions if 
            they illegally reentered the United States after an order 
            of removal or a grant of voluntary departure. The technical 
            amendments found in section of 1505 of the LIFE Amendments 
            exempt otherwise eligible aliens from this bar to 
            adjustment and provided aliens already denied NACARA or 
            HRIFA benefits for this reason with the ability to file 
            motions to reopen. (Interim rule, 66 FR 29449, May 31, 
            2001).
 The Bush Administration and Commissioner Ziglar will be steering the 
INS to ensure that obligations under immigrations laws will be met with 
good judgment, compassion and common sense.
_______________________________________________________________________



DOJ--Civil Rights Division (CRT)

                              -----------

                          PROPOSED RULE STAGE

                              -----------




77. NONDISCRIMINATION ON THE BASIS OF DISABILITY IN PUBLIC 
ACCOMMODATIONS AND COMMERCIAL FACILITIES (SECTION 610 REVIEW)
Priority:


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


Legal Authority:


5 USC 301; 28 USC 509; 28 USC 510; 42 USC 12186(b)


CFR Citation:


28 CFR 36


Legal Deadline:


None


Abstract:


In 1991, the Department of Justice published regulations to implement 
title III of the Americans with Disabilities Act of 1990 (ADA). Those 
regulations include the ADA Standards for Accessible Design, which 
establish requirements for the design and construction of accessible 
facilities that are consistent with the ADA Accessibility Guidelines 
(ADAAG) published by the U.S. Architectural and Transportation Barriers 
Compliance Board (Access Board). In the time since the regulations 
became effective, the Department of Justice and the Access Board have 
each gathered a great deal of information regarding the implementation 
of the Standards. The Access Board is currently in the process of 
revising ADAAG, and it published a Notice of Proposed Rulemaking (NPRM) 
on November 16, 1999. In order to maintain consistency between ADAAG 
and the ADA Standards, the Department is reviewing its title III 
regulation and expects to propose, in one or more stages, to adopt the 
revisions proposed by the Access Board and to make related revisions to 
the Department's title III regulation. In addition to maintaining 
consistency between ADAAG and the Standards, the purpose of this review 
and these revisions will be to more closely coordinate with voluntary 
standards, to clarify areas which, through inquiries and comments to 
the Department's technical assistance phone lines, have been shown to 
cause confusion, to reflect evolving technologies in areas affected by 
the Standards, and to comply with section 610 of the Regulatory 
Flexibility Act, which requires agencies once every 10 years to review 
rules that have a significant economic impact upon a substantial number 
of small entities.


The adoption of revised ADAAG will also serve to 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.


The timetable set forth below refers to the notice of proposed 
rulemaking that the Department will issue as the first stage of the 
above-described title III rulemaking. This notice of proposed 
rulemaking will be issued under both title II and title III. For 
purposes of the title III regulation, this notice will propose to adopt 
revised ADAAG as the ADA Standards for Accessible Design and will 
initiate the review of the regulation in accordance with the 
requirements of section 610 of the Regulatory Flexibility Act, as 
amended by the Small Business Regulatory Enforcement Fairness Act of 
1996 (SBREFA).


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 title III. Section 306(c) 
of the ADA requires the Attorney General to promulgate regulations 
implementing

[[Page 61217]]

title III that are consistent with the Access Board's ADA guidelines. 
Because this rule will adopt standards that are consistent with the 
minimum guidelines issued by the Access Board, 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 of 1996.


Summary of Legal Basis:


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


Alternatives:


The Department is required by the ADA to issue this regulation. 
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 Access Board has analyzed the effect of applying its proposed 
amendments to ADAAG to entities covered by titles II and III of the ADA 
and has determined that they constitute a significant regulatory action 
for purposes of Executive Order 12866. 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 prepared a regulatory assessment, which includes a 
cost impact analysis for certain accessibility elements and a 
discussion of the regulatory alternatives considered. 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.


Risks:


Without the proposed changes to the Department's title III regulation, 
the ADA Standards will fail to be consistent with the ADAAG.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           12/00/01
NPRM Comment Period End                                        02/00/02
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses, Organizations


Government Levels Affected:


None


Additional Information:


RIN 1190-AA44, which will effect changes to 28 CFR 36 (the Department's 
regulation implementing title III of the ADA), is related to another 
rulemaking of the Civil Rights Division, RIN 1190-AA46, which will 
effect changes to 28 CFR 35 (the Department's regulation implementing 
title II of the ADA). By adopting revised ADAAG, this rulemaking will, 
among other things, address changes to the ADA Standards previously 
proposed in RIN 1190-AA26, which has been withdrawn and merged into RIN 
1190-AA44 and RIN 1190-AA46. These changes include technical 
specifications for facilities designed for use by children that had 
been previously 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-AA44
_______________________________________________________________________



DOJ--CRT



78. NONDISCRIMINATION ON THE BASIS OF DISABILITY IN STATE AND LOCAL 
GOVERNMENT SERVICES (SECTION 610 REVIEW)
Priority:


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


Legal Authority:


5 USC 301; 28 USC 509 to 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). On November 16, 
1999, the U.S. Architectural and Transportation Barriers Compliance 
Board (Access Board) issued 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 Department will publish a Notice of Proposed 
Rulemaking (NPRM) proposing to adopt the revisions proposed by the 
Access Board. The Department will also, in one or more stages, review 
its title II regulation for purposes of section 610 of the Regulatory 
Flexibility Act and make related changes to its title II regulation.


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.


The timetable set forth below refers to the notice of proposed 
rulemaking that the Department will issue as the first stage of the 
above-described title II rulemaking. This notice of proposed rulemaking 
will be issued under both title II and title III. For purposes of the 
title II regulation, this notice will propose to eliminate the Uniform 
Federal Accessibility Standards (UFAS) as an alternative to the ADA 
Standards for Accessible Design and to adopt revised ADAAG as the ADA 
Standards.


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 title II. Section 204(c) 
of the ADA

[[Page 61218]]

requires the Attorney General to promulgate regulations implementing 
title II that are consistent with the Access Board's ADA guidelines. 
Because this rule will adopt standards that are consistent with the 
minimum guidelines issued by the Access Board, this rule is required by 
statute. Similarly, the Department's review of its title II 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 under Legal Authority and 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 II regulation will consider whether alternatives to 
the currently published requirements are appropriate.


Anticipated Cost and Benefits:


The 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 effect of applying its proposed 
amendments to ADAAG to entities covered by titles II and III of the ADA 
and has determined that they constitute a significant regulatory action 
for purposes of Executive Order 12866. 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 prepared a regulatory assessment, which includes a 
cost impact analysis for certain accessibility elements and a 
discussion of the regulatory alternatives considered. 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 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 effects. These affects 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                                              12/00/01
Supplemental NPRM Comment Period End                           02/00/02
Regulatory Flexibility Analysis Required:


Undetermined


Small Entities Affected:


Governmental Jurisdictions


Government Levels Affected:


State, Local


Federalism:


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


Additional Information:


RIN 1190-AA46, which will effect changes to 28 CFR 35 (the Department's 
regulation implementing title II of the ADA), is related to another 
rulemaking of the Civil Rights Division, RIN 1190-AA44, which will 
effect changes to 28 CFR 36 (the Department's regulation implementing 
title III of the ADA). By adopting revised ADAAG, this rulemaking will, 
among other things, address changes to the ADA Standards previously 
proposed in RINs 1190-AA26 and 1190-AA38, which have been withdrawn and 
merged into this rulemaking. These changes include technical 
specifications for facilities designed for use by children and 
accessibility standards for State and local government facilities that 
had been previously 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

                              -----------




79. AMERICAN COMPETITIVENESS IN THE TWENTY-FIRST CENTURY ACT OF 2000 
AND OTHER RELATED BILLS
Priority:


Other Significant


Legal Authority:


8 USC 1101; 8 USC 1103; 8 USC 1182; 8 USC 1186a; 8 USC 1187; 8 USC 
1221; 8 USC 1281; 8 USC 1282


CFR Citation:


8 CFR 103; 8 CFR 202; 8 CFR 212; 8 CFR 274a


Legal Deadline:


None


Abstract:


The American Competitiveness in the 21st Century Act, Public Law 106-
313, was enacted on October 17, 2000, along with two bills, the Visa 
Waiver Permanent Program Act, Public Law 106-311, and a bill to 
increase the fee for certain H-1B petitions. Together, these bills make 
significant changes to

[[Page 61219]]

the H-1B classification. Public Law 106-313 increases the numerical H-
1B cap to 195,000 for FYs 2000-2002 and the percentage of the fees that 
INS receives to 4 percent. It exempts certain aliens from the numerical 
cap, provides for the ``portability'' of employment authorization, in 
certain circumstances, 1-year extensions of stay for certain aliens who 
have permanent residence applications pending. It also authorizes the 
creation of an Immigration Services and Infrastructure Improvements 
Account for appropriation of funds to eliminate the immigration benefit 
application processing backlog. This regulation clarifies several 
interpretive questions raised by the bills and ensures INS practice is 
consistent with these laws.


Statement of Need:


This regulation is necessary to implement the AC21 and VWPPA. Failure 
to fully implement will result in adverse consequences for the public. 
For example, the scope of the ``portability'' benefit is unclear. This 
lack of clarity combined with the self executing nature of the 
portability benefit means that aliens who incorrectly interpret the 
provisions may incur adverse immigration consequences. A clear 
regulatory interpretation will prevent this situation.


Summary of Legal Basis:


See Statement of Need. This action is not required by the statute or by 
a court order but as explained in the statement of need.


Alternatives:


None.


Anticipated Cost and Benefits:


The INS anticipates a moderate cost associated with the staff time and 
resources necessary to conduct training and disseminate new guidelines 
and standard operating procedures to the field. There is little or no 
additional workload for adjudications officers involved with this 
regulation.


Risks:


This regulatory action is critical for complete and clear 
implementation of the provisions of this legislation. The regulation 
will clarify the confusion that exists in the immigration community as 
to the scope and applicability of many of these provisions and will 
thus prevent the public from taking actions which may unintentionally 
trigger adverse immigration consequences. Delay in this rulemaking or 
failure to promulgate will perpetuate confusion among the public and 
lead to members of the public unwittingly incurring adverse immigration 
consequences.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           12/00/01
NPRM Comment Period End                                        02/00/02
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


None


Agency Contact:
John W. Brown
Adjudications Officer, Adjudications Division
Department of Justice
Immigration and Naturalization Service
Room 3214
425 I Street NW
Washington, DC 20536
Phone: 202 616-7435

Deborah Misir
Attorney, Office of General Counsel
Department of Justice
Immigration and Naturalization Service
425 I Street NW
Washington, DC 20536
Phone: 202 307-6596
RIN: 1115-AG11
_______________________________________________________________________



DOJ--INS

                              -----------

                            FINAL RULE STAGE

                              -----------




80. NEW CLASSIFICATION FOR VICTIMS OF SEVERE FORMS OF TRAFFICKING IN 
PERSONS ELIGIBLE FOR THE T NONIMMIGRANT STATUS
Priority:


Other Significant


Legal Authority:


5 USC 552; 5 USC 552a; 8 USC 1101; 8 USC 1102; 8 USC 1103; 8 USC 1104; 
8 USC 1182; 8 USC 1184; 8 USC 1187; 8 USC 1201; 8 USC 1224; 8 USC 1225; 
8 USC 1226; 8 USC 1227; 8 USC 1252; 8 USC 1252a; 22 USC 7101; 22 USC 
7105; ...


CFR Citation:


8 CFR 204; 8 CFR 212; 8 CFR 214; 8 CFR 299


Legal Deadline:


None


Abstract:


This rule sets forth application requirements for a new nonimmigrant 
visa classification. The T classification was created by 107(e) of the 
Victims of Trafficking and Violence Protection Act of 2000 (VTVPA), 
Public Law 106-386. The T visa was designed for eligible victims of 
severe forms of trafficking in persons who aid the Government with 
their case against the traffickers and who can establish that they 
would suffer extreme hardship involving unusual and severe harm if they 
were removed from the United States after having completed their 
assistance to law enforcement. The rule establishes application 
procedures and responsibilities for the Immigration and Naturalization 
Service (Service) and provides guidance to the public on how to meet 
certain requirements to obtain T nonimmigrant status.


There is a statutory cap for victims of severe form of trafficking 
(principals), which is set at 5,000 T visas per annum. The law also 
provides that certain family members can derive a T status through the 
principal's application. It is estimated that there may be four 
derivative visas issued for each principal.


Statement of Need:


This rule is necessary to establish how an eligible alien can obtain 
temporary immigration benefits as a victim of a severe form of 
trafficking in persons while providing a means of assistance for law 
enforcement officials at the Federal level to investigate and prosecute 
trafficking in persons.


Summary of Legal Basis:


Public Law 106-386, The Victims of Trafficking and Violence Protection 
Act of 2000.


Alternatives:


None


Anticipated Cost and Benefits:


No money has been authorized or appropriated for the anticipated 
administrative or operational costs for this program. While there is no 
precise formula for determining anticipated costs, there will be 
additional costs for adjudicating benefits and investigating claims, 
particularly those deemed fraudulent. There will be training costs for 
INS staff. The T visa regulation builds on protections and assistance 
for victims of severe forms of trafficking

[[Page 61220]]

in persons outlined in section 107(c) of the VTVPA and implemented in 
amendments to 28 CFR part 1100 in the recent rulemaking 66 FR 38514 
(July 24, 2001) (See RIN 1115-AG20). Part 1100 outlined procedures for 
Federal officials to identify and protect victims of severe forms of 
trafficking in persons; provided for access to information and 
translation services for victims; and outlined legal mechanisms to 
grant ``continued presence'' to victims of severe forms of trafficking 
in persons to allow them to remain in the U.S. during the pendency of 
law enforcement investigations and prosecutions. The T visa 
classification allows victims of severe forms of trafficking in persons 
to remain in the U.S. past the time of their assistance to law 
enforcement, if they can demonstrate that they will face extreme 
hardship involving unusual and severe harm if they were removed from 
the United States.


There may be thousands of applications that will not be approved for a 
variety of reasons, including failure to meet the basic T nonimmigrant 
requirements. All applications will be reviewed and some will require 
extensive investigation both here and abroad to determine if they are 
bona fide.


The anticipated benefit of these expenditures includes the assistance 
to trafficked victims and their families and the prosecution of 
traffickers in persons and the elimination of the abuses caused by 
their trafficking activities.


Benefits which may be attributed to the implementation of this rule are 
expected to be:


--an increase in the number of cases brought forward for investigation 
and/or prosecution;


--heightened awareness by the law enforcement community of trafficking 
in persons;


--enhanced ability to develop and work cases in trafficking in persons 
cross-organizationally and multi-jurisdictionally which may begin to 
influence changes in trafficking patterns.


Risks:


This rule is not an initiative of the INS but rather promulgated as a 
result of congressional action to develop a new nonimmigrant category. 
Risks associated with the implementation of the congressionally 
mandated new nonimmigrant classification include:


--increased workload on adjudicators and investigators which may impact 
overall efficiency and productivity;


--increases in fraudulent applications/claims of such victimization in 
order to obtain T nonimmigrant status; and


--changes in human trafficking patterns to elude law enforcement.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
Interim Final Rule                                             12/00/01
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


State, Federal


Additional Information:


INS No. 2132-01


There is a related rulemaking INS No. 2170-01, the new U non-immigrant 
status. [RIN 1115-AG39]


Agency Contact:
Anne M. Veysey
Director, Program Strategy and Development Branch
Department of Justice
Immigration and Naturalization Service
Investigations Division
425 I Street NW
Washington, DC 20536
Phone: 202 514-3479
RIN: 1115-AG19
BILLING CODE 4410-BP-S

[[Page 61221]]




DEPARTMENT OF LABOR (DOL)



2001 Regulatory Plan
Executive Summary: Goals and Priorities
In its Strategic Plan for 1999-2004, the Department of Labor (DOL) set 
three overall goals: 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.
To help achieve these goals, Secretary of Labor Elaine L. Chao has set 
a new course for the Department. DOL will emphasize prevention and 
compliance assistance, relying on the use of common-sense standards of 
safety and fairness to protect workers before they are harmed 
physically or economically. Education and encouragement of employers 
will help workers far more than enforcement alone, since no enforcement 
process can possibly identify every violation of the law, and fines and 
penalties can never fully redress losses of life, health, and economic 
well-being. As part of this effort, DOL will seek new strategies for 
advising employers and workers of their rights and responsibilities. In 
addition, the Department will work towards humanizing and rationalizing 
the immigrant worker programs. We must deal promptly and efficiently 
with immigrant worker applications and ensure the integrity of 
guestworker programs if we are to provide safe, predictable and 
appropriate working conditions for immigrant workers.
DOL also recognizes that the emerging 21st century economy presents 
challenges to workers at all skill levels and in all walks of life. 
Those who have been laid off from jobs because their companies could 
not adapt to technological changes or foreign competition, or who did 
not get a full education, or who made a wrong turn at some point in 
their lives, cannot be left behind. Some of these workers, especially 
young workers, need training in basic skills and help in becoming 
acclimated to working life. Other workers may need assistance in 
learning new skills or in obtaining advanced schooling. We must also 
take advantage of advances in technology to open the doors of the 
workplaces to the disabled.
At the same time, high-technology industries are creating job 
opportunities unheard of even a decade ago, and DOL must help employers 
and workers bridge the gap between the requirements of those jobs and 
the skills of the workers who would fill them. Workers who can keep 
their skills up to date throughout their careers have more productive 
and more rewarding economic futures.
The tools the Department will use to reach its goals revolve around 
five Secretarial priorities:
 Ensure the safety of every workplace;
 Guarantee an honest day's pay for an honest day's work;
 Stop discrimination;
 Protect workers from coercion and intimidation;
 Safeguard the pension and health benefits of every American 
            worker.
The Secretary of Labor's Plan for Accomplishing These Objectives
The balance between labor and management that underlies the country's 
labor laws is a crucial source of stability in our economy, and the 
need for labor and management to work together has become increasingly 
evident in recent years. For these reasons, any change in the 
regulations that implement the country's labor and employment laws must 
be carefully considered, and the views of all parties affected must be 
taken into account.
In general, DOL will try to help employees and employers meet their 
needs in a cooperative fashion, with a minimum of rulemaking. However, 
to reflect changes in technology and business practices, and to clarify 
existing rules in light of new laws and legal interpretations, DOL will 
need to promulgate new regulations periodically.
In doing so, DOL will craft proposals that are responsive to workers' 
needs. Those needs span an entire range of work environments, from 
traditional settings that have well-defined conditions and locations of 
work, to newly emerging settings that are more flexibly structured in 
terms of schedules and workplaces.
Similarly, the skills needed by today's workforce are more varied than 
at any time in our country's history, and they continue to change at a 
rapid rate. Changes in the financial marketplace, as well as in 
compensation and benefit arrangements, present both challenges and 
opportunities for today's workers.
The following proposals represent what DOL believes to be a balanced 
plan for protecting workers in their current jobs and preparing them 
for future employment. DOL considers these proposals to be proactive, 
common-sense approaches to the issues most clearly needing regulatory 
attention.
DOL will continue to use plain language to explain the need for the 
rules proposed, to describe the methods for obtaining compliance, and 
to outline the effects of noncompliance. DOL will also explore new ways 
to help its various constituencies comply with existing rules and with 
new rules once they are adopted.
The Department's Regulatory Priorities
DOL has identified 17 high-priority items for regulatory action. Eight 
of them address health and safety issues, which are central to DOL's 
mission and which represent a major focus of the Secretary. Two 
agencies, the Mine Safety and Health Administration (MSHA) and the 
Occupational Safety and Health Administration (OSHA), are responsible 
for these initiatives.
MSHA administers the Federal Mine Safety and Health Act of 1977 (Mine 
Act). The agency demonstrates its commitment to ensuring safer and 
healthier workplaces for our nation's miners in a number of ways, but 
government intervention alone cannot eliminate occupational deaths, 
injuries and illnesses in mining. The commitment of miners and mine 
operators is also needed. MSHA will continue to concentrate on 
improving existing health and safety standards and addressing emerging 
health hazards in mining.
While levels of respirable coal dust have been significantly reduced 
over the years, some miners continue to develop coal workers' 
pneumoconiosis. MSHA intends to issue final rules that will provide a 
means to verify operators' coal dust control plans, allow MSHA to 
assume responsibility for the operator coal dust sampling program, and 
prevent overexposure to respirable coal dust during every working shift 
(RIN 1219-AB14, RIN 1219-AB18). MSHA also proposes to lower the 
permissible exposure limit (PEL) for asbestos in surface and 
underground metal and non-metal mines (RIN 1219-AB24). This rule, which 
reflects current scientific data, is intended to reduce miners' risk of 
developing asbestos-related occupational diseases.
The Occupational Safety and Health Administration administers a wide 
range of measures throughout the public and private sectors. OSHA is 
committed to establishing clear and sensible priorities, reducing 
occupational deaths, injuries, and illnesses, and simplifying its 
recordkeeping requirements.

[[Page 61222]]

Two of OSHA's initiatives address health standards. The first, 
``Standards Improvement,'' will streamline a number of such standards 
by removing language that is outdated, duplicative, unnecessary or 
inconsistent (RIN 1218-AB81). These changes will reduce the amount of 
time and effort needed to understand and comply with these standards.
The second proposes improvements in respiratory protection against 
airborne contaminants, which include a variety of particulates, gases, 
vapors and biological agents, for employees who routinely wear 
respirators on the job (RIN 1218-AA05).
A third proposal concerns fires in shipyards, which claim the lives of 
several workers each year (RIN 1218-AB51). Using the negotiated 
rulemaking process, OSHA proposes to update requirements set in 1971 
for fire extinguishers, sprinkler systems, detection systems, alarm 
systems and fire brigades to reduce fire-related injuries and 
fatalities.
Finally, OSHA proposes two changes in response to concerns raised by 
stakeholders. One of these relates to highway signs, signals and 
barricades (RIN 1218-AB88). OSHA will revise this rule to bring it into 
conformity with rules set forth by the Department of Transportation and 
to reflect new technology and offer more flexibility for compliance. 
The other addresses emergency exit routes used by employees (RIN 1218-
AB82). Updating the standard and using clearer language should lead to 
better compliance and fewer disputes about violations.
Another of the Secretary's priorities, protection of pension and health 
benefits, is exemplified in three initiatives by the Pension and 
Welfare Benefits Administration (PWBA), which administers the Employee 
Retirement Income Security Act (ERISA). This law establishes reporting, 
disclosure, fiduciary and other standards that apply to an estimated 
700,000 private sector employee pension benefit plans (covering 
approximately 92 million participants); an estimated 2.5 million group 
health benefit plans (covering 131 million participants and 
dependents); and 3.4 million other welfare benefits plans (covering 
approximately 190 million participants).
PWBA's initiatives focus on encouraging voluntary compliance with the 
laws and regulations that apply to employee benefit plans. The first 
provides for adoption of a Voluntary Fiduciary Correction Program, 
which will promote compliance with ERISA's fiduciary responsibility 
requirements (RIN 1210-AA76). The second addresses revisions to PWBA's 
Delinquent Filer Voluntary Compliance program, which will facilitate 
compliance with ERISA's annual reporting requirements (RIN 1210-AA86). 
The third advocates development of model COBRA notices, which will 
promote compliance with the provisions of ERISA and the Internal 
Revenue Code that govern continuation of health benefits coverage (RIN 
1210-AA60).
The Secretary's emphasis on meeting the needs of the 21st century 
workforce is reflected in a regulatory initiative developed by the 
Employment and Training Administration (ETA). This rule will improve 
the quality of employment services provided to low-income senior 
citizens under the Older Americans Act (RIN 1205-AB28). These 
individuals often need assistance in developing skills and obtaining 
work experience so that they can obtain unsubsidized work. This rule 
will also improve the performance accountability system for providers 
of such services and enhance the ability of the States to coordinate 
services.
The Department is working on certain rules in the immigration area that 
will enhance the security of the employment-related immigration system. 
One such rule is an ETA rule that will allow employers to submit H-1B 
labor condition applications via the Internet (RIN 1205-AB29). Another 
is a related Employment Standards Administration (ESA) rule that 
implements amendments to the H-1B program contained in the American 
Competitiveness and Workforce Improvement Act of 1998 (RIN 1215-AB09). 
The Department is evaluating comments received on an interim final rule 
published in December 2000.
Finally, ESA has set forth three regulatory initiatives. The Office of 
Labor-Management Standards (OLMS) has proposed a rule that will 
implement the requirements of Executive Order 13201 (RIN 1215-AB33). 
This Order requires Federal contractors to notify their employees that 
they are not required to join a union, and to inform employees of their 
rights with respect to use of union dues and fees.
The Secretary's priority of ensuring that appropriate wages are paid at 
legal levels is the subject of two proposals set forth by ESA's Wage 
and Hour Division. Among the statutes enforced by the Wage and Hour 
Division is the Fair Labor Standards Act (FLSA), which sets 
requirements for payment of minimum wages and overtime pay to more than 
100 million employees. It also defines conditions for the employment of 
minors.
The Wage and Hour Division's first initiative updates the child labor 
rules issued under the FLSA to address changes in the nature of the 
workplace and situations in which minors may operate certain kinds of 
machinery (RIN 1215-AA09). While young workers need employment 
experiences that will help them gain the skills needed to find and hold 
good jobs later in life, they also need to focus on obtaining high-
quality educations. It is our responsibility to ensure that they work 
in jobs that are not hazardous, and that younger workers (14 and 15 
years old) work hours that will not interfere with their education, and 
under conditions that will not interfere with their health and well 
being.
The Wage and Hour Division's second initiative revises and clarifies 
the criteria that define the minimum wage and overtime exemptions for 
``executive'', ``administrative'', ``professional'', and ``outside 
sales'' employees under the FLSA (RIN 1215-AA14). Changes to these 
rules will help employers meet their obligations voluntarily and 
enhance workers' understanding of their rights and benefits.
_______________________________________________________________________



DOL--Employment Standards Administration (ESA)

                              -----------

                          PROPOSED RULE STAGE

                              -----------




81. 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

[[Page 61223]]

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.


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 Period End                                       03/22/86
NPRM                                                           09/00/02
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses, Governmental Jurisdictions, Organizations


Government Levels Affected:


State, Local, Federal


Federalism:


 Undetermined

[[Page 61224]]

Agency Contact:
Annabelle T. Lockhart
Acting Administrator, Wage and Hour Division
Department of Labor
Employment Standards Administration
200 Constitution Avenue, NW
FP Building, Room S3502
Washington, DC 20210
Phone: 202 693-0051
Fax: 202 693-1432
RIN: 1215-AA14
_______________________________________________________________________



DOL--ESA



82. OBLIGATION OF FEDERAL CONTRACTORS AND SUBCONTRACTORS, NOTICE OF 
EMPLOYEE RIGHTS CONCERNING PAYMENT OF UNION DUES OR FEES
Priority:


Other Significant


Legal Authority:


EO 13201


CFR Citation:


29 CFR 470


Legal Deadline:


None


Abstract:


This regulation will implement E.O. 13201 which requires Government 
contractors and subcontractors to post notices informing their 
employees that (1) under Federal law they cannot be required to join a 
union or maintain membership in a union to retain their jobs, and (2) 
employees who choose not to be union members may object to the use of 
their compulsory union dues and fees for activities other than 
collective bargaining, contract administration, and grievance 
adjustment, and may be entitled to a refund and an appropriate 
reduction in their future payments. The proposed regulation, in 
accordance with E.O. 13201, will also require that, where applicable, 
each Government contracting agency include certain provisions of the 
Order in its Government contracts, and that Government contractors and 
subcontractors include these provisions in their nonexempt subcontracts 
and purchase orders.


Statement of Need:


The regulation is necessary in order to implement Executive Order 
13201.


Summary of Legal Basis:


The legal basis for this regulation is section 1(b) of Executive Order 
13201. The legal basis for the Executive Order is the Constitution and 
laws of the United States, including the Federal Property and 
Administrative Services Act, 40 U.S.C. 471 et seq.


Alternatives:


There is no feasible alternative to issuing regulations. Regulations 
are needed in order to implement Executive Order 13201 by (1) 
clarifying the obligations of Federal contractors and subcontractors, 
(2) providing exemptions as authorized by the Executive order, and (3) 
establishing enforcement mechanisms as authorized by the Executive 
order. Alternatives to the specific provisions of the proposed rule 
suggested in comments by the public will be considered in developing 
the final rule.


Anticipated Cost and Benefits:


The only costs that Federal contractors will incur are for (1) posting 
the notice and (2) applying for waivers from the posting requirement. 
These will be minimal since (1) under the proposed regulation, the 
Department will supply the posters, and (2) the Department's experience 
under similar posting requirements is that few contractors request 
waivers. The benefits of the Executive order and the implementing 
regulation are the promotion of economy and efficiency in Government 
procurement by having workers who are informed of their rights 
regarding union membership and the use of union dues and fees.


Risks:


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


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
Interim Procedur66 FR 19988                                    04/18/01
NPRM            66 FR 50010                                    10/01/01
NPRM Comment Period End                                        11/30/01
Final Rule                                                     02/00/02
Regulatory Flexibility Analysis Required:


No


Government Levels Affected:


Federal


Agency Contact:
Don Todd
Deputy Assistant Secretary
Department of Labor
Employment Standards Administration
200 Constitution Avenue NW.
FP Building, Room S2321
Washington, DC 20210
Phone: 202 693-0200
Fax: 202 693-1340
RIN: 1215-AB33
_______________________________________________________________________



DOL--ESA

                              -----------

                            FINAL RULE STAGE

                              -----------




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


Other Significant


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 are 
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

[[Page 61225]]

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 are 
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.


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 was 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 are 
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 Action Effective                                         12/20/91
ANPRM           59 FR 25167                                    05/13/94
ANPRM Comment Pe59 FR 40318                                    08/11/94
NPRM            64 FR 67130                                    11/30/99
NPRM Comment Period End                                        01/31/00
Final Action                                                   06/00/02
Regulatory Flexibility Analysis Required:


No


Government Levels Affected:


None


Agency Contact:
Annabelle T. Lockhart
Acting Administrator, Wage and Hour Division
Department of Labor
Employment Standards Administration
200 Constitution Avenue, NW
FP Building, Room S3502
Washington, DC 20210
Phone: 202 693-0051
Fax: 202 693-1432
RIN: 1215-AA09
_______________________________________________________________________



DOL--ESA



84. LABOR CONDITION APPLICATIONS AND REQUIREMENTS FOR EMPLOYERS USING 
NONIMMIGRANTS ON H-1B VISAS IN SPECIALTY OCCUPATIONS AND AS FASHION 
MODELS
Priority:


Other Significant


Legal Authority:


8 USC 1101(a)(15)(H)(i)(b); 8 USC 1182(n); 8 USC 1184; 29 USC 49 et 
seq; PL 102-232; PL 105-277


CFR Citation:


20 CFR 655, subparts H and I


Legal Deadline:


None


Abstract:


The H-1B visa program of the Immigration and Nationality Act allows 
employers to temporarily employ nonimmigrants admitted into the United 
States under the H-1B visa category in specialty occupations and

[[Page 61226]]

as fashion models, under specified labor conditions. An employer must 
file a labor condition application with the Department of Labor before 
the Immigration and Naturalization Service may approve a petition to 
employ a foreign worker on an H-1B visa. The Department's Employment 
and Training Administration administers the labor condition application 
process; the Wage and Hour Division of the Department's Employment 
Standards Administration handles complaints and investigations 
regarding labor condition applications. The Department published a 
proposed rule on January 5, 1999, in response to statutory changes in 
the H-1B program made by the American Competitiveness and Workforce 
Improvement Act of 1998 (Title IV, Pub. L. 105-277; Oct. 21, 1998). 
Those changes placed additional obligations on ``H-1B-dependent'' 
employers (generally, those with work forces comprised of more than 15 
percent H-1B workers) and on willful violators. These employers must 
recruit for U.S. workers, hire U.S. workers who are at least as 
qualified as H-1B workers, and not displace U.S. workers by hiring H-1B 
workers or placing them at another employer's job site. The 1998 
amendments also imposed additional obligations on all H-1B employers, 
such as offering benefits to H-1B workers on the same basis and 
according to the same criteria as offered to U.S. workers, and payment 
to H-1B workers during periods they are not working for an employment-
related reason. The 1999 proposed rule also requested further public 
comment on earlier proposed provisions published in October 1995, and 
on particular interpretations of the statute and of the existing 
regulations which the Department proposed to incorporate into the 
regulations. Since publishing the proposed rule, Congress enacted 
further amendments to the H-1B provisions under the American 
Competitiveness in the Twenty-First Century Act of 2000 (Pub. L. 106-
313; Oct. 17, 2000), the Immigration and Nationality Act - Amendments 
(Pub. L. 106-311; Oct. 17, 2000), and section 401 of the Visa Waiver 
Permanent Program Act (Pub. L. 106-396; Oct. 30, 2000). On December 20, 
2000, the Department published an Interim Final Rule to implement the 
recent amendments and clarify the existing rules, and requested further 
public comment on those provisions.


Statement of Need:


Statutory amendments to the Immigration and Nationality Act relating to 
the H-1B visa program were enacted in 1998 and again in 2000. Under the 
H-1B visa program, employers may temporarily employ nonimmigrants 
admitted into the U.S. under H-1B visas in specialty occupations and as 
fashion models, provided certain conditions are met. Section 412(d) of 
the American Competitiveness and Workforce Improvement Act of 1998 
(Title IV of the Omnibus Consolidated and Emergency Supplemental 
Appropriations Act, 1999, Public Law 105-277), provides that some of 
the amendments made by the 1998 legislation (those relating to ``H-1B-
dependent'' employers and willful violators) do not take effect until 
the Department of Labor issues implementing regulations, which are the 
subject of this rulemaking.


Summary of Legal Basis:


This rule is issued pursuant to provisions of the Immigration and 
Nationality Act, as amended, and the American Competitiveness and 
Workforce Improvement Act of 1998, 8 U.S.C. 1101(a)(15)(H)(i)(b), 
1182(n), and 1184; sec. 303(a)(8), Pub. L. 102-232 (8 U.S.C. 1182 
note); and secs. 412(d) and (e), Pub. L. 105-277. The objectives of the 
rule are to enable employers to understand and comply with applicable 
requirements of the amended H-1B visa program, and to advise employees 
and applicants for employment of the protections afforded by the 
amendments to U.S. and H-1B workers.


Alternatives:


Various regulatory alternatives were considered during the notice-and-
comment period for implementing the statutory provisions, as discussed 
in the preamble to the December 2000 interim final rule. Alternatives 
considered included, among others, various approaches to the manner and 
timing for determining H-1B dependency status (and the meaning of 
``full-time equivalent employees'' (FTEs) in the employer's work 
force), documentation of the dependency determination and designation 
of such status on the Labor Condition Application, and implementing the 
requirements for no ``displacement'' and recruitment of U.S. workers, 
payment of required wages and benefits to H-1B and U.S. workers, and 
determining short-term placement options.


Anticipated Cost and Benefits:


The Department concluded that the anticipated costs and benefits of 
this rule were not economically significant. This conclusion was based 
on the analysis that the direct, incremental costs that employers would 
incur because of the rule that were above customary business expenses 
associated with recruiting qualified job applicants and retaining 
qualified employees in specialized jobs would not exceed $100 million 
per year or otherwise trigger ``economic significance'' under Executive 
Order 12866. However, because of the importance of the rule to the 
public, it was treated as a significant regulatory action and was, 
therefore, reviewed by the Office of Management and Budget under 
Executive Order 12866.


