[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]


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                          The Regulatory Plan 
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                THE INTRODUCTION TO THE FALL 2002 REGULATORY PLAN

                Federal regulation is a fundamental instrument of 
                national policy. It is one of the three major tools -- 
                in addition to spending and taxing -- used to implement 
                policy. It is used to advance numerous public 
                objectives, including homeland security, environmental 
                protection, food safety, transportation safety, quality 
                health care, equal employment opportunity, energy 
                security, educational quality, immigration control, and 
                consumer protection. The Office of Management and 
                Budget's (OMB) Office of Information and Regulatory 
                Affairs (OIRA) is responsible for overseeing and 
                coordinating the Federal Government's regulatory 
                policies.

                Citizen-centered service is a vital element of the 
                President's Management Agenda and The Regulatory Plan 
                is a vital piece of this initiative. The Regulatory 
                Plan is published as part of the fall edition of the 
                Unified Agenda of Federal Regulatory and Deregulatory 
                Actions. The Regulatory Plan serves as a statement of 
                the Administration's regulatory and deregulatory 
                policies and priorities. The purpose of The Regulatory 
                Plan is to make the regulatory process more accessible 
                to the public and to ensure that the planning and 
                coordination necessary for a well-functioning 
                regulatory process occurs. The Plan identifies 
                regulatory priorities and contains information about 
                the most significant regulatory actions that agencies 
                expect to take in the coming year.

                Federal Regulatory Policy 

                The Bush Administration supports Federal regulations 
                that are sensible and based on sound science, 
                economics, and the law. Accordingly, the Administration 
                is striving for a ``smarter regulatory process'' that 
                adopts new rules when markets fail to serve the public 
                interest, simplifies and modifies existing rules to 
                make them more effective and/or less costly or less 
                intrusive, and rescinds outmoded rules whose benefits 
                do not justify their costs. In pursuing this agenda, 
                OIRA has adopted an approach based on the principles of 
                regulatory analysis and policy espoused in Executive 
                Order 12866, signed by President Clinton in 1993.

                Smart regulatory policy is not uniformly pro-regulation 
                or anti-regulation. It starts, of course, with the 
                authority granted under the law. Within the discretion 
                available to the regulating agency by its statutory 
                authority, agencies apply a number of principles 
                articulated in Executive Order 12866 (as well as other 
                orders, such as Executive Order 13211, Actions 
                Concerning Regulations That Significantly Affect Energy 
                Supply, Distribution, or Use) in order to design 
                regulations that achieve their ends in the most 
                efficient and economical way -- the smartest way. This 
                means bringing to bear on the regulatory problem sound 
                economic principles, the highest quality information, 
                and the best possible science. This is not always an 
                easy task -- science and economics may point in very 
                different directions for example -- and does not mean 
                the rote application of quantified data to reach policy 
                decisions. In making regulatory decisions, we expect 
                agencies to consider other attributes and factors that 
                cannot be integrated readily in a benefit-cost 
                framework, such as fairness and privacy, as well as 
                benefit and cost items that can be quantified and 
                expressed in monetary units. However, smart regulation 
                is the result of the careful use of all available data 
                and the application of broad principles established by 
                the President.

                In pursuing this goal of establishing a smarter 
                regulatory system, the Bush Administration has 
                increased the level of public involvement and trans-

[[Page 74058]]

                parency in its review and clearance of new and existing 
                regulations. First, OMB has solicited public 
                suggestions for improving the quality of existing 
                regulations. In OMB's draft 2002 Report to Congress on 
                the Costs and Benefits of Regulation, OMB asked for 
                public comment on a number of regulatory issues, 
                including: (1) regulatory programs that need to be 
                extended, modified or rescinded, (2) issues of 
                regulatory analysis that need to be refined in OMB's 
                formal guidance documents to agencies, and (3) ideas 
                for new regulatory priorities that we can suggest to 
                agencies in the form of prompt letters. This year, OMB 
                has made every effort to publicize the public comment 
                period, and at the President's request, OMB for the 
                first time made available an electronic comment form. 
                As a result, the public provided over 1700 comments, 
                compared with 71 comments for last year's report. OMB 
                is in the process of reviewing these comments and 
                identifying candidates for reform. The results of this 
                review will be published in our final report to 
                Congress and shared with the agencies.

                Second, OIRA has enhanced the transparency of OMB's 
                regulatory review process to the public. By consulting 
                the Web site, for example, the public can find 
                information on rules that are formally under review at 
                OMB, rules that have recently been cleared, and rules 
                have been returned to agencies for reconsideration. 
                OIRA has also increased the amount of information 
                available on the OIRA Web site. In addition to 
                information on meetings and correspondence, OIRA makes 
                available communications from the OIRA Administrator to 
                agencies, including ``prompt letters,'' ``return 
                letters,'' and ``post clearance letters,'' as well as 
                the Administrator's memorandum to the Presidents 
                Management Council (September 20, 2001) on Presidential 
                review of agency rulemaking by OIRA.

                Third, the Bush Administration has moved aggressively 
                to establish basic quality performance goals for all 
                information disseminated by Federal agencies, including 
                information disseminated in support of proposed and 
                final regulations. The Federal agencies have now issued 
                guidelines in effect as of October 1, 2002, under the 
                Information Quality Law to ensure the ``quality, 
                objectivity, utility, and integrity'' of all Federal 
                information. Under these guidelines, Federal agencies 
                are taking appropriate steps to incorporate the 
                information quality performance standards into agency 
                information dissemination practices, and developing 
                pre-dissemination review procedures to substantiate the 
                quality of information before it is disseminated. OMB 
                worked toward this October 1 deadline for over a year, 
                developing its Governmentwide guidelines for the 
                agencies, providing interpretive memos, organizing 
                working groups, and meeting with agencies to give views 
                on what the agency-specific guidelines should say.

                In addition, under the agency guidelines, ``affected 
                persons'' can petition if they believe that scientific, 
                technical, economic, statistical or other information 
                does not meet these standards and if necessary appeal a 
                denial of such a petition. While OMB agreed with 
                agencies to meld the information complaint resolution 
                process into their established notice-and-comment 
                rulemaking procedures, OMB ensured that substantive 
                standards of quality, the information quality standards 
                provided in both the OMB and agency guidelines, would 
                remain applicable to any information disseminated in 
                support of a regulation. Through the combination of 
                ongoing agency commitment, public interaction with the 
                agencies, and OMB oversight, the underlying information 
                and resulting analyses that agencies rely upon in 
                developing regulations should become ever ``smarter'' 
                and more reliable.

                Fourth, early OMB involvement is under way to increase 
                the impact of OMB's analytical perspective. The OIRA 
                Administrator has devised the ``prompt letter'' to 
                agencies as a new way to suggest promising regulatory 
                priorities. The prompt letter highlights issues that 
                may warrant the attention of regulators. These prompt 
                letters are not meant to have legal authority but are 
                designed to bring issues to the attention of agencies 
                in a transparent manner that permits public scrutiny 
                and debate. Prompt letters may highlight regulations 
                that should be pursued, rescinded, revised, or further 
                investigated.

[[Page 74059]]

                For example, OIRA's first set of prompts has suggested 
                lifesaving opportunities at FDA, NHTSA, OSHA and EPA. 
                In a letter to FDA, OIRA suggested that priority should 
                be given to completing a promising rulemaking started 
                in the previous Administration, a consumer labeling 
                rule that would require food companies to report the 
                trans-fatty acid content of foods. Trans-fats are now 
                recognized as a significant contributor to coronary 
                heart disease. OSHA has responded to an OIRA prompt 
                letter by notifying each employer in the country of the 
                lifesaving effects and cost-effectiveness of automatic 
                defibrillators, a lifesaving technology designed to 
                save lives during sudden cardiac arrest.

                In addition to increasing the level of public 
                involvement and transparency in its review of 
                regulations, the Bush Administration has aggressively 
                sought coordination of Federal agencies to stimulate 
                and foster the development of ``smarter'' regulations.

                OIRA, for example, played a key role in implementing 
                the Card Memorandum, a January 20, 2001, directive from 
                the President's Chief of Staff, Andrew H. Card, Jr., to 
                agency heads initiating the first regulatory action 
                taken by the Bush Administration. As OMB discussed in 
                its 2001 Report to Congress on the Costs and Benefits 
                of Regulations, agencies conducted numerous reviews of 
                new and pending regulations pursuant to the Card memo 
                and a subsequent OMB memorandum to agencies. OIRA 
                provided oversight of these agency actions. The 2002 
                Regulatory Plan continues OIRA's effort to ensure 
                coordination across Federal agencies in pursuing 
                regulatory policies.

                Improvements Made to the 2002 Regulatory Plan

                The Administration has modified the format and content 
                of agencies' regulatory plans for the fall 2002 
                publication. Since The Regulatory Plan is integral in 
                enhancing quality of Federal regulations, OMB 
                instituted a number of changes to ensure that the 
                public is provided with the information needed to 
                understand and comment on the Federal regulatory 
                agenda. Specifically, the 2002 Regulatory Plan has been 
                modified to highlight several themes. These include:

                        1. Regulations that are related to the events 
                            of September 11, 2001.

                        2. Regulations that are of particular concern 
                            to small businesses.

                        3. Regulations that were among the 71 nominated 
                            by the public as reform candidates last 
                            year. (See OMB's 2001 Report to Congress on 
                            the Costs and Benefits of Regulations.)

                        4. Issues that have been the subject of an OIRA 
                            ``prompt letter.''

                The regulatory improvements proposed in the 2002 
                Regulatory Plan may be incremental but promise to have 
                a powerful positive long-run effect on the quality of 
                Federal regulation. With regard to Federal regulation, 
                the Bush Administration's objective is quality, not 
                quantity. Those rules that are adopted promise to be 
                more effective, less intrusive, and more cost-effective 
                in achieving national objectives while demonstrating 
                greater durability in the face of political and legal 
                attack.

                The Administration's 2002 Regulatory Priorities

                The Administration's regulatory priorities can be 
                grouped into five national policy objectives: (1) 
                strengthening economic performance; (2) reducing 
                barriers to the growth of small businesses, (3) 
                improving public health and safety, (4) enhancing 
                environmental protection, and (5) ensuring homeland 
                security. The Administration is committed to pursuing 
                regulatory actions that achieve each of these goals. 
                Below are examples of regulatory priorities in the 
                upcoming year that address each objective.

                Strengthening Economic Performance

                One of the Administration's primary goals is to 
                strengthen the country's economic performance. Agencies 
                across the Federal Government are actively pursuing 
                this goal through regulatory changes. The Department of 
                Housing

[[Page 74060]]

                and Urban Development will undergo rulemakings on 
                simplifying and improving the process of obtaining 
                mortgages to reduce settlement costs to consumers. The 
                rule simplifies the mortgage application process and 
                allows a greater understanding of the upfront and long-
                term costs of a mortgage. The rule should strengthen 
                market competition among mortgage providers and 
                ultimately lower costs to consumers.

                Similarly, the Department of Transportation will begin 
                a review of its Computer Reservations System 
                Regulations. The Department regulates computer 
                reservations systems owned by airlines or airline 
                affiliates that are used by travel agencies. The 
                current rules are designed to prevent the systems from 
                unreasonably prejudicing the competitive position of 
                other airlines and to ensure that travel agencies can 
                provide accurate and unbiased information to the 
                public. The Department is reexamining its rules to see 
                whether they should be readopted and, if so, whether 
                they should be changed in response to greater use of 
                the Internet in airline reservations and ticketing and 
                changes in the industry

                Reducing Barriers to the Growth of Small Business

                This Administration has endeavored to encourage the 
                growth of small businesses in our economy. As President 
                George W. Bush has noted, ``Wealth is created by 
                Americans -- by creativity and enterprise and risk-
                taking. But government can create an environment where 
                businesses and entrepreneurs and families can dream and 
                flourish.'' For example, the Small Business 
                Administration will pursue rulemaking on the HUBZone 
                Empowerment Contracting Program. This regulation 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.

                Improving Public Health and Safety

                The Federal Government's role in improving public 
                health and safety is broad in scope. The 
                Administration's 2002 regulatory priorities include a 
                Department of Labor rulemaking on child labor, 
                Regulations, Orders and Statements of Interpretation. 
                This regulation will set forth the permissible 
                industries and occupations in which 14- and 15-year-
                olds may be employed, and specify 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 of Energy is addressing a different area 
                of health and safety in its regulatory proposal to 
                examine radiation protection of the public and the 
                environment. This regulation will set forth 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 include a dose limitation 
                system for the protection of the public and reporting 
                and monitoring requirements.

                The Department of Health and Human Services' Food and 
                Drug Administration (FDA) will issue a rule on Food 
                Labeling Requirements for Trans-Fatty Acids. This rule 
                will specify how trans-fatty acids, which have been 
                shown to have adverse health consequences, should be 
                labeled on food products.

                Enhancing Environmental Protection

                Environmental protection is an integral consideration 
                in U.S. policies concerning natural resources, human 
                health, economic growth, energy, transportation, 
                agriculture, industry, and international trade. These 
                factors are similarly considered in establishing 
                environmental policy. The Administration is dedicated 
                to enhancing environmental protection through smart 
                regulations, based on the best scientific data 
                available.

                The Environmental Protection Agency (EPA) is 
                considering a new rulemaking to reduce the particulate 
                matter and nitrogen oxide emissions from diesel-

[[Page 74061]]

                powered non-road vehicles and equipment. Non-road 
                engines emit significant amounts of fine particles and 
                nitrogen oxide emissions; these pollutants are 
                associated with a variety of adverse health effects, 
                ranging from lost work days and greater numbers of 
                hospital admissions to premature mortality. The 
                proposal will evaluate not only new emission control 
                devices that would be required for new engines, but 
                also the reductions in sulfur levels that are likely to 
                be needed to enable the control systems to operate 
                effectively. This comprehensive systems approach is 
                similar to that taken for the heavy-duty diesel highway 
                rule for trucks and buses that takes effect in the 
                2006-2007 timeframe. EPA plans to publish a formal 
                proposal for public comments early next year.

                EPA will also propose two companion rules designed to 
                protect drinking water against the risks of both 
                microbial pathogens and the disinfectants that are used 
                to control them. The rules will enhance existing 
                monitoring and treatment requirements to ensure that 
                risks from disinfection byproducts, which have been 
                linked to various adverse health effects, are 
                minimized, without compromising the important 
                protection they provide against pathogens.

                Ensuring Homeland Security

                After the shocking terrorist attacks of September 11, 
                2001, the American public looked to the Federal 
                Government to take action not only to prevent future 
                security threats but also to provide relief for 
                individuals affected by the tragedies. In response, the 
                Federal Government revisited its current practices and 
                procedures and sought solutions to address these 
                concerns. Several agencies, including the Departments 
                of Justice, Transportation, Labor, Health and Human 
                Services, Commerce, the Office of Personnel Management, 
                Small Business Administration, and the Office of 
                Management and Budget, issued new regulations.

                The Administration will continue to pursue regulatory 
                actions necessary to ensure homeland security. The 
                Department of Transportation proposes to examine 
                limitations on the issuance of commercial drivers' 
                licenses with a hazardous materials endorsement. This 
                rule will implement section 1012 of the USA Patriot 
                Act. It would prohibit States from issuing licenses to 
                operate motor vehicles transporting hazardous materials 
                unless DOT has determined that the operator does not 
                pose a security risk.

                The Department of Justice's Immigration and 
                Naturalization Service (INS) will pursue rulemaking 
                related to manifest requirements under section 231 of 
                the Act. This rule will implement section 402 of the 
                Enhanced Border Security and Visa Entry Reform Act of 
                2002 (Pub. L. 107-173), which requires the submission 
                of arrival and departure manifests electronically in 
                advance of an aircraft or vessel's arrival in or 
                departure from the United States. This rule also 
                proposes to require manifest data on certain passengers 
                and voyages previously exempt from this requirement. 
                The information required in this rule will assist in 
                the efficient inspection of passengers and crew members 
                and is necessary for the effective enforcement of the 
                immigration laws as part of the larger entry-exit 
                system.

                The Food and Drug Administration in the Department of 
                Health and Human Services will issue four rules 
                implementing the Bioterrorism Act of 2002. These rules 
                include one that will authorize FDA to order the 
                detention of food if there is credible evidence that it 
                will create a threat of serious adverse health 
                consequences to humans or animals. Another rule will 
                require the maintenance of records to allow FDA to 
                identify the previous source and subsequent recipient 
                of food including its packaging. FDA will use this 
                information to assess credible threats to human or 
                animal health.

                The Administration is committed to: (1) strengthening 
                economic performance; (2) reducing barriers to the 
                growth of small businesses; (3) improving public health 
                and safety; (4) enhancing environmental protection; and 
                (5) ensuring homeland security. Smarter regulatory 
                policies, created through public participation, 
                transparency, and cooperation across Federal agencies, 
                seek to

[[Page 74062]]

                accomplish these five national objectives. Each of the 
                following department or agency's plans is a reflection 
                of these objectives and provides information of 
                regulatory priorities in the context of specific 
                programs and initiatives.

[FR Doc. 02-28020
Filed 12-06-02; 8:45 am]
BILLING CODE 6820-27-S





[[Page 74063]]


                                                                Department of Agriculture
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                        Regulation
   Sequence                                                     Title                                                 Identification   Rulemaking Stage
    Number                                                                                                                Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
1                Livestock Mandatory Reporting Program--Lamb Amendment (LS-01-08)                                         0581-AB98       Proposed Rule
2                National Dairy Promotion and Research Program (DA-02-03)                                                    0581-AC16    Proposed Rule
3                Chronic Wasting Disease in Elk and Deer; Interstate Movement Restrictions and Payment of Indemnity       0579-AB35       Proposed Rule
4                Foot-and-Mouth Disease; Payment of Indemnity                                                             0579-AB34          Final Rule
5                Biological Agents and Toxins                                                                             0579-AB47          Final Rule
6                Multi-Family Housing (MFH)                                                                                  0575-AC13    Proposed Rule
7                Special Supplemental Nutrition Program for Women, Infants, and Children (WIC): Revisions in the WIC         0584-AC90    Proposed Rule
                 Food Packages
8                Food Stamp Program: Simplification and State Flexibility                                                 0584-AD22       Proposed Rule
9                FSP: High Performance Bonuses                                                                            0584-AD29       Proposed Rule
10               FSP: Eligibility and Certification Provisions of the Farm Security and Rural Investment Act of 2002      0584-AD30       Proposed Rule
11               FSP: Quality Control Provisions of the Farm Security and Rural Investment Act of 2002                    0584-AD31       Proposed Rule
12               FSP: Employment and Training Program Provisions of the Farm Security and Rural Investment Act of         0584-AD32       Proposed Rule
                 2002
13               Child and Adult Care Food Program: Improving Management and Program Integrity                               0584-AC24       Final Rule
14               Performance Standards for Bacon                                                                             0583-AC49    Proposed Rule
15               Egg and Egg Products Inspection Regulations                                                                 0583-AC58    Proposed Rule
16               Elimination of Chilling Time and Temperature Requirements for Ready-To-Cook Poultry (Section 610            0583-AC87    Proposed Rule
                 Review)
17               Emergency Regulations To Prevent Meat Food and Meat Products That May Contain the BSE Agent From            0583-AC88    Proposed Rule
                 Entering Commerce
18               Performance Standards for Ready-To-Eat Meat and Poultry Products                                            0583-AC46       Final Rule
19               Meat Produced by Advanced Meat/Bone Separation Machinery and Recovery Systems                               0583-AC51       Final Rule
20               Nutrition Labeling of Ground or Chopped Meat and Poultry Products and Single-Ingredient Products            0583-AC60       Final Rule
--------------------------------------------------------------------------------------------------------------------------------------------------------


                                                                  Department of Defense
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                        Regulation
   Sequence                                                     Title                                                 Identification   Rulemaking Stage
    Number                                                                                                                Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
21               Programmatic Regulations for the Comprehensive Everglades Restoration Plan                               0710-AA49          Final Rule
--------------------------------------------------------------------------------------------------------------------------------------------------------


                                                                 Department of Education
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                        Regulation
   Sequence                                                     Title                                                 Identification   Rulemaking Stage
    Number                                                                                                                Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
22               Reauthorization of the Educational, Research, Development, Dissemination, and Improvement Act of         1850-AA57       Proposed Rule
                 1994 (Section 610 Review)
23               Reauthorization of Title I of the Elementary and Secondary Education Act of 1965 (Section 610            1810-AA91          Final Rule
                 Review)
24               Reauthorization of the Individuals With Disabilities Education Act (Section 610 Review)                  1820-AB54       Proposed Rule
--------------------------------------------------------------------------------------------------------------------------------------------------------


                                                                  Department of Energy
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                        Regulation
   Sequence                                                     Title                                                 Identification   Rulemaking Stage
    Number                                                                                                                Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
25               Energy Efficiency Standards for Residential Furnaces, Boilers, and Mobile Home Furnaces                  1904-AA78             Prerule
26               Energy Efficiency Standards for Electric Distribution Transformers                                       1904-AB08             Prerule
27               Energy Efficiency Standards for Commercial Central Air Conditioning Units and Heat Pumps Rated 65-       1904-AB09             Prerule
                 240 kBtus/Hr
28               Radiation Protection of the Public and the Environment                                                   1901-AA38          Final Rule
--------------------------------------------------------------------------------------------------------------------------------------------------------


[[Page 74064]]


                                                         Department of Health and Human Services
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                        Regulation
   Sequence                                                     Title                                                 Identification   Rulemaking Stage
    Number                                                                                                                Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
29               Control of Communicable Diseases                                                                         0920-AA03       Proposed Rule
30               Possession, Use, and Transfer of Select Agents                                                           0920-AA08          Final Rule
31               Safety Reporting Requirements for Human Drug and Biological Products                                     0910-AA97       Proposed Rule
32               Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary Ingredients and        0910-AB88       Proposed Rule
                 Dietary Supplements
33               Control of Salmonella Enteritidis in Shell Eggs During Production and Retail                                0910-AC14    Proposed Rule
34               Exception From General Requirements for Informed Consent; Request for Comments and Information              0910-AC25    Proposed Rule
35               Bar Code Label Requirements for Human Drug Products                                                         0910-AC26    Proposed Rule
36               Administrative Detention                                                                                    0910-AC38    Proposed Rule
37               Establishment and Maintenance of Records to Identify Immediate Previous Source and Immediate                0910-AC39    Proposed Rule
                 Subsequent Recipient of Foods
38               Registration of Food and Animal Feed Facilities                                                             0910-AC40    Proposed Rule
39               Establishment of Prior Notification Requirement for All Imported Food Shipments                             0910-AC41    Proposed Rule
40               Applications for FDA Approval to Market a New Drug: Patent Listing Requirements and Application of          0910-AC48    Proposed Rule
                 30-Month Stays on Approval of Abbreviated New Drug Applications
41               Labeling for Human Prescription Drugs; Revised Format                                                    0910-AA94          Final Rule
42               Food Labeling: Trans Fatty Acids in Nutrition Labeling, Nutrient Content Claims, and Health Claims       0910-AB66          Final Rule
43               CGMPs for Blood and Blood Components: Notification of Consignees and Transfusion Recipients              0910-AB76          Final Rule
                 Receiving Blood and Blood Components at Increased Risk of Transmitting HCV (Lookback)
44               Toll-Free Number for Reporting Adverse Events on Labeling for Human Drugs                                   0910-AC35       Final Rule
45               End Stage Renal Disease (ESRD) Conditions for Coverage (CMS-3818-P) (Section 610 Review)                 0938-AG82       Proposed Rule
46               National Standard for Identifiers of Health Plans (CMS-6017-P)                                           0938-AH87       Proposed Rule
47               Health Insurance Reform: Claims Attachments Standards (CMS-0050-P)                                       0938-AK62       Proposed Rule
48               Organ Procurement Organization Conditions for Coverage (CMS-3064-P)                                      0938-AK81       Proposed Rule
49               Use of Restraint and Seclusion in Medicare and Medicaid Participating Facilities that Provide            0938-AL26       Proposed Rule
                 Inpatient or Residential Care (CMS-2130-P)
50               Prospective Payment System for Psychiatric Hospitals (CMS-1213-P)                                        0938-AL50       Proposed Rule
51               Revisions to the Medicare Appeals Process (CMS-4004-P)                                                   0938-AL67       Proposed Rule
52               Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities--Update for FY        0938-AL90       Proposed Rule
                 2004 (CMS-1469-P)
53               Changes to the Hospital Outpatient Prospective Payment System and Calendar Year 2004 Payment Rates       0938-AL91       Proposed Rule
                 (CMS-1471-P)
54               Revisions to Payment Policies Under the Physician Fee Schedule for Calendar Year 2004 (CMS-1476-P)       0938-AL96       Proposed Rule
55               Revisions to Average Wholesale Price Methodology (CMS-1229-P)                                            0938-AM12       Proposed Rule
56               Electronic Medicare Claims Submission (CMS-0008-P)                                                       0938-AM22       Proposed Rule
57               Revision of Medicare/Medicaid Hospital Conditions of Participation (CMS-3745-F)                          0938-AG79          Final Rule
58               Health Insurance Reform: Standard Unique Health Care Provider Identifier (CMS-0045-F)                    0938-AH99          Final Rule
59               Security Standards (CMS-0049-F)                                                                          0938-AI57          Final Rule
60               Hospital Conditions of Participation: Quality Assessment and Performance Improvements (QAPI) (CMS-       0938-AK40          Final Rule
                 3050-F)
61               Review of National Coverage Determinations and Local Coverage Determinations (CMS-3063-F)                0938-AK60          Final Rule
62               Health Insurance Reform: Modifications to Standards for Electronic Transactions (CMS-0003-F)             0938-AK64          Final Rule
63               Changes to the Hospital Inpatient Prospective Payment System and FY 2004 Rates (CMS-1470-N)              0938-AL89          Final Rule
64               Application of Emergency Medical and Treatment Act (EMTALA) (CMS-1063-F)                                 0938-AM34          Final Rule
--------------------------------------------------------------------------------------------------------------------------------------------------------


                                                       Department of Housing and Urban Development
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                        Regulation
   Sequence                                                     Title                                                 Identification   Rulemaking Stage
    Number                                                                                                                Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
65               Participation in HUD Programs by Faith-Based Organizations; Providing for Equal Treatment for All           2501-AC89    Proposed Rule
                 HUD Program Participants (FR-4782)
66               The Secretary of HUD's Regulation of Fannie Mae and Freddie Mac (FR-4790)                                   2501-AC92    Proposed Rule

[[Page 74065]]

 
67               Disposition of HUD-Owned Single Family Assets in Asset Control Areas (FR-4471)                           2502-AH40       Proposed Rule
68               FHA Appraiser Watch Initiative (FR-4744)                                                                 2502-AH81       Proposed Rule
69               Appraiser Qualifications for Placement on FHA Single Family Appraiser Roster (FR-4620)                   2502-AH59          Final Rule
70               RESPA--Improving the Process for Obtaining Mortgages (FR-4727)                                           2502-AH85          Final Rule
71               Project-Based Voucher Program (FR-4636)                                                                     2577-AC25    Proposed Rule
72               Changes to the Public Housing Assessment System (PHAS)(FR-4707)                                             2577-AC32    Proposed Rule
73               Streamlining and Deregulation of Public Housing Agency Plans (FR-4788)                                      2577-AC40    Proposed Rule
74               Deregulation for Small Public Housing Agencies (FR-4753)                                                    2577-AC34       Final Rule
--------------------------------------------------------------------------------------------------------------------------------------------------------


                                                               Department of the Interior
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                        Regulation
   Sequence                                                     Title                                                 Identification   Rulemaking Stage
    Number                                                                                                                Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
75               Snowmobile Regulations; Yellowstone and Grand Teton National Parks and John D. Rockefeller Memorial      1024-AD09          Final Rule
                 Parkway
76               Relief or Reduction in Royalty Rates -- Deep Gas Provisions                                              1010-AD01       Proposed Rule
77               Valuation of Oil from Indian Leases                                                                      1010-AD00          Final Rule
--------------------------------------------------------------------------------------------------------------------------------------------------------


                                                                  Department of Justice
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                        Regulation
   Sequence                                                     Title                                                 Identification   Rulemaking Stage
    Number                                                                                                                Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
78               Nondiscrimination on the Basis of Disability in Public Accommodations and Commercial Facilities          1190-AA44       Proposed Rule
                 (Section 610 Review)
79               Nondiscrimination on the Basis of Disability in State and Local Government Services (Section 610         1190-AA46       Proposed Rule
                 Review)
80               Carrier Arrival and Departure Electronic Manifest Requirements                                           1115-AG57       Proposed Rule
81               Revision of the Regulations Concerning F, J, and M Nonimmigrant Classifications                          1115-AG55          Final Rule
--------------------------------------------------------------------------------------------------------------------------------------------------------


                                                                   Department of Labor
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                        Regulation
   Sequence                                                     Title                                                 Identification   Rulemaking Stage
    Number                                                                                                                Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
82               Defining and Delimiting the Term ``Any Employee Employed in a Bona Fide Executive, Administrative,       1215-AA14       Proposed Rule
                 or Professional Capacity'' (ESA/W-H)
83               Family and Medical Leave Act of 1993                                                                     1215-AB35       Proposed Rule
84               Child Labor Regulations, Orders, and Statements of Interpretation (ESA/W-H)                              1215-AA09          Final Rule
85               Senior Community Service Employment Program                                                              1205-AB28       Proposed Rule
86               Trade Adjustment Assistance for Workers                                                                  1205-AB32       Proposed Rule
87               Labor Certification Process for the Permanent Employment of Aliens in the United States                  1205-AA66          Final Rule
88               Rulemaking Relating to Notice Requirements for Continuation of Health Care Coverage                      1210-AA60       Proposed Rule
89               Regulations Implementing the Health Care Access, Portability, and Renewability Provisions of the         1210-AA54          Final Rule
                 Health Insurance Portability and Accountability Act of 1996
90               Prohibiting Discrimination Against Participants and Beneficiaries Based on Health Status                 1210-AA77          Final Rule
91               Blackout Notice Regulation                                                                               1210-AA90          Final Rule
92               Blackout Notice Civil Penalty                                                                            1210-AA91          Final Rule
93               Diesel Particulate Matter Exposure of Underground Metal and Nonmetal Miners                              1219-AB29             Prerule
94               Verification of Underground Coal Mine Operators' Dust Control Plans and Compliance Sampling for          1219-AB14       Proposed Rule
                 Respirable Dust
95               Determination of Concentration of Respirable Coal Mine Dust                                              1219-AB18       Proposed Rule
96               Asbestos Exposure Limit                                                                                  1219-AB24       Proposed Rule
97               Assigned Protection Factors: Amendments to the Final Rule on Respiratory Protection                      1218-AA05       Proposed Rule
98               Fire Protection in Shipyard Employment (Part 1915, Subpart P) (Shipyards: Fire Safety)                   1218-AB51       Proposed Rule
99               Occupational Exposure to Crystalline Silica                                                              1218-AB70       Proposed Rule
100              Standards Improvement (Miscellaneous Changes) for General Industry, Marine Terminals, and                1218-AB81       Proposed Rule
                 Construction Standards (Phase II)

[[Page 74066]]

 
101              Update and Revision of the Exit Routes Standard                                                          1218-AB82          Final Rule
--------------------------------------------------------------------------------------------------------------------------------------------------------


                                                              Department of Transportation
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                        Regulation
   Sequence                                                     Title                                                 Identification   Rulemaking Stage
    Number                                                                                                                Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
102              Computer Reservations System Regulations Comprehensive Review                                               2105-AC65    Proposed Rule
103              Salvage and Marine Firefighting Requirements; Vessel Response Plans for Oil (USCG-1998-3417)             2115-AF60          Final Rule
104              Flight Crewmember Duty Period Limitations, Flight Time Limitations, and Rest Requirements                2120-AF63       Proposed Rule
105              Improved Flammability Standards for Thermal/Acoustic Insulation Materials Used in Transport              2120-AG91          Final Rule
                 Category Airplanes
106              Certification of Airports                                                                                2120-AG96          Final Rule
107              Hours of Service of Drivers; Driver Rest and Sleep for Safe Operations (Rulemaking Resulting From a      2126-AA23          Final Rule
                 Section 610 Review)
108              Limitations on Issuance of Commercial Driver's License With Hazardous Materials Endorsement              2126-AA70          Final Rule
109              Frontal Offset Protection                                                                                2127-AH73       Proposed Rule
110              Standards for Development and Use of Processor-Based Signal and Train Control Systems                    2130-AA94          Final Rule
111              Pipeline Safety: Pipeline Integrity Management in High-Consequence Areas (Gas Transmission Pipeline      2137-AD54       Proposed Rule
                 Operators)
--------------------------------------------------------------------------------------------------------------------------------------------------------


                                                               Department of the Treasury
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                        Regulation
   Sequence                                                     Title                                                 Identification   Rulemaking Stage
    Number                                                                                                                Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
112              Revision of Brewery Regulations and Issuance of Regulations for Taverns on Brewery Premises              1512-AB37       Proposed Rule
                 (Brewpubs)
113              Commerce in Explosives (Including Explosives in the Fireworks Industry) (Rulemaking Resulting From       1512-AB48       Proposed Rule
                 a Section 610 Review)
--------------------------------------------------------------------------------------------------------------------------------------------------------


                                                             Department of Veterans Affairs
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                        Regulation
   Sequence                                                     Title                                                 Identification   Rulemaking Stage
    Number                                                                                                                Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
114              Payment or Reimbursement for Emergency Treatment Furnished at Non-VA Facilities                          2900-AK08          Final Rule
--------------------------------------------------------------------------------------------------------------------------------------------------------


                                                             Environmental Protection Agency
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                        Regulation
   Sequence                                                     Title                                                 Identification   Rulemaking Stage
    Number                                                                                                                Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
115              Pesticides; Emergency Exemption Process Revisions                                                        2070-AD36             Prerule
116              Endocrine Disruptor Screening Program; Priority Setting Criteria                                         2070-AD59             Prerule
117              Sustainable Futures; Voluntary Pilot Project Under the TSCA New Chemical Program                         2070-AD60             Prerule
118              Clean Water Act Definition of Waters of the United States                                                2040-AB74             Prerule
119              NESHAP: Plywood and Composite Wood Products                                                              2060-AG52       Proposed Rule
120              NESHAP: Reciprocating Internal Combustion Engine                                                         2060-AG63       Proposed Rule
121              NESHAP: Industrial, Commercial, and Institutional Boilers and Process Heaters                            2060-AG69       Proposed Rule
122              NESHAP: Surface Coating of Automobiles and Light-Duty Trucks                                             2060-AG99       Proposed Rule
123              Transportation Conformity Amendments: Response to March 2, 1999, Court Decision                          2060-AI56       Proposed Rule
124              Control of Emissions from Spark Ignition Marine Vessels and Highway Motorcycles                          2060-AJ90       Proposed Rule
125              Implementation Rule for 8-hour Ozone NAAQS                                                               2060-AJ99       Proposed Rule

[[Page 74067]]

 
126              Control of Emissions of Air Pollution from Nonroad Diesel Engines and Fuel                               2060-AK27       Proposed Rule
127              Prevention of Significant Deterioration (PSD) and Nonattainment New Source Review (NSR): Routine         2060-AK28       Proposed Rule
                 Maintenance, Repair, and Replacement
128              Endocrine Disrupter Screening Program; Implementing the Screening and Testing Phase                      2070-AD61       Proposed Rule
129              Modifications to RCRA Rules Associated With Solvent-Contaminated Shop Towels and Wipes                   2050-AE51       Proposed Rule
130              Revision of Wastewater Treatment Exemptions for Hazardous Waste Mixtures                                 2050-AE84       Proposed Rule
131              Increase Metals Reclamation from F006 Waste Streams                                                      2050-AE97       Proposed Rule
132              Revisions to the Definition of Solid Waste                                                               2050-AE98       Proposed Rule
133              NPDES Permit Requirements for Municipal Sanitary and Combined Sewer Collection Systems, Municipal        2040-AD02       Proposed Rule
                 Satellite Collection Systems, Sanitary Sewer Overflows, and Peak Excess Flow Treatment Facilities
134              National Primary Drinking Water Regulations: Long Term 2 Enhanced Surface Water Treatment Rule           2040-AD37       Proposed Rule
135              National Primary Drinking Water Regulations: Stage 2 Disinfection Byproducts Rule                        2040-AD38       Proposed Rule
136              Minimizing Adverse Environmental Impact from Cooling Water Intake Structures at Existing Facilities      2040-AD70       Proposed Rule
                 Under Section 316(b) of the Clean Water Act, Phase 3
137              Watershed Rule: Total Maximum Daily Load (TMDL) Program Revisions                                        2040-AD82       Proposed Rule
138              Withdrawal of Total Maximum Daily Load (TMDL) Program Revisions                                          2040-AD84       Proposed Rule
139              Overview of Rulemakings for the Purpose of Reducing Interstate Ozone Transport                           2060-AJ20          Final Rule
140              Control of Emissions of Air Pollution From New Marine Compression-Ignition Engines At or Above 30        2060-AJ98          Final Rule
                 Liters per Cylinder
141              Management of Cement Kiln Dust (CKD)                                                                     2050-AE34          Final Rule
142              Standardized Permit for RCRA Hazardous Waste Management Facilities                                       2050-AE44          Final Rule
143              Office of Solid Waste Burden Reduction Project                                                           2050-AE50          Final Rule
144              National Primary Drinking Water Regulations: Groundwater Rule                                            2040-AA97          Final Rule
145              Effluent Guidelines and Standards for the Metal Products and Machinery Category, Phases 1 and 2          2040-AB79          Final Rule
146              National Pollutant Discharge Elimination System Permit Regulation and Effluent Guidelines and            2040-AD19          Final Rule
                 Standards for Concentrated Animal Feeding Operations (CAFOs)
147              Minimizing Adverse Environmental Impact From Cooling Water Intake Structures at Existing Facilities      2040-AD62          Final Rule
                 Under Section 316(b) of the Clean Water Act, Phase 2
148              Cross-Media Electronic Reporting (ER) and Recordkeeping Rule                                             2025-AA07          Final Rule
--------------------------------------------------------------------------------------------------------------------------------------------------------


                                                         Equal Employment Opportunity Commission
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                        Regulation
   Sequence                                                     Title                                                 Identification   Rulemaking Stage
    Number                                                                                                                Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
149              Coordination of Retiree Health Benefits With Medicare and State Health Benefits                          3046-AA72       Proposed Rule
--------------------------------------------------------------------------------------------------------------------------------------------------------


                                                      National Archives and Records Administration
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                        Regulation
   Sequence                                                     Title                                                 Identification   Rulemaking Stage
    Number                                                                                                                Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
150              Federal Records Management                                                                               3095-AB16             Prerule
--------------------------------------------------------------------------------------------------------------------------------------------------------


                                                          Pension Benefit Guaranty Corporation
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                        Regulation
   Sequence                                                     Title                                                 Identification   Rulemaking Stage
    Number                                                                                                                Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
151              Allocation of Assets in Single-Employer Plans; Valuation of Benefits and Assets                          1212-AA55       Proposed Rule
--------------------------------------------------------------------------------------------------------------------------------------------------------


[[Page 74068]]


                                                                Railroad Retirement Board
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                        Regulation
   Sequence                                                     Title                                                 Identification   Rulemaking Stage
    Number                                                                                                                Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
152              Application for Annuity or Lump Sum                                                                      3220-AB55       Proposed Rule
153              Account Benefits Ratio                                                                                   3220-AB56       Proposed Rule
154              Requests for Reconsideration and Appeals Within the Board                                                3220-AB03          Final Rule
--------------------------------------------------------------------------------------------------------------------------------------------------------


                                                              Small Business Administration
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                        Regulation
   Sequence                                                     Title                                                 Identification   Rulemaking Stage
    Number                                                                                                                Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
155              Small Business Lending Companies Regulations                                                             3245-AE14       Proposed Rule
156              HUBZone Empowerment Contracting Program                                                                  3245-AE66          Final Rule
--------------------------------------------------------------------------------------------------------------------------------------------------------


                                                             Social Security Administration
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                        Regulation
   Sequence                                                     Title                                                 Identification   Rulemaking Stage
    Number                                                                                                                Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
157              Federal Salary Offset (Withholding a Portion of a Federal Employee's Salary To Collect a Delinquent      0960-AE89       Proposed Rule
                 Debt Owed to the Social Security Administration) (721P)
158              Administrative Wage Garnishment (To Repay a Debt Owed to the Social Security Administration) (724P)      0960-AE92       Proposed Rule
159              Evidence Requirement for Assignment of Social Security Administration Numbers (SSNs) and Assignment      0960-AF05       Proposed Rule
                 of SSNs for Nonwork Purposes (751P)
160              Claimant Identification Pilot Projects (937P)                                                            0960-AF79       Proposed Rule
161              Representative Payment Under Titles II, VIII, and XVI of the Social Security Act (949P)                  0960-AF83       Proposed Rule
162              Removal of Clothing from the Definitions of Income and In-Kind Support and Maintenance, Exclusions       0960-AF84       Proposed Rule
                 of One Automobile and Household Goods and Personal Effects Under SSI from Resources (950P)
163              OASDI and SSI; Administrative Review Process; Video Teleconferencing Appearances Before                  0960-AE97          Final Rule
                 Administrative Law Judges of the Social Security Administration (737F)
164              Revised Medical Criteria for Evaluating Impairments of the Digestive System (800F)                       0960-AF28          Final Rule
165              Access to Information Held by Financial Institutions (815F)                                              0960-AF43          Final Rule
166              New Disability Claims Process--Roles of State Agency (816F)                                              0960-AF44          Final Rule
--------------------------------------------------------------------------------------------------------------------------------------------------------


                                                            National Indian Gaming Commission
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                        Regulation
   Sequence                                                     Title                                                 Identification   Rulemaking Stage
    Number                                                                                                                Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
167              Freedom of Information Act Procedures (Amendments)                                                       3141-AA21       Proposed Rule
168              Debt Collection                                                                                          3141-AA25          Final Rule
--------------------------------------------------------------------------------------------------------------------------------------------------------


[[Page 74069]]




DEPARTMENT OF AGRICULTURE (USDA)



Statement of Regulatory Priorities
 The Department of Agriculture will implement the recently enacted Farm 
Security and Rural Investment Act of 2002 (Farm Bill) through the 
promulgation of regulations to ensure the viability of the Nation's 
domestic farm economy and promote and maintain the world's safest, most 
abundant, and most affordable food supply. USDA is also actively 
engaged in the Nation's homeland security and will promulgate 
regulations that protect the food supply from all sources of potential 
threats.
 Farm Bill implementation will be a high priority in 2003 as new 
regulations are issued and farmers, ranchers, and other USDA customers 
participate in new and existing Federal farm programs over the next 6 
years through direct payments, counter-cyclical payments, and marketing 
loans. While the Farm Bill and other future legislative initiatives are 
implemented, the Department is working to reduce the regulatory burden 
on program participants through focusing as much as possible on 
outcome-based regulation through implementing more efficient and 
simplified information collections and the continued migration to 
efficient electronic services and capabilities.
[sbull] 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).
[sbull] 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 that yields the best outcomes. Further, USDA is 
            developing new regulations that address emerging and exotic 
            threats to the safety of the Nation's meat, poultry, and 
            egg products supply.
[sbull] The Department is also improving 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.
[sbull] Nutrition programs are being improved to strengthen dietary 
            quality for 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 
responsibilities of State and local governments, private industry, 
businesses, and individuals that are necessary to comply with their 
provisions.
 The diversity in purpose and outreach of 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 
Farm Security and Rural Investment Act of 2002, Public Law 107-171, has 
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
 Seven agencies are represented in this regulatory plan as well as the 
Rural Development mission area. They include the Farm Service Agency, 
the Food and Nutrition Service, the Food Safety and Inspection Service, 
the Animal and Plant Health Inspection Service, the Agricultural 
Marketing Service, the Natural Resources Conservation Service, and the 
Rural Housing Service. This document represents summary information on 
prospective significant regulations as called for in Executive Order 
12866. A brief comment on each of the seven agencies and Rural 
Development appears below, which summarizes the Agency mission and its 
key regulatory priorities. The Agency summaries are followed by the 
regulatory plan entries.
Farm Service Agency
 Mission: The Farm Service Agency's (FSA) mission is to stabilize farm 
income; to assist owners and operators of farms and ranches to conserve 
and enhance soil, water, and related natural resources; to provide 
credit to new or

[[Page 74070]]

existing farmers and ranchers who are temporarily unable to obtain 
credit from commercial sources; and to help farm operations recover 
from the effects of disaster, as prescribed by various statutes.
 Priorities: FSA's priority for 2003 will be to fully implement the new 
Farm Bill, the Farm Security and Rural Investment Act of 2002. The 2002 
Farm Bill, which was enacted on May 13, 2002, governs Federal farm 
programs for the next 6 years. Among its major provisions is to provide 
income support for wheat, feed grains, upland cotton, rice, and 
oilseeds through three programs: Direct payments, counter-cyclical 
payments, and marketing loans. Support for peanuts is changed from a 
price support program with marketing quotas to a program with marketing 
loans, counter-cyclical payments, direct payments, and a quota buyout. 
These are entirely new programs that require complete revision of the 
existing program regulations. FSA will develop and issue the 
regulations and make program funds available to eligible clientele in 
as timely a manner as possible. As these and future changes required by 
Administration initiatives and new legislation are made, the Agency's 
focus will be to implement the changes in such a way as to provide 
benefits while minimizing program complexity and regulatory burden for 
program participants. Opportunities will be taken to clarify, simplify, 
and reduce confusion whenever possible. 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.
 The 2002 Farm Bill exempts most of the new programs from the 
requirements of the Paperwork Reduction Act of 1995. However, FSA is 
still committed to the Act's goal of reducing the information 
collection burden on the public. New information collections are being 
designed to minimize our customers' time and cost to participate in the 
programs, while maintaining program integrity. In addition, FSA is 
streamlining its existing 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. FSA also 
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 loan program regulations and 
internal Agency directives will be completely rewritten.
 FSA has completed the streamlining of the Guaranteed Loan Program, the 
Indian Tribal Land Acquisition Loan Program, the Emergency Loan 
Program, and portions of the Direct Loan Program. The balance of the 
Direct Loan Program will be published in two separate rulemaking 
packages. Two proposed rules, one streamlining the loan-making process 
for farm ownership and operating loans and servicing of direct loans 
and another streamlining special loan programs, including boll weevil 
eradication, drainage and irrigation, and grazing association, will be 
published by the end of 2002.
 Finally, FSA continues to be a full participant in the USDA Electronic 
Access Initiative and continues to work with other USDA county-based 
agencies to implement the Government Paperwork Elimination Act as we 
migrate to an environment where a greater proportion of information 
exchange and transaction processing occurs through off-site 
alternatives. Key components include: Providing farm program 
information, availability, and eligibility requirements electronically; 
providing on-line information collection and transaction processing 
capability; and developing information collection and management 
partnerships to integrate information collection and sharing mechanisms 
among service providers. In a continuing effort to accomplish these 
goals, all FSA information collections, forms, and procedures are 
reviewed for their applicability to electronic submission and 
collection. FSA has identified and made accessible on-line 
approximately 143 forms used by farm program and farm loan program 
customer groups. Approximately 90 of these forms are available for 
electronic submission. The agency intends to provide full electronic 
access and submission capabilities to the commodity operations customer 
group by October 2003.
Food and Nutrition Service
 Mission: FNS increases food security and reduces hunger in partnership 
with cooperating organizations by providing children and low-income 
people access to food, a healthful diet, and nutrition education in a 
manner that supports American agriculture and inspires public 
confidence.
 Priorities: In addition to responding to provisions of legislation 
authorizing and modifying Federal nutrition assistance programs, FNS' 
2003 regulatory plan supports the broad goals and objectives in the 
Agency's strategic plan, which include:
[sbull] 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, 
            school lunch, and other child nutrition programs and 
            commodities), including nutrition education, quality meals, 
            and other benefits. It includes three major objectives: 1) 
            Improve food security, which reflects nutrition assistance 
            benefits issued to program eligibles; 2) improve the 
            healthfulness of program participants' food choices, which 
            represents efforts to improve nutrition knowledge and 
            behavior through nutrition education and breastfeeding 
            promotion; and 3) improve nutritional quality of meals, 
            food packages, commodities, and other program benefits, 
            which represents efforts to ensure that program benefits 
            meet appropriate nutrition standards and help to 
            effectively improve nutritional intakes for program 
            participants.
[sbull] In support of this goal, FNS plans to propose rules 
            implementing provisions of the Farm Security and Rural 
            Investment Act of 2002 (Pub. L. 107-171), as well as under 
            other authorities, that will give States additional new 
            flexibility by streamlining complex rules, simplifying 
            program administration, supporting work, and improving 
            access to benefits. This includes provisions to restore 
            food stamp eligibility to certain legal immigrants who have 
            lived in this country for at least 5 years, as well as 
            immigrant children and disabled without a waiting period. 
            Other changes will be implemented to reduce reporting 
            burden on working families.
[sbull] 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

[[Page 74071]]

            Americans and to increase the nutritional adequacy of food 
            packages for those with special medical needs.
[sbull] 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 the 
            Agency's efforts to streamline program operations and 
            improve program structures as necessary to maximize their 
            effectiveness.
 In support of this goal, FNS plans to propose rules implementing 
provisions of Public Law 107-171 that give States substantial new 
flexibility by streamlining some of the Food Stamp Program's complex 
rules, making it easier to administer, less error prone, and more 
accessible to those eligible for its benefits. Another proposed rule 
implementing this law will offer most States some relief from current 
sanction rules related to Food Stamp payment errors, allowing them to 
focus on program improvements, and will introduce new incentives to 
reward States for high performance on a variety of important program 
outcomes. FNS also plans to publish a final rule making changes in 
Child and Adult Care Food Program (CACFP) designed to improve 
management and financial integrity in this important program.
Food Safety and Inspection Service
 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: FSIS is reviewing its regulations to eliminate duplication 
of and inconsistency with its own and other agencies' regulations and 
to improve 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, the establishments 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 HAACP 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 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 
for partially heat-treated meat and poultry products that are not 
ready-to-eat.
 FSIS will propose removing from the poultry products inspection 
regulations the requirement for ready-to-cook poultry products to be 
chilled to 40 degrees Fahrenheit or below within certain time periods 
according to the weight of the dressed carcasses.
 In addition, FSIS will be proposing to require shell egg packers and 
federally inspected egg product plants to develop and implement HACCP 
systems and sanitation standard operating procedures. The Agency will 
be proposing pathogen reduction performance standards for pasteurized 
shell eggs and 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 the 
major cuts of single ingredient, raw products and would 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.
 Post-September 11, 2001, initiatives: FSIS has not proposed new 
regulations in response to the September 11, 2001, events. The Agency 
has, however, issued non-regulatory security guidelines for food plants 
within the Agency's jurisdiction.
 Small business concerns: Nearly all FSIS regulations affect small 
businesses in some way because the majority of FSIS-inspected 
establishments and other FSIS-regulated entities are small businesses. 
FSIS makes available to small and very small establishments technical 
materials and guidance on how to comply with FSIS regulations.

[[Page 74072]]

The Agency's post-September 11, 2001, security guidance materials were 
prepared with small food producing establishments in mind.
Animal and Plant Health Inspection Service
 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 plans 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 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). In addition, 
APHIS, in coordination with the Department's Food Safety Inspection 
Service, and with input from the public, is considering various options 
for addressing the disease risks that may be presented by nonambulatory 
animals and dead stock should BSE be introduced into the United States. 
APHIS is also working in conjunction with the Centers for Disease 
Control and Prevention to establish regulations for the possession, 
use, and transfer of biological agents and toxins that could pose a 
severe disease or pest risk to animals and plants or their products. In 
addition, APHIS plans to strengthen its regulations for the importation 
of plants and plant products, including unmanufactured wood, in 
response to new pest detections and the adoption, recently, of an 
international standard for treatment of solid wood packing material.
 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 Service
 Mission: The Agricultural Marketing Service (AMS) facilitates the 
marketing of agricultural products in domestic and international 
markets, while ensuring fair trading practices and promoting a 
competitive and efficient marketplace to the benefit of producers, 
traders, and consumers of U.S. food and fiber products.
 Priorities: (A) The recently enacted Farm Security and Rural 
Investment Act of 2002 (2002 Farm Bill) amended the Dairy Production 
and Stabilization Act of 1983 (the authorizing legislation for the 
National Dairy Promotion and Research Program (NDP&RP). The 2002 Farm 
Bill requires that the NDP&RP be amended to provide for: (1) 
Implementation of a mandatory 15-cent per hundred weight assessment on 
dairy products imported into the 48 contiguous States; (2) importer 
representation on the National Dairy Board; (3) importer voter 
eligibility during referenda; (4) the definition of imported dairy 
products to include casin; and (5) the order must be implemented in a 
manner consistent with the U.S. trade obligations. A proposed rule 
providing interested parties an opportunity to submit comments on the 
implementation of the mandatory assessment on imported dairy products 
will be published fall 2002.
 (B) Livestock Mandatory Reporting-Lamb Amendments. These proposed 
amendments to the lamb reporting requirements are necessary to ensure 
that consistent, accurate, and easily understood information on the 
marketing of domestic and imported boxed lamb cuts is available to 
producers, packers, and other lamb market participants. AMS believes 
that the lamb industry would be better served by decreasing the lamb 
importer threshold to 2,500 metric tons of lamb meat products and 
redefining carlot of boxed lamb cuts to increase the ability to report 
import product and to reduce the volume of inappropriate or 
incompatible data submitted. AMS is presently working on burden-related 
issues placed on importers with the Office of Management and Budget. 
The Agency expects to have the proposed rule ready for departmental 
review by late fall.
 (C) 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 on various rules.
Natural Resources Conservation Service
 Mission: The Natural Resources Conservation Service (NRCS) mission is 
to provide leadership in a partnership effort to help people conserve, 
maintain, and improve our natural resources and environment.
 Priorities: NRCS's priority for 2003 will be to implement fully the 
conservation provisions of the Farm Security and Rural Investment Act 
of 2002 (the 2002 Farm Bill), while continuing to meet the needs of 
landowners and land users who participate in non-Farm Bill programs. 
The 2002 Farm Bill was enacted on May 13, 2002, and governs Federal 
farm programs for the next 6 years. Title II of the 2002 Farm Bill 
reauthorized and made amendments to existing conservation programs, 
authorized new conservation programs, and expanded the overall funding 
for conservation.
 The changes made by title II necessitate the revisions of existing 
regulations and the promulgation of proposed and final regulations to 
implement new programs. The 2002 Farm Bill exempts administration of 
title II from the requirements of the Paperwork Reduction Act of 1995. 
However, NRCS is still committed to the Act's goal of reducing the 
information collection burden on the public. New information 
collections are being designed to minimize program participants' time 
and cost to participate in the programs, while maintaining program 
integrity. NRCS is also committed to compliance with the Government 
Paperwork Elimination Act and the Freedom to E-File Act, which require 
Government agencies in general and NRCS in particular to provide the 
public the option of submitting information or transacting business 
electronically to the maximum extent possible. NRCS is designing its 
program forms to allow the public to conduct business with NRCS 
electronically.

[[Page 74073]]

 The NRCS plans to publish the following proposed or final rules during 
FY 2003:
1. Conservation of Private Grazing Land (CPGL) Final Rule
2. Environmental Quality Incentives Program (EQIP) Proposed Rule and 
            Final Rule
3. Technical Service Provider Assistance (TSPA) Interim Final Rule and 
            Final Rule
4. Conservation Security Program (CSP) Proposed Rule and Final Rule
5. Farmland Protection Program (FPP) Proposed Rule and Final Rule
6. Emergency Watershed Protection (EWP) Program Proposed Rule and Final 
            Rule
7. Highly Erodible Land and Wetland Conservation (HEL/WC) Final Rule
8. Categorical Minimal Effects (CME) Final Rule
 The rulemaking for EQIP, EWP, and HEL/WC consist of changes being made 
to current regulations. The remainder of the rulemaking involves the 
creation of new regulatory provisions. NRCS will develop and issue the 
regulations and make program funds available to program participants in 
as timely a manner as possible. Opportunities will be taken to clarify, 
simplify, and reduce confusion whenever possible.
Rural Development
 Mission: Enhance the ability of rural communities to develop, to grow, 
and to improve their quality of life by targeting financial and 
technical resources in areas of greatest need through activities of 
greatest potential.
 Priorities: Rural Development priorities for 2003 will include timely 
implementation of the 2002 Farm Bill sections for which it is 
responsible. In addition to the regulations identified in the 
regulatory agenda, there are several sections of titles VI and IX of 
the Farm Bill for which work plans are being developed for future 
regulatory action.
Rural Housing Service
 Mission: As part of USDA Rural Development, Rural Housing Service 
(RHS) works to improve the quality of life in rural areas. RHS helps 
rural communities and individuals by providing loans and grants for 
housing and community facilities. The Agency provides funding for 
single-family homes, apartments for low-income persons or the elderly, 
housing for farm laborers, childcare centers, fire and police stations, 
hospitals, libraries, nursing homes, and schools.
 Priorities: A key priority for RHS is to identify ways to improve 
customer service, ensure borrower accountability and performance, and 
streamline the administration of its Multi-Family Housing (MFH) 
programs. These programs include the section 515 Rural Rental Housing 
(RRH) loan program, the section 514/516 Farm Labor Housing loan and 
grant programs, and the section 521 Rental Assistance (RA) program.
 The new regulation substantially updates the current regulations and 
programs to current industry practices. Many of the current regulations 
had not been substantially updated for over 15 years. The new 
regulation consolidates the 13 current regulations that govern the 
programs. The new regulation and three handbooks substantially reduce 
the number of pages published in the Code of Federal Regulations.
 Prior USDA Office of Inspector General (OIG) program audits identified 
weaknesses in the regulations that let some program participants commit 
program fraud, waste, and abuse. The new regulation was developed to 
correct such problems.
 Significant automation initiatives have been implemented since the 
current regulations were written. The regulation addresses the 
permanent implementation of several pilot automation projects along 
with other innovative e-Government improvements.
 The regulation focuses on the challenge of the Agency's aging 
portfolio. Areas such as conducting comprehensive needs analyses, 
reserve account administration, financial statement standards, and 
tenant quality of life issues are addressed.
 As part of the regulatory process, RHS has solicited input from MFH 
program stakeholders, including borrowers (who are also owners of the 
projects), management agents, tenant representatives, State housing 
finance agencies, accounting firms, and the USDA, Office of Inspector 
General (OIG). The Agency has held several stakeholders meetings on 
issues that needed to be considered before proposing to revise the 
regulations. Stakeholders concurred with RHS that the MFH regulations 
were in need of a substantial revision, particularly with regard to 
asset management, housing preservation, and financial reporting.
_______________________________________________________________________



USDA--Agricultural Marketing Service (AMS)

                              -----------

                          PROPOSED RULE STAGE

                              -----------




1. LIVESTOCK MANDATORY REPORTING PROGRAM--LAMB AMENDMENT (LS-01-08)
Priority:


Other Significant


Legal Authority:


7 USC 1621


CFR Citation:


7 CFR 59


Legal Deadline:


None


Abstract:


The Agricultural Marketing Service is amending the Livestock Reporting 
Act of 1999 regulations. The amendments would: (1) Amend regulations 
requiring lamb packers to report negotiated purchases of live lamb and 
sales of carcass lamb; (2) adjust requirements for reporting of 
imported and domestic boxed lamb sales; and (3) make adjustments to 
input data collection forms. The Act was implemented April 2, 2001, and 
requires packers to report purchase and sales transactions for cattle, 
swine, sheep, boxed beef, and lamb meat.


Statement of Need:


These proposed amendments and adjustments to the lamb reporting 
requirements of the Livestock Mandatory Reporting (LMR) regulations are 
necessary to ensure that consistent, accurate, and easily understood 
information on the marketing of domestic and imported boxed lamb cuts 
is available to producers, packers, and other lamb market participants. 
The amendment is intended to address problems that have occurred in the 
collection and publishing of lamb market information in the period 
since the implementation of the LMR on April 2, 2001.


Summary of Legal Basis:


The Livestock Mandatory Act of 1999 (Act) was enacted into law on 
October 22, 1999 (Pub. L. 106-78; 113 Stat. 1188; 7 U.S.C. 1635-
1636(h)) as an amendment to the Agricultural Marketing Act of 1946, as 
amended (7 U.S.C. 1621 et seq.). The Act gives the Secretary of 
Agriculture (Secretary) the latitude to require mandatory reporting

[[Page 74074]]

of market information on lamb transactions.


Alternatives:


None.


Anticipated Cost and Benefits:


The Agricultural Marketing Service believes that the lamb industry 
would be better served by decreasing the lamb importer threshold to 
2,500 metric tons of lamb meat products and redefining carlot of boxed 
lamb cuts to increase the ability to report import product and reduce 
the volume of inappropriate or incompatible data.


Risks:


None.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           11/00/02
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:
John Edward Van Dyke
Chief, Livestock and Grain Market News Branch
Department of Agriculture
Agricultural Marketing Service
Stop 0252, Room 2619-South
Washington, DC 20250
Phone: 202 720-6231
Fax: 202 690-3732
Email: [email protected]
RIN: 0581-AB98
_______________________________________________________________________



USDA--AMS



2. [bull] NATIONAL DAIRY PROMOTION AND RESEARCH PROGRAM (DA-02-03)
Priority:


Other Significant


Legal Authority:


7 USC 450 et seq


CFR Citation:


7 CFR 1150


Legal Deadline:


NPRM, Statutory, November 2002, Proposed Rule necessary for industry 
input.


Final, Statutory, February 2003, Final Rule to be issued after 60-day 
comment period.


Abstract:


Recently enacted Farm Security and Rural Investment Act of 2002 (2002 
Farm Bill) amended the Dairy Production and Stabilization Act of 1983 
(the authorizing legislation for the National Dairy Promotion and 
Research Program) concerning implementation of mandatory 15-cent per 
hundred weight assessment on dairy products imported into the 48 
contiguous States and other related amendments.


Statement of Need:


The National Dairy Promotion and Research Program must be amended to 
conform with the recently enacted Farm Security and Rural Investment 
Act of 2002 (2002 Farm Bill), which amended the Dairy Promotion and 
Research Programs. The amendments relate to implementation of a 
mandatory 15-cent per hundred weight assessment on dairy products 
imported into the 48 contiguous States and other related amendments.


Summary of Legal Basis:


The Farm Security and Rural Investment Act of 2002 (2002 Farm Bill) 
mandated changes to the National Dairy Promotion and Research Program.


Alternatives:


None.


Anticipated Cost and Benefits:


The incremental costs associated with the assessments collection on 
imported dairy products by U.S. Customs will be paid from the 
assessments collected. It is estimated that the fees will range between 
$30,000-$40,000 monthly after start-up. The annual assessment collected 
will be approximately $9 million.


Risks:


None.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           11/00/02
Final Action                                                   02/00/03
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


None


Agency Contact:
David Jamison
Chief, Promotion and Research Branch
Department of Agriculture
Agricultural Marketing Service
Stop 0233
Dairy Progams
1400 Independence Avenue SW
Washington, DC 20250-0233
Phone: 202 720-6909
Fax: 202 720-0285
Email: [email protected]
RIN: 0581-AC16
_______________________________________________________________________



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

                              -----------

                          PROPOSED RULE STAGE

                              -----------




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


Other Significant


Legal Authority:


7 USC 8301 to 8316


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 deer and to provide indemnity for the 
depopulation of farmed elk and deer 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. This project includes an interim rule 
to establish indemnity for voluntary depopulation of CWD-affected 
herds, followed by a proposed rule to establish a voluntary 
certification

[[Page 74075]]

program and interstate movement restrictions on captive elk and deer. 
APHIS believes that establishing restrictions on the interstate 
movement of infected and exposed farmed elk and deer, coupled with the 
payment of some level of indemnity for infected and exposed animals, 
will encourage producers who are not yet engaging in surveillance 
activities to begin doing so. To date, the level of support from States 
and the farmed cervid industry for such a program has been high. 
Without a Federal program in place to depopulate infected and exposed 
animals, the movement of infected animals 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 other Federal agencies, States or political subdivisions of 
States, national governments of foreign countries, local governments of 
foreign countries, domestic or international organizations, domestic or 
international associations, Indian tribes, and other persons, may carry 
out operations and measures to detect, control, or eradicate any pest 
or disease of livestock of the United States, including the payment of 
claims arising out of the destruction of any animal, article, or means 
of conveyance, if necessary to prevent the dissemination of the pest or 
disease of livestock (7 U.S.C. 8305 to 8306, 8308, 8310, and 8315).


Alternatives:


APHIS has identified two additional alternatives to our selected 
action. 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 cervid 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, 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 and deer 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. Fear of CWD can severely affect the domestic prices for 
deer and elk, as it is more difficult for producers to sell cervid that 
are associated with any hint of exposure to the disease.


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

_______________________________________________________________________
Interim Final Ru67 FR 5925                                     02/08/02
Interim Final Rule Comment Period End                          04/09/02
NPRM                                                           02/00/03
Regulatory Flexibility Analysis Required:


No


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--APHIS

                              -----------

                            FINAL RULE STAGE

                              -----------




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


Other Significant


Legal Authority:


7 USC 8301 to 8317


CFR Citation:


9 CFR 53


Legal Deadline:


None


Abstract:


APHIS is proposing to amend its regulations for the cooperative control 
and eradication of foot-and-mouth disease (FMD) and other serious 
diseases, including both cooperative programs and extraordinary 
emergencies. The purpose of this rule is to remove possible sources of 
delay in eradicating foot-and-mouth disease, should an occurrence of 
that disease occur in this country, so that eligible claimants will be 
fully compensated while at the same time protecting the U.S. livestock 
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

[[Page 74076]]

property as a result of foot-and-mouth disease.


Summary of Legal Basis:


The Secretary of Agriculture, either independently or in cooperation 
with other Federal agencies, States or political subdivisions of 
States, national governments of foreign countries, local governments of 
foreign countries, domestic or international organizations, domestic or 
international associations, Indian tribes, and other persons, may carry 
out operations and measures to detect, control, or eradicate any pest 
or disease of livestock that threatens the livestock of the United 
States, including the payment of claims arising out of the destruction 
of any animal, article, or means of conveyance, if necessary to prevent 
the dissemination of the pest or disease of livestock (7 U.S.C. 8306, 
8308, 8310, and 8315).


Alternatives:


The rule comprises 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 rule would be to not make any changes at 
all and rely on the current regulations as applied to cooperative 
programs and extraordinary emergencies.


Anticipated Cost and Benefits:


The 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 characteristics of the outbreak and mitigation strategy. The 
proposed changes would strengthen programs for the control and 
eradication of FMD by broadening USDA's options. The changes would also 
lessen the chances that FMD's eradication would be delayed.


Risks:


The changes contained in the rule would be particularly important in 
removing sources of delay in achieving FMD eradication, 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            67 FR 21934                                    05/01/02
NPRM Comment Per67 FR 43566d                                   06/28/02
NPRM Comment Period End                                        07/01/02
NPRM Comment Period End                                        07/31/02
Final Rule                                                     04/00/03
Regulatory Flexibility Analysis Required:


Undetermined


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



5. [bull] BIOLOGICAL AGENTS AND TOXINS
Priority:


Other Significant


Legal Authority:


7 USC 8401


CFR Citation:


7 CFR 331; 9 CFR 121


Legal Deadline:


None


Abstract:


In accordance with the Agricultural Bioterrorism Protection Act of 
2002, APHIS has established, by regulation, an initial list of 
biological agents and toxins determined to have the potential to pose a 
severe threat to animal or plant health or to animal or plant products. 
The Act requires that all persons in possession of any listed 
biological agent or toxin must, within 60 days of the publication of 
the interim rule, notify the Secretary of such possession. The interim 
rule establishes APHIS' initial list of biological agents and toxins 
and provides guidance on the manner in which the required notice is to 
be provided. A second interim rule, also required by the Act, will 
follow this interim rule and will establish regulations regarding the 
possession, use, and transfer of listed biological agents and toxins.


Statement of Need:


The second interim rule referred to in the abstract is required under 
section 212 of the Public Health Security and Bioterrorism Response Act 
of 2002 (Pub. L. 107-188), which requires the Secretary of Agriculture 
to establish regulations by interim rule for the possession, use, and 
transfer of biological agents and toxins that she determines has the 
potential to pose a severe threat to animal or plant health or to 
animal or plant products. Among other things, the regulations must 
require registration with the Secretary and include appropriate 
safeguard and security measures, including data base checks by the 
Attorney General of individuals and facilities seeking to register with 
the Secretary. The Act imposes a deadline of December 9, 2002, for the 
promulgation of the regulations and requires an effective date of 
February 12, 2003.


Summary of Legal Basis:


The President signed into law the Public Health Security and 
Bioterrorism Preparedness and Response Act of 2002 on June 12, 2002. 
Title II of Public Law 107-188 ``Enhancing Controls on Dangerous 
Biological Agents and Toxins'' (sections 201 through 231) provides for 
the regulation of certain biological agents and toxins by the 
Department of Health and Human Services (subtitle A, sections 201-204) 
and the Department of Agriculture (subtitle B, sections 211-213) and 
provides for interagency coordination between the two departments 
regarding overlap agents and toxins (subtitle C, section 221). Subtitle 
D (section 231) provides for criminal penalties regarding certain 
biological agents and toxins. For the Department of Health and Human 
Services, the Centers for Disease Control and Prevention has been 
designated as the agency with primary responsibility for implementing 
the provisions of the Act; the Animal and Plant Health Inspection 
Service (APHIS) is the agency fulfilling

[[Page 74077]]

that role for the Department of Agriculture.


Alternatives:


APHIS' Veterinary Services and Plant Protection and Quarantine programs 
have had regulations in place for some years that require prior 
authorization from APHIS for the importation or interstate movement of 
certain animal disease agents and plant pests. Those regulations 
further require that appropriate safeguards be applied to the handling 
and containment of those animal disease agents and plant pests. While 
the biological agents and toxins that the Secretary has determined have 
the potential to pose a severe threat to animal or plant health or to 
animal or plant products have historically fallen within the scope of 
the existing regulations, those regulations do not contain the 
individual/facility registration requirements, physical security, and 
other considerations that the Public Health Security and Bioterrorism 
Response Act of 2002 requires the Agency to address in the second 
interim rule.


Anticipated Cost and Benefits:


APHIS is currently preparing a regulatory flexibility analysis and 
cost/benefit analysis to accompany the second interim rule. Among the 
costs we anticipate will be examined in those analyses are the costs 
associated with compliance with the administrative requirements of the 
rule (e.g., salary costs associated with the time needed to complete 
required forms), as well as costs that may be incurred in the course of 
making any necessary upgrades to the physical, computer, and biological 
security capabilities of facilities that possess, use, or transfer 
listed biological agents and toxins. The regulations are intended to 
increase the security over such agents and toxins and establish a 
comprehensive national data base of the location and characterization 
of those agents and toxins and the identities of those in possession of 
them. These enhanced security measures will prevent the use in domestic 
or international terrorism of those biological agents and toxins, thus 
protecting human, animal, and plant health and preventing the economic 
impacts that would be associated with the release of those agents and 
toxins.


Risks:


The regulations will include appropriate safeguard and security 
requirements for persons possessing, using, or transferring a listed 
agent or toxin commensurate with the risk such agent or toxin poses to 
public health and safety (including the risk of use in domestic or 
international terrorism).


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
Interim Final Ru67 FR 52383                                    08/12/02
Interim Final Rule Effective                                   08/12/02
Interim Final Rule Comment Period End                          10/11/02
Second Interim Final Rule                                      12/00/02
Regulatory Flexibility Analysis Required:


No


Government Levels Affected:


State, Federal


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. Arnold T. Tschanz
Senior Staff Officer, Regulatory Coordination, Plant Health Programs, 
PPQ
Department of Agriculture
Animal and Plant Health Inspection Service
Unit 141
4700 River Road
Riverdale, MD 20737-1236
Phone: 301 734-8790

Dr. Denise Spencer
Senior Staff Veterinarian, Technical Trade Services, NCIE, VS
Department of Agriculture
Animal and Plant Health Inspection Service
Unit 40
4700 River Road
Riverdale, MD 20737-1231
Phone: 301 734-3277
RIN: 0579-AB47
_______________________________________________________________________



USDA--Rural Housing Service (RHS)

                              -----------

                          PROPOSED RULE STAGE

                              -----------




6. MULTI-FAMILY HOUSING (MFH)
Priority:


Other Significant


Legal Authority:


5 USC 301; 42 USC 1490a; 7 USC 1989; 42 USC 1475; 42 USC 1479; 42 USC 
1480; 42 USC 1481; 42 USC 1484; 42 USC 1485; 42 USC 1486


CFR Citation:


7 CFR 1806 subpart A; 7 CFR 1955 subpart B; 7 CFR 1955 subpart C; 7 CFR 
1956 subpart B; 7 CFR 1965 subpart B; 7 CFR 1965 subpart E; 7 CFR 1930 
subpart C; 7 CFR 1944 subpart D; 7 CFR 1944 subpart E; 7 CFR 1951 
subpart C; 7 CFR 1951 subpart D; 7 CFR 1951 subpart K; 7 CFR 1951 
subpart N; 7 CFR 1955 subpart A


Legal Deadline:


None


Abstract:


The Rural Housing Service (RHS) proposes to consolidate regulations 
pertaining to section 515 Rural Rental Housing, section 514 Farm Labor 
Housing Loans, section 516 Farm Labor Housing Grants, and section 521 
Rental Assistance Payments. Fourteen published regulations will be 
reduced to one regulation and handbooks for program administration. 
This will simplify loan origination and portfolio management for 
applicants, borrowers, and housing operators, as well as Rural 
Development field staff. This will also provide flexibility for program 
modifications to reflect current and foreseeable changes. It will also 
reduce regulations that address solely internal Agency program 
administration. Finally, the regulation will be more customer friendly 
and responsive to the needs of the public.


Statement of Need:


The new regulation for the program known as the Multi-Family Housing 
Loan and Grant Programs will be more user friendly for lenders, 
borrowers, and Agency staff. These changes are essential to allow for 
improved service to the public and for an expanded program with 
increased impact on rural housing opportunities without a corresponding 
expansion in Agency staff. The regulations will be shorter, better 
organized, and more simple and clear. Many documentation requirements 
will be eliminated or consolidated into more convenient formats.


Summary of Legal Basis:


The existing statutory authority for the MFH programs was established 
in title V of the Housing Act of 1949, which gave authority to the RHS 
(then the Farmers Home Administration) to make

[[Page 74078]]

housing loans to farmers. As a result of this Act, the Agency 
established single-family and multifamily housing programs. Over time, 
the sections of the Housing Act of 1949 addressing MFH have been 
amended a number of times. Amendments have involved issues such as the 
provision of interest credit, broadening definitions of eligible areas 
and populations to be served, participation of limited profit entities, 
the establishment of a rental assistance program, and the imposition of 
a number of restrictive use provisions and prepayment restrictions.


The MFH program, as it exists today, began in the 1960s. Its first 
loans were primarily for small rental projects. In the mid-sixties, the 
program expanded and changed from making small rural rental housing 
loans to individuals to making larger loans to organizations, such as 
limited partnerships. Regulations for the program have been amended 
several times over the years to reflect statutory changes and to revise 
the Agency's procedures for administering the program. The most recent 
significant regulatory revisions took place after the Appropriations 
Act of 1997 directed the Agency to implement six reforms to the MFH 
program. This was accomplished with the publication of a final rule for 
the reforms on December 23, 1997. Reforms addressed such items as 
equity skimming, review of other Government assistance, the maximum 
loan terms, and the use of a Notice of Funding Availability and 
competitive process to award funds for new projects.


Statistics show that the MFH program fills a significant need for rural 
Americans. Two primary types of households occupy RHS-financed, section 
515 rental housing--elderly households who have decided that they 
prefer renting over continued ownership of their own dwellings and 
younger female and male headed households that do not have sufficient 
resources available to purchase their own home. Additionally, the 
sections 514/516 Farm Labor Housing loan and grant programs are the 
only Federal programs available for the provision of housing to 
farmworkers, one of the most chronically underhoused populations within 
America.


Alternatives:


The proposed rule is important to all program participants, 
beneficiaries, and agency staff. Any budgetary impacts of the 
regulation are minor and reflect good business practices rather than 
policy shifts. Funding for major program needs as rehabilitation, 
preservation, and future new construction may be addressed through the 
budget process rather than publication of the rule. To not publish the 
rule will substantially restrict RHS' ability to effectively administer 
the programs and cost the Agency significant credibility with the 
public and oversight organizations.


If the Agency were not to publish the proposed rule, the 25 percent 
reduction in Government burden not achieved would be significant. 
During the past 6 years, the number of staff-years assigned MFH 
functions has decreased approximately 25 percent. RHS' limited staff 
resources could be utilized more effectively on activities that would 
improve program performance by decreasing and simplifying the paperwork 
for the MFH program.


Current regulations include standards for physical condition, 
maintenance, and reserve levels to address the physical condition of 
the property. However, projects are experiencing physical maintenance 
problems due to their average age. One of the sources of this problem 
is that project reserves are inadequate to cover ongoing capital needs. 
Current regulations require that borrowers contribute initially 1 
percent annually of total development costs toward a reserve for 
project improvements until a total of 10 percent is reached. While 
borrowers are permitted to request adjustments to their reserve 
contributions, there is no systematic provision for reevaluating 
reserves over the life of the project. A recent study found that while 
an average MFH project has accumulated $5,000 in reserves per unit at 
the end of 10 years and maintained at that level thereafter, the full 
cost of rehabilitation is likely to be close to $16,000 per unit. When 
rehabilitation is needed and the reserve is inadequate to meet the 
need, the project owner usually applies for a subsequent loan, which, 
if received, requires that rents be increased. In recent years, RHS has 
been experiencing a growing number of requests for subsequent loans and 
rent increases to cover costs of rehabilitation, while funding for such 
loans has been limited. For example, the President's budget for 2002 
provides funding to rehabilitate 4,115 units, which is consistent with 
the funding received in recent years. However, at that rate, it will 
take more than 109 years to cycle once through the entire portfolio.


Consistently, RHS is taking several steps to link reserve levels more 
closely to projects' capital needs. The proposed rule allows a life 
cycle costs analysis to be used to establish the initial reserve amount 
needed to meet the capital needs for new projects. For existing 
projects, the proposed rule requires that any servicing action that 
involves additional agency funds must take into account physical needs 
of the project, based on a capital needs assessment. The proposed rule 
also allows borrowers with existing projects to include the cost of 
capital needs assessments in their budgets, which is expected to focus 
attention on the use of such assessments. Alternatively, by not 
publishing the proposed rule, properties financed under the programs 
may deteriorate.


Anticipated Cost and Benefits:


Based on analysis of the proposed rule, the following impacts may 
occur, some of which could be considered significant:


There would be cost savings due to reduced paperwork, estimated to be 
about $1.8 million annually for the public and about $10.1 million for 
the Government.


Rents for about half the 459,000 units in MFH projects would likely be 
increased by an average of about $15 per month. This estimate combines 
the impacts on rents of two different changes--an increase in reserve 
requirements for project improvements from $5,000 to $10,000 per unit 
and a change in RHS' policies relating to the investment of funds in 
reserves accounts. The latter change is expected to increase interest 
earnings on reserve accounts from 2 percent currently earned to 6 
percent, with 25 percent of the earnings becoming eligible to be taken 
out of the accounts for owners to pay taxes and the rest remaining for 
improvements.


Government costs for rental assistance payments would increase by at 
least $23 million annually, and those for section 8 project-based 
assistance would increase by about $4 million annually.


Tenants of an estimated 79,500 units, about half the 159,000 units that 
do not receive rental assistance payments or similar assistance from 
HUD, would have to pay higher rents of about 5 percent. This amounts to 
an annual cost of about $14 million for these tenants. Most of these 
tenants are expected to remain in the projects because rents would 
remain competitive.

[[Page 74079]]

Increasing the reserve requirements would provide additional funds for 
improving projects. However, the full impact of this change is not 
expected to be reached until 10 years after it is implemented. Thus, 
projects that are in need of immediate rehabilitation will likely 
remain short of adequate funds for making needed improvements in the 
near term. Only a substantial increase in funding for rehabilitation 
loans would help resolve this problem.


Allowing project improvement needs to be considered in RHS' servicing 
actions could result in increased write-downs of the $12 billion MFH 
portfolio. This potential impact cannot be easily estimated.


Project owners who have or soon will meet the 20-year restriction on 
the use of their projects for low-income housing will have a clearer 
picture of RHS' policies in trying to maintain these projects in the 
program. In particular, establishment of a 15-month limit on waiting 
for incentives to be offered to them to stay in a program should help 
them make decisions on either staying in the program or prepaying their 
loans and possibly converting the projects to other uses.


Risks:


The risk associated with this regulatory initiative is that some 
program participants may be faced with increased replacement reserve 
requirements without sufficient cashflow in the property to make the 
deposits. The Agency believes that the need to adequately address 
project physical replacement needs offsets this risk. The Agency also 
believes that for the three-quarters of the properties that have deep 
tenant subsidies, this impact will be mitigated as rents can be 
increased in those situations without impacting the affordability of 
the units to eligible program beneficiaries.


The primary risk to the Agency is if the proposed rule is not 
implemented. Without the streamlining, program improvements and focus 
on current industry practices, including the increased use of third-
party funds to rehabilitate program properties that are included in the 
regulation, the underlying assets for the loans and grants made under 
the programs will deteriorate as the properties age. This will cause a 
decrease in the ability of the Agency to provide safe, decent, and 
sanitary housing to program beneficiaries.


The loans made to recipients will become undersecured as the 
properties' values decrease. Lastly, there will be a greater propensity 
of borrowers to elect to either default on their loans or to pay off 
loans and remove their properties from the stock of affordable housing.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           12/00/02
NPRM Comment Period End                                        02/00/03
Regulatory Flexibility Analysis Required:


No


Government Levels Affected:


None


Agency Contact:
Patrick Sheridan
Assistant Deputy Administrator, Multi-Family Housing
Department of Agriculture
Rural Housing Service
Room 1263/Stop 0782
1400 Independence Avenue SW
Washington, DC 20250
Phone: 202 720-1609
Email: [email protected]
RIN: 0575-AC13
_______________________________________________________________________



USDA--Food and Nutrition Service (FNS)

                              -----------

                          PROPOSED RULE STAGE

                              -----------




7. 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 74080]]

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                                                           12/00/02
NPRM Comment Period End                                        04/00/03
Final Action                                                   01/00/04
Final Action Effective                                         03/00/04
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
3101 Park Center Drive
Room 308
Alexandria, VA 22302
Phone: 703 305-2246
Fax: 703 605-0220
Email: [email protected]
RIN: 0584-AC90
_______________________________________________________________________



USDA--FNS



8. FOOD STAMP PROGRAM: SIMPLIFICATION AND STATE FLEXIBILITY
Priority:


Economically Significant. Major under 5 USC 801.


Legal Authority:


7 USC 2011 to 2036


CFR Citation:


7 CFR 272; 7 CFR 273


Legal Deadline:


None


Abstract:


This action will 1) propose to streamline the regulations by removing 
unnecessary or redundant provisions and reorganizing several sections; 
2) propose to increase State flexibility by moving overly prescriptive 
regulations; 3) re-propose several provisions that were proposed in a 
previous rule, the Noncitizen Eligibility Certification Provisions 
(NECP) of Public Law 104-193, as amended by Public Laws 104-208, 105-
33, and 105-185, published on February 29, 2000, but were not accepted 
in the final NECP rule published on November 21, 2001; 4) propose to 
remove or revise several provisions that were finalized in the NECP 
final rule; and 5) propose to incorporate current policy from the Food 
Stamp Program's Policy Interpretation Response System (PIRS). (01-018)


Statement of Need:


This rule is discretionary in nature. However, it simplifies the food 
stamp regulations and allows State flexibility in administering the 
program.


Summary of Legal Basis:


The legal basis for this rule is Public Law 104-193, as amended by 
Public Laws 104-208, 105-33, and 105-185.


Alternatives:


This rule is discretionary in nature; therefore it is not mandatory 
that we publish it.


Anticipated Cost and Benefits:


Undetermined


Risks:


The FSP provides nutrition assistance to millions of Americans 
nationwide--working families, eligible non-citizens, and elderly and 
disabled individuals. Many low-income families don't earn enough money 
and many elderly and disabled individuals don't receive enough in 
retirement or disability benefits to meet all of their expenses and 
purchase healthy and nutritious meals. The FSP serves a vital role in 
helping these families and individuals achieve and maintain self-
sufficiency and purchase a nutritious diet. This rule is intended to 
simplify the regulations and allow State flexibility in administering 
the program, thus decreasing barriers to access benefits.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

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


No


Small Entities Affected:


No


Government Levels Affected:


State, Local, Tribal, Federal


Federalism:


 Undetermined


URL For Public Comments:
http://www.fns.usda.gov/fsp/
Agency Contact:
Sharon Ackerman
Agency Regulatory Officer
Department of Agriculture
Food and Nutrition Service
3101 Park Center Drive
Room 308
Alexandria, VA 22302
Phone: 703 305-2246
Fax: 703 605-0220
Email: [email protected]
RIN: 0584-AD22

[[Page 74081]]

_______________________________________________________________________



USDA--FNS



9. [bull] FSP: HIGH PERFORMANCE BONUSES
Priority:


Economically Significant. Major under 5 USC 801.


Legal Authority:


PL 107-171


CFR Citation:


7 CFR 272; 7 CFR 275


Legal Deadline:


None


Abstract:


This action will propose implementation of the high performance bonuses 
as provided for in the Farm Security and Rural Investment Act of 2002 
for States that demonstrate high or improved performance in 
administration of the Food Stamp Program. This action will propose the 
measurement criteria for fiscal year 2005 and beyond. (02-006)


Statement of Need:


This rule is mandated by Public Law 107-171 to codify the performance 
measures used to award high performance bonuses for fiscal years 2005 
and beyond.


Summary of Legal Basis:


The legal basis for this rule is Public Law 107-171.


Alternatives:


This rule is mandated by law. Therefore, there are no alternatives.


Anticipated Cost and Benefits:


Undetermined


Risks:


The law mandates that we codify the performance measures for the high 
performance bonuses for FY 2005 and beyond. If we did not publish this 
proposed rule, we would be unable to publish a final rule, thus making 
us out of compliance with a legislative mandate.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           08/00/03
NPRM Comment Period End                                        10/00/03
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


State, Local, Tribal, Federal


Federalism:


 Undetermined


URL For More Information:
http://www.fns.usda.gov/fsp
Agency Contact:
Sharon Ackerman
Agency Regulatory Officer
Department of Agriculture
Food and Nutrition Service
3101 Park Center Drive
Room 308
Alexandria, VA 22302
Phone: 703 305-2246
Fax: 703 605-0220
Email: [email protected]
RIN: 0584-AD29
_______________________________________________________________________



USDA--FNS



10. [bull] FSP: ELIGIBILITY AND CERTIFICATION PROVISIONS OF THE FARM 
SECURITY AND RURAL INVESTMENT ACT OF 2002
Priority:


Economically Significant. Major under 5 USC 801.


Legal Authority:


PL 107-171, secs 4101 to 4109, 4114, 4115, and 4401


CFR Citation:


7 CFR 273


Legal Deadline:


None


Abstract:


This proposed rule will amend Food Stamp Program regulations to 
implement the food stamp eligibility and certification provisions of 
Public Law 107-171, the Farm Security and Rural Investment Act of 2002. 
The rule allows States, at their option, to treat legally obligated 
child support payments to a non-household member as an income exclusion 
rather than a deduction (as provided in current law); allows a State 
option to exclude certain types of income that are not counted under 
the State's Temporary Assistance for Needy Families (TANF) cash 
assistance or Medicaid programs; replaces the current, fixed standard 
deduction with a deduction that varies according to household size and 
is adjusted annually for cost-of-living increases; allows States to 
simplify the Standard Utility Allowance (SUA) if the States elect to 
use the SUA rather than actual utility costs for all households; allows 
States to use a standard deduction from income of $143 per month for 
homeless households with some shelter expenses; allows States to 
disregard reported changes in deductions during certification periods 
except for changes associated with a new residence or earned income 
until the next recertification; increases the resource limit for 
households with a disabled member from $2,000 to $3,000 consistent with 
the limit for households with an elderly member; allows States to 
exclude certain types of resources that the State does not count for 
TANF or Medicaid (section 1931); allows USDA to approve alternate 
methods for issuing food stamp benefits during disasters when reliance 
on electronic benefit transfer systems (EBT) is impracticable; allows 
States to extend semiannual reporting of changes to all households not 
exempt from periodic reporting; requires State agencies that have a 
website to post applications on these sites in the same languages that 
the State uses for its written applications; allows States to extend 
from the current 3 months up to 5 months the period of time households 
may receive transitional food stamp benefits when they lose TANF cash 
assistance; and restores food stamp eligibility to qualified aliens who 
are otherwise eligible AND who (1) are receiving disability benefits 
regardless of date of entry (current law requires them to have been in 
the country on 8/22/96)--effective FY 2003, (2) are under 18 regardless 
of date of entry (current law limits eligibility to children who were 
in the country on 8/22/96)--effective FY 2004 and beyond, or (3) have 
lived in the U.S. continuously for 5 years as a qualified alien 
beginning on date of entry--effective April 2003. (02-007)


Statement of Need:


The rule is needed to implement the food stamp certification and 
eligibility provisions of Public Law 107-171, the Farm Security and 
Rural Investment Act of 2002.


Summary of Legal Basis:


The legal basis for this rule is Public Law 107-171, the Farm Security 
and Rural Investment Act of 2002.


Alternatives:


This proposed rule deals with changes required by Public Law 107-171, 
the Farm Security and Rural Investment Act of 2002. The Department has 
limited discretion in implementing

[[Page 74082]]

provisions of that law. Most of the provisions in this rule are 
effective October 1, 2002, and must be implemented by State agencies 
prior to publication of this rule.


Anticipated Cost and Benefits:


The provisions of this rule will simplify State administration of the 
Food Stamp Program, increase eligibility for the program among certain 
groups, increase access to the program among low-income families and 
individuals, and increase benefit levels. The provisions of Public Law 
107-171 implemented by this rule will have a 5-year cost of 
approximately $1.9 billion.


Risks:


The FSP provides nutrition assistance to millions of Americans 
nationwide--working families, eligible non-citizens, and elderly and 
disabled individuals. Many low-income families don't earn enough money 
and many elderly and disabled individuals don't receive enough in 
retirement or disability benefits to meet all of their expenses and 
purchase healthy and nutritious meals. The FSP serves a vital role in 
helping these families and individuals achieve and maintain self-
sufficiency and purchase a nutritious diet. This rule is intended to 
implement the certification and eligibility provisions of Public Law 
107-171, the Farm Security and Rural Investment Act of 2002. It will 
simplify State administration of the Food Stamp Program, increase 
eligibility for the program among certain groups, increase access to 
the program among low-income families and individuals, and increase 
benefit levels. The provisions of this rule will increase benefits by 
approximately $1.95 billion over 5 years. When fully effective in FY 
2006, the provisions of this rule will add approximately 415,000 new 
participants.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           09/00/03
NPRM Comment Period End                                        11/00/03
Final Action                                                   12/00/04
Final Action Effective                                         02/00/05
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


State, Local, Tribal, Federal


Federalism:


 Undetermined


URL For Public Comments:
http://www.fns.usda.gov/fsp/
Agency Contact:
Sharon Ackerman
Agency Regulatory Officer
Department of Agriculture
Food and Nutrition Service
3101 Park Center Drive
Room 308
Alexandria, VA 22302
Phone: 703 305-2246
Fax: 703 605-0220
Email: [email protected]
RIN: 0584-AD30
_______________________________________________________________________



USDA--FNS



11. [bull] FSP: QUALITY CONTROL PROVISIONS OF THE FARM SECURITY AND 
RURAL INVESTMENT ACT OF 2002
Priority:


Other Significant


Legal Authority:


7 USC 2011 to 2032; PL 107-171


CFR Citation:


7 CFR 273; 7 CFR 275


Legal Deadline:


None


Abstract:


This proposed rule will implement quality control changes to the Food 
Stamp Act required by sections 4118 and 4119 of the Farm Security and 
Rural Investment Act of 2002 in the following areas: 1) Timeframes for 
completing quality control reviews; 2) timeframes for completing the 
arbitration process; 3) timeframes for determining final error rates; 
4) the threshold for potential sanctions and time period for sanctions; 
5) the calculation of State error rates; 6) the formula for determining 
States' liability amounts; 7) sanction notification and method of 
payment; and 8) corrective action plans. (02-008)


Statement of Need:


The rule is needed to implement the food stamp quality control 
provisions of Public Law 107-171, the Farm Security and Rural 
Investment Act of 2002.


Summary of Legal Basis:


The legal basis for this rule is Public Law 107-171, the Farm Security 
and Rural Investment Act of 2002.


Alternatives:


This proposed rule deals with changes required by Public Law 107-171, 
the Farm Security and Rural Investment Act of 2002. The Department has 
limited discretion in implementing provisions of that law. The 
provisions in this rule are effective for fiscal year 2002 quality 
control review period and must be implemented by FNS and State agencies 
during fiscal year 2002.


Anticipated Cost and Benefits:


The provisions of this rule will eliminate enhanced funding for low 
payment error rates and revise the quality control sanction and 
liability requirements. The provisions of Public Law 107-171 
implemented by this rule will save $190 million over 5 years through 
elimination of the current enhanced funding system. This savings will 
be partially offset by costs of implementing a new performance system. 
The costs for the new performance system are estimated to be $144 
million.


Risks:


The FSP provides nutrition assistance to millions of Americans 
nationwide. The quality control system measures the accuracy of States 
providing food stamp benefits to the program recipients. This rule is 
intended to implement the quality control provisions of Public Law 107-
701, the Farm Security and Rural Investment Act of 2002. The provisions 
of this rule will eliminate enhanced funding for low payment error 
rates. It will significantly revise the system for determining State 
agency liabilities and sanctions for high payment error rates.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

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


No


Government Levels Affected:


State, Local, Federal


Federalism:


 Undetermined

[[Page 74083]]

Agency Contact:
Sharon Ackerman
Agency Regulatory Officer
Department of Agriculture
Food and Nutrition Service
3101 Park Center Drive
Room 308
Alexandria, VA 22302
Phone: 703 305-2246
Fax: 703 605-0220
Email: [email protected]
RIN: 0584-AD31
_______________________________________________________________________



USDA--FNS



12. [bull] FSP: EMPLOYMENT AND TRAINING PROGRAM PROVISIONS OF THE FARM 
SECURITY AND RURAL INVESTMENT ACT OF 2002
Priority:


Economically Significant. Major under 5 USC 801.


Legal Authority:


PL 107-171


CFR Citation:


7 CFR 273.7


Legal Deadline:


None


Abstract:


This proposed rule will implement revisions to the Food Stamp 
Employment and Training (E&T) Program funding requirements. (02-009)


Statement of Need:


This rule is necessary to implement statutory revisions to E&T Program 
funding provisions.


Summary of Legal Basis:


All provisions of this proposed rule are mandated by Public Law 107-
171.


Alternatives:


The alternative is not to revise current funding rules. This is not 
practical. The current rules have been superseded by changes brought 
about by Public Law 107-171. These changes were effective on May 13, 
2002, the date of enactment of Public Law 107-171.


Anticipated Cost and Benefits:


None.


Risks:


None.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           09/00/03
NPRM Comment Period End                                        11/00/03
Final Action                                                   12/00/04
Final Action Effective                                         02/00/05
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


State, Local, Federal


Agency Contact:
Sharon Ackerman
Agency Regulatory Officer
Department of Agriculture
Food and Nutrition Service
3101 Park Center Drive
Room 308
Alexandria, VA 22302
Phone: 703 305-2246
Fax: 703 605-0220
Email: [email protected]
RIN: 0584-AD32
_______________________________________________________________________



USDA--FNS

                              -----------

                            FINAL RULE STAGE

                              -----------




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


Other Significant


Legal Authority:


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


CFR Citation:


7 CFR 226


Legal Deadline:


None


Abstract:


This rule amends the Child and Adult Care Food Program (CACFP) 
regulations. The changes in this rule result from the findings of State 
and Federal program reviews and from audits and investigations 
conducted by the Office of Inspector General. This rule will revise: 
State agency criteria for approving and renewing institution 
applications; program training and other operating requirements for 
child care institutions and facilities; and State- and institution-
level monitoring requirements. This rule also includes changes that are 
required by the Healthy Meals for Healthy Americans Act of 1994 (Pub. 
L. 103-448), the Personal Responsibility and Work Opportunities 
Reconciliation Act of 1996 (Pub. L. 104-193), and the William F. 
Goodling Child Nutrition Reauthorization Act of 1998 (Pub. L. 105-336).


The changes are designed to improve program operations and monitoring 
at the State and institution levels and, where possible, to streamline 
and simplify program requirements for State agencies and institutions. 
(95-024)


Statement of Need:


In recent years, State and Federal program reviews have found numerous 
cases of mismanagement, abuse, and in some instances, fraud by child 
care institutions and facilities in the CACFP. These reviews revealed 
weaknesses in management controls over program operations and examples 
of regulatory noncompliance by institutions, including failure to pay 
facilities or failure to pay them in a timely manner; improper use of 
program funds for non-program expenditures; and improper meal 
reimbursements due to incorrect meal counts or to 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), and the William F. Goodling Child Nutrition 
Reauthorization Act of 1998 (Pub. L. 105-336).


Alternatives:


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

[[Page 74084]]

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                                             06/00/03
Interim Final Rule Effective                                   07/00/03
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


State, Local


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
3101 Park Center Drive
Room 308
Alexandria, VA 22302
Phone: 703 305-2246
Fax: 703 605-0220
Email: [email protected]
RIN: 0584-AC24
_______________________________________________________________________



USDA--Food Safety and Inspection Service (FSIS)

                              -----------

                          PROPOSED RULE STAGE

                              -----------




14. 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


Abstract:


FSIS is proposing to revise the regulatory provisions concerning the 
production and testing of pumped bacon (9 CFR 424.22(b)). FSIS is 
proposing to remove provisions that prescribe the substances and 
amounts of such substances that must be used to produce pumped bacon. 
FSIS is proposing to replace these provisions with an upper limit for 
nitrite and a performance standard that establishments producing pumped 
bacon must meet. To meet the proposed performance standard, the process 
used would be required to limit the presence of nitrosamines when the 
product is cooked.


Statement of Need:


FSIS is proposing to replace restrictive provisions concerning the 
processing of pumped bacon with an upper limit for nitrite and a 
performance standard. The proposed performance standard concerns 
limiting the presence of volatile nitrosamines in pumped bacon. These 
proposed changes are necessary to make the regulations concerning 
pumped bacon 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 they are carcinogenic, and though 
not added directly to pumped bacon, they may be produced when the 
pumped bacon is fried. Processors can control the levels of 
nitrosamines that may be present when the product is fried by 
controlling the levels of ingoing nitrite and of ingoing curing 
accelerators that are used in the production of pumped bacon. In 1978, 
USDA stated that nitrosamines present at confirmable levels in pumped 
bacon after preparation for eating were deemed to adulterate the 
product. FSIS still maintains that pumped bacon with confirmable levels 
of nitrosamines after preparation for eating is adulterated. Under this 
proposed rule, processors meeting the performance standard would 
control the levels of nitrosamines in the finished product by complying 
with a performance standard.


Alternatives:


No action; performance standards for all types of bacon (not just 
pumped bacon, as proposed).


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 pumped bacon, FSIS does not anticipate that 
this proposed rule would result in any significant costs or benefits. 
Pumped 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

[[Page 74085]]

processors who develop cheaper means of producing product or who 
develop a product with wide consumer appeal.


Risks:


None.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           12/00/02
Regulatory Flexibility Analysis Required:


No


Government Levels Affected:


None


Agency Contact:
Dr. Daniel L. Engeljohn
Director, Regulations and Directives Development Staff
Department of Agriculture
Food Safety and Inspection Service
Room 112 Cotton Annex Building
1400 Independence Avenue SW
Washington, DC 20250
Phone: 202 720-5627
Fax: 202 690-0486
Email: [email protected]
RIN: 0583-AC49
_______________________________________________________________________



USDA--FSIS



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


Statement of Need:


FSIS is proposing to require shell egg packers and egg products plants 
to develop and implement HACCP systems and sanitation SOPs. FSIS also 
is proposing pathogen reduction performance standards that would be 
applicable to pasteurized eggs and egg products. Plants would be 
expected to develop HACCP systems that ensure that these products meet 
the lethality required by the pathogen reduction performance standards. 
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 plants. Finally, the Agency 
plans to eliminate the pre-marketing label approval system for egg 
products but to require safe-handling labels on all shell eggs.


The actions being proposed are part of FSIS' regulatory reform effort 
to improve FSIS' 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' 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 of several 
alternatives on the public, the shell egg and egg products industry, 
and FSIS. These alternatives include: (1) Taking no regulatory action; 
(2) requiring all inspected egg products plants to develop, adopt, and 
implement written sanitation SOPs and HACCP plans; and (3) converting 
to a lethality-based pathogen reduction performance standard many of 
the current highly prescriptive egg products processing requirements. 
The team will consider the effects of 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, FSIS and other Federal agencies, State and local governments, 
small entities, and foreign countries. The expected costs to industry 
will depend on a number of factors. These costs include the required 
lethality, or level of pathogen reduction, and the cost of HACCP plan 
and sanitation SOP development, implementation, and associated employee 
training. The pathogen reduction costs will depend on the amount of 
reduction sought and in what classes of product, product formulations, 
or processes.


Relative enforcement costs to FSIS and Food and Drug Administration may 
change because the two agencies share responsibility for inspection and 
oversight of the egg industry and a common farm-to-table approach for 
shell egg and egg products food safety. Other Federal agencies and 
local

[[Page 74086]]

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 products plants, 
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.


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 intra-Agency group of scientific and technical experts 
is conducting a risk management analysis. The group has been charged 
with identifying the lethality requirement sufficient to ensure the 
safety of egg products and the alternative methods for implementing the 
requirement. 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.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           06/00/03
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses, Governmental Jurisdictions


Government Levels Affected:


Federal, State


Federalism:


 Undetermined


Agency Contact:
Dr. Daniel L. Engeljohn
Director, Regulations and Directives Development Staff
Department of Agriculture
Food Safety and Inspection Service
Room 112 Cotton Annex Building
1400 Independence Avenue SW
Washington, DC 20250
Phone: 202 720-5627
Fax: 202 690-0486
Email: [email protected]
RIN: 0583-AC58
_______________________________________________________________________



USDA--FSIS



16. 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


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 
(PR/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 are inconsistent with the PR/HACCP regulations, the retained 
water regulations, and the meat inspection regulations.


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

[[Page 74087]]

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                                                           06/00/03
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


Businesses


Government Levels Affected:


None


Agency Contact:
Dr. Daniel L. Engeljohn
Director, Regulations and Directives Development Staff
Department of Agriculture
Food Safety and Inspection Service
Room 112 Cotton Annex Building
1400 Independence Avenue SW
Washington, DC 20250
Phone: 202 720-5627
Fax: 202 690-0486
Email: [email protected]
RIN: 0583-AC87
_______________________________________________________________________



USDA--FSIS



17. 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. FSIS may 
also propose to issue certain regulations in the absence of BSE as 
preventive measures. 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 if, and when, 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 185,000 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 if, and when, 
BSE is detected in native cattle. The proposed regulations would: (1) 
Prohibit certain materials that have been shown to contain the BSE 
agent in BSE-infected cattle to be used for human food or in the 
production of human food; (2) prescribe handling, storage, and 
transportation requirements for such materials; (3) prohibit slaughter 
procedures that may cause potentially infective tissues to migrate to 
edible tissues; (4) impose restrictions on the use of the vertebral 
column as a source material in the production of meat produced using 
advanced meat recovery systems (AMRS) and in the production of 
``Mechanically Separated (Beef)'' (MS(Beef)) meat food product; (5) 
prescribe requirements for the slaughtering and processing of cattle 
whose materials are most likely to contain the BSE agent if the animal 
is infected with BSE; and (6) prescribe requirements for the sanitation 
or disposal of plant equipment that may be contaminated with the BSE 
agent. 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.

[[Page 74088]]

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:


If issued as a final rule, this proposal would result in costs to the 
regulated industry. FSIS expects to minimize the costs by targeting the 
regulations to apply to those cattle whose materials are most likely to 
contain the BSE agent if the animal is infected with BSE. Banning 
certain materials, such as brain and spinal cord, for use as human food 
may require additional staff and time to remove such materials. 
Materials prohibited for use as human food could not be sold 
domestically or exported. Companies may be required to find new ways to 
handle and dispose of these materials, which would impose additional 
costs. Prohibiting the use of bovine vertebral column as a source 
material in AMRS and systems used to produce MS (Beef) product could 
result in a decrease in product yield and may require companies that 
use these systems to produce boneless beef and beef products to find 
other uses for bovine vertebral column. Establishments whose equipment 
may have been contaminated with the BSE agent may have costs associated 
with sanitation or disposal of plant equipment.


FSIS may incur costs to increase inspection and compliance activities 
to ensure that the measures taken to prevent meat and meat food 
products that may contain the BSE agent from entering commerce are 
effective. Producers may receive lower prices from processors, and some 
of their stock may be condemned outright. The price consumers pay for 
meat may rise or fall depending on how the discovery of BSE in the U.S. 
would affect consumer demand for beef.


The main benefit of this proposed rule is the prevention of vCJD in the 
United States. There have been over 100 definite and probable cases of 
vCJD detected worldwide since the disease was first identified in 1986 
in the United Kingdom. While vCJD is still considered a rare condition, 
the extent or occurrence of a vCJD epidemic in the United Kingdom 
cannot be determined because of the long incubation period (up to 25 
years). Thus, if issued as a final rule, this proposal could have 
widespread public health benefits if it serves to prevent a vCJD 
epidemic from developing in the U.S. Even if vCJD remains a rare 
condition, this proposed rule will still have public health benefits 
because of the severity of the symptoms associated with vCJD and the 
fact that vCJD is always fatal.


This proposed rule may benefit the meat industry by helping to restore 
confidence in the domestic meat supply when, and if, a native case of 
BSE is detected in the U.S. This may limit losses to meat slaughter and 
processing operations in the long run.


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                                                           09/00/03
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses


Government Levels Affected:


Undetermined


Federalism:


 Undetermined


Agency Contact:
Dr. Daniel L. Engeljohn
Director, Regulations and Directives Development Staff
Department of Agriculture
Food Safety and Inspection Service
Room 112 Cotton Annex Building
1400 Independence Avenue SW
Washington, DC 20250
Phone: 202 720-5627
Fax: 202 690-0486
Email: [email protected]
RIN: 0583-AC88
_______________________________________________________________________



USDA--FSIS

                              -----------

                            FINAL RULE STAGE

                              -----------




18. PERFORMANCE STANDARDS FOR READY-TO-EAT MEAT AND POULTRY PRODUCTS
Priority:


Economically Significant


Unfunded Mandates:


Undetermined

[[Page 74089]]

Legal Authority:


21 USC 451 et seq; 21 USC 601 et seq


CFR Citation:


9 CFR 317; 9 CFR 381; 9 CFR 430


Legal Deadline:


None


Abstract:


FSIS has proposed to establish pathogen reduction performance standards 
for all ready-to-eat and partially heat-treated meat and poultry 
products. The performance standards spell out the objective level of 
pathogen reduction that establishments must meet during their 
operations in order to produce safe products but allow the use of 
customized, plant-specific processing procedures other than those 
prescribed in the earlier regulations. Along with HACCP, food safety 
performance standards will give establishments the incentive and 
flexibility to adopt innovative, science-based food safety processing 
procedures and controls, while providing objective, measurable 
standards that can be verified by Agency inspectional oversight. This 
set of performance standards will include and be consistent with those 
already in place for certain ready-to-eat meat and poultry products. 
FSIS also proposed testing requirements intended to reduce the 
incidence of Listeria in ready-to-eat meat and poultry products.


Statement of Need:


The Food Safety and Inspection Service (FSIS) has proposed to amend the 
Federal meat and poultry inspection regulations by establishing food 
safety performance standards for all ready-to-eat and all partially 
heat-treated meat and poultry products. The proposed performance 
standards set forth both levels of pathogen reduction and limits on 
pathogen growth that official meat and poultry establishments must 
achieve during their operations in order to produce unadulterated 
products but allow the use of customized, plant-specific processing 
procedures. The proposed performance standards apply to ready-to-eat 
meat and poultry products, categorized as follows: Dried products 
(e.g., beef or poultry jerky); salt-cured products (e.g. country ham); 
fermented products (e.g., salami and Lebanon bologna); cooked and 
otherwise processed products (e.g., beef and chicken burritos, corned 
beef, pastrami, poultry rolls, and turkey franks); and thermally-
processed, commercially sterile products (e.g., canned spaghetti with 
meat balls and canned corned beef hash).


Although FSIS routinely samples and tests some ready-to-eat products 
for the presence of pathogens prior to distribution, there are no 
specific regulatory pathogen reduction requirements for most of these 
products. The proposed performance standards will help ensure the 
safety of these products; give establishments the incentive and 
flexibility to adopt innovative, science-based food safety processing 
procedures and controls; and provide objective, measurable standards 
that can be verified by Agency oversight.


FSIS also proposed requirements intended to reduce the incidence of 
Listeria in ready-to-eat meat and poultry products. First, FSIS 
proposed to require establishments that produce ready-to-eat meat and 
poultry products to conduct environmental testing for Listeria to 
verify that they are controlling the presence of L. monocytogenes 
within their processing environments. Establishments that have 
developed and implemented HACCP controls for L. monocytogenes would be 
exempt from these testing requirements.


FSIS also has proposed to eliminate its regulations that require that 
both ready-to-eat and not-ready-to-eat pork and products containing 
pork be treated to destroy trichinae (Trichinella spiralis). These 
requirements are inconsistent with HACCP, and some will be unnecessary 
if FSIS makes final the proposed performance standards for ready-to-eat 
meat and poultry products.


Summary of Legal Basis:


Under the Federal Meat Inspection Act (21 U.S.C 601-695) and the 
Poultry Product Inspection Act (21 U.S.C 451-470) FSIS issues 
regulations governing the production of meat and poultry products 
prepared for distribution in commerce. The regulations, along with FSIS 
inspection programs, are designed to ensure that meat and poultry 
products are safe, not adulterated, and properly marked, labeled, and 
packaged.


Alternatives:


As an alternative to all of the proposed requirements, FSIS considered 
taking no action. As alternatives to the proposed requirements for 
Listeria testing, FSIS considered: End-product testing; mandatory post-
lethality interventions for L. monocytogenes; mandatory food-contact 
surface testing for all establishments that produce read-to-eat 
products; redesignation of hotdogs and other ready-to-eat products as 
not-ready-to-eat; and requiring ``use-by'' date labeling on certain 
ready-to-eat products.


Anticipated Cost and Benefits:


If the proposed regulations could achieve a complete elimination of 
listeriosis that results from the consumption of contaminated RTE meat 
and poultry products, the expected annual reduction in listeriosis 
cases and deaths would range from 1,660 cases and 331 deaths (based on 
the draft FDA-FSIS risk assessment and on 100 percent program 
effectiveness) to 167 cases and 35 deaths (based on two independent CDC 
studies and on 100 percent program effectiveness). FSIS is uncertain 
about the effectiveness of its proposed testing requirements in 
reducing listeriosis and therefore unable to adequately quantify a 
range of benefits. FSIS intends to use comments and data received 
during the comment period and at the planned technical conference to 
refine the proposed regulations and to better estimate benefits. It is 
of course unlikely that the proposed regulations could achieve complete 
elimination of the listeriosis that results from contaminated meat and 
poultry, but FSIS believes that the benefits of the regulations would 
exceed the total costs of all of the proposed provisions.


The two main provisions of the proposed rule are: (1) Mandatory in-
plant testing for Listeria and (2) Salmonella and E. coli performance 
standards firms must employ as measures of process control. Much of the 
costs of these actions are associated with first-year, one-time 
validation pertaining to the achievement of the performance standards 
and with the incorporation of new information into plants' HACCP plans. 
These initial costs are projected at over $6.5 million, while annual 
recurring costs are estimated at $6.2 million. Benefits are expected to 
result from less contaminated product entering commercial channels due 
to increased sanitation efforts and in-plant verification through 
testing.


Risks:


None.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            66 FR 12590                                    02/27/01
NPRM Comment Period End                                        05/29/01
NPRM Comment Per66 FR 35112d                                   07/03/01

[[Page 74090]]

NPRM Comment Period End                                        09/10/01
Final Action                                                   06/00/03
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses


Government Levels Affected:


Undetermined


Agency Contact:
Dr. Daniel L. Engeljohn
Director, Regulations and Directives Development Staff
Department of Agriculture
Food Safety and Inspection Service
Room 112 Cotton Annex Building
1400 Independence Avenue SW
Washington, DC 20250
Phone: 202 720-5627
Fax: 202 690-0486
Email: [email protected]
RIN: 0583-AC46
_______________________________________________________________________



USDA--FSIS



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


Other Significant


Legal Authority:


21 USC 601 to 695


CFR Citation:


9 CFR 301.2; 9 CFR 318.24 (Revision); 9 CFR 320.1(b)(10)


Legal Deadline:


None


Abstract:


In 1994, the Food Safety and Inspection Service (FSIS) amended its 
regulations to recognize that products 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 1995. The rule would replace the present compliance program 
parameters with non-compliance criteria for bone and bone-related 
material. The rule would require, as a prerequisite to labeling or 
using product derived by mechanically separating skeletal muscle tissue 
from cattle and swine bones as meat, that establishments implement and 
document procedures for ensuring that their production process is in 
control. The proposed rule was published in 1998.


FSIS intends to implement more rigid measures for central nervous 
system tissue and prohibiting the use of vertebral columns in the AMR 
final product unless the establishment can demonstrate effective 
process control to ensure that no spinal cord and dorsal root ganglia 
will be present in the final AMR product. Current FSIS policy prohibits 
the presence of spinal cord in AMR products but not the presence of DRG 
or the use of vertebral columns. In January 2002, FSIS began the first 
of two surveys on AMR products derived from non-vertebral and vertebral 
beef and pork columns.


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 enforcing the misbranding 
provisions will ensure that the product does not contain materials not 
consistent with boneless, comminuted meat.


Risks:


None.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            63 FR 17959                                    04/13/98
NPRM Comment Period End                                        06/12/98
Final Action                                                   09/00/03
Regulatory Flexibility Analysis Required:


Undetermined


Government Levels Affected:


None


Agency Contact:
Dr. Daniel L. Engeljohn
Director, Regulations and Directives Development Staff
Department of Agriculture
Food Safety and Inspection Service
Room 112 Cotton Annex Building
1400 Independence Avenue SW
Washington, DC 20250
Phone: 202 720-5627
Fax: 202 690-0486
Email: [email protected]
RIN: 0583-AC51
_______________________________________________________________________



USDA--FSIS



20. NUTRITION LABELING OF GROUND OR CHOPPED MEAT AND POULTRY PRODUCTS 
AND SINGLE-INGREDIENT PRODUCTS
Priority:


Other Significant


Legal Authority:


21 USC 601 et seq; 21 USC 451 et seq


CFR Citation:


9 CFR 317; 9 CFR 381


Legal Deadline:


None


Abstract:


FSIS has proposed to amend the Federal meat and poultry products 
inspection regulations to require that nutrition information be 
provided for the major cuts of single-ingredient, raw meat and poultry 
products, either on their label or at their point-of-purchase. FSIS 
proposed to require nutrition labeling of the major cuts of single-
ingredient, raw meat and poultry products because, during the most 
recent surveys of retailers, the Agency did not find significant 
participation in the voluntary nutrition labeling program for single-
ingredient, raw meat and poultry products.


In this rule, FSIS also proposed to amend its regulations to extend 
mandatory labeling to single-ingredient ground or chopped products. 
Under this proposal, individual retail packages of ground or chopped 
meat and ground or chopped poultry products would bear nutrition 
labeling. The Agency has determined that ground or chopped products are 
different from other single-

[[Page 74091]]

ingredient products in several important respects. Thus, FSIS proposed 
to make nutrition labeling requirements for ground or chopped products 
consistent with those for multi-ingredient products.


Finally, FSIS has proposed to amend the nutrition labeling regulations 
to provide that, when a ground or chopped product does not meet the 
criteria to be labeled ``low fat,'' a lean percentage claim may be 
included on the product label or in labeling as long as a statement of 
the fat percentage also is displayed on the label or in labeling.


Statement of Need:


The Agency has proposed to require that nutrition information be 
provided for the major cuts of single-ingredient, raw meat and poultry 
products, either on their label or at their point-of-purchase, because 
during the most recent surveys of retailers, the Agency did not find 
significant participation in the voluntary nutrition labeling program 
for single-ingredient, raw meat and poultry products. Without the 
nutrition information for the major cuts of single-ingredient, raw meat 
and poultry products that would be provided if significant 
participation in the voluntary nutrition labeling program existed, FSIS 
believes that these products would be misbranded.


FSIS has also proposed to amend its regulations to require nutrition 
labels on the packages of all ground or chopped meat and poultry 
products. The Agency has determined that single-ingredient, ground or 
chopped products are different from other single-ingredient products in 
several important respects. Thus, FSIS has proposed to make nutrition 
labeling requirements for all ground or chopped products consistent 
with those for multi-ingredient products.


Finally, FSIS has proposed to amend the nutrition labeling regulations 
to provide that when a ground or chopped product does not meet the 
criteria to be labeled ``low fat,'' a lean percentage claim may be 
included on the product as long as a statement of the fat percentage is 
also displayed on the label or in labeling. FSIS proposed this 
provision because many consumers have become accustomed to this 
labeling on ground beef products and because FSIS believed this 
labeling provides a quick, simple, accurate means of comparing all 
ground or chopped meat and poultry products.


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; nutrition labels required on all single-ingredient, raw 
products (major cuts and non-major cuts) and all ground or chopped 
products; nutrition labels required on all major cuts of single-
ingredient, raw products (but not non-major cuts) and all ground or 
chopped products; nutrition information at the point-of-purchase 
required for all single-ingredient, raw products (major and non-major 
cuts) and for all ground or chopped products.


Anticipated Cost and Benefits:


Costs would include the equipment for making labels, labor, and 
materials used for labels for ground or chopped products. FSIS believes 
that the cost of providing nutrition labeling for the major cuts of 
single-ingredient, raw meat and poultry products should be negligible. 
Retail establishments would have the option of providing nutrition 
information through point-of-purchase materials. These materials are 
available for a nominal fee through the Food Marketing Institute. Also, 
FSIS intends to make point-of-purchase materials available, free of 
charge, on the FSIS web site.


Benefits of the nutrition labeling rule would result from consumers 
modifying their diets in response to new nutrition information 
concerning ground or chopped products and the major cuts of single-
ingredient, raw products. Reductions in consumption of fat and 
cholesterol are associated with reduced incidence of cancer and 
coronary heart disease.


Risks:


None.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            66 FR 4970                                     01/18/01
NPRM Comment Period End                                        04/18/01
Extension of Com66 FR 20213                                    04/20/01
NPRM Comment Period End                                        07/17/01
Final Action                                                   07/00/03
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses


Government Levels Affected:


None


Agency Contact:
Robert Post
Director, Labeling and Consumer Protection Staff
Department of Agriculture
Food Safety and Inspection Service
Washington, DC 20250
Phone: 202 205-0279
RIN: 0583-AC60
BILLING CODE 3410-90-S

[[Page 74092]]




DEPARTMENT OF COMMERCE (DOC)



Statement of Regulatory and Deregulatory Priorities
The mission of the Department of Commerce (Commerce) is to promote job 
creation, economic growth, technological competitiveness and 
sustainable development, and improved living standards for all 
Americans by working in partnership with business, universities, 
communities, and workers to:
[sbull] Build for the future and promote U.S. competitiveness in the 
            global marketplace by strengthening and safeguarding the 
            nation's economic infrastructure;
[sbull] Keep America competitive with cutting-edge science and 
            technology and an unrivaled information base; and
[sbull] Provide effective management and stewardship of our Nation's 
            resources and assets to ensure sustainable economic 
            opportunities.
The Commerce mission statement, containing our three strategic themes, 
provides the vehicle for understanding Commerce's aims, how they 
interlock, and how they are to be implemented through our programs. 
This statement was developed with the intent that it serve as both a 
statement of departmental philosophy and as the guiding force behind 
the Department's programs.
The importance that this mission statement and these strategic themes 
have for the Nation is amplified by the vision they pursue for 
America's communities, businesses, and families. Commerce is the 
smallest Cabinet agency, yet our presence is felt, and our 
contributions are found, in every State.
Commerce 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.
Commerce 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, national security, 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 needs of the Nation, according to the priorities of 
the President and the Congress. The President's priorities for Commerce 
range from issues concerning the economy, the environment, and national 
security. For example, the President directs Commerce to promote 
electronic commerce activities; encourage open and free trade; 
represent American business interests abroad; assist small businesses 
to expand and create jobs; and regulate the export of goods and 
technology that may compromise national security. 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.
Commerce promotes and expedites American exports, helps nurture 
business contacts abroad, protects U.S. firms from unfair foreign 
competition, and makes how-to-export information accessible to small 
and mid-sized companies throughout the Nation, thereby ensuring that 
U.S. market opportunities span the globe. Commerce completes these 
activities all the while preserving national security. For example, 
Commerce works to implement export controls on dual-use goods and 
technology to prevent the proliferation of weapons of mass destruction 
and to limit the U.S. transactions of terrorists and those who support 
them.
Commerce encourages development in every community, clearing the way 
for private-sector growth by building or 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, 
Commerce works as a partner with private entities to build America with 
an eye on the future. Through technology, research and development, and 
innovation, we are making sure America continues to prosper in the 
short term, while also helping industries prepare for long-term 
success.
Commerce's considerable information capacities help businesses 
understand clearly where our national and world economies are going, 
and take advantage of that knowledge by planning the road ahead. Armed 
with this information, businesses can undertake the new ventures, 
investments, and expansions that make our economy grow.
Commerce has instituted programs and policies that lead to cutting-
edge, competitive, and better paying jobs. We work every day to boost 
exports, to deregulate business, to help smaller manufacturers battle 
foreign competition, to advance the technologies critical to our future 
prosperity, to invest in our communities, and to fuse economic and 
environmental goals.
Commerce is American business' surest ally in job creation, serving as 
a vital resource base, a tireless advocate, and its Cabinet-level 
voice.
The Department's regulatory plan directly tracks these policy and 
program priorities, only a few of which involve regulation of the 
private sector by the Department.
Responding to the Administration's Regulatory Philosophy and Principles
The vast majority of Commerce's programs and activities do not involve 
regulation. Of Commerce's 12 primary operating units, only 2--the 
Bureau of Industry and Security (BIS) 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 
Commerce's ``significant regulatory actions'' planned for the 
Regulatory Plan year.

[[Page 74093]]

Though not principally a regulatory agency, Commerce 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 Commerce Department 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 down-sized, 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 Commerce's goal of 
promoting stewardship by providing assessments of the global 
environment.
Recognizing that economic growth must go hand-in-hand with 
environmental stewardship, Commerce, through NOAA, conducts programs 
designed to provide a better understanding of the connections between 
environmental health, economics, and national security. Commerce's 
emphasis on ``sustainable fisheries'' is saving fisheries and 
confronting short-term economic dislocation, while boosting long-term 
economic growth. Commerce is where business and environmental interests 
intersect, and the classic debate on the use of natural resource 
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 be guided by a comprehensive 
understanding of the environment. Commerce, through NOAA, has a unique 
role in promoting stewardship of the global environment through 
effective management of the Nation's marine and coastal resources and 
in monitoring and predicting changes in the Earth's environment, thus 
linking trade, development, and technology with environmental issues. 
NOAA has the primary Federal responsibility for providing sound 
scientific observations, assessments, and forecasts of environmental 
phenomena on which resource management 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) rulemaking concerns the conservation and management of 
fishery resources in the U.S. 3-to-200-mile Exclusive Economic Zone 
(EEZ). Among the several hundred rulemakings that NOAA plans to issue 
in the Regulatory Plan year, a number of the preregulatory and 
regulatory actions will be significant. The exact number of such 
rulemakings is unknown, since they are usually initiated by the actions 
of eight regional Fishery Management Council (FMCs) that are 
responsible for preparing fishery management plans (FMPs) and FMP 
amendments, and for drafting implementing regulations for each managed 
fishery. Once a rulemaking is triggered by an FMC, the Magnuson-Stevens 
Act places stringent deadlines upon NMFS by which it must exercise its 
rulemaking responsibilities. Most of these rulemakings will be minor, 
involving only the opening or closing of a fishery under an existing 
FMP. While no one Magnuson-Stevens Act rulemaking is among the 
Department's most important significant regulatory actions, and, 
therefore, none is specifically described below, the sum of these 
actions, and a few of the individual actions themselves, are highly 
significant.

[[Page 74094]]

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 Industry and Security
The Bureau of Industry and Security (BIS) promotes U.S. national and 
economic security and foreign policy interests by managing and 
enforcing Commerce's security-related trade and competitiveness 
programs. BIS plays a key role in challenging issues involving national 
security and nonproliferation, export growth, and high technology, 
which has become especially important in light of the tragic events of 
September 11, 2001. The Bureau's continuing major challenge is 
combating the proliferation of weapons of mass destruction while 
furthering the growth of U.S. exports, which are critical to 
maintaining our leadership in an increasingly competitive global 
economy. BIS strives to be the leading innovator in transforming U.S. 
strategic trade policy and programs to adapt to the changing world.
Major Programs and Activities
The Export Administration Regulations (EAR) provide for export controls 
on dual-use goods and technology (primarily commercial goods that have 
potential military applications) not only to fight proliferation, but 
also to pursue other national security, short supply, and foreign 
policy goals (such as combating terrorism). Simplifying and updating 
these controls in light of the end of the Cold War has been a major 
accomplishment of BIS.
One of the most important updates to the EAR came as a result of the 
acts of terrorism committed on September 11, 2001. The President's 
Executive Order 13224, entitled ``Blocking Property and Prohibiting 
Transactions with Persons Who Commit, Threaten to Commit, or Support 
Terrorism,'' directs agencies to, among other things, block property 
and interests in property of persons listed in the Annex of the 
Executive Order. This action was taken to ensure the continued 
preservation of national security, foreign policy, and the economy of 
the United States. To implement EO 13224, the EAR was updated to 
implement license requirements on all exports and reexports to persons 
designated in, or pursuant to, the Executive order.
BIS is also responsible for:
Enforcing the export control and antiboycott provisions of the Export 
Administration Act (EAA), as well as other statutes such as the 
Fastener Quality Act. The EAA is enforced through a variety of 
administrative, civil, and criminal sanctions.
Analyzing and protecting the defense industrial and technology base, 
pursuant to the Defense Production Act and other laws. As the Defense 
Department increases its reliance on dual-use high technology goods as 
part of its cost-cutting efforts, ensuring that we remain competitive 
in those sectors and subsectors is critical to our national security.
Helping Ukraine, 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 74095]]




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, 16 Defense agencies, and 7 DoD field 
activities. It has over 1,400,000 military personnel and 670,000 
civilians assigned as of May 31, 2002, and over 200 large and medium 
installations in the continental United States, U. S. territories, and 
foreign countries. The overall size, composition, and dispersion of 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 affect the regulatory agencies. DoD, as an integral 
part of its program, not only receives coordinating actions from the 
regulating agencies, but coordinates with the agencies that are 
impacted by its regulations as well.
 The regulatory program within DoD fully incorporates the provisions of 
the President's priorities and objectives under Executive Order 12866. 
Promulgating and implementing the regulatory program throughout DoD 
presents a unique challenge to the management of our regulatory 
efforts.
Coordination
Interagency
 DoD annually receives regulatory plans from those agencies that impact 
the operation of the Department through the issuance of regulations. A 
system for coordinating the review process is in place, regulations are 
reviewed, and comments are forwarded to the Office of Management and 
Budget. The system is working in the Department, and the feedback from 
the Defense components is most encouraging, since they are able to see 
and comment on regulations from the other agencies before they are 
required to comply with them. The coordination process in DoD continues 
to work as outlined in Executive Order 12866.
Internal
 Through regulatory program points of contact in the Department, we 
have established a system that provides information from the 
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 Identification
 Congress typically passes legislation to authorize or require an 
agency to issue regulations and often is quite specific about the 
problem identified for correction. Therefore, DoD does not generally 
initiate regulations as a part of its mission.
Conflicting Regulations
 Since DoD plans to issue just 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.
Alternatives
 DoD will identify feasible alternatives that will obtain the desired 
regulatory objectives. Where possible, the Department encourages the 
use of incentives to include financial, quality of life, and others to 
achieve the desired regulatory results.
Risk Assessment
 Assessing and managing risk is a high priority in the DoD regulatory 
program. The Department is committed to risk prioritization and an 
``anticipatory'' approach to regulatory planning, which focuses 
attention on the identification of future risk. Predicting future 
regulatory risk is exceedingly difficult due to rapid introduction of 
new technologies, side effects of Government intervention, and changing 
societal concerns. These difficulties can be mitigated to a manageable 
degree through the incorporation of risk prioritization and 
anticipatory regulatory planning into DoD's decisionmaking process, 
which results in an improved regulatory process and increases the 
customer's understanding of risk.
Cost-Effectiveness
 One of the highest priority objectives of DoD is to obtain the desired 
regulatory objective by the most cost-effective method available. This 
may or may not be through the regulatory process. When a regulation is 
required, DoD considers incentives for innovation to achieve desired 
results, consistency in the application of the regulation, 
predictability of the activity outcome (achieving the expected 
results), and the costs for regulation development, enforcement, and 
compliance. These will include costs to the public, Government, and 
regulated entities, using the best available data or parametric 
analysis methods, in the

[[Page 74096]]

cost-benefit analysis and the decisionmaking process.
Cost-Benefit
 Conducting cost-benefit analyses on regulation alternatives is a 
priority in the Department of Defense so as to ensure that the 
potential benefits to society outweigh the costs. Evaluations of these 
alternatives are done quantitatively or qualitatively or both, 
depending on the nature of the problem being solved and the type of 
information and data available on the subject. DoD is committed to 
considering the most important alternative approaches to the problem 
being solved and providing the reasoning for selecting the proposed 
regulatory change over the other alternatives.
Information-Based Decisions
 The Defense Department uses the latest technology to provide access to 
the most current technical, scientific, and demographic information in 
a timely manner through the world-wide communications capabilities that 
are available on the 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 and increase public 
access in the regulatory process. Notable progress has been made in the 
Defense acquisition regulations area toward achieving the 
Administration's E-government initiative of making it simpler for 
citizens to receive high-quality service from the Federal government, 
inform citizens, and allow access to the development of rules.
Performance-Based Regulations
 Where appropriate, DoD is incorporating performance-based standards 
that allow the regulated parties to achieve the regulatory objective in 
the most cost-effective manner.
Outreach Initiatives
 DoD endeavors to obtain the views of appropriate State, local, and 
tribal officials and the public in implementing measures to enhance 
public awareness and participation both in developing and implementing 
regulatory efforts. Historically, this has included such activities as 
receiving comments from the public, holding hearings, and conducting 
focus groups. This reaching out to organizations and individuals that 
are affected by or involved in a particular regulatory action remains a 
significant regulatory priority of the Department and, we feel, results 
in much better regulations.
 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. This is consistent with the Administration's 
strategy of advancing E-government as expressed in ``The President's 
Management Agenda.''
Coordination
 DoD has enthusiastically embraced the coordination process between and 
among other Federal agencies in the development of new and revised 
regulations. Annually, DoD receives regulatory plans from key 
regulatory agencies and has established a systematic approach to 
providing the plans to the appropriate policy officials within the 
Department. Feedback from the DoD components indicates that this 
communication among the Federal agencies is a major step forward in 
improving regulations and the regulatory process, as well as in 
improving Government operations.
Minimize Burden
 In the regulatory process, there are more complaints concerning burden 
than anything else. In DoD, much of the burden is in the acquisition 
area. Over the years, acquisition regulations have grown and become 
burdensome principally because of legislative action. But, in 
coordination with Congress, the Office of Federal Procurement Policy, 
and the public, DoD is initiating significant reforms in acquisition so 
as to effect major reductions in the regulatory burden on personnel in 
Government and the private sector. DoD has implemented a multi-year 
strategy for reducing the paperwork burden imposed on the public. This 
plan shows that DoD has met and will exceed the goals set forth in the 
Paperwork Reduction Act. It is the goal of the Department of Defense to 
impose upon the public the smallest burden viable, as infrequently as 
possible, and for no longer than absolutely necessary.
Plain Language
 Ensuring that regulations are simple and easy to understand is a high 
regulatory priority in the Department of Defense. All too often, the 
regulations are complicated, difficult to understand, and subject to 
misinterpretation, all of which can result in the costly process of 
litigation. The objective in the development of regulations is to write 
them in clear, concise language that is simple and easy to understand.
 DoD recognizes that it has a responsibility for drafting clearly 
written rules that are reader-oriented and easily understood. Rules 
will be written for the customer using natural expressions and simple 
words. Stilted jargon and complex construction will be avoided. Clearly 
written rules will tell our customers what to do and how to do it. DoD 
is committed to a more customer-oriented approach and uses plain 
language rules thereby improving compliance and reducing litigation.
 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.
Regulations Related to the Events of September 11, 2001
 The Department of Defense promulgated two acquisition regulations 
relating to the events of September 11, 2001. Defense Federal 
Acquisition Regulation Supplement (DFARS) Case 2001-D018, Performance 
of Security Functions, implements section 1010 of the USA Patriot Act. 
An interim rule was published in the Federal Register on March 14, 
2002. Section 1010 provides an exception to the prohibition on 
contracting for security functions at a military installation or 
facility. The exception applies during the period of time that the 
United States Armed Forces are engaged in Operation Enduring Freedom 
and the 180 days thereafter. The interim rule was finalized without 
change on August 30, 2002 (67 FR 55730).
 Federal Acquisition Regulation (FAR) Case 2002-003, Temporary 
Emergency Procurement Authority, implements section 836 of the Fiscal 
Year (FY) 2002 National Defense Authorization Act. Section 836 
increases the

[[Page 74097]]

micropurchase threshold and the simplified acquisition threshold for 
purchases during FY 2002 and 2003 that facilitate the defense against 
terrorism or biological or chemical attack against the United States. 
The section also specifies that the procurement of biotechnology 
property or services to facilitate the defense against terrorism or 
biological or chemical attack shall be treated as procurement of 
commercial items. The interim rule was published in the Federal 
Register on August 30, 2002, as part of Federal Acquisition Circular 
(FAC) 2001-009 (67 FR 56120-56122).
Suggestions From the Public for Reform--Status of DoD Item
 In the draft report on costs and benefits published May 2, 2001, the 
Office of Information and Regulatory Affairs asked the public to 
recommend specific proposals for regulatory reform. Of the 71 
suggestions involving 17 agencies, one specifically addressed the Army 
Corps of Engineers' Regulatory Program. The nationwide permits were 
classified as priority 3 in appendix A of the report, ``Making Sense of 
Regulation: 2001 Report to Congress on the Costs and Benefits of 
Regulations and Unfunded Mandates on State, Local, and Tribal 
Entities.''
 In the January 15, 2002, issue of the Federal Register (67 FR 2019-
2095), the Army Corps of Engineers reissued 43 nationwide permits and 
26 general conditions, with minor modifications. The Corps also issued 
one new nationwide permit general condition. The implementing 
regulations for the nationwide permit program are found at 33 CFR part 
330. The most recent substantive modifications to 33 CFR part 330 were 
published in the Federal Register on November 22, 1991 (56 FR 59110). 
On February 14, 1997, the Corps removed appendix A (which contained the 
text of the nationwide permits) from the Code of Federal Regulations at 
33 CFR part 330 (see 62 FR 6877). The nationwide permits are not 
classified as regulations. They are permits to authorize certain minor 
activities in waters of the United States that result in minimal 
adverse effects on the aquatic environment, individually and 
cumulatively. Nationwide permits cannot be issued for a period of more 
than 5 years and must be reviewed prior to reissuance to ensure 
compliance with section 404(e) of the Clean Water Act and other 
applicable laws. Although the permits and general conditions are not 
regulations, the Corps coordinated the reissue package with the Office 
of Management and Budget, who subsequently vetted the submission with 
other Federal agencies interested in the Army's Regulatory Program. The 
43 nationwide permits and 27 general conditions that were published on 
January 15, 2002, reflect the result of this interagency coordination.
Specific Priorities
 For this regulatory plan, there are three specific DoD priorities, all 
of which reflect the established regulatory principles. One of these, 
``U.S. Army Corps of Engineers, Directorate of Civil Works,'' will have 
one significant regulatory action as defined by E.O. 12866. In those 
areas where rulemaking or participation in the regulatory process is 
required, DoD has studied and developed policy and regulations that 
incorporate the provisions of the President's priorities and objectives 
under the Executive order.
 DoD has focused its regulatory resources on the most serious 
environmental, health, and safety risks. Perhaps most significant is 
that each of the 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 installations and the environment.
U.S. Army Corps of Engineers, Directorate of Civil Works
Preserve the Quality of Water and the Quality and Quantity of Wetlands
 During Fiscal Year (FY) 2003, the U.S. Army Corps of Engineers is 
proposing one significant regulation as defined by Executive Order 
12866. Although not economically significant, the ``Programmatic 
Regulations for the Comprehensive Everglades Restoration Plan'' has 
been classified as significant (``other significant'') because of the 
novel legal and policy issues that have arisen and will continue to 
arise over the 30-year implementation period. The Office of the 
Assistant Secretary of the Army (Civil Works) and the Corps have 
completed one regulation.
 The U.S. Army Corps of Engineers was directed by Congress in section 
601 of the Water Resources Development Act of 2000 (Public Law 106-541, 
114 Stat. 2680) to develop a Comprehensive Everglades Restoration Plan 
(Plan) to restore and preserve south Florida's natural ecosystem, while 
enhancing water supplies and maintaining flood protection. To guide the 
development of the Plan, Congress also directed the Secretary of the 
Army, after notice and opportunity for public comment, to develop and 
implement Programmatic Regulations within 2 years (not later than 
December 11, 2002). The Programmatic Regulations will establish a 
process for developing project implementation reports, project 
cooperation agreements, and project operating manuals that will ensure 
the goals and the objectives of the Plan are achieved. The regulations 
also will establish procedures for developing and using any new 
information resulting from ecosystem changes or unforeseen 
circumstances in accordance with the principles of adaptive management 
contained in the Plan. Finally, the Programmatic Regulations will 
facilitate the re-establishment of and protection of the natural system 
consistent with the interim and final goals of the Plan while providing 
thorough evaluation points during the 30-year project implementation 
schedule. The Office of Management and Budget (OMB) is facilitating 
development of the rule. OMB vetted the draft with appropriate Federal 
agencies and held several interagency meetings before clearing the 
draft for publication in the Federal Register in August 2002. The final 
Programmatic Regulations require the concurrence of the Governor of 
Florida and the Secretary of the Interior, and the consultation with 
the Seminole Tribe of Indians of Florida, the Miccosukee Tribe of 
Indians of Florida, the Administrator of the Environmental Protection 
Agency, and the Secretary of Commerce. Additionally, other Federal, 
State, and local agencies will continue to assist in promulgating the 
Programmatic Regulations to ensure that the goals and purposes of the 
Plan are achieved.
 The Office of the Assistant Secretary of the Army (Civil Works) and 
the U.S. Army Corps of Engineers completed one regulation in 2002. On 
April 20, 2001, the Corps proposed revisions to the Clean Water Act 
(Act) regulatory definitions of ``Fill Material'' and ``Discharge of 
Fill Material'' (65 FR 21292). On May 9, 2002, the Corps in conjunction 
with the U.S. Environmental Protection Agency (EPA), issued a final 
rule in the Federal Register (67 FR 31129) revising the Clean Water Act 
regulatory definitions of ``fill material'' and ``discharge of fill 
material.'' Revising the rule was necessary in order to clarify those 
pollutants that are regulated by the Corps under section 404 of the 
Act.
 Section 404 of the Clean Water Act requires a permit from the U.S. 
Army Corps of Engineers for discharges of dredged or fill material to 
waters of the

[[Page 74098]]

United States. The Environment Protection Agency and the Corps' 
regulations implementing section 404 previously contained differing 
definitions of the term ``fill material.'' In particular, the Corps 
regulations defined fill material as being used for the ``primary 
purpose'' of replacing an aquatic area with dry land or changing the 
bottom elevation of a waterbody. In contrast, EPA's definition of fill 
material looked to whether the effect is to replace waters of the U.S. 
with dry land or change the bottom elevation of waterbodies and did not 
contain a ``primary purpose'' test as found in the Corps regulations. 
In order to clarify what constitutes ``fill material'' for purposes of 
section 404 and provide improved regulatory certainty, the Corps and 
EPA have implemented the final rule under which both agencies have 
adopted identical, effect-based definitions of the terms ``fill 
material'' and ``discharge of fill material.''
National Historic Preservation Act--Army's Regulatory Program
 More than 20 years ago, the Army Corps of Engineers published as 
appendix C of 33 CFR part 325, a rule that governs compliance with the 
National Historic Preservation Act for the Army's Regulatory Program. 
Over the years, there have been significant changes in policy, and the 
Act was amended in 1992, leading to the publication in December 2000 of 
new implementing regulations, at 36 CFR part 800, developed by the 
Advisory Council on Historic Preservation (ACHP). Thus, on March 8, 
2002, the Corps published a notice in the Federal Register (67 FR 
10822), requesting comments on the implementation of the Army's 
regulatory program in view of the new ACHP regulations at 36 CFR part 
800. Thirty-nine comments were received in response to this notice. The 
Corps Regulatory Program currently uses 33 CFR part 325, appendix C, to 
comply with the National Historic Preservation Act and other laws that 
address historic properties. In Fiscal Year 2003, the Corps may propose 
changes to 33 CFR part 325, appendix C, to bring the regulation into 
conformance with the new Advisory Council on Historic Preservation's 
regulations at 36 CFR part 800.
Defense Procurement and Acquisition
 The Department continues its efforts to reengineer its acquisition 
system to achieve its vision of an acquisition system that is 
recognized as being the smartest, most efficient, most responsive buyer 
of best value goods and services, which meet the warfighter's needs 
from a globally competitive base. To achieve this vision, the 
Department will focus its attention on implementing and 
institutionalizing initiatives that may include additional changes to 
existing and recently modified regulations to ensure that the 
Department is achieving the outcomes it desires (continuous process 
improvement).
 The Department of Defense continuously reviews its supplement to the 
Federal Acquisition Regulation (FAR) and continues to lead Government 
efforts to simplify the following acquisition processes:
[sbull] Consider FAR and Defense Federal Acquisition Regulation 
            Supplement (DFARS) changes to facilitate timely contract 
            closeout.
[sbull] Consider policies and procedures to provide contractors an 
            adequate share of savings from cost efficiencies and 
            rationalization over a not-to-exceed 5-year period.
[sbull] Revise the FAR to provide for electronic listing of acquisition 
            vehicles available for use by more than one agency.
[sbull] Rewrite DFARS part 225, Foreign Acquisition, to improve clarity 
            and make procedures less complex, particularly for 
            evaluation of foreign offers and customs duty. The rewrite 
            also proposes to implement the determination of the Under 
            Secretary of Defense (AT&L) that for procurements subject 
            to the Trade Agreements Act, it would be inconsistent with 
            the public interest to apply the Buy American Act to U.S.-
            made end products that are substantially transformed in the 
            United States.
[sbull] Rewrite FAR part 27, Patents, Data and Copyrights, to clarify, 
            streamline, and update guidance and clauses on patents, 
            data, and copyrights.
[sbull] Review various FAR cost principles to determine whether certain 
            FAR cost principles are still relevant in today's business 
            environment, whether they place an unnecessary 
            administrative burden on contractors and the Government, 
            and whether they can be streamlined or simplified.
[sbull] Revise the FAR part 45, Government Property, to organize and 
            streamline the property disposal procedures and to 
            incorporate into the FAR the DoD deviations relating to 
            Government property rental and special tooling.
Defense Installations and the Environment
 The Department is committed to reducing the total ownership costs of 
the military infrastructure while providing the Nation with military 
installations that efficiently support the warfighter in: Achieving 
military dominance, ensuring superior living and working conditions, 
and enhancing the safety of the force and the quality of the 
environment. DoD has focused its regulatory priorities on explosives 
safety, human health, and the environment. These regulations provide 
means for the Department to provide information about restoration 
activities at Federal facilities and to take public advice on the 
restoration activities.
Restoration Advisory Boards
 Section 324(a) of Public Law 104-106, which amended section 2705 of 
title 10, United States Code, requires the Secretary of Defense to 
``prescribe regulations regarding the establishment, characteristics, 
composition, and funding of restoration advisory boards.'' Section 
324(a) also stated that DoD's issuance of regulations shall not be a 
precondition to the establishment of Restoration Advisory Boards (RABs) 
(amended section 2705(d)(2)(B)).
 The Department of Defense recognizes the importance of public 
involvement at military installations and formerly used defense sites 
that require environmental restoration. RABs provide an expanded 
opportunity for stakeholder input into the environmental restoration 
process at operating and closing DoD installations. They also act as a 
forum for the discussion and exchange of restoration program 
information between agencies and the community, as well as providing an 
opportunity for RAB members to review progress and participate in a 
dialogue with the installation's decisionmakers.
 In August 1996, the Department proposed and requested public comments 
on regulations regarding the characteristics, composition, funding, and 
establishment of Restoration Advisory Boards. The Boards were not 
subject to the Federal Advisory Committee Act (FACA), because DoD did 
not want to subject community members to the FACA requirements, such as 
financial disclosure. The General Services Administration did not agree 
that RABs are not subject to FACA. DoD continued its RABs but did not 
publish a final rule.
 In the fall of 2001, the RAB regulations were raised in a case before 
the 9th Circuit. On the RAB rule issue,

[[Page 74099]]

the Judge indicated that he would dismiss without prejudice and give 
the Department of Defense 18 months to promulgate a rule. The Judge was 
not inclined to grant the plaintiff's request that he order DoD to 
promulgate the rule, stating that the plaintiff could bring the matter 
back to the Court if the Department of Defense had not completed the 
rulemaking in 18 months. Accordingly, DoD is preparing a new RAB rule 
to meet this requirement and plans on publishing the rule by the middle 
of 2003.
Munitions Response Site Prioritization Protocol
 Section 2710(b)(1) of title 10, United States Code, directs the 
Secretary of Defense to develop, in consultation with representatives 
of the States and Indian tribes, a proposed protocol for assigning to 
each defense site a relative priority for munitions response 
activities. Section 2710 provides for public notice and comment on the 
proposed protocol and requires that the proposed protocol be available 
for public comment on or before November 30, 2002. DoD is directed to 
issue a final protocol to be applied to defense sites listed in the 
Department's munitions response site inventory.
 The proposed rule will be called the ``Munitions Response Site 
Prioritization Protocol'' and will assign a relative response priority 
for all sites addressed under the Military Munitions Response Program 
(MMRP) category of the Defense Environmental Restoration Program 
(DERP). The protocol will be a qualitative methodology used to sequence 
environmental restoration activities. The tool will make use of limited 
data and reflect the overall conditions at the site. It will be used to 
assign a relative priority based on an evaluation of factors relating 
to safety and environmental hazard potential.
 The proposed Munitions Site Prioritization Protocol Rule is being 
developed by a defense working group with input from other Federal 
agencies and State members of the Munitions Response Committee in 
consultation with tribal representatives. A notice was published in the 
Federal Register in March 2002 announcing DoD's intent to develop the 
protocol and requesting input from the public on the factors 
promulgated by Congress. Working documents are on the World Wide Web 
and the Department continues to meet with State and tribal 
representatives. DoD intends to prepare, in consultation with the 
States and Indian tribes, a proposed and final protocol according to 
the requirements. Currently a draft proposed protocol is being 
prepared. Meetings are scheduled to discuss it with the States and 
tribes prior to publication.
_______________________________________________________________________



DOD

                              -----------

                            FINAL RULE STAGE

                              -----------




21. PROGRAMMATIC REGULATIONS FOR THE COMPREHENSIVE EVERGLADES 
RESTORATION PLAN
Priority:


Other Significant


Legal Authority:


PL 106-541


CFR Citation:


33 CFR 385


Legal Deadline:


Final, Statutory, December 11, 2002.


Abstract:


The U.S. Army Corps of Engineers was directed by Congress in section 
601 of the Water Resources Development Act of 2000 (Public Law 106-541, 
114 Stat. 2680) to develop a Comprehensive Everglades Restoration Plan 
(Plan) to restore and preserve south Florida's natural ecosystem, while 
enhancing water supplies and maintaining flood protection. To guide the 
development of the Plan, Congress also directed the Secretary of the 
Army, after notice and opportunity for public comment, to develop and 
implement Programmatic Regulations within 2 years (NLT December 11, 
2002). The Programmatic Regulations will establish a process for 
developing project implementation reports, project cooperation 
agreements, and project operating manuals that will ensure the goals 
and the objectives of the Plan are achieved. The regulations also will 
establish procedures developing and using any new information resulting 
from ecosystem changes or unforeseen circumstances in accordance with 
the principles of adaptive management contained in the Plan. Finally, 
the Programmatic Regulations will facilitate the re-establishment and 
protection of the natural system consistent with the interim and final 
goals of the Plan while providing thorough evaluation points during the 
30-year project implementation schedule.


Statement of Need:


The Programmatic Regulations will fulfill the intent of Congress to 
establish explicit guidance on how this project, and its constituent 
parts, will be developed and implemented, with full public and agency 
participation.


Summary of Legal Basis:


Specifically, the Programmatic Regulations will implement the following 
sections of the Water Resources Development Act of 2000:


Section 601(h)(3)(A), requires Programmatic Regulations to be completed 
not later than 2 years after enactment;


Section 601(h)(3)(B), the Secretary of the Interior and the Governor 
shall provide the Secretary of the Army with a written statement of 
concurrence or nonconcurrence not later than 180 days after the end of 
the comment period;


Section 601(h)(3)(C), the regulations shall establish a process for the 
development of project implementation reports, project cooperation 
agreements, and operating manuals; ensure that new information 
resulting from changed or unforeseen circumstances, new science or 
technical information developed through adaptive management are 
integrated into the implementation of the Plan; and ensure the 
protection of the natural system consistent with the goals and purposes 
of the Plan;


Section 601(h)(3)(D), all project implementation reports approved 
before the date of promulgation of the Programmatic Regulations shall 
be consistent with the Plan;


Section 601(h)(3)(E), at least every 5 years the Secretary of the Army 
shall review the Programmatic Regulations for consistency with Plan 
goals and purposes.


Alternatives:


None.


Anticipated Cost and Benefits:


There are no economic costs, per say, attributed to the promulgation of 
the Programmatic Regulations. The regulations will help ensure that the 
$8 billion estimated Federal investment will result in ecosystem 
restoration benefits identified as individual projects are developed 
and implemented over a 30-year construction period.


Risks:


There are no risks associated with the Programmatic Regulations. 
Promulgation of the regulations will help ensure that the Army Corps of 
Engineers follows agreed upon project development and implementation

[[Page 74100]]

procedures, designed to achieve the environmental restoration and 
protection benefits outlined in the Plan. Although no regulatory 
impacts with other Federal, Tribal, State, or local regulations have 
been identified to date, the Corps will take comments on impacts as 
part of the public and agency comment period, and address them in the 
final regulations. The draft Programmatic Regulations have been drafted 
so as not to conflict with existing laws and regulations. Any 
oversights will be corrected in the final version.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            67 FR 50540                                    08/02/02
NPRM Comment Period End                                        10/01/02
Final Action                                                   12/00/02
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


Federal, State, Tribal, Local


Agency Contact:
Chip Smith
Assistant for Environmental, Tribal, and Regulatory Affairs
Department of Defense
U.S. Army Corps of Engineers
Office of the Deputy Assistant Secretary of the Army (Policy & 
Legislation)
108 Army Pentagon
Washington, DC 20310-0108
Phone: 703 693-3655
RIN: 0710-AA49
BILLING CODE 5001-08-S

[[Page 74101]]




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 773,600 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 
generally invite comments on all proposed regulations through the 
Internet.
 OMB's 2001 Report to Congress on the Costs and Benefits of Regulations 
identified as needing changes -- (priority 1) -- the Department's title 
IV regulations promulgated under the authority of the Higher Education 
Act. These regulations were recently negotiated with the financial aid, 
higher education, and other related community members through the 
negotiated rulemaking process and will reduce administrative burden for 
program participants, provide benefits to students and borrowers, and 
protect taxpayers' interests.
 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 Initiatives
 The Secretary's initiatives include One-ED, a new way of doing 
business for the Department of Education. One-ED represents the 
culmination of a series of changes that will transform the Department 
into a flexible, high-performing, high-integrity workplace focused on 
program outcomes and management reform. One-ED provides an integrated, 
5-year human capital, strategic sourcing and restructuring plan that 
builds on the President's Management Agenda and the Department's 
Strategic Plan, Culture of Accountability Report and Blueprint for 
Management Excellence, by providing employee learning and achievement 
opportunities.
 Some One-ED changes involve employees learning new skills so that 
staff can help the Department's partners achieve key education 
outcomes. Creating One-ED also means making organization structure 
changes to coordinate policymaking and avoid duplication. One-ED 
clients and partners will find knowledgeable people arrayed in a 
structure that is easy to access and navigate.
 Moving to One-ED also involves re-engineering work processes; i.e., 
changing how Department staff performs its work by reducing paperwork, 
introducing technology, and removing unnecessary steps. In some cases, 
through competitions and cost comparisons, the Department may find it 
less costly to provide high quality services by contracting with 
private sector organizations. In such cases, re-training and 
restructuring may become necessary.
 Also, the Department of Education and the National Council of Negro 
Women (NCNW) have joined forces to ignite a movement in communities 
across the country to close the achievement gap between African 
American students and their peers. The Partnership for Academic 
Achievement will leverage the new provisions of the No Child Left 
Behind Act of 2001 in conjunction with the tremendous outreach network 
of NCNW to improve academic achievement dramatically, reducing the 
difference in the gap between white and African American National 
Assessment of Educational Progress performance at the proficient level.
Principles for Regulating
 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:
[sbull] When essential to promote quality and equality of opportunity 
            in education.

[[Page 74102]]

[sbull] When a demonstrated problem cannot be resolved without 
            regulation.
[sbull] When necessary to provide legally binding interpretation to 
            resolve ambiguity.
[sbull] Not if entities or situations to be regulated are so diverse 
            that a uniform approach does more harm than good.
 How to regulate:
[sbull] Regulate no more than necessary.
[sbull] Minimize burden and promote multiple approaches to meeting 
            statutory requirements.
[sbull] Encourage federally funded activities to be integrated with 
            State and local reform activities.
[sbull] Ensure that benefits justify costs of regulation.
[sbull] Establish performance objectives rather than specify compliance 
            behavior.
[sbull] Encourage flexibility so institutional forces and incentives 
            achieve desired results.
Regulatory and Deregulatory Priorities for the Next Year
 Reauthorization of the Elementary and Secondary Education Act of 1965 
reflected 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.
 Reauthorization of the Individuals with Disabilities Education Act 
(IDEA), parts C and D, will make changes needed to improve 
implementation of the early intervention program for infants and 
toddlers with disabilities under part C, and the effectiveness of the 
National Activities under part D. The Secretary solicited public 
comment on the reauthorization of IDEA using the underlying framework 
of the President's principles of education reform to ensure that no 
child is left behind.
 Reauthorization of the Educational, Research, Development, 
Dissemination, and Improvement Act of 1994 will make changes needed to 
ensure that activities carried out by the Office of Educational 
Research and Improvement meet the highest standards of professional 
excellence.
_______________________________________________________________________



ED--Office of Educational Research and Improvement (OERI)

                              -----------

                          PROPOSED RULE STAGE

                              -----------




22. [bull] REAUTHORIZATION OF THE EDUCATIONAL, RESEARCH, DEVELOPMENT, 
DISSEMINATION, AND IMPROVEMENT ACT OF 1994 (SECTION 610 REVIEW)
Priority:


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


Unfunded Mandates:


Undetermined


Legal Authority:


20 USC 6001 et seq


CFR Citation:


34 CFR ch VII


Legal Deadline:


None


Abstract:


These regulations would implement changes made by the anticipated 
reauthorization of the Educational, Research, Development, 
Dissemination, and Improvement Act of 1994. This action is a notice 
that if regulations are necessary, ED would review the regulations in 
34 CFR chapter VII under section 610 of the Regulatory Flexibility Act 
(5 U.S.C. 610). The purpose of this review would be 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 would request comments 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 regulations; and the 
degree to which technology, economic conditions, or other relevant 
factors have changed since the regulations were promulgated.


Statement of Need:


Regulations may be necessary to implement new legislation. The 
Department would also complete its review of these regulations under 
610(c) of the Regulatory Flexibility Act. In developing any 
regulations, the Department would seek to reduce regulatory burden and 
increase flexibility to the maximum extent possible.


Summary of Legal Basis:


New legislation.


Alternatives:


In addition to implementing the anticipated reauthorization of the 
Educational, Research, Development, Dissemination, and Improvement Act 
of 1994, the purpose of this review would be 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                                                           09/00/03
Regulatory Flexibility Analysis Required:


Undetermined


Small Entities Affected:


No


Government Levels Affected:


Undetermined


Federalism:


 Undetermined


Agency Contact:
Elizabeth Payer
Department of Education
Office of Educational Research and Improvement
Room 502E
Capitol Place
555 New Jersey Avenue NW
Washington, DC 20208-5530
Phone: 202 219-1385
RIN: 1850-AA57
_______________________________________________________________________



ED--Office of Elementary and Secondary Education (OESE)

                              -----------

                            FINAL RULE STAGE

                              -----------




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


Other Significant


Legal Authority:


PL 107-110

[[Page 74103]]

CFR Citation:


34 CFR 200


Legal Deadline:


Final, Statutory, July 8, 2002.


Abstract:


These regulations would implement changes made by the reauthorization 
of title I of the Elementary and Secondary Education Act of 1965, as 
amended by the No Child Left Behind Act of 2001. This action is a 
notice that ED is reviewing the regulations in 34 CFR part 200 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 regulations; and the degree to which technology, 
economic conditions, or other relevant factors have changed since the 
regulations were promulgated.


Statement of Need:


These regulations are necessary to implement new legislation. The 
Department is also completing its review of these regulations under 
section 610(c) of the Regulatory Flexibility Act. In developing any 
regulations, the Department will seek to reduce regulatory burden and 
increase flexibility to the maximum extent possible.


Summary of Legal Basis:


New legislation.


Alternatives:


In addition to implementing the reauthorization of title I of the 
Elementary and Secondary Education Act of 1965, 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            67 FR 50986                                    08/06/02
NPRM Comment Period End                                        09/05/02
Final Action                                                   11/00/02
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Governmental Jurisdictions


Government Levels Affected:


Local, State


Agency Contact:
Jacquelyn Jackson
Acting Director, Student Achievement and Student Accountability 
Programs
Department of Education
Office of Elementary and Secondary Education
Room 3W230
400 Maryland Avenue SW
Washington, DC 20202-6132
Phone: 202 260-0826
RIN: 1810-AA91
_______________________________________________________________________



ED--Office of Special Education and Rehabilitative Services (OSERS)

                              -----------

                          PROPOSED RULE STAGE

                              -----------




24. [bull] REAUTHORIZATION OF THE INDIVIDUALS WITH DISABILITIES 
EDUCATION ACT (SECTION 610 REVIEW)
Priority:


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


Unfunded Mandates:


Undetermined


Legal Authority:


20 USC 1400 to 1487


CFR Citation:


34 CFR ch III


Legal Deadline:


None


Abstract:


These regulations would implement changes made by the anticipated 
reauthorization of the Individuals with Disabilities Education Act. 
This action is a notice that if regulations are necessary, ED would 
review the regulations in 34 CFR chapter III under section 610 of the 
Regulatory Flexibility Act (5 U.S.C. 610). The purpose of this review 
would be 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 would 
request comments 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 
regulations; 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 would also complete its review of these regulations under 
610(c) of the Regulatory Flexibility Act. In developing any 
regulations, the Department would seek to reduce regulatory burden and 
increase flexibility to the maximum extent possible.


Summary of Legal Basis:


New legislation.


Alternatives:


In addition to implementing the anticipated reauthorization of the 
Individuals with Disabilities Education Act, the purpose of this review 
would be 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                                                           09/00/03
Regulatory Flexibility Analysis Required:


Undetermined


Small Entities Affected:


No


Government Levels Affected:


Undetermined


Federalism:


 Undetermined

[[Page 74104]]

Agency Contact:
JoLeta Reynolds
Department of Education
Office of Special Education and Rehabilitative Services
Room 3082
Switzer Building
400 Maryland Avenue SW
Washington, DC 20202-2570
Phone: 202 205-5507
RIN: 1820-AB54
BILLING CODE 4000-01-S

[[Page 74105]]




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:
[sbull] Foster a secure and reliable energy system that is 
            environmentally and economically sustainable;
[sbull] Provide responsible stewardship of the Nation's nuclear 
            weapons;
[sbull] Clean up the Department's facilities;
[sbull] Lead in the physical sciences and advance the biological, 
            environmental and computational sciences; and,
[sbull] 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
 On May 23, 2002, the Department published a final rule that amended 
the existing energy conservation standards for central air conditioners 
and heat pumps by raising the minimum energy efficiency levels by 20 
percent for most units. As part of this action, the Department withdrew 
a final rule, published on January 22, 2001, that would have 
established even higher standards. DOE determined the higher standards 
in the January 22 final rule, which was the only DOE regulation among 
the 23 identified as priority 1 reform candidates in OMB's 2001 Report 
to Congress on the Costs and Benefits of Regulations, were not 
economically justified under the Energy Policy and Conservation Act. 
DOE estimates that the revised standards will still save consumers $2 
billion and reduce energy consumption by an amount equivalent to 516 
million barrels of oil through the year 2030. By the year 2020, the new 
standards will eliminate the need for three 400 megawatt coal--fired 
powerplants and nineteen 400 megawatt gas-fired powerplants. In 
addition, the energy consumption thus avoided will reduce cumulative 
greenhouse gas emissions by 24 million metric tons of carbon, or an 
amount equal to that produced by approximately 2 million cars every 
year.
 The Department's ongoing rulemaking activities related to energy 
efficiency standards and determinations have been categorized as high, 
medium, or low priority. On August 21, 2002, the Department released 
its most recent priority-setting report, ``Appliance Standards Program 
-- The FY 2003 Priority Setting Summary Report and Actions Proposed.'' 
These priorities, established with significant input from the public, 
are reflected in the rulemaking schedules set forth in The Regulatory 
Plan and the Unified Agenda of Federal Regulatory and Deregulatory 
Actions. The complete report can be viewed online at the following 
website: http://www.eren.doe.gov/buildings/codes--standards/reports/
priority--setting/priority--setting.html
 During the coming year, the Department expects to revise the energy 
efficiency standards for residential furnaces, boilers, and mobile home 
furnaces; electric distribution transformers; and commercial unitary 
air conditioners and heat pumps rated 65-240 kBtu's/hr. Additional 
information and timetables for these high priority actions can be found 
below. In addition, the Department will begin the preliminary analyses 
required to revise the standards for packaged terminal air conditioners 
and heat pumps, oil- and gas-fired commercial packaged boilers, and 
tankless gas-fired instantaneous water heaters.
 The Department plans to publish 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, 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 2003.
_______________________________________________________________________



DOE--Energy Efficiency and Renewable Energy (EE)

                              -----------

                             PRERULE STAGE

                              -----------




25. 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.

[[Page 74106]]

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 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 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
Framework Workshop                                             07/17/01
Venting Workshop                                               05/08/02
ANPRM                                                          02/00/03
NPRM                                                           02/00/04
Final Action                                                   09/00/04
Regulatory Flexibility Analysis Required:


No


Government Levels Affected:


State, Local


Agency Contact:
Cyrus Nasseri, EE-2J
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



26. 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 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

[[Page 74107]]

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 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                                                          03/00/03
NPRM                                                           03/00/04
Final Action                                                   10/00/04
Regulatory Flexibility Analysis Required:


Undetermined


Government Levels Affected:


None


Agency Contact:
Antonio Bouza, EE-2J
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



27. ENERGY EFFICIENCY STANDARDS FOR COMMERCIAL CENTRAL AIR CONDITIONING 
UNITS AND HEAT PUMPS RATED 65-240 KBTUS/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 (EPCA), as amended, 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 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 Worksh66 FR 43123                                    10/01/01
ANPRM                                                          04/00/03
NPRM                                                           04/00/04
Final Action                                                   11/00/04
Regulatory Flexibility Analysis Required:


Undetermined


Government Levels Affected:


None

[[Page 74108]]

Agency Contact:
Bryan Berringer, EE-2J
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--Departmental and Others (ENDEP)

                              -----------

                            FINAL RULE STAGE

                              -----------




28. 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.