Risks:


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


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            60 FR 55339                                    10/31/95
NPRM Comment Period End                                        11/30/95
NPRM            64 FR 628                                      01/05/99
NPRM Comment Period End                                        02/04/99
Interim Final Ru65 FR 80110                                    12/20/00
Interim Final Rule Effective                                   01/19/01
Interim Final Ru66 FR 10865Period End                          04/23/01
Final Action                                                   09/00/02
Regulatory Flexibility Analysis Required:


No


Government Levels Affected:


Federal


Agency Contact:
Annabelle T. Lockhart
Acting Administrator, Wage and Hour Division
Department of Labor
Employment Standards Administration
200 Constitution Avenue, NW
FP Building, Room S3502
Washington, DC 20210
Phone: 202 693-0051
Fax: 202 693-1432
RIN: 1215-AB09

[[Page 61227]]

_______________________________________________________________________



DOL--Employment and Training Administration (ETA)

                              -----------

                          PROPOSED RULE STAGE

                              -----------




85. LABOR CERTIFICATION PROCESS FOR THE PERMANENT EMPLOYMENT OF ALIENS 
IN THE UNITED STATES
Priority:


Other Significant


Legal Authority:


8 USC 1182(a)(5)(A), 1189(p)(1); 29 USC 49 et seq


CFR Citation:


20 CFR 656


Legal Deadline:


None


Abstract:


The Employment and Training Administration (ETA) is in the process of 
reengineering the permanent labor certification process. ETA's goals 
are to make fundamental changes and refinements that will: streamline 
the process, save resources, improve the effectiveness of the program 
and better serve the Department of Labor's (DOL) customer.


Statement of Need:


The labor certification process has been described as being 
complicated, costly and time consuming. Due to the increases in the 
volume of applications received and a lack of adequate resources, it 
can take up to 2 years or more to complete processing an application. 
The process also requires substantial State and Federal resources to 
administer and is reportedly costly and burdensome to employers as 
well. Cuts in Federal funding for both the permanent labor 
certification program and the U.S. Employment Service have made it 
difficult for State and Federal administrators to keep up with the 
process. ETA, therefore, is taking steps to improve effectiveness of 
the various regulatory requirements and the application processing 
procedures, with a view to achieving savings in resources both for the 
government and employers, without diminishing protections now afforded 
U.S. workers by the current regulatory and administrative requirements.


Summary of Legal Basis:


Promulgation of these regulations is authorized by section 212(a)(5)(A) 
of the Immigration and Nationality Act.


Alternatives:


Regulatory alternatives are now being developed by the Department. The 
public will be afforded an opportunity to comment on the Department's 
plans for streamlining the permanent labor certification process in a 
notice of proposed rulemaking which will be published in the Federal 
Register.


Anticipated Cost and Benefits:


Preliminary estimates of the anticipated costs and benefits have not 
been determined at this time. Preliminary estimates will be developed 
after a decision is made as to what regulatory amendments are necessary 
and after the implementing forms and automated systems to support a 
streamlined permanent labor certification process have been developed.


Risks:


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


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           02/00/02
Final Rule                                                     08/00/02
Regulatory Flexibility Analysis Required:


Undetermined


Government Levels Affected:


State, Federal


Agency Contact:
Dale Ziegler
Chief, Division of Foreign Labor Certification
Department of Labor
Employment and Training Administration
200 Constitution Avenue NW.
Room C4318
FP Building
Washington, DC 20210
Phone: 202 693-2942
Fax: 202 693-2760
Email: [email protected]
RIN: 1205-AA66
_______________________________________________________________________



DOL--ETA



86. SENIOR COMMUNITY SERVICE EMPLOYMENT PROGRAM
Priority:


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


Legal Authority:


42 USC 3056(b)(2)


CFR Citation:


20 CFR 641


Legal Deadline:


None


Abstract:


The Employment and Training Administration will implement new 
regulations to govern the Senior Community Service Employment Program 
(SCSEP) under title V of the Older Americans Act Amendments of 2000. 
SCSEP is the only Federally sponsored job creation program targeted to 
low-income older Americans. The program subsidizes part-time community 
service jobs for low-income persons age 55 years and older who have 
poor employment prospects. Approximately 100,000 program enrollees 
annually work in a wide variety of community service jobs, including 
nurse's aides, teacher aides, librarians, clerical workers and day care 
assistants. The Department of Labor allocates funds to operate the 
program to State agencies on aging and to national organizations.


Proposed regulations will:


--improve integration of SCSEP with the broader workforce investment 
system;


--establish an enhanced performance accountability system to hold each 
grantee accountable for attaining quality levels of performance with 
respect to core measures, such as customer satisfaction and placement 
in unsubsidized employment;


--improve the ability of States to coordinate services, by providing 
for the broad participation of stakeholders in the development of an 
annual plan to ensure an equitable distribution of projects within the 
State;


--strengthen administrative procedures by incorporating fiscal 
accountability provisions similar to the Workforce Investment Act, 
including definitions of administrative and programmatic costs and the 
application of uniform cost principles; and


--revise the distribution of funding.


Statement of Need:


As the baby boom generation ages, the demand for employment and 
training services and income support for low-income older persons will 
increase. Low-income seniors generally must continue working and many 
may not be able to find employment without work experience and 
additional training. The basic goals of the SCSEP are to provide 
community service employment for older workers with few skills and 
little work experience, and

[[Page 61228]]

to move many of those seniors into unsubsidized employment. The 
Employment and Training Administration will issue regulations and other 
guidance, provide technical assistance, and establish performance 
standards that will drive State and national grantees' efforts towards 
the program's goals.


Summary of Legal Basis:


Promulgation of these regulations is authorized by section 502(b)(2) of 
Pub. L. 106-501 of the Older Americans Act Amendments of 2000.


Alternatives:


The public provided comments on changes to the statute due to the Older 
Americans Act Amendments of 2000 during Town Hall meetings held 
throughout the country in spring 2001. The public also will be afforded 
an opportunity to comment on the Department's plans for implementing 
the Amendments in a notice of proposed rulemaking that will be 
published in the Federal Register.


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.


Risks:


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


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           01/00/02
Final Action                                                   04/00/02
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


State, Local, Tribal, Federal


Federalism:


 Undetermined


Agency Contact:
Erich W. Larisch
Chief, Divison of Older Worker Programs
Department of Labor
Employment and Training Administration
200 Constitution Avenue, NW
FP Building, Room N4645
Washington, DC 20210
Phone: 202 693-3742
Fax: 202 693-3817
Email: [email protected]
RIN: 1205-AB28
_______________________________________________________________________



DOL--Pension and Welfare Benefits Administration (PWBA)

                              -----------

                          PROPOSED RULE STAGE

                              -----------




87. RULEMAKING RELATING TO NOTICE REQUIREMENTS FOR CONTINUATION OF 
HEALTH CARE COVERAGE
Priority:


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


Unfunded Mandates:


Undetermined


Legal Authority:


29 USC 1135; 29 USC 1136


CFR Citation:


29 CFR 2520


Legal Deadline:


None


Abstract:


This rulemaking will provide guidance concerning the notification 
requirements pertaining to continuation coverage under the Employee 
Retirement Income Security Act of 1974 (ERISA). Section 606 of ERISA 
requires that group health plans provide employees notification of the 
continuation coverage provisions of the plan and imposes notification 
obligations upon plan administrators, employers, employees, and 
qualified beneficiaries relating to certain qualifying events.


Statement of Need:


Part 6 of title I of ERISA requires that group health plans provide 
employees with notice of the continuation of health care coverage 
provisions of the plan; it imposes notification requirements upon 
employers, employees, plan administrators, and qualified beneficiaries 
in connection with certain qualifying events. The public needs guidance 
from the Department with regard to how they can fulfill their 
respective obligations under these statutory provisions.


Summary of Legal Basis:


Section 606 ERISA specifies the respective notification requirements 
for employers, employees, plan administrators, and qualified 
beneficiaries in connection with group health plan provisions relating 
to continuation of health care coverage. Section 606(a) of ERISA 
specifically refers to regulations to be issued by the Secretary of 
Labor clarifying these requirements. Section 505 of ERISA authorizes 
the Secretary to issue regulations clarifying the provisions of title I 
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 is needed by the public.


Anticipated Cost and Benefits:


Preliminary estimates of the anticipated costs and benefits will be 
developed once decisions are reached regarding the alternatives to be 
considered.


Risks:


Failure to provide guidance to the public concerning their notification 
obligations under section 606 of ERISA may complicate compliance by the 
public with the law and may reduce the availability of continued health 
care coverage in certain commonly encountered situations.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
ANPRM           62 FR 49894                                    09/23/97
ANPRM Comment Period End                                       11/24/97
NPRM                                                           09/00/02
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses, Organizations


Government Levels Affected:


None


Agency Contact:
Susan G. Lahne
Senior Pension Law Specialist
Department of Labor
Pension and Welfare Benefits Administration
Room N5669
200 Constitution Avenue NW
FP Building
Washington, DC 20210
Phone: 202 693-8500
RIN: 1210-AA60

[[Page 61229]]

_______________________________________________________________________



DOL--PWBA

                              -----------

                            FINAL RULE STAGE

                              -----------




88. VOLUNTARY FIDUCIARY CORRECTION PROGRAM (VFC PROGRAM)
Priority:


Other Significant


Legal Authority:


29 USC 1132; 29 USC 1134


CFR Citation:


29 CFR 2560


Legal Deadline:


None


Abstract:


Section 409 of ERISA provides that an employee benefit plan fiduciary 
who breaches any of the responsibilities, obligations, or duties 
imposed upon him or her by part 4 of title I of ERISA shall be 
personally liable to make good to such plan any losses to the plan 
resulting from each such breach, and to restore to such plan any 
profits that such fiduciary may have made through use of assets of the 
plan. The Department has the authority under section 504 of ERISA to 
conduct investigations to deter and correct violations of title I of 
ERISA and under section 502(a)(2) and 502(a)(5) to bring civil actions 
to enforce the provisions thereof. Section 502(l) of ERISA requires the 
assessment of a civil penalty in an amount equal to 20 percent of the 
applicable recovery amount with respect to any breach of fiduciary 
responsibility under (or other violation of) part 4 by a fiduciary.


To encourage and facilitate voluntary correction of certain breaches of 
fiduciary responsibility, PWBA is adopting a Voluntary Fiduciary 
Correction Program (VFC Program). Under the VFC Program, plan officials 
will be relieved of the possibility of investigation and civil action 
by the Department and imposition of civil penalties, to the extent that 
plan officials satisfy the conditions for correcting breaches described 
in the program.


Statement of Need:


The VFC Program is a key element in PWBA's effort to encourage and 
facilitate fiduciary voluntary correction of certain breaches of 
fiduciary responsibility. Under the Program, plan officials will be 
relieved of the possibility of investigation and civil action by the 
Department and imposition of civil penalties, to the extent that they 
satisfy the conditions for correcting breaches described in the 
Program.


Summary of Legal Basis:


Section 409 of ERISA provides that an employee benefit plan fiduciary 
who breaches any of the responsibilities, obligations, or duties 
imposed upon him or her by part 4 of title I of ERISA shall be 
personally liable to make good to such plan any losses to the plan 
resulting from each such breach, and to restore to such plan any 
profits that such fiduciary may have made through use of the assets of 
the plan. The Department has the authority under section 504 of ERISA 
to conduct investigations to deter and correct violations of title I of 
ERISA and under sections 502(a)(2) and 502(a)(5) of ERISA to bring 
civil actions to enforce the provisions thereof. Section 502(1) of 
ERISA requires the assessment of a civil penalty in the amount equal to 
20 percent of the applicable recovery amount with respect to any breach 
of fiduciary responsibility under (or other violation of) part 4 by a 
fiduciary.


Alternatives:


The VFC Program is essentially a deregulatory initiative, and 
participation in the Program is entirely voluntary. PWBA has determined 
that this approach is more flexible, efficient and protective of plans 
than regulatory alternatives which do not serve to encourage voluntary 
correction of fiduciary breaches.


Anticipated Cost and Benefits:


Participation in the VFC Program is entirely voluntary and, as such, it 
is assumed that plan officials will elect to participate only when the 
potential benefits to them are expected to exceed the costs of 
participation. Benefits may include the reduction of exposure to the 
risk of investigation and subsequent litigation, the potential cost of 
which cannot be specifically quantified, and the savings of penalties 
under section 502(1) of ERISA which would otherwise be payable on 
amounts required to be restored to plans by fiduciaries pursuant to a 
settlement agreement with the Department or court order.


Risks:


Failure to adopt the VFC Program would deprive plan officials of 
significant opportunities to voluntarily correct fiduciary breaches and 
to avoid costly litigation and civil penalties. Because the VFC Program 
encourages and facilitates compliance with the law, failure to 
implement the VFC Program may serve as a disincentive to the proper 
management of employee benefit plans.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
Enforcement Poli65 FR 14164                                    03/15/00
Comment Period End                                             05/15/00
Final Action                                                   12/00/01
Regulatory Flexibility Analysis Required:


No


Government Levels Affected:


None


Agency Contact:
Elizabeth A. Goodman
Pension Law Specialist, Office of Regulations and Interpretations
Department of Labor
Pension and Welfare Benefits Administration
Room N5669
200 Constitution Avenue NW
FP Building
Washington, DC 20210
Phone: 202 693-8500
RIN: 1210-AA76
_______________________________________________________________________



DOL--PWBA



89.   DELINQUENT FILER VOLUNTARY COMPLIANCE PROGRAM (DFVC 
PROGRAM)
Priority:


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


Unfunded Mandates:


Undetermined


Legal Authority:


29 USC 1132


CFR Citation:


Not Yet Determined


Legal Deadline:


None


Abstract:


Under ERISA section 502(c)(2) the Secretary of Labor is authorized to 
assess civil penalties of up to $1100 per day against plan 
administrators who fail or refuse to file complete and timely Form 5500 
Series Annual Returns/Reports. The Secretary may waive all or part of 
the civil penalty upon showing by the plan

[[Page 61230]]

administrator of reasonable cause for failure to file a timely annual 
report. The Department determined that the possible assessment of these 
civil penalties may deter certain delinquent filers from voluntarily 
complying with the annual reporting requirements under title I of ERISA 
and adopted, on April 27, 1995, the Delinquent Filer Voluntary 
Compliance (DFVC) Program which was published as a Federal Register 
rule-related notice (60 FR 20874). The DFVC Program permits delinquent 
plan administrators, who are otherwise subject to the assessment of 
higher civil penalties under ERISA section 502(c)(2), to pay reduced 
civil penalties for voluntarily complying with their annual reporting 
obligations under title I of ERISA.


PWBA is adopting modifications to the DFVC Program to further encourage 
and facilitate voluntary compliance by plan administrators who are 
delinquent in filing annual reports under title I of ERISA. The 
modifications will also simplify the procedures governing participation 
in the DFVC Program and conform the program's provisions to the ERISA 
Filing Acceptance System (EFAST).


Statement of Need:


Title I of ERISA authorizes the Secretary of Labor to assess civil 
penalties of up to $1100 per day against plan administrators who fail 
or refuse to file complete and timely Form 5500 Annual Returns/Reports 
for employee benefit plans. ERISA also authorizes the Secretary to 
waive all or part of the civil penalty upon a showing of reasonable 
cause for failure to file a timely report. The DFVC Program, adopted in 
1995, permits delinquent plan administrators, who are otherwise subject 
to the assessment of higher civil penalties to pay reduced civil 
penalties for voluntarily complying with their annual reporting 
obligations under Title I of ERISA. The modifications to the DFVC 
Program provided by this rulemaking will further encourage and 
facilitate voluntary compliance by plan administrators, simplify the 
procedures governing participation in the Program, and conform the 
Program to the ERISA Filing Acceptance System (EFAST).


Summary of Legal Basis:


Section 502(c)(2) authorizes the Secretary of Labor to assess the civil 
penalties described above upon plan administrators who are delinquent 
in fulfilling their annual reporting requirements with respect to 
employee benefit plans. A notice adopting the DFVC Program was 
published by the Department in the Federal Register on April 27, 1995, 
at 60 FR 20874. This notice will modify that Program.


Alternatives:


The DFVC Program is essentially a deregulatory initiative, and 
participation in the program is entirely voluntary. PWBA has determined 
that this approach is more flexible, efficient and protective of plans 
than regulatory alternatives which do not serve to encourage voluntary 
compliance with the statutory annual reporting requirements for 
employee benefit plans.


Anticipated Cost and Benefits:


Adoption of the DFVC Program modifications incorporated in this 
initiative will not impose increased costs upon participants, but will 
instead simplify the procedures for participation in the Program and 
facilitate compliance. Since participation in the Program is entirely 
voluntary, plan administrators would not be likely to participate if 
the costs in doing so were to exceed the benefits.


Risks:


Failure to adopt the modifications to the DFVC Program represented by 
this rulemaking would complicate compliance with ERISA's reporting 
requirements by plan administrators and may serve to discourage timely 
and complete reporting with regard to the operation of employee benefit 
plans.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
Modified Enforcement Policy                                    12/00/01
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: 202 693-8500
RIN: 1210-AA86
_______________________________________________________________________



DOL--Mine Safety and Health Administration (MSHA)

                              -----------

                             PRERULE STAGE

                              -----------




90. ASBESTOS EXPOSURE LIMIT
Priority:


Other Significant


Legal Authority:


30 USC 811; 30 USC 813


CFR Citation:


30 CFR 56; 30 CFR 57; 30 CFR 71


Legal Deadline:


None


Abstract:


MSHA's permissible exposure limit (PEL) for asbestos applies to surface 
(30 CFR part 56) and underground (30 CFR part 57) metal and nonmetal 
mines and to surface coal mines and surface areas of underground coal 
mines (30 CFR part 71) and is over 20 years old. Current scientific 
data indicate that this existing PEL is not adequate to protect miners' 
health. MSHA is considering rulemaking to lower the PEL in order to 
reduce the risk of miners developing asbestos-induced occupational 
disease. A recent report by the Office of the Inspector General (OIG) 
recommended that MSHA lower its existing permissible exposure limit for 
asbestos to a more protective level, and address take-home 
contamination from asbestos. It also recommended that MSHA use 
Transmission Electron Microscopy to analyze fiber samples that may 
contain asbestos.


Statement of Need:


Current scientific data indicate that the existing asbestos PEL is not 
protective of miners' health. MSHA's asbestos regulations date to 1967 
and are based on the Bureau of Mines (MSHA's predecessor) standard of 5 
mppcf (million particles per cubic foot of air). In 1969, the Bureau 
proposed a 2 mppcf and 12 fibers/ml standard. This standard was 
promulgated in 1969. In 1970, the Bureau proposed to lower the standard 
to 5 fibers/ml, which was promulgated in 1974. MSHA issued its current 
standard of 2 fibers/ml at the end of 1978 for metal and nonmetal 
mining [43 FR 54064]. Since enactment of the Mine Act, MSHA has 
conducted regular inspections at both surface and underground 
operations at metal and nonmetal mines. During these inspections, MSHA 
routinely takes

[[Page 61231]]

samples, which are analyzed for compliance with its standard.


Other Federal agencies have addressed this issue by lowering their PEL 
for asbestos. For example, the Occupational Safety and Health 
Administration, working in conjunction with the Environmental 
Protection Agency, enacted a revised asbestos standard in 1994 that 
lowered the permissible exposure limit and the excursion limit to an 
eight (8) hour time-weighted average limit of 0.1 fiber per cubic 
centimeter of air and to 1.0 fiber per cubic centimeter of air (1 f/cc) 
as averaged over a sampling period of thirty (30) minutes. These 
lowered limits reflected increased asbestos-related disease risk to 
asbestos-exposed workers.


Alternatives:


The Agency has increased sampling efforts in an attempt to determine 
current miners' exposure levels to asbestos, including taking samples 
at all existing vermiculite, taconite, talc, and other mines to 
determine whether asbestos is present and at what levels. Since the 
spring of 2000, MSHA has taken almost 900 samples at more than 40 
operations employing more than 4,000 miners. During those sampling 
events, the MSHA staff also discussed with the miners and mine 
operators the potential hazards of asbestos and the types of preventive 
measures that could be implemented to reduce exposures. The course of 
action MSHA takes in addressing asbestos hazards to miners will, in 
part, be based on these sampling results.


Anticipated Cost and Benefits:


MSHA will develop a preliminary economic analysis to accompany any 
proposed rule that may be developed.


Risks:


There is concern that miners could be exposed to the hazards of 
asbestos during mine operations where the ore body contains asbestos. 
There is also potential for exposure at facilities in which installed 
asbestos-containing material is present. Overexposure to asbestos 
causes mesothelioma and other forms of cancers, such as cancers of the 
digestive system, as well as asbestosis.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
ANPRM                                                          09/00/02
Regulatory Flexibility Analysis Required:


Undetermined


Small Entities Affected:


Businesses


Government Levels Affected:


None


Additional Information:


The Office of the Inspector General's ``Evaluation of MSHA's Handling 
of Inspections at the W.R. Grace & Company Mine in Libby, Montana,'' 
was issued in March 2001.


Agency Contact:
David L. Meyer
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-AB24
_______________________________________________________________________



DOL--MSHA

                              -----------

                            FINAL RULE STAGE

                              -----------




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


Other Significant


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 for each 
mechanized mining unit that we approve. 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 30 CFR parts 70 and 90.


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 mechanized 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, 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

[[Page 61232]]

powered air purifying respirators (PAPRS) in underground coal mines.


Anticipated Cost and Benefits:


Benefits sought are reduced dust levels over a miner's working lifetime 
by the elimination of over-exposures to respirable coal dust on each 
and every production shift. Additional benefits include reduced health 
care costs and 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. We developed 
cost 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. Occupational 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 non-regulatory 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                   09/08/00
Final Action                                                   09/00/02
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses


Government Levels Affected:


None


Additional Information:


This rulemaking is related to RIN 1219-AB18 (Determination of


Concentration of Respirable Coal Mine Dust).


Agency Contact:
David L. Meyer
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



92. 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 proposed that a single, full-
shift measurement (``single, full-shift sample'') will accurately 
represent the atmospheric condition to which a miner is exposed. The 
proposed rule addresses the U.S. Court of Appeals' concerns raised 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 they were over 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 dust 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 occupational 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 this regulation 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 reduced dust levels over a miner's working lifetime 
by the elimination of over-exposures to respirable coal dust on each 
and every production shift. Additional benefits include reduced health 
care costs and 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. We developed 
cost 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. Occupational exposure to excessive 
levels of respirable coal mine dust can cause 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                   09/08/00
Final Action                                                   09/00/02
Regulatory Flexibility Analysis Required:


Yes

[[Page 61233]]

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:
David L. Meyer
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

                              -----------




93. ASSIGNED PROTECTION FACTORS: AMENDMENTS TO THE FINAL RULE ON 
RESPIRATORY PROTECTION
Priority:


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


Unfunded Mandates:


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


Legal Authority:


29 USC 655(b); 29 USC 657


CFR Citation:


29 CFR 1910.134


Legal Deadline:


None


Abstract:


In January 1998, OSHA published the final Respiratory Protection 
standard (29 CFR 1910.134), except for reserved provisions on assigned 
protection factors (APFs) and maximum use concentrations (MUCs). APFs 
are numbers that describe the effectiveness of the various classes of 
respirators in reducing employee exposure to airborne contaminants 
(including particulates, gases, vapors, biological agents, etc.). 
Employers, employees, and safety and health professionals use APFs to 
determine the type of respirator to protect the health of employees in 
various hazardous environments. Maximum use concentrations establish 
the maximum airborne concentration of a contaminant in which a 
respirator with a given APF may be used.


Currently, OSHA relies on the APFs developed by NIOSH in the 1980s 
unless OSHA has assigned a different APF in a substance-specific health 
standard. However, many employers follow the more recent APFs published 
in the industry consensus standard, ANSI Z88.2-1992. For some classes 
of respirators, the NIOSH and ANSI APFs vary greatly.


When OSHA published the final Respiratory Protection standard in 1998, 
it reserved for later rulemaking those provisions of the standard 
dealing with APFs and MUCs. This rulemaking action will complete the 
1998 standard, reduce compliance confusion among employers, and provide 
employees with consistent and appropriate respiratory protection.


Statement of Need:


About 5 million employees wear respirators as part of their regular job 
duties. Due to inconsistencies between the APFs found in the current 
industry consensus standard (ANSI Z88.2-1992) and in the NIOSH 
Respirator Decision Logic, employers, employees, and safety and health 
professionals are often uncertain about what respirator to select to 
provide protection against hazardous air contaminants. Several industry 
and professional groups have asked OSHA to proceed with this rulemaking 
to resolve these inconsistencies and provide reliable protection of 
employees' health in cases where respirators must be worn.


Summary of Legal Basis:


The legal basis for this proposed rule is the determination that 
assigned protection factors and maximum use concentrations are 
necessary to complete the final Respiratory Protection standard and 
provide the full protection of that standard.


Alternatives:


OSHA has considered allowing the current situation to continue, in 
which OSHA generally enforces NIOSH APFs but many employers follow the 
more recent consensus standard APFs. However, allowing the continuation 
of this situation results in inconsistent enforcement, lack of guidance 
for employers, and the potential for inadequate employee protection.


Anticipated Cost and Benefits:


The scope of the proposed APF table is still under development, and 
estimates of the costs and benefits have not yet been developed.


Risks:


The preamble to the final Respiratory Protection rule (63 FR 1270, Jan. 
8, 1998) discusses the significance of the risks potentially associated 
with the use of respiratory protection. No independent finding of 
significant risk will be made for the APF rulemaking, since it only 
addresses a single provision of the larger rule.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
ANPRM           47 FR 20803                                    05/14/82
ANPRM Comment Period End                                       09/13/82
NPRM            59 FR 58884                                    11/15/94
Final Rule      63 FR 1152                                     01/08/98
Final Rule Effective                                           04/08/98
NPRM on APFs                                                   09/00/02
Regulatory Flexibility Analysis Required:


No


Government Levels Affected:


State, Local, Tribal, Federal


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-AA05
_______________________________________________________________________



DOL--OSHA



94. FIRE PROTECTION IN SHIPYARD EMPLOYMENT (PART 1915, SUBPART P) 
(SHIPYARDS: FIRE SAFETY)
Priority:


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


Unfunded Mandates:


Undetermined


Legal Authority:


29 USC 655

[[Page 61234]]

CFR Citation:


29 CFR 1915, subpart P


Legal Deadline:


None


Abstract:


This proposal is being developed through the negotiated rulemaking 
process. The rule will update and revise an important but outdated part 
of OSHA's shipyard rules. The original rule was adopted by OSHA in 1971 
and has remained unchanged since then. The negotiated rulemaking 
committee was convened on October 15, 1996; members of the committee 
include: OSHA, state government, Federal agency, small and large 
shipyard employers, and maritime and firefighter union representatives.


Statement of Need:


Fires in the shipyard environment claim the lives of several workers 
every year and thus account for a substantial number of deaths and more 
than 50 serious burns occurring in this 75,000-employee workforce. 
Updating OSHA's outdated shipyard requirements for fire extinguishers, 
sprinkler systems, detection systems, alarm systems, and fire brigades 
will facilitate compliance by employers and employees and reduce these 
fire-related injuries and fatalities.


Summary of Legal Basis:


The legal basis for this proposed rule is a preliminary determination 
that an unacceptable risk of fire-related injuries and fatalities 
exists in the shipyard industry.


Alternatives:


OSHA has considered but rejected the alternative of allowing the 
existing rule to remain in place, because the Agency believes that 
doing so would contribute to the unacceptable number of fire-related 
accidents occurring in shipyards every year.


Anticipated Cost and Benefits:


Detailed cost and benefits estimates have not yet been made for the 
rule, because it is still in draft form.


Risks:


A detailed risk analysis has not yet been completed for this rule.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           09/00/02
Regulatory Flexibility Analysis Required:


Undetermined


Small Entities Affected:


Businesses


Government Levels Affected:


Undetermined


Agency Contact:
Marthe B. Kent
Director, Directorate of Safety Standards Programs
Department of Labor
Occupational Safety and Health Administration
Room N3605
200 Constitution Avenue NW
FP Building
Washington, DC 20210
Phone: 202 693-2222
Fax: 202 693-1663
RIN: 1218-AB51
_______________________________________________________________________



DOL--OSHA



95. STANDARDS IMPROVEMENT (MISCELLANEOUS CHANGES) FOR GENERAL INDUSTRY, 
MARINE TERMINALS, AND CONSTRUCTION STANDARDS (PHASE II)
Priority:


Other Significant


Legal Authority:


29 USC 655(b)


CFR Citation:


29 CFR 1910.142; 29 CFR 1910.178; 29 CFR 1910.219; 29 CFR 1910.261; 29 
CFR 1910.265; 29 CFR 1910.410; 29 CFR 1910.1001 to 1910.1052; 29 CFR 
1926.60; 29 CFR 1926.62; 29 CFR 1926.1101; 29 CFR 1926.1127; 29 CFR 
1926.1129; 29 CFR 1917.92; 29 CFR 1910, subpart Z


Legal Deadline:


None


Abstract:


The Occupational Safety and Health Administration's (OSHA's) process of 
removing or revising provisions in its health standards are out of 
date, duplicative, unnecessary, or inconsistent. The Agency is 
proposing these changes to reduce the burden imposed on the regulated 
community by these requirements. In this document, substantive changes 
are proposed for standards that will revise or eliminate duplicative, 
inconsistent, or unnecessary regulatory requirements without 
diminishing employee protections. Phase I of this Standards Improvement 
process was completed in June 1998 (63 FR 33450). OSHA plans to 
initiate Phase III of this project at a future date to address problems 
in various safety standards.


Statement of Need:


Some of OSHA's standards are out of date, duplicative, unnecessary, or 
inconsistent. The Agency needs to periodically review its standards and 
make needed corrections. This effort results in standards that are 
easier for employers and employees to follow and comply with, and thus 
enhances compliance and worker protection.


Summary of Legal Basis:


The legal basis for the proposed rule is a preliminary finding that the 
OSHA standards need to be updated to bring them up to date, reduce 
inconsistency, and remove unneeded provisions.


Alternatives:


OSHA has considered updating each standard as problems are discovered, 
but has determined that it is better to make such changes to groups of 
standards so it is easier for the public to comment on like standards. 
OSHA has also considered the inclusion of safety standards that need to 
be updated. However, the Agency has decided to pursue a separate 
rulemaking for safety issues because the standards to be updated are of 
interest to different stakeholders.


Anticipated Cost and Benefits:


This revision of OSHA's standards is a deregulatory action. It will 
reduce employers' compliance obligations.


Risks:


The project does not address specific risks, but is intended to improve 
OSHA's standards by bringing them up do date and deleting unneeded 
provisions. The anticipated changes will have no negative effects on 
worker safety and health.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           09/00/02
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


None

[[Page 61235]]

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-AB81
_______________________________________________________________________



DOL--OSHA

                              -----------

                            FINAL RULE STAGE

                              -----------




96. UPDATE AND REVISION OF THE EXIT ROUTES STANDARD
Priority:


Other Significant


Legal Authority:


29 USC 655(b); 5 USC 353


CFR Citation:


29 CFR 1910.35; 29 CFR 1910.36; 29 CFR 1910.37; 29 CFR 1910.38


Legal Deadline:


None


Abstract:


Many Occupational Safety and Health Administration (OSHA) standards 
were adopted under section 6(a) of the Occupational Safety and Health 
Act (OSH Act; 29 U.S.C. 655(a)). This section of the OSH Act authorized 
the Agency, in its first 2 years of existence, to adopt national 
consensus standards without prior notice and comment. The versions of 
the consensus standards OSHA adopted are now typically well over 30 
years old and have been superseded by newer ones. In addition, many of 
these old standards were written in technical jargon and were hard for 
many employers and employees to understand.


To address these problems, OSHA is undertaking a consensus standards 
initiative to revise OSHA's exit routes (also known as means of egress) 
standard. The revisions will rewrite the standard in simple, easy-to-
understand language that will be easier for employers and employees to 
follow.


Statement of Need:


The standard being revised in this initiative is one of OSHA's oldest 
and most difficult to understand. The Agency has identified the exit 
routes standard as a standard in need of revision because it is out of 
date and unnecessarily complex, and stakeholders have recommended that 
the standard be updated quickly. OSHA also believes that revising the 
standard will lead to better voluntary compliance and fewer disputes 
about violations. With OSHA's limited resources, any effort that can 
substantially increase opportunities for compliance without sacrificing 
employee safety and health protection will have long-term benefits.


Summary of Legal Basis:


The legal basis for the final rule will be a finding that, by making 
these OSHA standards easier to understand and comply with, the Agency 
will increase compliance and reduce work-related injuries and deaths.


Alternatives:


The alternative considered - leaving the outdated standard on the books 
- has been rejected because doing so would not encourage compliance or 
enhance safety.


Anticipated Cost and Benefits:


The final standard for exit routes will have no economic impacts 
because this revision will not increase employers' obligations or 
reduce employee protections.


Risks:


Employees can be injured or killed if they are not able to exit an area 
safely when a fire or other emergency occurs.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            61 FR 47712                                    09/10/96
Public Hearing  62 FR 9402                                     04/29/97
Final Rule                                                     06/00/02
Regulatory Flexibility Analysis Required:


No


Government Levels Affected:


None


Agency Contact:
Marthe B. Kent
Director, Directorate of Safety Standards Programs
Department of Labor
Occupational Safety and Health Administration
Room N3605
200 Constitution Avenue NW
FP Building
Washington, DC 20210
Phone: 202 693-2222
Fax: 202 693-1663
RIN: 1218-AB82
_______________________________________________________________________



DOL--OSHA



97. SIGNS, SIGNALS, AND BARRICADES
Priority:


Other Significant


Unfunded Mandates:


Undetermined


Legal Authority:


29 USC 651(b); 29 USC 655(b); 40 USC 333


CFR Citation:


29 CFR 1926


Legal Deadline:


None


Abstract:


Subpart G of 29 CFR part 1926 addresses the types of signs, signals and 
barricades that must be used in situations such as work areas on 
highways. OSHA's rule incorporates a 1971 ANSI standard, known as the 
MUTCD (Manual on Uniform Traffic Control Devices). Since the early 
1970's, the U.S. Department of Transportation has drafted updates to 
the MUTCD. DOT requires all States to comply with its updates.


Several years ago, industry stakeholders asked OSHA to update its 
standard to reflect new technology and provide more flexibility for 
compliance.


OSHA has decided to use a Direct Final Rule to update its standard 
since it anticipates widespread support for and few objections to the 
change. The Agency's Advisory Committee on Construction Safety and 
Health endorsed using a Direct Final Rule to make this change in its 
Winter 2000 meeting.


With the current emphasis on rebuilding the Nation's highways and 
improving safety in work zone areas, OSHA's update is particularly 
appropriate.

[[Page 61236]]

Statement of Need:


The safe and efficient flow of traffic through construction work zones 
is a major concern to transportation officials, the highway industry 
and the traveling public. Today the majority of highway funds are being 
used on system preservation-type projects (resurfacing, restoration, 
rehabilitation, and reconstruction) on the existing highway system; 
highway construction of this type is at an all time high and will 
continue for several years to come.