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                                                   09/00/03
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 74109]]




DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)



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, support for 
biomedical research, substance abuse and mental health treatment, 
assuring safe and effective drugs and other medical products, food 
safety, financial assistance to low income families, Head Start, 
services to older Americans, and direct health services delivery. These 
programs and services are essential to the well being of tens 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 develop and issue regulations under a culture of responsiveness, 
where listening and responding to those we serve and those we regulate 
is our cornerstone. From health care to child welfare to food safety, 
the Secretary is committed to widening communication with consumers, 
beneficiaries, and all regulated entities. Furthermore, the Secretary 
wants to ensure that all HHS regulations are readily understandable, 
are clear and concise, and are grounded both in law and common sense.
 Since September 11, 2001, the Department has placed a renewed emphasis 
on taking action to prepare and protect all Americans from acts of 
terrorism and other public health emergencies. The Department is also 
moving aggressively to issue regulations addressing health care, foods 
and drugs, and the Medicare and Medicaid programs. In addition, 
consistent with the Secretary's priorities, the Department has taken 
important actions to enhance coordination of regulations across all its 
components.
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 can become 
caught in a web of mandates, rules and paperwork, and those whom the 
programs were intended to serve fail to receive the help they need. 
Last year, Secretary Thompson established a Secretary's Advisory 
Committee on Regulatory Reform (Advisory Committee), to provide 
recommendations regarding potential regulatory changes. The Advisory 
Committee has held public hearings across the country, in an effort to 
identify unnecessarily burdensome rules. The Advisory Committee's 
specific recommendations will be issued later this year.
FY 2003 Regulatory Themes
 The Secretary has adopted four overarching regulatory themes for FY 
2003:
[sbull] Improving the Department's ability to respond to emergencies 
            and disasters;
[sbull] Reducing medical errors and enhancing patient safety;
[sbull] Protecting America's consumers; and
[sbull] Reducing unnecessary and counter-productive regulations.
 Most of 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, increasing the percentage of the 
Nation's children and adults with access to regular health care; 
enhancing the capacity and productivity of the Nation's health science 
research enterprise; and supporting efforts to increase the 
independence of low-income families, the disabled, and older Americans.
Improving the Department's Ability to Respond to Emergencies and 
Diasters
 HHS is responsible for directing and coordinating the medical and 
public health response to terrorism, natural disasters, major 
accidents, and other events that can result in mass casualties. Timely 
and well-focused responses to such events are key to limiting death and 
injury. 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 designed to help ensure that HHS has 
appropriate authority and flexibility to address emergencies and 
disasters include:
[sbull] A final rule required under the Public Health Security and 
            Bioterrorism Preparedness and Response Act of 2002 (the 
            Bioterrorism Act) governing the possession, use and 
            transfer of certain biological agents and toxins known as 
            ``select agents;''
[sbull] A proposed rule emanating from the Bioterrorism Act 
            establishing registration requirements for all facilities 
            engaged in manufacturing, processing, packing, or holding 
            food for U.S. consumption;
[sbull] A proposed rule based on the Bioterrorism Act requiring the 
            establishment and maintenance of certain records regarding 
            food products; and
[sbull] A proposed rule under the Bioterrorism Act authorizing the FDA 
            to detain the release or shipment of food if it is 
            determined that such acts would present a serious health 
            threat.
Reducing Medical Errors and Enhancing Patient Safety
 Medical errors and other patient safety risks have been the subject of 
many recent studies and reports. The Secretary has directed that 
actions be taken to reduce these risks. Regulatory actions included in 
the Plan that are related to this category include:
[sbull] A proposed rule requiring human drug products to have a 
            scanable bar code that will reduce medication errors;
[sbull] A proposed rule to enhance and make more timely the safety 
            reporting on drugs and biologics;
[sbull] A final rule to strengthen requirements that hospitals maintain 
            policies and procedures to assess and improve the quality 
            of the medical care they provide;
[sbull] A final rule requiring that drug labels contain a toll-free 
            number in order to report adverse events;
[sbull] A final rule requiring improvements in the format and content 
            requirements of the ``professional'' labeling of drug 
            products, enabling health care practitioners to prescribe 
            drugs more safely.
Protecting America's Consumers
 Consumer health and safety is a major concern for the public and the 
Secretary. Consumers are inundated each year with an availability of 
new ingestible products and ingredients. Providing consumers with 
information about these products is a matter of great interest to the 
Secretary. Every year, tens of thousands of Americans become sick and 
some die from food borne pathogens, and the size of vulnerable

[[Page 74110]]

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:
[sbull] A proposed rule controlling the manufacturing and packaging of 
            dietary supplements;
[sbull] 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;
[sbull] A proposed rule to strengthen safety requirements for the 
            storage and distribution of eggs.
Reducing Unnecessary and Counterproductive Regulations
 The Secretary's Advisory Committee on Regulatory Reform is addressing 
HHS' priority of reducing regulatory burden on consumers, 
beneficiaries, health care providers, and other stakeholders. In 
addition to conducting the series of public meetings mentioned above, 
the Advisory Committee has reviewed an array of Departmental 
regulations, with the goal of identifying reforms that would maintain 
or enhance program performance while reducing burdens and costs. 
Proposed ways to accomplish these objectives include: a) clarifying and 
simplifying regulations; b) eliminating unnecessary paperwork; c) 
improving the quality and timeliness of information for consumers, 
beneficiaries, and providers; d) increasing flexibility in Federal 
health programs; and e) promoting collaboration and coordination among 
and between HHS agencies and other public and private stakeholders.
 Regulations under this theme include:
[sbull] A proposed rule under which current requirements for Medicare 
            reimbursement for services to persons with End Stage Renal 
            Disease would be completely overhauled and simplified;
[sbull] A final rule to clarify the responsibilities of Medicare 
            hospitals that provide emergency room treatment;
[sbull] A final rule to reduce the cost of drugs by eliminating a 
            current practice that allows manufacturers to repeatedly 
            obtain 30-month stays in order to block the approval of 
            generic versions of their drugs;
[sbull] A variety of other actions resulting from the recommendations 
            of the Advisory Committee.
Public Comments and Reactions
 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 2003, as well as the regulatory principles noted 
above. Such comments, as well as ideas and specific suggestions for 
regulatory improvements and initiatives, should be sent to Secretary 
Tommy G. Thompson, c/o Ann C. Agnew, Executive Secretary to the 
Department, Room 603, Hubert H. Humphrey Building, 200 Independence 
Avenue SW., Washington, DC 20201.
TITLES OF ALL PRIORITY REGULATIONS, BY THEME
Improving the Department's Ability to Respond to Emergencies and 
            Disasters
[sbull] Possession, Use, and Transfer of Select Agents
[sbull] Registration Requirements for Food Facilities
[sbull] Establishment and Maintenance of Records Regarding Food 
            Products
[sbull] Detainment of Food
[sbull] Control of Communicable Diseases through Quarantine
[sbull] Prior Notification Requirement for All Imported Food Shipments
1. Reducing Medical Errors and Enhancing Patient Safety
[sbull] Bar Code Label Requirements for Human Drug Products
[sbull] Safety Reporting on Drugs and Biologics
[sbull] Hospital Conditions of Participation
[sbull] Quality Assurance/Performance Improvement Program
[sbull] Toll-free Number for Reporting Adverse Drug Events
[sbull] Use of Restraint and Seclusion in Medicare and Medicaid 
            Facilities
[sbull] Notification of Consignees and Transfusion Recipients Receiving 
            Blood and Blood Components at Risk of Transmitting 
            Hepatitis C Virus
[sbull] ``Professional'' Labeling for Prescription Drugs
Protecting America's Consumers
[sbull] Manufacturing and Packaging of Dietary Supplements
[sbull] Food Labeling: Trans Fatty Acids
[sbull] Medicare: Review of National Coverage Determinations
[sbull] Control of Salmonella Enteriditis in Shell Eggs
[sbull] Exception from General Requirements for Informed Consent
1. Reducing Unnecessary and Counterproductive Regulations
[sbull] Application of the Emergency Medical Treatment and Labor Act
[sbull] End Stage Renal Disease Conditions for Coverage
[sbull] 30-Month Stays on Approvals of New Drug Applications
[sbull] A variety of actions resulting from the recommendations of the 
            Advisory Committee
 Also included in the Plan, are other regulatory actions entitled as 
follows, which would update or otherwise improve the Medicare program.
[sbull] Hospital Conditions of Participation
[sbull] Security Standards for Electronic Health Information
[sbull] Organ Procurement Organizations' Conditions for Coverage
[sbull] Revisions to the Medicare Appeals Process
[sbull] Revisions to Average Wholesale Price Methodology
[sbull] Electronic Claims Submission
[sbull] National Standard for Identifiers of Health Plans
[sbull] National Standard for Identifiers for Health Care Providers
[sbull] Prospective Payment System for Psychiatric Hospitals
[sbull] FY 2004 Changes--Hospital Inpatient Prospective Payment System
[sbull] FY 2004 Changes--Hospital Outpatient Prospective Payment System
[sbull] 2004 Physician Fee Schedule Changes
[sbull] Establishment of a Prospective Payment System for Skilled 
            Nursing Facilities
_______________________________________________________________________



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

                              -----------

                          PROPOSED RULE STAGE

                              -----------




29. 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

[[Page 74111]]

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 
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 some 
communicable diseases that currently pose a public health threat.


Summary of Legal Basis:


Section 264 of the U.S. Code, title 42 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 United States or 
its 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 
procedures and clarify due process procedures.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           12/00/02
Regulatory Flexibility Analysis Required:


Undetermined


Government Levels Affected:


State


Federalism:


 Undetermined


Agency Contact:
Jennifer Brooks
Department of Health and Human Services
Centers for Disease Control and Prevention
1600 Clifton Road NE.
Atlanta, GA 30333
Phone: 404 639-4915
RIN: 0920-AA03
_______________________________________________________________________



HHS--CDC

                              -----------

                            FINAL RULE STAGE

                              -----------




30. [bull] POSSESSION, USE, AND TRANSFER OF SELECT AGENTS
Priority:


Other Significant


Legal Authority:


PL 107-188


CFR Citation:


42 CFR 72; 42 CFR 72.6


Legal Deadline:


Final, Statutory, December 9, 2002.


Abstract:


On June 12, 2002, President George W. Bush signed Public Law 107-188, 
the Public Health Security and Bioterrorism Preparedness and Response 
Act of 2002 (the Bioterrorism Act). Title II, subtitle B of the 
Bioterrorism Act repeals, expands, and incorporates the Secretary's 
current authority to regulate the transfer of certain biological agents 
and toxins (select agents) as provided in section 511 of the 
Antiterrorism and Effective Death Penalty Act of 1996 (Pub. L. 104-132) 
(42 U.S.C. 262 note) and that Act's implementing regulations (42 CFR 
72.6). The Bioterrorism Act specifies that the Secretary develop and 
biennially review the list of select agents. Safety procedures must be 
established and enforced for the possession, use, and transfer of 
listed agents and toxins, and access to select agents is limited to 
those individuals and entities that pass background checks administered 
by the Attorney General. The Bioterrorism Act exempts certain 
information from disclosure under the Freedom of Information Act, 
including information that would identify the location of regulated 
entities or their security measures. Subtitle C of the Bioterrorism Act 
outlines the required interagency coordination between the Department 
of Health and Human Services and the Department of Agriculture 
regarding agents that are regulated by both departments (overlap 
agents).


CDC is currently in the rulemaking process that will culminate in the 
publication of an interim final rule on or before December 9, 2002. To 
date, CDC has published a notice of proposed data collection submitted 
for public comment and recommendations (Fed Reg. vol. 67, no. 127; 
Tuesday, July 2, 2002); a notice of OMB approval of data collection 
(Fed Reg, vol. 67, no 151; Tuesday, August 6, 2002); and a notice of 
preliminary guidance for notification of possession of select agents 
(Fed. Reg., vol. 67, no. 164; Friday, August 23, 2002).


Statement of Need:


Statutorily required by subtitles A and C of title II of the 
Bioterrorism Act, Public Law 107-188.


Summary of Legal Basis:


Subtitles A and C of title II of the Bioterrorism Act, Public Law 107-
188.


Alternatives:


On June 12, 2002, the President signed the Bioterrorism Act into law. 
Section 202 (a) of the Bioterrorism Act requires that all persons 
possessing, using, or transferring agents or toxins deemed a threat to 
public health to notify the Secretary of the Department of Health and 
Human Services (HHS). Since this is a mandate from Congress, the only 
alternative for this regulation would be to have HHS go back to 
Congress to request reconsideration.


Anticipated Cost and Benefits:


Modest internal cost implications for HHS/CDC can be foreseen at this 
time, but the potential costs to entities and individuals required to 
register under provisions of this rulemaking are currently unknown. CDC 
has issued a task order for support for the agency's responsibilities 
for the rulemaking and

[[Page 74112]]

related requirements of the Bioterrorism Act. The contractor 
implementing this task order will conduct an analysis of all 
anticipated costs of the rulemaking. The economic impact information 
resulting from this analysis will be set out in the preamble of the 
interim final rule.


Risks:


By establishing and enforcing standards for the possession, use, and 
transfer of potentially lethal biological agents and toxins, the 
regulation will serve as a preventive mechanism against bioterrorism, 
which complements some of the Department's other bioterrorism related 
activities.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
Interim Final Rule                                             12/00/02
Regulatory Flexibility Analysis Required:


Undetermined


Government Levels Affected:


Undetermined


Federalism:


 Undetermined


Agency Contact:
Stephen M. Ostroff MD
Department of Health and Human Services
Centers for Disease Control and Prevention
National Center for Infectious Diseases
1600 Clifton Road NE.
Atlanta, GA 30333
Phone: 404 639-3967
RIN: 0920-AA08
_______________________________________________________________________



HHS--Food and Drug Administration (FDA)

                              -----------

                          PROPOSED RULE STAGE

                              -----------




31. 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 320; 21 CFR 600; 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 add to or revise current reporting requirements; 
to revise certain reporting time frames; and propose 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 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                                                           11/00/02
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses


Government Levels Affected:


Undetermined

[[Page 74113]]

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
_______________________________________________________________________



HHS--FDA



32. 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 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 has 
considered 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:


The costs of the regulation will include the value of resources devoted 
to increased sanitation, process monitoring and controls, testing, and 
written records. The benefits of the proposed regulation are to improve 
both product safety and quality. We estimate that the proposed 
regulation will reduce the number of sporadic human illnesses and rare 
catastrophic illnesses from contaminated products. The current quality 
of these products is highly variable, and consumers lack information 
about the potential hazards and variable quality of these products. The 
product quality benefits occur because there will be fewer product 
recalls and more uniform products will reduce consumer search for 
preferred quality products. The proposed rule will have a significant 
impact on a substantial number of small businesses, so it will be 
significant under the Regulatory Flexibility Act. We anticipate that 
small businesses will bear a proportionately larger cost than large 
businesses.


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

[[Page 74114]]

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                                                           12/00/02
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses


Government Levels Affected:


Undetermined


Federalism:


 Undetermined


Agency Contact:
Karen Strauss
Consumer Safety Officer
Department of Health and Human Services
Food and Drug Administration
(HFS-820)
Center for Food Safety and Applied Nutrition
5100 Paint Branch Parkway
College Park, MD 20740
Phone: 301 436-1774
Fax: 301 436-2610
Email: [email protected]
RIN: 0910-AB88
_______________________________________________________________________



HHS--FDA



33. 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 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 (PHS 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 indicate 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 through 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

[[Page 74115]]

meetings in its consideration of the various alternatives.


Anticipated Cost and Benefits:


The benefits from the proposed regulation to control Salmonella 
Enteritidis in shell eggs on the farm and at retail derive from better 
farming practices and safer handling and cooking of eggs at the retail 
level. Improved practices reduce contamination and generate benefits 
measured as the value of the human illnesses prevented. FDA has 
produced preliminary estimates of costs and benefits for a number of 
options. The mitigations that would produce the highest benefits 
include on-farm rodent control, changes in retail food preparation 
practices, and diversion of eggs from infected flocks to 
pasteurization. Other mitigations considered include record keeping, 
refrigeration, and feed testing. The actual costs and benefits of the 
proposed rule will depend upon the set of mitigations chosen and the 
set of entities covered by the proposed rule.


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                                                           06/00/03
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
5100 Paint Branch Parkway
College Park, MD 20740
Phone: 301 436-1486
Fax: 301 436-2632
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
5100 Paint Branch Parkway
College Park, MD 20740
Phone: 301 436-1493
Fax: 301 436-2632
Email: [email protected]
RIN: 0910-AC14
_______________________________________________________________________



HHS--FDA



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


Other Significant


Legal Authority:


21 USC 321; 21 USC 351; 21 USC 352; 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 381


CFR Citation:


21 CFR 50.23


Legal Deadline:


None


Abstract:


FDA is proposing to clarify its regulations about the exception from 
the general requirement for informed consent in life-threatening 
situations necessitating the use of a test article. This proposal will 
explain how the informed consent provisions would apply during 
emergencies, including a response to chemical or biological terrorism, 
requiring the use of investigational in vitro diagnostic devices 
regulated by FDA.


Statement of Need:


The agency is proposing this action because of concern that confusion 
exists about how to apply the informed consent rules during a potential 
emergency, including a chemical or biological terrorism event. This 
confusion could delay the immediate use of investigational products 
thus threatening the rights, welfare, or lives of subjects.


Summary of Legal Basis:


FDA has already determined that the statutory authority provided in the 
Federal Food, Drug and Cosmetic Act (the Act) allows a limited 
exception to requiring informed consent in life-threatening situations 
such as those considered here. Section 505(i) of the Act requires 
informed consent except where it is not feasible or it is contrary to 
the best interests of the human beings involved. The Act also provides 
specifically for an exception from informed consent for investigational 
devices. Section 520(g)(3)(D) of the Act requires informed consent of 
the subject 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 or her 
representative. Further, a licensed physician uninvolved in the testing 
must agree with this three-part determination before 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 get 
such concurrence.


Alternatives:


The other option available to the agency is to work within the existing 
regulatory scheme. FDA believes that this option may result in improper 
or no diagnosis, and improper treatment or no treatment for persons 
with life-threatening illnesses because the health professionals may 
not use these investigational products.


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 may be required to obtain 
informed consent, which is just as burdensome, if not more so. The rule 
would permit use

[[Page 74116]]

of investigational products without 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 
may 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                                                           04/00/03
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


None


Agency Contact:
Bonnie M. Lee
Associate Director for Human Subject Protection Policy
Department of Health and Human Services
Food and Drug Administration
Room 9C24 (HF-34)
Office of Good Clinical Practice
Office of Science Coordination & Communication
5600 Fishers Lane
Rockville, MD 20857
Phone: 301 827-1259
Fax: 301 827-1169
Email: [email protected]
RIN: 0910-AC25
_______________________________________________________________________



HHS--FDA



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


Economically 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 and possibly other 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, 
would 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, at the 
right time. Most organizations and associations have recommended that 
the bar code contain, at a minimum, a unique numerical code identifying 
the manufacturer, product, and package size or type. In addition, some 
have advocated including the lot number and expiration date.


Thus, FDA is considering proposing to require certain medical 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

[[Page 74117]]

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 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 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 multiple 
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 might 
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, what products should be 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 more 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                                                           12/00/02
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



36. [bull] ADMINISTRATIVE DETENTION
Priority:


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


Unfunded Mandates:


Undetermined


Legal Authority:


PL 107-188, sec 303


CFR Citation:


21 CFR 1


Legal Deadline:


None


Abstract:


This rulemaking is one of a number of actions being taken to improve 
FDA's ability to respond to threats of bioterrorism. Section 303 of the 
Bioterrorism Act authorizes the Secretary, through FDA, to order the 
detention of food if an officer or qualified employee finds credible 
evidence or information indicating an article of food presents a threat 
of serious adverse health consequences or death to humans or animals. 
The Act requires the Secretary, through FDA, to issue final regulations 
to expedite court actions (i.e., seizures and injunctions) on 
perishable foods.


FDA intends to implement section 303 of the Act by proposing a 
regulation to provide for: 1) a detention procedure; 2) expedited 
procedures for enforcement actions with respect to perishable foods; 
and 3) an appeals procedure for detained goods.


Statement of Need:


The events of September 11, 2001 highlighted the need to enhance the 
security of the U.S. food supply. Congress responded by passing the 
Public Health Security and Bioterrorism Preparedness and Response Act 
of 2002, which was signed into law on June 12, 2002. The proposed 
regulation would implement section 303 of the Bioterrorism Act.


Summary of Legal Basis:


The Bioterrorism Act, section 303, amended the Federal Food, Drug, and 
Cosmetic Act (FFDCA) by adding section 304(h), which authorizes the 
Secretary to order the detention of domestic and imported food and 
specifies an appeals process that includes an opportunity for an 
informal hearing. Section 303 of the Bioterrorism Act also amends 
section 301 of the FFDCA by making it a prohibited act to transfer an 
article of food in violation of a detention order or to remove or alter 
any required mark or label identifying the article as detained. 
Furthermore, section 303 of the Bioterrorism Act amends section 801 of 
the FFDCA to provide for temporary holds at ports of entry.


Alternatives:


FDA's decision to promulgate a regulation is based primarily on clear 
statutory directive to establish regulations, and also on need. The 
Bioterrorism Act, section 303, clearly states that the Secretary must 
provide by regulation for procedures for instituting enforcement 
actions with

[[Page 74118]]

respect to perishable foods on an expedited basis.


Section 303 of the Bioterrorism Act also specifies an appeals process 
that requires the Secretary, after providing for an informal hearing, 
to confirm or terminate a detention order within five days of an 
appeal. Section 201(x) of the FFDCA defines ``informal hearing'' and 
describes the requirements necessary for informal hearings. 21 CFR part 
16 of FDA's regulations outlines FDA's informal hearing procedures in 
greater detail. Part 16 provides no requirements or limitations on the 
length of the informal hearing. FDA proposes to adopt part 16 with 
minor modifications (e.g., limiting length of hearing, delegating 
Secretary's duties as presiding officer to an FDA official in a 
regulation tailored to the administrative detention provisions in the 
Bioterrorism Act. If FDA were to include the minor modifications in a 
guidance document, FDA would not be able to enforce legally the new 
provisions because guidance documents are not binding (21 CFR 
10.115(d)). If FDA chose simply to follow part 16, we would run the 
risk of not providing the presiding officer sufficient time to consider 
and weigh the evidence for the informal hearing within the statutory 
timeframes.


Anticipated Cost and Benefits:


Administrative detention actions on imports would generate two types of 
costs: 1) enforcement costs, including marking or labeling, 
transporting, and storing detained or held products in secure 
facilities, as necessary, and the cost of preparing and administering 
detention appeal hearings; and 2) the loss of product value during the 
detention period (in the case of products that we detain or hold but 
that turn out to be non-violative) and firms' costs for preparing for 
detention appeal hearings. In those cases in which we could have used 
other means to detain the relevant goods (i.e., collaboration with 
states or Customs, or our own existing authority to detain imports, 
shell eggs, and infant formula), only the net change in these costs 
would be relevant to this rule. We do not have sufficient information 
to estimate these costs at this time. However, annual costs would 
probably be fairly small because we would only use these procedures 
under rare, extraordinary circumstances. In addition to potentially 
reducing enforcement costs, product value loss, and firms' appeals 
hearing preparation costs relative to current methods of detention, 
this rule would generate benefits by improving our ability to detect 
accidental and deliberate contamination of food and to deter deliberate 
contamination.


Risks:


Regulations implementing legislation to protect the health of citizens 
against bioterrorism 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' jurisdiction. 
These regulations will improve the ability to address credible threats 
of serious adverse health consequences or death to humans or animals.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

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


Yes


Small Entities Affected:


Businesses


Government Levels Affected:


Undetermined


Federalism:


 Undetermined


Agency Contact:
Marquita Steadman
Senior Policy Analyst
Department of Health and Human Services
Food and Drug Administration
HFS-007
Center for Food Safety and Applied Nutrition
5100 Paint Branch Parkway
College Park, MD 20740
Phone: 301 827-6733
Fax: 301 480-5730
Email: [email protected]
RIN: 0910-AC38
_______________________________________________________________________



HHS--FDA



37. [bull] ESTABLISHMENT AND MAINTENANCE OF RECORDS TO IDENTIFY 
IMMEDIATE PREVIOUS SOURCE AND IMMEDIATE SUBSEQUENT RECIPIENT OF FOODS
Priority:


Economically Significant. Major under 5 USC 801.


Unfunded Mandates:


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


Legal Authority:


PL 107-188, sec 306


CFR Citation:


21 CFR 1


Legal Deadline:


Final, Statutory, December 12, 2003.


The Public Health Security and Bioterrorism Preparedness and Response 
Act of 2002, section 306, directs the Secretary, through FDA, to issue 
final regulations establishing recordkeeping requirements by December 
12, 2003.


Abstract:


This rulemaking is one of a number of actions being taken to improve 
FDA's ability to respond to threats of bioterrorism. Section 414(b) of 
the Federal Food, Drug and Cosmetic Act (FFDCA), which was added by 
section 306 of the Public Health Security and Bioterrorism Preparedness 
and Response Act of 2002, authorizes the Secretary, through FDA, to 
promulgate final regulations by December 12, 2003. The regulations will 
require the establishment and maintenance of records, for not longer 
than two years, that would allow the Secretary to identify the 
immediate previous sources and the immediate subsequent recipients of 
food, including its packaging. The required records would be those that 
are needed by FDA in order to address credible threats of serious 
adverse health consequences or death to humans or animals. This section 
does not extend to recipes for food, financial data, pricing data, 
personnel data, research data, and sales data (other than shipment data 
regarding sales). Specific covered entities are those that manufacture, 
process, pack, transport, distribute, receive, hold, or import food. 
Farms and restaurants are excluded. The Secretary is directed to take 
into account the size of a business in promulgating these regulations. 
In addition, the Secretary is directed to take appropriate measures to 
ensure that effective procedures are in place to prevent the 
unauthorized disclosure of any trade secret or confidential information 
that is obtained by FDA pursuant to these regulations.


Statement of Need:


The events of September 11, 2001, highlighted the need to enhance the

[[Page 74119]]

security of the United States food supply. Congress responded by 
passing the Public Health Security and Bioterrorism Preparedness and 
Response Act of 2002 (the Bioterrorism Act), which was signed into law 
on June 12, 2002. The proposed regulations would implement section 306 
of the Bioterrorism Act.


Summary of Legal Basis:


Section 306 of the Bioterrorism Act amended the Federal Food, Drug and 
Cosmetic Act by adding section 414(b), which authorizes the Secretary 
to establish by regulation requirements for the creation and 
maintenance of records. In addition, section 306 of the Bioterrorism 
Act also amends section 301 of the Federal Food, Drug and Cosmetic Act 
by making the failure to establish or maintain any record, as required 
by the new regulations, a prohibited act.


Alternatives:


None, based on clear statutory authority to establish regulations.


Anticipated Cost and Benefits:


The records provisions will impose a substantial cost on industry. 
Using the 1999 Country Business Patterns (CBP) database from the U.S. 
Census and recordkeeping cost estimates based on other FDA regulations 
(and assuming no small establishment exemptions), a rough first 
estimate is that the current provisions will affect approximately 
500,000-600,000 establishments and will cost the food industry 
approximately $400 million in the first year and approximately $150 
million every year thereafter.


The provisions will improve substantially FDA's ability to respond to 
outbreaks from deliberate and accidental contamination of food. FDA 
will use data collected by the Center for Disease Control (CDC) and FDA 
on past outbreaks to estimate the benefit of improved documentation in 
standard tracing investigations. Of the 1,344 food-borne illness 
outbreaks CDC identified in 1999, only 368 (27 percent) had a confirmed 
etiology. A host of factors contribute to the inability to identify the 
cause of an outbreak, but many investigations are hampered by the lack 
of adequate records identifying the production history of foods. 
Unfortunately, it is not possible to directly estimate the benefits of 
averting a terrorist attack, as we do not know what form an attack 
might take or the probability of an attack occurring. Instead, to get 
an idea of the cost of a food disaster, we will look at the costs of 
some severe food-borne illness outbreaks.


Risks:


Regulations implementing legislation to protect the health of citizens 
against bioterrorism 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' jurisdiction. 
These regulations will improve the ability to address credible threats 
of serious adverse health consequences or death to humans or animals.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

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


Yes


Small Entities Affected:


Businesses


Government Levels Affected:


None


Agency Contact:
Nega Beru
Supervisory Chemist, Office of Plant, Dairy Foods and Beverages
Department of Health and Human Services
Food and Drug Administration
HFS-305
Center for Food Safety and Applied Nutrition
5100 Paint Branch Parkway
College Park, MD 20740
Phone: 301 436-1400
Fax: 301 436-2651
Email: [email protected]
RIN: 0910-AC39
_______________________________________________________________________



HHS--FDA



38. [bull] REGISTRATION OF FOOD AND ANIMAL FEED FACILITIES
Priority:


Economically Significant. Major under 5 USC 801.


Unfunded Mandates:


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


Legal Authority:


PL 107-188, sec 305


CFR Citation:


21 CFR 1


Legal Deadline:


Final, Statutory, December 12, 2003.


The Public Health Security and Bioterrorism Preparedness and Response 
Act of 2002, section 305, directs the Secretary, through FDA, to issue 
a final regulation establishing registration requirements by December 
12, 2003. The statute is self-implementing on this date if FDA does not 
issue a final regulation by December 12, 2003.


Abstract:


This rulemaking is one of a number of actions being taken to improve 
FDA's ability to respond to threats of bioterrorism. Section 415 of the 
Federal Food, Drug, and Cosmetic Act (FFDCA), which was added by 
section 305 of the Public Health Security and Bioterrorism Preparedness 
and Response Act of 2002 (the Bioterrorism Act), directs the Secretary 
to require any facility engaged in manufacturing, processing, packing, 
or holding food for consumption by humans or animals in the United 
States to be registered with the Secretary through FDA. Section 415 
directs the Secretary, through FDA, to promulgate final regulations 
implementing the requirements by December 12, 2003. The owner, 
operator, or agent in charge of the facility must submit the 
registration. Foreign facilities must include the name of the United 
States agent for the facility. The registration must include the name 
and address of each facility at which, and all trade names under which, 
the registrant conducts business. If FDA determines it is necessary 
through guidance, the registration must include the general food 
category (as identified under 21 CFR 170.3) of foods manufactured, 
processed, packed, or held at the facility. The registrant is required 
to notify the Secretary of changes to the registration in a timely 
manner. Upon receipt of the completed registration form, FDA is to 
notify the registrant of receipt of the registration and assign a 
unique registration number to the facility. The Secretary is also 
required to compile and maintain an up-to-date list of registered 
facilities. This list and any registration documents submitted to the 
Secretary are not subject to disclosure under the Freedom of 
Information Act. For purposes of section 415, ``facility'' includes any 
factory, warehouse, or establishment engaged in the manufacturing, 
processing, packing, or holding of food. Exempt from the registration 
requirement are farms, restaurants, retail food establishments,

[[Page 74120]]

nonprofit food establishments in which food is prepared for or served 
directly to the consumer, and fishing vessels (except those engaged in 
processing as defined in 21 CFR 123.3(k)). Foreign facilities required 
to register include only those from which food is exported to the 
United States without further processing or packaging outside the 
United States. The Bioterrorism Act provides that if a foreign facility 
attempts to import food into the United States without having 
registered, the food will be held at the port of entry until the 
foreign facility has registered.


Statement of Need:


The events of September 11, 2001, highlighted the need to enhance the 
security of the United States food supply. Congress responded by 
passing the Public Health Security and Bioterrorism Preparedness and 
Response Act of 2002, which was signed into law on June 12, 2002. 
Regulations are needed to implement the new statutory provisions.


Summary of Legal Basis:


Section 305 of the Public Health Security and Bioterrorism Preparedness 
and Response Act of 2002 (the Bioterrorism Act) amends the FFDCA by 
adding section 415, which directs the Secretary to establish by 
regulation requirements for the registration of food and animal feed 
facilities. Section 305 amends section 301 of the FFDCA by making the 
failure to register in accordance with section 415 a prohibited act. 
Section 305 also amends section 801 of the FFDCA by requiring food 
offered for import to be held at the port of entry until the foreign 
facility attempting to import the food has registered.


Alternatives:


None, based on clear statutory directive to establish regulations.


Anticipated Cost and Benefits:


Costs: Requiring registration for domestic and foreign facilities that 
manufacture, process, pack, or hold food will create costs for 
facilities to register and for FDA to set up and administer a database 
of firms. Industry costs are primarily a function of the number of 
firms affected and the amount of labor needed to register those firms. 
FDA estimates that 158,618 domestic establishments and 100,000 foreign 
establishments covered by the statute and proposed regulation will bear 
a cost of approximately $8.5 million in the first year. In subsequent 
years, new establishments will enter the industry. FDA estimates the 
number of new entrants each year will be equal to 10 percent of the 
current number of firms, for a recurring annual cost of $850,000. FDA's 
costs will include labor hours, hardware, software, and mailing costs 
for creating and administering a database. We estimate the costs to the 
agency for setting up the database and registering the first year 
registrants to be $17.4 million. This includes four FDA FTEs, 
contractor development of the database, hardware, software, industry 
outreach, and a firewall. We estimate costs for maintaining the 
database and adding new establishments to be $13.8 million in the 
second year. Total first year costs will be $25.9 million and second 
year costs will be $14.7 million. All of these cost estimates are 
preliminary and uncertain.


Benefits: These provisions will improve FDA's ability to respond to 
outbreaks from accidental and deliberate contamination from food and 
deter deliberate contamination. It is not possible to directly estimate 
the benefits of averting a terrorist attack, as we do not know what 
form an attack might take or the probability of an attack occurring. 
Instead, to get an idea of the cost of a food disaster, we will look at 
the costs of some severe, foodborne illness outbreaks.


Risks:


Regulations implementing legislation to protect the health of citizens 
against bioterrorism 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' jurisdiction. 
These regulations will improve the ability to address credible threats 
of serious adverse health consequences or death to humans or animals.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           12/00/02
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses


Government Levels Affected:


None


Agency Contact:
Leslye M. Fraser
Associate Director for Regulations, Office of Regulations and Policy
Department of Health and Human Services
Food and Drug Administration
Center for Food Safety and Applied Nutrition
5100 Paint Branch Parkway
College Park, MD 20740
Phone: 301 436-2378
Fax: 301 436-2637
Email: [email protected]
RIN: 0910-AC40
_______________________________________________________________________



HHS--FDA



39. [bull] ESTABLISHMENT OF PRIOR NOTIFICATION REQUIREMENT FOR ALL 
IMPORTED FOOD SHIPMENTS
Priority:


Economically Significant. Major under 5 USC 801.


Unfunded Mandates:


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


Legal Authority:


PL 107-188, sec 307


CFR Citation:


Not Yet Determined


Legal Deadline:


Final, Statutory, December 12, 2003.


The Public Health Security and Bioterrorism Preparedness and Response 
Act of 2002, section 307, directs the Secretary, through FDA, to issue 
final regulations establishing prior notification requirements for all 
imported food shipment by December 12, 2003. If FDA fails to issue 
final regulations by this date, the statute is self-executing on this 
date, and requires FDA to receive prior notice of not less than 8 
hours, nor more than 5 days until final regulations are issued.


Abstract:


This rulemaking is one of a number of actions being taken to improve 
FDA's ability to respond to threats of bioterrorism. Section 801(m) of 
the Federal Food, Drug and Cosmetic Act (FFDCA), which was added by 
section 307 of the Public Health Security and Bioterrorism Preparedness 
and Response Act of 2002, authorizes the Secretary, through FDA, to 
promulgate final regulations by December 12, 2003. Section 801(m) 
requires notification to FDA prior to the entry of imported food. The 
required prior notice would

[[Page 74121]]

provide the identity of the article of food; the manufacturer; the 
shipper; the grower, if known at the time of notification; the 
originating country; the shipping country; and the anticipated port of 
entry. The regulation would identify the parties responsible for 
providing the notice and explain the information that the prior notice 
is required to contain, the method of submission of the notice, and the 
minimum and maximum period of advance notice required. Section 307 also 
states that if FDA does not receive prior notice or receives inadequate 
prior notice, the imported food shall be held at the port of entry 
until proper notice is provided.


Statement of Need:


The events of September 11, 2001, highlighted the need to enhance the 
security of the U.S. food supply. Congress responded by passing the 
Public Health Security and Bioterrorism Preparedness and Response Act 
of 2002 (the Bioterrorism Act), was signed into law on June 12, 2002. 
The proposed regulations would implement section 307 of the 
Bioterrorism Act.


Summary of Legal Basis:


Section 307 of the Bioterrorism Act amended the FFDCA by adding section 
801(m), which authorizes the Secretary through FDA to establish by 
regulation requirements for the notification to FDA prior to the entry 
of imported food. In addition, section 307 of the Bioterrorism Act also 
amends section 301 of the FFDCA by making the offering of a food for 
import or the importing of a food without prior notification, as 
required by the new regulations, a prohibited act.


Alternatives:


None, based on clear statutory directive to establish regulations.


Anticipated Cost and Benefits:


The prior notification provision is an economically significant 
regulatory action, mainly because so many shipments are affected. For 
calendar year 2002, FDA estimates that about 4.7 million human and 
animal food and dietary supplements line items will be imported into 
U.S. commerce by airplane, train, vessel, and truck.


For those importers who currently do not notify FDA until their actual 
arrival (or later) at a point of entry, this proposed rule will create 
a burden as it would require a change in their current methods of 
operation. Prior notice requirements will also create some additional 
burdens if FDA requires more imported articles to be held for FDA 
inspection.


FDA costs will include the labor hours, hardware, and software costs 
for updating the present OASIS system. Technology costs will likely 
increase further if FDA has to create a stand alone system instead of 
working through U.S. Customs Service's ACE system to meet the statutory 
deadlines. FDA costs may also include hiring additional inspectors to 
certify the receipt of prior notice and clear the food to enter into 
U.S. commerce, and storing goods, if FDA has to take custody.


The provisions will improve substantially FDA's ability to examine 
imported food for deliberate and accidental contamination. The purpose 
of the prior notification of imported food shipments is to allow the 
FDA to determine whether there is any credible evidence or information 
indicating that an article of food presents a threat of serious adverse 
health consequences or death to humans or animals, and to receive and 
review the prior notification, and appropriately respond. It is not 
possible to directly estimate the benefits of averting a terrorist 
attack, as we do not know what form an attack might take or the 
probability of an attack occurring.


Risks:


Regulations implementing legislation to protect the health of citizens 
against bioterrorism 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' jurisdiction. 
These regulations will improve the ability to address credible threats 
of serious adverse health consequences or death to humans or animals.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           12/00/02
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses


Government Levels Affected:


Federal


Federalism:


 Undetermined


Agency Contact:
Mary Ayling
Lead, Inspection and Compliance Team, Food Safety Staff
Department of Health and Human Services
Food and Drug Administration
HFS-32
Center for Food Safety and Applied Nutrition
5100 Paint Branch Parkway
College Park, MD 20740
Phone: 301 436-2131
Fax: 301 436-2605
Email: [email protected]
RIN: 0910-AC41
_______________________________________________________________________



HHS--FDA



40. [bull] APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG: PATENT 
LISTING REQUIREMENTS AND APPLICATION OF 30-MONTH STAYS ON APPROVAL OF 
ABBREVIATED NEW DRUG APPLICATIONS
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 3321; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 355a; 21 
USC 356; 21 USC 356a; 21 USC 356b; 21 USC 356c; 21 USC 371; 21 USC 374; 
21 USC 379e


CFR Citation:


21 CFR 314.52(a)(3); 21 CFR 314.53(b); 21 CFR 314.53(c)(1); 21 CFR 
314.53(c)(2); 21 CFR 314.95(a)(3)


Legal Deadline:


None


Abstract:


The final rule would clarify the types of patents for which information 
must or must not be submitted to FDA. The final rule would also revise 
the patent declaration to make it more detailed. The rule would also 
revise the regulations regarding the approval date for certain 
abbreviated new drug applications or ``505(b)(2) applications'' by 
stating that there is only one opportunity for a 30-month stay in the 
approval date of an ANDA or 505(b)(2) application.


Statement of Need:


In recent years, FDA has seen new drug application (NDA) applicants 
submit

[[Page 74122]]

patent information to FDA shortly before other patents for the drug are 
to expire. Disputes have arisen whether the later-filed patents are 
appropriately submitted to FDA. The Federal Trade Commission (FTC) has 
also asked FDA to clarify whether NDA applicants can or should list 
various types of patents at FDA. The FTC has also issued a report 
questioning whether NDA applicants have used later-filed patents to 
seek unwarranted delays in the approval of generic drugs.


Summary of Legal Basis:


The principal legal authority for this rule is found at sections 505 
and 701 of the Federal Food, Drug, and Cosmetic Act (the Act). Section 
505(b) of the Act describes the contents of an NDA and 505(b)(2) 
application, including the patent listing and patent certification 
requirements. Section 505(j) of the Act describes the contents of an 
ANDA, including patent certification requirements. Both sections 505(b) 
and 505(j) of the Act also describe the 30-month stay of approval dates 
for ANDA's and 505(b)(2) applications if the ANDA or 505(b)(2) 
application applicant had certified that a patent was invalid or would 
not be infringed, and a timely suit for patent infringement ensued. 
Section 701(a) of the Act gives FDA the authority to issue regulations 
for the efficient enforcement of the Act.


Alternatives:


With respect to patent listing, one alternative would be to remain 
silent and defer to NDA applicants as to the appropriateness of any 
particular patent. This alternative, however, would not deter the 
submission of inappropriate patent information and could lead to 
unnecessary patent disputes between patent owners, NDA holders, and 
ANDA or 505(b)(2) application applicants.


As for the 30-month stay, there are alternative arguments to justify a 
single 30-month stay, but those alternative theories could also result 
in no notice to the patent owner or NDA holder and no opportunity for 
even a single 30-month stay. Such results would be contrary to the 
Act's desire to balance generic drug approvals against a need to 
preserve incentives for innovation. Another alternative would be to 
continue allowing multiple 30-month stays, but this would have the 
effect of delaying the introduction of generic drugs into the market.


Anticipated Cost and Benefits:


The one-year benefits of the regulation will include the increase in 
revenues to generic firms and the savings to consumers from the earlier 
availability of less expensive pharmaceuticals. The estimated total 
one-year benefit is approximately $3.2 billion. Adjusting this benefit 
to account for the expected increase in baseline pharmaceutical 
expenditures, the total benefit for the years 2002 through 2011 is 
expected to be approximately $53.9 billion.


Eliminating multiple 30-month stays per ANDA will prevent delays in 
generic drug competition. Generic drug companies gain through 
additional sales, and, to the extent that generic prices are lower than 
innovator prices, consumers benefit from the ``price gap.'' While the 
quantified benefits do exceed the quantified costs, this rule has the 
additional important benefit of preserving the balance struck in the 
Hatch-Waxman amendments.


Risks:


The regulation would deter misuse of the patent listing and patent 
certification process to obtain unwarranted, multiple 30-month delays 
in the approval of an ANDA or 505(b)(2) application. Court decisions 
indicate that ANDA applicants and 505(b)(2) applicants have no private 
right of action to have inappropriate patents removed from FDA's lists, 
and the FTC report suggests that some patents submitted to FDA have 
been inappropriately listed.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            67 FR 65448                                    10/24/02
NPRM Comment Period End                                        12/23/02
Final Rule                                                     03/00/03
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


None


Agency Contact:
Jarilyn Dupont
Department of Health and Human Services
Food and Drug Administration
Office of Policy, Planning and Legislation (HF-11)
5600 Fishers Lane
Rockville, MD 20857
Phone: 301 827-3360
Fax: 301 594-6777
Email: [email protected]
RIN: 0910-AC48
_______________________________________________________________________



HHS--FDA

                              -----------

                            FINAL RULE STAGE

                              -----------




41. 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 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


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

[[Page 74123]]

certain information to professional labeling.


Statement of Need:


The current format and content requirements in sections 201.56 and 
201.57 were established to help ensure that labeling includes adequate 
information to enable health care practitioners to prescribe drugs 
safely and effectively. However, various developments in recent years, 
such as technological advances in drug product development, have 
contributed to an increase in the amount, detail, and complexity of 
labeling information. This has made it harder for practitioners to find 
specific information and to discern the most critical information in 
product labeling.


FDA took numerous steps to evaluate the usefulness of prescription drug 
labeling for its principal audience and to determine whether, and how, 
its format and content can be improved. The agency conducted focus 
groups and a national survey of office-based physicians to ascertain 
how prescription drug labeling is used by health care practitioners, 
what labeling information is most important to practitioners, and how 
professional labeling should be revised to improve its usefulness to 
prescribing practitioners.


Based on the concerns cited by practitioners in the focus groups and 
physician survey, FDA developed and tested two prototypes of revised 
labeling formats designed to facilitate access to important labeling 
information. Based on this testing, FDA developed a third revised 
prototype that it made available to the public for comment. Ten written 
comments were received on the prototype. FDA also presented the revised 
prototype at an informal public meeting held on October 30, 1995. At 
the public meeting, the agency also presented the background research 
and provided a forum for oral feedback from invited panelists and 
members of the audience. The panelists generally supported the 
prototype.


The proposed rule described 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
NPRM Comment Period End                                        03/22/01
NPRM Comment Period Reopened                                   03/30/01

[[Page 74124]]

NPRM Comment Period Reopening End                              06/22/01
Final Action                                                   05/00/03
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses


Government Levels Affected:


Undetermined


Federalism:


 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-AA94
_______________________________________________________________________



HHS--FDA



42. 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 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                                                     03/00/03
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses

[[Page 74125]]

Government Levels Affected:


None


Agency Contact:
Susan Thompson
Chemist
Department of Health and Human Services
Food and Drug Administration
(HFS-832)
Center for Food Safety and Applied Nutrition
5100 Paint Branch Parkway
College Park, MD 20740
Phone: 301 436-1450
Fax: 301 436-2623
Email: [email protected]
RIN: 0910-AB66
_______________________________________________________________________



HHS--FDA



43. 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; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 
USC 371; 21 USC 374; 42 USC 216; 42 USC 262; 42 USC 263; 42 USC 263a; 
42 USC 264


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 reactive for evidence of HCV. The 
HIV lookback regulations will be amended for consistency.


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. 201 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 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 has been collected 
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 that infected donors 
are notified. They will therefore help prevent the further transmission 
of HCV.


Alternatives:


FDA has considered permitting continued voluntary compliance with the 
recommendations that have already been 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 with the tracing of previous 
donations of donors, quarantining in-date products, identifying the 
recipients of previous blood donations, and notifying these recipients, 
as appropriate. FDA believes these costs will be more balanced 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                                                   04/00/03
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses


Government Levels Affected:


None


Agency Contact:
Paula S. McKeever
Regulatory Policy Analyst
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
Related RIN: Related To 0910-AB26
RIN: 0910-AB76
_______________________________________________________________________



HHS--FDA



44. TOLL-FREE NUMBER FOR REPORTING ADVERSE EVENTS ON LABELING FOR HUMAN 
DRUGS
Priority:


Other Significant


Legal Authority:


21 USC 355a

[[Page 74126]]

CFR Citation:


21 CFR 201; 21 CFR 208; 21 CFR 209


Legal Deadline:


Final, Statutory, January 4, 2003.


Abstract:


To require the labeling of human drugs approved under section 505 of 
the Federal Food, Drug, and Cosmetic Act to include a toll-free number 
for reports of adverse events, and a statement that the number is to be 
used for reporting purposes only and not to receive medical advice.


Statement of Need:


Consumers may not be aware of FDA's adverse event reporting program 
under Medwatch. This requirement will promote FDA's mission to protect 
the public health by informing consumers of FDA's Medwatch system.


Summary of Legal Basis:


Section 17 of the Best Pharmaceuticals for Children Act (BPCA) requires 
this final rule to issue within one year of the date of its enactment 
on January 4, 2002.


Alternatives:


This final rule is required by section 17 of the BPCA. FDA has 
considered alternatives within the scope of the statutory requirements, 
in particular, ways to reach the broadest consumer audience and to 
minimize costs to the pharmacy profession.


Anticipated Cost and Benefits:


Anticipated costs are to drug manufacturers and authorized dispensers 
of drug products, including pharmacies. The BPCA contains a provision 
requiring the Secretary to seek to minimize the cost to the pharmacy 
profession. Anticipated benefits are to obtain information about 
adverse events from consumers, which may inform FDA of trends in 
reported adverse events and result in a review of the safety and/or 
effectiveness of particular drug products on the market.


Risks:


None.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
Interim Final Rule                                             01/00/03
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses


Government Levels Affected:


None


Agency Contact:
Carol Drew
Regulatory Counsel
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-AC35
_______________________________________________________________________



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

                              -----------

                          PROPOSED RULE STAGE

                              -----------




45. END STAGE RENAL DISEASE (ESRD) CONDITIONS FOR COVERAGE (CMS-3818-P) 
(SECTION 610 REVIEW)
Priority:


Other Significant


Legal Authority:


42 USC 1395rr


CFR Citation:


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


Legal Deadline:


None


Abstract:


This proposed rule would revise the requirements that end stage renal 
disease (ESRD) facilities must meet to be certified under the Medicare 
program.


Statement of Need:


The proposed rule is a complete overhaul of the current ESRD conditions 
for coverage in order to reduce unnecessary process and procedural 
requirements and focus on the patient and the results of the care 
provided to the patient. The proposed conditions for ESRD facilities 
would include, among other things, new infection control guidelines; 
updated water quality standards; new fire safety standards; as well as 
patient assessment, care planning, quality improvement, and electronic 
data reporting provisions that reflect the current advances in dialysis 
technology and standard care practices. The ESRD conditions were last 
published in their entirety in 1976.


Summary of Legal Basis:


Section 1881 [42 U.S.C. 1395rr] of the Social Security Act (the Act) 
authorizes benefits for individuals who have been determined to have 
end stage renal disease as provided in section 226A. Section 1881(b) of 
the Act authorizes payments on behalf of such individuals to providers 
of services and renal dialysis facilities ``which meet requirements as 
the Secretary shall by regulation prescribe.'' ESRD conditions for 
coverage may be revised as needed under the Secretary's rulemaking 
authority in section 1881.


Alternatives:


Retain the current conditions. CMS has undertaken various quality 
improvement initiatives, e.g., the Dialysis Facility Compare website 
and the CMS Clinical Performance Measures Project that have improved 
beneficiaries' quality of care. However, these initiatives lack the 
potential impact of an overall regulatory change.


Anticipated Cost and Benefits:


Undetermined.


Risks:


Failure to update would leave CMS with ESRD conditions for coverage 
that are over 26 years old and do not reflect current medical practices 
or scientific advances in the field.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           05/00/03
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses


Government Levels Affected:


None

[[Page 74127]]

Agency Contact:
Robert Miller
Health Insurance Specialist
Department of Health and Human Services
Centers for Medicare & Medicaid Services
S3-02-01
Office of Clinical Standards and Quality
7500 Security Boulevard
Baltimore, MD 21244-1850
Phone: 410 786-6797
Email: [email protected]

Teresa Casey
Health Insurance Specalist
Department of Health and Human Services
Centers for Medicare & Medicaid Services
S3-05-04
7500 Security Boulevard
Baltimore, MD 21244
Phone: 410 786-7215
RIN: 0938-AG82
_______________________________________________________________________



HHS--CMS



46. NATIONAL STANDARD FOR IDENTIFIERS OF HEALTH PLANS (CMS-6017-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 to 1320d-8


CFR Citation:


45 CFR 160; 45 CFR 162


Legal Deadline:


Final, Statutory, February 21, 1998.


Abstract:


This proposed 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.


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 
organizations 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 million and a benefit/cost ratio of 1.45. For 5 and 15 percent 
rates, the net present values are $179.2 million and $595.3 million, 
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

_______________________________________________________________________
Proposed Rule                                                  02/00/03
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



47. HEALTH INSURANCE REFORM: CLAIMS ATTACHMENTS STANDARDS (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 for claims attachments. The 
standard is required by the Health Insurance Portability and 
Accountability Act (HIPAA) of 1966. It

[[Page 74128]]

would be used to transmit clinical data, beyond those data contained in 
the claims standard, to help establish medical necessity for coverage.


Statement of Need:


The Administrative Simplification subtitle of HIPAA 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 for electronic claims attachments would 
decrease the amount of savings in health care costs.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
Proposed Rule                                                  03/00/03
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.


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



HHS--CMS



48. ORGAN PROCUREMENT ORGANIZATION CONDITIONS FOR COVERAGE (CMS-3064-P)
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 proposed 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. The Organ Procurement Organization Certification Act of 2000 
requires CMS to increase the certification cycle for OPOs from two 
years to four years and to promulgate new performance standards for 
OPOs.


Statement of Need:


This proposed rule contains new conditions for coverage for OPOs, 
including new performance standards. This proposed 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:


While this rule is expected to improve OPO performance and organ 
donations, CMS is uncertain at this time about the rule's economic 
impact on OPOs.


Risks:


Failure to publish new outcome performance standards would violate 
section 701 of Public Law 106-505, which amended the Public Health 
Service Act.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
Interim Final Ru66 FR 67109                                    12/28/01
Proposed Rule                                                  02/00/03
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


Businesses


Government Levels Affected:


None

[[Page 74129]]

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



49. USE OF RESTRAINT AND SECLUSION IN MEDICARE AND MEDICAID 
PARTICIPATING FACILITIES THAT PROVIDE INPATIENT OR RESIDENTIAL CARE 
(CMS-2130-P)
Priority:


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


Unfunded Mandates:


Undetermined


Legal Authority:


Children's Health Act of 2000


CFR Citation:


Not Yet Determined


Legal Deadline:


None


Abstract:


This proposed rule would implement provisions of the Children's Health 
Act (CHA) related to the use of restraints or seclusion for individuals 
receiving services in health care facilities that receive Federal 
funding. The rule would establish common terminology and basic 
expectations for the use of restraints and seclusion for health care 
facilities that furnish inpatient or residential care and receive 
Medicare or Medicaid funding.


Statement of Need:


In recent years, media, government, and consumer reports of deaths and 
injuries occurring due to the use of restraint or seclusion have 
heightened concern about these mechanisms as interventions. However, 
concern about use is nothing new; the appropriate use of restraint and 
seclusion has been debated and regulated in various health care 
settings for many years. Researchers have examined the use of restraint 
and seclusion, related injuries and deaths, and potential alternatives 
to address safety and care concerns while posing less inherent risk to 
the individual. Patient advocates have lobbied for reduced and more 
highly regulated use. Health care facilities and professionals have 
examined mechanisms for reduction, and some have implemented training 
programs to promote safe application and use. However, reports of 
injuries and deaths have brought concerns about care and safety to the 
forefront. The issue has gained national attention, with a call for 
regulation across health care settings.


Several highly publicized newspaper articles and Federal reports are 
considered the impetus for this regulation. The CHA established a 
significant collaboration of several important children's health bills. 
CMS has responsibility for part H, which established certain 
requirements related to the rights of residents of certain facilities 
receiving Federal funds. The CHA establishes for certain facilities 
common definitions, staff training standards, reporting requirements, 
and strict enforcement criteria.


Summary of Legal Basis:


The Children's Health Act of 2000 (Pub. L. 106-310), section 3207, part 
H.


Alternatives:


No other regulatory alternatives were considered. However, in some form 
current regulations exist for hospitals and residential treatment 
facilities, while nursing homes and ICFs/MR utilize survey guidelines. 
The CHA's intent is to develop consistency in requirements across all 
Federally funded patient or residential care facilities. The statutory 
language required that regulations be promulgated within one year of 
its enactment. This NPRM, CMS-2130-P, is currently one year behind its 
mandated time of publication.


Anticipated Cost and Benefits:


The anticipated benefits include the increase in staff education and 
training that leads to alternative usage of restraint or seclusion as a 
means of intervention and less traumatic experiences for beneficiaries 
within the given facilities, more involvement with developing 
alternative treatment mechanisms for staff and clients, alike. The 
regulation creates a change in facility practices and policies on the 
use of restraint or seclusion as a treatment mechanism. The regulation 
will create standard criteria for all patients or residential care 
facilities that receive Federal funds, which will establish an industry 
wide effect on beneficiaries who are receiving services within these 
Federal facilities. The regulation creates consistent criteria for 
staff training, and defining and reporting on restraint or seclusion.


The anticipated cost is based on regulations that will affect more than 
31,800 Medicare and Medicaid funded facilities. However, at this time, 
the extent of potential facilities affected is unattainable until 
comments are received from other HHS agencies. It is estimated that the 
cost will be roughly $500 million/yr for Federal Medicaid, and $2.5 - 3 
billion for all payors. However, the NPRM will request comments on 
actual staff training and reporting costs, it is assumed this cost will 
decrease since the majority of facilities currently have training and 
reporting requirements.


Risks:


The risks in implementing this regulation are: 1) increase in cost for 
facilities in staff training (However, facilities that currently 
utilize restraint or seclusion as a form of intervention, have some 
general staff training requirements. The CHA will only expand the 
content of this training.); 2) increased possibility of facilities 
having their Federal funding status placed in jeopardy due to non-
compliance with regulations (Industry may raise concern that the CHA's 
enforcement aspect is too harsh. For nursing homes, argument may occur 
that the CHA's enforcement goes against the intent of Congress and its 
OBRA `87 language to devise other alternative sanctions besides 
termination from the Medicare or Medicaid programs.); and 3) concern 
from facilities that currently do not have any regulations governing 
the use of restraints or seclusion (e.g., nursing homes, hospice 
inpatient facilities, and critical access hospitals. However, nursing 
homes have requirements in their survey guidance materials.)


And the risks in not implementing the regulation are: 1) increase in 
cost for facilities in staff training (However, facilities that 
currently utilize restraint or seclusion as a form of intervention, 
have some general staff training requirements. The CHA will only expand 
the content of this training.); 2) increased possibility of facilities 
having their Federal funding status placed in jeopardy due to non-
compliance with regulations (Industry may raise concern that the CHA's 
enforcement aspect is too harsh. For nursing homes, argument may occur 
that the CHA's enforcement goes against the intent of Congress and its

[[Page 74130]]

OBRA `87 language to devise other alternative sanctions besides 
termination from the Medicare or Medicaid programs.); and 3) concern 
from facilities that currently do not have any regulations governing 
the use of restraints or seclusion (e.g., nursing homes, hospice 
inpatient facilities, and critical access hospitals. However, nursing 
homes have requirements in their survey guidance materials.)


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

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


Undetermined


Small Entities Affected:


Businesses


Government Levels Affected:


Undetermined


Federalism:


 Undetermined


Agency Contact:
Frank Sokolik
Center for Medicaid and State Operations
Department of Health and Human Services
Centers for Medicare & Medicaid Services
S2-13-23
7500 Security Boulevard
Baltimore, MD 21244-1850
Phone: 410 786-7089
RIN: 0938-AL26
_______________________________________________________________________



HHS--CMS



50. PROSPECTIVE PAYMENT SYSTEM FOR PSYCHIATRIC HOSPITALS (CMS-1213-P)
Priority:


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


Unfunded Mandates:


Undetermined


Legal Authority:


PL 106-113, sec 124


CFR Citation:


Not Yet Determined


Legal Deadline:


NPRM, Statutory, October 1, 2002, per section 124 of Public Law 106-
113.


Abstract:


This proposed rule would set forth a prospective payment system (PPS) 
for psychiatric hospitals.


Statement of Need:


This proposed rule will set forth a PPS for psychiatric hospitals and 
distinct part units. It would replace the current TEFRA payment 
mechanism that is outdated and problematic for psychiatric facilities.


Summary of Legal Basis:


Section 124 of BBRA mandated implementation of an inpatient psychiatric 
facility (IPF) PPS.


Alternatives:


An IPF PPS is required by statute.


Anticipated Cost and Benefits:


The statute requires us to implement this PPS in a budget neutral 
fashion, however there will be CMS administrative costs associated with 
its implementation.


Risks:


Redistributional effects inherent in a new payment system may adversely 
affects certain classes of facilities.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

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


Undetermined


Government Levels Affected:


State, Local, Federal


Federalism:


 Undetermined


Agency Contact:
Lana Price
Director, Division of End-Stage Renal Disease, Bureau of Policy 
Development
Department of Health and Human Services
Centers for Medicare & Medicaid Services
C5-05-27
7500 Security Boulevard
Baltimore, MD 21244-1850
Phone: 410 786-4533
RIN: 0938-AL50
_______________________________________________________________________



HHS--CMS



51. REVISIONS TO THE MEDICARE APPEALS PROCESS (CMS-4004-P)
Priority:


Other Significant


Legal Authority:


Sec 521 of BIPA


CFR Citation:


42 CFR 426


Legal Deadline:


NPRM, Statutory, October 1, 2002, Statutory effective date 10/01/2002.


Abstract:


This proposed rule will also incorporate recommendations from an SSA/
HHS workgroup to improve the Administrative Law Judge (ALJ) hearing 
process. ALJs within the SSA who conduct hearings for Medicare fee-for-
service and managed care cases are currently governed by the SSA 
disability regulations. These regulations apply to disability cases and 
not to Medicare. In an effort to improve the integrity of the appeals 
process, CMS has recognized the need to develop regulations that are 
specific to the adjudication of Medicare cases.


Statement of Need:


Section 521 of the Benefits Improvement and Protection Act of 2000 
(BIPA) requires the Secretary to promulgate regulations implementing 
new claims appeal procedures that are scheduled to take effect by 
October 1, 2002. Although we are unable to meet this deadline, we 
anticipate publishing a proposed rule in October, 2002. Subsequently, a 
final rule will be needed to implement the changes required by the 
statute.


Summary of Legal Basis:


Section 521 of BIPA amended section 1869 of the Social Security Act to 
require significant revisions to Medicare claims appeal procedures. 
Section 1869(a)(1) specifically directs the Secretary to promulgate 
regulations implementing the required changes.


Alternatives:


Promulgation of this regulation is required by statute, therefore there 
is no alternative.


Anticipated Cost and Benefits:


We anticipate that the new appeals process created by this regulation 
will decrease the number of appeals requested, reduce the length of 
time required to adjudicate an appeal, improve the integrity of the 
appeals process, and improve the accuracy and consistency of appeals 
decisions. These changes will benefit Medicare providers, suppliers, 
and beneficiaries. The new appeal procedures should not impose any 
additional costs on these groups but fully implementing the changes 
required by the statue is anticipated to generate administrative costs 
for HHS exceeding $100 million.

[[Page 74131]]

Risks:


Failure to implement this regulation by the statutory effective date 
will expose CMS to potential lawsuits.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
Proposed Rule                                                  11/00/02
Regulatory Flexibility Analysis Required:


Undetermined


Small Entities Affected:


No


Government Levels Affected:


Undetermined


Agency Contact:
Michael Edmondson
Health Insurance Specialist
Department of Health and Human Services
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244
Phone: 410 786-6478
RIN: 0938-AL67
_______________________________________________________________________



HHS--CMS



52. PROSPECTIVE PAYMENT SYSTEM AND CONSOLIDATED BILLING FOR SKILLED 
NURSING FACILITIES--UPDATE FOR FY 2004 (CMS-1469-P)
Priority:


Other Significant. Major under 5 USC 801.


Legal Authority:


Sec 1888(e) of the Social Security Act


CFR Citation:


42 CFR 413.330 to 413.350


Legal Deadline:


NPRM, Statutory, April 1, 2003.


Final, Statutory, July 31, 2003, final rule to be published before 
August 1, 2003.


Abstract:


This annual proposed rule updates the payment rates used under the SNF 
PPS beginning October 1, 2003.


Statement of Need:


The Medicare SNF PPS was established by section 4432 of the Balanced 
Budget 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

_______________________________________________________________________
Proposed Rule                                                  04/00/03
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses


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-AL90
_______________________________________________________________________



HHS--CMS



53. CHANGES TO THE HOSPITAL OUTPATIENT PROSPECTIVE PAYMENT SYSTEM AND 
CALENDAR YEAR 2004 PAYMENT RATES (CMS-1471-P)
Priority:


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


Unfunded Mandates:


Undetermined


Legal Authority:


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


CFR Citation:


Not Yet Determined


Legal Deadline:


None


Abstract:


This rule would revise the Medicare hospital outpatient department 
prospective payment system for the January 1, 2004 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.

[[Page 74132]]

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                                                           06/00/03
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses


Government Levels Affected:


Federal


Agency Contact:
Cindy Read
Department of Health and Human Services
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244
Phone: 410 786-0378
RIN: 0938-AL91
_______________________________________________________________________



HHS--CMS



54. REVISIONS TO PAYMENT POLICIES UNDER THE PHYSICIAN FEE SCHEDULE FOR 
CALENDAR YEAR 2004 (CMS-1476-P)
Priority:


Other Significant. Major under 5 USC 801.


Legal Authority:


42 USC 1395W-4


CFR Citation:


42 CFR 410; 42 CFR 414


Legal Deadline:


None


Abstract:


Revisions to payment policies under the physician fee schedule for 
calendar year 2004.


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,'' which requires Medicare to pay for physicians' services 
under a fee schedule. Section 4644 of the Balanced Budget Act of 1997 
(Pub. L. 105-33) 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.


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                                                           05/00/03
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses


Government Levels Affected:


Federal


Agency Contact:
Latesha Walker
Department of Health and Human Services
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244
Phone: 410 786-1101
RIN: 0938-AL96
_______________________________________________________________________



HHS--CMS



55. [bull] REVISIONS TO AVERAGE WHOLESALE PRICE METHODOLOGY (CMS-1229-
P)
Priority:


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


Unfunded Mandates:


Undetermined


Legal Authority:


1842(o)


CFR Citation:


Not Yet Determined


Legal Deadline:


None


Abstract:


This rule would propose revisions to the source and methodology for 
determining the average wholesale price (AWP) of drugs covered by 
Medicare incident to a physician's service.


Statement of Need:


Studies by the Department of Justice, GAO, OIG, and others indicate 
that the current method of calculating AWP results in payments that are 
significantly higher than the providers' acquisition costs for 
Medicare-covered drugs. These revisions are intended to pay more 
appropriately for Medicare-covered drugs. A revision of AWP was 
included in the President's FY 2003 budget.


Summary of Legal Basis:


1842(o) requires that Medicare pay 95 percent of the average wholesale 
price for drugs not otherwise paid on a cost

[[Page 74133]]

or prospective payment basis. The definition of AWP is left to the 
Secretary to interpret.


Alternatives:


None.


Anticipated Cost and Benefits:


We anticipate significant savings for the program and beneficiaries 
from using a revised definition of AWP.


Risks:


Without this regulation, Medicare will continue to make payments that 
are significantly higher than market prices and providers' acquisition 
costs for Medicare-covered drugs.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
Proposed Rule                                                  05/00/03
Regulatory Flexibility Analysis Required:


Undetermined


Small Entities Affected:


Businesses


Government Levels Affected:


Undetermined


Federalism:


 Undetermined


Agency Contact:
Robert Niemann
Department of Health and Human Services
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244
Phone: 410 786-4569
RIN: 0938-AM12
_______________________________________________________________________



HHS--CMS



56. [bull] ELECTRONIC MEDICARE CLAIMS SUBMISSION (CMS-0008-P)
Priority:


Other Significant


Legal Authority:


PL 107-105


CFR Citation:


Not Yet Determined


Legal Deadline:


None


Abstract:


This proposed rule implements the requirements for electronic 
submission of Medicare claims, submitted on or after October 16, 2003. 
In addition, this rule also implements the conditions upon which a 
waiver could be granted for these requirements.


Statement of Need:


Needed to state how we will implement the Administrative Simplification 
Compliance Act (ASCA), Public Law 107-105. It requires the electronic 
submission of Medicare claims, although the Secretary has the authority 
to grant waivers. This requirements applies to claims on or after 
October 16, 2003.


Summary of Legal Basis:


Public Law 107-105


Alternatives:


If we do nothing, it demonstrates the Department's lack of commitment 
to HIPAA and its enforcement.


Anticipated Cost and Benefits:


Will have an impact on the Medicare contractors budget but the 
magnitude is unknown at this time. A presumed benefit is that providers 
will choose to switch to electronic claims submissions.


Risks:


Providers may choose not to participate in Medicare.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
Proposed Rule                                                  03/00/03
Regulatory Flexibility Analysis Required:


Undetermined


Government Levels Affected:


None


Agency Contact:
Elizabeth Holland
Center for Health Plans and Providers
Department of Health and Human Services
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244
Phone: 410 786-1309
RIN: 0938-AM22
_______________________________________________________________________



HHS--CMS

                              -----------

                            FINAL RULE STAGE

                              -----------




57. REVISION OF MEDICARE/MEDICAID HOSPITAL CONDITIONS OF PARTICIPATION 
(CMS-3745-F)
Priority:


Other Significant


Legal Authority:


42 USC 1395x; 42 USC 1302; 42 USC 1395(cc); 42 USC 1395hh; 42 USC 
13206-8


CFR Citation:


42 CFR 416; 42 CFR 482; 42 CFR 485; 42 CFR 489


Legal Deadline:


None


Abstract:


This final rule will revise the requirements that hospitals must meet 
to participate in the Medicare and Medicaid programs. The revised 
requirements focus on patient care, and how the outcomes of that care 
reflect a cross-functional view of how patients experience care and 
treatment in the hospital setting.


Statement of Need:


The purpose of the hospital conditions of participation is to protect 
patient health and safety and help assure that quality care is 
furnished to all hospital patients. Hospitals must meet the conditions 
of participation in order to participate in Medicare or Medicaid. 
Revised conditions are necessary to ensure that our regulations focus 
primarily on the actual quality of care furnished to patients, and the 
outcomes of that care, rather than on procedural compliance. These 
changes are intended to give hospitals the flexibility needed to 
achieve high-quality outcomes in the most cost-effective manner.


In addition, the regulations are intended to promote a cross-
functional, interdisciplinary approach to hospital performance, instead 
of an approach geared towards evaluating each department of a hospital 
as a stand-alone entity. This approach is in line with current best 
practices in hospitals, in which patients routinely encounter many 
caregivers and services that often cut across department lines.

[[Page 74134]]

Summary of Legal Basis:


Section 1861(e) of the Social Security Act (the Act) provides that a 
hospital participating in the Medicare program must meet certain 
specified requirements. In addition, section 1861(e)(9) of the Act 
specifies that a hospital also must meet such requirements that the 
Secretary finds are necessary in the interest of the health and safety 
of the hospital's patients. Under this authority, the Secretary has 
established in regulations the requirements that a hospital must meet 
to participate in Medicare. These requirements are set forth in 
regulations at 42 CFR part 482, ``Conditions of Participation for 
Hospitals.'' Section 1905(a) of the Act provides that Medicaid payments 
may be applied to hospital services. Under regulations at 42 CFR 
440.10(a)(3)(iii), hospitals generally are required to meet the 
Medicare conditions of participation in order to participate in 
Medicaid.


Alternatives:


CMS considered the possibility of revising individual sections of the 
current hospital regulations. However, we determined that the best 
means of achieving the systematic changes needed in the regulations was 
to revise the hospital conditions in their entirety. The specific areas 
that are likely to form the core of the revised requirements include 
patient rights, patient assessment, patient care, quality assessment 
and improvement, and information management.


Anticipated Cost and Benefits:


There would not be significant costs associated with this final rule. 
The benefits that would be derived from the rule are discussed in the 
Statement of Need section, above.


Risks:


By revising these regulations to focus on the quality of the actual 
care given to an individual and the effectiveness of that care for the 
individual patient, we hope to reduce risks to beneficiaries' health 
and safety. Revised procedures can better focus on ensuring that the 
care being given to a patient is the care that is actually necessary 
and effective for that patient. No quantitative estimates of risk 
reductions are available yet.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            62 FR 66726                                    12/19/97
NPRM Comment Period End                                        03/20/98
Final Action                                                   09/00/03
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses, Organizations


Government Levels Affected:


None


Federalism:


 Undetermined


Agency Contact:
Stephanie Dyson
Health Insurance Specialist
Department of Health and Human Services
Centers for Medicare & Medicaid Services
S3-02-01
7500 Security Boulevard
Baltimore, MD 21244
Phone: 410 786-9226
RIN: 0938-AG79
_______________________________________________________________________



HHS--CMS



58. 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 final rule establishes a standard unique ID for all health care 
providers under the Health Insurance Protability and Accountability Act 
(HIPAA) of 1966 (Pub. L. 104-191). The rule implements administrative 
simplification initiatives that have a national scope beyond Medicare 
and Medicaid.


Statement of Need:


HIPAA 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 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

[[Page 74135]]

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                                                   02/00/03
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



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


Other 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 final rule is being jointly developed by CMS and the Department of 
Commerce. This final rule adopts standards for the security of certain 
electronic, individually identifiable health information of health 
plans, health care clearinghouses, and certain health care providers. 
It implements administrative simplification initiatives that have a 
national scope beyond the Medicare and Medicaid programs.


Statement of Need:


The Administrative Simplification provisions of the Health Insurance 
Portability and Accountability Act (HIPAA) of 1966 required the 
Department to adopt standards for security.


Currently, no standard measures exist in the health care industry that 
address all aspects of the security of electronic health information 
while it is being stored or transmitted between entities.


The use of the security standards will improve the Medicare and 
Medicaid programs, and other Federal health programs and private health 
programs, and the effectiveness and efficiency of the health care 
industry in general by establishing a level of protection for certain 
electronic health information.


Summary of Legal Basis:


This final rule implements some of the requirements of the 
Administrative Simplification subtitle of HIPAA.


Alternatives:


Existing security standards do not encompass all the requirements set 
forth in the law.


Anticipated Cost and Benefits:


Although we cannot determine the specific economic impact of the 
standards in this final rule (and individually each standard may not 
have a significant impact), we are unable to estimate the cost of 
implementing the security standards as implementation needs will vary 
dependent upon each entity's risk assessment and upon what is already 
in place. In addition, it is important to recognize that security is 
not a one-time project, but rather an on-going, dynamic process. 
However, the overall impact analysis makes clear that, collectively, 
all the HIPAA standards will have a significant impact of over $100 
million on the economy. We believe that the overall Administrative 
Simplification costs will be offset by future savings.


Implementation of the security standards will provide confidentiality, 
integrity and availability protections to certain personaly 
identifiable health information. The synergistic effect of the 
employment of the security standards will also enhance all aspects of 
HIPAA's Administrative Simplification requirements.


Risks:


The security of electronic protected health information is, and has 
been for some time, a basic business

[[Page 74136]]

requirement that health care entities ignore at their peril. Instances 
of ``hacking'' and other security violations may be widely publicized, 
and can seriously damage an institution's community standing. 
Appropriate security protections are crucial for encouraging the growth 
and use of electronic data interchange.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            63 FR 43242                                    08/12/98
NPRM Comment Period End                                        10/13/98
Final Rule                                                     12/00/02
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



60. HOSPITAL CONDITIONS OF PARTICIPATION: QUALITY ASSESSMENT AND 
PERFORMANCE IMPROVEMENTS (QAPI) (CMS-3050-F)
Priority:


Other Significant


Legal Authority:


42 USC 1302; 42 USC 1395hh


CFR Citation:


42 CFR 482.21


Legal Deadline:


None


Abstract:


This final rule addresses provisions relating to the development and 
implementation of a QAPI program and its components. It imposes several 
requirements that are designed to increase patient safety and track the 
methodologies and/or programs or both used to increase patient safety.


Statement of Need:


In 1999, reports of deaths and serious injuries to patients associated 
with medical errors were published in a report issued by the Institute 
of Medicine (IOM) entitled, ``To Err is Human: Building a Safer Health 
System.'' This report generated much media, public, Congressional, and 
Departmental concern for patient health and safety, estimating that up 
to 98,000 Americans die each year as a result of preventable medical 
errors.


The Quality Interagency Coordination Task Force (QuiC), evaluated the 
recommendations in the IOM report and to respond with a strategy to 
identify patient safety issues and stimulate the reduction of medical 
errors by 50 percent over the next 5 years, as recommended by the IOM. 
This regulation will serve to accomplish this goal.


Summary of Legal Basis:


Hospitals must meet certain conditions in order to participate in the 
Medicare program that are intended to protect patient health and safety 
and ensure that high-quality care is provided. Hospitals receiving 
payment under Medicaid must meet the CoPs in Medicare. 42 U.S.C. 1302 
and 42 U.S.C. 1395hh authorizes promulgation of regulations in the 
interest of the health and safety of individuals who are furnished 
services in the institution.


Alternatives:


We considered adding requirements that were more prescriptive in 
nature. However, in response to public comments, and in recognition 
that this requirement will apply to hospitals of varying size, 
operating in wide ranges of localities, serving diverse populations, we 
opted not to utilize this approach. Development of more detailed 
strategies and policies to comply with the requirement will be left to 
the discretion of each hospital.


Anticipated Cost and Benefits:


Hospitals are currently required to have a quality assurance program 
and we believe that the costs associated with the QAPI program are 
similar to the costs associated with their existing quality assurance 
program. Therefore, we do not anticipate the implementation of the 
final rule to result in any significant increase in costs to hospitals 
or the Medicare and Medicaid programs. The information requirements 
contained within the regulations are comparable to those of JCAHO and 
are necessary safeguards against patient safety.


Given the variability of QAPI programs, it would be difficult to define 
the extent to which this would affect individual hospitals. CMS has 
allowed maximum flexibility in meeting these requirements, and Medicare 
hospitals have existing requirements for QA programs. We do, however, 
recognize that hospitals will have an increased minimal burden 
associated with the writing of internal policies and procedures that 
encompass all aspects of this requirement. Also, hospitals must 
continue to track incidents and analyze their causes, in addition to 
the new requirement of implementing preventive actions and mechanisms 
of learning. Accredited JCAHO hospitals should not experience increased 
burden associated with the requirement for performance projects; 
however, CMS' assessment of the rule's possible burden implications for 
these hospitals is currently under review. Also, the 1,485 non-
accredited hospitals will now be required to perform improvement 
projects that measure, analyze, and track quality indicators or other 
aspects of performance. We have minimized the burden to these 
facilities by allowing projects to be representative of the hospitals 
complexity of services and resources.


Risks:


This final rule is intended to encourage the emphasis of patient safety 
in hospitals, and serves as the first step toward providing the 
framework for and bringing to the forefront of medical practice, 
increased patient safety and accountability. The knowledge gained from 
QAPI and patient safety programs will lead to better health care for 
Medicare's more than 39 million beneficiaries.


Given the substantial media, public, Congressional, and Departmental 
concern regarding patients' health and safety, we believe that this 
final rule should be published as soon as possible. The QAPI CoP 
provides the framework to implement the Administration's initiatives, 
thereby addressing preventable medical errors and patient safety in 
hospitals.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            62 FR 66725                                    12/19/97
NPRM Comment Period End                                        02/17/98
Final Rule                                                     12/00/02

[[Page 74137]]

Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses


Government Levels Affected:


State


Agency Contact:
Stephanie Dyson
Health Insurance Specialist
Department of Health and Human Services
Centers for Medicare & Medicaid Services
S3-02-01
7500 Security Boulevard
Baltimore, MD 21244
Phone: 410 786-9226
RIN: 0938-AK40
_______________________________________________________________________



HHS--CMS



61. REVIEW OF NATIONAL COVERAGE DETERMINATIONS AND LOCAL COVERAGE 
DETERMINATIONS (CMS-3063-F)
Priority:


Other Significant


Legal Authority:


Sec 522 of the BIPA 2000


CFR Citation:


42 CFR 405


Legal Deadline:


NPRM, Statutory, October 1, 2001, The effective date for regulation 
changes is 10/01/01.


Abstract:


This final rule would announce a new process for beneficiaries to 
appeal national and local coverage determinations (LCDs).


Statement of Need:


Implementation of an LCD and national coverage determination (NCD) 
appeals process is required by section 522 of the Benefits Improvement 
and Protections Act (BIPA). The effective date for this section was 
October 1, 2001, so expeditious implementation of the regulation is 
crucial.


Summary of Legal Basis:


An appeal process for LCDs and NCDs is mandated by section 522 of BIPA.


Alternatives:


Because of the complex nature of the proposed processes, the agency 
opted to implement through a Notice of Proposed Rulemaking (NPRM) in 
order to grant the public an opportunity to comment on these complex 
processes. Though other approaches would not have granted such an 
opportunity to comment, alternatives could have also included not 
writing a regulation, or implementing via another mechanism, such as a 
Federal Register Notice. The agency decided that the processes were too 
complex to implement via anything other than an NPRM.


Anticipated Cost and Benefits:


The Medicare program would incur certain administrative costs 
associated with coverage determination reviews, the cost of being a 
party to coverage determination reviews, and the cost of reevaluating 
policies. A potential benefit for beneficiaries includes providing 
another avenue for beneficiaries to challenge NCDs (this time to a 
third party), and a new mechanism to challenge LCDs, as mandated by 
section 522 of BIPA.


Risks:


Risks include receiving so many comments from the public, or comments 
that are sufficiently complex, that thorough review of the comments 
would further delay implementation of a final rule.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
Proposed Rule   67 FR 54534                                    08/22/02
Comment Period End                                             10/21/02
Final Action                                                   07/00/03
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


Undetermined


Federalism:


 Undetermined


Agency Contact:
James Bossenmeyer
Health Insurance Specialist
Department of Health and Human Services
Centers for Medicare & Medicaid Services
C5-16-26
7500 Security Boulevard
Baltimore, MD 21244
Phone: 410 786-9317
Email: [email protected]
RIN: 0938-AK60
_______________________________________________________________________



HHS--CMS



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


Other Significant


Unfunded Mandates:


Undetermined


Legal Authority:


Social Security Act, sec 1871


CFR Citation:


45 CFR 162


Legal Deadline:


None


Abstract:


This rule finalizes provisions applicable to electronic data 
transaction standards, adopts implementation specifications for health 
care entities and others, and responds to public comments received on 
two related proposed rules published on May 31, 2002 in the Federal 
Register.


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. The modifications in this rule are required by the health care 
industry for initial implementation of the HIPAA transactions 
standards.


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 final rule, the health care industry would be 
unable to implement the adopted standard transactions.


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). It would loosen the financial burden 
on the health care industry.

[[Page 74138]]

Risks:


Modifying standards established in the Standard for Electronic 
Transaction final rule (65 FR 50312), as a result of the DSMO process, 
will allow the health care industry to be in compliance with 
regulations under HIPAA. This 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

_______________________________________________________________________
Proposed Rule   67 FR 38044                                    05/31/02
Final Action                                                   12/00/02
Regulatory Flexibility Analysis Required:


Undetermined


Government Levels Affected:


Undetermined


Agency Contact:
Gladys Wheeler
Department of Health and Human Services
Centers for Medicare & Medicaid Services
N2-14-17
7500 Security Boulevard
Baltimore, MD 21244
Phone: 410 786-0273
RIN: 0938-AK64
_______________________________________________________________________



HHS--CMS



63. CHANGES TO THE HOSPITAL INPATIENT PROSPECTIVE PAYMENT SYSTEM AND FY 
2004 RATES (CMS-1470-N)
Priority:


Economically Significant. Major under 5 USC 801.


Legal Authority:


Sec 1886(d) of the Social Security Act


CFR Citation:


42 CFR 412 to 413; 42 CFR 485; 42 CFR 489


Legal Deadline:


NPRM, Statutory, April 1, 2003.


Final, Statutory, August 1, 2003.


Abstract:


This notice would revise the Medicare acute hospital inpatient 
prospective payment systems for operating and capital market costs to 
implement changes arising from our continuing experience with these 
systems. These changes apply to discharges occurring on or after 
October 1, 2003.


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. These changes would be applicable 
to discharges occurring on or after October 1, 2003. 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

_______________________________________________________________________
Notice                                                         05/00/03
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses


Government Levels Affected:


None


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-AL89
_______________________________________________________________________



HHS--CMS



64. [bull] APPLICATION OF EMERGENCY MEDICAL AND TREATMENT ACT (EMTALA) 
(CMS-1063-F)
Priority:


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


Unfunded Mandates:


Undetermined


Legal Authority:


Not Yet Determined


CFR Citation:


Not Yet Determined


Legal Deadline:


None


Abstract:


This final rule regulation would clarify special responsibilities of 
Medicare hospitals that offer services for treatment of emergency 
medical conditions, to promote consistent application of the Emergency 
Treatment and Labor Act to situations not discussed in current 
regulations.

[[Page 74139]]

Statement of Need:


Revised regulations are needed to clarify the responsibilities of 
Medicare participating hospitals with respect to individuals who come 
to the hospital emergency department and request examination or 
treatment of a medical condition. The regulations would announce the 
agency's final position on proposals published on May 9, 2002 (67 FR 
31404).


Summary of Legal Basis:


The legal basis of this regulation are sections 1866(a)(1)(I) and 1867 
of the Social Security Act (42 U.S.C. 1385cc and 42 U.S.C. 1395dd).


Alternatives:


None feasible. If the regulations are not published in final, 
uncertainty among physicians and hospitals about their responsibilities 
will continue and increase.


Anticipated Cost and Benefits:


We are unable to provide objective dollar estimates of the impact of 
the regulations. We expect that publication of the regulations will 
enable hospitals and physicians to act in more focused and efficient 
ways to meet their statutory responsibilities, thus increasing the 
quality and availability of emergency care.


Risks:


Some physicians and hospitals may continue to have some concerns about 
these requirements, even after the publication of clarifying 
regulations. However, if current regulations are not clarified, 
hospitals and physicians will have continued uncertainty as to their 
statutory responsibilities, and patients with emergency medical 
conditions may face greater difficulty in receiving needed care in a 
timely manner.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
Final Action                                                   11/00/02
Regulatory Flexibility Analysis Required:


Undetermined


Government Levels Affected:


Undetermined


Federalism:


 Undetermined


Agency Contact:
Rebecca Hirshorn
Health Insurance Specialist
Department of Health and Human Services
Centers for Medicare & Medicaid Services
C4-06-06
7500 Security Boulevard
Baltimore, MD 21244
Phone: 410 786-3411
Related RIN: Related To 0938-AL23
RIN: 0938-AM34
BILLING CODE 4150-24-S

[[Page 74140]]




DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT (HUD)



Statement of Regulatory Priorities
The Regulatory Plan for the Department of Housing and Urban Development 
for fiscal year 2003 highlights the Department's most significant 
regulations and policy initiatives, as established by Secretary 
Martinez, for the upcoming fiscal year. As the Federal agency 
responsible for national policy and programs that address the housing 
needs of Americans, encourage community development, and enforce fair 
housing laws, HUD plays a significant role in communities throughout 
America. HUD touches the lives of individuals and families by helping 
to expand homeownership and affordable housing, and suitable living 
environments for all Americans. HUD's commitment to expand 
homeownership is achieved by underwriting homeownership for lower- and 
moderate-income families through its mortgage insurance programs, and 
by enforcing fair housing laws that operate to eliminate housing 
discrimination. HUD also provides housing and other essential support 
to a wide range of individuals and families with special needs, 
including homeless individuals, the elderly, persons with disabilities, 
and people living with HIV/AIDS.
From the beginning of his administration, Secretary Martinez has called 
on HUD to focus on activities that support the Department's core 
mission of providing affordable housing, expanding homeownership 
opportunities, and promoting economic growth in our Nation's 
communities. Consistent with that direction, HUD's regulatory plan for 
fiscal year 2003 builds upon the successes of the previous fiscal year 
through regulations that are designed to expand homeownership 
opportunities, that reform the home buying process by improving and 
simplifying the process of financing or refinancing homes, that 
strengthen HUD's oversight of Federal Housing Administration-approved 
mortgage lenders, and that combat predatory lending practices.
HUD is also committed to supporting its core community and economic 
development programs. Across America, faith-based and community-based 
organizations at the grassroots level share HUD's commitment and 
mission by providing critically important charitable services. In 
fiscal year 2003, HUD will comprehensively examine its programs to 
eliminate regulatory requirements that hinder these organizations from 
being able to fully participate in HUD programs and contribute to HUD's 
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: Ensuring the Equal Participation of Faith-Based Organizations 
in HUD's Efforts To Enhance Communities
Faith-based and other community organizations are indispensable in 
meeting the needs of poor Americans and distressed neighborhoods. HUD 
believes, however, that faith-based organizations have not been 
effectively utilized in assisting the Federal Government to address 
those needs. Faith-based organizations have a strong history of 
providing vital community services, such as assisting the homeless and 
preventing homelessness, counseling individuals and families on fair 
housing rights, providing the elderly with housing opportunities, 
increasing homeownership and rental housing opportunities, developing 
first-time homeownership programs, developing affordable and accessible 
housing, creating economic development programs, and supporting the 
residents of public housing facilities.
HUD's goal is to remove any restrictions in regulations or the 
appearance of restrictions so that faith-based and non-faith-based 
organizations can participate equally in HUD's programs. This removal 
of restrictions will ultimately make HUD programs more effective, 
efficient and accessible by expanding opportunities for all 
organizations to participate in developing creative solutions for their 
own communities.
Regulatory Action: Faith-Based Organizations: Providing for Equal 
Treatment of All HUD Program Participants
HUD believes that there is no need to single out faith-based 
organizations for special instructions or conditions before allowing 
them to participate in HUD programs. This proposed rule would remove 
regulatory language that appears to impose, or in fact imposes, special 
conditions or requirements on faith-based organizations. HUD's 
objective is to ensure that its programs are neutral with regard to the 
religious character of a grant-recipient organization, thereby ensuring 
that faith-based organizations have equal opportunity to participate in 
HUD programs. Programs that will be affected by this proposed rule 
include Community Development Block Grants; HOPE for Homeownership of 
Single Family Homes; Housing Opportunities for Persons with AIDS; 
Emergency Shelter Grants; Shelter Plus Care; Supportive Housing; 
Youthbuild; and Community Development Block Grants for Indian Tribes 
and Alaska Native Villages.
Priority: Establishing Housing Goals for Fannie Mae and Freddie Mac
Under the Federal Housing Enterprises Financial Safety and Soundness 
Act of 1992, HUD is required to establish housing goals for Fannie Mae 
and Freddie Mac (collectively, the Government Sponsored Enterprises or 
GSEs). The current goals, promulgated by regulation in 2000, cover the 
calendar years 2001 through 2003. The Secretary is therefore 
establishing new goals for future years. The new goals may be higher 
than the current goals; in the past, each new set of goals has in fact 
been higher than its predecessor. The purpose of the housing goals is 
to ensure that the two GSEs more fully address the housing finance 
needs of low- and moderate-income families and residents of underserved 
areas, and thereby to more fully realize their public purposes.
Regulatory Action: The Secretary of HUD's Regulation of Fannie Mae and 
Freddie Mac (Government Sponsored Entities)
Through this rule, HUD will issue new housing goal levels for the 
purchase of mortgages by Fannie Mae and Freddie Mac for calendar years 
2003 and beyond. The Department is required by statute to establish 
housing goals for the GSEs. The new goals to be established by this 
rule will have the benefit of increasing homeownership opportunities 
and affordable housing units for very low-, low- and moderate-income 
families, and will ensure that the GSEs carry out their statutory 
responsibilities.
Priority: Expanding Homeownership -- Making the Home Purchase Process 
Less Complicated and Less Costly
Homeownership plays a vital role in creating strong communities, 
generating wealth for families, and providing financial security for 
millions of Americans. Homeownership also helps to strengthen families 
and to provide a positive, stable environment for children. In brief, 
homeownership has a positive and pronounced effect on the

[[Page 74141]]

nation's economy. Yet every day Americans enter into mortgage loans, 
the largest investment most families will ever make, without the clear 
and useful information they receive with almost any other major 
purchase. Under the leadership of Secretary Martinez, HUD is determined 
to simplify the home buying process, and in doing so, expand 
homeownership to thousands of American first-time homebuyers. HUD is 
committed to streamlining the home mortgage finance process and making 
loan shopping and settlement simpler, so consumers have the information 
necessary to make informed decisions regarding mortgage costs.
Regulatory Action: RESPA: Simplifying and Improving the Process of 
Obtaining Mortgages To Reduce Settlement Costs to Consumers
The objective of this rule is to simplify and improve the process of 
obtaining home mortgages and reduce settlement costs for consumers by 
creating a more ``transparent'' settlement process to facilitate 
consumers' understanding of the true costs of a mortgage and the 
functions of an originator. Specifically, the proposed rule would: (1) 
address the issue of loan originator compensation, namely the problem 
of lender payments to mortgage brokers, by fundamentally changing the 
way in which these payments in brokered mortgage transactions are 
recorded and reported to consumers; (2) significantly improve HUD's 
Good Faith Estimate (GFE) settlement cost disclosure and HUD's related 
RESPA regulations to make the GFE firmer and more usable, to facilitate 
shopping for mortgages, to make mortgage transactions more transparent, 
and to prevent unexpected charges to consumers at settlement; and (3) 
remove regulatory barriers to allow guaranteed packages of settlement 
services and mortgages to be made available to consumers, and to permit 
consumers to shop for financing and further reduce settlement costs.
Priority: Expanding Homeownership -- Through Revitalization of 
Communities
HUD is committed to expanding homeownership opportunities, particularly 
among racial and ethnic minorities and families with disabilities. 
Homeownership helps families establish strong roots, which in turn 
strengthens communities. One way in which HUD will expand homeownership 
opportunities for minorities is through implementation of section 204 
of the National Housing Act, as recently amended. The stated purpose of 
this authority is to make HUD-held single family homes and formerly 
insured mortgages on single family properties, referred to as eligible 
assets, available for sale in a manner that promotes the revitalization 
of certain areas through expanded homeownership opportunities. Through 
this authority, HUD together with local government and nonprofit 
organizations can revitalize distressed areas and increase 
homeownership opportunities.
Regulatory Action: Disposition of HUD-Owned Single Family Assets in 
            Asset Control Areas
This proposed rule would make available HUD-held single family homes 
and mortgage assets for sale to governmental and nonprofit 
organizations, among others, for use in homeownership programs to 
revitalize certain areas. By statute, governmental and nonprofit 
organizations are to be given preference. Under this program, 
revitalization areas would be identified by applying specified economic 
and housing criteria. Eligible purchasers would be able to establish an 
Asset Control Area within a revitalization area identified by the 
Secretary, and would commit by contract to purchase all HUD-owned 
single family homes or mortgages that become available in that area for 
a time frame specified by the contract. These purchasers would then 
make available the assets in accordance with a HUD-approved plan to 
encourage homeownership and revitalize the area.
Priority: Expanding Homeownership -- Enhancing Accountability in the 
Home Purchase Process
HUD is committed to continuing its efforts to reduce predatory lending 
practices and enhance accountability in the home purchase process. 
Predatory lending, whether undertaken by creditors, brokers or 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 undertake one or more of the following 
practices: charge borrowers excessive, often hidden fees; successively 
refinance loans at no benefit to the borrower; make loans without 
regard to a borrower's ability to repay; and engage in high-pressure 
sales tactics or outright fraud and deception. In addition, faulty 
appraisals, whether intentional or unintentional, are a significant 
part of this problem and contribute to the inability of homebuyers to 
make monthly mortgage payments and to the instability of neighborhoods. 
Vulnerable populations, including elderly and low-income individuals, 
and low-income or minority neighborhoods may be targeted by these 
unscrupulous lenders. As a result, predatory lending threatens 
homeownership by placing on borrowers loans that are so expensive or 
have such high rates that borrowers are unable to pay and risk default. 
This significantly undercuts HUD's efforts to revitalize communities 
and expand homeownership.
To date, HUD has issued several regulations directed to curbing 
predatory lending practices, such as the rule prohibiting property 
flipping, the rule establishing criteria for house inspectors to be 
placed on and removed from the FHA Inspector Roster, and the rule to 
clarify the responsibilities of lenders in the FHA appraisal process. 
Additional rules designed to enhance lender accountability and 
strengthen FHA's oversight of mortgage transactions are planned for 
fiscal year 2003, and include the following:
Regulatory Action: FHA Appraiser Watch Initiative
Through the Appraiser Watch Initiative, HUD plans to establish and 
monitor a performance standard that appraisers must meet to maintain 
their status on the FHA Appraiser Roster. This rule will cover 
approximately 25,000 individuals who conduct appraisals on FHA-insured 
single family homes. The Appraiser Watch Initiative is modeled on FHA's 
Credit Watch Termination Initiative and would provide for an 
electronic, fully computerized Appraiser Watch monitoring system. The 
rule would permit an appraiser to be removed from the FHA Appraiser 
Roster if the rate of defaults and claims on closed mortgages linked to 
the appraiser exceeds a rate established by HUD. Under the terms of 
this approach, FHA would notify appraisers before removing them from 
the FHA Appraiser Roster. Any appraiser who receives such notice would 
be permitted to meet with HUD officials and present evidence that 
factors beyond his or her control contributed to the excessive rates. 
The proposal would also make provisions for appraisers to be reinstated 
to the roster.

[[Page 74142]]

Regulatory Action: Appraiser Qualifications for Placement on Single 
            Family Appraiser Roster
This rule is designed to strengthen the integrity of FHA appraisals by 
requiring that appraisers have, at a minimum, the professional 
credentials required by the Appraiser Qualifications Board of the 
Appraisal Foundation. This rule helps ensure that homebuyers seeking 
FHA-insured mortgages receive an accurate and complete appraisal of the 
homes they seek to purchase.
Priority: Improving the Quality of Public and Assisted Housing
A central HUD objective is to help low-income working families acquire 
skills that will move them toward self-sufficiency. Combined with this 
objective, it is HUD's goal to improve the quality of the housing 
opportunities provided to families in public and assisted housing. To 
do this, HUD will focus on improving the management accountability and 
physical conditions of public and assisted housing through the 
following regulations.
Regulatory Action: Deregulation of Small Public Housing Agencies (PHAs)
Although HUD has an obligation to monitor and regulate the use of 
Federal housing funds in order to ensure that taxpayer dollars are well 
spent, HUD is also mindful that compliance with its regulatory 
requirements may impose administrative burdens on PHAs and divert 
scarce resources. The cost of excessive regulation is especially 
problematic for small entities, in this case small PHAs, because they 
often possess the fewest staff and technical resources. In response to 
the limitations faced by many small PHAs, HUD is undertaking efforts to 
alleviate the regulatory and other administrative burdens Departmental 
requirements impose on small PHAs, while still requiring basic 
accountability. HUD believes that deregulating small PHAs will 
alleviate burden, and better enable them to focus on their core mission 
of providing safe, decent, and affordable housing to the neediest 
American families.
This final rule would simplify and streamline HUD's regulatory 
requirements for small PHAs that administer the public housing and 
voucher assistance programs under the United States Housing Act of 
1937. Specifically, the final rule would further streamline the PHA 
Annual Plan requirements for certain small PHAs. The final rule will 
also deregulate the assessment and scoring of small PHAs under the 
Public Housing Assessment System (PHAS) and the Section 8 Management 
Assessment Program (SEMAP), consistent with its basic regulatory 
responsibilities. In addition to the changes that solely concern small 
PHAs, this final rule would also streamline HUD's review of the annual 
plans submitted by all PHAs (large and small). The final rule follows 
publication of an August 12, 2002, proposed rule, and takes into 
consideration the public comments received on the proposed rule.
Regulatory Action: Simplification of PHA Planning Requirements
This rule would streamline various aspects of the PHA Plan requirements 
to eliminate redundancies and unnecessary reporting requirements that 
do not relate to PHAs' strategic planning efforts, and are burdensome 
to PHAs and HUD. The rule would retain aspects of the current process 
that bolster resident participation and ensure the public's access to 
PHA records and documents.
PHA strategic planning involving residents and the community can be 
accomplished in a manner that is less dictated from Washington and 
involves fewer elements of bureaucratic compliance. The current PHA 
Plan statute requires eighteen specific Plan elements and a HUD 
approval process that in many respects does not affect the substance of 
the Plans. The proposal would deregulate various elements of the PHA 
Plan now requiring HUD approval, leaving these to local discretion. The 
rule would allow and encourage PHAs to focus on performance rather than 
form and process.
Regulatory Action: Improve the Public Housing Assessment System
This 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; the management operations; and the 
satisfaction of the residents with the housing and services. The 
Department has met with public housing agencies, residents, 
representatives of these groups and other interested parties, to 
solicit input on how the PHAS can be improved. As a result of these 
meetings, the Department will publish a proposed rule for public 
comment incorporating some of the proposed changes from the 
stakeholders and seeking additional suggestions and proposals from the 
public. Improvements made to the PHAS will in turn promote maintaining 
affordable rental housing.
Regulatory Action: Project-Based Voucher Program
The Project-Based Voucher Program replaces the former and long-term 
Project-Based Certificate Program and provides PHAs with flexibility in 
administering the program that will assist PHAs in increasing housing 
opportunities. The Project-Based Program was authorized by law in 1998, 
as part of the statutory merger of the certificate and voucher tenant-
based programs. In 2000, the Congress substantially revised the 
project-based voucher law. The statutory revisions of 2000 made a 
number of changes to the program including permitting a PHA to pay 
project-based assistance for a term of up to 10 years, permitting a PHA 
to provide project-based assistance for existing housing that does not 
need rehabilitation, as well as for newly constructed or rehabilitated 
housing, and allowing a family to move from a project-based voucher 
unit after one year and transfer to the PHA's tenant-based voucher 
program. Initial guidance on the new law was provided to PHAs and 
residents in January 2001. This rulemaking begins the process of 
providing the more permanent regulatory framework for this new program.
The Priority Regulations That Comprise HUD's FY 2003 Regulatory Plan
A more detailed description of the priority regulations that comprise 
HUD's FY 2003 regulatory plan follows.
_______________________________________________________________________



HUD--Office of the Secretary (HUDSEC)

                              -----------

                          PROPOSED RULE STAGE

                              -----------




65. [bull] PARTICIPATION IN HUD PROGRAMS BY FAITH-BASED ORGANIZATIONS; 
PROVIDING FOR EQUAL TREATMENT FOR ALL HUD PROGRAM PARTICIPANTS (FR-
4782)
Priority:


Other Significant


Legal Authority:


42 USC 3535(d), 42 USC 12701 to 12839;42 USC 5301 to 5320; 42 USC 
12891, 42 USC 12901 to 12912; 42 USC

[[Page 74143]]

11376; 42 USC 11403 to 114706, 42 USC 11389; 42USC 8011


CFR Citation:


24 CFR 92; 24 CFR 570; 24 CFR 572; 24 CFR 574; 24 CFR 576; 24 CFR 582; 
24 CFR 583; 24 CFR 585; 24 CFR 1003; ...


Legal Deadline:


None


Abstract:


This rule would revise those HUD regulations that appear to deter or 
preclude the participation of faith-based organizations in HUD 
programs. Faith-based organizations are welcome participants in HUD 
programs. They are eligible to participate in HUD programs and are 
subject to the same HUD and other Federal requirements to which all 
other program participants are subject. The rule therefore would 
clarify that the prohibitions against discriminating on the basis of 
religion and engaging in efforts to advance religion in the provision 
of HUD-funded activities are applicable to all HUD program participants 
and not just one category of participants. The rule would also clarify 
that faith-based organizations participating in HUD programs may 
consider religion as a factor in hiring, consistent with Title VII of 
the Civil Rights Act of 1964. The rule would amend the regulations for 
the following HUD programs: (1) HOME Investment Partnerships; (2) 
Community Development Block Grants (CDBG); (3) Hope for Homeownership 
of Single Family Homes (HOPE 3); (4) Housing Opportunities for Persons 
with AIDS(HOPWA); (5) Emergency Shelter Grants (ESG); (6) Shelter Plus 
Care; (7) Supportive Housing; (8) Youthbuild; and (9) Community 
Development Block Grants for Indian Tribes and Alaska Native Villages 
(ICDBG).


Statement of Need:


HUD regulations must treat all program participants fairly. The 
regulations should ensure that all grantees use HUD funds for the 
purposes specified in the regulations, and only those purposes, and 
under the conditions specified in the regulations. Consistent with 
recent judicial decision, this rule would ensure that HUD programs are 
neutral with regard to the religious character of participating 
organizations.


Summary of Legal Basis:


The statutes establishing the various programs amended by this proposed 
rule and HUD's general rulemaking authority under the Department of 
Housing and Urban Development Act authorize HUD to establish regulatory 
policies and procedures for the operation of these programs. This 
authority includes the establishment of eligibility requirements for 
organizations seeking to participate in HUD's programs, the conditions 
for receipt of funding, and the eligible uses of the HUD funds.


Alternatives:


The changes made by this rule would modify regulatory requirements and, 
therefore, must also be promulgated through regulation. Nonregulatory 
alternatives (such as promulgation through HUD notice or handbook) 
would not be binding upon HUD program participants.


Anticipated Cost and Benefits:


This rule would remove regulatory language that appears to present 
barriers to equal participation by faith-based organizations in HUD's 
programs. The anticipated benefit is that the rule would help to ensure 
equal opportunity for all organizations to participate as partners in 
HUD's programs.


Risks:


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


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           02/00/03
NPRM Comment Period End                                        04/00/03
Final Action                                                   08/00/03
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


Governmental Jurisdictions, Organizations


Government Levels Affected:


None


Agency Contact:
Steven Wagner
Director, Center for Faith-Based and Community Initiatives
Department of Housing and Urban Development
Office of the Secretary
Phone: 202 708-2404
RIN: 2501-AC89
_______________________________________________________________________



HUD--HUDSEC



66. [bull] THE SECRETARY OF HUD'S REGULATION OF FANNIE MAE AND FREDDIE 
MAC (FR-4790)
Priority:


Other Significant


Legal Authority:


12 USC 1451 et seq; 12 USC 1716 to 1723h; 12 USC 4501 to 4641; 28 USC 
2641 note; 42 USC 3535(d); 42 USC 3601 to 3619


CFR Citation:


24 CFR 81


Legal Deadline:


None


Abstract:


Through this rule, the Department will propose housing goals for the 
purchase of mortgages by Fannie Mae and Freddie Mac (collectively, the 
Government Sponsored Enterprises, or GSEs) for calendar year 2004 
forward and make any necessary revisions to HUD's GSE rules to ensure 
that the GSEs meet the laws' requirements and carry out their public 
missions. In accordance with the Federal Housing Enterprises Financial 
Safety and Soundness Act of 1992 (FHEFSSA), this rule would establish 
new goals for the GSEs' purchase of mortgages financing low- and 
moderate-income housing, special affordable housing, and housing in 
central cities, rural areas, and other underserved areas. This rule 
would clarify, as necessary, HUD's guidelines for counting different 
types of mortgage purchases toward those goals. The current housing 
goals apply through 2003. The Secretary of HUD has general regulatory 
power over each GSE and is required to make such rules and regulations 
as shall be necessary to ensure that the purposes of FHEFSSA and the 
GSEs' charters are accomplished. HUD's current GSE regulations 
implement FHEFSSA's provisions and include fair housing, new program 
approval, reporting and access to information requirements. This rule 
will propose any necessary revisions to HUD's rules to implement 
FHEFSSA and carry out the Secretary's regulatory responsibilities.


Statement of Need:


In the absence of new goals, the goals already established for 2003 
remain in place, but the Secretary intends to establish goals for 2004 
and later years, with the objective of ensuring that the two 
enterprises fully address the housing finance needs of very low-,

[[Page 74144]]

low- and moderate-income families and residents of underserved areas, 
and thus realize more fully their public purposes. FHEFSSA sets forth 
the Secretary's responsibilities regarding the GSEs and the GSEs' 
charters specify their public missions. Under FHEFSSA, the Secretary 
must make necessary rules and regulations to ensure that the purposes 
of FHEFSSA and the GSEs' Charters are accomplished.


Summary of Legal Basis:


The Department is required to establish housing goals for the GSEs 
pursuant to the Federal Housing Enterprises Financial Safety and 
Soundness Act of 1992 (12 U.S.C. 4501 et seq.). HUD also has general 
regulatory power over each GSE (12 U.S.C. 4541) and is required to make 
such rules and regulations as are necessary to ensure that the purposes 
of FHEFSSA and the GSEs' charters are accomplished. (See 12 USC 4501-
4641.)


Alternatives:


The Department considered the alternative of leaving the housing goals 
unchanged. However, HUD takes very seriously its obligations under the 
law to establish the housing goals using the most current data and 
information.


The alternative of leaving other provisions of the GSE rules unchanged 
also has been considered but it is not evident that the existing rules 
will ensure that the purposes of the law are accomplished.


Anticipated Cost and Benefits:


This rule will have the benefit of increasing homeownership 
opportunities and affordable housing units for low- and moderate-income 
families and underserved communities from 2004 and beyond and it will 
ensure that the GSEs otherwise carry out their responsibilities under 
FHEFSSA. However, there is no indication that these objectives would be 
costly for the GSEs. HUD's analyses have consistently indicated that 
meeting housing goals will have little impact on the GSEs' financial 
returns or on the safety and soundness of GSE operations. Additionally, 
increased GSE activity in the affordable lending arena has not 
adversely affected traditional portfolio lenders.


Risks:


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


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           06/00/03
NPRM Comment Period End                                        08/00/03
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


None


Agency Contact:
Sandra Fostek
Director, Office of Government Sponsored Enterprise Oversight
Department of Housing and Urban Development
Office of Housing
Phone: 202 708-2224
RIN: 2501-AC92
_______________________________________________________________________



HUD--Office of Housing (OH)

                              -----------

                          PROPOSED RULE STAGE

                              -----------




67. DISPOSITION OF HUD-OWNED SINGLE FAMILY ASSETS IN ASSET CONTROL 
AREAS (FR-4471)
Priority:


Other Significant


Legal Authority:


12 USC 1710(h); 42 USC 3535(d)


CFR Citation:


24 CFR 291


Legal Deadline:


NPRM, Statutory, September 15, 2002.


Abstract:


This rule would implement a new program to make available HUD-held 
single family assets for sale to governmental organizations and 
nonprofits for use in homeownership programs to revitalize certain 
areas. Under the new program, HUD would identify revitalization areas 
by applying specified economic and housing criteria. Eligible 
purchasers, that is, units of general local government and nonprofit 
organizations, may establish an Asset Control Area within a 
revitalization area and commit by contract to purchase all HUD-owned 
single family homes or mortgages that become available in that area for 
a time frame specified by the contract. By statute, these purchasers 
are to be given preference. The entities would then make available the 
assets pursuant to a HUD-approved plan to encourage homeownership and 
revitalize the area.


Statement of Need:


The authorizing statute requires HUD to issue regulations for this 
program through rulemaking in accordance with the procedures 
established under section 553 of title 5, United States Code.


Summary of Legal Basis:


Section 602 of the Departments of Veterans Affairs and Housing and 
Urban Development, and Independent Agencies Appropriations Act, 1999 
(Pub.L. 105-276) added a new subsection (h) to section 204 of the 
National Housing Act to authorize this program.


Alternatives:


Administration of this program under a generally applicable rule will 
provide all interested parties with a level playing field and notice of 
what requirements must be followed in order to participate. This is 
more efficient than proceeding on a case-by-case basis.


Anticipated Cost and Benefits:


The costs of this rule will mainly be borne by the Department, since 
the discounts offered on eligible assets could represent a loss to the 
Mutual Mortgage Insurance Fund. The benefits are those related to the 
revitalization of, and increased homeownership within, the designated 
areas.


Risks:


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


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

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


No


Small Entities Affected:


No


Government Levels Affected:


None

[[Page 74145]]

Agency Contact:
Thomas Thompson
Field Manager, Office of Assistant Secretary for Single Family Housing
Department of Housing and Urban Development
Office of Housing
Phone: 202 708-2121
RIN: 2502-AH40
_______________________________________________________________________



HUD--OH



68. FHA APPRAISER WATCH INITIATIVE (FR-4744)
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 would establish HUD's regulations for the Federal Housing 
Administration (FHA) Appraiser Watch Initiative. Modeled on FHA's 
Credit Watch Termination Initiative, the proposed rule would provide 
for an electronic, fully computerized Appraiser Watch monitoring 
system. The Appraiser Watch Initiative establishes and monitors a 
performance standard that appraisers must meet to maintain their status 
on the Appraiser Roster. An appraiser may be removed from the Roster if 
the rate of defaults and claims on closed mortgages linked to the 
appraiser exceeds the rate established in this rule.


Statement of Need:


This rule is needed to increase appraiser accountability and address 
the role of faulty appraisals in the misuse of FHA insurance to 
underwrite bad loans that lead to defaults and foreclosed homes. Such 
defaulted properties contribute to neighborhood destabilization and 
decline. Faulty appraisals, whether intentional or not, are a 
significant part of this problem and contribute to the inability of 
homebuyers to make monthly mortgage payments and to the instability of 
neighborhoods.


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 for first-time 
homebuyers and low-income families.


Alternatives:


Individual fact-finding investigations and adjudications on a case-by-
case basis as presently conducted, and which will continue on an 
ongoing basis, are lengthy and time-consuming proceedings. The 
Department is planning to adopt a streamlined approach to increase 
appraiser accountability modeled on its successful Credit Watch 
Initiative.


Anticipated Cost and Benefits:


Anticipated costs are mainly those of information collection and 
recordkeeping requirements related to establishing an electronic, fully 
computerized Appraiser Watch monitoring system. The anticipated benefit 
is an increase in sound appraisals and a corresponding decrease in 
defaults, foreclosures, and FHA losses.


Risks:


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


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
ANPRM           67 FR 48344                                    07/23/02
NPRM                                                           12/00/02
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-AH81
_______________________________________________________________________



HUD--OH

                              -----------

                            FINAL RULE STAGE

                              -----------




69. 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 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 whose license or certification in any State 
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. The final rule 
follows publication of a November 30, 2001, proposed rule and takes 
into consideration the public comments received on the proposed rule.


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 ensure the competency of 
appraisers performing FHA appraisals. The Appraiser Roster is an 
important part of the FHA Single Family Mortgage

[[Page 74146]]

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 help 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            66 FR 60128                                    11/30/01
NPRM Comment Period End                                        01/29/02
Final Action                                                   01/00/03
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



70. RESPA--IMPROVING THE PROCESS FOR OBTAINING MORTGAGES (FR-4727)
Priority:


Economically Significant. Major under 5 USC 801.


Legal Authority:


12 USC 2601; 42 USC 3535(d)


CFR Citation:


24 CFR 3500 et seq


Legal Deadline:


None


Abstract:


This rule would establish a new framework for borrower disclosures 
under RESPA that would: (1) address the issue of mortgage broker 
compensation, specifically the problem of lender payments to mortgage 
brokers, by fundamentally changing the way in which such lender 
payments in brokered mortgage transactions are recorded and reported to 
borrowers; (2) significantly improve HUD's Good Faith Estimate (GFE) 
settlement cost disclosure, and amend HUD's related RESPA regulations, 
to make the GFE firmer and more usable, to facilitate shopping for 
mortgages, and to avoid unexpected charges to borrowers at settlement; 
and (3) remove regulatory barriers to allow guaranteed packages of 
settlement services and mortgages to be made available to borrowers, to 
make borrower shopping for mortgages easier and further reduce 
settlement costs.


Statement of Need:


The rule is needed to simplify and improve the process of obtaining a 
home mortgage to lower costs for consumers. The current disclosure 
requirements under RESPA have not been substantially revised in 
decades. Under current rules, there is confusion concerning the role of 
the mortgage broker and how the broker is compensated. Recent 
developments have only heightened the need for greater clarity. The GFE 
does not result in reliable estimates for consumers nor does it 
facilitate shopping to lower costs. Current rules present regulatory 
impediments to offering consumers simpler guaranteed packages of 
mortgages and settlement services to make shopping for a mortgage even 
easier and to lower settlement costs further. There have been 
continuing changes to the home mortgage process in the marketplace 
including new products and greater accessibility of mortgage 
information through the Internet. If properly addressed by Government, 
these and other factors can result in price reductions for consumers.


Summary of Legal Basis:


The Secretary is authorized to prescribe such rules and regulations as 
may be necessary to achieve the purpose of the Act under the Real 
Estate Settlement and Procedures Act of 1974 (12 USC 2617).


Alternatives:


As noted above, the Department has not updated the disclosure 
requirements in decades. The Department tried to bring some clarity to 
the process through two policy statements: a Statement of Policy on 
Lender Payments to Mortgage Brokers issued on March 1, 1999, and a 
Clarification of the 1999 Statement of Policy, issued on October 17, 
2001. Nonregulatory alternatives were considered and acted upon, but it 
was determined that the changes in the marketplace and recent judicial 
decisions call for new regulations on the part of HUD.


Anticipated Cost and Benefits:


Because the Nation's home mortgage market is a billion-dollar industry, 
there are costs and benefits associated with this rule that were 
described in detail in the Initial Economic Analysis that accompanied 
the proposed rule. The Economic Analysis identifies a wide range of 
benefits, costs, efficiencies, transfers and market impacts. The 
effects on consumers from improved borrower shopping could be 
substantial as a result of this rulemaking. Similarly, increased 
competition associated with packaging could result in large reductions 
in settlement service costs and associated income transfers from 
service providers who are earning ``economic rents'' in today's system 
to borrowers, who would most likely be the ultimate

[[Page 74147]]

beneficiaries of more competition among settlement service providers. 
Entities that would suffer revenue losses under this rulemaking are 
usually those who now overcharge uninformed borrowers, or are high-cost 
producers, or are benefiting from the current system's restrictions on 
competition.


Risks:


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


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            67 FR 49134                                    07/29/02
NPRM Comment Period End                                        10/28/02
Final Action                                                   01/00/03
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses


Government Levels Affected:


None


Agency Contact:
Ivy Jackson
Acting Director, Interstate Land Sales and RESPA Division
Department of Housing and Urban Development
Office of Housing
Phone: 202 708-0502
RIN: 2502-AH85
_______________________________________________________________________



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

                              -----------

                          PROPOSED RULE STAGE

                              -----------




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


Other Significant


Legal Authority:


42 USC 1437f(o); 42 USC 3535(d)


CFR Citation:


24 CFR 983


Legal Deadline:


None


Abstract:


The Project-Based Voucher Program replaces the Project-Based 
Certificate Program that was in existence for many years. Under the 
Project-Based Voucher Program, HUD pays rental assistance for eligible 
families to live in specific housing developments or units. A public 
housing agency (PHA) that administers a tenant-based housing choice 
voucher program may ``project-base'' up to 20 percent of voucher units 
funded by HUD. The Project-Based Program was authorized by law in 1998, 
as part of the statutory merger of the certificate and voucher tenant-
based programs. In 2000, the Congress substantially revised the 
project-based voucher law. The law made a number of changes including 
permitting a PHA to pay project-based assistance for a term of up to 10 
years, permitting a PHA to provide project-based assistance for 
existing housing that does not need rehabilitation, as well as for 
newly constructed or rehabilitated housing, and allowing a family to 
move from a project-based voucher unit after one year and transfer to 
the PHA's tenant-based voucher program.


Statement of Need:


This rule will implement the requirements for the new Section 8 
Project-Based Voucher program. The regulations will provide the 
appropriate notice of the legal framework for the program, and clear 
and uniform guidance for program operation for PHAs and the residents 
that the PHAs serve.


Summary of Legal Basis:


The statute is not self-implementing. Regulations are needed to present 
the legal framework for the program. The Secretary is authorized under 
the U.S. Housing Act of 1937 and the Department of Housing and Urban 
Development Act to prescribe such rules and regulations as may be 
necessary to effectively administer Department programs.


Alternatives:


This is a new program that provides assistance for housing and replaces 
a previous HUD program. Effective and fair administration of the 
program necessitates a permanent legal framework rather than informal 
and sporadic HUD notices.


Anticipated Cost and Benefits:


The new law and the regulations to be implemented by HUD provide 
additional flexibility to PHAs to manage their project-based voucher 
programs, and also provide more housing choices to the individuals and 
families served by the PHA.


Risks:


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


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
Notice          66 FR 3605                                     01/16/01
NPRM                                                           11/00/02
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



72. CHANGES TO THE PUBLIC HOUSING ASSESSMENT SYSTEM (PHAS)(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 stakeholder groups in the 
public housing assessment process, and solicit additional input from 
the public.


Statement of Need:


The Department has agreed to consider changes to the current PHAS 
regulations based on consultation with public housing stakeholders 
including industry representatives, resident groups and other 
interested Federal and congressionally chartered agencies.

[[Page 74148]]

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.


Alternatives:


The current interim scoring methodologies provide the Department with a 
fully implemented assessment system while the amended PHAS regulation 
is being developed. Other alternatives that have been considered, such 
as utilizing the Management Indicator (MASS) only, fail 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 proposed rule is 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                                                           11/00/02
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


None


Agency Contact:
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

Wanda Funk
Real Estate Assessment Center
Department of Housing and Urban Development
Office of Housing
Phone: 202 708-4932
RIN: 2577-AC32
_______________________________________________________________________



HUD--PIH



73. [bull] STREAMLINING AND DEREGULATION OF PUBLIC HOUSING AGENCY PLANS 
(FR-4788)
Priority:


Other Significant


Legal Authority:


42 USC 1437c-1; 42 USC 3535(d)


CFR Citation:


24 CFR 903


Legal Deadline:


None


Abstract:


This rule would simplify and streamline the regulations for the Public 
Housing Agency (PHA) Plans to eliminate redundancies and unnecessary 
reporting requirements that do not relate to the strategic planning 
efforts of PHAs. The rule would also deregulate certain components of 
the PHA Plans that currently require HUD approval, leaving these 
policies to the local discretion of individual PHAs. The rule would 
retain those PHA Plan requirements that bolster resident participation 
in the strategic planning of PHAs and that ensure the public's access 
to PHA records and documents. The regulatory changes will alleviate 
administrative burden on both PHAs and HUD. The changes will also 
further the goals of the PHA Plan process by enabling PHAs to focus 
their resources on strategic planning and performance, rather than on 
the forms and processes required under the current PHA Plan 
regulations.


Statement of Need:


The PHA Plans provide an easily identifiable source by which program 
participants and other members of the public may locate basic PHA 
policies and requirements concerning its operations, plans and 
services. The current PHA Plan regulations, however, impose several 
requirements on PHAs that are duplicative or administratively 
burdensome. For example, the regulations establish eighteen specific 
elements that must be addressed by PHAs and a HUD approval process that 
in many respects does not affect the substance of the Plans. Moreover, 
other statutory and HUD regulatory requirements facilitate and 
encourage successful PHA planning. For example, HUD has implemented 
management assessment systems for public housing and tenant-based 
assistance, and PHAs are statutorily required to include a resident on 
their governing boards. Accordingly, HUD has determined that PHA 
strategic planning involving residents and the community can be 
accomplished in a manner that is less dictated by the Federal 
Government and involves fewer elements of bureaucratic compliance.


Summary of Legal Basis:


Section 5A of the United States Housing Act of 1937 (42 U.S.C. 1437c-
1), which establishes the PHA Plan process, and HUD's general 
rulemaking authority under the Department of Housing and Urban 
Development Act authorize HUD to establish regulatory policies and 
procedures governing the content, submission and approval of the PHA 
Plans.


Alternatives:


The changes contained in this rule would modify regulatory requirements 
and therefore, must also be promulgated through regulation. 
Nonregulatory alternatives (such as promulgation through HUD Notice) 
would not be binding upon PHAs.


Anticipated Cost and Benefits:


This rule simplifies and streamlines regulatory requirements for PHAs 
that are required to prepare and submit Annual and 5-Year PHA Plans. 
The anticipated benefit is that the rule will alleviate the 
administrative burden imposed on PHAs, thereby freeing limited 
resources that may be better used in strategic planning efforts and in 
the provision of housing assistance for poor families.


Risks:


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


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           12/00/02
NPRM Comment Period End                                        02/00/03
Final Action                                                   05/00/03
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


Governmental Jurisdictions


Government Levels Affected:


State, Local

[[Page 74149]]

Agency Contact:
Rod Solomon
Deputy Assistant Secretary for Policy, Program and Legislative 
Initiatives
Department of Housing and Urban Development
Office of Public and Indian Housing
Phone: 202 708-0713
RIN: 2577-AC40
_______________________________________________________________________



HUD--PIH

                              -----------

                            FINAL RULE STAGE

                              -----------




74. DEREGULATION FOR SMALL PUBLIC HOUSING AGENCIES (FR-4753)
Priority:


Other Significant


Legal Authority:


42 USC 1437a; 42 USC 1437c; 42 USC 1437d(j); 42 USC 1437f; 42 USC 
3535(d)


CFR Citation:


24 CFR 902; 24 CFR 903; 24 CFR 985


Legal Deadline:


None


Abstract:


This rule simplifies and streamlines HUD's regulatory requirements for 
small public housing agencies (PHAs) that administer the public housing 
and voucher assistance programs under the United States Act of 1937 
(1937 Act). Specifically, the rule will further streamline the PHA 
Annual Plan requirements for certain small PHAs. HUD also proposes to 
deregulate the assessment and scoring of small PHAs under the Public 
Housing Assessment System (PHAS) and the Section 8 Management 
Assessment Program (SEMAP), consistent with its basic regulatory 
responsibilities. In addition to the changes that solely concern small 
PHAs, this rule will also streamline HUD's review of the Annual Plans 
submitted by all PHAs (large and small). This final rule follows 
publication of an August 14, 2002, proposed rule and takes into 
consideration the public comments received on the proposed rule.


Statement of Need:


Although HUD has an obligation to monitor and regulate the use of 
Federal housing funds in order to ensure that taxpayer dollars are well 
spent, HUD is also mindful that compliance with its regulatory 
requirements may impose administrative burdens on PHAs and divert 
scarce resources. The cost of excessive regulation is especially 
problematic for small PHAs, because they often possess the fewest staff 
and technical resources. The changes made by this final rule will 
alleviate administrative burden, and better enable small PHAs to focus 
on their core mission of providing decent, safe, and affordable housing 
for the neediest American families.


Summary of Legal Basis:


The 1937 Act and HUD's authority under the Department of Housing and 
Urban Development Act authorize HUD to establish regulatory policies 
and procedures for the operation of the Federal public and assisted 
housing programs authorized by the 1937 Act.


Alternatives:


The changes made by this final rule would modify regulatory 
requirements and, therefore, must also be promulgated through 
regulation. Nonregulatory alternatives (such as promulgation through 
HUD Notice) would not be binding upon PHAs.


Anticipated Cost and Benefits:


This rule simplifies and streamlines regulatory requirements for small 
PHAs that administer HUD's public housing and voucher assistance 
programs. The anticipated benefit is that the rule will alleviate the 
administrative burden imposed on small PHAs, thereby freeing limited 
resources that may be better used for the provision of housing 
assistance for poor families.


Risks:


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


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            67 FR 53276                                    08/14/02
NPRM Comment Period End                                        09/13/02
Final Action                                                   01/00/03
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


Governmental Jurisdictions


Government Levels Affected:


Local


Agency Contact:
Rod Solomon
Deputy Assistant Secretary for Policy, Program and Legislative 
Initiatives
Department of Housing and Urban Development
Office of Public and Indian Housing
Phone: 202 708-0713
RIN: 2577-AC34
BILLING CODE 4210-01-S

[[Page 74150]]




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 385 park units, 538 wildlife 
refuges, 24,000 miles of trails, and approximately 1.7 billion acres 
submerged in offshore waters. The Department recovers endangered 
species, manages water projects, fights wildland fires, leases public 
lands for coal, oil and gas production 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. To fulfill these responsibilities, the Department generates 
scientific information relating to land and resource management.
 The Department is committed to achieving its stewardship objectives in 
partnership with States, communities, landowners, 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:
[sbull] Adopt performance-based approaches focusing on achieving 
            results in the most cost-effective and timely manner;
[sbull] Incorporate the best available science, and utilize peer review 
            where appropriate;
[sbull] Promote partnerships with States, other groups and individuals;
[sbull] Provide incentives for private landowners to achieve 
            conservation goals; and
[sbull] Minimize regulatory and procedural burdens, promoting fairness, 
            transparency, 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 a significant 
concentration of regulatory responsibilities. OSM, in partnership with 
the States and Indian tribes, sets and enforces environmental standards 
during coal mining and reclamation operations. Other DOI bureaus rely 
on regulations to implement legislatively mandated programs that focus 
on the management of natural resources and public or trust lands. Some 
of these regulatory activities include:
[sbull] Management of migratory birds and preservation of certain 
            marine mammals and endangered species;
[sbull] Management of dedicated lands, such as national parks, wildlife 
            refuges, and American Indian trust lands;
[sbull] Management of public lands open to multiple use;
[sbull] Leasing and oversight of development of Federal energy, 
            minerals, and renewable resources;
[sbull] Management of revenues from American Indian and Federal 
            minerals;
[sbull] Fulfillment of trust and other responsibilities pertaining to 
            American Indian tribes;
[sbull] Natural resource damage assessments; and
[sbull] Management of financial and nonfinancial assistance programs.
Regulatory Policy
How DOI Regulatory Procedures Relate to the Administration's Regulatory 
Policies
Within the requirements and guidance in Executive Orders 12866, 12630, 
and 13132, DOI's regulatory programs seek to:
[sbull] Fulfill all legal requirements as specified by statutes or 
            court orders;
[sbull] Perform essential functions that cannot be handled by non-
            Federal entities;
[sbull] Minimize regulatory costs to society while maximizing societal 
            benefits; and
[sbull] 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. Regulatory 
improvement is a continuing process that requires the participation of 
all affected parties. We strive to include all affected entities in the 
decisionmaking process and to issue rules efficiently. To better manage 
and review the regulatory process, we have revised our internal 
rulemaking and information quality guidance. Results have included:
[sbull] Increased bureau awareness of and responsiveness to the needs 
            of small businesses and better compliance with the Small 
            Business Regulatory Enforcement Fairness Act (SBREFA);
[sbull] A Departmentwide effort to evaluate the economic effects of 
            planned rules and regulations;
[sbull] Issuance of new guidance in the Departmental Manual to ensure 
            the use of plain language;
[sbull] Issuance of new guidance in the Departmental Manual to ensure 
            that Departmental National Environmental Policy Act reforms 
            are institutionalized; and
[sbull] In the Natural Resources Damage Assessment Program, 
            deemphasizing actions stemming from litigation while 
            increasing outreach to involved parties and stressing 
            cooperation and restoration of affected sites.
 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 burdens while meeting the 
requirements of the laws they enforce and improving their stewardship 
of the environment and resources under their purview.
Implementing the President's National Energy Policy
 The President's National Energy Policy promotes ``dependable, 
affordable, and environmentally sound production and distribution of 
energy for the future.'' The Department of the Interior plays a vital 
role in implementing the President's energy policy goals. The lands and 
facilities managed by the Department account for nearly 30 percent of 
all the energy produced in the United States, and undeveloped 
conventional and renewable energy resources on these lands suggest that 
this share will increase in the future.

[[Page 74151]]

 The Department is taking over 100 actions to implement the President's 
energy policy, including several regulatory actions. The Bureau of Land 
Management recently completed a final rule that provides a 
comprehensive set of regulations for managing oil and gas leases in the 
National Petroleum Reserve -- Alaska. The Minerals Management Service 
will soon propose a rule that would provide an incentive for 
development of deep gas resources offshore in order to encourage 
drilling of these high-risk wells and help tap into an important new 
source of natural gas supply. The Office of Surface Mining will propose 
regulations that will create a stable regulatory environment in order 
to encourage the development of better mining and reclamation practices 
that will reduce environmental damages associated with coal operations, 
while maintaining coal production. These and other regulatory actions 
within the Department are designed to streamline permitting processes 
and encourage environmentally sound energy production.
Encouraging Responsible Management of the Nation's Resources
 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, ameliorating land and resource-management 
problems on public lands, and ensuring accountability and compliance 
with Federal laws and regulations.
 The Department is continuing to work together with State and local 
governments, landowners, conservation groups, and the business 
community to conserve species and habitat. Building on successful 
approaches such as habitat conservation plans, safe harbor agreements, 
and candidate conservation agreements, the Department is reviewing its 
policies and regulations to identify opportunities to streamline the 
regulatory process where possible, consistent with protection of 
wildlife, and to enhance incentive-based programs to encourage 
landowners and others to implement voluntary conservation measures. For 
example, the Fish and Wildlife Service is developing guidance to 
promote the establishment of conservation banks as a tool to offset 
adverse impacts to species listed under the Endangered Species Act and 
restore habitat. The Service will be publishing a proposed rule to 
facilitate projects that improve habitat for listed species.
 The Department is also developing a uniform code of scientific conduct 
and policy on research. The code describes ethical conduct for all 
Department employees who are engaged in conducting scientific 
activities on behalf of the Department. The primary reason for 
developing the code is to implement a new Federal policy on research 
misconduct as required by the Office of Science and Technology Policy. 
The new policy applies to all Federal agencies and federally funded 
research, whether conducted in-house or by partners at universities or 
in nongovernmental organizations. This new policy meets the 
expectations of the Secretary regarding the conduct of scientific 
activities with honesty, integrity, and accuracy; to make decisions 
based on the best science available; and is consistent with 
professional codes of conduct of other organizations.
 Earlier this year, Secretaries Norton and Veneman signed an historic 
agreement with 17 western governors, county commissioners and other 
affected parties on a plan to make communities safer from wildfires 
through coordinating Federal, State and local action. Under the 10-year 
Comprehensive Strategy Implementation Plan, Federal wildfire agencies, 
affected States, counties, and local governments agreed to the same 
goals, implementation outcomes, performance measures and tasks that 
need to be accomplished by specific deadlines. The plan covers all 
phases of the fire program, including fire preparedness, suppression 
and prevention, hazardous fuels management, restoration of burned 
areas, community assistance and monitoring of progress.
 The National Park Service is completing a Supplemental Environmental 
Impact Statement regarding snowmobile management in Yellowstone and 
Grand Teton National Parks and John D. Rockefeller, Jr. Memorial 
Parkway. Although a final decision is not expected until spring 2003, 
the NPS has made preliminary indications that snowmobile use will 
continue at some level in all three units. In order to continue this 
use, the NPS will likely require the use of new snowmobile engine 
technology in machines entering the parks. The new technology will 
likely improve air quality associated with the use of older machines 
and unlimited numbers of users. The subsequent changes to the existing 
rules will also likely reduce adverse economic impact projected to 
result from completely prohibiting the use of snowmobiles in all three 
parks.
 The Bureau of Land Management is working on a grazing administration 
rule that would ensure grazing decision rules conform with the 
Administrative Procedure Act, are in compliance with recent court 
decisions regarding conservation use permits, require BLM to consider 
social and economic factors when considering changes to grazing use, 
and offer other improvements to grazing activities on public lands.
Minimizing Regulatory Burdens 
 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.
 Over the last year, the Department's bureaus have worked extensively 
with the Federal Energy Regulatory Commission, along with the 
Departments of Commerce and Agriculture, to establish new licensing 
procedures that will reduce both the cost and time of obtaining a FERC 
hydropower license. In September 2002 the above agencies published a 
Federal Register notice inviting the public to comment on the new draft 
licensing procedures, and the agencies will be conducting public 
meetings around the

[[Page 74152]]

country throughout this fall. Over the course of the next year, the 
Department will be working closely with FERC and the other agencies in 
drafting new regulations that should embody many of the aspects of the 
agencies' draft new procedures.
Encouraging Public Participation and Involvement in the Regulatory 
Process
 The Department is 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 and regulations that it issues under the Rangeland 
Reform Act.
We encourage public consultation during the regulatory process. For 
example:
[sbull] 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;
[sbull] 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;
[sbull] The National Park Service has granted cooperating agency status 
            to three states and several local governments surrounding 
            Yellowstone and Grand Teton National Parks to participate 
            in the development of a sustainable winter use management 
            plan that will include two phases of snowmobile regulations 
            during 2002 and 2003.
Regulatory Actions Related to the Events of September 11, 2001
 The Bureau of Reclamation is responsible for protecting 348 reservoirs 
and more than 500 Federal dams, 58 hydroelectric plants, and over 8 
million acres of Federal property. Public Law 107-69 granted 
Reclamation law enforcement authority for its lands. Reclamation will 
finalize an interim rule published in April 2002 that implements this 
authority.
Rules of Particular Interest to Small Businesses
 The National Park Service snowmobiling rule for Yellowstone and Grand 
Teton National Parks and the John D. Rockefeller Memorial Parkway is of 
great interest to small business in the area of the parks, in 
particular those who rent snowmobiles. If, as discussed above, 
snowmobile use does continue in all three units, those small businesses 
and others will benefit.
The Future of DOI
 Interior has developed a draft Departmentwide strategic plan 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 the new strategic plan provides the Secretary 
with an opportunity to:
[sbull] Incorporate key Administration and Secretarial priorities into 
            Interior's goals and performance measures;
[sbull] Consult with key interested constituents on the future 
            direction of the Department; and
[sbull] 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 Program
 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 revisions, 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 approach for 
determining compensation rather than monetizing economic damages, and 
(c) facilitating negotiated settlements rather than litigation over 
natural resource damages.
Bureau of Indian Affairs
 The Bureau of Indian Affairs (BIA) is responsible for managing trust 
responsibilities to the Indian tribes and encouraging tribal 
governments to assume responsibility for BIA programs.
 The Bureau's rulemaking and policy development processes are designed 
to foster public and tribal awareness of the standards and procedures 
that directly affect them. The processes also encourage the public and 
the tribes to participate in developing these standards and procedures. 
The goals of BIA regulatory policies are to: (a) ensure consistent 
policies within BIA that result in 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 Management
 The Bureau of Land Management manages about 262 million acres of land

[[Page 74153]]

surface and about 700 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:
[sbull] Providing for a wide variety of public uses while maintaining 
            the long-term health and diversity of the land and 
            preserving significant natural, cultural, and historical 
            resources;
[sbull] 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;
[sbull] Understanding the needs of the public that use BLM-managed 
            lands and providing them with quality service;
[sbull] Committing to recovering a fair return for using publicly owned 
            resources and avoiding the creation of long-term 
            liabilities for American taxpayers; and
[sbull] 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:
[sbull] Are the product of communication, coordination and consultation 
            with all affected members of the public;
[sbull] Are understandable to the general public, especially those to 
            whom they are directly applicable; and
[sbull] Are subject to periodic review to determine whether BLM still 
            needs them, whether they need to be updated to reflect 
            statutory and policy changes, and whether they are 
            achieving desired results.
The regulatory priorities of BLM include:
[sbull] Completing the revision of oil and gas leasing and operations 
            regulations in order to make the program more efficiently 
            serve the regulated public;
[sbull] Completing the updating and consolidation of the regulations on 
            locating, filing, and maintaining mining claims and mill 
            and tunnel sites in order to remove unnecessary and 
            outdated provisions, reorder the regulations more 
            logically, and make them easier to read and follow;
[sbull] Completing the revision of the regulations on administration of 
            rights-of-way on the public lands in order to increase cost 
            recovery to levels that properly compensate BLM for our 
            administrative and monitoring costs and to raise the cap on 
            strict liability for right-of-way holders to a reasonable 
            level in light of costs for environmental cleanup; and
[sbull] Completing the revision of the regulations on disclaimers of 
            interest in public lands in order to remove claims on 
            titles to lands in which the Federal Government no longer 
            has an interest.
 None of these specific priorities is based on recent legislation. They 
derive from programmatic needs and awareness of national budget 
constraints.
Minerals Management Service
 The Minerals Management Service (MMS) has two major responsibilities. 
The first is 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. The second is 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) (Pub. L. 104-58), we plan to issue a final regulation to revise 
current regulations at 30 CFR part 203. The new rule would provide 
temporary incentives in the form of royalty suspension volumes for deep 
wells (at least 15,000 feet below sea level) in the Gulf of Mexico, 
that explore for or produce gas. 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; (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
 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 26 key coal-producing 
States have primacy. In return for assuming primacy, States are 
entitled to regulatory grants and to grants for reclaiming abandoned 
mine lands. In addition, under cooperative agreements, some primacy 
States have agreed to regulate mining on Federal lands within their 
borders. Thus, OSM regulates mining directly only in nonprimacy States, 
on Federal lands in States where no cooperative agreements are in 
effect, and on Indian lands.

[[Page 74154]]

 SMCRA charges OSM with the responsibility of publishing rules as 
necessary to carry out the purposes of the Act. The fundamental 
mechanism for ensuring that the purposes of SMCRA are achieved is the 
basic policy and guidance established through OSM's permanent 
regulatory program and related rulemakings. This regulatory framework 
is developed, reviewed, and applied according to policy directives and 
legal requirements.
 Litigation by the coal industry and environmental groups is 
responsible for some of the rules now being considered by OSM. Others 
are the result of efforts by OSM to address areas of concern that have 
arisen during the course of implementing OSM's regulatory program, and 
one is the result of legislation.
 OSM has sought to develop an economical, safe, and environmentally 
sound program for the surface mining of coal by providing a stable, 
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:
[sbull] Regulatory certainty so that coal companies know what is 
            expected of them and citizens know what is intended and how 
            they can participate; and
[sbull] Continuing consultation, cooperation, and communication with 
            interest groups during the rulemaking process in order to 
            increase the quality of the rulemaking, and, to the 
            greatest extent possible, reflect consensus on regulatory 
            issues.
U.S. Fish and Wildlife Service
 The mission of the U.S. Fish and Wildlife Service is to work 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:
[sbull] The sustainability of fish and wildlife populations. FWS 
            conserves, protects, restores, and enhances fish, wildlife, 
            and plant populations entrusted to our care. FWS carries 
            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 
            international partners.
[sbull] Habitat conservation--a network of lands and waters. 
            Cooperating with others, FWS strives 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 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. The FWS habitat 
            conservation strategy uses an ecosystem approach to focus 
            on the interaction and balance of people, lands and waters, 
            and fish and wildlife.
[sbull] Public use and enjoyment. FWS provides 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.
[sbull] Partnerships in natural resources. FWS supports and strengthens 
            partnerships with tribal, State, and local governments and 
            others in their efforts to conserve and enjoy fish, 
            wildlife, and plants and habitats. FWS administers Federal 
            grants to States and territories for restoration of fish 
            and wildlife resources and has a continuing commitment to 
            work with tribal governments. FWS also promotes 
            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. The Service attempts to ensure a balance between 
any possible public burdens and adequate protection for the natural 
resource.
 The Service implements and enforces regulations that govern public 
access, use, and recreation on more than 500 national wildlife refuges 
and in national fish hatcheries. The Service authorizes 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.
 The Service administers 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 its 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 its assistance programs, the Service 
administers regulations to help interested parties obtain Federal 
assistance and also to help assistance recipients comply with 
applicable laws and Federal requirements.

[[Page 74155]]

National Park Service
 The National Park Service is dedicated to conserving the natural and 
cultural resources and values of the National Park System for the 
enjoyment, education, and inspiration of this and future generations. 
The Service also manages 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 385 units in the National Park System, including national 
parks and monuments; scenic parkways, preserves, trails, riverways, 
seashores, lakeshores, and recreation areas; and historic sites 
associated with important movements, events, and personalities of the 
American past.
 The National Park Service develops and implements park management 
plans and staffs the areas under its administration. It relates the 
natural values and historical significance of these areas to the public 
through talks, tours, films, exhibits, and other interpretive media. It 
operates campgrounds and other visitor facilities and provides, usually 
through concessions, lodging, food, and transportation services in many 
areas. The National Park Service also administers the following 
programs: the State portion of the Land and Water Conservation Fund, 
Nationwide Outdoor Recreation coordination and information and State 
comprehensive outdoor recreation planning, planning and technical 
assistance for the National Wild and Scenic Rivers System, and the 
National Trails System, natural area programs, the National Register of 
Historic Places, national historic landmarks, historic preservation, 
technical preservation services, Historic American Buildings survey, 
Historic American Engineering Record, and interagency archeological 
services.
 The National Park Service maintains regulations that help manage 
public use, access, and recreation in units of the National Park 
System. The Service provides visitor and resource protection to ensure 
public safety and prevent degradation of resources. The regulatory 
program develops and reviews regulations, maintaining consistency with 
State and local laws, to allow these uses if they are compatible with 
the purpose for which each area was established.
Bureau of Reclamation
 The Bureau of Reclamation's mission is to manage, develop, and protect 
water and related resources in an environmentally and economically 
sound manner in the interest of the American public. To accomplish this 
mission, Reclamation applies management, engineering, and scientific 
skills that result in effective and environmentally sensitive 
solutions.
 Reclamation projects provide for some or all of the following 
concurrent purposes: irrigation water service, municipal and industrial 
water supply, hydroelectric power generation, water quality 
improvement, groundwater management, fish and wildlife enhancement, 
outdoor recreation, flood control, navigation, river regulation and 
control, system optimization, and related uses. Reclamation has 
increased security at its facilities and is implementing its law 
enforcement authorization received in November 2001.
 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--National Park Service (NPS)

                              -----------

                            FINAL RULE STAGE

                              -----------




75. [bull] SNOWMOBILE REGULATIONS; YELLOWSTONE AND GRAND TETON NATIONAL 
PARKS AND JOHN D. ROCKEFELLER MEMORIAL PARKWAY
Priority:


Other Significant


Legal Authority:


16 USC 1; 16 USC 3; 16 USC 9a; 16 USC 460(q); 16 USC 462(k)


CFR Citation:


36 CFR 7.13; 36 CFR 7.21; 36 CFR 7.22


Legal Deadline:


Final, Judicial, November 15, 2002.


Abstract:


This is a multiphase rule with the next phase legally due to be 
published by November 15, 2002. This phase will delay, for one year, 
certain provisions of the existing snowmobile and snowcoach regulations 
at the parks. The next phase will implement any new provisions for 
snowmobile management that arise from the record of decision due to be 
issued in spring 2003. It is expected that those provisions will become 
effective before the winter use season of 2003-2004.


Statement of Need:


The rulemaking is necessary as a result of legal action taken by the 
International Snowmobile Manufacturers Association (ISMA) and others in 
June 2001. The NPS agreed to reevaluate the impacts of the existing 
regulations on local economies and to analyaze and incorporate 
provisions for new technology snowmobile engines into the existing 
Winter Use Management Plan.


Summary of Legal Basis:


The National Park Service entered into a settlement agreement with ISMA 
and others in June 2001. This agreement was a result of a lawsuit 
initiated by ISMA disputing provisions of the snowmobile regulations 
written at the end of the Clinton administration. The settlement 
agreement required publication of a final rule, if necessary, by 
November 15, 2002.


Alternatives:


The only alternative to these regulations would be to allow provisions 
of the existing regulations for the parks to go into effect for the 
winter use season 2002-2003. The result would be a 50 percent reduction 
in snowmobiles allowed into Yellowstone and Grand Teton National Parks 
with each entrance station being allotted a set number of users to 
enter per day.


Anticipated Cost and Benefits:


This rule would delay adverse economic impacts from the existing rule 
for one year. There may be economic benefits resulting from the 
proposed extension. In the draft supplemental environmental impact 
statement (DSEIS) the NPS estimated that in 2003-2004, the economic 
outputs and employment impacts of implementing actions under this rule 
are: in the five-county, greater Yellowstone area, an estimated loss of 
$15.9 to $21.1 million; in the three-State area surrounding the parks, 
a variance of a possible $18.4 million loss to a $7.0 million increase. 
Increased winter visitation from new visitors to the park under 
existing regulations could substantially offset estimated losses and 
employment reductions from current visitors.


Risks:


If the rulemaking were not to proceed, the gateway communities 
surrounding Yellowstone and Grand Teton National

[[Page 74156]]

Parks would experience a decrease in snowmobile use of 50 percent 
beginning this winter use season. Allowing the existing regulations to 
become effective would cause adverse economic impacts on the local 
communities and potentially to the surrounding three-State area.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            67 FR 15145                                    03/29/02
Final Action                                                   11/00/02
Regulatory Flexibility Analysis Required:


No


Government Levels Affected:


None


Agency Contact:
Kym A. Hall
Regulations Program Manger
Department of the Interior
National Park Service
1849 C Street NW.
Washington, DC 20240
Phone: 202 208-4206
Fax: 202 208-6756
Email: [email protected]
RIN: 1024-AD09
_______________________________________________________________________



DOI--Minerals Management Service (MMS)

                              -----------

                          PROPOSED RULE STAGE

                              -----------




76. [bull] RELIEF OR REDUCTION IN ROYALTY RATES -- DEEP GAS PROVISIONS
Priority:


Economically Significant. Major under 5 USC 801.


Legal Authority:


43 USC 1331 et seq


CFR Citation:


30 CFR 203


Legal Deadline:


None


Abstract:


Declines in outer continental shelf production from existing fields 
need to be offset by new sources to keep up with growing demand. Very 
little of the deep gas potential in shallow water areas of the Gulf of 
Mexico has yet been explored. Extensive infrastructure already exists 
in shallow water, unlike in deep water, so new production could reach 
market quickly. Because the most prospective tracts in shallow water 
are already under lease, most of the deep gas potential in shallow 
water may already have been acquired. This rule proposes temporary 
incentives in the form of royalty suspension volumes for deep wells (at 
least 15,000 feet below significant energy action level) on existing 
leases that explore for or produce gas.


Statement of Need:


Very little of the deep gas potential in shallow water areas of the 
Gulf of Mexico has yet been explored. Extensive infrastructure already 
exists in shallow water, unlike in deep water, so new production could 
reach market quickly. Because the most productive


tracts in shallow water are already under lease, most of the deep gas 
potential in shallow water may already have been acquired. This rule 
would accelerate exploration and production of deep gas by providing 
temporary incentives in the form of royalty suspension volumes for deep 
wells on existing leases that explore for or produce gas.


Summary of Legal Basis:


The OCS Lands Act is the basis for our regulations on suspending or 
lowering royalties on ``producing'' OCS leases. The Deep Water Royalty 
Relief Act, which amended the OCS Lands Act, is the basis for 
regulations to reduce or eliminate royalty on ``non-producing'' leases 
in the Gulf of Mexico 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:


There are two alternatives -- providing incentives only through the 
lease sale process, or through an application process. Reserving the 
deep gas incentive only for new leases issued in future sales


will not encourage exploration and production of much of the deep gas 
potential that underlies existing leases. Many of the best blocks have 
not been through a sale in decades. Also, new leases would be less able 
to use the existing infrastructure than existing leases so additional 
gas production would be delayed. Granting royalty relief on a case-by-
case basis to existing leases would better protect against unnecessary 
royalty relief but is unlikely to encourage much additional production. 
The unavoidable complexity and delays in a system like we use in the 
discretionary deep water royalty relief program would discourage many 
lessees and delay the desired activity by those that would apply.


Anticipated Cost and Benefits:


Costs of this program to the federal government are the foregone 
royalties associated with drilling and production of deep gas that 
would have occurred even if no royalty suspension incentives were 
offered. We estimate that recipients of deep gas royalty relief will 
earn an average of 350 Bcf of gas royalty relief each year from 
activity that would have taken place without the program.


This rule's royalty benefits derive from the extra gas production 
(i.e., gas produced in excess of the royalty suspension volumes) from 
discoveries induced by the program incentives and resulting drilling. 
We estimate this benefit to be, on average, 370 Bcf of gas each year, 
yielding a net annual royalty benefit of 20 Bcf.


The additional gas production resulting from this rule also offers an 
important timing benefit. We do not expect significant gas production 
from deep water for another 10-15 years. We estimate that this rule 
will result in twice as many deep wells drilled each year of the 
program producing 1 to 2 Tcf more gas production in shallow water. The 
additional gas volumes will help offset declines in other OCS gas 
production until deep water gas comes on stream, thereby moderating gas 
prices and reducing the need for gas imports and consumption of dirtier 
fuels.


Risks:


The risk of not offering royalty relief provided in this rulemaking


action is that some deep gas resources in shallow water will not be


developed, at least not during a period when growing demand and 
declines in traditional sources for natural gas will lead to volatile 
prices.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

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


No

[[Page 74157]]

Government Levels Affected:


None


Agency Contact:
Kumkum Ray
Geologist
Department of the Interior
Minerals Management Service
381 Elden Street
Herndon, VA 20170
Phone: 703 787-1600
Fax: 703 787-1093
Email: [email protected]
RIN: 1010-AD01
_______________________________________________________________________



DOI--MMS

                              -----------

                            FINAL RULE STAGE

                              -----------




77. [bull] 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 351 et seq; 30 USC 181 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 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 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 for the market center nearest the 
lease for oil most similar in quality to that of the lease production.


Anticipated Cost and Benefits:


We estimate compliance with this rulemaking would cost the oil industry 
approximately $5.4 million the first year and $4.9 million each year 
thereafter. These estimates include the up-front computer programming 
and other administrative costs associated with processing the new form. 
The monetary benefits of this rulemaking are an estimated $4.7 million 
increase in annual royalties collected on oil produced from Indian 
leases. Additional benefits 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
NPRM            63 FR 7089                                     02/12/98
NPRM Comment Period Extended                                   04/09/98
NPRM Comment Period End                                        05/13/98
Supplementary Pr65 FR 10436                                    01/05/00
ANPRM Comment Period End                                       03/19/00
NPRM Comment Period Extended                                   03/20/00
Final Action                                                   10/00/03
Final Action Effective                                         01/00/04
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses, Governmental Jurisdictions


Government Levels Affected:


Tribal


Agency Contact:
Sharron Gebhardt
Regulatory Specialist
Department of the Interior
Minerals Management Service
MS 320B2
PO Box 25165
Denver, CO 80225-3211
Phone: 303 231-3211
Fax: 303 231-3385
Email: [email protected]
Related RIN: Previously reported as 1010-AC24
RIN: 1010-AD00
BILLING CODE 4310-RK-S

[[Page 74158]]




DEPARTMENT OF JUSTICE (DOJ)



Statement of Regulatory Priorities
 The first and overriding priority of the Department of Justice is to 
prevent, detect, disrupt, and dismantle terrorism while preserving 
constitutional liberties. To fulfill this mission, the Department is 
devoting all the resources necessary and utilizing all legal 
authorities to eliminate terrorist networks, to prevent terrorist 
attacks, and to bring to justice those who kill Americans in the name 
of murderous ideologies. It is engaged in an aggressive arrest and 
detention campaign of lawbreakers with a single objective: To get 
terrorists off the street before they can harm more Americans. In 
addition to using investigative, prosecutorial, and other law 
enforcement activities, the Department is also using the regulatory 
process to enhance its ability to prevent future terrorist acts and 
safeguard our borders while ensuring that America remains a place of 
welcome to foreigners who come here to visit, work, or live peacefully.
 Accordingly, the Department has issued immigration regulations: (1) to 
register and more closely monitor certain nonimmigrants from designated 
countries; reinvent the processes for monitoring the admission and 
status of foreign students; (2) to provide for a uniform policy on the 
safeguarding of information relating to INS detainees; and (3) to 
establish greater control over the visitor visa process. In addition, 
the Department has also issued regulations to prevent dissemination by 
selected inmates of information that could endanger the national 
security and regulations authorizing immigration judges to issue 
protective orders and seal records relating to law enforcement or 
national security information. (These and other completed and ongoing 
antiterrorism regulatory actions are described in a separate section of 
this Statement below.)
Immigration
 Although the Congress is currently considering legislation to 
restructure the immigration agencies, this Statement presents the 
Department's past and current efforts to improve the enforcement and 
administration of the immigration laws. The Department will continue to 
advance the President's antiterrorism objectives with regulatory 
initiatives that support law enforcement activities and increase border 
security along with its immigration mission responsibilities. The INS 
administers regulations governing the admission of legal immigrants and 
temporary visitors, apprehension and deportation of illegal aliens, 
alien employment authorization and verification, asylum, and 
naturalization.
 The Department's top regulatory initiatives are described below, but 
many of the Agency's key initiatives occur either outside of the 
rulemaking process or supplement it. Although this regulatory agenda 
focuses on strengthening homeland security, the Department is pursuing 
an aggressive agenda, through both regulations and systems development, 
to enhance the delivery of immigration services.
Strengthening Immigration Enforcement
 During the next 12 months, the Department will continue to implement 
rulemakings focused on supporting the President's homeland defense 
initiatives. In addition to regulations published as a result of the 
events of September 11, 2001, the Agency is pursuing rulemaking to 
implement three major components of the President's directive on 
Homeland Security: (1) control and tracking of foreign students and 
exchange visitors; (2) an improved entry-exit system that will track 
the arrivals and departures of foreign visitors who come to the United 
States. The Attorney General has also mandated that one aspect of this 
system will include additional registration requirements for certain 
nonimmigrants from countries of concern to the United States for 
national security reasons; and (3) a surrender requirement for aliens 
removed from the United States.
[sbull] Tracking Foreign Students and Exchange Visitors
 In response to the first component of the President's directive, the 
Service is implementing section 641 of the Illegal Immigration Reform 
and Immigrant Responsibility Act of 1996 (IIRIRA). Section 641 requires 
the Service to collect current information, on an ongoing basis, from 
schools and exchange programs relating to nonimmigrant foreign students 
and exchange visitors during the course of their stay in the United 
States. In addition, the USA PATRIOT Act, Public Law 107-56, amended 
section 641 to require full implementation and expansion of Student and 
Exchange Visitor Information System (SEVIS) prior to January 1, 2003. 
Furthermore, the Enhanced Border Security and Visa Entry Reform Act of 
2002 (Pub. L. 107-173) (Border Security Act) adds to and clarifies the 
collection of student and school information and specifically requires 
an educational institution to report any failure of an alien to enroll 
not later than 30 days after registration deadline. The Service is 
promulgating several regulations focused on addressing control issues 
for over 500,000 international students attending colleges and 
universities in the United States and a similar number of exchange 
visitors entering the United States through the Department of State's 
(DOS) ``J'' visa program.
 The Service has embarked on a series of regulatory and nonregulatory 
initiatives to improve the tracking of foreign students. A key 
component of this initiative is the creation of SEVIS, an Internet-
based system through which schools must submit current information on 
nonimmigrant students (F and M visa) and exchange visitors (J visa) and 
their dependents (F-2, M-2, and J-2). SEVIS enables schools and program 
sponsors to transmit electronic information and event notifications, 
via the Internet, to the Service and DOS throughout a student's or 
exchange visitor's stay in the United States. SEVIS will be informed of 
status events for international students and exchange visitors 
including, but not limited to, entry/exit data, changes of address, 
program extensions, employment notifications, and changes in program of 
study. SEVIS will also provide system alerts, event notifications, and 
reports to the end-user schools and programs, as well as for Service 
and DOS offices. SEVIS will be mandatory after January 30, 2003, for 
all institutions wishing to bring F/M/J aliens into the United States.
 Also, on December 21, 1999, the Service published a proposed rule at 
64 FR 71323 establishing a fee and a fee collection system allowing the 
Service to collect the fee authorized by section 641 of the Illegal 
Immigration Reform and Immigrant Responsibility Act of 1996 (IIRIRA). 
The interim final rule currently under expedited development differs 
from the earlier proposed rule in several ways. First, Public Law 106-
396 amended section 641 of IIRIRA to provide that the Attorney General, 
rather than schools, is to collect the fee. Second, Congress 
appropriated startup funds for the program after the publication of the 
proposed rule. Accordingly, the forthcoming final rule will reflect a 
lower fee, based on a new fee study, which does not recapture those 
startup funds already appropriated. Finally, the Service will build 
into the final rule additional flexibility regarding the means and 
methods of payment. The interim final rule will make compliance easier 
than what was initially proposed.

[[Page 74159]]

 In addition, INS published on August 27, 2002, at 67 FR 54941, an 
interim rule governing F and M nonimmigrants. This rule clarifies that 
nonimmigrant aliens who reside outside the U.S. and regularly commute 
across a land border to study may do so on a part-time basis within the 
F or M nonimmigrant category. These changes are being made to 
facilitate and legitimate part-time study along border communities 
while ensuring that all applicable requirements and safeguards are met. 
(INS No. 2220-02, RIN 1115-AG75)
[sbull] Entry-Exit System and Special Registration Requirements for 
            Certain Nonimmigrants
 Congress has mandated that, by 2005, the Department must complete 
deployment of an entry-exit system that integrates the available alien 
arrival and departure data that exists in the Department and DOS 
systems. This system also must include the arrival and departure data 
for any visitor who transits through the air and seaports and is 
admitted under the Visa Waiver Program. In addition, recent legislation 
requires that visas and other entry travel documents issued on or after 
October 26, 2004, be machine readable and contain biometrics and that 
INS deploy machines to read those documents at all ports-of-entry by 
that date. The entry-exit system must capture arrival and departure 
data from these biometric documents. The Administration is also 
planning to make the entry-exit system as comprehensive as possible to 
include arrival and departure information that is not currently 
recorded by existing systems.
 As part of this initiative, the Service will promulgate regulations to 
implement the provisions of section 217(h) of the Immigration and 
Nationality Act (INA) concerning electronic passenger manifest 
requirements for carriers who transport Visa Waiver Program applicants, 
as well as the provisions of section 402 of the Border Security Act 
that requires submission of arrival and departure manifests 
electronically in advance of a commercial aircraft or vessel's arrival 
in or departure from the United States. The rule also proposes to 
require manifest data on certain passengers, crew, and voyages 
previously exempt from this requirement.
 In addition, the Service and DOS plan to promulgate complementary 
regulations under section 212 of the INA that will remove the current 
visa and passport waivers for permanent residents of Canada and Bermuda 
who are citizens of approximately 55 other countries. Although these 
regulations are being promulgated for national security and related 
reasons, and not strictly for purposes of the entry-exit system, the 
system will be improved as a result of the arrival/departure data that 
will now be available on these previously document-exempt visitors to 
the U.S.
[sbull] Surrender Requirement for Aliens Ordered Removed from the U.S.
 In an effort to streamline the removal process, the Service will 
promulgate a rule that requires aliens who become subject to a final 
order of removal to surrender themselves to the Service within 30 days 
thereafter. This rule provides that aliens who are given notice of the 
mandatory duty to surrender and later fail to comply with the surrender 
obligation will be denied all discretionary immigration benefits for 
the remainder of their presence in the U.S. and for 10 years after 
their departure. This action enhances the integrity of the removal 
process by shifting the burden upon termination of removal 
proceedings--eliminating the requirement that the Service seek out 
those subject of final removal orders--and instead requiring that such 
persons present themselves for removal. The surrender requirement will 
apply to aliens who receive notice of the obligation in the course of 
their immigration proceedings or concurrently with the final order of 
removal.
 Concurrently, the Service has launched an initiative to address the 
fact that hundreds of thousands of aliens who already have final 
removal orders have not departed the United States. Such aliens, termed 
absconders, are the subject of the Service's sub-regulatory Absconder 
Apprehension Initiative (AAI), which is designed to enhance the ability 
of the Service's limited workforce to apprehend absconders. In the AAI, 
the Service has begun reviewing the files of absconders to enter 
appropriate records into the National Crime Information Center (NCIC) 
data base so that they may be apprehended when encountered by Federal, 
State, or local law enforcement officials. This effort supplements 
efforts being undertaken by the Service to use recent resource 
enhancements to apprehend those absconders whom the Service can locate.
Strengthening Immigration Services
 In addition to the initiatives to strengthen homeland security as set 
forth above, the Service plans to re-engineer its regulations that 
govern nonimmigrant classes and admission requirements. These 
regulations are codified in 8 CFR 214 and have grown in size and 
complexity during the past 15 years as Congress has added at least 10 
new nonimmigrant classes and expanded the requirements and restrictions 
on many of the existing classes. The regulatory outline for part 214 
has become extremely complicated. This initiative provides for a 
comprehensive reorganization, streamlining, and rewriting of 8 CFR part 
214. There are a number of other planned regulatory actions focused on 
improving benefit processing and adjudication services that are 
delineated in DOJ's unified agenda. For example, the following key 
regulatory initiatives are being pursued.
[sbull] Proposed Rule, INS No. 2134-01, RIN 1115-AG21, Removal and 
            Adjustment Procedures for Victims of Trafficking and 
            Certain Criminal Activities. This rule proposes that 
            certain victims of severe forms of trafficking and victims 
            of certain crimes who have been granted T or U nonimmigrant 
            status may apply for adjustment to permanent resident 
            status.
[sbull] Proposed Rule, INS No. 2170-01, RIN 1115-AG39, New 
            Classification for Victims of Certain Criminal Activity; 
            Eligibility for the U Nonimmigrant Status. This proposed 
            action establishes the application requirements for a new 
            nonimmigrant status ``U.'' The U classification is for non-
            United States citizens/Lawful Permanent Residents who are 
            victims of certain crimes and who cooperate with an 
            investigation or prosecution of such crimes. There is a 
            limit of 10,000 principals per year.
[sbull] Proposed Rule, INS No. 2228-02, RIN 1115-AG78, Petitions for 
            Aliens to Perform Temporary Nonagricultural Services of 
            Labor (H-2B). This action proposes to make significant 
            changes to the regulations affecting H-2B nonimmigrant 
            classification. The proposed changes are aimed to increase 
            the usefulness of the H-2B nonimmigrant classification 
            program for U.S. employers by eliminating certain 
            regulatory barriers, by adding protections for foreign 
            workers, and by increasing the Government efficiency and 
            coordination.
[sbull] Proposed Rule, INS No. 2080-00, RIN 1115-AE73, Certificates for 
            Certain Health Care Workers. This rule proposes to 
            implement the foreign health care worker certification 
            requirements by providing that all

[[Page 74160]]

            immigrants and nonimmigrants, including nonimmigrants 
            changing status, who are coming to the U.S. for the primary 
            purpose of performing labor in a health care occupation, 
            obtain health care worker certification and present this 
            certificate to a consular officer and/or the INS.
Regulations Published or Being Developed Because of September 11, 2001
INS
[sbull] Final Rule, Registration and Monitoring of Certain 
            Nonimmigrants (INS 2216-02, RIN 1115-AG70). This regulation 
            broadened the special registration requirements for 
            nonimmigrant aliens from certain designated countries, and 
            other nonimmigrant aliens whose presence in the United 
            States requires closer monitoring, to require that they 
            provide specific information at regular intervals to ensure 
            their compliance with the terms of their visas and 
            admission and to ensure that they depart the United States 
            at the end of their authorized stay. (67 FR 52584, 8-12-02)
[sbull] Interim Rule, Custody Procedures (INS 2171-01, RIN 1115-AG40). 
            This rule changes the period of time after an alien's 
            arrest within which the INS must make a determination 
            whether the alien will be continued in custody or released 
            on bond or recognizance and whether to issue a notice to 
            appear and warrant of arrest. This rule provides that 
            unless voluntary departure has been granted, the INS must 
            make such determinations within 48 hours of arrest, except 
            in the event of emergency or other extraordinary 
            circumstance in which case the INS must make such 
            determinations within an additional reasonable period of 
            time. (66 FR 48334, 9-20-01)
[sbull] Interim Rule, Release of Information Regarding INS Detainees in 
            Non-Federal Facilities (INS No. 2203-02, RIN 1115-AG67). 
            This rule governs disclosure by any State or local 
            government entity or by any privately operated facility of 
            the name or other information relating to any immigration 
            detainee being housed or otherwise maintained or provided 
            service on behalf of the INS. This rule establishes a 
            uniform policy on the public release of information on INS 
            detainees. (67 FR 19508, 4-22-02)
[sbull] Proposed Rule, Limiting the Period of Admission for B 
            Nonimmigrant Aliens (INS No. 2176-01, RIN 1115-AG43). This 
            proposed action eliminates the minimum admission of B-2 
            visitors for pleasure, reducing the maximum admission 
            period of B-1 and B-2 visitors from 1 year to 6 months. It 
            will establish greater control over a B visitor's ability 
            to extend status or to change status to that of 
            nonimmigrant student. (67 FR 18605, 4-12-02)
[sbull] Interim Rule, Requiring Change of Status from B to F-1 or M-1 
            Nonimmigrant Prior to Pursuing a Course of Study (INS No. 
            2195-01, RIN 1115-AG60). This rule eliminates the current 
            provisions allowing a B-1 or B-2 nonimmigrant visitor for 
            business or pleasure to begin attending school without 
            first obtaining approval of a change of nonimmigrant status 
            request from the INS. This change ensures that no B 
            nonimmigrant is allowed to enroll in school until the alien 
            has applied for, and the INS has approved, a change of 
            nonimmigrant status to that of F-1 or M-1 nonimmigrant 
            student. (67 FR 18061, 4-12-02)
[sbull] Proposed Rule, Limiting the Number of Transit Without Visa 
            (TWOV) Stops in the United States to One (INS No. 2194-02, 
            RIN 1115-AG59). This proposed action limits the number of 
            transit stops in the United States for those passengers 
            participating in the TWOV program from two stops to one 
            stopover. Current regulations allow an alien to be 
            transported in transit through the United States to another 
            foreign country without first obtaining a nonimmigrant visa 
            from the DOS overseas, provided the carrier and the INS 
            have entered into an immediate and continuous transit 
            agreement pursuant to section 233(c) of the INA.
[sbull] Interim Rule, Additions to the List of Countries whose Citizens 
            or Nationals are Ineligible for TWOV Privileges to the 
            United States under the TWOV Program (INS No. 2199-02, RIN 
            1115-AG16). This rule will rescind standing waivers for 
            certain countries because the Attorney General acting 
            jointly with DOS has determined that it is in the best 
            interests of the United States that nationals of these 
            countries be required to obtain a visa before traveling to 
            the United States.
Bureau of Prisons
[sbull] RIN 1120-AB08 ``National Security; Prevention of Acts of 
            Violence and Terrorism'' (BOP 1116). This rule imposed 
            special administrative measures with respect to specified 
            inmates, where it has been determined to be necessary to 
            prevent the dissemination either of classified information 
            that could endanger the national security or of other 
            information that could lead to acts of violence and 
            terrorism.
Civil Division
[sbull] RIN 1105-AA79 ``September 11th Victim Compensation Fund of 
            2001'' (CIV 104). Shortly after the attacks the President 
            signed the ``September 11th Victim Compensation Fund of 
            2001'' (the ``Fund'') into law. This Act authorized 
            compensation to any individual (or the personal 
            representative of a deceased individual) who was physically 
            injured or killed as a result of the terrorist-related 
            aircraft crashes on that day. The Department implemented 
            this Act by an Interim rule (published on December 21, 
            2001, as required by statute), and then provided 
            clarifications and other changes in a final rule (published 
            on March 13, 2002.)
Executive Office for Immigration Review
[sbull] RIN 1115-AG41 ``Review of Custody Determinations.'' This rule 
            amended EOIR regulations to expand an existing regulatory 
            provision for a temporary automatic stay of an immigration 
            judge's decision to order an alien's release in any case in 
            which a district director has ordered that the alien be 
            held without bond or has set a bond of $10,000 or more. The 
            detention of an alien during the pendency of proceedings 
            ensures removal by preventing the alien from fleeing and 
            protects the public from potential harm.
[sbull] RIN 1125-AA38 ``Protective Orders in Immigration Administrative 
            Proceedings'' (EOIR 133). In this post-September 11, 2001, 
            era, the highest priority of the Department is to prevent, 
            detect, disrupt, and dismantle terrorism while preserving 
            constitutional liberties. Disclosures of sensitive 
            information could allow terrorists to discern patterns in 
            an investigation, enabling them to evade detection in the 
            future. Accordingly, the Department published the rule 
            ``Protective Orders in Immigration Administrative 
            Proceedings'' authorizing immigration judges to issue 
            protective orders and seal records relating to law 
            enforcement or national security information.
Foreign Terrorist Tracking Task Force
[sbull] RIN 1105-AA80 ``Screening of Aliens and Other Designated 
            Individuals Seeking Flight Training'' (OAG 104). Also, 
            after September 11th, Congress

[[Page 74161]]

            enacted the ``Aviation and Transportation Security Act'' 
            (Pub. L. 107-71) to enhance air safety by prohibiting 
            certain flight schools from training aliens without the 
            prior notification of the Attorney General. Relevant 
            components of the Department (including FBI, INS, and the 
            Foreign Terrorist Tracking Task Force) consulted with the 
            FAA and representatives of the aviation industry to 
            coordinate the Department's implementation of this 
            notification program. Two temporary Federal Register 
            Notices were published (on January 16, 2002, and on 
            February 8, 2002) to provide relief for flight schools who 
            were prohibited from furnishing recurrent training to 
            aliens who were pilots in order to relieve the financial 
            burden imposed by the Act imposed on the aviation industry. 
            The Department published a proposed rule on June 14, 2002, 
            to implement notification procedures for all prospective 
            alien pilots.
 The Department of Justice's regulatory priorities focus in particular 
on four regulatory initiatives in the areas of immigration and civil 
rights. However, in addition to these four specific initiatives, 
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 antiterrorism and law enforcement priorities.
Drug Enforcement Administration
 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. However, now, the growing combination 
of drug trafficking and terrorism serves to call us even more urgently 
to action. Nearly one-third of the organizations on the State 
Department's list of Foreign Terrorist Organizations appear also on the 
Department's list of targeted United States drug suppliers. 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 (MCA) and the Methamphetamine Anti-
Proliferation Act of 2000 (MAPA), which regulate certain drug products 
that are being diverted for the illicit production of methamphetamine. 
DEA has determined that proceeds from an illegal drug operation in the 
United States (that was diverting regulated drug products for the 
production of methamphetamine in violation of the diversion control 
requirements and the MCA and MAPA) have been funneled to Middle East 
terrorist groups like Hezbollah.
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, although not a part of the regulatory process, 
since September 11, 2001, the Civil Rights Division has been and 
remains committed to the investigation and prosecution of incidents 
involving violence or threats of violence against people of Middle-
Eastern origin, including Arab Americans, Muslim Americans, Sikh 
Americans, and South-Asian Americans. The Division is also actively 
involved in outreach efforts to individuals and organizations to 
provide information about Government services to vulnerable 
communities.
 Additionally, 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 and in final draft form in April 2002. 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 multiyear 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 facilities, 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 section 610 of the Small 
Business Regulatory Enforcement Fairness Act (SBREFA).
 The Department is planning to adopt and interpret the Access Board's 
revised and amended guidelines in two parts. The first part will be a 
proposed rule adopting the Access Board's revised and amended 
guidelines as enforceable standards, which will, in addition to 
revising the current ADA Standards for Accessible Design, supplement 
the standards with specifications for prisons, jails, court houses, 
legislative facilities, building elements designed for use by children, 
play areas, and recreation facilities. The second part will be an 
advanced notice of proposed rulemaking seeking public comment on two 
discreet sets of issues: (i) the Department's interpretation of the new 
ADAAG and (ii) the section 610 review of the ADA regulations under 
SBREFA.
 The Department's revised and supplemented regulations under the ADA 
will affect small businesses, small governmental jurisdictions, and 
other

[[Page 74162]]

small organizations (together, small entities). The Access Board has 
prepared regulatory assessments (including cost impact analyses) to 
accompany its new guidelines, which estimate the annual compliance 
costs that will be incurred by covered entities with regard to 
construction of new facilities. These assessments include the effect on 
small entities and will apply to new construction under the 
Department's revised and supplemented regulations. With respect to 
existing facilities, the Department will prepare an additional 
regulatory assessment of the estimated annual cost of compliance with 
regard to existing facilities. In this process, the Department will 
give careful consideration to the cost effects on small entities, 
including the solicitation of comments specifically designed to obtain 
compliance data relating to small entities.
 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.
_______________________________________________________________________



DOJ--Civil Rights Division (CRT)

                              -----------

                          PROPOSED RULE STAGE

                              -----------




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


Economically Significant. Major under 5 USC 801.