The fatality rate for highway construction workers is twice the rate 
for other types of construction trades (DOT FHWA Office of Program 
Quality Coordination, Sept. 1998).


Summary of Legal Basis:


The legal basis for this direct final rule is a finding by the 
Secretary of Labor that the number of highway work zone injuries and 
fatalities is high and that the outdated OSHA standard may be 
contributing to this result.


Alternatives:


The Directorate of Construction has formed a task group to formulate a 
plan for reducing the number of highway work zone fatalities. In order 
for this group to accomplish its mission the standards must reflect new 
technology and best practices. Other alternatives, such as compliance 
assistance and partnership programs, will not achieve these goals.


Anticipated Cost and Benefits:


The overwhelming majority of public roads are currently covered by DOT 
regulations and their related State traffic control manuals. Moreover, 
private roads constitute the minority of total roads, and some local 
governments extend coverage to these roads. Accordingly, OSHA will be 
solely responsible for regulating only a fraction of all highway work. 
The costs of compliance for those solely regulated by OSHA will, 
therefore, be much lower than those estimated for compliance with DOT 
regulations. Because DOT has found no significant costs of compliance 
for revisions of the MUTCD over the years, the costs of compliance for 
OSHA's direct final rule likewise will not be significant under 
Executive Order 12866.


Risks:


OSHA believes that the adoption of the direct final rule will have a 
direct impact on the safety of workers engaged in work zone activities, 
although the extent of this risk reduction has not been quantified at 
this point.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
Direct Final Rule                                              01/00/02
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


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-AB88
BILLING CODE 4510-23-S

[[Page 61237]]




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, occupational safety and health, 
property asset management, seismic safety, security, and the use of 
aircraft and vehicles.
 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.
 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. 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. During the next year, the Department will be taking 
steps to further improve our regulations by ensuring timely completion 
of quality rulemaking actions. We will be creating an Internet site 
where the public can access up-to-date information about the status of 
our significant rulemakings. We will also be developing a ``list 
serve'' for our Internet-accessible rulemaking dockets to permit the 
public to sign up for email notification when the Department issues a 
rulemaking document.
 In addition, the Department continues to engage 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, and Executive Order 12866. This also includes determining 
if the rules would be more understandable if they are written using the 
plain language approach. 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 new statutes and Executive 
orders. Although OST's principal role concerns the review of the 
Department's significant rulemakings, this office has the lead 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.
 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.
 During fiscal year 2002, OST expects to publish a notice of proposed 
rulemaking (NPRM) on whether it should readopt its rules governing 
airline computer reservation systems (CRS) and, if so, whether they 
should be strengthened, and if they should be applied to the sale of 
airline services over the Internet. OST expects to substantially 
complete work on a CRS final rule during the fiscal year. OST also 
expects to publish two NPRMs to implement provisions of the Aviation 
Investment and Reform Act for the 21st Century, signed into law in 
April 2000. One NPRM will seek to amend 14 CFR part 382, DOT's Air 
Carrier Access Act (ACAA) implementing rule, to cover foreign carriers 
operating to and from the United States or code sharing with the U.S. 
carriers. Another NPRM will propose to require air carriers to file 
with DOT detailed information on the disability-related complaints they 
receive to be used for enforcement, educational and other relevant 
purposes by DOT, disabled air travelers and Congress. OST also expects 
to substantially complete work on a final rule on the reporting 
requirements during FY 2002.
 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

[[Page 61238]]

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 include 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 20 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 continues using plain language format for its 
            notices and regulations. 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 recognizes that this format facilitates better 
            understanding of regulations and promotes more public 
            participation.
 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 an effort to make sure 
their rules are concise and easy to understand, the FAA re-examined the 
use of plain language in their 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 the regulations. 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 Aviation Rulemaking Advisory 
            Committee completed numerous reports and recommendations, 
            leading to the publication of seven regulatory actions and 
            issuance of several advisory circulars and other guidance 
            materials. The FAA Aging Transport Nonstructural Systems 
            Plan addresses concerns with potential safety issues 
            associated with problems that may develop in transport 
            category airplanes systems as a result of wear and 
            degradation in service. One important component of the plan 
            is use of the Aging Transport Nonstructural Systems 
            Rulemaking Advisory Committee to provide a mechanism for 
            public input to FAA activities. The FAA will receive 
            recommendation from the Committee in the form of 
            regulations, guidance materials and training requirements 
            supporting enhanced airworthiness for airplane systems.
 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 FAA has published 30 regulations based on 
            recommendations of ARAC that will lead to harmonizing FAA 
            regulations and Joint Aviation Requirements.
 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 2001-2002 include a duty limitations and 
rest requirements proposal to ensure that pilots are sufficiently 
rested for duty, and final rules concerning certification of airports 
and thermal acoustic insulation flammability and fractional ownership.
Federal Highway Administration (FHWA)
 The FHWA anticipates that its priority for fiscal year 2002 will be 
continuing implementation of the

[[Page 61239]]

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 continue to 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.
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 
toward the goal of reducing the number of fatalities resulting from 
crashes involving large trucks. Setting new performance standards for 
vehicles, drivers, and motor carriers through regulation will 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. Several new 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, the use/misuse of air bag on-off switches, and odometer 
fraud. 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 processor-based signal and train control systems; 
(7) the development of a new accident reporting threshold; (8) the 
revision of FRA's accident/incident reporting regulations to ensure 
conformity with OSHA's revised occupational injury and illness 
reporting regulations; and (9) the 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 also employed a working group to develop 
Passenger Train Emergency Preparedness regulations. FRA continues to 
conduct research related to the second phase of the rule, and expects 
to convene a reconstituted working group on Passenger Safety Standards 
in late 2001. 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.

[[Page 61240]]

 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 2001-2002 
are to continue to issue rulemakings required under the Transportation 
Equity Act for the 21st Century (TEA-21), to amend existing regulations 
as needed, and to update existing regulations for plain language.
 FTA will publish a rule implementing the Clean Fuels Formula Grant 
Program authorized by TEA-21. The program will assist eligible 
applicants in meeting the objectives of reducing transit bus emissions 
and supporting emerging markets for clean fuel technologies.
 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.
Maritime Administration (MARAD)
 MARAD administers Federal laws and programs designed to promote and 
maintain a 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.
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.
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.
 During FY 2002, BTS expects to publish a notice of proposed rulemaking 
(NPRM) and final rule concerning airline delays and cancellations. BTS 
is exploring the feasibility of collecting information as to the causes 
of flight delays and cancellations. As part of a pilot project 
examining the feasibility of developing a uniform collection 
methodology, four volunteer air carriers have been providing to BTS, on 
a confidential basis, flight delay and cancellation causal data. BTS 
hopes to develop a reporting system that would allow relevant causal 
information to be disseminated to the traveling public. In addition, a 
reporting system would enable the Department to better identify the 
causes of delays and evaluate its efforts to mitigate such causes.
 BTS' 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 created by Congress in 1954. The primary 
operating service of the SLSDC is to ensure the safe transit of

[[Page 61241]]

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

                              -----------




98. +SALVAGE AND MARINE FIREFIGHTING REQUIREMENTS; VESSEL RESPONSE 
PLANS FOR OIL (USCG-1998-3417)
Priority:


Other Significant


Legal Authority:


33 USC 1321


CFR Citation:


33 CFR 155


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 salvage and marine 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                                02/12/98
Final Rule - Par66 FR 3876nsion                                01/17/01
NPRM                                                           02/00/02
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. The project was 
originally titled ``Salvage and Firefighting Equipment; Vessel Response 
Plans.'' The change was made in order to distinguish this project from 
other similarly titled projects within the Coast Guard.


Agency Contact:
Douglas Lincoln
Project Manager, G-MOR-3
Department of Transportation
U.S. Coast Guard
2100 Second Street SW
Washington, DC 20593-0001
Phone: 202 267-0448
RIN: 2115-AF60
_______________________________________________________________________



DOT--USCG



99. +TANK LEVEL OR PRESSURE MONITORING DEVICES (USCG-2001-9046)
Priority:


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


Unfunded Mandates:


Undetermined


Legal Authority:


46 USC 3703


CFR Citation:


46 CFR 32; 33 CFR 157


Legal Deadline:


Final, Statutory, August 1991, Section 4110 of the Oil Pollution Act of 
1990 (OPA 90).


Final, Judicial, May 2002.


Abstract:


The U.S. Court of Appeals for the District of Columbia issued a Writ of 
Mandamus requiring the Coast Guard to promulgate regulations for tank 
level or pressure monitoring (TLPM) devices as mandated by OPA 90. This 
regulatory project will establish performance standards for TLPM 
devices and require tank vessels to install such devices. This project 
is considered economically significant because of substantial public 
and industry interest and possible significant economic impact of the 
rulemaking. This rulemaking falls under the Coast Guard's strategic 
goal of protection of natural resources.


Statement of Need:


This rulemaking is required by section 4110 of the Oil Pollution Act of 
1990, P.L. 101-380.

[[Page 61242]]

Summary of Legal Basis:


This rule is required by section 4110 of the Oil Pollution Act of 1990 
as determined by the U.S. Court of Appeals for the D.C. circuit in May 
2001. The Coast Guard is under a Writ of Mandamus to publish a rule 
requiring the use of Tank Vessel Pressure Monitoring devices.


Alternatives:


Alternatives considered for analysis include two performance standards, 
however, the same cost will be achieved using either standard. We also 
considered the applicability of the rule to different types of vessels. 
Variations of these alternatives are presented as eight options in the 
NPRM.


Anticipated Cost and Benefits:


The present value cost of the proposed rule over the 13-year period of 
analysis (2002-2014) would range from approximately $64 million to $211 
million depending on the option selected. Virtually all of the costs 
will be incurred during the 3-year or 5-year phase-in period. Under the 
most expensive option, the cost in nominal terms is estimated to be $80 
million. Over the 13-year period of analysis, this analysis estimates 
that TLPM devices will reduce the amount of oil spilled in the United 
States by an estimated range of 211 barrels to 1,425 barrels, depending 
on the option selected.


Risks:


This rule addresses the risk of slow leakage from tank vessels that 
might otherwise go undetected. It is one of the many statutory 
requirements mandated by the Oil Pollution Act of 1990, which 
eliminates a number of oil pollution risks.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            66 FR 49877                                    10/01/01
NPRM Comment Period End                                        11/30/01
Regulatory Flexibility Analysis Required:


Undetermined


Small Entities Affected:


Businesses


Government Levels Affected:


Undetermined


Energy Effects:


 Statement of Energy Effects planned as required by Executive Order 
13211.


Additional Information:


This project is reopened with a new RIN and DMS docket number. The 
Coast Guard is reopening this project per writ of mandamus by the D.C. 
Circuit Court directing the Coast Guard to implement certain provisions 
of the Oil Pollution Act of 1990. It was previously captioned with 
docket number 90-071, and RIN 2115-AD69.


Agency Contact:
LCDR Glen Mine
Project Manager, G-MSR-2
Department of Transportation
U.S. Coast Guard
2100 Second Street SW
Washington, DC 20593-0001
Phone: 202 267-1303
RIN: 2115-AG10
_______________________________________________________________________



DOT--USCG

                              -----------

                            FINAL RULE STAGE

                              -----------




100. +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 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 
are 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

[[Page 61243]]

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
Interim Final Rule                                             08/00/02
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


None


Additional Information:


Old Docket Number CGD 94-048. 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.


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



DOT--USCG



101. +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 United States 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 
are 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

[[Page 61244]]

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 Period Extended                                   06/15/99
NPRM Comment Period End                                        06/21/99
NPRM Extended Comment Period End                               08/30/99
Interim Final Rule                                             02/00/02
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


None


Additional Information:


Old Docket Number CGD 94-032.


Public meetings 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 
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 Street SW
Washington, DC 20593-0001
Phone: 202 267-0106
RIN: 2115-AE88
_______________________________________________________________________



DOT--Federal Aviation Administration (FAA)

                              -----------

                          PROPOSED RULE STAGE

                              -----------




102. +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
NPRM Comment Per61 FR 11492d to 6/19/96                        03/20/96
SNPRM                                                          12/00/01
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

[[Page 61245]]

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

                              -----------




103. +IMPROVED FLAMMABILITY STANDARDS FOR THERMAL/ACOUSTIC INSULATION 
MATERIALS USED IN TRANSPORT CATEGORY AIRPLANES
Priority:


Other Significant


Legal Authority:


49 USC 106(g); 49 USC 44701; 49 USC 44702; 49 USC 44704


CFR Citation:


14 CFR 25


Legal Deadline:


None


Abstract:


This document proposes upgraded flammability standards that 
specifically address flame propagation and entry of an external fire 
into the airplane (burnthrough) under realistic fire scenarios. The 
proposed standards are intended to reduce the incidence and severity of 
cabin fires, particularly those ignited in inaccessible areas where 
thermal/acoustic insulation materials are typically installed. Also the 
proposed standards would provide an increased level of safety with 
respect to post-crash fires by delaying the entry of such a fire into 
the cabin, thereby providing additional time for evacuation and 
enhancing survivability. The new standards would apply to new type 
designs, and newly manufactured airplanes entering parts 91, 121, 125, 
and 135 service. This action is significant because of substantial 
public interest.


Statement of Need:


Service history and laboratory testing demonstrate that the current 
flammability requirements applicable to thermal/acoustic insulation 
materials may not be providing the intended protection against the 
spread of fires. Additionally, the FAA considers that increased 
protection against external fire penetrating the fuselage can be 
provided by proper selection of the same material. These new test 
methods would not only provide for increased in-flight fire safety, by 
reducing the flammability of thermal/acoustic insulation blankets, but 
would provide increased time for evacuation during externally fed, post 
crash fires by increasing fuselage burnthrough resistance.


Summary of Legal Basis:


49 USC 4401 empowers the Administrator to prescribe regulations and 
minimum standards in the interest of safety for aircraft and equipment.


Alternatives:


The FAA considered several options to identify the least intrusive and 
most cost effective alternative to increase the level of safety for 
insulation materials. The alternatives considered were as follows: (1) 
Utilize the industry test instead of the requirements proposed; this 
would not screen out certain types of materials shown to propagate a 
fire under more realistic conditions, but would screen out the worst 
performers. (2) Limit replacement of insulation materials to only 
certain parts of the airplane; it is not feasible to specify areas of 
the airplane that are more crucial than others. This would be an 
economic consideration that would not address safety issues. (3) Change 
the effectivity or compliance times to reduce the number of airplanes 
affected; the proposal will be designed to optimize costs versus 
benefits in this regard. Changes to either would be less than optimal. 
(4) Propose some combination of the above. Other combinations would 
either reduce the level of safety or be less cost-effective.


Anticipated Cost and Benefits:


The total costs of this rule is $68.0 million, or $36.5 million 
discounted to present value if only blanket material changes are made 
to the aircraft. If manufacturers need to make configuration changes to 
the aircraft as well as material changes to their drawings, the FAA 
estimates that total costs would be $103.1 million or $68.2 million 
discounted to present value. The FAA is unable to quantify the benefits 
for this rule. However, preventing the loss of one airplane and its 
passengers over the 20-year period is not likely. Assuming such a loss 
would occur at the midpoint of the analysis, or in 2009, with 169 
passengers, the nondiscounted loss would be $455.5 million, or $231.5 
million discounted to present value (again, assuming society's 
willingness to pay $2.7 million to avoid a fatality). This loss does 
not include the value of the airplane. Even without loss of life, as 
several of the incidents show, a hull loss could exceed tens of 
millions of dollars. The FAA therefore has determined that this 
proposed rule would be cost beneficial.


Risks:


The FAA is aware of several events in which the flammability 
characteristics of thermal/acoustic insulation material may have been a 
contributing factor of airplane fires. The FAA initiated investigations 
and research to determine the appropriateness of applying existing 
Bunsen burner flammability criteria to thermal/acoustic insulation, as 
typically installed in concealed and inaccessible areas. This rule is 
necessary to decrease the risk of fires on airplanes and to improve 
airplane fire safety.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            65 FR 56992                                    09/20/00
NPRM Comment Period End                                        01/18/01
Final Rule                                                     05/00/02
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


None


Additional Information:


Project Number: ANM-99-086R.


ANALYSIS: Regulatory Evaluation, 04/00/01


Agency Contact:
Jeff Gardlin
Aircraft Certification Service
Department of Transportation
Federal Aviation Administration
1601 Lind Avenue SW
Renton, WA 98055-4056
Phone: 425 227-2136
RIN: 2120-AG91

[[Page 61246]]

_______________________________________________________________________



DOT--FAA



104. +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


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 to 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 to 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 to 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 proposal. 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
Correction      65 FR 50669                                    08/21/00
NPRM Comment Per65 FR 50945d                                   08/22/00
NPRM Comment Period End                                        09/19/00
NPRM Comment Period End                                        11/03/00
Final Action                                                   01/00/02
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 Motor Carrier Safety Administration (FMCSA)

                              -----------

                            FINAL RULE STAGE

                              -----------




105. +HOURS OF SERVICE OF DRIVERS; DRIVER REST AND SLEEP FOR SAFE 
OPERATIONS (RULEMAKING RESULTING FROM A SECTION 610 REVIEW)
Priority:


Economically Significant. Major under 5 USC 801.

[[Page 61247]]

Unfunded Mandates:


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


Legal Authority:


49 USC 31136; 49 USC 31502; PL 74-255; PL 84-939; PL 98-554; PL 103-
311; PL 104-59; PL 104-88; PL 106-159


CFR Citation:


49 CFR 1.73; 49 CFR 395


Legal Deadline:


Other, Statutory, March 1, 1996, ANPRM. PL 104-88,sec 408(a).


NPRM, Statutory, November 5, 1997, PL 104-88, sec 408(b).


Final, Statutory, November 5, 1999, PL 104-88, sec 408(b).


Abstract:


This action would revise the regulations for commercial motor vehicle 
driver rest requirements and duty period limitations for safe highway 
transportation. A broad rulemaking is required by the ICC Termination 
Act of 1995 (ICCTA). Other congressional actions prior to the ICCTA 
require modifications to the current rules.


This rulemaking responds to public and congressional interest in 
regulating commercial motor vehicle driver rest requirements, the 
NTSB's safety recommendations, petitions for rulemaking, and scientific 
data. There is substantial public and congressional interest in the 
regulation of medium- and heavy-duty truck and bus drivers' sleep, off-
duty, and working periods of time. The FMCSA has proposed new rules 
based upon comments and scientific data submitted to the advance notice 
of proposed rulemaking docket. The proposal includes an initial 
regulatory flexibility analysis, a cost-benefit analysis, an unfunded 
mandates analysis, and a paperwork reduction analysis. This action is 
considered significant because of substantial public and congressional 
interest.


Statement of Need:


The motor carrier industry requires 24-hour activities to meet the 
operational demands of a healthy U.S. economy. Growth in long-haul, 
regional, overnight, local, for-hire and private carriage operations is 
increasing with the unprecedented growth of the U.S. economy. 
Therefore, night work, shift work, and irregular work schedules 
continue to be commonplace.


The scientific knowledge about sleep, sleep disorders, circadian 
physiology, fatigue, and performance decrements has also grown. One of 
the purposes of this rulemaking is to incorporate as much of the 
scientific knowledge as possible into the applicable regulations.


Summary of Legal Basis:


Section 31136 of title 49, United States Code, authorizes the Secretary 
of Transportation to prescribe minimum safety standards for commercial 
motor vehicles (Motor Carrier Safety Act of 1984, Pub. L. 98-554, Title 
II, October 30, 1984). Regulations prescribed under this section must 
ensure that: (1) commercial motor vehicles are operated safely; (2) the 
responsibilities imposed on operators of commercial motor vehicles do 
not impair their ability to operate the vehicle safely (3) the physical 
condition of operators of commercial motor vehicles is adequate to 
enable them to operate the vehicles safely; and (4) the operation of 
commercial motor vehicles does not have a deleterious effect on the 
physical condition of the operators.


Section 31502 of Title 49, United States Code, authorizes the Secretary 
of Transportation to prescribe maximum hours-of-service and 
qualifications requirements for operators of motor carriers when needed 
to promote the safety of operations (Motor Carrier Act of 1935, Pub. L. 
74-255, August 9, 1935; and Migrant Farm Workers-Regulation of 
Interstate Transportation Act, Public Law 84-939, August 3, 1956).


Section 113 of the Hazardous Materials Transportation Authorization Act 
of 1994 (Pub. L. 103-311, August 26, 1994) requires the Secretary of 
Transportation to prescribe regulations amending part 395 to improve 
the compliance by commercial motor vehicle drivers and motor carriers 
with HOS requirements and the effectiveness and efficiency of Federal 
and State enforcement officers reviewing such compliance.


Section 345 of the National Highway System Designation Act of 1995 
(Pub. L. 104-159, November 28, 1995) created four specific exemptions 
from the hours-of-service-of-drivers requirements of part 395. A fifth 
exemption applied only to commercial driver licensing-related 
requirements requiring testing of operators for alcohol and controlled 
substances. The Secretary of Transportation was authorized to conduct 
rulemaking, except for the water well drilling hours-of-service 
exemption, to negate or modify the exemptions upon a determination, 
after a rulemaking proceeding, that the exemption is not in the public 
interest and would have a significant adverse impact on the safety of 
commercial motor vehicles.


Section 408 of the ICC Termination Act of 1995 (Pub. L. 104-88, 
December 29, 1995) requires the Federal Highway Administration 
(functions transferred to the Federal Motor Carrier Safety 
Administration under Pub. L. 106-159) to issue a final rule dealing 
with a variety of fatigue-related issues pertaining to commercial motor 
vehicle safety (including 8 hours of continuous sleep after 10 hours of 
driving, loading and unloading operations, automated and tamper-proof 
recording devices, rest and recovery cycles, fatigue and stress in 
longer combination vehicles, fitness for duty, and other appropriate 
regulatory and enforcement countermeasures for reducing fatigue-related 
incidents and increasing driver-alertness).


Alternatives:


The FMCSA proposes replacing the current rules with an alternative set 
of rules based upon scientific knowledge and submitted comments. The 
FMCSA is considering different regulations for different types of 
drivers and operations.


The FMCSA will also consider modifying the information collection 
burdens that have been placed upon the motor carrier industry, 
including the following types of recordkeeping methods: (1) Reducing 
the required items on the record of duty status (log book); (2) adding 
electronic on-board recording devices to commercial motor vehicles; (3) 
eliminating all FMCSA hours-of-service record keeping requirements 
while relying exclusively on the duplicative hours-of-work record 
keeping system required by the U.S. Department of Labor under the Fair 
Labor Standards Act of 1938, as amended.


The FMCSA is proposing a revision to the hours-of-service regulations 
to require motor carriers to provide their drivers with better 
opportunities to obtain sleep than the current rules, and thereby 
reduce the number of fatigue-related crashes involving these drivers. 
We estimate that 755 fatalities and 19,705 injuries occur each year on 
the Nation's roads because of drowsy, tired or fatigued CMV drivers.


The proposed rules would make three major changes. First, and most 
importantly, the new rules would be science-based (related to sleep 
cycles) and put all drivers in a 24-hour daily cycle. Second, they 
would reduce the total number of hours behind the wheel in a given 24-
hour cycle to no more

[[Page 61248]]

than 12 hours. Under current rules, a driver can reach the 60-hour on-
duty limit in 4 days and 4 hours, and the 70-hour limit in less than 5 
days. Third, long-haul and regional drivers (who spend one or more 
nights away from their normal work reporting locations) would be 
required, eventually, to use electronic on-board recording devices 
(EOBRs). These proposed changes would abandon a one-size-fits-all 
approach to work-rest cycles and adopt different rest periods for 
different types of operations.


The FMCSA has received more than 51,000 comments to date. As we are 
committed to fully exploring all issues and concerns of stakeholders, 
we held eight public hearings in may, June and July 2000, and followed 
up three public roundtable discussions in September and October 2000 on 
issues that attracted significant comment in the hearings.


The roundtables drew broad public participation and elicited in-depth 
discussion and exchange of supporting data on critical issues, 
including issues surrounding the economic analyses and assumptions used 
by the agency. The discussions provided the agency with information 
requiring careful analysis. This will help the FMCSA identify any 
necessary changes to the proposal that would address stakeholders' 
divergent concerns and support the development of a successful rule.


The FY 2001 Department of Transportation Appropriations Act, Pub. L. 
106-346, includes language that prohibits the Department from adopting 
a final rule before October 1, 2001. This is consistent with the 
Department's pledge to carefully review and consider the extensive 
record that has been established on the rulemaking before deciding on 
the next appropriate step in the rulemaking process.


Anticipated Cost and Benefits:


The FMCSA has placed a Preliminary Regulatory Evaluation (PRE) in the 
docket. The PRE evaluates five options, based on identified key 
parameters. The selected option, which divides the industry into 
different types of motor carrier operations, is projected to save 115 
lives and 2,995 injuries per year with a total net benefit of almost 
$3.359 billion, assuming that 15 percent of CMV-involved crashes are 
fatigue-related. Readers are directed to the PRE and the preamble of 
the NPRM for additional information.


Risks:


Fatigue is increasingly becoming the focus of possible causes following 
many crashes. Driver reports of being fatigued to the point of 
incapacity are not uncommon, and intuitively, it is reasonable, given 
the sheer volume of traffic, to expect fatigue to be a factor in future 
crashes if the regulations are not corrected. Fatigue was identified by 
the industry, public, and government as the highest priority safety 
issue at a 1995 Truck and Bus Safety Summit in Kansas City, MO.


The FMCSA has established a goal to reduce by 50 percent over ten years 
the number of fatalities from crashes involving any commercial motor 
vehicle. The FMCSA anticipates its proposal will reduce fatigue-related 
crashes by at least 15 percent each year to assist in its efforts to 
meet its overall goal of 50 percent reduction in deaths.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
ANPRM           61 FR 57251                                    11/05/96
Notice of Meetin62 FR 6161                                     02/11/97
ANPRM Comment Period End                                       03/31/97
NPRM            65 FR 25540                                    05/02/00
Notice of Hearin65 FR 26166                                    05/05/00
Notice of Hearin65 FR 32070                                    05/22/00
Notice of change65 FR 34132 structure                          05/26/00
NPRM; Correction65 FR 34904                                    05/31/00
Notice of Hearin65 FR 36809                                    06/12/00
Comment Period E65 FR 37956                                    06/19/00
Comment Period E65 FR 49780undtable Meetings                   08/15/00
NPRM Comment Period End                                        12/15/00
Final Action                                                   09/00/02
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses, Governmental Jurisdictions, Organizations


Government Levels Affected:


State, Local, Federal


Federalism:


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


Additional Information:


Transferred from RIN 2125-AD93.


During the agency's broad section 610 review of the 65-year history of 
the rule and all its amendments and revisions, the agency identified 
that RINs 2125-AD52, 2125-AD81, 2126-AA16, and 2126-AA29 also contain 
pertinent actions that must be incorporated into this action. 
Therefore, the agency incorporated them and has published a combined 
proposal addressing the entire topic of hours-of-service of drivers and 
related recordkeeping issues.


The DOT Docket Management System now identifies this rulemaking as 
number FMCSA-1997-2350.


More Information on ALTERNATIVES:


The FMCSA is proposing a revision to the hours-of-service regulations 
to require motor carriers to provide their drivers with better 
opportunities to obtain sleep than the current rules, and thereby 
reduce the number of fatigue-related crashes involving these drivers. 
We estimate that 755 fatalities and 19,705 injuries occur each year on 
the Nation's roads because of drowsy, tired or fatigued CMV drivers.


The proposed rules would make three major changes. First, and most 
importantly, the new rules would be science-based (related to sleep 
cycles) and put all drivers in a 24-hour daily cycle. Second, they 
would reduce the total number of hours behind the wheel in a given 24-
hour cycle to no more than 12 hours. Under current rules, a driver can 
reach the 60-hour on-duty limit in 4 days and 4 hours, and the 70-hour 
limit in less than 5 days. Third, long-haul and regional drivers (who 
spend one or more nights away from their normal work reporting 
locations) would be required, eventually, to use electronic on-board 
recording devices (EOBRs). These proposed changes would abandon a one-
size-fits-all approach to work-rest cycles and adopt different rest 
periods for different types of operations.


The NPRM is a proposal. The FMCSA has extensively solicited public 
comments at 8 public hearings and 3 public roundtable discussions. The 
agency has received more than 51,000 comments in docket no. FMCSA-97-
2350. The agency is reviewing these comments to ensure that it can make 
appropriate decisions about the next steps in the rulemaking process.

[[Page 61249]]

Agency Contact:
David R. Miller
Transportation Specialist, Office of Policy, Plans and Regulations
Department of Transportation
Federal Motor Carrier Safety Administration
MC-PRR
400 Seventh Street SW.
Washington, DC
Phone: 202 366-5011
RIN: 2126-AA23
_______________________________________________________________________



DOT--National Highway Traffic Safety Administration (NHTSA)

                              -----------

                          PROPOSED RULE STAGE

                              -----------




106. +FRONTAL OFFSET PROTECTION
Priority:


Other Significant


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 
an 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 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                                                           06/00/02
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


Businesses


Government Levels Affected:


None


Agency Contact:
Roger Saul
Director, Office of Crashworthiness Standards
Department of Transportation
National Highway Traffic Safety Administration
400 Seventh Street SW.
Washington, DC 20590
Phone: 202 366-1740
Fax: 202 366-4329
Email: [email protected]
RIN: 2127-AH73
_______________________________________________________________________



DOT--Federal Railroad Administration (FRA)

                              -----------

                          PROPOSED RULE STAGE

                              -----------




107. +STANDARDS FOR DEVELOPMENT AND USE OF PROCESSOR-BASED SIGNAL AND 
TRAIN CONTROL SYSTEMS
Priority:


Other Significant


Legal Authority:


49 USC 20103


CFR Citation:


49 CFR 234; 49 CFR 236; 49 CFR 209


Legal Deadline:


None


Abstract:


Consistent with congressional mandate, FRA has continued its commitment 
to supporting Positive Train Control (PTC) technology development, 
testing and compatibility; and promoting deployment of PTC technology 
in the

[[Page 61250]]

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 formed the basis 
for proceeding to an NPRM that can facilitate introduction of advanced 
technology, including systems that support PTC functions. The 
rulemaking will address technical standards for all processor-based 
signal and train control products, amending 49 CFR part 236.


Statement of Need:


Current FRA regulations do not adequately address the use of signal and 
train control technology that is processor-based. In fact, application 
of current regulations to processor-based systems can create 
unnecessarily 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 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 requirement as is, and (2) adopting a single 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 single design 
standard would inhibit innovative signal and train control system 
designs.


Anticipated Cost and Benefits:


The proposed rule would provide flexible performance 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 accrue.


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 
that occur due to improper train operations and certain types of 
vandalism. Types of accidents that may be prevented include train-to-
train collisions, derailments due to excessive train speed, and trains 
penetrating the work limits of roadway workers.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            66 FR 42351                                    08/10/01
NPRM Comment Period End                                        10/09/01
Final Rule                                                     03/00/02
Regulatory Flexibility Analysis Required:


Undetermined


Small Entities Affected:


Businesses


Government Levels Affected:


Undetermined


Federalism:


 Undetermined


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--Federal Transit Administration (FTA)

                              -----------

                          PROPOSED RULE STAGE

                              -----------




108. +CLEAN FUELS FORMULA GRANT PROGRAM
Priority:


Other Significant


Legal Authority:


PL 105-178, sec 3008; 49 USC 5308


CFR Citation:


49 CFR 624


Legal Deadline:


None


Abstract:


Section 3008 of the Transportation Equity Act for the 21st Century 
establishes the Clean Fuels Formula

[[Page 61251]]

Grant Program. This grant program will assist transit systems in 
purchasing or leasing clean fuel vehicles; constructing clean fuel or 
electrical re-charging facilities; modifying existing garage facilities 
to accommodate clean fuel vehicles; repowering pre-1993 engines with 
clean fuel technology which meets the current bus emission standards; 
and retrofitting or rebuilding pre-1993 engines before their half-life 
for rebuilding. This provision requires the Secretary to issue an 
implementing regulation that sets forth eligibility requirements and an 
apportionment formula for eligible projects. In FY 1999, all funds were 
apportioned to earmarked projects. This action is considered 
significant because of considerable congressional and public interest.


Statement of Need:


This rulemaking is intended to assist nonattainment and maintenance 
areas in achieving or maintaining air quality attainment status. The 
program also seeks to support emerging clean fuel and advanced 
propulsion technologies for transit buses and to create markets for 
these technologies.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            66 FR 45551                                    08/28/01
NPRM Comment Period End                                        10/21/01
Final Rule                                                     01/00/02
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


Local


Agency Contact:
Scheryl Portee
Attorney Advisor
Department of Transportation
Federal Transit Administration
400 Seventh Street SW.
Washington, DC 20590
Phone: 202 366-1936
Fax: 202 366-3809
RIN: 2132-AA64
_______________________________________________________________________



DOT--Research and Special Programs Administration (RSPA)

                              -----------

                          PROPOSED RULE STAGE

                              -----------




109. +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:


RSPA made a preliminary determination that there is neither an increase 
nor decrease in the costs of compliance with the HMR for persons who 
offer hazardous materials for transportation or transport hazardous 
materials in commerce. The preliminary regulatory evaluation was 
entered into the docket and is available for review.


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.

[[Page 61252]]

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            66 FR 32420                                    06/14/01
NPRM Comment Per66 FR 40174d & Public Meetings                 08/02/01
Comment Period E66 FR 40174                                    08/02/01
Comment Period End                                             11/30/01
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.