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 
regulations 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 regulations. 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 Access 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 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 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. 
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

[[Page 74163]]

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                                                           01/00/03
NPRM Comment Period End                                        03/00/03
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).


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



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


Economically Significant. Major under 5 USC 801.


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 regulations for purposes of section 610 of the Regulatory 
Flexibility Act and make related changes to its title II regulations.


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 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 
regulations 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 persons with disabilities will 
be better served.


The Access Board has analyzed the effect of applying its proposed

[[Page 74164]]

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                                                           01/00/03
NPRM Comment Period End                                        03/00/03
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, 1190-AA36, and 1190-AA38, which have been 
withdrawn and merged into this rulemaking. These changes include 
accessibility standards for State and local government facilities that 
had been previously published by the Access Board (RIN 1190-AA26) and 
the timing for the compliance of State and local governments with the 
curb-cut requirements of the title II regulation (RIN 1190-AA36). In 
order to consolidate regulatory actions implementing title II of the 
ADA, on February 15, 2000, RINs 1190-AA26 and 1190-AA38 were merged 
into this rulemaking and on March 5, 2002, RIN 1190-AA36 was merged 
into this rulemaking.


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

                              -----------




80. CARRIER ARRIVAL AND DEPARTURE ELECTRONIC MANIFEST REQUIREMENTS
Priority:


Other Significant


Legal Authority:


PL 107-173; PL 106-96; 8 USC 1101; 8 USC 1103; 8 USC 1182; 8 USC 1221; 
8 USC 1228; 8 USC 1229


CFR Citation:


8 CFR 231


Legal Deadline:


Final, Statutory, January 1, 2003.


Public Law 107-173, the Visa Waiver Permanent Program Act (VWPPA), sets 
a mandatory deadline of October 1, 2002.


Abstract:


There are four principal laws that require the Attorney General to 
develop an automated and integrated entry/exit data system for aliens:


1. The Immigration and Naturalization Service Data Management 
Improvement Act (DMIA), Public Law 106-21;


2. The Visa Waiver Permanent Program Act (VWPPA), Public Law 106-396;


3. The USA PATRIOT Act, Public Law 107-56; and


4. The Enhanced Border Security and Visa Entry Reform Act (Border 
Security Act), Public Law 107-173.


Implementation of the relevant provisions in these four laws together 
will result in the Entry/Exit System. One of the basic legislative 
mandates is that the system integrate the available alien arrival and 
departure data that exist in any Department of Justice (DOJ) or 
Department of State (DOS) data base or system. This necessarily must 
include the systems that incorporate carrier manifest data on 
passengers and crew members who are entering or leaving the U.S. via 
air or sea. Section 231 of the Immigration and Nationality Act (INA) 
and 8 CFR part 231 state the requirements for carrier manifests.


In section 402 of the Border Security Act, Congress amended the 
manifest requirements in INA, section 231. The Border Security Act 
requires the submission of arrival and departure manifests 
electronically in advance of a commercial aircraft or vessel's arrival 
in or departure from the United States not later than January 1, 2003. 
Promulgation of regulations to implement this law will provide the 
Service with advance notification of information necessary for the 
identification of passengers and crewmembers on commercial carriers. 
The contents of the electronic arrival and departure manifest include: 
(1) complete name; (2) date of birth; (3) citizenship; (4) sex; (5) 
passport number and country of issuance; (6) country of residence; (7) 
United States visa number, date, and place of issuance, where 
applicable; (8) alien registration; (9) United States address while in 
the United States; and (10) such other information the Attorney 
General, in consultation with the Secretary of State and the Secretary 
of Treasury determines as being necessary for the identification of the 
persons transported and for the enforcement of the immigration laws and 
to protect safety and national security.

[[Page 74165]]

In October 2000, Congress also amended section 217 of the INA to make 
the Visa Waiver Pilot a permanent program. The VWPPA also added a 
specific requirement for a ``fully automated entry and exit control 
system'' covering all aliens who enter the United States under the VWP 
at airports and seaports. The requirements for this system are both 
narrower and broader, in different respects, than the DMIA automated 
system requirements. The VWP entry/exit system will be incorporated 
into the broader Entry/Exit System mandated by DMIA. In addition, the 
VWPPA states that no alien arriving by air or sea may be granted a visa 
waiver under INA, section 217, on or after October 1, 2002, unless the 
carrier is submitting passenger information electronically to the VWP 
entry/exit system, as required by the Attorney General. The Service is 
separately promulgating regulations to amend 8 CFR part 217 to 
implement the electronic manifest requirements for VWP purposes.


Statement of Need:


The INS is pursuing rulemaking to aid in implementing a major component 
of the President's directive on Homeland Security: An improved entry/
exit system that will track the arrival and departures of foreign 
visitors who come to the United States. The carrier electronic manifest 
regulations are necessary to implement the statutory requirements of 
the Border Security Act and VWPPA. In addition, collection of this 
electronic arrival/departure manifest information will be incorporated 
into the Entry/Exit system that is mandated in DMIA, the USA PATRIOT 
Act, and the Border Security Act. Failure to fully implement these 
regulations could result in adverse consequences to national security 
because INS would not have advance notification of the arrival and 
departure of foreign visitors and therefore would be unable to check 
their names against relevant law enforcement data bases. The historical 
record reveals that Congress has a strong interest in documenting the 
arrival and departure of aliens, and recent legislation demonstrates 
that relief from this requirement is unlikely. Therefore, the 
Immigration and Naturalization Service must immediately begin 
development of an entry/exit system, which includes the electronic 
manifest information and that meets the will of Congress.


Summary of Legal Basis:


See Statement of Need. These actions are required by the statute as 
explained in the Statement of Need.


Alternatives:


Public Law 107-173 statutorily amends section 231 of the Immigration 
and Nationality Act and requires that commercial carriers submit 
electronic arrival and departure manifests to the INS. The only means 
of implementing this change is through rulemaking.


Anticipated Cost and Benefits:


The enactment of section 402 of Public Law 107-173 reflects Congress' 
desire to ensure that commercial air and sea carriers submit to 
immigration officials passenger and crew information in such timeframes 
and in such a format so as to maximize the Government's efforts to (1) 
timely identify persons being transported to and from the United 
States, (2) enforce the immigration laws, and (3) protect public safety 
and national security. In addition to strengthening homeland security, 
the INS has focused on reengineering its regulations that govern 
nonimmigrant and admission requirements. The INS will continue to 
advance the President's objectives with regulatory initiatives that are 
focused on minimizing regulatory burdens on the public and increasing 
the efficiency of the Agency operations. The President's FY 2003 budget 
has allocated $362 million for the development of the entry/exit 
system. The INS is in the process of developing a project plan and 
estimated costs and benefits of different alternatives for utilizing 
this funding.


The INS is in the process of reengineering its inspections process with 
automated inspections systems for low-risk travelers. Commercial air 
carriers operating passenger flights have been required to 
electronically submit many of the data elements to the U. S. Customs 
Service in advance of arrival since December 21, 2001, and therefore, 
the INS plans to build upon these existing concepts to benefit the 
business community and the public.


Risks:


This regulatory action is critical for complete and clear 
implementation of the provisions of the recent legislation discussed 
above. The regulation will clarify the confusion that exists in the 
immigration and business 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. Failure to 
implement these regulations in a timely manner may jeopardize national 
security and increase the costs to implement new alternative 
inspections methods. Finally, and not insignificantly, failure to 
publish the amended section 231 regulations will result in INS and DOJ 
not being in compliance with the laws as passed by Congress. As with 
any major program, implementation of the new electronic manifest 
requirements is not without some challenges.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

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


Yes


Small Entities Affected:


Businesses


Government Levels Affected:


None


Additional Information:


INS No. 2182-01


Sectors Affected:


481 Air Transportation


Agency Contact:
Michael J. Flemmi
Assistant Chief Inspector, Inspections Division
Department of Justice
Immigration and Naturalization Service
Room 4064
425 I Street NW
Washington, DC 20536
Phone: 202 305-9247
Related RIN: Related To 1115-AG73, Related To 1115-AG68
RIN: 1115-AG57

[[Page 74166]]

_______________________________________________________________________



DOJ--INS

                              -----------

                            FINAL RULE STAGE

                              -----------




81. REVISION OF THE REGULATIONS CONCERNING F, J, AND M NONIMMIGRANT 
CLASSIFICATIONS
Priority:


Other Significant


Legal Authority:


5 USC 552, 552(a); 8 USC 1101, 1103, 1201, 1252 note, 1252(b), 1304, 
1356; 31 USC 9701; EO 12356; 8 USC part 2; ...


CFR Citation:


8 CFR 103; 8 CFR 214


Legal Deadline:


None


Abstract:


This rule lays the foundation for the implementation of the Student and 
Exchange Visitor Information System (SEVIS), an Internet-based system 
that provides tracking and monitoring functionality, with access to 
accurate and current information on nonimmigrant students and exchange 
visitors. There are three principal laws that require the Attorney 
General to develop an automated system to track foreign students and 
exchange visitors:


1. Section 641 of the Illegal Immigration Reform and Immigrant 
Responsibility Act of 1996 (IIRIRA);


2. Section 416 of the Uniting and Strengthening America by Providing 
Appropriate Tools Required to Intercept and Obstruct Terrorism Act of 
2001 (USA PATRIOT ACT); and


3. Section 501 of the Enhanced Border Security and Visa Entry Reform 
Act of 2002 (Border Security Act).


IIRIRA requires the Service to collect current information, on an 
ongoing basis, from schools and exchange programs relating to 
nonimmigrant foreign students and exchange visitors during their course 
of stay in the United States. In addition, the USA PATRIOT Act amended 
section 641 of IIRIRA to require full implementation and expansion of 
SEVIS prior to January 1, 2003. Furthermore, the Border Security Act 
clarifies the collection of information required by SEVIS and adds the 
specific requirement that educational institutions report any failure 
of an alien to enroll not later than 30 days after the registration 
deadline of the institution. Finally, Presidential Directive No. 2 and 
the findings released by the Office of the Inspector General have also 
had a significant impact on the direction of the student program at the 
Service.


While this rule implements SEVIS and its requirements, SEVIS is only 
one component of the Service's Student and Exchange Visitor Program 
(SEVP). Further rulemakings are a necessary part of the overall 
reengineering process and success of SEVP, which encompasses the review 
and registration of all schools and exchange programs in SEVIS prior to 
January 30, 2003, subsequent recertifications every 2 years, and the 
student fee regulation mandated by Congress in IIRIRA to pay for the 
operation and maintenance of SEVIS.


As part of this ongoing program, the Service published an interim rule 
at 67 FR 44344 (July 1, 2002) allowing schools that met certain 
criteria to preliminarily enroll in SEVIS beginning on July 1, 2002. In 
early fall, the Service will publish another rule that will require all 
schools to apply for certification in SEVIS in order to be able to 
begin accepting or continue accepting foreign students after the SEVIS 
mandatory compliance date. Additionally, the Service will publish a 
rule describing the recertification, withdrawal, and denial process for 
SEVIS. Finally, the Service will reintroduce a rule for the collection 
of the fee for all F, J, and M nonimmigrants.


Statement of Need:


This regulation is necessary to implement the statutory requirements of 
IIRIRA, the USA PATRIOT ACT, and the Border Security Act. Failure to 
implement will result in adverse consequences to national security. The 
historical record reveals that Congress has a strong interest in 
monitoring foreign students and exchange visitors for the duration of 
their stay in the United States.


Additionally, the climate of the current administration as evidenced by 
Presidential Directive No. 2 and the findings of the Office of the 
Inspector General demonstrate that the student program is a high 
priority. Therefore, the Service must steadfastly continue to improve 
upon the SEVP program, implement the process to monitor foreign 
students and exchange visitors, as well as to complete the process by 
which all schools and programs use SEVIS prior to the acceptance of any 
foreign students or exchange visitors.


Summary of Legal Basis:


See Abstract and Statement of Need. These actions are required by 
statute as explained in the Abstract and the Statement of Need.


Alternatives:


None.


Anticipated Cost and Benefits:


This regulation implements the new processes and requirements for the 
electronic exchange and update of information. In 1994, the Service 
began conducting a comprehensive review and analysis of the foreign 
student program, both upon admission to the United States and on a 
continuing basis. Based on these findings, the Service established a 
plan to reengineer the business process.


Currently, updates to nonimmigrant student and exchange visitor 
information (e.g., change of address, extensions, curricular practical 
training) are submitted by the Service or the educational institution 
or exchange program to the Service via a paper copy. A significant 
amount of time lapses as the paperwork is routed and data entered by a 
contractor.


The utilization of SEVIS gives the schools and program sponsors the 
ability to make real-time updates without routing paperwork to a 
contractor. The SEVIS process reduces the risk of paperwork being lost 
or sent to an incorrect address and eliminates the risk of inaccurate 
information being entered by the data entry contractor. The elimination 
of the contractor will result in a monetary savings as the current data 
entry costs associated with the existing process average $800,000 per 
year. Finally, the information is stored electronically in SEVIS, thus 
reducing the need to store paper copies during and after routing and 
data entry, by both the Service and the educational institutions and 
sponsors.


Risks:


This regulatory action is critical for complete and clear 
implementation of the provisions of the legislation as well as the 
overall student program. The regulation will clarify for designated 
school officials and others in the education community the scope, 
applicability, and process for the exchange of student and school 
information and will prevent actions which may unintentionally trigger 
adverse immigration consequences.

[[Page 74167]]

Delay in this rulemaking or failure to promulgate will cause the 
Service to miss the dates mandated by Congress.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM (INS 2185-067 FR 34862                                    05/16/02
NPRM Comment Period End                                        06/16/02
Interim Final Ru67 FR 443431-02)                               07/01/02
Interim Final Rule Comment Period End                          07/31/02
Final Action (INS 2185-02)                                     11/00/02
Final Action (INS 2211-02)                                     12/00/02
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


None


Additional Information:


INS No. 2185-02 (See also RIN 1115-AF56, INS No. 1991-99, which amends 
Service regulations to establish a fee for F, J, and M nonimmigrants. 
See also RIN 1115-AG71 ``Requiring Certification of Service Approved 
Schools for Enrollment in SEVIS.)


Agency Contact:
Maura Deadrick
Assistant Director, Adjudication Division
Department of Justice
Immigration and Naturalization Service
Room 3040
425 I Street NW
Washington, DC 20536
Phone: 202 514-3228
RIN: 1115-AG55
BILLING CODE 4410-BP-S

[[Page 74168]]




DEPARTMENT OF LABOR (DOL)



2002 Regulatory Plan
Executive Summary: Making Worker Protections Work
A new culture of responsibility is being built at the Department of 
Labor (DOL) whereby its employees will be responsible for helping the 
regulated community understand DOL's exhaustive list of rules and 
regulations. The Department understands that before any business or 
other regulated entity can comply with DOL's rules, they must be 
understandable and communicated clearly.
Since its creation in 1913, the Department of Labor has been guided by 
the idea that employers must be held responsible for the protection of 
their employees -- protection of their wages, pensions, safety and 
health. In turn, the Department of Labor recognizes that it is 
responsible for helping employers and others understand and comply with 
their responsibilities under the Department's many laws and 
regulations.
The Department has always known that the vast majority of employers 
work hard to keep their employees and workplaces safe and secure and 
that employers who knowingly neglect or abuse their employees are a 
very small minority. DOL must provide this vast majority who want to 
comply with the knowledge and tools they need to carry out their legal 
responsibilities and obligations. To ensure DOL does this, the 
Secretary has made protecting workers through compliance assistance one 
of her top priorities. Her compliance assistance initiative is based on 
the proven success that comes when Government, employers, unions and 
employees work together to ensure that worker protections work.
As an essential part of this initiative, the Department of Labor is 
making the information it provides, including new or revised 
regulations, clearer, more helpful and more accessible. DOL has 
developed compliance materials in plain language, as well as online 
programs that answer questions and direct users to information that is 
easy to understand. DOL also is using its Web site, e-mail, toll-free 
numbers (e.g., the Call Center), and partnerships to convey this 
information when and where it is needed. And employers know that 
requesting compliance assistance materials through any of these means 
will not lead to referrals for investigation.
DOL's goal is to touch every workplace in a positive way, through 
sharing information and offering a helping hand. DOL will emphasize 
prevention, relying on the use of common-sense standards of safety and 
fairness to prevent workers from being 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.
DOL has responsibilities beyond worker protection. It 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 those workers who are disabled, 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 need assistance in learning 
new skills or in obtaining advanced schooling.
At the same time, high-technology industries are creating job 
opportunities unheard of even a decade ago. DOL must help employers and 
workers bridge the gap between the requirements of those jobs and the 
skills of the workers who are needed to fill them. Workers who can keep 
their skills up to date throughout their careers have more productive 
and more rewarding economic futures.
The Secretary of Labor's Regulatory 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 laws must be carefully 
considered, and the views of all affected parties 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, to implement 
new laws and clarify existing rules in light of new laws and legal 
interpretations, and to rewrite rules in plain language, DOL needs to 
engage in rulemaking.
In doing so, DOL will craft proposals that are responsive to workers' 
needs yet understanding of employers' desire for the least burdensome 
regulatory alternative. These proposals will 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 while making it easier for the regulated 
community to play its part. DOL considers these proposals to be 
proactive, common-sense approaches to the issues most clearly needing 
regulatory attention.
The Department's Regulatory Priorities
DOL has identified 20 high-priority items for regulatory action. Nine 
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 the 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 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 reopen the record for the

[[Page 74169]]

rulemaking on the Determination of Concentration of Respirable Coal 
Mine Dust (RIN 1219-AB18), and repropose Verification of Underground 
Coal Mine Operators' Dust Control Plans and Compliance Sampling for 
Respirable Dust (RIN 1219-AB14). The former rule would permit MSHA to 
determine the level of mine dust on the basis of a single sample. The 
latter rule would help assure that operators' dust control plans are 
effective under typical mining conditions. These rules work in tandem 
to address miners' exposure to respirable coal dust.
MSHA is considering lowering the permissible exposure limit (PEL) for 
asbestos at metal and nonmetal and coal mines, addressing take-home 
contamination, and reevaluating the method used for sample analysis 
(RIN 1219-AB24). MSHA conducted a series of public meetings earlier 
this year to allow early participation in the rulemaking by interested 
parties. MSHA will be evaluating those comments as it prepares a notice 
of proposed rulemaking.
In response to litigation and a partial settlement agreement regarding 
its final rule on Diesel Particulate Matter, MSHA has initiated a 
rulemaking on Diesel Particulate Matter Exposure of Underground Metal 
and Nonmetal Miners (RIN 1219-AB29). MSHA will address several 
provisions of the final standard, including changing the diesel 
particulate matter surrogate from total carbon to elemental carbon for 
the concentration limits, addressing the diesel particulate matter 
control plan, and revising requirements regarding the use of personal 
protective equipment and administrative controls to comply with the 
concentration limits.
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.
Three of OSHA's high-priority initiatives address health standards. The 
first, Standards Improvement, will streamline a number of such health 
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, a revision to the Respiratory Protection Standard, will 
address Assigned Protection Factors for different types of respirators 
(RIN 1218-AA05). This action will improve respiratory protection for 
employees required to wear respirators, as well as making it easier for 
employers to choose the appropriate respirator for a given task.
OSHA's third initiative in the area of health standards addresses 
worker exposure to Crystalline Silica (RIN 1218-AB70). This substance 
is one of the most widely found in workplaces, and data have indicated 
that exposure to it may cause a debilitating respiratory disease called 
silicosis. Exposure also has been linked to cancer. OSHA is collecting 
information to determine what regulatory action might be appropriate to 
address these occupational health concerns.
OSHA has two initiatives in the area of safety standards. The first 
concerns Fires in Shipyards (RIN 1218-AB51). A negotiated rulemaking 
committee completed its work earlier this year, and recommended 
regulatory actions to address this issue. Fires in shipyards claim an 
average of one life a year, as well as causing 110 lost-workday ``heat/
burn'' injuries, and more than three times that many total injuries. 
This rule will provide a comprehensive approach to dealing with fires 
in shipyard environments to help prevent these deaths and injuries.
OSHA's second safety initiative addresses requirements for Exit Routes, 
formerly known as Means of Egress (RIN 1218-AB82). OSHA has rewritten 
these important provisions in plain language to help ensure they are 
properly understood and implemented.
Protection of pension and health benefits continues to be a priority of 
the Secretary of Labor. As a member of the President's Task Force to 
strengthen retirement security, the Secretary played a major role in 
formulating legislative proposals to give workers better information 
about their pension rights, increased freedom to choose where to invest 
their retirement savings, and expanded access to investment advice. Two 
of these proposals were enacted as part of the Sarbanes-Oxley Act of 
2002.
Consistent with the Secretary's priorities, the Pension and Welfare 
Benefits Administration (PWBA), which administers the Employee 
Retirement Income Security Act (ERISA), will focus on implementation of 
the recently enacted retirement security amendments to ERISA relating 
to the timely notification of participants and beneficiaries of periods 
during which they will be unable to direct investments in their 401(k) 
plan (RIN 1210-AA90) and civil penalties for failures to provide these 
notices (RIN 1210-AA91).
PWBA's regulatory program also will focus on compliance assistance to 
group health plans through issuance of guidance, as well as model forms 
and notices. Specific initiatives include guidance for group health 
plans on the application of the continuation of coverage notice 
provisions (RIN 1210-AA60); access, portability and renewability 
provisions (RIN 1210-AA54); and nondiscrimination provisions of ERISA 
(RIN 1210-AA77).
ERISA's requirements affect an estimated 730,000 private sector 
employee pension benefit plans (covering approximately 99 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).
The Secretary's emphasis on meeting the needs of the 21st century 
workforce is reflected in the first regulatory initiative developed by 
the Employment and Training Administration (ETA). ETA will issue 
regulations reflecting recent changes to the Trade Adjustment 
Assistance (TAA) program, as enacted in the Trade Act of 2002 (RIN 
1205-AB32). The proposed rule would address the many new features of 
the TAA program: consolidation of the TAA and NAFTA-TAA programs; 
immediate services to workers to facilitate more rapid reemployment; 
expanded eligibility; increased benefits, including health care 
assistance; and an Alternative TAA Program for older workers. The new 
regulations will be in plain English, making them easier to read and 
use.
ETA's second regulatory initiative also focuses on meeting the needs of 
our workforce by improving 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 performance accountability and enhance the 
ability of the States to coordinate services.
In its third initiative, ETA proposes to reengineer the permanent labor 
certification process (RIN 1205-AA66). ETA's goals are to make 
fundamental changes that will streamline the process; save resources; 
improve the

[[Page 74170]]

effectiveness of the program; and better serve the Department of 
Labor's customers.
Finally, the Employment Standards Administration (ESA) has set forth 
three priority regulatory initiatives. 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, and ensuring that their work hours are reasonable 
will help them do so.
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). These regulations 
were nominated for reform in a public comment on OMB's 2001 Report to 
Congress on the Costs and Benefits of Regulations. The issues of 
concern raised by various interested parties are being carefully 
examined in the development of proposed changes. Changes to these rules 
will help employers meet their obligations voluntarily and enhance 
workers' understanding of their rights and benefits.
The Wage and Hour Division's third initiative pertains to regulations 
issued under the Family and Medical Leave Act (FMLA) that were also 
nominated as a reform candidate in OMB's 2001 Report to Congress on 
Costs and Benefits of Regulations. Revisions will be proposed to the 
FMLA's implementing regulations to address issues raised by the 
decision of the U.S. Supreme Court in Ragsdale v. Wolverine World Wide, 
Inc., 122 S. Ct. 1155 (2002), and the decisions of other courts.
_______________________________________________________________________



DOL--Employment Standards Administration (ESA)

                              -----------

                          PROPOSED RULE STAGE

                              -----------




82. 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.


Legal Authority:


29 USC 213(a)(1)


CFR Citation:


29 CFR 541


Legal Deadline:


None


Abstract:


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


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


Statement of Need:


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


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


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.

[[Page 74171]]

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 19 to 26 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 18998                                    03/27/81
ANPRM           50 FR 47696                                    11/19/85
Extension of ANP51 FR 2525 Period                              01/17/86
ANPRM Comment Period End                                       03/22/86
NPRM                                                           01/00/03
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.


Agency Contact:
Tammy D. McCutchen
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



83. [bull] FAMILY AND MEDICAL LEAVE ACT OF 1993
Priority:


Other Significant


Unfunded Mandates:


Undetermined


Legal Authority:


29 USC 2654


CFR Citation:


29 CFR 825


Legal Deadline:


None


Abstract:


The U.S. Supreme Court, in Ragsdale v. Wolverine World Wide, Inc., 122 
S. Ct. 1155 (2002), invalidated regulatory provisions issued under the 
Family and Medical Leave Act (FMLA) pertaining to the effects of an 
employer's failure to timely designate leave that is taken by an 
employee as being covered by the FMLA. The Department intends to 
propose revisions to the FMLA regulations to address issues raised by 
this and other judicial decisions.


Statement of Need:


The FMLA requires covered employers to grant eligible employees up to 
12 workweeks of unpaid, job-protected leave a year for specified family 
and medical reasons, and to maintain group health benefits during the 
leave as if the employees continued to work instead of taking leave. 
When an eligible employee returns from FMLA leave, the employer must 
restore the employee to the same or an equivalent job with equivalent 
pay, benefits, and other conditions of employment. FMLA makes it 
unlawful for an employer to interfere with, restrain, or deny the 
exercise of any right provided by the FMLA.


The FMLA regulations require employers to designate if an employee's 
use of leave is counting against the employee's FMLA leave entitlement, 
and to notify the employee of that designation (29 CFR section 
825.208). Section 825.700(a) of the regulations provides that if an 
employee takes paid or unpaid leave and the employer does not designate 
the leave as FMLA leave, the leave taken does not count against the 
employee's 12 weeks of FMLA leave entitlement.


On March 19, 2002, the U.S. Supreme Court issued its decision in 
Ragsdale v. Wolverine World Wide, Inc., 122 S. Ct. 1155 (2002). In that 
decision, the Court invalidated regulatory provisions pertaining to the 
effects of an employer's failure to timely designate leave that is 
taken by an employee as being covered by the FMLA. The Court ruled that 
29 CFR section 825.700(a) was invalid absent evidence that the 
employer's failure to designate the leave as FMLA leave interfered with 
the employee's exercise of FMLA rights. This proposed rule is being 
prepared to address issues raised by this and other judicial decisions.


Summary of Legal Basis:


This rule is issued pursuant to section 404 of the Family and Medical 
Leave Act, 29 U.S.C. section 2654.


Alternatives:


After completing a review and analysis of the Supreme Court's decision 
in Ragsdale and other judicial decisions, regulatory alternatives will 
be developed for notice-and-comment rulemaking.

[[Page 74172]]

Anticipated Cost and Benefits:


The costs and benefits of this rulemaking action are not expected to 
exceed $100 million per year or otherwise trigger economic significance 
under Executive Order 12866.


Risks:


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


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

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


Undetermined


Small Entities Affected:


Businesses, Governmental Jurisdictions, Organizations


Government Levels Affected:


Undetermined


Federalism:


 Undetermined


Agency Contact:
Tammy D. McCutchen
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-AB35
_______________________________________________________________________



DOL--ESA

                              -----------

                            FINAL RULE STAGE

                              -----------




84. 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 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(l), 11, 12, and 13 of the 
Fair Labor Standards Act, 29 USC sections 203(l), 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.

[[Page 74173]]

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    56 FR 58626                                    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                                                   12/00/02
Regulatory Flexibility Analysis Required:


No


Government Levels Affected:


None


Agency Contact:
Tammy D. McCutchen
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--Employment and Training Administration (ETA)

                              -----------

                          PROPOSED RULE STAGE

                              -----------




85. 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 and introduce performance measures and 
sanctions.


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 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                                                           01/00/03
Final Action                                                   05/00/03
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

[[Page 74174]]

_______________________________________________________________________



DOL--ETA



86. [bull] TRADE ADJUSTMENT ASSISTANCE FOR WORKERS
Priority:


Other Significant


Legal Authority:


19 USC 2320


CFR Citation:


20 CFR 617; 29 CFR 90


Legal Deadline:


None


Abstract:


The Trade Act of 2002, enacted on August 6, 2002, contains provisions 
amending title 2, chapter 2 of the Trade Act of 1974, entitled 
Adjustment Assistance for Workers. The amendments, effective 90 days 
from enactment (November 4, 2002), make additions to where and by whom 
a petition may be filed, expand eligibility to workers whose production 
has been shifted to certain foreign countries and to worker groups 
secondarily affected, and make substantive amendments regarding trade 
adjustment assistance (TAA) program benefits.


Additionally, a final rule implementing the 1988 Amendments to the TAA 
program was published in the Federal Register on January 6, 1994. 
Although published as a final rule, comments were requested on several 
material changes, which were not included in the proposed rule. 
Comments were received and will be considered and included in the final 
rule implementing the amendments under the Trade Act of 2002.


Furthermore, it is the agency's intention to rewrite both 20 CFR 20 
part 617 and 29 FR 29 part 90 in plain English.


Statement of Need:


The Trade Act of 2002, enacted August 6, 2002, repeals the North 
American Free Trade Agreement-Transitional Adjustment Assistance 
provisions for workers affected by the NAFTA Implementation Act and 
adds significant amendments to worker benefits under Trade Adjustment 
Assistance for Workers, as provided for in the Trade Act of 1974.


The Department is mandated to implement the amendments in 90 days from 
enactment, November 4, 2002. The 2002 Trade Act amends where and by 
whom a petition may be filed. Program benefits for TAA eligible 
recipients are expanded to include for the first time a health care tax 
credit, and eligible recipients now include secondarily affected 
workers impacted by foreign trade. Income support is extended by 26 
weeks and by up to one year under certain conditions. Waivers of 
training requirements in order to receive income support are explicitly 
defined. Job search and relocation benefit amounts are increased. 
Within one year of enactment, the amendments offer an Alternative TAA 
Program for Older Workers that targets older worker groups at firms who 
are certified as TAA eligible and provides the option of a wage 
supplement instead of training, job search, relocation and income 
support.


State agencies rely on the regulations to make determinations as to 
individual eligibility for TAA program benefits. TAA program 
regulations as written have been described as complicated to interpret. 
With the new TAA program benefit amendments contained in the Trade Act 
of 2002, it is imperative that the regulations be in an easy to read 
and understandable format.


Summary of Legal Basis:


These regulations are authorized by the Trade Act of 2002 amendments to 
the Trade Act of 1974.


Alternatives:


The public will be afforded an opportunity to provide comments on the 
TAA program changes when the Department publishes the interim final 
rule 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                                                           12/00/02
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


State, Federal


Agency Contact:
Edward A. Tomchick
Assistance
Department of Labor
Employment and Training Administration
Room C5311
200 Constitution Avenue NW.
Washington, DC 20210
Phone: 202 693-3577
Fax: 202 693-3585
Email: [email protected]
RIN: 1205-AB32
_______________________________________________________________________



DOL--ETA

                              -----------

                            FINAL RULE STAGE

                              -----------




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


Other Significant


Legal Authority:


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


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

[[Page 74175]]

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:


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


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            67 FR 30465                                    05/06/02
NPRM Comment Per67 FR 30466                                    07/05/02
Final Rule                                                     01/00/03
Regulatory Flexibility Analysis Required:


Undetermined


Government Levels Affected:


State, Federal


Agency Contact:
Dale Ziegler
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--Pension and Welfare Benefits Administration (PWBA)

                              -----------

                          PROPOSED RULE STAGE

                              -----------




88. 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 1166


CFR Citation:


29 CFR 2590


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 of 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                                                           03/00/03
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses, Organizations


Government Levels Affected:


None


Agency Contact:
Susan G. Lahne
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 74176]]

_______________________________________________________________________



DOL--PWBA

                              -----------

                            FINAL RULE STAGE

                              -----------




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


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


Unfunded Mandates:


Undetermined


Legal Authority:


29 USC 1027; 29 USC 1059; 29 USC 1135; 29 USC 1171; 29 USC 1172; 29 USC 
1191c


CFR Citation:


29 CFR 2590


Legal Deadline:


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


Abstract:


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


Statement of Need:


In general, the health care portability provisions in part 7 of ERISA 
provide for increased portability and availability of group health 
coverage through limitations on the imposition of any preexisting 
condition exclusion and special enrollment rights in group health plans 
after loss of other health coverage or a life event. Plan sponsors, 
administrators and participants need guidance from the Department with 
regard to how they can fulfill their respective obligations under these 
statutory provisions.


Summary of Legal Basis:


Part 7 of ERISA specifies the portability and other requirements for 
group health plans and health insurance issuers. Section 734 of ERISA 
provides that the Secretary may promulgate such regulations as may be 
necessary or appropriate to carry out the provisions of part 7 of 
ERISA. In addition, section 505 of ERISA authorizes the Secretary to 
issue regulations clarifying the provisions of title I of ERISA.


Alternatives:


Regulatory alternatives will be considered after determining the scope 
and nature of additional regulatory guidance needed by the public.


Anticipated Cost and Benefits:


Determinations on the anticipated costs and benefits will be developed 
once determinations have been made with regard to the alternatives to 
be developed.


Risks:


Failure to provide guidance concerning Part 7 of ERISA may impede 
compliance with the law.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
Interim Final Ru62 FR 16894                                    04/08/97
Interim Final Rule Effective                                   06/07/97
Interim Final Rule Comment Period End                          07/07/97
Request for Info64 FR 57520                                    10/25/99
Comment Period End                                             01/25/00
Final Rule                                                     03/00/03
Regulatory Flexibility Analysis Required:


No


Government Levels Affected:


None


Agency Contact:
Amy Turner
Pension Law Specialist
Department of Labor
Pension and Welfare Benefits Administration
Room N5677
200 Constitution Avenue NW
FP Building
Washington, DC 20210
Phone: 202 693-8335
RIN: 1210-AA54
_______________________________________________________________________



DOL--PWBA



90. PROHIBITING DISCRIMINATION AGAINST PARTICIPANTS AND BENEFICIARIES 
BASED ON HEALTH STATUS
Priority:


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


Legal Authority:


29 USC 1027; 29 USC 1059; 29 USC 1135; 29 USC 1194; 29 USC 1182; 29 USC 
1191c


CFR Citation:


29 CFR 2590.702


Legal Deadline:


None


Abstract:


Section 702 of the Employee Retirement Income Security Act of 1974, 
amended by the Health Insurance Portability and Accountability Act of 
1996 (HIPAA), establishes that a group health plan or a health 
insurance issuer may not establish rules for eligibility (including 
continued eligibility) of any individual to enroll under the terms of 
the plan based on any health status-related factor. These provisions 
are also contained in the Internal Revenue Code under the jurisdiction 
of the Department of the Treasury, and the Public Health Service Act 
under the jurisdiction of the Department of Health and Human Services.


On April 8, 1997, the Department, in conjunction with the Departments 
of the Treasury and Health and Human Services (collectively, the 
Departments) published interim final regulations implementing the 
nondiscrimination provisions of HIPAA. These regulations can be found 
at 26 CFR 54.9802-1 (Treasury), 29 CFR 2590.702 (Labor), and 45 CFR 
146.121 (HHS). That notice of rulemaking also solicited comments on the 
nondiscrimination provisions and indicated that the Departments intend 
to issue further regulations on the nondiscrimination rules. This 
rulemaking contains additional regulatory interim guidance under 
HIPAA's nondiscrimination provisions. In addition, the rulemaking 
contains proposed guidance on bona fide wellness programs.


Statement of Need:


Part 7 of ERISA establishes that group health plans and health 
insurance issuers may not establish rules for eligibility (including 
continued eligibility) of any individual to enroll under the terms of 
the plan based on any health status-related factor. Plan sponsors, 
administrators and participants need additional guidance from the 
Department with regard to how they can fulfill their respective 
obligations under these statutory provisions.


Summary of Legal Basis:


Section 702 of ERISA specifies the respective nondiscrimination 
requirements for group health plans and health insurance issuers. 
Section 734 of ERISA provides that the

[[Page 74177]]

Secretary may promulgate such regulations as may be necessary or 
appropriate to carry out the provisions of part 7 ERISA. In addition, 
section 505 of ERISA authorizes the Secretary to issue regulations 
clarifying the provisions of title I of ERISA.


Alternatives:


Regulatory alternatives will be considered after determining the scope 
and nature of additional regulatory guidance needed by the public.


Anticipated Cost and Benefits:


Determinations on the anticipated costs and benefits will be developed 
once determinations have been made with regard to the alternatives to 
be developed.


Risks:


Failure to provide guidance concerning part 7 of ERISA may impede 
compliance with the law.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
Interim Final Ru62 FR 16894                                    04/08/97
Interim Final Rule Comment Period End                          07/07/97
NPRM            66 FR 1421                                     01/08/01
Second Interim F66 FR 1378                                     01/08/01
NPRM Comment Period End                                        04/09/01
Interim Final Rule Comment Period End                          04/09/01
Final Rule                                                     04/00/03
Regulatory Flexibility Analysis Required:


No


Government Levels Affected:


Undetermined


Additional Information:


This item has been split off from RIN 1210-AA54 in order to provide 
focused guidance on section 702 of ERISA, which prohibits 
discrimination against participants and beneficiaries by group health 
plans and health insurance issuers based on health status.


Agency Contact:
Amy Turner
Pension Law Specialist
Department of Labor
Pension and Welfare Benefits Administration
Room N5677
200 Constitution Avenue NW
FP Building
Washington, DC 20210
Phone: 202 693-8335
RIN: 1210-AA77
_______________________________________________________________________



DOL--PWBA



91. [bull] BLACKOUT NOTICE REGULATION
Priority:


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


Unfunded Mandates:


Undetermined


Legal Authority:


PL 107-204; 29 USC 1135; 116 Stat 745 (29 USC 1132)


CFR Citation:


29 CFR 2520


Legal Deadline:


Other, Statutory, October 13, 2002, Interim Final Rule, PL 107-204.


Abstract:


This regulation will provide guidance with respect to the requirement 
that plan administrators furnish advance notice of blackout periods 
affecting individual account plans pursuant to section 101(i) of ERISA, 
as added by section 306 of the Sarbanes-Oxley Act of 2002.


Statement of Need:


The Sarbanes-Oxley Act of 2002 (the Act), amended ERISA by adding a new 
section 101(i), which requires plan administrators to notify individual 
account plan participants in advance of any period during which their 
ability to give investment directions will be suspended. The Act also 
added a new section 502(c)(7) to ERISA authorizing the Secretary of 
Labor to assess civil penalties against a plan administrator who fails 
or refuses to provide the required notice. The Act specifically 
requires the Secretary of Labor to provide regulatory guidance to the 
public with regard to new section 101(i) and establishes deadlines for 
the issuance of such guidance.


Summary of Legal Basis:


The Act requires the Secretary to issue regulatory guidance by October 
13, 2002, and a model notice by January 1, 2003. Section 505 of ERISA 
authorizes the Secretary to issue regulations clarifying the provisions 
of title I of ERISA.


Alternatives:


The Department will develop regulatory alternatives after determining 
the scope and nature of the regulatory guidance needed by the public.


Anticipated Cost and Benefits:


Determinations on the anticipated costs and benefits will be developed 
once determinations have been made with regard to the alternatives to 
be developed.


Risks:


Failure to provide the regulatory guidance mandated by the Act would 
contravene the provisions of law. Moreover, failure to issue such 
guidance would increase the potential risks of loss to plan 
participants and beneficiaries, and deprive plan administrators of 
information they need to enable them to comply with the new notice 
requirements.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
Interim Final Ru67 FR 64765                                    10/21/02
Interim Final Rule Comment Period End                          11/20/02
Interim Final Rule Effective                                   01/26/03
Regulatory Flexibility Analysis Required:


Undetermined


Government Levels Affected:


Undetermined


Federalism:


 Undetermined


Agency Contact:
Louis J. Camagna
Department of Labor
Pension and Welfare Benefits Administration
200 Constitution Avenue NW
Rm N5669
FP Building
Washington, DC 20210
Phone: 202 693-8500
RIN: 1210-AA90

[[Page 74178]]

_______________________________________________________________________



DOL--PWBA



92. [bull] BLACKOUT NOTICE CIVIL PENALTY
Priority:


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


Unfunded Mandates:


Undetermined


Legal Authority:


PL 107-204; 29 USC 1135; 29 USC 1021(b)(1)


CFR Citation:


29 CFR 2560


Legal Deadline:


Final, Statutory, October 13, 2002.


Abstract:


These regulations will provide guidance with respect to the requirement 
that plan administrators furnish advance notice of blackout periods 
affecting individual account plans pursuant to section 101(i) of ERISA, 
as added by section 306 of the Sarbanes-Oxley Act of 2002, as well as 
the related civil penalty provisions.


Statement of Need:


The Sarbanes-Oxley Act of 2002 (the Act), amended ERISA by adding a new 
section 101(i), which requires plan administrators to notify individual 
account plan participants in advance of any period during which their 
ability to give investment directions will be suspended. The Act also 
added a new section 502(c)(7) to ERISA authorizing the Secretary of 
Labor to assess civil penalties against a plan administrator who fails 
or refuses to provide the required notice. The Act specifically 
requires the Secretary of Labor to provide regulatory guidance to the 
public with regard to new section 101(i) and establishes deadlines for 
the issuance of such guidance.


Summary of Legal Basis:


The Act requires the Secretary to issue regulatory guidance by October 
13, 2002, and a model notice by January 1, 2003. Section 505 of ERISA 
authorizes the Secretary to issue regulations clarifying the provisions 
of title I of ERISA.


Alternatives:


The Department will develop regulatory alternatives after determining 
the scope and nature of the regulatory guidance needed by the public.


Anticipated Cost and Benefits:


Determinations on the anticipated costs and benefits will be developed 
once determinations have been made with regard to the alternatives to 
be developed.


Risks:


Failure to provide the regulatory guidance mandated by the Act would 
contravene the provisions of law. Moreover, failure to issue such 
guidance would increase the potential risks of loss to plan 
participants and beneficiaries, and deprive plan administrators of 
information they need to enable them to comply with the new notice 
requirements.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
Interim Final Ru67 FR 64774                                    10/21/02
Interim Final Rule Comment Period End                          11/20/02
Interim Final Rule Effective                                   01/26/03
Regulatory Flexibility Analysis Required:


Undetermined


Government Levels Affected:


Undetermined


Federalism:


 Undetermined


Agency Contact:
John J. Canary
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-AA91
_______________________________________________________________________



DOL--Mine Safety and Health Administration (MSHA)

                              -----------

                             PRERULE STAGE

                              -----------




93. [bull] DIESEL PARTICULATE MATTER EXPOSURE OF UNDERGROUND METAL AND 
NONMETAL MINERS
Priority:


Other Significant


Legal Authority:


30 USC 811


CFR Citation:


30 CFR 57


Legal Deadline:


None


Abstract:


On January 19, 2001, MSHA published a final rule addressing diesel 
particulate matter (DPM) exposure of underground metal and nonmetal 
miners. The final rule established new health standards for underground 
metal and nonmetal mines that use equipment powered by diesel engines. 
The rule establishes an interim concentration limit of 400 micrograms 
of total carbon per cubic meter of air that became applicable July 20, 
2002, and a final concentration limit of 160 micrograms to become 
applicable after January 19, 2006. This rule has been legally 
challenged and settlement negotiations with the litigants have resulted 
in further regulatory action on several requirements in the January 19, 
2001 final rule. Several of the actions have been completed. This new 
rulemaking will address the remaining issues. MSHA issued an ANPRM to 
obtain additional information and to develop a proposed rule 
thereafter.


Statement of Need:


Several entities legally challenged the January 19, 2001 final rule. As 
a result of partial settlement with the litigants, MSHA published two 
documents in the Federal Register on July 5, 2001. One document delayed 
the effective date of 57.5066(b) regarding the evidence and the tagging 
provisions of the maintenance standards; clarified the effective dates 
of certain provisions of the final rule; and gave correction 
amendments.


The second document was a proposed rule to clarify 57.5066(b)(1) and 
(b)(2) of the maintenance standards and to add a new paragraph (b)(3) 
to 57.5067 regarding the transfer of existing diesel equipment from one 
underground mine to another underground mine. The final rule on these 
issues was published February 27, 2002, and became effective March 29, 
2002.


Also as part of the settlement agreement, MSHA agreed to conduct joint 
sampling with industry and labor at 31 underground mines to determine 
existing concentration levels of DPM; assess the performance of the SKC 
sampler and the NIOSH Analytical Method 5040; assess the feasibility of 
achieving compliance with the standard's concentration limit at the 31 
mines; and, to assess the impact of

[[Page 74179]]

interferences on the sample in the metal and nonmetal underground 
mining environment before the limits established in the final rule 
became effective. Sampling and date analyses are completed and the 
final report is being developed.


MSHA also agreed to reenter rulemaking on several other provisions. The 
following provisions will constitute the basis for this new rulemaking:


 57.5060(a) and (b) - changing the diesel particulate matter surrogate 
from total carbon to elemental carbon for both the interim and final 
concentration limits;


 57.5060(d) - permitting miners to work in areas where diesel 
particulate matter exceeds the applicable concentration limit;


 57.5060(e) - prohibiting the use of personal protective equipment to 
comply with the concentration limits;


 57.5060(f) - prohibiting the use of administrative controls to comply 
with the concentration limits;


 57.5061(b) - changing reference of total carbon to elemental carbon;


 57.5061(c) - deleting reference to ``area'' and ``occupational'' 
sampling for compliance;


 57.5062 - addressing the diesel particulate matter control plan.


Summary of Legal Basis:


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


Alternatives:


This rulemaking action is a result of the parties' settlement 
negotiations. This action will not decrease protection for miners.


Anticipated Cost and Benefits:


MSHA will develop a preliminary economic analysis to accompany the 
proposed rule.


Risks:


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


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
ANPRM           67 FR 60199                                    09/25/02
ANPRM Comment Period End                                       11/25/02
NPRM                                                           02/00/03
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses


Government Levels Affected:


None


Agency Contact:
Marvin W. Nichols, Jr.
Director, Office of Standards
Department of Labor
Mine Safety and Health Administration
Room 2352
1100 Wilson Boulevard
Arlington, VA 22209-3939
Phone: 202 693-9457
Fax: 202 693-9441
Email: [email protected]
RIN: 1219-AB29
_______________________________________________________________________



DOL--MSHA

                              -----------

                          PROPOSED RULE STAGE

                              -----------




94. 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. 
However, given significant public comments, MSHA will repropose this 
rule.


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

[[Page 74180]]

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 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 overexposures to respirable coal mine 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                             09/08/00
NPRM                                                           02/00/03
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:
Marvin W. Nichols Jr.
Director, Office of Standards
Department of Labor
Mine Safety and Health Administration
Room 2352
1100 Wilson Boulevard
Arlington, VA 22209
Phone: 202 693-9457
Fax: 202 693-9441
Email: [email protected]
RIN: 1219-AB14
_______________________________________________________________________



DOL--MSHA



95. 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 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 3d 1264 (11th Cir. 1998). MSHA 
is supllmenting the record with additional data and will reopen the 
record for comments.


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 sample) will work in tandem with 
those of the proposed rule (RIN 1219-AB14) in which MSHA proposed to 
verify the effectiveness of ventilation plans as well as conduct all 
compliance sampling in underground coal mines. However, given 
significant public comments, MSHA will repropose RIN 1219-AB14 - 
Verification of Underground Coal Mine Operators' Dust Control Plans and 
Compliance Sampling for Respirable Dust.


Anticipated Cost and Benefits:


Benefits sought are reduced dust levels over a miner's working lifetime 
by the elimination of overexposures to respirable coal mine dust on 
each and every production shift. Additional benefits include reduced 
health care costs and disability and black lung benefit payments.


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                             09/08/00
Reopen Record for Comments                                     02/00/03

[[Page 74181]]

Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses


Government Levels Affected:


None


Additional Information:


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


Agency Contact:
Marvin W. Nichols Jr.
Director, Office of Standards
Department of Labor
Mine Safety and Health Administration
Room 2352
1100 Wilson Boulevard
Arlington, VA 22209
Phone: 202 693-9457
Fax: 202 693-9441
Email: [email protected]
RIN: 1219-AB18
_______________________________________________________________________



DOL--MSHA



96. 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 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           67 FR 15134                                    03/29/02
Notice of Public Meetings                                      03/29/02
Notice of Change67 FR 19140Meetings                            04/18/02
ANPRM Comment Period End                                       06/27/02
NPRM                                                           09/00/03
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:
Marvin W. Nichols Jr.
Director, Office of Standards
Department of Labor
Mine Safety and Health Administration
Room 2352
1100 Wilson Boulevard
Arlington, VA 22209
Phone: 202 693-9457
Fax: 202 693-9441
Email: [email protected]
RIN: 1219-AB24

[[Page 74182]]

_______________________________________________________________________



DOL--Occupational Safety and Health Administration (OSHA)

                              -----------

                          PROPOSED RULE STAGE

                              -----------




97. ASSIGNED PROTECTION FACTORS: AMENDMENTS TO THE FINAL RULE ON 
RESPIRATORY PROTECTION
Priority:


Other Significant


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 completed.


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                                                           02/00/03
Regulatory Flexibility Analysis Required:


Undetermined


Government Levels Affected:


State, Local, Tribal, Federal


Agency Contact:
Steven F. Witt
Director, Directorate of Standards and Guidance
Department of Labor
Occupational Safety and Health Administration
Room N3605
200 Constitution Avenue NW.
Washington, DC 20210
Phone: 202 693-2222
Fax: 202 693-1663
RIN: 1218-AA05
_______________________________________________________________________



DOL--OSHA



98. 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


CFR Citation:


29 CFR 1915, subpart P


Legal Deadline:


None


Abstract:


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. A negotiated rulemaking 
committee was convened on October 15, 1996. Members of the committee 
included: OSHA, State government, Federal agency, small and large 
shipyard employers, and maritime and firefighter union representatives. 
The committee completed work in February 2002, and recommended proposal 
requirements to OSHA. The Agency has developed an NPRM based on their 
recommendations.


Statement of Need:


Fires in the shipyard environment may cause death and serious injuries 
in this 100,000-employee workforce. Updating OSHA's outdated shipyard

[[Page 74183]]

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 are being prepared for the NPRM.


Risks:


A risk analysis is incldued in the NPRM.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           12/00/02
Regulatory Flexibility Analysis Required:


Undetermined


Small Entities Affected:


Businesses


Government Levels Affected:


Undetermined


Agency Contact:
Steven F. Witt
Director, Directorate of Standards and Guidance
Department of Labor
Occupational Safety and Health Administration
Room N3605
200 Constitution Avenue NW.
Washington, DC 20210
Phone: 202 693-2222
Fax: 202 693-1663
RIN: 1218-AB51
_______________________________________________________________________



DOL--OSHA



99. OCCUPATIONAL EXPOSURE TO CRYSTALLINE SILICA
Priority:


Economically Significant. Major under 5 USC 801.


Unfunded Mandates:


Undetermined


Legal Authority:


29 USC 655(b); 29 USC 657


CFR Citation:


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


Legal Deadline:


None


Abstract:


Crystalline silica is a significant component of the earth's crust, and 
many workers in a wide range of industries are exposed to it, usually 
in the form of respirable quartz or, less frequently, cristobalite. 
Chronic silicosis is a uniquely occupational disease resulting from 
exposure of employees over long periods of time (10 years or more). 
Exposure to high levels of respirable crystalline silica causes acute 
or accelerated forms of silicosis that are ultimately fatal. The 
current OSHA permissible exposure limit (PEL) for general industry is 
based on a formula recommended by the American Conference of 
Governmental Industrial Hygienists (ACGIH) in 1971 [PEL=10mg/cubic 
meter/(%silica + 2), as respirable dust]. The current PEL for 
construction and maritime (derived from ACGIH's 1962 Threshold Limit 
Value) is based on particle counting technology, which is considered 
obsolete. NIOSH and ACGIH recommend a 50ug/m3 exposure limit for 
respirable crystalline silica.


Both industry and worker groups have recognized that a comprehensive 
standard for crystalline silica is needed to provide for exposure 
monitoring, medical surveillance, and worker training. The American 
Society of Testing Materials (ASTM) recently published a final 
recommended standard to address the hazards of crystalline silica. The 
Building Construction Trades Department of the AFL-CIO has also 
developed a recommended comprehensive program standard. These standards 
include provisions for methods of compliance, exposure monitoring, 
training, and medical surveillance.


In developing a proposed standard, OSHA is currently considering 
several options ranging from proposing comprehensive standards 
simultaneously for general industry, construction, and maritime, to 
focusing the proposal on one or more specific issues, such as 
modernizing the construction and maritime PELs or standardizing 
sampling and employee exposures. OSHA is continuing to coordinate 
closely with the Mine Safety and Health Administration (MSHA) and the 
National Institute for Occupational Safety and Health (NIOSH) in 
collecting and developing information for a proposed standard.


Statement of Need:


Over 2 million workers are exposed to crystalline silica dust in 
general industry, construction and maritime industries. Industries that 
could be particularly affected by a standard for crystalline silica 
include: foundries, industries that have abrasive blasting operation, 
paint manufacture, glass and concrete product manufacture, brick 
making, china and pottery manufacture, manufacture of plumbing 
fixtures, and many construction activities including highway repair, 
masonry, concrete work, rock drilling, and tuckpointing. The 
seriousness of the health hazards associated with silica exposure is 
demonstrated by the fatalities and disabling illnesses that continue to 
occur. Between 1990 and 1996, 200 to 300 deaths per year are known to 
have occurred where silicosis was identified on death certificates as 
an underlying or contributing cause. It is likely that many more cases 
have occurred where silicosis went undetected. In addition, the 
International Agency for Research on Cancer (IARC) has designated 
crystalline silica as a known human carcinogen. Exposure to crystalline 
silica has also been associated with an increased risk of developing 
tuberculosis and other nonmalignant respiratory diseases. Exposure 
studies and OSHA enforcement data indicate that some workers continue 
to be exposed to levels of crystalline silica far in excess of current 
exposure limits. Congress has recently included compensation of 
silicosis victims on Federal nuclear testing sites in the Energy 
Employees' Occupational Illness Compensation Program Act of 2000. There 
is a particular need for the Agency to modernize its exposure limits 
for construction and maritime, and to address some specific issues that 
will need to be resolved to propose a comprehensive standard.


Summary of Legal Basis:


The legal basis for the proposed rule is a preliminary determination 
that workers are exposed to a significant risk of silicosis and other 
serious disease and that rulemaking is needed to substantially reduce 
the risk. In addition, the proposed rulemaking will recognize that the 
PELs for construction

[[Page 74184]]

and maritime are outdated and need to be revised to reflect current 
sampling and analytical technologies.


Alternatives:


Over the past several years, the Agency has attempted to address this 
problem through a variety of nonregulatory approaches, including 
initiation of a Special Emphasis Program on silica in October 1997, 
sponsorship with NIOSH and MSHA of the National Conference to Eliminate 
Silicosis, and dissemination of guidance information on its Web site. 
OSHA has determined that rulemaking is a necessary step to ensure that 
workers are protected from the hazards of crystalline silica. The 
Agency is currently evaluating several options for the scope of the 
rulemaking.


Anticipated Cost and Benefits:


The scope of the proposed rulemaking is still under development, and 
estimates of the costs and benefits have not yet been developed.


Risks:


A detailed risk analysis has not yet been completed for this rule.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
Initiate SBREFA Process or Initiate                            06/00/03
NPRM                                                           11/00/03
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses


Government Levels Affected:


Undetermined


Agency Contact:
Steven F. Witt
Director, Directorate of Standards and Guidance
Department of Labor
Occupational Safety and Health Administration
Room N3605
200 Constitution Avenue NW.
Washington, DC 20210
Phone: 202 693-2222
Fax: 202 693-1663
RIN: 1218-AB70
_______________________________________________________________________



DOL--OSHA



100. 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, subpart Z; 29 CFR 1910.1001 to 1910.1052; 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 1917.92; 29 CFR 1926.1101; 29 CFR 1926.1127; 29 
CFR 1926.1129; 29 CFR 1926.60; 29 CFR 1926.62


Legal Deadline:


None


Abstract:


The Occupational Safety and Health Administration (OSHA) is proposing 
to remove or revise provisions in its health standards that 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            67 FR 66493                                    10/31/02
NPRM Comment Period End                                        12/20/02
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


None


Agency Contact:
Steven F. Witt
Director, Directorate of Standards and Guidance
Department of Labor
Occupational Safety and Health Administration
Room N3605
200 Constitution Avenue NW.
Washington, DC 20210
Phone: 202 693-2222
Fax: 202 693-1663
RIN: 1218-AB81

[[Page 74185]]

_______________________________________________________________________



DOL--OSHA

                              -----------

                            FINAL RULE STAGE

                              -----------




101. 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 revising OSHA's exit routes (also 
known as means of egress) standard. The revisions 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 is 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                                                     12/00/02
Regulatory Flexibility Analysis Required:


No


Government Levels Affected:


None


Agency Contact:
Steven F. Witt
Director, Directorate of Standards and Guidance
Department of Labor
Occupational Safety and Health Administration
Room N3605
200 Constitution Avenue NW.
Washington, DC 20210
Phone: 202 693-2222
Fax: 202 693-1663
RIN: 1218-AB82
BILLING CODE 4510-23-S

[[Page 74186]]




DEPARTMENT OF TRANSPORTATION (DOT)



Statement of Regulatory Priorities
 The Department of Transportation (DOT) consists of eleven 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 development of regulatory process and related training 
courses for its employees; creation of an electronic, Internet-
accessible docket that can also be used to submit comments 
electronically; a ``list serve'' that allows the public to sign up for 
e-mail notification when the Department issues a rulemaking document; 
creation of an electronic rulemaking tracking system; the use of direct 
final rulemaking; and the use of regulatory negotiation are a few 
examples of this.
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. The Department's agencies also 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 includes determining if the 
rules would be more understandable if they are written using a 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 2003, OST expects to substantially complete work on 
a CRS final rule. 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 2003.
Transportation Security Administration (TSA)
The TSA was established on November 19, 2001, by the Aviation and 
Transportation Security Act (ATSA) (Pub. L. 107-71). Under ATSA, TSA is 
responsible for civil aviation security, as well as security in other 
modes of transportation regulated by the DOT. TSA's regulatory 
priorities for 2002-2003 are to continue to issue rulemakings necessary 
to meet the requirements of ATSA, including rules needed to address new 
security vulnerabilities that may arise. TSA also will undertake a 
review of its rules to eliminate duplicative and unnecessary 
requirements.
United States Coast Guard (USCG)
 The United States Coast Guard's statutory responsibilities include

[[Page 74187]]

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 apply to a specific 
location and most take effect for a limited time. These actions allow 
local Coast Guard units to respond quickly to ensure safety and 
security for our ports and waterways.
 From its headquarters in Washington, DC, the Coast Guard issues 
approximately 20 regulations annually. These regulations 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:
[sbull] The Coast Guard continues using a 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.
[sbull] Another way the Coast Guard encourages early public involvement 
            in rulemaking is through public meetings and the ongoing 
            work of 10 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. The Coast Guard is a staunch supporter of the 
            Department of Transportation Docket Management System 
            (DMS). DMS provides electronic docketing for all Coast 
            Guard headquarters rulemaking projects. The public can view 
            agency documents and public comments on each rulemaking 
            project. DMS is located at http://dms.dot.gov/.
[sbull] As part of its response to the terrorist attacks of September 
            11, 2001, the Coast Guard conducted a public workshop on 
            Maritime Security in January 2002. The public comments from 
            this workshop have helped guide our work on security plans 
            for ports, waterfront facilities (including passenger 
            facilities), passenger vessels and high-consequences 
            vessels, and identification credentials for persons on 
            vessels and in waterfront facilities. Since September 11, 
            2001, the Coast Guard has created more than 100 security 
            zones to protect vessels and waterfront facilities. We are 
            also working to enhance our maritime domain awareness 
            capabilities.
[sbull] 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 
            developed several Quality Partnerships.
[sbull] Finally, to ensure that all regulations are necessary, each 
            agenda item specifies how it supports at least one of the 
            five goals of the Coast Guard's Strategic Plan -- maritime 
            safety, protection of natural resources, maritime security, 
            maritime mobility, and national defense. As indicated by 
            the project in our regulatory plan, our post-September 11, 
            2001, emphasis on maritime security and national defense 
            has not prevented us from addressing our other strategic 
            goals. Our regulatory plan is structured to help us achieve 
            the Commandant's new direction emphasizing readiness, 
            people and stewardship.
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 reexamined the 
use of plain language in its 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:
[sbull] 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.
[sbull] 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 nine 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.
[sbull] 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 39 regulations based on 
            recommendations of ARAC that will lead to harmonizing FAA 
            regulations and Joint Aviation Requirements.
[sbull] 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 74188]]

            page, a toll-free number, and an e-mail address for receipt 
            of inquiries.
[sbull] 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 2002-2003 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 2003 will be 
continuing implementation of the Transportation Equity Act for the 21st 
Century (TEA-21), which reauthorizes the surface transportation 
programs administered by the FHWA. The FHWA will continue to implement 
this legislation in the least burdensome and restrictive way possible 
consistent with the FHWA's mission. The FHWA will 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 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 regulatory initiatives are 
required by MCSIA. Over the next year, 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. FMCSA's regulatory program will assist the 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. For example, during FY 2003, NHTSA's 
implementation of the TREAD Act will remain a high priority. 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's regulatory program includes safety improvements that address 
significant numbers of fatalities and injuries and that are of the most 
concern to the public. Within this context, an important regulatory 
priority is offset frontal protection.
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 roadway 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 revision of 
FRA's accident/incident reporting regulations to ensure conformity with 
OSHA's revised occupational injury and illness reporting regulations; 
and (8) the revision of FRA's blue signal protection requirements for 
workers performing certain duties on, under or between rolling 
equipment.
 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 2002. 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

[[Page 74189]]

State and local governments for mass transportation purposes. The 
regulatory activity of FTA focuses on establishing the terms and 
conditions of Federal financial assistance available under the Federal 
transit laws.
 FTA's policy regarding regulations is to:
[sbull] Implement statutory authorities in ways that provide the 
            maximum net benefits to society;
[sbull] Keep paperwork requirements to a minimum;
[sbull] Allow for as much local flexibility and discretion as is 
            possible within the law;
[sbull] Ensure the most productive use of limited Federal resources;
[sbull] Protect the Federal interest in local investments; and
[sbull] 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 2002-2003 
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.
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 2003, BTS will continue its efforts to develop a reporting 
system that would allow relevant causal information to be disseminated 
to the traveling public. This reporting system would enable the 
Department to better identify the causes of delays and evaluate its 
efforts to mitigate such causes. BTS' goal is to publish a final rule 
concerning airline delays and cancellations during FY 2003.
 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 
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

[[Page 74190]]

safest, most reliable, and most efficient Seaway System possible.
_______________________________________________________________________



DOT--Office of the Secretary (OST)

                              -----------

                          PROPOSED RULE STAGE

                              -----------




102. [rplus]COMPUTER RESERVATIONS SYSTEM REGULATIONS COMPREHENSIVE 
REVIEW
Priority:


Other Significant


Legal Authority:


49 USC 41712; 49 USC 40101(a); 49 USC 40113(a); 49 USC 40105


CFR Citation:


14 CFR 255; 14 CFR 399


Legal Deadline:


Final, Statutory, December 31, 1997.


Abstract:


The Department regulates computer reservations systems owned by 
airlines or airline affiliates that are used by travel agencies. The 
current rules are designed to prevent the systems from unreasonably 
prejudicing the competitive position of other airlines and to ensure 
that travel agencies can provide accurate and unbiased information to 
the public. The Department is reexamining its rules to see whether they 
should be readopted and, if so, whether they should be changed in 
response to greater use of the Internet in airline reservations and 
ticketing and changes in the industry. The Department is also reviewing 
its policies on the requirements for advertising fares by airline 
travel agencies that charge fees for brokering airline tickets. As part 
of this action, we will be looking at ways to lessen impacts on small 
entities.


Statement of Need:


The Department's existing rules require the Department to reexamine 
whether the rules are necessary and effective. In addition, two 
developments since the Department's last review of rules necessitate a 
reexamination. Those developments are the growing role of the Internet 
in airline distribution and the decline in airline control of the 
systems. A number of airlines obtain a large share of their bookings 
from their own Web sites, online travel agencies account for a 
significant share of all airline bookings, and the two largest systems 
operating in the United States are not owned by any airline.


Summary of Legal Basis:


The Department has the authority under 49 U.S.C. 41712 to prohibit 
unfair and deceptive practices and unfair methods of competition in the 
sale of air transportation by airlines and ticket agents. The 
Department accordingly may prohibit conduct by airlines and ticket 
agents that is likely to cause deception or violate the antitrust laws 
or antitrust principles. The original CRS rules were affirmed in United 
Air Lines v. CAB, 766 F.2d 1107 (7th Cir. 1985).


Alternatives:


The Department will consider alternatives ranging from allowing some or 
all of the rules to expire at their sunset date to readopting the rules 
with some additional provisions. The Department has issued two advance 
notices of proposed rulemaking asking for comment on whether the rules 
remain necessary in light of the developments in airline distribution 
and the systems' declining airline control and on whether rules are 
necessary for governing the sale of airline services through the 
Internet. The rules can be phased out or eliminated, along with comment 
on whether the rules should be strengthened in several respects raised 
by the comments on the advance notices of proposed rulemaking.


Anticipated Cost and Benefits:


The Department will include a preliminary regulatory evaluation in its 
notice of proposed rulemaking.


Risks:


The Department found in its last overall review of the rules that the 
systems had the ability and potential incentives to engage in conduct 
that could prejudice airline competition and cause consumers and their 
travel agents to receive misleading and inaccurate information on 
airline services. Systems could also engage in practices that would 
deny airlines and travel agencies a reasonable opportunity to use 
alternative electronic services that would provide information and 
booking capabilities. The rules may also impose costs on the systems 
and airlines. The Department will ask for comment on whether the risks 
still exist and, if so, whether the costs imposed by the rules outweigh 
the benefits provided by the rules.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
ANPRM           62 FR 47606                                    09/10/97
Notice Extending62 FR 58700riod                                10/30/97
Request for Comm62 FR 60195                                    11/07/97
ANPRM Comment Period End                                       11/10/97
Extended Comment Period End                                    12/09/97
Notice Extending63 FR 3491ment Period                          01/23/98
Extended Comment Period End                                    02/03/98
SANPRM          65 FR 45551                                    07/24/00
SANPRM Comment Period End                                      09/22/00
SANPRM Reply Comment Period End                                10/23/00
NPRM                                                           01/00/03
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses


Government Levels Affected:


None


Additional Information:


The extensions for the existing rule are under RINs 2105-AC75 and 2105-
AD00 and AD09.


Agency Contact:
Thomas Ray
Office of General Counsel
Department of Transportation
Office of the Secretary
400 Seventh Street SW.
Washington, DC 20590
Phone: 202 366-4731
RIN: 2105-AC65
_______________________________________________________________________



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

                              -----------

                            FINAL RULE STAGE

                              -----------




103. [rplus]SALVAGE AND MARINE FIREFIGHTING REQUIREMENTS; VESSEL 
RESPONSE PLANS FOR OIL (USCG-1998-3417)
Priority:


Economically Significant. Major under 5 USC 801.


Unfunded Mandates:


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


Legal Authority:


33 USC 1321

[[Page 74191]]

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 also 
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:


Response plans are required by statute. A response plan will not 
prevent a discharge of oil, but it may help minimize the discharge and 
resulting damage to the environment. We estimate the provisions 
included in the salvage and firefighting requirements will prevent 
approximately 85,000 barrels of oil from entering the water during the 
next 25 years. As a point of reference, we further estimate the eleven 
major Oil Pollution Act of 1990 rulemakings will prevent approximately 
1.2 million barrels of oil from entering the water over that same 
period. Consequently, the salvage and firefighting rulemaking 
represents a significant portion of the benefits to sociey of OPA 90.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
Final Rule - Par63 FR 7069nsion                                02/12/98
Final Rule - Par66 FR 3876nsion                                01/17/01
NPRM            67 FR 31868                                    05/10/02
Public Meeting 767 FR 40254/02, 7/25/02                        06/12/02
Public Meeting 967 FR 51159                                    08/07/02
NPRM Comment Period Extended                                   08/07/02
NPRM Comment Period End                                        10/18/02
Final Rule                                                     12/00/03
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.


URL For More Information:
http://dms.dot.gov
URL For Public Comments:
http://dms.dot.gov
Agency Contact:
LT Reed Kohberger
Project Manager, G-MOR-3
Department of Transportation
U.S. Coast Guard
2100 Second Street SW.
Washington, DC 20593-0001
Phone: 202 267-0448
Related RIN: Related To 2115-AD81
RIN: 2115-AF60
_______________________________________________________________________



DOT--Federal Aviation Administration (FAA)

                              -----------

                          PROPOSED RULE STAGE

                              -----------




104. [rplus]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. Growth in long-haul,

[[Page 74192]]

regional, overnight cargo, and short-haul domestic operations is 
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                                                          11/00/02
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses


Government Levels Affected:


None


Additional Information:


Project Number: AFS-94-443R


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


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

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



DOT--FAA

                              -----------

                            FINAL RULE STAGE

                              -----------




105. [rplus]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

[[Page 74193]]

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 cost 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                                                     12/00/02
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


None


Additional Information:


Project Number: ANM-99-086R.


Analysis: Regulatory Evaluation 12/00/2002.


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
_______________________________________________________________________



DOT--FAA



106. [rplus]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 responsibility 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 to 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

[[Page 74194]]

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                                                   12/00/02
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

                              -----------




107. [rplus]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.


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:


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 was required by the ICC Termination 
Act of 1995 (ICCTA), Pub. L. 104-88. 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. 
This action is one of the 23 ``high priority'' rule reform nominations 
in the 2001 cost benefit report.


Statement of Need:


Growth in long-haul, regional, overnight, local, for-hire and private 
carriage operations has kept pace with the growth of the U.S. economy. 
The scientific knowledge about sleep, sleep disorders, circadian 
physiology, fatigue, and performance decrements has also grown. The 
agency intends to incorporate as much of the scientific knowledge as 
possible into the regulations.


Summary of Legal Basis:


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).


The FY 2001 Department of Transportation Appropriations Act, Pub. L. 
106-346, included language prohibiting the Department from adopting a 
final rule before October 1, 2001.


Alternatives:


FMCSA received more than 53,000 comments on the NPRM. The agency is 
committed to fully exploring all issues and concerns of stakeholders; 
eight public hearings were held in May, June and July 2000; and three 
additional roundtables were held in September and October 2000. 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. This will help FMCSA identify any necessary changes to 
the proposal that would address stakeholders' divergent concerns and 
support the development of a successful rule.


Anticipated Cost and Benefits:


FMCSA has placed a Preliminary Regulatory Evaluation of the NPRM in the 
docket.


Risks:


Driver reports of being fatigued to the point of incapacity are not 
uncommon, and it is reasonable to expect fatigue to be a factor in 
future crashes if the regulations are not corrected. FMCSA has 
established a goal to reduce by 50 percent over ten years the number of

[[Page 74195]]

fatalities from crashes involving any commercial motor vehicle.


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                                                   03/00/03
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.


Agency Contact:
David R. Miller
Regulatory Development Division
Department of Transportation
Federal Motor Carrier Safety Administration
MC-PRR
Office of Policy Plans and Regulation
400 Seventh Street, SW.
Washington, DC 20590
Phone: 202 366-5011
RIN: 2126-AA23
_______________________________________________________________________



DOT--FMCSA



108. [rplus]LIMITATIONS ON ISSUANCE OF COMMERCIAL DRIVER'S LICENSE WITH 
HAZARDOUS MATERIALS ENDORSEMENT
Priority:


Other Significant


Legal Authority:


49 USC 5103a; PL 107-56, sec 1012


CFR Citation:


49 CFR 383


Legal Deadline:


None


Abstract:


This rule would amend the Federal Motor Carrier Safety Regulations to 
prohibit States from issuing, renewing, transferring, or upgrading a 
commercial driver's license to transport hazardous materials unless and 
until the U.S. Department of Justice first conducts a background 
records check of the applicant and the U.S. Department of 
Transportation determines that the applicant does not pose a security 
risk which would warrant denial of the hazardous materials endorsement. 
This interim final action is required by section 1012 of the USA 
PATRIOT Act of 2001. This action is considered significant because of 
significant public interest in security issues since the events that 
occurred on September 11, 2001.


Statement of Need:


National security and intelligence officials continue to warn that 
future terrorist attacks against civilian targets are possible. One 
potential method could include obtaining hazardous materials for 
malicious purposes. This action responds to the requirement of section 
1012 of the USA PATRIOT Act which is intended to make obtaining a 
hazardous materials endorsement difficult for those intending to do 
harm to the United States.


Summary of Legal Basis:


In response to the events of September 11, 2001, Congress passed the 
Uniting and Strengthening America by Providing Appropriate Tools 
Required to Intercept and Obstruct Terrorism Act of 2001 (USA PATRIOT 
Act) (Pub. L. 107-56, October 26, 2001, 115 Stat. 272). Section 1012 of 
the USA PATRIOT Act (115 Stat. 396) amended the Hazardous Materials 
Transportation Act (49 U.S.C. chapter 51) by adding new section 
5103a(a)(1), Limitation on issuance of hazmat licenses. Further, 
section 1012(b) of the USA PATRIOT Act amended the fitness and testing 
standards of the Commercial Motor Vehicle Safety Act of 1986, which 
created the Commercial Driver's License (CDL) Program (49 U.S.C. 
31305(a)(5)(C)).


Alternatives:


The purpose of section 1012 of the USA PATRIOT Act is to obstruct 
potential terrorists from gaining access to hazardous materials. If 
other, less costly methods were available to attain the same end, they 
would be employed. However, FMCSA does not believe any such 
alternatives exist.


Anticipated Cost and Benefits:


This rule will not have a significant impact on a substantial number of 
small entities because the impact of the rule will be gradual. 
Nonetheless, a regulatory analysis was prepared and placed in the 
docket.


Risks:


A failure to require background records checks of hazardous materials 
drivers could pose a national security risk.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
Interim Final Rule                                             11/00/02
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


Businesses, Governmental Jurisdictions


Government Levels Affected:


State


Agency Contact:
Valerie Height
Regulatory Development Division
Department of Transportation
Federal Motor Carrier Safety Administration
MC-PRR
Office of Policy Plans and Regulation
400 Seventh Street, SW.
Washington, DC 20590
Phone: 202 366-0901
RIN: 2126-AA70
_______________________________________________________________________



DOT--National Highway Traffic Safety Administration (NHTSA)

                              -----------

                          PROPOSED RULE STAGE

                              -----------




109. [rplus]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

[[Page 74196]]

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 be 
largely harmonized 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 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:


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:


The agency is evaluating the benefits and costs associated with 
requiring an offset frontal crash test procedure in FMVSS No. 208. 
Additional vehicle crash tests with advanced lower-leg instrumentation 
and new injury criteria are being conducted to develop comprehensive 
benefits estimates. The agency is also studying the societal costs 
associated with long-term lower-leg impairment.


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. While lower-extremity injuries are rarely fatal, they 
do account for substantial societal costs associated with long-term 
impairment.


NHTSA is also examining whether implementing a new offset test might 
create disbenefits in other crash modes such as side impacts.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           05/00/03
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


Businesses


Government Levels Affected:


None


Additional Information:


In December 2001, the Office of Management and Budget (OMB) sent a 
prompt letter to NHTSA suggesting that it give higher priority to this 
rulemaking. NHTSA advised OMB that it is making offset frontal crash 
protection one of its highest safety rulemaking priorities.


Agency Contact:
Lori Summers
Division Chief
Department of Transportation
National Highway Traffic Safety Administration
NVS-112
Light Duty Vehicles Division
400 Seventh Street, SW
Washington, DC 20590
Phone: 202 366-4917
Fax: 202 366-4329
Related RIN: Related To 2127-AI39
RIN: 2127-AH73
_______________________________________________________________________



DOT--Federal Railroad Administration (FRA)

                              -----------

                            FINAL RULE STAGE

                              -----------




110. [rplus]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 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 
of an NPRM that would facilitate introduction of advanced technology, 
including systems that support PTC functions. The NPRM addresses 
technical standards for all processor-based signal and train control 
products, amending 49 CFR part 236. The comment period ended 11/08/01, 
and FRA is now preparing a final rule.


Statement of Need:


Current FRA regulations do not adequately address the use of signal and 
train control technology that is

[[Page 74197]]

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 rule 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 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 
rule would ensure that any replacement system is at least as safe as 
the current system. Concerning existing processor-based systems, the 
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 proceeding 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 rule would 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 rule would 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                                        11/08/01
Final Rule                                                     06/00/03
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses


Government Levels Affected:


Undetermined


Federalism:


 Undetermined


Agency Contact:
Cynthia Walters
Trial Attorney
Department of Transportation
Federal Railroad Administration
400 Seventh Street SW.
Washington, DC 20590
Phone: 202 493-6064
RIN: 2130-AA94
_______________________________________________________________________



DOT--Research and Special Programs Administration (RSPA)

                              -----------

                          PROPOSED RULE STAGE

                              -----------




111. [rplus]PIPELINE SAFETY: PIPELINE INTEGRITY MANAGEMENT IN HIGH-
CONSEQUENCE AREAS (GAS TRANSMISSION PIPELINE OPERATORS)
Priority:


Other Significant


Legal Authority:


49 USC 5121; 49 USC 60102 to 60104; 49 USC 60108, 60117, 60118, 60124; 
49 CFR 1.53


CFR Citation:


49 CFR 192


Legal Deadline:


None


Abstract:


An October 21, 1999, notice announced a public meeting to consider the 
need for additional safety and environmental regulations for gas 
transmission lines, hazardous liquid pipelines, and distribution 
pipelines in high-density population areas, commercially navigable 
waterways, and areas unusually sensitive to environmental damage. The 
public meeting was held on November 18-19, 1999 in Herndon, Virginia. 
The meeting was to determine the extent to which operators now have 
integrity management programs, to explore effective ways to promote 
their development and implementation by all operators, and to discuss 
mechanisms to confirm the adequacy of such operator-developed programs. 
Participants in the meeting discussed

[[Page 74198]]

a practical definition of high-consequence areas, as well as the need, 
if any, for increased inspection, enhanced damage prevention, improved 
emergency response, and other measures to prevent and mitigate pipeline 
leaks and ruptures in these areas. Comments from the public were due by 
January 17, 2000.