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 61253]]




DEPARTMENT OF THE TREASURY (TREAS)



Statement of Regulatory Priorities
 The primary missions of the Department of the Treasury are:
 To promote prosperous and stable American and world economics, 
including promoting domestic economic growth and maintaining our 
Nation's leadership in global economic issues, supervising national 
banks and thrift institutions, and helping to bring residents of 
distressed communities into the economic mainstream;
 To manage the Government's finances by protecting and collecting the 
correct amount of revenue under the Internal Revenue Code and customs 
laws, financing the Federal Government and managing its fiscal 
operations, and producing our Nation's coins and currency; and
 To safeguard our financial systems, protect our Nation's leaders, and 
secure a safe and drug-free America by 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; protecting the President, 
Vice President, certain foreign diplomatic personnel, and others; and 
training Federal, State, and local law enforcement officers.
 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.
 On October 26, 2001, the President signed into law the USA PARTRIOT 
Act of 2001. In the coming months the Department of the Treasury will 
accord the highest priority to developing and issuing regulations that 
are within its jurisdiction that are necessary to implement this 
historic anti-terrorism legislation.
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 2002, the IRS will accord priority to the following 
regulatory projects:
 Qualified Tuition Programs. Section 529 of the Internal 
            Revenue Code provides tax-deferred growth on college 
            savings that are contributed to a section 529 program. 
            Congress made significant amendments to section 529 in the 
            Economic Growth and Tax Relief Reconciliation Act of 2001 
            (EGTRRA). Earnings on college savings in a section 529 
            program are excluded from the gross income of a student if 
            used to pay qualified higher education expenses. The 
            Service expects to issue regulations that will clarify 
            various rules and definitions. Regulations are necessary 
            because many taxpayers will use a Qualified Tuition Program 
            to save for college.
 Research Credit. Section 41 of the Internal Revenue Code, 
            enacted in 1981 and modified in 1986, provides a credit for 
            increasing research expenditures as an incentive to spur 
            increased research spending and thereby encourage economic 
            growth. Regulations dealing with the definition of credit-
            eligible research expenses (and with the computation of the 
            credit) were proposed in January, 1997 and December, 1998. 
            The proposed regulations were adopted as final rules in 
            December, 2000. In Notice 2001-19, Treasury and the IRS 
            announced a review of the policies embodied in the final 
            research credit regulations. Treasury and the IRS intend to 
            issue another set of proposed regulations with a definition 
            of qualified research that is both more concordant with 
            congressional intent and more administrable than the 
            approach taken in the final rules adopted in December 2000.
 Deduction and Capitalization of Expenditures. Section 162 of 
            the Internal Revenue Code allows a deduction for ordinary 
            and necessary expenses paid or incurred during the taxable 
            year in carrying on any trade or business. Under section 
            263, however, no deduction is allowed for any amount paid 
            out for new buildings, or for permanent improvements or 
            betterments, made to increase the value of any property or 
            estate, such as the cost of acquisition, construction, or 
            erection of buildings, machinery and equipment, and similar 
            property having a useful life substantially beyond the 
            taxable year. Case law interpreting section 263 establishes 
            that an expenditure generally must be capitalized if it 
            creates or enhances a separate and distinct asset or 
            produces a significant future benefit. The IRS intends to 
            publish proposed regulations to clarify the circumstances 
            in which taxpayers must capitalize expenditures that are 
            expected to create future benefits for the taxpayer, but do 
            not result in a separate and distinct tangible asset 
            (``self-created intangibles''). The proposed are expected 
            to address three primary issues: (1) whether costs incurred 
            in connection with self-created intangibles are subject to 
            capitalization under section 263; (2) if such costs are 
            subject to capitalization, the circumstances for which 
            capitalization is warranted (e.g., can recurring, day-to-
            day expenditures of the taxpayer's business create 
            significant future benefits); and (3) if capitalization is 
            warranted, the types of costs that must be capitalized 
            (e.g., external costs, internal costs, direct costs, 
            indirect/overhead costs).
 Required Notice Regarding Certain Pension Plan Amendments. 
            Section 204(h) of the Employee Retirement Income Security 
            Act (ERISA) requires the administrator of certain qualified 
            retirement plans to provide notices to

[[Page 61254]]

            plan participants and others of certain reductions in the 
            rate of future benefit accruals under the plan. Section 659 
            of EGTRRA substantially amended section 204(h) of ERISA, 
            added section 4980F to the Internal Revenue Code, and 
            required notices to be given on the elimination or 
            reduction of early retirement benefits or retirement-type 
            subsidies. Section 4980F generally parallels section 204(h) 
            of ERISA, but also provides for an excise tax for failure 
            to comply with the notice requirements. The IRS expects to 
            issue a notice of proposed rulemaking that will provide 
            guidance on complying with the notice requirements of both 
            section 204(h) of ERISA, as amended by EGTRRA, and section 
            4980F. This guidance is needed in order to assist plan 
            administrators in complying with their obligations and to 
            ensure that participants receive the timely, understandable 
            and accurate notices required by the statute.
 Relief from Joint and Several Liability. Section 3201 of the 
            IRS Restructuring and Reform Act of 1998 repealed section 
            6013(e) and added section 6015 to the Internal Revenue 
            Code, effective for liabilities unpaid as of July 22, 1998, 
            and for liabilities that arose after July 22, 1998. Prior 
            to July 22, 1998, section 6013(e) provided the only relief 
            from joint and several liability for married taxpayers who 
            elected to file a joint return (``innocent spouse'' 
            relief). Section 6015 provides three types of relief from 
            joint and several liability: traditional ``innocent 
            spouse'' relief; allocation of liability for spouses no 
            longer married, legally separated, or not members of the 
            same household for 12 months; and equitable relief for 
            spouses who do not qualify for innocent spouse relief and 
            allocation of liability, if it is inequitable to hold them 
            liable for the joint liability. Proposed regulations under 
            section 6015 were issued in January 2001. The IRS intends 
            to issue final regulations regarding the three types of 
            relief from joint and several liability under section 6015, 
            as well as rules regarding the allocation of items, the 
            procedures for filing a claim for relief, and the rights of 
            the nonrequesting spouse.
 Offers in Compromise. Temporary regulations were issued in 
            July 1999, which permit compromise of liabilities when 
            there is doubt as to the amount of the liability owed, when 
            there is doubt whether the full amount of the tax can be 
            collected, and when, in light of all the facts and 
            circumstances, compromise would promote effective tax 
            administration. A compromise may be entered into to promote 
            effective tax administration when collection of the full 
            liability would create economic hardship or where, 
            regardless of the taxpayer's financial circumstances, 
            exceptional circumstances exist such that collection of the 
            full liability would be detrimental to voluntary 
            compliance. In determining a taxpayer's ability to pay, the 
            temporary regulations require the IRS to evaluate the 
            taxpayer's individual facts and circumstances. Guidelines 
            published by the Secretary on national and local living 
            expenses are to be taken into account in making this 
            determination. A taxpayer may appeal the rejection of an 
            offer to compromise to the IRS Office of Appeals.
 Collection Due Process. Section 3401 of the IRS Restructuring 
            and Reform Act of 1998 added to the Internal Revenue Code 
            sections 6320 and 6330 (Collection Due Process (CDP) 
            procedures), which provide taxpayers an opportunity for a 
            hearing before the Office of Appeals when a notice of tax 
            lien has been filed or a levy is proposed to be made 
            against them. These sections also provide for judicial 
            review of Appeals' determination. The CDP procedures 
            afforded new rights to taxpayers resulting in a significant 
            change in the Service's administrative collection process. 
            Temporary regulations were issued in January 1999, which 
            provide detailed guidance to taxpayers, practitioners and 
            Service employees for navigating the new procedural 
            landscape. In FY 2002, the IRS intends to issue final 
            regulations implementing the CDP procedures.
 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 were proposed in 
            January of 2001 interpreting the phrase ``plan (or series 
            of related transactions).'' The IRS and Treasury intend to 
            revise those regulations and also intend to propose 
            regulations that will address the definition of an 
            acquisition.
 Division and Geographical Source of Income in Global Dealing 
            Operations. In today's global capital markets, financial 
            institutions are trading in securities, currencies, and 
            sophisticated financial instruments in multiple 
            jurisdictions. Because of the cross-border nature of their 
            operations, these businesses face the risk of international 
            double taxation. That risk is exacerbated by various 
            regulatory provisions that are ill-suited for these types 
            of businesses. Proposed regulations were issued in 1998 for 
            public comment on the appropriate division and geographical 
            source of income in such global dealing operations. 
            Treasury and the IRS anticipate issuing a final rule during 
            fiscal year 2002 that reflects changes in response to the 
            comments that have been received.
 Allocation of Losses on the Disposition of Stock and Other 
            Personal Property. The allocation of losses and expenses to 
            U.S. and foreign source income is relevant in computing the 
            amount of foreign taxes that may be claimed as a credit 
            against the U.S. tax on foreign source taxable income. In 
            general, a U.S. taxpayer's credit for foreign income taxes 
            on foreign source taxable income is limited to an amount 
            equal to what otherwise would have been the U.S. income tax 
            on such income. This limitation is separately computed with 
            respect to different categories of foreign source income. 
            Proposed regulations were issued for public comment in 1996 
            on how losses with respect to stock and other personal 
            property should be allocated to and among U.S. source 
            income and the various categories of foreign source income 
            in determining foreign source taxable income for these 
            purposes. In January 1999, portions of these regulations 
            were finalized and other portions were issued as temporary 
            rules with a request for further public comment. Because 
            the temporary regulations will sunset by operation of law 
            in January 2002, Treasury and the IRS anticipate issuing 
            final regulations prior to the sunset date with certain 
            changes in response to public comments.

[[Page 61255]]

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 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 rules issued during fiscal year 2001 (or expected to 
be issued before publication of this Regulatory Plan) include:
 Safety and Soundness Standards for Safeguarding Customer 
            Information (12 CFR part 30). This rule, issued jointly 
            with the other Federal banking agencies, established 
            standards governing the administrative, technical, and 
            physical safeguards of bank and customer records.
 Consumer Protections for Depository Institution Sales of 
            Insurance (12 CFR part 14). This rule, issued jointly with 
            the other Federal banking agencies, prescribed 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.
 Fiduciary Activities of National Banks (12 CFR part 9). The 
            OCC amended its regulations regarding the authority and 
            standards for national banks to conduct multi-state trust 
            operations. The rule provides enhanced guidance to national 
            banks engaging in fiduciary activities.
 Investment Securities; Bank Activities and Operations; 
            Leasing (12 CFR parts 1, 7, and 23). This rule amended its 
            rules governing investment securities, bank activities and 
            operations, and leasing. These changes updated and revised 
            the OCC regulations to keep pace with developments in the 
            law and in the national banking system.
 Debt Cancellation Contracts (12 CFR part 37). The OCC 
            published a notice of proposed rulemaking that addresses 
            debt cancellation contracts and debt suspension agreements. 
            The purposes of the customer protections are to facilitate 
            customers' informed choice about whether to purchase debt 
            cancellation contracts and debt suspension agreements, 
            based on an understanding of the costs, benefits, and 
            limitations of the products and to discourage inappropriate 
            or abusive sales practices. The proposed rule also promotes 
            safety and soundness by requiring national banks that 
            provide these products to maintain adequate loss reserves.
 Operating Subsidiaries of Federal Branches and Agencies (12 
            CFR part 5). The rule will amend its regulations to enable 
            a Federal branch or agency to establish, acquire, or 
            maintain an operating subsidiary in generally the same 
            manner that a national bank may acquire or establish an 
            operating subsidiary.
 The OCC's regulatory priorities for fiscal year 2002 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 banking 
agencies' 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. 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 on 
recourse and direct credit substitutes 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. This rule also would impose 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.
 Managed Assets. This rulemaking will seek information on approaches to 
amend the risk-based capital guidelines to address the treatment of 
assets under management in asset securitizations. Specifically, the 
rulemaking will focus on the risks associated with management of assets 
within a securitization structure, both for the originator as well as 
servicer of such assets, as well as the appropriate framework within 
which to assess capital charges, if appropriate, to address the risks.
 Domestic Capital Framework (formerly referred to as Simplified Capital 
Framework for Noncomplex Institutions). This rule would propose a 
revised capital framework to be applied to domestic banks that would 
not subject to the new Basel Capital Accord.
 Claims on Securities Firms. This final rule would amend the risk-based 
capital guidelines to lower the risk weight applied to certain claims 
on, and claims guaranteed by, certain securities firms incorporated in 
countries that are members of the Organization for

[[Page 61256]]

Economic Cooperation and Development (OECD) from 100 percent to 20 
percent, subject to certain prudential requirements. This reduced risk 
weighting applies to those securities firms that are subject to 
supervision and regulation comparable to that imposed on banks, 
including risk-based capital requirements that are no less stringent 
than those imposed on banks under the Basel Accord and its market risk 
amendment. This rule would implement a change made to the Basel Accord.
 Merchant Banking Capital. This rule would amend the risk-based capital 
guidelines to establish special minimum regulatory capital requirements 
for equity investments in nonfinancial companies. The capital 
requirement would apply symmetrically to equity investments of banks 
and bank holding companies and would impose a series of marginal 
capital charges on covered equity investments that increase with the 
level of a banking organization's overall exposure to equity 
investments relative to the organization's Tier 1 capital.
 Securities Borrowing Transactions. This final rule generally would 
lower the capital requirements for certain qualifying securities 
borrowing transactions by permitting the collateralized portion of the 
securities borrowing transactions to be subject to the market risk 
capital requirements at 12 C.F.R. part 3, appendix B, as opposed to the 
risk-based capital requirements at 12 C.F.R. part 3, appendix A. Among 
other things, in order to qualify for the lower market risk capital 
requirement under this joint interim rule, a bank must be subject to 
the market risk capital requirements, and the securities borrowing 
transaction must result in a receivable that arises from the posting of 
the cash collateral. Only the portion of the receivable collateralized 
by the market value of the securities borrowed qualifies for the lower 
market risk capital requirement; noncollateralized portions must 
continue to be risk weighted under the risk-based capital guidelines.
 Electronic Banking (12 CFR part 7). The OCC published a 
            notice of proposed rulemaking that addressed ways to 
            facilitate national banks in their efforts to engage in 
            various forms of electronic banking. The proposal addresses 
            national banks' exercise of their federally authorized 
            powers through electronic means; the location of a national 
            bank that engages in electronic activities; and the 
            disclosures required when a national bank provides its 
            customers with access to other service providers through 
            hyperlinks in the bank's web site or other shared 
            electronic space. The OCC will be evaluating the comments 
            received and considering what changes, if any, should be 
            made to the OCC's rules affecting electronic banking.
 Community Reinvestment Act Regulations (12 CFR part 25). The 
            OCC, along with the other Federal banking agencies, 
            published an advance notice of proposed rulemaking 
            soliciting comments on ways to improve the CRA regulation. 
            Based on the comments received, the OCC and other agencies 
            will consider the need for changes to the CRA rules and 
            will propose such changes as are deemed appropriate.
 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 consumer protection 
            safeguards are needed.
 Implementation of Sections 1204-1206 of the Financial 
            Regulatory Relief and Economic Efficiency Act of 2000 (the 
            Act) (12 CFR part 5). The OCC intends to initiate a 
            rulemaking to implement the authority vested in national 
            banks by the Act to reorganize into a holding company 
            through a share exchange and to merge with a subsidiary or 
            affiliate.
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 continues to work with the other federal banking agencies on 
regulations where the agencies share the responsibility to implement 
statutory requirements. The agencies are working to update capital 
standards to maintain, and, where necessary, improve consistency in the 
agencies' rules. Regulatory projects in this area include the 
following:
 Risk-Based Capital Treatment of Recourse and Direct Credit 
            Substitutes; and Residuals in Securitizations. OTS expects 
            to issue a final rule jointly with the other federal 
            banking agencies that would treat recourse obligations and 
            direct credit substitutes comparably. The final rule would 
            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. This rule would be published in tandem 
            with a final rule on residual interests that would better 
            align regulatory capital requirements with the risk 
            exposure of residual interests in asset securitizations and 
            other transfers of assets.
 Managed Assets. This initiative, possibly in the form of an 
            advance notice of proposed rulemaking, would seek 
            information on approaches to amend the risk-based capital 
            guidelines to address the treatment of assets under 
            management in asset securitizations. Specifically, this 
            rulemaking would focus on the risks associated with 
            management of assets within a securitization structure, 
            both for the originator as well as servicer of such assets, 
            as well as the appropriate framework within which to assess 
            capital charges, if appropriate, to address the risks.
 Capital Adequacy. The four Federal banking agencies expect to 
            issue a joint notice of proposed rulemaking seeking comment 
            on ways to modify the capital adequacy framework for those 
            domestic institutions that would not be subject to the 
            Basel Capital Accord.
 Claims on Securities Firms. The four Federal banking agencies 
            expect to issue a final rule that would reduce the risk 
            weight assigned to claims on, and claims guaranteed by, 
            certain qualifying securities firms, subject to certain 
            prudential requirements.
 Miscellaneous Capital Revisions. OTS also plans to issue a 
            final rule to make miscellaneous amendments to update its 
            capital rules.
 OTS and the other Federal banking agencies anticipate reproposing a 
rule implementing provisions of the Fair Credit Reporting Act (FCRA) 
concerning information sharing with affiliates. The agencies informed 
those institutions potentially affected by the rulemaking that any 
final rule would not apply to

[[Page 61257]]

privacy notices sent before January 1, 2002 or before the effective 
date of the final FCRA rule, whichever is later.
 The four Federal banking agencies published a joint advance notice of 
proposed rulemaking seeking comments on how to improve the Community 
Reinvestment Act (CRA) regulations. The OTS, as well as the other 
banking agencies, will consider changes to the CRA rules based upon the 
comments received, and will propose such changes as are deemed 
appropriate.
 OTS also is reviewing its lending and subordinate organization 
regulations to give thrifts additional flexibility, enabling them to 
better serve their communities and compete with other lenders. OTS also 
plans to issue a final rule revising its regulations governing 
conversion from mutual to stock or mutual holding company form. OTS is 
also reviewing its current holding company regulations to determine 
whether and how they should be modified to reflect statutory changes 
made by the Gramm-Leach-Bliley Act. Additionally, OTS is considering 
possible amendments to its regulations governing directors and officers 
of savings associations and the fiduciary activities of savings 
associations.
 Finally, OTS may revise its lending regulations, including the rules 
implementing the Alternative Mortgage Transactions Parity Act, to 
encourage responsible lending and limit the potential for predatory 
lending practices.
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 2002 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 2001, one of Customs' priorities was to develop and 
publish regulations to implement provisions of the Trade and 
Development Act of 2000. To that end, Customs published the following 
documents during the past fiscal year:
 United States-Caribbean Basin Trade Partnership Act and 
            Caribbean Basin Initiative. This interim rule implements 
            the trade provisions for Caribbean Basin countries 
            contained in title II of the Trade and Development Act.
 African Growth and Opportunity Act and Generalized System of 
            Preferences. This interim rule implements the trade 
            provisions for sub-Saharan Africa contained in title I of 
            the Trade and Development Act.
 Refunds of Duties Paid on Imports of Certain Wool Products. 
            This rulemaking implements the provisions of section 505 of 
            title V of the Trade and Development Act. This rule set 
            forth the eligibility, documentation and procedural 
            requirements necessary to substantiate a refund claim for 
            duties paid on imports of certain wool products.
 Duty-free Treatment for Certain Beverages Made with Caribbean 
            Rum. This interim rule implemented a change made by the 
            Trade and Development Act that enables certain spirituous 
            beverages to obtain duty-free treatment under specified 
            conditions when the beverages are processed in the 
            territory of Canada from rum that is the growth, product or 
            manufacture either of a CBI beneficiary country or of the 
            U.S. Virgin Islands.
 Rules of Origin for Textile and Apparel Products. This 
            interim rule aligned the existing country of origin rules 
            for textile and apparel products with the statutory 
            amendments to section 334 of the Uruguay Round Agreements 
            Act as set forth in section 405 within title IV of the 
            Trade and Development Act.
 During fiscal year 2001, one of Customs' priorities was to continue 
moving forward with amendments reinventing its regulatory procedures 
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 E.O. 12886, have involved and will continue to 
involve significant input from the importing public. Of particular note 
regarding Customs' progress implementing the Customs Mod Act, Customs, 
during the last fiscal year, issued a proposal to revise the procedures 
by which Customs will issue administrative rulings responding to 
requests from prospective importers concerning how Customs will treat 
their transactions.
 During fiscal year 2002, Customs plans to continue its progress with 
the Customs Mod Act. Customs plans during fiscal year 2002 to issue a 
final rule regarding its administrative ruling procedures and to 
propose revisions to its procedures regarding protests. In addition, 
Customs' reinvention efforts continue to involve the testing of 
programs to see if they work before proceeding with proposed rulemaking 
to permanently establish the programs.
 During fiscal year 2002, Customs also plans to undertake several other 
regulatory actions that will affect the traveling and importing public, 
customs brokers, carriers and commercial importers. Consistent with the 
Customs Mod Act, Customs will accord priority to several projects to 
foster the development of a more automated environment to expedite the 
entry and release of imported commercial merchandise, and the 
processing 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. 
            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

[[Page 61258]]

            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.
 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 2002, 
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 2002, FinCEN will continue to review and revise its 
existing regulations. FinCEN has issued two rules concerning the 
application of the BSA to certain non-bank financial institutions 
called money services businesses or ``MSBs.'' MSBs include currency 
exchangers, check cashers, money order and traveler's check businesses, 
and money transmitters. Under the first rule, MSBs would be required to 
register with the Department of the Treasury by December 31, 2001. 
Under the second rule, three categories of MSBs--money order and 
traveler's check businesses and money transmitters--would be required 
to report suspicious transactions beginning January 1, 2002. To ensure 
the rules are implemented effectively and efficiently, FinCEN intends 
to publish by early fiscal 2002 a rule extending the effective date of 
the registration and suspicious activity reporting requirements. As a 
result, MSBs will not be required to register until June 30, 2002, and 
money order and traveler's check businesses and money transmitters will 
not be required to report suspicious transactions until October 1, 
2002. FinCEN also intends to publish a notice re-opening the comment 
period for a prior notice of proposed rulemaking that would extend the 
requirement to report suspicious transactions to casinos and card 
clubs. Finally, FinCEN will 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.
 Implementing Treasury's borrowing authority, including rules 
            governing the sale and issue of marketable Treasury 
            securities.
 Setting out the terms and conditions by which Treasury may 
            redeem (buy back) outstanding, unmatured marketable 
            Treasury securities through debt buyback operations.
 Governing the acceptability and valuation of all collateral 
            pledged 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 TreasuryDirect system. The Uniform Offering Circular 
describes the types of securities offered for sale, the auction method 
by which they are sold, the process for submitting bids, the process 
for awarding securities

[[Page 61259]]

to successful bidders, and the authorized payment methods.
 During fiscal year 2002, 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. BPD will also give 
priority to any further regulatory action the Department deems 
appropriate regarding the net long position calculation and the 35 
percent award limit in marketable Treasury securities auctions. An 
advance notice of proposed rulemaking was published for comment on this 
matter in July 2001.
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 2002, FMS will continue to 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. FMS issued an implementing 
regulation in December 1992. FMS issued a notice of proposed rulemaking 
to update the CMIA in fiscal year 2001. FMS will issue a final rule 
governing the CMIA in fiscal year 2002.
 Also, FMS will revise its rule concerning the payment of Federal taxes 
and the Treasury Tax and Loan Program (TT&L). This revision will 
support operational changes to the system used for the collection of 
corporate withholding taxes. In addition, FMS will streamline the TT&L 
rule and write it in plain language.
 During fiscal year 2002, FMS will propose revisions to its rule 
governing the indorsement and payment of checks drawn on the United 
States Treasury. The proposed revisions will relate to, among other 
things, finality of payment, liability for checks bearing material 
defects or alterations, and the use of powers of attorney.
 Finally, FMS will continue to implement provisions of the Debt 
Collection Improvement Act of 1996.
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 CDFI Program has four components: the Core Component, 
the Intermediary Component, the Small and Emerging CDFI Assistance 
Component, and the newly developed Native American CDFI Technical 
Assistance Component. The Fund also 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.
 In addition, the Fund is developing a new program, the New Markets Tax 
Credit (NMTC) Program, which the Fund will administer, in coordination 
with Treasury's Office of Tax Policy and the Internal Revenue Service. 
The NMTC Program is intended to spur investments in businesses located 
in low-income communities. Under the NMTC Program, taxpayers will be 
provided a credit against Federal income taxes for qualified 
investments made to acquire stock or other equity interests in 
designated Community Development Entities (CDEs). Substantially all of 
the proceeds of qualified investments must in turn be used by the CDE 
to make qualified investments in low-income communities.
 The Fund's fiscal year 2002 regulatory priority will focus on the NMTC 
Program, by developing guidance regarding the submission of 
applications for CDE certification and guidance regarding the 
submission of applications for NMTC allocations.
_______________________________________________________________________



TREAS

                              -----------

                          PROPOSED RULE STAGE

                              -----------




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


Other Significant


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.

[[Page 61260]]

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                                                           08/00/02
Regulatory Flexibility Analysis Required:


No


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



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


Other Significant


Legal Authority:


5 USC 552(a); 31 USC 9303; 31 USC 9304; 40 USC 304(k); 18 USC 847; 18 
USC 921 to 930; 18 USC 1261; 19 USC 1612; 19 USC 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 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                                                           04/00/02
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 61261]]




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.
 The Department of Veterans Affairs' 2001 regulatory plan contains one 
rulemaking action from the Veterans Benefits Administration and two 
rulemaking actions from the Veterans Health Administration. The 
Veterans Benefits Administration rulemaking is RIN 2900-AK64 ``Diseases 
Specific to Radiation-Exposed Veterans.'' This proposes to amend the 
Department's adjudication regulations concerning presumptive service 
connection for certain diseases for veterans who participated in 
radiation-risk activities during active service or while members of 
reserve components during active duty for training or inactive duty 
training. One of the Veterans Health Administration (VHA) rulemakings 
is RIN 2900-AK08 ``Payment or Reimbursement for Emergency Treatment 
Furnished at Non-VA Facilities,'' which amends the Department's medical 
regulations by establishing a mechanism for payment or reimbursement 
for certain non-VA emergency services furnished to veterans for 
nonservice-connected conditions. The other VHA rulemaking is RIN 2900-
AK85 ``Copayments for Medications,'' which proposes to amend VA's 
medical regulations to set forth copayment requirements for medications 
provided to veterans by VA.
_______________________________________________________________________



VA

                              -----------

                          PROPOSED RULE STAGE

                              -----------




112. DISEASES SPECIFIC TO RADIATION-EXPOSED VETERANS
Priority:


Economically Significant. Major under 5 USC 801.


Legal Authority:


38 USC 1112(c); PL 100-321


CFR Citation:


38 CFR 3.309(d)


Legal Deadline:


None


Abstract:


The Department of Veterans Affairs (VA) is proposing to amend its 
adjudication regulations concerning presumptive service connection for 
certain diseases for veterans who participated in radiation-risk 
activities during active service or while members of reserve components 
during active duty for training or inactive duty training. This 
proposed amendment would add cancers of the bone, brain, colon, lung, 
and ovary to the list of diseases which may be presumptively service-
connected and amend the definition of the term ``radiation-risk 
activity.'' The intended effect of this amendment is to ensure that 
veterans who may have been exposed to radiation during military service 
have the same burden of proof as civilians exposed to ionizing 
radiation who may be entitled to compensation for these cancers under 
comparable Federal statutes.


Statement of Need:


This proposed amendment would add cancers of the bone, brain, colon, 
lung, and ovary to the list of diseases that may be presumptively 
service-connected and amend the definition of the term ``radiation-risk 
activity.'' This proposed amendment would also ensure that veterans who 
may have been exposed to radiation during military service have the 
same burden of proof as civilians exposed to ionizing radiation who may 
be entitled to compensation for these cancers under comparable Federal 
statutes.


Summary of Legal Basis:


Section 501(a)(1) of title 38, United States Code, provides that the 
Secretary of Veterans Affairs has the authority to promulgate 
regulations regarding the nature and extent of proof and evidence in 
order to establish entitlement to veterans' benefits. Pursuant to this 
authority, VA proposes to amend 38 CFR 3.309(d)(2) to add bone, brain, 
colon, lung, and ovarian cancers, which are covered under the Energy 
Employees Occupational Illness Compensation Program Act or are covered 
under the RECA Amendments but are currently not included in the list of 
diseases in 38 U.S.C. 1112(c)(2) that are presumed to be service-
connected for radiation-exposed veterans. This regulation is not 
required by statute or court order.


Alternatives:


Veterans may establish service connection for these five cancers under 
38 U.S.C. 1110 or 1131 or the Veterans' Dioxin and Radiation Exposure 
Compensation Standards Act, Public Law No. 98-542, 98 Stat. 2725 
(1984). Doing so is difficult because, among other things, it requires 
sound scientific and medical evidence establishing that it is at least 
as likely as not the veteran's disease resulted from exposure to 
radiation in service, based in part on an assessment of the amount of 
radiation to which a veteran was exposed.


Anticipated Cost and Benefits:


This regulatory amendment will not have a significant economic impact 
on a substantial number of small entities as they are defined in the 
Regulatory Flexibility Act (RFA), 5 U.S.C. 601-612. These amendments 
would not directly affect any small entities. Only VA beneficiaries 
could be directly affected. Therefore, pursuant to 5 U.S.C. 605(b), 
these amendments are exempt from the initial and final regulatory 
flexibility analysis requirements of sections 603 and 604.


Risks:


This regulation will not increase or reduce risks to public health, 
safety, or the environment.

[[Page 61262]]

Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            66 FR 41483                                    08/08/01
NPRM Comment Period End                                        10/09/01
Final Action                                                   04/00/02
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


None


Agency Contact:
Bill Russo
Attorney-Advisor, Compensation and Pension (211)
Department of Veterans Affairs
Veterans Benefits Administration
810 Vermont Avenue NW
Washington, DC 20420
Phone: 202 273-7211
Fax: 202 275-1728
Email: [email protected]
RIN: 2900-AK64
_______________________________________________________________________



VA

                              -----------

                            FINAL RULE STAGE

                              -----------




113. PAYMENT OR REIMBURSEMENT FOR EMERGENCY TREATMENT FURNISHED AT NON-
VA FACILITIES
Priority:


Economically Significant. Major under 5 USC 801.


Legal Authority:


38 USC 501; 38 USC 1725; PL 106-117


CFR Citation:


38 CFR 17


Legal Deadline:


NPRM, Statutory, May 22, 2000, 180 days after effective date of PL 106-
117.


Abstract:


This document amends the Department of Veterans Affairs medical 
regulations by establishing a mechanism for payment or reimbursement 
for certain non-VA emergency services furnished to veterans for 
nonservice-connected conditions. This amendment is necessary to 
implement provisions of ``The Veterans Millennium Health Care and 
Benefits Act.''


Statement of Need:


Public Law No. 106-117 ``The Veterans Millennium Health Care and 
Benefits Act'' requires this amendment to implement its provisions.


Summary of Legal Basis:


38 U.S.C. 1725 authorizes VA to establish provisions for payment or 
reimbursement for certain non-VA emergency services furnished to 
Veterans for nonservice-connected conditions.


Alternatives:


The alternatives that the Department had to consider are the amount of 
reimbursement and the location where claimants can file a claim.


Anticipated Cost and Benefits:


Cost projection for FY 2001 is $66 to $75 million. The FY 2003 budget, 
in accordance with section 1725 of title 38, will provide an updated 
estimate of the full year impact of this legislation expected to be 
incurred in FY 2003.


Risks:


None.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
Interim Final Ru66 FR 36467                                    07/12/01
Interim Final Rule Effective                                   05/29/00
Interim Final Rule Effective (38 CFR 17.004)                   07/19/01
Interim Final Rule Comment Period End (Information Collection) 07/19/01
Interim Final Rule Comment Period End                          09/10/01
Final Action                                                   04/00/02
Regulatory Flexibility Analysis Required:


Undetermined


Government Levels Affected:


None


Agency Contact:
Roscoe G. Butler
Chief, Policy and Operations (10C3)
Department of Veterans Affairs
Veterans Health Administration
810 Vermont Avenue NW
Washington, DC 20420
Phone: 202 273-8302
Fax: 202 273-9609
Email: [email protected]
RIN: 2900-AK08
_______________________________________________________________________



VA



114.   COPAYMENTS FOR MEDICATIONS
Priority:


Economically Significant. Major under 5 USC 801.


Legal Authority:


PL 106-117; 38 USC 1722A


CFR Citation:


38 CFR 17


Legal Deadline:


None


Abstract:


This rule proposes to amend VA's medical regulations to set forth 
copayment requirements for medications provided to veterans by VA.


Statement of Need:


This rule is intended to make the copayments for medications more in 
line with industry standards.


Summary of Legal Basis:


Public Law 106-117 amended 38 U.S.C. 1722A to allow the copayment 
amount to be increased.


Alternatives:


Although the amount could be set at a number of different levels, we 
attempted to establish a rate in line with industry standards.


Anticipated Cost and Benefits:


We anticipate that this will increase collections $250 million 
annually.


Risks:


None.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            66 FR 36960                                    07/16/01
NPRM Comment Period End                                        09/14/01
Final Action                                                   12/00/01
Regulatory Flexibility Analysis Required:


No


Government Levels Affected:


None

[[Page 61263]]

Agency Contact:
Nancy Howard
Senior Program Analyst (174)
Department of Veterans Affairs
Veterans Health Administration
810 Vermont Avenue NW
Washington, DC 20420
Phone: 202 273-8198
Fax: 202 273-4897
Email: [email protected]
RIN: 2900-AK85
BILLING CODE 8320-01-S

[[Page 61264]]




ENVIRONMENTAL PROTECTION AGENCY (EPA)



Statement of Priorities
 The President has made it clear that he expects the American people to 
get full value for every taxpayer dollar government spends, and they 
will from the EPA. The environmental challenges we face in the 21st 
century are too important to allow us to do anything but use our 
resources wisely, efficiently, and effectively.
 The President has called for Governmentwide management reforms that 
will, when implemented, make the Federal Government more accountable 
while improving the government services we provide to the American 
people. In order to improve the regulatory process within EPA, we 
established a task force to examine the Agency's rulemaking process, 
and to recommend ways to improve the internal process and strengthen 
the supporting science and analysis. The task force concluded that the 
regulatory process is essentially sound but improvements should be made 
in several areas to more effectively carry out our mission.
Better Science and Economic Analyses56
 Today's environmental problems are far more complex than they 
were in the past, and there has been a dramatic expansion in the 
universe of scientific, economic and social issues that we must 
consider. Our decisions must reflect the latest findings in relevant, 
high quality research, both in science and economics. To strengthen the 
analyses that support EPA decisions, we will involve scientists and 
economists in more prominent ways throughout our decisionmaking process 
-- in identifying needed information and research, developing a range 
of alternative approaches, and selecting from available options. 
Administrator Whitman is also designating senior experts in both 
science and economics to advise her on the strengths and weaknesses of 
EPA analyses and provide Agency leadership in improving analytical 
consistency and quality.
Broader Consideration of Policy Options56
 To produce the best environmental outcomes at an acceptable 
cost, EPA decisionmakers must consider a broader array of policy 
options, including innovative alternatives and market-based approaches. 
We will strengthen analysis of policy issues by more systematically 
identifying relevant issues and providing regulatory workgroups with 
better training and support. We will engage EPA's senior managers more 
actively in selecting options and consult more effectively with 
internal policy advisors, co-regulators, and stakeholders. As we 
develop and consider available options, we will pay more attention to 
implementation -- how EPA regions and states will be affected, what 
kinds of compliance assistance will be needed, and how we can tell if 
we're achieving desired results.
Greater Accountability56
 The task force found that the policymaking process in place at 
EPA is well designed and can function effectively, but greater 
accountability is needed to ensure that managers and staff properly 
follow the process. Senior managers will take greater responsibility 
for setting strategic direction, assuring high quality analysis of 
relevant issues, and selecting the best available options. We are 
creating a better management system to ensure thorough analyses and 
timely decision points, and that process requirements are met. We will 
also evaluate the effectiveness of the regulatory development process 
and of the regulations themselves.
Better Management of Significant Nonregulatory Decisions56
 Finally, we are developing a system to better manage significant 
nonregulatory actions that will provide the cross-agency attention that 
these decisions deserve. We have included three of these nonregulatory 
actions in this year's Plan (Persistent, Bioaccumulative, and Toxic 
(PBT) Pollutants Strategy (RIN 2070-AD45), TSCA Policy Statement on 
Oversight of Transgenic Organisms (RIN 2070-AD13), and the 
Acceptability of Using Human Subjects (RIN 2070-AD57).
Better Environmental Results
 All of these reforms are designed to help us reach the goal of making 
our air cleaner, our water purer, and our land better protected. This 
will be the ultimate measure of our success. Everything we do should be 
looked at through that prism. Will this make the air cleaner? Will this 
make the water purer? To that end we continue to apply new methods to 
protect the environment by building flexibility into regulations up 
front, through nonregulatory approaches where effective, by creating 
strong partnerships with States and conducting extensive public 
outreach.
 EPA's Regulatory Plan will address 34 of the most important actions 
currently under development or review. These actions will have a 
significant effect on public health and the environment. The 
accompanying regulatory agenda identifies more than 350 additional 
rules, policies and voluntary programs that are also underway.
 The following are specific EPA priorities that will help us achieve 
cleaner air, purer water and better protected lands.
Cleaner air56
 Enact the President's multi-emission bill
 Focus on reducing indoor air pollution, especially as it 
            relates to children
 Promote energy conservation
Purer water56
 Take a broader watershed approach to address water 
            quality issues
 Begin to bring America's water infrastructure up to date
Land better protected56
 Expand our efforts to reclaim the thousands of 
            brownfields that continue to scar too many neighborhoods.
Highlights of the Regulatory Plan Rules and Policies
Office of Air and Radiation56
 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 cost-effective approaches. The 
following are the most significant of our air activities.
 In 1997, we established new, more stringent air quality standards for 
ozone and particulate matter based on new scientific and technical 
information indicating that new standards were needed to protect public 
health and the environment. In 1999, the D.C. Circuit Court found that 
the Clean Air Act provision authorizing the new standards is 
unconstitutional as EPA applied it. We successfully appealed this 
decision to the United States Supreme Court, and we are now working on 
an implementation program to respond to the Court's decision.
 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 plants.