A final rule was published to require validation/testing of the 
integrity of certain hazardous liquid pipelines in high-consequence 
areas (RIN 2137-AD45).


Consideration of a similar gas rule is underway. A public meeting was 
held on February 12-14, 2001 to present information on integrity 
requirements for gas transmission pipelines. Additional information was 
requested June 27, 2001 (66 FR 34318). Rulemakings addressing gas 
transmission line high-consequence areas, direct assessment, and 
overall integrity management program will be published in 2002.


Statement of Need:


This action would address risks that have evolved as a growing economy 
brought people closer and closer to pipelines that are constructed in 
once rural areas. This action would provide added protection to areas 
where a gas release could do the greatest harm to people, and increase 
the public's assurance about the safety of pipelines.


In addition, this action would address four recommendations from the 
National Transportation Safety Board (NTSB): (1) require periodic 
testing and inspection to identify corrosion and other time-dependent 
damage; (2) establish criteria to determine appropriate intervals for 
inspections and tests, including safe service intervals between 
pressure testing; (3) determine hazards to public safety from electric 
resistance welded (ERW) pipe and take appropriate regulatory action; 
and (4) expedite requirements for installing automatic or remote-
operated mainline valves on high-pressure lines to provide for rapid 
shutdown or failed pipeline segments.


Summary of Legal Basis:


Section 60102 of title 49, United States Code, provides broad authority 
to address pipeline operations and maintenance. In addition, paragraph 
(f) of that section requires that the Department prescribe, if 
necessary, additional standards requiring the periodic inspection of 
pipelines in high-density population areas, to include any 
circumstances when an instrumented internal inspection device, or 
similarly effective inspection method, should be used to inspect the 
pipeline (49 U.S.C. 60102(f)(2)). Paragraph (j) of that section 
requires that the Department prescribe standards on the circumstances 
where an operator of a gas transmission pipeline facility must use 
remote control valves to shut off the flow of natural gas in the event 
of a rupture of an interstate natural gas pipeline facility. (49 U.S.C. 
60102(j)).


Alternatives:


The Office of Pipeline Safety considered several alternatives to 
provide the necessary increased level of protection to high consequence 
areas. These alternatives were: (1) no action; (2) prescriptive 
requirements for inspection and repair of pipelines in high consequence 
areas; (3) requiring pipeline operators to develop integrity management 
programs providing for inspection and testing based on risk factors and 
integration of information related to pipeline risk; and (4) requiring 
pipeline operators to develop integrity management programs providing 
for expedited inspection and testing.


Anticipated Cost and Benefits:


RSPA has estimated the following costs and benefits from the gas 
integrity management rulemaking and they have been subjected to peer 
review by the technical advisory committee charged by statute with 
reviewing the costs and benefits of proposed regulation.


For option 3, costs for the first year are estimated at $250M; for 
years 2-10 at $90M/year; and years 11-20 at $65M. In addition to a 
large amount of qualitative benefits, quantified benefits are estimated 
to be on order of $40 million annually.


Risks:


In conjunction with the existing pipeline safety requirements, this 
action creates a protective superstructure through more comprehensive 
assessment, repair, preventive, and mitigative actions in those areas 
(high consequence areas) where a failure would do the greatest damage. 
This assessment process will produce better information about problems 
that may have been missed and creates checks and balances to assure 
that the best use is made of available information to correct the 
problems.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM - Integrity Management Program                            11/00/02
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


None


Additional Information:


Docket No. RSPA-00-7666.


Agency Contact:
Mike Israni
General Engineer
Department of Transportation
Research and Special Programs Administration
400 Seventh Street SW.
Washington, DC 20590
Phone: 202 366-4571
Email: [email protected]
RIN: 2137-AD54
BILLING CODE 4910-62-S

[[Page 74199]]




DEPARTMENT OF THE TREASURY (TREAS)



Statement of Regulatory Priorities
 The primary missions of the Department of the Treasury are:
[sbull] 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;
[sbull] 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
[sbull] 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, border security, 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 and carefully consider public 
comments before adopting a final rule. Also, in particular cases, the 
Department invites interested parties to submit views on rulemaking 
projects while a proposed rule is being developed, and holds public 
hearings to discuss proposed rules.
 In response to the events of September 11, 2002, the President signed 
the USA PATRIOT Act of 2001 into law on October 26, 2001. Over the past 
year, the Department of the Treasury has accorded the highest priority 
to developing and issuing regulations to implement the provisions in 
this historic legislation that target money laundering and terrorist 
financing. These efforts, which will continue during the coming year, 
are reflected in the regulatory priorities of the Financial Crimes 
Enforcement Network (FinCEN). Also over the past year, the U.S. Customs 
Service has undertaken important regulatory initiatives to enhance our 
Nation's border security. These efforts will also continue during the 
coming year and are reflected in the regulatory priorities of the U.S. 
Customs Service.
 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.
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. 
FinCEN's regulations implement the Bank Secrecy Act (BSA), as amended 
in October 2001 by the USA PATRIOT Act. The 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 
matters, or in the conduct of intelligence or counter-intelligence 
activities to protect against international terrorism, and to implement 
counter-money laundering programs and compliance procedures. FinCEN is 
working closely with the Treasury Offices of the General Counsel, 
Enforcement, and Financial Institutions to develop regulations to 
implement the amendments to the BSA made by the USA PATRIOT Act that 
target money laundering and terrorist financing.
 FinCEN's regulatory priorities for fiscal year 2003 include the 
following projects, all of which are related to the events of September 
11, 2001:
[sbull] Due Diligence for Correspondent Accounts and Private Banking 
            Accounts. This final rule would implement section 312 of 
            the USA PATRIOT Act, which requires certain financial 
            institutions to establish due diligence policies, 
            procedures, and controls reasonably designed to detect and 
            report money laundering through correspondent accounts and 
            private banking accounts established or maintained for non-
            U.S. persons.
[sbull] Foreign Shell Banks and Recordkeeping for Foreign Banks with 
            U.S. Correspondent Accounts. This final rule would 
            implement section 313 of the USA PATRIOT Act, which 
            prohibits certain financial institutions from providing 
            correspondent accounts in the United States to foreign 
            shell banks (banks without a physical presence in any 
            country) and requires certain financial institutions to 
            take reasonable steps to ensure that correspondent accounts 
            are not being used indirectly by foreign shell banks. The 
            final rule would also implement section 319(b) of the USA 
            PATRIOT Act, which requires certain financial institutions 
            that provide correspondent accounts to a foreign bank to 
            maintain records of the foreign bank's owners and agent in 
            the United States designated to accept service of legal 
            process regarding the correspondent account.
[sbull] Anti-Money Laundering Programs. These final and proposed rules 
            would implement section 352 of the USA PATRIOT Act, under 
            which financial institutions must adopt anti-money 
            laundering programs. FinCEN expects to finalize rules 
            proposed in April 2002 for banks and other depository 
            institutions, casinos, securities broker-dealers, futures 
            commission merchants, mutual funds, operators of credit 
            card systems, and money services businesses. FinCEN also 
            expects to issue a series of proposed rules for other 
            financial institutions.
[sbull] Customer Identification and Verification Procedures. These 
            final and proposed rules would implement section 326 of the 
            USA PATRIOT Act, which mandates regulations requiring 
            financial institutions to implement reasonable procedures 
            for verifying the identity of customers opening an account, 
            maintaining records of the information used to verify 
            customer identity, and consulting lists of known or 
            suspected terrorists or terrorist organizations. These 
            procedures are required to be part of a financial 
            institution's anti-money laundering program. FinCEN expects 
            to finalize rules proposed in July 2002 for banks and other 
            depository institutions, securities broker-dealers, futures 
            commission merchants, and mutual funds and to publish 
            proposed rules for other financial institutions.
[sbull] Suspicious Activity Reporting. FinCEN expects to issue a 
            proposed rule to implement section 356(b) of the USA 
            PATRIOT Act, which requires futures commission

[[Page 74200]]

            merchants to report suspicious transactions.
United States Customs Service
 The United States Customs Service (Customs) is responsible for, among 
other things, 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. During the past fiscal year, due to the 
events of September 11, 2001, Customs also stressed its role in border 
security and in defending our nation's homeland. The regulatory 
priorities of Customs for fiscal year 2003 are: to continue to 
facilitate procedures for legitimate commercial transactions; to 
provide further obstacles to the flow of narcotics and other contraband 
into the United States; and to help secure the nation's borders from 
the introduction into this country of terrorists and weapons of 
terrorism. Customs also expects a regulatory priority to be amending 
its regulations to reflect its anticipated transition from the 
Department of the Treasury to the Department of Homeland Security.
 During fiscal year 2002, Customs issued the following rules relating 
to border security:
[sbull] Passenger and Crew Manifests Required for Passenger Flights in 
            Foreign Air Transportation to the United States. This 
            interim rule requires that each air carrier, foreign and 
            domestic, operating a passenger flight in foreign air 
            transportation to the United States electronically transmit 
            to Customs in advance of arrival a passenger and crew 
            manifest that contains certain specified information.
[sbull] Passenger Name Record Information Required for Passengers on 
            Flights in Foreign Air Transportation To or From the United 
            States. This interim rule requires that each air carrier 
            must provide Customs with electronic access to Passenger 
            Name Record information contained in the carrier's 
            automated reservation system and/or departure control 
            system that sets forth the identity and travel plans of any 
            passengers on flights in foreign air transportation either 
            to or from the United States.
[sbull] Access to Customs Security Areas at Airports. This interim rule 
            enhances the security environment at airports in Customs 
            security areas at airports that accommodate international 
            air commerce.
[sbull] Presentation of Vessel Cargo Declaration to Customs Before 
            Cargo Is Laden Aboard Vessel at Foreign Port for Transport 
            to the United States. This notice of proposed rulemaking 
            would require that vessel carriers destined for the United 
            States provide advance and accurate presentation of 
            manifest information to Customs prior to cargo being loaded 
            on the vessels at foreign ports and encourages electronic 
            presentation of the advance information.
 During fiscal year 2003, Customs plans to continue issuing regulations 
to enhance border security. In addition to finalizing the proposed rule 
and interim rules described above, Customs plans to issue rules that 
require advance manifesting for other modes of transportation pursuant 
to the Trade Act of 2002.
 During fiscal year 2002, Customs developed and issued several rules to 
implement various provisions of the Tariff and Suspension Act of 2000 
concerning the importation of goods into the United States. Customs 
published proposed rules on the following subjects:
[sbull] Single Entry for Split Shipments. This proposed rule would 
            establish procedures to allow a single entry for a split 
            shipment.
[sbull] Single Entry for Unassembled or Disassembled Entities Imported 
            on Multiple Conveyances. This proposed rule would allow for 
            a single entry to cover multiple portions of a single 
            entity which, due to its size or nature, arrives in the 
            United States on separate conveyances.
[sbull] Prototypes Used Solely for Product Development, Testing, 
            Evaluation, or Quality Control Purposes. This proposed rule 
            would establish procedures for allowing the duty-free entry 
            of prototypes that are to be used exclusively in product 
            development, testing, evaluation, or quality control.
 Customs plans to finalize these proposals during fiscal year 2003.
 Customs also plans to continue moving forward with amendments to 
improve its regulatory procedures that began under the authority 
granted by the Customs Modernization provisions of the North American 
Free Trade Implementation Act (Customs Mod Act). These efforts, in 
accordance with the principles of Executive Order 12866, have involved 
and will continue to involve significant input from the importing 
public. Customs will also continue to test new programs to see if they 
work before proceeding with proposed rulemaking to permanently 
establish the programs.
 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 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:
[sbull] Liquidations. Customs intends to 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 liquidations.
[sbull] 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 
            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.
[sbull] Remote Location Filing. Customs will continue to develop 
            through testing the procedures that will allow electronic 
            filing of entries with Customs from locations in the United 
            States other than the port of arrival of the merchandise or 
            the place at which the merchandise is examined. Remote 
            location filing will provide entry filers (such as brokers 
            and couriers) with greater flexibility and will allow 
            Customs to make more efficient use of its resources. After 
            Customs is satisfied with the testing, regulations will be 
            proposed to allow remote location filing on a permanent 
            basis.
 In addition, Customs also plans to undertake several other regulatory 
actions that will affect the traveling and importing public, customs 
brokers, carriers, and commercial importers.

[[Page 74201]]

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 2003, the IRS will accord priority to the following 
regulatory projects:
[sbull] Deduction and Capitalization of Costs To Create Intangible 
            Assets. Section 162 of the Internal Revenue Code allows a 
            current deduction for ordinary and necessary expenses paid 
            or incurred during the taxable year in carrying on any 
            trade or business. Under section263(a) of the Internal 
            Revenue Code, however, no immediate deduction is allowed 
            for expenditures to acquire or create property with a 
            useful life that extends substantially beyond the taxable 
            year. Such expenditures are capital expenditures that 
            generally may be deducted only in future taxable years as 
            the property is used in the taxpayer's trade or business. 
            In recent years, there has been much uncertainty and 
            controversy regarding whether expenditures that produce or 
            enhance intangible assets or benefits are currently 
            deductible under section 162, or are capital expenditures 
            under section 263(a). The IRS and Treasury intend to 
            publish proposed regulations that clarify the circumstances 
            in which taxpayers must capitalize expenditures to produce 
            or enhance intangible assets or benefits. As a first step 
            in this process, the IRS and Treasury issued an advance 
            notice of proposed rulemaking on January 24, 2002, 
            describing and explaining rules that they expect to propose 
            in the regulations and requesting public comment on these 
            rules.
[sbull] R&E Credit. Section 41 of the Internal Revenue Code provides a 
            credit for increasing research expenditures. The R&E Credit 
            has been the subject of significant controversy between the 
            Internal Revenue Service and taxpayers. In December 2001, 
            the IRS and Treasury issued proposed regulations that 
            clarify the types of research expenditures eligible for the 
            credit. After a full review of the comments received from 
            taxpayers, the IRS and Treasury expect to issue further 
            guidance in FY 2003.
[sbull] Abusive Tax Avoidance Transactions. In February 2000, the IRS 
            and Treasury issued temporary regulations requiring 
            taxpayers to disclose potentially questionable transactions 
            on their returns and requiring promoters to register, and 
            maintain lists of investors for, similar types of 
            transactions. The Treasury issued its Enforcement Proposals 
            for Abusive Tax Avoidance Transactions on March 20, 2002, 
            and, among other things, indicated that these rules would 
            be revised based on the disclosures that had been made 
            under the existing temporary regulations. New regulatory 
            guidance will be issued revising the definition the types 
            of transactions covered by these rules. In addition, in 
            January 2001, the IRS and Treasury issued proposed Circular 
            230 regulations governing practice before the IRS. In July 
            2002, a number of these proposed changes were finalized. 
            Additional guidance covering opinion standards for certain 
            types of transactions will be issued in FY 2003.
[sbull] 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 IRS and Treasury 
            expect to issue regulations that will clarify various rules 
            and definitions. Regulations are necessary because many 
            taxpayers use a Qualified Tuition Program to save for 
            college.
[sbull] Losses on Consolidated Group Member Stock. In response to Rite 
            Aid v. United States, 255 F.3d 1357 (Fed. Cir. 2001), the 
            IRS and Treasury will propose regulations to implement 
            Notice 2002-11, 2002-7 I.R.B. 526, and Notice 2002-18, 
            2002-12 I.R.B. 644, which address the repeal of the General 
            Utilities doctrine and duplication of losses if the stock 
            of a member of a consolidated group is sold.
[sbull] Cash Balance Pension Plans. The IRS and Treasury will issue 
            proposed regulations concerning approaches for cash balance 
            plans to use to comply with the prohibition on 
            discrimination on the account of age that is contained in 
            the Internal Revenue Code, ERISA, and the Age 
            Discrimination in Employment Act. A cash balance plan is a 
            type of defined benefit plan under which benefits are 
            calculated using a hypothetical account balance to which 
            annual pay credits and interest credits are made. This 
            proposed regulation will also address the circumstances in 
            which a conversion from a traditional defined benefit 
            pension plan to a cash balance plan is discriminatory on 
            the account of age.
[sbull] Split-Dollar Life Insurance Arrangements. A split-dollar life 
            insurance contract is an arrangement used to share or 
            ``split'' the costs and benefits of a whole life insurance 
            policy between two parties. Split-dollar insurance 
            contracts usually arise in compensation-related and 
            corporation-shareholder contexts, but have also been used 
            in gift contexts. In a typical split-dollar insurance 
            contract, an employer (the policy sponsor) agrees to 
            contribute all or a significant portion of the premiums on 
            a policy insuring the life of a key executive. Proposed 
            regulations issued in July 2002 provide two mutually 
            exclusive regimes to tax split-dollar life insurance 
            arrangements for Federal income, employment, and gift tax 
            purposes. Under the economic benefit regime, the owner of 
            the life insurance contract is treated as providing current 
            life insurance protection and other taxable economic 
            benefits to the nonowner of the contract. Under the loan 
            regime, the nonowner of the life insurance contract is 
            treated as lending premium payments to the owner of the 
            contract. If the loan from the non-owner does not provide 
            for sufficient interest, the loan is a below-market loan, 
            and is subject to imputations under section 7872 of the 
            Internal Revenue Code as implemented by the proposed 
            regulations. The IRS and Treasury

[[Page 74202]]

            intend to issue additional guidance regarding the taxation 
            of split-dollar life insurance arrangements in FY 2003.
[sbull] Cost Sharing Arrangements. Under existing regulations, 
            affiliates within a multinational group may enter into so-
            called cost sharing arrangements and share the costs of 
            developing intangibles in exchange for rights to exploit 
            the resulting intangibles. Group affiliates that contribute 
            pre-existing intangibles to the R&D effort must receive 
            arm's length compensation (known as the buy-in) from the 
            other affiliates participating in the arrangement. A number 
            of technical issues have arisen that raise serious concerns 
            that the cost sharing regulations are not operating in 
            practice as intended. Treasury and the IRS anticipate 
            issuing proposed amendments to the cost sharing regulations 
            addressing these issues during FY 2003. In addition, 
            Treasury and IRS anticipate following up the July 2002 
            issuance of proposed regulations addressing the treatment 
            of stock option compensation under cost sharing 
            arrangements with the issuance in FY 2003 of final 
            regulations reflecting any revisions that may be 
            appropriate in light of comments to be received on those 
            proposed regulations.
[sbull] Cross-Border Services. Under existing regulations, if an 
            affiliate within a multinational group provides services 
            for other group affiliates' benefit, it must receive arm's 
            length compensation (in certain cases cost reimbursement) 
            from such other affiliates. A number of technical issues 
            have arisen that raise serious concerns that the services 
            regulations are not operating in practice as intended. 
            Treasury and the IRS anticipate issuing proposed amendments 
            to the services regulations addressing these issues during 
            FY 2003.
[sbull] Notices to Plan Participants. Both the Internal Revenue Code 
            and the Employee Retirement Income Security Act (ERISA) 
            impose certain requirements on retirement plan 
            administrators to provide notices to plan participants and 
            beneficiaries about the plan benefits for which they are 
            eligible. The IRS and Treasury will finalize guidance under 
            section 204(h) of ERISA and section 4980F of the Internal 
            Revenue Code on the requirements of the administrator of 
            certain qualified retirement plans to provide notices to 
            plan participants and others of certain reductions in the 
            rate of future benefit accruals under the plan and the 
            elimination or reduction of early retirement benefits or 
            retirement-type subsidies. 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. In addition, the IRS and Treasury will revise 
            existing regulations dealing with disclosure requirements 
            to participants when a defined benefit pension plan offers 
            participants a choice between a subsidized early retirement 
            pension and a lump sum payment that does not include the 
            subsidy. The new rules respond to complaints that employers 
            are failing to warn participants that the lump sum 
            distribution from the retirement plan that a participant 
            may choose to receive is worth considerably less than the 
            subsidized retirement annuity that is available to the 
            participant.
[sbull] Excess Parachute Payments. Section 280G of the Internal Revenue 
            Code imposes an excise tax on payments made to employees on 
            account of a change in control of a corporation and denies 
            the corporation the tax deduction for such payments. The 
            IRS and Treasury will finalize proposed regulations that 
            detail the way in which these rules work.
[sbull] Nonwritten Consents To Disclose Return Information. Prior to 
            1996, a taxpayer's request or consent to disclose his or 
            her return information was required to be in written form. 
            In 1996, section 1207 of the Taxpayer Bill of Rights II 
            amended section 6103(c) of the Internal Revenue Code by 
            removing the requirement that a request or consent 
            authorizing the Service to disclose tax information to a 
            third party designated by the taxpayer be in writing. 
            Section 6103(c) provides that the Secretary may disclose 
            returns or return information to a taxpayer's designee, 
            subject to such requirements and procedures as the 
            Secretary may prescribe by regulation. Temporary 
            regulations were published in January 2001 authorizing the 
            IRS to accept nonwritten requests or consents for 
            disclosure in certain circumstances, providing parameters 
            for developing consents applicable to the electronic filing 
            program, easing the burden on taxpayers in combined 
            Federal-State return filing programs, and clarifying the 
            requirements for written consents. In FY 2003, the IRS and 
            Treasury intend to issue final regulations regarding these 
            important procedures.
[sbull] New Markets Tax Credit. Section 45D of the Internal Revenue 
            Code, enacted as part of the Community Renewal Tax Relief 
            Act of 2000, provides a credit for qualified equity 
            investments in qualified community development entities 
            that have received a new markets tax credit allocation. 
            Temporary and proposed regulations were issued in December 
            2001, which provide guidance for taxpayers claiming the new 
            markets tax credit under section 45D. The IRS and Treasury 
            intend to issue additional guidance during FY 2003 in 
            response to public comments that have been received.
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:
[sbull] The OCC's regulations help ensure safety and soundness by 
            establishing standards that set the limits of acceptable 
            conduct for national banks.
[sbull] 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.
[sbull] 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.
[sbull] 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.

[[Page 74203]]

 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 2002 include:
[sbull] Capital; Treatment of Recourse, Direct Credit Substitutes and 
            Residual Interests in Asset Securitizations (12 CFR Part 
            3). This rulemaking, issued jointly with the Board of 
            Governors of the Federal Reserve System, the Federal 
            Deposit Insurance Corporation, and the Office of Thrift 
            Supervision, amended the agencies' regulatory capital 
            standards to change the treatment of certain recourse 
            obligations, direct credit substitutes, residual interests, 
            and other positions in securitized transactions that expose 
            banking organizations to credit risk. This final rule 
            amended the agencies' regulatory capital standards to align 
            more closely the risk-based capital treatment of recourse 
            obligations and direct credit substitutes, to vary the 
            capital requirements for positions in securitized 
            transactions (and certain other credit exposures) according 
            to their relative risk, and required capital commensurate 
            with the risks associated with residual interests.
[sbull] Capital; Nonfinancial Equity Investments (Merchant Banking) (12 
            CFR Part 3). This rulemaking, issued jointly with the Board 
            of Governors of the Federal Reserve System and the Federal 
            Deposit Insurance Corporation, amended the agencies' 
            capital guidelines to establish special minimum capital 
            requirements for equity investments in nonfinancial 
            companies. The new capital requirements, which apply 
            symmetrically to equity investments of banks and bank 
            holding companies, 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.
[sbull] Capital; Claims on Securities Firms (12 CFR Part 3). This 
            rulemaking, issued jointly with the Board of Governors of 
            the Federal Reserve System, the Federal Deposit Insurance 
            Corporation, and the Office of Thrift Supervision, amended 
            the agencies' risk-based capital standards with regard to 
            the risk weighting of claims on, and claims guaranteed by, 
            qualifying securities firms. This rule reduced the risk 
            weight applied to certain claims on, and claims guaranteed 
            by, qualifying securities firms in countries that are 
            members of the Organization for Economic Cooperation and 
            Development from 100 percent to 20 percent under the 
            agencies' risk-based capital rules. This rule implemented a 
            change made to the Basel Accord.
[sbull] Operating Subsidiaries of Federal Branches and Agencies (12 CFR 
            Parts 5 and 28). This rulemaking provided that a Federal 
            branch or agency may establish, acquire, or maintain an 
            operating subsidiary in generally the same manner that a 
            national bank may acquire or establish an operating 
            subsidiary.
[sbull] International Banking Activities: Capital Equivalency Deposits 
            (12 CFR Part 28). This rulemaking revised certain 
            requirements regarding capital equivalency deposit 
            arrangements to increase flexibility for and reduce burden 
            on certain Federal branches and agencies, based on a 
            supervisory assessment of the risks presented by the 
            particular institution.
[sbull] Electronic Activities (formerly Electronic Banking) (12 CFR 
            Part 7). This rulemaking facilitated national banks' 
            ability to conduct business using electronic technologies, 
            consistent with safety and soundness. The rule groups 
            together new and revised regulations addressing: national 
            banks' exercise of their Federally authorized powers 
            through electronic means; the location, for purposes of the 
            Federal banking laws, of a national bank that engages in 
            activities through electronic means; 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.''
[sbull] Prohibition Against Use of Interstate Branches Primarily for 
            Deposit Production (12 CFR Part 25). This rulemaking, 
            issued jointly with the Board of Governors of the Federal 
            Reserve System and the Federal Deposit Insurance 
            Corporation, amended the regulatory prohibition against 
            branches being used as deposit production offices to 
            include any bank or branch of a bank controlled by an out-
            of-State bank holding company, including a bank consisting 
            only of a main office. The rulemaking implemented section 
            109 of the Riegle-Neal Interstate Banking and Branching 
            Efficiency Act of 1994 to effectuate the amendment 
            contained in section 106 of the Gramm-Leach-Bliley Act of 
            1999.
[sbull] Debt Cancellation Contracts and Debt Suspension Agreements (12 
            CFR Part 37). The OCC published a final rule 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 final rule also promotes 
            safety and soundness by requiring national banks that 
            provide these products to maintain adequate loss reserves.
 The OCC's regulatory priorities for fiscal year 2003 include projects 
in the following areas:
[sbull] Implementation of a Revised Basel Capital Accord (formerly 
            Domestic Capital Framework) (12 CFR Part 3). The OCC plans 
            to initiate one or more rulemakings to revise its 
            regulatory capital requirements to take account of expected 
            revisions to the 1988 Basel Accord. These rulemakings, 
            which will be undertaken jointly with the other Federal 
            banking agencies, will address the implementation of 
            provisions of the revised Accord such as the internal 
            ratings-based approach, as well as other revisions to the 
            U.S. domestic capital framework that are appropriate in 
            light of the revised Accord.
[sbull] Capital; Securities Borrowing Transactions (12 CFR Part 3). 
            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 CFR part 3, appendix 
            B, as opposed to the risk-based capital requirements at 12 
            CFR 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

[[Page 74204]]

            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.
[sbull] 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.
[sbull] Implementation of Sections 1204-1206 of the Financial 
            Regulatory Relief and Economic Efficiency Act of 2000 (the 
            Act) (12 CFR Parts 5 and 7). 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. The rulemaking may make other changes as well.
[sbull] Fair Credit Reporting Act (12 CFR Part 41). The OCC, along with 
            the other Federal banking agencies, intends to publish a 
            revised notice of proposed rulemaking to implement the 
            affiliate-sharing provisions of the Fair Credit Reporting 
            Act. This rulemaking would clarify the notice and opt-out 
            obligations arising from the sharing of consumer 
            information with affiliates.
[sbull] Change in Business Plans (12 CFR Part 5). The OCC intends to 
            seek comment on a proposed rule that would require national 
            banks to notify the OCC of material changes in business 
            plans.
[sbull] Suspension and Debarment of Accounts (12 CFR Part 19). The OCC, 
            along with the other Federal banking agencies, intends to 
            issue proposed rules implementing the agencies' authority 
            to suspend or debar accountants and accounting firms from 
            performing the annual independent audits that are required 
            by section 36 of the Federal Deposit Insurance Act (12 
            U.S.C. 1831m).
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:
[sbull] Implementation of a Revised Basel Capital Accord. The OTS plans 
            to initiate one or more rulemakings to revise its 
            regulatory capital requirements to take account of expected 
            revisions to the 1988 Basel Accord. These rulemakings, 
            which will be undertaken jointly with the other Federal 
            banking agencies, will address the implementation of 
            provisions of the revised Accord such as the internal 
            ratings-based approach, as well as other revisions to the 
            U.S. domestic capital framework that are appropriate in 
            light of the revised Accord.
 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 privacy notices sent before the effective 
date of the final FCRA rule.
 The banking agencies are considering changes to the Community 
Reinvestment Act (CRA) rules, based upon the comments received on the 
joint advance notice of proposed rulemaking seeking comments on how to 
improve the CRA regulations, and will propose such changes as are 
deemed appropriate.
 The banking agencies are considering rules on the corporate governance 
of depository institutions and on the ability of accountants and other 
professionals to provide audit services and practice before the 
agencies.
 OTS has proposed regulations codifying certain interpretations 
affecting the fiduciary activities of savings associations and 
providing recordkeeping requirements for securities transactions. OTS 
is also considering possible amendments to its regulations governing 
directors and officers of savings associations.
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 
missions and regulations are designed to:
[sbull] 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;
[sbull] Facilitate investigations of violations of Federal explosives 
            laws and arson-for-profit schemes;
[sbull] Regulate the alcohol, tobacco, firearms, and explosives 
            industries, including systems for licenses and permits;
[sbull] 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;
[sbull] Suppress commercial bribery, consumer deception, and other 
            prohibited practices in the alcoholic beverage industry; 
            and
[sbull] Assist the States in their efforts to eliminate interstate 
            trafficking in, and the sale and distribution of, 
            cigarettes in avoidance of State taxes.
 In 2003, ATF is initiating a multiyear plan to revise its regulations 
in plain language. As resources permit, the ATF will update and revise 
regulations to be more clear and concise, using the principles of plain 
language. ATF began the groundwork for this priority in 2002 by 
starting recodifications in Title 27. These changes reorganize ATF 
regulations into a more logical sequence. The plain language revisions 
will make ATF rules more accessible to small businesses and to the 
public.
 ATF will continue, as a priority during fiscal year 2003, 
modifications to its regulations governing commerce in explosives. ATF 
continues analysis of its regulations governing storage requirements 
for explosives, including fireworks explosive materials. ATF plans to 
issue regulations in response to closing loopholes in purchasing 
explosives materials, as directed by legislation now pending or 
contemplated.

[[Page 74205]]

Bureau of the Public Debt
 The Bureau of the Public Debt (BPD) administers regulations:
[sbull] Governing transactions in government securities by Government 
            securities brokers and dealers under the Government 
            Securities Act of 1986 (GSA).
[sbull] Implementing Treasury's borrowing authority, including rules 
            governing the sale and issue of savings bonds, marketable 
            Treasury securities, and State and local government 
            securities.
[sbull] Setting out the terms and conditions by which Treasury may 
            redeem (buy back) outstanding, unmatured marketable 
            Treasury securities through debt buyback operations.
[sbull] Governing the acceptability and valuation of all collateral 
            pledged to secure deposits of public monies and other 
            financial interests of the Federal Government.
 Treasury's GSA rules govern 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. During fiscal year 2003, BPD 
will give priority to the issue of final amendments to Treasury's Large 
Position Rules that pertain to very large positions in certain Treasury 
securities. The modifications will improve the information available to 
Treasury concerning the causes of market shortages. A proposed rule was 
published for comment on this matter in July 2002.
 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. During fiscal year 2003, 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 
reporting. An advance notice of proposed rulemaking was published in 
April 2002 soliciting comments on the timing and reporting of the net 
long position in Treasury auctions.
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 2003, FMS' regulatory priorities will include 
several ongoing initiatives in the following areas:
[sbull] Payment of Federal Taxes and the Treasury Tax and Loan Program 
            (TT&L) (31 CFR Part 203). FMS expects to revise this rule 
            to support operational changes to the system used for the 
            collection of corporate withholding taxes. FMS will 
            streamline this rule and write it in plain language.
[sbull] Automated Clearing House (ACH) (31 CFR Part 210). FMS will 
            continue to update this rule, which establishes standards 
            for Federal Government payments and collections via the ACH 
            system. FMS will revise this rule in order to stay current 
            with private industry rules and to facilitate the continued 
            expansion of electronic commerce.
[sbull] Checks Drawn On the United States Treasury (31 CFR Part 240). 
            FMS intends to 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.
[sbull] Debt Collection Improvement Act of 1996 (DCIA) (31 CFR Part 
            285). FMS plans to issue general rules governing the offset 
            of Federal Government payments to collect delinquent non-
            tax debt owed to Federal agencies. These rules will clarify 
            the policies and procedures applicable to the collection of 
            debt through the Treasury Offset Program and will 
            facilitate full implementation of the program.
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. In FY 2003, the CDFI Program will comprise three 
components: the Core/Intermediary Component, the Small Capitalization 
Component, and the Technical Assistance Component. In addition, the 
Fund administers the Native American CDFI Technical Assistance Program, 
which provides capacity building grants to promote the development of 
CDFIs that serve Native American, Alaska Native and Native Hawaiian 
communities, and 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 administers the New Markets Tax Credit (NMTC) 
Program, 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 are 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 2003 regulatory priority will focus on the NMTC 
Program, by developing guidance and/or regulations regarding aspects of 
the administration and operation of the program. In the last quarter of 
FY 2002, the Fund is developing revisions to the regulations that 
govern the CDFI Program and the BEA Program.
_______________________________________________________________________



TREAS

                              -----------

                          PROPOSED RULE STAGE

                              -----------




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


Other Significant


Legal Authority:


26 USC 5051 to 5057; 26 USC 5401 to 5418; 27 USC 205


CFR Citation:


27 CFR 7; 27 CFR 25


Legal Deadline:


None

[[Page 74206]]

Abstract:


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


Statement of Need:


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


Summary of Legal Basis:


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


Alternatives:


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


Anticipated Cost and Benefits:


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


Risks:


Not applicable.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           12/00/02
NPRM Comment Period End                                        03/00/03
Final Action                                                   12/00/03
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


Businesses


Government Levels Affected:


None


Agency Contact:
Charles N. Bacon
Program Manager
Department of the Treasury
Bureau of Alcohol, Tobacco and Firearms
Room 701
10 Causeway Street
Boston, MA 02222
Phone: 617 557-1323
Fax: 617 557-1251
Email: [email protected]
RIN: 1512-AB37
_______________________________________________________________________



TREAS



113. COMMERCE IN EXPLOSIVES (INCLUDING EXPLOSIVES IN THE FIREWORKS 
INDUSTRY) (RULEMAKING RESULTING FROM A SECTION 610 REVIEW)
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 2002.


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.

[[Page 74207]]

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                                                           12/00/02
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


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 74208]]




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.
 A new priority undertaken at VA includes a comprehensive effort to 
review, reorganize, and rewrite the existing VA regulations contained 
in part 3 of 38 CFR. The goal of the Regulation Rewrite Project is to 
improve the clarity and logical consistency of these regulations in 
order to better inform veterans and their family members of their 
entitlements.
 The Department of Veterans Affairs' 2002 regulatory plan contains one 
rulemaking action from the Veterans Health Administration. The Veterans 
Health Administration rulemaking 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.
_______________________________________________________________________



VA

                              -----------

                            FINAL RULE STAGE

                              -----------




114. 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 36467e                                   05/29/00
Interim Final Ru66 FR 36467                                    07/19/01
Interim Final Rule Comment Period End (Information Collection) 07/19/01
Interim Final Rule Effective (38 CFR 17.004)                   07/19/01
Interim Final Rule Comment Period End                          09/10/01
Final Action                                                   12/00/02
Regulatory Flexibility Analysis Required:


Undetermined


Government Levels Affected:


None


Agency Contact:
Roscoe G. Butler
Chief, Policy and Operations (163)
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
BILLING CODE 8320-01-S

[[Page 74209]]




ENVIRONMENTAL PROTECTION AGENCY (EPA)



Statement of Priorities
OVERVIEW
Since 1970 the U.S. Environmental Protection Agency (EPA) has had the 
major Federal responsibility for protecting the quality of the American 
environment and controlling the effects of pollution on public health. 
EPA fulfills these responsibilities using a combination of tools, and 
over the past three decades EPA's actions have led to measurable 
improvements in air and water quality, significant reductions in solid 
and hazardous wastes, and limitations on the use of harmful pesticides.
In the year ahead EPA will continue its regulatory and nonregulatory 
activities in order to further protect the Nation's air, water, and 
land from the harmful effects of pollution. In particular, the Agency 
will focus its attention on the President's Clear Skies Initiative, the 
protection of specific watersheds and the strengthening of urban 
economies through the enhanced cleanup of brownfields.
But in one particular area EPA's responsibilities have changed 
substantially over the past year, and they will continue to change in 
the year ahead. After the terrorist attacks of September 11, 2001, EPA 
-- like the rest of the nation -- reordered its priorities so that it 
could sharply increase the services it provides in terms of both 
preventing future terrorist attacks and cleaning up the effects of such 
attacks, should any occur in the future. The response to future 
terrorism and its potential effects on human health and environmental 
quality is now one of EPA's top priorities. This new priority is 
affecting the structure of EPA's programs, the Agency's budget, and its 
regulatory agenda.
EPA also has made assistance to small businesses a top priority both in 
terms of the direct services it provides to those businesses and the 
consideration it gives them when developing regulations. The Agency is 
committed to fulfilling the President's pledge that ``...we're going to 
do everything we can to clean up the regulatory burden on small 
businesses.''
EPA continues to give a high priority to fresh thinking and innovation 
in its efforts to protect human health and the environment. Innovative 
methods of achieving environmental goals are being incorporated into 
EPA's regulations, and they are an important part of the Agency's 
regulatory agenda in each of its program offices.
Moreover, EPA's innovations extend beyond regulations and into a range 
of voluntary partnerships with industry, State governments, and local 
communities, partnerships that are leading to measurable environmental 
improvements. Although those partnerships often support activities that 
generate environmental benefits beyond those required by environmental 
regulations, many of them also result in more effective and less 
burdensome regulations. Like EPA's emphasis on innovation, partnerships 
involving individual facilities and whole industries cut across all of 
EPA's program offices.
Water Infrastructure Security
EPA's response to the terrorist attacks of September 11, 2001, and its 
subsequent homeland security efforts have not involved the need to 
promulgate new regulations.
The responsibility and authority provided to the Agency with respect to 
certain public drinking water systems under the Public Health Security 
and Bioterrorism Response Act, signed into law on June 12, 2002, may 
require the promulgation of a codification rule or other regulation.
Assistance to Small Businesses
Because of the crucial role played by small businesses in sustaining 
the health of the national economy, EPA has undertaken several 
activities that make it easier for those businesses to understand and 
fulfill their environmental responsibilities. Those activities 
constitute a strategically important priority in EPA's regulatory 
agenda, and in many cases they provide assistance that goes beyond 
EPA's formal regulatory responsibilities, while encouraging small 
businesses to improve their environmental performance beyond what is 
required by regulation.
In particular, the Small Business Regulatory Enforcement Fairness Act 
(SBREFA) amendments to the Regulatory Flexibility Act (RFA) give small 
businesses the opportunity to participate early in the development of 
certain regulations so that their special needs are given full 
consideration. For rules that may have a significant effect on small 
businesses, EPA solicits input from those businesses and considers 
alternatives that minimize adverse impacts. All of EPA's activities 
under SBREFA and RFA have a high priority on the Agency's regulatory 
agenda.
EPA also will encourage wider use of self-certification for small 
businesses, a system that is starting to become a reality in several 
states. Under this sector-based program, industrywide environmental 
performance standards are established with annual certifications of 
compliance. This system eases the regulatory burden on small businesses 
while improving and rewarding compliance with regulation. EPA's 
emphasis on small-business assistance extends to all of its program 
offices.
Regulatory Innovation
Innovation has been an important priority at EPA for the past several 
years, and it will be a priority into the future, because it has 
demonstrated its potential for improving environmental quality beyond 
what is possible with traditional regulations. As EPA develops its 
regulations, the Agency will continue to include economic incentives, 
compliance assistance, and other types of mechanisms that have proven 
capable of motivating better environmental performance by individuals, 
communities, businesses, and industry sectors. EPA also will support 
environmental technology innovation by ensuring that environmental 
regulations encourage and provide the flexibility for use of innovative 
technologies. Regulatory flexibility, cost reduction, information 
transfer, and technology development are all key parts of EPA's 
emphasis on regulatory innovation, and they will be evident in EPA's 
efforts to develop a number of regulations, including those related to 
Clear Skies.
Voluntary Partnerships
For the past several years EPA has placed a high priority on working as 
partners with both individual facilities and whole industries to help 
them improve their environmental performance. In many cases, these 
partnerships -- such as Energy Star and WasteWise -- support industry 
efforts to reduce pollution in ways that are not required by Federal 
regulation. But voluntary partnerships between EPA and regulated 
businesses also are directly affecting the quality of the Agency's 
regulations. For example, by working closely with trade associations, 
the Agency has been able to develop regulations that meet environmental 
goals while still being responsive to the special needs or 
circumstances of particular industries. Because EPA/private sector 
partnerships hold so much potential for improving regulations, they 
will continue to be a

[[Page 74210]]

priority for the Agency's regulatory agenda.
HIGHLIGHTS OF EPA'S REGULATORY PLAN
Office of Air and Radiation
EPA's Office of Air and Radiation (OAR) 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. Consequently, this flexibility is a major 
priority in OAR's regulatory agenda for the coming year.
In 1997 the Agency established new, more stringent national ambient air 
quality standards for ozone and particulate matter (PM) based on new 
scientific information indicating that new standards were needed to 
protect public health with an adequate margin for safety. In 1999 a 
panel of the D.C. Circuit Court, in a 2 to 1 decision, held that the 
statutory provision authorizing issuance of such standards constituted 
an impermissible delegation of authority, as interpreted by EPA, and 
therefore was unconstitutional. On appeal to the United States Supreme 
Court, this decision was reversed in a unanimous vote. On remand, the 
same panel of the D.C. Circuit upheld all of the challenged standards 
for PM and ozone. The Agency now is working on an implementation 
program for ozone to respond to different aspects of the court 
decisions. The Agency also is proceeding with the next legislatively 
mandated review of the standards. In addition, in response to a 
recommendation from the Office of Management and Budget's Office of 
Information and Regulatory Affairs (OIRA), OAR is collaborating with 
OIRA to identify specific types of health research that would be useful 
in enhancing OAR's ability to quantify the health benefits from future 
reductions in human exposure to particulate matter.
To date, EPA's air toxics program has focused primarily on reducing 
emissions from large industrial sources through technology-based 
standards. Since 1990, the Agency has issued standards affecting 77 
different industries, such as petroleum refineries and chemical 
manufacturing plants. When fully implemented, these standards will 
reduce more than one million tons of toxic air emissions per year. 
Through other efforts such as phasing lead out of gasoline, EPA also 
has significantly reduced air toxics from cars and trucks.
OAR will continue 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, OAR is beginning to evaluate those sources with 
standards already in place to determine if the remaining risk from 
those sources warrants additional regulation.
OAR also is implementing an Urban Air Toxics Strategy, which focuses on 
33 air toxics that pose the greatest risk to the largest number of 
urban areas. This strategy presents OAR's plan, both nationally and 
locally, to reduce these toxic emissions. Finally, to better understand 
and measure risks from air toxics, OAR is conducting important health 
research while improving emissions inventories, modeling capability, 
and monitoring networks.
To assist States in meeting clean air goals, OAR is proceeding with 
Federal programs aimed at achieving large, cost-effective reductions in 
particulate matter (PM) and ozone-forming nitrogen oxide (NOX) 
emissions. OAR also is working to develop a rule to control emissions 
from off-road vehicles such as construction equipment. In addition, OAR 
is in the final stages of completing a rulemaking to help States reduce 
airborne ozone concentrations resulting from the windblown transfer of 
NOX emissions from the Midwest to the East Coast.
Of these actions, one supports nominations of reform candidates in 
public comments responding to OMB's 2001 Report to the Congress on the 
costs and Benefits of Regulations. This action is the rulemaking 
entitled Review of the National Ambient Air Quality Standards for 
Particulate Matter, which supports the nomination to revise this 
standard.
Office of Water
EPA's Office of Water (OW) has established six regulatory priorities 
for the coming year. They include rules affecting cooling-water 
intakes, industrial and municipal wastewater pollution, concentrated 
animal feeding operations (CAFOs), the Total Maximum Daily Load (TMDL) 
program, Clean Water Act (CWA) jurisdiction, and drinking water.
EPA intends to issue two rules to minimize the adverse environmental 
impacts associated with cooling-water intakes. As the name implies, 
certain industrial operations require large volumes of water to be 
drawn in from a surface water body in order to regulate the operating 
temperature of equipment. Given the makeup of the regulated community, 
entities that own or operate steam electric power plants would bear 
most of the costs of these rules. The expected benefits would 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).
EPA also will issue two regulations to help control industrial and 
municipal wastewater pollution. First, for the metal products and 
machinery industry, EPA expects to issue effluent limitations to reduce 
the discharge of millions of pounds of conventional and toxic 
pollutants. These reductions would achieve significant improvements in 
water quality. Second, EPA expects to propose a rule to better control 
sanitary sewer overflows (SSOs). EPA estimates that about 60,000 SSOs 
discharge untreated sewage to the environment yearly, exposing the 
public to health risks (primarily from pathogens in untreated sewage). 
The proposed rule would clarify the existing prohibition of these 
overflows, improve public notification and reporting, and provide 
guidelines for planning and managing sewer systems. It also would 
ensure that several thousand ``satellite'' sewer collection systems are 
covered by permit requirements.
CAFOs present significant risks to water quality through runoff from 
animal feeding facilities and farmland where manure has been spread. 
EPA will revise existing regulations to better control these risks. The 
revisions will control the discharge and runoff of excess nutrients and 
other pollutants and, in turn, improve surface water quality.
EPA plans to propose to withdraw the July 2000 TMDL program revisions 
and, at the same time, to propose a rule establishing a new framework 
for accomplishing the water quality planning and management provisions 
of the Total Maximum Daily Load (TMDL) program. EPA believes this 
framework, based on the watershed approach, will allow more 
jurisdictions -- i.e., States, territories, and tribes -- to use the 
program to contribute more effectively to improving the Nation's water 
quality. The proposal recognizes that the major responsibility for 
water quality management resides with these jurisdictions. The goal of 
the proposal is to provide jurisdictions with a tailored

[[Page 74211]]

yet flexible approach to water quality management that meets the unique 
needs and situation of each jurisdiction and of local communities, 
while ensuring that progress is made towards restoring the Nation's 
waters so they attain and maintain water quality standards. EPA's 
proposal revitalizes and strengthens the Continuing Planning Process 
(CPP) as a focus for a variety of jurisdictions' water quality planning 
and implementation activities. The proposed new framework seeks to 
increase TMDL program flexibility and enhance stakeholder 
participation, promote opportunities for trading, and increase 
efficiencies in establishing, approving, and implementing TMDLs.
EPA intends to undertake joint proposed rulemaking with the Department 
of the Army to amend the regulatory definition of waters subject to the 
CWA. The existing regulations contain language asserting jurisdiction 
over isolated intrastate waters, but a January 9, 2001, U.S. Supreme 
Court opinion limits use of that regulatory provision. The revisions of 
the regulations will address the Court's decision, improve regulatory 
clarity, and provide more specificity regarding the scope of CWA 
jurisdiction.
Finally, EPA is developing three rules to protect the safety of 
drinking water. First, EPA is developing a proposed Long Term 2 
Enhanced Surface Water Treatment Rule (LT2ESWTR) to reduce risks from 
microbial pathogens, especially Cryptosporidium, in public water 
systems that use surface water sources. LT2ESWTR provisions would 
target systems where current standards do not provide sufficient 
protection, including both filtered systems with elevated source water 
pathogen levels and also unfiltered systems. Second, EPA plans to 
finalize the Ground Water Rule, a rule that addresses fecal 
contamination in public water systems served by ground water sources. 
Finally, EPA is developing a proposed Stage 2 Disinfectants and 
Disinfection Byproducts Rule to control exposure to disinfection 
byproducts beyond the requirements of the Stage 1 Disinfectants and 
Disinfection Byproducts Rule. This rule will respond to new data the 
Agency has received on disinfection byproduct occurrence and possible 
reproductive and developmental health effects.
Office of Prevention, Pesticides, and Toxic Substances
The Food Quality Protection Act (FQPA) overhauled U.S. pesticides laws, 
enhancing protections related to pesticide residues in food by 
requiring aggregate and cumulative risk assessments, with a special 
emphasis on children and infants. EPA is currently working on the 
Pesticide Tolerance Reassessment Program, a ten-year program to 
reevaluate the safety of all pesticide residues in food. Under this 
program, EPA has completed reassessment of two-thirds of the tolerances 
for pesticide residues in foods. Implementation of FQPA has required an 
increase of the activities of the Scientific Advisory Panel (SAP) 
established under the Federal Insecticide, Fungicide, and Rodenticide 
Act (FIFRA). Significant risk-assessment methodology issues continue to 
be addressed by the SAP, including drinking water assessment 
methodologies, approaches for conducting cumulative and aggregate risk 
assessments, use of 10x safety factors, and guidelines for assessing 
protein plant pesticides. The SAP also jointly sponsored with the EPA 
Science Advisory Board several meetings on ethical considerations 
related to the testing of human subjects, and the Agency has asked the 
National Academy of Science to evaluate the ethics of testing human 
subjects.
The Agency will be announcing revisions to its pesticide emergency 
exemption program, under which States and other Federal agencies may 
obtain permission to temporarily use a pesticide not in accordance with 
registration requirements under emergency conditions. In response to 
State concerns, EPA already has reduced the review time for emergency 
exemptions significantly. Other changes that EPA is considering have 
the potential for further streamlining the exemption program and 
allowing more flexibility.
Evidence suggests that environmental exposure to manmade chemicals that 
mimic hormones (endocrine disruptors) may cause adverse health effects 
in human and wildlife populations. FQPA directed EPA to develop a 
chemical screening program, using appropriate validated test systems 
and other scientifically relevant information, to determine whether 
certain substances may have hormonal effects in humans. In October 
1996, EPA chartered a scientific advisory committee to advise it on 
establishing a program to carry out the legislated directive. The 
advisory committee recognized that there currently were no validated 
test systems for determining whether a chemical may have an effect in 
humans that is similar to an effect produced by naturally occurring 
hormones.
EPA is in the process of developing and validating the screens and 
tests that the advisory committee recommended, and designing a 
framework for regulatory information. As part of this process, EPA is 
developing priority-setting criteria to be used by the Agency to 
identify the initial list of chemicals for which testing will be 
required. The proposed criteria will be published in the Federal 
Register in December 2002 for public comment. The final criteria will 
be published in the Federal Register approximately six months later.
Bioengineering is on the cutting edge of an emerging technology with 
new and different products rapidly being developed and introduced into 
commerce. A Plant-Incorporated Protectant (PIP) is a bioengineered 
pesticidal substance produced and used by the living plant to protect 
itself from pests, typically insects, viruses, and fungi. EPA regulates 
the domestic manufacture, sale, and use of pesticides, including PIPs, 
under FIFRA and FFDCA to assure that any pesticide residue in/on a food 
product is safe. The Agency sets appropriate residue limits and assures 
that there is no adverse affect to the environment from the PIP.
Through the voluntary High Production Volume (HPV) Challenge Program, 
certain international efforts, and rulemaking under the Toxic 
Substances Control Act (TSCA), basic data related to the environmental 
fate and potential hazards associated with HPR chemicals, i.e., organic 
chemicals manufactured (including imported) at or above 1 million 
pounds per year, based on information submitted under the 1990 
Inventory Update Rule (TSCA) will be collected or, where necessary, 
developed. When combined with information about exposure and uses, this 
data will allow the Agency and others to evaluate and prioritize 
potential health and environmental effects and take appropriate action.
EPA received commitments from 357 companies, individually or through 
106 consortia, and the International Council of Chemical Associations 
(ICCA) to sponsor 2,214 of the estimated 2,800 HPV chemicals included 
in the voluntary HPV Challenge Program.
As an integrated approach for addressing the widespread problems 
associated with toxic pollutants that persist and bioaccumulate in the 
environment, EPA launched the Persistent, Bioaccumulative, and Toxic 
(PBT) pollutants program in November 1998. The goal of the program is 
to further reduce risks to human health and the environment from 
existing and

[[Page 74212]]

future exposure to PBT pollutants such as mercury, PCBs, and dioxin 
through the use of chemical- specific action plans. Through this 
program, the Agency is committed to create an enduring cross-office 
system that will address the cross-media issues associated with 
priority PBT pollutants.
To encourage the application of pollution prevention principles during 
the development of new chemicals submitted as premanufacture notices 
(PMNs) under TSCA section 5, EPA has initiated a new and innovative 
voluntary pilot project entitled Sustainable Futures. The goal of this 
pilot project is to encourage pollution prevention and the development 
of inherently low-hazard chemicals. Also, the Agency seeks to gain 
additional data and experience regarding the pollution prevention, risk 
reduction, and source reduction benefits of use of hazard, exposure, 
and risk screening methodologies such as EPA's Pollution Prevention 
Framework in new product development efforts.
Office of Solid Waste and Emergency Response
The Office of Solid Waste and Emergency Response (OSWER) is planning 
regulatory actions to reduce risks to human health and the environment, 
reduce burden on the regulated community, encourage recycling and 
reuse, and standardize certain aspects of recordkeeping programs. All 
these actions will be taken under the Resource Conservation and 
Recovery Act (RCRA), the Federal law governing waste management.
During the 1990s EPA determined that additional control is needed for 
cement kiln dust, a high-volume material byproduct of the cement 
manufacturing process that potentially contains hazardous constituents 
such as lead, cadmium and chromium. EPA is assessing regulatory 
approaches for waste management of cement kiln dust.
EPA also is taking steps to encourage recycling and reuse. EPA is 
considering modifying RCRA rules that impact the management of solvent-
contaminated shop towels and wipes. This effort would encourage 
pollution prevention and recycling of hazardous solvents, make 
management standards more consistent with the risks these materials 
pose, and clarify existing Federal policies regarding these materials.
Under RCRA, wastewater treatment sludge from electroplating operations 
is listed as hazardous waste (waste code F006). F006 represents one of 
the largest hazardous waste streams amenable to recycling. EPA is 
considering changes to the existing RCRA regulations to encourage safe 
recycling and management practices of wastewater treatment sludge from 
electroplating operations, and to reduce regulations applicable to 
electroplating sludge that is sufficiently high in metals and 
sufficiently low in other toxic constituents.
Under RCRA, a hazardous waste is defined as a solid waste. EPA's 
framework for determining whether a material is a solid waste is based 
on what the material is and how it is managed. EPA is planning to 
revise the definition of solid waste, removing the necessity of RCRA 
control where it is unnecessary and thereby increasing reuse and 
recycling of hazardous waste, improving resource conservation, and 
improving materials management.
To reduce regulatory burdens, EPA is considering adding four solvents 
to the hazardous-waste exemptions for mixtures of spent solvents (used 
solvents that are not fit for further use without being processed) in 
wastewater treatment plants; revising provisions, such as de minimis 
quantities and the definition of point of application of exemption; and 
clarifying the applicability of exemptions to incinerator scrubber 
water. This effort, if finalized, would allow more facilities to be 
eligible for regulatory exemptions and more wastes to be exempted from 
hazardous-waste regulation.
To further reduce administrative burdens, efforts are underway to 
eliminate duplicative and nonessential paperwork imposed by RCRA 
reporting and recordkeeping requirements. This rule would have minimal 
impact on the protectiveness of RCRA regulations. It would eliminate or 
streamline paperwork requirements that are unnecessary because they add 
little to the protectiveness of RCRA regulations.
EPA also plans to streamline the permit process by creating a 
standardized permit for facilities that generate waste and routinely 
manage the waste on-site in tanks, containers, and containment 
buildings. This standardized permit process would allow facilities to 
obtain and modify permits more easily, while maintaining the 
protectiveness currently existing in the individual RCRA permit 
process.
Of these actions, two support nominations of reform candidates in 
public comments responding to OMB's 2001 Report to Congress on the 
Costs and Benefits of Regulations. The Revision of Wastewater Treatment 
Exemptions for Hazardous Waste Mixtures proposed rule supports the 
nomination to revise the Mixture and Derived-From final rule to exempt 
waste streams resulting from the treatment of hazardous wastes from 
RCRA subtitle C, unless those waste streams themselves exhibit a 
characteristic of hazardous wastes. This nomination received an OMB 
priority level of 1 (high priority). This proposal is expected to be 
published in January 2003.
Likewise, the Revisions to the Definition of Solid Waste proposed rule 
supports the nomination to revise the definition of solid waste to 
grant an exemption from RCRA for materials destined for recycling or 
reuse. This nomination received an OMB priority level of 2 (medium 
priority). This proposal is expected to be published in April 2003.
Furthermore, one of OSWER's proposed actions, Modifications to RCRA 
Rules Associated with Solvent-Contaminated Shop Towels and Wipes 
proposed rule, may have small-business impacts. Initial analysis of 
options has found that some approaches may impose some costs on small 
business. The economic impacts are expected to be minor, since the 
estimated incremental costs are small relative to sales.
Office of Environmental Information
The top regulatory priority of EPA's Office of Environmental 
Information (OEI) will be the finalization of the Cross-Media 
Electronic Reporting and Record-Keeping Rule (CROMERRR). This rule will 
address electronic reporting by companies regulated under all of EPA's 
programs -- air, water, pesticides, toxic substances, wastes, and 
emergency response. CROMERRR would remove existing regulatory obstacles 
to electronic reporting, and it would set requirements for companies 
choosing to report electronically. In addition, this rule would set the 
conditions for allowing electronic reporting under State, tribal, or 
local environmental programs that operate under EPA authorization.
CROMERRR is intended to make electronic reporting as simple, efficient, 
and cost effective as possible for regulated companies, while ensuring 
that a transition from paper to electronic reporting does not 
compromise EPA's compliance and enforcement programs. Consequently, the 
Agency's strategy is to impose as few specific requirements as 
possible, and to keep those requirements neutral with respect to 
technology, so the rule will pose no

[[Page 74213]]

obstacles to adopting new technologies as they emerge.
To ensure that authorized programs at the State, tribal, and local 
levels meet CROMERRR's goals, the rule would specify a set of criteria 
that these programs must satisfy as they initiate electronic reporting 
or recordkeeping. The final rule would specify a process for certifying 
that these programs meet the criteria. EPA is on schedule to finalize 
CROMERRR by the third quarter of FY 2003. In response to public 
comment, a decision was made to focus the final rule on electronic 
reporting only, and to defer coverage of electronic recordkeeping until 
a later time. Also in response to comments, EPA currently is exploring 
a streamlined process to review State programs for electronic 
reporting.
Finally, in response to OMB's prompt letter pertaining to EPA's 
progress in implementing an integrated system of reporting, EPA has 
made further progress in implementing the Central Data Exchange (CDX). 
CDX is on track to provide electronic reporting services for all 
significant environmental data collections. All but one of the major 
environmental data exchanges with states will be operational through 
CDX by the end of 2004. Also, for the first time next year, Toxics 
Release Inventory (TRI) reporters will be able to send and view 
paperless reports using a form of electronic authentication that will 
substitute for a paper signature.
EPA ACTIONS OF SPECIAL INTEREST TO SMALL BUSINESSES
Many EPA regulations, and several actions included in this Regulatory 
Plan, are of substantial interest to small businesses. Because small 
businesses face special challenges in their efforts to understand and 
comply with environmental regulations, EPA is taking a number of 
actions across the Agency to help small businesses fulfill their 
environmental responsibilities. The Agency's Small Business Ombudsman 
provides one-stop assistance to small businesses looking for answers to 
environmental questions. The Agency is involving small businesses 
earlier in the regulatory development process, and developing 
alternative approaches -- like self-certification -- that work better 
for small businesses. EPA is providing a number of services, like 
compliance assistance centers, disclosure incentives, and a National 
Compliance Assistance Clearinghouse, that help small businesses better 
manage their compliance efforts. Small businesses are being rewarded 
for voluntary innovative efforts and environmental leadership, and EPA 
is investing in new technologies and management tools that small 
businesses can use in the future.
Because EPA's regulations affect many small businesses in many 
different ways, the Agency is committed to integrating and simplifying 
its activities in ways that help small businesses comply. In 
particular, EPA is preparing a revised small business strategy entitled 
Integrating EPA's Small Business Activities: A Strategy to Meet the 
Needs of Small Businesses. The revised strategy reflects input received 
over the past two years from a series of interviews within EPA and with 
focus groups, States, industry representatives, and other interested 
stakeholders to better understand the environmental regulatory issues 
and obstacles facing small businesses. In FY 2003, EPA will implement 
the strategy's recommendations to better integrate its activities that 
support small businesses, including how the Agency provides technical 
assistance and outreach, develops regulations that minimize burden, and 
simplifies participation in EPA's voluntary programs.
_______________________________________________________________________



EPA

                              -----------

                             PRERULE STAGE

                              -----------




115. PESTICIDES; EMERGENCY EXEMPTION PROCESS REVISIONS
Priority:


Other Significant


Legal Authority:


7 USC 136(p)


CFR Citation:


40 CFR 166


Legal Deadline:


None


Abstract:


EPA will publish a Federal Register notice to revise the pesticide 
emergency exemption process under section 18 of the Federal 
Insecticide, Fungicide and Rodenticide Act, based on recent 
recommendations from the States. Rulemaking will not be undertaken at 
this time because the revisions are to operational practices used to 
implement the program and are consistent with current regulations. 
Emergency exemptions allow temporary use of a pesticide not in 
accordance with registration requirements when emergency conditions 
exist. EPA identified a number of issues, which have been refined 
through informal discussions with States, user groups, and other 
stakeholders.


Statement of Need:


In 1996, stakeholders, including States and Federal agencies, 
identified a number of issues related to improving the 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 section 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, including specific recommendations from 
a group representing States' interests. Since the modifications would 
generally constitute regulatory relief, and are not expected to cause 
any economic impact, options with varying cost do not apply.


Anticipated Cost and Benefits:


Because this action 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, 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 primarily intended to

[[Page 74214]]

reduce burdens for States and EPA and achieve efficiencies in the 
program. There is potential risk reduction in reduced use of 
pesticides.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
Notice                                                         11/00/02
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


Federal, State


Additional Information:


SAN No. 4216


Sectors Affected:


9241 Administration of Environmental Quality Programs


Agency Contact:
Joe 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
Phone: 703 305-5944
Fax: 703 305-5884
Email: [email protected]
RIN: 2070-AD36
_______________________________________________________________________



EPA



116. [bull] ENDOCRINE DISRUPTOR SCREENING PROGRAM; PRIORITY SETTING 
CRITERIA
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:


None


Abstract:


EPA published a proposed policy statement in the Federal Register 
setting forth the Endocrine Disruptor Screening Program on December 28, 
1998. In that FR Notice, the Agency described the major elements that 
the Program had developed to comply with the requirements of FFDCA 
section 408(p) as amended by FQPA. One of those elements is Priority 
Setting which was defined as the collection, evaluation, and analysis 
of relevant information to determine the general order in which 
chemical substances and mixtures will be subjected to screening and 
testing. Under this current action, EPA is developing priority setting 
criteria to be used by the Agency to identify the initial list of 
chemicals for which Tier 1 testing will be required.


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:


None.


Risks:


Evidence is continuing to mount that wildlife and humans may be at risk 
from exposure to chemicals operating through an endocrine mediated 
pathway. Preliminary studies show possible adverse effects on humans. 
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 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 Proposed Priority Setting Criteria & Request for Comment12/00/02
Notice Final Priority Setting Criteria                         06/00/03
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


None


Additional Information:


SAN No. 4727


Agency Contact:
Greg Schweer
Environmental Protection Agency
Office of Prevention, Pesticides and Toxic Substances
7201M
Washington, DC 20460
Phone: 202 564-8469
Fax: 202 564-8482
Email: [email protected]

Gary Timm
Environmental Protection Agency
Office of Prevention, Pesticides and Toxic Substances
7201M
Washington, DC 20460
Phone: 202 564-8474
Fax: 202 564-8483
Email: [email protected]
RIN: 2070-AD59

[[Page 74215]]

_______________________________________________________________________



EPA



117. [bull] SUSTAINABLE FUTURES; VOLUNTARY PILOT PROJECT UNDER THE TSCA 
NEW CHEMICAL PROGRAM
Priority:


Other Significant


Legal Authority:


Not Yet Determined


CFR Citation:


Not Yet Determined


Legal Deadline:


None


Abstract:


Sustainable Futures is a voluntary pilot project initiated by EPA to 
encourage the application of pollution prevention principles during the 
development of new chemicals submitted as premanufacture notices (PMNs) 
under section 5 of the Toxic Substances Control Act (TSCA). The goal of 
this pilot project is to encourage pollution prevention and the 
development of inherently low-hazard chemicals. Also, the Agency seeks 
to gain additional data and experience regarding the pollution 
prevention, risk reduction, and source reduction benefits of use of 
hazard, exposure, and risk-screening methodologies such as EPA's 
Pollution Prevention Framework in new product development efforts.


Statement of Need:


Chemical manufacturers need quick, inexpensive, reliable methods for 
screening chemicals for risk early-on in the chemical development 
process. Manufacturers of new chemical substances often have product or 
process alternatives available and/or under consideration at R&D. 
Unfortunately, little or no data are available about the potential 
hazards or risks of alternatives under consideration. As a result, 
stakeholders often make commercialization decisions without an 
understanding of the risk trade-offs of product or process alternatives 
under consideration. Commercialization decisions are often made 
``blind'' to risk considerations. Sustainable Futures is a technology-
transfer approach to risk reduction and pollution prevention. Under 
Sustainable Futures, the Agency will give sophisticated computerized 
risk-screening methodologies, called the P2 Framework, to chemical 
companies, together with training and detailed technical assistance. 
The P2 Framework allows companies to evaluate chemical alternatives 
based on a computerized analysis of chemical structure. The P2 
Framework can be used early-on in R&D, even before a chemical is 
synthesized, to render screening-level assessments of chemicals under 
study and alternatives available. R&D is the optimal point to 
initiative risk screening because alternatives are more plentiful at 
R&D and the cost of change is lowest. Risk screening at R&R is the 
purest form of pollution prevention.


Summary of Legal Basis:


Section 5 of TSCA gives EPA authority to review and, where necessary, 
control unreasonable risks associated with new chemicals. An important 
approach to risk control is to give chemical manufacturers 
sophisticated, cost-effective screening methodologies that allow 
stakeholders to self-identify problematic chemicals, resulting in 
submission of inherently low-risk new chemicals. The Pollution 
Prevention Act encourages approaches that prevent the introduction of 
hazardous materials. The P2 Framework is one approach toward this 
objective.


Alternatives:


One alternative would be to ask the industry to test new chemical 
substances to determine the level of risk, if any. Such an approach 
would increase costs and delay introduction of materials into the 
market place. There is no statutory authority to require testing prior 
to submission of a premanufacture notice. A second alternative is the 
status quo, where chemical commercialization decisions are made without 
an understanding of risk trade-offs of product and process 
alternatives.


Anticipated Cost and Benefits:


Cost to participating stakeholders will be low. Almost all stakeholders 
currently have computer equipment sufficiently powerful to run 
assessment methodologies offered through Sustainable Futures. Training, 
offered by EPA at no cost, will be needed, however. Eastman Kodak 
conducted an independent study of the benefits of conducting risk 
screening at R&D using the P2 Framework - the central concept of the 
Sustainable Futures Initiative. Kodak found they saved between 13.5 
percent and 100 percent of product development costs for each chemical 
evaluated at R&D. Other benefits seen in the Kodak case study include 
reduction in generation of chemical wastes, reduced time to market, 
reduced regulatory liability and better utilization of health, safety 
and environmental staff.


Risks:


The methodologies included in the P2 Framework, i.e., the foundation of 
the Sustainable Futures Initiative, are screening-level methodologies 
with an inherent degree of uncertainty. As a result, it is possible 
that a low risk chemical might be mistakenly identified as posing human 
or environment concerns. The opposite is also possible, i.e., a 
hazardous chemical might be mistakenly viewed as posing low hazard as a 
result of application of the P2 Framework methodologies.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
Notice Announcing Voluntary Pilot Project                      11/00/02
Regulatory Flexibility Analysis Required:


Undetermined


Government Levels Affected:


Undetermined


Federalism:


 Undetermined


Additional Information:


SAN No. 4734


Sectors Affected:


325 Chemical Manufacturing; 32411 Petroleum Refineries


Agency Contact:
Bill Waugh
Environmental Protection Agency
Office of Prevention, Pesticides and Toxic Substances
7403M
Washington, DC 20460
Phone: 202 564-7657
Fax: 202 564-7440
Email: [email protected]

Kenneth Moss
Environmental Protection Agency
Office of Prevention, Pesticides and Toxic Substances
7405M
Phone: 202 564-9232
Email: [email protected]
RIN: 2070-AD60
_______________________________________________________________________



EPA



118. CLEAN WATER ACT DEFINITION OF WATERS OF THE UNITED STATES
Priority:


Other Significant

[[Page 74216]]

Legal Authority:


33 USC 1361 CWA sec 501; 33 USC 1362 CWA sec 502


CFR Citation:


33 CFR 328.3(a); 40 CFR 110.1; 40 CFR 112.2; 40 CFR 116.3; 40 CFR 
117.1; 40 CFR 122.2; 40 CFR 230.3(s); 40 CFR 232.2; 40 CFR 257.3-1(d); 
40 CFR Part 300, Appendix E; 40 CFR 401.11(I)


Legal Deadline:


None


Abstract:


This action involves joint rulemaking by EPA and the Department of the 
Army to amend the regulatory definition of waters of the United States. 
The action would clarify the jurisdictional status under the Clean 
Water Act (CWA) of ``isolated intrastate non-navigable waters and 
wetlands.'' The existing regulations contain language asserting 
jurisdiction over isolated intrastate waters, but that regulatory 
provision has been the subject of a January 9, 2001, U.S. Supreme Court 
opinion, Solid Waste Agency of Northern Cook County v. U.S. Army Corps 
of Engineers (SWANCC). In SWANCC, the Court held that the scope of 
``waters of the United States'' protected under the Clean Water Act did 
not extend to isolated intrastate non-navigable waters based solely on 
presence of migratory birds. While SWANCC did not actually invalidate 
regulations under the CWA, the decision does establish limitations on 
their use. Revision of the regulatory language is necessary to address 
the Court's decision, improve regulatory clarity, and provide more 
specificity regarding CWA jurisdiction. Among others things, the 
rulemaking would clarify CWA jurisdiction for entities (e.g., 
industrial, commercial, governmental) that discharge pollutants, 
including dredged or fill material, to isolated intrastate surface 
waters or wetlands. Small entities or State/local/tribal governments 
might be affected by a change in regulatory definition of ``waters of 
the United States'' if they either are regulated under or help 
administer CWA programs affecting such waters, e.g. sections 402, 404, 
311.


Significant impacts on such entities or governments are not 
anticipated, as the proposed regulatory revisions would be consistent 
with the Supreme Court ruling.


Statement of Need:


The need for this rule stems from the Supreme Court's 2001 decision in 
Solid Waste Agency of Northern Cook County v. U.S. Army Corps of 
Engineers (SWANCC), which has raised substantive questions regarding 
the extent to which isolated intrastate non-navigable waters are 
included within the geographic scope of jurisdiction under the Clean 
Water Act. Rulemaking will help clarify issues to ensure that Clean 
Water Act protections are in place for the appropriate set of wetlands 
and other waters of the United States.


Summary of Legal Basis:


Although the Supreme Court's decision in SWANCC did not invalidate 
regulations under the CWA, it raised questions that can be most 
effectively answered via rulemaking on the various regulations 
concerning CWA jurisdiction.


Alternatives:


The Agency will seek public input on alternatives via an advance notice 
of proposed rulemaking prior to proposing a rulemaking.


Anticipated Cost and Benefits:


Cost/benefit information will be developed/solicited as part of the 
ANPRM and proposal process. However, significant changes in the 
magnitude or distribution of costs and benefits are not anticipated, as 
the rule is primarily focused on how Clean Water Act jurisdiction for 
relevant programs is interpreted in light of the SWANCC Supreme Court 
decision.


Risks:


Risk information will be solicited as part of the ANPRM and proposal 
process. However, significant changes in the magnitude or distribution 
of risk are not anticipated as the rule is primarily focused on how 
Clean Water Act jurisdiction for relevant programs is interpreted in 
light of the SWANCC Supreme Court decision.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
ANPRM                                                          11/00/02
NPRM                                                           06/00/03
Final Action                                                   02/00/04
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


Businesses, Governmental Jurisdictions


Government Levels Affected:


Federal, State, Local, Tribal


Additional Information:


SAN No. 2804


Agency Contact:
Donna Downing
Environmental Protection Agency
Water
4502T
Washington, DC 20460
Phone: 202 566-1367
Fax: 202 566-1375
Email: [email protected]

John Lishman
Environmental Protection Agency
Water
4502T
Washington, DC 20460
Phone: 202 566-1364
Fax: 202 566-1375
Email: [email protected]
RIN: 2040-AB74
_______________________________________________________________________



EPA

                              -----------

                          PROPOSED RULE STAGE

                              -----------




119. 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

[[Page 74217]]

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.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           11/00/02
Final Action                                                   02/00/04
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
C504-05
Research Triangle Park, NC 27711
Phone: 919 541-4516
Fax: 919 541-0246
Email: [email protected]

K. C. Hustvedt
Environmental Protection Agency
Air and Radiation
C439-03
Research Triangle Park, NC 27711
Phone: 919 541-5395
Fax: 919 541-0246
Email: [email protected]
RIN: 2060-AG52
_______________________________________________________________________



EPA



120. NESHAP: RECIPROCATING INTERNAL COMBUSTION ENGINE
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; 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.


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. Total annualized cost for rule is $248 million, 
average cost/facility $62,000 for 4600 existing sources and 20,000 new 
sources.


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.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           11/00/02
Final Action                                                   02/00/04
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


Businesses, Governmental Jurisdictions


Government Levels Affected:


State, Local


Additional Information:


SAN No. 3656

[[Page 74218]]

Agency Contact:
Sims Roy
Environmental Protection Agency
Air and Radiation
C439-01
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
C439-01
Research Triangle Park, NC 27711
Phone: 919 541-1045
Fax: 919 541-5450
Email: [email protected]
RIN: 2060-AG63
_______________________________________________________________________



EPA



121. 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 presented as part of the proposed rule.


Anticipated Cost and Benefits:


Implementation of the rulemaking would reduce nationwide emissions of 
air toxics by 58,000 tons per year in the 5th year. Mercury emissions 
would be reduced by almost 2 tons per year. Those reductions would 
lower ambient air concentrations and levels of exposure. In addition to 
HAP emissions reductions, reductions in criteria pollutant emissions 
(i.e., particulate matter, sulfur dioxide) would also be realized. The 
total nationwide capital costs for the rulemaking as proposed is about 
$1.7 billion, with an annualized cost of $840 million.


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. 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                                                           11/00/02
Final Action                                                   02/00/04
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


Businesses


Government Levels Affected:


None


Additional Information:


SAN No. 3837


Agency Contact:
James A. Eddinger
Environmental Protection Agency
Air and Radiation
C439-01
Research Triangle Park, NC 27711
Phone: 919 541-5426
Fax: 919 541-5450
Email: [email protected]

William H. Maxwell
Environmental Protection Agency
Air and Radiation
C439-01
Research Triangle Park, NC 27711
Phone: 919 541-5430
Fax: 919 541-5450
Email: [email protected]
RIN: 2060-AG69
_______________________________________________________________________



EPA



122. 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 and are to require 
the maximum achievable control technology as described in section 112 
of the CAA.


Statement of Need:


Surface coating of automobiles and light-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.

[[Page 74219]]

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:


The estimated total annual costs, including costs for recordkeeping and 
reporting, to the affected industry of the rule is $150 million. The 
rule is projected to reduce emissions of hazardous air pollutants by 
6,000 tons per year. A regulatory impact analysis will accompany 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. 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                                                           11/00/02
Final Action                                                   05/00/04
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


State, Local


Additional Information:


SAN No. 3907


Sectors Affected:


33611 Automobile and Light Duty Motor Vehicle Manufacturing; 336112 
Light Truck and Utility Vehicle Manufacturing; 336211 Motor Vehicle 
Body Manufacturing


Agency Contact:
Dave Salman
Environmental Protection Agency
Air and Radiation
C539-03
Research Triangle Park, NC 27711
Phone: 919 541-0859
Fax: 919 541-5689
Email: [email protected]

Dianne Byrne
Environmental Protection Agency
Air and Radiation
C504-05
Research Triangle Park, NC 27711
Phone: 919 541-5342
Fax: 919 541-5689
Email: [email protected]
RIN: 2060-AG99
_______________________________________________________________________



EPA



123. 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                                                           12/00/02
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


Federal, State, Local, Tribal


Additional Information:


SAN No. 4340


Agency Contact:
Angela Spickard
Environmental Protection Agency
Air and Radiation
6406
Washington, DC 20460
Phone: 734 214-4240
Fax: 734 214-4906
Email: spickard,[email protected]
RIN: 2060-AI56

[[Page 74220]]

_______________________________________________________________________



EPA



124. CONTROL OF EMISSIONS FROM SPARK IGNITION MARINE VESSELS AND 
HIGHWAY MOTORCYCLES
Priority:


Economically Significant. Major under 5 USC 801.


Legal Authority:


42 USC 7401 to 7671(q)


CFR Citation:


40 CFR 94


Legal Deadline:


None


Abstract:


EPA is proposing to take actions to reduce emissions from two 
categories of engines. The first category, highway motorcycles, have 
existing emission standards that were put in place over twenty years 
ago. Emissions control technologies have advanced significantly since 
that time, and EPA believes it is appropriate to put in place more 
stringent standards for HC and NOx that reflect this progress. The 
proposed standards are consistent with standards California has 
recently promulgated, thereby creating the opportunity to industry to 
produce and market products nationwide. The second categoy of emissions 
sources addressed in this proposal is gasoline-powered marine vessels. 
Specifically, EPA is proposing to control evaporative emissions from 
these sources through the application of fuel tank and hose controls 
that can significantly reduce HC emissions from these sources. This 
proposal is the first set of emissions standards for this category.


Statement of Need:


Ozone pollution poses a serious threat to the health and well-being of 
millions of Americans. This rulemaking addresses control measures to 
reduce emissions from highway motorcycles and gasoline fuel systems for 
marine vessels.


Summary of Legal Basis:


42 USC 7521 and 7547.


Alternatives:


The proposal describes alternatives that could be adopted as part of 
the final rule. Small business compliance flexibilities are included 
for both categories of standards. For the motorcycle portion of the 
proposal, alternative emission standards are less attractive given the 
benefits associated with harmonizing the Federal program with existing 
California requirements.


Anticipated Cost and Benefits:


Costs and benefits will be analyzed as part of the final rule review 
process. The standards included in the proposal are cost-effective, 
with significant reductions estimated for HC and NOx emissions from 
motorcycles and HC for the evaporative emissions controls. In addition, 
the evaporative emissions controls are expected to lead to significant 
fuel savings for the owners and operators of these sources.


Risks:


The risks addressed by this program are primarily those associated with 
nonattainment of the National Ambient Air Quality Standards for ozone. 
There are also serious public health and welfare benefits from 
controlling emissions from these sources, such as reductions in 
regional haze and acid deposition.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           11/00/02
Final Action                                                   08/00/03
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses


Government Levels Affected:


None


Additional Information:


SAN No. 4626


Sectors Affected:


333924 Industrial Truck, Tractor, Trailer and Stacker Machinery 
Manufacturing; 335312 Motor and Generator Manufacturing; 42183 
Industrial Machinery and Equipment Wholesalers


Agency Contact:
Alan Stout
Environmental Protection Agency
Air and Radiation
EPCD
Ann Arbor, MI 48105
Phone: 734 214-4805
Fax: 734 214-4816
Email: [email protected]

Don Kopinski
Environmental Protection Agency
Air and Radiation
OMS EPCD
Washington, DC 20460
Phone: 734 214-4229
Fax: 734 214-4816
Email: [email protected]
RIN: 2060-AJ90
_______________________________________________________________________



EPA



125. IMPLEMENTATION RULE FOR 8-HOUR OZONE NAAQS
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 7408; 42 USC 7410; 42 USC 7501-7511f; 42 USC 7601(a)(1)


CFR Citation:


40 CFR 51 (revision)


Legal Deadline:


None


Abstract:


This rule would provide specific requirements for State and local air 
pollution control agencies to prepare State implementation plans (SIPs) 
under the 8-hour national ambient air quality standard (NAAQS) for 
ozone, published by EPA on July 18, 1997. The Clean Air Act requires 
EPA to set ambient air quality standards and requires States to submit 
SIPs to implement those standards. The 1997 standards were challenged 
in court, but in February 2001, the Supreme Court determined that EPA 
has authority to implement a revised ozone standard, but ruled that EPA 
must reconsider its implementation plan for moving from the 1-hour 
standard to the revised standard. The Supreme Court identified 
conflicts between different parts of the Clean Air Act related to 
implementation of a revised NAAQS,

[[Page 74221]]

provided some direction to EPA for resolving the conflicts, and left it 
to EPA to develop a reasonable approach for implementation. Thus, this 
rulemaking must address the requirements of the Clean Air Act and the 
Supreme Court's ruling. This rule would provide detailed provisions to 
address the Clean Air Act's requirements for State Implementation Plans 
(SIPs) and would thus affect State and local air agencies. States with 
areas that are not attaining the 8-hour ozone NAAQS will have to 
develop -- as part of their SIPs -- emission limits and other 
requirements to attain the NAAQS within the timeframes set forth in the 
Clean Air Act. Tribal lands that are not attaining the 8-hour ozone 
standard may be affected and could voluntarily submit a Tribal 
Implementation Plan (TIP), but would not be required to submit a TIP. 
In cases where a TIP is not submitted, EPA would have the 
responsibility for planning in those areas.


Statement of Need:


This action is needed in response to the U.S. Supreme Court's ruling in 
February 2001 (Whitman v. American Trucking Assoc.,, 121 S.Ct.903) that 
stated that EPA has the authority to implement a revised ozone NAAQS 
but that EPA could not ignore the provisions of subpart 2 when 
implementing the 8-hour NAAQS. The Supreme Court identified several 
portions of subpart 2 that are ill-fitted to the revised NAAQS but left 
it to EPA to develop a reasonable implementation approach. 
Consequently, EPA is developing a rule to implement the 8-hour ozone 
NAAQS under the provisions of subpart 2 of the CAA.


Summary of Legal Basis:


Title I of the Clean Air Act.


Alternatives:


This entry comprises the action the Agency plans to take to implement 
the 8-hour ozone NAAQS. The major alternative facing the Agency was 
whether to implement the standard 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 ozone NAAQS. The other major set of alternatives 
involved various possible strategies for infrastructure design, such as 
the designations of nonattainment areas and the requirements that apply 
to them.