[[Page 61265]]

When fully implemented, these standards will reduce more than one 
million tons of toxic air emissions per year. Through other efforts 
such as phasing-out of lead in gasoline, we have also significantly 
reduced air toxics from cars and trucks.
 We are continuing to set technology-based standards for large 
industries. The rules listed in this year's Regulatory Plan -- covering 
industrial boilers, institutional/commercial boilers, wood 
manufacturing, reciprocating engines, combustion turbines, and 
automobile painting operations -- 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.
Office of Water56
 Congress has directed the EPA to work with States, tribes and 
other Federal agencies to help finance water infrastructure, to set 
national drinking water standards, to protect wetlands, to control 
discharges from industries and sewage treatment plants, and to reduce 
nonpoint pollution. To fulfill these goals, the Office of Water is 
undertaking, among others, the following actions:
 Under the Safe Drinking Water Act (SDWA) Amendments of 1996:
 We will finalize a rule that will allow States and/or systems to adopt 
multimedia programs which reduce radon risks from indoor air and 
drinking water in combination.
 The SWDA requires EPA to revise the existing 50 parts per billion 
(ppb) standard for arsenic in drinking water. In January 2001, we 
published a new standard for arsenic in drinking water that would 
require public water supplies to reduce arsenic to 10 ppb by 2006. We 
have delayed the effective date of this rule until February 22, 2002 to 
allow time for expert review of key issues, review of this standard, 
and requested further public comment. This is to assure that 
communities that need to reduce arsenic in drinking water can proceed 
with confidence that the final standard is based on sound science and 
accurate cost and benefit estimates.
 The SDWA also requires EPA to review and revise, if appropriate, all 
National Primary Drinking Water Regulations no less frequently than 
once every six years (6-Year Review). According to SDWA, any revisions 
of drinking water regulations must maintain, or increase, the level of 
public health protection provided; however, EPA may identify regulatory 
changes that will streamline or reduce existing requirements without 
lessening the level of public health protection. The purpose of the 
review is to determine whether new data, technology, or other factors 
exist that justify revisions to existing NPDWRs. The outcome of the 
review will be a Federal Register preliminary notice for comment making 
available the results of our review. Following a review of public 
comments, we will issue a second notice with our final regulatory 
review determination together with a rulemaking schedule for any 
regulation the Agency determines warrants revision.
 We are also taking a number of important steps under the Clean Water 
Act:
 To control the discharge of pollutants from point sources, we are 
developing effluent limitations guidelines for the construction and 
development industry. Water quality improvements will result from a 
reduction in storm water and sediment discharged from construction 
sites and from sediment generated from stream bank erosion. Other 
expected benefits include protection of fishery and wildlife habitat 
and downstream urban flood control.
 We will issue a rule to minimize the adverse impacts associated with 
cooling water intakes. Most costs would be borne by entities that own 
or operate steam electric power plants. The expected benefits will be 
significant reductions in aquatic organisms killed or injured by 
impingement (being pinned against screens or other parts of a cooling 
water intake structure) or entrainment (being drawn into cooling water 
systems and subjected to thermal, physical or chemical stresses).
 In July 2000 we published a final rule amending the Agency's existing 
regulations implementing Total Maximum Daily Load (TMDL) program. The 
rule sought to provide for a more complete accounting of impaired 
waters, track progress towards restoration, clarify and provide more 
specificity regarding the scope and content of TMDLs, require 
implementation plans, and reasonable assurance that these plans would 
be implemented, and speed up the pace of TMDL establishment.
 On October 18, 2001 we delayed the effective date of the July 2000 
rule by 18 months to April 30, 2003. The delay in effective date would 
allow the Agency time to reconsider specific aspects of the rule and to 
develop an effective national program that involves the active 
participation and support of all levels of government and local 
communities. Over the next several months, we will conduct a 
stakeholder process, propose necessary changes by spring 2002, and hope 
to adopt such changes by April 30, 2003.
Office of Prevention, Pesticides, and Toxic Substances56
 Because of the potentially serious consequences of human 
exposure to endocrine disrupting chemicals, Congress included specific 
provisions on endocrine disruption in the Food Quality Protection Act. 
It also amended the Safe Drinking Water Act in 1996 to require EPA to 
develop an endocrine disruptor screening program and to screen for 
endocrine disruptors found in drinking water sources. The Agency has 
established an Endocrine Disruptor Screening and Testing Program based 
on the recommendations of the advisory committee we established to 
consider human health and ecological effects, and hormonal effects of 
pesticides, industrial chemicals and drinking water contaminants. In 
2002-2003 we will standardize and validate assays in the screening 
battery and complete the priority setting system. We will issue a 
proposed procedural rule in 2002.
 EPA is evaluating how our current policy on the protection of human 
subjects in testing should apply to testing that is not conducted or 
supported by the Agency. Current policy does not address non-EPA 
research. EPA will also be seeking public comment on a series of issues 
related to Agency use of human research data in pesticide 
decisionmaking. We believe this will serve two important Agency goals: 
ensuring the availability of sound and appropriate scientific data in 
its decisions, and protection of the interests, rights and safety of 
human research subjects. We may issue one or more documents, which may 
include policy statements, rulemaking or requests for public comment.
 Almost a million children under 5 years of age have blood-lead levels 
exceeding the Center for Disease

[[Page 61266]]

Control's level of concern (10 ug/dl), and reducing childhood exposure 
to lead-based paint activities continues to be a priority. Elevated 
blood-lead levels can damage intelligence and create neuro-behavioral 
problems in young children, and can cause other health problems in 
children and adults. We are considering proposed approaches to address 
lead risks associated with renovation and remodeling activities, and 
investigating the lead risks associated with bridges and structures.
 In FY 2002, EPA will issue final amendments to the current Toxic 
Substances Control Act (TSCA) Inventory Update Rule (IUR). The proposed 
rule requires chemical manufacturers to report to EPA data on exposure-
related information and the industrial and consumer end uses of 
chemicals they produce or import. EPA will also consider other 
amendments to the existing IUR. These include removing the inorganic 
chemicals exemption; providing 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.
 EPA has developed National Action Plans under a national strategy to 
address priority Persistent Bioaccumulative Toxic (PBT) pollutants. 
These pollutants pose risks because they are toxic, persist in 
ecosystems, and accumulate in fish and up the food chain. The PBT 
challenges remaining stem from the pollutants' ability to travel long 
distances, to transfer rather easily among air, water, and land, and to 
linger for generations. Through this strategy, we will create an 
enduring cross-office system that will address the cross-media issues 
associated with priority PBT pollutants. In FY 2002, we expect to issue 
the draft action plan for benzo(a)pyrene, and to issue the final action 
plans for alkyl-lead and mercury. We will also continue developing 
other action plans as outlined in the PBT Strategy.
Office of Solid Waste and Emergency Response56
 The Office of Solid Waste and Emergency Response (OSWER) is 
planning actions to reduce burden on the regulated community and 
provide regulatory innovations under the Resource Conservation and 
Recovery Act (RCRA), the Federal law governing hazardous waste 
management. Several actions of significance are listed below.
 We are planning to reduce the burden imposed by RCRA reporting and 
recordkeeping requirements.
 We will revise current Federal hazardous waste regulations to 
encourage recycling and better management of cathode ray tubes, the 
display components of televisions and computer monitors. The goal is to 
minimize the disposal of lead, increase resource recovery, and enhance 
protection of human health and the environment.
 OSWER will revise current RCRA regulations that apply to recycling of 
hazardous wastes in the manufacturing of zinc fertilizers. We are 
considering establishing a more consistent application of recycling 
requirements to zinc fertilizer products and establishing a set of 
standards for contaminants in RCRA-regulated zinc fertilizers that are 
more appropriate to fertilizers. We are also considering specifying 
more appropriate, protective requirements for management of zinc-
bearing hazardous secondary materials prior to recycling.
Office of Policy, Economics, and Innovation56
 OPEI has taken the lead in EPA's re-examination of its 
regulatory process to assure that all regulatory actions are 
scientifically sound, cost-effective, and reflect decisions based on a 
broad consideration of policy options. OPEI will continue its work to 
assure that our procedural and policy reforms are implemented 
throughout the Agency.
 We have also designed a variety of incentives to encourage high 
performing facilities to participate in the National Environmental 
Performance Track. These include actions which recognize and highlight 
the achievements of the facilities that successfully fulfill the 
requirements for entry, but also include other incentives.
 We are offering some of those incentives through administrative 
actions, but others will require changes in existing Federal 
regulations. We are now changing regulations that set reporting 
requirements for facilities covered by the MACT provisions of the Clean 
Air Act. Facilities meeting the criteria for membership in Performance 
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. We are also reducing reporting 
requirements for participating publicly owned treatment works (POTWs), 
under the Clean Water Act. A third change 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 change 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. We will consolidate 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 Performance 
Track facilities in other industry sectors.
Summary56
 In developing all of these actions, EPA is committed to 
flexible, cost-effective programs that offer increased protections for 
public health and the environment and get full value for our 
investments.
_______________________________________________________________________



EPA

                              -----------

                             PRERULE STAGE

                              -----------




115.   ACCEPTABILITY OF RESEARCH USING HUMAN SUBJECTS
Priority:


Other Significant


Legal Authority:


7 USC 136a; 21 USC 346a


CFR Citation:


40 CFR 26 (Revision)


Legal Deadline:


None


Abstract:


EPA is evaluating how its current policy with respect to the protection 
of

[[Page 61267]]

human subjects in testing should be applied to testing not conducted or 
supported by the Agency. Current EPA regulations apply to research 
conducted or supported by the Agency or ``otherwise subject to 
regulation.'' The action needed to give effect to the ``otherwise 
subject to regulation'' phrase has not been taken. In addition, EPA 
will seek public comment on issues related to Agency use of human 
research data in pesticide decisionmaking. EPA believes the process 
being initiated will serve two important Agency goals: ensuring the 
availability of sound and appropriate scientific data in its decisions, 
and protection of the interests, rights and safety of human research 
subjects. EPA may issue one or more documents, which may include policy 
statements, rulemaking or requests for public comment.


Statement of Need:


In July 1998, the Agency committed that EPA would not consider human 
research on pesticides in support of decisions under the Food Quality 
Protection Act revisions to FIFRA and FFDCA unless a policy were in 
place that could assure any such studies met the highest scientific and 
ethical standards. The Agency convened a special joint subcommittee of 
the FIFRA Scientific Advisory Panel and the EPA Science Advisory Board 
to advise on this policy. The subcommittee has completed its work. If 
deemed acceptable for consideration, some human research already 
performed could significantly affect the Agency's risk assessments of 
some pesticides. Clarification of Agency policy with respect to use of 
human data is thus needed.


Summary of Legal Basis:


FIFRA sec. 3 authorizes EPA to define data requirements supporting 
pesticide decisions and to establish guidelines for conducting research 
to support pesticide decisions. FFDCA sec. 408 authorizes EPA to 
consider available and reliable data in support of pesticide tolerance 
decisions.


Alternatives:


Still to be identified.


Anticipated Cost and Benefits:


No analysis has been performed yet.


Risks:


No analysis has been performed yet.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
ANPRM                                                          07/00/02
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


Federal


Additional Information:


SAN No. 4610


Sectors Affected:


32532 Pesticide and Other Agricultural Chemical Manufacturing


Agency Contact:
Vanessa Vu
Environmental Protection Agency
Office of Prevention, Pesticides and Toxic Substances
7201
Washington, DC 20460
Phone: 202 260-6900
Fax: 202 401-0849
Email: [email protected]

John Carley
Environmental Protection Agency
Office of Prevention, Pesticides and Toxic Substances
7501C
Phone: 703 305-7019
Email: [email protected]
RIN: 2070-AD57
_______________________________________________________________________



EPA



116. 6-YEAR REVIEW OF EXISTING NATIONAL PRIMARY DRINKING WATER 
REGULATIONS
Priority:


Other Significant


Legal Authority:


42 USC 300f et seq


CFR Citation:


Not Yet Determined


Legal Deadline:


Other, Statutory, August 6, 2002, Complete review for contaminants with 
NPDWRs promulgated prior to August 1996.


Abstract:


The Safe Drinking Water Act (SDWA) requires EPA to review and revise, 
if appropriate, all National Primary Drinking Water Regulations 
(NPDWRs) no less frequently than once every six years. According to 
SDWA, any revisions of drinking water regulations must maintain, or 
increase, the level of public health protection provided; however, EPA 
may identify regulatory changes that will streamline or reduce existing 
requirements without lessening the level of public health protection. 
As a part of this action, EPA will do two things: (1) develop an 
overall protocol for conducting each six year review; and (2) review 
the chemical contaminants (with the exception of arsenic which is being 
revised and atrazine which is being reviewed on an accelerated schedule 
for which NPDWRS were promulgated prior to 1996). No new requirements 
will be imposed by this action. The purpose of the review is to 
determine whether new data, technology, or other factors exist that 
justify revisions to existing NPDWRs. The outcome of each review will 
be a Federal Register notice making available the results of the 
Agency's review and a rulemaking schedule for the regulations the 
Agency believes are appropriate candidates for revision at this time. 
EPA may decide that any of the following need to be revised: maximum 
contaminant level goals, maximum contaminant levels, analytical 
methods, monitoring, treatment, recordkeeping and reporting 
requirements. EPA plans extensive stakeholder outreach and consultation 
in the development of the protocol and throughout the review process.


Statement of Need:


The review of each existing NPDWR is necessary to determine whether 
there are more current data, since the NPDWR was promulgated, that 
suggest a regulatory revision may be appropriate to maintain, or 
improve, the level of public health protection. Data considered as a 
part of the review include changes in risk assessment, changes in 
analytical feasibility (where appropriate), changes in treatment 
feasibility, other issues that may be relevant to the specific NPDWR, 
and occurrence and exposure. NPDWRs identified as candidates for 
revision will be those where the review suggests a regulatory revision 
will significantly improve public health protection or significantly 
reduce costs while at least maintaining the current level of public 
health protection.


Summary of Legal Basis:


Section 1412(b)(9) of the SDWA, as amended in 1996, requires that the 
Administrator shall, not less often than every 6 years, review and 
revise, as

[[Page 61268]]

appropriate, each primary drinking water regulation. SDWA also mandates 
that any revision maintain, or provide for greater, protection of the 
health of persons.


Alternatives:


The review ends with a decision by EPA that the NPDWR is, or is not, a 
candidate for regulatory revision at this time. NPDWRs may be 
eliminated from further consideration for regulatory revision at this 
time for one or more of the following reasons: (1) no data were 
identified that suggest the need for regulatory revision; (2) some 
potential changes were identified but are likely to result in little or 
no improvement in public health protection or cost savings; (3) an 
update of the risk assessment is in process or planned for the near 
future; or (4) the review identified significant data gaps or research 
needs that need to be addressed to determine the appropriateness of any 
regulatory revision. EPA will determine, on a case-by-case basis, 
whether to initiate activity to address these data gaps/research needs. 
Otherwise, EPA does not plan any further review/revision of these 
NPDWRs until the next review cycle. If EPA identifies the NPDWR as a 
candidate for revision, the Agency will begin the rulemaking process. 
The first part of this process will be to perform all of the analyses 
required to consider alternative regulatory options and to develop a 
Notice of Proposed Rulemaking (NPRM) for public comment. If the results 
of these analyses continue to suggest a regulatory revision is 
appropriate, and after taking the public comments received into 
consideration, EPA will promulgate regulatory revisions to the NPDWR.


Anticipated Cost and Benefits:


EPA is not performing detailed cost and benefit analyses during the 
review phase because such analyses are premature until the Agency has 
identified specific regulatory options. EPA will conduct the cost and 
benefit analyses as a part of the rulemaking phase for those NPDWRs 
identified as potential candidates for revision.


Risks:


As a part of the review, EPA is identifying any relative source 
contribution assumptions that may need further evaluation and factoring 
this consideration into the decision whether or not to designate the 
NDPWR as a candidate for regulatory revision. For those NPDWRs that EPA 
identifies as candidates for revision, the Agency will evaluate 
relative source contribution assumptions in more detail as a part of 
the rulemaking phase. Therefore, no statement of the magnitude of the 
risk, relative to other risks within EPA's jurisdiction, can be made 
during the review phase.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
Notice of Preliminary Decision                                 01/00/02
Notice of Final Decision                                       08/00/02
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


None


Additional Information:


SAN No. 4424


Sectors Affected:


22131 Water Supply and Irrigation Systems


Agency Contact:
Judy Lebowich
Environmental Protection Agency
Water
4607
Washington, DC 20460
Phone: 202 260-7595
Fax: 202 260-3762
Email: [email protected]

Wynne Miller
Environmental Protection Agency
Water
4607
Washington, DC 20460
Phone: 202 260-0259
Fax: 202 260-3762
Email: [email protected]
RIN: 2040-AD67
_______________________________________________________________________



EPA

                              -----------

                          PROPOSED RULE STAGE

                              -----------




117. 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 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

[[Page 61269]]

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                                                           01/00/02
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
_______________________________________________________________________



EPA



118. 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:


None


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 5-minute 
NAAQS. On January 30, 1998, the court found that EPA did not

[[Page 61270]]

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 
published an informational notice in the Federal Register on January 9, 
2001 (66 FR 1665).


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 Revie59 FR 58958                                    11/15/94
NPRM NAAQS Imple60 FR 12492Part 51)                            03/07/95
Final Rule NAAQS61 FR 25566                                    05/22/96
NPRM Revised NAA62 FR 210entation (Part 51)                    01/02/97
Notice Schedule 63 FR 24782e to NAAQS Remand                   05/05/98
Notice Informati66 FR 1665tice                                 01/09/01
Notice          Determined                                        To Be
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


Federal, State, Local, Tribal


Additional Information:


SAN No. 1002


Agency Contact:
Susan Stone
Environmental Protection Agency
Air and Radiation
MD-15
RTP, NC 27711
Phone: 919 541-1146
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: 919 541-0237
Email: [email protected]
RIN: 2060-AA61
_______________________________________________________________________



EPA



119. 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). 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. 
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-hour 
standard in approximately 3000 counties across the U.S. On February 27, 
2001, the U.S. Supreme Court issued a ruling largely upholding EPA's 
positions on the issues in question, the most significant exception 
being the determination that EPA must reconsider its approach to 
implementing the revised ozone standard. EPA is now working to address 
this element of the Supreme Court decision, as well as another issue 
stemming from the earlier D.C. Circuit Court decision. EPA is also 
developing guidelines for determining Best Available Retrofit 
Technology (BART) under the Regional Haze Regulations, as well as 
moving forward on other revisions to the Regional Haze Regulations to 
incorporate the efforts of the Western Regional Air Partnership (WRAP).


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.

[[Page 61271]]

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.


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 Areas63 FR 31013hour ozone standard                 06/05/98
Final Rule Addit63 FR 39432 meeting 1-hour ozone standard      07/22/98
Draft Guidance I63 FR 65593on Planning                         11/17/98
Final Rule Addit64 FR 30911 Meeting 1-Hour Ozone NAAQS: 96-98 D06/09/99
Final Rule Regio64 FR 35713                                    07/01/99
Final Action Rei65 FR 45182of 1-hr standard                    07/20/00
NPRM BART Guidan66 FR 381080)                                  07/20/01
NPRM WRAP Rule (SAN 4495)                                      01/00/02
Final Action BART Guidance (SAN 4450)                          07/00/02
Final Action WRAP Rule (SAN 4495)                              01/00/03
Final Action ImpDeterminedn Guidance                              To Be
Regulatory Flexibility Analysis Required:


No


Government Levels Affected:


None


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



120. OPERATING PERMITS: REVISIONS (PART 70)
Priority:


Other Significant


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.


Summary of Legal Basis:


Clean Air Act, Title V


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
NPRM                                                           03/00/02
Final Action                                                   03/00/03

[[Page 61272]]

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
Email: [email protected]
RIN: 2060-AF70
_______________________________________________________________________



EPA



121. NESHAP: PLYWOOD AND COMPOSITE WOOD PRODUCTS
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(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 (MDF), 
oriented strandboard (OSB), medium density fiberboard, 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 minimum stringency 
implied by the congressionally given formula in section 112 of the 
Clean Air Act.


Anticipated Cost and Benefits:


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. In addition, an Economic 
Impact Analysis and Regulatory Impact Analysis have been prepared.


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                                                           03/00/02
Final Action                                                   03/00/03
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


Businesses


Government Levels Affected:


None


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
Phone: 919 541-5395
Fax: 919 541-0246
Email: [email protected]
RIN: 2060-AG52
_______________________________________________________________________



EPA



122. 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. 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.

[[Page 61273]]

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:


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 cost/
benefit analyses are not conducted for individual rulemakings within 
the MACT program.


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                                                           06/00/02
Final Action                                                   06/00/03
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



123. 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


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. 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:


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 cost/
benefit analyses are not conducted for individual rulemakings within 
the MACT program.


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                                                           05/00/02
Final Action                                                   05/00/03
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


Businesses, Governmental Jurisdictions


Government Levels Affected:


None


Additional Information:


SAN No. 3657

[[Page 61274]]

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



124. 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:


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. The risks from this industry are those normally associated 
with combustion, such as exposure to particulate matter and sulfur 
oxides.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           05/00/02
Final Action                                                   05/00/03
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


Businesses


Government Levels Affected:


None


Additional Information:


SAN No. 3837


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



125. NESHAP: SURFACE COATING OF AUTOMOBILES AND LIGHT-DUTY TRUCKS
Priority:


Economically Significant. Major under 5 USC 801.


Legal Authority:


42 USC 7401 et seq


CFR Citation:


40 CFR 63


Legal Deadline:


None


Abstract:


The Clean Air Act, as amended in 1990, requires EPA to develop emission 
standards for sources of hazardous air pollutants (HAPs). The surface 
coating of new automobiles and light-duty trucks is among the 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 this source category in 1980. The 
standards for the NESHAP are to be technology-based are are to require 
the maximum achievable control technology as described in section 112 
of the CAA.


Statement of Need:


Surface coating of automobiles and ligh-duty trucks is a source 
category listed to be regulated under section 112 of the CAA.


Summary of Legal Basis:


Section 112 of the Clean Air Act


Alternatives:


Alternatives have been explored as the proposal has been developed. The 
alternatives include the minimum required ``floor'' level of control 
and other more stringent options.


Anticipated Cost and Benefits:


This rule will result in significant costs to the affected industry, 
including costs for recordkeeping and reporting. These costs are being 
identified as the proposal is being developed, and will be addressed in 
a Regulatory Impact Analysis accompanying the proposed rule.


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.

[[Page 61275]]

Therefore, separate risk analyses are normally not conducted for 
individual rulemakings within the MACT program. The risks from this 
industry are those normally associated with surface coating operations, 
such as exposure to coating solvents which are hazardous air 
pollutants.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           03/00/02
Final Action                                                   03/00/03
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


Businesses


Government Levels Affected:


State, Local


Additional Information:


SAN No. 3907


Agency Contact:
Dave Salman
Environmental Protection Agency
Air and Radiation
(MD-13)
Research Triangle Park, NC 27711
Phone: 919 541-0859
Fax: 919 541-5689
Email: [email protected]

Dianne Byrne
Environmental Protection Agency
Air and Radiation
MD-13
Research Triangle Park, NC 27711
Phone: 919 541-5689
Fax: 919 541-5342
Email: [email protected]
RIN: 2060-AG99
_______________________________________________________________________



EPA



126. REVIEW OF THE NATIONAL AMBIENT AIR QUALITY STANDARDS FOR 
PARTICULATE MATTER
Priority:


Economically Significant


Legal Authority:


42 USC 7408; 42 USC 7409


CFR Citation:


40 CFR 50


Legal Deadline:


Final, Statutory, July 1, 2002, Under the Clean Air Act - the next 
standards review is to be completed July 2002.


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). Due to the unprecedented volume of new research, the 
completion of the Criteria Document has been extended and as a result 
the overall schedule for the review of the PM NAAQS is anticipated to 
extend beyond the original target of July 2002. 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.


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                                                           08/00/02
Final Action                                                   07/00/03
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


Undetermined


Additional Information:


SAN No. 4255

[[Page 61276]]

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: 919 541-0237
Email: [email protected]
RIN: 2060-AI44
_______________________________________________________________________



EPA



127. TRANSPORTATION CONFORMITY AMENDMENTS: RESPONSE TO MARCH 2, 1999, 
COURT DECISION
Priority:


Other Significant


Legal Authority:


42 USC 7401 to 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, 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                                                           12/00/01
Final Action                                                   06/00/02
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
NFEVL
Ann Arbor, MI 48105
Phone: 734 214-4441
Fax: 734 214-4052
Email: [email protected]
RIN: 2060-AI56
_______________________________________________________________________



EPA



128. 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 precursor and 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. On March 3, 
2000, the Court of Appeals issued a decision largely upholding the NOx 
SIP Call, but remanded four narrow issues to EPA for further rulemaking 
action. In an August 30, 2000 Court Order, emission reduction measures 
are required to be in place by May 31, 2004. On June 8, 2001, the D.C. 
Circuit made a related decision concerning the NOx SIP Call Technical 
Amendment rulemakings which largely upheld Phase I of the NOx SIP Call, 
but remanded one issue to EPA. EPA is now addressing in a

[[Page 61277]]

separate rulemaking the remanded issues mentioned above -- see SAN 4433 
in today's Regulatory Agenda. Another issue remanded, or remanded and 
vacated, in the technical amendments and section 126 court decisions 
dealing with growth projections will be addressed separately. A notice 
of data availability was published on 8/3/01 which made new data 
publicly available for notice-and-comment. Final action is expected in 
November 2001. 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.


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


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

_______________________________________________________________________
Final Action NOx63 FR 57355                                    10/27/98
NPRM NOx FIPs (S63 FR 56393                                    10/21/98
Final Action Sec64 FR 28250ndings                              05/25/99
Final Action Sec65 FR 2674pprovals and Remedy                  01/18/00
NODA Notice of D66 FR 40609ility for the NOx SIP Call & Section08/03/01
NPRM Response to NOx SIP Call Court Decision (SAN 4433)        12/00/01
Final Action Response to Remands Concerning Growth Factors     01/00/02
Final Action Response to NOx SIP Call Court Decision (SAN 4433)04/00/02
Final Action NOxDetermined 4096)                                  To Be
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


State


Additional Information:


SAN No. 4466


Agency Contact:
Jan King
Environmental Protection Agency
Air and Radiation
MD-15
Research Triangle Park, NC 27711
Phone: 919 541-5665
Fax: 919 541-0824
Email: [email protected]

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]
RIN: 2060-AJ20
_______________________________________________________________________



EPA



129.   ELECTRIC UTILITY STEAM GENERATING UNIT MACT REGULATION
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 7412


CFR Citation:


40 CFR 63


Legal Deadline:


NPRM, Judicial, December 15, 2003.


Final, Judicial, December 15, 2004.


Abstract:


In December 2000, the EPA determined that regulation of hazardous air 
pollutant emissions (HAP) from oil- and coal-fired electric utility 
steam generating units was necessary and appropriate. This finding was 
based on the results of the study mandated by section 112(n)(1)(A) of 
the Clean Air Act, as amended. The regulation(s) will be developed 
under section 112 and will result in standards based on the use of 
maximum achievable control technology (MACT). The primary benefit will 
be the reduction of mercury emissions to the atmosphere from coal-fired 
units but other HAP will also be reduced. Small businesses and State/
local/tribal governments could be impacted (particularly those 
governments owning or operating oil- or coal-fired electric generation 
facilities).

[[Page 61278]]

Statement of Need:


Oil and coal-fired electric utility steam generating units were added 
(December 20, 2000) to the list of source categories to be regulated 
under section 112 of the Clean Air Act, as amended.


Summary of Legal Basis:


Section 112 of the Clean Air Act, as amended.


Alternatives:


Alternatives will be identified as the proposal is developed.


Anticipated Cost and Benefits:


It is anticipated that this rule will result in significant costs to 
the affected industry, including Federal, State, and local entities 
that own/operate electric utility steam generating units. These costs 
will be identified as the proposal is developed.


Risks:


Risk information will become available as the proposal is developed.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           12/00/03
Final Rule                                                     12/00/04
Regulatory Flexibility Analysis Required:


Undetermined


Small Entities Affected:


Businesses, Governmental Jurisdictions


Government Levels Affected:


Federal, State, Local


Federalism:


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


Energy Effects:


Statement of Energy Effects planned as required by Executive Order 
13211.


Additional Information:


SAN No. 4571


Sectors Affected:


221112 Fossil Fuel Electric Power Generation


Agency Contact:
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]

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-AJ65
_______________________________________________________________________



EPA



130. LEAD-BASED PAINT ACTIVITIES; TRAINING AND CERTIFICATION FOR 
RENOVATION AND REMODELING
Priority:


Other Significant. Major under 5 USC 801.


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 
types 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 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

[[Page 61279]]

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 Pb 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 Pb 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 by 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                                                           08/00/02
Final Action                                                   08/00/03
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses, Governmental Jurisdictions, Organizations


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:
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]

Julie Simpson
Environmental Protection Agency
Office of Prevention, Pesticides and Toxic Substances
7404
Washington, DC 20460
Phone: 202 260-7873
Fax: 202 260-0770
Email: [email protected]
RIN: 2070-AC83
_______________________________________________________________________



EPA



131. 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:


Final, Statutory, August 3, 1999.


Abstract:


This final policy statement will set forth EPA's Endocrine Disruptor 
Screening Program and the procedures to be followed by regulated 
entities and the Agency. 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 address certain issues 
related to implementing the Program. The major actions in 2001-2003 
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 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.


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 in Paragraph 22 below.


Risks:


Evidence is continuing to mount that wildlife and humans may be at risk 
from exposure to chemicals operating through a endocrine mediated 
pathway. Preliminary studies show decreases on IQ tests and increases 
in aggression in children. Severe malformations of the genitals of boys 
has 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 U.S., Europe, 
Japan, Canada, and Australia which have been linked to specific 
chemical exposures. Evidence is sufficient for the U.S. to proceed on a 
two track strategy: research on the basic science regarding endocrine 
disruption and screening to identify which chemicals are capable of

[[Page 61280]]

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 and Request for Comment    12/28/98
NPRM - Proposed Procedural Rule                                06/00/02
Final Action - Final Screening Program                         06/00/03
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



132. PESTICIDE EMERGENCY EXEMPTION REGULATIONS
Priority:


Other Significant


Legal Authority:


7 USC 136(p)


CFR Citation:


40 CFR 166


Legal Deadline:


None


Abstract:


EPA will propose revisions to its regulations on emergency exemptions 
under section 18 of the Federal Insecticide, Fungicide and Rodenticide 
Act. Emergency exemptions allow temporary use of a pesticide not in 
accordance with registration requirements when emergency conditions 
exist. In the 1995 Presidential Reinvention Initiative, EPA identified 
a number of issues, which have been refined through informal 
discussions with States, user groups, and other stakeholders.


Statement of Need:


Stakeholders, including States and Federal agencies, have requested 
that EPA review its regulations for the FIFRA section 18 emergency 
exemption process. States and Federal agencies are the only applicants 
for emergency exemptions. Representatives of States have recommended 
modifications to the current process for application, review and 
approval of emergency exemptions. If adopted, the changes would reduce 
unnecessary burden to both applicants and EPA, expedite decisions on 
applications (which is critical in emergency situations) and 
potentially reduce risk to human health and the environment.


Summary of Legal Basis:


FIFRA sec. 18 authorizes EPA to temporarily exempt States from the 
requirements of registration to alleviate an emergency condition.


Alternatives:


Several measures for streamlining or improving the emergency exemption 
process are being considered by the Agency. EPA has analyzed these 
measures and has received considerable comment, both formally and 
informally, from stakeholders. Since this rule generally constitutes 
regulatory relief, and is not expected to cause any economic impact, 
options with varying cost do not apply.


Anticipated Cost and Benefits:


Because this regulation would provide regulatory relief, no costs are 
anticipated. Potential benefits include the reduced burden and cost to 
States and Federal agencies that apply for emergency exemptions, 
reduced burden to EPA, and, in some cases, reduced risk to human health 
and the environment. Indirect benefits may accrue to users of 
pesticides under emergency exemptions if changes result in faster 
review and approval, or greater availability of pesticides. No economic 
assessment of costs and benefits has yet been conducted.


Risks:


In general, the measures being considered are intended to achieve 
efficiencies and reduce burdens, not to reduce risks.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           07/00/02
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


Federal, State, Tribal


Additional Information:


SAN No. 4216


Sectors Affected:


9241 Administration of Environmental Quality Programs


Agency Contact:
Joseph Hogue
Environmental Protection Agency
Office of Prevention, Pesticides and Toxic Substances
7506C
Washington, DC 20460
Phone: 703 308-9072
Fax: 703 305-5884
Email: [email protected]

Jean M. Frane
Environmental Protection Agency
Office of Prevention, Pesticides and Toxic Substances
7506C
Washington, DC 20460
Phone: 703 305-5944
Email: [email protected]
RIN: 2070-AD36
_______________________________________________________________________



EPA



133.   PLANT INCORPORATED PROTECTANTS (PIPS); EXEMPTION FOR 
PIPS THAT ACT BY PRIMARILY AFFECTING THE PLANT
Priority:


Other Significant


Legal Authority:


7 USC 136 et seq; 21 USC 346a et seq


CFR Citation:


40 CFR 174

[[Page 61281]]

Legal Deadline:


None


Abstract:


EPA is considering the addition of plant-incorporated protectants that 
act by primarily affecting the plant to its plant-incorporated 
protectants exemptions at 40 CFR 174. Substances which plants produce 
for protection against pests, and the genetic material necessary to 
produce them, are pesticides under the Federal Insecticide, Fungicide 
and Rodenticide Act (FIFRA), if humans intend these substances to 
``prevent, repel or mitigate any pest.'' These substances are also 
``chemical pesticide residues'' under the Federal Food, Drug, and 
Cosmetic Act (FFDCA). EPA has determined that it will no longer issue 
split registrations for biotechnology products. Therefore, EPA is 
concurrently considering the exemption of plant-incorporated 
protectants derived through genetic engineering from sexually 
compatible plants from the requirement of a tolerance under section 408 
of the FFDCA. Due to public interest and new scientific information, 
additional public comment on this proposal, originally published in 
1994, was requested in a recent Supplemental Proposal (66 FR 37855).


Statement of Need:


Publication of the policy document ``Coordinated Framework for the 
Regulation of Biotechnology'' established a framework using existing 
statutes for inter-Agency regulation of biotechnology products. EPA 
began the process of establishing an internal framework for regulation 
of biotechnology under it's product-specific statutes through the 
finalization of the first set of plant-incorporated protectants rules. 
These rules are necessary to continue the development of and further 
define EPA's framework for regulation of products derived through 
biotechnology. The proposed exemption of plant incorporated protectants 
that act by primarily affecting the plant from requirements under FIFRA 
was originally published in 1994. At that time, it was not necessary to 
consider exemptions from the requirement of a tolerance under FFDCA 
simultaneously with FIFRA exemptions. Therefore, it will be neccessary 
to publish a NPRM proposing the FFDCA exemption before a Final Action 
on the FIFRA and FFDCA exemptions can be considered.


Summary of Legal Basis:


Under FIFRA (7 USC 136 et seq) and section 408 of the FFDCA (21 USC 
346a), EPA has the authority to require the registration of pesticides 
and to establish tolerances, or exemptions from the requirement of a 
tolerance as appropriate, of pesticidal residues in food. As EPA will 
no longer issue split registrations for pesticides, these decisions 
must be considered simultaneously.


Alternatives:


The choice is either to provide an exemption or not to. There are no 
other alternatives to evaluate.


Anticipated Cost and Benefits:


The anticipated costs and benefits are based on those associated with 
the recently finalized exemption for PIPs derived through conventional 
breeding from sexually compatible plants. No costs are associated with 
this action. Benefits would include a reduction in regulatory oversight 
and the use of associated resources.


Risks:


This rule is an exemption, so potential risk will be examined to ensure 
implementation would not present a risk to public health or to the 
environment.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM FIFRA Exemp59 FR 60496                                    11/23/94
Supplemental NPR61 FR 37891                                    07/22/96
Supplemental NPR62 FR 27132                                    05/16/97
Supplemental NPR64 FR 19958                                    04/23/99
Supplemental NPR66 FR 37855                                    07/19/01
NPRM FFDCA Tolerance Exemption                                 09/00/02
Final Action FFDCA Tolerance Exemption                         12/00/03
Final Action FIFRA Exemption                                   12/00/03
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


Businesses, Organizations


Government Levels Affected:


Federal


Additional Information:


SAN No. 4612


This action is a continuation of the action described in RIN 2070-AC02. 
Since several pieces of that action are now finalized, the Agency is 
spliting this piece into a separate Agenda entry so that it can 
continue to be tracked separately.


Sectors Affected:


32532 Pesticide and Other Agricultural Chemical Manufacturing; 111 Crop 
Production; 54171 Research and Development in the Physical Sciences and 
Engineering Sciences


Agency Contact:
Elizabeth Milewski
Environmental Protection Agency
Office of Prevention, Pesticides and Toxic Substances
7201
Washington, DC 20460
Phone: 202 260-0699
Fax: 202 260-0949
Email: [email protected]

Janet Andersen
Environmental Protection Agency
Office of Prevention, Pesticides and Toxic Substances
7511C
Phone: 703 308-8128
Fax: 703 308-7026
RIN: 2070-AD56
_______________________________________________________________________



EPA



134. OFFICE OF SOLID WASTE BURDEN REDUCTION PROJECT
Priority:


Other Significant


Legal Authority:


42 USC 6907; 42 USC 6912(a); 42 USC 6921 to 6927; 42 USC 6930; 42 USC 
6934; 42 USC 6935; 42 USC 6937 to 6939; 42 USC 6944; 42 USC 6949(a); 42 
USC 6974; PL 104-13


CFR Citation:


40 CFR 260; 40 CFR 261; 40 CFR 264; 40 CFR 265; 40 CFR 266; 40 CFR 268; 
40 CFR 270


Legal Deadline:


None


Abstract:


EPA plans to reduce the burden imposed by the RCRA reporting and 
recordkeeping requirements to help meet the Federal Governmentwide goal 
established by the Paperwork Reduction Act (PRA).


In June 1999, EPA published a Notice of Data Availability (NODA) in the 
Federal Register (64 FR 32859) to seek comment on a number of burden 
reduction ideas. After reviewing the

[[Page 61282]]

comments received on the NODA, EPA is drafting a proposed rulemaking to 
implement many of these ideas. The proposals are designed to eliminate 
duplicative and nonessential paperwork.


The main ideas being considered for the proposed rulemaking are: (1) 
eliminating or modifying one-third of the 334 RCRA-required notices and 
reports that are sent by the regulated community to states and EPA; (2) 
eliminating the RCRA emergency response training requirements that 
overlap with the Occupational Safety and Health Administration 
requirements; (3) eliminating the need for facilities to record 
personnel descriptions; (4) decreasing the owner/operator self-
inspection frequency of hazardous waste tanks to weekly; (5) providing 
states and EPA with the opportunity to lengthen owner/operator self-
inspection frequencies on a case-by-case basis for containers, 
containment buildings, and tanks; (6) eliminating the Land Disposal 
Restrictions generator waste determinations, recycler notifications and 
certifications, hazardous debris notifications and characteristic waste 
determinations, and streamlining the characteristic waste notification 
procedures; and (7) modifying the groundwater monitoring requirements 
for hazardous waste facilities.


Statement of Need:


The Paperwork Reduction Act of 1995 establishes a Federal 
Governmentwide goal to reduce the paperwork and reporting burden it 
imposes. The RCRA Burden Reduction Initiative Proposed Rulemaking makes 
the regulatory changes necessary to meet this goal.


Summary of Legal Basis:


This action is not required by statute or court order.


Alternatives:


Reducing recordkeeping and reporting will require changes in our 
regulations. There was no alternative to a rulemaking. The Agency 
sought opinions from the regulated community on various burden 
reduction possibilities.


Anticipated Cost and Benefits:


Our cost-benefit analysis showed a savings of $120 million and 929,000 
hours. The proposed rule will have minimal impact on the protectiveness 
of the RCRA regulations. The proposal will eliminate or streamline 
paperwork requirements that are unnecessary because they add little to 
the protectiveness of the RCRA regulations.


Risks:


The proposed rule will have no risk impacts.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
Notice of Data A64 FR 32859                                    06/18/99
NPRM                                                           01/00/02
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


Federal, State, Local, Tribal


Additional Information:


SAN No. 4084


Applicable SIC codes: Chemicals and Allied Products (28), Primary Metal 
Industries (33), Fabricated Metals (34), Industrial Machinery and 
Equipment (35), Electrical Equipment (36), Transportation Equipment 
(37), Other Manufacturing, Transportation and Utilities (40-49), 
Wholesale Trade (50-51), Services (70-89) and Other SIC Groups


Sectors Affected:


323 Printing and Related Support Activities; 324 Petroleum and Coal 
Products Manufacturing; 325 Chemical Manufacturing; 326 Plastics and 
Rubber Products Manufacturing; 331 Primary Metal Manufacturing; 332 
Fabricated Metal Product Manufacturing; 334 Computer and Electronic 
Product Manufacturing; 562 Waste Management and Remediation Services


Agency Contact:
Robert Burchard
Environmental Protection Agency
Solid Waste and Emergency Response
5302W
Washington, DC 20460
Phone: 703 308-8450
Fax: 703 308-8433
Email: [email protected]
RIN: 2050-AE50
_______________________________________________________________________



EPA



135. RECYCLING OF CATHODE RAY TUBES (CRTS) AND MERCURY-CONTAINING 
EQUIPMENT: CHANGES TO HAZARDOUS WASTE REGULATIONS
Priority:


Other Significant


Legal Authority:


42 USC 6912(a); 42 USC 6921; 42 USC 6922; 42 USC 6923; 42 USC 6924; 42 
USC 6925


CFR Citation:


40 CFR 261; 40 CFR 273


Legal Deadline:


None


Abstract:


This action will ultimately revise the existing Federal hazardous waste 
regulations to encourage recycling and better management of Cathode Ray 
Tubes (CRTs) by proposing a conditional exclusion from the definition 
of solid waste for CRTs being recycling. A CRT is display component of 
a television or computer monitor. A CRT is made largely of specialized 
glasses, some of which contain lead to protect the user from X-rays 
inside the CRT. Due to the lead, when they are disposed of or 
reclaimed, some CRTs are hazardous wastes under the Federal Resource 
Conservation and Recovery Act (RCRA) regulations. This rule will also 
propose to streamline RCRA requirements for managing mercury-containing 
equipment by adding such equipment to the universal waste rule. This 
rule is planned in response to a June 9, 1998 recommendation on CRT 
recycling from the Common Sense Initiative (CSI) Council to the 
Environmental Protection Agency (EPA), and in response to a petition 
from the Utilities Solid Waste Activities Group regarding mercury-
containing equipment. CSI is a consensus-based process for developing 
cleaner, cheaper, smarter environmental improvements that includes 
representatives of: industry; environmental groups; community groups; 
environmental justice groups; labor and, Federal, State, local, and 
tribal governments. The goal of this proposal is to improve management 
and encourage recycling, thereby minimizing disposal of lead, 
increasing resource recovery, and enhancing protection of human health 
and the environment.

[[Page 61283]]

Statement of Need:


This proposal is needed to respond to recommendations of the 
Electronics Subcommittee of the CSI Council regarding CRT recycling, 
and also to respond to a petition from the Utilities Solid Waste 
Activities Group regarding management of mercury-containing equipment. 
It is also needed to streamline RCRA requirements for these materials 
to encourage better management and recycling.


Summary of Legal Basis:


This action is not required by statute or court order.


Alternatives:


EPA plans to solicit comments on alternative management requirements, 
including notification and tracking, accumulation requirements, 
requirements for CRT glass processors, export requirements, and 
disposal requirements.


Anticipated Cost and Benefits:


EPA estimates that this proposal, if finalized, would result in annual 
savings of up to 3 million dollars to reduce administrative, 
transportation, and management costs compared to current regulations.


Risks:


The risks are undetermined.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           02/00/02
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


Federal, State, Local, Tribal


Additional Information:


SAN No. 4092


Sectors Affected:


334411 Electron Tube Manufacturing


Agency Contact:
Marilyn Goode
Environmental Protection Agency
Solid Waste and Emergency Response
5304W
Washington, DC 20460
Phone: 703 308-8800
Fax: 703 308-0522
Email: [email protected]
RIN: 2050-AE52
_______________________________________________________________________



EPA



136. NPDES PERMIT REQUIREMENTS FOR MUNICIPAL SANITARY SEWER COLLECTION 
SYSTEMS, MUNICIPAL SATELLITE COLLECTION SYSTEMS, AND SANITARY SEWER 
OVERFLOWS
Priority:


Economically Significant. Major under 5 USC 801.


Unfunded Mandates:


This action may affect State, local or tribal goverments.


Legal Authority:


33 USC 1311 CWA sec 301; 33 USC 1314 CWA sec 304; 33 USC 1318 CWA sec 
308; 33 USC 1342 CWA sec 402; 33 USC 1361 CWA sec 501(a)


CFR Citation:


40 CFR 122.38; 40 CFR 122.41; 40 CFR 122.42


Legal Deadline:


None


Abstract:


EPA is developing a notice of proposed rulemaking that would propose a 
broad-based reevaluation framework for sanitary sewer collection 
systems under the NPDES program. The Agency is proposing standard 
permit conditions for inclusion in permits for publicly owned treatment 
works (POTWs) and municipal sanitary sewer collection systems. The 
standard requirements address reporting, public notification, and 
recordkeeping requirements for sanitary sewer overflows (SSOs), 
capacity assurance, management, operation and maintenance requirements 
for municipal sanitary sewer collection systems; and a prohibition on 
SSOs.


Statement of Need:


The proposed regulation is intended to address three interrelated 
issues: (1) The risks to health and the environment caused by SSOs; (2) 
The need to protect and enhance local, State and Federal investments in 
sewer system infrastructure; and (3) The need to provide a clear and 
consistent regulatory program for collection systems.


Risks to health/environment: EPA estimates that about 40,000 SSO events 
occur each year, and perhaps ten times this many instances occur where 
sewage backs up into basements. These events lead to a variety of 
damages, including exposure of people to health risks; lowered water 
quality; and property damage and clean-up costs.


Protection of Investments in Sewer System Infrastructure : Sanitary 
sewer collection systems represent a major national investment in 
community infrastructure. EPA estimates that these systems have a 
replacement value of $1 to $2 trillion. Another source estimates that 
wastewater collection and treatment systems represent about 10 to 15 
percent of the value of all publicly owned infrastructure in the United 
States. The substantial frequency of SSOs and other collection system 
failures indicates that operation, maintenance, repair and 
rehabilitation of sewer systems need to improve.


Providing Clear and Consistent Regulatory Program for Collection 
Systems - States are implementing the existing NPDES regulations for 
sanitary sewer collection systems in widely differing ways.


Summary of Legal Basis:


EPA is considering whether to publish a proposed rule that would 
require NPDES permits for municipal sanitary sewer collection systems 
to contain a standard provision for better operation and management of 
systems to avoid SSOs, increased attention to system planning, and 
better notification to the public in the event of an overflow. These 
proposed standard permit conditions would derive from Clean Water Act 
(CWA) sections 304(i), 308, and 402(a). Section 402(a) of the CWA 
authorizes EPA to prescribe permit conditions as necessary to carry out 
the provisions of the CWA, including permit conditions on data and 
information collection and reporting. Section 308 of the CWA authorizes 
EPA to require NPDES permittees to establish, maintain, and report 
records for determining whether there has been a violation of the CWA. 
The prohibition of SSO discharges is a technology-based limitation that 
is based, in part, on CWA section 301(a) which prohibits a discharge to 
waters of the United States except in compliance with an NPDES permit. 
The prohibition is also based on EPA's interpretation of the Act that 
discharges from a separate sanitary sewer system need to meet effluent 
limitations based on secondary treatment as defined by EPA and any more 
stringent limitation necessary to meet water quality standards.


Legal authority for the requirements for municipal satellite collection 
systems derives from the definition of ``publicly owned treatment 
works.'' CWA section 212(2)(A) defines ``treatment works'' to include 
``any devices and systems used in the storage, treatment, recycling, 
and

[[Page 61284]]

reclamation of municipal sewage or industrial wastes of a liquid nature 
. . . including . . . intercepting sewers, outfall sewers, sewage 
collection systems . . . .'' EPA regulations define the term ``publicly 
owned treatment works'' similarly at 40 CFR 122.2 and 403.1.


Alternatives:


NPDES requirements for municipal sanitary sewer collection systems 
currently under consideration include the five major alternatives 
discussed below. The first alternative would require NPDES permits for 
municipal sanitary sewer collection systems to contain a standard 
provision for better operation and management of systems to avoid SSOs, 
increased attention to system planning, and better notification to the 
public in the event of an overflow. The second alternative would 
involve extending the requirements of the proposed rule to privately 
owned satellite collection systems. The third alternative would be to 
change the technology-based standard for discharges from sanitary 
sewers from secondary treatment to best available technology 
economically achievable (BAT)/ best practicable control technology 
currently available (BCT). The fourth alternative would be a no action 
alternative. The fifth alternative would be a prescriptive capacity, 
management, operation, and maintenance provision. In addition to these 
alternatives, a number of municipalities have suggested additional 
alternatives which are being considered.


Anticipated Cost and Benefits:


EPA estimates that the total annual incremental cost for municipalities 
and Federal/State permitting authorities to comply could range from 
$93.5 million to $126.5 million. EPA estimates the total annual 
monetized benefits would range from $36 million to $97 million. The 
benefits are based on estimates of the benefits to water quality and 
the benefits associated with ``smarter'' management, operation and 
maintenance (MOM). The estimated range of benefits associated with 
water quality including benefits from: reduced human exposure to SSOs, 
leading to fewer cases of illness; increased opportunities for 
recreation, tourism, and fishing; and less property damage due to 
basement backups, ranged from $12 to $73 million annually. The range of 
benefits associated with improved water quality and better planning and 
MOM are estimated to result in a national cost savings of $24 million 
annually.


Risks:


EPA estimates that there are at least 40,000 SSO events per year and an 
additional 400,000 occurrences of sewage backing up into basements. The 
health and environmental risks attributed to SSOs vary depending on a 
number of factors including location and season (potential for public 
exposure), frequency, volume, the amount and type of pollutants present 
in the discharge, and the uses, conditions, and characteristics of the 
receiving waters. SSOs can release raw sewage to areas where they 
present high risks of human exposure, such as streets, private 
property, basements, and receiving waters used for drinking water, 
fishing and shellfishing, or contact recreation. The most immediate 
health risks associated with SSOs are potential exposure to bacteria, 
viruses, and other pathogens. EPA estimates that these overflow events 
cause an estimated 1.8 to 3.6 million illnesses per year. Major groups 
of disease-causing organisms or agents associated with untreated SSOs 
include: bacteria, viruses, protozoa, and helminths (intestinal worms). 
These pathogens can cause diseases range in severity from mild 
gastroenteritis (causing stomach cramps and diarrhea) to diseases that 
can be life-threatening, such as cholera, infectious hepatitis, 
dysentery, and severe gastroenteritis. Adverse health consequences can 
be more severe for children, the elderly, and those with weakened 
immune systems. In addition to pathogens, raw sewage may contain 
metals, synthetic chemicals (including endocrine system disruptors), 
nutrients, pesticides, and oils, which also can be detrimental to the 
health of humans and wildlife.


SSOs may affect the quality and uses of waters of the United States. 
Adverse water quality impacts from SSOs may include changes to the 
physical characteristics and viability of aquatic habitats, causing 
fish kills. Sewage spills and overflows (including sewage overflows 
from combined sewers and sanitary sewers, malfunctioning sewage 
treatment plants and pump stations, sewage spills and sewer-line 
breaks) are the leading identified cause of beach closures and swimming 
advisories in the United States.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           04/00/02
Final Action                                                   04/00/03
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


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. 3999


Note: This rule was formerly known as ``Revisions to NPDES Requirements 
for Compliance Reporting and Collection System Discharges.''


Sectors Affected:


22132 Sewage Treatment Facilities


Agency Contact:
Kevin Weiss
Environmental Protection Agency
Water
4203M
Washington, DC 20460
Phone: 202 564-0742
Fax: 202 564-6392
Email: [email protected]

Sharie Centilla
Environmental Protection Agency
Water
4203M
Washington, DC 20460
Phone: 202 564-0697
Fax: 202 564-6392
Email: [email protected]
RIN: 2040-AD02
_______________________________________________________________________



EPA



137. EFFLUENT GUIDELINES AND STANDARDS FOR THE CONSTRUCTION AND 
DEVELOPMENT INDUSTRY
Priority:


Economically Significant. Major under 5 USC 801.


Unfunded Mandates:


Undetermined


Legal Authority:


33 USC 1311 CWA 301; 33 USC 1314 CWA 304; 33 USC 1316 CWA 306; 33 USC 
1317 CWA 307; 33 USC 1318 CWA 308; 33 USC 1342 CWA 402; 33 USC 1361 CWA 
501


CFR Citation:


40 CFR 450

[[Page 61285]]

Legal Deadline:


NPRM, Judicial, March 31, 2002.


Final, Judicial, March 31, 2004.


Abstract:


The effluent guidelines will apply to construction activities 
associated with new development, as well as to those associated with 
re-development activities. The regulations will address storm water 
runoff from construction sites during the active phase of construction, 
as well as post-construction runoff. Construction activity is a major 
source of sediment and other pollutants discharged to the nation's 
waters. Industries potentially affected by this rulemaking include land 
developers, home builders, builders of commercial and industrial 
property, and other private and public sector construction site owners 
and operators. EPA will develop design criteria for erosion and 
sediment controls and storm water best management practices (BMPs). 
These requirements will be implemented in NPDES storm water permits 
issued to construction site owners and operators.


Statement of Need:


The 1998 National Water Quality Inventory Report to Congress indicates 
that 35 percent of assessed stream miles are not supporting their 
designated use. Siltation contributes to 38 percent of reported water 
quality problems in impaired rivers and streams. Construction and 
development projects contribute to stream impairment, because erosion 
and sediment controls (ESC) are not properly designed for active 
construction projects. The frequency of performance failure for ESCs is 
high due to inappropriate application, improper sizing, and lack of 
maintenance. For post construction projects, permanent 
hydromodification degrades 20 percent of the impaired river miles.


Summary of Legal Basis:


The Clean Water Act authorizes 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 
March 31, 2002.


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 construction site size 
exemptions to reduce the impact on small dischargers.


Anticipated Cost and Benefits:


EPA expects effluent reduction benefits from more than 20,000 
construction projects each year. The types of benefits associated with 
the effluent guidelines for construction and development involve 
improvements to surface water quality. The benefits from the guidelines 
will occur from improved control over stormwater and sediment 
discharged from construction sites. In addition, the guidelines will 
contribute to a reduction in stream bank erosion, the source of 
significant downstream sedimentation, flooding, and habitat 
destruction. The costs associated with this regulation will include 
capital costs to install best management practices (BMP) for active and 
post construction controls.


Risks:


EPA estimates that 2.2 million acres of agricultural and forest are 
developed each year for residential and nonresidential projects. The 
active construction processes require land clearing and grading that 
contribute to stormwater and sediment discharges. The impervious 
surfaces that are created within developed watersheds increase the 
stormwater volume and velocity and accelerate stream bank erosion and 
downstream sedimentation.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           03/00/02
Final Action                                                   03/00/04
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses


Government Levels Affected:


Federal, State, Local, Tribal


Federalism:


 Undetermined


Additional Information:


SAN No. 4280


For more information on construction and development visit Web site: 
NPRM-http://www.epa.gov /ost/guide/construction


Sectors Affected:


23 Construction; 23311 Land Subdivision and Land Development; 23321 
Single Family Housing Construction; 23322 Multifamily Housing 
Construction; 23331 Manufacturing and Industrial Building Construction; 
23332 Commercial and Institutional Building Construction; 23411 Highway 
and Street Construction; 23412 Bridge and Tunnel Construction; 23491 
Water, Sewer, and Pipeline Construction; 23492 Power and Communication 
Transmission Line Construction; 23493 Industrial Nonbuilding Structure 
Construction; 23499 All Other Heavy Construction; 23593 Excavation 
Contractors; 23594 Wrecking and Demolition Contractors


Agency Contact:
Eric Strassler
Environmental Protection Agency
Water
4303
Washington, DC 20460
Phone: 202 260-7150
Fax: 202 260-7185
Email: [email protected]

Jesse Pritts
Environmental Protection Agency
Water
4303
Washington, DC 20460
Phone: 202 260-7191
Fax: 202 260-7185
Email: [email protected]
RIN: 2040-AD42
_______________________________________________________________________



EPA



138. MINIMIZING ADVERSE ENVIRONMENTAL IMPACT FROM COOLING WATER INTAKE 
STRUCTURES AT EXISTING FACILITIES UNDER SECTION 316(B) OF THE CLEAN 
WATER ACT, PHASE 2
Priority:


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


Unfunded Mandates:


Undetermined


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, February 28, 2002.

[[Page 61286]]

Final, Judicial, August 28, 2003.


Abstract:


This rulemaking affects, at a minimum, existing electricity generating 
facilities that employ cooling water intake structures and whose intake 
flow levels exceed a minimum threshold to be determined by EPA during 
the rulemaking. 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 any adverse environmental impact that may be associated with 
the impingement and entrainment of fish and other aquatic organisms by 
cooling water intake structures. Impingement refers to trapping fish 
and other aquatic life on intake screens or similar devices where they 
may be injured or killed. Entrainment occurs when smaller aquatic 
organisms, eggs, and larvae are drawn into a cooling system, and then 
pumped back out, often with significant injury or mortality due to 
heat, physical stress or exposure to chemicals.


Statement of Need:


In the absence of national regulations, Permit Directors have 
implemented cooling water intake limitations incompletely and 
inconsistently and, in some cases, permit issuance or reissuance has 
been significantly delayed. Tons of fish and other aquatic organisms 
may be cropped annually as a result of cooling water intake structures 
at a single large facility. By court order, EPA must propose and take 
final action on this regulation. This regulation may have substantial 
ecological benefits.


Summary of Legal Basis:


This action is required under an amended consent decree in settlement 
of Riverkeeper Inc. et al. v. Whitman, 93 Civ. 0314 (AGS) (U.S.D.C., 
Southern District of New York, November 21, 2000).


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 not yet determined. 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                                                           02/00/02
Final Action                                                   08/00/03
Regulatory Flexibility Analysis Required:


Undetermined


Small Entities Affected:


Businesses, Governmental Jurisdictions


Government Levels Affected:


Federal, State, Local, Tribal


Additional Information:


SAN No. 4474


Split from RIN 2040-AC34.


Sectors Affected:


21 Mining; 22111 Electric Power Generation; 22133 Steam and Air-
Conditioning Supply; 311 Food Manufacturing; 3122 Tobacco 
Manufacturing; 313 Textile Mills; 321 Wood Product Manufacturing; 322 
Paper Manufacturing; 324 Petroleum and Coal Products Manufacturing; 325 
Chemical Manufacturing; 326 Plastics and Rubber Products Manufacturing; 
327 Nonmetallic Mineral Product Manufacturing; 331 Primary Metal 
Manufacturing; 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; 61131 
Colleges, Universities and Professional Schools


Agency Contact:
Deborah Nagle
Environmental Protection Agency
Water
4303
Washington, DC 20460
Phone: 202 260-2656
Fax: 202 260-7185
Email: [email protected]

Debra Hart
Environmental Protection Agency
Water
4303
Washington, DC 20460
Phone: 202 260-0905
Fax: 202 260-7185
Email: [email protected]
RIN: 2040-AD62
_______________________________________________________________________



EPA

                              -----------

                            FINAL RULE STAGE

                              -----------




139. NEW SOURCE REVIEW (NSR) IMPROVEMENT
Priority:


Other Significant


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 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

[[Page 61287]]

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, Utility Sector New Source Review (NSR) 
Alternative Compliance 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:


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. 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 1996, this effort 
was considered far enough along to be proposed for public comment, and 
a proposed rule was issued. Thereafter, EPOA has conducted numerous 
meetings with interested stakeholders. More recently, the Agency has 
been conducting a review of the NSR program in response to a 
recommendation from the President's National Energy Policy Development 
Group. EPA is examning the impact of the NSR regulations, including 
administrative interpreataion and implementation, on investment in new 
utility and refinery generation capacity, energy efficiency and 
environmental protection. EPA plans to report to the President on the 
impact of NSR on the three areas mentioned above. At that time we will 
also make recommendations on whether improvements to the NSR program 
are needed to provide more flexibility and certainty, while ensuring 
protection of the environment. Many of the approaches proposed in 1996 
to improve NSR are being considered as part of review recommended by 
the President's National Energy Policy Development Group.


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 (WEPCO).


Alternatives:


In January 1996, EPA, as part of another regulatory streamling 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. Additionally, EPA conducted 
extensive stakeholder meetings as part of the NSR review recommended by 
the President's National Energy Policy Development Group. EPA continues 
to review the alternatives presented by interested stakeholders.


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 pre-existing 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
Final Action                                                   03/00/02
Regulatory Flexibility Analysis Required:


No


Government Levels Affected:


Federal, State


Additional Information:


SAN No. 3259


See also SAN 4390


Agency Contact:
Lynn Hutchinson
Environmental Protection Agency
Air and Radiation
MD-12
Research Triangle Park, NC 27711
Phone: 919 541-5795
Fax: 919 541-5509
Email: [email protected]
RIN: 2060-AE11
_______________________________________________________________________



EPA



140. GROUNDWATER AND PESTICIDE MANAGEMENT PLAN RULE
Priority:


Economically Significant. Major under 5 USC 801.


Legal Authority:


7 USC 136(a) FIFRA sec 3; 7 USC 136(w)


CFR Citation:


40 CFR 152.170

[[Page 61288]]

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 
ground-water contamination potential. The rule will establish PMPs as 
an other regulatory restriction and 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 ground water 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 
ground-water 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 ground-water contamination potential) without those 
restrictions.


Alternatives:


This Rule is a direct outgrowth of the Pesticides and Ground Water 
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' ground-water 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 ground-water contamination. At the other 
extreme, outright cancellation of candidate pesticides with significant 
ground-water contamination potential was considered to provide full 
assurance that no further ground water 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 ground-water 
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 ground water, and a 
corresponding reduction in: (1) human and ecological risk (see below); 
and (2) threats to the economic and intrinsic values of the ground-
water resource. Significant uncertainties attend the quantification of 
these benefits, however. Under EO 12866, OMB designated this as an 
economically significant regulatory action under section 3(f) of the 
Executive order because of its potentially significant impact on a 
sector of the economy.


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 and Extension of Comment 
        Period  65 FR 15885                                    03/24/00
Final Action                                                   09/00/02
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

[[Page 61289]]

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
Fax: 703 305-5884
Email: [email protected]
RIN: 2070-AC46
_______________________________________________________________________



EPA



141. 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                                                   02/00/02
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

[[Page 61290]]

Agency Contact:
Susan Sharkey
Environmental Protection Agency
Office of Prevention, Pesticides and Toxic Substances
7406
Washington, DC 20460
Phone: 202 564-8789
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



142. 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:


None


Abstract:


The Chemical RTK Initiative was established in 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 assessment 
for chemicals to which children are substantially exposed; and the 
listing and lowering of thresholds for persistent, bioaccumulative, 
toxic chemicals reported to the Toxic Release Inventory (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% of the 2,800 high production volume 
chemicals have a full set of baseline testing information readily 
available, while almost 50% 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 rule-making 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 rule-writing to accomplish its goals. For 
instance, the HPV Challenge Program has asked industry to voluntarily 
provide both new and existing data on high production volume chemicals, 
while a series of HPV test rules 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.


Risks:


None.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
Notice Data Coll65 FR 81686Development on HPV Chemiclas        12/26/00
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


See also items identified under the following RINs 2070-AD09; 2070-
AD38; RIN 2070-AD16; RIN 2070-AC27.


Sectors Affected:


32411 Petroleum Refineries; 325 Chemical Manufacturing


Agency Contact:
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]

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]
RIN: 2070-AD25
_______________________________________________________________________



EPA



143.   PLANT INCORPORATED PROTECTANTS (PIPS); EXEMPTION FOR 
THOSE BASED ON VIRAL COAT PROTEINS
Priority:


Other Significant


Legal Authority:


21 USC 346(a) et seq; 7 USC 136 et seq


CFR Citation:


40 CFR 174


Legal Deadline:


None


Abstract:


EPA is considering the addition of plant-incorporated protectants based 
on viral coat proteins to its plant-incorporated protectants exemptions 
at

[[Page 61291]]

40 CFR 174. Substances which plants produce for protection against 
pests, and the genetic material necessary to produce them, are 
pesticides under the Federal Insecticide, Fungicide and Rodenticide Act 
(FIFRA), if humans intend these substances to ``prevent, repel or 
mitigate any pest.'' These substances are also ``chemical pesticide 
residues'' under the Federal Food, Drug, and Cosmetic Act (FFDCA). EPA 
has determined that it will no longer issue split registrations for 
biotechnology products. Therefore, EPA is concurrently considering the 
exemption of plant-incorporated protectants derived through genetic 
engineering from sexually compatible plants from the requirement of a 
tolerance under section 408 of the FFDCA. Due to public interest and 
new scientific information, additional public comment on this proposal, 
originally published in 1994, was requested in a recent Supplemental 
Proposal (66 FR 37855).


Statement of Need:


Publication of the policy document ``Coordinated Framework for the 
Regulation of Biotechnology'' established a framework using existing 
statutes for inter-Agency regulation of biotechnology products. EPA 
began the process of establishing an internal framework for regulation 
of biotechnology under its product-specific statutes through the 
finalization of the first set of plant-incorporated protectants rules. 
This rule is necessary to continue the development of and further 
define EPA's framework for regulation of products derived through 
biotechnology.


Summary of Legal Basis:


Under FIFRA (7 USC 136 et seq) and section 408 of the FFDCA (21 USC 
346a et seq), EPA has the authority to require the registration of 
pesticides and to establish tolerances, or exemptions from the 
requirement of a tolerance as appropriate, of pesticidal residues in 
food. As EPA will no longer issue split registrations for pesticides, 
these decisions must be considered simultaneously.


Alternatives:


The choice is either to provide an exemption or not to. There are no 
other alternatives to evaluate.


Anticipated Cost and Benefits:


The anticipated costs and benefits are based on those associated with 
the recently finalized exemption for PIPs derived through conventional 
breeding from sexually compatible plants. No costs are associated with 
this action. Benefits would include a reduction in regulatory oversight 
and the use of associated resources.


Risks:


This rule is an exemption, so potential risk will be examined to ensure 
implementation would not present a risk to public health or to the 
environment.


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 NPR66 FR 37855itional Comment Based on NAS Report 07/19/01
FFDCA Final Action                                             06/00/02
FIFRA Final Action                                             06/00/02
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


Businesses, Organizations


Government Levels Affected:


Federal


Additional Information:


SAN No. 4602


This action is a continuation of RIN 2070-AC02, which now contains 
several completed actions.


Sectors Affected:


32532 Pesticide and Other Agricultural Chemical Manufacturing; 111 Crop 
Production; 54171 Research and Development in the Physical Sciences and 
Engineering Sciences


Agency Contact:
Elizabeth Milewski
Environmental Protection Agency
Office of Prevention, Pesticides and Toxic Substances
7201
Washington, DC 20460
Phone: 202 260-0699
Fax: 202 260-0949
Email: [email protected]

Phil Hutton
Environmental Protection Agency
Office of Prevention, Pesticides and Toxic Substances
7511C
Washington, DC 20460
Phone: 703 308-8260
Fax: 703 308-7026
Email: [email protected]
RIN: 2070-AD49
_______________________________________________________________________



EPA



144.   PLANT-INCORPORATED PROTECTANTS (PIPS); EXEMPTION FOR 
THOSE DERIVED THROUGH GENETIC ENGINEERING FROM SEXUALLY COMPATIBLE 
PLANTS
Priority:


Other Significant


Legal Authority:


7 USC 136 et seq; 21 USC 346a et seq


CFR Citation:


40 CFR 174


Legal Deadline:


None


Abstract:


EPA is considering the addition of plant-incorporated protectants 
derived through genetic engineering from sexually compatible plants to 
its plant-incorporated protectants exemptions at 40 CFR 174. Substances 
which plants produce for protection against pests, and the genetic 
material necessary to produce them, are pesticides under the Federal 
Insecticide, Fungicide and Rodenticide Act (FIFRA), if humans intend 
these substances to ``prevent, repel or mitigate any pest.'' These 
substances are also ``chemical pesticide residues'' under the Federal 
Food, Drug, and Cosmetic Act (FFDCA). EPA has determined that it will 
no longer issue split registrations for biotechnology products. 
Therefore, EPA is concurrently considering the exemption of plant-
incorporated protectants derived through genetic engineering from 
sexually compatible plants from the requirement of a

[[Page 61292]]

tolerance under section 408 of the FFDCA. Due to public interest and 
new scientific information, additional public comment on this proposal, 
originally published in 1994, was requested in a recent supplemental 
proposal (66 FR 37855).