Anticipated Cost and Benefits:


EPA prepared a regulatory impact analysis for the final ozone NAAQS, 
and is preparing a cost analysis for this implementation rule. The 
benefits of the rule are those associated with attainment of the ozone 
NAAQS including 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, and increases in yields of 
commercial forests currently exposed to elevated ozone levels.


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 were outlined in detail in the Regulatory Impact 
Analysis for the ozone NAAQS rulemaking. The results are summarized in 
the Federal Register notice for that rulemaking (62 FR 38856, July 18, 
1997).


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           12/00/02
Final Action                                                   12/00/03
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


State, Local, Tribal


Additional Information:


SAN No. 4625


Agency Contact:
John Silvasi
Environmental Protection Agency
Air and Radiation
C539-02
Research Triangle Park, NC 27711
Phone: 919 541-5666
Fax: 919 541-0824
Email: [email protected]

Denise Gerth
Environmental Protection Agency
Air and Radiation
C539-02
Research Triangle Park, NC 27711
Phone: 919 541-5550
Fax: 919 541-0824
RIN: 2060-AJ99
_______________________________________________________________________



EPA



126. CONTROL OF EMISSIONS OF AIR POLLUTION FROM NONROAD DIESEL ENGINES 
AND FUEL
Priority:


Economically Significant. Major under 5 USC 801.


Unfunded Mandates:


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


Legal Authority:


15 USC 2002


CFR Citation:


40 CFR 89


Legal Deadline:


None


Abstract:


On October 23, 1998, EPA finalized emission standards for nonroad 
compression ignition (i.e., diesel) engines for engines over 37 
kW(50hp). The regulation reduced the NOx + HC emissions standard by 30 
percent to 37 percent (based on the power class) from the previous 6.9 
g/hp-hr NOx and 1.0 g/hp-hr HC standard beginning in 1999. As a follow-
up to that 1998 rulemaking, the Agency is now undertaking a technology 
review, pursuant to the Clean Air Act, to assess whether more stringent 
standards are now feasible, and to promulgate such standards if the 
findings are positive. The technology review will reassess the NOx + HC 
standards and will set the next phase of particulate matter standards 
for over 37 kW and up to 560 kW. The emission limits will also be 
reexamined for the under 37 kW scheduled for implementation in 2004. 
The issue of the sulfur content of nonroad diesel

[[Page 74222]]

fuel will be raised and consideration given to lowering the fuel sulfur 
level with an ultimate 15 ppm cap. The certification duty cycle for 
this class of engines will also be revisited to implement a transient 
duty cycle that gives some assurance of better in-use control of 
particulate matter.


Statement of Need:


Ozone and particulate pollution pose a serious threat to the health and 
well-being of millions of Americans and a large burden to the U.S. 
economy. This rulemaking will address additional national control 
measures to reduce emissions, including emissions of nitrogen oxides, 
hydrocarbons and particulate matter, from nonroad heavy-duty diesel 
engines, and will also require reduced sulfur levels in nonroad diesel 
fuel, in order to protect the public health and welfare.


Summary of Legal Basis:


CAA title II part A section 213, 217.


Alternatives:


Alternatives will be considered as the rulemaking proposal is 
developed.


Anticipated Cost and Benefits:


Costs and benefits will be assessed as the rulemaking proposal is 
developed.


Risks:


The risks addressed by this program are primarily those associated with 
nonattainment of the National Ambient Air Quality Standards for ozone 
and particulate matter. There are also serious public health and 
environmental problems associated with toxic air pollution, acid rain, 
reduced visibility and nitrogen loading of estuaries.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           04/00/03
Final Action                                                   04/00/04
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses


Government Levels Affected:


Federal, State, Local


Additional Information:


SAN No. 4675


Agency Contact:
Cleophas Jackson
Environmental Protection Agency
Air and Radiation
ASD
Washington, DC 20460
Phone: 734 214-4824
Fax: 734 214-4816
Email: [email protected]

William Charmley
Environmental Protection Agency
Air and Radiation
ASD
Phone: 734 214-4408
Fax: 734 214-4050
Email: [email protected]
RIN: 2060-AK27
_______________________________________________________________________



EPA



127. PREVENTION OF SIGNIFICANT DETERIORATION (PSD) AND NONATTAINMENT 
NEW SOURCE REVIEW (NSR): ROUTINE MAINTENANCE, REPAIR, AND REPLACEMENT
Priority:


Economically Significant


Legal Authority:


42 USC 7401 et seq


CFR Citation:


40 CFR 51.165; 40 CFR 51.166; 40 CFR 52.21; 40 CFR 52.24


Legal Deadline:


None


Abstract:


The EPA is proposing revisions to the regulations governing the NSR 
programs mandated by parts C and D of title I of the Clean Air Act 
(Act). These proposed changes reflect the EPA's consideration of the 
discussions and recommendations of the President's National Energy 
Policy Report and from various stakeholders including representatives 
from industry, State and local governments, and environmental groups. 
The proposed changes provide a future category of activities that would 
be considered to be routine maintenance, repair, and replacement 
(RMR&R) under the NSR program. The changes are intended to provide 
greater regulatory certainty without sacrificing the current level of 
environmental protection and benefit derived from the program. We 
believe that these changes will facilitate the safe, efficient, and 
reliable operation of affected facilities.


Statement of Need:


The current New Source Review regulations provide for an exclusion from 
the definition of major modifications for ``routine maintenance, 
repair, and replacement'' activities; however, they do not provide a 
definition of this term. Specific questions regarding the application 
of this term have been addressed on a case-by-case basis. By providing 
a future category of activities that would be considered to be routine 
maintenance, repair, and replacement (RMR&R) under the NSR program, 
these changes will provide greater regulatory certainty without 
sacrificing the current level of environmental protection and benefit 
derived from the program.


Summary of Legal Basis:


42 USC 7411(a)(4)


Alternatives:


Alternative considerations that will affect what activities would be 
considered to be RMR&R will be included in the proposal.


Anticipated Cost and Benefits:


The Agency will conduct analyses to the extent appropriate to inform 
decisions on the rule. Such analyses will be introduced as part of the 
proposed rule and developed further for the final rule.


Risks:


Risk information will be developed as appropriate as the rulemaking 
proceeds.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           11/00/02
Final Rule                                                     10/00/03
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


Federal, State, Local, Tribal


Additional Information:


SAN No. 4676

[[Page 74223]]

Agency Contact:
Dave Svendsgaard
Environmental Protection Agency
Air and Radiation
C339-03
Research Triangle Park, NC 27711
Phone: 919 541-2380
Fax: 919 541-5509
Email: [email protected]

Lynn Hutchinson
Environmental Protection Agency
Air and Radiation
C33903
Research Triangle Park, NC 27711
Phone: 919 541-5795
Fax: 919 541-5509
Email: [email protected]
RIN: 2060-AK28
_______________________________________________________________________



EPA



128. [bull] ENDOCRINE DISRUPTER SCREENING PROGRAM; IMPLEMENTING THE 
SCREENING AND TESTING PHASE
Priority:


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


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:


None


Abstract:


The screening and testing phase of the Endocrine Disruptor Screening 
Program (EDSP) potentially will encompass a broad range of types of 
chemicals, including pesticide chemicals, TSCA chemicals, chemicals 
that may be found in sources of drinking water, chemicals that may have 
an effect that is cumulative to the effect of a pesticide chemical, 
chemicals that are both pesticide chemicals and TSCA chemicals, and 
other chemicals that are combinations of these types of chemicals. This 
proposed rule will describe EPA's proposed procedures and processes 
that EPA will use when implementing the screening and testing phase of 
the EDSP. Specifically, depending on decisions that the Agency makes 
regarding implementation of the testing phase of the EDSP, the proposed 
rule will describe the authorities that it may invoke to require 
testing and, if necessary, establish the process that the Agency will 
use to require the testing.


Statement of Need:


The Endocrine Disruptor Screening Program Implementation of the 
Screening and Testing Phase 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 screening and testing phase of the Endocrine Disruptor Screening 
Program (EDSP) potentially will encompass a broad range of types of 
chemicals, including pesticide chemicals, TSCA chemicals, chemicals 
that may be found in sources of drinking water, chemicals that may have 
an effect that is cumulative to the effect of a pesticide chemical, 
chemicals that are both pesticide chemicals and TSCA chemicals, and 
other chemicals that are combinations of these types of chemicals. As 
discussed in the Proposed Statement of Policy, EPA has a number of 
authorities at its disposal to require testing of these types of 
chemicals. The Federal Food, Drug, and Cosmetics Act (FFDCA) section 
408(p) provides EPA authority to require testing of all pesticide 
chemicals and any other substance that may have an effect that is 
cumulative to an effect of a pesticide chemical if EPA determines that 
a substantial population may be exposed to the substance (21 U.S.C. 
346a)(p)). Likewise, the Safe Drinking Water Act (SDWA) provides EPA 
with authority to require testing of any substance that may be found in 
sources of drinking water if EPA determines that a substantial 
population may be exposed to the substance (42 U.S.C. section 300j-17). 
The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) 
provides EPA with authority to require testing of pesticides if EPA 
determines that additional data are required to maintain in effect an 
existing registration (7 U.S.C. section 136a(c)(2)(B)). The Toxic 
Substances Control Act (TSCA) provides authority for EPA to require 
testing of TSCA chemicals, provided that it makes certain hazard and/or 
exposure findings (15 U.S.C. section 2603). In addition, EPA has 
authority to issue consent orders to require testing when interested 
parties agree on an acceptable testing program (51 FR 23706 (June 30, 
1986)).


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, the Agency recognizes that the rule could 
potentially have significant cost implications, depending on the 
screening criteria and testing requirements. For example, as a rough 
estimate, the screening battery currently under consideration is 
estimated to cost $200,000 per chemical. It is also too early to 
quantify the benefits of this program mathematically. The goal of the 
program is to reduce the risks identified below.


Risks:


Evidence is continuing to mount that wildlife and humans may be at risk 
from exposure to chemicals operating through an endocrine mediated 
pathway. Preliminary studies show possible adverse effects on humans. 
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 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

_______________________________________________________________________
NPRM Proposed Procedural Rule                                  12/00/02
Regulatory Flexibility Analysis Required:


Undetermined


Small Entities Affected:


Businesses

[[Page 74224]]

Government Levels Affected:


None


Additional Information:


SAN No. 4728


Agency Contact:
Jane Smith
Environmental Protection Agency
Office of Prevention, Pesticides and Toxic Substances
7201M
Washington, DC 20460
Phone: 919 380-4541
Fax: 202 564-8483
Email: [email protected]

Joe Nash
Environmental Protection Agency
Office of Prevention, Pesticides and Toxic Substances
7201M
Washington, DC 20460
Phone: 202 564-8886
Fax: 202 564-8483
Email: [email protected]
RIN: 2070-AD61
_______________________________________________________________________



EPA



129. MODIFICATIONS TO RCRA RULES ASSOCIATED WITH SOLVENT-CONTAMINATED 
SHOP TOWELS AND WIPES
Priority:


Other Significant


Legal Authority:


42 USC 6921


CFR Citation:


40 CFR 261


Legal Deadline:


None


Abstract:


This action would modify RCRA rules that impact the management of 
solvent-contaminated shop towels and wipes. Solvent-contaminated shop 
towels and wipes are used throughout industry for equipment cleaning 
and other related facility operations. The spent shop towels and wipes 
can be hazardous wastes when the solvent used is either a 
characteristic or listed solvent. An examination of industry use and 
management practices reveals that many facilities may use only small 
amounts of solvent on their disposable wipes, and use small numbers of 
wipes daily, suggesting that these materials may sometimes pose little 
or no risk to human health and the environment if disposed in municipal 
landfills. Similarly, situations exist where both disposable wipes and 
reusable shop towels are not being managed according to prescribed 
Federal and States' rules and policies. Problems with this issue have 
persisted since the late 1980s.


Statement of Need:


After being asked by multiple stakeholders to examine this waste 
stream, EPA is considering changing the requirements for management of 
both reusable and disposable solvent-contaminated industrial wipes. 
This will encourage pollution prevention and recycling of hazardous 
solvents, make the management standards more consistent with the risks 
these materials pose, and clarify existing Federal policies regarding 
these materials.


Summary of Legal Basis:


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


Alternatives:


EPA is considering options that would either exempt solvent-
contaminated industrial wipes from the definition of hazardous waste or 
exclude them from the definition of solid waste when certain conditions 
are met. These conditions would address the amount of solvent present 
in the wipes during transportation, as well as container requirements 
for accumulation and transportation.


Anticipated Cost and Benefits:


The anticipated benefits of this rule include annual cost savings for 
generators of disposable and reusable industrial wipes. Other benefits 
include the potential for pollution prevention and for increased 
recycling of hazardous solvents used in conjunction with industrial 
wipes.


Risks:


The analyses associated with this action find that the options being 
considered would not cause risks from disposal or re-use of solvent-
contaminated wipes to increase from current regulations.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

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


No


Small Entities Affected:


Businesses


Government Levels Affected:


Federal, State


Additional Information:


SAN No. 4091


Sectors Affected:


323 Printing and Related Support Activities; 325 Chemical 
Manufacturing; 332 Fabricated Metal Product Manufacturing; 333 
Machinery Manufacturing; 334 Computer and Electronic Product 
Manufacturing; 336 Transportation Equipment Manufacturing; 337 
Furniture and Related Product Manufacturing; 441 Motor Vehicle and 
Parts Dealers; 811 Repair and Maintenance; 812 Personal and Laundry 
Services


Agency Contact:
Kathy Blanton
Environmental Protection Agency
Solid Waste and Emergency Response
5304W
Washington, DC 20460
Phone: 703 605-0761
Fax: 703 308-0514
Email: [email protected]
RIN: 2050-AE51
_______________________________________________________________________



EPA



130. REVISION OF WASTEWATER TREATMENT EXEMPTIONS FOR HAZARDOUS WASTE 
MIXTURES
Priority:


Other Significant


Legal Authority:


42 USC 6912(a); 42 USC 6921; 42 USC 6922; 42 USC 6924; 42 USC 6926


CFR Citation:


40 CFR 261.3(a)(2)(iv)(A)-(E)(Revision)


Legal Deadline:


None


Abstract:


EPA is looking into proposing to add up to four solvents (benzene, 2-
ethoxyethanol, 1,1,2-trichloroethane, and 2-nitropropane) to the 
hazardous waste exemptions for mixtures of spent solvents in wastewater 
treatment plants (headworks rule) at 40 CFR 261.3(a)(2)(iv)(A)-(B). 
Spent solvents are solvents that have been used and are no longer fit 
for use without being regenerated, reclaimed, or otherwise processed. 
In addition, EPA is considering proposing: (1) changes to 
implementation of rule from using mass balance only, to choice of using 
direct monitoring; (2) adding certain leachates to allowed categories 
of wastestreams; (3) revising other provisions of rule, such as de 
minimis quantities and the

[[Page 74225]]

definition of point of application of exemption; and (4) clarifying 
applicability of exemption to incinerator scrubber waters.


Statement of Need:


This action is deregulatory. Federal action in this case will give 
States more flexibility in implementing the regulations. In addition, 
the Agency has been asked to look into this issue in Congressional 
Committee Appropriations Report Language.


Summary of Legal Basis:


This action is not required by statutory or court order.


Alternatives:


The Agency is considering this rule without any alternatives. Some 
aspects of the proposal provide alternatives for the regulated 
community in complying with the regulations (e.g., direct monitoring of 
solvents vs. mass balance). Future rulemaking may expand on some of the 
regulatory options contained in the proposal.


Anticipated Cost and Benefits:


This proposal, if finalized, is expected to provide cost savings to the 
regulatory community because more facilities will be eligible for 
regulatory exemptions and more wastes may be exempt from hazardous 
waste regulation.


Risks:


Since this is deregulatory, there is no risk reduction. However, the 
Agency performed a conservative risk analysis and found that risk is 
not increased above any level of concern by this action.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM Revisions for wastewater treatment exemptions             01/00/03
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


Federal, State


Additional Information:


SAN No. 4501


Sectors Affected:


31-33 Manufacturing; 562 Waste Management and Remediation Services


Agency Contact:
Ron Josephson
Environmental Protection Agency
Solid Waste and Emergency Response
5304W
Washington, DC 20460
Phone: 703 308-0442
Fax: 703 308-0522
Email: [email protected]

Laura Burrell
Environmental Protection Agency
Solid Waste and Emergency Response
5304W
Phone: 703 308-0005
Fax: 703 308-0514
Email: [email protected]
RIN: 2050-AE84
_______________________________________________________________________



EPA



131. INCREASE METALS RECLAMATION FROM F006 WASTE STREAMS
Priority:


Other Significant


Unfunded Mandates:


Undetermined


Legal Authority:


Not Yet Determined


CFR Citation:


40 CFR 261


Legal Deadline:


None


Abstract:


Currently wastewater treatment (WWT) sludges from electroplating 
operations (waste code F006) are identified as listed hazardous wastes. 
EPA is considering proposing changes to existing regulations intended 
to encourage safe recycling and management practices of this waste 
stream. We are considering reducing regulations for electroplating 
sludges that are sufficiently high in metal(s) and sufficiently low in 
other toxic constituents to be recovered.


Statement of Need:


F006 represents one of the largest hazardous waste streams amenable to 
recycling. Eliminating impediments to the safe recycling of F006 
through regulatory changes would potentially facilitate this outcome - 
thereby decreasing the amount of hazardous waste disposed.


Summary of Legal Basis:


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


Alternatives:


EPA is evaluating alternatives that would either exempt from the 
definition of hazardous waste or exclude from the definition of solid 
waste F006 destined for recycling provided specified conditions were 
met. Specific conditions would address proper handling, possibly 
notification, certification, etc.


Anticipated Cost and Benefits:


Costs to generating facilities would be reduced relative to current 
compliance costs. Benefits include the potential for increased 
recycling of F006, thereby reducing the amount of virgin materials that 
must be extracted from the land. Safe handling of this material also 
would be maintained.


Risks:


Any options evaluated and proposed would ensure that the risks from 
recycling F006 would not increase over current regulations. In 
particular, the risks from managing the material on the land would be 
addressed.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

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


No


Small Entities Affected:


Businesses


Government Levels Affected:


Undetermined


Federalism:


 Undetermined


Additional Information:


SAN No. 4651


Agency Contact:
Jim O'Leary
Environmental Protection Agency
Solid Waste and Emergency Response
5304W
Washington, DC 20460
Phone: 703 308-8827
Fax: 703 308-0514
Email: [email protected]

Jim Michael
Environmental Protection Agency
Solid Waste and Emergency Response
5304W
Washington, DC 20460
Phone: 703 308-8610
Fax: 703 308-0514
Email: [email protected]
RIN: 2050-AE97

[[Page 74226]]

_______________________________________________________________________



EPA



132. REVISIONS TO THE DEFINITION OF SOLID WASTE
Priority:


Other Significant


Legal Authority:


RCRA Section 1004(27); 42 USC 6903(27)


CFR Citation:


40 CFR 261.2


Legal Deadline:


None


Abstract:


Under RCRA, to be a hazardous waste, a material must also be a solid 
waste. EPA's framework for determining whether a material is a solid 
waste is based on what the material is and how it is managed (e.g., how 
it is used, reused, etc.). For materials being recycled, RCRA 
jurisdiction is complex and the history of legal decisions related to 
the definition of solid waste is extensive (AMC I, API I, AMC II, ABR, 
API II, etc.). In response to American Mining Congress v. EPA, 824 F. 
2d 1177(D.C. Cir. 1987) (AMC I) and one of the most recent decisions, 
the Association of Battery Recyclers, v. EPA 208 F.3d 1047 (2000) 
(ABR), EPA has decided to initiate development of a proposed rule to 
revise the definition of solid waste. We expect that the proposed rule 
will be broad in scope and will specifically address materials 
undergoing reclamation. In the context of reclamation, we plan to 
discuss options for how to distinguish materials that are discarded 
from materials that remain in use in a continuous industrial process 
and we anticipate proposing a definition of ``continuous industrial 
process.'' Generally, we believe that removing the specter of RCRA 
control where it is not necessary can spur increased reuse and 
recycling of hazardous waste, and will lead to better resource 
conservation and improved materials management overall.


Statement of Need:


This proposal responds to court decisions about EPA's definition of 
solid waste under RCRA. See Association of Battery Recyclers v. EPA, 
208 F.3d 1047 (2000).


Summary of Legal Basis:


See above.


Alternatives:


No alternatives are being considered.


Anticipated Cost and Benefits:


EPA currently anticipates that this rule, when finalized, will result 
in a net savings to the part of the regulated community affected by the 
rule (those facilities involved in recycling that is part of a 
continuous process within the generating industry). These facilities 
will no longer have to comply with the RCRA hazardous waste management 
requirements.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           04/00/03
Regulatory Flexibility Analysis Required:


Undetermined


Government Levels Affected:


Undetermined


Federalism:


 Undetermined


Additional Information:


SAN No. 4670


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]

Ingrid Rosencrantz
Environmental Protection Agency
Solid Waste and Emergency Response
5307W
Washington, DC 20460
Phone: 703 605-0709
Fax: 703 308-0522
Email: [email protected]
RIN: 2050-AE98
_______________________________________________________________________



EPA



133. NPDES PERMIT REQUIREMENTS FOR MUNICIPAL SANITARY AND COMBINED 
SEWER COLLECTION SYSTEMS, MUNICIPAL SATELLITE COLLECTION SYSTEMS, 
SANITARY SEWER OVERFLOWS, AND PEAK EXCESS FLOW TREATMENT FACILITIES
Priority:


Other Significant


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 regulatory 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. The 
Agency is also proposing a regulatory framework for applying NPDES 
permit conditions, including applicable standard permit conditions, to 
municipal satellite collection systems. Municipal satellite collection 
systems are sanitary sewers owned or operated by a municipality that 
conveys wastewater to a POTW operated by a different municipality. EPA 
is also proposing to clarify NPDES requirements, including secondary 
treatment requirements, for discharges from peak excess flow treatment 
facilities.


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 55,000 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

[[Page 74227]]

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 
needs to improve.


Providing Clear and Consistent Regulatory Program for Collection 
Systems -- States are implementing the existing NPDES regulations 
relevant to 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 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 is considering a proposed rule that would require NPDES permits for 
municipal sanitary sewer collection systems contain standard provisions 
for better operation and management of systems, increase attention to 
system planning, and better public notification in the event of an 
overflow. EPA is in the process of estimating the annual costs and 
benefits associated with this proposal.


Risks:


EPA estimates that there are at least 55,000 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. 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. In 2001, sewer line blockages and breaks were cited in 4 
percent and SSOs were cited in 2 percent of beach closures and swimming 
advisories in the United States.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           12/00/02
Final Action                                                   12/00/04
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


Sectors Affected:


22132 Sewage Treatment Facilities

[[Page 74228]]

Agency Contact:
Kevin Weiss
Environmental Protection Agency
Water
4203M
Washington, DC 20460
Phone: 202 564-0742
Fax: 202 564-6392
Email: [email protected]

Kevin DeBell
Environmental Protection Agency
Water
4203M
Washington, DC 20460
Phone: 202 564-0040
Fax: 202 564-6392
Email: [email protected]
RIN: 2040-AD02
_______________________________________________________________________



EPA



134. NATIONAL PRIMARY DRINKING WATER REGULATIONS: LONG TERM 2 ENHANCED 
SURFACE WATER TREATMENT RULE
Priority:


Economically Significant. Major under 5 USC 801.


Unfunded Mandates:


This action may affect State, local or tribal goverments and the 
private sector.


Legal Authority:


40 USC 300g-1(b); SDWA 1412(b); 42 USC 300f; 42 USC 300g-1; 42 USC 
300g-2; 42 USC 300g-3; 42 USC 300g-4; 42 USC 300g-5; 42 USC 300g-6; 42 
USC 300j-4; 42 USC 300j-9; 42 USC 300j-11


CFR Citation:


40 CFR 141 to 142; 40 CFR 9


Legal Deadline:


None


Abstract:


The Long Term 2 Enhanced Surface Water Treatment Rule (LT2ESWTR) will 
control risk from microbial pathogens in drinking water. It is being 
developed simultaneously with the Stage 2 Disinfectants and 
Disinfection Byproducts Rule (DBPR) which will address risk caused by 
the use of disinfectants in drinking water. This rule could affect all 
public water systems that use surface water as a source. Promulgating 
the LT2ESWTR and the Stage 2 DBPR as a paired rulemaking is necessary 
to ensure that adequate protection from microbial risk is maintained 
while EPA manages risk from disinfection byproducts. In developing the 
LT2ESWTR, EPA will analyze a significant body of new survey data on 
microbial pathogens in source and finished waters, as well as data on 
parameters which could serve as indicators of microbial risk. This 
survey data, which was collected under the Information Collection Rule 
(ICR), Supplemental Surveys to the ICR, and additional research 
projects, will provide a substantially more comprehensive and complete 
picture of the occurrence of waterborne pathogens than was available 
previously. EPA will also use significant new data on the efficiency of 
treatment processes for the removal and inactivation of microorganisms, 
as well as new information on the pathogenicity of certain pathogens, 
to determine effective regulatory requirements for controlling 
microbial risk. On March 30, 1999, EPA established a committee of 
stakeholders under the Federal Advisory Committee Act (FACA) to assist 
in the development of these rules and an agreement in principle was 
signed in September 2000 outlining the proposed rule options.


Statement of Need:


The purpose of the Long Term 2 Enhanced Surface Water Treatment Rule 
(LT2ESWTR) is to reduce health risks posed by Cryptosporidium and other 
microbial pathogens in drinking water. Cryptosporidium is a protozoa 
which causes cryptosporidiosis, a severe gastrointestinal disease. 
While cryptosporidiosis is generally self-limiting in healthly 
individuals, it can be fatal for people with compromised immune 
systems. Cryptosporidium is removed to a degree by filtration but is 
highly resistant to conventional drinking water disinfectants, 
including chlorine and chloramines. EPA has recently collected a 
significant amount of data on occurrence of Cryptosporidium in drinking 
water sources through the Information Collection Rule (ICR) and ICR 
Supplemental Surveys. These data indicate that a subset of drinking 
water systems have an unacceptably high risk for Cryptosporidium in 
their treated water. The LT2ESWTR is intended to identify systems at 
high risk for Cryptosporidium through monitoring and prescribe an 
appropriate level of additional treatment. In addition, the LT2ESWTR 
will be promulgated simultaneously with the Stage 2 Disinfectants and 
Disinfection Byproducts Rule (DBPR). This will help to ensure that 
drinking water utilities do not compromise adequate microbial 
protection while they take steps to control DBPs.


Summary of Legal Basis:


Section 1412(b)(7)(A) of SDWA allows the Administrator to promulgate a 
national primary drinking water regulation that requires the use of a 
treatment technique in establishing a maximum contaminant level if the 
Administrator makes a finding that it is not feasible to ascertain the 
level of the contaminant. The MCLG for Cryptosporidium is zero and it 
is not feasible for public water systems to measure Cryptosporidium 
concentrations in treated water. Consequently, under section 
1412(b)(1)(A), the Administrator may establish a treatment technique 
for Cryptosporidium if this presents a meaningful opportunity for 
health risk reduction. Although the 1996 Amendments do not require EPA 
to finalize a Long Term 2 Enhanced Surface Water Treatment Rule along 
with the Stage 2 Disinfectants and Disinfection Byproducts Rule, 
Congress did emphasize the importance of ensuring proper balance 
between microbial and DBP risks and, therefore, EPA believes it is 
important to finalize these rules together.


Alternatives:


EPA is considering various rule scenarios to reduce risk from 
Cryptosporidium. These scenarios include treatment requirements that 
would apply to all systems, such as requiring all conventional plants 
to achieve 2-log inactivation of Cryptosporidium. Alternative scenarios 
have involved assigning systems to bins based on mean Crypto source 
water concentrations. Additional treatment requirements would then 
depend on the bin to which a system was assigned. Issues associated 
with the binning approach include: amount of monitoring necessary to 
assign systems to bins, appropriate Crypto concentrations to demarcate 
bin boundaries, and appropriate level of additional treatment for a 
given bin. EPA is exploring analyses that evaluate the impact of these 
issues on costs and benefits. EPA has also considered options to reduce 
the impact on small systems.


Anticipated Cost and Benefits:


EPA estimates that the LT2ESWTR will have an annual economic impact of 
$100 million or more. The majority of people (approximately 67 percent) 
are served by public water systems that use a surface water or ground 
water under

[[Page 74229]]

the direct influence of surface water. Thus, a large number of people 
will benefit from the LT2ESWTR. In addition, EPA has recently 
identified UV light as a technology that can achieve high levels of 
Cryptosporidium inactivation at relatively low cost.


Risks:


Approximately 67 percent of consumers are served by drinking water 
systems that use surface water sources or ground water under the direct 
influence of surface water. Survey data indicate that Cryptosporidium 
is prevalent in drinking water sources and current levels of treatment 
may not be adequate to control highly resistant pathogens like 
Cryptosporidium. Cryptosporidiosis is a potentially fatal disease in 
people with weak immune systems, such as infants, the elderly, people 
with AIDS, and people taking immune suppressing drugs like cancer and 
transplant patients. By requiring additional treatment for those 
systems with the highest concentrations of Cryptosporidium in their 
source waters, EPA expects to significantly reduce current risk.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           06/00/03
Final Action                                                   07/00/04
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses, Governmental Jurisdictions, Organizations


Government Levels Affected:


Federal, State, Local, Tribal


Federalism:


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


Additional Information:


SAN No. 4341


Sectors Affected:


22131 Water Supply and Irrigation Systems


Agency Contact:
Dan Schmelling
Environmental Protection Agency
Water
4607
Washington, DC 20460
Phone: 202 564-5281
Fax: 202 564-3767
Email: [email protected]

Thomas Grubbs
Environmental Protection Agency
Water
4607
Washington, DC 20460
Phone: 202 564-5262
Fax: 202 564-3758
Email: [email protected]
RIN: 2040-AD37
_______________________________________________________________________



EPA



135. NATIONAL PRIMARY DRINKING WATER REGULATIONS: STAGE 2 DISINFECTION 
BYPRODUCTS RULE
Priority:


Economically Significant. Major under 5 USC 801.


Unfunded Mandates:


This action may affect State, local or tribal goverments and the 
private sector.


Legal Authority:


40 USC 300g-1(b); SDWA 1412(b); 42 USC 300f; 42 USC 300g-2; 42 USC 
300g-3; 42 USC 300g-4; 42 USC 300g-5; 42 USC 300g-6; 42 USC 300j-4; 42 
USC 300j-9; 42 USC 300j-11


CFR Citation:


40 CFR 141 to 142; 40 CFR 9


Legal Deadline:


Final, Statutory, July 14, 2003.


Abstract:


This Regulation, along with a Long Term 2 Enhanced Surface Water 
Treatment Rule (LT2ESWTR) that will be promulgated simultaneously, is 
intended to expand existing public health protections and address 
concerns about risk trade-offs between pathogens and disinfection 
byproducts. This rule could affect all public water systems that add a 
disinfectant to the drinking water during any part of the treatment 
process although the impacts may be limited to community water systems 
(CWSs) and nontransient noncommunity water systems (NTNCWSs). 
Promulgating the LT2ESWTR and the Stage 2 DBPR as a paired rulemaking 
is necessary to ensure that adequate protection from microbial risk is 
maintained while EPA manages risk from disinfection byproducts. In 
developing the Stage 2 DBPR, EPA will analyze a significant body of new 
survey data on source water quality parameters, treatment data and 
disinfection byproduct occurrence. This survey data, which was 
collected under the Information Collection Rule (ICR), Supplemental 
Surveys to the ICR, and additional research projects, will provide a 
substantially more comprehensive and complete picture of the occurrence 
of DBPs and microbiological pathogens than was available previously. 
EPA will also use new information on the health effects of exposure to 
DBPs to determine effective regulatory requirements for controlling 
risk. On March 30, 1999, EPA reconvened a committee of stakeholders 
under the Federal Advisory Committee Act (FACA) to assist in the 
development of these rules and an Agreement in Principle was signed in 
September 2000 outlining the proposed rule options.


Statement of Need:


The purpose of the Stage 2 Disinfectants/Disinfection Byproducts Rule 
(DBPR) is to reduce potential health risks posed by disinfection 
byproducts (DBPs). Certain DBPs have been shown in laboratory tests to 
be carcinogens or to cause adverse reproductive and developmental 
health effects. In addition, epidemiology studies have indicated that 
exposure to chlorinated water may increase the risk of bladder cancer, 
miscarriage, and certain developmental defects. The Stage 2 DBPR is 
designed to reduce peak events in DBP exposure in order to mitigate 
these potential health risks.


Summary of Legal Basis:


Section 1412(b)(2)(C) of SDWA, as amended in 1996, requires EPA to 
promulgate a Stage 2 Disinfectants/Disinfection Byproducts Rule no 
later than July 14, 2003. Although the 1996 Amendments do not require 
EPA to finalize a Long Term 2 Enhanced Surface Water Treatment Rule 
along with the Stage 2 Disinfectants and Disinfection Byproducts Rule, 
Congress did emphasize the importance of ensuring proper balance 
between microbial and DBP risks and, therefore, EPA believes it is 
important to finalize these rules together.

[[Page 74230]]

Alternatives:


EPA is considering various rule scenarios to achieve reductions in 
disinfection byproduct exposure. These alternatives include: decreasing 
the standard set in the Stage 1 DBPR (0.080 mg/L total trihalomethanes 
(TTHM) and 0.060 mg/L the sum of 5 haloacetic acids (HAA5)) by half and 
maintaining a running annual average compliance calculation; 
maintaining 80/60 TTHM/HAA5 standards but revising the compliance 
calculation to a stricter locational running annual average; setting 
the 80/60 TTHM/HAA5 standard as a never-to-be exceeded maximum; and 
revising the standard for bromate which is currently 0.010 mg/L. EPA 
has also considered options to reduce the impact on small systems.


Anticipated Cost and Benefits:


EPA estimates that the Stage 2 DBPR will have an annual economic impact 
of $100 million or more. Over 200 million people are served by public 
water systems that apply a disinfectant (e.g., chlorine) to water in 
order to provide protection against microbial contaminants and 
potentially exposed to DBPs. Thus, a large number of people will 
benefit from the Stage 2 DBPR.


Risks:


Over 200 million people are served by public water systems that apply a 
disinfectant (e.g., chlorine) to water in order to provide protection 
against microbial contaminants. Due to the large number of people 
exposed to DBPs, there is a substantial concern for any risks 
associated with DBPs that may impact public health. EPA estimates that 
the Stage 2 DBPR will decrease exposure to DBPs on average but more 
importantly, the rule will significantly reduce exposure to peak 
occurrences of DBPs.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           06/00/03
Final Action                                                   07/00/04
Regulatory Flexibility Analysis Required:


Undetermined


Small Entities Affected:


Businesses, Governmental Jurisdictions, Organizations


Government Levels Affected:


Federal, State, Local, Tribal


Federalism:


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


Additional Information:


SAN No. 4342


Sectors Affected:


22131 Water Supply and Irrigation Systems


Agency Contact:
Mary Manibusan
Environmental Protection Agency
Water
4607
Washington, DC 20460
Phone: 202 564-5265
Fax: 202 564-3758
Email: [email protected]

Thomas Grubbs
Environmental Protection Agency
Water
4607
Washington, DC 20460
Phone: 202 564-5262
Fax: 202 564-3758
Email: [email protected]
RIN: 2040-AD38
_______________________________________________________________________



EPA



136. MINIMIZING ADVERSE ENVIRONMENTAL IMPACT FROM COOLING WATER INTAKE 
STRUCTURES AT EXISTING FACILITIES UNDER SECTION 316(B) OF THE CLEAN 
WATER ACT, PHASE 3
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; 40 CFR 122; 40 CFR 123; 40 CFR 124; 40 CFR 125


Legal Deadline:


NPRM, Judicial, June 15, 2003.


Final, Judicial, December 15, 2004.


Abstract:


This rulemaking affects, at a minimum, existing facilities that use 
cooling water intake structures, and whose intake flow levels exceed a 
minimum threshold EPA will determine during this rulemaking. The 
affected facilities include: (1) electricity generating facilities not 
covered by Phase 2 regulations; (2) pulp and paper manufacturing 
facilities; (3) chemicals and allied products manufacturing facilities; 
(4) petroleum and coal products manufacturing facilities; and (5) 
primary metals manufacturing facilities. 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 this 
action is to minimize the impingement and entrainment of fish and other 
aquatic organisms by cooling water intake structures. Impingement 
refers to trapping fish and other aquatic life against cooling water 
intake structures. Entrainment occurs when aquatic organisms, eggs and 
larvae are drawn into the cooling system, through the heat exchanger, 
and then pumped back out with significant injury or mortality to the 
entrained organisms.


Statement of Need:


In the absence of national regulations, Permit Directors have regulated 
cooling water intake structures incompletely and inconsistently, 
especially with respect to the manufacturing sector. In some instances, 
permit issuance or reissuance has been significantly delayed or permit 
decisions from 20 years ago have not been reevaluated. Tons of fish and 
other aquatic organisms may be cropped annually as a result of cooling 
water intake structures at a single large intake or cumulative impact 
at multiple small intakes on the same waterbody. 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 Riverkeeper 
Inc. et al. v. Whitman, 93 Civ. 0314 (AGS)(U.S. District Court, 
Southern District of New York, November 21, 2000).


Alternatives:


This analysis will cover various sizes and types of potentially 
regulated facilities. EPA is considering whether to regulate on a site-
specific, waterbody category, or national basis. EPA is also

[[Page 74231]]

considering several flow thresholds, below which the regulation would 
not apply.


Anticipated Cost and Benefits:


Costs are not yet determined, but are expected to exceed $100 million. 
A qualitative assessment of benefits at several large and small 
facilities indicates the potential for significant benefits when 
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                                                           06/00/03
Final Action                                                   12/00/04
Regulatory Flexibility Analysis Required:


Undetermined


Small Entities Affected:


Businesses, Governmental Jurisdictions


Government Levels Affected:


Federal, State, Local, Tribal


Additional Information:


SAN No. 4543


Sectors Affected:


21 Mining; 211111 Crude Petroleum and Natural Gas Extraction; 211112 
Natural Gas Liquid Extraction; 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
4303T
Washington, DC 20460
Phone: 202 566-1063
Fax: 202 566-1053
Email: [email protected]

Debbi Hart
Environmental Protection Agency
Water
4303T
Washington, DC 20460
Phone: 202 566-6379
Fax: 202 566-1053
Email: [email protected]
RIN: 2040-AD70
_______________________________________________________________________



EPA



137. WATERSHED RULE: TOTAL MAXIMUM DAILY LOAD (TMDL) PROGRAM REVISIONS
Priority:


Other Significant


Legal Authority:


33 USC 1313; 33 USC 1329; 33 USC 1342


CFR Citation:


40 CFR 9; 40 CFR 122; 40 CFR 123; 40 CFR 124; 40 CFR 130; 40 CFR 131


Legal Deadline:


None


Abstract:


Amend regulations governing the TMDL program to ensure that it is 
effective and allows for active participation by all stakeholders 
including local governments and communities. The amendments will 
address: the scope and content of the list of impaired waters required 
by section 303(d) of the Clean Water Act, the scope and content of 
TMDLs, EPA's role in helping States establish 303(d) lists and TMDLs so 
that impaired waters are restored, and the framework for implementing 
TMDLs provided by State CPPs and watershed plans. EPA is also proposing 
revision to the NPDES permitting regulations.


Statement of Need:


This action will propose a new framework for accomplishing the water 
quality planning and management provisions of the Clean Water Act 
(CWA). EPA believes that this framework based on the watershed approach 
will allow jurisdictions ( i.e., State, territories and authorized 
tribes) to use the Total Maximum Daily Load (TMDL) program to more 
effectively contribute to improving the Nation's water quality. The 
proposal recognizes that the major responsibility for water quality 
management resides with these jurisdictions. The goal of the proposal 
is to provide jurisdictions with a tailored yet flexible approach to 
water quality management that meets the unique needs and situation of 
each jurisdiction and of local communities while at the same time 
ensuring that progress is made towards restoring the Nation's waters so 
that they attain and maintain water quality standards. The proposal 
revitalizes and strengthens the Continuing Planning Process (CPP) as a 
focus for a variety of jurisdictions' water quality planning and 
implementation activities. The proposal seeks to increase TMDL program 
flexibility and enhance stakeholder participation, promote 
opportunities for trading, and increase efficiencies in establishing, 
approving and implementing TMDLs. EPA is also proposing revisions to 
the NPDES permit regulations.


Summary of Legal Basis:


These revisions to EPA's TMDL rules are authorized by, among others, 
sections 303(d) and (e) of the CWA that: (1) require States to identify 
impaired waters within their boundaries and establish TMDLs for those 
waters at levels necessary to implement water quality standards, and 
(2) require States to have a continuing planning process resulting in a 
plan for all navigable waters that EPA reviews from time to time.


Anticipated Cost and Benefits:


Estimates under development.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           12/00/02
Final Action                                                   06/00/04
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


Federal, State, Tribal


Additional Information:


SAN No. 4623

[[Page 74232]]

Agency Contact:
Christine Ruf
Environmental Protection Agency
Water
4503T
Washington, DC 20460
Phone: 202 566-1220
Fax: 202 566-1333
Email: [email protected]

Francois Brasier
Environmental Protection Agency
Water
4503T
Washington, DC 20460
Phone: 202 566-1214
Fax: 202 566-1333
Email: [email protected]
RIN: 2040-AD82
_______________________________________________________________________



EPA



138. [bull] WITHDRAWAL OF TOTAL MAXIMUM DAILY LOAD (TMDL) PROGRAM 
REVISIONS
Priority:


Other Significant


Legal Authority:


33 USC 1313


CFR Citation:


40 CFR 9; 40 CFR 122; 40 CFR 123; 40 CFR 124; 40 CFR 130


Legal Deadline:


None


Abstract:


EPA is proposing to withdraw the July 2000 rule, rather than allow it 
to go into effect. EPA believes that significant changes would need to 
be made to the July 2000 rule before it could serve as the blueprint 
for an efficient and effective TMDL program. Furthermore, EPA needs 
additional time beyond April 2003 to promulgate new revisions to the 
TMDL program that will enable EPA and jurisdictions to best achieve the 
goals of the Clean Water Act. Regulations that EPA promulgated in 1985 
and amended in 1992 would remain the regulations in effect for 
implementing the TMDL Program until EPA finalizes any future TMDL 
rules.


Statement of Need:


Due to the significant controversy, pending litigation and lack of 
stakeholder consensus on key aspects of the July 2000 rule, it has 
become apparent to EPA that, as promulgated, the July 2000 rule cannot 
function as the blueprint for an efficient and effective TMDL program 
without significant revisions. Moreover, the existence of the 
approaching April 30, 2003, effective date for the July 2000 rule - a 
mere eight months away - is beginning to act as an unnecessary and 
artificial distraction from an orderly completion of the Agency's 
efforts now underway to chart the future direction and scope of the 
TMDL program. Consequently, EPA is proposing to withdraw the July 2000 
TMDL rule so that the Agency can proceed in an orderly process to 
revise the TMDL rules without concern that those efforts will be 
adversely affected by the July 2000 rule's effective date.


Summary of Legal Basis:


These revisions to EPA's TMDL rules are authorized by, among others, 
sections 303(d) and (e) of the CWA that: (1) require States to identify 
impaired waters within their boundaries and establish TMDLs for those 
waters at levels necessary to implement water quality standards, and 
(2) require States to have a continuing planning process resulting in a 
plan for all navigable waters that EPA reviews from time to time. If 
the July 2000 TMDL regulations are not withdrawn, they will become 
effective on April 30, 2003.


Alternatives:


Whether the July 2000 rule should be withdrawn or not.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           12/00/02
Final Action                                                   03/00/03
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


Federal, State, Tribal


Additional Information:


SAN No. 4729


Agency Contact:
Christine Ruf
Environmental Protection Agency
Water
4503T
Washington, DC 20460
Phone: 202 566-1220
Fax: 202 566-1333
Email: [email protected]

Francois Brasier
Environmental Protection Agency
Water
4503T
Washington, DC 20460
Phone: 202 566-1214
Fax: 202 566-1333
Email: [email protected]
RIN: 2040-AD84
_______________________________________________________________________



EPA

                              -----------

                            FINAL RULE STAGE

                              -----------




139. OVERVIEW OF RULEMAKINGS FOR THE PURPOSE OF REDUCING INTERSTATE 
OZONE TRANSPORT
Priority:


Economically Significant. Major under 5 USC 801.


Legal Authority:


42 USC 7410


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 two-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

[[Page 74233]]

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. This rule was 
challenged in court, and on March 3, 2000, the U.S. Court of Appeals 
for the District of Columbia 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 Court 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 the 
remanded issues in separate rulemakings (see SAN 4433 and SAN 4679 in 
today's Regulatory Agenda). A notice of data availability was published 
on 8/3/01 which made new data publicly available for notice-and-
comment. A second notice of data availability was published in on March 
11, 2002, listing additional items which were made publicly available. 
Final action was published on 5/1/02 (67 FR 21868). 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


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 Section 110 provides the legal basis for addressing 
transport of air pollution.


Alternatives:


The Clean Air Act specifies the SIP Call process, the FIP process, and 
the Section 126 petition process as alternate approaches to remedying 
the problem of ozone transport. EPA intends to use these alternatives 
as appropriate in an integrated program.


Anticipated Cost and Benefits:


As outlined in the Regulatory Impact Analysis for the NOx SIP Call, the 
rule will result in significant improvements in premature mortality, 
chronic asthma, chronic and acute bronchitis, upper and lower 
respiratory symptoms, work days lost, decreased worker productivity, 
visibility in urban and suburban areas, increases in yields of 
commercial forests currently exposed to elevated ozone levels, and 
reductions in loadings of nitrogen to sensitivity estuaries, helping 
State and local government reach target reduction goals for estuaries 
such as Chesapeake Bay, Albermarle-Pamlico Sound and Long Island Sound. 
Due to practical analytical limitations, we cannot quantify and/or 
monetize all potential benefits of this action. Within these 
limitations, the quantified and monetized benefits were estimated in 
the Regulatory Impact Analysis to range from $1.1 billion to $4.2 
billion annually. Annual costs were estimated at $1.7 billion. All 
figures are in 1990 dollars.


Risks:


The risks addressed by this action are the likelihood of experiencing 
increased health and environmental effects associated with 
nonattainment of the National Ambient Air Quality Standard for ozone. 
These effects are briefly described above in the ``costs and benefits'' 
section, and they are outlined in detail in the Regulatory Impact 
Analysis for the NOx SIP Call.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM NOx FIPs (S63 FR 56393                                    10/21/98
Final Action NOx63 FR 57355                                    10/27/98
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 NOx SIP Call/Section 126 r08/03/01
NPRM Phase II NO67 FR 8395 Proposal (SAN 4433)                 02/22/02
NODA Notice of D67 FR 10844ility for NOx SIP Call/Section126 Ru03/11/02
Final Action Dat67 FR 21522tion (Section 126/NOx SIP Call)     04/30/02
Final Action Res67 FR 21868mands Concerning Growth Factors     05/01/02
Final Action Final Phase II NOx SIP Call (SAN 4433)            12/00/02
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
C539-02
Research Triangle Park, NC 27711
Phone: 919 541-5665
Fax: 919 541-0824
Email: [email protected]

Carla Oldham
Environmental Protection Agency
Air and Radiation
C539-02
RTP, NC 27711
Phone: 919 541-3347
Fax: 919 541-0824
Email: [email protected]
RIN: 2060-AJ20
_______________________________________________________________________



EPA



140. CONTROL OF EMISSIONS OF AIR POLLUTION FROM NEW MARINE COMPRESSION-
IGNITION ENGINES AT OR ABOVE 30 LITERS PER CYLINDER
Priority:


Other Significant


Legal Authority:


42 USC 7621 et seq; 42 USC 7542 et seq


CFR Citation:


40 CFR 94

[[Page 74234]]

Legal Deadline:


Final, Judicial, January 31, 2003, Finalize emission standards for new 
compression-ignition marine engines at or above 30 liters per cylinder.


Abstract:


This rule will set exhaust emission standards for new marine 
compression-ignition engines at or above 30 liters per cylinder 
installed on vessels flagged by the United States and will determine 
whether it is appropriate to apply these standards to foreign flag 
vessels that use U.S. ports. The proposed rule set out a primary 
control option of aligning emission standards with standards included 
in a pending international agreement beginning in 2004. The status of 
the international agreement is an issue to consider as we determine 
appropriate final standards. We also asked for comment on a second tier 
of more stringent NOx standards starting in 2007 as well as potential 
controls on sulfur levels in diesel fuel used in these vessels. 
Emissions control from marine vessels is important to various port 
cities as the contribution from marine vessels to their emissions 
inventories is projected to grow as steps are taken to reduce Nox and 
PM emissions from other sources.


Statement of Need:


Ozone and particulate pollution pose a serious threat to the health and 
well-being of millions of Americans. This rulemaking addresses control 
measures to reduce emissions from large diesel-powered marine engines, 
with a focus on engine controls that can reduce NOx emissions. The 
proposal also asked for comments on controlling sulfur levels in diesel 
fuel used in such vessels, which can lead to particulate matter 
reductions.


Summary of Legal Basis:


42 USC 7522-7525, 7541-7545, 7547, 7549, 7550, and 7601(a)


Alternatives:


The proposed rule included extensive cost and emissions reductions 
estimates for one primary option and two different control scenarios 
for NOx emissions - 30 percent, 50 percent, and 80 percent reductions 
from the assumed baseline levels associated with compliance with 
international standards. This rule also includes information regarding 
costs and benefits associated with fuel control options.


Anticipated Cost and Benefits:


There are negligible costs and marginal unanticipated benefits 
associated with compliance with the baseline control scenario included 
in the proposal as engine manufacturers are already meeting the 
specified emission levels through application of a pending 
international agreement. The costs and benefits of the primary option 
for a second tier of standards are estimated to be less than $200/ton 
for NOx control. Cost and benefit information is also provided for the 
alternative options as well.


Risks:


The risks addressed by this program are primarliy those associated with 
nonattainment of the National Ambient Air Quality Standards for ozone 
and particulate matter. There are also serious public health and 
welfare benefits from controlling emissions from these sources, such as 
reductions in regional haze and acid deposition.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            67 FR 37548                                    05/29/02
Final Action                                                   01/00/03
Regulatory Flexibility Analysis Required:


No


Government Levels Affected:


Federal


Additional Information:


SAN No. 4622


Sectors Affected:


333618 Other Engine Equipment Manufacturing; 3366 Ship and Boat 
Building


Agency Contact:
Jean Marie Revelt
Environmental Protection Agency
Air and Radiation
ASD
Washington, DC 20460
Phone: 734 214-4822
Fax: 734 214-4816
Email: [email protected]

Pat Scoville
Environmental Protection Agency
Air and Radiation
6401A
Phone: 202 564-1101
Fax: 202 564-1342
Email: [email protected]
RIN: 2060-AJ98
_______________________________________________________________________



EPA



141. MANAGEMENT OF CEMENT KILN DUST (CKD)
Priority:


Other Significant


Legal Authority:


42 USC 6912(a) RCRA sec 2002(a); 42 USC 6921(a) RCRA sec 3001(a)


CFR Citation:


40 CFR 256; 40 CFR 259; 40 CFR 261; 40 CFR 264


Legal Deadline:


None


Abstract:


In December 1993, EPA submitted a Report to Congress with its findings 
on the nature and management practices associated with cement kiln dust 
(CKD). In 1995, EPA determined that some additional control of CKD was 
needed and published a regulatory determination (60 FR 7366, 2/7/95). 
On August 20, 1999, EPA issued a proposed rule (64 FR 45632) outlining 
the Agency's preferred regulatory approach (i.e., an exemption from 
hazardous waste listing for properly managed CKD) and several optional 
approaches including requirements solely under RCRA Subtitle D. On July 
25, 2002, the Agency published a Notice of Data Availability to 
announce the availability for public inspection and comment of recently 
acquired data on CKD. The Agency is considering an approach whereby it 
would finalize protective CKD management standards.


Statement of Need:


EPA issued a regulatory determination finding that additional control 
of CKD was warranted. The Agency stated that its concerns about the 
potential harm to human health and the environment posed by some CKD 
suggest the need for some level of regulation under RCRA Subtitle C 
authority. The Agency is now considering an approach whereby it would 
finalize protective CKD management standards. Active consideration of 
the proposed mismanagement-based listing would be temporarily suspended 
for a period of three to five years. During this time EPA would collect 
data to evaluate the effectiveness of CKD management practices and 
States' regulatory programs. If after its evaluation the Agency deems 
CKD management practices and States' regulatory programs to be 
effective in protecting human health and the environment, the Agency 
would formally withdraw the

[[Page 74235]]

Subtitle C portion of the 1999 proposal and would revisit the 1995 CKD 
regulatory determination. Otherwise, if the Agency deems CKD management 
practices and State regulatory programs to be ineffective after this 
period, the Agency would pursue regulation of mismanaged CKD under RCRA 
Subtitle C.


Summary of Legal Basis:


There are no applicable statutory or judicial deadlines for the CKD 
rulemaking effort. However, section 3001(b)(3)(C) of RCRA contemplates 
a rule in light of the Administrator's 1995 determination that further 
regulation of CKD was warranted.


Alternatives:


In the 1995 Regulatory Determination, the Agency stated its concerns 
about the potential harm to human health and the environment posed by 
some CKD suggest the need for some level of regulation under RCRA 
subtitle authority. Although the Agency is considering issuing the 
protective CKD management standards as a RCRA subtitle D rule, if after 
a three- to five-year evaluation period the Agency deems CKD management 
practices and State regulatory programs to be ineffective, the Agency 
would pursue regulation of mismanagement CKD under RCRA subtitle C.


Anticipated Cost and Benefits:


The Agency estimated the proposed rule would affect the economy by less 
than $100 million per year. EPA also estimated that the proposed rule 
may result in a reduced risk of 0.0004 to 0.003 cancer cases per year 
(best estimate - 0.0006) and 29 to 315 fewer persons (best estimate - 
43) exposed to potential noncancer health effects due to food chain 
exposures (i.e., vegetables, beef, and/or milk) to ``backyard'' 
gardeners and subsistence farmers. In addition, the population analysis 
indicated that between 669 and 5,895 recreational fishers (best 
estimate - 999) would avoid exposure to contaminant levels that may 
result in noncancer health effects. The population analysis indicated 
that 18 to 4,118 individuals (best estimate - 2,378) would avoid 
exposure to particulate matter in excess of the National Ambient Air 
Quality Standards (NAAQS). The rule should also help prevent 
contaminated CKD leachate from impacting groundwater resources.


Risks:


For the 1993 Report to Congress and 1995 Regulatory Determination, the 
Agency modeled individual risks from direct and indirect pathways for 
83 plants. The Agency concluded that the risks from direct pathways 
(i.e., drinking water ingestion, incidental ingestion, and chemical 
inhalation) were low or negligible. The Agency caveated these 
conclusions by noting that (1) about half of the plants are underlain 
by limestone formations in areas of karst landscape and may be 
susceptible to fissures and hydraulic characteristics that allow 
leachate to directly enter groundwater without dilution or attenuation 
and cannot be modeled with current techniques; (2) empirical evidence 
indicated groundwater contamination in areas of both karst and non-
karst terrain; and (3) modeling results for fine particulate emissions 
for 28 cement plants out of 52 modeled may have exceedances of NAAQS at 
plant boundaries and may result in risks from fine particulate 
inhalation at nearby residences.


For the indirect pathways, the Agency concluded that releases from 
about 12 percent of the 83 plants studied may result in cancer risks 
greater than 1x10-5 for highly exposed individuals (i.e., subsistence 
fishers and subsistence farmers). Similarly, the Agency concluded that 
releases from about 12 percent of the 83 plants may result in noncancer 
hazard ratios greater than 1.0 for highly exposed individuals.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
Notice Regulator60 FR 7366ation                                02/07/95
NPRM            64 FR 45632                                    08/20/99
Notice of Data A67 FR 48648                                    07/25/02
Final Action                                                   06/00/03
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


Businesses


Government Levels Affected:


Federal, State


Additional Information:


SAN No. 3856


Sectors Affected:


32731 Cement Manufacturing


Agency Contact:
Anthony Carrell
Environmental Protection Agency
Solid Waste and Emergency Response
5306W
Washington, DC 20460
Phone: 703 308-0458
Fax: 703 308-8686
Email: [email protected]

Steve Souders
Environmental Protection Agency
Solid Waste and Emergency Response
5306W
Washington, DC 20460
Phone: 703 308-8431
Fax: 703 308-8686
Email: [email protected]
RIN: 2050-AE34
_______________________________________________________________________



EPA



142. STANDARDIZED PERMIT FOR RCRA HAZARDOUS WASTE MANAGEMENT FACILITIES
Priority:


Other Significant


Legal Authority:


42 USC 6905; 42 USC 6912; 42 USC 6924; 42 USC 6925; 42 USC 6927; 42 USC 
6974


CFR Citation:


40 CFR 124; 40 CFR 267; 40 CFR 270


Legal Deadline:


None


Abstract:


EPA has proposed creating a new type of general permit, called a 
standardized permit, for facilities that generate waste and routinely 
manage the waste on-site in tanks, containers, and containment 
buildings. Under the standardized permit, facility owners and operators 
would certify compliance with generic design and operating conditions 
set on a national basis. The permitting agency would review the 
certifications submitted by the facility owners and operators. The 
permitting agency would also be able to impose additional site-specific 
terms and conditions for corrective action or other purposes, as called 
for by RCRA. Ensuring compliance with the standardized permit's terms 
and conditions would occur during inspection of the facility after the 
permit has been issued. The standardized permit should streamline the 
permit process by allowing facilities to obtain and modify permits more 
easily while maintaining the protectiveness currently existing in the

[[Page 74236]]

individual RCRA permit process. The proposal raised issues for public 
comment on how all facilities receiving RCRA permits can satisfy RCRA 
corrective action requirements under appropriate alternative state 
cleanup programs and on financial assurance issues. The Agency is 
developing a final rule addressing this topic.


Statement of Need:


The Agency convened a special task force in 1994 to look at permitting 
activities throughout its different programs and to make specific 
recommendations to improve these permitting programs. This task force, 
known as the Permits Improvement Team (PIT), spent two years working 
with stakeholders from the Agency, State permitting agencies, industry, 
and the environmental community. The PIT stakeholders mentioned, among 
other things, that permitting activities should be commensurate with 
the complexity of the activity. The stakeholders felt that current 
Agency permitting programs were not flexible enough to allow 
streamlined procedures for routine permitting activities. Currently, 
facilities that store, treat, or dispose of hazardous waste must obtain 
site-specific ``individual'' permits prescribing conditions for each 
``unit'' (e.g., tank, container area, etc.) in which hazardous waste is 
managed. Experience gained by the Agency and States over the past 165 
years has shown that not all the waste management activities are at the 
same level of complexity. Some activities, such as thermal treatment or 
land disposal of hazardous wastes, are more complex than storage of 
hazardous waste. The Agency believes that thermal treatment and land 
disposal activities continue to warrant ``individual'' permits, 
prescribing unit-specific conditions. However, the Agency believes that 
some accommodation can be made for hazardous waste management practices 
in standardized units such as tanks, container storage areas, and 
containment buildings. In April 1996, the PIT tentatively recommended, 
among other things, that regulations be developed to allow 
``standardized permits'' for on-site storage and nonthermal treatment 
of hazardous waste in tanks, containers, and containment buildings. On 
October 12, 2001, the Agency proposed revising the RCRA regulations to 
allow for this type of permit, and is preparing to finalize the rule.


Summary of Legal Basis:


Facilities that manage hazardous waste are required under RCRA to 
obtain a permit and carry out corrective action as necessary (see: RCRA 
Section 3004, 3005, 3008, and 3010). EPA has discretion under these 
statutory provisions to apply different permitting procedures to 
different types of facilities. No aspect of this streamlining action is 
required by court order.


Alternatives:


EPA considered several options regarding RCRA permits and corrective 
action alternatives. The Agency proposed to limit the scope of the rule 
to facilities that generate waste and manage it on-site, but asked for 
comment on whether to expand that scope to facilities that manage 
wastes generated off-site. The Agency also asked for comment on the 
option of allowing a facility's RCRA corrective action activities to be 
postponed if corrective action is being carried out under an approved 
state remedial program.


Anticipated Cost and Benefits:


The RCRA standardized permit is an optional rule designed to streamline 
the regulatory burden to EPA/States, as well as to private sector 
facilities covered by the rule, by reducing the amount of information 
collected, submitted, and reviewed for RCRA hazardous waste permit 
actions (i.e., new permit applications, permit modifications, and 
permit renewals). Because the rule proposed to streamline existing RCRA 
regulation, rather than add new RCRA regulation, implementation of the 
rule by the EPA and by States with EPA-authorized permitting programs 
is expected to result in economic benefits in the form of national cost 
savings from reducing both government and private sector resources 
required for the RCRA permit process. The national workload level of 
RCRA permit actions involving on-site hazardous waste storage and 
nonthermal treatment units has averaged 92 permit determinations per 
year over the 10-year period 1990-1999. Relative to this average annual 
workload, EPA estimates that the potential average annual cost savings 
to eligible facilities from implementation of this rule will range from 
approximately $100 to $5,800 (i.e., 2 to 140 burden hours) per permit 
action, depending on such things as the type of permit and the type of 
storage equipment. On a national basis, the rule is expected to 
generate a minimum of $0.36 to $0.53 million in average annual 
paperwork cost savings, based on the scope of the proposed rule, which 
was limited to on-site waste management facilities. However, the final 
rule may expand the initial scope of eligible facilities, which could 
easily double or triple the national cost savings benefits (i.e., $1.1 
to $1.6 million per year in cost savings).


Risks:


The purpose of this rule is to streamline existing RCRA permit 
application and issuance procedures to achieve national paperwork 
burden reduction. Because of the facts that facilities covered by this 
rule: (a) are currently already required to obtain RCRA permits, and 
(b) are relatively simple to design, install/construct, operate, and 
clean-close, this rule is expected to have minimal incremental effects 
on existing levels of human health and environmental risk for these 
types of hazardous waste management facilities.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            66 FR 52191                                    10/12/01
Final Action                                                   05/00/03
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


Federal, State


Additional Information:


SAN No. 4028


Sectors Affected:


32411 Petroleum Refineries; 3251 Basic Chemical Manufacturing; 3252 
Resin, Synthetic Rubber, and Artificial and Synthetic Fibers and 
Filaments Manufacturing; 325211 Plastics Material and Resin 
Manufacturing; 32532 Pesticide and Other Agricultural Chemical 
Manufacturing; 32551 Paint and Coating Manufacturing; 332813 
Electroplating, Plating, Polishing, Anodizing and Coloring


Agency Contact:
Jeff Gaines
Environmental Protection Agency
Solid Waste and Emergency Response
5303W
Washington, DC 20460
Phone: 703 308-8655
Fax: 703 308-8609
Email: [email protected]
RIN: 2050-AE44

[[Page 74237]]

_______________________________________________________________________



EPA



143. OFFICE OF SOLID WASTE BURDEN REDUCTION PROJECT
Priority:


Other Significant


Legal Authority:


42 USC 6907; 42 USC 6912(a); 42 USC 6921; 42 USC 6922; 42 USC 6923; 42 
USC 6924; 42 USC 6925; 42 USC 6926; 42 USC 6927; 42 USC 6930; 42 USC 
6934; 42 USC 6935; 42 USC 6937; 42 USC 6938; 42 USC 6939; ...


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 government-wide 
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 comments received on the NODA, EPA 
proposed (67 FR 2518, 1/17/02) to implement many of these ideas. The 
proposal was designed to eliminate duplicative and nonessential 
paperwork.


The main ideas for the final 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 government-
wide 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 doing 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 rule will have minimal impact on the protectiveness of the 
RCRA regulations. It will eliminate or streamline paperwork 
requirements that are unnecessary because they add little to the 
protectiveness of the RCRA regulations.


Risks:


The rule will have no risk impacts.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
Notice of Data A64 FR 32859                                    06/18/99
NPRM            67 FR 2518                                     01/17/02
Final Action                                                   05/00/03
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


Federal, State, Local, Tribal


Additional Information:


SAN No. 4084


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



144. NATIONAL PRIMARY DRINKING WATER REGULATIONS: GROUNDWATER RULE
Priority:


Economically Significant. Major under 5 USC 801.


Unfunded Mandates:


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


Legal Authority:


42 USC 300f; SDWA 1412


CFR Citation:


40 CFR 141 400 to 406; 40 CFR 142 14 to 16 (revision)


Legal Deadline:


Final, Statutory, October 30, 2004, Before Stage 2 Disinfection 
Byproducts Rule.


Abstract:


EPA has proposed a targeted risk-based regulatory strategy for all 
public water systems served by ground water. The proposed requirements 
provide a meaningful opportunity to reduce public health risk 
associated with the consumption of waterborne pathogens from fecal 
contamination for a substantial number of people served by ground water 
sources. The proposed strategy addresses risks through a multiple-
barrier approach that relies on five major components: periodic 
sanitary surveys of ground water systems requiring the evaluation of 
eight elements and the identification of significant deficiencies; 
hydrogeologic assessments to identify wells sensitive to fecal 
contamination; source water monitoring for systems drawing from 
sensitive wells without treatment or with other indications of risk; a 
requirement for correction of significant deficiencies and fecal 
contamination through the following actions: eliminate the source of 
contamination, correct the

[[Page 74238]]

significant deficiency, provide an alternative source water, or provide 
a treatment which achieves at least 99.99 percent (4-log) inactivation 
or removal of viruses, and compliance monitoring to insure disinfection 
treatment is reliably operated where it is used.


Statement of Need:


Public water systems (PWSs) that use ground water as their sole source 
of water, as opposed to surface water PWSs, are not federally regulated 
as to treatment for microorganisms. There is data that indicates that a 
number of ground water PWSs are contaminated with microorganisms of 
fecal origin that can and have caused illness.


Summary of Legal Basis:


Section 1412(b)(8) of the Safe Drinking Water Act requires that EPA 
develop regulations specifying the use of disinfectants for ground 
water systems as necessary and ``...(as part of the regulations) 
promulgate criteria...to determine whether disinfection shall be 
required as a treatment technique for any public water system served by 
ground water.


Alternatives:


EPA considered four regulatory alternatives in the development of the 
GWR proposal; the proposed regulatory alternative (multi-barrier 
option), the sanitary survey option, the sanitary survey and triggered 
monitoring option, and the across-the-board disinfection option. All 
options include the sanitary survey provision. The sanitary survey 
option would require the primacy agency to perform surveys every three 
to five years, depending on the type of system. If any significant 
deficiency is identified, a system is required to correct it. The 
sanitary survey and triggered monitoring option adds a source water 
fecal indicator monitoring requirement triggered by a total coliform 
positive sample in the distribution system. The multi-barrier option, 
which was proposed by EPA, adds a hydrogeologic sensitivity assessment 
to these elements which, if a system is found to be sensitive, results 
in a routine source water fecal indicator monitoring requirement. The 
multi-barrier option and the sanitary survey and triggered monitoring 
options are targeted regulatory approaches designed to identify wells 
that are fecally contaminated or are at a high risk for contamination. 
These across-the-board disinfection option would require all systems to 
install treatment instead of trying to identify only the high risk 
systems; therefore, it has no requirement for sensitivity assessment or 
microbial monitoring.


Anticipated Cost and Benefits:


EPA estimates the cost of the proposed GWR will be $183 million dollars 
per year (using a 3 percent discount rate). More than half of the 
estimated costs are for corrective actions which systems will be 
required to take to fix or prevent fecal contamination. The remainder 
of the costs are due to increased scope and frequency of sanitary 
surveys, hydrogeologic sensitivity assessments and source water 
monitoring. System costs are expected to be $162 million per year for 
implementation of the GWR. States are expected to incur costs of $21 
million per year. Cost estimates do not include land acquisition, 
public notification or the potential cost of illness due to exposure to 
disinfection byproducts. The total estimated value of these benefits is 
$205 million per year, $139 million from avoided illness and $66 
million from avoided deaths. These benefits are monetized based on a 
cost of illness and a value of statistical life. These estimates do not 
include pain and suffering associated with viral and bacterial illness 
avoided outbreak response costs (such as the costs of providing public 
health warnings and boiling drinking water), and possibly the avoided 
costs of averting behavior and reduced uncertainty about drinking water 
quality.


Risks:


EPA estimates that currently over 200,000 illnesses and 18 deaths occur 
each year due to viral and bacterial contamination of public ground 
water systems. Children, the elderly and the immunocompromised are 
particularly sensitive to the waterborne pathogens and account for 
between 20 and 30 percent of the illnesses and deaths. As proposed, the 
GWR is expected to reduce the total number of illness by 115,000 and 
the total number of deaths by 11 each year. The GWR in conjunction with 
the Surface Water Treatment Rule (SWTR), Total Coliform Rule (TCR) the 
Interim Enhanced Surface Water Treatment Rule (IESWTR), the Filter 
Backwash Rule (FBR) and the Long Term Enhanced Surface Water Treatment 
Rules (LT1ESWTR & LT2ESWTR) will provide protections to the consumers 
of public water supply systems from waterborne pathogens.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            65 FR 30194                                    05/10/00
Final Action                                                   08/00/03
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses, Governmental Jurisdictions, Organizations


Government Levels Affected:


Federal, State, Local, Tribal


Federalism:


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


Additional Information:


SAN No. 2340


Statutory deadline for final rule: After August 6, 1999, but before the 
Administrator promulgates a Stage II rulemaking for disinfection 
byproducts (currently scheduled for October 2004).


Sectors Affected:


22131 Water Supply and Irrigation Systems


Agency Contact:
Crystal Rodgers
Environmental Protection Agency
Water
4607M
Washington, DC 20460
Phone: 202 564-5275
Fax: 202 564-3767
Email: [email protected]

Tracy Bone
Environmental Protection Agency
Water
4607M
Washington, DC 20460
Phone: 202 564-5257
Fax: 202 564-3767
Email: [email protected]
RIN: 2040-AA97
_______________________________________________________________________



EPA



145. EFFLUENT GUIDELINES AND STANDARDS FOR THE METAL PRODUCTS AND 
MACHINERY CATEGORY, PHASES 1 AND 2
Priority:


Economically Significant. Major under 5 USC 801.


Unfunded Mandates:


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

[[Page 74239]]

Legal Authority:


33 USC 1311CWA sec 301; 33 USC 1314 CWA sec 304; 33 USC 1316 CWA sec 
306; 33 USC 1317 CWA sec 307; 33 USC 1318 CWA sec 308; 33 USC 1342 CWA 
sec 402; 33 USC 1361 CWA sec 501


CFR Citation:


40 CFR 413; 40 CFR 433; 40 CFR 438; 40 CFR 463; 40 CFR 464; 40 CFR 467; 
40 CFR 471


Legal Deadline:


NPRM, Judicial, October 31, 2000.


Final, Judicial, December 31, 2002.


Abstract:


EPA is developing effluent limitations guidelines for facilities that 
generate wastewater while processing metal parts; metal products; and 
machinery, including manufacture, assembly, rebuilding, repair, and 
maintenance. In 1995 EPA proposed regulations for seven industrial 
groups: aircraft, aerospace, hardware, ordnance, stationary industrial 
equipment, mobile industrial equipment, and electronic equipment. EPA 
has consolidated this rulemaking with a second phase, whose scope would 
include additional industrial groups such as: bus and truck, household 
equipment, instruments, motor vehicles, office machines, precious 
metals and jewelry, railroads, job shops, printed circuit boards, and 
ships and boats. The rule will cover sites not currently covered by 
previous metals effluent limitations guidelines and will update 20 year 
old regulations to reflect changes in process control and pollution 
prevention practices. The deadlines and timetable apply to the 
consolidated Phase 1 and 2 rulemaking.


Statement of Need:


Roughly a quarter of the facilities in this industry are currently 
regulated by national effluent limitations guidelines. Many facilities 
have inadequate wastewater treatment, in terms of best available 
technology. Current effluent limitations guidelines for parts of this 
industry were developed 20 years ago and do not always reflect current 
practices of pollution prevention and wastewater treatment. The MP&M 
rule enhances protection of public health and the environment by 
reducing the discharge of toxic metals and organics into the 
environment.


Summary of Legal Basis:


The Clean Water Act requires EPA to establish effluent limitations 
guidelines and pretreatment 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. Whitman (D.D.C. No. 89-2980) to propose regulations 
for this industry by October 2000.


Alternatives:


The Agency is deliberating on final regulatory options. Estimates of 
costs and benefits are not available at the time EPA prepared this 
entry for the Regulatory Plan.


Anticipated Cost and Benefits:


The Agency is deliberating on final regulatory options. Estimates of 
risk and risk reduction are not available at the time EPA prepared this 
entry for the Regulatory Plan.


Risks:


EPA estimates that compliance with this regulation will reduce the 
annual discharge of conventional pollutants by at least 115 million 
pounds, priority pollutants by 12 million pounds, and non-conventional 
metal and organic pollutants by 43 million pounds. These reductions 
represent significant improvements in water quality. The amounts are 
substantial in terms of point source controls.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM (Phase 1)  60 FR 28210                                    05/30/95
NPRM (Consolidat66 FR 4241 and 2)                              01/03/01
NODA            67 FR 38752                                    06/05/02
Final Action                                                   12/00/02
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses


Government Levels Affected:


Federal, State, Local


Additional Information:


SAN No. 2806


Sectors Affected:


332 Fabricated Metal Product Manufacturing; 333 Machinery 
Manufacturing; 334 Computer and Electronic Product Manufacturing; 335 
Electrical Equipment, Appliance and Component Manufacturing; 336 
Transportation Equipment Manufacturing; 337 Furniture and Related 
Product Manufacturing; 339 Miscellaneous Manufacturing


Agency Contact:
Shari Barash
Environmental Protection Agency
Water
4303T
Washington, DC 20460
Phone: 202 566-0996
Fax: 202 566-1053
Email: [email protected]

Carey Johnston
Environmental Protection Agency
Water
4303T
Washington, DC 20460
Phone: 202 566-1014
Fax: 202 566-1053
Email: [email protected]
RIN: 2040-AB79
_______________________________________________________________________



EPA



146. NATIONAL POLLUTANT DISCHARGE ELIMINATION SYSTEM PERMIT REGULATION 
AND EFFLUENT GUIDELINES AND STANDARDS FOR CONCENTRATED ANIMAL FEEDING 
OPERATIONS (CAFOS)
Priority:


Economically Significant. Major under 5 USC 801.


Unfunded Mandates:


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


Legal Authority:


33 USC 1311 CWA sec 301; 33 USC 1314 CWA sec 304; 33 USC 1316 CWA sec 
306; 33 USC 1317 CWA sec 307; 33 USC 1318 CWA sec 308; 33 USC 1342 CWA 
sec 402; 33 USC 1361 CWA sec 501


CFR Citation:


40 CFR 122.23; 40 CFR 412


Legal Deadline:


NPRM, Judicial, December 15, 2000, Effluent guidelines and standards 
only.


Final, Judicial, December 15, 2002, Effluent guidelines and standards 
only.


Abstract:


Concentrated animal feeding operations (CAFOs) are covered by existing 
effluent guidelines at 40 CFR 412 and by permitting regulations at 40 
CFR 122.23. This action will revise the existing effluent guidelines 
primarily to address swine, poultry, beef, and dairy cattle operations 
and will revise the NPDES regulation for CAFOs. Feedlot operations are 
substantial contributors of nutrients in surface waters that have

[[Page 74240]]

severe anoxia (low levels of dissolved oxygen) and problem algae 
blooms.


Statement of Need:


The existing CAFO regulations were promulgated in the 1970's. Since 
that time, the animal production industry has changed significantly, 
and revisions to those regulations are appropriate. Contamination of 
surface water results from breaches of lagoons, runoff from feedlots, 
direct contact of animals with surface water, and manure applied to 
land in excess of crop nutrient needs. Nutrients, most notably nitrogen 
and phosphorus, are essential for profitable crop and animal 
agriculture. However, nitrogen and phosphorus export in watershed 
runoff can accelerate the eutrophication of surface waters. Rapid 
growth and intensification of animal production in many areas has 
created regional imbalances in nutrient inputs and nutrient output. In 
many of these areas nutrients produced in animal manure exceed crop 
needs and pose risks to the environment.


Summary of Legal Basis:


The Clean Water Act (CWA) authorizes EPA to establish and to revise if 
appropriate effluent limitations guidelines and standards to regulate 
the quality of point source discharges. The Act also authorizes EPA to 
promulgate implementating regulations for NPDES permitting program.EPA 
is also required to revisit these effluent guidelines to satisfy a 
provision in a Consent Decree entered in settlement of Natural 
Resources Defense Council et al v. Whitman, (D.D.C No. 89-2980).


Alternatives:


The CWA requires effluent guidelines to be established on a technology 
basis. EPA generally bases limitations on the performance of specific 
technology levels, such as the best available technology economically 
achievable. For animal feeding operations, EPA is considering a range 
of regulatory alternatives that includes management practices, 
traditional pollution control technologies, and alternative 
technologies/practices that recover the energy value or alter the 
handling /marketability characteristics of animal wastes. EPA is also 
considering whether alternative pollution control requirements should 
be established for smaller animal feeding operations. The NPDES 
regulation for CAFOs defines which facilities are covered by the permit 
regulation, and will specify the permit requirements necessary to 
protect water quality. EPA is considering adding additional animal 
types to its definition, and is considering amending the size facility 
or conditions that define which facilities are CAFOs subject to 
permitting. Requirements that specifically address land application of 
manure are also being considered.


Anticipated Cost and Benefits:


The Agency is deliberating on final regulatory options. Estimates of 
costs and benefits are not available at the time this Regulatory Plan 
was prepared.


Risks:


The regulatory changes under consideration will reduce adverse water 
quality impacts caused by runoff from animal feeding operations, 
thereby reducing risks to aquatic habitat and public health.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            66 FR 2959                                     01/12/01
NODA            66 FR 58556                                    11/21/01
NODA            67 FR 48107                                    07/23/02
Final Action                                                   12/00/02
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses


Government Levels Affected:


Federal, State, Local, Tribal


Additional Information:


SAN No. 4153


Sectors Affected:


11221 Hog and Pig Farming; 11232 Broilers and Other Meat Type Chicken 
Production; 11231 Chicken Egg Production; 112112 Cattle Feedlots; 11212 
Dairy Cattle and Milk Production; 11241 Sheep Farming; 11233 Turkey 
Production; 11292 Horse and Other Equine Production; 11239 Other 
Poultry Production


Agency Contact:
Paul Shriner
Environmental Protection Agency
Water
4303T
Washington, DC 20460
Phone: 202 566-1076
Fax: 202 566-1053
Email: [email protected]

Karen Metchis
Environmental Protection Agency
Water
4203
Washington, DC 20460
Phone: 202 564-0734
Email: [email protected]
RIN: 2040-AD19
_______________________________________________________________________



EPA



147. 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 under 5 USC 801.


Unfunded Mandates:


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


Legal Authority:


33 USC 1311 CWA sec 301; 33 USC 1316 CWA sec 306; 33 USC 1326 CWA sec 
316; 33 USC 1361 CWA sec 501


CFR Citation:


40 CFR 9; 40 CFR 122; 40 CFR 123; 40 CFR 124; 40 CFR 125


Legal Deadline:


NPRM, Judicial, February 28, 2002.


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

[[Page 74241]]

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 Riverkeeper 
Inc. et al. v. Whitman, 93 Civ. 0314 (AGS) (U.S. District Court, 
Southern District of New York, November 21, 2000).


Alternatives:


The analysis will cover various sizes, types of potentially regulated 
facilities, and control technologies. 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 estimated in the proposal to be $182 million annually 
(capital and compliance). The benefits of the proposed rule are 
approximately $700 million. Costs and benefits are generally, as 
expected, 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            67 FR 17122                                    04/09/02
Final Action                                                   08/00/03
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


Businesses, Governmental Jurisdictions


Government Levels Affected:


Federal, State, Local, Tribal


Additional Information:


SAN No. 4474


Sectors Affected:


22111 Electric Power Generation


Agency Contact:
Deborah Nagle
Environmental Protection Agency
Water
4303T
Washington, DC 20460
Phone: 202 566-1063
Fax: 202 566-1053
Email: [email protected]

Debbi Hart
Environmental Protection Agency
Water
4303T
Washington, DC 20460
Phone: 202 566-6379
Fax: 202 566-1053
Email: [email protected]
RIN: 2040-AD62
_______________________________________________________________________



EPA



148. CROSS-MEDIA ELECTRONIC REPORTING (ER) AND RECORDKEEPING RULE
Priority:


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


Legal Authority:


PL 104-13; PL 105-277


CFR Citation:


40 CFR 3 (New); 40 CFR 9 (Revision)


Legal Deadline:


None


Abstract:


As proposed, the Cross-Media Electronic Reporting (ER) and 
Recordkeeping Rule (CROMERRR) was intended to provide a uniform legal 
framework for paperless electronic reporting and recordkeeping, 
including electronic signature/certification, across EPA's 
environmental compliance programs. Based on public comment, however, 
EPA now plans to focus on finalizing the electronic reporting 
components of proposed CROMERRR, and to defer further action on the 
electronic recordkeeping components until a later time. Under current 
plans, the final electronic reporting (ER) rule will address electronic 
reporting by companies regulated under all of EPA's programs: air, 
water, pesticides, toxic substances, wastes, and emergency response. 
The final rule would remove existing regulatory obstacles to electronic 
reporting, and it would set requirements for companies choosing to 
report electronically. In addition, the rule would set the conditions 
for allowing electronic reporting under State, tribal or local 
environmental programs that operate under EPA authorization.


The final ER rule is intended to make electronic reporting as simple, 
efficient, and cost-effective as possible for regulated companies, 
while ensuring that a transition from paper to electronic reporting 
does not compromise EPA's compliance and enforcement programs. 
Consequently, the Agency's strategy is to impose as few specific 
requirements as possible, and to keep those requirements neutral with 
respect to technology, so the rule will pose no obstacles to adopting 
new technologies as they emerge.


To ensure that authorized programs at the State, tribal, and local 
levels meet EPA's electronic reporting goals, the final ER rule would 
specify a set of criteria that these program s must satisfy as they 
initiate electronic reporting. In response to public comments, EPA is 
also planning to include provisions for a streamlined process for EPA 
to review and approve authorized program revisions or modifications to 
allow electronic reporting.


Statement of Need:


EPA is required by the Government Paperwork Elimination Act (GPEA) of 
1998 to make the option of electronic reporting and recordkeeping 
available, where practicable, to its regulated community by 2003. To 
meet this deadline and comply with GPEA, EPA believes that it needs to 
put a new legal framework in place by that time at least for electronic 
reporting. A final ER rule would provide for this legal framework by: 
(1) removing legal obstacles to electronic reporting posed by explicit 
references to paper and paper-based processes in EPA regulations; and 
(2) assuring that electronically submitted documents will have the same 
legal and evidentiary force as their paper counterparts, whether the 
submission is

[[Page 74242]]

directly to EPA or under an EPA-authorized program.


Summary of Legal Basis:


Government Paperwork Elimination Act (GPEA) of 1998. GPEA requires 
Federal agencies to provide, where practicable, the option of 
electronic reporting and recordkeeping to their regulated communities 
by 2003.