Statement of Need:


Publication of the policy document ``Coordinated Framework for the 
Regulation of Biotechnology'' established a framework using existing 
statutes for interagency regulation of biotechnology products. EPA 
began the process of establishing an internal framework for regulation 
of biotechnology under it's product-specific statutes through the 
finalization of the first set of plant-incorporated protectants rules. 
This rule is necessary to continue the development of and further 
define EPA's framework for regulation of products derived through 
biotechnology.


Summary of Legal Basis:


Under FIFRA (7USC 136 et seq) and section 408 of the FFDCA (21 USC 
346a), EPA has the authority to require the registration of pesticides 
and to establish tolerances, or exemptions from the requirement of a 
tolerance as appropriate, of pesticidal residues in food. As EPA will 
no longer issue split registrations for pesticides, these decisions 
must be considered simultaneously.


Alternatives:


The choice is either to provide an exemption or not to. There are no 
other alternatives to evaluate.


Anticipated Cost and Benefits:


The anticipated costs and benefits are based on those associated with 
the recently finalized exemption for PIPs derived through conventional 
breeding from sexually compatible plants. No costs are associated with 
this action. Benefits would include a reduction in regulatory oversight 
and the use of associated resources.


Risks:


This rule is an exemption, so potential risk will be examined to ensure 
implementation would not present a risk to public health or to the 
environment.


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 NPR66 FR 43552 of Comment Period                  08/20/01
Final Action                                                   09/00/02
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


Businesses, Organizations


Government Levels Affected:


Federal


Additional Information:


SAN No. 4611


This action is a continuation of the action described in RIN 2070-AC02. 
Since several pieces of that action are now finalized, the Agency is 
spliting this piece into a separate Agenda entry so that it can 
continue to be tracked separately.


Sectors Affected:


32532 Pesticide and Other Agricultural Chemical Manufacturing; 111 Crop 
Production; 54171 Research and Development in the Physical Sciences and 
Engineering Sciences


Agency Contact:
Elizabeth Milewski
Environmental Protection Agency
Office of Prevention, Pesticides and Toxic Substances
7201
Washington, DC 20460
Phone: 202 260-0699
Fax: 202 260-0949
Email: [email protected]

Janet Andersen
Environmental Protection Agency
Office of Prevention, Pesticides and Toxic Substances
7511C
Phone: 703 308-8128
Fax: 703 308-7026
RIN: 2070-AD55
_______________________________________________________________________



EPA



145. REQUIREMENTS FOR ZINC FERTILIZER MADE FROM RECYCLED HAZARDOUS 
SECONDARY MATERIALS
Priority:


Other Significant


Legal Authority:


42 USC 1006 et seq


CFR Citation:


40 CFR 261; 40 CFR 266; 40 CFR 268; 40 CFR 271


Legal Deadline:


NPRM, Judicial, November 15, 2000, Settlement agreement met deadline.


Final, Judicial, May 15, 2002, Settlement agreement.


Abstract:


This rulemaking is intended to revise the current RCRA regulations that 
apply to recycling of hazardous wastes in the manufacture of zinc 
fertilizers. Specifically, it is intended to establish a more 
consistent application of these recycling requirements to zinc 
fertilizer products, to establish a set of standards for contaminants 
in RCRA-regulated zinc fertilizers that are more appropriate to 
fertilizers and are protective of human health and the environment, and 
to specify more appropriate, protective conditions for management of 
zinc-bearing hazardous secondary materials prior to recycling. These 
regulatory revisions are expected to directly affect companies that 
manufacture zinc fertilizers from hazardous secondary materials, and is 
likely to benefit such manufacturers that are small businesses by 
removing certain regulatory disincentives to legitimate recycling 
activities.


Statement of Need:


This rulemaking responds to concerns expressed by industry, 
environmental groups and state agencies regarding the need to amend 
current RCRA regulations that apply to zinc fertilizers made from 
recycled hazardous wastes. The rule is expected to encourage legitimate 
recycling of zinc-bearing hazardous wastes, reduce costs, and establish 
more appropriate standards for these products.


Summary of Legal Basis:


This rulemaking is subject to a settlement agreement with the Sierra 
Club, The Washington Toxics Coalition, and the Environmental Technology 
Council. The agreement was signed on June 20, 2000.


Alternatives:


A number of regulatory alternatives are being examined in the context 
of reaching final Agency decisions for the final rule.

[[Page 61293]]

Anticipated Cost and Benefits:


The economic impact analysis prepared for the proposed rule estimated 
net cost savings to industry of several million dollars from the rule. 
The analysis is being refined based on comments received on the 
proposal and other information.


Risks:


The rulemaking will result in lower levels of contaminants, such as 
lead and cadmium, in zinc fertilizers made from hazardous wastes, with 
corresponding reductions in potential risks.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
Final Action                                                   05/00/02
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


Businesses


Government Levels Affected:


Federal, State


Additional Information:


SAN No. 4208


Sectors Affected:


32532 Pesticide and Other Agricultural Chemical Manufacturing; 32531 
Fertilizer Manufacturing; 331111 Iron and Steel Mills; 331419 Primary 
Smelting and Refining of Nonferrous Metal (except Copper and Aluminum); 
331492 Secondary Smelting, Refining, and Alloying of Nonferrous Metal 
(except Copper and Aluminum); 562112 Hazardous Waste Collection


Agency Contact:
Dave Fagan
Environmental Protection Agency
Solid Waste and Emergency Response
5301W
Washington, DC 20460
Phone: 703 308-0603
Fax: 703 308-0513
Email: [email protected]
RIN: 2050-AE69
_______________________________________________________________________



EPA



146. 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 300f et seq; SDWA 1412


CFR Citation:


40 CFR 141; 40 CFR 142


Legal Deadline:


NPRM, Statutory, August 6, 1999.


Final, Statutory, November 2, 2000.


Other, Statutory, February 6, 1999, Publish radon health risk reduction 
and cost analysis.


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 15,000-22,000 lung cancer deaths 
each year in the United States, according to a landmark report 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 NAS 
report, EPA estimates that radon in drinking 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 at or 
below the higher, alternative maximum contaminant level MCL proposed at 
4,000 pCi/L (picoCuries per liter, a standard unit of radiation), 
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 one year after proposal. 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 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

[[Page 61294]]

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 used in setting the 
proposed 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 $341-408 million. In complying 
with 300 pCi/l, an estimated 62.0 fatal and 3 non-fatal 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 $408 million. If most States 
and systems comply with the AMCL and implement a 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 $360 million for either implementation scenario. EPA expects 
compliance with the AMCL and implementation of a 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 
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.


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
Second NPRM     64 FR 59245                                    11/02/99
Notice          65 FR 39113                                    06/23/00
Final Action                                                   03/00/02
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:
Mariana Cubbedo-Negro
Environmental Protection Agency
Water
4607
Washington, DC 20460
Phone: 202 260-5746
Fax: 202 260-3762

James Taft
Environmental Protection Agency
Water
4607
Washington, DC 20460
Phone: 202 260-5519
Fax: 202 260-3762
Email: [email protected]
RIN: 2040-AA94
_______________________________________________________________________



EPA



147. 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 300f SDWA 1412


CFR Citation:


40 CFR 141(Revision); 40 CFR 142 (Revision)


Legal Deadline:


NPRM, Statutory, January 1, 2000.


Final, Statutory, June 22, 2001.


Abstract:


On January 22, 2001, EPA published a final Arsenic Rule (66 FR 6975). 
On March 23, 2001, EPA published a notice delaying the effective date 
of the final Arsenic Rule from March 23, 2001, to May 22, 2001 (66 FR 
16134), in accordance with a January 20, 2001, memorandum from the 
Assistant to the President and Chief of Staff, entitled Regulatory 
Review Plan, (published in the Federal Register on January 24, 2001). 
The 60-day delay in effective date was necessary to give Agency 
officials the opportunity for further review and to consider the new 
rule. On May 22, 2001, EPA published a rule that further delayed the 
effective date of the final Arsenic Rule from May 22, 2001, to February 
22, 2002 (66 FR

[[Page 61295]]

20579). As its next step in the process of reviewing the final Arsenic 
Rule, on July 19, 2001, EPA published a proposal for comment on a range 
of arsenic maximum contaminant level options from 3 ppb to 20 ppb to 
facilitate Agency review of the January 22, 2001 rule.


Statement of Need:


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. The 
1999 report issued by the National Academy of Sciences (NAS) definitely 
implicated inorganic arsenic's effects on bladder, lung, and skin 
cancer. Based on data that existed at that time, NAS urged EPA 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 
$2,500,000 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:


As discussed in the January 2001 Arsenic Rule, at a seven percent 
discount rate, the Arsenic Rule would be expected to have a total 
annualized cost of $792.1 million for a MCL of 3 ug/L, $471.7 million 
for a MCL 5 ug/L, $205.6 million for a MCL of 10 ug/L, and $76.5 
million for a MCL of 20 ug/L. The Arsenic Rule would have total health 
benefits as a result of avoided bladder and lung cancer cases of 
approximately $213.8 to $490.9 million if the MCL were set at 3 ug/L, 
$191.1 to $355.6 million if the MCL were set at 5 ug/L, $139.6 to 
$197.7 million if the MCL were set at 10 ug/L, and $66.2 to $75.3 
million if the MCL were set at 20 ug/L. These monetized health benefits 
of reducing arsenic exposures in drinking water are attributable to the 
reduced incidence of fatal and non-fatal bladder cancer and lung 
cancer. Under baseline assumptions (no control of arsenic exposure), 
there are annual fatal cancers and non-fatal cancers associated with 
arsenic exposures through CWSs. At an arsenic MCL level of 3 ug/L, an 
estimated 33 to 74 fatal cancers and 25 to 64 non-fatal cancers per 
year are prevented; at a arsenic level of 5 ug/L, an estimated 29 to 54 
fatal cancers and 22 to 47 non-fatal cancers per year are prevented; at 
10 ug/L, 21 to 30 fatal and 16 to 26 non-fatal cancers per year are 
prevented; and at 20 ug/L, 10 to 11 fatal and approximately 9 non-fatal 
cancers per year are prevented. In addition to quantifiable benefits, 
many potential non-quantifiable benefits associated with reducing 
arsenic exposures in drinking water have been identified. These 
potential benefits were not able to be quantified for the January 2001 
Rule, but may include reduced risk of skin cancer and numerous non-
cancerous health effects. In addition, certain non-health related 
benefits may exists, such as ecological improvements and an increase in 
consumers' perception of drinking water. The cost/benefit analysis for 
the Arsenic Rule is being revised.


Risks:


According to the 1999 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 1-1.5x10-3, 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    66 FR 6975                                     01/22/01
Final Action - D66 FR 16134ective Date                         03/23/01
NPRM - Further D66 FR 20580ective Date                         04/23/01
Final Action - F66 FR 28342y of Effective Date                 05/22/01
Second NPRM     66 FR 37617                                    07/19/01
Notice Result of66 FR 50961iew                                 10/05/01
Final Action                                                   02/00/02
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.

[[Page 61296]]

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



148. CROSS-MEDIA ELECTRONIC REPORTING (ER) AND RECORDKEEPING RULE
Priority:


Economically Significant


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 
provide a uniform legal framework for paperless electronic reporting 
and recordkeeping, including electronic signature/ certification, 
across EPA's environmental compliance programs. The rule will remove 
current legal requirements for paper and provide for mechanisms to 
assure the validity and authenticity of electronic documents and 
associated electronic signatures, whether transmitted as reports or 
maintained as records. This rule is important because of 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.


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 framework for electronic reporting must be in place by that 
time. The CROMERR rule would establish a framework to remove obstacles 
to electronic reporting and recordkeeping under most EPA regulations. 
Electronic government is also a capstone of the President's Management 
Agenda.


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:


Two alternatives to an EPA cross-media rule that applies to most 
compliance reports under 40 CFR, would include: (1) a business-as-usual 
approach to electronic recordkeeping with additional rulemaking to 
cover electronic reporting; or (2) individual rulemakings by each of 
the program offices. EPA's past experience with such rulemakings has 
demonstrated that such a course of action may be less effective in 
bringing EPA into compliance with GPEA by the 2003 deadline.


Risks:


The risks are undetermined.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            66 FR 46161                                    08/31/01
Final Action                                                   04/00/03
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


Businesses, Governmental Jurisdictions


Government Levels Affected:


Federal, State, Local, Tribal


Procurement:


This is a procurement-related action for which there is no statutory 
requirement. There is a paperwork burden associated with this action.


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
BILLING CODE 6560-50-S

[[Page 61297]]




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 one significant action of a regulatory 
nature. It has been published for public comment.
 The 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 Chair of the Agency. The statement has 
not been reviewed or approved by the other members of the Commission).
_______________________________________________________________________



EEOC

                              -----------

                            FINAL RULE STAGE

                              -----------




149. 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 reviewed comments and has considered suggested 
alternatives in developing this regulatory proposal.


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 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                                                   07/00/02
Regulatory Flexibility Analysis Required:


No

[[Page 61298]]

Government Levels Affected:


Federal


Agency Contact:
Carol Miaskoff
Assistant Legal Counsel, Office of Legal Counsel
Equal Employment Opportunity Commission
1801 L Street NW
Washington, DC 20507
Phone: 202 663-4689
TDD Phone: 202 663-7026
Fax: 202 663-4639
RIN: 3046-AA57
BILLING CODE 6570-01-S

[[Page 61299]]




GENERAL SERVICES ADMINISTRATION (GSA)



Statement of Regulatory and Deregulatory Priorities
 The General Services Administration (GSA) establishes Governmentwide 
policy for construction and operation of buildings, procurement and 
distribution of supplies, travel and transportation, acquisition, 
information technology and electronic commerce, management of advisory 
committees, and utilization and disposal of real and personal property.
 GSA's fiscal year 2002 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 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. GSA is rewriting them 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 such as customer 
service guides.
BILLING CODE 6840-34-S

[[Page 61300]]




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 2000 Strategic Plan, 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) 2002.
 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 2002, except to conform to FAR changes that are currently being 
promulgated in part 12, Acquisition of Commercial Items; part 45, 
Government Property; part 30, Cost Accounting Standards Administration; 
and part 27, Patents, Data, and Copyrights.
 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 is working on enhancing its risk-centered 
approach to acquisition by ensuring that all contracts address safety 
and also by applying it to non-contract instruments such as grants and 
cooperative agreements. NFS regulations addressing Acquisition of 
Investigations, part 1872, will be amended to incorporate NASA's risk-
centered approach to acquisition, including safety, and to update 
guidance.
 Additionally, NASA's risk-centered approach to acquisition includes 
security of unclassified information technology (IT) resources and 
dissemination of data produced or used in performance of research and 
development (R&D) contracts. The NFS will be amended to clarify NASA's 
requirements for IT security and the review requirements for data 
produced under R&D contracts including data contained in final reports.
 To reduce the time and cost spent by the Agency and our industry 
partners in the procurement of basic and applied research under 
cooperative agreements, NASA is focusing on streamlining our processes. 
To go forward in this effort, regulations governing Cooperative 
Agreements with Commercial Firms at 14 CFR part 1274 will be rewritten 
to incorporate improvements and policy consistent with other NASA 
initiatives.
 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.
BILLING CODE 7510-01-S

[[Page 61301]]




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 2002 are: (1) updating 
and rewriting in plain language our research room regulations in 36 CFR 
part 1254; (2) evaluating possible revisions to 36 CFR part 1234 
relating to electronic text documents; (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 61302]]




OFFICE OF PERSONNEL MANAGEMENT (OPM)



Statement of Regulatory Priorities
 As the Federal Government's human resource and personnel manager, the 
Office of Personnel Management's (OPM) regulatory priorities for the 
coming year will focus on human resource management reforms and 
flexibilities that will enable the Federal Government to recruit, 
manage, and retain the high-quality, diverse workforce needed by 
departments and agencies to deliver their respective missions to the 
American people.
 The President's Management Agenda recognizes the critical role that 
human resources management must play in reforming Government, 
identifying it as one of five core Governmentwide strategies. It is, 
after all, the people who work in Government who are key to delivering 
citizen-centered, results-oriented, and market-based services to the 
American people. Consistent with its core mission, OPM anticipates a 
central role in implementing the President's Management Agenda--
particularly its focus on strategic management of human capital--and 
stands ready to advance the agenda by way of regulation as necessary 
and appropriate.
 Since the events of September 11, 2001, OPM's activities have focused 
primarily on five broad Administration priorities. We anticipate that 
OPM's regulatory activity over the next year will serve to facilitate 
implementation of the President's priorities.
War on Terrorism
 Immediately following the terrorist attacks on the Pentagon and the 
World Trade Center, the Director of OPM communicated to all Federal 
departments and agencies her ability and desire to work closely with 
them to address immediate personnel needs. To that end, OPM has helped 
agencies fill the emergency vacancies in essential positions by 
providing flexibilities and facilitating the return to the workforce of 
Federal retirees wanting to help in the emergency. OPM also has worked 
to speed benefits to the victims of the attacks and their families, has 
provided guidance on helping employees deal with the traumatic events, 
and is serving as a central point to facilitate communication regarding 
anthrax and other bioterrorism threats.
 In addition, OPM has provided guidance and assistance to the Office of 
Homeland Security on staffing issues, and intends to facilitate the 
placing of personnel to assist in accomplishing its mission. Congress 
presently is considering legislation on airport security. Regardless of 
whether or not airport security personnel are made Federal employees, 
OPM anticipates working closely with whatever department or agency is 
given oversight responsibility.
 On all these issues, to the extent regulatory action is needed, we 
stand ready to promulgate regulations to facilitate successful pursuit 
of America's war on terrorism.
Managerial Flexibilities Act
 Anticipated passage of the President's Managerial Flexibilities Act of 
2001 will require OPM to promulgate new, or modify existing, 
regulations to implement employment restructuring assistance; voluntary 
early retirement; recruitment and retention incentives; results-
oriented performance evaluation and compensation for senior executives; 
human resources management innovations; and hiring flexibilities.
Outsourcing
 OPM is examining ways the private sector can add to mission delivery. 
OPM already has privatized two service areas--investigations and 
training. OPM further intends to convert positions in the Employment 
Service Technology Support Center to the private sector over a five-
year period. We also will examine all Federal Retirement Program 
functions that are comparable to functions performed by commercial 
entities. The most sweeping long-term change under study is a 
comprehensive review of OPM's reimbursable services to determine if a 
different structure based on increased reliance on private-sector 
providers would be more cost-efficient.
Delayering and Restructuring
 To improve OPM's organization to better deliver services to the 
Federal workforce, our agency customers and the American people, OPM 
anticipates a sweeping restructuring plan that dramatically redesigns 
the agency. The new plan will result in a significantly flatter, more 
streamlined agency that is much better positioned to focus on customer 
service and strategically aligned to help the President carry out his 
agenda. Supervisory ratios will be increased, and employees redeployed 
to service delivery by centralizing internal functions and terminating 
programs when their missions have been completed. Most of this can be 
done administratively, without the need for further regulatory action. 
However, to the extent program functions are defined by regulation, 
they will have to be promulgated, modified, or eliminated.
e-Government
 OPM is the lead agency on three of the e-Government initiatives 
recently announced by OMB to accelerate Federal Government improvements 
in effectiveness, efficiency, and customer service. OPM is responsible 
for e-Training, Recruitment One-Stop, and Enterprise HR Integration. 
OPM currently is examining the necessary regulatory efforts needed to 
implement these programs.
 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 and produces results for our citizens.
_______________________________________________________________________



OPM

                              -----------

                            FINAL RULE STAGE

                              -----------




150.   RETENTION ALLOWANCES
Priority:


Other Significant. Major under 5 USC 801.


Legal Authority:


5 USC 5754


CFR Citation:


5 CFR 575, subpart C


Legal Deadline:


None


Abstract:


These final regulations would provide agencies with greater flexibility 
in the use of retention allowances by allowing them to pay such 
allowances to employees who are likely to leave their position for 
other Federal employment under certain limited circumstances.


Statement of Need:


Agencies have specifically requested this regulatory change to provide 
them with additional flexibility to help retain Federal employees.


Summary of Legal Basis:


The governing United States Code provision is 5 U.S.C. 5754.

[[Page 61303]]

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 the 
agencies were seeking


Anticipated Cost and Benefits:


The final regulations would help agencies 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 final regulations expand the circumstances 
under which 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 this incentive, we cannot 
specifically predict or quantify these costs.


Risks:


These final regulations would delegate to agencies increased authority 
to pay retention allowances to employees under certain limited 
circumstances. Through our monitoring and oversight activities, we will 
continue to ensure that agencies do not violate the merit system 
principles and prohibited personnel practices under 5 U.S.C. 2301 and 
2302 when using these new authorities.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            66 FR 5491                                     01/10/01
NPRM Comment Period End                                        03/20/01
Final Action                                                   12/00/01
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-AJ48
BILLING CODE 6325-01-S

[[Page 61304]]




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 38,000 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 2000, the PBGC was 
trustee of almost 2,900 plans and paid $903 million in benefits to 
about 244,000 people during 2000. Another 314,000 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 1,750 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.
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:
 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.
 Extended the filing date for PBGC premiums to match the latest 
            Form 5500 filing date.
 Encouraged self-correction of premium underpayments by making 
            it easier to qualify for safe-harbor penalty relief.
 Simplified its valuation assumptions by adopting a single set 
            of assumptions for allocation purposes.
 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.
 Solicited public comment on benefit valuation and payment 
            issues relating to terminated cash balance plans that use 
            variable indices to determine future retirement benefits.
 In FY 2001, the PBGC:
 Amended its premium regulation to allow plan administrators to 
            pay a prorated premium for a short plan year rather than 
            paying a full year's premium and requesting a refund (final 
            rule, December 1, 2000).
 Amended its premium regulation to simplify and narrow the 
            definition of ``participant'' for PBGC premium purposes 
            (final rule, December 1, 2000).
 Simplified its premium forms by introducing a new ``Form 1-
            EZ'' for use by single-employer plans that are exempt from 
            the PBGC's variable-rate premium.
 Proposed to amend its benefit payments regulations to give 
            participants more choices of annuity benefit forms, to 
            clarify what it means to be able to ``retire'' under plan 
            provisions for certain purposes under title IV of ERISA, 
            and to add rules on who will get certain payments the PBGC 
            owes to a participant at the time of death (proposed rule, 
            December 26, 2000).
 Published a proposed penalty policy to provide guidance on 
            assessment and review of penalties and on what constitutes 
            ``reasonable cause'' for a penalty waiver (proposed rule, 
            January 12, 2001).
 The PBGC is continuing to review its regulations to look for further 
simplification opportunities. The PBGC's regulatory plan for October 1, 
2001, to September 30, 2002, consists of one significant regulatory 
action.

[[Page 61305]]

_______________________________________________________________________



PBGC

                              -----------

                          PROPOSED RULE STAGE

                              -----------




151. 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 
Insurers. 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                                                           07/00/02
NPRM Comment Period End                                        09/00/02
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 61306]]




SMALL BUSINESS ADMINISTRATION (SBA)



Statement of Regulatory Priorities
Overview
 The Small Business Administration (SBA) is America's small business 
resource. SBA's mission is to promote and deliver financial and 
business development programs to America's entrepreneurs in the most 
efficient and effective manner possible.
 With a portfolio of guaranteed business and disaster loans, SBA is the 
Nation's largest single financial backer of small businesses. Through 
our financial assistance programs, each year, SBA seeks to serve small 
companies by facilitating access to capital and credit. The SBA also 
helps entrepreneurs to start and grow their businesses through its 
resource-partner programs.
 SBA is committed to:
 Listening to small businesses to make sure SBA is meeting the 
            needs of the small business community;
 Working with its financial partners to improve small business 
            access to capital through SBA's loan and venture capital 
            programs;
 Providing technical assistance and guidance through its 
            entrepreneurial development partners 24 hours a day;
 Establishing new and strengthening existing its public and 
            private partnerships to encourage greater contracting and 
            business opportunities for small businesses.
 Measuring outcomes, such as revenue growth, job creation, and 
            business longevity, to ensure SBA operates its programs in 
            an efficient and effective manner.
 SBA's regulatory priorities for the coming year will focus on 
strengthening SBA's management of programs, streamlining its HUBZone 
Program, and increasing opportunities for women-owned businesses.
SBA's Regulatory Plan
Small Business Lending Company Regulations56
 SBA is currently drafting proposed regulations that will 
strengthen the Agency's management and oversight of the Small Business 
Lending Company (SBLC) Program. SBA guarantees loans through 
approximately 7,000 lenders, of which 14 are SBLCs that are not 
otherwise regulated by Federal or State authorities. Further, 
consistent with congressional and Administration policy, certain SBA 
lenders are delegated authority to make credit decisions on loans 
guaranteed by SBA. At the present time, all of the SBLCs are preferred 
lenders with authority to make such credit decisions. The SBLCs hold 
approximately 20 percent of the outstanding loans guaranteed by SBA and 
are subject to safety and soundness examinations by SBA on a 12 to 24 
month cycle. This rulemaking will clarify and strengthen the existing 
rules governing SBLCs in the areas of monitoring, oversight and 
enforcement, safe and sound operations, and compliance with SBA 
regulations.
HUBZone Empowerment Contracting Program56
 SBA is proposing regulations that will incorporate changes 
enacted by Public Law 106-554. The amended regulations will address 
eligibility requirements for small business concerns owned by Native 
American Tribal Governments and Community Development Corporations and 
the addition of new HUBZone areas called redesignated areas. The 
proposed amendments will streamline the program to make it more 
efficient.
The Women-Owned Small Business Federal Contract Assistance 
Program56
 SBA is currently drafting regulations that will implement a 
``restricted competition'' procurement program for women-owned small 
businesses (WOSB). It will contain provisions about how a WOSB can be 
certified to participate in the program, who is eligible, and how 
protests will be handled. Specifically, section 8(m) of the Small 
Business Act limits the contracting officer's authority to restrict 
competition to contracts not exceeding $3 million for services or $5 
million in manufacturing. This proposed rule would establish a WOSB 
Federal Contract Assistance Program to be administered by the Office of 
Federal Contract Assistance for Women Business Owners within the SBA's 
Office of Government Contracting. This proposed rule would also 
encourage contracting officers to include a subcontracting 
participation evaluation factor in solicitations to evaluate the 
participation of certain small businesses in contract performance.
_______________________________________________________________________



SBA

                              -----------

                          PROPOSED RULE STAGE

                              -----------




152. SMALL BUSINESS LENDING COMPANIES REGULATIONS
Priority:


Other Significant


Legal Authority:


15 USC 634(b)(6); 15 USC 636(a); 15 USC 636(b)


CFR Citation:


13 CFR 120.470


Legal Deadline:


None


Abstract:


This rulemaking would amend 13 CFR 120.470 to clarify and strengthen 
the rules regarding Small Business Lending Companies (SBLCs) monitoring 
and oversight for safety and soundness, compliance, and related areas.


Statement of Need:


Section 7(a) of the Small Business Act states that the Small Business 
Administration (SBA) may provide financing to small businesses 
``directly or in cooperation with banks or other financial 
institutions.'' Today, SBA guarantees loans through approximately 7,000 
lenders. Of these lenders, about 14 are Small Business Lending 
Companies (SBLCs) that are not otherwise regulated by Federal or State 
chartering, licensing, or similar regulatory control. SBA examines or 
audits these SBLCs periodically. Congressional and Administration 
policy to privatize SBA lending and levels in loan volume require that 
SBA increase its SBLC oversight. To that end, SBA will draft 
regulations that strengthen the Agency's management of the SBLC 
Program.


Summary of Legal Basis:


Not required by statute or court order.


Alternatives:


This rulemaking amends and expands SBA's existing regulations on the 
SBLC Program.


Anticipated Cost and Benefits:


This rulemaking is designed to strengthen SBA's regulations regarding 
the SBLC Program. No additional costs to the Government or the SBLCs 
associated with this rulemaking will result.

[[Page 61307]]

Risks:


This regulation addresses no risks to the public health and safety or 
to the environment.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           03/00/02
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


None


Agency Contact:
Janet A. Tasker
Associate Administrator for Lender Oversight
Small Business Administration
409 Third Street SW
Washington, DC 20416
Phone: 202 205-3049
Email: [email protected]
RIN: 3245-AE14
_______________________________________________________________________



SBA



153.   THE WOMEN-OWNED SMALL BUSINESS FEDERAL CONTRACT 
ASSISTANCE PROGRAM
Priority:


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


Legal Authority:


15 USC 644(g)


CFR Citation:


13 CFR 127


Legal Deadline:


None


Abstract:


The Small Business Reauthorization Act of 2000 established a 
``restricted competition'' procurement program for women-owned small 
businesses (WOSB). The SBA will add 13 CFR part 127 to implement this 
program. The Office of Contract Assistance for Women Business Owners 
(CAWBO) in the Office of Government Contracting is drafting proposed 
regulations to implement the program. The proposed rule is expected to 
be published in February 2002. It will contain provisions about how a 
WOSB can be certified to participate in the program, who is eligible, 
how protests will be handled, etc.


Statement of Need:


Women-owned businesses have long been regarded as the fastest growing 
segment of the United States business community. Although women-owned 
small businesses (WOSBs) in particular have increased by 78 percent 
between 1987 and 1996, almost twice the rate of growth of all U.S. 
businesses, they do not receive a commensurate share of Federal 
contracting dollars.


This disparity has continued despite several congressional and 
executive efforts over a number of years to increase Federal 
contracting with WOSBs. One effort that had no significant result was 
the 1979 Executive Order 12138 that charged Federal agencies with 
providing procurement assistance to WOSBs. Awards thereafter to WOSBs 
reached only 0.2 percent of all Federal procurements. Prior to the 
legislation implemented by the instant regulations, the most current 
legislation containing significant guidance to Federal agencies 
regarding increased awards with WOSBs is the Federal Acquisition 
Streamlining Act (FASA) of 1994. FASA established a target award of 5 
percent of all Federal prime and subcontracting contract dollars to 
WOSBs. However, actual subsequent awards to WOSBs have never exceeded 
2.5 percent of prime contract dollars and have not achieved 5 percent 
of subcontract dollars. In FY 2000, prime contract awards to WOSBs were 
below 2.3 percent of total Federal dollars, a drop from the percentage 
awarded to WOSBs in FY 1999.


Summary of Legal Basis:


On December 21, 2000, Congress enacted section 811 of the Small 
Business Reauthorization Act of 2000, Public Law 106-554, to provide 
contracting officials a mechanism that targeted Government programs for 
contracting with WOSBs. Section 811 amended the Small Business Act by 
adding a new section 8(m), 15 U.S.C. 637(m), authorizing contracting 
officers to restrict competition to eligible WOSBs for certain Federal 
contracts in industries that SBA has determined that WOSBs are under 
represented or substantially under represented in Federal procurement.


The new section 8(m) of the Small Business Act limits the contracting 
officer's authority to restrict competition to contracts not exceeding 
$3 million for services or $5 million in manufacturing. To implement 
the new section 8(m) of the Act, this proposed rule would establish a 
WOSB Federal Contract Assistance Program to be administered by the 
CAWBO within SBA's Office of Government Contracting. The program would 
be considered part of SBA's Government contracting programs set forth 
under part 125 of title 13 of the Code of Federal Regulations, for ease 
of reference, the proposed WOSB regulations would be contained in the 
new part 127 of title 13.


The proposed rule provides conforming amendments necessary to integrate 
the program into SBA's size and Government contracting regulations. The 
proposed rule would amend part 125.3 of the title 13 of the Code of 
Federal Regulations to encourage contracting officers to include a 
subcontracting participation evaluation factor in certain solicitations 
to evaluate the participation of certain small businesses in contract 
performance. This would provide consistency with the statutory mandate 
that small businesses, including WOSBs, have the maximum practicable 
opportunity to become subcontractors for Federal contracts exceeding 
$100,000 and that they be included in subcontracting plans required 
under section 8(d) of the Small Business Act, 15 U.S.C. 632(d).


Alternatives:


Prior to the implementation of the Women-Owned Small Business Federal 
Contract Assistance Program, the SBA has supported an increase in 
Federal prime and subcontracting to WOSBs through a number of avenues. 
SBA personnel from Headquarters and the district offices have provided 
training across the country to WOSBs through conference participation 
and individual counseling. Special efforts to provide this support and 
outreach to WOSBs have been made by the personnel of the SBA's Area 
Offices of the Office of Government Contracting. In addition, the 
Office of Government Contracting negotiates the yearly prime and sub-
contracting goals for WOSBs with other Federal agencies, encouraging 
each agency to award at least 5 percent in both prime and 
subcontracting dollars to WOSBs.


A major step toward an increase in Federal training and awards to WOSBs 
was the formation in early FY 2001 of the CAWBO. This office, part of 
the Office of Government Contracting, now has the primary 
responsibility for the yearly award of the Frances Perkins Award to 
deserving large businesses that have been exemplary in their support 
and subcontracting to WOSBs.

[[Page 61308]]

Through CAWBO, the Office of Government Contracting also continues to 
sponsor the Federal $ and Sense Program for Women, which requires 
Federal participants to provide procurement training and support to 
WOSBs through a variety of events. CAWBO personnel also work to assist 
WOSBs through regular meetings with Women's Advocates from most of the 
primary Federal agencies. Another CAWBO effort, in concert with the 
National Women's Business Counsel, to train and provide Federal 
procurement data to WOSBs has been the launch of a web site, 
www.WomenBiz.gov, which provides extensive information through the 
procurement material on-line and links to many related web sites.


These efforts to date have resulted in an increase in Federal prime 
contract awards to WOSBs from 0.2 percent in the early 1990s to a 
current 2.3 percent, but never higher than 2.5 percent. It is 
anticipated that the regulations contained in section 811 of the Small 
Business Reauthorization Act of 2000, Public Law 106-554, will now 
provide contracting officers a tool that will allow all agencies to 
reach awards of 5 percent in both prime and subcontracting to WOSBs.


Anticipated Cost and Benefits:


In October 2000, the CAWBO was established as part of the general 
reorganization of the Office of Government Contracting and Business 
Development (GC/BD). This was the beginning of FY 2001 and neither the 
salaries of the six members of CAWBO, nor any other CAWBO expenses, 
were included in the budget. However, CAWBO has the primary 
responsibility for implementing the regulations now in review. To the 
greatest extent possible, the program has been developed to utilize 
already existing SBA offices, personnel, and resources. Further, the 
cost of certification for WOSBs not currently eligible through another 
Federal program will be the responsibility of the applicants and will 
be performed in the private sector. Most of the personnel costs 
associated with this new program have been absorbed in FY 2001 by the 
Office of Government Contracting. Some additional new program costs, 
once regulations are approved, are overseeing the selection of 
certifiers for WOSBs, providing program evaluations for the certifiers 
and selected certified firms, and overseeing protests of certified or 
self-certified WOSBs. Development and ongoing costs of the tracking 
systems for certification and protest data are related expenses. An 
initial study and later reexamination of data regarding the percentages 
of Federal dollars being awarded in various industries to WOSBs is 
central to the program. Training of both WOSBs and the Federal 
contracting community about the new program is also paramount to the 
success of the program and will require some travel and related 
training aids.