Alternatives:


One alternative to an EPA cross-media ER rule that applies to most 
compliance reports under 40 CFR would be individual rulemakings by each 
of the program offices. EPA's past experience with program-by-program 
ER rulemakings has demonstrated that such an approach would not bring 
EPA into compliance with GPEA by the 2003 deadline. EPA also considered 
the use of guidance instead of rulemaking, but rejected this 
alternative based principally on a concern that program enforceability 
depends greatly on the ability to mandate a certain level of 
functionality for systems that will be used to receive electronic 
reports and other electronic documents.


Anticipated Cost and Benefits:


EPA received a number of comments on the assumptions used to generate 
the cost and benefit estimates for the electronic reporting components 
of proposed CROMERRR; based on this feedback, EPA decided to develop a 
new analysis of the costs and benefits for the final ER rule. As a part 
of this effort, EPA has conducted extensive follow-up interviews with 
commenters, reevaluated existing sources of information, and conducted 
new market research on ER technologies. The results have led to 
revisions in certain of the assumptions associated with the CROMERRR 
proposal that bear on the ER rule=s costs and benefits to State and 
local governments, to regulated entities, and to the federal 
government. For example, with respect to State and local governments, 
proposed CROMERRR had assumed that the costs and benefits of electronic 
reporting under authorized programs could be attributed entirely to the 
rule. EPA has since learned that a significant number of electronic 
reporting systems already operate under such programs; correspondingly, 
the ER rule cannot take credit for the costs and benefits of electronic 
reporting in such cases, but only for the costs or benefits that result 
from changes that occur as a result of the rule. With respect to 
regulated entities, EPA had had to adjust a number of assumptions 
associated with electronic signature requirements, including those 
related to the number of registered signature-holders at each facility, 
and the availability of acceptable alternatives to Public Key 
Infrastructure- based electronic signature approaches in many 
instances. EPA is also refining its estimate of the number of 
potentially affected regulated entities. With respect to the federal 
government, EPA has reconsidered the general costs and benefits of 
electronic reporting based on experience operating EPA's Central Data 
Exchange and other EPA systems, and based also on an in-depth analyses 
of business processes and associated costs for several major EPA 
programs implementing electronic reporting.


Based on these and other revisions to our assumptions, EPA has 
developed preliminary new cost/benefit results. They indicate that 
regulated entities will accrue modest net benefits from the ER rule; 
state and local government agencies will break even or experience 
modest benefits; and EPA will experience modest benefits. Concerning 
regulated entities in particular, the costs of the ER rule for those 
that use web forms would be negligible, insofar as EPA intends to 
provide the web forms and signature capabilities needed. For entities 
that use some form of file exchange B in XML, flat file, or other 
format B EPA anticipates that entities would incur additional up-front 
costs, but the savings would be larger over time, given the greater 
opportunities to fully automate the reporting functions. Qualitative 
benefits of electronic reporting were also identified, including: 
enhanced data quality, faster public access to submitted data, better 
tracking of compliance submissions, and opportunities for reengineering 
current paper processes.


Finally, comments on the CROMERRR also indicated the need for 
substantial reworking of the cost and benefit analyses with respect to 
the electronic record-keeping components of the proposal. Given EPA's 
current focus on electronic reporting, EPA will defer additional 
economic analysis in this area until we resume work on electronic 
recordkeeping.


Risks:


The risks are undetermined.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM Resubmittal66 FR 46161                                    08/31/01
Final Action                                                   05/00/03
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


Businesses, Governmental Jurisdictions


Government Levels Affected:


Federal, State, Local, Tribal


Federalism:


 Undetermined


Additional Information:


SAN No. 4270


Agency Contact:
Evi Huffer
Environmental Protection Agency
Office of Environmental Information
2823T
Washington, DC 20460
Phone: 202 566-1697
Fax: 202 401-0182
Email: [email protected]

David Schwarz
Environmental Protection Agency
Office of Environmental Information
2823T
Washington, DC 20460
Phone: 202 566-1704
Fax: 202 401-0182
Email: [email protected]
RIN: 2025-AA07
BILLING CODE 6560-50-S

[[Page 74243]]




EQUAL EMPLOYMENT OPPORTUNITY COMMISSION (EEOC)



Statement of Regulatory and Deregulatory Priorities
 The mission of the Equal Employment Opportunity Commission (EEOC, 
Commission, or Agency) is to ensure equality of opportunity in 
employment by vigorously enforcing six Federal statutes. These statutes 
are: 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; the Age 
Discrimination in Employment Act of 1967 (ADEA), as amended; title I of 
the Americans with Disabilities Act of 1990 (ADA), as amended, and 
sections 501 and 505 of the Rehabilitation Act of 1973, as amended 
(disability); and the Government Employee Rights Act of 1991, which 
extends protections against employment discrimination to certain 
employees who were not previously covered.
 Under the Chair's Five-Point Plan, the EEOC is focusing on emerging 
workplace trends and using proactive prevention, proficient resolution, 
strategic enforcement, alternative dispute resolution, and our own 
model workplace to enhance enforcement efforts. The significant 
regulatory action now under consideration by the EEOC resolves an 
important and timely question under the ADEA and serves the goals of 
proactive prevention and proficient resolution.
 The significant action of a regulatory nature now under consideration 
is amending regulations governing age discrimination in employment to 
exempt from the prohibitions of the ADEA the practice of altering, 
reducing, or eliminating employer-sponsored retiree health benefits 
when retirees become eligible for Medicare or comparable State retiree 
health benefits. This rule will ensure that the application of the ADEA 
does not discourage employers from providing health benefits to their 
retirees.
 (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

                              -----------

                          PROPOSED RULE STAGE

                              -----------




149. COORDINATION OF RETIREE HEALTH BENEFITS WITH MEDICARE AND STATE 
HEALTH BENEFITS
Priority:


Other Significant


Legal Authority:


29 USC 628


CFR Citation:


29 CFR 1625


Legal Deadline:


None


Abstract:


The Commission proposes to exempt from the prohibitions of the Age 
Discrimination in Employment Act of 1967, 29 USC 621 et seq. (ADEA or 
Act), the practice of altering, reducing, or eliminating employer-
sponsored retiree health benefits when retirees become eligible for 
Medicare or comparable State retiree health benefits.


Statement of Need:


In August 2001, the Commission announced that it would consider the 
relationship between the ADEA and employer-sponsored retiree health 
benefit plans that alter, reduce, or eliminate benefits upon 
eligibility for Medicare or a comparable State-sponsored retiree health 
benefits program. There has been a decline in the number of employers 
providing retiree health benefits over the last 10 years. Various 
factors have contributed to this erosion, including the increased cost 
of health care coverage, an increased demand for such coverage as large 
numbers of workers near retirement age, and changes in the way 
accounting rules treat the long-term costs of providing retiree health 
benefits. Another factor has been employer concern about the potential 
application of the ADEA to employer-sponsored retiree health benefits. 
The Commission is proposing a narrowly drawn ADEA exemption that 
permits the practice of coordinating employer-provided retiree health 
coverage with eligibility for Medicare or a State-sponsored retiree 
health benefits program, so that the ADEA does not discourage employers 
from providing, or continuing to provide, health benefits to their 
retirees.


Summary of Legal Basis:


Pursuant to section 9 of the ADEA, the Commission is authorized to 
establish reasonable exemptions to and from any or all provisions of 
the Act as it may find necessary and proper in the public interest.


Alternatives:


The Commission considered various alternatives in developing this 
proposal. The Commission will consider all alternatives offered by the 
public commenters.


Anticipated Cost and Benefits:


The Commission recognizes that while employers are under no legal 
obligation to offer retiree health benefits, some employers choose to 
do so in order to maintain a competitive advantage in the marketplace, 
using these and other benefits to attract and retain the best talent 
available to work for their organizations. The proposed rule will 
ensure that the application of the ADEA does not discourage employers 
from providing, or continuing to provide, health benefits to their 
retirees who otherwise would have to obtain such coverage in the 
private individual marketplace at significant personal expense. The 
Commission believes that it is in the best interest of both employers 
and employees for the Commission to pursue a policy that permits 
employers to offer these benefits to the greatest extent possible. It 
is not anticipated that the proposal will result in increased costs.


Risks:


The proposed regulatory action will reduce the risks of liability for 
noncompliance with the statute by exempting certain employer practices 
from regulation. This proposal does not address risks to public safety 
or the environment.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           01/00/03
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


Federal, State, Local

[[Page 74244]]

Agency Contact:
Lynn Clements
Special Assistant to the 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
Email: [email protected]
RIN: 3046-AA72
BILLING CODE 6570-01-S

[[Page 74245]]




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, 
electronic commerce, management of advisory committees, and utilization 
and disposal of real and personal property.
 GSA's fiscal year 2003 regulatory priorities are to complete 
conversion of the Federal Property Management Regulations to the 
Federal Management Regulation (FMR) and to complete the rewrite of the 
Federal Travel Regulation (FTR).
 GSA is writing the FMR and FTR so that its regulations are consistent 
and sensible, and limit the regulatory burden placed on Government 
officials and the public. GSA has adopted 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.
 As necessary, GSA will prepare its regulations so that they address 
national health and security concerns, particularly those created as a 
result of the events of September 11, 2001.
BILLING CODE 6840-34-S

[[Page 74246]]




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) 2003.
 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 2003, except to conform to FAR changes that are currently being 
promulgated in part 27, Patents, Data, and Copyrights, and part 47, 
Transportation.
 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, NFS regulations addressing Acquisition of 
Investigations, part 1872, will be amended to incorporate NASA's risk-
centered approach to acquisition including safety and security, and to 
update guidance. Current policy and procedures for NASA's midrange 
acquisitions, part 1871, are being reviewed for incorporation into NFS 
part 1815. Changes to internal administrative procedures, such as 
internal notification of awards, are being considered in response to 
the Freedom to Manage initiative, as well as use of electronic 
reporting mechanisms.
 Additionally, changes to policy and guidance in the NFS and Grant and 
Cooperative Agreement Handbook (14 CFR 1260 and 14 CFR 1274) are being 
considered with the aim of introducing further competition in support 
of competitive sourcing activities at NASA.
 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, policy and guidance associated with the 
generation and review of Cooperative Agreements Notices (CAN) is being 
considered. Additionally, changes necessary for implementing a common 
format for grant announcements and addressing other internal management 
practices will be made.
 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 74247]]




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 has three regulatory priorities for fiscal year 2003. The first, 
included in the regulatory plan, is to review and revise, where 
necessary, our records management regulations in 36 CFR ch. XII, 
subchapter B. This regulatory activity is part of a major NARA 
initiative to review and redesign our records management program that 
started in 2000.
The second, completing rulemaking actions relating to electronic 
records management and transfer of electronic records to NARA, is part 
of our Electronic Records Management (ERM) Initiative, one of the 
Administration's 24 E-Government Initiatives. This initiative will 
provide guidance on electronic records management applicable 
Governmentwide and will enable agencies to transfer electronic records 
to NARA in a variety of data types and formats so that they may be 
preserved for future use by the Government and citizens.
Our third priority regulatory action is updating and rewriting in plain 
language our research room regulations and restrictions on access 
regulations in 36 CFR parts 1254 and 1256. NARA's mission is to ensure 
ready access to the essential evidence that documents the rights of 
American citizens, the actions of Federal officials, and the national 
experience. NARA research rooms receive more than 270,000 research 
visits per year from individuals using our archival holdings. We also 
respond to nearly 477,000 inquiries about our archival holdings 
annually. The regulations in 36 parts 1254 and 1256 address how we 
serve these researchers.
NARA does not have any planned regulatory actions that relate to the 
events of September 11, 2001 or that are of particular concern to small 
businesses.
_______________________________________________________________________



NARA

                              -----------

                             PRERULE STAGE

                              -----------




150. [bull] FEDERAL RECORDS MANAGEMENT
Priority:


Other Significant


Legal Authority:


44 USC 2104(a); 44 USC ch 21; 44 USC ch 29; 44 USC ch 33


CFR Citation:


36 CFR 1201


Legal Deadline:


None


Abstract:


As part of its initiative to redesign Federal records management, NARA 
is reviewing its records management regulations in 36 CFR ch. XII, 
subchapter B to ensure that the regulations are appropriate, effective, 
and clear. Where needed, we intend to develop updated regulations.


Statement of Need:


NARA's records management program was developed in the 20th century in 
a paper environment. This program has not kept up with a Federal 
Government that creates and uses most of its records electronically. 
Today's Federal records environment requires different management 
strategies and techniques.


The revision of NARA's records disposition policies, processes, and 
tools is identified in our Strategic Plan as a key Strategy to meet the 
primary goal that ``essential evidence will be created, identified, 
appropriately scheduled, and managed for as long as needed.'' Without 
effective records management, records needed to document citizens 
rights, actions for which Federal officials are responsible, and the 
historical experience of our Nation will be at risk of loss, 
deterioration, or destruction.


Summary of Legal Basis:


Under the Federal Records Act, the Archivist of the United States is 
responsible for: 1)providing guidance and assistance to Federal 
agencies to ensure adequate and proper documentation of the policies 
and transactions of the Federal Government and ensuring proper records 
disposition (44 U.S.C. 2904); 2) approving the disposition of Federal 
records (44 U.S.C. ch. 33); and 3) preserving and making available the 
Federal records of continuing value that have been transferred to the 
National Archives of the United States (44 U.S.C. ch. 21).


The Federal Records Act also makes the heads of Federal agencies 
responsible for making and preserving records containing adequate and 
proper documentation of the organization, functions, policies, 
decisions procedures, and essential transactions of the agency and 
designed to furnish the information necessary to protect the legal and 
financial rights of the Government and of persons directly affected by 
the agency's activities (44 U.S.C. 3101). Agency heads must also have 
an active, continuing records management program (44 U.S.C. 3102).


Alternatives:


None.


Anticipated Cost and Benefits:


The revision of NARA's records disposition policies and processes, of 
which this regulation review is a part, is intended to reduce the 
burden on agencies and NARA in the area of records disposition 
activities.


Risks:


None.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
Begin Review                                                   11/00/02
End Review                                                     12/00/03
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


None


URL For More Information:
http://www.archives.gov/records--management/initiatives/rm--redesign--
project.html
URL For Public Comments:
http://www.archives.gov/about--us/opportunities--for--comment/
opportunities--for--comment.html

[[Page 74248]]

Agency Contact:
Nancy Allard
Regulatory Contact
National Archives and Records Administration
Room 4100, NPOL
8601 Adelphi Road
College Park, MD 20740-6001
Phone: 301 837-1850
Fax: 301 837-0319
Email: [email protected]
RIN: 3095-AB16
BILLING CODE 7515-01-S

[[Page 74249]]




OFFICE OF PERSONNEL MANAGEMENT (OPM)



Statement of Regulatory Priorities
 The Office of Personnel Management (OPM) is the Federal Government's 
human resources and personnel manager. In the coming year, the priority 
for OPM's regulatory efforts will continue to be the modernization and 
improvement of human resources management to support the 
Administration's initiatives. In particular, it has been and continues 
to be OPM's primary regulatory objective to institute human resources 
management reforms and flexibilities that will enable the Federal 
Government to recruit, manage, and retain the high-quality, diverse 
workforce that departments and agencies require to carry out their 
respective missions for the American people.
 OPM's focus on reforming human resources management also supports the 
Administration's objectives and priorities expressed in the President's 
Management Agenda, which recognizes the critical role that human 
resources management must play in reforming Government by identifying 
the Strategic Management of Human Capital as the first of its five core 
Governmentwide initiatives. On February 28, 2002, the Director of OPM, 
Kay Coles James, appointed Marta Brito Perez as the agency's Project 
Director for Human Capital Performance to implement this critical 
element of the President's Management Agenda. This project will advance 
the agenda by way of regulation as necessary and appropriate during the 
coming year.
 Other than any regulations that may be required to implement 
legislation creating the Department of Homeland Security, none of the 
regulations are related to the events of September 11, 2001. Similarly, 
none of the regulations addressed in OPM's regulatory plan are of 
particular concern to small businesses, were among the 71 regulations 
nominated as reform candidates in public comments responding to OMB's 
2001 Report to Congress on the Costs and Benefits of Regulations, or 
have been the subject of an OIRA ``prompt letter.''
Department of Homeland Security
 On June 6, 2002, President Bush proposed the creation of a new 
Department of Homeland Security. As proposed, this new Department would 
be formed by consolidating approximately 170,000 Federal employees, who 
are currently employed in numerous agencies and under a multitude of 
employment and pay titles and systems, into one organization. In 
addition, the President's proposal specifically requested flexibility 
in the management of any of the Department's human resources that may 
be directly engaged in critical security functions. Once the 
President's proposed legislation is passed, it is anticipated that the 
massive reorganization will require regulatory action by OPM to 
implement the specific legislation and develop a human resources 
management system. Given the urgent mission of the Department of 
Homeland Security, it is certain that this regulatory activity will be 
a priority for OPM in the coming year. However, until the actual 
legislation creating the Department is passed and signed, no specific 
necessary regulatory action can be identified.
Compensation Reform
 On May 1, 2002, OPM Director, Kay Coles James, initiated a discussion 
of Federal compensation reform by releasing an agency White Paper: A 
Fresh Start for Federal Pay: The Case for Modernization. The purpose of 
the paper was to stimulate debate toward developing concrete proposals 
for improving the current Federal pay system. Proposals discussed may 
require statutory and regulatory action to implement. All stakeholders 
will be consulted before any modifications to the system are initiated. 
Compensation reform is a central element to a modern Federal workforce 
and is necessary for improving the management of human capital, a 
central element of the President's Management Agenda.
Managerial Flexibilities Act
 The President's Managerial Flexibilities Act of 2001 is still pending 
in Congress. When it is passed, OPM will 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 continues to examine new ways to allow the private sector to 
contribute to mission delivery. OPM continues to work on converting 
positions in the Employment Service Technology Support Center to the 
private sector over a five-year period. OPM is also examining 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
 OPM is finalizing a sweeping restructuring plan that will dramatically 
redesign the agency to improve OPM's organization to better deliver 
services to the Federal workforce, our agency customers, and the 
American people. The new structure 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
 A second initiative in the President's Management Agenda is Expanded 
Electronic Government. The Office of Management and Budget has broken 
this item down into 24 e-Government initiatives and OPM has been 
designated as the managing partner on 5 of these initiatives: e-
Recruitment (Recruitment One Stop), e-Clearance, e-Training, e-Payroll, 
and e-Enterprise HR Integration (e-EHRI). 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 resources 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, to effectively protect the 
homeland, and to create a Government that truly serves and produces 
results for our citizens.
BILLING CODE 6325-44-S

[[Page 74250]]




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 
44 million working men and women in about 35,000 private defined 
benefit plans, including about 1,700 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 2001, the PBGC was 
trustee of almost 3,000 plans and paid $1,044 million in benefits to 
about 269,000 people during 2001. Another 355,000 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 9.4 million workers and 
retirees in about 1,700 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 and PBGC in the event of plan 
termination are effectively implemented; (4) to encourage the 
establishment and maintenance of voluntary private pension plans; (5) 
to facilitate the collection of monies owed to plans and to the PBGC, 
while keeping the related costs and burdens as low as possible; and (6) 
to simplify the termination process.
Regulatory Priorities
 The PBGC has focused on changes that would simplify the rules and 
reduce regulatory burden.
Relief for Plans and Sponsors Affected by the September 11, 2001, 
Terrorist Attacks
 In response to the needs of covered plans and sponsors affected by the 
September 11, 2001, terrorist attacks, PBGC provided the following 
relief for plans in designated federal disaster areas and others 
affected by the disaster:
[sbull] Waived penalties for late payment of PBGC premiums.
[sbull] Extended the deadlines for fully funded terminating plans to 
            give notices to participants and the PBGC and to transfer 
            to the PBGC payments for missing participants.
[sbull] Extended the deadline for issuing the notice to participants 
            that certain underfunded plans are required to provide to 
            inform participants of plan funding levels and limitations 
            on PBGC guarantees.
[sbull] Extended the deadlines for reporting certain Reportable Events.
[sbull] Extended the deadline for requesting reconsideration or 
            appealing PBGC determinations under the PBGC's 
            administrative review regulation.
[sbull] Provided case-by-case relief in other cases.
Relief for Small Businesses
 A large percentage of the plans insured by the PBGC are small or 
maintained by small employers. The PBGC takes the special needs and 
concerns of small entities into account in developing its regulatory 
policies. For example, in recent years, the PBGC made the following 
changes, which are very helpful to small plans and their sponsors:
[sbull] Extended the time limits for various actions required to 
            terminate a fully funded single-employer plan in a standard 
            termination.
[sbull] 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.
[sbull] Extended the filing date for PBGC premiums to match the latest 
            Form 5500 filing date.
[sbull] Reduced penalties for late premiums that are paid before the 
            PBGC notifies the plan of the delinquency.
Other Regulatory Simplifications and Relief
 PBGC has provided additional regulatory simplifications and relief. 
Specifically, the PBGC:
[sbull] Stopped the reduction of monthly benefits under its actuarial 
            recoupment method once the nominal amount of the benefit 
            overpayment is repaid.
[sbull] 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.
[sbull] Encouraged self-correction of premium underpayments by making 
            it easier to qualify for safe-harbor penalty relief.
[sbull] Published a proposed penalty policy to provide guidance on 
            assessment and review of penalties and on what constitutes 
            ``reasonable cause'' for a penalty waiver.

[[Page 74251]]

[sbull] Simplified its valuation assumptions by adopting a single set 
            of assumptions for allocation purposes.
[sbull] Decided 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.
[sbull] Solicited public comment on benefit valuation and payment 
            issues relating to terminated cash balance plans that use 
            variable indices to determine future retirement benefits.
[sbull] 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.
[sbull] Amended its premium regulation to simplify and narrow the 
            definition of ``participant'' for PBGC premium purposes.
 In FY 2002, the PBGC:
[sbull] Amended 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.
[sbull] Amended its administrative review regulation to expedite the 
            appeals process by authorizing a single member of the 
            PBGC's Appeals Board to decide routine appeals.
 The PBGC is continuing to review its regulations to look for further 
simplification opportunities. The PBGC's regulatory plan for October 1, 
2002, to September 30, 2003, consists of one significant regulatory 
action.
_______________________________________________________________________



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                                                           03/00/03
NPRM Comment Period End                                        05/00/03
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 74252]]




RAILROAD RETIREMENT BOARD (RRB)



Statement of Regulatory and Deregulatory Priorities
 The Railroad Retirement Board (Board) administers a retirement program 
for railroad workers and their families under the Railroad Retirement 
Act of 1974, and an unemployment insurance and sickness benefit program 
for railroad workers under the Railroad Unemployment Insurance Act. 
Regulations by the Board under these two statutes and certain 
Governmentwide statutes are contained in chapter II of title 20 of the 
Code of Federal Regulations.
 The Board has been involved in a multiyear project to review, revise, 
and update its regulations. During this project the Board has published 
final rules amending all of its regulations. In addition, there are 
several regulations actively under consideration by the Board at this 
time. The Board's short-term plan is to publish final regulations to 
complete the total review and revision project undertaken previously. 
The agency has also initiated a review of its regulations to assess the 
need for changes that may be required by the Railroad Retirement and 
Survivors Improvement Act of 2001.
 The regulations issued by the Board are designated to be informative 
and to assist the agency's constituents in the railroad industry with 
an understanding of the benefit systems administered by the Board. In 
promulgating regulations, the agency is mindful of the burdens that may 
be imposed on the public and crafts its regulations in such a way as to 
impose the least possible burden on the public. In addition, through 
regulation, the Board makes every effort to simplify and streamline 
administration of the programs it administers. We believe the Board's 
regulatory review program is consistent with the priorities of the 
Administration.
 The Board has not implemented regulations related to the events of 
September 11, 2001, and is unlikely to do so. The agency does, however, 
follow the guidelines and regulations instituted by other Government 
agencies that have Homeland Security authority for establishing such 
regulations. Examples of those areas would be: Federal agency facility 
management and security and computer security awareness.
 It is highly unlikely that any regulations in the regulatory plan of 
this agency would be of particular concern to small business.
_______________________________________________________________________



RRB

                              -----------

                          PROPOSED RULE STAGE

                              -----------




152. [bull] APPLICATION FOR ANNUITY OR LUMP SUM
Priority:


Other Significant


Legal Authority:


45 USC 231d; 45 USC 231f


CFR Citation:


20 CFR 217.5; 20 CFR 217.6; 20 CFR 217.15 to 217.18


Legal Deadline:


None


Abstract:


The Railroad Retirement Board amends its regulations to permit the 
filing of applications for annuity or lump sum electronically via the 
Internet in accordance with the provisions of the Government Paperwork 
Elimination Act.


Statement of Need:


Sections 1701-1710 of the Government Paperwork Elimination Act, Public 
Law 205-277 (codified as 44 U.S.C. sec. 3504n), require Federal 
agencies to provide for the option of electronic maintenance, 
submission, or disclosure of information, when practicable, as a 
substitute for paper. The proposed changes to part 217 of the Board's 
regulations will permit the filing of applications under the Railroad 
Retirement Act electronically via the Internet.


Summary of Legal Basis:


The general authority for the issuance of regulations under the 
Railroad Retirement Act (RRA) is provided for in section 7(b)(5) of the 
RRA (45 U.S.C. 231f(b)(5)).


Alternatives:


None.


Anticipated Cost and Benefits:


While this amendment should result in modest savings in administrative 
costs due to the streamlining of procedures, the benefits are those 
extended to the agency's constituents who may file applications for 
benefits electronically via the Internet.


Risks:


None anticipated.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           12/00/02
Regulatory Flexibility Analysis Required:


No


Government Levels Affected:


Federal


Agency Contact:
Marguerite P. Dadabo
Assistant General Counsel
Railroad Retirement Board
844 North Rush Street
Chicago, IL 60611-2092
Phone: 312 751-4945
TDD Phone: 312 751-4701
Fax: 312 751-7102
RIN: 3220-AB55
_______________________________________________________________________



RRB



153. [bull] ACCOUNT BENEFITS RATIO
Priority:


Other Significant


Legal Authority:


45 USC 231f(b)(5); 45 USC 231u(a)


CFR Citation:


20 CFR 206


Legal Deadline:


None


Abstract:


The Railroad Retirement Board adds a new part 206 to its regulations as 
information, and to advise that the Board will annually compute the 
account benefits ratio for the railroad retirement system, and will 
make a projection of the account benefits ratio and the average account 
benefits ratio for future years.


Statement of Need:


Sections 108 and 204 of the Railroad Retirement and Survivors' 
Improvement Act of 2001 (Pub.L. 107-90) amended the Railroad Retirement 
Act to require the Board to annually compute the account benefits 
ratios for the railroad retirement system and make a projection of the 
account benefits ratio and the average account benefits ratio for 
future years. Effective for calendar years after 2003, the tier II tax 
rate will be determined in accord with a formula that relies on the 
average account benefits ratio. See section 3241 of the Internal 
Revenue Code as amended by section 204 of Public Law 107-90. The 
Railroad Retirement Board has decided

[[Page 74253]]

to set forth in a new part 206 of the Board's regulations (20 CFR 206) 
how it will compute the ``account benefits ratio'' in accordance with 
sections 108 and 204 of the Railroad Retirement and Survivors' 
Improvement Act of 2001 so that all parties, rail labor, rail 
management, and the public, will be aware of how the Board intends to 
compute the account benefits ratio.


Summary of Legal Basis:


The general authority for the issuance of regulations under the 
Railroad Retirement Act (RRA) is provided for in section 7(b)(5) of the 
RRA (45 U.S.C. 231f(b)(5)); see also 45 U.S.C. 231u(a)(l).


Alternatives:


None.


Anticipated Cost and Benefits:


The costs associated with the addition of a new part to the Board's 
regulations are administrative in nature, and include the costs 
associated with drafting and publishing the regulation as a proposed 
and then a final rule. The benefits are those extended to the agency's 
constituents who will be aware of how the account benefits ratio is 
computed.


Risks:


None.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           12/00/02
Regulatory Flexibility Analysis Required:


No


Government Levels Affected:


Federal


Agency Contact:
Marguerite P. Dadabo
Assistant General Counsel
Railroad Retirement Board
844 North Rush Street
Chicago, IL 60611-2092
Phone: 312 751-4945
TDD Phone: 312 751-4701
Fax: 312 751-7102
RIN: 3220-AB56
_______________________________________________________________________



RRB

                              -----------

                            FINAL RULE STAGE

                              -----------




154. REQUESTS FOR RECONSIDERATION AND APPEALS WITHIN THE BOARD
Priority:


Other Significant


Legal Authority:


45 USC 231f(b)(5); 45 USC 231g; 45 USC 355


CFR Citation:


20 CFR 260; 20 CFR 320


Legal Deadline:


None


Abstract:


The Railroad Retirement Board is amending 20 CFR sections 260 and 320 
to provide for its field offices to make timeliness determinations on 
requests for reconsideration of decisions of the RRB's various 
adjudicating units.


Statement of Need:


The amendments to parts 260 and 320 deal with administrative reviews of 
denials of claims for benefits or requests for waiver of recovery of 
overpayments under the Railroad Retirement and Railroad Unemployment 
Insurance Acts. The amendments streamline the admininstrative review 
process, and generally provide certain protections for a claimant that 
have not previously been available, without diminishing his or her 
rights in other areas.


Summary of Legal Basis:


The general authority for the issuance of regulations under the 
Railroad Retirement Act (RRA) is provided for in section 7(b)(5) of the 
RRA (45 U.S.C. 231f(b)(5)); under the Railroad Unemployment Insurance 
Act (RUIA), the general authority for the issuance of regulations is 
found in section 5(a) (45 U.S.C. 355(a)) of the RUIA.


Alternatives:


None.


Anticipated Cost and Benefits:


While this regulation should result in modest savings in administrative 
costs due to the streamlining of procedures, the benefits are those 
extended to the agency's constituents as a result of the overall 
additional protections provided.


Risks:


None.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            67 FR 15127                                    03/29/02
NPRM Comment Period End                                        05/28/02
Final Action                                                   12/00/02
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


Federal


Agency Contact:
Marguerite P. Dadabo
Assistant General Counsel
Railroad Retirement Board
844 North Rush Street
Chicago, IL 60611-2092
Phone: 312 751-4945
TDD Phone: 312 751-4701
Fax: 312 751-7102
RIN: 3220-AB03
BILLING CODE 7905-01-S

[[Page 74254]]




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:
[sbull] Listening to small businesses to make sure SBA is meeting the 
            needs of the small business community;
[sbull] Working with its financial partners to improve small business 
            access to capital through SBA's loan and venture capital 
            programs;
[sbull] Providing technical assistance and guidance through its 
            entrepreneurial development partners 24 hours a day;
[sbull] Establishing new and strengthening existing public and private 
            partnerships to encourage greater contracting and business 
            opportunities for small businesses.
[sbull] 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 Regulations
 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 Program
 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.
Regulation as a Result of September 11, 2001, Events
Small Business Size Standards; Travel Agencies Affected by September 
11, 2001
 The events of September 11, 2001, directly impacted travel agencies. 
The traveling public cancelled and rescheduled existing travel 
arrangements and many postponed further travel. Many small travel 
agencies saw their business decline by 20 to 50 percent. To address 
this situation, after consultation with the industry and other 
interested parties, SBA issued an interim final rule on March 15, 2002, 
that increased the size standard for travel agencies, North American 
Industry Classification System (NAICS) code 561510, from $1 million to 
$3 million for economic injury disaster loan (EIDL) assistance. SBA 
believes that this action better defines the size of businesses in this 
industry that should be eligible for EIDL loans as a result of the 
September 11, 2001, terrorist attacks and for EIDL assistance to 
businesses in the declared disaster areas. On May 31, 2002, SBA issued 
a final rule, after taking into consideration comments received on the 
interim final rule.
_______________________________________________________________________



SBA

                              -----------

                          PROPOSED RULE STAGE

                              -----------




155. 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.'' Presently, 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. Some additional costs associated with additional 
reporting by the SBLCs to the SBA is anticipated.

[[Page 74255]]

Risks:


This regulation poses no risks to the public health and safety or to 
the environment.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           12/00/02
Regulatory Flexibility Analysis Required:


Undetermined


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

                              -----------

                            FINAL RULE STAGE

                              -----------




156. HUBZONE EMPOWERMENT CONTRACTING PROGRAM
Priority:


Other Significant


Legal Authority:


15 USC 632(a); 15 USC 634(b)(6); 15 USC 637(a); 15 USC 644(c); 15 USC 
662(5); PL 105-135, sec 601 et seq, 111 Stat 2592; sec 304, PL 103-403, 
108 Stat 4175, 4188


CFR Citation:


13 CFR 121; 13 CFR 125; 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. This rule proposes: (1) consolidating 
all subcontracting requirements into one regulation, (2) language on 
how to petition for changes in subcontracting requirements, (3) to 
apply nonmanufacturer rules consistently for all programs, (4) how 
small nonmanufacturers should submit products of any manufacturer for 
contracts below the simplified acquisition threshold, (5) addressing 
statutory amendments, and (6) making technical changes.


Statement of Need:


SBA must amend its HUBZone regulations in order to implement changes in 
the Small Business Act mandated by Public Law 106-554, to correct 
typographical errors, and to streamline the program.


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            67 FR 3826                                     01/28/02
NPRM Comment Per67 FR 8739ed                                   02/26/02
NPRM Comment Period End                                        02/27/02
NPRM Comment Period End                                        03/29/02
Final Action                                                   12/00/02
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses


Government Levels Affected:


None


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 74256]]




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. Our regulations codify the 
requirements for eligibility and entitlement to benefits under the 
programs that we administer. Generally, SSA's regulations do not impose 
burdens on the private sector or on State or local governments.
 Our ten entries for the Regulatory Plan represent areas of major 
importance to the administration of the retirement, survivors', 
disability, and SSI benefit programs. Each individual initiative is 
described more fully after this Statement of Regulatory Priorities.
Serve the Public
 Providing the best service possible to the public remains a principal 
objective of SSA. To that end, we have included in the Plan a final 
rule on Expansion of the Use of Video Teleconference Technology in 
Hearings Before Administrative Law Judges of the Social Security 
Administration. We expect that expanding the availability of this 
technology will improve service by providing faster access to a 
hearing.
Improve the Disability Process
 As the continued improvement of the disability program is an area of 
vital interest to SSA, we have included on the Plan two final rules 
that address disability. One final rule will update the medical 
listings used to evaluate digestive impairments. The revisions will 
ensure that the listings reflect advances in medical knowledge, 
treatment, and methods of evaluating these impairments. The other final 
rule implements elements of the redesigned disability claims process 
that have been tested and found to use our resources more effectively 
to award benefits at the earliest point possible.
Reduce Fraud
 SSA bears a responsibility to ensure we are effective stewards of the 
public trust placed in us. We are including in the Plan several 
regulatory initiatives designed to strengthen our stewardship and 
program integrity activities.
 To further enhance the integrity of SSA's enumeration process for 
assigning Social Security Numbers (SSNs), we plan to publish a proposed 
rule that would change evidence requirements for assigning SSNs. This 
proposed rule would clarify what ``valid nonwork reasons'' are in order 
to reduce the opportunity for fraud through misusing and/or improperly 
attaining SSNs.
 For beneficiaries who are not able to manage their own benefits due to 
legal incompetence or medical infirmity, we must assure that benefits 
paid to representatives on their behalf are used properly. We are 
proposing rules that reflect provisions of various laws intended to 
strengthen our oversight of the representative payee program.
 We have also included final rules that provide us with additional 
tools to strengthen the integrity of the Social Security and SSI 
programs. One final rule implements a provision of the Foster Care 
Independence Act of 1999, authorizing SSA to obtain information from 
financial institutions in order to determine initial or continuing 
eligibility for SSI benefits.
 The Debt Collection Improvement Act of 1996, as amended by the Foster 
Care Independence Act of 1999, provided SSA with new tools for our 
efforts in collecting debts, including the use of administrative wage 
garnishment. We are developing a final rule that will enable us to 
collect qualifying, delinquent title II and XVI debts owed by former 
beneficiaries who are currently employed in other-than-Federal 
employment. We are also developing a proposed rule on Federal salary 
offset to provide the same authority for similar debts owed by former 
beneficiaries who are currently employed by the Federal government.
 Another proposal would enable us to conduct six-month pilot projects 
in order to test and gather information on the use of photographic 
identification to address the issue of impersonation in the disability 
claims process.
Simplify the SSI Program
 SSA is proposing a rule that would simplify our SSI regulations. This 
proposed change would modify three rules concerning what we consider as 
income or resources available to an applicant or recipient. We propose 
to no longer consider gifts of clothing as income when we decide 
whether a person can receive SSI benefits or when we compute the amount 
of benefits. We also propose to exclude, from our determination of 
resources, one automobile if it is used for transportation, without 
consideration of its value. Finally, we propose to no longer count 
household goods and personal effects as resources when we decide 
whether a person can receive SSI benefits.
_______________________________________________________________________



SSA

                              -----------

                          PROPOSED RULE STAGE

                              -----------




157. FEDERAL SALARY OFFSET (WITHHOLDING A PORTION OF A FEDERAL 
EMPLOYEE'S SALARY TO COLLECT A DELINQUENT DEBT OWED TO THE SOCIAL 
SECURITY ADMINISTRATION) (721P)
Priority:


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


Unfunded Mandates:


Undetermined


Legal Authority:


42 USC 404; 42 USC 405; 42 USC 902; 42 USC 1383; 5 USC 5514


CFR Citation:


20 CFR 422


Legal Deadline:


None


Abstract:


This initiative would enable the Social Security Administration (SSA) 
to collect from Federal salaries qualifying, delinquent title II and 
title XVI overpayment debts and administrative debts owed by 
individuals who are currently Federal employees. The debt collection 
would be accomplished by the partial reduction of the employee's 
disposable salary.


Statement of Need:


This regulation is required by 5 U.S.C. 5514(b) and by regulations of 
the Department of the Treasury (Treasury) in order for SSA to 
participate in the Federal Salary Offset program. Treasury's regulation 
31 CFR section 3714 (administrative offset) and 5 U.S.C. 5514 (salary 
offset).


Summary of Legal Basis:


SSA's use of the Federal Salary Offset program is authorized by 42 
U.S.C. 404(f), as amended by section 31001(z)(2) of Public Law 104-134, 
the Debt Collection Improvement Act of 1996, 42 U.S.C. 1383(b), as 
amended by section 203 of Public Law 106-169, the Foster Care 
Independence Act of 1999 and 5 U.S.C. 5514.

[[Page 74257]]

Alternatives:


None. SSA must have regulations, approved by the Office of Personnel 
Management, in order to use Federal salary offset to collect debts owed 
by Federal employees. See 5 U.S.C. 5514(b) and 5 CFR 550.1104.


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                                                           09/00/03
Final Action                                                   03/00/04
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


Federal


Agency Contact:
Edward Johns
Financial Management Analyst
Social Security Administration
6401 Security Boulevard
Baltimore, MD 21235-6401
Phone: 410 965-0392

Robert J. Augustine
Social Insurance Specialist
Social Security Administration
6401 Security Boulevard
Baltimore, MD 21235-6401
Phone: 410 965-0020
RIN: 0960-AE89
_______________________________________________________________________



SSA



158. ADMINISTRATIVE WAGE GARNISHMENT (TO REPAY A DEBT OWED TO THE 
SOCIAL SECURITY ADMINISTRATION) (724P)
Priority:


Other Significant


Unfunded Mandates:


Undetermined


Legal Authority:


31 USC 3720D; 42 USC 405; 42 USC 902; 42 USC 1383


CFR Citation:


20 CFR 404.527; 20 CFR 404.903; 20 CFR 4416.590; 20 CFR 416.1403; 20 
CFR 422.401 to 422.403; 20 CFR 422.405; 20 CFR 422.410; 20 CFR 422.415; 
20 CFR 422.420; 20 CFR 422.425; 20 CFR 422.430; 20 CFR 422.435; 20 CFR 
422.440; 20 CFR 422.445


Legal Deadline:


None


Abstract:


This initiative will enable the Social Security Administration (SSA) to 
use administrative wage garnishment to collect administrative debts and 
to collect qualifying, delinquent titles II and XVI overpayment debts 
owed by individuals 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:


The administrative costs for the first year of implementation, 
including systems start-up costs, will be about 25 work years (WY) and 
$2 million in fiscal year (FY) 2003. Ongoing costs, once the regulation 
is fully implemented, are estimated to be about 65 WYs and $5 million 
per year, with higher costs of 80 WYs and $6 million for FY 2005 as 
older cases are cleared.


The estimated overpayment collections that we could receive for the 
title II program will be nothing in FY 2003, $25 million in FYs 2004 
and 2005, and $15 million in FYs 2006 and 2007. The estimated 
collections for the title XVI program will be less than $2.5 million in 
FYs 2003 and 2004, and $10 million in FYs 2005, 2006, and 2007.


Risks:


At this time we have not identified any risks associated with the 
proposal.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           11/00/02
Final Action                                                   09/00/03
Regulatory Flexibility Analysis Required:


Undetermined


Small Entities Affected:


Businesses, Organizations


Government Levels Affected:


State, Local, Tribal, Federal


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
6401 Security Boulevard
Baltimore, MD 21235-6401
Phone: 410 965-7183
RIN: 0960-AE92
_______________________________________________________________________



SSA



159. EVIDENCE REQUIREMENT FOR ASSIGNMENT OF SOCIAL SECURITY 
ADMINISTRATION NUMBERS (SSNS) AND ASSIGNMENT OF SSNS FOR NONWORK 
PURPOSES (751P)
Priority:


Other Significant


Legal Authority:


42 USC 405; 42 USC 432; 42 USC 902(a)(5); 42 USC 1320b-1; 42 USC 1320b-
13


CFR Citation:


20 CFR 422.104; 20 CFR 422.107


Legal Deadline:


None


Abstract:


We propose to change our rules regarding the age at which a mandatory

[[Page 74258]]

in-person interview is required for original applications for an SSN. 
In addition, we propose eliminating the waiver of evidence of identity 
for children under age 7 who are applying for an original SSN card. 
Under these proposals, SSA will require an in-person interview with all 
individuals age 12 or older who are applying for an original SSN, and 
SSA will no longer waive the requirement to provide evidence of 
identity in original applications for a child under age 7. SSA will 
clarify that evidence of identity must contain sufficient biographical 
information to identify the individual. Additionally, we propose to 
eliminate reference to a pilot no longer under consideration by SSA 
pertaining to the processing of replacement SSN cards for United States 
(U.S.) citizens.


We also propose to clarify our rules regarding when we will assign an 
SSN to an alien who is legally in the U.S. but not under authority of 
law permitting him or her to work in the U.S. We are proposing to 
define a ``valid nonwork purpose'' as those instances when a Federal 
statute or regulation requires an alien to have an SSN in order to 
receive a federally-funded benefit to which the alien has established 
entitlement, or when a State or local law requires an alien to have an 
SSN in order to receive general public assistance benefits (i.e., a 
public benefit that is means-tested) to which the alien has established 
entitlement.


Statement of Need:


These revised regulations are necessary to further enhance the 
integrity of SSA's enumeration processes for assigning Social Security 
Numbers (SSNs). By changing evidence requirements for assignment of 
SSNs and by defining ``valid nonwork reasons,'' we intend to reduce the 
opportunity for fraud through misuse and/or improper attainment of 
SSNs.


Summary of Legal Basis:


None.


Alternatives:


In developing the policies for the age at which a mandatory in-person 
interview is required and the reasons for which a nonwork SSN is 
assigned, we considered but rejected the following options.


Age for Mandatory In-Person Interview -


When considering the age at which to set the in-person interview, we 
felt that it was rare for individuals to obtain an SSN for the first 
time as late as 12 years of age. However, we rejected a younger age 
because we felt that such interviews with younger children would be 
overly burdensome on the child and unproductive for SSA, even with the 
parent in attendance. We believe that the proposed age 12 threshold for 
in-person interviews provides the best balance between allowing us to 
screen effectively for a prior SSN without being overly burdensome on 
the child.


Reasons for Nonwork SSN -


We considered limiting the assignment of nonwork SSNs to where there is 
a Federal statute or regulation that requires the alien to furnish an 
SSN to receive a federally-funded benefit or service and the alien is 
legally in the U.S. but not under authority of law permitting him or 
her to work in the U.S. However, we have not observed significant fraud 
in the area of nonwork SSNs assigned for general public assistance 
benefits and we do not want to unnecessarily impact access to general 
public assistance programs.


Anticipated Cost and Benefits:


This regulation may result in a negligible increase in administrative 
costs. Enhancing the integrity of SSA's enumeration processes should 
result in fewer opportunities for SSN fraud, including the fraud 
associated with identity theft.


Risks:


None.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
ANPRM           64 FR 55217                                    10/12/99
ANPRM Comment Period End                                       12/13/99
NPRM                                                           12/00/02
Final Action                                                   11/00/03
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


State


Agency Contact:
Arthur LaVeck
Social Insurance Specialist
Social Security Administration
Office of Program Benefits
6401 Security Boulevard
Baltimore, MD 21235-6401
Phone: 410 966-5665

Karen Cool
Social Insurance Specialist
Social Security Administration
Office of Program Benefits
6401 Security Boulevard
Baltimroe, MD 21235-6401
Phone: 410 966-7094

Fran O. Thomas
Social Insurance Specialist
Social Security Administration
6401 Security Boulevard
Baltimore, MD 21235-6401
Phone: 410 966-9822
RIN: 0960-AF05
_______________________________________________________________________



SSA



160. [bull] CLAIMANT IDENTIFICATION PILOT PROJECTS (937P)
Priority:


Other Significant


Unfunded Mandates:


Undetermined


Legal Authority:


42 USC 405


CFR Citation:


20 CFR 404.617 (New); 20 CFR 416.217 (New)


Legal Deadline:


None


Abstract:


This initiative will enable the Social Security Administration (SSA) to 
conduct six-month pilot projects in order to test and gather 
information on the use of photographic identification to address the 
issue of complicit impersonation in the disability claims process. All 
field offices in South Carolina and Kansas, nine field offices in New 
York City, and the Augusta, Georgia field office will require that 
applicants filing for title II and title XVI disability benefits allow 
SSA to take their photographs and make them part of the SSA disability 
claims file. Failure to cooperate will result in denial of benefits. We 
will permit an exception to the photograph requirement when an 
individual has a valid religious objection.

[[Page 74259]]

Statement of Need:


The rule would provide regulatory authority to conduct the pilot 
projects.


Summary of Legal Basis:


Section 205(a) of the Social Security Act, as amended (42 U.S.C. 405) 
provides SSA with broad authority to set reasonable rules to ensure the 
integrity of Social Security programs. The proposed Claimant ID 
regulation is not specifically required by any statute or court order.


Alternatives:


None.


Anticipated Cost and Benefits:


Costs are undetermined at this time. Benefits would include the 
collection of data that will be used to analyze the feasibility and 
effectiveness of rolling out such a regulation on a national basis. 
This process will strengthen the integrity of the disability claims 
process by helping to ensure that the individual filing the application 
is the same individual examined by the consultative examination 
physician. These procedures would help to identify and/or deter 
individuals who are attempting to defraud the disability programs.


Risks:


At this time we have not identified any risks associated with the 
proposal.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           11/00/02
Final Action                                                   02/00/03
Regulatory Flexibility Analysis Required:


Undetermined


Small Entities Affected:


No


Government Levels Affected:


Federal


Agency Contact:
Suzanne DiMarino
Social Insurance Specialist
Social Security Administration
6401 Security Boulevard
Baltimore, MD 21235-6401
Phone: 410 965-1769
RIN: 0960-AF79
_______________________________________________________________________



SSA



161. [bull] REPRESENTATIVE PAYMENT UNDER TITLES II, VIII, AND XVI OF 
THE SOCIAL SECURITY ACT (949P)
Priority:


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


Unfunded Mandates:


Undetermined


Legal Authority:


42 USC 401(j); 42 USC 902(a)(5); 42 USC 405 note; 42 USC 421 note; 42 
USC 1383(a)(2); 42 USC 1383(d)(1); 42 USC 404(f); 42 USC 405(a); 42 USC 
405(b); 42 USC 405(d) to 405(h); 42 USC 405(j); 42 USC 405(k); 42 USC 
421; 42 USC 425; 42 USC 1007


CFR Citation:


20 CFR 404.902; 20 CFR 404.2011; 20 CFR 404.2021; 20 CFR 404.2022; 20 
CFR 404.2024; 20 CFR 404.2025; 20 CFR 404.2030; 20 CFR 404.2035; 20 CFR 
404.2040(a); 20 CFR 404.2041; 20 CFR 404.2045; 20 CFR 404.2050; 20 CFR 
404.2065; 20 CFR 416.611; 20 CFR 416.621; 20 CFR 416.622; 20 CFR 
416.624; 20 CFR 416.625; 20 CFR 416.630; 20 CFR 416.635; 20 CFR 
416.640(a); 20 CFR 416.641; 20 CFR 416.645; 20 CFR 416.650; 20 CFR 
416.665; 20 CFR 416.1402


Legal Deadline:


None


Abstract:


Effective stewardship of SSA programs requires mechanisms to assure 
that benefits are used to meet the needs of beneficiaries determined 
incapable of managing or directing someone else to manage their 
benefits. Congress determined that improvements to the representative 
payment procedures were needed to assure program integrity. These 
regulations are required to reflect these legislative improvements and 
to further our program integrity efforts.


Statement of Need:


These regulations, which reflect certain provisions of Public Law 101-
508, 103-296, 104-121, 105-33, 106-169 and 106-170, modify existing 
representative payee procedures by: (1) requiring the Social Security 
Administration to do a more extensive investigation of representative 
payee applicants, generally limiting to one month the deferral or 
suspension of direct payment of benefits pending selection of a payee; 
(2) providing stricter standards in determining the fitness of 
representative payee applicants to manage benefit payments on behalf of 
beneficiaries; (3) requiring SSA to repay the beneficiary or an 
alternate payee, an amount equal to any misused funds resulting from 
SSA's negligent failure to investigate or monitor a representative 
payee; (4) granting certain payees the authority to collect a fee from 
beneficiaries and defining 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; (5) changing how 
SSA treats persons whose drug addition or an alcohol condition is 
material to his/her disability; and (6) requiring SSA to compile and 
maintain a centralized file of certain beneficiary and payee 
information.


Summary of Legal Basis:


These regulations implement section 5105 of Public Law 101-508, section 
210 of Public Law 103-296, section 105 of Public Law 104-121, section 
5525 of Public Law 105-33, section 251 and 1136 of Public Law 106-169 
and section 401 of Public Law 106-70.


Alternatives:


None.


Anticipated Cost and Benefits:


Any costs associated with these regulations are reflected in the 
President's budget as part of legislative implementation. They are 
required to further our program integrity efforts.


Risks:


None.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           09/00/03
Final Action                                                   06/00/04
Regulatory Flexibility Analysis Required:


Undetermined


Small Entities Affected:


Governmental Jurisdictions, Organizations


Government Levels Affected:


State, Local

[[Page 74260]]

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

Robert J. Augustine
Social Insurance Specialist
Social Security Administration
6401 Security Boulevard
Baltimore, MD 21235-6401
Phone: 410 965-0020
RIN: 0960-AF83
_______________________________________________________________________



SSA



162. [bull] REMOVAL OF CLOTHING FROM THE DEFINITIONS OF INCOME AND IN-
KIND SUPPORT AND MAINTENANCE, EXCLUSIONS OF ONE AUTOMOBILE AND 
HOUSEHOLD GOODS AND PERSONAL EFFECTS UNDER SSI FROM RESOURCES (950P)
Priority:


Other Significant


Legal Authority:


Sec 1612 of the Social Security Act; Sec 1613(a)(2)(A) of the Social 
Security Act


CFR Citation:


20 CFR 416.1102 to 416.1104; 20 CFR 416.1121; 20 CFR 416.1124; 20 CFR 
416.1130; 20 CFR 416.1133; 20 CFR 416.1140; 20 CFR 416.1142; 20 CFR 
416.1144 to 416.1145; 20 CFR 416.1147 to 416.1149; 20 CFR 416.1157; 20 
CFR 416.1210; 20 CFR 416.1216; 20 CFR 416.1218


Legal Deadline:


None


Abstract:


We propose to make the following changes to our rules on determining 
income and resources under the Supplemental Security Income (SSI) 
program.


1. We propose to remove clothing from the definition of income and from 
the definition of in-kind support and maintenance. As a result, we 
generally will not count gifts of clothing as income when we decide 
whether a person can receive SSI benefits or when we compute the amount 
of benefits.


2. We propose to simplify our rules on how we exclude an automobile in 
determining the resources of a SSI applicant or recipient. 
Specifically, we propose to exclude one automobile from resources if it 
is used for transportation, without consideration of its value.


3. We propose to change our resources counting rules in the SSI program 
by eliminating the dollar value limit for the exclusion of household 
goods and personal effects. As a result, we would not count household 
goods and personal effects as resources when we decide whether a person 
can receive SSI benefits.


Statement of Need:


These changes will simplify our rules, making them less cumbersome to 
administer and easier for the public to understand and follow, and 
thereby reducing the potential for payment errors. These changes also 
will make SSI financial eligibility rules more consistent with those of 
other means-tested Federal programs. The changes also will eliminate 
the need to ask claimants, beneficiaries, and other members of their 
household certain questions that have been viewed as intrusive. By no 
longer counting gifts of clothing as income, we will remove a 
disincentive for family members to help needy relatives.


Summary of Legal Basis:


None.


Alternatives:


Clothing


None.


Automobile -


We considered revising the regulations to provide that SSA will assume 
that the recipient's automobile meets the use requirements for total 
exclusion of one automobile, absent evidence to the contrary. We did 
not select this option because it would not change the rule but only 
how we apply it. It does not go far enough in simplifying the SSI 
program. By revising the use requirements to exclude a car if it is 
used for transportation, thus replacing the four present specific 
transportation exclusion criteria, we will simplify the process.


We considered excluding the value of one automobile, regardless of use. 
We did not select this option because it would allow for the routine 
exclusion of an automobile even if it were not used for transportation. 
Such an approach would exclude an inoperable vehicle, a vehicle not 
being used at all, or a vehicle only used for recreation (such as a 
dune buggy). We maintain that it is unreasonable to exclude from 
resources the value of a vehicle that is not used for transportation.


We also considered increasing the excludable value of an automobile not 
meeting the use test to $11,000. We did not select this option because 
it would not simplify the SSI program.


Household Goods and Personal Effects -


Instead of excluding the entire value of household goods and personal 
effects, we considered raising the excludable limit to $10,000 from the 
current level of $2,000. We decided not to pursue this option because 
it would not provide any policy simplification. It would increase the 
amount excluded but it would not eliminate the need for the current 
time-consuming and complex procedures for determining the market value 
of an individual's household goods and personal effects.


Anticipated Cost and Benefits:


We estimate that the program costs and administrative costs for these 
regulatory changes would be negligible.


The proposed rules will simplify the administrative process of valuing 
noncash items. The change to the household goods and personal effects 
exclusion would simplify our rules and improve work efficiency by 
eliminating the need to inventory an individual's household goods and 
personal effects and determine their current market value. The proposed 
changes would also serve to make our rules less intrusive and more 
protective of the dignity of individuals seeking SSI benefits.


Risks:


These proposed changes would simplify complex SSI rules without 
disadvantaging SSI applicants or recipients or significantly increasing 
program or administrative costs.


Clothing -


There are no significant concerns.


Automobile -


Our experience shows that most SSI beneficiaries do not own expensive 
cars. Still, it is possible that a beneficiary may, under our proposal, 
own an automobile that is used for transportation (and therefore 
excluded) and that is worth a considerable amount of money.


Household Goods and Personal Effects -


Under the proposed change to the household goods and personal effects 
exclusion, we would continue to

[[Page 74261]]

recognize that individuals applying for SSI may own items that have 
investment value and which may be quite valuable. Such items as gems, 
jewelry, and collectibles would still be considered countable resources 
and subject to the SSI resource limit. Thus, the proposed exclusion for 
household goods and personal effects would not create an unintended 
exclusion for items that have investment value.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           01/00/03
Final Action                                                   09/00/03
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


None


Agency Contact:
Kenneth A. Brown
Social Insurance Specialist
Social Security Administration
Office of Program Benefits
6401 Security Boulevard
Baltimore, MD 21235-6401
Phone: 410 965-9772

Robert J. Augustine
Social Insurance Specialist
Social Security Administration
6401 Security Boulevard
Baltimore, MD 21235-6401
Phone: 410 965-0020
RIN: 0960-AF84
_______________________________________________________________________



SSA

                              -----------

                            FINAL RULE STAGE

                              -----------




163. OASDI AND SSI; ADMINISTRATIVE REVIEW PROCESS; VIDEO 
TELECONFERENCING APPEARANCES BEFORE ADMINISTRATIVE LAW JUDGES OF THE 
SOCIAL SECURITY ADMINISTRATION (737F)
Priority:


Other Significant


Legal Authority:


42 USC 205(a); 42 USC 205(b); 42 USC 902(a)(5); 42 USC 1383


CFR Citation:


20 CFR 404.929; 20 CFR 404.936; 20 CFR 404.938; 20 CFR 404.950; 20 CFR 
416.1429; 20 CFR 416.1436; 20 CFR 416.1438; 20 CFR 416.1450


Legal Deadline:


None


Abstract:


This final rule revises our rules to permit us to conduct hearings 
before an administrative law judge (ALJ) at which a party or parties to 
the hearing and/or witness or witnesses may appear before the ALJ by 
video teleconference (VTC). The revised rules provide that if we 
schedule a hearing as one at which a party would appear by VTC, rather 
than in person, and the party objects to use of that procedure, we will 
reschedule the hearing as one at which the party may appear in person. 
We will be requesting public comments on this final rule.


Statement of Need:


Our regulations provide for a hearing in person before an ALJ. 
Traditionally, this has meant that the individual requesting a hearing 
makes his or her appearance in the same room as the ALJ. These changes 
will allow us to schedule a party to appear by VTC without requiring 
prior written consent, and set out the right of the party to decline 
such an appearance. We believe that conducting hearings by VTC will 
improve our efficiency and allow us to improve the service we can 
provide to individuals requesting a hearing.


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 appearance with no right to 
decline a VTC appearance.


Anticipated Cost and Benefits:


Improved public 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                                                   11/00/02
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


None


Agency Contact:
Cynthia Pullen-Carroll
Social Insurance Specialist
Social Security Administration
6401 Security Boulevard
Baltimore, MD 21235-6401
Phone: 410 965-3691
Related RIN: Previously reported as 0960-AA05
RIN: 0960-AE97
_______________________________________________________________________



SSA



164. REVISED MEDICAL CRITERIA FOR EVALUATING IMPAIRMENTS OF THE 
DIGESTIVE SYSTEM (800F)
Priority:


Economically Significant. Major under 5 USC 801.


Legal Authority:


42 USC 405; 42 USC 1302; 42 USC 1383


CFR Citation:


20 CFR 404, subpart P, app 1


Legal Deadline:


None


Abstract:


Listings 5.00 and 105.00 of appendix 1 to the disability regulation at 
20 CFR part 404, subpart P describe those digestive impairments that 
are considered severe enough to prevent a person from doing any gainful 
activity or, for a child claiming SSI payments under title XVI, that 
are considered severe enough to result in marked and severe functional 
limitations. Comprehensive revisions to these listings are being made 
to ensure that the medical evaluation criteria are up to date and 
consistent with the latest advances in medicine. The SSI program 
incorporates by reference and uses the same medical criteria as the 
old-age, survivors, and disability insurance program.


Statement of Need:


These regulations are necessary to update the digestive listings to 
reflect advances in medical knowledge, treatment, and methods of 
evaluating digestive impairments. They ensure that determinations of 
disability have a sound medical basis, that claimants receive equal 
treatment through the use

[[Page 74262]]

of specific criteria, and that people who are disabled can be readily 
identified and awarded benefits if all other factors of entitlement or 
eligibility are met.


Summary of Legal Basis:


Administrative--not required by statute or court order.


Alternatives:


We considered not revising the listings, or making only minor technical 
changes, and thus continuing to use our current criteria. However, we 
believe that proposing these revisions is preferable because of the 
medical advances that have been made in treating and evaluating these 
types of impairments. The current listings are now over 15 years old. 
Medical advances in disability evaluation and treatment and our program 
experience make clear that the current listings do not reflect state-
of-the-art medical knowledge and technology.


Since there would be no changes or only minor technical changes in 
using this alternative, the program and administrative costs would be 
the same as under the current rules. However, the program savings 
associated with the proposed rules would not be achieved.


Anticipated Cost and Benefits:


We are projecting savings in program expenditures as a result of these 
actions, described in more detail below.


Program Savings -


1. Title II


We estimate that, if finalized, these proposed rules would result in 
reduced program outlays resulting in the following savings (in millions 
of dollars) to the title II program ($295 million total in a 5-year 
period beginning in FY 2003).


2. Title XVI


We estimate that, if finalized, these proposed rules will result in 
reduced program outlays resulting in the following savings (in millions 
of dollars) to the SSI program ($85 million in a 5-year period 
beginning in FY 2003).


(Note: Federal SSI payments due on October 1st in fiscal years 2006 and 
2007 are included with payments for the prior fiscal year.)


Program Costs -


We do not expect any program costs to result from these proposed 
regulations.


Administrative Savings -


We do not expect any administrative savings to result from these 
proposed regulations.


Administrative Costs -


We expect that, if finalized, there will be some administrative costs 
associated with these proposed rules. If finalized, the proposed rules 
are expected to result in administrative costs less than 25 work years 
and less than $2 million per year.


Risks:


None.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            66 FR 57009                                    11/14/01
NPRM Comment Period End                                        01/14/02
Final Action                                                   03/00/03
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


None


Agency Contact:
Cheryl Wrobel
Policy Specialist
Social Security Administration
Office of Disability
6401 Security Boulevard
Baltimore, MD 21235-6401
Phone: 410 965-9108

Suzanne DiMarino
Social Insurance Specialist
Social Security Administration
6401 Security Boulevard
Baltimore, MD 21235-6401
Phone: 410 965-1769
RIN: 0960-AF28
_______________________________________________________________________



SSA



165. ACCESS TO INFORMATION HELD BY FINANCIAL INSTITUTIONS (815F)
Priority:


Other Significant


Unfunded Mandates:


Undetermined


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:


These final rules implement law that will enhance our access to bank 
account information of Supplemental Security Income (SSI) applicants 
and recipients and other individuals whose income and resources we 
consider as being available to the applicant or recipient.


Statement of Need:


This final rule 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:


First year administrative costs are projected not to exceed $1.5 
million. Subsequent year costs are projected not to exceed $6 million 
annually. It is estimated that this project will produce first-year 
program savings of $22 million. When fully implemented, it is estimated 
that program savings will be $85 million annually.


Risks:


Undetermined at this time.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            67 FR 22021                                    05/02/02
NPRM Comment Period End                                        07/01/02
Final Action                                                   11/00/02
Regulatory Flexibility Analysis Required:


No


Government Levels Affected:


None

[[Page 74263]]

Agency Contact:
Eric Ice
Social Insurance Specialist
Social Security Administration
Office of Program Benefits
6401 Security Boulevard
Baltimore, MD 21235-6401
Phone: 410 966-3233

Suzanne DiMarino
Social Insurance Specialist
Social Security Administration
6401 Security Boulevard
Baltimore, MD 21235-6401
Phone: 410 965-1769
RIN: 0960-AF43
_______________________________________________________________________



SSA



166. NEW DISABILITY CLAIMS PROCESS--ROLES OF STATE AGENCY (816F)
Priority:


Economically Significant. Major under 5 USC 801.


Legal Authority:


42 USC 405(a); 42 USC 902(a)(5)


CFR Citation:


20 CFR 404.1512; 20 CFR 404.1513; 20 CFR 404.1526; 20 CFR 404.1527; 20 
CFR 404.1529; 20 CFR 404.1546; 20 CFR 404.1615; 20 CFR 404.1616; 20 CFR 
416.912; 20 CFR 416.913; 20 CFR 416.926; 20 CFR 416.927; 20 CFR 
416.929; 20 CFR 416.946; 20 CFR 416.1015; 20 CFR 416.1016


Legal Deadline:


None


Abstract:


We plan to revise our regulations that pertain to the processing of 
initial claims for disability benefits under title II and title XVI of 
the Social Security Act at the initial and reconsideration steps of the 
administrative review process. Under these final rules, certain State 
agency disability examiners, familiarly called ``single 
decisionmakers,'' will be responsible for the disability determinations 
in many initial claims for disability benefits. However, they will be 
able to ask for advice from State agency medical or psychological 
consultants when they decide they need it. We also plan to review other 
rules to reflect these changes, including our rules about how we decide 
whether a person's impairment(s) medically equals a listing.


Statement of Need:


This regulation will permit us to use 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 continues to consider various options for further redesign 
of the disability claims process.


Anticipated Cost and Benefits:


The 5-year estimates for implementation indicates an incremental 
benefit cost of $2.4 billion for OASDI and SSI combined, and $1.3 
billion for Medicare and Medicaid combined.


Risks:


Not yet established.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            66 FR 5494                                     01/19/01
NPRM Comment Period End                                        03/20/01
Final Action                                                   12/00/02
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


State, Federal


Agency Contact:
Susan Grier
Social Security Administration
Disability Process Redesign Staff
Office of Disability
6401 Security Boulevard
Baltimore, MD 21235-6401
Phone: 410 966-5005

Robert J. Augustine
Social Insurance Specialist
Social Security Administration
6401 Security Boulevard
Baltimore, MD 21235-6401
Phone: 410 965-0020
Related RIN: Merged With 0960-AE73
RIN: 0960-AF44
BILLING CODE 4191-02-S

[[Page 74264]]




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 cooperative Banks 
that are owned by their respective member financial institutions. The 
Banks 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 a regulatory plan pursuant to section 4 of Executive Order 
12866. At this time, the Finance Board does not anticipate taking any 
significant regulatory or deregulatory actions during 2003 that would 
be required to be included in a regulatory plan.
The Finance Board's highest regulatory priorities during 2003 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 develop, based on its analysis of recently-
solicited comments, an appropriate regulatory response to requests that 
a single financial institution be permitted to become a member of more 
than one Bank.
The Finance Board also intends to consider regulations that will:
[sbull] Review the structure of authorized acquired member asset 
            products to determine if Banks have sufficient flexibility 
            in creating new products that will be responsive to member 
            needs;
[sbull] More clearly delineate the responsibilities and the 
            accountability of the board of directors for governance of 
            a Bank, thereby strengthening the role of the boards in the 
            Banks' operations;
[sbull] Streamline the Finance Board's review of new business 
            activities proposed by a Bank to more clearly focus the 
            regulatory review process on ensuring that a new product, 
            service, or activity will not endanger the continued safe 
            and sound operation of the Bank;
[sbull] Streamline the community support requirements to eliminate 
            unnecessary regulatory burden, while preserving the 
            statutory intent of ensuring that members' access to long-
            term advances reflects such factors as their record of 
            performance under the Community Reinvestment Act and their 
            record of lending to first-time homebuyers; and
[sbull] Improve public disclosure by the Banks including addressing the 
            requirements of the Securities Act of 1933 and Securities 
            Exchange Act of 1934, as these Acts are interpreted and 
            applied by the SEC.
BILLING CODE 6725-01-S

[[Page 74265]]




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 2002. The Commission also oversees the financial 
responsibility of passenger vessel operators to indemnify passengers 
and other persons in cases of death or injury, and to indemnify 
passengers for nonperformance of voyages. The Commission has been 
updating its nonperformance coverage requirements to correspond more 
closely with current industry conditions and contemplates proposing 
additional changes in calendar year 2002.
 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 issued 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 certain requirements applicable to vessel-operating common 
carrier agreements 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 74266]]




FEDERAL TRADE COMMISSION (FTC)



I. REGULATORY PRIORITIES
Background
 The Federal Trade Commission (FTC or Commission) is an independent 
agency charged with protecting American consumers from ``unfair methods 
of competition'' and ``unfair or deceptive acts or practices'' in the 
marketplace. The Commission strives to ensure that consumers benefit 
from a vigorously competitive marketplace. The Commission's work is 
rooted in a belief that free markets work -- that competition among 
producers and information in the hands of consumers bring the best 
products at the lowest prices for consumers, spur efficiency and 
innovation, and strengthen 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 thirteen 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.
Regulatory Actions Related to Events of September 11, 2001
 On October 25, 2001, President Bush signed the USA PATRIOT Act of 
2001, Pub. L. 107-56, 115 Stat. 272, which contains provisions that 
have a significant impact on the Telemarketing Sales Rule (TSR). The 
TSR, 16 CFR part 310, which was adopted pursuant to the Telemarketing 
and Consumer Fraud and Abuse Prevention Act of 1994 (Telemarketing 
Act), 15 USC 6101-6108, 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. Sec. 1011 of the USA PATRIOT Act, 
also referred to as the Crimes Against Charitable Americans Act of 
2001, 15 U.S.C. 6101 note, amends the Telemarketing Act to extend the 
coverage of the TSR to charitable fund raising conducted by for-profit 
telemarketers for, or on behalf of, charitable organizations.
 On January 30, 2002, the Commission announced its proposal to amend 
the TSR and published a Notice of Proposed Rulemaking (NPRM). Among 
other things, the proposed Rule would establish a centralized national 
``do not call'' registry, would prohibit telemarketers from receiving 
or sharing a consumer's billing information with anyone else, and would 
prohibit telemarketers from blocking ``Caller ID'' information. In 
addition, as mandated by the USA PATRIOT Act, the Commission's proposal 
adds certain disclosures and other requirements applicable to for-
profit telemarketers who solicit charitable donations. Staff held a 
three-day public workshop from June 5-7, 2002, to discuss these and 
other proposed changes to the Rule. On May 24, 2002, the Commission 
also issued a related NPRM proposing that user fees be imposed on 
telemarketers and their seller or telemarketer clients for access to 
the national ``do not call'' registry in order to establish and 
maintain the registry. See 67 FR 37362 (May 29, 2002). Staff plans to 
forward its recommendations to the Commission by fall 2002.
Ten-Year Review Program
 In 1992, the Commission implemented a program to review its rules and 
guides regularly. The Commission's review program is patterned after 
provisions in the Regulatory Flexibility Act, 5 USC 601 et seq. Under 
the Commission's program, however, rules 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 its continuing 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 55 percent of its 
guides since 1992.
Calendar Year 2002 Reviews and Reviews in Process
 As part of the Commission's ten-year review program, in 2002 the 
Commission continued reviews of seven rules. The Commission also 
commenced the review of one rule regarding Labeling Requirements for 
Alternative Fuels and Alternative Fueled Vehicles, 16 CFR part 309 and 
one industry guide regarding Guides Concerning Use of Endorsements and 
Testimonials in Advertising, 16 CFR part 255.\1\
---------------------------------------------------------------------------
\1\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., 67 FR 9630 (Mar. 4, 2002).
---------------------------------------------------------------------------
 All of the matters currently under review 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, as discussed in greater detail in 
the September 11, 2001

[[Page 74267]]

section above, the Commission announced on January 22, 2002, its 
proposal to amend the Telemarketing Sales Rule (TSR), 16 CFR part 310, 
and published a notice of proposed rulemaking (NPRM). Among other 
things, the proposed Rule would establish a centralized national ``do 
not call'' registry, would prohibit telemarketers from receiving or 
sharing a consumer's billing information with anyone else, and would 
prohibit telemarketers from blocking ``Caller ID'' information. In 
addition, as mandated by Sec. 1011 of the USA PATRIOT Act, also 
referred to as the Crimes Against Charitable Americans Act of 2001, 15 
U.S.C. 6101 note, the Commission's proposal adds certain disclosures 
and other requirements applicable to for-profit telemarketers who 
solicit charitable donations. Staff held a three-day public workshop 
from June 5-7, 2002, to discuss these and other proposed changes to the 
Rule. On May 24, 2002, the Commission also issued a related NPRM 
proposing that user fees be imposed on telemarketers and their seller 
or telemarketer clients for access to the national ``do not call'' 
registry in order to establish and maintain the registry. See 67 Fed. 
Reg. 37362 (May 29, 2002). Staff plans to forward its recommendations 
to the Commission by fall 2002.
 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, 1999, 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, the requirements for a presubscription agreement, and the need 
for obtaining express authorization from consumers before placing 
charges on their telephone bills. Staff anticipates forwarding its 
recommendation to the Commission by early 2003.
 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 by the end of 2002.
 In addition, the Commission's review of the Regulations Under the 
Comprehensive Smokeless Tobacco Health Education Act of 1986 (Smokeless 
Regulations), 16 CFR part 307, is proceeding. Issued to implement the 
requirements of the Comprehensive Smokeless Tobacco Health Education 
Act of 1986, the Smokeless Regulations govern the format and display of 
statutorily mandated health warnings on all packages and advertisements 
for smokeless tobacco. In fiscal year 2000, the Commission undertook 
its periodic review of the Smokeless Regulations to determine whether 
the Regulations continue to effectively meet the goals of the Act and 
to seek information concerning the Regulations' economic impact in 
order to decide whether they should be amended. Staff is currently 
assessing the public comments and anticipates forwarding its 
recommendations to the Commission early next year.
 The review of the R-Value Rule, 16 CFR part 460, is also proceeding. 
As part of the Commission's regulatory review program, the Commission 
published an advance notice of proposed rulemaking (ANPRM) on the R-
Value Rule for home insulation. See 64 FR 48023 (Sept. 1, 1999). Staff 
is currently reviewing the comments and expects to forward its 
recommendation to the Commission regarding proposed substantive 
amendments to the Rule, and anticipates publication of the NPRM 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 by early 2003.
Final Actions
 Since publication of the 2001 Regulatory Plan, the Commission has 
taken final actions on three rulemakings. First, on May 17, 2002, the 
Commission issued a final Financial Information Safeguards Rule, 16 
CFR, part 314, governing the safeguarding of customer records and 
information for the financial institutions that are subject to its 
jurisdiction. Section 501(b) of the Gramm-Leach-Bliley Act, Pub. L. No. 
106-102,\2\ required the Federal Trade Commission to implement and 
enforce appropriate standards for financial institutions subject to the 
agency's jurisdiction to safeguard customers' records and information 
(safeguards standards) by rule. After publishing both a request for 
comments and a notice of proposed rulemaking. See 66 FR 41162 (Aug. 7, 
2001), the Commission considered about forty-five public comments 
before issuing the final Financial Information Safeguards Rule, 16 CFR 
part 314, on May 17, 2002. See 67 FR 36483 (May 23, 2002). As required 
by section 501(b) of Gramm-Leach-Bliley, the standards are intended to 
ensure the security and

[[Page 74268]]

confidentiality of customer records and information; protect against 
any anticipated threats or hazards to the security or integrity of such 
records; and protect against unauthorized access to or use of such 
records or information that could result in substantial harm or 
inconvenience to any customer.
---------------------------------------------------------------------------
\2\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).
---------------------------------------------------------------------------
 Second, on April 17, 2002, the Commission amended the Children's 
Online Privacy Protection (COPPA) Rule, 16 CFR part 312, extending by 
three years (until April 21, 2005) the sliding scale mechanism of 
verifying parental consent by Web sites or online services. See 67 FR 
18818 (Apr. 17, 2002). During October 2001, the Commission had proposed 
a two-year extension of the sliding scale mechanism from April 21, 
2002, until April 21, 2004 because the anticipated progress in 
available technology of verifying such consent had not occurred since 
the initial COPPA Rule became effective April 21, 2000. 66 FR 54963 
(Oct. 31, 2001). The public comments received in response to the 
Commission's October 2001 NPRM indicated that secure electronic 
technology and infomediary services are not yet widely available at a 
reasonable cost and that the sliding scale mechanism to date has been 
an effective method for obtaining parental consent.
 Third, the Commission has also withdrawn its review of a portion of 
the Amplifier Rule, 16 CFR part 432, from the Unified Agenda because 
the Commission does not anticipate any further action in this 
supplemental rulemaking proceeding in the near future. On December 22, 
2000, the Commission issued a final rule clarifying the testing 
procedure for self-powered speakers, and eliminating or modifying 
certain testing and disclosure requirements that had outlived their 
usefulness to consumers. See 65 FR 81232 (Dec. 22, 2000). At the same 
time, the Commission also issued a supplemental notice of proposed 
rulemaking (SNPRM) to seek comment on proposed testing procedures for 
``home theater'' receivers with five or more channels. See 65 FR 80798 
(Dec. 22, 2000). The comment period for the SNPRM ended on March 30, 
2001. On January 15, 2002, the Commission announced that it would keep 
the rulemaking record open but defer action on the proposed 
supplemental rule to allow an industry working group time to establish 
a voluntary consensus standard of measuring the power output of 
multichannel receivers and amplifiers. See 67 FR 1915 (Jan. 15, 2002).
 With respect to Industry Guides, the Commission finished its review 
and rescinded the Guides for the Household Furniture Industry 
(Furniture Guides), 16 CFR part 250. On April 11, 2000, the Commission 
had initiated its regulatory review of the Furniture Guides, which were 
issued on December 21, 1973, and had requested comments about the 
overall costs and benefits and the continuing need for them. See 65 FR 
18933 (Apr. 11, 2000). The Commission received one comment from the 
American Furniture Manufacturers Association (AFMA), which expressed 
concern that the Furniture Guides have little practical use to members 
of the furniture industry due to significant changes in technology and 
terminology since they were first promulgated. In the almost thirty 
years since the Furniture Guides were issued, the Commission has not 
received any complaints relating to practices covered by the Guides. 
Further, within the last ten years, the Commission has not had to 
initiate any enforcement action relating to these Guides. For these 
reasons, the Commission has determined that the Guides are no longer 
necessary. If deceptive practices prove to be a problem in this 
industry in the future, the Commission can deter manufacturers and 
sellers from misleading consumers in the labeling, advertising or sale 
of household furniture products by pursuing enforcement actions under 
the FTC Act on a case-by-case basis.
 The Commission completed its review and retained Guides for the 
Rebuilt, Reconditioned, and Other Used Automobile Parts Industry (Used 
Auto Parts Guides or Guides), 16 CFR part 20, with updated language and 
minor revisions. See 67 FR 9919 (Mar. 5, 2002). 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. During April 1998, the Commission published 
a Federal Register notice seeking comment on the overall costs and 
benefits of the Used Auto Parts Guides and whether there was a 
continuing need for them. See 63 FR 17132 (Apr. 8, 1998). Seven of the 
eight written comments received favored keeping these Guides. In 
retaining the Used Auto Parts Guides, the Commission also updated the 
list of commonly rebuilt used automobile parts contained in section 
20.0 of these Guides and clarified that these Guides apply to 
advertising in electronic format, such as on the Internet. Finally, the 
Commission updated and streamlined certain language in the Used Auto 
Parts Guides to conform to current FTC practice.
The Commission has also completed its review and retained the Guide 
Concerning Fuel Advertising for New Automobiles (Fuel Economy Guide or 
Guide), concluding that consumers will continue to benefit from 
accurate information in the advertising of fuel economy figures for new 
vehicles. See 67 FR 9924 (March 4, 2002). Adopted in 1975 and 
subsequently revised twice, 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, this 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. After considering a variety of 
factors during its review, including eight public comments, the 
Commission has concluded that the Fuel Economy Guide's benefits to 
consumers far outweigh the minimal cost to vehicle manufacturers of 
complying with its provisions.
Calendar Year 2003 Reviews
 On March 4, 2002, the Commission issued a Federal Register notice 
announcing that the agency will commence the review of one rule and two 
guides during calendar year 2003. See 67 FR 9630 (Mar. 4, 2002). The 
review will include the Rules and Regulations Under the Hobby 
Protection Act, 16 CFR part 304; Tire Advertising and Labeling Guides, 
16 CFR part 228; and Statements of General Policy or Interpretations 
Under the Fair Credit Reporting Act, 16 CFR part 600.
Summary
 With regard to both content and process, the FTC's ongoing and 
proposed regulatory actions are compatible with the President's 
priorities. The actions under consideration inform and protect 
consumers and reduce the regulatory burdens on businesses. The 
Commission will continue working toward these goals. The Commission's 
ten-year

[[Page 74269]]

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 Financial Information Safeguards 
Rule, 16 CFR, part 314 (2002) is consistent with the President's 
Statement of Regulatory Philosophy and Principles, Executive Order. 
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 55 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.
BILLING CODE 6750-01-S

[[Page 74270]]




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. Amend regulations implementing the Freedom of Information Act 
            (FOIA); and
2. Finalize rules that set forth procedures for collecting debts owed 
            to the agency.
_______________________________________________________________________



NIGC

                              -----------

                          PROPOSED RULE STAGE

                              -----------




167. FREEDOM OF INFORMATION ACT PROCEDURES (AMENDMENTS)
Priority:


Other Significant


Legal Authority:


5 USC 552


CFR Citation:


25 CFR 517.3; 25 CFR 517.6; 25 CFR 517.8


Legal Deadline:


None


Abstract:


These rules will revise the current regulations to make them consistent 
with the amended Freedom of Information Act (FOIA). The rules will also 
update information such as addresses and copying fees.


Statement of Need:


Amendments to the Freedom of Information Act (FOIA) Procedures are 
necessary to better implement the amended Act.


Summary of Legal Basis:


The Freedom of Information Act (FOIA) requires that each Federal agency 
shall publish procedures by which the public may obtain information. (5 
U.S.C. 552(a)(1)). The Commission relies on this section of FOIA to 
authorize promulgation of this regulation.


Alternatives:


At this time, the only alternative is to continue using the current 
FOIA Procedures.


Anticipated Cost and Benefits:


The potential benefit of this regulatory action is improved compliance 
with FOIA. The anticipated costs of the regulation are unknown at this 
time.


Risks:


There are no known risks to this regulatory action.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           01/00/03
Regulatory Flexibility Analysis Required:


No


Government Levels Affected:


None


Agency Contact:
Gregory Smith
FOIA/PA Officer
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-AA21
_______________________________________________________________________



NIGC

                              -----------

                            FINAL RULE STAGE

                              -----------




168. DEBT COLLECTION
Priority:


Other Significant


Legal Authority:


31 USC 3716; 25 USC 2713(a)(1)


CFR Citation:


25 CFR 580


Legal Deadline:


None


Abstract:


This regulation will establish a process for the assessment, 
notification, and collection of debts owed the National Indian Gaming 
Commission.


Statement of Need:


The Commission has determined that regulations are necessary for the 
assessment, notification, and collection of debts owed the NIGC.


Summary of Legal Basis:


IGRA expressly authorizes the Commission to ``promulgate such 
regulations and guidelines as it deems appropriate to implement the 
provisions of the [Act].'' (25 U.S.C. 2706(b)(10)). The Commission 
relies on this section of the statute to authorize the promulgation of 
standards for collecting debts owed the Commission.


Alternatives:


The Commission has no alternative but to promulgate this debt 
collection procedure for gaming facilities operated on Indian lands.


Anticipated Cost and Benefits:


The potential benefits to this regulatory action are to establish and 
define for the regulated community the procedure by which the 
Commission will enforce the collection debts owed the Commission. This 
regulatory action will provide the Commission with a process for the 
efficient and effective collection of debts.


Risks:


There are no known risks to this regulatory action.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
Interim Final Ru66 FR 58056                                    11/20/01
Interim Final Rule Comment Period End                          01/04/02
Interim Final Ru67 FR 1273 Period Reopened                     01/09/02
Interim Final Rule Comment Period End                          01/14/02
Final Rule                                                     01/00/03
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No

[[Page 74271]]

Government Levels Affected:


Tribal


Agency Contact:
Cynthia S. Omberg
Attorney
National Indian Gaming Commission
Suite 9100
1441 L Street NW.
Washington, DC 20005
Phone: 202 632-7003
Fax: 202 632-7066
Email: [email protected]
RIN: 3141-AA25
BILLING CODE 7565-01-S