Assistance from other SBA offices will continue to be required to 
support the legislation underlying this program. The initial reviews of 
protests will be done in the Area Offices of the Office of Government 
Contracting. The Office of the General Counsel has been instrumental in 
producing the regulations. Other agency offices are already 
participating in the development of program support functions. Thus, 
the expense of developing and implementing the regulations is being 
minimized through existing offices and use of private certifiers. And 
to the extent possible, cooperation with other agencies, the Federal 
procurement community, and use of the Internet for training also reduce 
the costs associated with the program.


Risks:


The primary risk related to the draft regulations for the Women-Owned 
Small Business Federal Contract Assistance Program is the possibility 
that the review and implementation of the regulations will not be 
within the time frame planned by the Agency. However, the regulations, 
when examined regarding their relationship to other SBA small business 
contracting and certification programs, should be complimentary to 
programs already in existence. This program for WOSBs addresses the 
segment of the small business community that has been statistically 
most underrepresented in Federal prime and subcontracting. Further, 
training and other support provided by SBA personnel for this and other 
SBA contracting programs will benefit all segments of the small 
business community. In addition to higher awards to WOSBs, this 
synergistic relationship among SBA contracting programs is expected to 
produce an increase in the total Federal prime and subcontracting 
percentages being awarded to all small businesses.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           02/00/02
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses


Government Levels Affected:


Federal


Procurement:


This is a procurement-related action for which there is a statutory 
requirement. There is no paperwork burden associated with this action.


Agency Contact:
Sheryl Swed
Asst. Administrator, Office of Federal Contract Assistance Women 
Business Owners (CAWBO)
Small Business Administration
Suite 8100, Mail Stop 6730
409 Third Street SW
Washington, DC 20416
Phone: 202 205-6413
Email: [email protected]
RIN: 3245-AE65
_______________________________________________________________________



SBA



154.   HUBZONE EMPOWERMENT CONTRACTING PROGRAM
Priority:


Other Significant


Legal Authority:


15 USC 632(a); PL 105-135 sec 601 et seq; PL 106-554 sec 601 et seq


CFR Citation:


13 CFR 126


Legal Deadline:


None


Abstract:


SBA proposes to amend its regulations for the HUBZone Empowerment 
Contracting Program to incorporate changes enacted by Public Law 106-
554. The amended regulation addresses eligibility requirements for 
small business concerns owned by Native American Tribal Governments and 
Community Development Corporations and the addition of new HUBZone 
areas called redesignated areas.


Statement of Need:


SBA must amend its HUBZone regulations in order to implement changes in 
the Small Business Act mandated by Public Law 106-553, to correct 
typographical errors and to streamline the program.

[[Page 61309]]

Summary of Legal Basis:


According to 15 U.S.C. section 657a, SBA's Administrator is charged 
with carrying out the HUBZone Program. On December 21, 2000, the 
President signed into law Public Law 106-554, which amends the HUBZone 
Program. To carry out the program, SBA must implement these statutory 
changes by amending its regulations.


Alternatives:


The Agency considered issuing policy notices explaining the changes to 
the statute. However, this is not sufficient because the current 
regulations do not address the statutory changes to the program and 
therefore, if the regulations are not amended, the public would be 
confused.


Anticipated Cost and Benefits:


The proposed amendments to the HUBZone regulation would simplify the 
program to make it more efficient. Therefore, the benefits would be 
quicker processing time of HUBZone applications.


Risks:


There is no risk to the Agency.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           03/00/02
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


Businesses


Government Levels Affected:


Federal, Tribal


Procurement:


This is a procurement-related action for which there is a statutory 
requirement. There is no paperwork burden associated with this action.


Agency Contact:
Michael P. McHale
Associate Administrator for HUBZone Empowerment Contracting Program
Small Business Administration
409 Third Street SW
Washington, DC 20416
Phone: 202 205-6731
RIN: 3245-AE66
BILLING CODE 8025-01-S

[[Page 61310]]




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 Disability Insurance (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 is the final 
regulation that will provide more choices for people with disabilities 
who seek return-to-work services so that they may become self-
sufficient. This regulation implements legislation, The Ticket to Work 
and Work Incentives Improvement Act of 1999, which removes barriers to 
work for individuals with disabilities.
 An area of vital interest to the Agency is the continued improvement 
of the disability program. We are currently preparing a final 
regulation that implements elements of the redesigned disability claims 
process that have been tested and found to further redesign goals.
 Providing the best service possible 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 define the amount of bonding 
necessary to provide adequate protection for our beneficiaries and the 
nature of licenses that are pertinent for organizational payees that 
are authorized to collect a fee for their services.
 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 (FCIA) 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 implements another 
provision of the FCIA of 1999, which provides for the imposition by SSA 
of a penalty on any person for knowingly making false or misleading 
statements or misrepresenting a material fact for use in determining 
initial or continuing right to benefits.
Public Law 104-134, the Debt Collection Improvement Act of 1996, 
provided SSA with new tools to strengthen our efforts in collecting 
debts; one such provision concerns administrative wage garnishment. We 
are developing regulations, which will enable us to collect qualifying, 
delinquent title II and XVI debts owed by former beneficiaries who are 
now employed in other than Federal employment.
The final proposal on our Plan revises our privacy and disclosure rules 
to describe adequate safeguards against inappropriate disclosure of 
personal information, including electronic requests. In this same 
proposal, we revise our special procedures on access to medical records 
and add a new section about granting access to a minor's medical 
records for the minor's parent or legal guardian.
We continue to work diligently to improve our program and 
administrative 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

                              -----------




155. PRIVACY AND DISCLOSURE OF OFFICIAL RECORDS AND INFORMATION (711P)
Priority:


Other Significant


Legal Authority:


5 USC 552; 5 USC 552a; 42 USC 1306(a); 42 USC 902(a)(5)


CFR Citation:


20 CFR 401.30; 20 CFR 401.45; 20 CFR 401.55; 20 CFR 401.150; 20 CFR 
401.180


Legal Deadline:


None


Abstract:


We propose to revise our privacy and disclosure rules to:


1. Describe safeguards against inappropriate disclosure of personal 
information when individuals request information about themselves by 
electronic means (e.g., through the Internet);


2. Revise our special procedures on an individual's access to medical 
records;


3. Add a new section to grant direct access to a minor's medical 
records by the minor's parent or legal guardian acting on the minor's 
behalf; and


4. Fully describe the role and function of the Privacy Officer.


Statement of Need:


These revised regulations are necessary to:


1. Articulate the safeguards that ensure the appropriate procedures for 
access to and disclosure of personally identifiable information in the 
electronic environment;


2. Support the judicial interpretation which allows individuals whose 
medical records may potentially have an adverse effect to have access 
to this information;


3. Implement a consistent policy for both minors and adults in 
providing access to medical records; and


4. Provide the expanded regulatory support for the existing 
responsibilities and functions of the Privacy Officer as required by 
the Privacy Act and related Office of Management and Budget (OMB) 
guidelines.

[[Page 61311]]

Summary of Legal Basis:


Revisions to procedures for individual's access to medical records 
having a potentially adverse effect are required by Bavido v. Apfel, 
No. 98-4046, 2000 U.S. App. Lexis 13547, the Seventh Circuit.


Alternatives:


None.


Anticipated Cost and Benefits:


1. Description of safeguards against inappropriate disclosure of 
personal information by electronic means:


a. Cost--none.


b. Benefit--Increase public awareness of the safeguards employed by SSA 
to maintain the security, confidentiality, and integrity of the 
information we collect and maintain.


2. Revise our special procedures on an individual's access to medical 
records; and


3. Add a new section to grant direct access to a minor's medical 
records by the minor's parent or legal guardian acting on the minor's 
behalf:


a. Cost--none.


b. Benefit--regulatory guidelines will facilitate access for 
individuals whose medical records may have adverse effects.


4. Revised role of Privacy Officer


a. Cost--none.


b. Benefit--Increased public awareness of the privacy officer's role 
and responsibility in protecting the privacy and disclosure of the 
information SSA collects and maintains; general oversight to the Agency 
on privacy and disclosure activities.


Risks:


None.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           03/00/02
Final Action                                                   07/00/02
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


None


Agency Contact:
Chris W. Johnson
Social Insurance Specialist
Social Security Administration
Office of Disclosure Policy
6401 Security Boulevard
Baltimore, MD 21235-6401
Phone: 410 965-8563

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
RIN: 0960-AE88
_______________________________________________________________________



SSA



156. ADMINISTRATIVE WAGE GARNISHMENT (TO REPAY A DEBT OWED TO THE 
SOCIAL SECURITY ADMINISTRATION) (724P)
Priority:


Other Significant


Unfunded Mandates:


Undetermined


Legal Authority:


42 USC 405; 42 USC 902; 42 USC 1383; 31 USC 3720D


CFR Citation:


20 CFR 422.311; 20 CFR 422.312


Legal Deadline:


None


Abstract:


This initiative will enable the Social Security Administration (SSA) to 
collect qualifying, delinquent titles II and XVI debts owed by former 
beneficiaries who are now employed in other than Federal employment. 
Administrative wage garnishment allows SSA to order an employer to 
deduct a percentage of the disposable pay earned by the worker/debtor, 
and to send that amount to SSA as payment toward satisfying the 
delinquent debt. Administrative wage garnishment does not require a 
court judgment to impose the withholding order.


Statement of Need:


This regulation is necessary in order for SSA to use administrative 
wage garnishment as a tool in its debt collection process.


Summary of Legal Basis:


SSA is authorized to use administrative wage garnishment by 31 U.S.C. 
3720D, added by section 31001(o) of Public Law 104-134, the Debt 
Collection Improvement Act of 1996.


Alternatives:


None--without regulatory authority SSA would be unable to proceed with 
administrative wage garnishment in a manner that addresses SSA's 
particular needs and processes. SSA must either adopt by reference the 
Treasury Department's regulations on wage garnishment hearings or 
prescribe SSA regulations regarding such hearings consistent with those 
Treasury Department regulations. See 31 CFR 285.11(f)(1).


Anticipated Cost and Benefits:


Undetermined at this time.


Risks:


At this time we have not identified any risks associated with the 
proposal.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           12/00/01
Final Action                                                   06/00/02
Regulatory Flexibility Analysis Required:


Undetermined


Small Entities Affected:


No


Government Levels Affected:


State, Local, Tribal


Agency Contact:
Edward Johns
Financial Management Analyst
Social Security Administration
6401 Security Boulevard
Baltimore, MD 21235-6401
Phone: 410 965-0392

Patricia Hora
Social Insurance Specialist
Social Security Administration
Office of Process and Innovation Management
6401 Security Boulevard
Baltimore, MD 21235-6401
Phone: 410 965-7183
RIN: 0960-AE92
_______________________________________________________________________



SSA



157. ACCESS TO INFORMATION HELD BY FINANCIAL INSTITUTIONS (815P)
Priority:


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


Unfunded Mandates:


Undetermined

[[Page 61312]]

Legal Authority:


42 USC 1383(e); PL 106-169, sec 213


CFR Citation:


20 CFR 416.200; 20 CFR 416.207; 20 CFR 416.421; 20 CFR 416.640; 20 CFR 
416.1231; 20 CFR 416.1242; 20 CFR 416.1245; 20 CFR 416.1247; 20 CFR 
416.1320; 20 CFR 416.1321; 20 CFR 416.1335; 20 CFR 416.1337; 20 CFR 
416.1618


Legal Deadline:


None


Abstract:


We propose 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                                                           11/00/01
Final Action                                                   04/00/02
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

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
RIN: 0960-AF43
_______________________________________________________________________



SSA



158.   COMPENSATION FOR QUALIFIED ORGANIZATIONS SERVING AS A 
REPRESENTATIVE PAYEE (846P)
Priority:


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


Unfunded Mandates:


Undetermined


Legal Authority:


42 USC 405(j)(4(B); 42 USC 1383(a)(2)(D)


CFR Citation:


20 CFR 404.2040a; 20 CFR 416.640a


Legal Deadline:


None


Abstract:


We are proposing to amend these regulations to further define ``bonded 
or licensed in the State in which an organizational payee serves as 
representative payee.'' We are proposing to further define the amount 
of bonding necessary to provide adequate protection for our 
beneficiaries and the nature of licenses that are pertinent for a fee-
for-service organization.


Statement of Need:


Following congressional hearings, a representative payee task force was 
formed to improve the representative payment program; bonding and 
licensing of organizational payees was identified as an area in 
regulations that needs further definition.


Summary of Legal Basis:


None.


Alternatives:


There are no alternatives for this regulation, this regulation will 
further define existing rules.


Anticipated Cost and Benefits:


We are providing protection for our beneficiaries by defining an amount 
that an organization must be bonded for and defining the nature of 
licenses that are permissible. We do not anticipate any costs.


Risks:


None.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           03/00/02
Final Action                                                   12/00/02
Regulatory Flexibility Analysis Required:


Undetermined


Small Entities Affected:


Organizations, Governmental Jurisdictions


Government Levels Affected:


State, Local


Agency Contact:
Betsy Byrd
Social Insurance Specialist
Social Security Administration
Office of Program Benefits
6401 Security Boulevard
Baltimore, MD 21235-6401
Phone: 410 965-7981

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
RIN: 0960-AF66
_______________________________________________________________________



SSA

                              -----------

                            FINAL RULE STAGE

                              -----------




159. OASDI AND SSI; EXPANSION OF THE USE OF VIDEO TELECONFERENCE 
TECHNOLOGY IN HEARINGS BEFORE ADMINISTRATIVE LAW JUDGES OF THE SOCIAL 
SECURITY ADMINISTRATION (737F)
Priority:


Other Significant

[[Page 61313]]

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 are amending our regulations to permit us to conduct hearings before 
an administrative law judge (ALJ) by video teleconference (VTC). We 
will 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. These 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.


The VTC provision will aid in reducing the average processing time for 
hearings 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.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            66 FR 1059                                     01/05/01
NPRM Comment Period End                                        03/06/01
Final Action                                                   12/00/01
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


None


Agency Contact:
Cynthia Pullen-Carroll
Social Insurance Specialist
Social Security Administration
Office of Process and Innovation Management
6401 Security Boulevard
Baltimore, MD 21235-6401
Phone: 410 965-3691
RIN: 0960-AE97
_______________________________________________________________________



SSA



160. TICKET TO WORK AND SELF-SUFFICIENCY PROGRAM (TICKET TO WORK AND 
WORK INCENTIVES IMPROVEMENT ACT OF 1999) (767F)
Priority:


Other Significant


Unfunded Mandates:


Undetermined


Legal Authority:


42 USC 902(a)(5); 42 USC 1320b-19; PL 106-170, sec 101


CFR Citation:


20 CFR 411.100 to 411.730


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 final regulations will 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. 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 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.


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

[[Page 61314]]

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.


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            65 FR 82843                                    12/28/00
NPRM Comment Period End                                        02/26/01
Final Action                                                   11/00/01
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


State


Agency Contact:
Geoffrey Funk
Social Insurance Specialist
Social Security Administration
Office of Employment Support Programs
6401 Security Boulevard
Baltimore, MD 21235-6401
Phone: 410 965-9010

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
RIN: 0960-AF11
_______________________________________________________________________



SSA



161. ADMINISTRATIVE PROCEDURES FOR IMPOSING PENALTIES FOR FALSE OR 
MISLEADING STATEMENTS (784F)
Priority:


Other Significant


Legal Authority:


42 USC 402; 42 USC 403; 42 USC 404(a); 42 USC 404(e); 42 USC 405(a); 42 
USC 405(c); 42 USC 422(b); 42 USC 423(e); 42 USC 424a; 42 USC 425; 42 
USC 902(a)(5); 42 USC 1382 to 1382d; 42 USC 1382h; 42 USC 1320a-8a; 42 
USC 1383


CFR Citation:


20 CFR 404.475; 20 CFR 416.1339


Legal Deadline:


Final, Statutory, June 14, 2000.


Abstract:


These final rules reflect and implement section 207 of Public Law 106-
169, which provides that SSA may impose a penalty on any person who 
knowingly makes, or causes to be made, a false or misleading statement 
or representation of a material fact for use in determining any initial 
or continuing right to or the amount of monthly insurance benefits 
under title II or benefits or payments under title XVI.


Statement of Need:


This regulation is required to implement section 207 of Public Law 106-
169 enacted on December 14, 1999. Public Law 106-169 provided that SSA 
may impose a penalty on any person who makes or causes to be made, a 
statement or representation of a material fact, for use in determining 
title II or title XVI benefit eligibility or amount, that the person 
knows or should know is false or misleading or omits a material fact. 
The penalty is nonpayment of benefits under title II and ineligibility 
for cash benefits under title XVI for six consecutive months for the 
first violation, 12 consecutive months for the second violation and 24 
consecutive months for any subsequent violation.


Summary of Legal Basis:


Public Law 106-169 required SSA to develop regulatory guidelines to 
implement the process within six months of enactment. That regulation 
was issued on July 10, 2000 at 65 FR 42283 as interim final regulations 
which invited public comments. This regulation will finalize the 
interim final regulation.


Alternatives:


None.


Anticipated Cost and Benefits:


The Office of Budget estimated that administrative costs associated 
with this regulation would be negligible; i.e. less than $1 million. 
The costs are attributable to the enactment of Public Law 106-169 
rather than the regulation.


Risks:


None.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
Interim Final Ru65 FR 42283                                    07/10/00
Interim Final Rule Comment Period End                          09/08/00
Final Action                                                   11/00/01

[[Page 61315]]

Regulatory Flexibility Analysis Required:


No


Government Levels Affected:


None


Agency Contact:
Gareth N. Dence
Social Insurance Specialist
Social Security Administration
Division of Payment Policy
Office of Program Benefits Policy
6401 Security Boulevard
Baltimore, MD 21235-6401
Phone: 410 965-9872

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
RIN: 0960-AF20
_______________________________________________________________________



SSA



162. IMPLEMENTING THE REDESIGNED DISABILITY PROCESS (816F)
Priority:


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


Legal Authority:


42 USC 301


CFR Citation:


20 CFR 404; 20 CFR 416


Legal Deadline:


None


Abstract:


We plan to implement elements of the redesigned disability claims 
process that have been tested and found to further redesign goals. 
Specifically, we plan 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 plan to implement the redesigned process in phases; the 
existing process will remain in effect for States that are not yet 
using the redesigned process.


Statement of Need:


This regulation will permit us to redesign the disability claims 
process to use our resources more effectively to ensure that disabled 
claimants are awarded benefits at the earliest point in the claims 
process.


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            66 FR 5494                                     01/19/01
NPRM Comment Period End                                        03/20/01
Final Action                                                   06/00/02
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:
Phillip Landis
Director, Disability Process Redesign Staff
Social Security Administration
Office of Disability
6401 Security Boulevard
Baltimore, MD 21235-6401
Phone: 410 965-7414

Cheryl A. Williams
Social Insurance Specialist
Social Security Administration
Office of Process and Innovation Management
6401 Security Boulevard
Baltimore, MD 21235-6401
Phone: 410 966-4163
RIN: 0960-AF44
BILLING CODE 4191-02-S

[[Page 61316]]




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.
BILLING CODE 6351-01-S

[[Page 61317]]




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 repair, 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 2002, the Commission's significant rulemaking 
activities will involve addressing risks of fire associated with 
ignition of upholstered furniture by small open flames. The emphasis on 
this rulemaking activity in the Commission's FY 2002 regulatory plan is 
consistent with the Commission's statutory mandate and its criteria for 
setting priorities.
_______________________________________________________________________



CPSC

                              -----------

                          PROPOSED RULE STAGE

                              -----------




163. FLAMMABILITY STANDARD FOR UPHOLSTERED FURNITURE
Priority:


Economically Significant. Major under 5 USC 801.


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 present 
alternatives for future action by the Commission.

[[Page 61318]]

Statement of Need:


In 1998, approximately 480 deaths, more than 1,300 injuries, and about 
$191 million in property damage resulted from 9,400 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 $2.8 billion in 1998. This total 
includes fires ignited by small open-flame sources, large open-flame 
sources, and cigarettes. Of these, small open-flame fires accounted for 
approximately 80 deaths, 350 injuries and $32 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 $2.8 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 Sent Briefing Package to Commission                      11/01/01
Commission Decision                                            04/00/02
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
BILLING CODE 6355-01-S

[[Page 61319]]




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. At this 
time, we do not anticipate any significant regulatory or deregulatory 
actions that would be required to be included in a regulatory plan.
 The Finance Board's highest regulatory priorities during the coming 
year continue to be 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 expects to issue a solicitation of comments 
on the implications for the Bank System raised by structural changes 
that have been occurring in the membership base. This action is 
prompted by the receipt of several petitions, each requesting that the 
Finance Board permit a single depository institution to be a member of 
two Banks simultaneously. The solicitation would request comments on 
how developments in the membership base have affected the Bank System, 
and how permitting a single depository institution to be a member of 
more than one Bank might affect the Bank System.
BILLING CODE 6725-01-S

[[Page 61320]]




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, competitive, market-driven, 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 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 continues to impact 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.
 Common carriers remain concerned 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. The 
Commission previously 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 continues to be assessed and will be considered during 
calendar year 2001.
 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 is scheduled to issue its 2-year 
study of the Ocean Shipping Reform Act of 1998 in September 2001. 
Findings and conclusions from that report could result in consideration 
of specific issues for rulemaking proposals.
 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 61321]]




FEDERAL TRADE COMMISSION (FTC)



Statement of Regulatory Priorities
I. REGULATORY PRIORITIES
 Background56
 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 Initiative56
 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 both a 
request for comments and a notice of proposed rulemaking (NPRM) to 
further implement the statutorily mandated safeguards standards. See 66 
FR 41162 (Aug. 7, 2001).
 The Commission has proposed amending the Children's Online Privacy 
Protection Rule, 16 CFR part 312, to extend by two years (until April 
2004) the sliding scale mechanism of verifying parental consent for 
collection of data about children by Web sites or online services. The 
Commission proposed the rule amendment because the anticipated progress 
in available technology of verifying such consent has not occurred. The 
notice of proposed rulemaking also requests comments responding to a 
number of questions relating to the current and anticipated 
availability and affordability of secure electronic mechanisms or 
infomediary services for obtaining parental consent. See 66 FR 54963 
(Oct. 31, 2001).
 Ten-Year Review Program56
 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 have been 
reviewed on a ten-year schedule as resources permit, 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 ten-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 2001 Reviews and Reviews in Process56
 As part of the Commission's ten-year review program, in 2001 the 
Commission continued reviews of seven rules and three industry guides. 
The reviews scheduled to begin in 2001 have been deferred.\2 \The 
Commission will commence its review of those rules and 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 (Rule), 
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 Commission 
anticipates completing this

[[Page 61322]]

review and reporting to the Congress on its results late this fall.
 In 1999, the Commission began its regulatory review of certain aspects 
of the Funeral Industry Practices Rule (Funeral Rule or 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 prices 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 early next year.
 The Commission's review of the Franchise Rule, 16 CFR part 436, is 
also continuing. The Commission accepted comments on an NPRM 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 
franchiser-initiated lawsuits involving the franchise relationship, 
franchiser 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. In June 2001, Bureau of 
Consumer Protection Staff issued Franchise and Business Opportunity 
Program Review 1993-2000: A Review of the Complaint Data, Law 
Enforcement and Consumer Education. Staff expects to forward its report 
on the rulemaking 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 Commission completed a portion of its review of the Amplifier 
Rule, 16 CFR part 432, in December 2000 and, at the same time, issued a 
supplemental notice of proposed rulemaking (SNPRM). The SNPRM seeks 
comment on proposed revisions to the Rule's testing procedures to 
provide appropriate power output ratings for the recently introduced 
class of ``home theater'' receivers that incorporate five or more 
channels of amplification. The reopened comment period ended on March 
30, 2001. See 66 FR 12915 (Mar. 1, 2001). Staff anticipates forwarding 
a recommendation to the Commission this fall and Commission action by 
the end of the calendar year, 65 FR 80798 (Dec. 22, 2000).
 The reviews of the Ophthalmic Practice Rule, 16 CFR part 456, and the 
R-Value Rule, 16 CFR part 460, are proceeding. Staff expects to forward 
its recommendations to the Commission regarding these Rules early next 
year.
 With respect to Industry Guides, the Commission continued 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 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. 65 FR 37317 (Jun. 14, 2000). Staff expects to forward its 
recommendation to the Commission before the end of the calendar year.
 The Commission is continuing its review of the Guides for the Rebuilt, 
Reconditioned, and Other Used Automobile Parts Industry (Used Auto 
Parts Guides), 16 CFR part 20. The Used Auto Parts Guides, effective 
since 1962, advise industry members not to misrepresent the age of the 
product, the condition of the product, the extent of the rebuilding of 
the product, or that the rebuilder was the original manufacturer. 
Industry members must also conspicuously disclose in advertising and 
packaging that the products include used parts, if that is the case. 
The Commission's review will examine, among other things, the overall 
costs and benefits of the Used Auto Parts Guides and whether there is a 
continuing need for them. The Commission has published a Federal 
Register notice seeking comment on several questions concerning the 
Used Auto Parts Guides. See 63 FR 17132 (Apr. 8, 1998). Staff has 
completed its review of the comments and plans to forward its 
recommendation to the Commission this fall.
 In addition, 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 the Environmental Protection Agency (EPA) under the 
Automobile Information Disclosure Act, 15 USC 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

[[Page 61323]]

the Fuel Economy Guide in 1978 and 1995 to make it consistent with the 
Information Disclosure Act changes regarding fuel economy disclosures. 
Staff has completed its review of the comments and plans to forward its 
recommendation to the Commission this fall.
 Final Actions 56
 Since publication of the 2000 Regulatory Plan, the Commission 
has completed a portion of its review of the Amplifier Rule, 16 CFR 
part 432. The Final Rule clarifies the testing procedure for self-
powered speakers, and eliminates or modifies certain testing and 
disclosure requirements that have outlived their usefulness to 
consumers. See 65 FR 881232 (Dec. 22, 2000).
 The Commission also has completed its regulatory review of the Guides 
for the Jewelry, Precious Metals and Pewter Industry, 16 CFR part 23, 
by amending the Guides to require disclosure of permanent treatments to 
gemstones that significantly affect their value, including laser 
drilling of diamonds and certain other treatments. Although these 
Guides were reviewed in 1992 under the ten-year plan, the Commission 
responded to a petition from industry members. See 65 FR 78738 (Dec. 
15, 2000).
 Calendar Year 2002 Reviews56
 The specific rules and guides to be addressed under the 
Commission's Regulatory Review Program will be announced early next 
year.\3\
 Summary56
 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 
ten-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 ten-year program 
also is consistent with 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 Rule Concerning Privacy of 
Consumer Financial Information, 16 CFR part 313 (2001), promulgated in 
2000 and effective July 1, 2001 is consistent with the 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.
II. 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 61324]]




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 technical amendments to the Minimum Internal Control 
            Standards;
2.  Develop standards for constructing and maintaining gaming 
            facilities operated on Indian lands;
3.  Revise the definitions to exclude ``electronic or electromechanical 
            facsimile,'' and
4.  Develop regulations to establish processes for the classification, 
            review, and approval of games and devices used in tribal 
            gaming.
_______________________________________________________________________



NIGC

                              -----------

                          PROPOSED RULE STAGE

                              -----------




164. DEFINITIONS: ELECTRONIC OR ELECTROMECHANICAL FACSIMILE
Priority:


Other Significant


Legal Authority:


25 USC 2701 et seq.


CFR Citation:


25 CFR 502


Legal Deadline:


None


Abstract:


The rule will remove the definition of ``electronic and 
electromechanical facsimile'' now set forth at 25 CFR 502.8.


Statement of Need:


In several recent decisions, Federal courts have not relied on the 
Commission's definition of electronic or electromechanical facsimile. 
Instead, courts have relied exclusively on the terms contained in the 
Indian Gaming Regulatory Act (IGRA) and have applied a plain language 
interpretation of the phrase. To ensure consistency with developments 
in case law and a uniform approach to the term by the Commission and 
the courts, the Commission has determined that the definition set forth 
at 25 CFR 502.8 should be removed.


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 define terms set forth in the 
Act and to redefine terms as necessary to implement the Act.


Alternatives:


The Commission is evaluating other alternatives, including the status 
quo, and considering public comments to the proposals before 
determining which is the most worthy.


Anticipated Cost and Benefits:


The potential benefit of this regulatory action is consistency with 
development in case law and a uniform approach to the term by the 
Commission and the courts.


Risks:


There are no known risks to this regulatory action.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            66 FR 33494                                    06/22/01
NPRM Comment Period End                                        08/21/01
Final Rule                                                     01/00/02
Regulatory Flexibility Analysis Required:


No


Government Levels Affected:


Tribal


Agency Contact:
Michele F. Mitchell
Attorney
National Indian Gaming Commission
Suite 9100
1441 L Street NW.
Washington, DC 20005
Phone: 202 632-7003
Fax: 202 632-7066
RIN: 3141-AA10
_______________________________________________________________________



NIGC



165. 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 tribal gaming 
ordinances or resolutions submitted for the Chairman's approval ensure 
that ``the construction and maintenance of the gaming facility, and the 
operation of that gaming is conducted in a manner which 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:


The regulations proposed today rely on the Commission's authority to 
issue environment, public health and safety regulations. This criteria 
is set forth in 25 U.S.C. 2710(b)(2)(E). 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

[[Page 61325]]

Commission relies on these sections of the statute to authorize the 
promulgation of regulations to ensure that gaming facilities on Indian 
lands are constructed, maintained and operated in a manner that 
adequately protects the environment and public health and safety.


Alternatives:


The Commission is evaluating alternatives to the proposed rule while 
considering public comments.


Anticipated Cost and Benefits:


The potential benefits to this regulatory action are to establish and 
define for the regulated community the environmental, public 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, public 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                                        01/19/01
Second NPRM     66 FR 50127                                    10/02/01
Second NPRM Comment Period End                                 12/29/01
Final Action                                                   03/00/02
Regulatory Flexibility Analysis Required:


No


Government Levels Affected:


Tribal


Agency Contact:
Christine Nagle
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-AA17
_______________________________________________________________________



NIGC



166. TECHNICAL AMENDMENTS TO THE MINIMUM INTERNAL CONTROL STANDARDS
Priority:


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


Legal Authority:


25 USC 2702; 25 USC 2706(b)(10)


CFR Citation:


25 CFR 542


Legal Deadline:


None


Abstract:


The National Indian Gaming Commission anticipates that there will be a 
need to make technical changes to the minimum internal control 
standards in response to changes in technology and the gaming industry. 
Because these standards are established by Federal regulation, it is 
necessary to make the changes to the current standards, which should 
result in better internal control standards with minimal anticipated 
costs.


Statement of Need:


The Indian Gaming Regulatory Act (IGRA) establishes a comprehensive 
system for regulating gambling activities on Indian lands. Following a 
thorough rulemaking process, the Commission published Minimum Internal 
Control Standards (MICS), 25 C.F.R. part 542, in 1999. In the period 
since publication, there have been changes in Indian gaming and gaming 
technology that need to be reflected in the MICS. Additionally, there 
are technical errors in the existing regulation that require 
correction. The Commission has determined that these changes and 
corrections are needed to ensure that Indian gaming continues to be 
adequately regulated, while maintaining the ability to adopt to, and 
take advantage of, technological changes in the gaming industry.


Summary of Legal Basis:


The purpose of IGRA is clearly stated in its declaration of policy: 
``to provide a statutory basis for the regulation of gaming by an 
Indian tribe adequate to 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....'' 25 
U.S.C. 2702(2). In order to accomplish these and the other stated 
purposes of IGRA, the Commission was expressly authorized 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 these sections of the statute to authorize the 
promulgation of Minimum Internal Control Standards in order to ensure 
the integrity of gaming on Indian lands and to safeguard this source of 
tribal revenues.


Alternatives:


The Commission sees no alternative but to revise its current Minimum 
Internal Control Standards for gaming operations on Indian lands.


Anticipated Cost and Benefits:


The potential benefits of this regulatory action are to revise the 
current Minimum Internal Control Standards to reflect the types of 
gaming occurring on Indian lands, to allow the Indian gaming industry 
to take advantage of technological changes occurring in the gaming 
industry so that it may be more competitive, and to clarify areas of 
the existing standards that, based on comments received, have led to 
conflicting interpretations and applications.


Risks:


There are no known risks to this regulatory action.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
ANPRM           65 FR 70673                                    11/27/00
ANPRM Comment Pe66 FR 12916                                    03/30/01
NPRM                                                           12/00/01
Regulatory Flexibility Analysis Required:


No


Government Levels Affected:


Tribal


Agency Contact:
Penny J. Coleman
Deputy General Counsel
National Indian Gaming Commission
Suite 9100
1441 L Street NW.
Washington, DC 20005
Phone: 202 632-7003
Fax: 202 632-7066
RIN: 3141-AA24

[[Page 61326]]

_______________________________________________________________________



NIGC

                              -----------

                            FINAL RULE STAGE

                              -----------




167. GAME CLASSIFICATION
Priority:


Other Significant


Legal Authority:


25 USC 2702; 25 USC 2703; 25 USC 2705; 25 USC 2706; 25 USC 2710; 25 USC 
2713


CFR Citation:


25 CFR 504


Legal Deadline:


None


Abstract:


This rule will establish processes for the classification, review, and 
approval of games and devices used in tribal gaming.


Statement of Need:


Over the course of the past couple of years, the NIGC has received 
numerous requests for advisory opinions on the classification of a 
particular game or device. The Commission has through an informal 
process issued several advisory opinions. However, given the growing 
number of requests and the need for some degree of predictability and 
certainty in the industry regarding the classification of games or 
devices, the Commission believes it is necessary to develop a formal 
process. Consequently, the Commission will use the rulemaking process 
to promulgate regulations in this area.


Summary of Legal Basis:


The Indian Gaming Regulatory Act specifically defines both Class II and 
Class III gaming (25 U.S.C. 2703). The Act also expressly authorizes 
the Commission to ``promulgate such regulations and guidelines as it 
deems appropriate to implement the provisions of this Act.'' (25 U.S.C. 
2706(b)(10)). The Commission relies on these sections of the statute to 
authorize the development by regulation of a process of formal 
classification of particular games and devices.


Alternatives:


At this time, the only identified alternative is to continue with the 
informal process of issuing advisory opinions regarding particular 
games.


Anticipated Cost and Benefits:


The potential benefits to this regulatory action are to bring more 
clarity and predictability to the industry regarding classification. 
Those engaged in Indian gaming need to have some degree of certainty 
regarding the legal consequences of playing a particular game. For 
those tribes without tribal-State compacts, the need is even greater to 
know with as much certainty as possible the classification of a 
particular game or device. The anticipated costs of implementing a 
classification system are unknown at this time.


Risks:


There are no known risks to this regulatory action.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            64 FR 61234                                    11/10/99
NPRM Comment Period End                                        02/24/00
Final Action                                                   12/00/01
Regulatory Flexibility Analysis Required:


No


Government Levels Affected:


State, Tribal


Agency Contact:
Penny J. Coleman
Deputy General Counsel
National Indian Gaming Commission
Suite 9100
1441 L Street NW.
Washington, DC 20005
Phone: 202 632-7003
Fax: 202 632-7066
RIN: 3141-AA12
BILLING CODE 7565-01-S
